Offlabel

Offlabel refers to the use of a drug, device, or medical procedure for an indication, dosage, patient population, or route of administration not explicitly listed in the approved labeling or guidelines. The term usually applies to pharmacological agents but can also describe use of medical devices or surgical techniques beyond their intended approvals. The term does not imply that the use is illegal or untested; many off-label uses arise from clinical judgment and evolving evidence.

In practice, off-label prescribing is common in fields like pediatrics, psychiatry, oncology, and neurology, where approved options may be limited. Physicians may rely on published studies, expert consensus, or case reports to support such uses. Examples include using a medication approved for one condition to treat another, or using a different dose, formulation, or age group.

Regulation and safety: In many jurisdictions, including the United States, physicians may prescribe off-label when they judge it appropriate. Manufacturers, however, are restricted from marketing off-label indications. Insurance coverage for off-label uses varies. The quality of evidence supporting off-label use ranges from high to weak, and ongoing monitoring for safety is important due to potential unanticipated adverse effects.

Ethics and oversight: Informed consent and patient discussion are important, including explaining the rationale, potential benefits, and uncertainties. Regulatory agencies differentiate between off-label use and clinical trials or unapproved experimentation; the latter typically requires formal oversight and consent.