Off-label use
Off-label use means a doctor prescribes an approved medicine for something other than what it was approved for. It is generally allowed, but the regulator has not checked that the medicine is safe and works for that other use. It is different from an unapproved drug that has never been approved for anything.
For experts
FDA uses "unapproved use of an approved drug" to describe use for a different condition, in a different way, or at a different dose from that in the approved labelling. Once FDA approves a drug, healthcare providers generally may prescribe it for an unapproved use when they judge it medically appropriate, but FDA has not determined that the drug is safe and effective for that use. Off-label use of an approved drug is distinct from use of a product that has no approval at all.
Sources (1)
- 01Understanding Unapproved Use of Approved Drugs "Off Label"U.S. Food and Drug Administration · 2018-02-05 · accessed 2026-09-29