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VORICONAZOLE

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Voriconazole Adverse Events Reported to the FDA Over Time

How are Voriconazole adverse event reports trending over time?

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

Most Common Voriconazole Adverse Events Reported to the FDA

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

Drug Interaction
137 (2.19%)
Death
127 (2.03%)
Renal Failure Acute
117 (1.87%)
Drug Ineffective
98 (1.57%)
Pneumonia
88 (1.41%)
Respiratory Failure
88 (1.41%)
Hepatotoxicity
83 (1.33%)
Bronchopulmonary Aspergillosis
76 (1.21%)
Drug Level Increased
75 (1.2%)
Pyrexia
69 (1.1%)
Liver Function Test Abnormal
67 (1.07%)
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Photosensitivity Reaction
66 (1.05%)
Septic Shock
63 (1.01%)
Dilatation Intrahepatic Duct Acquir...
60 (.96%)
Graft Versus Host Disease
57 (.91%)
Venoocclusive Liver Disease
53 (.85%)
Sepsis
52 (.83%)
Aspergillosis
51 (.81%)
Squamous Cell Carcinoma
50 (.8%)
Renal Failure
47 (.75%)
Hallucination
46 (.73%)
Alanine Aminotransferase Increased
45 (.72%)
Multi-organ Failure
44 (.7%)
Blood Alkaline Phosphatase Increase...
43 (.69%)
Fungal Infection
43 (.69%)
Drug Resistance
41 (.65%)
Blood Bilirubin Increased
40 (.64%)
Pancytopenia
39 (.62%)
Diarrhoea
37 (.59%)
Hypotension
36 (.57%)
Neutropenia
36 (.57%)
Acute Respiratory Distress Syndrome
35 (.56%)
Convulsion
35 (.56%)
Hepatic Enzyme Increased
34 (.54%)
Zygomycosis
33 (.53%)
Muscular Weakness
31 (.5%)
Disease Progression
30 (.48%)
Febrile Neutropenia
30 (.48%)
Cardiac Arrest
27 (.43%)
Cholestasis
27 (.43%)
Hypoaesthesia
27 (.43%)
Nausea
27 (.43%)
Pain
27 (.43%)
Vomiting
27 (.43%)
Confusional State
26 (.42%)
Blood Creatinine Increased
25 (.4%)
Visual Impairment
25 (.4%)
Condition Aggravated
24 (.38%)
Dyspnoea
24 (.38%)
Neuropathy Peripheral
24 (.38%)
Bradycardia
23 (.37%)
Encephalopathy
23 (.37%)
Neurotoxicity
23 (.37%)
Aspartate Aminotransferase Increase...
22 (.35%)
Disseminated Intravascular Coagulat...
22 (.35%)
Electrocardiogram Qt Prolonged
22 (.35%)
Hepatic Failure
22 (.35%)
Lung Disorder
22 (.35%)
Acute Myeloid Leukaemia
21 (.34%)
Drug Toxicity
21 (.34%)
Nervous System Disorder
21 (.34%)
Pleural Effusion
21 (.34%)
Polyneuropathy
21 (.34%)
Renal Impairment
21 (.34%)
Venoocclusive Disease
21 (.34%)
Cardio-respiratory Arrest
20 (.32%)
Erythema
20 (.32%)
Nephropathy Toxic
20 (.32%)
Rash
20 (.32%)
Cytomegalovirus Infection
19 (.3%)
Headache
19 (.3%)
Hepatic Encephalopathy
19 (.3%)
Hepatic Function Abnormal
19 (.3%)
Hydropneumothorax
19 (.3%)
Pneumothorax
19 (.3%)
Haemoptysis
18 (.29%)
Hallucination, Visual
18 (.29%)
Hypokalaemia
18 (.29%)
Pain In Extremity
18 (.29%)
Torsade De Pointes
18 (.29%)
Transaminases Increased
18 (.29%)
Abdominal Pain
17 (.27%)
Actinic Keratosis
17 (.27%)
Drug Level Decreased
17 (.27%)
Hepatic Cirrhosis
17 (.27%)
Hyperbilirubinaemia
17 (.27%)
Hyponatraemia
17 (.27%)
Pseudomonas Infection
17 (.27%)
Rhabdomyolysis
17 (.27%)
Scedosporium Infection
17 (.27%)
Agitation
16 (.26%)
Cardiac Failure
16 (.26%)
Haemodialysis
16 (.26%)
Malaise
16 (.26%)
Pericardial Effusion
16 (.26%)
Arrhythmia
15 (.24%)
Cerebral Haemorrhage
15 (.24%)
Haemoglobin Decreased
15 (.24%)
Pathogen Resistance
15 (.24%)
Abasia
14 (.22%)
Fatigue
14 (.22%)

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

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

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

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

Aspergillosis
513
Bronchopulmonary Aspergillosis
244
Antifungal Prophylaxis
215
Product Used For Unknown Indication
151
Fungal Infection
145
Prophylaxis
134
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Drug Use For Unknown Indication
110
Infection Prophylaxis
81
Pneumonia
34
Candidiasis
31
Antifungal Treatment
24
Ill-defined Disorder
22
Systemic Candida
21
Febrile Neutropenia
17
Infection
17
Bronchopulmonary Aspergillosis Alle...
16
Pneumonia Fungal
16
Gastrointestinal Candidiasis
15
Sepsis
13
Pyrexia
12
Aspergilloma
12
Fusarium Infection
10
Lung Disorder
10
Keratitis Fungal
10
Sinusitis Aspergillus
10
Eye Infection Fungal
9
Systemic Mycosis
8
Oesophageal Candidiasis
8
Scedosporium Infection
7
Trichosporon Infection
7
Systemic Antifungal Treatment
6
Evidence Based Treatment
6
Mucormycosis
6
Pneumonia Aspiration
6
Coccidioidomycosis
6
Fungaemia
5
Septic Shock
5
Chronic Granulomatous Disease
5
Antibiotic Prophylaxis
5
Meningitis Cryptococcal
4
Cerebral Aspergillosis
4
Dermatophytosis
4
Lung Abscess
4
Respiratory Tract Infection Fungal
4
Antiviral Prophylaxis
4
Pseudomonas Infection
4
Respiratory Moniliasis
4
Zygomycosis
4
Endocarditis
4
Drug Level
3
Prophylaxis Against Transplant Reje...
3

Drug Labels

LabelLabelerEffective
VfendRoerig06-JUL-11
VfendCardinal Health10-NOV-11
VoriconazoleSandoz Inc30-NOV-11
VfendRoerig30-NOV-11
VoriconazoleMylan Pharmaceuticals Inc.22-DEC-11
VoriconazoleGreenstone LLC27-DEC-11
VoriconazoleMylan Institutional Inc.04-MAY-12
VoriconazoleSandoz Inc30-MAY-12
VoriconazoleAmerican Health Packaging12-JUL-12
VoriconazoleTeva Pharmaceuticals USA Inc31-JUL-12
VfendRoerig31-JUL-12
VfendRoerig31-MAR-13
VoriconazoleCardinal Health03-APR-13

Voriconazole Case Reports

What Voriconazole 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 Voriconazole. 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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