FDA — authorised 25 August 1988
- Application: NDA016295
- Marketing authorisation holder: WAYLIS THERAP
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 HYDROXYUREA in United States
FDA authorised HYDROXYUREA on 25 August 1988 · 9,757 US adverse-event reports
Marketing authorisations
FDA — authorised 16 October 1998
- Application: ANDA075143
- Marketing authorisation holder: BARR
- Local brand name: HYDROXYUREA
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 February 1999
- Application: ANDA075340
- Marketing authorisation holder: PH HEALTH
- Status: supplemented
FDA — authorised 29 August 2000
- Application: ANDA075734
- Marketing authorisation holder: BARR
- Local brand name: HYDROXYUREA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 April 2020
- Application: ANDA213438
- Marketing authorisation holder: LEADING
- Indication: Labeling
- Status: approved
FDA — authorised 7 December 2021
- Application: NDA208843
- Marketing authorisation holder: THERAVIA
- Indication: Efficacy
- Status: approved
FDA — authorised 6 March 2024
- Application: ANDA218021
- Marketing authorisation holder: QILU
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 9,757
Most-reported reactions
- Off Label Use — 1,626 reports (16.66%)
- Sickle Cell Anaemia With Crisis — 1,250 reports (12.81%)
- Fatigue — 1,111 reports (11.39%)
- Diarrhoea — 1,098 reports (11.25%)
- Nausea — 990 reports (10.15%)
- Headache — 814 reports (8.34%)
- Death — 751 reports (7.7%)
- Product Dose Omission Issue — 739 reports (7.57%)
- Drug Ineffective — 702 reports (7.19%)
- Haemoglobin Decreased — 676 reports (6.93%)
HYDROXYUREA in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is HYDROXYUREA approved in United States?
Yes. FDA authorised it on 25 August 1988; FDA authorised it on 16 October 1998; FDA authorised it on 24 February 1999.
Who is the marketing authorisation holder for HYDROXYUREA in United States?
WAYLIS THERAP holds the US marketing authorisation.