BREXPIPRAZOLE

N/A

Manufactured by Otsuka America Pharmaceutical, Inc.

26,345 FDA adverse event reports analyzed

Last updated: 2026-04-14

About BREXPIPRAZOLE

BREXPIPRAZOLE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Otsuka America Pharmaceutical, Inc.. The most commonly reported adverse reactions for BREXPIPRAZOLE include WEIGHT INCREASED, PRODUCT USE IN UNAPPROVED INDICATION, OFF LABEL USE, DRUG INEFFECTIVE, AKATHISIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BREXPIPRAZOLE.

Top Adverse Reactions

WEIGHT INCREASED1,673 reports
PRODUCT USE IN UNAPPROVED INDICATION1,277 reports
OFF LABEL USE1,092 reports
DRUG INEFFECTIVE929 reports
AKATHISIA854 reports
TREMOR630 reports
ANXIETY591 reports
TARDIVE DYSKINESIA590 reports
DEPRESSION568 reports
SUICIDAL IDEATION538 reports
PRODUCT USE ISSUE492 reports
FATIGUE485 reports
INSOMNIA477 reports
FEELING ABNORMAL471 reports
DEATH428 reports
SOMNOLENCE401 reports
NAUSEA400 reports
DIZZINESS380 reports
HEADACHE359 reports
INABILITY TO AFFORD MEDICATION359 reports
CONDITION AGGRAVATED345 reports
DRUG INTERACTION345 reports
RESTLESSNESS330 reports
FALL328 reports
INCORRECT DOSE ADMINISTERED328 reports
AGITATION285 reports
THERAPY CESSATION280 reports
PRODUCT DOSE OMISSION ISSUE267 reports
MALAISE242 reports
DIARRHOEA234 reports
ELECTROCARDIOGRAM QT PROLONGED231 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS231 reports
RASH227 reports
DYSKINESIA225 reports
HALLUCINATION, AUDITORY219 reports
SUICIDE ATTEMPT216 reports
VOMITING212 reports
HALLUCINATION207 reports
EXTRAPYRAMIDAL DISORDER204 reports
NO ADVERSE EVENT201 reports
INSURANCE ISSUE198 reports
MANIA195 reports
SCHIZOAFFECTIVE DISORDER195 reports
SEDATION193 reports
WEIGHT DECREASED192 reports
PAIN190 reports
UNDERDOSE186 reports
CONFUSIONAL STATE183 reports
DRUG LEVEL INCREASED180 reports
BLOOD GLUCOSE INCREASED179 reports
MEMORY IMPAIRMENT174 reports
IRRITABILITY171 reports
ASTHENIA170 reports
DYSPNOEA168 reports
ADVERSE EVENT164 reports
OVERDOSE164 reports
DRUG EFFECTIVE FOR UNAPPROVED INDICATION158 reports
GAIT DISTURBANCE158 reports
TREATMENT NONCOMPLIANCE157 reports
ADVERSE DRUG REACTION155 reports
ANGER153 reports
SEIZURE151 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION144 reports
SCHIZOPHRENIA144 reports
PSYCHOTIC DISORDER141 reports
DEPRESSED MOOD135 reports
HYPERHIDROSIS135 reports
DYSPHAGIA128 reports
AGGRESSION126 reports
MUSCLE SPASMS126 reports
PARKINSONISM126 reports
ARTHRALGIA125 reports
CRYING122 reports
DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE121 reports
DYSTONIA121 reports
COMPLETED SUICIDE120 reports
CONSTIPATION119 reports
MUSCULOSKELETAL STIFFNESS119 reports
PAIN IN EXTREMITY118 reports
HOSPITALISATION116 reports
PRURITUS116 reports
VISION BLURRED116 reports
DISTURBANCE IN ATTENTION115 reports
DRUG DOSE OMISSION115 reports
ABNORMAL BEHAVIOUR113 reports
INCREASED APPETITE109 reports
MUSCLE TWITCHING106 reports
PNEUMONIA106 reports
THERAPEUTIC RESPONSE UNEXPECTED105 reports
PYREXIA104 reports
DECREASED APPETITE103 reports
BLOOD PRESSURE INCREASED101 reports
PANIC ATTACK100 reports
MENTAL DISORDER97 reports
WITHDRAWAL SYNDROME97 reports
ABDOMINAL DISCOMFORT96 reports
PERIPHERAL SWELLING95 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE95 reports
HYPOAESTHESIA94 reports
DELUSION91 reports

Report Outcomes

Out of 15,753 classified reports for BREXPIPRAZOLE:

Serious 39.4%Non-Serious 60.6%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female9,542 (68.8%)
Male4,320 (31.2%)

Reports by Age

Age 5182 reports
Age 6164 reports
Age 65161 reports
Age 50160 reports
Age 48149 reports
Age 40147 reports
Age 4141 reports
Age 55128 reports
Age 60128 reports
Age 52127 reports
Age 43126 reports
Age 45121 reports
Age 59116 reports
Age 56115 reports
Age 72113 reports
Age 51112 reports
Age 35110 reports
Age 62110 reports
Age 47108 reports
Age 53108 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with BREXPIPRAZOLE?

This profile reflects 26,345 FDA FAERS reports that mention BREXPIPRAZOLE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BREXPIPRAZOLE?

Frequently reported terms in FAERS include WEIGHT INCREASED, PRODUCT USE IN UNAPPROVED INDICATION, OFF LABEL USE, DRUG INEFFECTIVE, AKATHISIA, TREMOR. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BREXPIPRAZOLE?

Labeling and FAERS entries often list Otsuka America Pharmaceutical, Inc. in connection with BREXPIPRAZOLE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.