This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Exjade (Deferasirox) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (3496)
Death (820)
Life Threatening Events (99)
Disability (73)
Reports by Reaction Type
Sickle Cell Anaemia With Crisis (526),
Death (480),
Diarrhoea (475),
Pneumonia (277),
Pyrexia (261),
Nausea (253),
Haemoglobin Decreased (204),
Pain (198),
Vomiting (195),
Fatigue (187),
Malaise (173),
Serum Ferritin Increased (162)
Below are a few examples of reports where side effects / adverse reactions may be related to Exjade (Deferasirox). For a complete list or a specific selection of reports, please use the links above.
Possible Exjade side effects in male
Reported by a physician from Algeria on 2012-08-27
Patient: male
Reactions: Nutritional Condition Abnormal, Mucosal Inflammation, Gastrointestinal Haemorrhage, Dyspepsia, Platelet Count Increased
Drug(s) suspected as cause:
Exjade
Dosage: 30 mg/kg, per day
Administration route: Oral
Indication: Thalassaemia Beta
Start date: 2010-11-29
Exjade
Dosage: 20 mg/kg/day
Administration route: Oral
End date: 2012-08-12
Other drugs received by patient: Methylene Blue; Omeprazole; Amphotericin B
Possible Exjade side effects in female
Reported by a consumer/non-health professional from Venezuela on 2012-08-27
Patient: female
Reactions: Nausea, Pain in Extremity, Tachycardia, Pain, Chromaturia, Serum Ferritin Increased, Hepatitis, Arthralgia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Exjade
Dosage: 500 mg, qd
Indication: Sickle Cell Anaemia
Start date: 2009-07-01
Exjade
Dosage: 1000 mg, qd
Indication: Serum Ferritin Increased
Exjade
Dosage: 2000 mg, daily
Other drugs received by patient: Sucralfate; Metronidazole; Ciprofloxacin HCL; Omeprazole; Hydrea; Folic Acid
Possible Exjade side effects in male
Reported by a consumer/non-health professional from Canada on 2012-08-27
Patient: male
Reactions: Dental Caries, Lung Infection, Pain, Ear Infection, Visual Acuity Reduced, Serum Ferritin Increased, Strabismus, Abdominal Pain Upper, Liver Disorder, Haemoglobin Decreased, Abdominal Discomfort, Fatigue, Hypermetropia, Tooth Disorder, Gaze Palsy
Drug(s) suspected as cause:
Exjade
Dosage: 375 mg, unk
Administration route: Oral
Exjade
Dosage: 250 mg, qd
Administration route: Oral
Indication: Congenital Aplastic Anaemia
Start date: 2011-01-01
Exjade
Dosage: 125 mg, qod
Administration route: Oral
Start date: 2012-01-01
Other drugs received by patient: Prednisone TAB; Prevacid
Possible Exjade side effects in male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-26
Patient: male
Reactions: Diarrhoea, Irritable Bowel Syndrome
Drug(s) suspected as cause:
Exjade
Possible Exjade side effects in
Reported by a health professional (non-physician/pharmacist) from Brazil on 2012-08-24
Patient:
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Exjade
Possible Exjade side effects in female
Reported by a physician from Germany on 2012-08-24
Patient: female, weighing 87.0 kg (191.4 pounds)
Reactions: Abdominal Pain Lower, Confusional State, Vomiting, Nausea, Bronchopneumonia, Pain, Pleurisy, Pyrexia, Haemoglobin Decreased, Diarrhoea, Gastroenteritis, Blood Creatinine Increased, Hallucination, Crying
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Exjade
Other drugs received by patient: Omeprazole; Kliogest ^novo Industri^; Ramipril; Ramipril; Pulmicort; Valproate Sodium; Valproate Sodium; Pantoprazole; Fluticasone Propionate / Salmeterol
Possible Exjade side effects in female
Reported by a physician from Germany on 2012-08-24
Patient: female, weighing 62.0 kg (136.4 pounds)
Reactions: Cataract, Macular Degeneration
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Exjade
Dosage: 500 mg, tid
Administration route: Oral
Indication: Iron Overload
Inc424
Indication: Myelofibrosis
Inc424
Dosage: 15-10 mg
Indication: Polycythaemia Vera
Start date: 2011-12-30
Other drugs received by patient: RED Blood Cells
Possible Exjade side effects in female
Reported by a physician from Canada on 2012-08-24
Patient: female
Reactions: Confusional State, Weight Decreased, Hepatic Steatosis, Heart Rate Decreased, Serum Ferritin Decreased, Dizziness, Haemosiderosis, Hepatic Cirrhosis
Drug(s) suspected as cause:
Exjade
Dosage: 2000 mg, unk
Administration route: Oral
Indication: Congenital Aplastic Anaemia
Start date: 2007-09-01
Exjade
Dosage: 1250 mg, unk
Exjade
Dosage: 1000 mg, unk
Administration route: Oral
Exjade
Dosage: unk ukn, unk
Other drugs received by patient: Atenolol; Ventolin
Possible Exjade side effects in male
Reported by a consumer/non-health professional from Colombia on 2012-08-24
Patient: male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Exjade
Possible Exjade side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: male
Reactions: Weight Decreased, Dyspnoea, Nausea, Colitis, Myelodysplastic Syndrome
Drug(s) suspected as cause:
Exjade
Other drugs received by patient: Vidaza; Bumetanide; Blood Transfusion, Auxiliary Products; Azathioprine Sodium; Diltiazem HCL; Folic Acid; Metoprolol Tartrate; Lansoprazole; Multi-Vitamins; Vitamin TAB; Asacol; Potassium; Digoxin; Ondansetron
Possible Exjade side effects in male
Reported by a consumer/non-health professional from Canada on 2012-08-23
Patient: male
Reactions: Back Pain, Pruritus, Nasopharyngitis, Pneumonia, Dementia, Muscle Strain, Leukaemia, Death, Road Traffic Accident, Fatigue, Cough, Influenza
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Exjade
Other drugs received by patient: Omeprazole; Citalopram Hydrobromide; Transfusions
Possible Exjade side effects in male
Reported by a physician from Japan on 2012-08-23
Patient: male, weighing 44.0 kg (96.8 pounds)
Reactions: Pneumonia, Nausea, Diarrhoea, Urinary Tract Infection, Hypotension, White Blood Cell Count Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Exjade
Dosage: 875 mg, daily
Administration route: Oral
Start date: 2009-10-07
Exjade
Dosage: 20 mg/kg, unk
Administration route: Oral
End date: 2010-07-01
Exjade
Dosage: 875 mg, daily
Administration route: Oral
Indication: Iron Overload
Start date: 2009-06-24
End date: 2009-07-22
Exjade
Dosage: 875 mg, daily
Administration route: Oral
Indication: Myelofibrosis
Start date: 2009-07-29
End date: 2009-08-12
Exjade
Dosage: 20 mg/kg, unk
Administration route: Oral
Other drugs received by patient: Lasix; Primperan TAB; Sitafloxacin Hydrate; Phenobarbital TAB; Prednisolone; Urief; Magnesium Oxide; Phenytoin Sodium CAP; Lansoprazole; Mucosta; Lasix
Possible Exjade side effects in female
Reported by a physician from United States on 2012-08-23
Patient: female, weighing 53.0 kg (116.6 pounds)
Reactions: Breast Cancer
Adverse event resulted in: death
Drug(s) suspected as cause:
Exjade
Other drugs received by patient: Gabapentin
Possible Exjade side effects in female
Reported by a consumer/non-health professional from Colombia on 2012-08-23
Patient: female
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Exjade
Possible Exjade side effects in 61 year old female
Reported by a physician from Germany on 2012-08-23
Patient: 61 year old female, weighing 45.0 kg (99.0 pounds)
Reactions: Diarrhoea, Crohn's Disease, Gastrointestinal Inflammation, Blood Iron Increased
Drug(s) suspected as cause:
Exjade
Dosage: 500 mg plus 3/4
Indication: Iron Overload
Start date: 2010-04-01
Exjade
Dosage: 750 mg, daily
Indication: Myelodysplastic Syndrome
Other drugs received by patient: Blood Transfusion, Auxiliary Products
Possible Exjade side effects in male
Reported by a physician from United States on 2012-08-23
Patient: male, weighing 79.4 kg (174.6 pounds)
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Exjade
Other drugs received by patient: Flomax; Cardura; Finasteride
Possible Exjade side effects in female
Reported by a consumer/non-health professional from Australia on 2012-08-23
Patient: female
Reactions: HIP Fracture, Fall
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Exjade
Possible Exjade side effects in 89 year old female
Reported by a pharmacist from Japan on 2012-08-23
Patient: 89 year old female
Reactions: Sepsis, Platelet Count Decreased, Drug Administration Error, Decreased Appetite
Adverse event resulted in: death
Drug(s) suspected as cause:
Desferal
Dosage: 1000 mg, unk
Indication: Iron Overload
Start date: 2012-07-05
End date: 2012-07-01
Exjade
Dosage: 625 mg, daily
Administration route: Oral
Start date: 2012-05-25
End date: 2012-07-04
Exjade
Dosage: 625 mg, daily
Administration route: Oral
Indication: Iron Overload
Start date: 2012-05-18
End date: 2012-05-23
Other drugs received by patient: Onealfa; Prednisolone
Possible Exjade side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: female, weighing 181.8 kg (400.0 pounds)
Reactions: Haemoglobin Decreased, Lung Disorder, Hypoxia
Drug(s) suspected as cause:
Azacitidine
Dosage: 137 mg
Exjade
Dosage: 250 mg, tid
Administration route: Oral
Indication: Haemochromatosis
Start date: 2012-06-01
Vidaza
Start date: 2011-02-01
Other drugs received by patient: Lasix; RED Blood Cells, Concentrated; Wydase; Lomotil; Metoprolol Tartrate; Tylenol; Folic Acid; Diphenhydramine HCL; Dexamethasone; Hydrocodone Bitartrate + Acetaminophen; Zoloft; Allopurinol; Amlodipine Besylate
Possible Exjade side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: male, weighing 85.3 kg (187.6 pounds)
Reactions: Metastatic Neoplasm, Gastrointestinal Carcinoma
Adverse event resulted in: death
Drug(s) suspected as cause:
Exjade
Dosage: 1250 mg, qd
Administration route: Oral
Indication: Blood Disorder
End date: 2012-07-18
Exjade
Indication: Lymphatic System Neoplasm
Other drugs received by patient: Zocor; Ultram; Vicodin; Metformin; Metoprolol Tartrate; Lasix; Prednisone TAB
Possible Exjade side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: female, weighing 79.1 kg (174.0 pounds)
Reactions: Haemoglobin Decreased, Hypoxia, Myelodysplastic Syndrome, Asthenia, Respiratory Distress
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Exjade
Possible Exjade side effects in male
Reported by a physician from Canada on 2012-08-22
Patient: male
Reactions: Nausea, Chromaturia, Liver Disorder, Abdominal Discomfort, Malaise, Diarrhoea, Dizziness, Asthenia, Decreased Appetite
Drug(s) suspected as cause:
Exjade
Dosage: 2500 mg, unk
Administration route: Oral
End date: 2012-07-01
Exjade
Dosage: 1000 mg, unk
Administration route: Oral
Indication: Myelodysplastic Syndrome
Start date: 2012-01-01
Other drugs received by patient: Flomax; Metamucil-2; Altace
Possible Exjade side effects in male
Reported by a physician from United States on 2012-08-22
Patient: male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Exjade
Possible Exjade side effects in female
Reported by a physician from Germany on 2012-08-22
Patient: female
Reactions: Sepsis, Organ Failure
Adverse event resulted in: death
Drug(s) suspected as cause:
Exjade
Other drugs received by patient: Levofloxacin; Novalgin; Tramadol HCL; Ondansetron
Possible Exjade side effects in male
Reported by a physician from United States on 2012-08-22
Patient: male
Reactions: Dehydration, Pain, Asthenia, Haemolysis, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Exjade
Possible Exjade side effects in male
Reported by a individual with unspecified qualification from United States on 2012-08-22
Patient: male, weighing 101.2 kg (222.5 pounds)
Reactions: Abdominal Pain Upper
Drug(s) suspected as cause:
Exjade
Possible Exjade side effects in female
Reported by a physician from United States on 2012-08-21
Patient: female
Reactions: Renal Failure, Hypertension
Drug(s) suspected as cause:
Exjade
Possible Exjade side effects in female
Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-08-21
Patient: female, weighing 29.0 kg (63.8 pounds)
Reactions: C-Reactive Protein Increased, White Blood Cell Count Increased, Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Exjade
Possible Exjade side effects in female
Reported by a consumer/non-health professional from Canada on 2012-08-21
Patient: female
Reactions: Glaucoma, Nasopharyngitis, Clostridium Difficile Colitis, Serum Ferritin Increased, Fatigue, Dehydration, Liver Function Test Abnormal, Blood Creatinine Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Exjade
Dosage: 2 df, a day
Administration route: Oral
Indication: Aplastic Anaemia
Exjade
Dosage: 1000 mg
Administration route: Oral
Start date: 2011-01-01
Other drugs received by patient: Blood Cells, Packed Human; Ranitidine; Platelets
Possible Exjade side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-20
Patient: female
Reactions: Haematochezia, Diarrhoea
Drug(s) suspected as cause:
Exjade
Dosage: unk
Jakafi
Dosage: 15 mg, bid
Administration route: Oral
Indication: Lymphatic Disorder
Start date: 2012-03-16
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