News article
The oral antihistamine promethazine, sold under the brand names Phenergan, AllerSoothe and AdiraMedica-Promethazine, should not be used for children under 6 years of age.
A safety review by Sanofi, the company which makes Phenergan Tablets and Elixir, found a link between promethazine and mood and behaviour related side effects in children under the age of six. Due to these risks, oral medicines containing promethazine are now restricted to use in adults and children aged over 6 years only.
If your child has been using promethazine, speak to your pharmacist or doctor about alternative treatment options.
Do not give any child under 6 years of age promethazine tablets or promethazine elixir.
There will be a time lag before promethazine products with updated package labelling for use in children aged over 6 years only will be available in pharmacies. Always check with your pharmacist or doctor if a medicine is suitable for your child.
If you have any concerns about medicines your child is using, talk to your pharmacist or doctor.
If any side effects are suspected, talk to your doctor or pharmacist, and report it to Centre for Adverse Reaction Monitoring (CARM).
You can read more about the Alert Communication on the Medsafe website - Promethazine (oral): Do not use in children under 6 years of age due to risk of psychiatric and central nervous system side effects.