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Feraheme

Last reviewed on RxList: 4/7/2015
Feraheme Side Effects Center

Last reviewed on RxList 02/03/2017

Feraheme (ferumoxytol) Injection is a type of iron 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. Common side effects of Feraheme include:

  • dizziness,
  • fainting,
  • low blood pressure (hypotension),
  • injection site reactions (pain, swelling, or redness),
  • nausea,
  • vomiting,
  • stomach pain,
  • diarrhea,
  • constipation,
  • headache,
  • swelling in your hands or feet,
  • chest pain, or
  • cough.

Tell your doctor if you have unlikely but serious side effects of Feraheme including:

  • unusual bruising,
  • skin darkening (bronze tone),
  • swelling of lower legs, or
  • chest pain.

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 medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant while using Feraheme; it is unknown if it will harm a fetus. It is unknown if Feraheme passes into breast milk or if it could harm a nursing baby. Breastfeeding while using Feraheme is not recommended.

Our Feraheme (ferumoxytol) Injection 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.

Feraheme Consumer Information

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)

Feraheme Professional Information

SIDE EFFECTS

Feraheme administration 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 3.1% 7.5%
Dizziness 2.6% 1.8%
Hypotension 2.5% 0.4%
Peripheral Edema 2.0% 3.2%
Headache 1.8% 2.1%
Edema 1.5% 1.4%
Vomiting 1.5% 5.0%
Abdominal Pain 1.3% 1.4%
Chest Pain 1.3% 0.7%
Cough 1.3% 1.4%
Pruritus 1.2% 0.4%
Pyrexia 1.0% 0.7%
Back Pain 1.0% 0%
Muscle Spasms 1.0% 1.4%
Dyspnea 1.0% 1.1%
Rash 1.0% 0.4%

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.

Postmarketing Experience

Because adverse 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 experience with Feraheme: fatal, life-threatening, and serious 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 usually occurred within 30 minutes after the administration of Feraheme. Reactions have occurred following the first dose or subsequent doses of Feraheme.

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

Related Resources for Feraheme

Read the Feraheme User Reviews »

© Feraheme Patient Information is supplied by Cerner Multum, Inc. and Feraheme Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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