Drug Safety Update

Mesalazine and idiopathic intracranial hypertension

Issued 4 Dec 2025

Read and act on the official notice on GOV.UK

The MHRA's summary

Idiopathic intracranial hypertension (IIH) has been very rarely reported in patients treated with mesalazine. Following a recent review, warnings for IIH are being added to the product information for all mesalazine products.

MHRA's audience tags: Emergency medicine, General practice, Gi hepatology pancreatic disorders, Neurology, Pharmacy

Pharmshark is not an official alerting route. Make sure your pharmacy receives alerts directly from the MHRA and through your organisation, and always act on the official GOV.UK notice.

Source: the MHRA on GOV.UK. Contains public sector information licensed under the Open Government Licence v3.0. Pharmshark is not affiliated with or endorsed by the MHRA.