🇺🇸 cetirizine 10 mg in United States

113 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. Drug Ineffective — 19 reports (16.81%)
  2. Product Quality Issue — 16 reports (14.16%)
  3. No Adverse Event — 15 reports (13.27%)
  4. Extra Dose Administered — 13 reports (11.5%)
  5. Fatigue — 11 reports (9.73%)
  6. Headache — 9 reports (7.96%)
  7. Somnolence — 9 reports (7.96%)
  8. Nausea — 8 reports (7.08%)
  9. Dyspnoea — 7 reports (6.19%)
  10. Dizziness — 6 reports (5.31%)

Source database →

cetirizine 10 mg 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 cetirizine 10 mg approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for cetirizine 10 mg in United States?

Maastricht University Medical Center is the originator. The local marketing authorisation holder may differ — check the official source linked above.