What is off-label drug use?

When the FDA approves a drug, the approved labeling specifies, among other things, the diseases or conditions for which the drug has been approved by the FDA.

“Off-label” is the phrase used when a doctor prescribes medication for uses not necessarily included in the FDA-approved listing for the drug.

Licensed physicians are generally permitted to prescribe a drug for an “off-label” use when they determine it medically appropriate for a patient.