Written by the Fiveable Content Team • Last updated September 2025
Verified for the 2026 exam
Verified for the 2026 exam•Written by the Fiveable Content Team • Last updated September 2025
Definition
Off-label refers to the usage of a medication for purposes other than those approved by regulatory authorities like the FDA. It involves prescribing drugs for conditions not specifically mentioned on the label.
Related terms
Clinical trial: Research studies conducted to evaluate the safety and effectiveness of using medications off-label before formal approval.
FDA-approved indication: The specific condition(s) for which a medication has been officially approved by regulatory authorities.
Risk-benefit analysis: Evaluating potential risks versus benefits associated with using medications off-label.