🇺🇸 Phenylephrine Ophthalmic in United States

11 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 — 5 reports (45.45%)
  2. Documented Hypersensitivity To Administered Drug — 1 report (9.09%)
  3. Eye Pain — 1 report (9.09%)
  4. Eye Swelling — 1 report (9.09%)
  5. Hypertension — 1 report (9.09%)
  6. Paralysis — 1 report (9.09%)
  7. Throat Tightness — 1 report (9.09%)

Source database →

Phenylephrine Ophthalmic 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 Phenylephrine Ophthalmic approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Phenylephrine Ophthalmic in United States?

University of Miami is the originator. The local marketing authorisation holder may differ — check the official source linked above.