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Details

Stereochemistry ABSOLUTE
Molecular Formula C17H19FN2O2
Molecular Weight 302.344
Optical Activity UNSPECIFIED
Defined Stereocenters 1 / 1
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of SAFINAMIDE

SMILES

C[C@@]([H])(C(=N)O)NCc1ccc(cc1)OCc2cccc(c2)F

InChI

InChIKey=NEMGRZFTLSKBAP-LBPRGKRZSA-N
InChI=1S/C17H19FN2O2/c1-12(17(19)21)20-10-13-5-7-16(8-6-13)22-11-14-3-2-4-15(18)9-14/h2-9,12,20H,10-11H2,1H3,(H2,19,21)/t12-/m0/s1

HIDE SMILES / InChI

Description
Curator's Comment:: Description was created based on several sources, including https://www.ncbi.nlm.nih.gov/pubmed/27536120 | http://adisinsight.springer.com/drugs/800009612

Safinamide (FCE 26743, NW 1015, PNU 151774, PNU 151774E, trade name Xadago) combines potent, selective, and reversible inhibition of MAO-B with blockade of voltage-dependent Na+ and Ca2+ channels and inhibition of glutamate release. Safinamide is under development with Newron, Zambon and Meiji Seika Pharma for the treatment of Parkinson's disease. Safinamide has been launched in the EU, Iceland and Liechtenstein. Safinamide was well tolerated and safe in the clinical development program that demonstrated the amelioration of motor symptoms and OFF phenomena by safinamide when combined with dopamine agonists or levodopa.

Approval Year

Targets

Targets

Primary TargetPharmacologyConditionPotency
98.0 nM [IC50]
8.0 µM [IC50]
56.4 µM [IC50]
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
XADAGO

Approved Use

Xadago (safinamide) is indicated for the treatment of adult patients with idiopathic Parkinson’s disease (PD) as add-on therapy to a stable dose of Levodopa (L-dopa) alone or in combination with other PD medicinal products in mid-to late-stage fluctuating patients.

Launch Date

1.42464962E12
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
650 ng/mL
100 mg single, oral
dose: 100 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
SAFINAMIDE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
19000 ng × h/mL
100 mg single, oral
dose: 100 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
SAFINAMIDE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
26 h
single, intravenous
SAFINAMIDE plasma
Homo sapiens
population: UNKNOWN
age: UNKNOWN
sex: UNKNOWN
food status: UNKNOWN
Funbound

Funbound

ValueDoseCo-administeredAnalytePopulation
11.5%
100 mg single, oral
dose: 100 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
SAFINAMIDE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
Doses

Doses

DosePopulationAdverse events​
400 mg 1 times / day single, oral
Highest studied dose
Dose: 400 mg, 1 times / day
Route: oral
Route: single
Dose: 400 mg, 1 times / day
Sources:
healthy, mean age 28.7 years
n = 6
Health Status: healthy
Age Group: mean age 28.7 years
Sex: M
Population Size: 6
Sources:
Other AEs: Headache...
Other AEs:
Headache (grade 1, 16.7%)
Sources:
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Co-administed with::
tyramine(100 to 700 mg; 7 days)
Sources:
healthy, mean age 41.2 years
n = 18
Health Status: healthy
Age Group: mean age 41.2 years
Sex: M+F
Population Size: 18
Sources:
Disc. AE: ALT increased...
Other AEs: Palpitations, Nausea...
AEs leading to
discontinuation/dose reduction:
ALT increased (5.5%)
Other AEs:
Palpitations (5.5%)
Nausea (5.5%)
Pharyngitis (5.5%)
Headache (5.5%)
Sources:
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Sources:
healthy, mean age 41.2 years
n = 18
Health Status: healthy
Age Group: mean age 41.2 years
Sex: M+F
Population Size: 18
Sources:
Other AEs: Diarrhea, Headache...
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Sources: Page: 207145Orig1s000CrossR.pdf - p.13(14)
healthy
n = 59
Health Status: healthy
Population Size: 59
Sources: Page: 207145Orig1s000CrossR.pdf - p.13(14)
Other AEs: Headache, Dizziness...
Other AEs:
Headache (11.9%)
Dizziness (5.1%)
Nausea (3.4%)
Nasopharyngitis (1.7%)
Fatigue (3.4%)
Vomiting (1.7%)
Diarrhea (1.7%)
Skin laceration (1.7%)
Sources: Page: 207145Orig1s000CrossR.pdf - p.13(14)
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Disc. AE: Angina pectoris, Aortic valve incompetence...
AEs leading to
discontinuation/dose reduction:
Angina pectoris (0.3%)
Aortic valve incompetence (0.3%)
Atrial flutter (0.3%)
Creatine phosphokinase increased (0.3%)
Vertigo (0.3%)
Cataract (0.3%)
Lacrimation increased (0.3%)
Macular oedema (0.3%)
Maculopathy (0.3%)
Ocular vascular disorder (0.3%)
Papilloedema (0.3%)
Paraesthesia (0.3%)
Pain of skin (0.3%)
Rash erythematous (0.3%)
Anaemia iron deficiency (0.3%)
Depressed mood (0.3%)
Bronchospasm (0.3%)
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Disc. AE: Dyskinesia, Parkinson's disease...
AEs leading to
discontinuation/dose reduction:
Dyskinesia (1.4%)
Parkinson's disease (0.6%)
Dizziness (0.2%)
Paraesthesia (0.2%)
Cognitive disorder (0.2%)
Presyncope (0.2%)
Abdominal pain (0.2%)
Vomiting (0.2%)
Hallucination, visual (0.6%)
Hallucination (0.2%)
Sleep terror (0.2%)
Asthenia (0.2%)
Muscle spasms (0.4%)
Basal cell carcinoma (0.2%)
Breast cancer (0.2%)
Non-Hodgkin's lymphoma (0.2%)
Arrhythmia (0.2%)
Ventricular tachycardia (0.2%)
Cataract subcapsular (0.2%)
Vision blurred (0.2%)
Change in ECG (0.2%)
QT interval prolonged (0.2%)
Blister (0.2%)
Hyperhidrosis (0.2%)
Fall (0.2%)
Subdural haematoma (0.2%)
Cachexia (0.2%)
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.18(19)
unhealthy
n = 1
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 1
Sources: Page: 207145Orig1s000MedR.pdf - p.18(19)
Disc. AE: Swollen tongue, Dyspnea...
AEs leading to
discontinuation/dose reduction:
Swollen tongue
Dyspnea
Redness mouth
Gingival swelling
Rash trunk
Decreased appetite
Increased appetite
Inner restlessness
Redness of face
Pruritus
Hyperhidrosis
Dry mouth
Hoarseness
Malaise
Sources: Page: 207145Orig1s000MedR.pdf - p.18(19)
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Disc. AE: Dyskinesia, Dizziness...
AEs leading to
discontinuation/dose reduction:
Dyskinesia (1.3%)
Dizziness (0.4%)
Paraesthesia (0.4%)
Balance disorder (0.4%)
Tremor (0.4%)
Abdominal pain (0.4%)
Vomiting (0.4%)
Aphthous stomatitis (0.4%)
Constipation (0.4%)
Nausea (0.4%)
Asthenia (0.4%)
Chest discomfort (0.4%)
Muscle rigidity (0.4%)
Dyspnoea (0.9%)
Pneumonitis (0.4%)
Palpitations (0.4%)
Urinary tract infection (0.4%)
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 226
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 226
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Disc. AE: Myocardial infarction, Palpitations...
AEs leading to
discontinuation/dose reduction:
Myocardial infarction (0.4%)
Palpitations (0.4%)
Ventricular tachycardia (0.4%)
QT interval prolonged (0.9%)
Blood glucose increased (0.4%)
Vertigo (0.4%)
Muscle spasms (0.4%)
Tremor (0.4%)
Nausea (0.4%)
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
200 mg 1 times / day multiple, oral
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 89
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 89
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Disc. AE: Head titubation, Nausea...
AEs leading to
discontinuation/dose reduction:
Head titubation (1.1%)
Nausea (2.2%)
Diarrhea (1.1%)
GERD (1.1%)
Vomiting (1.1%)
Anxiety (1.1%)
Nightmare (1.1%)
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
AEs

AEs

AESignificanceDosePopulation
Headache grade 1, 16.7%
400 mg 1 times / day single, oral
Highest studied dose
Dose: 400 mg, 1 times / day
Route: oral
Route: single
Dose: 400 mg, 1 times / day
Sources:
healthy, mean age 28.7 years
n = 6
Health Status: healthy
Age Group: mean age 28.7 years
Sex: M
Population Size: 6
Sources:
Headache 5.5%
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Co-administed with::
tyramine(100 to 700 mg; 7 days)
Sources:
healthy, mean age 41.2 years
n = 18
Health Status: healthy
Age Group: mean age 41.2 years
Sex: M+F
Population Size: 18
Sources:
Nausea 5.5%
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Co-administed with::
tyramine(100 to 700 mg; 7 days)
Sources:
healthy, mean age 41.2 years
n = 18
Health Status: healthy
Age Group: mean age 41.2 years
Sex: M+F
Population Size: 18
Sources:
Palpitations 5.5%
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Co-administed with::
tyramine(100 to 700 mg; 7 days)
Sources:
healthy, mean age 41.2 years
n = 18
Health Status: healthy
Age Group: mean age 41.2 years
Sex: M+F
Population Size: 18
Sources:
Pharyngitis 5.5%
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Co-administed with::
tyramine(100 to 700 mg; 7 days)
Sources:
healthy, mean age 41.2 years
n = 18
Health Status: healthy
Age Group: mean age 41.2 years
Sex: M+F
Population Size: 18
Sources:
ALT increased 5.5%
Disc. AE
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Co-administed with::
tyramine(100 to 700 mg; 7 days)
Sources:
healthy, mean age 41.2 years
n = 18
Health Status: healthy
Age Group: mean age 41.2 years
Sex: M+F
Population Size: 18
Sources:
Diarrhea 5.5%
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Sources:
healthy, mean age 41.2 years
n = 18
Health Status: healthy
Age Group: mean age 41.2 years
Sex: M+F
Population Size: 18
Sources:
Headache 5.5%
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Sources:
healthy, mean age 41.2 years
n = 18
Health Status: healthy
Age Group: mean age 41.2 years
Sex: M+F
Population Size: 18
Sources:
Diarrhea 1.7%
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Sources: Page: 207145Orig1s000CrossR.pdf - p.13(14)
healthy
n = 59
Health Status: healthy
Population Size: 59
Sources: Page: 207145Orig1s000CrossR.pdf - p.13(14)
Nasopharyngitis 1.7%
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Sources: Page: 207145Orig1s000CrossR.pdf - p.13(14)
healthy
n = 59
Health Status: healthy
Population Size: 59
Sources: Page: 207145Orig1s000CrossR.pdf - p.13(14)
Skin laceration 1.7%
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Sources: Page: 207145Orig1s000CrossR.pdf - p.13(14)
healthy
n = 59
Health Status: healthy
Population Size: 59
Sources: Page: 207145Orig1s000CrossR.pdf - p.13(14)
Vomiting 1.7%
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Sources: Page: 207145Orig1s000CrossR.pdf - p.13(14)
healthy
n = 59
Health Status: healthy
Population Size: 59
Sources: Page: 207145Orig1s000CrossR.pdf - p.13(14)
Headache 11.9%
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Sources: Page: 207145Orig1s000CrossR.pdf - p.13(14)
healthy
n = 59
Health Status: healthy
Population Size: 59
Sources: Page: 207145Orig1s000CrossR.pdf - p.13(14)
Fatigue 3.4%
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Sources: Page: 207145Orig1s000CrossR.pdf - p.13(14)
healthy
n = 59
Health Status: healthy
Population Size: 59
Sources: Page: 207145Orig1s000CrossR.pdf - p.13(14)
Nausea 3.4%
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Sources: Page: 207145Orig1s000CrossR.pdf - p.13(14)
healthy
n = 59
Health Status: healthy
Population Size: 59
Sources: Page: 207145Orig1s000CrossR.pdf - p.13(14)
Dizziness 5.1%
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Sources: Page: 207145Orig1s000CrossR.pdf - p.13(14)
healthy
n = 59
Health Status: healthy
Population Size: 59
Sources: Page: 207145Orig1s000CrossR.pdf - p.13(14)
Anaemia iron deficiency 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Angina pectoris 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Aortic valve incompetence 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Atrial flutter 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Bronchospasm 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Cataract 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Creatine phosphokinase increased 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Depressed mood 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Lacrimation increased 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Macular oedema 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Maculopathy 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Ocular vascular disorder 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Pain of skin 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Papilloedema 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Paraesthesia 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Rash erythematous 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Vertigo 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Abdominal pain 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Arrhythmia 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Asthenia 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Basal cell carcinoma 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Blister 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Breast cancer 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Cachexia 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Cataract subcapsular 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Change in ECG 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Cognitive disorder 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Dizziness 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Fall 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Hallucination 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Hyperhidrosis 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Non-Hodgkin's lymphoma 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Paraesthesia 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Presyncope 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
QT interval prolonged 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Sleep terror 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Subdural haematoma 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Ventricular tachycardia 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Vision blurred 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Vomiting 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Muscle spasms 0.4%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Hallucination, visual 0.6%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Parkinson's disease 0.6%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Dyskinesia 1.4%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Decreased appetite Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.18(19)
unhealthy
n = 1
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 1
Sources: Page: 207145Orig1s000MedR.pdf - p.18(19)
Dry mouth Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.18(19)
unhealthy
n = 1
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 1
Sources: Page: 207145Orig1s000MedR.pdf - p.18(19)
Dyspnea Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.18(19)
unhealthy
n = 1
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 1
Sources: Page: 207145Orig1s000MedR.pdf - p.18(19)
Gingival swelling Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.18(19)
unhealthy
n = 1
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 1
Sources: Page: 207145Orig1s000MedR.pdf - p.18(19)
Hoarseness Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.18(19)
unhealthy
n = 1
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 1
Sources: Page: 207145Orig1s000MedR.pdf - p.18(19)
Hyperhidrosis Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.18(19)
unhealthy
n = 1
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 1
Sources: Page: 207145Orig1s000MedR.pdf - p.18(19)
Increased appetite Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.18(19)
unhealthy
n = 1
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 1
Sources: Page: 207145Orig1s000MedR.pdf - p.18(19)
Inner restlessness Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.18(19)
unhealthy
n = 1
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 1
Sources: Page: 207145Orig1s000MedR.pdf - p.18(19)
Malaise Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.18(19)
unhealthy
n = 1
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 1
Sources: Page: 207145Orig1s000MedR.pdf - p.18(19)
Pruritus Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.18(19)
unhealthy
n = 1
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 1
Sources: Page: 207145Orig1s000MedR.pdf - p.18(19)
Rash trunk Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.18(19)
unhealthy
n = 1
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 1
Sources: Page: 207145Orig1s000MedR.pdf - p.18(19)
Redness mouth Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.18(19)
unhealthy
n = 1
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 1
Sources: Page: 207145Orig1s000MedR.pdf - p.18(19)
Redness of face Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.18(19)
unhealthy
n = 1
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 1
Sources: Page: 207145Orig1s000MedR.pdf - p.18(19)
Swollen tongue Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.18(19)
unhealthy
n = 1
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 1
Sources: Page: 207145Orig1s000MedR.pdf - p.18(19)
Abdominal pain 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Aphthous stomatitis 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Asthenia 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Balance disorder 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Chest discomfort 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Constipation 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Dizziness 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Muscle rigidity 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Nausea 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Palpitations 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Paraesthesia 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Pneumonitis 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Tremor 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Urinary tract infection 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Vomiting 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Dyspnoea 0.9%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Dyskinesia 1.3%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources: Page: 207145Orig1s000MedR.pdf - p.124(156)
Blood glucose increased 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 226
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 226
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Muscle spasms 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 226
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 226
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Myocardial infarction 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 226
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 226
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Nausea 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 226
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 226
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Palpitations 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 226
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 226
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Tremor 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 226
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 226
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Ventricular tachycardia 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 226
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 226
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Vertigo 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 226
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 226
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
QT interval prolonged 0.9%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 226
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 226
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Anxiety 1.1%
Disc. AE
200 mg 1 times / day multiple, oral
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 89
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 89
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Diarrhea 1.1%
Disc. AE
200 mg 1 times / day multiple, oral
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 89
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 89
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
GERD 1.1%
Disc. AE
200 mg 1 times / day multiple, oral
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 89
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 89
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Head titubation 1.1%
Disc. AE
200 mg 1 times / day multiple, oral
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 89
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 89
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Nightmare 1.1%
Disc. AE
200 mg 1 times / day multiple, oral
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 89
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 89
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Vomiting 1.1%
Disc. AE
200 mg 1 times / day multiple, oral
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 89
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 89
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
Nausea 2.2%
Disc. AE
200 mg 1 times / day multiple, oral
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 89
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 89
Sources: Page: 207145Orig1s000MedR.pdf - p.121(153)
OverviewDrug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
no [IC50 43 uM]
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
yes [IC50 3.7 uM]
yes [IC50 35 uM]
yes [IC50 47.7 uM]
yes
yes
yes
yes
Drug as victimTox targets

Tox targets

TargetModalityActivityMetaboliteClinical evidence
Sourcing

Sourcing

Vendor/AggregatorIDURL
PubMed

PubMed

TitleDatePubMed
Future prospects for the drug treatment of epilepsy.
2001
Safinamide (Newron Pharmaceuticals).
2001 Jun
Novel anticonvulsant medications in development.
2002 Oct
Progress report on new antiepileptic drugs: a summary of the Sixth Eilat Conference (EILAT VI).
2002 Sep
Pressor response to intravenous tyramine in healthy subjects after safinamide, a novel neuroprotectant with selective, reversible monoamine oxidase B inhibition.
2003 Jul-Aug
Safinamide: FCE 26743, NW 1015, PNU 151774, PNU 151774E.
2004
Improvement of motor function in early Parkinson disease by safinamide.
2004 Aug 24
Pharmacokinetics and pharmacodynamics of safinamide, a neuroprotectant with antiparkinsonian and anticonvulsant activity.
2004 Jul
Crystal structures of monoamine oxidase B in complex with four inhibitors of the N-propargylaminoindan class.
2004 Mar 25
Progress report on new antiepileptic drugs: a summary of the Seventh Eilat Conference (EILAT VII).
2004 Sep-Oct
Voltage gated ion channels: targets for anticonvulsant drugs.
2005
Bioassay of safinamide in biological fluids of humans and various animal species.
2006
New pharmacologic horizons in the treatment of Parkinson disease.
2006 Oct 10
Symptom relief in Parkinson disease by safinamide: Biochemical and clinical evidence of efficacy beyond MAO-B inhibition.
2006 Oct 10
Safinamide: from molecular targets to a new anti-Parkinson drug.
2006 Oct 10
Monoamine oxidase-B inhibition in the treatment of Parkinson's disease.
2007 Dec
Safinamide for the treatment of Parkinson's disease, epilepsy and restless legs syndrome.
2007 Jul
Solid-phase synthesis and insights into structure-activity relationships of safinamide analogues as potent and selective inhibitors of type B monoamine oxidase.
2007 Oct 4
An expert opinion on safinamide in Parkinson's disease.
2008 Jul
Computational systems analysis of dopamine metabolism.
2008 Jun 18
Third-generation antiepileptic drugs: mechanisms of action, pharmacokinetics and interactions.
2009 Mar-Apr
Novel reversible monoamine oxidase A inhibitors: highly potent and selective 3-(1H-pyrrol-3-yl)-2-oxazolidinones.
2011 Dec 8
3-Acetyl-2,5-diaryl-2,3-dihydro-1,3,4-oxadiazoles: a new scaffold for the selective inhibition of monoamine oxidase B.
2011 Sep 22
1,3-Dialkyl-substituted tetrahydropyrimido[1,2-f]purine-2,4-diones as multiple target drugs for the potential treatment of neurodegenerative diseases.
2013 Dec 1
A novel selective LSD1/KDM1A inhibitor epigenetically blocks herpes simplex virus lytic replication and reactivation from latency.
2013 Feb 5
Patents

Sample Use Guides

Treatment with Xadago (Safinamide) should be started at 50 mg per day. This daily dose may be increased to 100 mg/day on the basis of individual clinical need.
Route of Administration: Oral
Safinamide (PNU-151774E) reduces sustained repetitive firing in a use-dependent manner without modifying the first action potential in hippocampal cultured neurons. The inhibition of the currents by PNU-151774E was concentration-related from 10 to 200 μM.
Name Type Language
SAFINAMIDE
DASH   INN   MI   USAN   WHO-DD  
INN   USAN  
Official Name English
EMD-1195686
Code English
SAFINAMIDE [INN]
Common Name English
EMD 1195686
Code English
SAFINAMIDE [MI]
Common Name English
SAFINAMIDE [WHO-DD]
Common Name English
SAFINAMIDE [USAN]
Common Name English
Classification Tree Code System Code
WHO-ATC N04BD03
Created by admin on Fri Jun 25 21:42:40 UTC 2021 , Edited by admin on Fri Jun 25 21:42:40 UTC 2021
NDF-RT N0000175762
Created by admin on Fri Jun 25 21:42:40 UTC 2021 , Edited by admin on Fri Jun 25 21:42:40 UTC 2021
NCI_THESAURUS C667
Created by admin on Fri Jun 25 21:42:40 UTC 2021 , Edited by admin on Fri Jun 25 21:42:40 UTC 2021
Code System Code Type Description
MESH
C092797
Created by admin on Fri Jun 25 21:42:40 UTC 2021 , Edited by admin on Fri Jun 25 21:42:40 UTC 2021
PRIMARY
LACTMED
Safinamide
Created by admin on Fri Jun 25 21:42:40 UTC 2021 , Edited by admin on Fri Jun 25 21:42:40 UTC 2021
PRIMARY
CAS
133865-89-1
Created by admin on Fri Jun 25 21:42:40 UTC 2021 , Edited by admin on Fri Jun 25 21:42:40 UTC 2021
PRIMARY
DRUG BANK
DB06654
Created by admin on Fri Jun 25 21:42:40 UTC 2021 , Edited by admin on Fri Jun 25 21:42:40 UTC 2021
PRIMARY
MERCK INDEX
M9720
Created by admin on Fri Jun 25 21:42:40 UTC 2021 , Edited by admin on Fri Jun 25 21:42:40 UTC 2021
PRIMARY Merck Index
FDA UNII
90ENL74SIG
Created by admin on Fri Jun 25 21:42:40 UTC 2021 , Edited by admin on Fri Jun 25 21:42:40 UTC 2021
PRIMARY
PUBCHEM
131682
Created by admin on Fri Jun 25 21:42:40 UTC 2021 , Edited by admin on Fri Jun 25 21:42:40 UTC 2021
PRIMARY
ChEMBL
CHEMBL396778
Created by admin on Fri Jun 25 21:42:40 UTC 2021 , Edited by admin on Fri Jun 25 21:42:40 UTC 2021
PRIMARY
IUPHAR
8291
Created by admin on Fri Jun 25 21:42:40 UTC 2021 , Edited by admin on Fri Jun 25 21:42:40 UTC 2021
PRIMARY
NCI_THESAURUS
C76771
Created by admin on Fri Jun 25 21:42:40 UTC 2021 , Edited by admin on Fri Jun 25 21:42:40 UTC 2021
PRIMARY
EVMPD
SUB32946
Created by admin on Fri Jun 25 21:42:40 UTC 2021 , Edited by admin on Fri Jun 25 21:42:40 UTC 2021
PRIMARY
WIKIPEDIA
SAFINAMIDE
Created by admin on Fri Jun 25 21:42:40 UTC 2021 , Edited by admin on Fri Jun 25 21:42:40 UTC 2021
PRIMARY
INN
8013
Created by admin on Fri Jun 25 21:42:40 UTC 2021 , Edited by admin on Fri Jun 25 21:42:40 UTC 2021
PRIMARY
DRUG CENTRAL
4921
Created by admin on Fri Jun 25 21:42:40 UTC 2021 , Edited by admin on Fri Jun 25 21:42:40 UTC 2021
PRIMARY
RXCUI
1922448
Created by admin on Fri Jun 25 21:42:40 UTC 2021 , Edited by admin on Fri Jun 25 21:42:40 UTC 2021
PRIMARY