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TIPRANAVIR ›
Regulatory · United States
Marketing authorisation
FDA — authorised 11 August 2006
Application: NDA021814
Marketing authorisation holder: BOEHRINGER INGELHEIM
Indication: Labeling
Status: approved
Read official source →
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.
Window: 20 April 2025 – 20 April 2026
Total reports: 1,050
Most-reported reactions
Death — 136 reports (12.95%) Nausea — 128 reports (12.19%) Vomiting — 121 reports (11.52%) Pneumonia — 112 reports (10.67%) Hepatotoxicity — 95 reports (9.05%) Cholelithiasis — 93 reports (8.86%) Condition Aggravated — 93 reports (8.86%) Hepatic Enzyme Increased — 91 reports (8.67%) Oedema Peripheral — 91 reports (8.67%) Schizophrenia — 90 reports (8.57%)
Source database →
TIPRANAVIR 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 TIPRANAVIR approved in United States?
Yes. FDA authorised it on 11 August 2006.
Who is the marketing authorisation holder for TIPRANAVIR in United States?
BOEHRINGER INGELHEIM holds the US marketing authorisation.