Tetrabenazine side effects: what 7,301 FDA adverse event reports show
Drug class
Vesicular Monoamine Transporter 2 Inhibitor
Who reports
7,301 reports · 56% serious · 1,531 with death outcome · 58% female
Used for
Tetrabenazine tablets are indicated for the treatment of chorea associated with Huntington's disease. Tetrabenazine tablet is a vesicular monoamine transporter 2 (VMAT) inhibitor indicated for the treatment of chorea associated with Huntington's disease (1).
What it is
Tetrabenazine tablet is a monoamine depletor for oral administration.
Boxed warning
DEPRESSION AND SUICIDALITY WARNING: DEPRESSION AND SUICIDALITY Tetrabenazine tablets can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Anyone considering the use of tetrabenazine tablets must balance the risks of depression and suicidality with the clinical need for control of chorea.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 145 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Parkinsonism | 113 | 33.7 28.0–40.5ROR 34.2 · χ² 3,508 / p <1e-300 | 33.1 EB05 28.3 · IC025 +4.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 36.3 | no trial data cached |
| Prescribed overdose | 195 | 29.2 25.4–33.6ROR 30.0 · χ² 5,238 / p <1e-300 | 28.9 EB05 25.6 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 30.1 | no trial data cached |
| Drug administration error | 241 | 22.4 19.8–25.4ROR 23.1 · χ² 4,876 / p <1e-300 | 22.2 EB05 19.9 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 18.5 · 78% consumer | no trial data cached |
| Dystonia | 130 | 19.3 16.3–22.9ROR 19.6 · χ² 2,225 / p <1e-300 | 19.1 EB05 16.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 18.9 | no trial data cached |
| Hospice care | 62 | 18.2 14.2–23.3ROR 18.3 · χ² 984 / p 3e-216 | 18.0 EB05 14.5 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 | no trial data cached |
| Movement disorder | 189 | 16.9 14.7–19.5ROR 17.3 · χ² 2,802 / p <1e-300 | 16.8 EB05 14.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 · 81% consumer | no trial data cached |
| Tardive dyskinesia (persistent involuntary movements) | 162 | 16.4 14.1–19.1ROR 16.8 · χ² 2,320 / p <1e-300 | 16.3 EB05 14.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 17.1 | no trial data cached |
| Dyskinesia (involuntary movements) | 223 | 15.9 13.9–18.1ROR 16.3 · χ² 3,082 / p <1e-300 | 15.8 EB05 14.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 | no trial data cached |
| Restlessness | 133 | 10.5 8.8–12.4ROR 10.6 · χ² 1,126 / p 4e-247 | 10.3 EB05 8.9 · IC025 +3.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.7 · 75% consumer | no trial data cached |
| Treatment noncompliance | 196 | 10.4 9.1–11.9ROR 10.7 · χ² 1,653 / p <1e-300 | 10.3 EB05 9.1 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 · 79% consumer | no trial data cached |
| Akathisia (inner restlessness) | 43 | 9.1 6.7–12.2ROR 9.1 · χ² 300 / p 2e-67 | 8.6 EB05 6.5 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 9.9 | no trial data cached |
| Sedation | 82 | 9.1 7.3–11.2ROR 9.2 · χ² 579 / p 4e-128 | 8.8 EB05 7.3 · IC025 +2.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.9 | no trial data cached |
| Intentional product use issue | 274 | 9.0 8.0–10.1ROR 9.3 · χ² 1,935 / p <1e-300 | 8.9 EB05 8.0 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 · 92% consumer | no trial data cached |
| Salivary hypersecretion | 29 | 8.4 5.8–12.0ROR 8.4 · χ² 180 / p 2e-41 | 7.6 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Muscle rigidity | 32 | 7.7 5.5–10.9ROR 7.7 · χ² 180 / p 3e-41 | 7.1 EB05 5.2 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.2 | no trial data cached |
| Neuroleptic malignant syndrome | 31 | 7.5 5.3–10.7ROR 7.5 · χ² 168 / p 1e-38 | 6.9 EB05 5.0 · IC025 +2.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 7.5 · ♀ 17% (drug 58%) · 93% clinician | no trial data cached |
| Hypersomnia | 69 | 6.9 5.5–8.8ROR 7.0 · χ² 344 / p 4e-77 | 6.7 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · 81% consumer | no trial data cached |
| Crying | 87 | 6.9 5.6–8.5ROR 6.9 · χ² 430 / p 9e-96 | 6.6 EB05 5.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Anger | 80 | 6.8 5.4–8.4ROR 6.8 · χ² 388 / p 1e-86 | 6.5 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Aspiration | 25 | 6.6 4.5–9.8ROR 6.7 · χ² 114 / p 7e-27 | 6.0 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.0 | no trial data cached |
| Drug ineffective for unapproved indication | 126 | 6.5 5.5–7.7ROR 6.6 · χ² 582 / p 8e-129 | 6.4 EB05 5.5 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.9 | no trial data cached |
| Somnolence (drowsiness) | 451 | 6.5 5.9–7.1ROR 6.8 · χ² 2,089 / p <1e-300 | 6.4 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.8 | no trial data cached |
| Abnormal behaviour | 89 | 6.4 5.2–7.9ROR 6.5 · χ² 402 / p 1e-89 | 6.2 EB05 5.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Depression | 475 | 6.0 5.5–6.5ROR 6.3 · χ² 1,983 / p <1e-300 | 5.9 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.1 | no trial data cached |
| Hospitalisation | 299 | 5.6 5.1–6.3ROR 5.8 · χ² 1,144 / p 4e-251 | 5.6 EB05 5.1 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 5.9 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 179 | 5.6 4.9–6.5ROR 5.7 · χ² 677 / p 2e-149 | 5.5 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.0 | no trial data cached |
| Aggression | 95 | 5.4 4.5–6.7ROR 5.5 · χ² 341 / p 2e-76 | 5.3 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 | no trial data cached |
| Agitation | 138 | 5.4 4.6–6.4ROR 5.5 · χ² 490 / p 8e-109 | 5.3 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.0 | no trial data cached |
| Extrapyramidal disorder | 46 | 5.3 4.0–7.0ROR 5.3 · χ² 155 / p 7e-36 | 5.0 EB05 3.9 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 | no trial data cached |
| Eating disorder | 39 | 5.2 3.8–7.2ROR 5.3 · χ² 130 / p 2e-30 | 4.9 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.7 | no trial data cached |
| Muscle twitching | 42 | 5.2 3.9–7.1ROR 5.3 · χ² 139 / p 2e-32 | 4.9 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 · 72% consumer | no trial data cached |
| Medication error | 97 | 5.0 4.1–6.1ROR 5.1 · χ² 309 / p 2e-69 | 4.9 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 0.7 · 89% consumer | no trial data cached |
| Dysphagia (difficulty swallowing) | 164 | 5.0 4.3–5.8ROR 5.1 · χ² 520 / p 3e-115 | 4.9 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | no trial data cached |
| Pneumonia aspiration | 43 | 5.0 3.7–6.7ROR 5.0 · χ² 132 / p 7e-31 | 4.7 EB05 3.7 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 | no trial data cached |
| Apathy | 24 | 4.8 3.2–7.1ROR 4.8 · χ² 67 / p 1e-16 | 4.4 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Activities of daily living impaired | 33 | 4.7 3.4–6.6ROR 4.7 · χ² 93 / p 2e-22 | 4.4 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Speech disorder | 86 | 4.7 3.8–5.8ROR 4.8 · χ² 249 / p 3e-56 | 4.6 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| No therapeutic response | 19 | 4.4 2.8–6.9ROR 4.4 · χ² 47 / p 4e-12 | 4.0 EB05 2.7 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 6.4 | no trial data cached |
| Psychomotor hyperactivity | 25 | 4.3 2.9–6.4ROR 4.3 · χ² 60 / p 4e-15 | 4.0 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 | no trial data cached |
| Choking | 29 | 4.3 3.0–6.2ROR 4.3 · χ² 70 / p 3e-17 | 4.0 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Death | 1,219 | 4.1 3.9–4.3ROR 4.7 · χ² 2,936 / p <1e-300 | 4.1 EB05 3.9 · IC025 +1.9 3/3 methods agree | Outcome field, not a reaction | serious PRR 4.2 | no trial data cached |
| Off label use (used outside approved label) | 1,135 | 3.8 3.6–4.0ROR 4.3 · χ² 2,393 / p <1e-300 | 3.8 EB05 3.6 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 | no trial data cached |
| Drug ineffective (drug did not work) | 703 | 1.5 1.4–1.6ROR 1.6 · χ² 139 / p 3e-32 | 1.5 EB05 1.4 · IC025 +0.5 | Reporting / coding artifact | serious PRR 1.3 | no trial data cached |
| Depression | 475 | 6.0 5.5–6.5ROR 6.3 · χ² 1,983 / p <1e-300 | 5.9 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.1 | no trial data cached |
| Somnolence (drowsiness) | 451 | 6.5 5.9–7.1ROR 6.8 · χ² 2,089 / p <1e-300 | 6.4 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.8 | no trial data cached |
| Fall | 318 | 2.7 2.5–3.1ROR 2.8 · χ² 357 / p 5e-80 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 | no trial data cached |
| Hospitalisation | 299 | 5.6 5.1–6.3ROR 5.8 · χ² 1,144 / p 4e-251 | 5.6 EB05 5.1 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 5.9 | no trial data cached |
| Insomnia (trouble sleeping) | 276 | 3.0 2.6–3.3ROR 3.1 · χ² 364 / p 2e-81 | 3.0 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.9 | no trial data cached |
| Intentional product use issue | 274 | 9.0 8.0–10.1ROR 9.3 · χ² 1,935 / p <1e-300 | 8.9 EB05 8.0 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 · 92% consumer | no trial data cached |
| Anxiety | 263 | 2.6 2.4–3.0ROR 2.7 · χ² 272 / p 2e-61 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Drug administration error | 241 | 22.4 19.8–25.4ROR 23.1 · χ² 4,876 / p <1e-300 | 22.2 EB05 19.9 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 18.5 · 78% consumer | no trial data cached |
| Condition aggravated | 228 | 2.2 1.9–2.5ROR 2.2 · χ² 145 / p 1e-33 | 2.2 EB05 1.9 · IC025 +0.9 | Reporting / coding artifact | serious PRR 1.7 | no trial data cached |
| Drug dose omission | 224 | 3.8 3.4–4.4ROR 3.9 · χ² 471 / p 1e-104 | 3.8 EB05 3.4 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 · 77% consumer | no trial data cached |
| Dyskinesia (involuntary movements) | 223 | 15.9 13.9–18.1ROR 16.3 · χ² 3,082 / p <1e-300 | 15.8 EB05 14.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 | no trial data cached |
| Tremor (shaking) | 221 | 3.8 3.4–4.4ROR 3.9 · χ² 461 / p 2e-102 | 3.8 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Prescribed overdose — n=195, PRR 29.2
- Dystonia — n=130, PRR 19.3
- Hospice care — n=62, PRR 18.2
- Movement disorder — n=189, PRR 16.9
- Tardive dyskinesia — n=162, PRR 16.4
- Dyskinesia — n=223, PRR 15.9
- Salivary hypersecretion — n=29, PRR 8.4
- Hypersomnia — n=69, PRR 6.9
- Crying — n=87, PRR 6.9
- Anger — n=80, PRR 6.8
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Tetrabenazine?
In FDA FAERS, the most frequently co-reported reaction terms for Tetrabenazine are depression, somnolence, fall, insomnia, anxiety, dyskinesia. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Tetrabenazine have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: DEPRESSION AND SUICIDALITY WARNING: DEPRESSION AND SUICIDALITY Tetrabenazine tablets can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Anyone considering the use of tetrabenazine tablets must balance the risks of depression and suicidality with the clinical need for control of chorea.
Do FAERS signals prove that Tetrabenazine causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID a03c3cf8-fcd4-4dbf-a4f5-59bd7887c902, effective 20180116; matched on
openfda.generic_name.exact:"TETRABENAZINE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 185 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.