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Novoseven Adverse Events Reported to the FDA Over Time

How are Novoseven adverse event reports trending over time?

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

Most Common Novoseven Adverse Events Reported to the FDA

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

Death
229 (3.84%)
Multi-organ Failure
190 (3.19%)
Drug Ineffective
185 (3.1%)
Haemorrhage
121 (2.03%)
Concomitant Disease Progression
120 (2.01%)
Thrombosis
102 (1.71%)
Cardiac Arrest
98 (1.64%)
Cerebral Infarction
93 (1.56%)
Disseminated Intravascular Coagulat...
91 (1.53%)
Myocardial Infarction
88 (1.48%)
Pulmonary Embolism
88 (1.48%)
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Sepsis
86 (1.44%)
Deep Vein Thrombosis
83 (1.39%)
Shock Haemorrhagic
69 (1.16%)
Cerebrovascular Accident
68 (1.14%)
Pneumonia
59 (.99%)
Acute Respiratory Distress Syndrome
53 (.89%)
Therapeutic Response Decreased
53 (.89%)
Renal Failure Acute
48 (.81%)
Acute Myocardial Infarction
47 (.79%)
Renal Failure
43 (.72%)
Condition Aggravated
41 (.69%)
Septic Shock
41 (.69%)
Portal Vein Thrombosis
40 (.67%)
Respiratory Failure
40 (.67%)
Intestinal Ischaemia
38 (.64%)
Intestinal Infarction
34 (.57%)
Cerebral Haemorrhage
33 (.55%)
Haemodynamic Instability
32 (.54%)
Hypotension
32 (.54%)
Hydrocephalus
31 (.52%)
Peripheral Ischaemia
31 (.52%)
Myocardial Ischaemia
30 (.5%)
Coma
29 (.49%)
Gastrointestinal Haemorrhage
29 (.49%)
Catheter Related Complication
28 (.47%)
Post Procedural Complication
28 (.47%)
Vomiting
28 (.47%)
Hepatic Failure
27 (.45%)
Pulmonary Oedema
27 (.45%)
Cardiac Failure
26 (.44%)
Gastrointestinal Necrosis
26 (.44%)
Haematuria
26 (.44%)
Venous Thrombosis
26 (.44%)
Haemorrhage Intracranial
25 (.42%)
Jugular Vein Thrombosis
25 (.42%)
Renal Impairment
25 (.42%)
Arterial Thrombosis
24 (.4%)
Anaemia
23 (.39%)
Cardiac Tamponade
23 (.39%)
Platelet Count Decreased
23 (.39%)
Pleural Effusion
23 (.39%)
Blood Pressure Increased
22 (.37%)
Bradycardia
22 (.37%)
Exsanguination
22 (.37%)
Atrial Fibrillation
21 (.35%)
Embolism
21 (.35%)
Haemoglobin Decreased
21 (.35%)
Arterial Thrombosis Limb
20 (.34%)
Coagulopathy
20 (.34%)
Haemodialysis
20 (.34%)
Pneumonia Aspiration
20 (.34%)
Pulmonary Haemorrhage
20 (.34%)
Shock
20 (.34%)
Back Pain
19 (.32%)
Brain Oedema
19 (.32%)
Cardio-respiratory Arrest
19 (.32%)
Medical Device Complication
19 (.32%)
Thrombocytopenia
19 (.32%)
Thrombosis In Device
19 (.32%)
Troponin I Increased
19 (.32%)
Abdominal Pain
18 (.3%)
Cerebral Ischaemia
18 (.3%)
Ischaemia
18 (.3%)
Troponin Increased
18 (.3%)
Vena Cava Thrombosis
18 (.3%)
Venous Thrombosis Limb
18 (.3%)
Activated Partial Thromboplastin Ti...
17 (.29%)
Cardiogenic Shock
17 (.29%)
Encephalopathy
17 (.29%)
Hepatic Neoplasm Malignant
17 (.29%)
Intracardiac Thrombus
17 (.29%)
Nausea
17 (.29%)
Post Procedural Haemorrhage
17 (.29%)
Anaphylactic Reaction
16 (.27%)
Convulsion
16 (.27%)
Hepatic Function Abnormal
16 (.27%)
International Normalised Ratio Incr...
16 (.27%)
Atrial Thrombosis
15 (.25%)
Depressed Level Of Consciousness
15 (.25%)
Dialysis
15 (.25%)
Disease Progression
15 (.25%)
Heart Rate Increased
15 (.25%)
Necrosis Ischaemic
15 (.25%)
Respiratory Distress
15 (.25%)
Thrombotic Stroke
15 (.25%)
Acidosis
14 (.23%)
Blood Pressure Decreased
14 (.23%)
Brain Death
14 (.23%)
Cyanosis
14 (.23%)
Dyspnoea
14 (.23%)

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

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

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

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

Haemorrhage
540
Traumatic Haemorrhage
185
Cerebral Haemorrhage
164
Post Procedural Haemorrhage
122
Acquired Haemophilia
113
Coagulopathy
67
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Factor Vii Deficiency
60
Haemophilia A With Anti Factor Viii
57
Factor Viii Deficiency
57
Ill-defined Disorder
52
Drug Use For Unknown Indication
51
Operative Haemorrhage
47
Upper Gastrointestinal Haemorrhage
42
Gastrointestinal Haemorrhage
39
Haemophilia
35
Shock Haemorrhagic
34
Haemorrhage Intracranial
32
Product Used For Unknown Indication
32
Prophylaxis
31
Injury
30
Postpartum Haemorrhage
28
Acquired Haemophilia With Anti Fvii...
24
Haemostasis
22
Cardiac Operation
22
Disseminated Intravascular Coagulat...
20
Surgery
19
Pulmonary Haemorrhage
18
Brain Contusion
16
Factor Viii Inhibition
11
Haemarthrosis
11
Haemorrhage Control
10
Haemophilia B With Anti Factor Ix
10
Intra-abdominal Haemorrhage
9
Traumatic Brain Injury
9
Anaphylactoid Syndrome Of Pregnancy
8
Factor Xi Deficiency
7
Pleural Haemorrhage
7
Haematemesis
7
Pulmonary Alveolar Haemorrhage
6
Liver Disorder
6
Haematuria
6
Haemorrhage Prophylaxis
6
Off Label Use
6
Hepatic Haemorrhage
6
Intraventricular Haemorrhage Neonat...
6
Aortic Aneurysm Rupture
6
Liver Transplant
5
Haematoma
5
Thrombasthenia
5
Subdural Haematoma
5
International Normalised Ratio Incr...
5

Drug Labels

LabelLabelerEffective
NovosevenrtNovo Nordisk21-DEC-12

Novoseven Case Reports

What Novoseven 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 Novoseven. 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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