🇺🇸 Subutex in United States

6,800 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: 28 March 2025 – 28 March 2026
• Total reports: 6,800

Most-reported reactions

1. Foetal Exposure During Pregnancy — 1,180 reports (17.35%)
2. Drug Dependence — 1,136 reports (16.71%)
3. Drug Withdrawal Syndrome Neonatal — 1,025 reports (15.07%)
4. Drug Abuse — 765 reports (11.25%)
5. Maternal Exposure During Pregnancy — 575 reports (8.46%)
6. Drug Withdrawal Syndrome — 483 reports (7.1%)
7. Pain — 427 reports (6.28%)
8. Anxiety — 415 reports (6.1%)
9. Substance Abuse — 408 reports (6%)
10. Intentional Product Misuse — 386 reports (5.68%)

Source database →

Frequently asked questions

Is Subutex approved in United States?

Subutex does not currently have US marketing authorisation in our dataset.

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

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