The most commonly reported side effects of hydroxyurea include off label use, sickle cell anaemia with crisis, and fatigue, based on 20,754 FDA adverse event reports from 2004 to 2025. 3.7% of reports found the drug to be ineffective.
Percentages show how often each reaction appears relative to total reports for hydroxyurea.
These are voluntary reports and do not establish that hydroxyurea caused these reactions.
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Other drugs that appear in adverse event reports alongside hydroxyurea. 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.
42.3% of hydroxyurea adverse event reports involve female patients and 38.1% involve male patients. The largest age group is elderly at 47%. These figures reflect who reports side effects, not underlying risk.
Sex
Age group
Conditions and purposes for which patients were taking hydroxyurea when the adverse event was reported.
Showing 15 of 582 indications
Hydroxyurea is sold under the brand name Hydrea.
An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.
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