Summary

More frequently reported side effects include: neutropenia and increased serum alanine aminotransferase. Continue reading for a comprehensive list of adverse effects.

Applies to deferiprone: oral solution, oral tablet.

Serious side effects of Deferiprone

Along with its needed effects, deferiprone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking deferiprone:

More common

• Black, tarry stools
• bone pain
• chills
• cough
• fever
• lower back or side pain
• painful or difficult urination
• pale skin
• sore throat
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness

Less common

• Fever with or without chills
• general feeling of tiredness or weakness
• hoarseness

Incidence not known

• Anxiety
• bleeding gums
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the urine or stools
• blurred vision
• chest pain, discomfort, or tightness
• clay-colored stools
• confusion
• dark urine
• decreased urination
• dilated neck veins
• dizziness or lightheadedness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• dry mouth
• fainting
• fast or irregular heartbeat
• headache
• hives, itching, skin rash
• increase in heart rate
• increased sweating
• irregular breathing
• irritation
• joint pain, stiffness, or swelling
• large, flat, blue or purplish patches in the skin
• loss of appetite
• muscle tremors
• nausea
• nervousness
• painful knees and ankles
• pinpoint red spots on the skin
• pounding in the ears
• raised red swellings on the skin, the buttocks, legs, or ankles
• rapid weight gain
• rapid, deep or shallow breathing
• redness of the skin
• restlessness
• seizures
• severe nausea or vomiting
• slow heartbeat
• sneezing
• spots on your skin resembling a blister or pimple
• stomach pain or cramps
• sudden trouble breathing
• sugar in the urine
• sunken eyes
• sweating
• swelling of the eyelids, around the eyes, face, lips, hands, or feet
• thirst
• tingling of the hands or feet
• trouble with balance
• trouble breathing or swallowing
• unpleasant breath odor
• unusual weight gain or loss
• vision changes
• vomiting of blood
• weight gain
• wrinkled skin
• yellow eyes or skin

Other side effects of Deferiprone

Some side effects of deferiprone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Difficulty with moving
• muscle pain or stiffness
• reddish or brown discoloration of the urine
• stomach discomfort

Less common

• Back pain
• belching
• diarrhea
• heartburn
• increased or decreased appetite
• indigestion
• pain in the arms or legs
• stomach upset

Incidence not known

• Bloody nose
• clenching, gnashing, or grinding teeth
• constipation
• coughing or spitting up blood
• depression
• difficulty opening the mouth
• difficulty with speaking
• drooling
• impaired psychomotor skills
• increased sensitivity of the skin to sunlight
• lockjaw
• loss of balance control
• muscle spasm, especially of the neck and back
• muscle trembling, jerking, or stiffness
• pains in the stomach, side, or abdomen, possibly radiating to the back
• severe sunburn
• shuffling walk
• sleepiness or unusual drowsiness
• stiffness of the limbs
• stomach bloating, burning, cramping, or pain
• twisting movements of the body
• uncontrolled movements, especially of the face, neck, and back

For Healthcare Professionals

Applies to deferiprone: oral liquid, oral tablet.

General

The most common adverse events were chromaturia, nausea, vomiting, abdominal pain, alanine aminotransferase increased, arthralgia, and neutropenia.^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (12.6%), abdominal pain/discomfort (10.4%), vomiting

Common (1% to 10%): Diarrhea, dyspepsia, abdominal discomfort, abdominal pain, abdominal pain upper

Uncommon (0.1% to 1%): Abdominal distension, abdominal pain lower, aphthous stomatitis, constipation, epigastric discomfort, eructation, gastritis, reflux esophagitis, stomach discomfort, gastroenteritis, gastroenteritis viral

Postmarketing reports: Enterocolitis, rectal hemorrhage, gastric ulcer, pancreatitis, parotid gland enlargement, cecitis, dysphagia^[Ref]

Gastrointestinal effects are more frequent at the beginning of therapy, and in most patients resolve within a few weeks without the discontinuation of treatment.^[Ref]

Genitourinary

Very common (10% or more): Chromaturia (14.6%)

Uncommon (0.1% to 1%): Pollakiuria, amenorrhea, menstruation irregular

Postmarketing reports: Glycosuria, hypospadias, congenital anomaly, non-acute porphyria, urinary tract infection, urine color abnormal, intra-uterine death, balanitis^[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia

Common (1% to 10%): Back pain, pain in extremity, arthropathy, joint swelling

Uncommon (0.1% to 1%): Epicondylitis, arthritis, bone pain, joint crepitation, joint effusion, joint range of motion decreased, joint stiffness, metatarsalgia, muscle spasms, muscular weakness, musculoskeletal chest pain, musculoskeletal pain, myalgia, polyarthritis, synovial cyst

Postmarketing reports: Myositis, chondropathy, trismus^[Ref]

Hematologic

Common (1% to 10%): Neutrophil count decreased, neutropenia, agranulocytosis, white blood cell count decreased

Uncommon (0.1% to 1%): Blood disorder, hypersplenism, leukopenia, thrombocytopenia, platelet count decreased, platelet count increased

Postmarketing reports: Thrombocytosis, pancytopenia, febrile neutropenia, thrombocythemia, granulocytopenia, hemoglobin decrease, neutropenic sepsis^[Ref]

Hepatic

Common (1% to 10%): Alanine aminotransferase increased, aspartate aminotransferase increased, increased liver enzymes

Uncommon (0.1% to 1%): Hepatic pain, hepatitis, hepatomegaly, jaundice, liver tenderness, cytomegalovirus hepatitis, blood bilirubin increased, hepatic enzyme increased

Postmarketing reports: Hepatic function abnormal, infectious hepatitis^[Ref]

Other

Common (1% to 10%): Fatigue, peripheral edema

Uncommon (0.1% to 1%): Deafness, ear pain, tinnitus, vertigo, asthenia, chest pain, discomfort, fatigue, influenza like illness, malaise, pyrexia, thirst, diabetic foot infection, sepsis, Yersinia infection, transfusion reaction, blood creatinine increased, blood phosphorus increased, blood zinc decreased, gamma-glutamyl transferase increased

Frequency not reported: Progression of fibrosis

Postmarketing reports: Chills, multi-organ failure, pharyngitis, pneumonia, sepsis, blood creatinine phosphokinase increased, difficulty in walking, hyperpyrexia, anti-HBs antibody positive, blood arsenic increased^[Ref]

Metabolic

Common (1% to 10%): Increased appetite, weight increased, decreased appetite, anorexia

Uncommon (0.1% to 1%): Weight decreased, fluid retention

Postmarketing reports: Metabolic acidosis, dehydration, metabolic disorder^[Ref]

Respiratory

Uncommon (0.1% to 1%): Influenza, nasopharyngitis, upper respiratory tract infection, asthma, dry throat, oropharyngeal pain

Postmarketing reports: Acute respiratory distress syndrome, epistaxis, hemoptysis, pulmonary embolism, respiratory acidosis, dyspnea, lung disorder, oropharyngolaryngeal pain, pharyngeal erythema, tonsillitis, parapharyngeal abscess^[Ref]

Nervous system

Common (1% to 10%): Headache

Uncommon (0.1% to 1%): Dizziness, hypogeusia, migraine, somnolence

Frequency not reported: Psychomotor slowdown, hand movements, axial hypotonia

Postmarketing reports: Cerebellar syndrome, cerebral hemorrhage, convulsion, gait disturbance, intracranial pressure increased, psychomotor skills impaired, pyramidal tract syndrome, dystonia, febrile convulsion, coordination abnormal, hypotonia, nystagmus, depressed level of consciousness, balance disorder, enteroviral encephalitis^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity

Postmarketing reports: Anaphylactic shock^[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Arrhythmia, Torsades de Pointes, electrocardiogram T wave inversion

Postmarketing reports: Atrial fibrillation, cardiac failure, hypotension, hypertension, cardiac disorder, congestive cardiac failure, sinus tachycardia^[Ref]

Dermatologic

Uncommon (0.1% to 1%): Alopecia, hyperhidrosis, pruritus, rash, rash generalized, rash pruritic, skin hypopigmentation, urticaria, xeroderma

Frequency not reported: Henoch-Schönlein purpura, urticaria, periorbital edema with skin rash

Postmarketing reports: Cryptococcal cutaneous infection, rash pustular, subcutaneous abscess, hyperhidrosis, photosensitivity reaction, rash erythematous, rash maculopapular, face edema, furuncle, subcutaneous abscess^[Ref]

Renal

Postmarketing reports: Hemoglobinuria, renal failure, glycosuria, chromaturia^[Ref]

Endocrine

Postmarketing reports: Blood corticotrophin decreased, blood cortisol decreased^[Ref]

Ocular

Frequency not reported: Lateral nystagmus

Postmarketing reports: Diplopia, papilledema, retinal toxicity, eye movement disorder, periorbital edema, retinal toxicity, visual impairment^[Ref]

Oncologic

Postmarketing reports: Hepatic neoplasm malignant^[Ref]

Psychiatric

Postmarketing reports: Bruxism, depression, obsessive-compulsive disorder^[Ref]