PALIPERIDONE

N/A

Manufactured by Janssen Pharmaceuticals, Inc.

45,344 FDA adverse event reports analyzed

Last updated: 2026-04-14

About PALIPERIDONE

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

Top Adverse Reactions

INJURY4,330 reports
GYNAECOMASTIA3,664 reports
DRUG INEFFECTIVE1,729 reports
ABNORMAL WEIGHT GAIN1,660 reports
OFF LABEL USE1,502 reports
WEIGHT INCREASED1,360 reports
HYPERPROLACTINAEMIA1,255 reports
GALACTORRHOEA1,051 reports
SEDATION735 reports
DYSTONIA695 reports
DYSKINESIA686 reports
SUICIDE ATTEMPT662 reports
TREATMENT NONCOMPLIANCE651 reports
SCHIZOPHRENIA644 reports
PRODUCT USE IN UNAPPROVED INDICATION619 reports
EXTRAPYRAMIDAL DISORDER590 reports
EMOTIONAL DISORDER589 reports
SOMNOLENCE576 reports
TREMOR514 reports
OBESITY511 reports
CONDITION AGGRAVATED507 reports
HOSPITALISATION500 reports
BLOOD GLUCOSE INCREASED487 reports
SEXUAL DYSFUNCTION474 reports
PSYCHOTIC DISORDER455 reports
INSOMNIA450 reports
ANXIETY443 reports
FATIGUE443 reports
BLOOD PROLACTIN ABNORMAL408 reports
DRUG INTERACTION402 reports
DEPRESSION398 reports
METABOLIC DISORDER389 reports
AKATHISIA387 reports
BLOOD PROLACTIN INCREASED387 reports
DISTURBANCE IN SOCIAL BEHAVIOUR387 reports
ANOSOGNOSIA386 reports
DIZZINESS364 reports
EMOTIONAL DISTRESS362 reports
TACHYCARDIA353 reports
PERSONALITY CHANGE348 reports
HALLUCINATION, AUDITORY337 reports
INTENTIONAL OVERDOSE326 reports
SUICIDAL IDEATION321 reports
TARDIVE DYSKINESIA317 reports
ADVERSE EVENT315 reports
AGGRESSION312 reports
AGITATION312 reports
HEADACHE310 reports
ADVERSE DRUG REACTION307 reports
CONFUSIONAL STATE294 reports
NAUSEA289 reports
PRODUCT USE ISSUE286 reports
DELUSION284 reports
FEELING ABNORMAL279 reports
NEUROLEPTIC MALIGNANT SYNDROME279 reports
VOMITING276 reports
DYSPNOEA275 reports
HALLUCINATION274 reports
OVERDOSE268 reports
DRUG DOSE OMISSION261 reports
MALAISE260 reports
TOXICITY TO VARIOUS AGENTS247 reports
CONSTIPATION245 reports
INTENTIONAL SELF INJURY232 reports
COMPLETED SUICIDE225 reports
HYPOTENSION213 reports
RESTLESSNESS212 reports
ABNORMAL BEHAVIOUR211 reports
PYREXIA209 reports
ASTHENIA208 reports
PARKINSONISM195 reports
PAIN193 reports
AMENORRHOEA189 reports
VISION BLURRED180 reports
DRUG ABUSE178 reports
DIARRHOEA177 reports
MYOCARDITIS177 reports
RHABDOMYOLYSIS174 reports
HYPERHIDROSIS172 reports
FALL171 reports
CHEST PAIN170 reports
MANIA168 reports
NEUTROPENIA166 reports
MUSCULOSKELETAL STIFFNESS165 reports
MENTAL IMPAIRMENT161 reports
PARANOIA159 reports
DEATH157 reports
WEIGHT DECREASED153 reports
INCORRECT DOSE ADMINISTERED149 reports
RASH145 reports
MUSCLE SPASMS144 reports
SEIZURE144 reports
PALPITATIONS143 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION142 reports
INTENTIONAL PRODUCT MISUSE142 reports
PRODUCT DOSE OMISSION ISSUE141 reports
SALIVARY HYPERSECRETION141 reports
HYPERGLYCAEMIA138 reports
DIABETES MELLITUS137 reports
GAIT DISTURBANCE136 reports

Report Outcomes

Out of 22,766 classified reports for PALIPERIDONE:

Serious 48.5%Non-Serious 51.5%

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

Male12,929 (68.0%)
Female5,979 (31.5%)
Unknown95 (0.5%)

Reports by Age

Age 23465 reports
Age 32270 reports
Age 35260 reports
Age 19250 reports
Age 25231 reports
Age 20228 reports
Age 30215 reports
Age 29199 reports
Age 24198 reports
Age 28194 reports
Age 37193 reports
Age 22185 reports
Age 31184 reports
Age 40184 reports
Age 44183 reports
Age 38181 reports
Age 45170 reports
Age 21169 reports
Age 27168 reports
Age 26166 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 PALIPERIDONE?

This profile reflects 45,344 FDA FAERS reports that mention PALIPERIDONE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for PALIPERIDONE?

Frequently reported terms in FAERS include INJURY, GYNAECOMASTIA, DRUG INEFFECTIVE, ABNORMAL WEIGHT GAIN, OFF LABEL USE, WEIGHT INCREASED. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures PALIPERIDONE?

Labeling and FAERS entries often list Janssen Pharmaceuticals, Inc. in connection with PALIPERIDONE. 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.