🇺🇸 Kaletra in United States

8,153 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 Interaction — 1,273 reports (15.61%)
  2. Depression — 1,126 reports (13.81%)
  3. Diarrhoea — 784 reports (9.62%)
  4. Nausea — 775 reports (9.51%)
  5. Drug Exposure During Pregnancy — 752 reports (9.22%)
  6. Anxiety — 710 reports (8.71%)
  7. Foetal Exposure During Pregnancy — 698 reports (8.56%)
  8. Pain — 694 reports (8.51%)
  9. Vomiting — 691 reports (8.48%)
  10. Off Label Use — 650 reports (7.97%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Kaletra approved in United States?

Yes. FDA has authorised it.

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

Therapeutic Concepts is the originator. The local marketing authorisation holder may differ — check the official source linked above.