Pseudoephedrine is used for the symptomatic relief of coughs, colds and allergies. Pseudoephedrine has been used in the UK for decades in millions and millions of people. All pseudoephedrine-containing medicines in the UK are taken orally and come in tablet, capsule, powder, liquid, or syrup form; none of the decongestant nasal sprays authorised in the UK contain pseudoephedrine.
We are reviewing the available evidence relating to the very rare risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) associated with pseudoephedrine-containing medicines. PRES and RCVS are rare, reversible conditions, and most patients fully recover with appropriate treatment.
Since these products were authorised, we have received two UK Yellow Card reports of these possible side effects associated with pseudoephedrine, despite very widespread usage. The potential risk is considered to be very rare.
If signs or symptoms of PRES/RCVS develop, pseudoephedrine should be discontinued, and medical advice sought immediately. Symptoms reported include sudden onset of severe headache, nausea, vomiting, seizures, confusion and visual disturbances.
We would also like to remind patients and parents/carers to report any suspected side effects to our Yellow Card scheme.
We will provide any further advice as appropriate.
If you have any concerns about your medicine, please seek advice from a healthcare professional.
