🇺🇸 Tramacet in United States

1,320 US adverse-event reports

Marketing authorisation

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.

Most-reported reactions

  1. Drug Ineffective — 202 reports (15.3%)
  2. Pain — 176 reports (13.33%)
  3. Off Label Use — 142 reports (10.76%)
  4. Arthralgia — 139 reports (10.53%)
  5. Fatigue — 130 reports (9.85%)
  6. Malaise — 121 reports (9.17%)
  7. Rheumatoid Arthritis — 115 reports (8.71%)
  8. Diarrhoea — 107 reports (8.11%)
  9. Nausea — 102 reports (7.73%)
  10. Headache — 86 reports (6.52%)

Source database →

Tramacet 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 Tramacet approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Tramacet in United States?

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the originator. The local marketing authorisation holder may differ — check the official source linked above.