Feraheme

Feraheme Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Feraheme (ferumoxytol) Injection is used to treat iron deficiency anemia in people with chronic kidney disease. Anemia is a lack of red blood cells caused by having too little iron in the body. It is a type of iron. Common side effects include dizziness or fainting (hypotension). Pain, swelling, or redness at the injection site may also occur.

The recommended dose of Feraheme is an initial 510 mg intravenous injection followed by a second 510 mg intravenous injection 3 to 8 days later. Feraheme may interact with oral iron supplements (including ferrous gluconate, ferrous fumarate, or ferrous sulfate), making it harder for your body to absorb those iron supplements. Other drugs can interact with Feraheme. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, Feraheme should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Feraheme (ferumoxytol) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Feraheme in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Feraheme (Ferumoxytol Injection) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Feraheme Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness or fainting (hypotension) may occur. Pain, swelling, or redness at the injection site may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness or fainting, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: unusual bruising, skin darkens (bronze tone), swelling of hands/feet/lower legs, chest pain.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Feraheme (Ferumoxytol Injection)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Feraheme FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Feraheme injection may cause serious hypersensitivity reactions and hypotension [see WARNINGS AND PRECAUTIONS].

In clinical studies, 1,726 subjects were exposed to Feraheme; 1,562 of these had CKD and 164 did not have CKD. Of these subjects 46% were male and the median age was 63 years (range of 18 to 96 years).

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug may not reflect the rates observed in practice.

Adverse Reactions In Clinical Studies

Across the three randomized clinical trials [Trial 1, 2, and 3, see Clinical Studies], a total of 605 patients were exposed to two injections of 510 mg of Feraheme and a total of 280 patients were exposed to 200 mg/day of oral iron for 21 days. Most patients received their second Feraheme injection 3 to 8 days after the first injection.

Adverse reactions related to Feraheme and reported by ≥ 1% of Feraheme-treated patients in the randomized clinical trials are listed in Table 1. Diarrhea (4.0%), constipation (2.1%) and hypertension (1.0%) have also been reported in Feraheme-treated patients.

Table 1: Adverse Reactions to Feraheme Reported in ≥ 1% of Patients with CKD

Adverse Reactions Feraheme 2 x 510 mg
(n = 605)
Oral Iron
(n = 280)
Nausea 3.10% 7.50%
Dizziness 2.60% 1.80%
Hypotension 2.50% 0.40%
Peripheral Edema 2.00% 3.20%
Headache 1.80% 2.10%
Edema 1.50% 1.40%
Vomiting 1.50% 5.00%
Abdominal Pain 1.30% 1.40%
Chest Pain 1.30% 0.70%
Cough 1.30% 1.40%
Pruritus 1.20% 0.40%
Pyrexia 1.00% 0.70%
Back Pain 1.00% 0%
Muscle Spasms 1.00% 1.40%
Dyspnea 1.00% 1.10%
Rash 1.00% 0.40%

In clinical trials, adverse reactions leading to treatment discontinuation and occurring in ≥ 2 Feraheme-treated patients included hypotension, infusion site swelling, increased serum ferritin level, chest pain, diarrhea, dizziness, ecchymosis, pruritus, chronic renal failure, and urticaria.

Following completion of the controlled phase of the trials, 69 patients received two additional 510 mg intravenous injections of Feraheme (for a total cumulative dose of 2.04 g). Adverse reactions following this repeat Feraheme dosing were similar in character and frequency to those observed following the first two intravenous injections.

In a placebo-controlled, cross-over trial, 713 patients with CKD received a single 510 mg dose of Feraheme. Adverse reactions reported by these patients were similar in character and frequency to those observed in other clinical trials.

Adverse Reactions From Post-Marketing Spontaneous Reports

The following adverse reactions have been identified during post-approval use of Feraheme. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following serious adverse reactions have been reported from the post-marketing spontaneous reports with Feraheme: life-threatening anaphylactic-type reactions, 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. These adverse reactions have occurred up to 30 minutes after the administration of Feraheme injection. Reactions have occurred following the first dose or subsequent doses of Feraheme.

Read the entire FDA prescribing information for Feraheme (Ferumoxytol Injection) »

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Feraheme - User Reviews

Feraheme User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Feraheme sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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