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POSACONAZOLE

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Posaconazole Adverse Events Reported to the FDA Over Time

How are Posaconazole adverse event reports trending over time?

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

Most Common Posaconazole Adverse Events Reported to the FDA

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

Drug Interaction
54 (2.4%)
Respiratory Failure
32 (1.42%)
Drug Ineffective
31 (1.38%)
Disease Progression
29 (1.29%)
Fungal Infection
24 (1.07%)
Pyrexia
23 (1.02%)
Renal Failure
21 (.93%)
Nausea
20 (.89%)
Condition Aggravated
19 (.84%)
Thrombocytopenia
19 (.84%)
Diarrhoea
18 (.8%)
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Multi-organ Failure
18 (.8%)
Pneumonia
18 (.8%)
Vomiting
18 (.8%)
Convulsion
17 (.76%)
Haemoglobin Decreased
17 (.76%)
Septic Shock
17 (.76%)
Blood Alkaline Phosphatase Increase...
16 (.71%)
Hypokalaemia
16 (.71%)
Abdominal Pain
14 (.62%)
Aspartate Aminotransferase Increase...
14 (.62%)
Aspergillosis
14 (.62%)
Lung Infiltration
14 (.62%)
Neutropenia
14 (.62%)
Cytolytic Hepatitis
13 (.58%)
Dyspnoea
13 (.58%)
Haematocrit Decreased
13 (.58%)
Hepatic Enzyme Increased
13 (.58%)
Hyperbilirubinaemia
13 (.58%)
Alanine Aminotransferase Increased
12 (.53%)
Hepatotoxicity
12 (.53%)
Zygomycosis
12 (.53%)
Bronchopulmonary Aspergillosis
11 (.49%)
Drug Toxicity
11 (.49%)
Encephalopathy
11 (.49%)
Febrile Neutropenia
11 (.49%)
Hypomagnesaemia
11 (.49%)
Hypotension
11 (.49%)
Transaminases Increased
11 (.49%)
Death
10 (.44%)
Electrocardiogram Qt Prolonged
10 (.44%)
Gamma-glutamyltransferase Increased
10 (.44%)
Hepatic Function Abnormal
10 (.44%)
Hyponatraemia
10 (.44%)
Lung Neoplasm
10 (.44%)
No Therapeutic Response
10 (.44%)
Sepsis
10 (.44%)
Blood Bilirubin Increased
9 (.4%)
Cholelithiasis
9 (.4%)
Cholestasis
9 (.4%)
Constipation
9 (.4%)
Gastrointestinal Toxicity
9 (.4%)
Graft Versus Host Disease
9 (.4%)
Leukopenia
9 (.4%)
Lymphadenopathy
9 (.4%)
Mitral Valve Incompetence
9 (.4%)
Neutrophil Pelger-huet Anomaly Pres...
9 (.4%)
Pancytopenia
9 (.4%)
Paraesthesia
9 (.4%)
Platelet Count Decreased
9 (.4%)
Pleural Effusion
9 (.4%)
Rash
9 (.4%)
Respiratory Distress
9 (.4%)
Anxiety
8 (.36%)
Hepatic Failure
8 (.36%)
Hepatitis Toxic
8 (.36%)
Hypercapnia
8 (.36%)
Infection
8 (.36%)
Leukocytosis
8 (.36%)
Liver Disorder
8 (.36%)
Mucormycosis
8 (.36%)
Neurotoxicity
8 (.36%)
Weight Decreased
8 (.36%)
Anaemia
7 (.31%)
Bacterial Infection
7 (.31%)
Bacterial Sepsis
7 (.31%)
Bilirubin Conjugated Increased
7 (.31%)
Bradycardia
7 (.31%)
Cardio-respiratory Arrest
7 (.31%)
Cough
7 (.31%)
Gastrointestinal Haemorrhage
7 (.31%)
General Physical Health Deteriorati...
7 (.31%)
Haemolytic Anaemia
7 (.31%)
Hypertension
7 (.31%)
Jaundice
7 (.31%)
Liver Function Test Abnormal
7 (.31%)
Myocardial Infarction
7 (.31%)
Pleuritic Pain
7 (.31%)
Pneumonia Fungal
7 (.31%)
Prothrombin Time Abnormal
7 (.31%)
Splenic Infarction
7 (.31%)
Systemic Mycosis
7 (.31%)
Bronchitis
6 (.27%)
Cardiac Arrest
6 (.27%)
Cytomegalovirus Infection
6 (.27%)
Fluid Overload
6 (.27%)
Long Qt Syndrome
6 (.27%)
Neuropathy Peripheral
6 (.27%)
Pulmonary Embolism
6 (.27%)
Stem Cell Transplant
6 (.27%)
Stenotrophomonas Infection
6 (.27%)

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

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

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

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

Prophylaxis
103
Antifungal Prophylaxis
96
Fungal Infection
93
Product Used For Unknown Indication
41
Drug Use For Unknown Indication
40
Aspergillosis
32
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Infection Prophylaxis
16
Bronchopulmonary Aspergillosis
16
Systemic Mycosis
12
Mucormycosis
12
Zygomycosis
11
Aspergilloma
8
Antifungal Treatment
7
Hepatosplenic Candidiasis
7
Infection
5
Antibiotic Therapy
5
Febrile Neutropenia
3
Neutropenia
3
Candidiasis
3
Fungal Skin Infection
3
Acute Myeloid Leukaemia
2
Acute Promyelocytic Leukaemia
2
Bone Marrow Failure
2
Scedosporium Infection
2
Oral Candidiasis
2
Pulmonary Mycosis
2
Prophylaxis Against Graft Versus Ho...
2
Immunosuppression
2
Pyrexia
1
Haematological Malignancy
1
Epilepsy
1
Lung Infection
1
Allogenic Bone Marrow Transplantati...
1
Upper Respiratory Tract Infection
1
Sinusitis Fungal
1
Fusarium Infection
1
Lung Disorder
1
Cellulitis
1
Antibiotic Prophylaxis
1
Lung Infiltration
1
Coccidioidomycosis
1
Pain
1
Oesophagitis
1
Sepsis
1
Oesophageal Candidiasis
1
Cerebral Aspergillosis
1
Brain Abscess
1
Culture Positive
1
Prophylaxis Against Transplant Reje...
1
Drug Therapy
1
Pneumonia Fungal
1

Drug Labels

LabelLabelerEffective
NoxafilMerck Sharp & Dohme Corp.12-DEC-12

Posaconazole Case Reports

What Posaconazole 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 Posaconazole. 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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