🇺🇸 Fosphenytoin Injection in United States

10 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. Abnormal Behaviour — 1 report (10%)
  2. Drug Monitoring Procedure Not Performed — 1 report (10%)
  3. Drug Reaction With Eosinophilia And Systemic Symptoms — 1 report (10%)
  4. Encephalopathy — 1 report (10%)
  5. Gait Disturbance — 1 report (10%)
  6. Overdose — 1 report (10%)
  7. Product Use In Unapproved Indication — 1 report (10%)
  8. Respiratory Failure — 1 report (10%)
  9. Screaming — 1 report (10%)
  10. Somnolence — 1 report (10%)

Source database →

Fosphenytoin Injection 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 Fosphenytoin Injection approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Fosphenytoin Injection in United States?

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