Praluent Side Effects

Generic name: alirocumab

Medically reviewed by Philip Thornton, DipPharm. Last updated on Dec 23, 2022.

Note: This document contains side effect information about alirocumab. Some dosage forms listed on this page may not apply to the brand name Praluent.

Applies to alirocumab: subcutaneous solution.

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:

More common

Chest pain or tightness
difficulty with breathing or swallowing
fast heartbeat
fever
hives, itching, skin rash
hoarseness
irritation
joint pain, stiffness, or swelling
nausea
reddening of the skin, especially around the ears
swelling of eyelids, face, lips, hands, or feet
unusual tiredness or weakness

Less common

Cough producing mucus

Incidence not known

Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs

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:

More common

Bleeding, blistering, burning, coldness, discoloration of the 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
chills
cough
diarrhea
general feeling of discomfort or illness
headache
loss of appetite
muscle aches, cramps, stiffness, or pains
shivering
sore throat
stuffy or runny nose
sweating
trouble sleeping
vomiting

Less common

Bladder pain
bloody or cloudy urine
bone pain
bruise
difficult, burning, or painful urination
difficulty with moving
frequent urge to urinate
lower back or side pain
muscle spasms
pain or tenderness around the eyes and cheekbones

For Healthcare Professionals

Applies to alirocumab: subcutaneous solution.

General

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

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]

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

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.

Frequency not reported: Low LDL-C values