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Cotareg Adverse Events Reported to the FDA Over Time

How are Cotareg adverse event reports trending over time?

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

Most Common Cotareg Adverse Events Reported to the FDA

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

Hyponatraemia
72 (3.74%)
Renal Failure Acute
39 (2.03%)
Malaise
37 (1.92%)
Fall
34 (1.77%)
Dehydration
32 (1.66%)
Blood Creatinine Increased
29 (1.51%)
Asthenia
27 (1.4%)
Vomiting
25 (1.3%)
Confusional State
23 (1.2%)
Disorientation
23 (1.2%)
Blood Urea Increased
22 (1.14%)
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Drug Interaction
22 (1.14%)
Hypokalaemia
22 (1.14%)
Hypotension
22 (1.14%)
Renal Failure
21 (1.09%)
Fatigue
19 (.99%)
General Physical Health Deteriorati...
19 (.99%)
Headache
19 (.99%)
Loss Of Consciousness
18 (.94%)
Dizziness
17 (.88%)
Haemoglobin Decreased
17 (.88%)
Cerebrovascular Accident
16 (.83%)
Diarrhoea
15 (.78%)
Pruritus
15 (.78%)
Weight Decreased
14 (.73%)
Creatinine Renal Clearance Decrease...
13 (.68%)
C-reactive Protein Increased
12 (.62%)
Drug Exposure During Pregnancy
12 (.62%)
Dyspnoea
12 (.62%)
Gamma-glutamyltransferase Increased
11 (.57%)
Nausea
11 (.57%)
Alanine Aminotransferase Increased
10 (.52%)
Aspartate Aminotransferase Increase...
10 (.52%)
Epilepsy
10 (.52%)
Pyrexia
10 (.52%)
Anaemia Haemolytic Autoimmune
9 (.47%)
Hypochloraemia
9 (.47%)
Thrombocytopenia
9 (.47%)
Agitation
8 (.42%)
Anaemia
8 (.42%)
Anorexia
8 (.42%)
Blood Alkaline Phosphatase Increase...
8 (.42%)
Erythema
8 (.42%)
Hyperkalaemia
8 (.42%)
Lung Disorder
8 (.42%)
Overdose
8 (.42%)
Pregnancy
8 (.42%)
Somnolence
8 (.42%)
Amnesia
7 (.36%)
Anaemia Macrocytic
7 (.36%)
Atrial Fibrillation
7 (.36%)
Face Oedema
7 (.36%)
Haematoma
7 (.36%)
Hepatic Enzyme Increased
7 (.36%)
Hypertriglyceridaemia
7 (.36%)
Oligohydramnios
7 (.36%)
Toxic Skin Eruption
7 (.36%)
Weight Increased
7 (.36%)
Blood Creatine Phosphokinase Increa...
6 (.31%)
Bronchitis
6 (.31%)
Hyperglycaemia
6 (.31%)
Hypoglycaemia
6 (.31%)
Hypoxia
6 (.31%)
Lipase Increased
6 (.31%)
Orthostatic Hypotension
6 (.31%)
Phlebitis
6 (.31%)
Rash Papular
6 (.31%)
Syncope
6 (.31%)
White Blood Cell Count Increased
6 (.31%)
Balance Disorder
5 (.26%)
Blood Phosphorus Abnormal
5 (.26%)
Blood Pressure Decreased
5 (.26%)
Blood Sodium Decreased
5 (.26%)
Cardiac Murmur
5 (.26%)
Cognitive Disorder
5 (.26%)
Cough
5 (.26%)
Deep Vein Thrombosis
5 (.26%)
Depressed Level Of Consciousness
5 (.26%)
Dermatitis Bullous
5 (.26%)
Dyspnoea Exertional
5 (.26%)
Eczema
5 (.26%)
Embolism
5 (.26%)
Gait Disturbance
5 (.26%)
Haematocrit Decreased
5 (.26%)
Idiopathic Thrombocytopenic Purpura
5 (.26%)
Interstitial Lung Disease
5 (.26%)
Leukocytosis
5 (.26%)
Oedema Peripheral
5 (.26%)
Pain
5 (.26%)
Proteinuria
5 (.26%)
Pulmonary Fibrosis
5 (.26%)
Rales
5 (.26%)
Red Blood Cell Count Decreased
5 (.26%)
Reticulocytosis
5 (.26%)
Septic Shock
5 (.26%)
Toxic Epidermal Necrolysis
5 (.26%)
Vertigo
5 (.26%)
Wheezing
5 (.26%)
Abnormal Behaviour
4 (.21%)
Abortion Induced
4 (.21%)
Aphasia
4 (.21%)

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

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

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

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

Hypertension
241
Essential Hypertension
41
Drug Use For Unknown Indication
35
Product Used For Unknown Indication
10
Atrial Fibrillation
3
Drug Exposure During Pregnancy
3
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Aortic Valve Disease
2
Ill-defined Disorder
2
Superinfection Lung
1
Arterial Disorder
1

Cotareg Case Reports

What Cotareg 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 Cotareg. 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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