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SINTROM

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Sintrom Adverse Events Reported to the FDA Over Time

How are Sintrom adverse event reports trending over time?

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

Most Common Sintrom Adverse Events Reported to the FDA

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

International Normalised Ratio Incr...
161 (5.81%)
Drug Interaction
132 (4.76%)
Anaemia
89 (3.21%)
Haematoma
50 (1.8%)
Prothrombin Time Prolonged
40 (1.44%)
Overdose
39 (1.41%)
Fall
36 (1.3%)
Gastrointestinal Haemorrhage
31 (1.12%)
Haemoglobin Decreased
30 (1.08%)
Renal Failure Acute
28 (1.01%)
Epistaxis
25 (.9%)
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Melaena
24 (.87%)
Dyspnoea
23 (.83%)
Hypotension
23 (.83%)
Asthenia
20 (.72%)
Cardiac Failure
20 (.72%)
Atrial Fibrillation
19 (.69%)
Haematuria
19 (.69%)
Pruritus
19 (.69%)
Renal Failure
19 (.69%)
Thrombocytopenia
19 (.69%)
Cerebral Haemorrhage
18 (.65%)
Hyponatraemia
18 (.65%)
General Physical Health Deteriorati...
17 (.61%)
International Normalised Ratio Decr...
16 (.58%)
Muscle Haemorrhage
16 (.58%)
Multi-organ Failure
15 (.54%)
Pulmonary Fibrosis
15 (.54%)
Pyrexia
14 (.51%)
Subdural Haematoma
14 (.51%)
Diarrhoea
13 (.47%)
Malaise
13 (.47%)
Oedema Peripheral
13 (.47%)
Vomiting
13 (.47%)
Cerebral Haematoma
12 (.43%)
Coagulopathy
12 (.43%)
Prothrombin Level Decreased
12 (.43%)
Confusional State
11 (.4%)
Dehydration
11 (.4%)
Eosinophilia
11 (.4%)
Gastritis Erosive
11 (.4%)
Hyperkalaemia
11 (.4%)
Hypertension
11 (.4%)
Loss Of Consciousness
11 (.4%)
Prothrombin Time Shortened
11 (.4%)
Pulmonary Embolism
11 (.4%)
Rectal Haemorrhage
11 (.4%)
Abdominal Pain
10 (.36%)
Bradycardia
10 (.36%)
Haematocrit Decreased
10 (.36%)
Haemorrhagic Anaemia
10 (.36%)
Pulmonary Alveolar Haemorrhage
10 (.36%)
Alanine Aminotransferase Increased
9 (.32%)
Aspartate Aminotransferase Increase...
9 (.32%)
Blood Creatinine Increased
9 (.32%)
Drug Ineffective
9 (.32%)
Haemorrhage
9 (.32%)
Hypercapnia
9 (.32%)
Activated Partial Thromboplastin Ti...
8 (.29%)
Blood Pressure Decreased
8 (.29%)
Cardiomegaly
8 (.29%)
Coma
8 (.29%)
Disorientation
8 (.29%)
Haemoptysis
8 (.29%)
Head Injury
8 (.29%)
Headache
8 (.29%)
Nausea
8 (.29%)
Respiratory Failure
8 (.29%)
Retroperitoneal Haematoma
8 (.29%)
Somnolence
8 (.29%)
Tachycardia
8 (.29%)
Thrombosis
8 (.29%)
Abdominal Distension
7 (.25%)
Abdominal Wall Haematoma
7 (.25%)
Acute Respiratory Distress Syndrome
7 (.25%)
Anuria
7 (.25%)
Blood Bilirubin Increased
7 (.25%)
Cerebral Hypoperfusion
7 (.25%)
Cerebrovascular Accident
7 (.25%)
Condition Aggravated
7 (.25%)
Cutaneous Vasculitis
7 (.25%)
Decreased Appetite
7 (.25%)
Dialysis
7 (.25%)
Disturbance In Attention
7 (.25%)
Dyspnoea Exertional
7 (.25%)
Haematochezia
7 (.25%)
Hepatocellular Injury
7 (.25%)
Pallor
7 (.25%)
Rash Morbilliform
7 (.25%)
Shock
7 (.25%)
Subarachnoid Haemorrhage
7 (.25%)
Total Lung Capacity Decreased
7 (.25%)
Toxic Skin Eruption
7 (.25%)
Aphasia
6 (.22%)
Blood Lactate Dehydrogenase Increas...
6 (.22%)
Coagulation Time Prolonged
6 (.22%)
Convulsion
6 (.22%)
Faeces Discoloured
6 (.22%)
Gamma-glutamyltransferase Increased
6 (.22%)
Gingival Bleeding
6 (.22%)
Haemorrhage Intracranial
6 (.22%)

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

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

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

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

Atrial Fibrillation
378
Drug Use For Unknown Indication
138
Product Used For Unknown Indication
76
Arrhythmia
73
Thrombosis Prophylaxis
56
Atrial Flutter
56
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Prophylaxis
55
Pulmonary Embolism
48
Anticoagulant Therapy
47
Cardiac Disorder
18
Phlebitis
18
Deep Vein Thrombosis
17
Ill-defined Disorder
17
Cardiac Valve Prosthesis User
16
Thrombosis
14
Hypertension
12
Myocardial Ischaemia
12
Cardiac Valve Disease
9
Cardiac Failure
8
Embolism
7
Coronary Artery Disease
7
Cerebrovascular Accident
6
Cardiac Flutter
6
Cardiac Fibrillation
5
Mitral Valve Replacement
5
Heart Valve Replacement
5
Myocardial Infarction
5
Blood Disorder
5
Ventricular Dysfunction
4
Pulmonary Hypertension
4
Portal Vein Thrombosis
4
Coagulopathy
4
Cardiovascular Disorder
3
Arrhythmia Supraventricular
3
Sick Sinus Syndrome
3
Transient Ischaemic Attack
3
Aortic Valve Replacement
3
Implant Site Thrombosis
3
Myeloproliferative Disorder
3
Venous Thrombosis
2
Antiphospholipid Syndrome
2
Antiplatelet Therapy
2
Vena Cava Thrombosis
2
Cardiac Pacemaker Insertion
2
Cardiomyopathy
2
Conduction Disorder
2
Heart Valve Operation
2
Prostate Cancer Metastatic
2
Thrombophlebitis
2
Promotion Of Peripheral Circulation
1
Crepitations
1

Sintrom Case Reports

What Sintrom 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 Sintrom. 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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