Feridex Side Effects

Generic Name: ferumoxides

Please note - some side effects for Feridex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Feridex Side Effects - for the Professional

Feridex

In clinical trials, a total of 2240 subjects (32 healthy volunteers and 2208 patients with known or suspected liver lesions) received Feridex I.V. Of these subjects, 35% received the recommended dose of 0.56 mg Fe/kg and 62% received a dose of 0.84 mg Fe/kg. Forty-four percent were female and 56% were male, with a mean age of 54.9 years (range 11–89).

Of 866 subjects in whom race is known, 647 (75%) were Asian, 199 (22%) were Caucasian, 14 (2%) were Black, 3 (<1%) were Hispanic, and 3 (<1%) other. Racial demographic information was not available for the 1374 subjects in European clinical trials.

Of the 2240 subjects, 197 (8.8%) experienced an adverse event. The most commonly noted adverse experiences were back pain (3.4%), and vasodilation (2.3%).

In a subgroup of 1535 patients in controlled clinical trials, in 44 (2.9%) of the patients [9/226 (3.9%) in US, 10/635 (1.6%) in Japanese, and 25/674 (3.7%) in European studies] the infusion was interrupted or discontinued because of acute, moderate to severe pain (back, lower torso, chest, groin, or upper leg) with or without hypotension. Some patients required treatment. In a few of the patients with pain 11/44 (25%), the infusion was interrupted, restarted, and completed.

Pain in any location was reported in 4.2% of these 1535 patients given Feridex I.V.

In a subgroup of 689 patients in whom associated underlying disorders were evaluated, back pain occurred in 18/144 (12.5%) patients with cirrhosis and in 10/545 (1.8%) patients who did not have cirrhosis. The frequency of pain in patients with other liver abnormalities is not known.

Anaphylactic and allergic adverse events (e.g., generalized urticaria, respiratory symptoms, and hypotension) that required acute treatment occurred in 11/2240 (0.5%) of patients who received Feridex I.V.

Most other adverse reactions were mild to moderate, of short duration, and resolved spontaneously without treatment. A relationship between adverse events and dose, age, or gender was not observed.

Adverse reactions that occurred in greater than or equal to 0.5% of the 1535 patients in controlled clinical trials are listed below in related categories, in decreasing order of occurrence within each system, and regardless of causality:

The following adverse reactions were observed in <0.5% of the subjects receiving Feridex I.V.: DIGESTIVE: diarrhea, vomiting, anorexia; BODY PAIN: pain abdomen, pain neck, fatigue, fever; CARDIOVASCULAR: hypertension, hypotension, arrhythmias; NERVOUS: dizziness, paresthesia; SKIN AND APPENDAGES: pruritus, sweating; SPECIAL SENSES: abnormal vision, taste perversion; RESPIRATORY: cough, epistaxis, rhinitis.

In 705 patients who received Feridex I.V. in other trials, similar adverse events were reported.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.