What Does Off-Label Use Mean?

There are times when a healthcare professional may recommend that you take off-label. This means that while the medication has a license to treat another condition, it isn’t licensed to treat your condition.

Off-label medication is typically recommended by a doctor or prescribing pharmacist if they think that it will treat your condition effectively, that the benefits are greater than the risks and that it is in your best interest.

Below we cover everything you need to know about off-label medication, including if it’s safe, how common it is and when we might recommend certain off-label uses.

Three key takeaways

• Off-label use is when medication is being prescribed for a condition it isn’t licensed for.
• Medication may be prescribed off-label to provide a dose higher or lower than the recommended amount.
• Our clinicians may recommend off-label use of medications in certain circumstances if they judge the benefits to outweigh the risks.

Is off-label medication safe to use?

Off-label medication is safe to use as it has still been approved by the MHRA. It is only prescribed at the discretion of a qualified healthcare professional. Off-label medication is not the same as medication used for experimental use. Legally, a license is evidence that a medicine is:

• effective
• safe
• high quality

When a prescriber issues a prescription off-label, they will have considered all other medical options for a patient and will have reviewed the evidence to support any off-label prescribing.

This includes the use of resources provided to them by regulated bodies such as the National Institute for Health and Care Excellence, and the British National Formulary.

How common is off-label use?

The UK doesn’t currently have figures on overall off-label prescribing. Off-label prescribing in the UK is most common with children aged 0-16, with studies reporting that 26% are prescribed medication off-label. Similarly, in palliative care, between 14.5% to 35% of prescriptions are off-label.

The most common reason medication is prescribed off-label is in order to provide a dose higher than the recommend dosage. The most common types of medication given to children off-label are anti-asthmatics, topical corticosteroids and laxatives.

Examples of off-label medication

There are many examples of medication being prescribed off-label that have become the primary treatment option.

• Beta-blockers: in the 1960s, these were originally developed and licensed to treat heart conditions like angina. Physicians later noticed that had people who had been prescribed them who also suffered with migraines had their migraine symptoms improved after they started taking the medication. This led to beta-blockers being prescribed as a first-line migraine prevention treatment.
• Ozempic (semaglutide): this was developed as a treatment for diabetes, but it was noticed that it also was very effective for weight loss. The increase in off-label prescribing for Ozempic eventually led to the development of Wegovy for weight loss.
• Finasteride: while more commonly known for its use in treating male pattern hair loss, this medication was originally approved in 1992 for treating enlarged prostates. During further clinical trials, researchers discovered an unexpected benefit: hair stabilisation and regrowth in patients. This finding led to additional research, and, in 1997 the medication was licensed at a lower dose for male pattern hair loss. Before this, pharmacists had already been prescribing it off-label for this purpose.

How our expert team of clinicians can help

Our Chemist4U clinicians are all GPHC-registered or GMC-registered. This means they certified to prescribe medications on an off-label basis if they believe there to be a sufficient reason.

Our team will always outline when a medicine is being recommended for off-label use. They’ll explain why they believe it would be beneficial to you, any risks that might be associated with it, and ultimately make sure that the decision is shared between you both. We ensure that every step of this process is transparent to make sure you’re well equipped to make the best choice for you.

Some prescribed medication is deemed off-label even if it is being used for its intended purpose. For example, weight loss injections may be prescribed for off-label use to treat weight loss if your BMI is over 27, but you don’t have any other weight-related health issues.

Frequently asked questions about off-label use

Is off-label use illegal?

Off-label use of medication is not illegal. It’s used commonly to prescribe medicine in a patient’s best interest if the benefits outweigh any risks, there is a need for a higher or lower dosage or another reason that the medication’s license does not cover.

What’s the difference between misuse and off-label use?

Drug misuse is defined by the World Health Organization as the ‘use of a substance not consistent with legal or medical guidelines.’

This can include using a drug for a different purpose than it is prescribed, taking a different dosage of the drug or taking the drug at different intervals that what was prescribed.

On the other hand, off-label use means that it has been prescribed to you while not being licensed for that purpose. A healthcare professional has still delivered their clinical judgement before prescribing.

Sources

• Medicines information. (2023). NHS. [accessed on 22/12/2025]
• Off-label prescribing among office-based physicians. PubMed. [accessed on 22/12/2025]
• Off-label prescribing to children in primary care: retrospective observational study. PubMed. [accessed on 22/12/2025]
• Drug use beyond the licence in palliative care: A systematic review and narrative synthesis. (2019). PubMed. [accessed on 22/12/2025]
• Drug Misuse: Psychosocial Interventions. NLM. [accessed on 22/12/2025]