FLOMAX

Adverse Events

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Flomax Adverse Events Reported to the FDA Over Time

How are Flomax adverse event reports trending over time?

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

Most Common Flomax Adverse Events Reported to the FDA

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

Drug Ineffective	918 (4.36%)
Dizziness	798 (3.79%)
Nocturia	421 (2%)
Pollakiuria	272 (1.29%)
Syncope	270 (1.28%)
Iris Disorder	260 (1.23%)
Dysuria	257 (1.22%)
Loss Of Consciousness	255 (1.21%)
Hypotension	230 (1.09%)
Fatigue	194 (.92%)
Headache	191 (.91%)
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Urinary Retention	189 (.9%)
Dyspnoea	186 (.88%)
Insomnia	185 (.88%)
Fall	182 (.86%)
Rhinorrhoea	170 (.81%)
Vision Blurred	165 (.78%)
Ejaculation Failure	162 (.77%)
Orthostatic Hypotension	156 (.74%)
Semen Volume Decreased	152 (.72%)
Erectile Dysfunction	150 (.71%)
Procedural Complication	145 (.69%)
Asthenia	140 (.66%)
Cataract	136 (.65%)
Nausea	135 (.64%)
Back Pain	134 (.64%)
Blood Pressure Decreased	134 (.64%)
Rash	130 (.62%)
Nasal Congestion	129 (.61%)
Pruritus	125 (.59%)
Floppy Iris Syndrome	124 (.59%)
Miosis	123 (.58%)
Urinary Incontinence	123 (.58%)
Urine Flow Decreased	118 (.56%)
Drug Effect Decreased	114 (.54%)
Drug Interaction	112 (.53%)
Diarrhoea	109 (.52%)
Prostate Cancer	109 (.52%)
Pain	108 (.51%)
Atrial Fibrillation	107 (.51%)
Constipation	107 (.51%)
Malaise	105 (.5%)
Retrograde Ejaculation	102 (.48%)
Somnolence	100 (.47%)
Middle Insomnia	95 (.45%)
Oedema Peripheral	92 (.44%)
Feeling Abnormal	88 (.42%)
Dry Mouth	87 (.41%)
Product Substitution Issue	87 (.41%)
Confusional State	81 (.38%)
Iridocele	81 (.38%)
Visual Acuity Reduced	78 (.37%)
Abdominal Pain	77 (.37%)
Gynaecomastia	75 (.36%)
Micturition Urgency	75 (.36%)
Cataract Operation Complication	74 (.35%)
Urinary Tract Infection	74 (.35%)
Palpitations	73 (.35%)
Urticaria	73 (.35%)
Hypertension	72 (.34%)
Pain In Extremity	70 (.33%)
Blindness Unilateral	69 (.33%)
Muscle Spasms	69 (.33%)
Cough	68 (.32%)
Chest Pain	64 (.3%)
Benign Prostatic Hyperplasia	63 (.3%)
Cerebrovascular Accident	62 (.29%)
Vertigo	62 (.29%)
Anxiety	61 (.29%)
Pyrexia	60 (.28%)
Blood Pressure Increased	59 (.28%)
Haematuria	58 (.28%)
Hyperhidrosis	58 (.28%)
Prostatic Specific Antigen Increase...	57 (.27%)
Heart Rate Increased	54 (.26%)
Tachycardia	54 (.26%)
Therapeutic Response Decreased	54 (.26%)
Condition Aggravated	53 (.25%)
Dysphagia	52 (.25%)
Vomiting	52 (.25%)
Residual Urine	51 (.24%)
Tremor	50 (.24%)
Arthralgia	49 (.23%)
Epistaxis	49 (.23%)
Head Injury	49 (.23%)
Libido Decreased	48 (.23%)
Muscular Weakness	48 (.23%)
Aspartate Aminotransferase Increase...	47 (.22%)
Abdominal Pain Upper	46 (.22%)
Abdominal Discomfort	45 (.21%)
Blood Glucose Increased	45 (.21%)
Death	45 (.21%)
Ejaculation Disorder	45 (.21%)
Myocardial Infarction	45 (.21%)
Presyncope	45 (.21%)
Heart Rate Decreased	44 (.21%)
Hypersensitivity	44 (.21%)
Myalgia	44 (.21%)
Blood Urine Present	43 (.2%)
Sexual Dysfunction	43 (.2%)
Transient Ischaemic Attack	43 (.2%)

Share/Embed Graph Export Data

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

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

Neurological	1866 (8.86%)
Urinary Tract Signs	1751 (8.31%)
Therapeutic And Nontherapeutic Effe...	1293 (6.14%)
Respiratory	661 (3.14%)
Epidermal And Dermal Conditions	659 (3.13%)
Sexual Function And Fertility	597 (2.83%)
Gastrointestinal Signs	580 (2.75%)
Anterior Eye Structural Change, Dep...	510 (2.42%)
Decreased And Nonspecific Blood Pre...	447 (2.12%)
Procedural And Device Related Injur...	423 (2.01%)
Vision	420 (1.99%)
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Cardiac And Vascular Investigations	408 (1.94%)
Cardiac Arrhythmias	397 (1.88%)
Injuries	392 (1.86%)
Sleep Disorders	347 (1.65%)
Infections - Pathogen Unspecified	344 (1.63%)
Musculoskeletal And Connective Tiss...	306 (1.45%)
Gastrointestinal Motility And Defec...	253 (1.2%)
Upper Respiratory Tract Disorders	248 (1.18%)
Muscle	222 (1.05%)
Ocular Neuromuscular	215 (1.02%)
Headaches	212 (1.01%)
Hepatic And Hepatobiliary	188 (.89%)
Reproductive Organ And Breast Inves...	184 (.87%)
Medication Errors	177 (.84%)
Hepatobiliary	159 (.75%)
Central Nervous System Vascular	156 (.74%)
Breast	143 (.68%)
Renal And Urinary Tract Investigati...	133 (.63%)
Anxiety Disorders	132 (.63%)
Deliria	132 (.63%)
Prostatic Disorders	130 (.62%)
Reproductive Neoplasms Male Maligna...	129 (.61%)
Eye	127 (.6%)
Joint	127 (.6%)
Coronary Artery	126 (.6%)
Hematology Investigations	126 (.6%)
Renal Disorders	121 (.57%)
Skin Appendage Conditions	112 (.53%)
Product Quality Issues	111 (.53%)
Mental Impairment	109 (.52%)
Movement Disorders	109 (.52%)
Lower Respiratory Tract Disorders	106 (.5%)
Angiedema And Urticaria	103 (.49%)
Cardiac Disorder Signs	101 (.48%)
Inner Ear And Viiith Cranial Nerve	101 (.48%)
Bone And Joint Injuries	97 (.46%)
Sexual Dysfunctions, Disturbances A...	95 (.45%)
Salivary Gland Conditions	92 (.44%)
Allergic Conditions	88 (.42%)
Physical Examination Topics	83 (.39%)
Electrolyte And Fluid Balance Condi...	80 (.38%)
Vascular Hypertensive	77 (.37%)
Oral Soft Tissue Conditions	76 (.36%)
Immunology And Allergy	73 (.35%)
Fatal Outcomes	69 (.33%)
Vascular	68 (.32%)
Body Temperature Conditions	67 (.32%)
Anemias Nonhemolytic And Marrow Dep...	66 (.31%)
Penile And Scrotal Disorders	66 (.31%)
Ocular Infections, Irritations And ...	65 (.31%)
Metabolic, Nutritional And Blood Ga...	63 (.3%)
Bacterial Infectious	62 (.29%)
Dental And Gingival Conditions	60 (.28%)
Disturbances In Thinking	59 (.28%)
Suicidal And Self-injurious Behavio...	59 (.28%)
Bronchial Disorders	58 (.28%)
Appetite And General Nutritional	55 (.26%)
Lifestyle Issues	55 (.26%)
Ocular Structural Change, Deposit A...	55 (.26%)
Seizures	55 (.26%)
White Blood Cell	53 (.25%)
Neurological, Special Senses And Ps...	52 (.25%)
Depressed Mood Disorders	49 (.23%)
Glucose Metabolism Disorders	47 (.22%)
Bone Disorders	46 (.22%)
Heart Failures	45 (.21%)
Platelet	45 (.21%)
Enzyme	44 (.21%)
Gastrointestinal Hemorrhages	44 (.21%)
Mood Disorders	44 (.21%)
Gastrointestinal Neoplasms Malignan...	43 (.2%)
Water, Electrolyte And Mineral	41 (.19%)
Respiratory And Mediastinal Neoplas...	40 (.19%)
Testicular And Epididymal	40 (.19%)
Bladder And Bladder Neck Disorders	38 (.18%)
Exocrine Pancreas Conditions	38 (.18%)
Therapeutic Procedures And Supporti...	38 (.18%)
Urolithiases	38 (.18%)
Vascular Hemorrhagic	36 (.17%)
Viral Infectious	36 (.17%)
Genitourinary Tract	35 (.17%)
Personality Disorders	35 (.17%)
Musculoskeletal And Connective Tiss...	32 (.15%)
Eye Therapeutic Procedures	30 (.14%)
Reproductive Tract	30 (.14%)
Glaucoma And Ocular Hypertension	29 (.14%)
Tissue	29 (.14%)
Cardiac Valve	28 (.13%)
Arteriosclerosis, Stenosis, Vascula...	27 (.13%)
Peripheral Neuropathies	27 (.13%)

Share/Embed Graph Export Data

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

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

Benign Prostatic Hyperplasia	4618
Product Used For Unknown Indication	1065
Drug Use For Unknown Indication	862
Prostatomegaly	647
Prostatic Disorder	497
Dysuria	286
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Pollakiuria	282
Urinary Retention	268
Urinary Tract Disorder	186
Prostate Cancer	154
Urine Flow Decreased	122
Micturition Disorder	102
Prostatism	101
Bladder Disorder	98
Nocturia	97
Neurogenic Bladder	75
Prostatitis	66
Nephrolithiasis	66
Prostate Examination Abnormal	63
Micturition Urgency	51
Prophylaxis	50
Urinary Incontinence	48
Hypertonic Bladder	46
Prostatic Adenoma	43
Ill-defined Disorder	43
Hypertension	36
Urinary Tract Infection	31
Residual Urine	27
Cystitis	19
Urinary Hesitation	18
Bladder Obstruction	18
Incontinence	16
Urine Abnormality	13
Urinary Tract Obstruction	13
Asthma	12
Prostatic Specific Antigen Increase...	12
Lower Urinary Tract Symptoms	12
Calculus Ureteric	11
Bladder Dysfunction	10
Chronic Obstructive Pulmonary Disea...	9
Bladder Neck Obstruction	9
Infection Prophylaxis	9
Blood Pressure	9
Drug Therapy	8
Bladder Cancer	8
Hyperplasia	7
Nasopharyngitis	7
Infection	7
Prostatic Operation	7
Prostate Tenderness	7
Bladder Spasm	7

Drug Labels

Label	Labeler	Effective
Flomax	A-S Medication Solutions LLC	04-SEP-09
Flomax	Physicians Total Care, Inc.	29-DEC-09
Flomax	STAT RX USA LLC	18-JAN-10
Flomax	Lake Erie Medical DBA Quality Care Products	14-MAY-10
Flomax	REMEDYREPACK INC.	30-MAR-11
Flomax	Cardinal Health	08-MAR-12
Flomax	Boehringer Ingelheim Pharmaceuticals, Inc.	25-MAY-12
Flomax	Bryant Ranch Prepack	21-JAN-13

Flomax Case Reports

What Flomax 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 Flomax. 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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