Drug class
Opioid agonist; Schedule IV controlled substance
Uses
"Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate." Not for as-needed use; reserved for patients where non-opioid analgesics or immediate-release opioids prove ineffective or intolerable.
Warnings
BOXED WARNING: Addiction/Abuse Risk - "exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death"; Respiratory Depression - "serious, life-threatening, or fatal respiratory depression may occur"; Accidental Ingestion - risk of fatal overdose, especially in children; contraindicated under age 12 and post-tonsillectomy under age 18; CNS Depressants - concomitant use with benzodiazepines may cause "profound sedation, respiratory depression, coma, and death."
Side effects
Occurring in >=10% of patients at recommended doses: "dizziness, constipation, nausea, headache, somnolence, flushing, pruritus, vomiting, insomnia, and dry mouth." Additional reactions: respiratory depression, seizures, serotonin syndrome, hypotension, withdrawal symptoms.