Off-label prescribing.
A licensed medicine, prescribed in a way its licence doesn’t specifically cover. It’s legal, regulated and common across medicine.
What off-label means
Off-label is
- A medicine approved by the MHRA, the UK medicines regulator
- Prescribed by a doctor who takes responsibility for it
- Used in a way the licence doesn’t specifically cover
- Recorded, explained to you and monitored
Off-label is not
- Unlicensed medicine
- Compounded or made up by a third party
- Counterfeit or bought without a prescription
- Experimental
It’s routine in children’s medicine and palliative care, where licensing trials often don’t exist.
What a licence covers
The condition
What the medicine treats.
The dose
The strength, and how often.
The patient
Who it was studied in.
The method
How it’s given, including the device.
Anything outside these is off-label.
Off-label in weight management
Which, if any, applies to you is decided at your consultation.
A different dose
Below the lowest licensed dose, or between two licensed doses.
A different interval
Doses given less or more often than once a week.
A different preparation
The same dose, measured by counting clicks or with a syringe.
The GMC rules
Before prescribing off-label, your doctor must:
Be satisfied it better serves your needs
Than a licensed use, where one exists.
Be satisfied there’s sufficient evidence or experience
To demonstrate the safety and effectiveness of using it that way.
Take responsibility, and monitor
For the prescription and for overseeing your care, including follow-up - or make sure another suitable clinician does.
Record the reasons
A clear record of what was prescribed and why it was decided to use it outside of its licence (off-label).
Source: General Medical Council, Good practice in prescribing and managing medicines and devices.
Off-label treatment is only ever prescribed after a live consultation with a doctor.
What it means for you
You’ll be told
Your doctor explains which parts of your plan are off-label, and why, before you start.
Closer review
Trial data covers licensed doses, so off-label plans are reviewed more often.
Report side effects
Report suspected side effects through the MHRA Yellow Card scheme.
Questions
Is off-label prescribing legal?
Yes. Doctors can prescribe a licensed medicine off-label when it better serves the patient and the GMC conditions are met.
Is microdosing in the guidelines?
No. It hasn’t been tested as a standalone approach. The American Association of Clinical Endocrinology says it may be considered for people with severe side effects, or who respond strongly at the lowest dose.
Is off-label riskier?
There’s less trial data for the specific use, so you’re monitored more closely. The medicine is the same licensed product.
Can I adjust my own dose?
Please don’t. Stretching doses, counting clicks or microdosing alone risks under- or over-dosing, and click counts differ between pen strengths. Your doctor can make these changes safely.
Can I choose standard treatment instead?
Yes. Standard licensed dosing is always available.
Any questions?
Ask your doctor at your consultation.