FDA — authorised 9 August 2002
- Application: NDA021492
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: ELOXATIN
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
🇺🇸 eloxatin in United States
FDA authorised eloxatin on 9 August 2002 · 3,848 US adverse-event reports
Marketing authorisations
FDA — authorised 31 January 2005
- Application: NDA021759
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: ELOXATIN
- Indication: INJECTABLE — INTRAVENOUS
- 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: 28 March 2025 – 28 March 2026
- Total reports: 3,848
Most-reported reactions
- Nausea — 590 reports (15.33%)
- Diarrhoea — 584 reports (15.18%)
- Vomiting — 520 reports (13.51%)
- Dyspnoea — 444 reports (11.54%)
- Pyrexia — 377 reports (9.8%)
- Abdominal Pain — 317 reports (8.24%)
- Dehydration — 264 reports (6.86%)
- Disease Progression — 262 reports (6.81%)
- Neuropathy Peripheral — 254 reports (6.6%)
- Fatigue — 236 reports (6.13%)
Other Other approved in United States
Frequently asked questions
Is eloxatin approved in United States?
Yes. FDA authorised it on 9 August 2002; FDA authorised it on 31 January 2005.
Who is the marketing authorisation holder for eloxatin in United States?
SANOFI AVENTIS US holds the US marketing authorisation.