ArticleDaru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences2025
Glucocorticoid withdrawal syndrome: Disproportionality analysis of cases using VigiBase data.
Article in Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Who cites it
2 citing papers in PubMed.
- Potential mechanisms of the glucocorticoid withdrawal syndrome.European journal of endocrinology · 2026Review
- Post-marketing safety surveillance and signal characterization of the novel dissociative steroid Vamorolone in Duchenne muscular dystrophy: a comparative disproportionality analysis based on FAERS data.Frontiers in pharmacology · 2026Article
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3 authors.
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Abstract
backgroundGlucocorticoids are associated with withdrawal syndrome, but specific glucocorticoid types that cause severe conditions remain unclear.
objectivesThis study identified glucocorticoids that exhibit significant pharmacovigilance signals for withdrawal, directly comparing the different types to determine those that exhibit a higher risk. We also aimed to investigate the routes of administration for glucocorticoids that are most likely to cause glucocorticoid withdrawal syndrome (GWS) and identify the age, sex, and regional groups among which GWS is more common.
methodsWe extracted the region, severity, age group, sex, and indications from VigiBase reports on GWS from January 2013 to December 2023.
resultsAmong 343,296 adverse drug reactions, 1,713 were withdrawal syndrome, with a higher prevalence among females (60%). Prednisone accounted for 28% of the cases, followed by hydrocortisone (17%) and betamethasone (14%). Case numbers tended to peak in 2021, with the highest incidence between ages 18-44 (36%) and significant regional variations for different glucocorticoids. Most cases (77%) were serious, with 18% requiring prolonged hospitalization. Predominant administration routes were topical for betamethasone, triamcinolone, and hydrocortisone; oral for prednisone and prednisolone; and intravenous for methylprednisolone. Disproportionality signals indicated that hydrocortisone exhibited the highest association with GWS (reporting odds ratio [ROR]: 4.04, 95% confidence interval [CI]: 3.59-4.53), followed by betamethasone (ROR: 3.81, 95% CI: 3.35-4.32), triamcinolone (ROR: 2.15, 95% CI: 1.83-2.52), and cortisone (ROR: 1.57, 95% CI: 0.99-2.50).
conclusionAbrupt withdrawal of glucocorticoid therapy may cause GWS. Healthcare providers should inform patients about the potential risks of withdrawal, particularly when prescribing topical hydrocortisone and betamethasone, topical and nasal triamcinolone, and oral and topical cortisone, to promote safer practices.
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