Off-label

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.