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Basen Adverse Events Reported to the FDA Over Time

How are Basen adverse event reports trending over time?

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

Most Common Basen Adverse Events Reported to the FDA

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

Hypoglycaemia
60 (4.5%)
Depressed Level Of Consciousness
32 (2.4%)
Pyrexia
30 (2.25%)
Liver Disorder
27 (2.03%)
Hepatic Function Abnormal
26 (1.95%)
Blood Glucose Increased
25 (1.88%)
Malaise
21 (1.58%)
Alanine Aminotransferase Increased
16 (1.2%)
Blood Lactate Dehydrogenase Increas...
16 (1.2%)
Hypoglycaemic Coma
16 (1.2%)
Aspartate Aminotransferase Increase...
15 (1.13%)
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Platelet Count Decreased
15 (1.13%)
Interstitial Lung Disease
13 (.98%)
Blood Alkaline Phosphatase Increase...
12 (.9%)
Dehydration
12 (.9%)
Gamma-glutamyltransferase Increased
12 (.9%)
Hyperkalaemia
12 (.9%)
Rash
12 (.9%)
Blood Pressure Decreased
11 (.83%)
Fall
11 (.83%)
Loss Of Consciousness
11 (.83%)
Blood Creatinine Increased
10 (.75%)
Coma
10 (.75%)
Decreased Appetite
10 (.75%)
Nasopharyngitis
10 (.75%)
Anaemia
9 (.68%)
Diarrhoea
9 (.68%)
Hepatitis Fulminant
9 (.68%)
Blood Urea Increased
8 (.6%)
Pneumonia
8 (.6%)
Pruritus
8 (.6%)
Renal Failure
8 (.6%)
C-reactive Protein Increased
7 (.53%)
Cerebral Infarction
7 (.53%)
Gastric Ulcer
7 (.53%)
Glycosylated Haemoglobin Increased
7 (.53%)
Haemoglobin Decreased
7 (.53%)
Hyperglycaemia
7 (.53%)
Hypoglycaemic Encephalopathy
7 (.53%)
Weight Decreased
7 (.53%)
Altered State Of Consciousness
6 (.45%)
Autoimmune Disorder
6 (.45%)
Biliary Cirrhosis Primary
6 (.45%)
Bladder Cancer
6 (.45%)
Blood Albumin Decreased
6 (.45%)
Dizziness
6 (.45%)
Dyspnoea
6 (.45%)
Pneumatosis Intestinalis
6 (.45%)
Toxic Skin Eruption
6 (.45%)
White Blood Cell Count Decreased
6 (.45%)
Abdominal Pain
5 (.38%)
Atrioventricular Block Complete
5 (.38%)
Bradycardia
5 (.38%)
Condition Aggravated
5 (.38%)
Contusion
5 (.38%)
Disease Progression
5 (.38%)
Disseminated Intravascular Coagulat...
5 (.38%)
Erythema
5 (.38%)
Gastric Cancer
5 (.38%)
General Physical Health Deteriorati...
5 (.38%)
Haemodialysis
5 (.38%)
Hemiplegia
5 (.38%)
Hypothyroidism
5 (.38%)
Metastases To Liver
5 (.38%)
Nausea
5 (.38%)
Pain
5 (.38%)
Peripheral Ischaemia
5 (.38%)
Pleural Effusion
5 (.38%)
Pneumonia Cytomegaloviral
5 (.38%)
Renal Impairment
5 (.38%)
Rhabdomyolysis
5 (.38%)
Shock
5 (.38%)
Thrombocytopenia
5 (.38%)
Toxic Epidermal Necrolysis
5 (.38%)
Vomiting
5 (.38%)
White Blood Cell Count Increased
5 (.38%)
Aphthous Stomatitis
4 (.3%)
Aspartate Aminotransferase Decrease...
4 (.3%)
Bile Duct Cancer
4 (.3%)
Blood Creatine Phosphokinase Increa...
4 (.3%)
Blood Glucose Fluctuation
4 (.3%)
Blood Pressure Increased
4 (.3%)
Convulsion
4 (.3%)
Drug Hypersensitivity
4 (.3%)
Eosinophil Count Increased
4 (.3%)
Eye Discharge
4 (.3%)
Fatigue
4 (.3%)
Flushing
4 (.3%)
Gingivitis
4 (.3%)
Headache
4 (.3%)
Hepatic Cancer Metastatic
4 (.3%)
Hepatic Steatosis
4 (.3%)
Hepatitis
4 (.3%)
Hyperammonaemia
4 (.3%)
Hyperhidrosis
4 (.3%)
Inflammation
4 (.3%)
Jaundice
4 (.3%)
Jaundice Cholestatic
4 (.3%)
Lymphocyte Stimulation Test Positiv...
4 (.3%)
Nephrotic Syndrome
4 (.3%)
Ocular Hyperaemia
4 (.3%)

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

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

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

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

Diabetes Mellitus
964
Diabetes Mellitus Non-insulin-depen...
67
Type 2 Diabetes Mellitus
61
Drug Use For Unknown Indication
54
Product Used For Unknown Indication
17
Hyperglycaemia
15
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Insulin-requiring Type Ii Diabetes ...
14
Glucose Tolerance Impaired
12
Hypertension
12
Diabetes Mellitus Inadequate Contro...
9
Blood Glucose Abnormal
7
Rheumatoid Arthritis
7
Ill-defined Disorder
6
Blood Glucose Increased
4
Diabetes Mellitus Insulin-dependent
3
Cerebral Infarction
3
Prophylaxis
3
Blood Glucose
2
Myocardial Infarction
2
Latent Autoimmune Diabetes In Adult...
2
Suicide Attempt
1
Diabetes Prophylaxis
1
Post Gastric Surgery Syndrome
1

Basen Case Reports

What Basen 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 Basen. 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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