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Ferriprox

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Ferriprox

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 Patient Information in Detail?

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

Ferriprox in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with deferiprone. Stop using this medicine and call your doctor right away if you have signs of infection such as: fever, chills, body aches, flu symptoms, or sores in your mouth and throat.

Stop using deferiprone and call your doctor at once if you have a serious side effect such as:

  • pounding heartbeats or fluttering in your chest;
  • feeling like you might pass out; or
  • seizure (convulsions).

Less serious side effects may include:

  • mild stomach pain or nausea;
  • vomiting, diarrhea;
  • joint pain, back pain;
  • increased appetite; or
  • headache.

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 Ferriprox (Deferiprone) »

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
(Adverse Reactions)

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 most serious adverse reaction reported in clinical trials with Ferriprox was agranulocytosis [see WARNINGS AND PRECAUTIONS].

The most common adverse reactions reported during clinical trials were chromaturia, nausea, vomiting, abdominal pain, alanine aminotransferase increased, arthralgia and neutropenia.

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
  Neutropenia 6.2
  Agranulocytosis 1.7
GASTROINTESTINAL DISORDERS  
  Nausea 12.6
  Abdominal pain/discomfort 10.4
  Vomiting 9.8
  Diarrhea 3.0
  Dyspepsia 2.0
INVESTIGATIONS
  Alanine Aminotransferase increased 7.5
  Neutrophil count decreased 7.3
  Weight increased 1.9
  Aspartate Aminotransferase increased 1.2
METABOLISM AND NUTRITION DISORDERS
  Increased appetite 4.0
  Decreased appetite 1.1
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS  
  Arthralgia 9.8
  Back pain 2.0
  Pain in extremity 1.9
  Arthropathy 1.4
NERVOUS SYSTEM DISORDERS
  Headache 2.5
URINARY DISORDERS
  Chromaturia 14.6

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.

Postmarketing Experience

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.

Blood and lymphatic system disorders: thrombocytosis, pancytopenia.

Cardiac disorders: atrial fibrillation, cardiac failure.

Congenital, familial and genetic disorders: hypospadias.

Eye disorders: diplopia, papilledema, retinal toxicity.

Gastrointestinal disorders: enterocolitis, rectal hemorrhage, gastric ulcer, pancreatitis, parotid gland enlargement.

General disorders and administration site conditions: chills, pyrexia, edema peripheral, multi-organ failure.

Hepatobiliary disorders: jaundice, hepatomegaly.

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.

Musculoskeletal and connective tissue disorders: myositis, chondropathy, trismus.

Nervous system disorders: cerebellar syndrome, cerebral hemorrhage, convulsion, gait disturbance, intracranial pressure increased, psychomotor skills impaired, pyramidal tract syndrome, somnolence.

Psychiatric disorders: bruxism, depression, obsessive-compulsive disorder.

Renal disorders: glycosuria, hemoglobinuria.

Respiratory, thoracic and mediastinal disorders: acute respiratory distress syndrome, epistaxis, hemoptysis, pulmonary embolism.

Skin, subcutaneous tissue disorders: hyperhidrosis, periorbital edema, photosensitivity reaction, pruritis, urticaria, rash, Henoch-Schönlein purpura.

Vascular disorders: hypotension, hypertension.

Read the entire FDA prescribing information for Ferriprox (Deferiprone) »

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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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