ERYTHROPOIETIN

N/A

Manufactured by Janssen Products, LP

39,177 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ERYTHROPOIETIN

ERYTHROPOIETIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Janssen Products, LP. The most commonly reported adverse reactions for ERYTHROPOIETIN include DEATH, ANAEMIA, FATIGUE, HAEMOGLOBIN DECREASED, ASTHENIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ERYTHROPOIETIN.

Top Adverse Reactions

DEATH2,586 reports
ANAEMIA1,500 reports
FATIGUE1,421 reports
HAEMOGLOBIN DECREASED1,380 reports
ASTHENIA1,030 reports
DIARRHOEA1,015 reports
NAUSEA975 reports
OFF LABEL USE852 reports
DYSPNOEA845 reports
PNEUMONIA757 reports
DRUG INEFFECTIVE684 reports
PAIN674 reports
VOMITING623 reports
PYREXIA603 reports
PLATELET COUNT DECREASED589 reports
RENAL FAILURE543 reports
WEIGHT DECREASED536 reports
MALAISE528 reports
DIZZINESS525 reports
HEADACHE512 reports
RASH507 reports
OEDEMA PERIPHERAL498 reports
THROMBOCYTOPENIA488 reports
DECREASED APPETITE484 reports
WHITE BLOOD CELL COUNT DECREASED428 reports
PAIN IN EXTREMITY418 reports
FALL416 reports
ARTHRALGIA413 reports
NEUTROPENIA409 reports
PRURITUS389 reports
CONSTIPATION383 reports
DEHYDRATION373 reports
URINARY TRACT INFECTION361 reports
HYPERTENSION360 reports
HOSPITALISATION353 reports
ABDOMINAL PAIN343 reports
HYPOTENSION342 reports
BACK PAIN333 reports
ANXIETY327 reports
DRUG DOSE OMISSION322 reports
SEPSIS320 reports
CARDIAC FAILURE CONGESTIVE314 reports
DISEASE PROGRESSION303 reports
THERAPEUTIC RESPONSE DECREASED302 reports
COUGH300 reports
CHEST PAIN298 reports
APLASIA PURE RED CELL293 reports
PANCYTOPENIA290 reports
GENERAL PHYSICAL HEALTH DETERIORATION271 reports
DEPRESSION266 reports
CONDITION AGGRAVATED264 reports
RED BLOOD CELL COUNT DECREASED255 reports
CEREBROVASCULAR ACCIDENT254 reports
ACUTE KIDNEY INJURY253 reports
BLOOD CREATININE INCREASED249 reports
CHRONIC KIDNEY DISEASE247 reports
FEELING ABNORMAL239 reports
INFECTION239 reports
DEEP VEIN THROMBOSIS235 reports
CARDIO RESPIRATORY ARREST231 reports
CONFUSIONAL STATE231 reports
GAIT DISTURBANCE227 reports
HAEMATOCRIT DECREASED225 reports
FEBRILE NEUTROPENIA218 reports
ATRIAL FIBRILLATION216 reports
INSOMNIA215 reports
MUSCLE SPASMS211 reports
MYOCARDIAL INFARCTION210 reports
NEUROPATHY PERIPHERAL204 reports
INJECTION SITE PAIN203 reports
UNEVALUABLE EVENT202 reports
GASTROINTESTINAL HAEMORRHAGE200 reports
WEIGHT INCREASED200 reports
ALOPECIA198 reports
PLEURAL EFFUSION198 reports
MYELODYSPLASTIC SYNDROME197 reports
ACUTE MYOCARDIAL INFARCTION193 reports
BONE PAIN192 reports
CONTUSION192 reports
EPISTAXIS190 reports
RENAL IMPAIRMENT190 reports
BLOOD PRESSURE INCREASED188 reports
SYNCOPE188 reports
RENAL FAILURE ACUTE186 reports
ERYTHEMA182 reports
HAEMOGLOBIN ABNORMAL182 reports
PULMONARY EMBOLISM180 reports
MALIGNANT NEOPLASM PROGRESSION179 reports
PERIPHERAL SWELLING179 reports
HYPOAESTHESIA178 reports
CHILLS174 reports
MYALGIA173 reports
RESPIRATORY FAILURE173 reports
PRODUCT STORAGE ERROR172 reports
BLOOD GLUCOSE INCREASED171 reports
HAEMORRHAGE168 reports
ABDOMINAL PAIN UPPER165 reports
MUSCULAR WEAKNESS165 reports
THROMBOSIS158 reports
PARAESTHESIA156 reports

Report Outcomes

Out of 20,174 classified reports for ERYTHROPOIETIN:

Serious 73.3%Non-Serious 26.7%

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

Female9,659 (53.4%)
Male8,052 (44.5%)
Unknown365 (2.0%)

Reports by Age

Age 72317 reports
Age 75317 reports
Age 76313 reports
Age 67310 reports
Age 80307 reports
Age 73306 reports
Age 70302 reports
Age 71302 reports
Age 64298 reports
Age 78293 reports
Age 69289 reports
Age 74287 reports
Age 63286 reports
Age 68281 reports
Age 77281 reports
Age 62279 reports
Age 79277 reports
Age 66268 reports
Age 58250 reports
Age 82249 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 ERYTHROPOIETIN?

This profile reflects 39,177 FDA FAERS reports that mention ERYTHROPOIETIN. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ERYTHROPOIETIN?

Frequently reported terms in FAERS include DEATH, ANAEMIA, FATIGUE, HAEMOGLOBIN DECREASED, ASTHENIA, DIARRHOEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ERYTHROPOIETIN?

Labeling and FAERS entries often list Janssen Products, LP in connection with ERYTHROPOIETIN. 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.