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Praluent Side Effects

Generic Name: alirocumab

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

For the Consumer

Applies to alirocumab: subcutaneous solution

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

  • Difficulty with breathing or swallowing
  • fever
  • hives
  • nausea
  • reddening of the skin, especially around the ears
  • swelling of the eyes, face, or inside of the nose
  • unusual tiredness or weakness

Less Common

  • Cough producing mucus
  • tightness in the chest

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

  • Chills
  • cough
  • diarrhea
  • general feeling of discomfort or illness
  • headache
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • redness, itching, swelling, or pain at the injection site
  • shivering
  • sore throat
  • stuffy or runny nose
  • sweating
  • trouble sleeping
  • vomiting

Less Common

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

For Healthcare Professionals

Applies to alirocumab: subcutaneous solution

General

The most common adverse reactions leading to treatment discontinuation were allergic reactions and elevated liver enzymes.[Ref]

Hypersensitivity

Very common (10% or more): 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 enzyme[Ref]

Immunologic

Common (1% to 10%): Development of antidrug antibody (ADA), neutralizing antibodies (NAb)[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]

References

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

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.

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