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DACLIZUMAB

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Daclizumab Adverse Events Reported to the FDA Over Time

How are Daclizumab adverse event reports trending over time?

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

Most Common Daclizumab Adverse Events Reported to the FDA

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

Cytomegalovirus Infection
269 (4.55%)
Sepsis
149 (2.52%)
Urinary Tract Infection
147 (2.49%)
Pneumonia
104 (1.76%)
Pyrexia
86 (1.46%)
Diarrhoea
80 (1.35%)
Leukopenia
73 (1.24%)
Enterococcal Infection
64 (1.08%)
Renal Impairment
59 (1%)
Complications Of Transplanted Kidne...
56 (.95%)
Dehydration
56 (.95%)
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Urosepsis
56 (.95%)
Anaemia
55 (.93%)
Blood Creatinine Increased
55 (.93%)
Escherichia Infection
55 (.93%)
Kidney Transplant Rejection
55 (.93%)
Transplant Rejection
51 (.86%)
Pleural Effusion
50 (.85%)
Renal Failure
43 (.73%)
Gastrointestinal Haemorrhage
37 (.63%)
Peritonitis
37 (.63%)
Graft Versus Host Disease
35 (.59%)
Renal Failure Acute
34 (.58%)
Infection
33 (.56%)
Pyelonephritis
32 (.54%)
Lymphocele
31 (.52%)
Pyelonephritis Acute
31 (.52%)
Post Procedural Bile Leak
29 (.49%)
Hypotension
28 (.47%)
Oedema Peripheral
28 (.47%)
Wound Infection
28 (.47%)
Ascites
27 (.46%)
Haemoglobin Decreased
27 (.46%)
Liver Function Test Abnormal
27 (.46%)
Herpes Zoster
26 (.44%)
Staphylococcal Infection
26 (.44%)
Liver Transplant Rejection
25 (.42%)
Pseudomonas Infection
25 (.42%)
Aspergillosis
24 (.41%)
Bacteraemia
24 (.41%)
Candidiasis
24 (.41%)
Diabetes Mellitus
24 (.41%)
Hepatic Artery Thrombosis
24 (.41%)
Hepatitis C
24 (.41%)
Multi-organ Failure
24 (.41%)
Wound Dehiscence
24 (.41%)
Asthenia
23 (.39%)
Blood Albumin Decreased
23 (.39%)
Constipation
23 (.39%)
Escherichia Urinary Tract Infection
23 (.39%)
Gastroenteritis
23 (.39%)
Vomiting
23 (.39%)
Haemodialysis
22 (.37%)
Intestinal Obstruction
22 (.37%)
Post Procedural Complication
22 (.37%)
Abdominal Pain
21 (.36%)
Disease Recurrence
21 (.36%)
Klebsiella Infection
21 (.36%)
Klebsiella Sepsis
21 (.36%)
Metabolic Acidosis
21 (.36%)
Pneumothorax
21 (.36%)
Thrombocytopenia
21 (.36%)
White Blood Cell Count Increased
21 (.36%)
Congenital Cystic Kidney Disease
20 (.34%)
Laceration
20 (.34%)
Hypertension
19 (.32%)
Ureteric Stenosis
19 (.32%)
Wound Secretion
19 (.32%)
Complications Of Transplanted Liver
18 (.3%)
Dyspnoea
18 (.3%)
Neutropenia
18 (.3%)
Upper Respiratory Tract Infection
18 (.3%)
Weight Decreased
18 (.3%)
Atrial Fibrillation
17 (.29%)
Bacterial Infection
17 (.29%)
Cholangitis
17 (.29%)
Gastric Ulcer
17 (.29%)
Graft Dysfunction
17 (.29%)
Hepatic Haematoma
17 (.29%)
Renal Cyst
17 (.29%)
Tachycardia
17 (.29%)
Haematoma Infection
16 (.27%)
Hepatic Enzyme Increased
16 (.27%)
Respiratory Distress
16 (.27%)
Septic Shock
16 (.27%)
Acute Respiratory Distress Syndrome
15 (.25%)
Haematoma
15 (.25%)
Pancytopenia
15 (.25%)
Rash
15 (.25%)
Cellulitis
14 (.24%)
Culture Urine Positive
14 (.24%)
Incisional Hernia
14 (.24%)
Nephrolithiasis
14 (.24%)
Arterial Haemorrhage
13 (.22%)
Back Pain
13 (.22%)
Enterobacter Infection
13 (.22%)
Fatigue
13 (.22%)
Impaired Healing
13 (.22%)
Interstitial Lung Disease
13 (.22%)
Lymphadenopathy
13 (.22%)
Oxygen Saturation Decreased
13 (.22%)

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This graph shows the top adverse events submitted to the FDA for Daclizumab, 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 Daclizumab 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 Daclizumab

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

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This graph shows the top categories of adverse events submitted to the FDA for Daclizumab, 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 Daclizumab 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 Daclizumab According to Those Reporting Adverse Events

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

Renal Transplant
116
Prophylaxis Against Transplant Reje...
75
Graft Versus Host Disease
45
Liver Transplant
43
Multiple Sclerosis
30
Immunosuppression
19
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Drug Use For Unknown Indication
16
Immunosuppressant Drug Therapy
10
Lung Transplant
9
Acute Graft Versus Host Disease
9
Psoriasis
6
Asthma
6
Product Used For Unknown Indication
6
Kidney Transplant Rejection
5
Small Intestine Transplant
4
Renal And Liver Transplant
3
Heart Transplant
3
Prophylaxis Against Graft Versus Ho...
2
Pancreas Islet Cell Transplant
2
Histiocytosis Haematophagic
2
Multiple Sclerosis Relapse
2
Renal And Pancreas Transplant
1
Rash
1
Acute Graft Versus Host Disease In ...
1
Intermediate Uveitis
1
Off Label Use
1
Aplasia Pure Red Cell
1
Type 1 Diabetes Mellitus
1
Congenital Nephrotic Syndrome
1
Organ Transplant
1

Daclizumab Case Reports

What Daclizumab 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 Daclizumab. 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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