🇺🇸 Nasonex in United States

FDA authorised Nasonex on 17 March 2022 · 16,263 US adverse-event reports

Marketing authorisations

FDA — authorised 17 March 2022

  • Application: NDA215712
  • Marketing authorisation holder: PERRIGO PHARMA INTL
  • Status: supplemented

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. Dyspnoea — 2,283 reports (14.04%)
  2. Headache — 1,885 reports (11.59%)
  3. Drug Ineffective — 1,834 reports (11.28%)
  4. Asthma — 1,696 reports (10.43%)
  5. Fatigue — 1,676 reports (10.31%)
  6. Nausea — 1,574 reports (9.68%)
  7. Cough — 1,523 reports (9.36%)
  8. Product Quality Issue — 1,279 reports (7.86%)
  9. Drug Dose Omission — 1,266 reports (7.78%)
  10. Wheezing — 1,247 reports (7.67%)

Source database →

Nasonex in other countries

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

Other Oncology approved in United States

Frequently asked questions

Is Nasonex approved in United States?

Yes. FDA authorised it on 17 March 2022; FDA has authorised it.

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

PERRIGO PHARMA INTL holds the US marketing authorisation.