Deutetrabenazine side effects: what 7,233 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Austedo, Austedo Xr
Who reports
7,233 reports · 47% serious · 581 with death outcome · 68% female
Used for
AUSTEDO XR ® and AUSTEDO ® are indicated in adults for the treatment of: chorea associated with Huntington’s disease tardive dyskinesia AUSTEDO XR and AUSTEDO are vesicular monoamine transporter 2 (VMAT2) inhibitors indicated in adults for the treatment of: Chorea associated with Huntington’s disease ( 1 ) Tardive dyskinesia ( 1 )
What it is
AUSTEDO XR extended-release tablets and AUSTEDO tablets are formulated with deutetrabenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor for oral administration.
Boxed warning
DEPRESSION AND SUICIDALITY IN PATIENTS WITH HUNTINGTON’S DISEASE AUSTEDO XR and AUSTEDO can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Anyo.
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.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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. 149 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 | 119 | 35.8 29.9–42.8ROR 36.4 · χ² 3,943 / p <1e-300 | 35.2 EB05 30.2 · IC025 +4.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 33.1 | no trial data cached |
| Dyskinesia (involuntary movements) | 468 | 33.8 31.0–36.9ROR 36.1 · χ² 14,731 / p <1e-300 | 33.4 EB05 30.9 · IC025 +4.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 24.4 · 79% consumer | no trial data cached |
| Tardive dyskinesia (persistent involuntary movements) | 260 | 26.7 23.7–30.1ROR 27.6 · χ² 6,353 / p <1e-300 | 26.4 EB05 23.8 · IC025 +4.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 34.2 | no trial data cached |
| Akathisia (inner restlessness) | 70 | 14.9 11.8–18.9ROR 15.1 · χ² 892 / p 2e-196 | 14.8 EB05 12.0 · IC025 +3.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 8.1 | no trial data cached |
| Therapy change | 43 | 13.0 9.6–17.5ROR 13.1 · χ² 462 / p 1e-102 | 12.6 EB05 9.6 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious n=16 | no trial data cached |
| Bipolar disorder | 47 | 12.5 9.4–16.6ROR 12.6 · χ² 484 / p 2e-107 | 12.2 EB05 9.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 16.6 · 80% consumer | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 343 | 10.9 9.8–12.1ROR 11.4 · χ² 3,071 / p <1e-300 | 10.8 EB05 9.9 · IC025 +3.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 13.3 · 77% consumer | no trial data cached |
| Insurance issue | 55 | 10.8 8.3–14.0ROR 10.8 · χ² 476 / p 7e-106 | 10.4 EB05 8.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.3 · 76% consumer | no trial data cached |
| Restlessness | 121 | 9.6 8.0–11.5ROR 9.7 · χ² 922 / p 8e-203 | 9.4 EB05 8.0 · IC025 +2.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 9.3 · 80% consumer | no trial data cached |
| Loss of personal independence in daily activities | 149 | 9.1 7.8–10.7ROR 9.3 · χ² 1,066 / p 3e-234 | 8.9 EB05 7.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.3 · 90% consumer | no trial data cached |
| Drug effect less than expected | 42 | 8.7 6.4–11.7ROR 8.7 · χ² 276 / p 3e-62 | 8.1 EB05 6.2 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious n=11 · 73% consumer | no trial data cached |
| Inability to afford medication | 28 | 8.3 5.7–12.0ROR 8.3 · χ² 171 / p 2e-39 | 7.5 EB05 5.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=8 · 81% consumer | no trial data cached |
| Initial insomnia | 27 | 7.7 5.3–11.2ROR 7.7 · χ² 150 / p 8e-35 | 7.0 EB05 5.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=18 · 89% consumer | no trial data cached |
| Muscle twitching | 55 | 6.9 5.3–9.0ROR 7.0 · χ² 272 / p 2e-61 | 6.6 EB05 5.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · 87% consumer | no trial data cached |
| Salivary hypersecretion | 23 | 6.7 4.4–10.1ROR 6.7 · χ² 105 / p 5e-25 | 6.0 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Depression | 521 | 6.6 6.1–7.2ROR 7.1 · χ² 2,502 / p <1e-300 | 6.6 EB05 6.1 · IC025 +2.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 7.4 · 74% consumer | no trial data cached |
| Tremor (shaking) | 365 | 6.4 5.8–7.0ROR 6.7 · χ² 1,659 / p <1e-300 | 6.3 EB05 5.8 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 | no trial data cached |
| Speech disorder | 115 | 6.4 5.3–7.6ROR 6.5 · χ² 516 / p 2e-114 | 6.2 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 · 74% consumer | no trial data cached |
| Movement disorder | 70 | 6.3 5.0–8.0ROR 6.4 · χ² 307 / p 6e-69 | 6.1 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Product use issue | 390 | 6.1 5.5–6.7ROR 6.3 · χ² 1,653 / p <1e-300 | 6.0 EB05 5.5 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 8.5 · 72% consumer | no trial data cached |
| Hallucination, auditory | 33 | 6.0 4.3–8.5ROR 6.0 · χ² 133 / p 5e-31 | 5.6 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 · 91% consumer | no trial data cached |
| Schizophrenia | 25 | 6.0 4.0–8.8ROR 6.0 · χ² 98 / p 2e-23 | 5.4 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.5 · ♀ 30% (drug 68%) | no trial data cached |
| Sedation | 53 | 5.9 4.5–7.7ROR 5.9 · χ² 211 / p 5e-48 | 5.6 EB05 4.5 · IC025 +2.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.4 | no trial data cached |
| Hypersomnia | 57 | 5.8 4.5–7.5ROR 5.8 · χ² 220 / p 4e-50 | 5.5 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 · 79% consumer | no trial data cached |
| Hospice care | 18 | 5.3 3.3–8.4ROR 5.3 · χ² 59 / p 1e-14 | 4.7 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Mood altered | 49 | 5.2 4.0–6.9ROR 5.3 · χ² 164 / p 1e-37 | 5.0 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.1 | no trial data cached |
| Somnolence (drowsiness) | 350 | 5.1 4.6–5.6ROR 5.3 · χ² 1,143 / p 8e-251 | 5.0 EB05 4.6 · IC025 +2.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.1 · 73% consumer | no trial data cached |
| Aggression | 87 | 5.0 4.1–6.2ROR 5.1 · χ² 277 / p 1e-62 | 4.9 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · 74% consumer | no trial data cached |
| Product prescribing error | 41 | 5.0 3.7–6.8ROR 5.0 · χ² 128 / p 5e-30 | 4.8 EB05 3.7 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.3 | no trial data cached |
| Restless legs syndrome | 30 | 4.8 3.3–6.8ROR 4.8 · χ² 86 / p 9e-21 | 4.5 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 · 73% consumer | no trial data cached |
| Crying | 60 | 4.8 3.7–6.1ROR 4.8 · χ² 175 / p 3e-40 | 4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Mania | 27 | 4.8 3.3–7.0ROR 4.8 · χ² 77 / p 1e-18 | 4.4 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Dry mouth | 124 | 4.4 3.7–5.3ROR 4.5 · χ² 328 / p 1e-73 | 4.4 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 · 76% consumer | no trial data cached |
| Product prescribing issue | 31 | 4.4 3.1–6.3ROR 4.4 · χ² 79 / p 4e-19 | 4.2 EB05 3.1 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 | no trial data cached |
| Balance disorder | 131 | 4.4 3.7–5.2ROR 4.5 · χ² 341 / p 2e-76 | 4.3 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.4 · 85% consumer | no trial data cached |
| Gait inability | 49 | 4.3 3.2–5.7ROR 4.3 · χ² 121 / p 2e-28 | 4.1 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · 73% consumer | no trial data cached |
| Choking | 28 | 4.2 2.9–6.1ROR 4.2 · χ² 65 / p 4e-16 | 3.9 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · 86% consumer | no trial data cached |
| Therapeutic product effect incomplete | 101 | 4.1 3.4–5.0ROR 4.2 · χ² 238 / p 5e-54 | 4.1 EB05 3.4 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 1.7 · 78% consumer | no trial data cached |
| Impaired driving ability | 16 | 4.1 2.5–6.7ROR 4.1 · χ² 34 / p 3e-9 | 3.7 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Aspiration | 15 | 4.0 2.4–6.7ROR 4.0 · χ² 31 / p 1e-8 | 3.6 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 1,012 | 2.2 2.1–2.4ROR 2.4 · χ² 730 / p 5e-161 | 2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 1.5 · 74% consumer | no trial data cached |
| Depression | 521 | 6.6 6.1–7.2ROR 7.1 · χ² 2,502 / p <1e-300 | 6.6 EB05 6.1 · IC025 +2.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 7.4 · 74% consumer | no trial data cached |
| Death | 512 | 1.7 1.6–1.9ROR 1.8 · χ² 161 / p 3e-37 | 1.7 EB05 1.6 · IC025 +0.6 | Outcome field, not a reaction | serious PRR 2.1 | no trial data cached |
| Dyskinesia (involuntary movements) | 468 | 33.8 31.0–36.9ROR 36.1 · χ² 14,731 / p <1e-300 | 33.4 EB05 30.9 · IC025 +4.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 24.4 · 79% consumer | no trial data cached |
| Product use issue | 390 | 6.1 5.5–6.7ROR 6.3 · χ² 1,653 / p <1e-300 | 6.0 EB05 5.5 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 8.5 · 72% consumer | no trial data cached |
| Tremor (shaking) | 365 | 6.4 5.8–7.0ROR 6.7 · χ² 1,659 / p <1e-300 | 6.3 EB05 5.8 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 | no trial data cached |
| Somnolence (drowsiness) | 350 | 5.1 4.6–5.6ROR 5.3 · χ² 1,143 / p 8e-251 | 5.0 EB05 4.6 · IC025 +2.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.1 · 73% consumer | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 343 | 10.9 9.8–12.1ROR 11.4 · χ² 3,071 / p <1e-300 | 10.8 EB05 9.9 · IC025 +3.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 13.3 · 77% consumer | no trial data cached |
| Insomnia (trouble sleeping) | 322 | 3.5 3.1–3.9ROR 3.6 · χ² 580 / p 2e-128 | 3.5 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 · 82% consumer | no trial data cached |
| Fall | 311 | 2.7 2.4–3.0ROR 2.8 · χ² 340 / p 4e-76 | 2.7 EB05 2.5 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 · 74% consumer | no trial data cached |
| Product use in unapproved indication | 310 | 3.7 3.3–4.1ROR 3.8 · χ² 609 / p 8e-135 | 3.7 EB05 3.3 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.5 · 75% consumer | no trial data cached |
| Tardive dyskinesia (persistent involuntary movements) | 260 | 26.7 23.7–30.1ROR 27.6 · χ² 6,353 / p <1e-300 | 26.4 EB05 23.8 · IC025 +4.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 34.2 | no trial data cached |
| Dizziness | 240 | 1.4 1.2–1.6ROR 1.4 · χ² 27 / p 8e-8 | 1.4 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Anxiety | 220 | 2.2 2.0–2.5ROR 2.3 · χ² 151 / p 5e-35 | 2.2 EB05 2.0 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.2 · 74% consumer | no trial data cached |
| Feeling abnormal | 184 | 2.2 1.9–2.6ROR 2.2 · χ² 123 / p 6e-29 | 2.2 EB05 2.0 · IC025 +0.9 | Not in label — unassessed | serious PRR 2.8 · 75% consumer | 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.
- Bipolar disorder — n=47, PRR 12.5
- Insurance issue — n=55, PRR 10.8
- Loss of personal independence in daily activities — n=149, PRR 9.1
- Inability to afford medication — n=28, PRR 8.3
- Initial insomnia — n=27, PRR 7.7
- Muscle twitching — n=55, PRR 6.9
- Salivary hypersecretion — n=23, PRR 6.7
- Speech disorder — n=115, PRR 6.4
- Movement disorder — n=70, PRR 6.3
- Hallucination, auditory — n=33, PRR 6.0
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 Deutetrabenazine?
In FDA FAERS, the most frequently co-reported reaction terms for Deutetrabenazine are depression, dyskinesia, tremor, somnolence, suicidal ideation, insomnia. 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 Deutetrabenazine have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: DEPRESSION AND SUICIDALITY IN PATIENTS WITH HUNTINGTON’S DISEASE AUSTEDO XR and AUSTEDO can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Anyo.
Do FAERS signals prove that Deutetrabenazine 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 7ea3c60a-45c7-44cc-afc2-d87fa53993c0, effective 20250228; matched on
openfda.generic_name.exact:"DEUTETRABENAZINE") - 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, 189 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.