LOPERAMIDE HCL

N/A

Manufactured by Rite Aid Corporation

26,027 FDA adverse event reports analyzed

Last updated: 2026-04-14

About LOPERAMIDE HCL

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

Top Adverse Reactions

DIARRHOEA1,592 reports
DRUG INEFFECTIVE1,258 reports
OFF LABEL USE968 reports
NAUSEA899 reports
INTENTIONAL PRODUCT USE ISSUE779 reports
FATIGUE744 reports
CONSTIPATION560 reports
PYREXIA554 reports
VOMITING540 reports
WEIGHT DECREASED463 reports
ABDOMINAL PAIN450 reports
DYSPNOEA434 reports
HEADACHE434 reports
ANAEMIA424 reports
PAIN424 reports
MALAISE418 reports
INCORRECT PRODUCT ADMINISTRATION DURATION392 reports
PNEUMONIA367 reports
DECREASED APPETITE362 reports
DEHYDRATION361 reports
DEATH349 reports
ASTHENIA340 reports
DIZZINESS301 reports
OVERDOSE301 reports
ARTHRALGIA266 reports
MACULAR DEGENERATION256 reports
RASH253 reports
NEUTROPENIA234 reports
FALL231 reports
INCORRECT DOSE ADMINISTERED227 reports
DYSPEPSIA225 reports
EXPIRED PRODUCT ADMINISTERED219 reports
ABDOMINAL PAIN UPPER217 reports
COUGH214 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION201 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE201 reports
HYPOTENSION198 reports
INTENTIONAL PRODUCT MISUSE197 reports
PAIN IN EXTREMITY196 reports
DRUG ABUSE194 reports
INCORRECT DRUG ADMINISTRATION DURATION193 reports
COLITIS187 reports
CONDITION AGGRAVATED186 reports
BLOOD CREATININE INCREASED183 reports
DRUG INTERACTION183 reports
ERYTHEMA182 reports
HYPERTENSION177 reports
SEPSIS177 reports
WHITE BLOOD CELL COUNT DECREASED177 reports
HAEMATOCHEZIA175 reports
TOXICITY TO VARIOUS AGENTS173 reports
SOMNOLENCE171 reports
ELECTROCARDIOGRAM QT PROLONGED170 reports
PLATELET COUNT DECREASED167 reports
HYPOKALAEMIA166 reports
THROMBOCYTOPENIA165 reports
FREQUENT BOWEL MOVEMENTS164 reports
BACK PAIN160 reports
INFUSION RELATED REACTION160 reports
INSOMNIA160 reports
ACUTE KIDNEY INJURY159 reports
URINARY TRACT INFECTION157 reports
ABDOMINAL DISCOMFORT155 reports
FEBRILE NEUTROPENIA154 reports
INFECTION152 reports
CARDIAC ARREST150 reports
ABDOMINAL DISTENSION149 reports
CONFUSIONAL STATE149 reports
UNDERDOSE148 reports
CHRONIC SINUSITIS147 reports
OEDEMA PERIPHERAL143 reports
PRURITUS143 reports
ANXIETY142 reports
PROCEDURAL PAIN142 reports
RECTAL HAEMORRHAGE142 reports
RENAL IMPAIRMENT141 reports
PARAESTHESIA ORAL135 reports
PERIPHERAL SWELLING134 reports
GASTROINTESTINAL DISORDER133 reports
CHEST PAIN131 reports
MUSCLE SPASMS131 reports
MALIGNANT NEOPLASM PROGRESSION130 reports
COLITIS ULCERATIVE129 reports
PRODUCT DOSE OMISSION ISSUE129 reports
WEIGHT INCREASED129 reports
HAEMOGLOBIN DECREASED128 reports
RENAL FAILURE126 reports
VENTRICULAR TACHYCARDIA126 reports
ORAL CANDIDIASIS123 reports
STOMATITIS120 reports
GAIT DISTURBANCE117 reports
NEUTROPHIL COUNT DECREASED115 reports
COVID 19114 reports
HYPERSENSITIVITY113 reports
NASOPHARYNGITIS113 reports
ALOPECIA112 reports
FEMALE GENITAL TRACT FISTULA112 reports
FLATULENCE112 reports
SYNCOPE112 reports
DISEASE PROGRESSION111 reports

Report Outcomes

Out of 11,979 classified reports for LOPERAMIDE HCL:

Serious 66.4%Non-Serious 33.6%

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

Female6,197 (58.1%)
Male4,453 (41.8%)
Unknown15 (0.1%)

Reports by Age

Age 72228 reports
Age 69227 reports
Age 75212 reports
Age 71211 reports
Age 73202 reports
Age 74202 reports
Age 64200 reports
Age 68196 reports
Age 65191 reports
Age 70191 reports
Age 67187 reports
Age 77181 reports
Age 76167 reports
Age 60164 reports
Age 66160 reports
Age 57159 reports
Age 63157 reports
Age 61151 reports
Age 78151 reports
Age 62149 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 HCL?

This profile reflects 26,027 FDA FAERS reports that mention LOPERAMIDE HCL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for LOPERAMIDE HCL?

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

Who manufactures LOPERAMIDE HCL?

Labeling and FAERS entries often list Rite Aid Corporation in connection with LOPERAMIDE HCL. 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.