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Tetrabenazine Side Effects

The most commonly reported side effects of tetrabenazine include off label use, death, and somnolence, based on 7,862 FDA adverse event reports from 2004 to 2025. 8.5% of reports found the drug to be ineffective.

Tetrabenazine side effects

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

1
Off Label Use14.4%1,134
2
Death14.2%1,117
3
Drug Ineffective8.5%665
4
Somnolence4.9%384
5
Depression4.6%365
6
Hospitalisation4.0%313
7
Fatigue3.9%306
8
Intentional Product Use Issue3.5%274
9
Fall3.4%268
10
Death3.4%264
11
Drug Dose Omission2.8%221
12
Drug Administration Error2.8%221
13
Insomnia2.7%209
14
Anxiety2.6%208
15
Prescribed Overdose2.5%194

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

Report severity

57.7%Serious4,533 reports
21.5%Hospitalizations1,689 reports
22.0%Fatal1,729 reports

Seriousness is determined by the reporter, not by OpenClaim.

Tetrabenazine drug interactions

Other drugs that appear in adverse event reports alongside tetrabenazine. 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
Baclofen1.3%101
2
Clonazepam1.3%100
3
Risperidone1.1%90
4
Aripiprazole1.0%81
5
Diazepam1.0%76
6
Midazolam0.9%73
7
Trihexyphenidyl-hydrochloride0.9%71
8
Quetiapine-fumarate0.9%71
9
Lorazepam0.8%61
10
Olanzapine0.8%61
11
Fluoxetine-hydrochloride0.7%52
12
Gabapentin0.6%51
13
Haloperidol0.6%51
14
Clonidine0.6%50
15
Clozapine0.6%49

Taken alongside

1
Clonazepam5.0%392
2
Acetaminophen3.5%275
3
Omeprazole3.0%235
4
Aspirin2.7%210
5
Lorazepam2.6%204
6
Levothyroxine-sodium2.3%184
7
Trazodone-hydrochloride2.3%180
8
Gabapentin2.3%178
9
Ergocalciferol2.0%161
10
Baclofen2.0%158
11
Sertraline-hydrochloride2.0%156
12
Citalopram-hydrobromide1.9%146
13
Quetiapine-fumarate1.8%144
14
Diazepam1.6%129
15
Simvastatin1.6%128

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 tetrabenazine side effects

57.4% of tetrabenazine adverse event reports involve female patients and 40.7% involve male patients. The largest age group is adult at 55%. These figures reflect who reports side effects, not underlying risk.

Sex

Female57.4%
Male40.7%
Unknown2.0%

Age group

< 20.4%
2–114.3%
12–173.9%
18–6454.9%
65+36.5%

What is tetrabenazine used for

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

Abnormal BehaviourAccidental Exposure To ProductAggressionAgitationAkathisiaAlpers^ DiseaseAngiopathyAnorexia NervosaAphasiaArnold-chiari MalformationArterial Occlusive DiseaseArthritisAstheniaAtaxiaAthetosis

Showing 15 of 267 indications

Tetrabenazine brand names and reporting trend

Tetrabenazine is sold under the brand name Xenazine.

Brand names

Xenazine1,756

Quarterly reports (20042025)

20052010201520202025

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

Taking tetrabenazine with another medication?

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