HALOPERIDOL

N/A

Manufactured by Advagen Pharma Ltd

49,192 FDA adverse event reports analyzed

Last updated: 2026-04-14

About HALOPERIDOL

HALOPERIDOL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Advagen Pharma Ltd. The most commonly reported adverse reactions for HALOPERIDOL include DRUG INEFFECTIVE, DRUG INTERACTION, NEUROLEPTIC MALIGNANT SYNDROME, OFF LABEL USE, WEIGHT INCREASED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for HALOPERIDOL.

Top Adverse Reactions

DRUG INEFFECTIVE2,086 reports
DRUG INTERACTION1,663 reports
NEUROLEPTIC MALIGNANT SYNDROME1,578 reports
OFF LABEL USE1,346 reports
WEIGHT INCREASED1,216 reports
EXTRAPYRAMIDAL DISORDER1,200 reports
TOXICITY TO VARIOUS AGENTS998 reports
AGITATION839 reports
SOMNOLENCE802 reports
PYREXIA795 reports
CONDITION AGGRAVATED783 reports
DELIRIUM755 reports
CONFUSIONAL STATE730 reports
VOMITING704 reports
DEATH702 reports
TREMOR678 reports
NAUSEA649 reports
SEDATION634 reports
ELECTROCARDIOGRAM QT PROLONGED623 reports
TACHYCARDIA620 reports
PSYCHOTIC DISORDER616 reports
DYSTONIA611 reports
AKATHISIA607 reports
AGGRESSION573 reports
SUICIDE ATTEMPT556 reports
PNEUMONIA555 reports
DIARRHOEA549 reports
HYPOTENSION549 reports
ANXIETY546 reports
NEUTROPENIA535 reports
DYSPNOEA521 reports
FATIGUE515 reports
FALL513 reports
OVERDOSE499 reports
PRODUCT USE IN UNAPPROVED INDICATION497 reports
SCHIZOPHRENIA496 reports
ACUTE KIDNEY INJURY465 reports
INSOMNIA457 reports
HYPERTENSION445 reports
MALAISE432 reports
LEUKOPENIA431 reports
HALLUCINATION428 reports
TREATMENT NONCOMPLIANCE425 reports
BLOOD CREATINE PHOSPHOKINASE INCREASED421 reports
COMPLETED SUICIDE420 reports
CARDIAC ARREST419 reports
RHABDOMYOLYSIS418 reports
HALLUCINATION, AUDITORY416 reports
CATATONIA411 reports
CONSTIPATION406 reports
HYPONATRAEMIA390 reports
MUSCLE RIGIDITY389 reports
PARKINSONISM386 reports
DELUSION384 reports
DEPRESSED LEVEL OF CONSCIOUSNESS376 reports
SUICIDAL IDEATION371 reports
RESPIRATORY FAILURE366 reports
RESTLESSNESS366 reports
DEPRESSION362 reports
PULMONARY EMBOLISM348 reports
TARDIVE DYSKINESIA347 reports
DYSPHAGIA346 reports
ASTHENIA345 reports
DYSKINESIA343 reports
SEIZURE335 reports
DIZZINESS330 reports
HYPERHIDROSIS325 reports
SALIVARY HYPERSECRETION325 reports
LOSS OF CONSCIOUSNESS324 reports
BRADYCARDIA311 reports
GENERAL PHYSICAL HEALTH DETERIORATION309 reports
ABDOMINAL PAIN298 reports
RENAL FAILURE298 reports
SEPSIS296 reports
DRUG ABUSE294 reports
COMA293 reports
THROMBOCYTOPENIA287 reports
PAIN286 reports
GAIT DISTURBANCE284 reports
INTENTIONAL OVERDOSE284 reports
PNEUMONIA ASPIRATION282 reports
HEADACHE281 reports
WEIGHT DECREASED281 reports
COGNITIVE DISORDER275 reports
DYSARTHRIA273 reports
ABNORMAL BEHAVIOUR263 reports
SEROTONIN SYNDROME263 reports
DECREASED APPETITE262 reports
WHITE BLOOD CELL COUNT DECREASED254 reports
HYPERPROLACTINAEMIA249 reports
DISORIENTATION247 reports
MENTAL IMPAIRMENT247 reports
DIABETES MELLITUS243 reports
LETHARGY242 reports
CARDIO RESPIRATORY ARREST236 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE236 reports
WHITE BLOOD CELL COUNT INCREASED235 reports
URINARY TRACT INFECTION234 reports
ANAEMIA232 reports
MENTAL STATUS CHANGES226 reports

Report Outcomes

Out of 23,504 classified reports for HALOPERIDOL:

Serious 93.2%Non-Serious 6.8%

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

Male11,830 (55.8%)
Female9,265 (43.7%)
Unknown107 (0.5%)

Reports by Age

Age 56351 reports
Age 49344 reports
Age 27342 reports
Age 40331 reports
Age 62326 reports
Age 55324 reports
Age 32318 reports
Age 34315 reports
Age 39312 reports
Age 44311 reports
Age 47311 reports
Age 42308 reports
Age 70303 reports
Age 61301 reports
Age 59299 reports
Age 52297 reports
Age 30296 reports
Age 35295 reports
Age 45290 reports
Age 25289 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 HALOPERIDOL?

This profile reflects 49,192 FDA FAERS reports that mention HALOPERIDOL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for HALOPERIDOL?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, DRUG INTERACTION, NEUROLEPTIC MALIGNANT SYNDROME, OFF LABEL USE, WEIGHT INCREASED, EXTRAPYRAMIDAL DISORDER. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures HALOPERIDOL?

Labeling and FAERS entries often list Advagen Pharma Ltd in connection with HALOPERIDOL. 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.