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Cialis Adverse Events Reported to the FDA Over Time

How are Cialis adverse event reports trending over time?

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

Most Common Cialis Adverse Events Reported to the FDA

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

Drug Ineffective
1325 (8.63%)
Therapeutic Response Decreased
676 (4.4%)
Headache
670 (4.36%)
Back Pain
506 (3.3%)
Vision Blurred
447 (2.91%)
Myalgia
221 (1.44%)
Dizziness
191 (1.24%)
Pain In Extremity
189 (1.23%)
Flushing
184 (1.2%)
Visual Acuity Reduced
150 (.98%)
Visual Impairment
147 (.96%)
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Dyspepsia
134 (.87%)
Optic Ischaemic Neuropathy
132 (.86%)
Nasal Congestion
123 (.8%)
Intentional Drug Misuse
111 (.72%)
Insomnia
109 (.71%)
Nausea
107 (.7%)
Blindness
100 (.65%)
Blindness Unilateral
99 (.64%)
Erectile Dysfunction
98 (.64%)
Hypotension
95 (.62%)
Loss Of Consciousness
93 (.61%)
Arthralgia
90 (.59%)
Prostate Cancer
87 (.57%)
Hypertension
86 (.56%)
Chest Pain
83 (.54%)
Pain
77 (.5%)
Myocardial Infarction
76 (.49%)
Drug Interaction
73 (.48%)
Vomiting
72 (.47%)
Fatigue
71 (.46%)
Tinnitus
71 (.46%)
Malaise
69 (.45%)
Muscle Spasms
69 (.45%)
Asthenia
68 (.44%)
Fall
67 (.44%)
Feeling Abnormal
67 (.44%)
Syncope
67 (.44%)
Off Label Use
66 (.43%)
Death
64 (.42%)
Priapism
64 (.42%)
Visual Field Defect
64 (.42%)
Cerebrovascular Accident
63 (.41%)
Gastrooesophageal Reflux Disease
63 (.41%)
Wrong Technique In Drug Usage Proce...
62 (.4%)
Dyspnoea
60 (.39%)
Eye Disorder
59 (.38%)
Ocular Hyperaemia
59 (.38%)
Cyanopsia
58 (.38%)
Diarrhoea
57 (.37%)
Erection Increased
57 (.37%)
Blood Pressure Decreased
56 (.36%)
Intentional Overdose
56 (.36%)
Blindness Transient
50 (.33%)
Atrial Fibrillation
48 (.31%)
Blood Cholesterol Increased
48 (.31%)
Blood Pressure Increased
47 (.31%)
Drug Effect Decreased
47 (.31%)
Penis Disorder
46 (.3%)
Anxiety
45 (.29%)
Spontaneous Penile Erection
44 (.29%)
Surgery
44 (.29%)
Cataract
43 (.28%)
Medication Error
43 (.28%)
Hypoaesthesia
42 (.27%)
Convulsion
41 (.27%)
Photopsia
40 (.26%)
Abdominal Pain Upper
39 (.25%)
Cerebral Haemorrhage
39 (.25%)
Intraocular Pressure Increased
39 (.25%)
Diplopia
38 (.25%)
Oedema Peripheral
38 (.25%)
Eye Pain
36 (.23%)
Retinal Vein Occlusion
36 (.23%)
Cardiac Disorder
35 (.23%)
Photophobia
35 (.23%)
Deafness Unilateral
34 (.22%)
Ejaculation Failure
34 (.22%)
Neck Pain
34 (.22%)
Hyperhidrosis
33 (.21%)
Neoplasm Malignant
33 (.21%)
Palpitations
33 (.21%)
Paraesthesia
33 (.21%)
Retinal Detachment
33 (.21%)
Transient Ischaemic Attack
33 (.21%)
Feeling Hot
31 (.2%)
Glaucoma
31 (.2%)
Amnesia
30 (.2%)
Eye Irritation
30 (.2%)
Overdose
30 (.2%)
Pyrexia
30 (.2%)
Balance Disorder
29 (.19%)
Eyelid Oedema
29 (.19%)
Influenza Like Illness
29 (.19%)
Retinal Haemorrhage
29 (.19%)
Abnormal Sensation In Eye
28 (.18%)
Chromatopsia
28 (.18%)
Heart Rate Increased
28 (.18%)
Painful Erection
28 (.18%)
Papilloedema
28 (.18%)
Arthritis
27 (.18%)

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

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

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

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

Erectile Dysfunction
3578
Product Used For Unknown Indication
93
Drug Use For Unknown Indication
61
Sexual Dysfunction
39
Ill-defined Disorder
38
Pulmonary Hypertension
23
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Prostatectomy
19
Benign Prostatic Hyperplasia
13
Off Label Use
12
Prophylaxis
12
Libido Decreased
7
Prostate Cancer
6
Organic Erectile Dysfunction
6
Raynauds Phenomenon
5
Radical Prostatectomy
4
Peyronies Disease
4
Anxiety
4
Penis Disorder
4
Scleroderma
4
Nerve Injury
4
Chillblains
3
Diabetes Mellitus
3
Male Sexual Dysfunction
3
Prostatism
3
Premature Ejaculation
3
Post Procedural Complication
3
Unevaluable Event
3
Peripheral Vascular Disorder
3
Blood Testosterone Decreased
3
Psychogenic Erectile Dysfunction
3
Intermittent Claudication
3
Prostatitis
2
Hypertension
2
Drug Therapy
2
Disturbance In Sexual Arousal
2
Angina Unstable
2
Ejaculation Disorder
2
Poor Peripheral Circulation
2
Erection Increased
2
Libido Disorder
2
Accidental Drug Intake By Child
2
Depression
2
Arthralgia
2
Blood Testosterone
2
Cardiovascular Insufficiency
2
Transurethral Prostatectomy
2
Surgery
1
Testicular Failure
1
Sexual Activity Increased
1
Urethral Disorder
1
Loss Of Libido
1

Drug Labels

LabelLabelerEffective
CialisRebel Distributors Corp.28-JUL-09
CialisPD-Rx Pharmaceuticals, Inc.19-MAY-10
CialisSTAT RX USA LLC30-AUG-10
CialisPhysicians Total Care, Inc.15-DEC-11
CialisEli Lilly and Company25-JUN-12
CialisDispensing Solutions, Inc.27-SEP-12
CialisBryant Ranch Prepack13-FEB-13
CialisBryant Ranch Prepack13-FEB-13
CialisBryant Ranch Prepack13-FEB-13
CialisEli Lilly and Company20-FEB-13

Cialis Case Reports

What Cialis 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 Cialis. 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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