FDA — authorised 17 July 2018
- Application: NDA210455
- Marketing authorisation holder: JANSSEN PRODS
- Local brand name: SYMTUZA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Symtuza in United States
FDA authorised Symtuza on 17 July 2018 · 5,603 US adverse-event reports
Marketing authorisations
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.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 5,603
Most-reported reactions
- Bone Density Decreased — 1,046 reports (18.67%)
- Bone Loss — 594 reports (10.6%)
- Osteonecrosis — 594 reports (10.6%)
- Chronic Kidney Disease — 574 reports (10.24%)
- Tooth Loss — 551 reports (9.83%)
- Multiple Fractures — 525 reports (9.37%)
- Renal Failure — 501 reports (8.94%)
- Osteoporosis — 425 reports (7.59%)
- Renal Injury — 423 reports (7.55%)
- Skeletal Injury — 370 reports (6.6%)
Symtuza in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Symtuza approved in United States?
Yes. FDA authorised it on 17 July 2018; FDA has authorised it.
Who is the marketing authorisation holder for Symtuza in United States?
JANSSEN PRODS holds the US marketing authorisation.