FDA BLACK-BOX WARNING
All hydrocodone-containing products have a lengthy FDA-approved black-box warning. The following are highlights from that warning:
Addiction, Abuse and Misuse
Hydrocodone 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 hydrocodone.
Accidental ingestion of even one dose of hydrocodone, especially by children, can result in a fatal overdose of hydrocodone.
Risk of Medication Errors
Ensure accuracy when prescribing, dispensing and administering hydrocodone. Dosing errors can result in accidental overdose and death.
Risks of Concomitant Use with Benzodiazepines or Other CNS Depressants
Concomitant use of opioids, like hydrocodone, with benzodiazepines or other central nervous system depressants, including alcohol, may result in profound sedation, respiratory depression, coma and death.
Interaction with Alcohol
Do not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking hydrocodone. The co-ingestion of alcohol with hydrocodone may result in increased blood levels and a potentially fatal overdose of hydrocodone.
Neonatal Opioid Withdrawal Syndrome
Prolonged use of hydrodone during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated appropriately.