SELBEX

Adverse Events

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Selbex Adverse Events Reported to the FDA Over Time

How are Selbex adverse event reports trending over time?

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

Most Common Selbex Adverse Events Reported to the FDA

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

Hepatic Function Abnormal	22 (2.21%)
Pyrexia	21 (2.11%)
Aspartate Aminotransferase Increase...	19 (1.91%)
Liver Disorder	19 (1.91%)
Alanine Aminotransferase Increased	17 (1.71%)
Oedema	15 (1.5%)
Platelet Count Decreased	13 (1.3%)
Drug Eruption	12 (1.2%)
Malaise	12 (1.2%)
Stevens-johnson Syndrome	10 (1%)
Stomatitis	10 (1%)
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Eyelid Oedema	9 (.9%)
Gamma-glutamyltransferase Increased	9 (.9%)
Interstitial Lung Disease	9 (.9%)
Pruritus	9 (.9%)
Rash	9 (.9%)
Sepsis	9 (.9%)
Vomiting	9 (.9%)
Blood Alkaline Phosphatase Increase...	8 (.8%)
Blood Lactate Dehydrogenase Increas...	8 (.8%)
Cheilitis	8 (.8%)
Decreased Appetite	8 (.8%)
Depressed Level Of Consciousness	8 (.8%)
Flushing	8 (.8%)
General Physical Health Deteriorati...	8 (.8%)
Generalised Erythema	8 (.8%)
Pain	8 (.8%)
Pancytopenia	8 (.8%)
Pneumonia	8 (.8%)
Toxic Epidermal Necrolysis	8 (.8%)
Abdominal Pain Upper	7 (.7%)
Anaphylactic Shock	7 (.7%)
Biliary Tract Infection	7 (.7%)
Blood Creatine Phosphokinase Increa...	7 (.7%)
Blood Pressure Decreased	7 (.7%)
Dehydration	7 (.7%)
Dyspnoea	7 (.7%)
Hyperkalaemia	7 (.7%)
Malnutrition	7 (.7%)
Mucosal Inflammation	7 (.7%)
Pulse Absent	7 (.7%)
Renal Impairment	7 (.7%)
Respiratory Arrest	7 (.7%)
White Blood Cell Count Decreased	7 (.7%)
Haemorrhage	6 (.6%)
Renal Failure	6 (.6%)
Skin Exfoliation	6 (.6%)
Blister	5 (.5%)
Cardio-respiratory Arrest	5 (.5%)
Chills	5 (.5%)
Coma Hepatic	5 (.5%)
Diarrhoea	5 (.5%)
Dizziness	5 (.5%)
Face Oedema	5 (.5%)
Hepatitis	5 (.5%)
Hepatitis Fulminant	5 (.5%)
Insomnia	5 (.5%)
Lymphocyte Stimulation Test Positiv...	5 (.5%)
Malignant Neoplasm Progression	5 (.5%)
Pharyngeal Oedema	5 (.5%)
Renal Failure Acute	5 (.5%)
Urticaria	5 (.5%)
Confusional State	4 (.4%)
Conjunctival Hyperaemia	4 (.4%)
Dermatitis	4 (.4%)
Disseminated Intravascular Coagulat...	4 (.4%)
Drug Interaction	4 (.4%)
Erythema	4 (.4%)
Feeling Abnormal	4 (.4%)
Feeling Hot	4 (.4%)
Lip Swelling	4 (.4%)
Lymphocyte Count Decreased	4 (.4%)
Nasopharyngitis	4 (.4%)
Neutropenia	4 (.4%)
Oculomucocutaneous Syndrome	4 (.4%)
Osteomyelitis	4 (.4%)
Pemphigoid	4 (.4%)
Sudden Hearing Loss	4 (.4%)
White Blood Cell Count Increased	4 (.4%)
Abdominal Discomfort	3 (.3%)
Abnormal Behaviour	3 (.3%)
Acute Promyelocytic Leukaemia	3 (.3%)
Acute Respiratory Distress Syndrome	3 (.3%)
Agranulocytosis	3 (.3%)
Anorexia	3 (.3%)
Asthma	3 (.3%)
Bacterial Infection	3 (.3%)
Biopsy Skin	3 (.3%)
Blast Cells Present	3 (.3%)
Blood Amylase Increased	3 (.3%)
Blood Bilirubin Increased	3 (.3%)
C-reactive Protein Increased	3 (.3%)
Cholestasis	3 (.3%)
Delirium	3 (.3%)
Ear Pain	3 (.3%)
Ejection Fraction Decreased	3 (.3%)
Endotracheal Intubation	3 (.3%)
Enterocolitis	3 (.3%)
Eye Disorder	3 (.3%)
Fatigue	3 (.3%)
Fear	3 (.3%)

Share/Embed Graph Export Data

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

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

Epidermal And Dermal Conditions	100 (10.03%)
Hepatic And Hepatobiliary	64 (6.42%)
Hepatobiliary	56 (5.62%)
Hematology Investigations	45 (4.51%)
Infections - Pathogen Unspecified	41 (4.11%)
Oral Soft Tissue Conditions	30 (3.01%)
Body Temperature Conditions	24 (2.41%)
Gastrointestinal Signs	24 (2.41%)
Respiratory	24 (2.41%)
Enzyme	23 (2.31%)
Renal Disorders	22 (2.21%)
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Neurological	21 (2.11%)
Cardiac And Vascular Investigations	20 (2.01%)
Appetite And General Nutritional	19 (1.91%)
Electrolyte And Fluid Balance Condi...	18 (1.81%)
Ocular Infections, Irritations And ...	17 (1.71%)
Lower Respiratory Tract Disorders	16 (1.6%)
Cardiac Arrhythmias	13 (1.3%)
Metabolic, Nutritional And Blood Ga...	13 (1.3%)
Upper Respiratory Tract Disorders	11 (1.1%)
Anemias Nonhemolytic And Marrow Dep...	10 (1%)
White Blood Cell	10 (1%)
Allergic Conditions	9 (.9%)
Gastrointestinal Hemorrhages	9 (.9%)
Gastrointestinal Inflammatory Condi...	9 (.9%)
Coagulopathies And Bleeding Diathes...	8 (.8%)
Vascular	8 (.8%)
Viral Infectious	8 (.8%)
Deliria	7 (.7%)
Injuries	7 (.7%)
Miscellaneous And Site Unspecified ...	7 (.7%)
Therapeutic And Nontherapeutic Effe...	7 (.7%)
Bacterial Infectious	6 (.6%)
Bone And Joint Injuries	6 (.6%)
Bronchial Disorders	6 (.6%)
Coronary Artery	6 (.6%)
Eye	6 (.6%)
Gastrointestinal Motility And Defec...	6 (.6%)
Sleep Disorders	6 (.6%)
Vascular Hemorrhagic	6 (.6%)
Vision	6 (.6%)
Angiedema And Urticaria	5 (.5%)
Fatal Outcomes	5 (.5%)
Urinary Tract Signs	5 (.5%)
Hearing	4 (.4%)
Leukemias	4 (.4%)
Ocular Structural Change, Deposit A...	4 (.4%)
Seizures	4 (.4%)
Anxiety Disorders	3 (.3%)
Aural	3 (.3%)
Cardiac Disorder Signs	3 (.3%)
Decreased And Nonspecific Blood Pre...	3 (.3%)
Disturbances In Thinking	3 (.3%)
Gastrointestinal	3 (.3%)
Gastrointestinal Ulceration And Per...	3 (.3%)
Gastrointestinal Vascular Condition...	3 (.3%)
Immune	3 (.3%)
Immunology And Allergy	3 (.3%)
Lifestyle Issues	3 (.3%)
Mycobacterial Infectious	3 (.3%)
Protein And Chemistry Analyses	3 (.3%)
Psychiatric And Behavioural Symptom...	3 (.3%)
Respiratory Tract Therapeutic Proce...	3 (.3%)
Schizophrenia And Other Psychotic	3 (.3%)
Skin	3 (.3%)
Skin And Subcutaneous Tissue	3 (.3%)
Vascular Inflammations	3 (.3%)
Water, Electrolyte And Mineral	3 (.3%)
Administration Site Reactions	2 (.2%)
Adrenal Gland	2 (.2%)
Chemical Injury And Poisoning	2 (.2%)
Gastrointestinal Neoplasms Benign	2 (.2%)
Gastrointestinal Stenosis And Obstr...	2 (.2%)
Headaches	2 (.2%)
Hematological	2 (.2%)
Hypothalamus And Pituitary Gland	2 (.2%)
Lymphomas Non-hodgkins B-cell	2 (.2%)
Medication Errors	2 (.2%)
Microbiology And Serology	2 (.2%)
Muscle	2 (.2%)
Musculoskeletal And Soft Tissue Inv...	2 (.2%)
Mycoplasmal Infectious	2 (.2%)
Nephropathies	2 (.2%)
Neuromuscular	2 (.2%)
Therapeutic Procedures And Supporti...	2 (.2%)
Thyroid Gland	2 (.2%)
Toxicology And Therapeutic Drug Mon...	2 (.2%)
Abortions And Stillbirth	1 (.1%)
Arteriosclerosis, Stenosis, Vascula...	1 (.1%)
Blood And Lymphatic System Disorder...	1 (.1%)
Cardiac Valve	1 (.1%)
Cornification And Dystrophic Skin	1 (.1%)
Embolism And Thrombosis	1 (.1%)
Endocrine Investigations	1 (.1%)
Exocrine Pancreas Conditions	1 (.1%)
Fungal Infectious	1 (.1%)
Gallbladder	1 (.1%)
Glucose Metabolism Disorders	1 (.1%)
Heart Failures	1 (.1%)
Hematological And Lymphoid Tissue T...	1 (.1%)
Increased Intracranial Pressure And...	1 (.1%)

Share/Embed Graph Export Data

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

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

Gastritis	731
Prophylaxis	355
Gastritis Prophylaxis	192
Gastric Ulcer	151
Drug Use For Unknown Indication	143
Prophylaxis Against Gastrointestina...	124
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Product Used For Unknown Indication	85
Gastrointestinal Disorder Therapy	36
Rheumatoid Arthritis	34
Gastrointestinal Disorder	26
Abdominal Pain Upper	21
Gastric Disorder	20
Nasopharyngitis	16
Reflux Oesophagitis	16
Herpes Zoster	15
Gastroenteritis	14
Duodenal Ulcer	13
Stomach Discomfort	12
Pain	11
Gastrooesophageal Reflux Disease	9
Gastric Mucosal Lesion	9
Excoriation	8
Nausea	7
Gastritis Erosive	7
Abdominal Pain	7
Abdominal Discomfort	7
Dyspepsia	6
Bronchitis	6
Metastatic Renal Cell Carcinoma	5
Back Pain	5
Osteoarthritis	5
Procedural Pain	5
Pneumonia	5
Influenza	4
Hypertension	4
Multiple Myeloma	4
Angina Unstable	4
Ill-defined Disorder	4
Antacid Therapy	4
Anorexia	3
Impetigo	3
Gastric Ulcer Haemorrhage	3
Hepatitis B	3
Hypopituitarism	3
Analgesic Therapy	3
Chronic Myeloid Leukaemia	3
Musculoskeletal Pain	3
Myocardial Infarction	3
Laryngeal Injury	3
Sinusitis	3
Drug Toxicity Prophylaxis	3

Selbex Case Reports

What Selbex safety concerns are being reported by doctors and researchers in the medical literature?

About Results

This report contains aggregated drug side effects and adverse events for Selbex. 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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