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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