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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.

PROGRAF: 1,028 Adverse Event Reports & Safety Profile

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1,028
Total FAERS Reports
139 (13.5%)
Deaths Reported
338
Hospitalizations
1,028
As Primary/Secondary Suspect
24
Life-Threatening
12
Disabilities

First Report: 19950105 · Latest Report: 20140607

What Are the Most Common PROGRAF Side Effects?

#1 Most Reported
Drug ineffective
143 reports (13.9%)
#2 Most Reported
Off label use
140 reports (13.6%)
#3 Most Reported
Acute graft versus host disease
64 reports (6.2%)

All PROGRAF Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 143 13.9% 20 24
Off label use 140 13.6% 13 41
Acute graft versus host disease 64 6.2% 3 2
Death 44 4.3% 44 5
Chronic graft versus host disease 43 4.2% 4 4
Renal failure 31 3.0% 5 12
Diarrhoea 30 2.9% 2 18
Pneumonia 30 2.9% 7 22
Kidney transplant rejection 29 2.8% 7 16
Malaise 27 2.6% 1 5
Transplant rejection 23 2.2% 7 11
Diabetes mellitus 21 2.0% 3 5
Anaemia 20 2.0% 4 13
Hospitalisation 20 2.0% 2 20
Asthenia 19 1.9% 1 8
Pyrexia 19 1.9% 3 16
Investigation 18 1.8% 1 18
Renal impairment 18 1.8% 3 9
Transplant failure 18 1.8% 3 6
Tremor 18 1.8% 0 3

Who Reports PROGRAF Side Effects? Age & Gender Data

Average age: 47.1 years. Most reports from: US. View detailed demographics →

Is PROGRAF Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 4 1 1
2001 1 0 0
2002 6 0 2
2003 2 0 1
2004 7 1 1
2005 3 0 2
2006 5 1 0
2007 11 0 4
2008 14 4 7
2009 21 1 8
2010 21 3 5
2011 37 4 16
2012 49 6 21
2013 311 49 135
2014 110 29 61

View full timeline →

What Is PROGRAF Used For?

IndicationReports
Renal transplant 350
Liver transplant 192
Prophylaxis against graft versus host disease 101
Product used for unknown indication 89
Heart transplant 52
Lung transplant 33
Pancreas transplant 28
Rheumatoid arthritis 23
Prophylaxis against transplant rejection 20
Immunosuppressant drug therapy 16

PROGRAF vs Alternatives: Which Is Safer?

PROGRAF vs PROHANCE PROGRAF vs PROLIA PROGRAF vs PROMACTA PROGRAF vs PROMAZINE PROGRAF vs PROMETHAZINE PROGRAF vs PROMETHAZINE\PROMETHAZINE PROGRAF vs PROMETHAZINE\THIOUREA PROGRAF vs PROPAFENONE PROGRAF vs PROPARACAINE PROGRAF vs PROPECIA

Official FDA Label for PROGRAF

Official prescribing information from the FDA-approved drug label.