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Primidone Side Effects

The most commonly reported side effects of primidone include fall, fatigue, and off label use, based on 10,184 FDA adverse event reports from 2004 to 2025. 7.0% of reports found the drug to be ineffective.

Primidone side effects

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

1
Drug Ineffective7.0%714
2
Fall5.6%568
3
Fatigue5.5%564
4
Off Label Use4.8%485
5
Tremor4.6%471
6
Diarrhoea4.1%418
7
Nausea3.7%375
8
Dizziness3.7%375
9
Drug Interaction3.2%323
10
Headache3.0%309
11
Somnolence3.0%302
12
Dyspnoea2.7%279
13
Seizure2.7%273
14
Death2.6%269
15
Asthenia2.6%269

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

Report severity

66.2%Serious6,740 reports
31.5%Hospitalizations3,213 reports
8.7%Fatal886 reports

Seriousness is determined by the reporter, not by OpenClaim.

Primidone drug interactions

Other drugs that appear in adverse event reports alongside primidone. 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
Phenytoin4.3%437
2
Levetiracetam4.1%420
3
Clonazepam3.3%338
4
Sodium-oxybate3.2%330
5
Lenalidomide3.2%321
6
Lamotrigine3.1%313
7
Gabapentin3.0%308
8
Carbamazepine3.0%302
9
Topiramate2.6%264
10
Adalimumab2.5%251
11
Propranolol-hydrochloride2.4%244
12
Lacosamide2.2%226
13
Dalfampridine2.2%225
14
Pregabalin2.2%220
15
Dimethyl1.8%187

Taken alongside

1
Aspirin17.5%1,782
2
Ergocalciferol16.2%1,645
3
Gabapentin15.7%1,595
4
Levothyroxine-sodium15.5%1,582
5
Acetaminophen15.5%1,577
6
Atorvastatin-calcium13.5%1,378
7
Omeprazole12.1%1,231
8
Furosemide12.0%1,217
9
Albuterol11.6%1,186
10
Fluticasone9.9%1,005
11
Metoprolol9.5%963
12
Amlodipine8.9%906
13
Propranolol-hydrochloride8.8%894
14
Pantoprazole-sodium8.5%867
15
Lisinopril8.3%847

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 primidone side effects

56.3% of primidone adverse event reports involve female patients and 37.2% involve male patients. The largest age group is elderly at 55%. These figures reflect who reports side effects, not underlying risk.

Sex

Female56.3%
Male37.2%
Unknown6.4%

Age group

< 20.6%
2–111.6%
12–171.4%
18–6441.2%
65+55.3%

What is primidone used for

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

Anticoagulant TherapyAnticonvulsant Drug LevelAnticonvulsant Drug Level TherapeuticAntidepressant TherapyAnxietyArthralgiaArthritisArthropathyAtaxiaAttention Deficit/hyperactivity DisorderAuraAutomatism EpilepticAbetalipoproteinaemiaAction TremorAcute Post Asthmatic Amyotrophy

Showing 15 of 260 indications

Primidone brand names and reporting trend

Primidone is sold under the brand name Primidone.

Brand names

Primidone9,435

Quarterly reports (20042025)

20052010201520202025

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

Taking primidone with another medication?

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