🇺🇸 Sertralin in United States

330 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. Dizziness — 50 reports (15.15%)
  2. Fatigue — 40 reports (12.12%)
  3. Drug Interaction — 36 reports (10.91%)
  4. Dyspnoea — 34 reports (10.3%)
  5. Nausea — 31 reports (9.39%)
  6. Diarrhoea — 29 reports (8.79%)
  7. Pneumonia — 29 reports (8.79%)
  8. General Physical Health Deterioration — 27 reports (8.18%)
  9. Headache — 27 reports (8.18%)
  10. Restlessness — 27 reports (8.18%)

Source database →

Sertralin in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Neuroscience approved in United States

Frequently asked questions

Is Sertralin approved in United States?

Yes. FDA has authorised it.

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

Poznan University of Medical Sciences is the originator. The local marketing authorisation holder may differ — check the official source linked above.