🇺🇸 quetiapine fumarate extended-release in United States

79 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. Pain — 10 reports (12.66%)
  2. Arthralgia — 9 reports (11.39%)
  3. Pain In Extremity — 9 reports (11.39%)
  4. Hypoaesthesia — 8 reports (10.13%)
  5. Insomnia — 8 reports (10.13%)
  6. Intentional Overdose — 8 reports (10.13%)
  7. Toxicity To Various Agents — 8 reports (10.13%)
  8. Bezoar — 7 reports (8.86%)
  9. Exposure During Pregnancy — 6 reports (7.59%)
  10. Gestational Diabetes — 6 reports (7.59%)

Source database →

quetiapine fumarate extended-release 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 quetiapine fumarate extended-release approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for quetiapine fumarate extended-release in United States?

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