Deferiprone Side Effects

Some side effects of deferiprone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to deferiprone: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking deferiprone: 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 of deferiprone 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.

For Healthcare Professionals

Applies to deferiprone: oral tablet

Cardiovascular

Cardiovascular side effects have included postmarketing reports of atrial fibrillation, cardiac failure, hypotension and hypertension.

Dermatologic

Dermatologic side effects have included postmarketing reports of hyperhidrosis, periorbital edema, photosensitivity reaction, pruritus, urticarial, rash and Henoch-Schonlein purpura.

Gastrointestinal

Gastrointestinal side effects have included nausea (12.6%), abdominal pain/discomfort (10.4%), vomiting (9.8%), diarrhea (3%), dyspepsia (2%) and postmarketing reports of enterocolitis, rectal hemorrhage, gastric ulcer, pancreatitis, and parotid gland enlargement.

General

General side effects have included postmarketing reports of chills, pyrexia, edema peripheral, and multi-organ failure.

Genitourinary

Genitourinary side effects have included chromaturia (14.6%).

Hematologic

Hematologic side effects have included neutropenia (6.2%), agranulocytosis (1.7%), and postmarketing reports of thrombocytosis, and pancytopenia.

Hepatic

Hepatic side effects have included postmarketing reports of jaundice, and hepatomegaly.

Hypersensitivity

Hypersensitivity reactions have included postmarketing reports of anaphylactic shock, and hypersensitivity.

Immunologic

Immunologic side effects have included postmarketing reports of cryptococcal cutaneous infection, enteroviral encephalitis, pharyngitis, pneumonia, sepsis, furuncle, infectious hepatitis, rash pustular, and subcutaneous abscess.

Metabolic

Metabolic side effects have included weight increased (1.9%) and postmarketing reports of metabolic acidosis, and dehydration.

Laboratory abnormalities have included alanine aminotransferase (ALT) increased (7.5%), neutrophil count decreased (7.3%), and aspartate aminotransferase (AST) increased (1.2%) and postmarketing reports of blood bilirubin increased, and blood creatinine phosphokinase increased.

Musculoskeletal

Musculoskeletal side effects have included arthralgia (9.8%), back pain (2.0%), pain in extremity (1.9%), arthropathy (1.4%) and postmarketing reports of myositis, chondropathy, and trismus.

Nervous system

Nervous system side effects have included headache (2.5%) and postmarketing reports of cerebellar syndrome, cerebral hemorrhage, convulsion, gait disturbance, intracranial pressure increased, psychomotor skills impaired, pyramidal tract syndrome, and somnolence.

Ocular

Ocular side effects have included postmarketing reports of diplopia, papilledema, and retinal toxicity.

Other

Other side effects have included postmarketing reports of hypospadias.

Psychiatric

Psychiatric side effects have included postmarketing reports of bruxism, depression, obsessive-compulsive disorder.

Renal

Renal side effects have included postmarketing reports of glycosuria and hemoglobinuria.

Respiratory

Respiratory side effects have included postmarketing reports of acute respiratory distress syndrome, epistaxis, hemoptysis, and pulmonary embolism.

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