Exjade (Deferasirox) - Serious Reactions - Suspected Cause - Side Effect Reports

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 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 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 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 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 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 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 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 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 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 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 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 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 physician from Germany on 2012-08-20

Patient: female, weighing 87.0 kg (191.4 pounds)

Reactions: Confusional State, Abdominal Pain Lower, Vomiting, Bronchopneumonia, Nausea, Pain, Pleurisy, Pyrexia, Haemoglobin Decreased, Diarrhoea, Gastroenteritis, Hallucination, Blood Creatinine Increased, Crying

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Exjade

Other drugs received by patient: Pulmicort; Omeprazole; Valproate Sodium; Valproate Sodium; Ramipril; Kliogest ^novo Industri^; Fluticasone Propionate / Salmeterol; Ramipril; Pantoprazole

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

Possible Exjade side effects in 32 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-20

Patient: 32 year old female

Reactions: Diarrhoea, Rash

Drug(s) suspected as cause:
Exjade

Possible Exjade side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: female, weighing 69.8 kg (153.5 pounds)

Reactions: Localised Infection, Pleural Effusion, Febrile Neutropenia, Pancytopenia, Clostridial Infection, Herpes Zoster

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Exjade

Possible Exjade side effects in male

Reported by a consumer/non-health professional from Canada on 2012-08-17

Patient: male

Reactions: Abdominal Pain, Extrasystoles, Flatulence, Tooth Infection, Macular Degeneration, Serum Ferritin Increased, Constipation, Abdominal Discomfort, RED Blood Cell Count Decreased, Abdominal Distension, Heart Rate Irregular, Gastrointestinal Motility Disorder, Atrial Flutter, Blood Creatine Increased, Appendicitis, Arrhythmia, Renal Impairment, Pneumonia Bacterial, Diarrhoea, Heart Rate Increased, Neutrophil Count Decreased, Infection

Drug(s) suspected as cause:
Exjade
    Dosage: 2000 mg, qd
    Administration route: Oral
    Start date: 2009-11-11
    End date: 2011-03-25

Exjade
    Dosage: unk ukn, unk
    Administration route: Oral

Exjade
    Dosage: 1500 mg, unk

Exjade
    Dosage: 500 mg, qd
    Administration route: Oral

Exjade
    Dosage: 2000 mg, unk
    Administration route: Oral

Exjade
    Dosage: 1750 mg
    Indication: Myelodysplastic Syndrome

Exjade
    Dosage: 1000 mg, qd
    Administration route: Oral

Revlimid
    Indication: Myelodysplastic Syndrome
    Start date: 2010-08-24

Other drugs received by patient: Testosterone; Digoxin

Possible Exjade side effects in female

Reported by a physician from Switzerland on 2012-08-17

Patient: female, weighing 51.0 kg (112.2 pounds)

Reactions: Back Pain, Abdominal Pain Lower, Metabolic Acidosis, Vomiting, Dyspepsia, Nausea, Flank Pain

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Exjade
    Dosage: 3 df, daily
    Administration route: Oral
    Indication: Haemosiderosis
    Start date: 2011-10-28

Exjade
    Dosage: 30 mg/kg, daily

Other drugs received by patient: Pantoprazole

Possible Exjade side effects in female

Reported by a consumer/non-health professional from Colombia on 2012-08-17

Patient: female

Reactions: Procedural Complication, Splenomegaly

Adverse event resulted in: death

Drug(s) suspected as cause:
Exjade

Other drugs received by patient: Folic Acid

Possible Exjade side effects in male

Reported by a physician from United States on 2012-08-16

Patient: male, weighing 72.0 kg (158.4 pounds)

Reactions: Pulmonary Hypertension, Femur Fracture, Dilatation Ventricular, Clostridium Difficile Colitis, Pyrexia, Palpitations, Staphylococcal Bacteraemia, Thoracic Vertebral Fracture, Acute Chest Syndrome, Back Pain, Muscle Oedema, Pneumonia, Pain in Extremity, Acne, Arterial Thrombosis Limb, Painful Respiration, Bursitis, Abdominal Wall Haematoma, Tibia Fracture, Back Injury, Osteoporosis, Atrioventricular Block Complete, Frequent Bowel Movements, Sickle Cell Anaemia With Crisis, Pulmonary Congestion, Chest Pain, Spinal Deformity, Oxygen Saturation Decreased, Dyspnoea, Rash, Haemoglobin Decreased, Diarrhoea, Arthralgia, Ejection Fraction Decreased, Sinus Tachycardia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Exjade

Other drugs received by patient: Dilaudid; Heparin; Dilaudid; Klonopin; Kadian; Phenergan HCL; Flexeril; Dilaudid; Dilaudid; Dilaudid; Folic Acid; Phenergan HCL; Restoril; Dilaudid; Phenergan HCL; Heparin; Kadian; Heparin; Dilaudid; Dilaudid; Dilaudid; Dilaudid; Dilaudid; Kadian; Dilaudid; Dilaudid

Possible Exjade side effects in male

Reported by a physician from United States on 2012-08-15

Patient: male

Reactions: Jaundice, Vomiting, Nausea, Chromaturia, Pyrexia, Abdominal Pain Upper, Diarrhoea, Blood Iron Increased, Infection

Drug(s) suspected as cause:
Exjade
    Dosage: 500 mg, tid
    Administration route: Oral
    Indication: Iron Overload
    Start date: 2008-08-22

Exjade
    Dosage: 500 mg, tid
    Administration route: Oral
    End date: 2012-08-07

Possible Exjade side effects in male

Reported by a physician from United States on 2012-08-15

Patient: male

Reactions: Pneumonia, Malaise, Diarrhoea, Myelodysplastic Syndrome, Neutropenia, Thrombocytopenia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Exjade

Other drugs received by patient: Vidaza

Possible Exjade side effects in female

Reported by a physician from Germany on 2012-08-14

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, Hallucination, Blood Creatinine Increased, Crying

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Exjade

Other drugs received by patient: Valproate Sodium; Pantoprazole; Ramipril; Kliogest ^novo Industri^; Omeprazole; Valproate Sodium; Ramipril; Pulmicort; Fluticasone Propionate / Salmeterol

Possible Exjade side effects in male

Reported by a physician from Australia on 2012-08-13

Patient: male, weighing 56.0 kg (123.2 pounds)

Reactions: Syncope, Diarrhoea, Malignant Melanoma

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Exjade
    Dosage: 2000 mg, daily
    Administration route: Oral
    Start date: 2011-03-16

Exjade
    Dosage: 500 mg, tid
    Administration route: Oral
    Start date: 2012-04-01

Exjade
    Dosage: 1250 mg, daily
    Administration route: Oral

Exjade
    Dosage: 500 mg, tid
    Administration route: Oral
    Indication: Iron Overload
    Start date: 2011-03-16

Exjade
    Dosage: 1250 mg
    Administration route: Oral

Other drugs received by patient: Blood Transfusion, Auxiliary Products

Possible Exjade side effects in female

Reported by a physician from Japan on 2012-08-10

Patient: female, weighing 43.0 kg (94.6 pounds)

Reactions: Nausea, Parathyroid Disorder, Renal Failure Chronic, Disease Progression, Diarrhoea, Ileus, Insomnia, Sepsis, Cholecystitis, Hypertension, Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Exjade
    Indication: Myelodysplastic Syndrome

Exjade
    Dosage: 500 mg, daily
    Administration route: Oral
    Indication: Iron Overload
    Start date: 2008-09-23
    End date: 2008-09-29

Other drugs received by patient: Lendormin; Diovan; Sevelamer Hydrochloride; Drug Therapy NOS; Norvasc; Marzulene S

Possible Exjade side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: female

Reactions: Malaise, Diarrhoea, Pain, Hypoaesthesia, Sinusitis, Walking Disability, Paraesthesia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Exjade

Other drugs received by patient: Myfortic; Prograf