🇺🇸 Smecta in United States

1,163 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. Diarrhoea — 281 reports (24.16%)
  2. Acute Kidney Injury — 167 reports (14.36%)
  3. Anaemia — 111 reports (9.54%)
  4. Asthenia — 96 reports (8.25%)
  5. Neutropenia — 95 reports (8.17%)
  6. Pyrexia — 91 reports (7.82%)
  7. Thrombocytopenia — 87 reports (7.48%)
  8. Vomiting — 84 reports (7.22%)
  9. General Physical Health Deterioration — 81 reports (6.96%)
  10. Off Label Use — 70 reports (6.02%)

Source database →

Smecta 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 Smecta approved in United States?

Yes. FDA has authorised it.

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

Ipsen is the originator. The local marketing authorisation holder may differ — check the official source linked above.