The most commonly reported side effects of sofosbuvir include fatigue, headache, and nausea, based on 52,285 FDA adverse event reports from 2013 to 2025. 6.9% of reports found the drug to be ineffective.
Percentages show how often each reaction appears relative to total reports for sofosbuvir.
These are voluntary reports and do not establish that sofosbuvir caused these reactions.
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Other drugs that appear in adverse event reports alongside sofosbuvir. 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.
37.9% of sofosbuvir adverse event reports involve female patients and 54.3% involve male patients. The largest age group is adult at 77%. These figures reflect who reports side effects, not underlying risk.
Sex
Age group
Conditions and purposes for which patients were taking sofosbuvir when the adverse event was reported.
Showing 15 of 324 indications
Sofosbuvir is sold under the brand name Harvoni.
An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.
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