What the label lists and what reports show
Brexpiprazole side effects
Brexpiprazole's FDA label: “Most common adverse reactions in adults were ( 6.1 ): Adult patients with major depressive disorder (adjunctive treatment to antidepressant therapy): Weight increased, somnolence, and akathisia (≥5% and at least twice the rate for placebo) Adult Patients with …” FAERS holds 16,505 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 weight increased (1,702 reports).
- Generic approved
- Boxed warning
Check it at the source: the brexpiprazole FDA label on DailyMed (effective May 6, 2026, Otsuka America Pharmaceutical, 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 REXULTI?REXULTI may cause serious side effects, including: See " What is the most important information I should know about REXULTI? " Cerebrovascular problems, including stroke, in elderly people with dementia-related psychosis that can lead to death. Neuroleptic malignant syndrome (NMS) is a serious condition that can lead to death. Call your healthcare provider or go to the nearest hospital emergency room right away if you develop some or all of the following signs and symptoms of NMS: high fever stiff muscles confusion changes in your pulse, blood pressure, heart rate, and breathing increased sweating Uncontrolled body movements (tardive dyskinesia). REXULTI may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking REXULTI. Tardive dyskinesia may also start after you stop taking REXULTI. […]
Source: FDA drug label, Otsuka America Pharmaceutical, Inc., effective May 6, 2026 (SPL set 2d301358-6291-4ec1-bd87-37b4ad9bd850), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions in adults were ( 6.1 ): Adult patients with major depressive disorder (adjunctive treatment to antidepressant therapy): Weight increased, somnolence, and akathisia (≥5% and at least twice the rate for placebo) Adult Patients with schizophrenia: Weight increased (≥4% and at least twice the rate for placebo) Pediatric patients (13 to 17 years) with schizophrenia: Extrapyramidal symptoms, excluding akathisia (≥5% and at least twice the rate for placebo) […]
Table 10 Adverse Reactions in ≥2% of REXULTI-Treated Patients and Greater than Placebo in 6-Week Placebo- and Active Controlled, Schizophrenia Study in Pediatric Patients 13 to 17 years of age (Study 6)
| Reaction | Placebo (N=104) % | REXULTI (N=110) % |
|---|---|---|
| Nausea | 4 | 6 |
| Akathisia | 3 | 4 |
| Extrapyramidal Symptoms Extrapyramidal Symptoms includes: blepharospasm, dystonia,… | 3 | 6 |
| Headache | 5 | 6 |
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 adverse reactions are discussed in more detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning, Warnings and Precautions (5.1) ] Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Boxed Warning, Warnings and Precautions (5.2) ] Cerebrovascular Adverse Reactions Including Stroke in Elderly Patients with Dementia-Related Psychosis [see Warnings and Precautions (5.3) ] Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions (5.4) ] Tardive Dyskinesia [see Warnings and Precautions (5.5) ] Metabolic Changes [see Warnings and Precautions (5.6) ] Pathological Gambling and Other Compulsive Behaviors [see Warnings and Precautions (5.7) ] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions (5.8) ] Orthostatic Hypotension and Syncope [see Warnings and Precautions (5.9) ] Falls [see Warnings and Precautions (5.10) ] Seizures [see Warnings and Precautions (5.11) ] Body Temperature Dysregulation [see Warnings and Precautions (5.12) ] Dysphagia [see Warnings and Precautions (5.13) ] Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.14) ] Most common adverse reactions in adults were ( 6.1 ): Adult patients with major depressive disorder (adjunctive treatment to antidepressant therapy): Weight increased, somnolence, and …
Source: FDA drug label, Otsuka America Pharmaceutical, Inc., effective May 6, 2026 (SPL set 2d301358-6291-4ec1-bd87-37b4ad9bd850), via openFDA; the full label on DailyMed
What do FAERS reports show?
16,505 reports list brexpiprazole among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,085 are coded as a death and 2,114 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. Of the 16 reactions below, 12 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?
- Brexpiprazole: 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