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SAMSCA

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Samsca Adverse Events Reported to the FDA Over Time

How are Samsca adverse event reports trending over time?

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

Most Common Samsca Adverse Events Reported to the FDA

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

Hypernatraemia
104 (4.22%)
Condition Aggravated
81 (3.28%)
Hyponatraemia
64 (2.59%)
Cardiac Failure
63 (2.55%)
Blood Urea Increased
62 (2.51%)
Thirst
56 (2.27%)
Dehydration
48 (1.95%)
Wrong Technique In Drug Usage Proce...
48 (1.95%)
Blood Sodium Increased
41 (1.66%)
Drug Ineffective
35 (1.42%)
Altered State Of Consciousness
30 (1.22%)
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Renal Impairment
29 (1.18%)
Vomiting
26 (1.05%)
Pleural Effusion
25 (1.01%)
Blood Sodium Decreased
24 (.97%)
Confusional State
24 (.97%)
Polyuria
23 (.93%)
Alanine Aminotransferase Increased
21 (.85%)
Aspartate Aminotransferase Increase...
21 (.85%)
Pneumonia
21 (.85%)
Pyrexia
21 (.85%)
Blood Creatinine Increased
20 (.81%)
Blood Pressure Decreased
20 (.81%)
General Physical Health Deteriorati...
19 (.77%)
Bronchial Carcinoma
18 (.73%)
Cardiac Failure Congestive
18 (.73%)
Death
18 (.73%)
Somnolence
17 (.69%)
Off Label Use
16 (.65%)
Ventricular Tachycardia
16 (.65%)
Blood Glucose Increased
15 (.61%)
Convulsion
15 (.61%)
Depressed Level Of Consciousness
15 (.61%)
Hepatic Function Abnormal
15 (.61%)
Hyperkalaemia
15 (.61%)
Interstitial Lung Disease
15 (.61%)
Nausea
15 (.61%)
Renal Failure Acute
15 (.61%)
Respiratory Failure
15 (.61%)
Neoplasm Progression
14 (.57%)
Urine Output Increased
14 (.57%)
Decreased Appetite
13 (.53%)
Haemoglobin Decreased
13 (.53%)
Dyspnoea
12 (.49%)
Weight Decreased
12 (.49%)
Disorientation
11 (.45%)
Hypotension
11 (.45%)
Respiratory Arrest
11 (.45%)
Cardiac Failure Acute
10 (.41%)
Liver Disorder
10 (.41%)
Malignant Neoplasm Progression
10 (.41%)
Pneumonia Aspiration
10 (.41%)
Urinary Tract Infection
10 (.41%)
Blood Bilirubin Increased
9 (.36%)
Fluid Retention
9 (.36%)
Haemodialysis
9 (.36%)
Hepatic Congestion
9 (.36%)
Lethargy
9 (.36%)
Pancytopenia
9 (.36%)
Renal Failure
9 (.36%)
Abdominal Pain
8 (.32%)
Cerebral Infarction
8 (.32%)
Chronic Obstructive Pulmonary Disea...
8 (.32%)
Cystitis
8 (.32%)
Demyelination
8 (.32%)
Dizziness
8 (.32%)
Fall
8 (.32%)
Gastrointestinal Haemorrhage
8 (.32%)
Hepatic Cirrhosis
8 (.32%)
Hypophagia
8 (.32%)
Leukocytosis
8 (.32%)
Mallory-weiss Syndrome
8 (.32%)
Red Blood Cell Count Decreased
8 (.32%)
Anaemia
7 (.28%)
Aspiration
7 (.28%)
Dysarthria
7 (.28%)
Dysphagia
7 (.28%)
Hypokalaemia
7 (.28%)
Malaise
7 (.28%)
Medication Error
7 (.28%)
No Adverse Event
7 (.28%)
Restlessness
7 (.28%)
Ventricular Fibrillation
7 (.28%)
White Blood Cell Count Decreased
7 (.28%)
Asthenia
6 (.24%)
Atrial Fibrillation
6 (.24%)
Balanitis
6 (.24%)
Bradycardia
6 (.24%)
Delirium
6 (.24%)
Disease Progression
6 (.24%)
Encephalopathy
6 (.24%)
Inappropriate Antidiuretic Hormone ...
6 (.24%)
Incorrect Drug Administration Rate
6 (.24%)
Mental Status Changes
6 (.24%)
Mucosal Inflammation
6 (.24%)
Neoplasm Malignant
6 (.24%)
Neutropenic Sepsis
6 (.24%)
Platelet Count Decreased
6 (.24%)
Pulmonary Hypertension
6 (.24%)
Rash
6 (.24%)
Small Cell Lung Cancer Stage Unspec...
6 (.24%)

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

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

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

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

Hyponatraemia
202
Inappropriate Antidiuretic Hormone ...
125
Fluid Retention
92
Cardiac Failure
87
Cardiac Failure Congestive
38
Cardiac Failure Chronic
27
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Blood Sodium Decreased
11
Neoplasm
10
Off Label Use
9
Congenital Cystic Kidney Disease
9
Oedema Peripheral
8
Congestive Cardiomyopathy
7
Diuretic Therapy
6
Hepatic Cirrhosis
5
Pleural Effusion
5
Oedema
4
Hypervolaemia
3
Polyuria
3
Product Used For Unknown Indication
3
Pulmonary Oedema
3
Renal Disorder
2
Weight Increased
2
Small Cell Lung Cancer Stage Unspec...
2
Renal Failure
2
Paraneoplastic Syndrome
2
Yellow Nail Syndrome
2
Oedema Due To Cardiac Disease
1
Depression
1
Lung Infection
1
Hepatic Neoplasm Malignant
1
Blood Sodium
1
Left Ventricular Failure
1
Urosepsis
1
Cardiomegaly
1
Capillary Leak Syndrome
1
Right Ventricular Failure
1
Blood Potassium Decreased
1
Cardiac Sarcoidosis
1
Scrotal Oedema
1
Cardiac Disorder
1
Fluid Overload
1
Bladder Cancer
1
Hypernatraemia
1
Breast Cancer
1
Bladder Disorder
1
Cardiac Failure Acute
1
Angina Pectoris
1

Drug Labels

LabelLabelerEffective
SamscaOtsuka America Pharmaceutical Inc.28-NOV-12
SamscaOtsuka America Pharmaceutical Inc.23-APR-13

Samsca Case Reports

What Samsca 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 Samsca. 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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