Off-Label
Using a licensed medicine outside its official approved use — legal, common, and often well evidenced.
What it means
Prescribing a licensed medicine for a condition, age group or dose outside what its licence formally covers.
It is legal, routine and frequently the standard of care. Licensing reflects what a manufacturer applied and paid to test for — not the limit of what a drug is known to do.
Examples you will meet: amitriptyline for nerve pain, propranolol for anxiety symptoms, melatonin for jet lag, and a great deal of paediatric prescribing, since children are under-represented in licensing trials.
It is not the same as experimental. Some off-label uses have decades of evidence behind them.
In practice
Mentioned by a prescriber, or spotted by you when the leaflet in the box does not mention your condition — which is the usual way people encounter it, often with alarm.
Why it matters
Ask what the evidence is for this particular use. That is the question that separates well-established off-label prescribing from something more speculative.
Do not be alarmed by the leaflet. It describes the licence, not the state of knowledge.
The prescriber takes responsibility for off-label use, which is why they should explain it — and you are entitled to ask them to.
Clinically reviewed by Dr Mohammad Zubair Khan, GMC 7563469
Last reviewed
August 30, 2026