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Ferriprox Side Effects Center
Medical Editor: Melissa Conrad Stöppler, MD
Ferriprox (deferiprone) is an oral iron chelator used to treat patients with iron overload due to the frequent blood transfusions required in certain disorders such as thalassemia.. Side effects of Ferriprox can include nausea, vomiting, abdominal and joint pain, urine discoloration (chromaturia), a decrease in the number of white blood cells (neutropenia), and an increase in the level of a liver enzyme that may be indicative of tissue or liver damage at unsafe amounts.
The recommended initial dose of Ferriprox is 25 mg/kg, orally, three times per day for a total of 75 mg/kg/day. The maximum dose is 33 mg/kg, three times per day for a total of 99 mg/kg/day. Allow at least a four-hour interval between ingesting Ferriprox and other medications or supplements containing iron, aluminum, and/or zinc. In patients taking Ferriprox, urine may show a reddish-brown discoloration due to the excretion of the iron-deferiprone complex. This is a very common sign of the desired effect of Ferriprox, and is not harmful.
If Ferriprox is used during pregnancy or if the patient becomes pregnant while taking Ferriprox, the patient should be apprised of the potential hazard to the fetus. Women of reproductive potential should be advised to avoid pregnancy when taking Ferriprox. Patients should notify their physicians immediately if they become pregnant or plan to become pregnant while take Ferriprox. Patients should not breastfeed while taking Ferriprox.
Our Ferriprox 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 Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Ferriprox FDA Prescribing Information: Side Effects
Clinical Trial Experience
The following adverse reactions are also discussed in other sections of the labeling: Agranulocytosis/Neutropenia [see WARNINGS AND PRECAUTIONS. Elevated ALT , Torsades de Pointes, Decreased plasma zinc concentrations].
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse reaction information for Ferriprox represents the pooled data collected from 642 patients who participated in single arm or active-controlled clinical studies.
The table below lists the adverse drug reactions that occurred in at least 1% of patients treated with Ferriprox in clinical trials.
Table 2: Adverse drug reactions occurring in ≥ 1%
of 642 Ferriprox-treated patients
|Body System Preferred Term||% Subjects|
|BLOOD AND LYMPHATIC SYSTEM DISORDERS|
|Alanine Aminotransferase increased||7.5|
|Neutrophil count decreased||7.3|
|Aspartate Aminotransferase increased||1.2|
|METABOLISM AND NUTRITION DISORDERS|
|MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS|
|Pain in extremity||1.9|
|NERVOUS SYSTEM DISORDERS|
Gastrointestinal symptoms such as nausea, vomiting, and abdominal pain were the most frequent adverse reactions reported by patients participating in clinical trials and led to the discontinuation of Ferriprox therapy in 1.6% of patients.
Chromaturia (reddish/brown discoloration of the urine) is a result of the excretion of the iron in the urine.
The following additional adverse reactions have been reported in patients receiving Ferriprox. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure.
Cardiac disorders: atrial fibrillation, cardiac failure.
Congenital, familial and genetic disorders: hypospadias.
General disorders and administration site conditions: chills, pyrexia, edema peripheral, multi-organ failure.
Immune system disorders: anaphylactic shock, hypersensitivity. Infections and infestations: cryptococcal cutaneous infection, enteroviral encephalitis, pharyngitis, pneumonia, sepsis, furuncle, infectious hepatitis, rash pustular, subcutaneous abscess.
Investigations: blood bilirubin increased, blood creatinine phosphokinase increased.
Metabolism and nutrition disorders: metabolic acidosis, dehydration.
Renal disorders: glycosuria, hemoglobinuria.
Read the entire FDA prescribing information for Ferriprox (Deferiprone) »
Additional Ferriprox Information
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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