What are the most common side effects of Leqvio (Inclisiran)?

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Last updated: April 14, 2025View editorial policy

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From the Guidelines

The most common side effects of Leqvio (inclisiran) include injection site reactions, such as pain, redness, and rash, which occur in about 5% of patients, as well as upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremities, anemia, elevated liver enzymes, diarrhea, arthralgia, sinusitis, and fatigue 1. These side effects are generally mild to moderate in severity and tend to resolve on their own without requiring discontinuation of treatment.

  • Injection site reactions are the most frequently reported side effect, occurring in approximately 5% of patients 1.
  • Other common side effects 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 It is essential for patients to inform their healthcare provider about any persistent or severe side effects they experience while on Leqvio, as well as any other medications they are taking to avoid potential drug interactions 1. Leqvio is administered as a subcutaneous injection by a healthcare professional, initially given as two injections 3 months apart, followed by maintenance injections every 6 months. This medication works by targeting PCSK9, a protein that regulates LDL cholesterol receptors, thereby increasing the liver's ability to remove LDL cholesterol from the bloodstream.

From the FDA Drug Label

Adverse reactions reported in at least 3% of LEQVIO-treated patients, and more frequently than in placebo-treated patients, are shown in Table 1 Table 1: Adverse Reactions Occurring in Greater Than or Equal to 3% of LEQVIO-treated Patients and More Frequently than with Placebo (Studies 1,2, and 3) Adverse Reactions | Placebo (N = 1,822) % | LEQVIO (N = 1,833) % †includes related terms such as: injection site pain, erythema and rash Injection site reaction† | 2 | 8 Arthralgia | 4 | 5 Bronchitis | 3 | 4

The most common side effects of Leqvio are:

  • Injection site reaction (8% of patients)
  • Arthralgia (5% of patients)
  • Bronchitis (4% of patients) 2

From the Research

Common Side Effects of Leqvio

The common side effects of Leqvio (inclisiran) are:

  • Mild to moderate, transient injection-site adverse reactions, which were more frequent with inclisiran compared to placebo 3

Comparison to Other Treatments

In terms of safety and tolerability, inclisiran has a similar profile to placebo, with the exception of more frequent injection-site reactions 3

Administration and Dosage

Leqvio is administered via subcutaneous injection, with an initial dose, a second dose at 3 months, and subsequent doses every 6 months 4, 5, 6, 7

Patient Selection

The decision to use Leqvio should be based on individual patient needs and circumstances, taking into account factors such as LDL-C levels, cardiovascular risk, and ability to tolerate other lipid-lowering therapies 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

A Critical Review of the Efficacy and Safety of Inclisiran.

American journal of cardiovascular drugs : drugs, devices, and other interventions, 2021

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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