The FDA classified tramadol as Schedule IV controlled drug in July 2014, and it’s a controlled substance in all 50 U.S. states. Tramadol is a medication that is only available by prescription, which means that it is a controlled substance. [1] The U.S. uses a drug classification system to categorize medications according to the level of risk associated with their use. Tramadol was on the U.S. market for almost 20 years before it was labeled as a controlled substance in 2014. Learn about the history, uses, harmful effects, and abuse of this drug. The other most common question that is asked about this medicine is: is tramadol a controlled substance? It is a class IV controlled substance that the US Food & Drug Administration has cleared since July 2024. Tramadol is a Schedule IV controlled substance, meaning it has a low risk of abuse and dependence. Schedule IV prescriptions are valid for six months with a maximum of five refills. In 2014, the Drug Enforcement Administration (DEA) made tramadol a controlled substance. Controlled substances have a greater risk for misuse and dependence than non-controlled substances. Tramadol is a narcotic (opioid) and a Schedule IV controlled substance by the U.S. federal government. Controlled substances are regulated by the government to prevent abuse and misuse and lower the risk of overdose. In 2021, Health Canada announced tramadol would be added to Schedule I of the Controlled Drugs and Substances Act and to the Narcotic Control Regulations due to tramadol being suspected of having contributed to 18 reported deaths in Canada between 2006 and 2017. Tramadol first gained FDA approval on March 3, 1995. Originally, it was classified as a non-controlled substance, but it was reclassified in 2014 to Schedule IV of the Controlled Substances Act with restrictions on its prescribing. Tramadol is an opioid (see Is tramadol an opioid?). Tramadol is controlled in schedule IV of the Controlled Substances Act.