ALIROCUMAB

N/A

Manufactured by Regeneron Pharmaceuticals, Inc.

42,209 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ALIROCUMAB

ALIROCUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Regeneron Pharmaceuticals, Inc.. The most commonly reported adverse reactions for ALIROCUMAB include MYALGIA, PRODUCT DOSE OMISSION, INJECTION SITE PAIN, MUSCLE SPASMS, ARTHRALGIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ALIROCUMAB.

Top Adverse Reactions

MYALGIA1,655 reports
PRODUCT DOSE OMISSION1,364 reports
INJECTION SITE PAIN1,278 reports
MUSCLE SPASMS1,162 reports
ARTHRALGIA1,053 reports
FATIGUE1,018 reports
PAIN945 reports
PAIN IN EXTREMITY935 reports
PRODUCT DOSE OMISSION ISSUE909 reports
INJECTION SITE BRUISING838 reports
INFLUENZA LIKE ILLNESS802 reports
DIARRHOEA797 reports
HEADACHE797 reports
DEVICE ISSUE788 reports
COUGH702 reports
INJECTION SITE ERYTHEMA699 reports
DYSPNOEA696 reports
PRURITUS691 reports
INJECTION SITE HAEMORRHAGE679 reports
RASH667 reports
NAUSEA652 reports
DIZZINESS623 reports
MALAISE610 reports
NASOPHARYNGITIS580 reports
DRUG INEFFECTIVE576 reports
RHINORRHOEA532 reports
PRODUCT DELIVERY MECHANISM ISSUE522 reports
BACK PAIN516 reports
ASTHENIA484 reports
CONDITION AGGRAVATED477 reports
DEVICE USE ISSUE472 reports
INJECTION SITE SWELLING471 reports
PRODUCT USE ISSUE425 reports
FEELING ABNORMAL415 reports
INJECTION SITE PRURITUS415 reports
MYOCARDIAL INFARCTION414 reports
PRODUCT PREPARATION ERROR407 reports
LOW DENSITY LIPOPROTEIN INCREASED353 reports
PRODUCT STORAGE ERROR351 reports
DRUG DOSE OMISSION342 reports
INCORRECT DOSE ADMINISTERED331 reports
INJURY ASSOCIATED WITH DEVICE329 reports
GAIT DISTURBANCE324 reports
BLOOD CHOLESTEROL INCREASED319 reports
MUSCULAR WEAKNESS317 reports
INJECTION SITE MASS300 reports
CHEST PAIN298 reports
OROPHARYNGEAL PAIN294 reports
DEATH293 reports
CHEST DISCOMFORT289 reports
INFLUENZA288 reports
CEREBROVASCULAR ACCIDENT287 reports
ERYTHEMA287 reports
OFF LABEL USE285 reports
HYPERSENSITIVITY284 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION281 reports
UNEVALUABLE EVENT281 reports
MEMORY IMPAIRMENT276 reports
FALL273 reports
CARDIAC DISORDER268 reports
PRODUCT ADMINISTERED AT INAPPROPRIATE SITE266 reports
DRUG DOSE OMISSION BY DEVICE265 reports
PYREXIA264 reports
URTICARIA258 reports
INJECTION SITE RASH252 reports
INJECTION SITE REACTION250 reports
BLOOD GLUCOSE INCREASED245 reports
WRONG TECHNIQUE IN DEVICE USAGE PROCESS245 reports
PERIPHERAL SWELLING239 reports
INSOMNIA238 reports
VOMITING228 reports
ABDOMINAL PAIN UPPER227 reports
ABDOMINAL DISCOMFORT226 reports
DYSPHONIA224 reports
UNDERDOSE218 reports
URINARY TRACT INFECTION216 reports
WEIGHT DECREASED215 reports
BLOOD PRESSURE INCREASED211 reports
WEIGHT INCREASED206 reports
CONTUSION203 reports
ATRIAL FIBRILLATION199 reports
NASAL CONGESTION199 reports
MUSCULOSKELETAL PAIN196 reports
HYPERTENSION191 reports
PNEUMONIA190 reports
SINUSITIS184 reports
HOSPITALISATION182 reports
CHILLS177 reports
HYPOAESTHESIA177 reports
ALOPECIA170 reports
PARAESTHESIA170 reports
CORONARY ARTERY DISEASE169 reports
ABDOMINAL PAIN165 reports
DECREASED APPETITE164 reports
MUSCULOSKELETAL STIFFNESS164 reports
THERAPEUTIC RESPONSE DECREASED162 reports
CONFUSIONAL STATE161 reports
THERAPY INTERRUPTED161 reports
COVID 19158 reports
WHEEZING158 reports

Report Outcomes

Out of 24,428 classified reports for ALIROCUMAB:

Serious 26.6%Non-Serious 73.4%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female12,559 (59.2%)
Male8,648 (40.7%)
Unknown19 (0.1%)

Reports by Age

Age 70588 reports
Age 68581 reports
Age 71536 reports
Age 69528 reports
Age 67526 reports
Age 72510 reports
Age 75509 reports
Age 74496 reports
Age 73491 reports
Age 65473 reports
Age 64466 reports
Age 66460 reports
Age 76458 reports
Age 63449 reports
Age 77443 reports
Age 62428 reports
Age 78383 reports
Age 60373 reports
Age 61370 reports
Age 59360 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with ALIROCUMAB?

This profile reflects 42,209 FDA FAERS reports that mention ALIROCUMAB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ALIROCUMAB?

Frequently reported terms in FAERS include MYALGIA, PRODUCT DOSE OMISSION, INJECTION SITE PAIN, MUSCLE SPASMS, ARTHRALGIA, FATIGUE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ALIROCUMAB?

Labeling and FAERS entries often list Regeneron Pharmaceuticals, Inc. in connection with ALIROCUMAB. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.