# Off-Label Use

> The use of an FDA-approved drug for a purpose, dosage, or patient population not included in the approved labeling.

**Category:** Medical Practice
**Canonical URL:** https://drugsmonitor.com/glossary/off-label-use
**Last updated:** 2026-06-11

Physicians may prescribe drugs off-label when they believe it is medically appropriate based on scientific evidence and clinical judgment. Off-label prescribing is common in oncology, pediatrics, and rare disease treatment.

While physicians can prescribe off-label, manufacturers are prohibited from promoting off-label uses without FDA approval. The Department of Justice has obtained billions in settlements from manufacturers for illegal off-label marketing.

Off-label use can affect litigation in two ways: if a manufacturer illegally promoted an off-label use without adequate safety warnings, liability may be enhanced. Conversely, if a physician chose an off-label use that was not medically supported, the doctor may share responsibility.

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*Glossary entry from DrugsMonitor.com.*