IMPORTANT INFORMATION FDA warning This drug has a black box warning. This is the most serious warning from the Food and Drug Administration (FDA).

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A black box warning alerts doctors and patients about drug effects that may be dangerous. Addiction and abuse warning. This drug can lead to addiction and misuse, which can result in overdose and death. Because of the potential for misuse, abuse, and addiction, you may only obtain fentanyl by enrolling in Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access Program. Decreased breathing rate warning. Program Do Wysylania Faxu. Fentanyl can decrease the rate at which you breathe. This can lead to breathing failure and possibly death.