Drug side effects
valbenazine Side Effects
The reactions most often reported to the FDA for valbenazine (also sold as Ingrezza), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 24,340
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2017 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of valbenazine come from 24,340 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 24,340 reports to the FDA Adverse Event Reporting System (FAERS) for valbenazine (Ingrezza): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
24,340
Reports Mentioning Death
1,271
5.2% of reports — not proof the medicine caused the death
Hospitalizations
3,386
13.9% of reports
Top Indication
Tardive Dyskinesia
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 1,271 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 911 |
| COMPLETED SUICIDE | 38 |
| HOSPITALISATION | 36 |
| MYOCARDIAL INFARCTION | 32 |
| PNEUMONIA | 31 |
| FALL | 28 |
| COVID-19 | 27 |
| CARDIAC ARREST | 21 |
| PNEUMONIA ASPIRATION | 20 |
| URINARY TRACT INFECTION | 18 |
| NEOPLASM MALIGNANT | 17 |
| SEPSIS | 17 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 15 |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 12 |
| DYSPHAGIA | 11 |
| CARDIAC FAILURE CONGESTIVE | 10 |
| DYSPNOEA | 10 |
| CEREBROVASCULAR ACCIDENT | 9 |
| CHOKING | 9 |
Reactions in Hospitalization Reports
Top reactions in 3,386 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| HOSPITALISATION | 650 |
| FALL | 411 |
| PNEUMONIA | 119 |
| URINARY TRACT INFECTION | 113 |
| TARDIVE DYSKINESIA | 111 |
| TREMOR | 109 |
| DEPRESSION | 99 |
| DEATH | 93 |
| DIZZINESS | 88 |
| SOMNOLENCE | 84 |
| SUICIDAL IDEATION | 80 |
| ANXIETY | 78 |
| COVID-19 | 72 |
| ASTHENIA | 71 |
| GAIT DISTURBANCE | 71 |
| PARKINSONISM | 63 |
| DEHYDRATION | 59 |
| DYSPNOEA | 59 |
Nearby, Related Medications
What the FAERS Data Reveals About valbenazine Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 24,340 voluntary reports linked to valbenazine and its brand equivalents (Ingrezza), spanning 2017 through 2025. Of those, 1,271 (5.2%) listed death as an outcome and 3,386 (13.9%) involved hospitalization. The most common indication reported alongside adverse events was Tardive Dyskinesia.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 67% were female and 33% male; age distribution skews toward 45-64, with 4,105 reports in that bracket. The single most reported reaction is somnolence with 2,412 submissions, followed by fatigue and tremor.
How to read these numbers
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice, speak with a licensed clinician about any side-effect concerns.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to valbenazine's 24,340.
Read our methodology - how this data is sourced, computed, and verified.