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Ambisome Adverse Events Reported to the FDA Over Time

How are Ambisome adverse event reports trending over time?

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

Most Common Ambisome Adverse Events Reported to the FDA

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

Hypokalaemia
233 (3.15%)
Renal Impairment
116 (1.57%)
Rhabdomyolysis
108 (1.46%)
Respiratory Failure
107 (1.45%)
Aspartate Aminotransferase Increase...
101 (1.37%)
Alanine Aminotransferase Increased
100 (1.35%)
Renal Failure
98 (1.33%)
Drug Ineffective
93 (1.26%)
Pyrexia
93 (1.26%)
Renal Failure Acute
91 (1.23%)
Platelet Count Decreased
84 (1.14%)
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Multi-organ Failure
81 (1.1%)
Anaemia
78 (1.06%)
Blood Bilirubin Increased
72 (.97%)
Blood Creatinine Increased
71 (.96%)
Condition Aggravated
69 (.93%)
Pancytopenia
63 (.85%)
Pneumonia
63 (.85%)
Sepsis
63 (.85%)
Death
55 (.74%)
Hepatic Function Abnormal
54 (.73%)
Haemoglobin Decreased
53 (.72%)
Liver Disorder
51 (.69%)
Blood Urea Increased
50 (.68%)
Disseminated Intravascular Coagulat...
50 (.68%)
Dyspnoea
50 (.68%)
Cardiac Arrest
49 (.66%)
Blood Alkaline Phosphatase Increase...
48 (.65%)
Blood Potassium Decreased
48 (.65%)
General Physical Health Deteriorati...
46 (.62%)
Hypotension
46 (.62%)
Renal Disorder
45 (.61%)
Cholestasis
44 (.6%)
Diarrhoea
42 (.57%)
White Blood Cell Count Decreased
42 (.57%)
Hyperkalaemia
41 (.55%)
Nausea
40 (.54%)
Vomiting
40 (.54%)
Shock
39 (.53%)
Septic Shock
38 (.51%)
Thrombocytopenia
38 (.51%)
Bronchopulmonary Aspergillosis
36 (.49%)
Convulsion
36 (.49%)
Fungal Infection
33 (.45%)
Abdominal Pain
32 (.43%)
Cardio-respiratory Arrest
32 (.43%)
Pancreatitis Acute
32 (.43%)
Infusion Related Reaction
31 (.42%)
Neutropenia
31 (.42%)
Pleural Effusion
30 (.41%)
Cardiac Failure
28 (.38%)
Haematocrit Decreased
27 (.37%)
Haemodialysis
27 (.37%)
Pulmonary Haemorrhage
26 (.35%)
Asthenia
25 (.34%)
Blood Lactate Dehydrogenase Increas...
25 (.34%)
Gamma-glutamyltransferase Increased
25 (.34%)
Hyperbilirubinaemia
25 (.34%)
Jaundice
25 (.34%)
Muscular Weakness
25 (.34%)
Gastrointestinal Haemorrhage
24 (.32%)
Hepatic Failure
24 (.32%)
Nephropathy Toxic
24 (.32%)
Blood Pressure Decreased
23 (.31%)
Cytolytic Hepatitis
23 (.31%)
Staphylococcal Infection
23 (.31%)
Tachycardia
23 (.31%)
Disease Progression
22 (.3%)
Renal Tubular Disorder
22 (.3%)
Back Pain
21 (.28%)
Bone Marrow Failure
21 (.28%)
Erythema
21 (.28%)
Blood Creatine Phosphokinase Increa...
20 (.27%)
Depressed Level Of Consciousness
20 (.27%)
Liver Function Test Abnormal
20 (.27%)
Oxygen Saturation Decreased
20 (.27%)
Pulmonary Oedema
20 (.27%)
Ascites
19 (.26%)
Chills
19 (.26%)
Hyperglycaemia
19 (.26%)
Toxic Epidermal Necrolysis
19 (.26%)
Urine Output Decreased
19 (.26%)
Ventricular Fibrillation
19 (.26%)
Hepatomegaly
18 (.24%)
Interstitial Lung Disease
18 (.24%)
Leukopenia
18 (.24%)
Myalgia
18 (.24%)
Rash
18 (.24%)
Acute Respiratory Distress Syndrome
17 (.23%)
Arrhythmia
17 (.23%)
Blood Potassium Increased
17 (.23%)
Flushing
17 (.23%)
Pneumonia Fungal
17 (.23%)
C-reactive Protein Increased
16 (.22%)
Dialysis
16 (.22%)
Drug Ineffective For Unapproved Ind...
16 (.22%)
Drug Interaction
16 (.22%)
Febrile Neutropenia
16 (.22%)
Malaise
16 (.22%)
Medication Error
16 (.22%)
No Therapeutic Response
16 (.22%)

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

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

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

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

Fungal Infection
190
Bronchopulmonary Aspergillosis
151
Visceral Leishmaniasis
120
Product Used For Unknown Indication
104
Drug Use For Unknown Indication
87
Aspergillosis
82
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Febrile Neutropenia
75
Meningitis Cryptococcal
64
Candidiasis
56
Antifungal Prophylaxis
56
Zygomycosis
55
Systemic Candida
55
Systemic Mycosis
45
Pneumonia
41
Infection
34
Cryptococcosis
30
Pulmonary Mycosis
28
Sepsis
23
Mucormycosis
22
Pneumonia Fungal
21
Prophylaxis
21
Pyrexia
20
Pyelonephritis Fungal
13
Leishmaniasis
10
Peritonitis
10
Antifungal Treatment
9
Fusarium Infection
9
Oesophageal Candidiasis
9
Endocarditis Candida
9
Histoplasmosis Disseminated
9
Brain Abscess
8
Evidence Based Treatment
8
Fungaemia
8
Histoplasmosis
7
Antibiotic Therapy
7
Pneumonia Cryptococcal
7
Candida Sepsis
6
Pneumonia Legionella
6
Cerebral Aspergillosis
6
Acute Myeloid Leukaemia
6
Candida Pneumonia
5
Sinusitis
5
Febrile Bone Marrow Aplasia
5
Adverse Event
5
Trichosporon Infection
5
Fungal Endocarditis
5
Blood Beta-d-glucan Abnormal
4
Hyperpyrexia
4
Encephalitis
4
Septic Shock
4
Fungal Sepsis
4

Drug Labels

LabelLabelerEffective
AmbisomeAstellas Pharma US, Inc.31-MAY-12

Ambisome Case Reports

What Ambisome 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 Ambisome. 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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