FDA-APPROVED BLACK-BOX WARNING
All codeine-containing products have a lengthy FDA-approved black-box warning. The following are highlights from that warning:
Addiction, Abuse and Misuse
Codeine exposes patients and other users to the risks of opioid addiction, abuse and misuse, which can lead to overdose and death.
Life-Threatening Respiratory Depression
Serious, life-threatening or fatal respiratory depression may occur with use of codeine.
Accidental ingestion of codeine, especially by children, can result in a fatal overdose of codeine.
Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children
Life-threatening respiratory depression and death have occurred in children who received codeine. Most of the reported cases occurred following tonsillectomy and/or adenoidectomy, and many of the children had evidence of being ultra-rapid metabolizers of codeine due to a particular genetic type for a liver enzyme involved in drug metabolism.
Neonatal Opioid Withdrawal Syndrome
Prolonged use of codeine during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated appropriately.
Risks of Concomitant Use with Benzodiazepines or Other CNS Depressants
Concomitant use of opioids, like codeine, with benzodiazepines or other central nervous system depressants, including alcohol, may result in profound sedation, respiratory depression, coma and death.