CARIPRAZINE

N/A

Manufactured by Allergan, Inc.

13,196 FDA adverse event reports analyzed

Last updated: 2026-04-14

About CARIPRAZINE

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

Top Adverse Reactions

OFF LABEL USE1,017 reports
DRUG INEFFECTIVE502 reports
WEIGHT INCREASED441 reports
AKATHISIA395 reports
ANXIETY354 reports
TARDIVE DYSKINESIA347 reports
NAUSEA331 reports
TREMOR327 reports
INSOMNIA324 reports
FATIGUE321 reports
SUICIDAL IDEATION300 reports
DIZZINESS268 reports
DEPRESSION266 reports
SOMNOLENCE231 reports
FEELING ABNORMAL212 reports
HEADACHE196 reports
DRUG INTERACTION195 reports
VOMITING183 reports
EXTRAPYRAMIDAL DISORDER180 reports
RESTLESSNESS180 reports
MANIA159 reports
DYSKINESIA144 reports
DYSPNOEA142 reports
PRODUCT USE IN UNAPPROVED INDICATION141 reports
DIARRHOEA138 reports
RASH136 reports
PAIN134 reports
CONDITION AGGRAVATED131 reports
FALL129 reports
MALAISE128 reports
AGITATION121 reports
VISION BLURRED118 reports
SEDATION115 reports
PRODUCT DOSE OMISSION ISSUE113 reports
HALLUCINATION107 reports
MUSCLE SPASMS107 reports
ASTHENIA106 reports
HALLUCINATION, AUDITORY104 reports
SEIZURE102 reports
SUICIDE ATTEMPT101 reports
PSYCHOTIC DISORDER99 reports
CONFUSIONAL STATE97 reports
HYPERHIDROSIS97 reports
DEATH95 reports
CONSTIPATION93 reports
WEIGHT DECREASED91 reports
ARTHRALGIA89 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION87 reports
PARKINSONISM85 reports
PAIN IN EXTREMITY84 reports
MUSCULOSKELETAL STIFFNESS83 reports
MEMORY IMPAIRMENT82 reports
TREATMENT NONCOMPLIANCE81 reports
PRURITUS80 reports
IRRITABILITY79 reports
GAIT DISTURBANCE78 reports
AGGRESSION73 reports
MATERNAL EXPOSURE DURING PREGNANCY73 reports
COMPLETED SUICIDE71 reports
HYPOAESTHESIA71 reports
MIGRAINE71 reports
HOSPITALISATION70 reports
BLOOD PRESSURE INCREASED69 reports
PANIC ATTACK69 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE69 reports
ABDOMINAL PAIN UPPER67 reports
DYSPHAGIA67 reports
PALPITATIONS67 reports
BIPOLAR DISORDER66 reports
SLEEP DISORDER66 reports
LOSS OF CONSCIOUSNESS65 reports
PRODUCT USE ISSUE65 reports
DYSTONIA63 reports
MUSCLE TWITCHING63 reports
SPEECH DISORDER63 reports
TACHYCARDIA63 reports
PYREXIA62 reports
WITHDRAWAL SYNDROME62 reports
DEPRESSED MOOD61 reports
INTENTIONAL OVERDOSE61 reports
OVERDOSE61 reports
ADVERSE DRUG REACTION60 reports
BACK PAIN60 reports
DELUSION60 reports
NEUROLEPTIC MALIGNANT SYNDROME60 reports
BLOOD GLUCOSE INCREASED59 reports
ILLNESS59 reports
PARAESTHESIA59 reports
DECREASED APPETITE58 reports
HYPERTENSION58 reports
MUSCULAR WEAKNESS58 reports
PARANOIA58 reports
ANGER57 reports
MYALGIA57 reports
CHEST PAIN56 reports
THERAPY INTERRUPTED56 reports
COVID 1955 reports
COUGH54 reports
DRUG HYPERSENSITIVITY54 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES54 reports

Report Outcomes

Out of 8,570 classified reports for CARIPRAZINE:

Serious 35.0%Non-Serious 65.0%

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

Female4,591 (67.1%)
Male2,240 (32.8%)
Unknown7 (0.1%)

Reports by Age

Age 50101 reports
Age 3092 reports
Age 1791 reports
Age 4087 reports
Age 2182 reports
Age 6079 reports
Age 2677 reports
Age 3877 reports
Age 3576 reports
Age 4576 reports
Age 4875 reports
Age 3173 reports
Age 5173 reports
Age 5470 reports
Age 1669 reports
Age 4769 reports
Age 4969 reports
Age 2967 reports
Age 3466 reports
Age 2565 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 CARIPRAZINE?

This profile reflects 13,196 FDA FAERS reports that mention CARIPRAZINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CARIPRAZINE?

Frequently reported terms in FAERS include OFF LABEL USE, DRUG INEFFECTIVE, WEIGHT INCREASED, AKATHISIA, ANXIETY, TARDIVE DYSKINESIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures CARIPRAZINE?

Labeling and FAERS entries often list Allergan, Inc. in connection with CARIPRAZINE. 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.