🇺🇸 Add-back in United States

64 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: 22 April 2025 – 22 April 2026
• Total reports: 64

Most-reported reactions

1. Hot Flush — 15 reports (23.44%)
2. Pain — 10 reports (15.62%)
3. Headache — 7 reports (10.94%)
4. Weight Increased — 7 reports (10.94%)
5. Drug Ineffective — 5 reports (7.81%)
6. Vaginal Haemorrhage — 5 reports (7.81%)
7. Arthralgia — 4 reports (6.25%)
8. Dizziness — 4 reports (6.25%)
9. Menorrhagia — 4 reports (6.25%)
10. Memory Impairment — 3 reports (4.69%)

Source database →

Frequently asked questions

Is Add-back approved in United States?

Add-back does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Add-back in United States?

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