ArticlePharmacological reports : PR2026
The onset of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) with the use of decongestant agents: a European pharmacovigilance analysis.
Article in Pharmacological reports : PR, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundOn December 1st, 2023, the Pharmacovigilance Risk Assessment Committee (PRAC) published a safety warning against using pseudoephedrine in patients with severe or uncontrolled hypertension and severe acute or chronic kidney disease for the risk of developing posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS). Based on this consideration and the availability of other decongestants with the same mechanism of action as pseudoephedrine in the European market, we decided to conduct a safety study to evaluate cases of RCVS or PRES reported with other decongestants.
methodsA European, retrospective, post-marketing surveillance study was conducted to describe individual case safety reports (ICSRs) of RCVS and PRES reported with decongestants and to compare the likelihood of reporting these events among decongestants. Data were retrieved from the EudraVigilance database from January 1st, 2001, to December 31st, 2025.
resultsA total of 65 ICSRs reported PRES or RCVS with decongestants, most of which referred to female patients aged 18-64 years. A disproportionate reporting of RCVS was found for xylometazoline (reporting odds ratio, ROR: 3.39; 95% confidence interval, CI: 1.94-5.93) and phenylephrine (ROR: 2.00; 95% CI: 1.11-3.61), and a disproportionate reporting of PRES for ephedrine (ROR: 6.44; 95% CI: 1.80-23.10) and phenylephrine (ROR: 3.47; 95% CI: 1.22-9.88) compared to all other decongestants.
conclusionOur results suggest that all decongestants should be used with caution, and attention should be paid to signs and symptoms of PRES and RCVS when taking these medicines.
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