Summary

Commonly reported side effects of epoetin alfa include: upper respiratory tract infection, arthralgia, decreased serum iron, diarrhea, edema, fever, low serum ferritin, paresthesia, respiratory congestion, skin rash, tachycardia, cough, dyspnea, headache, nausea, signs and symptoms of injection site, and vomiting. Other side effects include: chest pain. Continue reading for a comprehensive list of adverse effects.

Applies to epoetin alfa: injection solution.

Serious side effects of Epoetin alfa

Along with its needed effects, epoetin alfa may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking epoetin alfa:

More common

• Black, tarry stools
• blurred vision
• body aches or pain
• bone pain
• chest pain
• chills
• cough
• dizziness
• dry mouth
• ear congestion
• fever
• flushed, dry skin
• fruit-like breath odor
• headache
• increased hunger
• increased thirst
• increased urination
• itching, skin rash
• loss of voice
• nausea
• nervousness
• pain, redness, or swelling in the arm or leg
• painful or difficult urination
• pounding in the ears
• runny or stuffy nose
• slow or fast heartbeat
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain
• swollen glands
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
• trouble breathing
• unexplained weight loss
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

Less common

• Anxiety
• decreased urine
• difficulty swallowing
• fainting
• irregular heartbeat
• loss of appetite
• mood changes
• muscle pain or cramps
• numbness or tingling in the hands, feet, or lips
• seizures
• swelling

Incidence not known

• Blistering, peeling, or loosening of the skin
• dark urine
• diarrhea
• fluid-filled skin blisters
• hives
• joint pain
• light-colored stools
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• sensitivity to the sun
• skin thinness
• tightness in the chest
• yellow eyes or skin

Other side effects of Epoetin alfa

Some side effects of epoetin alfa may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Decreased weight
• difficulty in moving
• injection site irritation or pain
• muscle spasm or stiffness
• swelling or inflammation of the mouth
• swollen joints
• trouble sleeping

Less common

• Discouragement
• feeling sad or empty
• irritability
• loss of interest or pleasure
• trouble concentrating

For Healthcare Professionals

Applies to epoetin alfa: injectable solution.

General

The most common adverse reaction was dose-dependent increase in blood pressure or aggravation of existing hypertension.^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 56%), diarrhea (up to 30%), vomiting (up to 28%), stomatitis (10%)

Common (1% to 10%): Dysphagia

Frequency not reported: Vomiting^[Ref]

Other

Very common (10% or more): Pyrexia (up to 42%)

Common (1% to 10%): Chills, influenza-like illness, peripheral edema, artificial kidney clotting during dialysis, edema^[Ref]

Nervous system

Very common (10% or more): Headache (up to 34%)

Common (1% to 10%): Convulsion, dizziness

Frequency not reported: Cerebrovascular accident, transient ischemic attack^[Ref]

Cardiovascular

Very common (10% or more): Hypertension (up to 33%), embolism and thrombosis (up to 15%)

Common (1% to 10%): Deep vein thrombosis, thrombosis

Uncommon (0.1% to 1%): Myocardial infarction

Frequency not reported: Blood pressure increased, aneurysm^[Ref]

Respiratory

Very common (10% or more): Cough (up to 26%)

Common (1% to 10%): Respiratory tract congestion, upper respiratory tract infection, pulmonary embolism^[Ref]

Dermatologic

Very common (10% or more): Rash (up to 25%), pruritus (up to 21%)

Common (1% to 10%): Urticaria

Uncommon (0.1% to 1%): Erythema

Frequency not reported: Angioedema

Postmarketing reports: Severe cutaneous reactions^[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (up to 24%), pain in extremity (up to 15%), myalgia (up to 10%)

Common (1% to 10%): Bone pain, muscle spasm

Frequency not reported: Porphyria^[Ref]

Local

Very common (10% or more): Injection site reaction (up to 18%), injection site pain (up to 13%)

Common (1% to 10%): Vascular access thrombosis^[Ref]

Metabolic

Very common (10% or more): Hyperkalemia (up to 10%)

Common (1% to 10%): Weight decrease, hyperglycemia, hypokalemia^[Ref]

Psychiatric

Common (1% to 10%): Insomnia, depression^[Ref]

Hematologic

Common (1% to 10%): Leukopenia

Postmarketing reports: Erythropoietin antibody-mediated pure red cell aplasia, thrombocytopenia^[Ref]

Immunologic

Frequency not reported: Anaphylactic reaction, hypersensitivity

Postmarketing reports: Serious allergic reaction^[Ref]