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Real-World Data on Severe Cutaneous Adverse Reactions to Drugs
Sergey Zyryanov1, Elizaveta Terehina1,2, Olga Butranova1
1Department of General and Clinical Pharmacology, Peoples' Friendship University of Russia Named After Patrice Lumumba (RUDN University), 6 Miklukho-Maklaya St., 117198 Moscow, Russia.
Pharmaceuticals (Basel, Switzerland)
|January 28, 2026
Summary
This study identified 907 drug triggers for severe cutaneous adverse reactions (SCARs) using Russian pharmacovigilance data. Linagliptin, clindamycin, and piperacillin/beta-lactamase inhibitors showed the strongest association with SCARs.
Area of Science:
- Pharmacovigilance
- Drug Safety
- Epidemiology
Background:
- Cutaneous adverse drug reactions (CADRs) are common drug-induced allergies.
- Severe cutaneous adverse reactions (SCARs) are the most serious form of CADRs.
- Identifying causative drugs is critical for managing SCARs.
Purpose of the Study:
- To analyze drug-induced SCAR signals using spontaneous reports.
- To evaluate the structure of drugs associated with SCARs.
- To identify potential drug triggers for SCARs in clinical practice.
Main Methods:
- Retrospective, descriptive pharmacoepidemiological analysis.
- Utilized spontaneous reports from the Russian national pharmacovigilance database (April 2019 - March 2025).
- Calculated reporting odds ratio (ROR) and proportional reporting ratio (PRR) to assess drug-SCAR signals.
Main Results:
- 7011 spontaneous reports (SRs) of SCARs identified, with 907 associated drug triggers.
- Most frequent drug classes: antibacterials (22.8%), antineoplastics (17.8%), antiepileptics (6.0%).
- Strongest signals for linagliptin (PRR=15.37, ROR=17.24), clindamycin (PRR=12.44, ROR=13.62), and piperacillin/beta-lactamase inhibitor (PRR=10.02, ROR=10.81).
Conclusions:
- Pharmacovigilance databases effectively identify SCAR phenotypes and culprit drugs.
- Findings enhance understanding of drug-induced SCARs.
- Data supports improved clinical practice and healthcare monitoring for drug safety.
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