🇺🇸 EmSam in United States

FDA authorised EmSam on 27 February 2006 · 1,197 US adverse-event reports

Marketing authorisations

FDA — authorised 27 February 2006

  • Application: NDA021336
  • Marketing authorisation holder: SOMERSET
  • Status: supplemented

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. Application Site Erythema — 197 reports (16.46%)
  2. Drug Ineffective — 175 reports (14.62%)
  3. Insomnia — 141 reports (11.78%)
  4. Application Site Rash — 131 reports (10.94%)
  5. Application Site Pruritus — 126 reports (10.53%)
  6. Depression — 107 reports (8.94%)
  7. Anxiety — 89 reports (7.44%)
  8. Headache — 87 reports (7.27%)
  9. Application Site Reaction — 72 reports (6.02%)
  10. Dizziness — 72 reports (6.02%)

Source database →

EmSam 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 EmSam approved in United States?

Yes. FDA authorised it on 27 February 2006; FDA has authorised it.

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

SOMERSET holds the US marketing authorisation.