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Praluent Side Effects

Generic Name: alirocumab

Note: This page contains side effects data for the generic drug alirocumab. It is possible that some of the dosage forms included below may not apply to the brand name Praluent.

For the Consumer

Applies to alirocumab: subcutaneous solution

As well as its needed effects, alirocumab (the active ingredient contained in Praluent) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking alirocumab, check with your doctor immediately:

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

Minor Side Effects

Some alirocumab side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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, 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 pains or stiffness
  • muscle 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.

It is possible that some side effects of Praluent may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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