FDA — authorised 30 April 1996
- Application: NDA020573
- Marketing authorisation holder: HORIZON THERAP US
- Local brand name: BUPHENYL
- Indication: POWDER — ORAL
- Status: approved
🇺🇸 Buphenyl in United States
FDA authorised Buphenyl on 30 April 1996 · 172 US adverse-event reports
Marketing authorisations
FDA — authorised 13 May 1996
- Application: NDA020572
- Marketing authorisation holder: HORIZON THERAP US
- Local brand name: BUPHENYL
- Indication: TABLET — ORAL
- Status: approved
FDA
- 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: 172
Most-reported reactions
- Hyperammonaemia — 39 reports (22.67%)
- Vomiting — 29 reports (16.86%)
- Off Label Use — 27 reports (15.7%)
- Ammonia Increased — 19 reports (11.05%)
- Hyperammonaemic Crisis — 12 reports (6.98%)
- Death — 11 reports (6.4%)
- Condition Aggravated — 9 reports (5.23%)
- Decreased Appetite — 9 reports (5.23%)
- Diarrhoea — 9 reports (5.23%)
- Headache — 8 reports (4.65%)
Other Metabolic approved in United States
Frequently asked questions
Is Buphenyl approved in United States?
Yes. FDA authorised it on 30 April 1996; FDA authorised it on 13 May 1996; FDA has authorised it.
Who is the marketing authorisation holder for Buphenyl in United States?
HORIZON THERAP US holds the US marketing authorisation.