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Viagra (Sildenafil) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Viagra (Sildenafil) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (2260)
Death (47)
Life Threatening Events (5)
Disability (58)

Reports by Reaction Type

Drug Ineffective (734)Erection Increased (165)Headache (117)Erectile Dysfunction (96)Penis Disorder (85)Drug Effect Decreased (63)Drug Interaction (55)Incorrect Dose Administered (48)Penile Pain (47)Nausea (43)Flushing (43)Pain (41)

Below are a few examples of reports where side effects / adverse reactions may be related to Viagra (Sildenafil). For a complete list or a specific selection of reports, please use the links above.

Possible Viagra side effects in 71 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 71 year old male, weighing 93.0 kg (204.5 pounds)

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Viagra

Other drugs received by patient: Nexium



Possible Viagra side effects in 35 year old male

Reported by a physician from France on 2012-08-27

Patient: 35 year old male

Reactions: Penis Injury

Drug(s) suspected as cause:
Viagra



Possible Viagra side effects in 65 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 65 year old male, weighing 84.8 kg (186.6 pounds)

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Viagra

Other drugs received by patient: Atenolol



Possible Viagra side effects in 29 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 29 year old male

Reactions: Death, Overdose, Ear Haemorrhage, Drug Interaction, Eye Disorder, Epistaxis

Adverse event resulted in: death

Drug(s) suspected as cause:
Viagra

Other drugs received by patient possibly interacting with the suspect drug:
Alcohol

Cocaine

Other drugs received by patient: Xanax; Adderall



Possible Viagra side effects in 60 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 60 year old male, weighing 90.7 kg (199.5 pounds)

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Viagra



Possible Viagra side effects in 32 year old male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 32 year old male, weighing 104.3 kg (229.5 pounds)

Reactions: Genital Swelling, Genital Pain, Drug Administration Error, Penis Disorder, Penile Swelling

Drug(s) suspected as cause:
Viagra



Possible Viagra side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: male

Reactions: Erection Increased, Emotional Disorder, Feeling Abnormal

Drug(s) suspected as cause:
Viagra



Possible Viagra side effects in 63 year old male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 63 year old male, weighing 104.0 kg (228.8 pounds)

Reactions: Skin Ulcer, Circumstance or Information Capable of Leading To Medication Error, Drug Ineffective

Drug(s) suspected as cause:
Celebrex
    Dosage: unk. 2x/day
    Indication: Pain

Celebrex
    Dosage: unk
    Indication: Antiinflammatory Therapy

Feldene
    Dosage: unk, daily
    Indication: Pain

Feldene
    Dosage: unk
    Indication: Antiinflammatory Therapy

Oxycodone Hydrochloride
    Dosage: 5 mg, unk
    Indication: Pain
    Start date: 2012-08-01
    End date: 2012-08-01

Percocet
    Dosage: 25 mg, unk
    Indication: Pain

Percocet
    Dosage: unk

Viagra
    Dosage: unk
    Administration route: Oral

Viagra
    Dosage: 100 mg, unk
    Administration route: Oral
    Indication: Erectile Dysfunction

Vicodin
    Dosage: 7.5 mg, unk
    Indication: Pain

Vicodin
    Dosage: unk



Possible Viagra side effects in

Reported by a pharmacist from United Kingdom on 2012-08-24

Patient:

Reactions: Off Label Use, Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Viagra



Possible Viagra side effects in 45 year old male

Reported by a physician from United States on 2012-08-24

Patient: 45 year old male

Reactions: Hyperlipidaemia, Adjustment Disorder With Depressed Mood

Drug(s) suspected as cause:
Viagra



Possible Viagra side effects in 53 year old male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 53 year old male, weighing 77.1 kg (169.6 pounds)

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Viagra



Possible Viagra side effects in female

Reported by a physician from United States on 2012-08-24

Patient: female

Reactions: Dyspnoea, Chest Pain, Dizziness, Unevaluable Event, Headache, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Letairis
    Dosage: 10 mg, unk
    Administration route: Oral
    Indication: Pulmonary Hypertension
    Start date: 2012-04-12

Viagra



Possible Viagra side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: male

Reactions: Phimosis, Penis Disorder

Drug(s) suspected as cause:
Viagra



Possible Viagra side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: male

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Viagra



Possible Viagra side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Cardiac Disorder

Drug(s) suspected as cause:
Viagra



Possible Viagra side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: male

Reactions: Drug Effect Decreased, Testicular Disorder, Premature Ejaculation, Erection Increased, Penis Disorder

Drug(s) suspected as cause:
Viagra



Possible Viagra side effects in 69 year old male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 69 year old male, weighing 111.1 kg (244.4 pounds)

Reactions: Erection Increased, Erectile Dysfunction

Drug(s) suspected as cause:
Viagra



Possible Viagra side effects in

Reported by a physician from United States on 2012-08-24

Patient:

Reactions: Deafness Transitory

Drug(s) suspected as cause:
Viagra



Possible Viagra side effects in 76 year old male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 76 year old male, weighing 74.8 kg (164.6 pounds)

Reactions: Migraine, Nausea, Visual Acuity Reduced, Dizziness, Headache

Drug(s) suspected as cause:
Viagra



Possible Viagra side effects in 76 year old male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 76 year old male, weighing 74.8 kg (164.6 pounds)

Reactions: Drug Ineffective, Diabetes Mellitus

Drug(s) suspected as cause:
Viagra
    Dosage: 25 mg, as needed
    Administration route: Oral
    Indication: Erectile Dysfunction
    Start date: 2002-01-01

Viagra
    Dosage: 50 mg, as needed
    Administration route: Oral

Viagra
    Dosage: 100 mg, as needed
    Administration route: Oral
    End date: 2010-01-01



Possible Viagra side effects in male

Reported by a consumer/non-health professional from China on 2012-08-24

Patient: male

Reactions: Prostatitis, Pollakiuria, Prostatic Disorder

Drug(s) suspected as cause:
Viagra



Possible Viagra side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: male

Reactions: Throat Cancer

Drug(s) suspected as cause:
Viagra



Possible Viagra side effects in 32 year old male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 32 year old male, weighing 104.0 kg (228.8 pounds)

Reactions: Incorrect Dose Administered, Erection Increased, Penis Disorder

Drug(s) suspected as cause:
Viagra



Possible Viagra side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: male

Reactions: Sperm Concentration Increased, Scrotal Disorder

Drug(s) suspected as cause:
Viagra



Possible Viagra side effects in 61 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 61 year old female, weighing 81.6 kg (179.6 pounds)

Reactions: Off Label Use, Pruritus, Balance Disorder, Dyskinesia, Urticaria, Muscle Spasms, Tremor

Drug(s) suspected as cause:
Viagra



Possible Viagra side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Myocardial Infarction

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Protonix
    Dosage: unk

Viagra
    Dosage: unk



Possible Viagra side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: male

Reactions: Erection Increased

Drug(s) suspected as cause:
Viagra



Possible Viagra side effects in 29 year old male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 29 year old male

Reactions: Overdose

Adverse event resulted in: death

Drug(s) suspected as cause:
Alcohol
    Dosage: unk

Cocaine
    Dosage: unk

Viagra
    Dosage: unk



Possible Viagra side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: male

Reactions: Penile Curvature, Testicular Swelling, Erection Increased, Scrotal Disorder

Drug(s) suspected as cause:
Viagra



Possible Viagra side effects in 68 year old male

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 68 year old male, weighing 73.5 kg (161.6 pounds)

Reactions: Off Label Use, Drug Ineffective

Drug(s) suspected as cause:
Viagra

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