Hydroxyurea: Side Effects, Uses & Monitoring
Significant tumor response to hydroxyurea capsules USP has been demonstrated in melanoma, resistant chronic myelocytic leukemia, and recurrent, metastatic, or inoperable carcinoma of the ovary.
- Data source
- FDA labeling via NIH DailyMed (label 7a2e2305…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
No structured frequency data available in current labeling. Consult the official label.
Labeled uses (from FDA prescribing information)
Significant tumor response to hydroxyurea capsules USP has been demonstrated in melanoma, resistant chronic myelocytic leukemia, and recurrent, metastatic, or inoperable carcinoma of the ovary. Hydroxyurea, USP used concomitantly with irradiation therapy is intended for use in the local control of primary squamous cell (epidermoid) carcinomas of the head and neck, excluding the lip.
Conditions associated with Hydroxyurea in labeling
Frequently Asked Questions
What is Hydroxyurea used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Hydroxyurea?
Current labeling for this ingredient does not include a structured frequency table that we can reproduce. Review the official label linked below.
Does Hydroxyurea require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Hydroxyurea.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.