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Revatio (Sildenafil) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Revatio (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 (1308)
Death (670)
Life Threatening Events (15)
Disability (4)

Reports by Reaction Type

Death (377)Pulmonary Hypertension (93)Dyspnoea (90)Disease Progression (52)Pneumonia (52)Cardiac Failure (44)Hypotension (41)Headache (40)Malaise (39)Dizziness (38)Fall (33)Cardiac Failure Congestive (28)

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

Possible Revatio side effects in 63 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: 63 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Revatio



Possible Revatio side effects in female

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

Patient: female

Reactions: Tinnitus, Hearing Impaired

Drug(s) suspected as cause:
Revatio



Possible Revatio side effects in 57 year old female

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

Patient: 57 year old female, weighing 77.1 kg (169.6 pounds)

Reactions: Drug Ineffective, Dizziness, Epistaxis

Drug(s) suspected as cause:
Revatio
    Dosage: 20 mg, 3x/day
    Indication: Pulmonary Hypertension

Revatio
    Dosage: unk

Warfarin Sodium
    Dosage: alternating dose of 7.5mg and 10mg daily



Possible Revatio side effects in 68 year old male

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

Patient: 68 year old male, weighing 80.7 kg (177.6 pounds)

Reactions: Arrhythmia

Adverse event resulted in: death

Drug(s) suspected as cause:
Revatio

Other drugs received by patient: Metoprolol; Acetylsalicylic Acid



Possible Revatio side effects in 75 year old female

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

Patient: 75 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Revatio



Possible Revatio side effects in 68 year old female

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

Patient: 68 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Revatio



Possible Revatio side effects in 90 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: 90 year old female

Reactions: Interstitial Lung Disease

Adverse event resulted in: death

Drug(s) suspected as cause:
Revatio
    Dosage: 20 mg, 3x/day
    Administration route: Oral
    Indication: Pulmonary Hypertension
    Start date: 2010-10-01

Revatio
    Indication: Interstitial Lung Disease



Possible Revatio side effects in 84 year old male

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

Patient: 84 year old male

Reactions: Pulmonary Hypertension

Adverse event resulted in: death

Drug(s) suspected as cause:
Revatio



Possible Revatio side effects in 81 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient: 81 year old female, weighing 59.9 kg (131.7 pounds)

Reactions: Productive Cough, Pneumonia Fungal, Dyspnoea, Wheezing, Antibiotic Resistant Staphylococcus Test Positive, Chronic Obstructive Pulmonary Disease, Multi-Organ Failure, Lung Disorder, Fatigue, Respiratory Failure, Pneumonia Staphylococcal, Asthenia, Aspergillus Test Positive

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Revatio
    Dosage: 20 mg, 3x/day
    Administration route: Oral
    Indication: Pulmonary Hypertension
    Start date: 2012-02-20
    End date: 2012-07-30

Treprostinil Sodium
    Dosage: unk

Other drugs received by patient: Ativan; Lasix; Aleve; Tracleer; Ferrous Sulfate; Duoneb; Lipitor; Coumadin; Klor-CON; Cardizem; Zetia; Synthroid; Digoxin; Protonix



Possible Revatio side effects in 70 year old male

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

Patient: 70 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Revatio



Possible Revatio side effects in 97 year old male

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

Patient: 97 year old male

Reactions: Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Revatio



Possible Revatio side effects in 73 year old female

Reported by a physician from United States on 2012-08-23

Patient: 73 year old female

Reactions: Lung Neoplasm Malignant

Adverse event resulted in: death

Drug(s) suspected as cause:
Revatio

Revatio
    Dosage: 20 mg, 3x/day
    Indication: Pulmonary Hypertension
    Start date: 2011-05-16



Possible Revatio side effects in 81 year old female

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

Patient: 81 year old female, weighing 52.2 kg (114.7 pounds)

Reactions: HIP Fracture, Joint Swelling, Drug Ineffective, Diarrhoea, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flolan
    Dosage: 5 mg, unk
    Indication: Pulmonary Arterial Hypertension

Revatio
    Dosage: 80 mg, 3x/day
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension

Viagra
    Dosage: unk
    Indication: Pulmonary Arterial Hypertension

Other drugs received by patient: Ambrisentan; Cubicin



Possible Revatio side effects in 59 year old female

Reported by a physician from United States on 2012-08-22

Patient: 59 year old female

Reactions: Off Label Use, Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Revatio



Possible Revatio side effects in 74 year old female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 74 year old female

Reactions: Renal Failure Chronic, Cardiac Failure Congestive

Adverse event resulted in: death

Drug(s) suspected as cause:
Revatio
    Dosage: 20 mg 1/2 tablet bid
    Indication: Pulmonary Hypertension
    Start date: 2012-04-26
    End date: 2012-08-07

Revatio
    Indication: Cardiomyopathy



Possible Revatio side effects in

Reported by a pharmacist from United States on 2012-08-22

Patient:

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Revatio



Possible Revatio side effects in 48 year old female

Reported by a pharmacist from United States on 2012-08-22

Patient: 48 year old female

Reactions: Mental Impairment, Somnolence

Drug(s) suspected as cause:
Revatio

Other drugs received by patient: Plavix; Dexamethasone; Carvedilol; Atorvastatin; Buspirone; Furosemide; Celebrex



Possible Revatio side effects in 65 year old male

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 65 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Revatio



Possible Revatio side effects in 83 year old female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 83 year old female

Reactions: Rhinorrhoea, Gallbladder Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Revatio



Possible Revatio side effects in 67 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22

Patient: 67 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Revatio



Possible Revatio side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Ear Disorder, Hearing Impaired

Drug(s) suspected as cause:
Revatio



Possible Revatio side effects in 55 year old female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: 55 year old female, weighing 56.7 kg (124.7 pounds)

Reactions: Anxiety, Blood Electrolytes Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Revatio

Other drugs received by patient: Trazodone; Omeprazole



Possible Revatio side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: male

Reactions: COR Pulmonale, Drug Interaction, Chronic Obstructive Pulmonary Disease

Adverse event resulted in: death

Drug(s) suspected as cause:
Coumadin

Digoxin

Revatio
    Dosage: 60 mg
    Indication: Lung Disorder
    Start date: 2011-11-01



Possible Revatio side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Hypoacusis, Ear Disorder

Drug(s) suspected as cause:
Revatio



Possible Revatio side effects in 90 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: 90 year old female

Reactions: Pulmonary Hypertension, Disease Progression

Adverse event resulted in: death

Drug(s) suspected as cause:
Revatio



Possible Revatio side effects in 76 year old male

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: 76 year old male

Reactions: Head Injury, Cerebral Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Revatio



Possible Revatio side effects in 89 year old male

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: 89 year old male

Reactions: Death, Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Revatio



Possible Revatio side effects in 81 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20

Patient: 81 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Revatio



Possible Revatio side effects in 67 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20

Patient: 67 year old male

Reactions: Gout, Pain, Arthritis

Drug(s) suspected as cause:
Revatio



Possible Revatio side effects in 75 year old female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: 75 year old female, weighing 63.0 kg (138.7 pounds)

Reactions: Tooth Abscess, Dental Caries

Drug(s) suspected as cause:
Revatio

Other drugs received by patient: Paroxetine; Levothyroxine; Pravastatin; Warfarin; Lasix; Pantoprazole; Zolpidem

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