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Deferasirox Side Effects

In Summary

Commonly reported side effects of deferasirox 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.

For the Consumer

Applies to deferasirox: oral granule, oral tablet, oral tablet for suspension

Warning

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..

Side effects requiring immediate medical attention

Along with its needed effects, deferasirox 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:

More common

Rare

  • Blindness
  • blurred vision
  • change in hearing
  • change in vision
  • pain or discomfort in the eye

Incidence not known

  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • dark urine
  • decrease in the amount of urine
  • general feeling of tiredness or weakness
  • hives, welts, skin rash
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  • light-colored stools
  • lower back or side pain
  • pale skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness, soreness, itching of the skin
  • sores, blisters
  • stomach pain, continuing
  • unusual bleeding or bruising
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  • vomiting of blood or material that looks like coffee grounds
  • yellow eyes or skin

For Healthcare Professionals

Applies to deferasirox: oral granule for reconstitution, oral tablet, oral tablet dispersible

General

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.[Ref]

Gastrointestinal

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[Ref]

Renal

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[Ref]

Dermatologic

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[Ref]

Genitourinary

Very common (10% or more): Intermittent proteinuria (18.6%)

Common (1% to 10%): Proteinuria

Uncommon (0.1% to 1%): Glycosuria

Postmarketing reports: Hematuria[Ref]

Respiratory

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[Ref]

Other

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[Ref]

Nervous system

Very common (10% or more): Headache (15.9%)

Uncommon (0.1% to 1%): Hyperactivity, dizziness[Ref]

Hepatic

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[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, back pain[Ref]

Ocular

Uncommon (0.1% to 1%): Cataract, maculopathy, early cataract, optic neuritis[Ref]

Metabolic

Uncommon (0.1% to 1%): Edema

Postmarketing reports: Metabolic acidosis, hypokalemia[Ref]

Psychiatric

Uncommon (0.1% to 1%): Insomnia, sleep disorder, anxiety[Ref]

Hematologic

Postmarketing reports: Worsening anemia, cytopenias including neutropenia and thrombocytopenia, pancytopenia[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity reactions (including anaphylaxis and angioedema)[Ref]

Immunologic

Frequency not reported: Atypical tuberculosis[Ref]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Exjade (deferasirox)." Novartis Pharmaceuticals, East Hanover, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.