Ferumoxytol Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 3, 2024.

Applies to ferumoxytol: intravenous solution.

Important warnings This medicine can cause some serious health issues

Intravenous route (solution)

Risk For Serious Hypersensitivity/Anaphylaxis Reactions. Fatal and serious hypersensitivity reactions, including anaphylaxis, have occurred in patients receiving ferumoxytol.

Initial symptoms may include hypotension, syncope, unresponsiveness, and cardiac or cardiorespiratory arrest.Only administer ferumoxytol as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following ferumoxytol infusion including monitoring of blood pressure and pulse during and after ferumoxytol administration.Hypersensitivity reactions have occurred in patients in whom a previous ferumoxytol dose was tolerated.

Serious side effects of ferumoxytol

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 side effects

• 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

Other side effects of ferumoxytol

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 side effects

• back pain
• headache
• muscle spasms
• stomach pain

For healthcare professionals

Applies to ferumoxytol: intravenous solution.

General adverse events

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]

Further information

Ferumoxytol side effects can vary depending on the individual. 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.

Medical Disclaimer