🇺🇸 Carbamazepin in United States

FDA authorised Carbamazepin on 13 April 2021 · 367 US adverse-event reports

Marketing authorisations

FDA — authorised 13 April 2021

  • Application: ANDA213311
  • Marketing authorisation holder: CSPC OUYI
  • Status: approved

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. Fatigue — 59 reports (16.08%)
  2. Fall — 51 reports (13.9%)
  3. Drug Interaction — 38 reports (10.35%)
  4. Headache — 38 reports (10.35%)
  5. Seizure — 36 reports (9.81%)
  6. Pain In Extremity — 33 reports (8.99%)
  7. Dizziness — 30 reports (8.17%)
  8. Drug Ineffective — 29 reports (7.9%)
  9. Pain — 29 reports (7.9%)
  10. Gait Disturbance — 24 reports (6.54%)

Source database →

Carbamazepin 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 Carbamazepin approved in United States?

Yes. FDA authorised it on 13 April 2021; FDA has authorised it.

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

CSPC OUYI holds the US marketing authorisation.