Protonitazene is classified as a novel opioid of the benzimidazole sub-class and is structurally dissimilar from fentanyl. Novel opioids have been reported to cause psychoactive effects similar to heroin, fentanyl, and other opioids. Novel opioids have also caused adverse events, including death, as described in the literature. Structurally similar compounds include etonitazene, metonitazene, and isotonitazene. Etonitazene and structurally related synthetic opioids were first synthesized and reported in the literature in the 1950s.
Protonitazene is regulated as a Schedule I compound in the United States.