Ferriprox

Last updated on RxList: 6/8/2020
Ferriprox Side Effects Center

What Is Ferriprox?

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.

What Are Side Effects of Ferriprox?

Side effects of Ferriprox include:

  • nausea,
  • vomiting,
  • stomach/abdominal pain,
  • diarrhea,
  • joint pain,
  • back pain,
  • increased appetite,
  • headache,
  • reddish-brown urine discoloration (this is not harmful),
  • 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

Dosage for Ferriprox

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.

What Drugs, Substances, or Supplements Interact with Ferriprox?

Ferriprox may interact with antacids or mineral supplements taken within 4 hours before or 4 hours after taking Ferriprox, herbal supplements containing milk thistle, or other iron chelating medicines. Tell your doctor all medications and supplements you use.

Ferriprox During Pregnancy and Breastfeeding

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.

Additional Information

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.

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Ferriprox Consumer Information

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Get emergency medical help if you have 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;
  • skin sores; or
  • sores in your mouth and throat.

Further doses may be delayed until your infection clears up.

Deferiprone may cause your urine to turn a reddish-brown color. This side effect is usually not harmful. Call your doctor if you also have upper stomach pain, clay-colored stools, or jaundice (yellowing of your skin or the whites of your eyes).

Common side effects may include:

  • nausea, vomiting, stomach pain;
  • infections;
  • joint pain; or
  • abnormal liver function tests.

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)

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Ferriprox Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described below and elsewhere in the labeling:

  • Agranulocytosis and Neutropenia [see WARNINGS AND PRECAUTIONS]
  • Liver Enzyme Elevations [see WARNINGS AND PRECAUTIONS]
  • Zinc Deficiency [see WARNINGS AND PRECAUTIONS]

Clinical Trial Experience

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.

FERRIPROX tablets (twice a day) were evaluated in trials in healthy subjects. Currently, there are no clinical data in patients with FERRIPROX tablets (twice a day). FERRIPROX tablets (twice a day) contain deferiprone, the same active ingredient as FERRIPROX (deferiprone) tablets (three times a day) and oral solution. The following adverse reaction information represents the pooled data collected from 642 patients who participated in single arm or active-controlled clinical trials taking FERRIPROX (deferiprone) tablets (three times a day) and oral solution.

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 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 5:Adverse drug reactions occurring in ≥ 1% of FERRIPROX-treated patients

Body System
Adverse Reaction
(N=642)
% Subjects
BLOOD AND LYMPHATIC SYSTEM DISORDERS
  Neutropenia6
  Agranulocytosis2
GASTROINTESTINAL DISORDERS
  Nausea13
  Abdominal pain/discomfort10
  Vomiting10
  Diarrhea3
  Dyspepsia2
INVESTIGATIONS
  Alanine Aminotransferase increased7
  Weight increased2
  Aspartate Aminotransferase increased1
METABOLISM AND NUTRITION DISORDERS
  Increased appetite4
  Decreased appetite1
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
  Arthralgia10
  Back pain2
  Pain in extremity2
  Arthropathy1
NERVOUS SYSTEM DISORDERS
  Headache2

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 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)

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

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