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AMBRISENTAN

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Ambrisentan Adverse Events Reported to the FDA Over Time

How are Ambrisentan adverse event reports trending over time?

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

Most Common Ambrisentan Adverse Events Reported to the FDA

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

Death
73 (3.14%)
Dyspnoea
73 (3.14%)
Right Ventricular Failure
73 (3.14%)
Cardiac Failure
55 (2.36%)
Oedema Peripheral
47 (2.02%)
Haemoptysis
36 (1.55%)
Anaemia
35 (1.5%)
Liver Function Test Abnormal
34 (1.46%)
Oedema
32 (1.38%)
Dizziness
28 (1.2%)
Hypoxia
26 (1.12%)
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Pneumonia
26 (1.12%)
Respiratory Failure
26 (1.12%)
Fluid Retention
25 (1.07%)
Idiopathic Pulmonary Fibrosis
25 (1.07%)
Pulmonary Hypertension
25 (1.07%)
Pleural Effusion
22 (.95%)
Hepatic Enzyme Increased
21 (.9%)
Alanine Aminotransferase Increased
20 (.86%)
Diarrhoea
20 (.86%)
Cardiac Arrest
19 (.82%)
Hypotension
19 (.82%)
Nausea
19 (.82%)
Renal Failure
19 (.82%)
Weight Increased
19 (.82%)
Aspartate Aminotransferase Increase...
17 (.73%)
Epistaxis
17 (.73%)
Renal Impairment
17 (.73%)
Asthenia
16 (.69%)
Interstitial Lung Disease
16 (.69%)
Pulmonary Oedema
16 (.69%)
Sepsis
16 (.69%)
Syncope
16 (.69%)
Pulmonary Arterial Hypertension
15 (.64%)
Transaminases Increased
15 (.64%)
Tremor
15 (.64%)
International Normalised Ratio Incr...
14 (.6%)
Loss Of Consciousness
14 (.6%)
Pregnancy
14 (.6%)
Pyrexia
14 (.6%)
Abortion Induced
13 (.56%)
Chest Pain
13 (.56%)
Pneumonitis
13 (.56%)
Pulmonary Alveolar Haemorrhage
13 (.56%)
Renal Failure Acute
13 (.56%)
Abdominal Pain
12 (.52%)
Fatigue
12 (.52%)
Haemoglobin Decreased
12 (.52%)
Palpitations
12 (.52%)
Atrial Fibrillation
11 (.47%)
Dehydration
11 (.47%)
Headache
11 (.47%)
Hepatitis
11 (.47%)
Vomiting
11 (.47%)
Balance Disorder
10 (.43%)
Cerebellar Syndrome
10 (.43%)
Chronic Obstructive Pulmonary Disea...
10 (.43%)
Drug Exposure During Pregnancy
10 (.43%)
Drug Ineffective
10 (.43%)
Gait Disturbance
10 (.43%)
Ascites
9 (.39%)
Atrial Flutter
9 (.39%)
General Physical Health Deteriorati...
9 (.39%)
Thrombocytopenia
9 (.39%)
Anuria
8 (.34%)
Blood Bilirubin Increased
8 (.34%)
Bronchiectasis
8 (.34%)
Cerebellar Ataxia
8 (.34%)
Decreased Appetite
8 (.34%)
Electrocardiogram T Wave Inversion
8 (.34%)
Erythema
8 (.34%)
Flushing
8 (.34%)
Gastrointestinal Haemorrhage
8 (.34%)
Hyperkalaemia
8 (.34%)
Infection
8 (.34%)
Muscular Weakness
8 (.34%)
Oxygen Saturation Decreased
8 (.34%)
Pancytopenia
8 (.34%)
Pneumothorax
8 (.34%)
Rash
8 (.34%)
Upper Respiratory Tract Infection
8 (.34%)
Acute Respiratory Failure
7 (.3%)
Blood Creatinine Increased
7 (.3%)
Cholelithiasis
7 (.3%)
Condition Aggravated
7 (.3%)
Haemolytic Anaemia
7 (.3%)
Hepatic Encephalopathy
7 (.3%)
Hepatotoxicity
7 (.3%)
Hypoaesthesia
7 (.3%)
Hypokalaemia
7 (.3%)
Migraine
7 (.3%)
Pain In Extremity
7 (.3%)
Pancreatitis
7 (.3%)
Pulmonary Fibrosis
7 (.3%)
Adverse Event
6 (.26%)
Angina Unstable
6 (.26%)
Blood Alkaline Phosphatase Increase...
6 (.26%)
Cellulitis
6 (.26%)
Cerebrovascular Accident
6 (.26%)
Confusional State
6 (.26%)
Eating Disorder
6 (.26%)

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

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

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

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

Pulmonary Arterial Hypertension
448
Pulmonary Hypertension
250
Product Used For Unknown Indication
41
Idiopathic Pulmonary Fibrosis
37
Drug Use For Unknown Indication
16
Scleroderma
9
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Portopulmonary Hypertension
4
Pulmonary Fibrosis
4
Venoocclusive Disease
4
Pulmonary Thrombosis
3
Chronic Obstructive Pulmonary Disea...
3
Coronary Artery Disease
1
Nephropathy
1
Sarcoidosis
1
Right Ventricular Failure
1
Cardiac Disorder
1
Skin Ulcer
1
Collagen Disorder
1
Malnutrition
1
Eisenmengers Syndrome
1
Atrial Septal Defect
1
Anaemia
1
Hypertension
1
Sleep Apnoea Syndrome
1
Renal Failure Chronic
1
Fluid Overload
1

Drug Labels

LabelLabelerEffective
LetairisGilead Sciences, Inc22-OCT-12

Ambrisentan Case Reports

What Ambrisentan 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 Ambrisentan. 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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