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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

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

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

Less Common

  • Anxiety
  • blurred vision
  • change in skin color
  • change in vision
  • 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
  • pain in the chest, groin, or legs, especially calves of the legs
  • pale skin
  • partial or complete loss of vision in the eye
  • seizures
  • severe headache of sudden onset
  • skin rash or hives
  • slurred speech
  • sore throat
  • sudden and severe inability to speak
  • sudden loss of coordination
  • 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

Incidence Not Known

  • Blistering, peeling, or loosening of the skin
  • chills
  • diarrhea
  • itching
  • joint or muscle pain
  • red, irritated eyes
  • red skin lesions, often with a purple center
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips

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

  • Bone or joint pain
  • constipation
  • general feeling of tiredness or weakness
  • heartburn or belching
  • itching or stinging at the injection site
  • loss of strength or energy
  • muscle aches or weakness
  • shivering
  • skin pain
  • stomach discomfort, upset, pain, or swelling
  • 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

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]

References

1. "Product Information. Epogen (epoetin alfa)." Amgen, Thousand Oaks, CA.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

4. "Product Information. Procrit (epoetin alfa)." Ortho Biotech Inc, Raritan, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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