OpenClaim

Riluzole Side Effects

The most commonly reported side effects of riluzole include death, nausea, and diarrhoea, based on 2,784 FDA adverse event reports from 2004 to 2025. 4.0% of reports found the drug to be ineffective.

Riluzole side effects

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

1
Death12.1%338
2
Nausea5.7%159
3
Diarrhoea5.2%145
4
Amyotrophic Lateral Sclerosis4.1%113
5
Drug Ineffective4.0%112
6
Disease Progression3.8%107
7
Fatigue3.8%105
8
Dyspnoea3.6%101
9
Asthenia3.4%96
10
Off Label Use3.1%85
11
Dizziness3.0%83
12
Muscular Weakness2.7%74
13
Abdominal Discomfort2.6%71
14
Fall2.3%63
15
Headache2.2%62

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

Report severity

67.2%Serious1,872 reports
27.1%Hospitalizations754 reports
24.5%Fatal681 reports

Seriousness is determined by the reporter, not by OpenClaim.

Riluzole drug interactions

Other drugs that appear in adverse event reports alongside riluzole. 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
Edaravone19.5%544
2
Sodium-phenylbutyrate5.4%151
3
Taurursodiol5.4%150
4
Tofersen2.4%67
5
Amantadine0.9%24
6
Gabapentin0.8%21
7
Sodium-oxybate0.7%19
8
Dextromethorphan0.6%18
9
Quinidine0.6%18
10
Baclofen0.6%16
11
Alprazolam0.6%16
12
Oxcarbazepine0.5%15
13
Phenytoin0.5%15
14
Atorvastatin-calcium0.5%14
15
Omeprazole0.5%14

Taken alongside

1
Baclofen6.5%182
2
Edaravone6.1%171
3
Aspirin6.0%168
4
Acetaminophen6.0%168
5
Ergocalciferol5.8%161
6
Gabapentin4.7%131
7
Levothyroxine-sodium4.7%130
8
Omeprazole4.4%123
9
Amlodipine4.2%118
10
Atorvastatin-calcium4.0%110
11
Cyanocobalamin3.8%105
12
Albuterol3.4%96
13
Glycopyrrolate3.4%96
14
Lisinopril3.2%88
15
Dextromethorphan3.1%85

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 riluzole side effects

38.7% of riluzole adverse event reports involve female patients and 48.0% involve male patients. The largest age group is adult at 51%. These figures reflect who reports side effects, not underlying risk.

Sex

Female38.7%
Male48.0%
Unknown13.3%

Age group

< 20.9%
2–110.2%
12–170.6%
18–6450.7%
65+47.6%

What is riluzole used for

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

Accidental ExposureAffect LabilityAffective DisorderAggressionAlsAmyotrophic Lateral SclerosisAstheniaAutism Spectrum DisorderAmyotrophic Lateral SclerosisAnti-soluble Liver Antigen/liver Pancreas AntibodyAtaxiaBipolar DisorderBlindnessBronchial CarcinomaBulbar Palsy

Showing 15 of 100 indications

Riluzole brand names and reporting trend

Riluzole is sold under the brand name Tiglutik Kit.

Brand names

Tiglutik Kit1,859

Quarterly reports (20042025)

20052010201520202025

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

Taking riluzole with another medication?

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