Off-label

Off-label prescribing is the use of an FDA-approved drug for an indication, patient population, dose, or route of administration not listed on the approved label. The practice is legal under U.S. law, common across medicine, and governed by the individual clinician's judgment rather than FDA authorization, though manufacturers cannot promote off-label uses. Within cannabinoid pharmacotherapy, off-label use is pervasive: dronabinol (Marinol, Syndros) is formally approved only for CINV refractory to conventional antiemetics and for AIDS-related anorexia, but is frequently used off-label for non-AIDS anorexia, chronic pain, and behavioral symptoms of dementia; nabilone (Cesamet) is used off-label for fibromyalgia, MS-related spasticity, and neuropathic pain despite its sole FDA indication being CINV. Epidiolex, FDA-approved only for Dravet syndrome, Lennox-Gastaut syndrome, and tuberous sclerosis complex, is prescribed off-label for other treatment-resistant epilepsies, though insurance coverage for such use is frequently restricted. Off-label use is not the same as unapproved or investigational use. → See also: Dronabinol, Epidiolex, Nabilone.