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HEPARIN SODIUM

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Heparin Sodium Adverse Events Reported to the FDA Over Time

How are Heparin Sodium adverse event reports trending over time?

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

Most Common Heparin Sodium Adverse Events Reported to the FDA

What are the most common Heparin Sodium adverse events reported to the FDA?

Hypotension
4397 (3.09%)
Nausea
3392 (2.39%)
Dyspnoea
2934 (2.06%)
Heparin-induced Thrombocytopenia
2745 (1.93%)
Vomiting
2721 (1.91%)
Adverse Event
2538 (1.79%)
Abdominal Pain
1878 (1.32%)
Respiratory Failure
1727 (1.22%)
Asthenia
1698 (1.2%)
Chest Pain
1631 (1.15%)
Death
1583 (1.11%)
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Diarrhoea
1545 (1.09%)
Blood Pressure Decreased
1513 (1.06%)
Thrombocytopenia
1466 (1.03%)
Dizziness
1455 (1.02%)
Sepsis
1427 (1%)
Headache
1407 (.99%)
Anaemia
1313 (.92%)
Pyrexia
1287 (.91%)
Hyperhidrosis
1275 (.9%)
Cardiac Arrest
1244 (.88%)
Renal Failure
1171 (.82%)
Unresponsive To Stimuli
1166 (.82%)
Renal Failure Acute
1109 (.78%)
Atrial Fibrillation
1085 (.76%)
Haemorrhage
1052 (.74%)
Cardiac Failure Congestive
968 (.68%)
Deep Vein Thrombosis
931 (.66%)
Pneumonia
872 (.61%)
Hypersensitivity
853 (.6%)
Multi-organ Failure
837 (.59%)
Pulmonary Embolism
810 (.57%)
Tachycardia
777 (.55%)
Thrombosis
769 (.54%)
Malaise
735 (.52%)
Cardio-respiratory Arrest
723 (.51%)
Cerebrovascular Accident
720 (.51%)
Myocardial Infarction
719 (.51%)
Oedema Peripheral
712 (.5%)
Renal Failure Chronic
706 (.5%)
Platelet Count Decreased
699 (.49%)
Cardiogenic Shock
689 (.48%)
Rash
678 (.48%)
Pleural Effusion
665 (.47%)
Erythema
632 (.44%)
Fatigue
632 (.44%)
Hypertension
617 (.43%)
Coagulopathy
613 (.43%)
Syncope
610 (.43%)
Abdominal Pain Upper
601 (.42%)
Gastrointestinal Haemorrhage
599 (.42%)
Pain
584 (.41%)
Coronary Artery Disease
583 (.41%)
Septic Shock
569 (.4%)
Decreased Appetite
566 (.4%)
Pharyngeal Oedema
535 (.38%)
Chills
512 (.36%)
Loss Of Consciousness
503 (.35%)
Heart Rate Increased
499 (.35%)
Pulmonary Oedema
491 (.35%)
Mental Status Changes
486 (.34%)
Confusional State
477 (.34%)
Flushing
476 (.34%)
Shock
473 (.33%)
Hypoaesthesia
459 (.32%)
Dysphagia
456 (.32%)
Respiratory Distress
455 (.32%)
Lethargy
442 (.31%)
Drug Ineffective
433 (.3%)
Drug Hypersensitivity
427 (.3%)
Bradycardia
426 (.3%)
Paraesthesia
416 (.29%)
Cardiac Failure
415 (.29%)
Hypoxia
411 (.29%)
Acute Myocardial Infarction
396 (.28%)
Pruritus
396 (.28%)
Arrhythmia
395 (.28%)
Convulsion
395 (.28%)
Organ Failure
394 (.28%)
Burning Sensation
391 (.28%)
Haematoma
377 (.27%)
Anxiety
376 (.26%)
Pain In Extremity
369 (.26%)
Dehydration
366 (.26%)
Metabolic Acidosis
366 (.26%)
Leukocytosis
363 (.26%)
Back Pain
351 (.25%)
Ventricular Tachycardia
350 (.25%)
Urinary Tract Infection
348 (.24%)
Chest Discomfort
347 (.24%)
Cardiac Disorder
345 (.24%)
Haemoglobin Decreased
341 (.24%)
General Physical Health Deteriorati...
338 (.24%)
Hepatic Failure
336 (.24%)
Staphylococcal Infection
336 (.24%)
Vision Blurred
329 (.23%)
Fluid Overload
320 (.23%)
Abdominal Distension
317 (.22%)
Infection
315 (.22%)
Swelling
307 (.22%)
Diabetes Mellitus
302 (.21%)

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

What are the most common Heparin Sodium adverse events reported to the FDA?

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

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

Drug Use For Unknown Indication
4615
Thrombosis Prophylaxis
2276
Prophylaxis
1687
Anticoagulant Therapy
1483
Product Used For Unknown Indication
1452
Haemodialysis
736
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Deep Vein Thrombosis
614
Pulmonary Embolism
569
Coronary Artery Bypass
533
Intravenous Catheter Management
442
Myocardial Infarction
406
Catheterisation Cardiac
384
Acute Myocardial Infarction
292
Atrial Fibrillation
271
Dialysis
265
Thrombosis
249
Cardiac Operation
194
Peritoneal Dialysis
188
Central Venous Catheterisation
183
Percutaneous Coronary Intervention
131
Acute Coronary Syndrome
123
Aortic Valve Replacement
121
Coagulopathy
116
Ill-defined Disorder
112
Surgery
107
Stent Placement
105
Angioplasty
101
Cerebrovascular Accident
89
Vascular Graft
88
Cardiopulmonary Bypass
81
Angina Unstable
72
Chest Pain
68
Angiogram
65
Indwelling Catheter Management
64
Cystitis Interstitial
52
Mitral Valve Replacement
51
Antiphospholipid Syndrome
51
Coronary Angioplasty
49
Thrombectomy
48
Mitral Valve Repair
46
Intra-aortic Balloon Placement
44
Coronary Arterial Stent Insertion
37
Heart Valve Replacement
37
Drug Exposure During Pregnancy
36
Renal Failure Chronic
35
Therapeutic Procedure
34
Coronary Artery Disease
34
Thrombolysis
33
Arteriogram Coronary
32
Cerebral Infarction
31
Disseminated Intravascular Coagulat...
30

Drug Labels

LabelLabelerEffective
Heparin Sodium And Sodium ChlorideBaxter Healthcare Corporation01-JUL-10
Heparin SodiumGeneral Injectables & Vaccines, Inc15-JUL-10
Heparin SodiumGeneral Injectables & Vaccines, Inc12-AUG-10
Heparin SodiumGeneral Injectables & Vaccines, Inc13-AUG-10
Heparin Sodium In DextroseBaxter Healthcare Corporation23-AUG-10
Heparin SodiumPfizer Laboratories Div Pfizer Inc26-JUL-11
Heparin SodiumGeneral Injectables & Vaccines, Inc13-SEP-11
Heparin SodiumAPP Pharmaceuticals, LLC29-SEP-11
Heparin Sodium And DextroseHospira, Inc.05-JAN-12
Heparin SodiumHospira, Inc.05-JAN-12
Heparin SodiumHospira, Inc.05-JAN-12
Heparin SodiumWest-ward Pharmaceutical Corp.10-JAN-12
Heparin SodiumAPP Pharmaceuticals, LLC02-MAR-12
Heparin SodiumHospira, Inc.11-APR-12
Heparin SodiumCardinal Health27-APR-12
Heparin SodiumCardinal Health15-MAY-12
Heparin SodiumGeneral Injectables & Vaccines, Inc22-MAY-12
Heparin SodiumHospira, Inc.01-JUN-12
Heparin SodiumCardinal Health22-JUN-12
Heparin Sodium In Sodium ChlorideB. Braun Medical Inc.02-JUL-12
Heparin SodiumHospira, Inc.11-SEP-12
Heparin SodiumHospira, Inc.11-SEP-12
Heparin SodiumHospira, Inc.12-SEP-12
Heparin SodiumCantrell Drug Company26-OCT-12
Heparin SodiumCantrell Drug Company30-OCT-12
Heparin SodiumCantrell Drug Company30-OCT-12
Heparin SodiumGeneral Injectables & Vaccines, Inc12-NOV-12
Heparin SodiumCantrell Drug Company13-NOV-12
Heparin SodiumCantrell Drug Company13-NOV-12
Heparin SodiumCantrell Drug Company13-NOV-12
Heparin SodiumCantrell Drug Company13-NOV-12
Heparin SodiumCantrell Drug Company18-NOV-12
Heparin SodiumCantrell Drug Company18-NOV-12
Heparin SodiumCantrell Drug Company18-NOV-12
Heparin Sodium In DextroseB. Braun Medical Inc.30-NOV-12
Heparin SodiumCantrell Drug Company03-DEC-12
Heparin SodiumCantrell Drug Company19-DEC-12
Heparin SodiumCantrell Drug Company21-DEC-12
Heparin SodiumSagent Pharmaceticals23-JAN-13
Heparin SodiumSagent Pharmaceuticals23-JAN-13
Heparin SodiumSagent Pharmaceticals23-JAN-13
Heparin SodiumCantrell Drug Company21-MAR-13
Heparin Sodium And DextroseHospira, Inc.02-APR-13
Heparin SodiumHospira, Inc.03-APR-13
Heparin SodiumHospira, Inc.03-APR-13
Heparin SodiumHospira, Inc.03-APR-13
Heparin SodiumCardinal Health12-APR-13
Heparin SodiumCardinal Health25-APR-13
Heparin SodiumCantrell Drug Company01-MAY-13
Heparin SodiumCardinal Health02-MAY-13

Heparin Sodium Case Reports

What Heparin Sodium 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 Heparin Sodium. 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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