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Ferumoxytol Side Effects

For the Consumer

Applies to ferumoxytol: intravenous solution

Along with its needed effects, ferumoxytol 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 or nurse immediately if any of the following side effects occur while taking ferumoxytol:

Less Common

  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision
  • chest pain
  • confusion
  • difficult or labored breathing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fever
  • rapid weight gain
  • sweating
  • tightness in the chest
  • tingling of the hands or feet
  • unusual tiredness or weakness
  • unusual weight gain or loss

Incidence Not Known

  • Bluish color of the fingernails, lips, skin, palms, or nail beds
  • chest discomfort
  • cough
  • decreased urine output
  • difficulty with swallowing
  • dilated neck veins
  • dizziness
  • extreme tiredness or weakness
  • fainting
  • fast, pounding, or irregular heartbeat or pulse
  • hives, itching, or skin rash
  • irregular breathing
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of consciousness
  • nausea
  • no blood pressure or pulse
  • pain in the shoulders, arms, jaw, or neck
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • stopping of the heart
  • unconsciousness
  • unresponsiveness
  • vomiting
  • weight gain

Some side effects of ferumoxytol 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:

Less Common

For Healthcare Professionals

Applies to ferumoxytol: intravenous solution

General

The most common adverse events were injection site reactions, gastrointestinal symptoms, headache, dizziness, and hypotension.[Ref]

Local

Common (1% to 10%): Injection site reactions (infusion/injection site bruising, pain, reaction, swelling, warmth, hemorrhage, irritation, rash)[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting, abdominal pain (abdominal distension, abdominal pain upper, abdominal discomfort)

Uncommon (0.1% to 1%): Diarrhea, constipation, feces discolored

Rare (less than 0.1%): Dry mouth, dyspepsia, glossodynia

Frequency not reported: Lip swelling, swollen tongue[Ref]

Cardiovascular

Common (1% to 10%): Hypotension (hypotension, blood pressure decreased)

Uncommon (0.1% to 1%): Flushing (flushing, hot flush), hypertension (hypertension, accelerated hypertension)

Rare (less than 0.1%): Cardiac arrest, cardio-respiratory arrest, myocardial events, congestive heart failure

Frequency not reported: Tachycardia/arrhythmia, myocardial infarction, vasodilation, pulse absent

Postmarketing reports: Cyanosis[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache

Uncommon (0.1% to 1%): Dysgeusia, somnolence, burning sensation

Rare (less than 0.1%): Paresthesia

Frequency not reported: Syncope, unresponsiveness, loss of consciousness[Ref]

Dermatologic

Common (1% to 10%): Pruritus (pruritus generalized), rash (rash, rash generalized, rash pruritic, urticaria)

Uncommon (0.1% to 1%): Ecchymosis, sweating (hyperhidrosis, night sweats), skin hyperpigmentation, skin reaction

Frequency not reported: Angioedema[Ref]

Respiratory

Common (1% to 10%): Cough, dyspnea

Rare (less than 0.1%): Epistaxis

Frequency not reported: Bronchospasm, hyperventilation, hypoxia, laryngeal edema, pharyngeal edema, respiratory arrest, respiratory failure, throat irritation, throat tightness, wheezing[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, muscle spasms

Uncommon (0.1% to 1%): Muscle/joint pain or stiffness (arthralgia, myalgia, muscular weakness, musculoskeletal stiffness)[Ref]

Metabolic

Common (1% to 10%): Edema

Uncommon (0.1% to 1%): Decreased appetite, increased appetite

Rare (less than 0.1%): Dehydration, gout, hyperkalemia, blood glucose decreased

Frequency not reported: Oxygen saturation decreased[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity (including anaphylaxis)

Postmarketing reports: Life-threatening anaphylactic/anaphylactoid reactions[Ref]

Hematologic

Rare (less than 0.1%): Eosinophilia[Ref]

Hepatic

Rare (less than 0.1%): Hepatic function abnormal[Ref]

Other

Common (1% to 10%): Peripheral edema, chest pain (chest discomfort, chest pain), fever (feeling hot, pyrexia)

Uncommon (0.1% to 1%): Fatigue (asthenia, fatigue), chills, serum ferritin increased, contusion[Ref]

Ocular

Rare (less than 0.1%): Lacrimation increased, vision blurred[Ref]

Renal

Frequency not reported: Chronic renal failure[Ref]

References

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

2. "Product Information. Feraheme (ferumoxytol)." Alza Pharmaceuticals, Mountain View, CA.

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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