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INSPRA

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Inspra Adverse Events Reported to the FDA Over Time

How are Inspra adverse event reports trending over time?

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

Most Common Inspra Adverse Events Reported to the FDA

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

Renal Failure Acute
34 (2.39%)
Dyspnoea
26 (1.83%)
Dizziness
25 (1.76%)
Renal Failure
23 (1.62%)
Blood Creatinine Increased
20 (1.41%)
Headache
18 (1.26%)
Hyperkalaemia
18 (1.26%)
Nausea
17 (1.19%)
Hypertension
16 (1.12%)
Myalgia
16 (1.12%)
Asthenia
15 (1.05%)
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Blood Pressure Increased
14 (.98%)
Fatigue
14 (.98%)
Insomnia
14 (.98%)
Thrombocytopenia
14 (.98%)
Blood Potassium Increased
13 (.91%)
Dehydration
13 (.91%)
Cholestasis
12 (.84%)
Diarrhoea
12 (.84%)
Hypotension
12 (.84%)
Depression
11 (.77%)
General Physical Health Deteriorati...
11 (.77%)
Oedema Peripheral
11 (.77%)
Blood Glucose Increased
10 (.7%)
Cerebrovascular Accident
10 (.7%)
Drug Interaction
10 (.7%)
Epistaxis
10 (.7%)
Fall
10 (.7%)
Abdominal Pain Upper
9 (.63%)
Diabetes Mellitus
9 (.63%)
Drug Ineffective
9 (.63%)
Gout
9 (.63%)
Hyponatraemia
9 (.63%)
Jaundice
9 (.63%)
Muscle Spasms
9 (.63%)
Cardiac Failure Chronic
8 (.56%)
Condition Aggravated
8 (.56%)
Drug Intolerance
8 (.56%)
Dysphagia
8 (.56%)
Malaise
8 (.56%)
Pruritus
8 (.56%)
Weight Increased
8 (.56%)
Abdominal Distension
7 (.49%)
Anaemia
7 (.49%)
Atrial Fibrillation
7 (.49%)
Blood Sodium Decreased
7 (.49%)
Cognitive Disorder
7 (.49%)
Cough
7 (.49%)
Death
7 (.49%)
Decreased Appetite
7 (.49%)
Nervousness
7 (.49%)
Pain
7 (.49%)
Platelet Count Decreased
7 (.49%)
Prostatic Specific Antigen Increase...
7 (.49%)
Acute Hepatic Failure
6 (.42%)
Blood Alkaline Phosphatase Increase...
6 (.42%)
Blood Pressure Decreased
6 (.42%)
Cardiac Pacemaker Insertion
6 (.42%)
Eosinophilia
6 (.42%)
Hypoaesthesia
6 (.42%)
Lactic Acidosis
6 (.42%)
No Adverse Event
6 (.42%)
Pain In Extremity
6 (.42%)
Paraesthesia
6 (.42%)
Quality Of Life Decreased
6 (.42%)
Renal Tubular Necrosis
6 (.42%)
Urethral Haemorrhage
6 (.42%)
Weight Decreased
6 (.42%)
Abdominal Discomfort
5 (.35%)
Abdominal Pain
5 (.35%)
Alanine Aminotransferase Increased
5 (.35%)
Cardiac Failure
5 (.35%)
Chest Pain
5 (.35%)
Coagulopathy
5 (.35%)
Confusional State
5 (.35%)
Constipation
5 (.35%)
Dialysis
5 (.35%)
Drug Rash With Eosinophilia And Sys...
5 (.35%)
Dyspnoea Exertional
5 (.35%)
Erectile Dysfunction
5 (.35%)
Erysipelas
5 (.35%)
Gamma-glutamyltransferase Increased
5 (.35%)
Glomerular Filtration Rate Decrease...
5 (.35%)
Gynaecomastia
5 (.35%)
Haemorrhage Urinary Tract
5 (.35%)
Hallucination
5 (.35%)
Hypertensive Crisis
5 (.35%)
International Normalised Ratio Incr...
5 (.35%)
Leukopenia
5 (.35%)
Lividity
5 (.35%)
Palpitations
5 (.35%)
Pneumonia
5 (.35%)
Pyrexia
5 (.35%)
Sepsis
5 (.35%)
Swelling Face
5 (.35%)
Testicular Seminoma (pure)
5 (.35%)
Unevaluable Event
5 (.35%)
Arrhythmia
4 (.28%)
Arterial Thrombosis Limb
4 (.28%)
Blood Creatine Phosphokinase Increa...
4 (.28%)
Blood Potassium Decreased
4 (.28%)

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

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

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

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

Cardiac Failure
109
Hypertension
57
Drug Use For Unknown Indication
31
Cardiac Failure Congestive
25
Ill-defined Disorder
22
Product Used For Unknown Indication
20
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Myocardial Infarction
16
Hyperaldosteronism
15
Cardiac Disorder
12
Coronary Artery Disease
10
Hypokalaemia
8
Cardiomyopathy
8
Primary Hyperaldosteronism
6
Blood Pressure
6
Oedema
5
Adrenal Neoplasm
4
Breast Cancer
4
Congestive Cardiomyopathy
4
Cardiac Failure Chronic
4
Myocardial Ischaemia
4
Prophylaxis
4
Gynaecomastia
3
Breast Pain
3
Cardiovascular Insufficiency
3
Atrial Fibrillation
3
Ventricular Hypertrophy
2
Essential Hypertension
2
Cor Pulmonale
2
Blood Aldosterone
2
Bartters Syndrome
2
Left Ventricular Dysfunction
2
Cardiovascular Disorder
2
Ischaemic Cardiomyopathy
2
Blood Pressure Abnormal
2
Ascites
2
Pleural Effusion
2
Diastolic Dysfunction
2
Diuretic Therapy
2
Cardiac Failure Acute
2
Blood Aldosterone Increased
2
Blood Aldosterone Abnormal
1
Oedema Due To Cardiac Disease
1
Gitelmans Syndrome
1
Ventricular Arrhythmia
1
Dyspnoea
1
Ventricular Dysfunction
1
Hyperadrenalism
1
Pulmonary Arterial Hypertension
1
Implantable Defibrillator Insertion
1
Blood Potassium Decreased
1
Adrenal Gland Injury
1

Drug Labels

LabelLabelerEffective
InspraRebel Distributors Corp28-DEC-10
InspraG.D. Searle LLC Division of Pfizer Inc24-JUL-12

Inspra Case Reports

What Inspra 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 Inspra. 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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