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Safinamide Side Effects

The most commonly reported side effects of safinamide include fall, hallucination, and dyskinesia, based on 1,536 FDA adverse event reports from 2012 to 2025. 6.1% of reports found the drug to be ineffective.

Safinamide side effects

Percentages show how often each reaction appears relative to total reports for safinamide.

1
Fall11.8%181
2
Hallucination11.3%173
3
Dyskinesia10.7%164
4
Parkinson^s Disease7.9%122
5
Tremor6.9%106
6
Gait Disturbance6.8%104
7
Death6.6%102
8
Drug Ineffective6.1%94
9
On And Off Phenomenon6.1%93
10
Fatigue5.3%82
11
Confusional State5.3%82
12
Freezing Phenomenon5.3%82
13
Anxiety4.9%76
14
Nausea4.7%72
15
Somnolence4.6%70

These are voluntary reports and do not establish that safinamide caused these reactions.

Report severity

80.7%Serious1,240 reports
42.9%Hospitalizations659 reports
11.7%Fatal180 reports

Seriousness is determined by the reporter, not by OpenClaim.

Safinamide drug interactions

Other drugs that appear in adverse event reports alongside safinamide. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Levodopa34.4%529
2
Carbidopa28.7%441
3
Amantadine6.3%97
4
Rotigotine5.8%89
5
Pimavanserin5.3%81
6
Opicapone4.6%70
7
Apomorphine-hydrochloride4.1%63
8
Istradefylline3.7%57
9
Pramipexole-dihydrochloride3.5%53
10
Entacapone2.5%38
11
Ropinirole-hydrochloride2.3%35
12
Quetiapine-fumarate1.9%29
13
Rasagiline-mesylate1.0%15
14
Metformin0.9%14
15
Sertraline-hydrochloride0.8%13

Taken alongside

1
Levodopa46.4%712
2
Carbidopa39.2%602
3
Amantadine14.1%217
4
Aspirin12.6%193
5
Pramipexole-dihydrochloride11.6%178
6
Entacapone11.0%169
7
Quetiapine-fumarate10.5%162
8
Rotigotine9.1%140
9
Rivastigmine7.4%114
10
Pantoprazole-sodium7.4%113
11
Levothyroxine-sodium7.4%113
12
Ropinirole-hydrochloride7.0%107
13
Cyanocobalamin6.6%102
14
Clonazepam6.6%102
15
Omeprazole6.5%100

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports safinamide side effects

38.4% of safinamide adverse event reports involve female patients and 53.1% involve male patients. The largest age group is elderly at 81%. These figures reflect who reports side effects, not underlying risk.

Sex

Female38.4%
Male53.1%
Unknown8.5%

Age group

< 2<0.1%
2–110.0%
12–170.0%
18–6419.2%
65+80.7%

What is safinamide used for

Conditions and purposes for which patients were taking safinamide when the adverse event was reported.

Adjuvant TherapyAnxietyApathyAccidental Exposure To Product By ChildDepressive SymptomDementiaDepressive SymptomDysphoniaFreezing PhenomenonGait DisturbanceGeneral Physical Condition AbnormalHallucinationIll-defined DisorderIntellectual DisabilityMultiple Sclerosis

Showing 15 of 25 indications

Safinamide brand names and reporting trend

Safinamide is sold under brand names including Safinamide, Safinamide Mesylate.

Brand names

Safinamide432
Safinamide Mesylate7

Quarterly reports (20122025)

2016202020242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking safinamide with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.