Fentanyl Transdermal System Box

Fentanyl is a potent synthetic opioid drug approved by the Food and Drug Administration for use as an analgesic (pain reliever) and anesthetic. Fentanyl transdermal patches slowly deliver the drug through the skin to treat moderate to severe chronic pain. Fentanyl was first developed in 1959 and introduced in the 1960s as an intravenous anesthetic. It is legally manufactured and distributed in the United States as a Schedule II narcotic under the Controlled Substances Act (CSA) of 1970. The CSA places all substances that were in some manner regulated under existing federal law into one of five schedules. Placement is based upon the substance’s accepted medical use, potential for abuse, and safety or dependence liability. As a Schedule II narcotic, fentanyl has a high potential for abuse and a currently accepted medical use in treatment in the United States. Fentanyl is produced illegally in the form of powder or counterfeit tablets and is sold alone or in combination with other drugs such as heroin or cocaine. Fentanyl patches are misused by removing their gel contents and then injecting or ingesting these contents. Patches have also been frozen, cut into pieces, and placed under the tongue or cheek cavity. Misuse can result in overdose and death. In 2021, DEA launched the One Pill Can Kill campaign to alert the American public of the alarming increase in the lethality and availability of counterfeit pills containing fentanyl and methamphetamine. To learn more, visit DEA.gov/OnePill.