ISSUE 4 AUGUST
Reproduced with permission from Therapeutic Goods Administration (TGA) Medicines Safety Update 19 May 2025.
Summary
Risperidone, marketed in Australia under the brand name Risperdal and various generic brands, is a prescription medicine used to treat patients with behavioural disorders.
We received 22 adverse event reports in 2024 involving the overdose of risperidone oral solution in Australian paediatric patients. Most reports involved accidentally administering more than the prescribed dose, leading to adverse effects and hospitalisation of the child. No deaths were reported.
We carried out an investigation and found that these administration errors were often due to:
- misunderstanding of dosing instruction
- incorrect use of the dosing syringe
- administration by alternative caregivers, such as babysitters or an extended family member.
To mitigate the risk, the Product Information (PI) and Consumer Medicines Information (CMI) for Risperdal have been updated, with generics required to align theirs with similar information. The revision includes clearer dosing instructions and illustrations to help ensure correct dosing.
The information updates involve oral solution presentations of risperidone, not tablet or injectable forms.
What health professional should do
Given the increased reports of paediatric dosing error, prescribers and pharmacists are advised to take extra care when counselling risperidone patients or caregivers by:
- ensuring all caregivers are aware of the correct dosing instructions
- providing clear explanation on how to measure the exact dose using the supplied syringe
- reminding caregivers to read the dosing label carefully before administration and confirm their understanding, especially with first-time users.
See the full article on the TGA website.
