ORLISTAT

N/A

Manufactured by Haleon US Holdings LLC

43,367 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ORLISTAT

ORLISTAT is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Haleon US Holdings LLC. The most commonly reported adverse reactions for ORLISTAT include DRUG INEFFECTIVE, RECTAL DISCHARGE, GASTROINTESTINAL DISORDER, CONSTIPATION, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ORLISTAT.

Top Adverse Reactions

DRUG INEFFECTIVE4,502 reports
RECTAL DISCHARGE2,432 reports
GASTROINTESTINAL DISORDER2,185 reports
CONSTIPATION1,990 reports
DIARRHOEA1,943 reports
WEIGHT INCREASED1,942 reports
STEATORRHOEA1,646 reports
FLATULENCE1,618 reports
ABDOMINAL PAIN UPPER1,362 reports
HEADACHE1,112 reports
ABDOMINAL DISTENSION1,003 reports
NAUSEA942 reports
TREATMENT NONCOMPLIANCE805 reports
MALAISE782 reports
ABDOMINAL PAIN691 reports
FREQUENT BOWEL MOVEMENTS639 reports
PRODUCT QUALITY ISSUE632 reports
PHARMACEUTICAL PRODUCT COMPLAINT616 reports
DIZZINESS605 reports
FAECES DISCOLOURED597 reports
VOMITING590 reports
FATIGUE532 reports
PAIN474 reports
MUSCLE SPASMS435 reports
RECTAL HAEMORRHAGE414 reports
DYSPNOEA337 reports
ILL DEFINED DISORDER337 reports
RASH330 reports
HAEMATOCHEZIA326 reports
DRUG INTERACTION321 reports
THERAPEUTIC RESPONSE UNEXPECTED309 reports
ASTHENIA308 reports
FEELING ABNORMAL292 reports
PRURITUS275 reports
BACK PAIN271 reports
FAECAL INCONTINENCE255 reports
INSOMNIA254 reports
ABDOMINAL DISCOMFORT251 reports
HUNGER251 reports
CHEST PAIN249 reports
CHANGE OF BOWEL HABIT240 reports
DRUG ADMINISTRATION ERROR235 reports
ANXIETY233 reports
DEPRESSION226 reports
DYSPEPSIA212 reports
URTICARIA205 reports
DEFAECATION URGENCY201 reports
ADVERSE EVENT200 reports
HYPERSENSITIVITY200 reports
HEPATIC ENZYME INCREASED196 reports
PRODUCT COMPLAINT193 reports
ABNORMAL FAECES184 reports
CHOLELITHIASIS179 reports
ADVERSE DRUG REACTION178 reports
WEIGHT FLUCTUATION175 reports
ARTHRALGIA169 reports
ALOPECIA163 reports
FOOD CRAVING163 reports
HYPERTENSION150 reports
NEPHROLITHIASIS150 reports
OEDEMA PERIPHERAL150 reports
PALPITATIONS147 reports
STOMACH DISCOMFORT147 reports
PAIN IN EXTREMITY144 reports
POLLAKIURIA144 reports
DISCOMFORT141 reports
PYREXIA141 reports
FALL136 reports
ANOREXIA134 reports
DECREASED APPETITE133 reports
MIGRAINE130 reports
BLOOD PRESSURE INCREASED126 reports
ANAL INCONTINENCE125 reports
DIVERTICULITIS125 reports
PANCREATITIS122 reports
WEIGHT DECREASED122 reports
MYOCARDIAL INFARCTION121 reports
HYPERHIDROSIS120 reports
CONDITION AGGRAVATED117 reports
CHROMATURIA116 reports
GALLBLADDER DISORDER109 reports
NONSPECIFIC REACTION107 reports
PRODUCT USE IN UNAPPROVED INDICATION107 reports
SUSPECTED COUNTERFEIT PRODUCT107 reports
DEHYDRATION106 reports
MENSTRUAL DISORDER106 reports
TREMOR106 reports
INFLUENZA103 reports
NASOPHARYNGITIS102 reports
SOMNOLENCE101 reports
COUGH100 reports
DEPRESSED MOOD100 reports
MENSTRUATION IRREGULAR100 reports
INFREQUENT BOWEL MOVEMENTS98 reports
SYNCOPE98 reports
OFF LABEL USE97 reports
GASTRIC DISORDER95 reports
FLUID RETENTION94 reports
LOSS OF CONSCIOUSNESS92 reports
ANAL HAEMORRHAGE91 reports

Report Outcomes

Out of 25,612 classified reports for ORLISTAT:

Serious 25.4%Non-Serious 74.6%

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

Female16,067 (86.9%)
Male2,377 (12.9%)
Unknown51 (0.3%)

Reports by Age

Age 50360 reports
Age 45342 reports
Age 53341 reports
Age 42339 reports
Age 48318 reports
Age 55311 reports
Age 49309 reports
Age 43304 reports
Age 54303 reports
Age 40298 reports
Age 47295 reports
Age 37293 reports
Age 44292 reports
Age 38289 reports
Age 56288 reports
Age 60284 reports
Age 46272 reports
Age 52272 reports
Age 57272 reports
Age 35269 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 ORLISTAT?

This profile reflects 43,367 FDA FAERS reports that mention ORLISTAT. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ORLISTAT?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, RECTAL DISCHARGE, GASTROINTESTINAL DISORDER, CONSTIPATION, DIARRHOEA, WEIGHT INCREASED. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ORLISTAT?

Labeling and FAERS entries often list Haleon US Holdings LLC in connection with ORLISTAT. 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.