Inclisiran-Induced Fixed Drug Eruption in a Patient With Refractory Hypercholesterolemia

Sep 30, 2026

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A 72-year-old man with atrial fibrillation, hypertension, and refractory hypercholesterolemia developed fixed drug eruption after inclisiran therapy. With documented statin intolerance and inadequate response to ezetimibe and bempedoic acid, inclisiran was started. After the second injection, a persistent pruritic erythematous rash appeared on the lower abdomen and legs. Dermatologic evaluation and skin biopsy confirmed drug eruption. Symptoms improved using topical therapy and antihistamines, and bempedoic acid was later reintroduced without rash recurrence.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages4

Reading Time10 min

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Abstract

Introduction

Case Presentation

Lipid profile and medication history

Initiation of inclisiran and rash onset

How to cite this article

Review began 11/30/2025 Review ended 12/04/2025 Published 12/08/2025 © Copyright 2025 Khan et al. This is an open access article distributed under the terms of the Creative Commons Attribution License CC-BY 4.0. , which permits unrestricted use , distribution , and reproduction in any medium , provided the original author and source are credited. DOI: 10.7759/cureus.98687 Open Access Case Report Inclisiran-Induced Fixed Drug Eruption in a Patient With Refractory Hypercholesterolemia Jawad A. Khan 1 , Shahab Shahab 2 1. Geriatric Medicine, Midland Metropolitan University Hospital, Birmingham, GBR 2. Cardiology, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, GBR Corresponding author: Jawad A. Khan, [doctorjawad2010@yahoo.com](doctorjawad2010@yahoo.com) Abstract We report the case of a 72-year-old man with a history of atrial fibrillation, hypertension, and refractory hypercholesterolemia who developed a fixed drug eruption following treatment with inclisiran, a small interfering RNA (siRNA) targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) . The patient had documented statin intolerance and inadequate response to ezetimibe and bempedoic acid, prompting initiation of inclisiran. Following the second injection, he developed a persistent pruritic erythematous rash affecting the lower abdomen and legs. Dermatologic assessment, including skin biopsy, confirmed a drug eruption. Symptoms improved with topical therapy and antihistamines. Due to the ongoing need for lipid control, bempedoic acid was reintroduced without recurrence of the rash. This case highlights a rare cutaneous adverse reaction to inclisiran and underscores the importance of monitoring for dermatologic complications associated with novel lipid-lowering therapies. Categories: Cardiology, Endocrinology/Diabetes/Metabolism, Dermatology Keywords: bempedoic acid, cutaneous adverse reaction, fixed drug eruption, hypercholesterolemia, inclisiran, lipidlowering therapy, pcsk9 inhibition, statin intolerance Introduction Hypercholesterolemia, or high levels of cholesterol in the blood, is a major contributor to atherosclerotic cardiovascular disease. Statins are the first-line therapy for lowering cholesterol, but some patients experience statin intolerance, which refers to adverse effects that prevent continued use or do not achieve adequate low-density lipoprotein (LDL) cholesterol reduction despite therapy. Inclisiran is a novel smallinterfering RNA (siRNA) therapy that targets proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that regulates LDL cholesterol levels. By silencing the PCSK9 gene, inclisiran reduces LDL cholesterol in the bloodstream. Clinical trials report that the most frequent adverse effects are mild injection-site reactions, with few descriptions of generalized or persistent cutaneous reactions. Fixed drug eruptions (FDEs) are a type of skin reaction that recurs at the same site upon exposure to a medication and can present as red, itchy, or inflamed patches. We present a rare case of an FDE associated with inclisiran in a patient with refractory hypercholesterolemia, highlighting the importance of recognizing atypical dermatologic reactions inpatients receiving novel lipid-lowering therapies. Case Presentation A 72-year-old male with a history of hypertension, atrial fibrillation, and refractory hypercholesterolemia was evaluated in May 2021 for dizziness. Holter monitoring revealed nocturnal bradycardia and sinus pauses. His lipid testing showed persistent hypercholesterolemia, with total cholesterol ranging between 5.2 and 5 .9 mmol/L. The patient had documented statin intolerance and reported inadequate responses to both ezetimibe and bempedoic acid. At the time of presentation, he had been taking losartan and bisoprolol for hypertension, and apixaban for atrial fibrillation, for over two years without any dermatologic reactions. None of these medications was suspected to

FAQs

What medication triggered the fixed drug eruption in this case?

The fixed drug eruption occurred after inclisiran injections, following the second injection.

How was the skin reaction diagnosed?

Dermatologic assessment including a skin biopsy confirmed the drug eruption.

Did restarting lipid therapy cause recurrence of the rash?

Reintroduction of bempedoic acid did not lead to recurrence of the rash, suggesting the reaction was linked to inclisiran.

Sep 30, 2026

Uploaded by Putri