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Exjade (Deferasirox) - Side Effect Reports to FDA

 
 



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 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 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 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 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 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 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 male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Exjade

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