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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

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


  • 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-colored 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 sex organs
  • 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


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]


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]


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[Ref]


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]


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

Common (1% to 10%): Proteinuria

Uncommon (0.1% to 1%): Glycosuria[Ref]


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]


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]


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]


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


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


Uncommon (0.1% to 1%): Edema

Postmarketing reports: Metabolic acidosis[Ref]


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


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


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


Frequency not reported: Atypical tuberculosis[Ref]


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

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

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

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.