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Vardenafil Adverse Events Reported to the FDA Over Time

How are Vardenafil adverse event reports trending over time?

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

Most Common Vardenafil Adverse Events Reported to the FDA

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

Erectile Dysfunction
1817 (13.4%)
Drug Ineffective
971 (7.16%)
Headache
745 (5.49%)
Flushing
346 (2.55%)
Adverse Event
289 (2.13%)
Dizziness
257 (1.9%)
Nasal Congestion
253 (1.87%)
Erection Increased
242 (1.78%)
Vision Blurred
195 (1.44%)
Nausea
145 (1.07%)
Drug Effect Decreased
125 (.92%)
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Chest Pain
107 (.79%)
Drug Use For Unknown Indication
103 (.76%)
Blindness Unilateral
96 (.71%)
Dyspepsia
94 (.69%)
Dyspnoea
91 (.67%)
Visual Acuity Reduced
91 (.67%)
Feeling Abnormal
86 (.63%)
No Adverse Event
85 (.63%)
Blindness Transient
80 (.59%)
Optic Ischaemic Neuropathy
79 (.58%)
Vomiting
77 (.57%)
Heart Rate Increased
74 (.55%)
Loss Of Consciousness
74 (.55%)
Blood Pressure Decreased
70 (.52%)
Tinnitus
70 (.52%)
Diarrhoea
69 (.51%)
Unevaluable Event
66 (.49%)
Blindness
64 (.47%)
Cerebrovascular Accident
63 (.46%)
Feeling Hot
61 (.45%)
Palpitations
61 (.45%)
Hypotension
57 (.42%)
Ejaculation Failure
56 (.41%)
Fatigue
56 (.41%)
Back Pain
55 (.41%)
Ejaculation Disorder
55 (.41%)
Erythema
55 (.41%)
Eye Pain
55 (.41%)
Photopsia
55 (.41%)
Priapism
54 (.4%)
Visual Field Defect
54 (.4%)
Cyanopsia
51 (.38%)
Visual Impairment
49 (.36%)
Asthenia
48 (.35%)
Deafness
48 (.35%)
Syncope
48 (.35%)
Penile Pain
47 (.35%)
Myocardial Infarction
46 (.34%)
Penis Disorder
46 (.34%)
Rhinorrhoea
46 (.34%)
Spontaneous Penile Erection
45 (.33%)
Deafness Unilateral
43 (.32%)
Ocular Hyperaemia
43 (.32%)
Transient Ischaemic Attack
43 (.32%)
Eye Disorder
42 (.31%)
Malaise
42 (.31%)
Blood Pressure Increased
41 (.3%)
Pain In Extremity
41 (.3%)
Myalgia
40 (.3%)
Photophobia
40 (.3%)
Hypertension
39 (.29%)
Anorgasmia
38 (.28%)
Abdominal Pain Upper
36 (.27%)
Chest Discomfort
36 (.27%)
Fall
36 (.27%)
Haematospermia
36 (.27%)
Pain
36 (.27%)
Paraesthesia
35 (.26%)
Anxiety
34 (.25%)
Rash
34 (.25%)
Therapeutic Response Delayed
34 (.25%)
Vertigo
34 (.25%)
Arthralgia
33 (.24%)
Insomnia
33 (.24%)
Macular Degeneration
33 (.24%)
Abdominal Discomfort
31 (.23%)
Vitreous Detachment
31 (.23%)
Chills
30 (.22%)
Hyperhidrosis
30 (.22%)
Retinal Artery Occlusion
30 (.22%)
Hypoaesthesia
29 (.21%)
Lacrimation Increased
28 (.21%)
Painful Erection
28 (.21%)
Amnesia
27 (.2%)
Chromatopsia
27 (.2%)
Hypersensitivity
27 (.2%)
Migraine
27 (.2%)
Drug Interaction
25 (.18%)
Pulmonary Embolism
25 (.18%)
Tremor
25 (.18%)
Burning Sensation
24 (.18%)
Flatulence
24 (.18%)
Pruritus
24 (.18%)
Sinus Congestion
24 (.18%)
Urticaria
24 (.18%)
Arrhythmia
23 (.17%)
Cataract
23 (.17%)
Diplopia
23 (.17%)
Amaurosis Fugax
22 (.16%)
Blood Glucose Increased
22 (.16%)

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

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

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

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

Erectile Dysfunction
3731
Drug Use For Unknown Indication
1041
Product Used For Unknown Indication
86
Sexual Dysfunction
48
Ill-defined Disorder
35
Unevaluable Event
17
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Organic Erectile Dysfunction
15
Libido Decreased
11
Premature Ejaculation
10
Prostatectomy
8
Disturbance In Sexual Arousal
8
Drug Interaction
8
Prostate Cancer
6
Penis Disorder
5
Depression
5
Pulmonary Hypertension
5
Prostatic Operation
5
Prostatomegaly
4
Hypertonic Bladder
4
Peyronies Disease
4
Raynauds Phenomenon
4
Aphrodisiac Therapy
4
Prostatitis
4
Libido Increased
4
Radical Prostatectomy
3
Anorgasmia
3
Testicular Pain
3
Adverse Event
3
Pain
3
Back Injury
3
Stress
3
Loss Of Libido
3
Ejaculation Disorder
3
Surgery
3
Urinary Retention
2
Sexual Activity Increased
2
Scleroderma
2
Angina Pectoris
2
Diabetes Mellitus
2
Ulcer
2
Skin Ulcer
2
Diabetic Complication
2
Postoperative Care
2
Dyspnoea
2
Prophylaxis
2
Fatigue
2
Drug Effect Prolonged
1
Atrophy
1
Blood Testosterone Decreased
1
Drug Ineffective
1
Hernia Repair
1

Drug Labels

LabelLabelerEffective
LevitraPD-Rx Pharmaceuticals, Inc.08-JUL-10
LevitraSchering Plough Corporation08-JUL-10
LevitraPhysicians Total Care, Inc.08-JUL-10
StaxynSchering Plough Corporation12-APR-11
LevitraPD-Rx Pharmaceuticals, Inc.22-APR-11
LevitraAPHENA PHARMA SOLUTIONS - TENNESSEE, INC.26-OCT-11
LevitraAPHENA PHARMA SOLUTIONS - TENNESSEE, INC.26-OCT-11
LevitraAPHENA PHARMA SOLUTIONS - TENNESSEE, INC.27-OCT-11
LevitraKAISER FOUNDATION HOSPITALS08-NOV-11
StaxynPhysicians Total Care, Inc.23-APR-12
StaxynGlaxoSmithKline LLC11-JUL-12
LevitraGlaxoSmithKline LLC12-JUL-12
LevitraBryant Ranch Prepack17-JAN-13

Vardenafil Case Reports

What Vardenafil 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 Vardenafil. 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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