FDA — authorised 31 October 1984
- Application: ANDA088762
- Marketing authorisation holder: G AND W LABS INC
- Local brand name: PROMETH W/ DEXTROMETHORPHAN
- Indication: SYRUP — ORAL
- Status: approved
🇺🇸 DEXTROMETHORPHAN in United States
FDA authorised DEXTROMETHORPHAN on 31 October 1984 · 10,421 US adverse-event reports
Marketing authorisations
FDA — authorised 4 January 1985
- Application: ANDA088864
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: PROMETHAZINE W/ DEXTROMETHORPHAN
- Indication: SYRUP — 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: 20 April 2025 – 20 April 2026
- Total reports: 10,421
Most-reported reactions
- Death — 3,295 reports (31.62%)
- Drug Abuse — 1,257 reports (12.06%)
- Toxicity To Various Agents — 1,245 reports (11.95%)
- Drug Ineffective — 1,170 reports (11.23%)
- Completed Suicide — 765 reports (7.34%)
- Diarrhoea — 594 reports (5.7%)
- Dizziness — 542 reports (5.2%)
- Nausea — 541 reports (5.19%)
- Dyspnoea — 531 reports (5.1%)
- Off Label Use — 481 reports (4.62%)
DEXTROMETHORPHAN 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 DEXTROMETHORPHAN approved in United States?
Yes. FDA authorised it on 31 October 1984; FDA authorised it on 4 January 1985; FDA has authorised it.
Who is the marketing authorisation holder for DEXTROMETHORPHAN in United States?
G AND W LABS INC holds the US marketing authorisation.