ASENAPINE MALEATE

N/A

Manufactured by Allergan, Inc.

20,068 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ASENAPINE MALEATE

ASENAPINE MALEATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Allergan, Inc.. The most commonly reported adverse reactions for ASENAPINE MALEATE include DRUG INEFFECTIVE, SEDATION, SUICIDE ATTEMPT, INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION, WEIGHT INCREASED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ASENAPINE MALEATE.

Top Adverse Reactions

DRUG INEFFECTIVE901 reports
SEDATION699 reports
SUICIDE ATTEMPT656 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION564 reports
WEIGHT INCREASED561 reports
DYSKINESIA528 reports
DYSTONIA519 reports
BLOOD GLUCOSE INCREASED479 reports
SEXUAL DYSFUNCTION431 reports
ANOSOGNOSIA420 reports
OFF LABEL USE418 reports
AKATHISIA414 reports
METABOLIC DISORDER410 reports
BLOOD PROLACTIN ABNORMAL409 reports
DISTURBANCE IN SOCIAL BEHAVIOUR407 reports
PERSONALITY CHANGE381 reports
CONDITION AGGRAVATED372 reports
UNDERDOSE353 reports
HYPOAESTHESIA ORAL338 reports
DYSGEUSIA336 reports
SCHIZOPHRENIA324 reports
SOMNOLENCE323 reports
INSOMNIA299 reports
DIZZINESS292 reports
NAUSEA274 reports
ANXIETY273 reports
TOXICITY TO VARIOUS AGENTS258 reports
SUICIDAL IDEATION228 reports
DEPRESSION226 reports
FEELING ABNORMAL206 reports
INCORRECT ROUTE OF DRUG ADMINISTRATION205 reports
INCREASED APPETITE203 reports
DYSPNOEA186 reports
VOMITING183 reports
AGITATION181 reports
OBSESSIVE COMPULSIVE DISORDER180 reports
HEADACHE179 reports
EUPHORIC MOOD171 reports
TREMOR170 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE168 reports
FATIGUE160 reports
SWOLLEN TONGUE154 reports
ADVERSE DRUG REACTION153 reports
PRODUCT USE IN UNAPPROVED INDICATION152 reports
LEUKOPENIA151 reports
ANTIPSYCHOTIC DRUG LEVEL BELOW THERAPEUTIC150 reports
DISINHIBITION150 reports
EXTRAPYRAMIDAL DISORDER150 reports
RASH148 reports
COMPLETED SUICIDE147 reports
THERAPEUTIC PRODUCT EFFECT VARIABLE142 reports
MANIA134 reports
DRUG INTERACTION132 reports
OEDEMA PERIPHERAL131 reports
HYPERTENSION127 reports
HYPOAESTHESIA125 reports
HALLUCINATION, AUDITORY118 reports
IRRITABILITY115 reports
FALL108 reports
RESTLESSNESS103 reports
CONFUSIONAL STATE100 reports
MALAISE100 reports
PSYCHOTIC DISORDER100 reports
DYSPHAGIA98 reports
GLOSSODYNIA98 reports
DEATH96 reports
TARDIVE DYSKINESIA96 reports
OVERDOSE93 reports
RESTLESS LEGS SYNDROME90 reports
PAIN89 reports
LEUKAEMIA88 reports
HALLUCINATION87 reports
ADVERSE EVENT84 reports
DYSLIPIDAEMIA84 reports
LOSS OF CONSCIOUSNESS84 reports
CONVULSION83 reports
OBESITY83 reports
WEIGHT DECREASED83 reports
GAIT DISTURBANCE82 reports
PRESCRIBED OVERDOSE82 reports
MUSCLE SPASMS81 reports
DRUG HYPERSENSITIVITY79 reports
SPEECH DISORDER79 reports
ORAL DISCOMFORT77 reports
HYPOTENSION76 reports
INSURANCE ISSUE76 reports
AGGRESSION74 reports
DIARRHOEA72 reports
ABNORMAL BEHAVIOUR71 reports
HYPERHIDROSIS70 reports
PRODUCT TASTE ABNORMAL68 reports
CONSTIPATION66 reports
SWELLING FACE66 reports
DYSARTHRIA65 reports
SYNCOPE64 reports
WRONG TECHNIQUE IN DRUG USAGE PROCESS64 reports
DECREASED APPETITE63 reports
HYPERSENSITIVITY62 reports
ANGER60 reports
ELECTROCARDIOGRAM QT PROLONGED60 reports

Report Outcomes

Out of 8,545 classified reports for ASENAPINE MALEATE:

Serious 47.6%Non-Serious 52.4%

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

Female4,579 (60.6%)
Male2,700 (35.7%)
Unknown275 (3.6%)

Reports by Age

Age 23293 reports
Age 40239 reports
Age 32193 reports
Age 30164 reports
Age 50159 reports
Age 20118 reports
Age 25116 reports
Age 44112 reports
Age 49112 reports
Age 38100 reports
Age 53100 reports
Age 5695 reports
Age 4592 reports
Age 5592 reports
Age 3591 reports
Age 5782 reports
Age 5178 reports
Age 4277 reports
Age 4377 reports
Age 2876 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 ASENAPINE MALEATE?

This profile reflects 20,068 FDA FAERS reports that mention ASENAPINE MALEATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ASENAPINE MALEATE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, SEDATION, SUICIDE ATTEMPT, INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION, WEIGHT INCREASED, DYSKINESIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ASENAPINE MALEATE?

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