Epoetin alfa Side Effects

In 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. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to epoetin alfa: injection solution

In addition to its needed effects, some unwanted effects may be caused by epoetin alfa. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking epoetin alfa:

• Chest pain
• fever
• headache
• increased blood pressure
• shortness of breath
• swelling of the face, fingers, ankles, feet, or lower legs
• weight gain

• Anxiety
• blurred vision
• change in skin color
• change in vision
• convulsions (seizures)
• cough
• dizziness or lightheadedness
• double vision
• fainting
• fast heartbeat
• migraine headache
• nausea
• pain or discomfort in the arms, jaw, back, or neck
• pain, tenderness, or swelling of the foot or leg
• pains in the chest, groin, or legs, especially calves of the legs
• pale skin
• partial or complete loss of vision in the eye
• severe headaches of sudden onset
• skin rash or hives
• slurred speech
• sore throat
• sudden and severe inability to speak
• sudden loss of coordination
• sudden vision changes
• sweating
• temporary blindness
• tenderness, pain, swelling, warmth, or skin discoloration at the injection site
• unusual bleeding or bruising
• unusual tiredness or weakness
• vision problems
• vomiting
• weakness in the arm or leg on one side of the body, sudden and severe

Minor Side Effects

Some of the side effects that can occur with epoetin alfa may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

• Abdominal or stomach pain and swelling
• bone or joint pain, muscle aches, chills, shivering, or sweating
• constipation
• diarrhea
• dizziness
• general feeling of tiredness or weakness
• heartburn or belching, acid or sour stomach
• inability to sleep
• itching or stinging at the injection site
• loss of strength or energy
• muscle pain or weakness
• skin pain
• stomach discomfort, upset, or pain
• weight loss

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^[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]

Not all side effects for epoetin alfa may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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