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EXJADE

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Exjade Adverse Events Reported to the FDA Over Time

How are Exjade adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Exjade, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Exjade is flagged as the suspect drug causing the adverse event.

Most Common Exjade Adverse Events Reported to the FDA

What are the most common Exjade adverse events reported to the FDA?

Death
4507 (4.76%)
Diarrhoea
2938 (3.1%)
Nausea
1632 (1.72%)
Pyrexia
1598 (1.69%)
Sickle Cell Anaemia With Crisis
1586 (1.68%)
Pneumonia
1324 (1.4%)
Vomiting
1247 (1.32%)
Haemoglobin Decreased
1239 (1.31%)
Blood Creatinine Increased
1099 (1.16%)
Fatigue
1081 (1.14%)
Abdominal Pain
961 (1.02%)
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Malaise
957 (1.01%)
Pain
929 (.98%)
Serum Ferritin Increased
909 (.96%)
Asthenia
877 (.93%)
Dyspnoea
828 (.87%)
Rash
755 (.8%)
Alanine Aminotransferase Increased
712 (.75%)
Aspartate Aminotransferase Increase...
691 (.73%)
Abdominal Pain Upper
674 (.71%)
Anaemia
670 (.71%)
Platelet Count Decreased
629 (.66%)
Sepsis
614 (.65%)
Fall
593 (.63%)
Renal Failure
586 (.62%)
Headache
576 (.61%)
Dehydration
565 (.6%)
Blood Urea Increased
554 (.59%)
Dizziness
553 (.58%)
Infection
550 (.58%)
Abdominal Discomfort
540 (.57%)
Back Pain
532 (.56%)
Blood Bilirubin Increased
532 (.56%)
Decreased Appetite
508 (.54%)
Constipation
494 (.52%)
Chest Pain
491 (.52%)
Oedema Peripheral
466 (.49%)
Thrombocytopenia
465 (.49%)
Renal Impairment
461 (.49%)
Weight Decreased
457 (.48%)
Urinary Tract Infection
437 (.46%)
Neoplasm Malignant
435 (.46%)
Renal Failure Acute
426 (.45%)
White Blood Cell Count Decreased
426 (.45%)
White Blood Cell Count Increased
416 (.44%)
Haematocrit Decreased
410 (.43%)
Arthralgia
385 (.41%)
Liver Function Test Abnormal
378 (.4%)
Cough
366 (.39%)
Cardiac Failure Congestive
365 (.39%)
Malignant Neoplasm Progression
363 (.38%)
Pain In Extremity
353 (.37%)
Pancytopenia
347 (.37%)
Pruritus
342 (.36%)
Liver Disorder
337 (.36%)
Renal Disorder
334 (.35%)
Hypotension
332 (.35%)
Blood Alkaline Phosphatase Increase...
329 (.35%)
Myelodysplastic Syndrome
316 (.33%)
Neutropenia
310 (.33%)
Abdominal Distension
303 (.32%)
Disease Progression
301 (.32%)
Acute Myeloid Leukaemia
299 (.32%)
Chills
296 (.31%)
Blood Glucose Increased
284 (.3%)
Vision Blurred
280 (.3%)
Gastrointestinal Haemorrhage
275 (.29%)
Red Blood Cell Count Decreased
272 (.29%)
Cerebrovascular Accident
268 (.28%)
Hepatic Enzyme Increased
266 (.28%)
Drug Ineffective
262 (.28%)
General Physical Health Deteriorati...
260 (.27%)
Visual Impairment
255 (.27%)
Confusional State
243 (.26%)
Jaundice
235 (.25%)
Blood Lactate Dehydrogenase Increas...
216 (.23%)
Treatment Noncompliance
215 (.23%)
Nasopharyngitis
211 (.22%)
Pleural Effusion
211 (.22%)
Influenza
210 (.22%)
Feeling Abnormal
209 (.22%)
Respiratory Failure
200 (.21%)
Multi-organ Failure
195 (.21%)
Bone Marrow Transplant
193 (.2%)
Haemorrhage
192 (.2%)
Splenomegaly
191 (.2%)
Blood Iron Increased
189 (.2%)
Neoplasm Progression
189 (.2%)
Cardiac Failure
185 (.2%)
Haematochezia
181 (.19%)
Rash Generalised
180 (.19%)
Surgery
180 (.19%)
Cholelithiasis
174 (.18%)
Hepatic Failure
174 (.18%)
Neutrophil Count Decreased
173 (.18%)
Febrile Neutropenia
170 (.18%)
Proteinuria
169 (.18%)
Septic Shock
168 (.18%)
Cellulitis
166 (.18%)
Myalgia
162 (.17%)
Haematuria
159 (.17%)

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This graph shows the top adverse events submitted to the FDA for Exjade, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Exjade is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Exjade

What are the most common Exjade adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Exjade, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Exjade is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Exjade According to Those Reporting Adverse Events

Why are people taking Exjade, according to those reporting adverse events to the FDA?

Iron Overload
4386
Myelodysplastic Syndrome
2915
Sickle Cell Anaemia
1681
Iron Metabolism Disorder
560
Haemochromatosis
471
Blood Iron Increased
419
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Neoplasm
402
Aplastic Anaemia
372
Thalassaemia
334
Serum Ferritin Increased
284
Haemosiderosis
270
Thalassaemia Beta
217
Acute Myeloid Leukaemia
208
Myelofibrosis
161
Anaemia
156
Lymphatic Disorder
134
Blood Disorder
123
Lymphoproliferative Disorder
101
Chelation Therapy
96
Chronic Lymphocytic Leukaemia
89
Multiple Myeloma
85
Transfusion
74
Haematopoietic Neoplasm
71
Sideroblastic Anaemia
69
Congenital Aplastic Anaemia
62
Haemolytic Anaemia
62
Chronic Myeloid Leukaemia
53
Sickle Cell Anaemia With Crisis
49
Drug Use For Unknown Indication
44
Lymphatic System Neoplasm
42
Acute Lymphocytic Leukaemia
39
Anaemia Of Chronic Disease
37
Lymphoma
34
Blood Product Transfusion Dependent
34
Leukaemia
30
Aplasia Pure Red Cell
29
Refractory Anaemia
28
Hereditary Haemochromatosis
28
Myeloproliferative Disorder
26
Lymphocytic Leukaemia
24
Breast Cancer
23
Thalassaemia Sickle Cell
21
Anaemia Haemolytic Autoimmune
21
Mineral Metabolism Disorder
20
Myeloid Leukaemia
19
Blood Test Abnormal
17
Product Used For Unknown Indication
17
Non-hodgkins Lymphoma
16
5q Minus Syndrome
12
Pancytopenia
11
Hereditary Spherocytosis
11

Drug Labels

LabelLabelerEffective
ExjadeNovartis Pharmaceuticals Corporation28-JAN-13

Exjade Case Reports

What Exjade safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Exjade. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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