🇺🇸 Jatenzo in United States

FDA authorised Jatenzo on 27 March 2019 · 199 US adverse-event reports

Marketing authorisations

FDA — authorised 27 March 2019

  • Application: NDA206089
  • Marketing authorisation holder: TOLMAR
  • Local brand name: JATENZO
  • Indication: CAPSULE — ORAL
  • Status: approved

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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. Off Label Use — 30 reports (15.08%)
  2. Drug Ineffective — 27 reports (13.57%)
  3. Blood Testosterone Abnormal — 21 reports (10.55%)
  4. Blood Testosterone Decreased — 21 reports (10.55%)
  5. Therapy Interrupted — 19 reports (9.55%)
  6. Fatigue — 18 reports (9.05%)
  7. Headache — 18 reports (9.05%)
  8. Intentional Product Use Issue — 16 reports (8.04%)
  9. Product Availability Issue — 16 reports (8.04%)
  10. Blood Testosterone Increased — 13 reports (6.53%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Jatenzo approved in United States?

Yes. FDA authorised it on 27 March 2019; FDA has authorised it.

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

TOLMAR holds the US marketing authorisation.