🇺🇸 raltegravir (Isentress) in United States

17 US adverse-event reports

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: 23 April 2025 – 23 April 2026
• Total reports: 17

Most-reported reactions

1. Maternal Drugs Affecting Foetus — 5 reports (29.41%)
2. Volvulus — 3 reports (17.65%)
3. Trisomy 21 — 2 reports (11.76%)
4. Abortion — 1 report (5.88%)
5. Abortion Induced — 1 report (5.88%)
6. Bacterial Test Positive — 1 report (5.88%)
7. Cellulitis — 1 report (5.88%)
8. Congenital Anomaly — 1 report (5.88%)
9. Device Failure — 1 report (5.88%)
10. Dysphagia — 1 report (5.88%)

Source database →

Frequently asked questions

Is raltegravir (Isentress) approved in United States?

raltegravir (Isentress) does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for raltegravir (Isentress) in United States?

Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux is the originator. The local marketing authorisation holder may differ — check the official source linked above.