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Exjade Side Effects

Generic Name: deferasirox

Note: This page contains information about the side effects of deferasirox. Some of the dosage forms included on this document may not apply to the brand name Exjade.

Not all side effects for Exjade may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to deferasirox: oral tablet, oral tablet for suspension

In addition to its needed effects, some unwanted effects may be caused by deferasirox (the active ingredient contained in Exjade). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking deferasirox:

More common
  • Abdominal pain
  • diarrhea
  • dizziness
  • earache or pain in the ear
  • nausea
  • voice changes
  • vomiting
  • 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 urine amount
  • general feeling of tiredness or weakness
  • hives or welts
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • lethargy
  • 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 or itching of the skin
  • skin rash
  • sores, welting, or blisters
  • stomach pain, continuing
  • unusual bleeding or bruising
  • vomiting of blood or material that looks like coffee grounds
  • yellow eyes or skin

For Healthcare Professionals

Applies to deferasirox: 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
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
Postmarketing reports: Stevens-Johnson syndrome, leukocytoclastic vasculitis, alopecia[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. "Australian Product Information." O 0

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

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

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