🇺🇸 Dolutegravir 50 mg in United States

FDA authorised Dolutegravir 50 mg on 12 August 2013 · 15 US adverse-event reports

Marketing authorisations

FDA — authorised 12 August 2013

  • Application: NDA204790
  • Marketing authorisation holder: VIIV HLTHCARE
  • Local brand name: TIVICAY
  • Indication: TABLET — 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. Depression — 2 reports (13.33%)
  2. Drug Interaction — 2 reports (13.33%)
  3. Fatigue — 2 reports (13.33%)
  4. Irritability — 2 reports (13.33%)
  5. Peripheral Sensorimotor Neuropathy — 2 reports (13.33%)
  6. Agitation — 1 report (6.67%)
  7. Anxiety — 1 report (6.67%)
  8. Appendicitis — 1 report (6.67%)
  9. Bacterial Sepsis — 1 report (6.67%)
  10. Blood Pressure Decreased — 1 report (6.67%)

Source database →

Dolutegravir 50 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 Dolutegravir 50 mg approved in United States?

Yes. FDA authorised it on 12 August 2013; FDA has authorised it.

Who is the marketing authorisation holder for Dolutegravir 50 mg in United States?

VIIV HLTHCARE holds the US marketing authorisation.