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Sigmart Adverse Events Reported to the FDA Over Time

How are Sigmart adverse event reports trending over time?

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

Most Common Sigmart Adverse Events Reported to the FDA

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

Liver Disorder
30 (3.53%)
Pyrexia
18 (2.12%)
Alanine Aminotransferase Increased
16 (1.88%)
Aspartate Aminotransferase Increase...
16 (1.88%)
Hepatic Function Abnormal
14 (1.65%)
Blood Alkaline Phosphatase Increase...
13 (1.53%)
Liver Function Test Abnormal
13 (1.53%)
White Blood Cell Count Decreased
13 (1.53%)
Asthma
12 (1.41%)
Loss Of Consciousness
12 (1.41%)
Cerebral Infarction
11 (1.29%)
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Gamma-glutamyltransferase Increased
10 (1.18%)
Agranulocytosis
9 (1.06%)
Coronary Arterial Stent Insertion
9 (1.06%)
Septic Shock
9 (1.06%)
Toxic Skin Eruption
9 (1.06%)
Ventricular Fibrillation
9 (1.06%)
Acute Generalised Exanthematous Pus...
8 (.94%)
Angina Pectoris
8 (.94%)
Cardiac Failure
8 (.94%)
Coronary Artery Restenosis
8 (.94%)
Coronary Artery Stenosis
8 (.94%)
Interstitial Lung Disease
8 (.94%)
Jaundice
8 (.94%)
Acute Respiratory Distress Syndrome
7 (.82%)
Arteriospasm Coronary
7 (.82%)
Blood Lactate Dehydrogenase Increas...
7 (.82%)
Blood Magnesium Decreased
7 (.82%)
Cardiovascular Disorder
7 (.82%)
Catheterisation Cardiac
7 (.82%)
Contusion
7 (.82%)
Coronary Angioplasty
7 (.82%)
Electrocardiogram St Segment Depres...
7 (.82%)
Electrocardiogram St Segment Elevat...
7 (.82%)
Exercise Electrocardiogram Abnormal
7 (.82%)
Exercise Test Abnormal
7 (.82%)
Fall
7 (.82%)
Gingival Swelling
7 (.82%)
Haemodialysis
7 (.82%)
Mouth Ulceration
7 (.82%)
Myocardial Ischaemia
7 (.82%)
Pancytopenia
7 (.82%)
Pneumonia
7 (.82%)
Pruritus
7 (.82%)
Renal Impairment
7 (.82%)
Thrombocytopenia
7 (.82%)
Ventricular Extrasystoles
7 (.82%)
Chest Discomfort
6 (.71%)
Condition Aggravated
6 (.71%)
Drug Level Increased
6 (.71%)
Granulocytopenia
6 (.71%)
Hepatocellular Injury
6 (.71%)
Hyperkalaemia
6 (.71%)
Hypoxia
6 (.71%)
In-stent Coronary Artery Restenosis
6 (.71%)
Lymphocyte Stimulation Test Positiv...
6 (.71%)
Nasopharyngitis
6 (.71%)
Platelet Count Decreased
6 (.71%)
Renal Failure Acute
6 (.71%)
Thrombocytopenic Purpura
6 (.71%)
Blood Pressure Decreased
5 (.59%)
Disseminated Intravascular Coagulat...
5 (.59%)
Dyspnoea
5 (.59%)
Eosinophilia
5 (.59%)
Malaise
5 (.59%)
Rash
5 (.59%)
Urine Output Decreased
5 (.59%)
Anorexia
4 (.47%)
Cardio-respiratory Arrest
4 (.47%)
Diarrhoea
4 (.47%)
Eosinophilic Pneumonia
4 (.47%)
Epilepsy
4 (.47%)
Escherichia Infection
4 (.47%)
Gingival Erythema
4 (.47%)
Haemoglobin Decreased
4 (.47%)
Hepatitis Cholestatic
4 (.47%)
Pulmonary Oedema
4 (.47%)
Anuria
3 (.35%)
Arteriovenous Fistula
3 (.35%)
Blood Bilirubin Increased
3 (.35%)
Blood Creatine Phosphokinase Increa...
3 (.35%)
C-reactive Protein Increased
3 (.35%)
Cardiac Disorder
3 (.35%)
Chest X-ray Abnormal
3 (.35%)
Dermatitis Exfoliative
3 (.35%)
Drug Eruption
3 (.35%)
Drug Ineffective
3 (.35%)
Eosinophil Count Increased
3 (.35%)
Gingivitis
3 (.35%)
Haematocrit Decreased
3 (.35%)
Hepatic Infiltration Eosinophilic
3 (.35%)
Histiocytosis Haematophagic
3 (.35%)
Infection
3 (.35%)
Monoplegia
3 (.35%)
Neutropenia
3 (.35%)
Neutrophil Count Decreased
3 (.35%)
Pain In Extremity
3 (.35%)
Pleural Effusion
3 (.35%)
Purpura
3 (.35%)
Rash Papular
3 (.35%)
Stent Placement
3 (.35%)

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

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

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

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

Angina Pectoris
476
Myocardial Infarction
84
Drug Use For Unknown Indication
73
Angina Unstable
48
Product Used For Unknown Indication
47
Hypertension
47
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Prophylaxis
43
Myocardial Ischaemia
36
Acute Myocardial Infarction
24
Cardiac Failure
23
Arrhythmia
15
Cardiac Failure Chronic
13
Cardiovascular Event Prophylaxis
10
Cardiac Failure Congestive
9
Prinzmetal Angina
8
Acute Coronary Syndrome
7
Vasodilatation
7
Cardiomyopathy
5
Ischaemic Heart Disease Prophylaxis
5
Coronary Artery Dilatation
4
Electrocardiogram Qt Prolonged
4
Coronary Artery Disease
3
Percutaneous Coronary Intervention
3
Arteriospasm Coronary
3
Ventricular Tachycardia
3
Cardiac Disorder
2
Ill-defined Disorder
2
Asthma
2
Vasodilation Procedure
2
Hepatic Function Abnormal
2
Sedative Therapy
2
Blood Pressure Management
2
Ischaemia
2
Coronary Artery Insufficiency
1
Coronary Arterial Stent Insertion
1
Atrial Fibrillation
1
Aortic Dissection
1
Concomitant Disease Progression
1
Coronary Artery Occlusion
1
Aortic Valve Replacement
1
Arteriosclerosis Coronary Artery
1
Sepsis
1
Disuse Syndrome
1
Stress Cardiomyopathy
1

Sigmart Case Reports

What Sigmart 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 Sigmart. 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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