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Mycamine Adverse Events Reported to the FDA Over Time

How are Mycamine adverse event reports trending over time?

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

Most Common Mycamine Adverse Events Reported to the FDA

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

Drug Ineffective
83 (1.77%)
Aspartate Aminotransferase Increase...
81 (1.73%)
Pyrexia
76 (1.62%)
Alanine Aminotransferase Increased
74 (1.58%)
Death
72 (1.54%)
Multi-organ Failure
72 (1.54%)
Condition Aggravated
70 (1.49%)
Liver Disorder
64 (1.36%)
Hepatic Function Abnormal
56 (1.19%)
Sepsis
56 (1.19%)
Septic Shock
54 (1.15%)
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Disseminated Intravascular Coagulat...
52 (1.11%)
Renal Failure Acute
50 (1.07%)
Blood Alkaline Phosphatase Increase...
47 (1%)
Pneumonia
47 (1%)
Respiratory Failure
47 (1%)
Blood Bilirubin Increased
42 (.9%)
Bronchopulmonary Aspergillosis
42 (.9%)
Renal Failure
41 (.87%)
Shock
38 (.81%)
Platelet Count Decreased
37 (.79%)
Renal Impairment
35 (.75%)
Cardiac Arrest
34 (.73%)
Hepatic Failure
34 (.73%)
White Blood Cell Count Decreased
33 (.7%)
Gamma-glutamyltransferase Increased
32 (.68%)
Infection
32 (.68%)
Depressed Level Of Consciousness
30 (.64%)
Vomiting
30 (.64%)
Blood Lactate Dehydrogenase Increas...
29 (.62%)
Interstitial Lung Disease
29 (.62%)
Nausea
29 (.62%)
Candidiasis
28 (.6%)
Rash
26 (.55%)
Chills
25 (.53%)
Haemodialysis
25 (.53%)
Acute Respiratory Distress Syndrome
24 (.51%)
Anaemia
24 (.51%)
Cardiac Failure
23 (.49%)
Blood Pressure Decreased
22 (.47%)
Convulsion
22 (.47%)
Thrombotic Microangiopathy
22 (.47%)
General Physical Health Deteriorati...
21 (.45%)
Jaundice
21 (.45%)
Diarrhoea
20 (.43%)
Febrile Neutropenia
20 (.43%)
Fungal Infection
20 (.43%)
Staphylococcal Infection
20 (.43%)
Trichosporon Infection
20 (.43%)
Bone Marrow Failure
19 (.41%)
Graft Versus Host Disease
19 (.41%)
Haematuria
18 (.38%)
Aspergillosis
17 (.36%)
Blood Creatinine Increased
17 (.36%)
Cerebral Haemorrhage
17 (.36%)
Hypokalaemia
17 (.36%)
Pancytopenia
17 (.36%)
Pulmonary Oedema
17 (.36%)
Ventricular Tachycardia
17 (.36%)
Abdominal Pain
16 (.34%)
No Therapeutic Response
16 (.34%)
Cholestasis
15 (.32%)
Dialysis
15 (.32%)
Fungal Sepsis
15 (.32%)
Confusional State
14 (.3%)
Disease Progression
14 (.3%)
Engraftment Syndrome
14 (.3%)
Hypertension
14 (.3%)
Renal Disorder
14 (.3%)
Thrombocytopenia
14 (.3%)
Anaphylactic Shock
13 (.28%)
Atrial Fibrillation
13 (.28%)
Back Pain
13 (.28%)
Bacterial Infection
13 (.28%)
Gastrointestinal Haemorrhage
13 (.28%)
Hyperbilirubinaemia
13 (.28%)
Intravascular Haemolysis
13 (.28%)
White Blood Cell Count Increased
13 (.28%)
Blood Beta-d-glucan Increased
12 (.26%)
Blood Glucose Increased
12 (.26%)
Cardio-respiratory Arrest
12 (.26%)
Infusion Related Reaction
12 (.26%)
Neutrophil Count Decreased
12 (.26%)
Pancreatitis Acute
12 (.26%)
Respiratory Arrest
12 (.26%)
Stem Cell Transplant
12 (.26%)
Tachycardia
12 (.26%)
Agranulocytosis
11 (.23%)
Altered State Of Consciousness
11 (.23%)
Blood Potassium Decreased
11 (.23%)
Bradycardia
11 (.23%)
Candida Sepsis
11 (.23%)
Dehydration
11 (.23%)
Drug Hypersensitivity
11 (.23%)
Drug Interaction
11 (.23%)
Dyspnoea
11 (.23%)
Haemoglobin Decreased
11 (.23%)
Haemolysis
11 (.23%)
Haemolytic Uraemic Syndrome
11 (.23%)
Hyperthermia
11 (.23%)
Neutropenia
11 (.23%)

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

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

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

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

Antifungal Prophylaxis
272
Infection Prophylaxis
143
Fungal Infection
127
Bronchopulmonary Aspergillosis
84
Product Used For Unknown Indication
83
Candidiasis
68
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Prophylaxis
65
Drug Use For Unknown Indication
64
Systemic Candida
54
Pneumonia
49
Aspergillosis
44
Febrile Neutropenia
26
Fungaemia
24
Sepsis
24
Pyrexia
22
Infection
21
Antifungal Treatment
19
Pulmonary Mycosis
14
Respiratory Moniliasis
13
Pneumonia Fungal
13
Candida Sepsis
11
Oesophageal Candidiasis
10
Pneumonia Aspergillus
8
Skin Candida
8
Septic Shock
8
Systemic Mycosis
8
Oral Candidiasis
6
Interstitial Lung Disease
5
Candida Pneumonia
5
Fungal Peritonitis
5
Anti-infective Therapy
5
Obliterative Bronchiolitis
4
Abdominal Infection
4
Blood Beta-d-glucan Increased
4
Pneumonia Aspiration
4
Pneumonia Primary Atypical
4
Brain Abscess
4
Acute Myeloid Leukaemia
4
Aspergilloma
4
Cryptosporidiosis Infection
4
Pneumonia Cytomegaloviral
3
Mucormycosis
3
Infectious Disease Carrier
3
Urosepsis
3
Device Related Infection
3
Oesophageal Infection
3
Evidence Based Treatment
3
Eye Infection Fungal
3
Sinusitis Fungal
3
Pleurisy
2
Gastrointestinal Surgery
2

Drug Labels

LabelLabelerEffective
MycamineAstellas Pharma US, Inc.01-JUN-12

Mycamine Case Reports

What Mycamine 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 Mycamine. 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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