HALOPERIDOL LACTATE

N/A

Manufactured by Fresenius Kabi USA, LLC

50,066 FDA adverse event reports analyzed

Last updated: 2026-04-14

About HALOPERIDOL LACTATE

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

Top Adverse Reactions

DRUG INEFFECTIVE2,092 reports
DRUG INTERACTION1,685 reports
NEUROLEPTIC MALIGNANT SYNDROME1,608 reports
OFF LABEL USE1,360 reports
EXTRAPYRAMIDAL DISORDER1,218 reports
WEIGHT INCREASED1,218 reports
TOXICITY TO VARIOUS AGENTS1,083 reports
AGITATION855 reports
SOMNOLENCE819 reports
PYREXIA805 reports
CONDITION AGGRAVATED797 reports
DELIRIUM767 reports
CONFUSIONAL STATE744 reports
DEATH720 reports
VOMITING717 reports
TREMOR685 reports
NAUSEA660 reports
TACHYCARDIA637 reports
SEDATION635 reports
ELECTROCARDIOGRAM QT PROLONGED634 reports
DYSTONIA627 reports
PSYCHOTIC DISORDER624 reports
AKATHISIA609 reports
AGGRESSION585 reports
HYPOTENSION569 reports
PNEUMONIA564 reports
DIARRHOEA561 reports
SUICIDE ATTEMPT560 reports
ANXIETY557 reports
NEUTROPENIA538 reports
DYSPNOEA536 reports
FATIGUE527 reports
FALL523 reports
PRODUCT USE IN UNAPPROVED INDICATION509 reports
OVERDOSE506 reports
SCHIZOPHRENIA497 reports
ACUTE KIDNEY INJURY474 reports
INSOMNIA465 reports
HYPERTENSION449 reports
HALLUCINATION440 reports
MALAISE437 reports
LEUKOPENIA434 reports
CARDIAC ARREST432 reports
BLOOD CREATINE PHOSPHOKINASE INCREASED431 reports
COMPLETED SUICIDE430 reports
RHABDOMYOLYSIS428 reports
TREATMENT NONCOMPLIANCE427 reports
CATATONIA424 reports
HALLUCINATION, AUDITORY416 reports
CONSTIPATION409 reports
MUSCLE RIGIDITY400 reports
HYPONATRAEMIA392 reports
PARKINSONISM391 reports
DELUSION387 reports
DEPRESSED LEVEL OF CONSCIOUSNESS383 reports
RESPIRATORY FAILURE377 reports
SUICIDAL IDEATION372 reports
RESTLESSNESS369 reports
DEPRESSION365 reports
PULMONARY EMBOLISM359 reports
TARDIVE DYSKINESIA351 reports
ASTHENIA350 reports
DYSPHAGIA350 reports
DYSKINESIA348 reports
SEIZURE340 reports
DIZZINESS333 reports
HYPERHIDROSIS333 reports
LOSS OF CONSCIOUSNESS329 reports
SALIVARY HYPERSECRETION328 reports
BRADYCARDIA314 reports
GENERAL PHYSICAL HEALTH DETERIORATION314 reports
RENAL FAILURE307 reports
SEPSIS304 reports
ABDOMINAL PAIN303 reports
DRUG ABUSE298 reports
COMA297 reports
INTENTIONAL OVERDOSE294 reports
WEIGHT DECREASED293 reports
GAIT DISTURBANCE291 reports
PAIN290 reports
THROMBOCYTOPENIA290 reports
HEADACHE288 reports
PNEUMONIA ASPIRATION286 reports
COGNITIVE DISORDER279 reports
DYSARTHRIA279 reports
SEROTONIN SYNDROME272 reports
ABNORMAL BEHAVIOUR268 reports
DECREASED APPETITE265 reports
WHITE BLOOD CELL COUNT DECREASED254 reports
DISORIENTATION253 reports
LETHARGY252 reports
HYPERPROLACTINAEMIA251 reports
CARDIO RESPIRATORY ARREST249 reports
ANAEMIA248 reports
MENTAL IMPAIRMENT248 reports
DIABETES MELLITUS245 reports
WHITE BLOOD CELL COUNT INCREASED239 reports
MENTAL STATUS CHANGES238 reports
URINARY TRACT INFECTION237 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE236 reports

Report Outcomes

Out of 23,959 classified reports for HALOPERIDOL LACTATE:

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

Male12,069 (55.9%)
Female9,420 (43.6%)
Unknown109 (0.5%)

Reports by Age

Age 56359 reports
Age 27349 reports
Age 49347 reports
Age 40336 reports
Age 55329 reports
Age 62329 reports
Age 32323 reports
Age 44320 reports
Age 34319 reports
Age 39318 reports
Age 42312 reports
Age 47312 reports
Age 61308 reports
Age 70307 reports
Age 59303 reports
Age 52302 reports
Age 30298 reports
Age 35298 reports
Age 25297 reports
Age 45295 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 LACTATE?

This profile reflects 50,066 FDA FAERS reports that mention HALOPERIDOL LACTATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for HALOPERIDOL LACTATE?

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

Who manufactures HALOPERIDOL LACTATE?

Labeling and FAERS entries often list Fresenius Kabi USA, LLC in connection with HALOPERIDOL LACTATE. 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.