SHIFT Newsroom · UK
Mesalazine warning follows rare intracranial-pressure reports
The MHRA called for warnings after a safety review; the medicine’s benefit-risk balance for approved uses was unchanged.
The MHRA announced warnings for mesalazine product information about idiopathic intracranial hypertension, following a European safety review considered by UK advisers. The MHRA's 4 December 2025 notice describes reports of this condition as very rare and says the medicine's benefit-risk balance remains unchanged for its approved uses.
The condition involves increased pressure inside the skull and can threaten vision. The notice draws attention to symptoms such as worsening or recurring headache, visual disturbance and tinnitus. It stresses that these symptoms are not unique to this diagnosis, so a news report cannot determine their cause.
The MHRA cited six UK Yellow Card reports of increased intracranial-pressure disorders associated with mesalazine. That is a count of suspected reports, not a measured rate among patients. It should not be divided by prescription-item totals to produce a risk percentage.
The warning applies across mesalazine formulations. The regulator asks clinicians to explain the warning, assess concerning symptoms promptly and coordinate care with relevant specialists. Its notice describes clinical management where the condition occurs; it does not announce a general withdrawal of mesalazine. This brief reports the safety update and leaves diagnosis and treatment changes to the clinical team.
Known facts
- Warnings apply to all mesalazine products.
- Six UK Yellow Card reports cited; reports described as very rare.
- Benefit-risk balance unchanged in approved indications.