Pfizer Fentanyl Citrate Warnings

Limitations of use: Because of the risks associated with the use of opioids, fentanyl should only be used in patients for whom other treatment options, including non-opioid analgesics, are ineffective, not tolerated or otherwise inadequate to provide appropriate management of pain (see Precautions).
Hazardous and harmful use: Fentanyl poses risks of hazardous and harmful use which can lead to overdose and death. Assess the patient's risk of hazardous and harmful use before prescribing and monitor the patient regularly during treatment (see Precautions).
Life-threatening respiratory depression: Serious, life-threatening or fatal respiratory depression may occur with the use of fentanyl. Be aware of situations which increase the risk of respiratory depression, modify dosing in patients at risk and monitor patients closely, especially on initiation or following a dose increase (see Precautions).
Concomitant use of benzodiazepines and other central nervous system (CNS) depressants, including alcohol: Concomitant use of opioids with CNS depressant medicines, such as other opioid analgesics, benzodiazepines, gabapentinoids, cannabis, sedatives, hypnotics, tricyclic antidepressants, antipsychotics, antihistamines, centrally-active anti-emetics, general anesthetics, tranquilisers, or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Limit dosages and durations to the minimum required; and monitor patients for signs and symptoms of respiratory depression and sedation. Caution patients not to drink alcohol while taking fentanyl (see Precautions).