🇺🇸 simethicon in United States

34 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. Abdominal Pain — 4 reports (11.76%)
  2. Nausea — 4 reports (11.76%)
  3. Pneumonia — 4 reports (11.76%)
  4. Vomiting — 4 reports (11.76%)
  5. Disease Progression — 3 reports (8.82%)
  6. Fatigue — 3 reports (8.82%)
  7. Malignant Neoplasm Progression — 3 reports (8.82%)
  8. Pain — 3 reports (8.82%)
  9. Pain In Extremity — 3 reports (8.82%)
  10. Rash — 3 reports (8.82%)

Source database →

simethicon 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 simethicon approved in United States?

Yes. FDA has authorised it.

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

Azienda Policlinico Umberto I is the originator. The local marketing authorisation holder may differ — check the official source linked above.