Repatha

N/A

Manufactured by Amgen USA Inc.

269,908 FDA adverse event reports analyzed

Last updated: 2026-05-19

About Repatha

Repatha is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amgen USA Inc.. The most commonly reported adverse reactions for Repatha include DEVICE DIFFICULT TO USE, DRUG DOSE OMISSION BY DEVICE, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS, ACCIDENTAL EXPOSURE TO PRODUCT, INJECTION SITE PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for Repatha.

Top Adverse Reactions

DEVICE DIFFICULT TO USE32,601 reports
DRUG DOSE OMISSION BY DEVICE24,421 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS22,053 reports
ACCIDENTAL EXPOSURE TO PRODUCT16,450 reports
INJECTION SITE PAIN10,546 reports
PRODUCT STORAGE ERROR6,647 reports
BACK PAIN5,497 reports
MYALGIA5,332 reports
DRUG DOSE OMISSION4,929 reports
INJECTION SITE BRUISING4,632 reports
DEVICE USE ERROR4,119 reports
ARTHRALGIA3,979 reports
FATIGUE3,927 reports
INJECTION SITE HAEMORRHAGE3,893 reports
OFF LABEL USE3,865 reports
RHINORRHOEA3,566 reports
PAIN IN EXTREMITY3,416 reports
MUSCLE SPASMS3,209 reports
INFLUENZA LIKE ILLNESS3,142 reports
PAIN3,025 reports
HEADACHE2,954 reports
INCORRECT DOSE ADMINISTERED BY DEVICE2,945 reports
CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR2,875 reports
PRODUCT PREPARATION ERROR2,829 reports
NASOPHARYNGITIS2,539 reports
INTERCEPTED PRODUCT ADMINISTRATION ERROR2,517 reports
PRODUCT COMMUNICATION ISSUE2,511 reports
DIARRHOEA2,505 reports
NAUSEA2,435 reports
DIZZINESS2,402 reports
DYSPNOEA2,218 reports
COUGH2,217 reports
INJECTION SITE SWELLING2,023 reports
RASH1,896 reports
INJECTION SITE ERYTHEMA1,872 reports
MALAISE1,869 reports
ASTHENIA1,719 reports
BLOOD GLUCOSE INCREASED1,711 reports
DEVICE ISSUE1,697 reports
FEELING ABNORMAL1,676 reports
PRURITUS1,613 reports
INCORRECT DISPOSAL OF PRODUCT1,608 reports
OROPHARYNGEAL PAIN1,473 reports
UNDERDOSE1,420 reports
INJURY ASSOCIATED WITH DEVICE1,419 reports
PRODUCT DOSE OMISSION ISSUE1,372 reports
DEATH1,369 reports
INJECTION SITE MASS1,318 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION1,312 reports
DRUG INEFFECTIVE1,295 reports
INFLUENZA1,163 reports
MEMORY IMPAIRMENT1,150 reports
BLOOD CHOLESTEROL INCREASED1,148 reports
LOW DENSITY LIPOPROTEIN INCREASED1,124 reports
MUSCULAR WEAKNESS1,117 reports
GAIT DISTURBANCE1,109 reports
MYOCARDIAL INFARCTION1,068 reports
HYPERSENSITIVITY1,031 reports
WEIGHT INCREASED1,031 reports
CHEST PAIN992 reports
INJECTION SITE PRURITUS962 reports
OCCUPATIONAL EXPOSURE TO PRODUCT955 reports
UNEVALUABLE EVENT952 reports
WEIGHT DECREASED933 reports
URTICARIA920 reports
ABDOMINAL PAIN UPPER916 reports
FALL914 reports
ADVERSE EVENT898 reports
INTENTIONAL PRODUCT MISUSE887 reports
PERIPHERAL SWELLING887 reports
BLOOD PRESSURE INCREASED848 reports
HYPERTENSION805 reports
CEREBROVASCULAR ACCIDENT801 reports
THERAPY INTERRUPTED793 reports
INCORRECT DOSE ADMINISTERED778 reports
MUSCULOSKELETAL PAIN757 reports
VOMITING756 reports
ABDOMINAL DISCOMFORT750 reports
MOBILITY DECREASED748 reports
HYPOACUSIS732 reports
INSOMNIA718 reports
LOW DENSITY LIPOPROTEIN DECREASED707 reports
CONTUSION705 reports
PNEUMONIA690 reports
WRONG TECHNIQUE IN DEVICE USAGE PROCESS682 reports
HOSPITALISATION679 reports
NASAL CONGESTION672 reports
PRODUCT DOSE OMISSION671 reports
SINUSITIS665 reports
URINARY TRACT INFECTION658 reports
ALOPECIA655 reports
CHEST DISCOMFORT637 reports
ARTHRITIS632 reports
ANXIETY627 reports
HYPOAESTHESIA627 reports
INJECTION SITE REACTION627 reports
PARAESTHESIA621 reports
DYSPHONIA620 reports
PRODUCT ADMINISTRATION ERROR617 reports
PYREXIA615 reports

Report Outcomes

Out of 157,011 classified reports for Repatha:

  • Serious: 24,539 reports (15.6%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 132,472 reports (84.4%)
Serious 15.6%Non-Serious 84.4%

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

Female84,636 (58.2%)
Male60,610 (41.7%)
Unknown65 (0.0%)

Reports by Age

Age 704,252 reports
Age 714,133 reports
Age 694,127 reports
Age 744,095 reports
Age 734,086 reports
Age 723,992 reports
Age 753,975 reports
Age 683,944 reports
Age 673,811 reports
Age 763,755 reports
Age 663,718 reports
Age 643,691 reports
Age 653,686 reports
Age 633,624 reports
Age 773,551 reports
Age 623,348 reports
Age 783,303 reports
Age 613,128 reports
Age 602,950 reports
Age 792,870 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 Repatha?

This profile reflects 269,908 FDA FAERS reports that mention Repatha. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for Repatha?

Frequently reported terms in FAERS include DEVICE DIFFICULT TO USE, DRUG DOSE OMISSION BY DEVICE, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS, ACCIDENTAL EXPOSURE TO PRODUCT, INJECTION SITE PAIN, PRODUCT STORAGE ERROR. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures Repatha?

Labeling and FAERS entries often list Amgen USA Inc. in connection with Repatha. Always verify the specific product and NDC with your pharmacist.

Other Drugs by Amgen USA Inc.

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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.