Ferumoxytol Side Effects

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

For the Consumer

Applies to ferumoxytol: intravenous solution

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

If any of the following side effects occur while taking ferumoxytol, check with your doctor or nurse immediately:

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 fatigue
  • 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 or vomiting
  • 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
  • swelling of the face, fingers, feet, or lower legs
  • unconsciousness
  • unresponsiveness
  • weight gain

Some of the side effects that can occur with ferumoxytol 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:

Less common
  • Abdominal or stomach pain
  • back pain
  • headache
  • muscle spasms

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.

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