Note: This document contains side effect information about deferasirox. Some of the dosage forms listed on this page may not apply to the brand name Exjade.
Common side effects of Exjade include: abdominal pain, cough, diarrhea, fever, headache, increased serum creatinine, influenza, nasopharyngitis, nausea, proteinuria, vomiting, and pharyngolaryngeal pain. Other side effects include: otic infection, respiratory tract infection, arthralgia, back pain, bronchitis, fatigue, increased serum alanine aminotransferase, pharyngitis, rhinitis, skin rash, tonsillitis, and upper abdominal pain. See below for a comprehensive list of adverse effects.
Applies to deferasirox: oral granule, oral tablet, oral tablet for suspension
Oral route (Tablet; Tablet for Suspension; Granule)
Renal Failure:Deferasirox can cause acute renal failure and death, particularly in patients with comorbidities and those who are in the advanced stages of their hematologic disorders.Evaluate baseline renal function prior to starting or increasing deferasirox dosing in all patients. Deferasirox is contraindicated in adult and pediatric patients with estimated GFR less than 40 mL/min/1.73 m(2). Measure serum creatinine in duplicate prior to initiation of therapy. Monitor renal function at least monthly. For patients with baseline renal impairment or increased risk of acute renal failure, monitor renal function weekly for the first month, then at least monthly. Reduce the starting dose in patients with pre-existing renal disease. During therapy, increase the frequency of monitoring and modify the dose for patients with an increased risk of renal impairment, including use of concomitant nephrotoxic drugs, and pediatric patients with volume depletion or overchelation.Hepatic Failure:Deferasirox can cause hepatic injury including hepatic failure and death Measure serum transaminases and bilirubin in all patients prior to initiating treatment, every 2 weeks during the first month, and at least monthly thereafter.Avoid use of deferasirox in patients with severe (Child-Pugh C) hepatic impairment and reduce the dose in patients with moderate (Child Pugh B) hepatic impairment.Gastrointestinal Hemorrhage:Deferasirox can cause gastrointestinal (GI) hemorrhages, which may be fatal, especially in elderly patients who have advanced hematologic malignancies and/or low platelet counts.Monitor patients and discontinue deferasirox for suspected GI ulceration or hemorrhage..
Along with its needed effects, deferasirox (the active ingredient contained in Exjade) 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 deferasirox:
Incidence not known
Applies to deferasirox: oral granule for reconstitution, oral tablet, oral tablet dispersible
The most common adverse events were abdominal pain, nausea, vomiting, diarrhea, skin rashes, and increases in serum creatinine. Gastrointestinal symptoms, increases in serum creatinine, and skin rash were dose related.
Very common (10% or more): Diarrhea (up to 47%), abdominal pain (28%), nausea (26%), vomiting (21%)
Common (1% to 10%): Abdominal pain upper, constipation, abdominal distension, dyspepsia
Uncommon (0.1% to 1%): Gastritis, gastrointestinal hemorrhage, gastric ulcer (including multiple ulcers), duodenal ulcer, esophagitis
Frequency not reported: Pancreatitis associated with gallstones (with and without underlying biliary conditions)
Postmarketing reports: Gastrointestinal perforation
Very common (10% or more): Creatinine increased (38%)
Common (1% to 10%): Abnormal serum creatinine, abnormal creatinine clearance values
Uncommon (0.1% to 1%): Renal tubulopathy (Fanconi's Syndrome)
Postmarketing reports: Renal tubular necrosis, acute renal failure, tubulointerstitial nephritis, acute kidney injury, decreased eGFR, renal tubular disorder
Very common (10% or more): Rash (13%)
Common (1% to 10%): Urticaria, pruritus
Uncommon (0.1% to 1%): Henoch Schonlein purpura, pigmentation disorder, erythema multiforme, drug reaction with eosinophilia and systemic symptoms (DRESS)
Postmarketing reports: Stevens-Johnson syndrome, leukocytoclastic vasculitis, alopecia, toxic epidermal necrolysis
Very common (10% or more): Intermittent proteinuria (18.6%)
Common (1% to 10%): Proteinuria
Uncommon (0.1% to 1%): Glycosuria
Postmarketing reports: Hematuria
Very common (10% or more): Cough (13.9%), nasopharyngitis (13.2%), influenza, (10.8%), pharyngolaryngeal pain (10.5%)
Common (1% to 10%): Respiratory tract infection, bronchitis, pharyngitis, acute tonsillitis, rhinitis
Very common (10% or more): Pyrexia (18.9%)
Common (1% to 10%): Death, fatigue, ear infection
Uncommon (0.1% to 1%): Drug fever, hearing loss
Very common (10% or more): Headache (15.9%)
Uncommon (0.1% to 1%): Hyperactivity, dizziness
Common (1% to 10%): Elevations in SGPT/ALT, gallstones, drug induced hepatitis, abnormal liver function tests, transaminases increased
Uncommon (0.1% to 1%): Cholelithiasis, hepatitis
Postmarketing reports: Hepatic failure
Common (1% to 10%): Arthralgia, back pain
Uncommon (0.1% to 1%): Cataract, maculopathy, early cataract, optic neuritis
Uncommon (0.1% to 1%): Edema
Postmarketing reports: Metabolic acidosis, hypokalemia
Uncommon (0.1% to 1%): Insomnia, sleep disorder, anxiety
Postmarketing reports: Worsening anemia, cytopenias including neutropenia and thrombocytopenia, pancytopenia
Postmarketing reports: Hypersensitivity reactions (including anaphylaxis and angioedema)
Frequency not reported: Atypical tuberculosis
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Exjade