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TAMSULOSIN

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Tamsulosin Adverse Events Reported to the FDA Over Time

How are Tamsulosin adverse event reports trending over time?

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

Most Common Tamsulosin Adverse Events Reported to the FDA

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

Drug Ineffective
948 (4.35%)
Dizziness
828 (3.8%)
Nocturia
430 (1.97%)
Pollakiuria
281 (1.29%)
Syncope
275 (1.26%)
Dysuria
261 (1.2%)
Loss Of Consciousness
261 (1.2%)
Iris Disorder
260 (1.19%)
Hypotension
239 (1.1%)
Fatigue
202 (.93%)
Dyspnoea
200 (.92%)
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Headache
199 (.91%)
Insomnia
193 (.89%)
Urinary Retention
192 (.88%)
Fall
186 (.85%)
Erectile Dysfunction
172 (.79%)
Rhinorrhoea
172 (.79%)
Ejaculation Failure
166 (.76%)
Vision Blurred
166 (.76%)
Orthostatic Hypotension
162 (.74%)
Semen Volume Decreased
157 (.72%)
Rash
150 (.69%)
Asthenia
148 (.68%)
Procedural Complication
145 (.67%)
Back Pain
143 (.66%)
Blood Pressure Decreased
140 (.64%)
Nausea
140 (.64%)
Cataract
136 (.62%)
Pruritus
136 (.62%)
Nasal Congestion
131 (.6%)
Urinary Incontinence
125 (.57%)
Floppy Iris Syndrome
124 (.57%)
Miosis
123 (.56%)
Urine Flow Decreased
122 (.56%)
Diarrhoea
118 (.54%)
Drug Interaction
117 (.54%)
Drug Effect Decreased
114 (.52%)
Pain
111 (.51%)
Constipation
110 (.5%)
Prostate Cancer
109 (.5%)
Malaise
108 (.5%)
Atrial Fibrillation
107 (.49%)
Retrograde Ejaculation
107 (.49%)
Somnolence
106 (.49%)
Oedema Peripheral
100 (.46%)
Middle Insomnia
96 (.44%)
Feeling Abnormal
90 (.41%)
Dry Mouth
88 (.4%)
Product Substitution Issue
88 (.4%)
Confusional State
84 (.39%)
Gynaecomastia
82 (.38%)
Iridocele
81 (.37%)
Abdominal Pain
80 (.37%)
Urticaria
80 (.37%)
Micturition Urgency
78 (.36%)
Visual Acuity Reduced
78 (.36%)
Palpitations
76 (.35%)
Urinary Tract Infection
75 (.34%)
Cataract Operation Complication
74 (.34%)
Muscle Spasms
74 (.34%)
Pain In Extremity
74 (.34%)
Hypertension
72 (.33%)
Blindness Unilateral
69 (.32%)
Chest Pain
69 (.32%)
Cough
68 (.31%)
Benign Prostatic Hyperplasia
65 (.3%)
Hyperhidrosis
65 (.3%)
Anxiety
64 (.29%)
Pyrexia
64 (.29%)
Vertigo
64 (.29%)
Cerebrovascular Accident
62 (.28%)
Blood Pressure Increased
61 (.28%)
Prostatic Specific Antigen Increase...
61 (.28%)
Haematuria
58 (.27%)
Condition Aggravated
57 (.26%)
Vomiting
56 (.26%)
Heart Rate Increased
55 (.25%)
Libido Decreased
55 (.25%)
Dysphagia
54 (.25%)
Muscular Weakness
54 (.25%)
Tachycardia
54 (.25%)
Therapeutic Response Decreased
54 (.25%)
Ejaculation Disorder
52 (.24%)
Arthralgia
51 (.23%)
Residual Urine
51 (.23%)
Tremor
51 (.23%)
Abdominal Pain Upper
50 (.23%)
Epistaxis
50 (.23%)
Blood Glucose Increased
49 (.22%)
Head Injury
49 (.22%)
Myalgia
49 (.22%)
Aspartate Aminotransferase Increase...
47 (.22%)
Abdominal Discomfort
46 (.21%)
Blood Urine Present
45 (.21%)
Death
45 (.21%)
Hypersensitivity
45 (.21%)
Myocardial Infarction
45 (.21%)
Presyncope
45 (.21%)
Sexual Dysfunction
45 (.21%)
Chest Discomfort
44 (.2%)
Heart Rate Decreased
44 (.2%)

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

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

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

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

Benign Prostatic Hyperplasia
4783
Product Used For Unknown Indication
1106
Drug Use For Unknown Indication
862
Prostatomegaly
671
Prostatic Disorder
512
Dysuria
289
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Pollakiuria
289
Urinary Retention
269
Urinary Tract Disorder
187
Prostate Cancer
154
Urine Flow Decreased
125
Nocturia
103
Micturition Disorder
103
Prostatism
101
Bladder Disorder
100
Neurogenic Bladder
75
Prostatitis
67
Nephrolithiasis
66
Prostate Examination Abnormal
63
Micturition Urgency
51
Urinary Incontinence
50
Prophylaxis
50
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
Prostatic Specific Antigen Increase...
15
Urinary Tract Obstruction
14
Urine Abnormality
13
Lower Urinary Tract Symptoms
12
Asthma
12
Calculus Ureteric
11
Bladder Dysfunction
10
Chronic Obstructive Pulmonary Disea...
9
Blood Pressure
9
Infection Prophylaxis
9
Bladder Cancer
9
Bladder Neck Obstruction
9
Drug Therapy
8
Nasopharyngitis
7
Prostatic Operation
7
Prostate Tenderness
7
Bladder Spasm
7
Infection
7
Polyuria
7

Drug Labels

LabelLabelerEffective
FlomaxA-S Medication Solutions LLC04-SEP-09
FlomaxPhysicians Total Care, Inc.29-DEC-09
FlomaxSTAT RX USA LLC18-JAN-10
Tamsulosin HydrochlorideWOCKHARDT USA LLC27-MAR-10
Tamsulosin HydrochlorideBryant Ranch Prepack27-APR-10
Tamsulosin HydrochloridePD-Rx Pharmaceuticals, Inc.28-APR-10
Tamsulosin HydrochlorideSynthon Pharmaceuticals, Inc.05-MAY-10
Tamsulosin HydrochlorideWOCKHARDT LIMITED23-JUN-10
Tamsulosin HydrochlorideContract Pharmacy Services-PA28-JUL-10
Tamsulosin HydrochlorideNCS HealthCare of KY, Inc dba Vangard Labs29-JUL-10
Tamsulosin HydrochlorideAmerican Health Packaging07-OCT-10
Tamsulosin HydrochloridePreferred Pharmaceuticals, Inc12-MAY-11
Tamsulosin Hydrochloride REMEDYREPACK INC. 18-MAY-11
Tamsulosin HydrochlorideSTAT RX USA LLC11-JUL-11
Tamsulosin HydrochlorideREMEDYREPACK INC. 20-JUL-11
Tamsulosin HydrochlorideGlobal Pharmaceuticals, Division of Impax Laboratories Inc.30-AUG-11
Tamsulosin HydrochloridePhysicians Total Care, Inc.30-AUG-11
Tamsulosin HydrochlorideSandoz Inc31-AUG-11
Tamsulosin HydrochlorideCadila Healthcare Limited05-SEP-11
Tamsulosin HydrochlorideZydus Pharmaceuticals (USA) Inc.05-SEP-11
Tamsulosin HydrochlorideRebel Distributors Corp25-OCT-11
Tamsulosin HydrochlorideActavis Elizabeth LLC27-OCT-11
Tamsulosin HydrochlorideMylan Pharmaceuticals Inc.09-NOV-11
Tamsulosin Hydrochloride H.J. Harkins Company, Inc.19-JAN-12
Tamsulosin HydrochloridePar Pharmaceutical Inc.30-JAN-12
FlomaxCardinal Health08-MAR-12
Tamsulosin HydrochlorideActavis Elizabeth LLC18-APR-12
JalynPhysicians Total Care, Inc.16-MAY-12
FlomaxBoehringer Ingelheim Pharmaceuticals, Inc.25-MAY-12
Tamsulosin HydrochlorideMcKesson Packaging Services a business unit of McKesson Corporation10-JUL-12
Tamsulosin HydrochlorideMajor Pharmaceuticals13-JUL-12
Tamsulosin HydrochlorideTeva Pharmaceuticals USA Inc20-JUL-12
Tamsulosin HydrochlorideMylan Institutional Inc.05-OCT-12
JalynGlaxoSmithKline LLC19-OCT-12
Tamsulosin HydrochlorideSun Pharmaceutical Industries Limited 25-OCT-12
FlomaxBryant Ranch Prepack21-JAN-13
Tamsulosin HydrochlorideMcKesson Packaging Services a business unit of McKesson Corporation20-FEB-13
Tamsulosin HydrochlorideREMEDYREPACK INC. 27-FEB-13
Tamsulosin HydrochlorideCardinal Health20-MAR-13
Tamsulosin HydrochlorideCardinal Health22-MAR-13
Tamsulosin HydrochlorideREMEDYREPACK INC. 22-APR-13
JalynGlaxoSmithKline LLC25-APR-13
Tamsulosin HydrochlorideAurobindo Pharma Limited02-MAY-13

Tamsulosin Case Reports

What Tamsulosin 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 Tamsulosin. 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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