EPOETIN ALFA

N/A

Manufactured by Amgen, Inc

25,704 FDA adverse event reports analyzed

Last updated: 2026-04-14

About EPOETIN ALFA

EPOETIN ALFA is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amgen, Inc. The most commonly reported adverse reactions for EPOETIN ALFA include PRODUCT STORAGE ERROR, ANAEMIA, DYSPNOEA, HAEMOGLOBIN DECREASED, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for EPOETIN ALFA.

Top Adverse Reactions

PRODUCT STORAGE ERROR1,123 reports
ANAEMIA762 reports
DYSPNOEA631 reports
HAEMOGLOBIN DECREASED593 reports
NAUSEA588 reports
PAIN559 reports
DIARRHOEA543 reports
CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR542 reports
VOMITING531 reports
NEPHROGENIC SYSTEMIC FIBROSIS530 reports
DEATH518 reports
OFF LABEL USE497 reports
ASTHENIA486 reports
THERAPEUTIC RESPONSE DECREASED458 reports
HYPOTENSION452 reports
FATIGUE430 reports
RENAL FAILURE415 reports
PNEUMONIA405 reports
PYREXIA376 reports
DRUG INEFFECTIVE368 reports
OEDEMA PERIPHERAL355 reports
ABDOMINAL PAIN326 reports
ANXIETY320 reports
SEPSIS313 reports
HYPERTENSION307 reports
PRURITUS301 reports
INTERCEPTED PRODUCT ADMINISTRATION ERROR283 reports
APLASIA PURE RED CELL273 reports
DIZZINESS266 reports
RASH257 reports
PAIN IN EXTREMITY256 reports
CHEST PAIN254 reports
THROMBOCYTOPENIA248 reports
ARTHRALGIA244 reports
HEADACHE244 reports
FALL237 reports
GENERAL PHYSICAL HEALTH DETERIORATION228 reports
MALAISE222 reports
PANCYTOPENIA221 reports
ACUTE KIDNEY INJURY211 reports
CEREBROVASCULAR ACCIDENT211 reports
WEIGHT DECREASED207 reports
SKIN INDURATION205 reports
CARDIAC FAILURE CONGESTIVE204 reports
CHRONIC KIDNEY DISEASE203 reports
EMOTIONAL DISTRESS191 reports
HYPERSENSITIVITY187 reports
BLOOD PRESSURE INCREASED185 reports
SKIN HYPERTROPHY185 reports
CONSTIPATION184 reports
MOBILITY DECREASED183 reports
DECREASED APPETITE182 reports
DEPRESSION181 reports
END STAGE RENAL DISEASE181 reports
INCORRECT PRODUCT STORAGE181 reports
PLATELET COUNT DECREASED181 reports
PERITONITIS179 reports
GAIT DISTURBANCE178 reports
PLEURAL EFFUSION177 reports
URINARY TRACT INFECTION174 reports
HYPOAESTHESIA173 reports
CARDIAC ARREST172 reports
MYOCARDIAL INFARCTION172 reports
ATRIAL FIBRILLATION171 reports
INJURY171 reports
NEUTROPENIA171 reports
DEHYDRATION170 reports
GASTROINTESTINAL HAEMORRHAGE169 reports
COUGH168 reports
HOSPITALISATION167 reports
BLOOD CREATININE INCREASED165 reports
RENAL FAILURE CHRONIC162 reports
CARDIAC FAILURE157 reports
BACK PAIN155 reports
SKIN TIGHTNESS154 reports
JOINT RANGE OF MOTION DECREASED152 reports
ANHEDONIA146 reports
CONFUSIONAL STATE145 reports
RENAL IMPAIRMENT145 reports
RENAL FAILURE ACUTE142 reports
NEPHROGENIC ANAEMIA141 reports
PERITONITIS BACTERIAL141 reports
MUSCULAR WEAKNESS138 reports
FIBROSIS136 reports
ERYTHEMA134 reports
OEDEMA133 reports
CONDITION AGGRAVATED131 reports
RESPIRATORY FAILURE131 reports
HYPERKALAEMIA127 reports
SCAR127 reports
INFECTION126 reports
MUSCULOSKELETAL STIFFNESS125 reports
NEUROPATHY PERIPHERAL124 reports
CARDIO RESPIRATORY ARREST123 reports
DEEP VEIN THROMBOSIS121 reports
ABDOMINAL PAIN UPPER120 reports
INSOMNIA119 reports
SKIN DISCOLOURATION119 reports
LOSS OF CONSCIOUSNESS116 reports
HAEMOGLOBIN ABNORMAL113 reports

Report Outcomes

Out of 11,674 classified reports for EPOETIN ALFA:

Serious 72.0%Non-Serious 28.0%

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

Male4,835 (50.5%)
Female4,615 (48.2%)
Unknown131 (1.4%)

Reports by Age

Age 60188 reports
Age 75172 reports
Age 67171 reports
Age 69168 reports
Age 73155 reports
Age 58154 reports
Age 71153 reports
Age 59152 reports
Age 68152 reports
Age 66151 reports
Age 64147 reports
Age 72147 reports
Age 61146 reports
Age 63143 reports
Age 70140 reports
Age 54137 reports
Age 57135 reports
Age 55134 reports
Age 65134 reports
Age 62133 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 EPOETIN ALFA?

This profile reflects 25,704 FDA FAERS reports that mention EPOETIN ALFA. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for EPOETIN ALFA?

Frequently reported terms in FAERS include PRODUCT STORAGE ERROR, ANAEMIA, DYSPNOEA, HAEMOGLOBIN DECREASED, NAUSEA, PAIN. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures EPOETIN ALFA?

Labeling and FAERS entries often list Amgen, Inc in connection with EPOETIN ALFA. 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.