U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS
This repository is under review for potential modification in compliance with Administration directives.

Details

Stereochemistry ACHIRAL
Molecular Formula C24H23FN4O3
Molecular Weight 434.4628
Optical Activity NONE
Defined Stereocenters 0 / 0
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of Olaparib

SMILES

FC1=CC=C(CC2=NNC(=O)C3=C2C=CC=C3)C=C1C(=O)N4CCN(CC4)C(=O)C5CC5

InChI

InChIKey=FDLYAMZZIXQODN-UHFFFAOYSA-N
InChI=1S/C24H23FN4O3/c25-20-8-5-15(14-21-17-3-1-2-4-18(17)22(30)27-26-21)13-19(20)24(32)29-11-9-28(10-12-29)23(31)16-6-7-16/h1-5,8,13,16H,6-7,9-12,14H2,(H,27,30)

HIDE SMILES / InChI
Molecular Formula C24H23FN4O3
Molecular Weight 434.4628
Charge 0
Count
Stereochemistry ACHIRAL
Additional Stereochemistry No
Defined Stereocenters 0 / 0
E/Z Centers 0
Optical Activity NONE

Description
Curator's Comment: Description was created based on several sources, including: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4880823/

Olaparib is an oral inhibitor of poly (ADP-ribose) polymerase enzymes, including PARP1, PARP2, and PARP3 which are involved in normal cellular homeostasis, such as DNA transcription, cell cycle regulation, and DNA repair. Olaparib has shown activity in ovarian and breast tumors with known BRCA mutations and was the first FDA approved drug in this class. Lynparza (olaparib) is indicated for treatment of gBRCA-mutated advanced ovarian cancer. Its use together with other chemotherapy medicines can lead to increased effects on the blood resulting in reduction in the numbers of white blood cells and platelets, and anaemia.

Originator

Approval Year

2014
503
Targets

Targets

Primary TargetPharmacologyConditionPotency
Poly [ADP-ribose] polymerase 1
7
Target ID: P09874
Gene ID: 142.0
Gene Symbol: PARP1
Target Organism: Homo sapiens (Human)
Inhibitor
8504
 1.94 nM [IC50]
Poly [ADP-ribose] polymerase 2
16
Target ID: Q9UGN5
Gene ID: 10038.0
Gene Symbol: PARP2
Target Organism: Homo sapiens (Human)
Inhibitor
8504
Poly [ADP-ribose] polymerase 3
4
Target ID: Q9Y6F1
Gene ID: 10039.0
Gene Symbol: PARP3
Target Organism: Homo sapiens (Human)
Inhibitor
8504
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
Approved
8583
LYNPARZA

Approved Use

Monotherapy in patients with deleterious or suspected deleterious germline BRCA mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

Launch Date

2014
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
6.875 ug/mL
Clinical Trial
https://clinicaltrials.gov/ct2/show/NCT02430311
300 mg single, oral
dose: 300 mg
route of administration: oral
experiment type: single
co-administered:
OLAPARIB plasma
Homo sapiens
population: unhealthy
age:
sex:
food status:
6.88 μg/mL
EXPERIMENT
https://www.ncbi.nlm.nih.gov/pubmed/30887180
300 mg single, oral
dose: 300 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
OLAPARIB blood
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
2.97 μg/mL
EXPERIMENT
https://www.ncbi.nlm.nih.gov/pubmed/30887180
100 mg 2 times / day multiple, oral
dose: 100 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
OLAPARIB blood
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
8.27 μg/mL
EXPERIMENT
https://www.ncbi.nlm.nih.gov/pubmed/30887180
300 mg 2 times / day steady-state, oral
dose: 300 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
OLAPARIB blood
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
3.75 μg/mL
EXPERIMENT
https://www.ncbi.nlm.nih.gov/pubmed/30887180
100 mg 2 times / day steady-state, oral
dose: 100 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
OLAPARIB blood
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
43.95 ug*h/mL
Clinical Trial
https://clinicaltrials.gov/ct2/show/NCT02430311
300 mg 2 times / day single, oral
dose: 300 mg
route of administration: oral
experiment type: single
co-administered:
OLAPARIB plasma
Homo sapiens
population: unhealthy
age:
sex:
food status:
43.91 ug*h/mL
Clinical Trial
https://clinicaltrials.gov/ct2/show/NCT02430311
300 mg 2 times / day single, oral
dose: 300 mg
route of administration: oral
experiment type: single
co-administered:
OLAPARIB plasma
Homo sapiens
population: unhealthy
age:
sex:
food status:
31.68 ug*h/mL
Clinical Trial
https://clinicaltrials.gov/ct2/show/NCT02430311
300 mg single, oral
dose: 300 mg
route of administration: oral
experiment type: single
co-administered:
OLAPARIB plasma
Homo sapiens
population: unhealthy
age:
sex:
food status:
36.37 ug*h/mL
Clinical Trial
https://clinicaltrials.gov/ct2/show/NCT02430311
300 mg single, oral
dose: 300 mg
route of administration: oral
experiment type: single
co-administered:
OLAPARIB plasma
Homo sapiens
population: unhealthy
age:
sex:
food status:
36.53 ug*h/mL
Clinical Trial
https://clinicaltrials.gov/ct2/show/NCT02430311
300 mg single, oral
dose: 300 mg
route of administration: oral
experiment type: single
co-administered:
OLAPARIB plasma
Homo sapiens
population: unhealthy
age:
sex:
food status:
31.7 μg × h/mL
EXPERIMENT
https://www.ncbi.nlm.nih.gov/pubmed/30887180
300 mg single, oral
dose: 300 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
OLAPARIB blood
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
10.9 μg × h/mL
EXPERIMENT
https://www.ncbi.nlm.nih.gov/pubmed/30887180
100 mg 2 times / day multiple, oral
dose: 100 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
OLAPARIB blood
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
44 μg × h/mL
EXPERIMENT
https://www.ncbi.nlm.nih.gov/pubmed/30887180
300 mg 2 times / day steady-state, oral
dose: 300 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
OLAPARIB blood
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
16.7 μg × h/mL
EXPERIMENT
https://www.ncbi.nlm.nih.gov/pubmed/30887180
100 mg 2 times / day steady-state, oral
dose: 100 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
OLAPARIB blood
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
6.52 h
EXPERIMENT
https://www.ncbi.nlm.nih.gov/pubmed/30887180
300 mg single, oral
dose: 300 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
OLAPARIB blood
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
7.17 h
EXPERIMENT
https://www.ncbi.nlm.nih.gov/pubmed/30887180
100 mg 2 times / day multiple, oral
dose: 100 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
OLAPARIB blood
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
Funbound

Funbound

ValueDoseCo-administeredAnalytePopulation
18%
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208558s001lbl.pdf
OLAPARIB plasma
Homo sapiens
population: UNKNOWN
age: UNKNOWN
sex: UNKNOWN
food status: UNKNOWN
Doses

Doses

DosePopulationAdverse events​
600 mg 2 times / day steady, oral
Highest studied dose
Dose: 600 mg, 2 times / day
Route: oral
Route: steady
Dose: 600 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206162Orig1s000ClinPharmR.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206162Orig1s000ClinPharmR.pdf
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206162Orig1s000ClinPharmR.pdf
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
Disc. AE: Anemia, Anemia...
AEs leading to
discontinuation/dose reduction:
Anemia (grade 1-2, 24%)
Anemia (grade 3-4, 20%)
Neutropenia (9%)
Nausea (grade 1-2, 73%)
Nausea (grade 3-4, 3%)
Vomiting (grade 1-2, 34%)
Vomiting (grade 3-4, 3%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Disc. AE: Fatigue, Fatigue...
Other AEs: Diarrhea, Diarrhea...
AEs leading to
discontinuation/dose reduction:
Fatigue (grade 1-2, 62%)
Fatigue (grade 3-4, 4%)
Other AEs:
Diarrhea (grade 1-2, 31%)
Diarrhea (grade 3-4, 2%)
Abscess oral (grade 1-2, 19%)
Aphthous ulcer (grade 1-2, 19%)
Gingival abscess (grade 1-2, 19%)
Gingival disorder (grade 1-2, 19%)
Gingival pain (grade 1-2, 19%)
Gingivitis (grade 1-2, 19%)
Mouth ulceration (grade 1-2, 19%)
Mucosal infection (grade 1-2, 19%)
Mucosal inflammation (grade 1-2, 19%)
Oral candidiasis (grade 1-2, 19%)
Oral discomfort (grade 1-2, 19%)
Oral herpes (grade 1-2, 19%)
Oral infection (grade 1-2, 19%)
Oral mucosal erythema (grade 1-2, 19%)
Oral pain (grade 1-2, 19%)
Oropharyngeal discomfort (grade 1-2, 19%)
Oropharyngeal pain (grade 1-2, 19%)
Abscess oral (grade 3-4, 1%)
Aphthous ulcer (grade 3-4, 1%)
Gingival abscess (grade 3-4, 1%)
Gingival disorder (grade 3-4, 1%)
Gingival pain (grade 3-4, 1%)
Gingivitis (grade 3-4, 1%)
Mouth ulceration (grade 3-4, 1%)
Mucosal infection (grade 3-4, 1%)
Mucosal inflammation (grade 3-4, 1%)
Oral candidiasis (grade 3-4, 1%)
Oral discomfort (grade 3-4, 1%)
Oral herpes (grade 3-4, 1%)
Oral infection (grade 3-4, 1%)
Oral mucosal erythema (grade 3-4, 1%)
Oral pain (grade 3-4, 1%)
Oropharyngeal discomfort (grade 3-4, 1%)
Oropharyngeal pain (grade 3-4, 1%)
Nasopharyngitis (grade 1-4, 36%)
Sinusitis (grade 1-4, 36%)
Rhinitis (grade 1-4, 36%)
Influenza (grade 1-4, 36%)
Decreased appetite (grade 1-4, 22%)
Arthralgia (grade 1-4, 30%)
Myalgia (grade 1-4, 30%)
Dysgeusia (grade 1-4, 27%)
Headache (grade 1-2, 25%)
Headache (grade 3-4, 1%)
Rash (<20%)
Cough (<20%)
Dyspepsia (<20%)
Leukopenia (<20%)
Hypomagnesemia (<20%)
Dizziness (<20%)
Thrombocytopenia (<20%)
Creatinine increased (<20%)
Lymphopenia (<20%)
Edema (<20%)
Mean corpuscular volume increased (grade 1-4, 89%)
Decreased hemoglobin (grade 1-2, 66%)
Decreased hemoglobin (grade 3-4, 17%)
Leukocyte count decreased (grade 1-2, 64%)
Leukocyte count decreased (grade 3-4, 5%)
Lymphocyte count low (grade 1-2, 56%)
Lymphocyte count low (grade 3-4, 11%)
Absolute neutrophil count decreased (grade 1-2, 44%)
Absolute neutrophil count decreased (grade 3-4, 7%)
Creatinine serum increased (grade 1-4, 44%)
Platelets decreased (grade 1-2, 40%)
Platelets decreased (grade 3-4, 2%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
Disc. AE: Thrombocytopenia, Myelodysplastic syndrome...
AEs leading to
discontinuation/dose reduction:
Thrombocytopenia (9 patients)
Myelodysplastic syndrome (2 patients)
Acute myeloid leukemia (2 patients)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
Disc. AE: Nausea, Nausea...
AEs leading to
discontinuation/dose reduction:
Nausea (grade 1-2, 61%)
Nausea (grade 3-4, 3%)
Vomiting (grade 1-2, 39%)
Vomiting (grade 3-4, 4%)
Fatigue (grade 1-2, 58%)
Fatigue (grade 3-4, 8%)
Anemia (grade 1-2, 75%)
Anemia (grade 3-4, 15%)
Thrombocytopenia (grade 1-2, 27%)
Thrombocytopenia (grade 3-4, 3%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Disc. AE: Myelodysplastic syndrome, Acute myeloid leukemia...
AEs leading to
discontinuation/dose reduction:
Myelodysplastic syndrome (grade 5, <1%)
Acute myeloid leukemia (grade 5, <1%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Disc. AE: Pneumonitis...
AEs leading to
discontinuation/dose reduction:
Pneumonitis (grade 5, <1%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Other AEs: Anemia, Anemia...
Other AEs:
Anemia (grade 1-2, 16%)
Anemia (grade 3-4, 18%)
Abdominal discomfort (grade 1-2, 35%)
Abdominal discomfort (grade 3-4, 8%)
Decreased appetite (grade 1-2, 21%)
Decreased appetite (grade 3-4, 1%)
Diarrhea (grade 1-2, 30%)
Diarrhea (grade 3-4, 1%)
Dyspepsia (grade 1-4, 25%)
Asthenia (grade 1-2, 58%)
Asthenia (grade 3-4, 8%)
Nasopharyngitis (grade 1-4, 26%)
Arthralgia (grade 1-4, 21%)
Musculoskeletal pain (grade 1-4, 21%)
Myalgia (grade 1-4, 22%)
Neutropenia (grade 1-2, 18%)
Neutropenia (grade 3-4, 7%)
Lymphopenia (grade 1-2, 39%)
Lymphopenia (grade 3-4, 17%)
Mean corpuscular volume increased (grade 1-4, 57%)
Creatinine increased (grade 1-2, 28%)
Creatinine increased (grade 3-4, 2%)
Cough (10-20)
Constipation (10-20)
Dysgeusia (10-20)
Peripheral edema (10-20)
Back pain (10-20)
Dizziness (10-20)
Headache (10-20)
Urinary tract infection (10-20)
Dyspnea (10-20)
Rash (10-20)
Leukopenia (1-10)
Stomatitis (1-10)
Peripheral neuropathy (1-10)
Pyrexia (1-10)
Hypomagnesemia (1-10)
Hyperglycemia (1-10)
Anxiety (1-10)
Depression (1-10)
Insomnia (1-10)
Dysuria (1-10)
Urinary incontinence (1-10)
Vulvovaginal disorder (1-10)
Dry skin (1-10)
Eczema (1-10)
Pruritis (1-10)
Hypertension (1-10)
Venous thrombosis (1-10)
Hot flush (1-10)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
AEs

AEs

AESignificanceDosePopulation
Neutropenia 9%
Disc. AE
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
Anemia grade 1-2, 24%
Disc. AE
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
Vomiting grade 1-2, 34%
Disc. AE
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
Nausea grade 1-2, 73%
Disc. AE
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
Anemia grade 3-4, 20%
Disc. AE
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
Nausea grade 3-4, 3%
Disc. AE
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
Vomiting grade 3-4, 3%
Disc. AE
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
Cough <20%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Creatinine increased <20%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Dizziness <20%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Dyspepsia <20%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Edema <20%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Hypomagnesemia <20%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Leukopenia <20%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Lymphopenia <20%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Rash <20%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Thrombocytopenia <20%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Abscess oral grade 1-2, 19%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Aphthous ulcer grade 1-2, 19%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Gingival abscess grade 1-2, 19%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Gingival disorder grade 1-2, 19%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Gingival pain grade 1-2, 19%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Gingivitis grade 1-2, 19%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Mouth ulceration grade 1-2, 19%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Mucosal infection grade 1-2, 19%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Mucosal inflammation grade 1-2, 19%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Oral candidiasis grade 1-2, 19%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Oral discomfort grade 1-2, 19%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Oral herpes grade 1-2, 19%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Oral infection grade 1-2, 19%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Oral mucosal erythema grade 1-2, 19%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Oral pain grade 1-2, 19%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Oropharyngeal discomfort grade 1-2, 19%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Oropharyngeal pain grade 1-2, 19%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Headache grade 1-2, 25%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Diarrhea grade 1-2, 31%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Platelets decreased grade 1-2, 40%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Absolute neutrophil count decreased grade 1-2, 44%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Lymphocyte count low grade 1-2, 56%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Fatigue grade 1-2, 62%
Disc. AE
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Leukocyte count decreased grade 1-2, 64%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Decreased hemoglobin grade 1-2, 66%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Decreased appetite grade 1-4, 22%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Dysgeusia grade 1-4, 27%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Arthralgia grade 1-4, 30%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Myalgia grade 1-4, 30%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Influenza grade 1-4, 36%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Nasopharyngitis grade 1-4, 36%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Rhinitis grade 1-4, 36%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Sinusitis grade 1-4, 36%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Creatinine serum increased grade 1-4, 44%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Mean corpuscular volume increased grade 1-4, 89%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Abscess oral grade 3-4, 1%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Aphthous ulcer grade 3-4, 1%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Gingival abscess grade 3-4, 1%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Gingival disorder grade 3-4, 1%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Gingival pain grade 3-4, 1%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Gingivitis grade 3-4, 1%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Headache grade 3-4, 1%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Mouth ulceration grade 3-4, 1%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Mucosal infection grade 3-4, 1%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Mucosal inflammation grade 3-4, 1%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Oral candidiasis grade 3-4, 1%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Oral discomfort grade 3-4, 1%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Oral herpes grade 3-4, 1%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Oral infection grade 3-4, 1%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Oral mucosal erythema grade 3-4, 1%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Oral pain grade 3-4, 1%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Oropharyngeal discomfort grade 3-4, 1%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Oropharyngeal pain grade 3-4, 1%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Lymphocyte count low grade 3-4, 11%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Decreased hemoglobin grade 3-4, 17%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Diarrhea grade 3-4, 2%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Platelets decreased grade 3-4, 2%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Fatigue grade 3-4, 4%
Disc. AE
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Leukocyte count decreased grade 3-4, 5%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Absolute neutrophil count decreased grade 3-4, 7%
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf
Acute myeloid leukemia 2 patients
Disc. AE
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
Myelodysplastic syndrome 2 patients
Disc. AE
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
Thrombocytopenia 9 patients
Disc. AE
300 mg 2 times / day steady, oral
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
Thrombocytopenia grade 1-2, 27%
Disc. AE
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
Vomiting grade 1-2, 39%
Disc. AE
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
Fatigue grade 1-2, 58%
Disc. AE
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
Nausea grade 1-2, 61%
Disc. AE
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
Anemia grade 1-2, 75%
Disc. AE
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
Anemia grade 3-4, 15%
Disc. AE
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
Nausea grade 3-4, 3%
Disc. AE
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
Thrombocytopenia grade 3-4, 3%
Disc. AE
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
Vomiting grade 3-4, 4%
Disc. AE
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
Fatigue grade 3-4, 8%
Disc. AE
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558Orig1s000MultidisciplineR.pdf
Acute myeloid leukemia grade 5, <1%
Disc. AE
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Myelodysplastic syndrome grade 5, <1%
Disc. AE
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Pneumonitis grade 5, <1%
Disc. AE
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Anxiety 1-10
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Depression 1-10
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Dry skin 1-10
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Dysuria 1-10
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Eczema 1-10
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Hot flush 1-10
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Hyperglycemia 1-10
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Hypertension 1-10
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Hypomagnesemia 1-10
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Insomnia 1-10
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Leukopenia 1-10
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Peripheral neuropathy 1-10
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Pruritis 1-10
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Pyrexia 1-10
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Stomatitis 1-10
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Urinary incontinence 1-10
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Venous thrombosis 1-10
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Vulvovaginal disorder 1-10
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Back pain 10-20
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Constipation 10-20
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Cough 10-20
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Dizziness 10-20
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Dysgeusia 10-20
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Dyspnea 10-20
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Headache 10-20
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Peripheral edema 10-20
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Rash 10-20
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Urinary tract infection 10-20
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Anemia grade 1-2, 16%
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Neutropenia grade 1-2, 18%
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Decreased appetite grade 1-2, 21%
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Creatinine increased grade 1-2, 28%
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Diarrhea grade 1-2, 30%
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Abdominal discomfort grade 1-2, 35%
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Lymphopenia grade 1-2, 39%
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Asthenia grade 1-2, 58%
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Arthralgia grade 1-4, 21%
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Musculoskeletal pain grade 1-4, 21%
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Myalgia grade 1-4, 22%
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Dyspepsia grade 1-4, 25%
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Nasopharyngitis grade 1-4, 26%
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Mean corpuscular volume increased grade 1-4, 57%
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Decreased appetite grade 3-4, 1%
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Diarrhea grade 3-4, 1%
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Lymphopenia grade 3-4, 17%
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Anemia grade 3-4, 18%
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Creatinine increased grade 3-4, 2%
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Neutropenia grade 3-4, 7%
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Abdominal discomfort grade 3-4, 8%
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Asthenia grade 3-4, 8%
400 mg 2 times / day steady, oral
Recommended|MTD
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
unhealthy
Health Status: unhealthy
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Overview

Overview

CYP3A4CYP2C9CYP2D6hERG
inducer
1087
inducer
440

inhibitor
2438
inhibitor
2507
inhibitor
2217

OverviewOther

Other InhibitorOther SubstrateOther Inducer
OAT
4

OCT1
620

OCT2
779

OAT3
747

MATE1
415

MATE2
267

OATP1B1
1079

MRP2
499

CYP1A2
2153

CYP2A6
879

CYP2B6
926

CYP2C8
1057

CYP2C19
2057

CYP2E1
1060

CYP3A
227

BCRP
910

P-gp
1741
CYP3A
220

CYP2A6
626

CYP1A1
389

P-gp
2052

BCRP
697
CYP2B6
669

CYP1A2
832

CYP2C19
329

CYP3A
142
Drug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
CYP1A2
2333
 no [Inhibition >100 uM]
CYP2A6
911
 no [Inhibition >100 uM]
CYP2B6
1160
 no [Inhibition >100 uM]
CYP2C19
2141
 no [Inhibition >100 uM]
CYP2C8
1117
 no [Inhibition >100 uM]
CYP2C9
2497
 no [Inhibition >100 uM]
CYP2D6
2546
 no [Inhibition >100 uM]
CYP2E1
1146
 no [Inhibition >100 uM]
CYP1A2
2333
 no
CYP2C19
2141
 no
CYP2C9
2497
 no
CYP3A
317
 no
P-gp
1932
 no
OAT3
749
 yes [IC50 18.4 uM]
OCT2
782
 yes [IC50 19.9 uM]
OATP1B1
1095
 yes [IC50 20.3 uM]
OCT1
656
 yes [IC50 37.9 uM]
MATE2
267
 yes [IC50 47.1 uM]
MATE1
416
 yes [IC50 5.5 uM]
CYP3A
317
 yes [Inhibition 100 uM]
BCRP
985
 yes
CYP2B6
1160
 yes
CYP3A4
2633
 yes
MRP2
625
 yes
OAT
4
 yes
Drug as victim

Drug as victim

TargetModalityActivityMetaboliteClinical evidence
BCRP
697
 no
CYP1A1
389
 yes
CYP2A6
626
 yes
P-gp
2052
 yes
CYP3A
220
 yes
yes (co-administration study)
Comment: Itraconazole (strong CYP3A inhibitor) increased the AUC of olaparib by 2.7-fold and PBPK modeling predicted that fluconazole (moderate CYP3A inhibitor) would likely increase olaparib AUC by 2-fold.
Page: -
Tox targets

Tox targets

TargetModalityActivityMetaboliteClinical evidence
hERG
2263
Sourcing

Sourcing

Vendor/AggregatorIDURL
ChEBI
CHEBI:83766
https://www.ebi.ac.uk/chebi/searchId.do?chebiId=CHEBI:83766
ChemicalBook
CB02473811
https://www.chemicalbook.com/ChemicalProductProperty_EN_CB02473811
ChemicalBook
CB02756176
https://www.chemicalbook.com/ChemicalProductProperty_EN_CB02756176
eMolecules
31526131
https://www.emolecules.com/cgi-bin/more?vid=31526131
MolPort
MolPort-009-679-395
https://www.molport.com/shop/molecule-link/MolPort-009-679-395
Selleck Chemicals
AZD2281(Olaparib)
http://www.selleckchem.com/products/AZD2281(Olaparib).html
ZINC
ZINC000040430143
http://zinc15.docking.org/substances/ZINC000040430143
PubMed

PubMed

TitleDatePubMed
Enhanced radiosensitization of human glioma cells by combining inhibition of poly(ADP-ribose) polymerase with inhibition of heat shock protein 90.
2009 Aug
Triple-negative breast cancer: novel therapies and new directions.
2009 Aug 20
Targeting the molecular defect in BRCA-deficient tumors for cancer therapy.
2009 Aug 4
Converting cancer mutations into therapeutic opportunities.
2009 Sep
Prevalence and predictors of loss of wild type BRCA1 in estrogen receptor positive and negative BRCA1-associated breast cancers.
2010
Chemotherapy resistance in metastatic breast cancer: the evolving role of ixabepilone.
2010
Targeted therapies in epithelial ovarian cancer.
2010
A current review of targeted therapeutics for ovarian cancer.
2010
PARP inhibitors in BRCA1/BRCA2 germline mutation carriers with ovarian and breast cancer.
2010 Feb 11
A high-throughput pharmaceutical screen identifies compounds with specific toxicity against BRCA2-deficient tumors.
2010 Jan 1
Society for biomolecular sciences - 16th annual conference & exhibition - advancing the science of drug discovery.
2010 Jun
Poly(adp-ribose) polymerase inhibitors: a novel drug class with a promising future.
2010 Mar-Apr
New developments in treatment of ovarian carcinoma: focus on trabectedin.
2010 Oct 1
Role for the mammalian Swi5-Sfr1 complex in DNA strand break repair through homologous recombination.
2010 Oct 14
Treatment options for patients with triple-negative breast cancer.
2010 Oct 27
Favorable response to doxorubicin combination chemotherapy does not yield good clinical outcome in patients with metastatic breast cancer with triple-negative phenotype.
2010 Oct 5
Patents

Patents

07692006
3
08183369
3
08247416
3
20080146575
3
20080200469
3

Sample Use Guides

In Vivo Use Guide
400 mg (eight 50 mg capsules) taken twice daily, for a total daily dose of 800 mg. Continue treatment until disease progression or unacceptable toxicity.
Route of Administration: Oral
In Vitro Use Guide
30-100 nM in SW620 cells
Substance Class Chemical
Created
by admin
on Mon Mar 31 18:03:40 GMT 2025
Edited
by admin
on Mon Mar 31 18:03:40 GMT 2025
Record UNII
WOH1JD9AR8
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
Olaparib
DASH   INN   MART.   MI   USAN   VANDF   WHO-DD  
USAN   INN  
Official Name English
AZ-2281
Preferred Name English
Olaparib [WHO-DD]
Common Name English
AZD2281
Code English
KEYLYNK-010 COMPONENT OLAPARIB
Code English
OLAPARIB [USAN]
Common Name English
OLAPARIB [ORANGE BOOK]
Common Name English
NSC-747856
Code English
OLAPARIB [JAN]
Common Name English
AZ2281
Code English
OLAPARIB [VANDF]
Common Name English
KU-0059436
Code English
olaparib [INN]
Common Name English
1(2H)-Phthalazinone, 4-[[3-[[4-(cyclopropylcarbonyl)-1-piperazinyl]carbonyl]-4-fluorophenyl]methyl]-
Systematic Name English
PIPERAZINE, 1-(CYCLOPROPYLCARBONYL)-4-(5-((3,4-DIHYDRO-4-OXO-1-PHTHALAZINYL)METHYL)-2-FLUOROBENZOYL)-
Systematic Name English
LYNPARZA
Brand Name English
4-[(3-{[4-(Cyclopropylcarbonyl)piperazin-1-yl]carbonyl}-4-fluorophenyl)methyl]phthalazin-1(2H)-one
Systematic Name English
AZD-2281
Code English
OLAPARIB [MI]
Common Name English
KU-59436
Code English
OLAPARIB [MART.]
Common Name English
Classification Tree Code System Code
NDF-RT N0000191623
Created by admin on Mon Mar 31 18:03:40 GMT 2025 , Edited by admin on Mon Mar 31 18:03:40 GMT 2025
EMA ASSESSMENT REPORTS LYNPARZA (AUTHORIZED: OVARIAN NEOPLASMS)
Created by admin on Mon Mar 31 18:03:40 GMT 2025 , Edited by admin on Mon Mar 31 18:03:40 GMT 2025
FDA ORPHAN DRUG 419013
Created by admin on Mon Mar 31 18:03:40 GMT 2025 , Edited by admin on Mon Mar 31 18:03:40 GMT 2025
FDA ORPHAN DRUG 417613
Created by admin on Mon Mar 31 18:03:40 GMT 2025 , Edited by admin on Mon Mar 31 18:03:40 GMT 2025
EU-Orphan Drug EU/3/07/501
Created by admin on Mon Mar 31 18:03:40 GMT 2025 , Edited by admin on Mon Mar 31 18:03:40 GMT 2025
FDA ORPHAN DRUG 409213
Created by admin on Mon Mar 31 18:03:40 GMT 2025 , Edited by admin on Mon Mar 31 18:03:40 GMT 2025
WHO-ATC L01XX46
Created by admin on Mon Mar 31 18:03:40 GMT 2025 , Edited by admin on Mon Mar 31 18:03:40 GMT 2025
FDA ORPHAN DRUG 655318
Created by admin on Mon Mar 31 18:03:40 GMT 2025 , Edited by admin on Mon Mar 31 18:03:40 GMT 2025
NCI_THESAURUS C62554
Created by admin on Mon Mar 31 18:03:40 GMT 2025 , Edited by admin on Mon Mar 31 18:03:40 GMT 2025
Code System Code Type Description
DAILYMED
WOH1JD9AR8
Created by admin on Mon Mar 31 18:03:40 GMT 2025 , Edited by admin on Mon Mar 31 18:03:40 GMT 2025
PRIMARY
EVMPD
SUB32234
Created by admin on Mon Mar 31 18:03:40 GMT 2025 , Edited by admin on Mon Mar 31 18:03:40 GMT 2025
PRIMARY
SMS_ID
100000124466
Created by admin on Mon Mar 31 18:03:40 GMT 2025 , Edited by admin on Mon Mar 31 18:03:40 GMT 2025
PRIMARY
MERCK INDEX
m8185
Created by admin on Mon Mar 31 18:03:40 GMT 2025 , Edited by admin on Mon Mar 31 18:03:40 GMT 2025
PRIMARY Merck Index
ChEMBL
CHEMBL521686
Created by admin on Mon Mar 31 18:03:40 GMT 2025 , Edited by admin on Mon Mar 31 18:03:40 GMT 2025
PRIMARY
DRUG CENTRAL
4907
Created by admin on Mon Mar 31 18:03:40 GMT 2025 , Edited by admin on Mon Mar 31 18:03:40 GMT 2025
PRIMARY
NCI_THESAURUS
C71721
Created by admin on Mon Mar 31 18:03:40 GMT 2025 , Edited by admin on Mon Mar 31 18:03:40 GMT 2025
PRIMARY
NSC
747856
Created by admin on Mon Mar 31 18:03:40 GMT 2025 , Edited by admin on Mon Mar 31 18:03:40 GMT 2025
PRIMARY
INN
8685
Created by admin on Mon Mar 31 18:03:40 GMT 2025 , Edited by admin on Mon Mar 31 18:03:40 GMT 2025
PRIMARY
RXCUI
1597582
Created by admin on Mon Mar 31 18:03:40 GMT 2025 , Edited by admin on Mon Mar 31 18:03:40 GMT 2025
PRIMARY RxNorm
IUPHAR
7519
Created by admin on Mon Mar 31 18:03:40 GMT 2025 , Edited by admin on Mon Mar 31 18:03:40 GMT 2025
PRIMARY
FDA UNII
WOH1JD9AR8
Created by admin on Mon Mar 31 18:03:40 GMT 2025 , Edited by admin on Mon Mar 31 18:03:40 GMT 2025
PRIMARY
CAS
763113-22-0
Created by admin on Mon Mar 31 18:03:40 GMT 2025 , Edited by admin on Mon Mar 31 18:03:40 GMT 2025
PRIMARY
PUBCHEM
23725625
Created by admin on Mon Mar 31 18:03:40 GMT 2025 , Edited by admin on Mon Mar 31 18:03:40 GMT 2025
PRIMARY
DRUG BANK
DB09074
Created by admin on Mon Mar 31 18:03:40 GMT 2025 , Edited by admin on Mon Mar 31 18:03:40 GMT 2025
PRIMARY
MESH
C531550
Created by admin on Mon Mar 31 18:03:40 GMT 2025 , Edited by admin on Mon Mar 31 18:03:40 GMT 2025
PRIMARY
CHEBI
83766
Created by admin on Mon Mar 31 18:03:40 GMT 2025 , Edited by admin on Mon Mar 31 18:03:40 GMT 2025
PRIMARY
LACTMED
Olaparib
Created by admin on Mon Mar 31 18:03:40 GMT 2025 , Edited by admin on Mon Mar 31 18:03:40 GMT 2025
PRIMARY
WIKIPEDIA
OLAPARIB
Created by admin on Mon Mar 31 18:03:40 GMT 2025 , Edited by admin on Mon Mar 31 18:03:40 GMT 2025
PRIMARY
EPA CompTox
DTXSID60917988
Created by admin on Mon Mar 31 18:03:40 GMT 2025 , Edited by admin on Mon Mar 31 18:03:40 GMT 2025
PRIMARY
NDF-RT
N0000191622
Created by admin on Mon Mar 31 18:03:40 GMT 2025 , Edited by admin on Mon Mar 31 18:03:40 GMT 2025
PRIMARY Poly(ADP-Ribose) Polymerase Inhibitors [MoA]
USAN
BC-28
Created by admin on Mon Mar 31 18:03:40 GMT 2025 , Edited by admin on Mon Mar 31 18:03:40 GMT 2025
PRIMARY
Related Record Type Details
Structure of Olaparib monohydrate
SOLVATE->ANHYDROUS
CYTOCHROME P450 3A4
METABOLIC ENZYME -> SUBSTRATE
MAJOR
MULTIDRUG RESISTANCE PROTEIN 1
TRANSPORTER -> SUBSTRATE
Structure of Olaparib
EXCRETED UNCHANGED
FECAL
MATE-2
TRANSPORTER -> INHIBITOR
INHIBITOR
IC50
ATP-BINDING CASSETTE SUB-FAMILY G MEMBER 2
TRANSPORTER -> INHIBITOR
The clinical relevance of these findings is unknown.
PLASMA PROTEIN FRACTION (HUMAN)
BINDER->LIGAND
BINDING
Structure of Olaparib monohydrate
SALT/SOLVATE -> PARENT
MULTIDRUG RESISTANCE PROTEIN 1
TRANSPORTER -> INHIBITOR
INHIBITOR
IC50
OAT-3
TRANSPORTER -> INHIBITOR
INHIBITOR
IC50
OATP1B1
TRANSPORTER -> INHIBITOR
INHIBITOR
IC50
Structure of Olaparib
EXCRETED UNCHANGED
URINE
OCT-2
TRANSPORTER -> INHIBITOR
INHIBITOR
IC50
CYTOCHROME P450 3A4
METABOLIC ENZYME -> INHIBITOR
Inhibitor at higher concentrations than are clinically achieved.
MINOR
OCT-1
TRANSPORTER -> INHIBITOR
INHIBITOR
IC50
Structure of Olaparib hemi-2-propanol
SOLVATE->ANHYDROUS
POLY (ADP-RIBOSE) POLYMERASE 1
TARGET -> INHIBITOR
MULTIDRUG AND TOXIN EXTRUSION PROTEIN 1
TRANSPORTER -> INHIBITOR
INHIBITOR
IC50
Structure of Olaparib hemi-2-propanol
SALT/SOLVATE -> PARENT
Related Record Type Details
Structure of Olaparib
ACTIVE MOIETY
Name Property Type Amount Referenced Substance Defining Parameters References
Volume of Distribution PHARMACOKINETIC
Tmax PHARMACOKINETIC
Biological Half-life PHARMACOKINETIC
NIH
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