FDA — authorised 22 January 1975
- Application: ANDA080445
- Marketing authorisation holder: WEST-WARD PHARMS INT
- Indication: Labeling
- Status: approved
🇺🇸 MEPERIDINE in United States
FDA authorised MEPERIDINE on 22 January 1975 · 3,355 US adverse-event reports
Marketing authorisations
FDA — authorised 30 January 1985
- Application: ANDA088744
- Marketing authorisation holder: HIKMA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 28 May 1999
- Application: ANDA040331
- Marketing authorisation holder: EPIC PHARMA LLC
- Indication: Labeling
- Status: approved
FDA — authorised 24 August 2001
- Application: NDA021171
- Marketing authorisation holder: HOSPIRA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 24 June 2009
- Application: ANDA040893
- Marketing authorisation holder: GENUS
- Indication: REMS
- 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: 3,355
Most-reported reactions
- Drug Hypersensitivity — 754 reports (22.47%)
- Nausea — 379 reports (11.3%)
- Pain — 363 reports (10.82%)
- Vomiting — 297 reports (8.85%)
- Drug Ineffective — 293 reports (8.73%)
- Dependence — 284 reports (8.46%)
- Overdose — 262 reports (7.81%)
- Drug Intolerance — 244 reports (7.27%)
- Drug Dependence — 240 reports (7.15%)
- Serotonin Syndrome — 239 reports (7.12%)
MEPERIDINE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is MEPERIDINE approved in United States?
Yes. FDA authorised it on 22 January 1975; FDA authorised it on 30 January 1985; FDA authorised it on 28 May 1999.
Who is the marketing authorisation holder for MEPERIDINE in United States?
WEST-WARD PHARMS INT holds the US marketing authorisation.