Skip to Content

Alirocumab Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 20, 2020.

For the Consumer

Applies to alirocumab: subcutaneous solution

Side effects requiring immediate medical attention

Along with its needed effects, alirocumab 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
  • difficulty with breathing or swallowing
  • fast heartbeat
  • fever
  • hives, itching, skin rash
  • irritation
  • hoarseness
  • joint pain, stiffness, or swelling
  • nausea
  • reddening of the skin, especially around the ears
  • swelling of eyelids, face, lips, hands, or feet
  • tightness in the chest
  • unusual tiredness or weakness

Less common

  • Cough producing mucus

Side effects not requiring immediate medical attention

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[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

References

1. "Product Information. Praluent Pen (alirocumab)." sanofi-aventis, Bridgewater, NJ.

Frequently asked questions

Further information

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.