Praluent Side Effects

Generic name: alirocumab

Medically reviewed by Philip Thornton, DipPharm. Last updated on Dec 13, 2024.

Note: This document provides detailed information about Praluent.

Applies to alirocumab: subcutaneous solution Side Effects associated with alirocumab. Some dosage forms listed on this page may not apply specifically to the brand name Praluent.

Applies to alirocumab: subcutaneous solution.

Precautions

It is very important that your doctor check your progress within 4 to 8 weeks of using this medicine. This will allow your doctor to see if the medicine is working properly to lower your cholesterol levels and to decide if you should continue to use it. Blood tests may be needed to check for unwanted effects.

Serious allergic reactions (eg, angioedema, vasculitis) may occur while you are using this medicine. Tell your doctor right away if you have a rash, itching skin, difficulty with breathing or swallowing, fever, hives, sores, welting, or blisters, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, nausea, reddening of the skin, especially around the ears, swelling of the eyes, face, or inside of the nose, or unusual tiredness or weakness.

Serious side effects of Praluent

Along with its needed effects, alirocumab (the active ingredient contained in Praluent) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking alirocumab:

Other side effects of Praluent

Some side effects of alirocumab 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:

For healthcare professionals

Applies to alirocumab: subcutaneous solution.

General adverse events

The most commonly reported adverse reactions have included nasopharyngitis, injection site reactions, and influenza.^[Ref]

Hypersensitivity

• Common (1% to 10%): Hypersensitivity reaction, nummular eczema, hypersensitivity vasculitis
• Postmarketing reports: Angioedema^[Ref]

Respiratory

• Very common (10% or more): Nasopharyngitis (11.3%)
• Common (1% to 10%): Influenza, bronchitis, sinusitis, cough^[Ref]

Gastrointestinal

• Common (1% to 10%): Diarrhea^[Ref]

Genitourinary

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

Hepatic

• Common (1% to 10%): Elevated liver enzymes^[Ref]

During clinical trials, 2.5% of patients treated with this drug reported abnormal liver enzymes (placebo=1.8%); treatment discontinuation occurred in 0.4% and 0.2% of patients receiving this drug and placebo, respectively. Increases in serum transaminases to greater than 3 times the upper limit of normal occurred in 1.7% of patients treated with this drug (placebo=1.4%).^[Ref]

Immunologic

• Common (1% to 10%): Development of antidrug antibody (ADA), neutralizing antibodies (NAb)
• Postmarketing reports: Flu-like illness^[Ref]

Local

• Common (1% to 10%): Injection site reaction (erythema, redness, itching, swelling, pain, tenderness)^[Ref]

Patients who developed ADA (antidrug antibody) had a higher incidence of injection site reactions compared with patients who did not develop ADA (10.2% vs 5.9%).^[Ref]

Musculoskeletal

• Common (1% to 10%): Myalgia, muscle spasm, contusion, musculoskeletal pain^[Ref]

Nervous system

• Uncommon (0.1% to 1%): Neurocognitive events, confusion or memory impairment^[Ref]

Metabolic

• Frequency not reported: Low LDL-C values

During clinical trials with both every 2 week or every 4 week dosing, reports of 2 consecutive calculated LDL-C values less than 25 mg/dL, and less than 15 mg/dL were reported in 914 and 335 patients, respectively. Low LDL-C values were observed more frequently in patients treated with 150 mg every 2 weeks or 400 mg every 4 weeks. Changes to background lipid therapy was not made and adverse consequences were not identified, but the long-term effects of very low levels of LDL-C are not known.

See also:

Frequently asked questions

• Praluent vs Repatha: What's the difference?
• What are PCSK9 Inhibitors and how do they work?
• How does Praluent work?
• How do you administer a Praluent injection?
• Does Praluent (alirocumab) lower triglycerides?

Further information

Praluent 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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer