FDA — authorised 15 December 1995
- Application: ANDA074413
- Marketing authorisation holder: HIKMA
- Local brand name: SUFENTANIL CITRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 SUFENTANIL CITRATE in United States
FDA authorised SUFENTANIL CITRATE on 15 December 1995 · 887 US adverse-event reports
Marketing authorisations
FDA — authorised 11 December 1996
- Application: ANDA074534
- Marketing authorisation holder: HOSPIRA
- Local brand name: SUFENTANIL CITRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA074406
- Marketing authorisation holder: WATSON LABS
- Local brand name: SUFENTANIL CITRATE
- Indication: INJECTABLE — INJECTION
- 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: 887
Most-reported reactions
- Anaphylactic Shock — 228 reports (25.7%)
- Hypotension — 130 reports (14.66%)
- Anaphylactic Reaction — 78 reports (8.79%)
- Pain — 75 reports (8.46%)
- Renal Failure — 73 reports (8.23%)
- Tachycardia — 70 reports (7.89%)
- Bronchospasm — 69 reports (7.78%)
- Cardiac Arrest — 60 reports (6.76%)
- Injury — 52 reports (5.86%)
- Toxic Epidermal Necrolysis — 52 reports (5.86%)
SUFENTANIL CITRATE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is SUFENTANIL CITRATE approved in United States?
Yes. FDA authorised it on 15 December 1995; FDA authorised it on 11 December 1996; FDA has authorised it.
Who is the marketing authorisation holder for SUFENTANIL CITRATE in United States?
HIKMA holds the US marketing authorisation.