Drug class
Opioid agonist (Schedule II controlled substance); this combination product pairs an opioid with a non-opioid analgesic (acetaminophen).
Uses
Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Warnings
BOXED WARNING: Addiction/abuse/misuse, life-threatening respiratory depression, accidental ingestion (especially in children), neonatal opioid withdrawal syndrome, CYP3A4 drug interactions, hepatotoxicity (from the acetaminophen component), and risks from concomitant use with benzodiazepines/CNS depressants. | "Serious, life-threatening, or fatal respiratory depression may occur" especially during initiation or dose increases.
Side effects
"Light-headedness, dizziness, sedation, nausea and vomiting." Other reactions include drowsiness, constipation, urinary retention, and respiratory depression.