Feraheme Side Effects

Generic name: ferumoxytol

Note: This document contains side effect information about ferumoxytol. Some of the dosage forms listed on this page may not apply to the brand name Feraheme.

Some side effects of Feraheme may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to ferumoxytol: intravenous solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking ferumoxytol (the active ingredient contained in Feraheme) hives; wheezing or difficult breathing; swelling of your face, lips, tongue, or throat.

Watch for signs of allergic reaction for at least 30 minutes after your injection.

Call your doctor at once if you have serious side effects such as:

• feeling like you might pass out;

• slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);

• easy bruising;

• swelling where the medicine was injected; or

• worsening symptoms of kidney failure (urinating less than usual or not at all, confusion, mood changes, increased thirst, loss of appetite, swelling, weight gain, feeling short of breath).

Less serious side effects of ferumoxytol may include:

• nausea, vomiting, stomach pain;

• diarrhea, constipation;

• headache, dizziness;

• swelling in your hands or feet;

• chest pain; or

• cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to ferumoxytol: intravenous solution

Cardiovascular

Cardiovascular side effects have included hypotension (2.5%), chest pain (1.3%), and hypertension (1%). Anaphylactic type reactions presenting with cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, unresponsiveness, loss of consciousness, tachycardia/rhythm abnormalities, angioedema, ischemic myocardial events, congestive heart failure, pulse absent, and cyanosis have been reported postmarketing.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (4%), nausea (3.1%), constipation (2.1%), vomiting (1.5%), and abdominal pain (1.3%).

Nervous system

Nervous system side effects have included dizziness (2.6%), headache (1.8%), and pyrexia (1%).

Respiratory

Respiratory side effects have included cough (1.3%) and dyspnea (1%).

Dermatologic

Dermatologic side effects have included pruritus (1.2%) and rash (1%).

Musculoskeletal

Musculoskeletal side effects have included back pain (1%) and muscle spasms (1%).

Metabolic

Metabolic side effects have included peripheral edema (2%) and edema (1.5%).

Hypersensitivity

Hypersensitivity reactions have included anaphylaxis and/or anaphylactoid reactions. Anaphylactic type reactions presenting with cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness have been reported in the postmarketing experience.

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