🇺🇸 Levitra in United States

FDA authorised Levitra on 19 August 2003 · 5,055 US adverse-event reports

Marketing authorisations

FDA — authorised 19 August 2003

  • Application: NDA021400
  • Marketing authorisation holder: BAYER HLTHCARE
  • Local brand name: LEVITRA
  • 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. Erectile Dysfunction — 1,562 reports (30.9%)
  2. Drug Ineffective — 1,279 reports (25.3%)
  3. Headache — 702 reports (13.89%)
  4. Flushing — 327 reports (6.47%)
  5. Dizziness — 234 reports (4.63%)
  6. Erection Increased — 222 reports (4.39%)
  7. Nasal Congestion — 220 reports (4.35%)
  8. Chronic Kidney Disease — 180 reports (3.56%)
  9. Adverse Event — 166 reports (3.28%)
  10. Nausea — 163 reports (3.22%)

Source database →

Levitra in other countries

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

Other Other approved in United States

Frequently asked questions

Is Levitra approved in United States?

Yes. FDA authorised it on 19 August 2003; FDA has authorised it.

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

BAYER HLTHCARE holds the US marketing authorisation.