🇺🇸 DIBUCAINE in United States

468 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. Malaise — 57 reports (12.18%)
  2. Pyrexia — 51 reports (10.9%)
  3. Weight Decreased — 49 reports (10.47%)
  4. Nasopharyngitis — 48 reports (10.26%)
  5. Dyspnoea — 47 reports (10.04%)
  6. Insomnia — 45 reports (9.62%)
  7. Dyspnoea Exertional — 44 reports (9.4%)
  8. Chest Pain — 43 reports (9.19%)
  9. Fall — 43 reports (9.19%)
  10. Cough — 41 reports (8.76%)

Source database →

DIBUCAINE 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 DIBUCAINE approved in United States?

Yes. FDA has authorised it.

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

Marketing authorisation holder not available in our data.