MHRA Alert – Pseudoephedrine and Risk of PRES and RCVS

MHRA Drug Safety Update

The MHRA has issued a safety alert regarding very rare reports of serious neurological conditions associated with pseudoephedrine use.

What You Need to Know

Very rare cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported in patients taking pseudoephedrine. While these events are uncommon, both conditions are potentially serious and require prompt recognition and management.

Affected Medications

This alert applies to all pseudoephedrine-containing products, including:

• Over-the-counter nasal decongestants
• Combination cold and flu remedies
• Prescription formulations

Clinical Recommendations

Healthcare professionals and responders should:

• Be aware of the risk, particularly in patients presenting with headache, seizures, visual disturbances, or altered mental status after pseudoephedrine use
• Consider PRES and RCVS in the differential diagnosis when these symptoms occur
• Review patient history for pseudoephedrine exposure
• Counsel patients on appropriate use and advise them to seek immediate medical attention if symptoms develop

Further Information

For the full MHRA safety alert and additional clinical guidance, visit the MHRA Drug Safety Update page.