Feraheme Side Effects
Generic Name: ferumoxytol
Please note - some side effects for Feraheme may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Feraheme - for the Consumer
Feraheme
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Feraheme:
Seek medical attention right away if any of these SEVERE side effects occur when using Feraheme:Constipation; diarrhea; dizziness; nausea.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bluish skin or nails; chest, jaw, or left arm pain; fainting; fast or irregular heartbeat; loss of consciousness or unresponsiveness; numbness of an arm or leg; severe or persistent dizziness or light-headedness; shortness of breath; sudden, severe headache or vomiting; swelling at the injection site; swelling of the hands, ankles, legs, or feet; wheezing.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopFeraheme Side Effects - for the Professional
Feraheme
Feraheme injection may cause serious hypersensitivity reactions and hypotension [see Warnings and Precautions (5.1)(5.2)].
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 (14)], 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.
| 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.
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.
TopSide Effects by Body System - for Healthcare Professionals
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.
TopMore Feraheme resources
- Feraheme Prescribing Information (FDA)
- Feraheme Monograph (AHFS DI)
- Feraheme Advanced Consumer (Micromedex) - Includes Dosage Information
- Feraheme Consumer Overview
- Feraheme MedFacts Consumer Leaflet (Wolters Kluwer)
- Ferumoxytol Professional Patient Advice (Wolters Kluwer)
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