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Revatio (Sildenafil) - Life Threatening Events - Suspected Cause - Side Effect Reports

 
 



Index of reports > Life Threatening Events (15)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Revatio (Sildenafil) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Revatio side effects in 84 year old female

Reported by a physician from Japan on 2012-08-02

Patient: 84 year old female, weighing 40.0 kg (88.0 pounds)

Reactions: Pneumonia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Revatio
    Dosage: 20 mg, 3x/day
    Start date: 2011-12-15
    End date: 2012-01-05

Revatio
    Dosage: 10 mg, 3x/day
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-12-01
    End date: 2011-12-14

Other drugs received by patient: Blopress; Digoxin; Pravastatin; Lansoprazole; Sigmart; Aspirin; Warfarin; Lasix; Artist



Possible Revatio side effects in 58 year old male

Reported by a physician from Japan on 2012-08-01

Patient: 58 year old male, weighing 62.5 kg (137.5 pounds)

Reactions: Hypotension

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Revatio
    Dosage: 20 mg, 2x/day
    Administration route: Oral
    Start date: 2011-09-01
    End date: 2011-09-09

Revatio
    Dosage: 20 mg, 3x/day
    Administration route: Oral
    Indication: Mitral Valve Stenosis
    Start date: 2011-08-26
    End date: 2011-08-31

Other drugs received by patient: Lantus; Prink; Aspirin; Levothyroxine Sodium; Warfarin; Vancomycin; Imipenem and Cilastatin Sodium; Epogin; Lansoprazole; Loxonin; Apidra



Possible Revatio side effects in 67 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-30

Patient: 67 year old female, weighing 86.2 kg (189.6 pounds)

Reactions: Cellulitis, Respiratory Arrest, Coma, Convulsion, Loss of Consciousness, Blood Glucose Increased

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Revatio
    Dosage: 3x/day
    Indication: Pulmonary Hypertension
    Start date: 2012-02-01

Aztreonam
    Dosage: intravenous (not otherwise specified)
    Indication: Cellulitis
    Start date: 2012-06-01

Other drugs received by patient: Coumadin; Metoprolol Tartrate; Pravastatin; Lisinopril



Possible Revatio side effects in male

Reported by a physician from Japan on 2012-07-23

Patient: male, weighing 26.0 kg (57.2 pounds)

Reactions: Flushing, Atrial Tachycardia, Oxygen Saturation Increased, Hypoxia, Pneumothorax, Blood Pressure Decreased, Erythema

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Revatio
    Dosage: 1 mg/kg/day, every 4 hrs (injection into stomach)
    Start date: 2010-03-05

Milrinone Lactate
    Dosage: 1 mg/kg/day (0.25 ug/kg/min)
    Indication: Cardiac Failure
    Start date: 2010-03-01
    End date: 2010-03-11

Dopamine HCL
    Dosage: 11 mg/kg/day (3 ug/kg/min)
    Indication: Cardiac Failure
    Start date: 2010-03-01
    End date: 2010-03-12

Milrinone Lactate
    Indication: Pulmonary Hypertension

Flolan
    Dosage: 6 mg/kg/min
    Indication: Pulmonary Hypertension
    Start date: 2010-03-02

Revatio
    Dosage: 0.4 mg, every 4 hrs
    Indication: Pulmonary Hypertension
    Start date: 2010-03-02

Dobutrex
    Dosage: 11 mg/kg/day (3 ug/kg/min)
    Indication: Cardiac Failure
    Start date: 2010-03-01
    End date: 2010-03-12

Other drugs received by patient: Nitric Oxide



Possible Revatio side effects in male

Reported by a physician from Japan on 2012-07-17

Patient: male, weighing 26.0 kg (57.2 pounds)

Reactions: Flushing, Atrial Tachycardia, Oxygen Saturation Increased, Hypoxia, Pneumothorax, Erythema, Blood Pressure Decreased

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Dobutrex
    Dosage: 11 mg/kg/day (3 ug/kg/min)
    Indication: Cardiac Failure
    Start date: 2010-03-01
    End date: 2010-03-12

Milrinone Lactate
    Indication: Pulmonary Hypertension

Flolan
    Dosage: 6 mg/kg/min
    Indication: Pulmonary Hypertension
    Start date: 2010-03-02

Revatio
    Dosage: 0.4 mg, every 4 hrs
    Indication: Pulmonary Hypertension
    Start date: 2010-03-02

Revatio
    Dosage: 1 mg/kg/day, every 4 hrs (injection into stomach)
    Start date: 2010-03-05

Milrinone Lactate
    Dosage: 1 mg/kg/day (0.25 ug/kg/min)
    Indication: Cardiac Failure
    Start date: 2010-03-01
    End date: 2010-03-11

Dopamine HCL
    Dosage: 11 mg/kg/day (3 ug/kg/min)
    Indication: Cardiac Failure
    Start date: 2010-03-01
    End date: 2010-03-12

Other drugs received by patient: Nitric Oxide



Possible Revatio side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-18

Patient: male

Reactions: Cardio-Respiratory Arrest, Rash Erythematous, Oesophageal Disorder, Dermatitis Bullous, Toxic Epidermal Necrolysis, Oropharyngeal Discomfort, Nikolsky's Sign

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Norfloxacin
    Dosage: unk
    Start date: 2011-12-13
    End date: 2012-01-18

Tracleer
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-11-29
    End date: 2012-01-20

Alfuzosin HCL
    Dosage: unk
    Start date: 2011-12-08
    End date: 2012-01-18

Imovane
    Dosage: unk
    Start date: 2011-12-01
    End date: 2012-01-18

Revatio
    Dosage: unk
    Start date: 2012-01-15
    End date: 2012-01-20

Paroxetine HCL
    Dosage: unk
    Start date: 2012-01-12
    End date: 2012-01-18

Xanax
    Dosage: unk
    Start date: 2012-01-07
    End date: 2012-01-18

Revatio
    Dosage: unk
    Start date: 2011-11-23
    End date: 2011-11-29

Prednisolone
    Dosage: unk
    Start date: 2011-12-01
    End date: 2012-01-21

Proscar
    Dosage: unk
    Start date: 2012-01-10
    End date: 2012-01-18

Other drugs received by patient: Nexium; Procoralan



Possible Revatio side effects in 66 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-15

Patient: 66 year old male

Reactions: Cardiac Failure, Toxic Epidermal Necrolysis, Respiratory Arrest, Cardiac Arrest

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Prednisolone
    Dosage: 10 mg, 1x/day
    Administration route: Oral
    Start date: 2011-12-01
    End date: 2012-01-20

Revatio
    Dosage: unk
    Start date: 2011-11-23

Proscar
    Dosage: unk
    Administration route: Oral
    Start date: 2012-01-10
    End date: 2012-01-18

Norfloxacin
    Dosage: unk
    Start date: 2011-12-13
    End date: 2012-01-18

Tracleer
    Dosage: unk
    Administration route: Oral
    Start date: 2011-11-29
    End date: 2012-01-20

Imovane
    Dosage: 1 df, 1x/day
    Administration route: Oral
    Start date: 2011-12-01
    End date: 2012-01-18

Paroxetine HCL
    Dosage: unk
    Administration route: Oral
    Start date: 2012-01-12
    End date: 2012-01-18

Xanax
    Dosage: unk
    Administration route: Oral
    Start date: 2012-01-07
    End date: 2012-01-18

Alfuzosin HCL
    Dosage: unk
    Administration route: Oral
    Start date: 2011-12-08
    End date: 2012-01-18

Revatio
    Dosage: unk
    Administration route: Oral
    Start date: 2012-01-15
    End date: 2012-01-20

Other drugs received by patient: Ivabradine; Nexium



Possible Revatio side effects in male

Reported by a physician from France on 2012-06-13

Patient: male

Reactions: Toxic Epidermal Necrolysis

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Proscar
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-10
    End date: 2012-01-18

Norfloxacin
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-13
    End date: 2012-01-18

Alfuzosin HCL
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-08
    End date: 2012-01-18

Imovane
    Dosage: 1unit per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-01
    End date: 2012-01-18

Paroxetine HCL
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-12
    End date: 2012-01-18

Tracleer
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-11-29
    End date: 2012-01-20

Xanax
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-07
    End date: 2012-01-18

Revatio
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-15
    End date: 2012-01-20

Prednisolone
    Dosage: 10mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-01
    End date: 2012-01-20

Other drugs received by patient: Procoralan; Nexium



Possible Revatio side effects in female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-05-03

Patient: female

Reactions: Cardiac Failure, Anaemia, Pulmonary Alveolar Haemorrhage

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Flolan
    Indication: Pulmonary Arterial Hypertension
    End date: 2010-11-29

Ambrisentan
    Dosage: unk unk, qd
    Administration route: Oral
    Indication: Pulmonary Hypertension
    Start date: 2010-10-19
    End date: 2010-12-24

Flolan
    Start date: 2010-11-30

Revatio
    Administration route: Oral
    Indication: Pulmonary Hypertension

Other drugs received by patient: Prednisolone Acetate; Urso / 00465701 /; Aspartic Acid; Aldactone; Glakay; Glakay; Loxonin; Magmitt; Lansoprazole; Furosemide; Furosemide; Mucosta; Mucosta; Loxonin; Lansoprazole; Prednisolone Acetate; Aldactone; Magmitt



Possible Revatio side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-07

Patient: male

Reactions: Cardio-Respiratory Arrest, Oesophageal Disorder, Rash Erythematous, Dermatitis Bullous, Toxic Epidermal Necrolysis, Oropharyngeal Discomfort, Nikolsky's Sign

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Paroxetine Hydrochloride
    Dosage: unk
    Start date: 2012-01-10
    End date: 2012-01-18

Alfuzosin HCL
    Dosage: unk
    Start date: 2011-12-08
    End date: 2012-01-18

Xanax
    Dosage: unk
    Start date: 2012-01-07
    End date: 2012-01-18

Tracleer
    Dosage: unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-11-29
    End date: 2012-01-20

Revatio
    Dosage: unk
    Start date: 2012-01-15
    End date: 2012-01-20

Proscar
    Dosage: unk
    Start date: 2012-01-10
    End date: 2012-01-18

Imovane
    Dosage: unk
    Start date: 2011-12-01
    End date: 2012-01-18

Norfloxacin
    Dosage: unk
    Start date: 2011-12-13
    End date: 2012-01-18

Other drugs received by patient: Prednisolone; Nexium; Procoralan



Possible Revatio side effects in male

Reported by a physician from France on 2012-03-07

Patient: male

Reactions: Toxic Epidermal Necrolysis

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Paroxetine Hydrochloride
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-12
    End date: 2012-01-18

Revatio
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-15
    End date: 2012-01-20

Proscar
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-10
    End date: 2012-01-18

Imovane
    Dosage: 1unit per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-01
    End date: 2012-01-18

Alfuzosin HCL
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-08
    End date: 2012-01-18

Norfloxacin
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-13
    End date: 2012-01-18

Xanax
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-07
    End date: 2012-01-18

Tracleer
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-11-29
    End date: 2012-01-20

Other drugs received by patient: Procoralan; Prednisolone; Nexium



Possible Revatio side effects in 66 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-02-29

Patient: 66 year old male

Reactions: Respiratory Arrest, Toxic Epidermal Necrolysis, Cardiac Arrest

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Paroxetine Hydrochloride
    Dosage: unk
    Administration route: Oral
    Start date: 2012-01-12
    End date: 2012-01-18

Tracleer
    Dosage: unk
    Administration route: Oral
    Start date: 2011-11-29
    End date: 2012-01-20

Xanax
    Dosage: unk
    Administration route: Oral
    Start date: 2012-01-07
    End date: 2012-01-18

Proscar
    Dosage: unk
    Administration route: Oral
    Start date: 2012-01-10
    End date: 2012-01-18

Imovane
    Dosage: 1 df, 1x/day
    Administration route: Oral
    Start date: 2011-12-01
    End date: 2012-01-18

Revatio
    Dosage: unk
    Start date: 2011-11-23

Revatio
    Dosage: unk
    Administration route: Oral
    Start date: 2012-01-15
    End date: 2012-01-20

Alfuzosin HCL
    Dosage: unk
    Administration route: Oral
    Start date: 2011-12-08
    End date: 2012-01-18

Chibroxine
    Dosage: unk
    Start date: 2011-12-13
    End date: 2012-01-18

Other drugs received by patient: Nexium; Prednisolone; Ivabradine



Possible Revatio side effects in female

Reported by a physician from United Kingdom on 2011-12-12

Patient: female

Reactions: Cardiac Failure, Pulmonary Alveolar Haemorrhage, Anaemia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Flolan
    Start date: 2010-11-30

Revatio
    Administration route: Oral
    Indication: Pulmonary Hypertension

Ambrisentan
    Dosage: unk unk, qd
    Administration route: Oral
    Indication: Pulmonary Hypertension
    Start date: 2010-10-19
    End date: 2010-12-24

Flolan
    Indication: Pulmonary Arterial Hypertension
    End date: 2010-11-29

Other drugs received by patient: Furosemide; Glakay; Lansoprazole; Aspartic Acid; Loxonin; Urso / 00465701 /; Aldactone; Magmitt; Lansoprazole; Prednisolone; Furosemide; Glakay; Aldactone; Prednisolone; Mucosta; Mucosta; Magmitt; Loxonin



Possible Revatio side effects in female

Reported by a physician from Japan on 2011-12-07

Patient: female, weighing 41.0 kg (90.2 pounds)

Reactions: Cardiac Failure, Pulmonary Alveolar Haemorrhage, Anaemia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Flolan
    Start date: 2010-11-30

Revatio
    Administration route: Oral
    Indication: Pulmonary Hypertension

Flolan
    Indication: Pulmonary Arterial Hypertension
    End date: 2010-11-29

Volibris
    Administration route: Oral
    Indication: Pulmonary Hypertension
    Start date: 2010-10-19
    End date: 2010-12-24

Other drugs received by patient: Magmitt; Urso 250; Aldactone; Prednisolone; Glakay; Furosemide; Loxonin; Lansoprazole; Aspartic Acid; Mucosta



Possible Revatio side effects in 7 year old female

Reported by a physician from Germany on 2011-10-18

Patient: 7 year old female, weighing 17.5 kg (38.5 pounds)

Reactions: Autoimmune Hepatitis

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Revatio
    Dosage: 20 mg, 2x/day
    Administration route: Oral
    Indication: Pulmonary Hypertension
    Start date: 2009-07-01

Bosentan
    Dosage: 62.5 mg, unk
    Indication: Pulmonary Arterial Hypertension
    Start date: 2009-08-01
    End date: 2010-10-01

Other drugs received by patient: Marcumar; Norvasc

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