FDA black box
Boxed warnings
The FDA’s strongest warnings: breathing can stop, addiction is a real risk, and mixing with sedatives can be fatal.
What the label emphasizes
- Life-threatening respiratory depression, especially when starting or increasing a dose
- Addiction, abuse, and misuse that can lead to overdose and death
- Dangerous interaction with benzodiazepines, alcohol, and other sedatives — profound sedation, coma, death
- Neonatal opioid withdrawal if used throughout pregnancy
- Accidental ingestion, especially by a child, can be fatal