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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.

TACROLIMUS\TACROLIMUS ANHYDROUS: 6,814 Adverse Event Reports & Safety Profile

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6,814
Total FAERS Reports
888 (13.0%)
Deaths Reported
2,610
Hospitalizations
6,814
As Primary/Secondary Suspect
375
Life-Threatening
144
Disabilities

First Report: 19471020 · Latest Report: 20190814

What Are the Most Common TACROLIMUS\TACROLIMUS ANHYDROUS Side Effects?

#1 Most Reported
Off label use
708 reports (10.4%)
#2 Most Reported
Death
321 reports (4.7%)
#3 Most Reported
Transplant rejection
278 reports (4.1%)

All TACROLIMUS\TACROLIMUS ANHYDROUS Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 708 10.4% 67 192
Death 321 4.7% 321 34
Transplant rejection 278 4.1% 18 50
Diarrhoea 257 3.8% 23 152
Pyrexia 243 3.6% 20 134
Alopecia 232 3.4% 0 6
Drug ineffective 198 2.9% 12 41
Transplant dysfunction 198 2.9% 2 15
Hospitalisation 194 2.9% 12 192
Pneumonia 193 2.8% 35 116
Acute kidney injury 185 2.7% 35 150
Renal impairment 185 2.7% 33 89
Nausea 170 2.5% 6 66
Vomiting 170 2.5% 8 91
Acne 169 2.5% 0 2
Ovarian cyst 168 2.5% 0 2
Renal failure 163 2.4% 46 93
Tremor 159 2.3% 4 38
Immunosuppressant drug level increased 142 2.1% 9 81
Malaise 139 2.0% 6 48

Who Reports TACROLIMUS\TACROLIMUS ANHYDROUS Side Effects? Age & Gender Data

Gender: 48.0% female, 52.0% male. Average age: 48.1 years. Most reports from: US. View detailed demographics →

Is TACROLIMUS\TACROLIMUS ANHYDROUS Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 8 0 3
2001 7 1 1
2002 8 2 2
2003 14 1 6
2004 21 4 10
2005 19 4 9
2006 20 7 10
2007 55 5 29
2008 53 10 29
2009 78 7 37
2010 89 19 40
2011 112 15 61
2012 139 24 85
2013 229 51 124
2014 584 96 311
2015 699 119 356
2016 598 97 318
2017 567 97 273
2018 472 49 212
2019 129 10 55

View full timeline →

What Is TACROLIMUS\TACROLIMUS ANHYDROUS Used For?

IndicationReports
Renal transplant 1,368
Product used for unknown indication 1,105
Liver transplant 756
Prophylaxis against transplant rejection 578
Rheumatoid arthritis 378
Heart transplant 269
Immunosuppression 264
Immunosuppressant drug therapy 257
Transplant 235
Lung transplant 195

TACROLIMUS\TACROLIMUS ANHYDROUS vs Alternatives: Which Is Safer?

TACROLIMUS\TACROLIMUS ANHYDROUS vs TADALAFIL TACROLIMUS\TACROLIMUS ANHYDROUS vs TAFAMIDIS TACROLIMUS\TACROLIMUS ANHYDROUS vs TAFAMIDIS MEGLUMINE TACROLIMUS\TACROLIMUS ANHYDROUS vs TAFASITAMAB TACROLIMUS\TACROLIMUS ANHYDROUS vs TAFASITAMAB-CXIX TACROLIMUS\TACROLIMUS ANHYDROUS vs TAFINLAR TACROLIMUS\TACROLIMUS ANHYDROUS vs TAFLUPROST TACROLIMUS\TACROLIMUS ANHYDROUS vs TAGRAXOFUSP-ERZS TACROLIMUS\TACROLIMUS ANHYDROUS vs TAHOR TACROLIMUS\TACROLIMUS ANHYDROUS vs TALAZOPARIB

Official FDA Label for TACROLIMUS\TACROLIMUS ANHYDROUS

Official prescribing information from the FDA-approved drug label.