What the label lists and what reports show
Valbenazine side effects
Valbenazine's FDA label: “Most common adverse reaction (≥5% and twice the rate of placebo): - Tardive dyskinesia: somnolence.” FAERS holds 25,010 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is somnolence (2,468 reports).
- No generic listed
- Boxed warning
Check it at the source: the valbenazine FDA label on DailyMed (effective April 17, 2026, Neurocrine Biosciences, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of INGREZZA or INGREZZA SPRINKLE ?INGREZZA or INGREZZA SPRINKLE can cause serious side effects, including: See “What is the most important information I should know about INGREZZA or INGREZZA SPRINKLE?” Allergic Reactions. Allergic reactions, including an allergic reaction that causes sudden swelling called angioedema, can happen after taking the first dose or after many doses of INGREZZA or INGREZZA SPRINKLE. Signs and symptoms of allergic reactions and angioedema include: ○ trouble breathing or shortness of breath ○ swelling of your face, lips, eyelids, tongue, or throat, or other areas of your skin ○ trouble with swallowing ○ rash, including raised, itchy red areas on your skin (hives) Swelling in the throat can be life-threatening and can lead to death. […]
Source: FDA drug label, Neurocrine Biosciences, Inc., effective April 17, 2026 (SPL set 4c970164-cafb-421f-9eb5-c226ef0a3417), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reaction (≥5% and twice the rate of placebo): - Tardive dyskinesia: somnolence.
Table 2: Adverse Reactions in the Placebo-Controlled Study of 12-week Treatment Duration Reported at ≥4% and >Placebo – Chorea Associated with Huntington’s Disease
| Adverse Reaction | INGREZZA (n=64) % | Placebo (n=63) % |
|---|---|---|
| Somnolence, lethargy, sedation | 18.8 | 3.2 |
| Akathisia | 6.3 | 4.8 |
| Fatigue | 14.1 | 9.5 |
| Urticaria | 9.4 | 0 |
| Rash | 7.8 | 0 |
| Diarrhea | 4.7 | 1.6 |
| Nausea | 4.7 | 0 |
| Insomnia, middle insomnia | 6.3 | 1.6 |
| Depression, depressed mood | 4.7 | 1.6 |
| Back pain | 4.7 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are discussed in more detail in other sections of the labeling: Depression and Suicidal Ideation and Behavior in Patients with Huntington’s Disease [see Boxed Warning and Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions [see Contraindications ( 4 ) and Warnings and Precautions ( 5.2 ) ] Somnolence and Sedation [see Warnings and Precautions ( 5.3 )] QT Prolongation [see Warnings and Precautions ( 5.4 )] Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions ( 5.5 )] Parkinsonism [see Warnings and Precautions ( 5.6 )] Most common adverse reaction (≥5% and twice the rate of placebo): - Tardive dyskinesia: somnolence. ( 6.1 ) - Chorea associated with Huntington’s disease: somnolence/lethargy/sedation, urticaria, rash, insomnia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Neurocrine Biosciences, Inc. at 877-641-3461 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of INGREZZA SPRINKLE has been established from adequate and well-controlled studies of INGREZZA [see Clinical Studies ( 14 )]. …
Source: FDA drug label, Neurocrine Biosciences, Inc., effective April 17, 2026 (SPL set 4c970164-cafb-421f-9eb5-c226ef0a3417), via openFDA; the full label on DailyMed
What do FAERS reports show?
25,010 reports list valbenazine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,295 are coded as a death and 3,493 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2021 (6,279, against a median of 1,200 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 17 reactions below, 13 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Valbenazine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions