# Off-label drug use and pharmaceutical liability

> How off-label prescribing can affect drug injury claims and manufacturer liability.

**Canonical URL:** https://drugsmonitor.com/guides/off-label-drug-use-litigation
**Last updated:** 2026-06-11

Off-label use means prescribing a drug for a purpose not approved by the FDA. While physicians may prescribe off-label when supported by medical evidence, manufacturers are heavily restricted in promoting off-label uses.

If a patient is injured by an off-label use that the manufacturer illegally promoted, the manufacturer may face enhanced liability. The False Claims Act has been used to recover billions from manufacturers for off-label marketing that caused harm.

If you were prescribed a drug off-label and suffered an injury, document why your physician prescribed it and whether you were aware it was not FDA-approved for your condition. Consult with counsel about whether manufacturer marketing played a role.

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*Educational guide from DrugsMonitor.com. Not legal advice.*