Side-effects from children’s medicines

This leaflet gives information about is about side-effects from children’s medicines. It will support you in discussing with your doctor or nurse any concerns you have about your child’s medicines.

This leaflet has been written for parents and carers about medicines in children. Keep it somewhere safe so that you can read it again.

What is a side-effect?

Medicines are important in preventing and treating children’s illnesses, but sometimes they can cause problems. For example, medicines can sometimes make people feel sick or cause an itchy rash. This is called a side-effect.

A side-effect is an unwanted reaction or symptom caused by taking a medicine. You may have also heard this called an ‘adverse drug reaction’. A side-effect may happen straight away, or it may happen a few days or weeks after your child has taken a medicine.

Can I be certain that a medicine has caused my child’s symptoms?

Often it is difficult to be certain whether a medicine has definitely caused a side-effect. This is because a child’s symptoms could be due to an illness or another cause. If your child is taking lots of different medicines, it can be difficult to pinpoint which (if any) medicine or medicines may have caused the symptoms. This uncertainty can be very frustrating for parents, children and health professionals.

Risks and benefits of children’s medicines

All medicines can have side-effects but it is important to balance these against the benefits of medicines. No one wants a child to miss out on a medicine when the benefits of taking it are greater than the side-effects. If your child has had a mild side-effect, she or he might still be able to keep taking the medicine. If they have had a serious side-effect, then you and your child’s doctor will want to discuss other options, such as changing the dose, stopping the medicine or switching to a different medicine.

Will there be a record of my concerns?

You can ask your child’s doctor to record any concerns about your child’s medicines in his or her medical records. If the doctor recommends stopping the medicine, he or she will usually put an alert in your child’s records. This will tell other health professionals that your child should not have the medicine.

If you think your child has had a side-effect to a medicine, you should mention this next time your child sees a doctor or nurse.

Reporting side-effects to the medicines safety ‘watchdog’

The Medicines and Health Care products Regulatory Agency (MHRA) watches out for side-effects. Anyone can report a side-effect to the MHRA via its Yellow Card Scheme:

• Website  https://yellowcard.mhra.gov.uk/

• Freephone – 0808 100 3352 (10am to 2pm Monday-Friday only)

The Yellow Card Scheme acts as an early warning system to identify new side-effects and get more information about other problems which might not have been known about before.

If a new side-effect is found, the MHRA will review the way that the medicine can be used, and the warnings that are given to people taking it to minimise risk and maximise benefit to the patient.

Where can I find out more information?

It is important to read about possible side-effects when getting a new medicine. Detailed information about side-effects is given in the leaflet for each medicine on the Medicines for Children website.

Acknowledgements

This information has been co-produced by:

• ADRIC - Adverse Drug Reactions in Children
• NHS National Institute for Health Research