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RAPAFLO

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Rapaflo Adverse Events Reported to the FDA Over Time

How are Rapaflo adverse event reports trending over time?

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

Most Common Rapaflo Adverse Events Reported to the FDA

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

Dizziness
65 (4.19%)
Drug Ineffective
50 (3.22%)
Retrograde Ejaculation
46 (2.96%)
Loss Of Consciousness
42 (2.71%)
Diarrhoea
38 (2.45%)
Nasal Congestion
34 (2.19%)
Syncope
25 (1.61%)
Headache
23 (1.48%)
Death
21 (1.35%)
Ejaculation Failure
21 (1.35%)
Hepatic Function Abnormal
21 (1.35%)
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Dyspnoea
20 (1.29%)
Liver Disorder
20 (1.29%)
Alanine Aminotransferase Increased
19 (1.22%)
Aspartate Aminotransferase Increase...
19 (1.22%)
Orthostatic Hypotension
18 (1.16%)
Anaemia
17 (1.1%)
Fatigue
17 (1.1%)
Malaise
16 (1.03%)
Nausea
15 (.97%)
Dehydration
14 (.9%)
Drug Interaction
14 (.9%)
Platelet Count Decreased
13 (.84%)
Pyrexia
13 (.84%)
Rash
13 (.84%)
Asthenia
12 (.77%)
Hypotension
12 (.77%)
Blood Pressure Decreased
11 (.71%)
Condition Aggravated
11 (.71%)
Decreased Appetite
11 (.71%)
Hepatitis Fulminant
11 (.71%)
Insomnia
11 (.71%)
Oedema Peripheral
11 (.71%)
Swelling Face
11 (.71%)
Erythema
10 (.64%)
Fall
10 (.64%)
Interstitial Lung Disease
10 (.64%)
Blood Bilirubin Increased
9 (.58%)
Blood Glucose Increased
9 (.58%)
Dysuria
9 (.58%)
Jaundice
9 (.58%)
Myalgia
9 (.58%)
Prostatic Specific Antigen Increase...
9 (.58%)
Urinary Retention
9 (.58%)
Circulatory Collapse
8 (.52%)
Erythema Multiforme
8 (.52%)
Gamma-glutamyltransferase Increased
8 (.52%)
Pollakiuria
8 (.52%)
Pruritus Generalised
8 (.52%)
Septic Shock
8 (.52%)
Tachypnoea
8 (.52%)
Unresponsive To Stimuli
8 (.52%)
Acute Myeloid Leukaemia
7 (.45%)
Back Pain
7 (.45%)
Constipation
7 (.45%)
Dysphagia
7 (.45%)
Hypertension
7 (.45%)
Lip Swelling
7 (.45%)
Off Label Use
7 (.45%)
Pruritus
7 (.45%)
Vertigo
7 (.45%)
Altered State Of Consciousness
6 (.39%)
Bilirubin Conjugated Increased
6 (.39%)
Pain
6 (.39%)
Pain In Extremity
6 (.39%)
Thrombocytopenia
6 (.39%)
White Blood Cell Count Decreased
6 (.39%)
Abdominal Pain
5 (.32%)
Abdominal Pain Upper
5 (.32%)
Arrhythmia
5 (.32%)
Blood Pressure Increased
5 (.32%)
Bradycardia
5 (.32%)
Cardiac Failure
5 (.32%)
Convulsion
5 (.32%)
Cough
5 (.32%)
Erectile Dysfunction
5 (.32%)
Feeling Abnormal
5 (.32%)
Flushing
5 (.32%)
Heart Rate Increased
5 (.32%)
Hyperhidrosis
5 (.32%)
Palpitations
5 (.32%)
Pneumonia
5 (.32%)
Rash Erythematous
5 (.32%)
Respiratory Tract Infection
5 (.32%)
Tachycardia
5 (.32%)
Urinary Incontinence
5 (.32%)
Visual Impairment
5 (.32%)
Abdominal Discomfort
4 (.26%)
Angina Pectoris
4 (.26%)
Anxiety
4 (.26%)
Aortic Aneurysm
4 (.26%)
Atrial Flutter
4 (.26%)
Blood Urine Present
4 (.26%)
Chromaturia
4 (.26%)
Dry Mouth
4 (.26%)
Eczema Asteatotic
4 (.26%)
Ejaculation Disorder
4 (.26%)
Eosinophilic Pneumonia Acute
4 (.26%)
Epilepsy
4 (.26%)
Feeling Hot
4 (.26%)
Gait Disturbance
4 (.26%)

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

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

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

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

Benign Prostatic Hyperplasia
235
Product Used For Unknown Indication
78
Dysuria
59
Bladder Obstruction
48
Prostatomegaly
37
Pollakiuria
31
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Urinary Retention
15
Prostatic Disorder
14
Bladder Disorder
12
Nephrolithiasis
9
Prostatitis
8
Drug Use For Unknown Indication
7
Hypertonic Bladder
6
Urinary Incontinence
6
Urinary Tract Disorder
6
Urine Flow Decreased
4
Nocturia
3
Incontinence
2
Lower Urinary Tract Symptoms
2
Urinary Tract Infection
2
Prostate Cancer
2
Unevaluable Event
2
Urethral Stenosis
1
Lyme Disease
1
Renal Colic
1
Micturition Urgency
1
Urine Output Decreased
1
Bladder Neck Obstruction
1
Bladder Spasm
1
Neurogenic Bladder
1
Urine Abnormality
1
Swelling
1
Bladder Cancer
1
Urethral Spasm
1
Convulsion
1
Prostatic Pain
1
Prostatic Specific Antigen
1

Drug Labels

LabelLabelerEffective
RapafloPhysicians Total Care, Inc.15-FEB-12
RapafloWatson Pharma, Inc.17-DEC-12
RapafloWatson Pharma, Inc.01-JAN-13

Rapaflo Case Reports

What Rapaflo 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 Rapaflo. 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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