Off-label use

Prescribing a licensed medication for a use its licence does not cover.

A medication is approved for specific conditions, age groups and doses, and that approval is what appears on its label. Prescribing it outside those bounds — a different condition, a different age group, a different dose — is off-label use. It is legal and routine in many fields, particularly paediatrics and psychiatry, and is often supported by published evidence that simply has not been submitted for a licence extension. It does mean, however, that the manufacturer has not established safety or efficacy for that use, so the responsibility rests with the prescriber.

The information on this website is provided for reference and educational purposes only. It does not replace consultation with a qualified healthcare professional.