What the label lists and what reports show
Alirocumab side effects
Alirocumab's FDA label: “The most common adverse reactions leading to treatment discontinuation in patients treated with PRALUENT were allergic reactions (0.6% versus 0.2% for PRALUENT and placebo, respectively) and elevated liver enzymes (0.3% versus <0.1%).” FAERS holds 24,935 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is myalgia (1,683 reports).
- No generic listed
Check it at the source: the alirocumab FDA label on DailyMed (effective July 16, 2026, Regeneron Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of PRALUENT?PRALUENT can cause serious side effects, including: allergic reactions. PRALUENT may cause allergic reactions that can be severe and require treatment in a hospital. Stop using PRALUENT and call your healthcare provider or go to the nearest hospital emergency room right away if you have any symptoms of an allergic reaction including: a severe rash redness hives severe itching trouble breathing swelling of the face, lips, throat or tongue The most common side effects of PRALUENT include: redness, itching, swelling, pain, or tenderness at the injection site flu muscle pain Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of PRALUENT. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects. […]
Source: FDA drug label, Regeneron Pharmaceuticals, Inc., effective July 16, 2026 (SPL set 7bcfbac2-e8ac-4569-8edc-bcde3b1fd172), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions leading to treatment discontinuation in patients treated with PRALUENT were allergic reactions (0.6% versus 0.2% for PRALUENT and placebo, respectively) and elevated liver enzymes (0.3% versus <0.1%).
Table 1: Adverse Reactions Occurring in >2% of PRALUENT-Treated Adult Patients and ≥1% More Frequently Than with Placebo
| Adverse Reactions | Placebo (N=1,276) % | PRALUENT 75 mg every 2 weeks and 150 mg every 2 weeks combined (N=2,476) % |
|---|---|---|
| Injection site reactions Includes erythema/redness, itching, swelling, pain/tenderness | 5 | 7 |
| Influenza | 5 | 6 |
| Diarrhea | 4 | 5 |
| Myalgia | 3 | 4 |
| Muscle spasms | 2 | 3 |
| Contusion | 1 | 2 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are also discussed in the other sections of the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Common (>5% of patients treated with PRALUENT and more frequently than placebo) adverse reactions in adults with: Primary hypercholesterolemia: injection site reactions, and influenza. ( 6 ) Established CV disease: myalgia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Regeneron at 1-844-734-6643 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adults with Hypercholesterolemia The data in Table 1 are derived from 9 primary hypercholesterolemia placebo-controlled trials that included 2,476 adult patients treated with PRALUENT 75 mg and/or 150 mg every 2 weeks, including 2,135 exposed for 6 months and 1,999 exposed for more than 1 year (median treatment duration of 65 weeks). The mean age of the population was 59 years, 40% of the population were female, 90% were White, 4% were Black or African American, 3% were Asian, and 3% other races; 6% identified as Hispanic or Latino ethnicity. …
Source: FDA drug label, Regeneron Pharmaceuticals, Inc., effective July 16, 2026 (SPL set 7bcfbac2-e8ac-4569-8edc-bcde3b1fd172), via openFDA; the full label on DailyMed
What do FAERS reports show?
24,935 reports list alirocumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 506 are coded as a death and 2,620 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Alirocumab: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions