Inclisiran Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 24, 2023.

Applies to inclisiran: subcutaneous solution.

Other side effects of inclisiran

Some side effects of inclisiran may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common side effects

• bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• difficulty in moving
• muscle pain or stiffness
• pain in the joints

Less common side effects

• chest tightness
• cough producing mucus
• trouble breathing

For healthcare professionals

Applies to inclisiran: subcutaneous solution.

Hepatic adverse events

• Very common (10% or more): Serum hepatic transaminase elevations, elevated ALT (up to 19.7%), elevated AST (up to 17.2%)

In clinical studies, more frequent elevations of serum hepatic transaminases between greater than 1 times the upper limit of normal (1 x ULN) and up to 3 x ULN in patients receiving this drug compared to placebo. ALT and AST elevations were reported in 19.7%, and 17.2%, respectively, of patients using this drug compared with 13.6% and 11.1%, respectively, of patients on placebo; these elevations did not progress to exceed the clinically relevant threshold of 3 x ULN, were asymptomatic, and were not associated with adverse reactions or other evidence of liver dysfunction.

Metabolic

• Very common (10% or more): Diabetes mellitus (up to 11.6%)

Local

• Common (1% to 10%): Injection site reactions (included injection site pain, injection site erythema, injection site rash)^[Ref]

Injection site reactions occurred in 8.2% of patients and included injection site reaction (3.1%), injection site pain (2.2%), injection site erythema (1.6%), and injection site rash (0.7%). These reactions were mild or moderate in severity, transient, and resolved without sequelae.^[Ref]

Musculoskeletal

• Common (1% to 10%): Arthralgia, back pain, pain in extremity^[Ref]

Genitourinary

• Common (1% to 10%): Urinary tract infection^[Ref]

Respiratory

• Common (1% to 10%): Bronchitis, nasopharyngitis, cough, dyspnea^[Ref]

Gastrointestinal

• Common (1% to 10%): Diarrhea^[Ref]

Nervous system

• Common (1% to 10%): Dizziness, headache

Cardiovascular

• Common (1% to 10%): Angina pectoris

Immunologic

• Common (1% to 10%): Anti-drug antibodies^[Ref]

Frequently asked questions

• What is the difference between Leqvio and Repatha?
• Can Leqvio be taken without a statin?
• Does Leqvio cause weight gain?
• How is Leqvio injection administered?
• What is the mechanism of action for Leqvio (inclisiran)?
• Is Leqvio FDA approved as a high cholesterol treatment?
• Who is the actor in the Leqvio commercial?
• Where can I find the Leqvio FDA package insert?
• How does Leqvio work in treating high cholesterol?

Further information

Inclisiran side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer