🇺🇸 SERTRALINE in United States

66,754 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 — 8,508 reports (12.75%)
  2. Nausea — 8,444 reports (12.65%)
  3. Fatigue — 7,597 reports (11.38%)
  4. Headache — 6,809 reports (10.2%)
  5. Diarrhoea — 6,679 reports (10.01%)
  6. Anxiety — 6,038 reports (9.05%)
  7. Dizziness — 6,036 reports (9.04%)
  8. Off Label Use — 5,740 reports (8.6%)
  9. Drug Interaction — 5,538 reports (8.3%)
  10. Depression — 5,365 reports (8.04%)

Source database →

SERTRALINE 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 SERTRALINE approved in United States?

Yes. FDA has authorised it.

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

Marketing authorisation holder not available in our data.