LOPERAMIDE HYDROCHLORIDE ORAL

N/A

Manufactured by AMERISOURCE BERGEN

21,604 FDA adverse event reports analyzed

Last updated: 2026-04-14

About LOPERAMIDE HYDROCHLORIDE ORAL

LOPERAMIDE HYDROCHLORIDE ORAL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AMERISOURCE BERGEN. The most commonly reported adverse reactions for LOPERAMIDE HYDROCHLORIDE ORAL include DRUG INEFFECTIVE, DIARRHOEA, OFF LABEL USE, INTENTIONAL PRODUCT USE ISSUE, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LOPERAMIDE HYDROCHLORIDE ORAL.

Top Adverse Reactions

DRUG INEFFECTIVE1,176 reports
DIARRHOEA1,157 reports
OFF LABEL USE928 reports
INTENTIONAL PRODUCT USE ISSUE775 reports
NAUSEA704 reports
FATIGUE582 reports
CONSTIPATION501 reports
PYREXIA424 reports
INCORRECT PRODUCT ADMINISTRATION DURATION392 reports
WEIGHT DECREASED386 reports
VOMITING372 reports
ABDOMINAL PAIN366 reports
HEADACHE364 reports
PAIN357 reports
MALAISE349 reports
ANAEMIA324 reports
DYSPNOEA313 reports
DECREASED APPETITE304 reports
OVERDOSE278 reports
PNEUMONIA276 reports
MACULAR DEGENERATION256 reports
ASTHENIA246 reports
DEATH225 reports
DIZZINESS223 reports
DEHYDRATION218 reports
ARTHRALGIA217 reports
INCORRECT DOSE ADMINISTERED217 reports
EXPIRED PRODUCT ADMINISTERED213 reports
DYSPEPSIA206 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE199 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION197 reports
INTENTIONAL PRODUCT MISUSE194 reports
INCORRECT DRUG ADMINISTRATION DURATION187 reports
COUGH185 reports
ABDOMINAL PAIN UPPER183 reports
DRUG ABUSE183 reports
RASH179 reports
COLITIS173 reports
HAEMATOCHEZIA162 reports
ERYTHEMA160 reports
ELECTROCARDIOGRAM QT PROLONGED157 reports
FREQUENT BOWEL MOVEMENTS155 reports
TOXICITY TO VARIOUS AGENTS155 reports
DRUG INTERACTION153 reports
PAIN IN EXTREMITY153 reports
INFUSION RELATED REACTION150 reports
BLOOD CREATININE INCREASED149 reports
NEUTROPENIA149 reports
CHRONIC SINUSITIS147 reports
ACUTE KIDNEY INJURY146 reports
CONDITION AGGRAVATED146 reports
FALL145 reports
UNDERDOSE141 reports
PROCEDURAL PAIN139 reports
SOMNOLENCE139 reports
PARAESTHESIA ORAL134 reports
WHITE BLOOD CELL COUNT DECREASED134 reports
HYPERTENSION132 reports
INSOMNIA131 reports
ABDOMINAL DISCOMFORT130 reports
ABDOMINAL DISTENSION130 reports
HYPOKALAEMIA129 reports
HYPOTENSION127 reports
INFECTION126 reports
RECTAL HAEMORRHAGE126 reports
BACK PAIN124 reports
CARDIAC ARREST122 reports
RENAL IMPAIRMENT122 reports
COLITIS ULCERATIVE120 reports
URINARY TRACT INFECTION117 reports
ORAL CANDIDIASIS116 reports
PLATELET COUNT DECREASED116 reports
PRODUCT DOSE OMISSION ISSUE116 reports
GASTROINTESTINAL DISORDER115 reports
VENTRICULAR TACHYCARDIA115 reports
THROMBOCYTOPENIA113 reports
FEMALE GENITAL TRACT FISTULA111 reports
PERIPHERAL SWELLING111 reports
PROCTITIS111 reports
MUSCLE SPASMS108 reports
ANXIETY107 reports
COVID 19106 reports
PRURITUS106 reports
RADICULOPATHY105 reports
VAGINAL DISCHARGE105 reports
VAGINAL FLATULENCE105 reports
FEBRILE NEUTROPENIA103 reports
MALIGNANT NEOPLASM PROGRESSION103 reports
SEPSIS103 reports
CONFUSIONAL STATE102 reports
TORSADE DE POINTES100 reports
HYPERSENSITIVITY99 reports
WEIGHT INCREASED99 reports
DRUG INTOLERANCE97 reports
OEDEMA PERIPHERAL95 reports
SYNCOPE94 reports
STOMATITIS92 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION91 reports
NEUTROPHIL COUNT DECREASED91 reports
ALOPECIA90 reports

Report Outcomes

Out of 9,348 classified reports for LOPERAMIDE HYDROCHLORIDE ORAL:

Serious 62.7%Non-Serious 37.3%

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

Female4,924 (60.3%)
Male3,233 (39.6%)
Unknown4 (0.0%)

Reports by Age

Age 72186 reports
Age 69183 reports
Age 73169 reports
Age 71167 reports
Age 75167 reports
Age 64162 reports
Age 74161 reports
Age 68159 reports
Age 65149 reports
Age 70148 reports
Age 67144 reports
Age 77140 reports
Age 60136 reports
Age 76136 reports
Age 63126 reports
Age 79124 reports
Age 83122 reports
Age 80120 reports
Age 57118 reports
Age 61117 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 LOPERAMIDE HYDROCHLORIDE ORAL?

This profile reflects 21,604 FDA FAERS reports that mention LOPERAMIDE HYDROCHLORIDE ORAL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for LOPERAMIDE HYDROCHLORIDE ORAL?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, DIARRHOEA, OFF LABEL USE, INTENTIONAL PRODUCT USE ISSUE, NAUSEA, FATIGUE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures LOPERAMIDE HYDROCHLORIDE ORAL?

Labeling and FAERS entries often list AMERISOURCE BERGEN in connection with LOPERAMIDE HYDROCHLORIDE ORAL. 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.