Praluent Side Effects: What to Expect and When to Call Your Doctor

Praluent (alirocumab) has an overall favorable safety profile — it doesn't have a boxed warning, it doesn't damage the liver, and it doesn't cause the muscle pain (myopathy) that statins sometimes do. But like any medication, it can cause side effects, and a few of them require prompt medical attention. Here's what you need to know.

Common Side Effects of Praluent (Over 5% of Patients)

In clinical trials, the most common side effects seen in more than 5% of Praluent patients (and more frequently than placebo) were:

For Patients with High Cholesterol (Primary Hyperlipidemia):

Injection site reactions: Redness, pain, swelling, bruising, or itching at the injection site. Usually mild and resolve on their own.

Influenza (flu): Flu and flu-like symptoms including fever, body aches, and fatigue. Also includes nasopharyngitis (cold-like symptoms such as runny nose, sore throat, sneezing).

For Patients with Established Cardiovascular Disease:

Myalgia (muscle pain): Muscle pain or aches, reported more frequently in cardiovascular disease patients. Note: unlike statins, Praluent does not appear to cause true drug-induced myopathy.

Less Common but Reported Side Effects

Diarrhea

Urinary tract infection

Bruising at injection sites

Mild skin rash, itching, or hives (usually not serious, but monitor for escalation)

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Serious Side Effects: When to Seek Immediate Medical Attention

Praluent can cause serious allergic reactions that require prompt medical attention. Stop using Praluent and seek emergency care immediately if you experience any of the following:

Angioedema: Swelling of the face, lips, tongue, or throat — can be life-threatening if it impairs breathing

Hypersensitivity vasculitis: Inflammation of blood vessels — a rare but serious allergic reaction reported with Praluent use

Severe skin reactions: Severe rash, widespread hives, or skin redness

Difficulty breathing or swallowing

These serious hypersensitivity reactions have been reported with Praluent use and have required hospitalization in some cases. Praluent is contraindicated in anyone with a history of a serious allergic reaction to alirocumab or any of its ingredients.

What Praluent Does NOT Cause

There are some common concerns about cholesterol medications that specifically do NOT apply to Praluent:

No liver toxicity: Unlike some older cholesterol drugs, Praluent does not require routine liver enzyme monitoring

No significant statin-type myopathy: The ODYSSEY trials found no significant difference in muscle-related adverse events between Praluent and placebo

No boxed warning (Black Box Warning): Praluent does not carry a boxed warning from the FDA

No known significant drug-drug interactions: Unlike many medications, alirocumab is degraded to small peptides and amino acids and doesn't interact with common drugs like statins, blood pressure medications, or anticoagulants

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Tips for Managing Injection Site Reactions

Injection site reactions are the most commonly reported side effect of Praluent. To minimize them:

Allow the pen to reach room temperature for 30–40 minutes before injecting — cold injections are more uncomfortable

Rotate injection sites — use the thigh, abdomen, or upper arm, alternating locations each time

Avoid injecting into areas that are bruised, red, tender, or hardened

Apply a cold compress before injection if you find it helps reduce discomfort

Pregnancy and Breastfeeding

The safety of Praluent during pregnancy is unknown. If you become pregnant while taking Praluent, contact your healthcare provider immediately and report the pregnancy to Regeneron at 1-844-734-6643. The decision to continue Praluent while breastfeeding should be made with your doctor, as it is unknown whether alirocumab passes into breast milk in significant amounts.

For information about drug interactions with Praluent, see our guide: Praluent Drug Interactions: What to Avoid and What to Tell Your Doctor.