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HEPARIN SODIUM INJECTION

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Heparin Sodium Injection Adverse Events Reported to the FDA Over Time

How are Heparin Sodium Injection adverse event reports trending over time?

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

Most Common Heparin Sodium Injection Adverse Events Reported to the FDA

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

Hypotension
2529 (3.23%)
Adverse Event
2437 (3.12%)
Nausea
1956 (2.5%)
Dyspnoea
1701 (2.17%)
Vomiting
1641 (2.1%)
Death
1209 (1.55%)
Abdominal Pain
1157 (1.48%)
Respiratory Failure
1126 (1.44%)
Asthenia
1112 (1.42%)
Heparin-induced Thrombocytopenia
1054 (1.35%)
Diarrhoea
973 (1.24%)
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Sepsis
933 (1.19%)
Chest Pain
914 (1.17%)
Dizziness
857 (1.1%)
Anaemia
818 (1.05%)
Cardiac Arrest
800 (1.02%)
Headache
793 (1.01%)
Unresponsive To Stimuli
775 (.99%)
Hyperhidrosis
767 (.98%)
Pyrexia
755 (.97%)
Blood Pressure Decreased
707 (.9%)
Renal Failure
696 (.89%)
Atrial Fibrillation
667 (.85%)
Renal Failure Acute
650 (.83%)
Thrombocytopenia
628 (.8%)
Cardiac Failure Congestive
622 (.8%)
Hypersensitivity
602 (.77%)
Renal Failure Chronic
547 (.7%)
Pneumonia
519 (.66%)
Multi-organ Failure
487 (.62%)
Haemorrhage
463 (.59%)
Cardio-respiratory Arrest
447 (.57%)
Malaise
436 (.56%)
Deep Vein Thrombosis
435 (.56%)
Oedema Peripheral
428 (.55%)
Syncope
420 (.54%)
Pleural Effusion
409 (.52%)
Rash
408 (.52%)
Decreased Appetite
407 (.52%)
Cerebrovascular Accident
403 (.52%)
Tachycardia
401 (.51%)
Fatigue
397 (.51%)
Hypertension
392 (.5%)
Cardiogenic Shock
391 (.5%)
Coronary Artery Disease
384 (.49%)
Thrombosis
379 (.48%)
Pulmonary Embolism
378 (.48%)
Erythema
375 (.48%)
Coagulopathy
370 (.47%)
Myocardial Infarction
370 (.47%)
Septic Shock
351 (.45%)
Pharyngeal Oedema
350 (.45%)
Chills
322 (.41%)
Mental Status Changes
309 (.39%)
Pain
309 (.39%)
Lethargy
307 (.39%)
Respiratory Distress
299 (.38%)
Confusional State
298 (.38%)
Gastrointestinal Haemorrhage
297 (.38%)
Shock
287 (.37%)
Dysphagia
283 (.36%)
Hypoaesthesia
279 (.36%)
Platelet Count Decreased
279 (.36%)
Loss Of Consciousness
278 (.36%)
Organ Failure
275 (.35%)
Abdominal Pain Upper
270 (.35%)
Convulsion
259 (.33%)
Pulmonary Oedema
258 (.33%)
Hypoxia
257 (.33%)
Arrhythmia
250 (.32%)
Heart Rate Increased
250 (.32%)
Acute Myocardial Infarction
242 (.31%)
Pruritus
241 (.31%)
Leukocytosis
238 (.3%)
Paraesthesia
238 (.3%)
Dehydration
236 (.3%)
Metabolic Acidosis
234 (.3%)
Burning Sensation
229 (.29%)
Cardiac Failure
228 (.29%)
Diabetes Mellitus
224 (.29%)
Ventricular Tachycardia
218 (.28%)
Cardiac Disorder
215 (.27%)
Back Pain
213 (.27%)
Bradycardia
212 (.27%)
Oedema
212 (.27%)
Swelling
210 (.27%)
Vision Blurred
210 (.27%)
Drug Hypersensitivity
207 (.26%)
Anxiety
205 (.26%)
Urinary Tract Infection
205 (.26%)
Fluid Overload
203 (.26%)
Abdominal Distension
197 (.25%)
Hepatic Failure
191 (.24%)
Staphylococcal Infection
191 (.24%)
Flushing
188 (.24%)
General Physical Health Deteriorati...
185 (.24%)
Pain In Extremity
185 (.24%)
Malnutrition
184 (.24%)
Muscle Spasms
183 (.23%)
Chest Discomfort
177 (.23%)
Acute Respiratory Failure
176 (.22%)

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

What are the most common Heparin Sodium Injection 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 Injection, 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 Injection 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 Injection According to Those Reporting Adverse Events

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

Drug Use For Unknown Indication
2775
Thrombosis Prophylaxis
776
Haemodialysis
496
Prophylaxis
426
Coronary Artery Bypass
306
Product Used For Unknown Indication
289
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Anticoagulant Therapy
242
Catheterisation Cardiac
240
Intravenous Catheter Management
231
Pulmonary Embolism
137
Peritoneal Dialysis
136
Dialysis
121
Deep Vein Thrombosis
116
Central Venous Catheterisation
89
Cardiac Operation
88
Myocardial Infarction
77
Aortic Valve Replacement
65
Thrombosis
57
Vascular Graft
47
Stent Placement
46
Atrial Fibrillation
43
Angioplasty
42
Surgery
37
Angiogram
35
Mitral Valve Repair
33
Cardiopulmonary Bypass
33
Thrombectomy
32
Intra-aortic Balloon Placement
30
Mitral Valve Replacement
28
Coagulopathy
27
Cerebrovascular Accident
26
Chest Pain
25
Acute Myocardial Infarction
25
Catheter Placement
23
Arteriovenous Fistula Operation
19
Indwelling Catheter Management
18
Arterial Bypass Operation
17
Heart Transplant
17
Heart Valve Replacement
15
Factor V Leiden Mutation
15
Arteriogram Coronary
15
Vascular Operation
13
Aortic Aneurysm Repair
13
Coronary Angioplasty
13
Coronary Arterial Stent Insertion
13
Aortic Bypass
12
Cardiac Pacemaker Insertion
11
Vena Cava Filter Insertion
10
Drug Exposure During Pregnancy
10
Thromboembolectomy
10
Tricuspid Valve Repair
10

Drug Labels

LabelLabelerEffective
Heparin SodiumPfizer Laboratories Div Pfizer Inc26-JUL-11
Heparin SodiumGeneral Injectables & Vaccines, Inc13-SEP-11
Heparin SodiumAPP Pharmaceuticals, LLC29-SEP-11
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 SodiumCardinal Health22-JUN-12
Heparin SodiumGeneral Injectables & Vaccines, Inc12-NOV-12
Heparin SodiumSagent Pharmaceticals23-JAN-13
Heparin SodiumSagent Pharmaceuticals23-JAN-13
Heparin SodiumSagent Pharmaceticals23-JAN-13
Heparin SodiumCardinal Health12-APR-13
Heparin SodiumCardinal Health02-MAY-13

Heparin Sodium Injection Case Reports

What Heparin Sodium Injection 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 Injection. 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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