LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

N/A

Manufactured by Aurohealth LLC

142 FDA adverse event reports analyzed

Last updated: 2026-04-15

About LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aurohealth LLC. The most commonly reported adverse reactions for LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE include DIARRHOEA, COUGH, DECREASED APPETITE, PRODUCTIVE COUGH, RHINORRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE.

Top Adverse Reactions

DIARRHOEA6 reports
COUGH3 reports
DECREASED APPETITE3 reports
PRODUCTIVE COUGH3 reports
RHINORRHOEA3 reports
UPPER AIRWAY COUGH SYNDROME3 reports
ABDOMINAL DISTENSION2 reports
ABDOMINAL PAIN UPPER2 reports
APPETITE DISORDER2 reports
DYSPNOEA2 reports
FALL2 reports
FATIGUE2 reports
GASTROOESOPHAGEAL REFLUX DISEASE2 reports
HEADACHE2 reports
HUMERUS FRACTURE2 reports
INFLUENZA2 reports
INJECTION SITE ERYTHEMA2 reports
INJECTION SITE IRRITATION2 reports
INSOMNIA2 reports
JOINT SWELLING2 reports
MUSCLE SPASMS2 reports
NAUSEA2 reports
OEDEMA2 reports
PAIN IN JAW2 reports
PARANASAL SINUS HYPERSECRETION2 reports
PNEUMOCYSTIS JIROVECII PNEUMONIA2 reports
PRODUCT DOSE OMISSION ISSUE2 reports
PRURITUS2 reports
SEASONAL ALLERGY2 reports
THERAPY PARTIAL RESPONDER2 reports
THROAT IRRITATION2 reports
VASCULAR DEVICE INFECTION2 reports
WEIGHT DECREASED2 reports
ABDOMINAL DISCOMFORT1 reports
ABDOMINAL PAIN1 reports
ARTHRALGIA1 reports
ASTHENIA1 reports
BICYTOPENIA1 reports
BLOOD ALBUMIN DECREASED1 reports
CATARACT1 reports
CEREBROVASCULAR ACCIDENT1 reports
COLITIS1 reports
COMA1 reports
COMPLICATION ASSOCIATED WITH DEVICE1 reports
CONDITION AGGRAVATED1 reports
CONFUSIONAL STATE1 reports
COVID 191 reports
DEPRESSED MOOD1 reports
DEPRESSION1 reports
DEVICE RELATED SEPSIS1 reports
DIZZINESS1 reports
DRUG INEFFECTIVE1 reports
DYSPHONIA1 reports
DYSPNOEA EXERTIONAL1 reports
FLUID RETENTION1 reports
FREQUENT BOWEL MOVEMENTS1 reports
FRUSTRATION TOLERANCE DECREASED1 reports
GALLBLADDER DISORDER1 reports
GASTROENTERITIS ASTROVIRAL1 reports
GASTROENTERITIS SALMONELLA1 reports
GASTROINTESTINAL DISORDER1 reports
HEPATIC CYTOLYSIS1 reports
HYPOGLYCAEMIA1 reports
INFECTION1 reports
INJECTION SITE PRURITUS1 reports
MALAISE1 reports
MICTURITION URGENCY1 reports
NASAL CONGESTION1 reports
NASOPHARYNGITIS1 reports
NEEDLE ISSUE1 reports
NOCTURIA1 reports
OEDEMA PERIPHERAL1 reports
OFF LABEL USE1 reports
OROPHARYNGEAL DISCOMFORT1 reports
OROPHARYNGEAL PAIN1 reports
OVERGROWTH BACTERIAL1 reports
PERIPHERAL COLDNESS1 reports
PERIPHERAL SWELLING1 reports
PNEUMONIA1 reports
POLLAKIURIA1 reports
PRODUCT PACKAGING ISSUE1 reports
PRODUCT PACKAGING QUANTITY ISSUE1 reports
PRODUCT USE ISSUE1 reports
PYREXIA1 reports
RASH1 reports
RESPIRATORY SYNCYTIAL VIRUS INFECTION1 reports
SECRETION DISCHARGE1 reports
SHOULDER FRACTURE1 reports
SINUS DISORDER1 reports
SKIN ATROPHY1 reports
SKIN FISSURES1 reports
SKIN REACTION1 reports
THERAPY NON RESPONDER1 reports
TREMOR1 reports
TRISMUS1 reports
UPPER LIMB FRACTURE1 reports
URINARY TRACT INFECTION1 reports
URINE OUTPUT INCREASED1 reports
URTICARIA1 reports
VIRAL INFECTION1 reports

Report Outcomes

Out of 19 classified reports for LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE:

Serious 57.9%Non-Serious 42.1%

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

Female15 (78.9%)
Male4 (21.1%)

Reports by Age

Age 653 reports
Age 572 reports
Age 121 reports
Age 351 reports
Age 601 reports
Age 751 reports
Age 771 reports
Age 821 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 AND SIMETHICONE?

This profile reflects 142 FDA FAERS reports that mention LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE?

Frequently reported terms in FAERS include DIARRHOEA, COUGH, DECREASED APPETITE, PRODUCTIVE COUGH, RHINORRHOEA, UPPER-AIRWAY COUGH SYNDROME. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE?

Labeling and FAERS entries often list Aurohealth LLC in connection with LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE. 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.