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Alirocumab Side Effects

The most commonly reported side effects of alirocumab include myalgia, product dose omission, and injection site pain, based on 24,468 FDA adverse event reports from 2015 to 2025.

Alirocumab side effects

Percentages show how often each reaction appears relative to total reports for alirocumab.

1
Myalgia6.8%1,659
2
Product Dose Omission5.6%1,364
3
Injection Site Pain5.2%1,278
4
Muscle Spasms4.7%1,162
5
Arthralgia4.3%1,055
6
Fatigue4.2%1,020
7
Pain3.9%945
8
Pain In Extremity3.8%936
9
Product Dose Omission Issue3.7%910
10
Injection Site Bruising3.4%838
11
Influenza Like Illness3.3%802
12
Headache3.3%800
13
Diarrhoea3.3%799
14
Device Issue3.2%788
15
Cough2.9%704

These are voluntary reports and do not establish that alirocumab caused these reactions.

Report severity

26.7%Serious6,533 reports
10.4%Hospitalizations2,540 reports
2.0%Fatal497 reports

Seriousness is determined by the reporter, not by OpenClaim.

Alirocumab drug interactions

Other drugs that appear in adverse event reports alongside alirocumab. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Evolocumab2.9%721
2
Rosuvastatin1.5%371
3
Ezetimibe1.4%354
4
Atorvastatin-calcium1.1%276
5
Aspirin0.8%189
6
Colesevelam-hydrochloride0.7%174
7
Rivaroxaban0.5%133
8
Simvastatin0.5%132
9
Pravastatin-sodium0.5%127
10
Diclofenac0.5%127
11
Ibuprofen0.5%127
12
Ergocalciferol0.5%119
13
Clopidogrel-bisulfate0.5%117
14
Tamsulosin-hydrochloride0.5%116
15
Mometasone-furoate0.5%114

Taken alongside

1
Aspirin7.7%1,885
2
Metoprolol4.8%1,165
3
Ezetimibe4.3%1,044
4
Ergocalciferol4.0%977
5
Levothyroxine-sodium3.8%923
6
Amlodipine3.6%872
7
Rosuvastatin2.7%662
8
Omeprazole2.7%660
9
Metformin2.6%630
10
Lisinopril2.6%625
11
Losartan-potassium2.5%618
12
Gemfibrozil2.4%581
13
Insulin2.2%535
14
Furosemide2.2%529
15
Acetaminophen2.2%529

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports alirocumab side effects

51.4% of alirocumab adverse event reports involve female patients and 35.4% involve male patients. The largest age group is elderly at 53%. These figures reflect who reports side effects, not underlying risk.

Sex

Female51.4%
Male35.4%
Unknown13.2%

Age group

< 2<0.1%
2–11<0.1%
12–17<0.1%
18–6446.5%
65+53.4%

What is alirocumab used for

Conditions and purposes for which patients were taking alirocumab when the adverse event was reported.

Accidental Exposure To ProductAcute Coronary SyndromeAcute Myocardial InfarctionAdjuvant TherapyAmino Acid Metabolism DisorderAneurysmAngina PectorisAngina UnstableAngiopathyAngioplastyAntiplatelet TherapyAortic ArteriosclerosisAortic OcclusionAortic Valve DiseaseAortic Valve Stenosis

Showing 15 of 332 indications

Alirocumab brand names and reporting trend

Alirocumab is sold under the brand name Praluent.

Brand names

Praluent10,171

Quarterly reports (20152025)

2016202020242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking alirocumab with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.