Details
Stereochemistry | RACEMIC |
Molecular Formula | C24H28F3N3O3 |
Molecular Weight | 463.4926 |
Optical Activity | ( + / - ) |
Defined Stereocenters | 0 / 1 |
E/Z Centers | 0 |
Charge | 0 |
SHOW SMILES / InChI
SMILES
COC1=NC2=C(C(C)=C1)C(OC3=CC=CC(=C3)C(F)(F)F)=C(OC)C=C2NC(C)CCCN
InChI
InChIKey=LBHLFPGPEGDCJG-UHFFFAOYSA-N
InChI=1S/C24H28F3N3O3/c1-14-11-20(32-4)30-22-18(29-15(2)7-6-10-28)13-19(31-3)23(21(14)22)33-17-9-5-8-16(12-17)24(25,26)27/h5,8-9,11-13,15,29H,6-7,10,28H2,1-4H3
Tafenoquine is anti-malaria drug originated in Walter reed army institute of research and developed by GSK and 60 Degrees Pharmaceuticals. In 2018 United States Food and Drug Administration (FDA) approved single dose tafenoquine for the radical cure (prevention of relapse) of Plasmodium vivax malaria.
Tafenoquine, an 8-aminoquinoline antimalarial, is active against all the stages of Plasmodium species that include the hypnozoite (dormant stage) in the liver. Studies in vitro with the erythrocytic forms of Plasmodium falciparum suggest that tafenoquine may exert its effect by inhibiting hematin polymerization and inducing apoptotic like death of the parasite. In addition to its effect on the parasite, tafenoquine causes red blood cell shrinkage in vitro. Tafenoquine is active against pre-erythrocytic (liver) and erythrocytic (asexual) forms as well as gametocytes of Plasmodium species that include P. falciparum and P. vivax. The activity of tafenoquine against the pre-erythrocytic liver stages of the parasite, prevents the development of the erythrocytic forms of the parasite.
CNS Activity
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210607Orig1s000MultidisciplineR.pdf
Curator's Comment: Drug related radioactivity in the brain indicated minimal penetration of the blood brain barrier.
Approval Year
Targets
Primary Target | Pharmacology | Condition | Potency |
---|---|---|---|
Target ID: map00190 Sources: https://www.ncbi.nlm.nih.gov/pubmed/20837758 |
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Target ID: CHEMBL612653 Sources: https://www.ncbi.nlm.nih.gov/pubmed/21141892 |
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Target ID: CHEMBL364 Sources: https://www.ncbi.nlm.nih.gov/pubmed/25650255 |
217.0 nM [IC50] |
Conditions
Condition | Modality | Targets | Highest Phase | Product |
---|---|---|---|---|
Curative | ARAKODA Approved UseARAKODA is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years and older Launch Date1.53359994E12 |
Cmax
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
147 ng/mL |
200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered: |
TAFENOQUINE plasma | Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: HIGH-FAT |
AUC
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
70 μg × h/mL |
200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered: |
TAFENOQUINE plasma | Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: HIGH-FAT |
T1/2
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
16.5 day |
200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered: |
TAFENOQUINE plasma | Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: HIGH-FAT |
Funbound
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
0.5% |
200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered: |
TAFENOQUINE plasma | Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: HIGH-FAT |
Doses
Dose | Population | Adverse events |
---|---|---|
200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Other AEs: Headache, Sinus headache... Other AEs: Headache (15%) Sources: Sinus headache (15%) Migraine (15%) Tension headache (15%) Dizziness (1%) Dizziness postural (1%) Nervous system disorders (22%) Musculoskeletal and connective tissue disorders (29%) Back pain (14%) Gastrointestinal disorders (36%) Diarrhea (18%) Nausea (7%) Vomiting (5%) Psychiatric disorders (5%) Abnormal dreams (2%) Insomnia (2%) Nightmares (2%) Sleep disorder (2%) Somnambulism (2%) Anxiety disorder (1%) Panic attack (1%) Ear and labyrinth disorders (7%) Motion sickness (5%) Vertigo (5%) Vertigo positional (5%) Stress (1%) Headache (15%) Sinus headache (15%) Migraine (15%) Tension headache (15%) Dizziness (1%) Dizziness postural (1%) Nervous system disorders (22%) Musculoskeletal and connective tissue disorders (29%) Back pain (14%) Gastrointestinal disorders (36%) Diarrhea (18%) Nausea (7%) Vomiting (5%) Psychiatric disorders (5%) Abnormal dreams (2%) Insomnia (2%) Nightmares (2%) Sleep disorder (2%) Somnambulism (2%) Anxiety disorder (1%) Panic attack (1%) Ear and labyrinth disorders (7%) Motion sickness (5%) Vertigo (5%) Vertigo positional (5%) Stress (1%) |
200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Other AEs: Headache, Sinus headache... Other AEs: Headache (32%) Sources: Sinus headache (32%) Migraine (32%) Tension headache (32%) Dizziness (5%) Dizziness postural (5%) Nervous system disorders (35%) Musculoskeletal and connective tissue disorders (27%) Back pain (14%) Gastrointestinal disorders (31%) Diarrhea (5%) Nausea (5%) Vomiting (2%) ALT increased (4%) Psychiatric disorders (2%) Abnormal dreams (1%) Insomnia (1%) Nightmares (1%) Sleep disorder (1%) Somnambulism (1%) Depression (1%) Depressed mood (1%) Hemolytic anemia (<1%) Anemia (<1%) Thrombocytopenia (<1%) Hyperacusis (<1%) Meniere's disease (<1%) Hyperbilirubinemia (<1%) Jaundice cholestatic (<1%) Blood bilirubin increased (<1%) Blood creatinine increased (<1%) Glomerular filtration rate decreased (<1%) Amnesia (<1%) Coordination abnormal (<1%) Hyperesthesia (<1%) Hypoesthesia (<1%) Somnolence (<1%) Visual field defect (<1%) Urticaria (<1%) Headache (32%) Sinus headache (32%) Migraine (32%) Tension headache (32%) Dizziness (5%) Dizziness postural (5%) Nervous system disorders (35%) Musculoskeletal and connective tissue disorders (27%) Back pain (14%) Gastrointestinal disorders (31%) Diarrhea (5%) Nausea (5%) Vomiting (2%) ALT increased (4%) Psychiatric disorders (2%) Abnormal dreams (1%) Insomnia (1%) Nightmares (1%) Sleep disorder (1%) Somnambulism (1%) Depression (1%) Depressed mood (1%) Hemolytic anemia (<1%) Anemia (<1%) Thrombocytopenia (<1%) Hyperacusis (<1%) Meniere's disease (<1%) Hyperbilirubinemia (<1%) Jaundice cholestatic (<1%) Blood bilirubin increased (<1%) Blood creatinine increased (<1%) Glomerular filtration rate decreased (<1%) Amnesia (<1%) Coordination abnormal (<1%) Hyperesthesia (<1%) Hypoesthesia (<1%) Somnolence (<1%) Visual field defect (<1%) Urticaria (<1%) |
400 mg 1 times / day multiple, oral (starting) Studied dose Dose: 400 mg, 1 times / day Route: oral Route: multiple Dose: 400 mg, 1 times / day Sources: |
unhealthy, 34 years (range: 18-50 years) n = 62 Health Status: unhealthy Condition: malaria Age Group: 34 years (range: 18-50 years) Sex: M+F Population Size: 62 Sources: |
|
200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Disc. AE: ALT increased, Hemoglobin decreased... Other AEs: ALT increased, Hemoglobin decreased... AEs leading to discontinuation/dose reduction: ALT increased (0.7%) Other AEs:Hemoglobin decreased (0.4%) GFR decreased (0.2%) Malaria (0.5%) Pneumonia (0.1%) Viral infection (0.1%) Fall (0.1%) Joint injury (0.1%) Meniscus lesion (0.1%) Thermal burn (0.1%) Soft tissue injury (0.1%) Upper limb fracture (0.1%) Upper abdominal pain (0.1%) Irritable bowel syndrome (0.1%) Musculoskeletal pain (0.1%) Depression (0.1%) Metamorphopsia (0.1%) Night blindness (0.1%) Rash (0.1%) Lactose intolerance (0.1%) Hyperbilirubinemia (0.1%) ALT increased (0.7%) Sources: Hemoglobin decreased (0.4%) GFR decreased (0.2%) Malaria (0.5%) Pneumonia (0.1%) Viral infection (0.1%) Fall (0.1%) Joint injury (0.1%) Meniscus lesion (0.1%) Thermal burn (0.1%) Soft tissue injury (0.1%) Upper limb fracture (0.1%) Upper abdominal pain (0.1%) Irritable bowel syndrome (0.1%) Musculoskeletal pain (0.1%) Depression (0.1%) Metamorphopsia (0.1%) Night blindness (0.1%) Rash (0.1%) Lactose intolerance (0.1%) Hyperbilirubinemia (0.1%) |
600 mg 1 times / day multiple, oral Highest studied dose Dose: 600 mg, 1 times / day Route: oral Route: multiple Dose: 600 mg, 1 times / day Sources: |
healthy n = 36 Health Status: healthy Sex: M+F Population Size: 36 Sources: |
|
600 mg 1 times / week multiple, oral Highest studied dose Dose: 600 mg, 1 times / week Route: oral Route: multiple Dose: 600 mg, 1 times / week Sources: |
healthy n = 36 Health Status: healthy Sex: M+F Population Size: 36 Sources: |
|
600 mg single, oral Highest studied dose Dose: 600 mg Route: oral Route: single Dose: 600 mg Sources: |
healthy n = 75 Health Status: healthy Sex: M Population Size: 75 Sources: |
|
400 mg 1 times / day multiple, oral Studied dose Dose: 400 mg, 1 times / day Route: oral Route: multiple Dose: 400 mg, 1 times / day Sources: |
healthy n = 52 Health Status: healthy Sex: unknown Population Size: 52 Sources: |
Disc. AE: Nausea, Vomiting... AEs leading to discontinuation/dose reduction: Nausea (1 patient) Sources: Vomiting (1 patient) |
600 mg single, oral Studied dose Dose: 600 mg Route: oral Route: single Dose: 600 mg Sources: |
healthy n = 52 Health Status: healthy Sex: unknown Population Size: 52 Sources: |
Other AEs: CPK increased, Hemoglobin increased... Other AEs: CPK increased (4%) Sources: Hemoglobin increased (2%) Hypersensitivity (2%) |
AEs
AE | Significance | Dose | Population |
---|---|---|---|
Anxiety disorder | 1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Anxiety disorder | 1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Dizziness postural | 1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Dizziness postural | 1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Dizziness | 1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Dizziness | 1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Panic attack | 1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Panic attack | 1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Stress | 1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Stress | 1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Back pain | 14% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Back pain | 14% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Headache | 15% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Headache | 15% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Migraine | 15% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Migraine | 15% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Sinus headache | 15% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Sinus headache | 15% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Tension headache | 15% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Tension headache | 15% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Diarrhea | 18% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Diarrhea | 18% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Abnormal dreams | 2% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Abnormal dreams | 2% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Insomnia | 2% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Insomnia | 2% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Nightmares | 2% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Nightmares | 2% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Sleep disorder | 2% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Sleep disorder | 2% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Somnambulism | 2% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Somnambulism | 2% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Nervous system disorders | 22% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Nervous system disorders | 22% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Musculoskeletal and connective tissue disorders | 29% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Musculoskeletal and connective tissue disorders | 29% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Gastrointestinal disorders | 36% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Gastrointestinal disorders | 36% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Motion sickness | 5% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Motion sickness | 5% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Psychiatric disorders | 5% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Psychiatric disorders | 5% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Vertigo positional | 5% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Vertigo positional | 5% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Vertigo | 5% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Vertigo | 5% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Vomiting | 5% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Vomiting | 5% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Ear and labyrinth disorders | 7% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Ear and labyrinth disorders | 7% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Nausea | 7% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Nausea | 7% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
healthy, 29 years (range: 17-69 years) n = 492 Health Status: healthy Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 492 Sources: |
Abnormal dreams | 1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Abnormal dreams | 1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Depressed mood | 1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Depressed mood | 1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Depression | 1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Depression | 1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Insomnia | 1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Insomnia | 1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Nightmares | 1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Nightmares | 1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Sleep disorder | 1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Sleep disorder | 1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Somnambulism | 1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Somnambulism | 1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Back pain | 14% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Back pain | 14% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Psychiatric disorders | 2% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Psychiatric disorders | 2% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Vomiting | 2% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Vomiting | 2% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Musculoskeletal and connective tissue disorders | 27% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Musculoskeletal and connective tissue disorders | 27% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Gastrointestinal disorders | 31% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Gastrointestinal disorders | 31% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Headache | 32% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Headache | 32% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Migraine | 32% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Migraine | 32% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Sinus headache | 32% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Sinus headache | 32% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Tension headache | 32% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Tension headache | 32% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Nervous system disorders | 35% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Nervous system disorders | 35% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
ALT increased | 4% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
ALT increased | 4% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Diarrhea | 5% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Diarrhea | 5% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Dizziness postural | 5% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Dizziness postural | 5% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Dizziness | 5% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Dizziness | 5% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Nausea | 5% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Nausea | 5% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Amnesia | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Amnesia | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Anemia | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Anemia | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Blood bilirubin increased | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Blood bilirubin increased | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Blood creatinine increased | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Blood creatinine increased | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Coordination abnormal | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Coordination abnormal | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Glomerular filtration rate decreased | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Glomerular filtration rate decreased | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Hemolytic anemia | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Hemolytic anemia | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Hyperacusis | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Hyperacusis | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Hyperbilirubinemia | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Hyperbilirubinemia | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Hyperesthesia | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Hyperesthesia | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Hypoesthesia | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Hypoesthesia | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Jaundice cholestatic | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Jaundice cholestatic | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Meniere's disease | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Meniere's disease | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Somnolence | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Somnolence | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Thrombocytopenia | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Thrombocytopenia | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Urticaria | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Urticaria | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Visual field defect | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Visual field defect | <1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, 29 years (range: 17-69 years) n = 333 Health Status: unhealthy Condition: malaria Age Group: 29 years (range: 17-69 years) Sex: M+F Population Size: 333 Sources: |
Depression | 0.1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Fall | 0.1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Hyperbilirubinemia | 0.1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Irritable bowel syndrome | 0.1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Joint injury | 0.1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Lactose intolerance | 0.1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Meniscus lesion | 0.1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Metamorphopsia | 0.1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Musculoskeletal pain | 0.1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Night blindness | 0.1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Pneumonia | 0.1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Rash | 0.1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Soft tissue injury | 0.1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Thermal burn | 0.1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Upper abdominal pain | 0.1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Upper limb fracture | 0.1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Viral infection | 0.1% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Depression | 0.1% Disc. AE |
200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Fall | 0.1% Disc. AE |
200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Hyperbilirubinemia | 0.1% Disc. AE |
200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Irritable bowel syndrome | 0.1% Disc. AE |
200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Joint injury | 0.1% Disc. AE |
200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Lactose intolerance | 0.1% Disc. AE |
200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Meniscus lesion | 0.1% Disc. AE |
200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Metamorphopsia | 0.1% Disc. AE |
200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Musculoskeletal pain | 0.1% Disc. AE |
200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Night blindness | 0.1% Disc. AE |
200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Pneumonia | 0.1% Disc. AE |
200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Rash | 0.1% Disc. AE |
200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Soft tissue injury | 0.1% Disc. AE |
200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Thermal burn | 0.1% Disc. AE |
200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Upper abdominal pain | 0.1% Disc. AE |
200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Upper limb fracture | 0.1% Disc. AE |
200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Viral infection | 0.1% Disc. AE |
200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
GFR decreased | 0.2% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
GFR decreased | 0.2% Disc. AE |
200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Hemoglobin decreased | 0.4% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Hemoglobin decreased | 0.4% Disc. AE |
200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Malaria | 0.5% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Malaria | 0.5% Disc. AE |
200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
ALT increased | 0.7% | 200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
ALT increased | 0.7% Disc. AE |
200 mg 1 times / day multiple, oral (starting) Recommended Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, adolescents; adults n = 825 Health Status: unhealthy Condition: malaria Age Group: adolescents; adults Sex: M+F Population Size: 825 Sources: |
Nausea | 1 patient Disc. AE |
400 mg 1 times / day multiple, oral Studied dose Dose: 400 mg, 1 times / day Route: oral Route: multiple Dose: 400 mg, 1 times / day Sources: |
healthy n = 52 Health Status: healthy Sex: unknown Population Size: 52 Sources: |
Vomiting | 1 patient Disc. AE |
400 mg 1 times / day multiple, oral Studied dose Dose: 400 mg, 1 times / day Route: oral Route: multiple Dose: 400 mg, 1 times / day Sources: |
healthy n = 52 Health Status: healthy Sex: unknown Population Size: 52 Sources: |
Hemoglobin increased | 2% | 600 mg single, oral Studied dose Dose: 600 mg Route: oral Route: single Dose: 600 mg Sources: |
healthy n = 52 Health Status: healthy Sex: unknown Population Size: 52 Sources: |
Hypersensitivity | 2% | 600 mg single, oral Studied dose Dose: 600 mg Route: oral Route: single Dose: 600 mg Sources: |
healthy n = 52 Health Status: healthy Sex: unknown Population Size: 52 Sources: |
CPK increased | 4% | 600 mg single, oral Studied dose Dose: 600 mg Route: oral Route: single Dose: 600 mg Sources: |
healthy n = 52 Health Status: healthy Sex: unknown Population Size: 52 Sources: |
Overview
CYP3A4 | CYP2C9 | CYP2D6 | hERG |
---|---|---|---|
OverviewOther
Other Inhibitor | Other Substrate | Other Inducer |
---|---|---|
Drug as perpetrator
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
no [IC50 18 uM] | ||||
no [IC50 54 uM] | ||||
no [IC50 7.1 uM] | ||||
no [IC50 81 uM] | ||||
no [IC50 >25 uM] | ||||
no [IC50 >25 uM] | ||||
no [IC50 >25 uM] | ||||
no [IC50 >25 uM] | ||||
yes [IC50 0.282 uM] | ||||
yes [IC50 0.632 uM] | ||||
yes [IC50 1.99 uM] | ||||
yes [IC50 15 uM] | ||||
yes [IC50 5.61 uM] | ||||
yes [Ki 15 uM] | no (co-administration study) Comment: Subsequent clinical DDI studies demonstrated no clinically significant effects of TQ on the PK of desipramine (CYP2D6 substrate) (Study SB252263/015), caffeine (CYP1A2 substrate), midazolam (CYP3A4 substrate), and flurbiprofen (CYP2C9 substrate) (Study SB252263/040). Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210607Orig1s000MultidisciplineR.pdf#page=72 Page: 72.0 |
|||
yes [Ki 5.2 uM] | no (co-administration study) Comment: Subsequent clinical DDI studies demonstrated no clinically significant effects of TQ on the PK of desipramine (CYP2D6 substrate) (Study SB252263/015), caffeine (CYP1A2 substrate), midazolam (CYP3A4 substrate), and flurbiprofen (CYP2C9 substrate) (Study SB252263/040). Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210607Orig1s000MultidisciplineR.pdf#page=72 Page: 72.0 |
|||
yes | ||||
yes | no (co-administration study) Comment: Subsequent clinical DDI studies demonstrated no clinically significant effects of TQ on the PK of desipramine (CYP2D6 substrate) (Study SB252263/015), caffeine (CYP1A2 substrate), midazolam (CYP3A4 substrate), and flurbiprofen (CYP2C9 substrate) (Study SB252263/040). Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210607Orig1s000MultidisciplineR.pdf#page=72 Page: 72.0 |
|||
yes | no (co-administration study) Comment: Subsequent clinical DDI studies demonstrated no clinically significant effects of TQ on the PK of desipramine (CYP2D6 substrate) (Study SB252263/015), caffeine (CYP1A2 substrate), midazolam (CYP3A4 substrate), and flurbiprofen (CYP2C9 substrate) (Study SB252263/040). Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210607Orig1s000MultidisciplineR.pdf#page=72 Page: 72.0 |
Drug as victim
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
yes | ||||
yes | ||||
yes | ||||
yes |
Tox targets
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
PubMed
Title | Date | PubMed |
---|---|---|
8-aminoquinolines effective against Pneumocystis carinii in vitro and in vivo. | 1993 Oct |
|
New drug developments for opportunistic infections in immunosuppressed patients: Pneumocystis carinii. | 1995 Nov 24 |
|
8-Aminoquinolines active against blood stage Plasmodium falciparum in vitro inhibit hematin polymerization. | 1999 Mar |
|
Malaria prophylaxis/radical cure: recent experiences of the Australian Defence Force. | 2001 |
|
Development of new drugs for chemoprophylaxis of malaria. | 2001 Jul |
|
Malaria chemoprophylaxis in the age of drug resistance. I. Currently recommended drug regimens. | 2001 Jul 15 |
|
Blood schizontocidal activity of WR 238605 (Tafenoquine) against Plasmodium cynomolgi and Plasmodium fragile infections in rhesus monkeys. | 2003 Apr |
|
Military aviators, special operations forces, and causal malaria prophylaxis. | 2003 Dec |
|
Plasma concentrations of tafenoquine, a new long-acting antimalarial agent, in thai soldiers receiving monthly prophylaxis. | 2003 Dec 15 |
|
Efficacy of a 14-day primaquine regimen in preventing relapses in patients with Plasmodium vivax malaria in Mumbai, India. | 2003 Jul-Aug |
|
Molecule of the month. Tafenoquine succinate. | 2003 May |
|
Randomized trial of 3-dose regimens of tafenoquine (WR238605) versus low-dose primaquine for preventing Plasmodium vivax malaria relapse. | 2004 Oct 15 |
|
Modern malaria chemoprophylaxis. | 2005 |
|
A plant-derived morphinan as a novel lead compound active against malaria liver stages. | 2006 Dec |
|
8-Aminoquinolines: future role as antiprotozoal drugs. | 2006 Dec |
|
Intermittent preventive treatment for malaria in pregnancy in Africa: what's new, what's needed? | 2007 Feb 16 |
|
Gender differences in gastrointestinal disturbances and plasma concentrations of tafenoquine in healthy volunteers after tafenoquine administration for post-exposure vivax malaria prophylaxis. | 2007 Mar |
|
The role of anti-malarial drugs in eliminating malaria. | 2008 Dec 11 |
|
Glucose-6-phosphate dehydrogenase deficiency in an endemic area for malaria in Manaus: a cross-sectional survey in the Brazilian Amazon. | 2009 |
|
In vitro activity of pyronaridine against Plasmodium falciparum and comparative evaluation of anti-malarial drug susceptibility assays. | 2009 Apr 23 |
|
A randomized, double-blind, safety and tolerability study to assess the ophthalmic and renal effects of tafenoquine 200 mg weekly versus placebo for 6 months in healthy volunteers. | 2009 Aug |
|
Effects of mefloquine and artesunate mefloquine on the emergence, clearance and sex ratio of Plasmodium falciparum gametocytes in malarious children. | 2009 Dec 16 |
|
Plasmodium berghei ANKA: selection of resistance to piperaquine and lumefantrine in a mouse model. | 2009 Jul |
|
Visualisation and quantitative analysis of the rodent malaria liver stage by real time imaging. | 2009 Nov 18 |
|
The role of simple mathematical models in malaria elimination strategy design. | 2009 Sep 14 |
|
Structural modifications of quinoline-based antimalarial agents: Recent developments. | 2010 Apr |
|
Population screening for glucose-6-phosphate dehydrogenase deficiencies in Isabel Province, Solomon Islands, using a modified enzyme assay on filter paper dried bloodspots. | 2010 Aug 5 |
|
Antileishmanial and antitrypanosomal activities of the 8-aminoquinoline tafenoquine. | 2010 Dec |
|
Anti-malarial drugs and the prevention of malaria in the population of malaria endemic areas. | 2010 Dec 13 |
|
Establishment of an in vitro assay for assessing the effects of drugs on the liver stages of Plasmodium vivax malaria. | 2010 Dec 9 |
|
Gateways to clinical trials. | 2010 Jun |
|
Efficacy and safety of chloroquine for treatment in patients with uncomplicated Plasmodium vivax infections in endemic countries. | 2010 Nov |
|
Operational strategies to achieve and maintain malaria elimination. | 2010 Nov 6 |
|
Anti-bacterial activity of intermittent preventive treatment of malaria in pregnancy: comparative in vitro study of sulphadoxine-pyrimethamine, mefloquine, and azithromycin. | 2010 Oct 29 |
|
A SYBR Green 1-based in vitro test of susceptibility of Ghanaian Plasmodium falciparum clinical isolates to a panel of anti-malarial drugs. | 2013 Dec 17 |
Patents
Sample Use Guides
Loading regimen: 200 mg (2 of the 100 mg tablets) once daily for 3 days
Maintenance regimen: 200 mg (2 of the 100 mg tablets) once weekly – start 7 days after the last loading regimen dose
Terminal prophylaxis regimen: 200 mg (2 of the 100 mg tablets) one-time 7 days after the last maintenance dose
Route of Administration:
Oral
In Vitro Use Guide
Sources: https://www.ncbi.nlm.nih.gov/pubmed/20837758
After 72 h of tafenoquine exposure, proliferation of L. donovani and Leishmania major promastigotes was inhibited at the micromolar range in a dose-dependent manner, with 50% effective concentrations (EC50s) of 5.6 ± 1.0 uM and 5.3 ± 2.1 uM for L. donovani.
Name | Type | Language | ||
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Official Name | English | ||
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Common Name | English | ||
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Code | English | ||
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Common Name | English | ||
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Common Name | English | ||
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Common Name | English | ||
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Common Name | English |
Classification Tree | Code System | Code | ||
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FDA ORPHAN DRUG |
385812
Created by
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NCI_THESAURUS |
C271
Created by
admin on Sat Dec 16 17:20:00 UTC 2023 , Edited by admin on Sat Dec 16 17:20:00 UTC 2023
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Code System | Code | Type | Description | ||
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m10429
Created by
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PRIMARY | Merck Index | ||
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106635-80-7
Created by
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Tafenoquine
Created by
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SUB04666MIG
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C73006
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PRIMARY | |||
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115358
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135752
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C055852
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262P8GS9L9
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DB06608
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DTXSID90869466
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2054023
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Tafenoquine
Created by
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3578
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AB-17
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CHEMBL298470
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100000092719
Created by
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262P8GS9L9
Created by
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7835
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PRIMARY |
ACTIVE MOIETY
METABOLITE (PARENT)
METABOLITE INACTIVE (PARENT)
METABOLITE INACTIVE (PARENT)
METABOLITE INACTIVE (PARENT)
METABOLITE INACTIVE (PARENT)
SALT/SOLVATE (PARENT)