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Updated: Jun 2, 2025

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Published on: July 11, 2013
A retrospective analysis of medications associated with pityriasis rosea reported in the FDA adverse events reporting
Kayla D Mashoudy1, Joselyn Ye-Tay2, Keyvan Nouri3
1Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, 1150 NW 14th Street, Miami, FL, 33136, USA. kmashoudy@med.miami.edu.
Abstract:
Pityriasis rosea (PR) is an acute exanthematous disease with an uncertain physiopathology, increasingly recognized as potentially drug induced. This study aims to investigate medication triggers associated with PR by analyzing cases reported in the FDA Adverse Event Reporting System (FAERS) database. A retrospective review of 343 PR cases reported in the FAERS database from January 1, 1998, to March 31, 2024, was conducted. Reporting odds ratios (ROR) were calculated to assess associations between PR and specific drug classes, including tumor necrosis factor (TNF) inhibitors and angiotensin-converting enzyme (ACE) inhibitors. Logistic regression analysis evaluated the influence of factors such as sex, age group, and seriousness of outcomes on the occurrence of PR. Females represented 56.3% of cases and the 18-64 age group comprised 55.4% of cases. TNF inhibitors were significantly associated with PR (ROR = 4.1881 [3.1970-5.4865], P < 0.0001), particularly infliximab (ROR = 6.5284 [3.9523-10.7837], P < 0.0001), etanercept (ROR = 3.4921 [2.2873-5.3315], P < 0.0001), and adalimumab (ROR = 3.086 [2.0213-4.7115], P < 0.0001). ACE inhibitors were also associated with PR (ROR = 9.9808 [6.0423-16.4864], P < 0.0001), with higher odds in older patients (OR 14.08 [4.2-47.2], P < 0.0001) and those reporting serious outcomes (OR 9.53 [1.24-72.99], P = 0.03). Based on the FAERS, there has been a consistent rise in PR cases, with TNF inhibitors and ACE inhibitors being associated medication classes tied to PR. Given the limited literature on drug-related triggers and patient demographics, we aimed to highlight the characteristics of PR cases that could enhance awareness and inform better clinical outcomes for affected patients.
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