🇺🇸 PRAZIQUANTEL in United States

FDA authorised PRAZIQUANTEL on 27 November 2017 · 152 US adverse-event reports

Marketing authorisations

FDA — authorised 27 November 2017

  • Application: ANDA208820
  • Marketing authorisation holder: PH HEALTH
  • Local brand name: PRAZIQUANTEL
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

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 — 28 reports (18.42%)
  2. Off Label Use — 26 reports (17.11%)
  3. Product Use In Unapproved Indication — 18 reports (11.84%)
  4. Pyrexia — 18 reports (11.84%)
  5. Seizure — 12 reports (7.89%)
  6. Schistosomiasis — 11 reports (7.24%)
  7. Condition Aggravated — 10 reports (6.58%)
  8. Urticaria — 10 reports (6.58%)
  9. Vomiting — 10 reports (6.58%)
  10. Headache — 9 reports (5.92%)

Source database →

PRAZIQUANTEL 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 PRAZIQUANTEL approved in United States?

Yes. FDA authorised it on 27 November 2017; FDA has authorised it.

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

PH HEALTH holds the US marketing authorisation.