In this section
Doctors and pharmacists caring for children have a lot of experience with medicines used for children. If your child has been prescribed any medicine, your doctor will have thought carefully about the best and safest medicine for your child. They will be able to tell you why they have
recommended a certain medicine, and the benefits that the medicine should make to your child's health.
There is a small chance that your child may have a reaction to a medicine that they are taking. A medicine reaction may also be called a side effect or an adverse drug reaction. In most cases, medicine reactions are not serious.
Always follow your doctor or pharmacist’s instructions for giving your child their medicine, even if it is different to the instructions on the packaging. Read the doses and measurements carefully, and make it a habit to double check everything before giving the medicine to your child.
For age-specific tips and advice on giving different types of medicines, see our brochure
How to give medications to children.
The Therapeutic Goods Administration (TGA) is a federal government agency and is responsible for ensuring medicines available in Australia are safe and of an acceptable standard.
Most medicines must be included on the Australian Register of Therapeutic Goods (ARTG). An AUST R or AUST L registration number on a label shows the medicine has been included on the ARTG.
To be sure that a medicine works and is safe, it is tested first on a small number of people in a clinical trial. Information gained from clinical trials is given to the TGA before the medicine is approved for use (registered).
Your child may have been prescribed a medicine that has not been registered as a treatment for your child’s medical condition. This may be because the clinical trials (and product registration) may be for one illness, but later it is found that the medicine works well for another illness.
Sometimes medicines are prescribed that are not registered for use in children. This may be because the clinical trials were only carried out on adults, but the medicine has been found to work well in children also.
Some medicines are not registered in Australia at all. Examples of these are some liquid medicines for children or medicines used for rare illnesses. These may not be registered because there may not be enough children with the illness to have a clinical trial in Australia. These
medicines may have already been registered overseas in places with larger populations, such as in Europe or the United States.
Your child’s doctor will only prescribe medicine if they believe it is safe and will help your child get better. If you have any questions about the safety of your child’s medicine, talk to your doctor or pharmacist.
Most children do not have reactions to medications, but it is hard to predict how your child will react to a medicine they haven’t had before. Different medicines can cause different reactions in each child.
Some common types of reactions are:
A pharmacist, doctor or nurse can give you information about reactions that can happen with different medicines. The packaging that comes with some medicines also includes this information.
In rare instances, medicine may cause anaphylaxis, which is a severe, life-threatening allergic reaction. Symptoms of anaphylaxis include:
Call an ambulance immediately if your child has any symptoms of anaphylaxis.
For other reactions to the medication, take a note of what the reaction is and when it started. Taking photos is very helpful for rashes or swelling.
Your doctor or pharmacist will be able to treat the reaction. You should make a note of the medicine that caused the reaction and tell your GP and pharmacist about the allergy the next time your child needs medicine, so your child is not given a similar type again. Doctors can test for
allergies, or they may be able to prescribe a different medicine that is less likely to cause the same reaction.
You or your doctor can then report this adverse reaction to the TGA. The medicine reaction reporting program helps to make sure the medicines used for children are safe. By reporting any reactions to medicines your child has, you can help stop reactions happening to other children in the future.
What are AUST R and AUST L registrations mean?
An AUST R number means the medicine has been shown to work for particular illnesses. It has been assessed for side effects or risks and has been made to a high standard. AUST L numbers are given to lower-risk products used for minor health complaints or health maintenance. They do not
have to undergo the same tests, but the TGA still considers them to be safe.
What should I do if I accidentally give my child too much
Do not induce vomiting in your child. If your child is well, you can contact the Victorian Poisons Information Centre on 13 11 26 and ask for phone advice. If your child is unwell (e.g. vomiting, becoming sleepy, showing signs of anaphylaxis) then call an ambulance immediately.
If my child has had an allergic reaction to antibiotics,
does this mean she is allergic to all antibiotics?
No. Most children with an allergy to antibiotics are allergic to a particular type of antibiotic, or ingredient in a specific medication. It is important to discuss this with your child’s doctor so that an alternative antibiotic can be prescribed.
If my child has a
reaction to a medicine, how can I report it?
You can report the medicine and the
reaction directly to the TGA by following the instructions on their website. You can ask your doctor or pharmacist for
assistance or to report the problem for you.
Developed by The Royal Children's Hospital Pharmacy. We acknowledge the input of RCH consumers and carers.
Reviewed October 2018.
Kids Health Info is supported by The Royal Children’s Hospital Foundation. To donate, visit
This information is intended to support, not replace, discussion with your doctor or healthcare professionals. The authors of these consumer health information handouts have made a considerable effort to ensure the information is accurate, up to date and easy to understand. The Royal Children's Hospital Melbourne accepts no responsibility for any inaccuracies, information perceived as misleading, or the success of any treatment regimen detailed in these handouts. Information contained in the handouts is updated regularly and therefore you should always check you are referring to the most recent version of the handout. The onus is on you, the user, to ensure that you have downloaded the most up-to-date version of a consumer health information handout.