Published: 13 May 2024
Safety Information
Alert communication
Promethazine (oral): Do not use in children under 6 years of age due to the risk of psychiatric and central nervous system side effects
13 May 2024
Promethazine (oral) products are now contraindicated (do not use) in children under 6 years of age.
This change follows a safety review by Sanofi, the pharmaceutical company that makes medicines containing promethazine. The link between promethazine and psychiatric and central nervous system side effects in children under 6 years of age led to this new contraindication.
The Phenergan Tablet and Phenergan Elixir data sheet and consumer medicines information (CMI) have been updated to reflect the new age limit. Sanofi are producing a Dear Healthcare Professional Letter.
Updates of the Phenergan Tablet and Phenergan Elixir packaging with the new age limit are under way. However, there will be a time lag before medicines with updated packaging are available in pharmacies.
Medsafe has requested the sponsors of other brands of promethazine tablets and oral solution (see below) to update their data sheets, CMI and package labels.
Products affected
Advice for consumers and caregivers
Information for healthcare professionals
More information
Useful links
Products affected
Promethazine is a sedating antihistamine.
Medicines containing promethazine may be used to treat allergies (including hay fever) and nausea and vomiting (including travel sickness) in children aged 6 years and older.1
| Product name | Sponsor |
|---|---|
| Phenergan Tablet, Phenergan Elixir | Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics on behalf of Sanofi |
| Allersoothe Tablet Allersoothe Elixir | AFT Pharmaceuticals Ltd |
| AdiraMedica Promethazine Tablet | AdiraMedica Pty Ltd |
Advice for consumers and caregivers
- Do not give medicines containing promethazine to children under 6 years of age.
- In children under 6 years of age these medicines can cause mood and behavioural changes such as restlessness, unable to stay still, aggression (feeling of anger) and hallucinations (see or hear something that isn’t really happening). Learning difficulties may also occur when high doses are given.
- If your child is under 6 years of age and was taking promethazine, speak with your pharmacist or doctor about alternative treatment options.
- There will be a time lag before medicines with updated package labelling will be available in pharmacies. Always check with your pharmacist or doctor if a medicine is suitable for your child.
Information for healthcare professionals
- Promethazine (oral) is now contraindicated in children under 6 years of age (previously under 2 years of age).
- A safety review identified a high risk of psychiatric and central nervous system side effects in this age group, including psychomotor hyperactivity, aggression and hallucination. Difficulties in learning and understanding, such as reversible cognitive deficit and intellectual disability, may also occur when high doses are given.
- Use alternative treatment options for children under 6 years of age requiring allergy or nausea treatment. Refer to local guidelines.
- There will be a time lag before medicines with updated package labelling are available in pharmacies.
- Remind consumers who may have this medicine at home not to use it in children under 6 years of age and to consult a pharmacist or doctor for alternative treatment options and advice.
More information
Promethazine was already contraindicated in children under 2 years of age due to the risk of fatal respiratory depression (breathing difficulties).
Drowsiness, paradoxical hyperexcitability (becoming overexcited instead of sleepy as expected), nightmares and disorientation have also been reported with promethazine use in children.
A review by Sanofi, the manufacturer of Phenergan Tablets and Phenergan Elixir, identified a high risk of psychiatric and central nervous system side effects related to promethazine use in children aged between 2 and 5 years. In addition to known side effects, children under 6 years of age experienced psychomotor hyperactivity, aggression and hallucinations. At high doses, promethazine caused learning and understanding difficulties. Due to these risks, Phenergan Tablets and Phenergan Elixir are now restricted to use in children and adults aged 6 years and older.
Useful links
- Search for consumer medicine information (CMI) and data sheets
- Report an adverse event to a medicine (side effect)
- Dear Healthcare Professional Letter (PDF, 4 pages, 88KB)
References
- Pharmacy Retailing (NZ) Limited trading as Healthcare Logistics. 2024. Phenergan Tablets and Phenergan Elixir New Zealand Data Sheet. 22 April 2024. URL: govt.nz/profs/Datasheet/p/Phenergantabelixir.pdf (accessed 6 May 2024)
