The Yellow Card scheme – why it’s important to report side-effects

We give our children medicines to help them get well and stay well, but sometimes these medicines have unwanted effects – side-effects.

When a medicine is being evaluated in clinical trials, all side-effects are recorded and reviewed. Information about these side-effects is included in the information leaflet that is provided with the medicine. However, clinical trials usually involve a relatively small number of people – and these people are usually adults. This means that some side-effects may not be identified until a medicine is used in a lot more people in daily clinical practice. Herbal products or complementary therapies do not go through the same rigorous clinical trials as medicines and may also cause side-effects.

The Medicines and Health Care products Regulatory Agency (MHRA) is the watchdog for the safety of medicines and health-related products in the UK. The MHRA monitors side-effects through its Yellow Card scheme. Members of the public (patients, their family members and carers) and health professionals are encouraged to report any side-effect they experience that is not listed on the medicine’s information leaflet.

The Yellow Card scheme acts as an early warning system to identify new side-effects and get more information about other problems that might not have been known about before. If a new side-effect is identified, the MHRA reviews the way the medicine or product is used, and if needed issues a warning to help minimise any risk to patients whilst maximising the benefit of treatment.

We recently reported that the medicine montelukast, which is used to treat asthma, may cause nightmares and difficulty sleeping in some children. This side-effect was identified through the Yellow Card scheme. You can read more about it in a recent Medicines for Children news post here.

Anyone can report a side-effect via the Yellow Card Scheme:

• mhra.gov.uk
• freephone (UK) 0808 100 3352 (10 am to 2 pm Monday–Friday)
• the Yellow Card app, which can be downloaded from app stores

You can report side-effects relating to:

• Medicines
• Vaccines
• Blood factors and immunoglobulin products
• Herbal products or complementary therapies such as homeopathic remedies
• Medical devices (including software, apps and artificial intelligence)
• E-cigarettes including their refill containers (e-liquids).