The most commonly reported side effects of simethicone include incorrect dose administered, diarrhoea, and off label use, based on 11,935 FDA adverse event reports from 2004 to 2025. 12.7% of reports found the drug to be ineffective.
Percentages show how often each reaction appears relative to total reports for simethicone.
These are voluntary reports and do not establish that simethicone caused these reactions.
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Other drugs that appear in adverse event reports alongside simethicone. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.
Also suspected
Taken alongside
Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.
59.4% of simethicone adverse event reports involve female patients and 34.1% involve male patients. The largest age group is elderly at 55%. These figures reflect who reports side effects, not underlying risk.
Sex
Age group
Conditions and purposes for which patients were taking simethicone when the adverse event was reported.
Showing 15 of 279 indications
Simethicone is sold under brand names including Loperamide Hydrochloride And Simethicone, Sonorx.
An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.
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