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Viagra Adverse Events Reported to the FDA Over Time

How are Viagra adverse event reports trending over time?

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

Most Common Viagra Adverse Events Reported to the FDA

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

Drug Ineffective
3803 (12.54%)
Erection Increased
998 (3.29%)
Headache
638 (2.1%)
Erectile Dysfunction
533 (1.76%)
Optic Ischaemic Neuropathy
519 (1.71%)
Flushing
425 (1.4%)
Drug Effect Decreased
423 (1.39%)
Blindness
404 (1.33%)
Vision Blurred
374 (1.23%)
Penis Disorder
342 (1.13%)
Dizziness
263 (.87%)
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Death
247 (.81%)
Hypertension
245 (.81%)
Drug Interaction
244 (.8%)
Blindness Unilateral
236 (.78%)
Incorrect Dose Administered
236 (.78%)
Visual Acuity Reduced
228 (.75%)
Nasal Congestion
227 (.75%)
Cyanopsia
206 (.68%)
Pain
198 (.65%)
Prostate Cancer
196 (.65%)
Myocardial Infarction
185 (.61%)
Penile Pain
174 (.57%)
Feeling Abnormal
169 (.56%)
Diabetes Mellitus
162 (.53%)
Chest Pain
161 (.53%)
Malaise
160 (.53%)
Dyspnoea
156 (.51%)
Cerebrovascular Accident
154 (.51%)
Blood Cholesterol Increased
141 (.46%)
Loss Of Consciousness
138 (.45%)
Nausea
136 (.45%)
Fatigue
132 (.44%)
Blood Pressure Increased
128 (.42%)
Ejaculation Disorder
125 (.41%)
Anxiety
123 (.41%)
Intentional Drug Misuse
123 (.41%)
Depression
121 (.4%)
Deafness
120 (.4%)
Visual Field Defect
118 (.39%)
Visual Impairment
116 (.38%)
Abdominal Discomfort
113 (.37%)
Cardiac Disorder
112 (.37%)
Blood Pressure Decreased
110 (.36%)
Medication Error
106 (.35%)
Fall
100 (.33%)
Vomiting
99 (.33%)
Insomnia
98 (.32%)
Convulsion
97 (.32%)
Erythema
97 (.32%)
Blindness Transient
96 (.32%)
Heart Rate Increased
96 (.32%)
Hypotension
93 (.31%)
Back Pain
92 (.3%)
Tinnitus
89 (.29%)
Condition Aggravated
87 (.29%)
Painful Erection
86 (.28%)
Dyspepsia
85 (.28%)
Feeling Hot
85 (.28%)
Penile Swelling
84 (.28%)
Palpitations
83 (.27%)
Weight Decreased
81 (.27%)
Atrial Fibrillation
79 (.26%)
Expired Drug Administered
79 (.26%)
Chest Discomfort
77 (.25%)
Eye Pain
77 (.25%)
Cataract
75 (.25%)
Dysuria
75 (.25%)
Ocular Hyperaemia
75 (.25%)
Hyperhidrosis
73 (.24%)
Skin Discolouration
73 (.24%)
Asthenia
70 (.23%)
Blood Glucose Increased
70 (.23%)
Syncope
70 (.23%)
Glaucoma
69 (.23%)
Priapism
68 (.22%)
Macular Degeneration
66 (.22%)
Diarrhoea
65 (.21%)
Ejaculation Failure
64 (.21%)
Weight Increased
62 (.2%)
Blood Testosterone Decreased
61 (.2%)
Abdominal Pain Upper
60 (.2%)
Pain In Extremity
60 (.2%)
Self-medication
60 (.2%)
Somnolence
60 (.2%)
Eye Disorder
59 (.19%)
Overdose
59 (.19%)
Coronary Artery Occlusion
58 (.19%)
Memory Impairment
57 (.19%)
Testicular Disorder
57 (.19%)
Amnesia
56 (.18%)
Arrhythmia
56 (.18%)
Deafness Unilateral
56 (.18%)
Eye Haemorrhage
56 (.18%)
Hypoaesthesia
56 (.18%)
Penile Haemorrhage
56 (.18%)
Road Traffic Accident
56 (.18%)
Wrong Technique In Drug Usage Proce...
54 (.18%)
Cardiac Failure
52 (.17%)
Myalgia
51 (.17%)
Nervousness
50 (.16%)

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

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

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

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

Erectile Dysfunction
6159
Ill-defined Disorder
1178
Pulmonary Hypertension
221
Drug Use For Unknown Indication
156
Sexual Dysfunction
154
Product Used For Unknown Indication
117
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Libido Decreased
27
Penis Disorder
23
In Vitro Fertilisation
20
Prostatectomy
19
Pulmonary Arterial Hypertension
15
Peripheral Vascular Disorder
14
Prostatic Disorder
14
Cardiovascular Disorder
14
Prostatic Operation
14
Loss Of Libido
13
Off Label Use
13
Prostate Cancer
12
Arthralgia
10
Back Pain
10
Organic Erectile Dysfunction
9
Male Sexual Dysfunction
7
Hypertension
7
Libido Increased
7
Post Procedural Complication
6
Cardiac Disorder
6
Anorgasmia
5
Pulmonary Embolism
5
Premature Ejaculation
5
Diabetes Mellitus
5
Decreased Ventricular Afterload
5
Libido Disorder
5
Ejaculation Disorder
5
Penile Vascular Disorder
4
Suicide Attempt
4
Persistent Foetal Circulation
4
Disturbance In Sexual Arousal
4
Peripheral Arterial Occlusive Disea...
4
Sexually Active
4
Blood Pressure
4
Skin Ulcer
3
Peyronies Disease
3
Priapism
3
Prostatism
3
Postoperative Care
3
Psychosomatic Disease
3
Radical Prostatectomy
3
Unevaluable Event
2
Phimosis
2
Renal Pain
2
Emphysema
2

Drug Labels

LabelLabelerEffective
ViagraPD-Rx Pharmaceuticals, Inc.20-JUL-09
ViagraPD-Rx Pharmaceuticals, Inc.20-JUL-09
ViagraRebel Distributors Corp22-DEC-10
ViagraPfizer Laboratories Div Pfizer Inc27-JUN-11
ViagraPD-Rx Pharmaceuticals, Inc.27-JUN-11
ViagraLake Erie Medical Surgical & Supply DBA Quality Care Products LLC28-DEC-11
ViagraPhysicians Total Care, Inc.02-APR-12
Viagra Professional SampleU.S. Pharmaceuticals10-APR-12
ViagraCardinal Health02-AUG-12
ViagraBryant Ranch Prepack18-JAN-13
ViagraBryant Ranch Prepack18-JAN-13

Viagra Case Reports

What Viagra 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 Viagra. 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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