Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Epoetin alfa
Drug ID BADD_D00787
Description Erythropoietin (EPO) is a growth factor produced in the kidneys that stimulates the production of red blood cells. It works by promoting the division and differentiation of committed erythroid progenitors in the bone marrow [FDA Label]. Epoetin alfa (Epoge) was developed by Amgen Inc. in 1983 as the first rhEPO commercialized in the United States, followed by other alfa and beta formulations. Epoetin alfa is a 165-amino acid erythropoiesis-stimulating glycoprotein produced in cell culture using recombinant DNA technology and is used for the treatment of patients with anemia associated with various clinical conditions, such as chronic renal failure, antiviral drug therapy, chemotherapy, or a high risk for perioperative blood loss from surgical procedures [FDA Label]. It has a molecular weight of approximately 30,400 daltons and is produced by mammalian cells into which the human erythropoietin gene has been introduced. The product contains the identical amino acid sequence of isolated natural erythropoietin and has the same biological activity as the endogenous erythropoietin. Epoetin alfa biosimilar, such as Retacrit (epoetin alfa-epbx or epoetin zeta), has been formulated to allow more access to treatment options for patients in the market [L2784]. The biosimilar is approved by the FDA and EMA as a safe, effective and affordable biological product and displays equivalent clinical efficacy, potency, and purity to the reference product [A7504]. Epoetin alfa formulations can be administered intravenously or subcutaneously.
Indications and Usage Indicated in adult and paediatric patients for the: - treatment of anemia due to Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis. - treatment of anemia due to zidovudine in patients with HIV-infection. - treatment of anemia due to the effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. - reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery.
Marketing Status approved
ATC Code Not Available
DrugBank ID DB00016
KEGG ID D03231
MeSH ID D000068817
PubChem ID 127893
TTD Drug ID D07PBZ
NDC Product Code 55513-113; 55513-136; 55513-126; 55513-283; 55513-168; 55513-148; 55513-144; 55513-154; 55513-101; 55513-120; 55513-142; 55513-267; 55513-478
UNII Not Available
Synonyms Epoetin Alfa | Alfa, Epoetin | Recombinant 1-165 Erythropoietin, Glycoform Alpha | Recombinant 1 165 Erythropoietin, Glycoform Alpha | Epoetin Alfa Hexal | Alfa Hexal, Epoetin | Hexal, Epoetin Alfa | Eprex | Heberitro | Procrit | Binocrit | HX575 Compound | Compound, HX575 | Epogen | HX575
Chemical Information
Molecular Formula C19H19NO4
CAS Registry Number 109138-11-6
SMILES C1=CC=C(C=C1)CC(CC(=O)CNC(=O)C2=CC=CC=C2)C(=O)O
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Arthralgia15.01.02.001--
Bone pain15.02.01.001--
Chills08.01.09.001; 15.05.03.016--
Cough22.02.03.001--
Depression19.15.01.001--
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Dysphagia07.01.06.003--
Erythema23.03.06.001---
Headache17.14.01.001--
Hyperglycaemia05.06.02.002; 14.06.02.002--
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Hypokalaemia14.05.03.002--
Injection site irritation08.02.03.027; 12.07.03.027---
Injection site pain08.02.03.010; 12.07.03.011---
Injection site reaction08.02.03.014; 12.07.03.015--
Insomnia17.15.03.002; 19.02.01.002--
Leukopenia01.02.02.001---
Muscle spasms15.05.03.004--
Myalgia15.05.02.001--
Myocardial infarction02.02.02.007; 24.04.04.009--
Nausea07.01.07.001--
Oedema08.01.07.006; 14.05.06.010---
Porphyria03.08.01.001; 14.14.01.001---
Pruritus23.03.12.001--
Pulmonary embolism22.06.02.001; 24.01.06.001---
Pyrexia08.05.02.003--
Rash23.03.13.001---
Seizure17.12.03.001--
Stomatitis07.05.06.005--
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