FLUDEX

Adverse Events

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Fludex Adverse Events Reported to the FDA Over Time

How are Fludex adverse event reports trending over time?

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

Most Common Fludex Adverse Events Reported to the FDA

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

Hyponatraemia	53 (4.85%)
Hypokalaemia	48 (4.4%)
Renal Failure Acute	29 (2.66%)
Fall	28 (2.56%)
Drug Interaction	23 (2.11%)
Malaise	20 (1.83%)
Rhabdomyolysis	19 (1.74%)
Renal Failure	18 (1.65%)
Dehydration	17 (1.56%)
Orthostatic Hypotension	16 (1.47%)
Loss Of Consciousness	15 (1.37%)
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Vomiting	15 (1.37%)
Asthenia	14 (1.28%)
Diarrhoea	14 (1.28%)
Confusional State	12 (1.1%)
Alanine Aminotransferase Increased	11 (1.01%)
Cytolytic Hepatitis	10 (.92%)
Pruritus	10 (.92%)
Hyperkalaemia	9 (.82%)
Nausea	9 (.82%)
Weight Decreased	9 (.82%)
Blood Creatinine Increased	8 (.73%)
Eosinophilia	8 (.73%)
Hepatitis Cholestatic	8 (.73%)
Hypochloraemia	8 (.73%)
Pathological Fracture	8 (.73%)
Pyrexia	8 (.73%)
Toxic Skin Eruption	8 (.73%)
Abdominal Pain Upper	7 (.64%)
Bradycardia	7 (.64%)
Cholestasis	7 (.64%)
Inappropriate Antidiuretic Hormone ...	7 (.64%)
Jaundice	7 (.64%)
Blood Creatine Phosphokinase Increa...	6 (.55%)
C-reactive Protein Increased	6 (.55%)
Hypotension	6 (.55%)
Jaundice Cholestatic	6 (.55%)
Primary Hyperaldosteronism	6 (.55%)
Rash Morbilliform	6 (.55%)
Thrombocytopenia	6 (.55%)
Abdominal Pain	5 (.46%)
Anaemia	5 (.46%)
Aspartate Aminotransferase Increase...	5 (.46%)
Atrioventricular Block First Degree	5 (.46%)
Convulsion	5 (.46%)
Depression	5 (.46%)
Localised Oedema	5 (.46%)
Myalgia	5 (.46%)
Rectal Haemorrhage	5 (.46%)
Tongue Oedema	5 (.46%)
Torsade De Pointes	5 (.46%)
Agranulocytosis	4 (.37%)
Alopecia	4 (.37%)
Arrhythmia	4 (.37%)
Blood Calcium Decreased	4 (.37%)
Bone Marrow Failure	4 (.37%)
Bundle Branch Block Right	4 (.37%)
Cholelithiasis	4 (.37%)
Coagulopathy	4 (.37%)
Dysphagia	4 (.37%)
Dyspnoea	4 (.37%)
Eczema	4 (.37%)
Erythema Nodosum	4 (.37%)
Face Oedema	4 (.37%)
Gastroenteritis	4 (.37%)
Haemolytic Anaemia	4 (.37%)
Hepatomegaly	4 (.37%)
Lung Infection	4 (.37%)
Microcytic Anaemia	4 (.37%)
Purpura	4 (.37%)
Rash Erythematous	4 (.37%)
Shock	4 (.37%)
Somnolence	4 (.37%)
Syncope	4 (.37%)
Tibia Fracture	4 (.37%)
Urinary Incontinence	4 (.37%)
Urinary Retention	4 (.37%)
Ventricular Extrasystoles	4 (.37%)
Angioedema	3 (.27%)
Aplasia Pure Red Cell	3 (.27%)
Blood Potassium Decreased	3 (.27%)
Blood Sodium Decreased	3 (.27%)
Blood Urea Increased	3 (.27%)
Bundle Branch Block Left	3 (.27%)
Cardiac Failure	3 (.27%)
Constipation	3 (.27%)
Dermatitis Exfoliative	3 (.27%)
Disorientation	3 (.27%)
Dizziness	3 (.27%)
Drug Rash With Eosinophilia And Sys...	3 (.27%)
Femur Fracture	3 (.27%)
Gamma-glutamyltransferase Increased	3 (.27%)
Heart Rate Decreased	3 (.27%)
Leukocytosis	3 (.27%)
Lipase Increased	3 (.27%)
Neutropenia	3 (.27%)
Pancreatitis Necrotising	3 (.27%)
Pemphigoid	3 (.27%)
Presyncope	3 (.27%)
Proteinuria	3 (.27%)
Rash	3 (.27%)

Share/Embed Graph Export Data

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

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

Electrolyte And Fluid Balance Condi...	141 (12.91%)
Epidermal And Dermal Conditions	54 (4.95%)
Hepatic And Hepatobiliary	54 (4.95%)
Renal Disorders	53 (4.85%)
Cardiac Arrhythmias	47 (4.3%)
Gastrointestinal Signs	47 (4.3%)
Injuries	38 (3.48%)
Neurological	38 (3.48%)
Decreased And Nonspecific Blood Pre...	27 (2.47%)
Therapeutic And Nontherapeutic Effe...	25 (2.29%)
Muscle	24 (2.2%)
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Hepatobiliary	21 (1.92%)
White Blood Cell	20 (1.83%)
Water, Electrolyte And Mineral	19 (1.74%)
Gastrointestinal Motility And Defec...	18 (1.65%)
Anemias Nonhemolytic And Marrow Dep...	17 (1.56%)
Infections - Pathogen Unspecified	17 (1.56%)
Deliria	15 (1.37%)
Renal And Urinary Tract Investigati...	15 (1.37%)
Urinary Tract Signs	15 (1.37%)
Cardiac And Vascular Investigations	13 (1.19%)
Bone And Joint Injuries	12 (1.1%)
Physical Examination Topics	11 (1.01%)
Protein And Chemistry Analyses	11 (1.01%)
Enzyme	10 (.92%)
Fractures	10 (.92%)
Hematology Investigations	10 (.92%)
Respiratory	10 (.92%)
Body Temperature Conditions	9 (.82%)
Exocrine Pancreas Conditions	8 (.73%)
Gastrointestinal Hemorrhages	7 (.64%)
Glucose Metabolism Disorders	7 (.64%)
Hypothalamus And Pituitary Gland	7 (.64%)
Adrenal Gland	6 (.55%)
Bacterial Infectious	6 (.55%)
Cardiac Valve	6 (.55%)
Coagulopathies And Bleeding Diathes...	6 (.55%)
Depressed Mood Disorders	6 (.55%)
Gallbladder	6 (.55%)
Metabolic, Nutritional And Blood Ga...	6 (.55%)
Platelet	6 (.55%)
Seizures	6 (.55%)
Skin Vascular Abnormalities	6 (.55%)
Skin And Subcutaneous Tissue	5 (.46%)
Skin Appendage Conditions	5 (.46%)
Tongue Conditions	5 (.46%)
Angiedema And Urticaria	4 (.37%)
Bone, Calcium, Magnesium And Phosph...	4 (.37%)
Central Nervous System Vascular	4 (.37%)
Gastrointestinal	4 (.37%)
Heart Failures	4 (.37%)
Hemolyses And Related Conditions	4 (.37%)
Nephropathies	4 (.37%)
Cardiac Disorder Signs	3 (.27%)
Gastrointestinal Inflammatory Condi...	3 (.27%)
Inner Ear And Viiith Cranial Nerve	3 (.27%)
Lower Respiratory Tract Disorders	3 (.27%)
Medication Errors	3 (.27%)
Microbiology And Serology	3 (.27%)
Oral Soft Tissue Conditions	3 (.27%)
Parathyroid Gland	3 (.27%)
Pulmonary Vascular	3 (.27%)
Spleen, Lymphatic And Reticulendoth...	3 (.27%)
Toxicology And Therapeutic Drug Mon...	3 (.27%)
Vitamin Related	3 (.27%)
Acid-base	2 (.18%)
Anxiety Disorders	2 (.18%)
Appetite And General Nutritional	2 (.18%)
Bone Disorders	2 (.18%)
Embolism And Thrombosis	2 (.18%)
Encephalopathies	2 (.18%)
Endocrine Investigations	2 (.18%)
Hematological And Lymphoid Tissue T...	2 (.18%)
Hepatobiliary Neoplasms Malignant A...	2 (.18%)
Lifestyle Issues	2 (.18%)
Mental Impairment	2 (.18%)
Myocardial	2 (.18%)
Neurological, Special Senses And Ps...	2 (.18%)
Psychiatric And Behavioural Symptom...	2 (.18%)
Renal And Urinary Tract Therapeutic...	2 (.18%)
Vascular	2 (.18%)
Vascular Hypertensive	2 (.18%)
Vascular Inflammations	2 (.18%)
Allergic Conditions	1 (.09%)
Breast	1 (.09%)
Connective Tissue Disorders	1 (.09%)
Cornification And Dystrophic Skin	1 (.09%)
Coronary Artery	1 (.09%)
Disturbances In Thinking	1 (.09%)
Fungal Infectious	1 (.09%)
Gastrointestinal Ulceration And Per...	1 (.09%)
Gastrointestinal Vascular Condition...	1 (.09%)
Headaches	1 (.09%)
Immune	1 (.09%)
Immunology And Allergy	1 (.09%)
Investigations, Imaging And Histopa...	1 (.09%)
Lipid Analyses	1 (.09%)
Lipid Metabolism	1 (.09%)
Movement Disorders	1 (.09%)
Musculoskeletal And Connective Tiss...	1 (.09%)
Mycobacterial Infectious	1 (.09%)

Share/Embed Graph Export Data

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

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

Hypertension	172
Drug Use For Unknown Indication	65
Essential Hypertension	49
Product Used For Unknown Indication	15
Myocardial Ischaemia	5
Ischaemic Cardiomyopathy	5
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Cardiac Failure	3
Cough	2
Arrhythmia	2
Atrial Fibrillation	2
Coronary Artery Insufficiency	2
Oedema	2
Hypertonia	2
Hypertensive Cardiomyopathy	2
Secondary Hypertension	1
Diabetes Insipidus	1
Hypotension	1
Oedema Peripheral	1
Unevaluable Event	1
Hypertensive Crisis	1
Cerebrovascular Accident Prophylaxi...	1
Cerebrovascular Accident	1

Fludex Case Reports

What Fludex 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 Fludex. 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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