🇺🇸 Buprenorphine/naloxone sublingual tablets in United States
13 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: 13
Most-reported reactions
- Nausea — 3 reports (23.08%)
- Accidental Exposure To Product By Child — 2 reports (15.38%)
- Decreased Appetite — 1 report (7.69%)
- Drug Effect Decreased — 1 report (7.69%)
- Headache — 1 report (7.69%)
- Irritability — 1 report (7.69%)
- Malaise — 1 report (7.69%)
- Product Solubility Abnormal — 1 report (7.69%)
- Product Substitution Issue — 1 report (7.69%)
- Product Taste Abnormal — 1 report (7.69%)
Other Psychiatry / Addiction Medicine approved in United States
Frequently asked questions
Is Buprenorphine/naloxone sublingual tablets approved in United States?
Buprenorphine/naloxone sublingual tablets does not currently have US marketing authorisation in our dataset.
Who is the marketing authorisation holder for Buprenorphine/naloxone sublingual tablets in United States?
Orexo AB is the originator. The local marketing authorisation holder may differ — check the official source linked above.