FDA — authorised 28 October 2011
- Application: NDA022496
- Marketing authorisation holder: PACIRA PHARMS INC
- Local brand name: EXPAREL
- Indication: INJECTABLE, LIPOSOMAL — INJECTION
- Status: approved
🇺🇸 Exparel in United States
FDA authorised Exparel on 28 October 2011 · 1,432 US adverse-event reports
Marketing authorisations
FDA — authorised 1 July 2024
- Application: ANDA214348
- Marketing authorisation holder: HENGRUI PHARMA
- Local brand name: BUPIVACAINE LIPOSOME
- Indication: INJECTABLE, LIPOSOMAL — INJECTION
- 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: 20 April 2025 – 20 April 2026
- Total reports: 1,432
Most-reported reactions
- Off Label Use — 245 reports (17.11%)
- Labelled Drug-Drug Interaction Medication Error — 236 reports (16.48%)
- No Adverse Event — 193 reports (13.48%)
- Drug Ineffective — 178 reports (12.43%)
- Hypoaesthesia — 134 reports (9.36%)
- Pain — 134 reports (9.36%)
- Hospitalisation — 120 reports (8.38%)
- Procedural Pain — 72 reports (5.03%)
- Extra Dose Administered — 63 reports (4.4%)
- Hypotension — 57 reports (3.98%)
Exparel in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Exparel approved in United States?
Yes. FDA authorised it on 28 October 2011; FDA authorised it on 1 July 2024; FDA has authorised it.
Who is the marketing authorisation holder for Exparel in United States?
PACIRA PHARMS INC holds the US marketing authorisation.