Valbenazine side effects: what 24,966 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Ingrezza, Ingrezza Sprinkle
Who reports
24,966 reports · 24% serious · 1,295 with death outcome · 67% female
Used for
INGREZZA and INGREZZA SPRINKLE are indicated for the treatment of adults with: - tardive dyskinesia . - chorea associated with Huntington’s disease . INGREZZA and INGREZZA SPRINKLE are vesicular monoamine transporter 2 (VMAT2) inhibitors indicated for the treatment of adults with: - tardive dyskinesia.
What it is
INGREZZA and INGREZZA SPRINKLE contains valbenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor, present as valbenazine tosylate salt, with the chemical name, L-Valine, ( 2R,3R ,11b.
Boxed warning
DEPRESSION AND SUICIDAL IDEATION AND BEHAVIOR IN PATIENTS WITH HUNTINGTON’S DISEASE VMAT2 inhibitors, including INGREZZA and INGREZZA SPRINKLE, can increase the risk of depression and suicidal thoughts and behavior in patients with Huntington’s disease.
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. 877 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 |
|---|---|---|---|---|---|---|
| Drooling | 909 | 127.9 119.4–137.0ROR 132.7 · χ² 99,050 / p <1e-300 | 110.7 EB05 104.8 · IC025 +6.6 3/3 methods agree | Labeled adverse reaction exact term | serious n=74 | no trial data cached |
| Parkinsonism | 624 | 57.3 52.9–62.1ROR 58.7 · χ² 32,240 / p <1e-300 | 53.6 EB05 50.1 · IC025 +5.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 25.2 | no trial data cached |
| Tardive dyskinesia (persistent involuntary movements) | 1,513 | 47.0 44.7–49.4ROR 50.0 · χ² 64,496 / p <1e-300 | 44.5 EB05 42.7 · IC025 +5.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 24.6 | no trial data cached |
| Cardiovascular symptom | 10 | 22.6 12.0–42.3ROR 22.6 · χ² 180 / p 2e-41 | 20.8 EB05 11.4 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=4 | no trial data cached |
| Parkinsonian gait | 14 | 19.3 11.4–32.8ROR 19.3 · χ² 220 / p 6e-50 | 18.2 EB05 11.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Dyskinesia (involuntary movements) | 881 | 18.6 17.4–19.9ROR 19.2 · χ² 14,358 / p <1e-300 | 18.2 EB05 17.2 · IC025 +4.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 8.1 | no trial data cached |
| Eyelid function disorder | 16 | 17.2 10.5–28.2ROR 17.2 · χ² 224 / p 7e-51 | 16.2 EB05 10.1 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Therapeutic product effect decreased | 880 | 16.9 15.9–18.1ROR 17.5 · χ² 12,949 / p <1e-300 | 16.6 EB05 15.7 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 | no trial data cached |
| Tongue movement disturbance | 17 | 16.9 10.5–27.4ROR 16.9 · χ² 234 / p 4e-53 | 16.0 EB05 10.1 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=2 | no trial data cached |
| Akathisia (inner restlessness) | 242 | 15.1 13.3–17.2ROR 15.3 · χ² 3,121 / p <1e-300 | 14.8 EB05 13.3 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 | no trial data cached |
| Bradykinesia | 101 | 14.8 12.1–18.0ROR 14.8 · χ² 1,260 / p 3e-276 | 14.4 EB05 12.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Sedation | 434 | 14.2 12.9–15.6ROR 14.4 · χ² 5,220 / p <1e-300 | 13.9 EB05 12.9 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.3 | no trial data cached |
| Reduced facial expression | 16 | 13.6 8.3–22.3ROR 13.6 · χ² 171 / p 2e-39 | 12.4 EB05 7.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=4 | no trial data cached |
| Head titubation | 21 | 12.9 8.4–19.9ROR 12.9 · χ² 216 / p 4e-49 | 12.0 EB05 7.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Salivary hypersecretion | 141 | 12.0 10.2–14.2ROR 12.1 · χ² 1,390 / p <1e-300 | 11.7 EB05 10.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Restlessness | 458 | 10.6 9.7–11.6ROR 10.8 · χ² 3,928 / p <1e-300 | 10.4 EB05 9.7 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 | no trial data cached |
| Tic | 68 | 10.6 8.3–13.4ROR 10.6 · χ² 572 / p 1e-126 | 10.2 EB05 8.2 · IC025 +2.9 3/3 methods agree | Labeled — boxed warning exact term | serious n=16 | no trial data cached |
| Somnolence (drowsiness) | 2,468 | 10.4 10.0–10.8ROR 11.4 · χ² 20,922 / p <1e-300 | 10.3 EB05 9.9 · IC025 +3.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 2.7 | no trial data cached |
| Tongue biting | 24 | 9.8 6.6–14.7ROR 9.8 · χ² 179 / p 4e-41 | 8.9 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=11 · 73% consumer | no trial data cached |
| Tremor (shaking) | 1,581 | 8.0 7.7–8.4ROR 8.5 · χ² 9,724 / p <1e-300 | 8.0 EB05 7.6 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Psychiatric symptom | 69 | 7.9 6.2–10.0ROR 7.9 · χ² 405 / p 2e-90 | 7.5 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=63 | no trial data cached |
| Bruxism | 48 | 7.5 5.7–10.0ROR 7.5 · χ² 262 / p 3e-59 | 7.0 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Slow speech | 21 | 7.4 4.8–11.4ROR 7.4 · χ² 109 / p 9e-26 | 6.5 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=2 | no trial data cached |
| Labelled drug-drug interaction issue | 12 | 7.2 4.1–12.7ROR 7.2 · χ² 58 / p 2e-14 | 5.8 EB05 3.5 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious n=3 | no trial data cached |
| Flat affect | 18 | 6.7 4.2–10.6ROR 6.7 · χ² 81 / p 1e-19 | 5.8 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Therapeutic product effect incomplete | 556 | 6.6 6.1–7.2ROR 6.8 · χ² 2,644 / p <1e-300 | 6.6 EB05 6.1 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 | no trial data cached |
| Excessive eye blinking | 11 | 6.3 3.5–11.4ROR 6.3 · χ² 43 / p 2e-11 | 5.1 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Neurological symptom | 39 | 5.8 4.2–7.9ROR 5.8 · χ² 149 / p 1e-34 | 5.4 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=26 | no trial data cached |
| Restless legs syndrome | 122 | 5.6 4.7–6.7ROR 5.7 · χ² 459 / p 3e-102 | 5.5 EB05 4.7 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 · 71% consumer | no trial data cached |
| Schizoaffective disorder | 12 | 5.6 3.2–10.0ROR 5.6 · χ² 41 / p 8e-11 | 4.7 EB05 2.9 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious n=12 | no trial data cached |
| Eye movement disorder | 44 | 5.4 4.0–7.3ROR 5.4 · χ² 153 / p 2e-35 | 5.1 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Trismus | 33 | 5.4 3.8–7.6ROR 5.4 · χ² 113 / p 1e-26 | 5.0 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=5 · ♀ 46% (drug 67%) | no trial data cached |
| Adverse drug reaction | 569 | 5.4 4.9–5.8ROR 5.5 · χ² 2,009 / p <1e-300 | 5.3 EB05 5.0 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 | no trial data cached |
| Balance disorder | 548 | 5.3 4.9–5.8ROR 5.4 · χ² 1,921 / p <1e-300 | 5.3 EB05 4.9 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 | no trial data cached |
| Catatonia | 33 | 5.3 3.8–7.5ROR 5.3 · χ² 111 / p 3e-26 | 5.0 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=15 · 90% clinician | no trial data cached |
| Torticollis | 13 | 5.2 3.0–9.0ROR 5.2 · χ² 40 / p 1e-10 | 4.4 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious n=4 | no trial data cached |
| Psychiatric decompensation | 12 | 5.2 2.9–9.1ROR 5.2 · χ² 36 / p 9e-10 | 4.4 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Prescribed overdose | 118 | 5.1 4.3–6.2ROR 5.2 · χ² 387 / p 2e-86 | 5.0 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Tachyphrenia | 21 | 5.1 3.3–7.8ROR 5.1 · χ² 65 / p 4e-16 | 4.6 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Staring | 14 | 4.9 2.9–8.3ROR 4.9 · χ² 39 / p 2e-10 | 4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious n=4 | 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) | 2,765 | 1.8 1.7–1.8ROR 1.9 · χ² 970 / p 3e-213 | 1.8 EB05 1.7 · IC025 +0.8 | Reporting / coding artifact | serious PRR 0.6 | no trial data cached |
| Somnolence (drowsiness) | 2,468 | 10.4 10.0–10.8ROR 11.4 · χ² 20,922 / p <1e-300 | 10.3 EB05 9.9 · IC025 +3.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 2.7 | no trial data cached |
| Fatigue (tiredness) | 1,681 | 1.8 1.7–1.9ROR 1.9 · χ² 638 / p 5e-141 | 1.8 EB05 1.7 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 0.5 · 72% consumer | no trial data cached |
| Tremor (shaking) | 1,581 | 8.0 7.7–8.4ROR 8.5 · χ² 9,724 / p <1e-300 | 8.0 EB05 7.6 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Tardive dyskinesia (persistent involuntary movements) | 1,513 | 47.0 44.7–49.4ROR 50.0 · χ² 64,496 / p <1e-300 | 44.5 EB05 42.7 · IC025 +5.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 24.6 | no trial data cached |
| Fall | 1,129 | 2.9 2.7–3.0ROR 2.9 · χ² 1,375 / p <1e-300 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 | no trial data cached |
| Dizziness | 955 | 1.6 1.5–1.7ROR 1.6 · χ² 225 / p 4e-51 | 1.6 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.0 | no trial data cached |
| Death | 932 | 0.9 0.9–1.0ROR 0.9 · χ² 9 / p 0.001 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 2.2 | no trial data cached |
| Drooling | 909 | 127.9 119.4–137.0ROR 132.7 · χ² 99,050 / p <1e-300 | 110.7 EB05 104.8 · IC025 +6.6 3/3 methods agree | Labeled adverse reaction exact term | serious n=74 | no trial data cached |
| Dyskinesia (involuntary movements) | 881 | 18.6 17.4–19.9ROR 19.2 · χ² 14,358 / p <1e-300 | 18.2 EB05 17.2 · IC025 +4.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 8.1 | no trial data cached |
| Therapeutic product effect decreased | 880 | 16.9 15.9–18.1ROR 17.5 · χ² 12,949 / p <1e-300 | 16.6 EB05 15.7 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 | no trial data cached |
| Off label use (used outside approved label) | 690 | 0.7 0.6–0.7ROR 0.7 · χ² 120 / p 4e-28 | 0.7 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.8 | no trial data cached |
| Anxiety | 678 | 2.0 1.9–2.1ROR 2.0 · χ² 339 / p 5e-76 | 2.0 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 1.4 | no trial data cached |
| Hospitalisation | 662 | 3.7 3.4–3.9ROR 3.7 · χ² 1,277 / p 5e-280 | 3.6 EB05 3.4 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 8.9 | no trial data cached |
| Nausea | 629 | 0.7 0.6–0.7ROR 0.7 · χ² 107 / p 2e-25 | 0.7 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.3 | 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.
- Bradykinesia — n=101, PRR 14.8
- Head titubation — n=21, PRR 12.9
- Salivary hypersecretion — n=141, PRR 12.0
- Tongue biting — n=24, PRR 9.8
- Bruxism — n=48, PRR 7.5
- Slow speech — n=21, PRR 7.4
- Neurological symptom — n=39, PRR 5.8
- Restless legs syndrome — n=122, PRR 5.6
- Eye movement disorder — n=44, PRR 5.4
- Trismus — n=33, PRR 5.4
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 Valbenazine?
In FDA FAERS, the most frequently co-reported reaction terms for Valbenazine are somnolence, fatigue, tremor, tardive dyskinesia, fall, dizziness. 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 Valbenazine have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: DEPRESSION AND SUICIDAL IDEATION AND BEHAVIOR IN PATIENTS WITH HUNTINGTON’S DISEASE VMAT2 inhibitors, including INGREZZA and INGREZZA SPRINKLE, can increase the risk of depression and suicidal thoughts and behavior in patients with Huntington’s disease.
Do FAERS signals prove that Valbenazine 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 4c970164-cafb-421f-9eb5-c226ef0a3417, effective 20260417; matched on
openfda.generic_name.exact:"VALBENAZINE") - 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, 917 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.