DrugCite
Search

SPORANOX

Adverse Events
Drug Profile
Learn More
Reference
About Results
Comments

Sporanox Adverse Events Reported to the FDA Over Time

How are Sporanox adverse event reports trending over time?

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

Most Common Sporanox Adverse Events Reported to the FDA

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

Dyspnoea
73 (2.45%)
Death
60 (2.02%)
Drug Interaction
49 (1.65%)
Oedema Peripheral
41 (1.38%)
Drug Exposure During Pregnancy
35 (1.18%)
Weight Increased
35 (1.18%)
Fatigue
28 (.94%)
Pyrexia
27 (.91%)
Renal Failure
26 (.87%)
Headache
25 (.84%)
Diarrhoea
24 (.81%)
Show More Show More
Rhabdomyolysis
24 (.81%)
Muscular Weakness
23 (.77%)
Vomiting
23 (.77%)
Cardiac Failure
22 (.74%)
Nausea
22 (.74%)
Renal Failure Acute
22 (.74%)
Sepsis
22 (.74%)
Chest Discomfort
20 (.67%)
Pneumonia
20 (.67%)
Septic Shock
20 (.67%)
Weight Decreased
20 (.67%)
Abdominal Pain
19 (.64%)
Adrenal Insufficiency
19 (.64%)
Dizziness
19 (.64%)
Liver Function Test Abnormal
19 (.64%)
Asthenia
18 (.61%)
Ascites
17 (.57%)
Drug Ineffective
17 (.57%)
Hypotension
17 (.57%)
Myalgia
17 (.57%)
Condition Aggravated
16 (.54%)
Multi-organ Failure
16 (.54%)
Palpitations
16 (.54%)
Alanine Aminotransferase Increased
15 (.5%)
Cardiac Failure Congestive
15 (.5%)
Generalised Oedema
15 (.5%)
Malaise
15 (.5%)
Pancreatitis
15 (.5%)
Pruritus
15 (.5%)
Respiratory Distress
15 (.5%)
Abortion Spontaneous
14 (.47%)
Arthralgia
14 (.47%)
Diabetes Mellitus
14 (.47%)
Erythema
14 (.47%)
Liver Injury
14 (.47%)
Pleural Effusion
14 (.47%)
Blood Creatine Phosphokinase Increa...
13 (.44%)
Cholestasis
13 (.44%)
Jaundice
13 (.44%)
Lung Disorder
13 (.44%)
Rash
13 (.44%)
Respiratory Failure
13 (.44%)
Anaemia
12 (.4%)
Aspartate Aminotransferase Increase...
12 (.4%)
Graft Versus Host Disease
12 (.4%)
Pain
12 (.4%)
Swelling Face
12 (.4%)
Thrombocytopenia
12 (.4%)
Cytolytic Hepatitis
11 (.37%)
Hepatotoxicity
11 (.37%)
Hypertension
11 (.37%)
Platelet Count Decreased
11 (.37%)
Blood Bilirubin Increased
10 (.34%)
Blood Pressure Increased
10 (.34%)
Chest Pain
10 (.34%)
Confusional State
10 (.34%)
General Physical Health Deteriorati...
10 (.34%)
Heart Rate Increased
10 (.34%)
Hyperhidrosis
10 (.34%)
Pseudomembranous Colitis
10 (.34%)
Stevens-johnson Syndrome
10 (.34%)
Blood Creatinine Increased
9 (.3%)
Hyperbilirubinaemia
9 (.3%)
Renal Impairment
9 (.3%)
Transaminases Increased
9 (.3%)
Anorexia
8 (.27%)
Atrial Fibrillation
8 (.27%)
Blood Cholesterol Increased
8 (.27%)
Convulsion
8 (.27%)
Dysphagia
8 (.27%)
Endocrine Neoplasm Malignant
8 (.27%)
Eyelid Oedema
8 (.27%)
Face Oedema
8 (.27%)
Gastrooesophageal Reflux Disease
8 (.27%)
Hypokalaemia
8 (.27%)
Mental Status Changes
8 (.27%)
Myositis
8 (.27%)
Pelvic Pain
8 (.27%)
Plantar Fasciitis
8 (.27%)
Pulmonary Oedema
8 (.27%)
Amyotrophy
7 (.24%)
Bronchopulmonary Aspergillosis
7 (.24%)
Cholecystitis
7 (.24%)
Electrocardiogram Qt Prolonged
7 (.24%)
Epilepsy
7 (.24%)
Insomnia
7 (.24%)
Myelocytosis
7 (.24%)
Myocardial Infarction
7 (.24%)
Off Label Use
7 (.24%)
Onychomycosis
7 (.24%)

ExportShare/Embed GraphExport Export Data

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

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

Show More Show More

ExportShare/Embed Graph Export Export Data

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

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

Drug Use For Unknown Indication
143
Onychomycosis
140
Fungal Infection
86
Antifungal Prophylaxis
41
Histoplasmosis
36
Bronchopulmonary Aspergillosis
32
Show More Show More
Aspergillosis
28
Product Used For Unknown Indication
26
Prophylaxis
22
Febrile Neutropenia
20
Candidiasis
15
Blastomycosis
13
Pulmonary Mycosis
13
Bronchopulmonary Aspergillosis Alle...
10
Lung Infection
10
Fungal Skin Infection
9
Vulvovaginal Candidiasis
8
Tinea Pedis
8
Systemic Mycosis
6
Oral Candidiasis
6
Drug Exposure During Pregnancy
6
Skin Disorder
6
Seborrhoeic Dermatitis
5
Sporotrichosis
5
Acute Myeloid Leukaemia
5
Dermatophytosis
5
Pruritus
5
Antifungal Treatment
5
Pneumonia Aspergillus
5
Tinea Infection
5
Infection
4
Tinea Versicolour
4
Histoplasmosis Disseminated
4
Cellulitis
3
Infection Prophylaxis
3
Bacterial Infection
3
Pneumonia Fungal
3
Ill-defined Disorder
3
Paracoccidioides Infection
3
Acute Lymphocytic Leukaemia
3
Sinusitis
3
Rash
3
Vaginal Infection
3
Bronchopneumonia
3
Respiratory Tract Infection Fungal
2
Fungal Rash
2
Psoriasis
2
Myelodysplastic Syndrome
2
Penicilliosis
2
Chronic Obstructive Pulmonary Disea...
2
Genital Candidiasis
2

Drug Labels

LabelLabelerEffective
SporanoxJanssen Pharmaceuticals, Inc.21-JUN-12
SporanoxJanssen Pharmaceuticals, Inc.08-JAN-13
SporanoxBryant Ranch Prepack21-JAN-13

Sporanox Case Reports

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

Powered by Google

About Results

This report contains aggregated drug side effects and adverse events for Sporanox. 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.

Comments

Share your experience with Sporanox.