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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

REVATIO: 434 Adverse Event Reports & Safety Profile

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434
Total FAERS Reports
199 (45.9%)
Deaths Reported
110
Hospitalizations
434
As Primary/Secondary Suspect
7
Life-Threatening
5
Disabilities

First Report: 2007 · Latest Report: 20140623

What Are the Most Common REVATIO Side Effects?

#1 Most Reported
Death
79 reports (18.2%)
#2 Most Reported
Pulmonary hypertension
44 reports (10.1%)
#3 Most Reported
Dyspnoea
41 reports (9.4%)

All REVATIO Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Death 79 18.2% 79 3
Pulmonary hypertension 44 10.1% 39 10
Dyspnoea 41 9.5% 6 14
Cardiac failure 26 6.0% 19 6
Fall 21 4.8% 2 10
Pneumonia 20 4.6% 10 9
Malaise 17 3.9% 1 6
Cardiac disorder 14 3.2% 6 3
Respiratory failure 13 3.0% 13 4
Fluid retention 11 2.5% 1 10
Hypotension 10 2.3% 4 6
Off label use 10 2.3% 5 2
Chronic obstructive pulmonary disease 9 2.1% 5 1
Myocardial infarction 9 2.1% 5 1
Cardiac failure congestive 8 1.8% 7 3
Drug ineffective 8 1.8% 1 1
Fatigue 8 1.8% 0 1
Lung disorder 8 1.8% 4 5
Depression 7 1.6% 1 4
Headache 7 1.6% 0 1

Who Reports REVATIO Side Effects? Age & Gender Data

Average age: 65.1 years. Most reports from: US. View detailed demographics →

Is REVATIO Getting Safer? Reports by Year

YearReportsDeathsHosp.
2007 2 0 0
2008 1 1 0
2009 3 0 3
2010 5 1 1
2011 14 4 7
2012 13 7 6
2013 71 29 29
2014 84 37 21

View full timeline →

What Is REVATIO Used For?

IndicationReports
Pulmonary hypertension 153
Pulmonary arterial hypertension 111
Product used for unknown indication 8
Cardiac disorder 6

REVATIO vs Alternatives: Which Is Safer?

REVATIO vs REVEFENACIN REVATIO vs REVLIMID REVATIO vs REVOLADE REVATIO vs REVUMENIB REVATIO vs REYATAZ REVATIO vs REZAFUNGIN REVATIO vs RIBASPHERE REVATIO vs RIBAVIRIN REVATIO vs RIBOCICLIB REVATIO vs RIBOFLAVIN

Official FDA Label for REVATIO

Official prescribing information from the FDA-approved drug label.