What are the long-term side effects of Leqvio (Inclisiran)?

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Last updated: March 17, 2025View editorial policy

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From the Guidelines

Leqvio (inclisiran) has been associated with several long-term side effects, including upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremities, anemia, elevated liver enzymes, diarrhea, arthralgia, sinusitis, fatigue, and influenza, as reported in the 2022 ACC expert consensus decision pathway on the role of nonstatin therapies for LDL-cholesterol lowering 1. The most common long-term side effects reported with Leqvio (inclisiran) include:

  • Upper respiratory tract infection
  • Muscle spasms
  • Hyperuricemia
  • Back pain
  • Abdominal pain or discomfort
  • Bronchitis
  • Pain in extremities
  • Anemia
  • Elevated liver enzymes
  • Diarrhea
  • Arthralgia
  • Sinusitis
  • Fatigue
  • Influenza It is essential to note that the use of Leqvio during pregnancy or lactation should be approached with caution, and the benefits of therapy should outweigh the potential risks to the fetus 1. In terms of drug-drug interactions, Leqvio should be used with caution when co-administered with cyclosporine or fibrates, and concomitant use with simvastatin >20 mg daily or pravastatin >40 mg daily should be avoided 1. Regular follow-up appointments and periodic blood tests are crucial to monitor for any developing side effects and assess liver function and lipid levels in patients on Leqvio. If a patient experiences persistent or concerning symptoms while on Leqvio, they should contact their healthcare provider rather than discontinuing the medication on their own. The 2022 ACC expert consensus decision pathway on the role of nonstatin therapies for LDL-cholesterol lowering provides guidance on the use of Leqvio, including its potential benefits and risks, and recommends its use in certain patient populations, such as those with clinical ASCVD at very high risk who require additional LDL-C lowering 1.

From the Research

Long-term Side Effects of Leqvio (Inclisiran)

  • The available studies do not provide comprehensive information on the long-term side effects of Leqvio (Inclisiran) 2, 3, 4, 5, 6.
  • However, the safety profile of inclisiran has been reported as favorable, with no substantial differences in adverse effects compared to placebo 3, 6.
  • Mild to moderate, transient injection-site adverse reactions were more frequent with inclisiran 3.
  • No statistically significant differences were noted in cholesterol reduction among the alirocumab, evolocumab, and inclisiran groups at 3 months, and no reported adverse cardiovascular events or significant changes in alanine transaminase, creatinine, or creatine kinase levels 2.
  • The convenience of a twice-yearly dosing regimen of inclisiran may promote adherence to therapy and facilitate achievement of LDL-C goals, potentially reducing the risk of cardiovascular events 5, 6.
  • Ongoing outcome clinical trials are expected to provide further information on the long-term safety and clinical benefit of inclisiran 5, 6.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Inclisiran: A Review in Hypercholesterolemia.

American journal of cardiovascular drugs : drugs, devices, and other interventions, 2023

Research

Inclisiran: How Widely and When Should We Use It?

Current atherosclerosis reports, 2022

Research

Efficacy, benefit and safety of inclisiran.

Clinica e investigacion en arteriosclerosis : publicacion oficial de la Sociedad Espanola de Arteriosclerosis, 2024

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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