🇺🇸 AndroGel in United States

FDA authorised AndroGel on 28 February 2000 · 15,982 US adverse-event reports

Marketing authorisations

FDA — authorised 28 February 2000

  • Application: NDA021015
  • Marketing authorisation holder: BESINS HLTHCARE
  • Status: supplemented

FDA — authorised 29 April 2011

  • Application: NDA022309
  • Marketing authorisation holder: BESINS HLTHCARE
  • 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. Myocardial Infarction — 2,821 reports (17.65%)
  2. Blood Testosterone Decreased — 1,883 reports (11.78%)
  3. Deep Vein Thrombosis — 1,755 reports (10.98%)
  4. Cerebrovascular Accident — 1,751 reports (10.96%)
  5. Pulmonary Embolism — 1,617 reports (10.12%)
  6. Drug Ineffective — 1,615 reports (10.11%)
  7. Pain — 1,526 reports (9.55%)
  8. Economic Problem — 1,072 reports (6.71%)
  9. Anxiety — 989 reports (6.19%)
  10. Fatigue — 953 reports (5.96%)

Source database →

AndroGel 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 AndroGel approved in United States?

Yes. FDA authorised it on 28 February 2000; FDA authorised it on 29 April 2011; FDA has authorised it.

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

BESINS HLTHCARE holds the US marketing authorisation.