FDA-Approved Cannabinoid Medications

Introduction to FDA-Approved Cannabinoids

The FDA has approved three specific cannabinoid medications: Epidiolex (cannabidiol/CBD) for rare epilepsy syndromes and tuberous sclerosis complex, and dronabinol and nabilone (synthetic THC compounds) for chemotherapy-induced nausea/vomiting and AIDS-related anorexia 1, 2

Epidiolex is approved for Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex 1, 2
Dronabinol is approved for chemotherapy-induced nausea and vomiting in patients who have failed conventional antiemetics, and for anorexia associated with weight loss in AIDS patients 1, 2
Nabilone is approved for chemotherapy-induced nausea and vomiting as an antiemetic 1, 2

Medical marijuana itself has NOT been FDA-approved for any indication, despite legalization in many states 3, 4, 5
Cannabis remains a Schedule I controlled substance federally, classified as having "no currently accepted medical use" and "high potential for misuse" 1, 5

Cannabinoids are not recommended as first-line treatment for chemotherapy-induced nausea and vomiting, but are reserved for breakthrough nausea and vomiting or refractory cases after failure of conventional antiemetics 3, 4, 6
Evidence for cannabinoids predates modern antiemetic regimens, limiting applicability 6
When choosing a cannabinoid for rescue therapy, dronabinol or nabilone are recommended over medical marijuana due to standardized dosing 6

Evidence for cannabis in chronic pain is inconsistent 1, 2
A 2022 meta-analysis concluded cannabis products "may be associated with short-term improvements in chronic pain and increased risk for dizziness and sedation" 1, 2
Data supporting cannabinoids as adjuvant analgesics for cancer pain are "extremely limited" with conflicting results 3, 5

Pregnant and breastfeeding individuals should avoid cannabinoids due to potential fetal brain development effects and increased premature birth risk 1, 2
Adolescents should avoid cannabis use due to association with neurodevelopmental decline, elevated psychotic disorder risk, depression, and suicidal ideation 1, 2
Elderly patients (≥65 years) are at higher risk for behavioral health issues, sedation, obtundation, and myocardial ischemia/infarction 1, 2

Cannabis can cause or exacerbate the same conditions it is intended to treat (nausea, vomiting, seizures) depending on THC content 4
Consider dose reduction or discontinuation if symptoms worsen during treatment 4

When prescribing FDA-approved cannabinoids, monitor for neuropsychiatric symptoms, hemodynamic changes, seizure activity, and signs of cannabis use disorder 1, 4