Tacrolimus Extended-

Common brands: Prograf, Tacrolimus, Envarsus Xr, Cellcept, Mycophenolate Mofetil

Top reporter: Astellas Pharma Us, Inc.

Calcineurin Inhibitor Immunosuppressant [EPC]Corticosteroid [EPC]Kinase Inhibitor [EPC]Antimetabolite Immunosuppressant [EPC]Azole Antifungal [EPC]
120,821
Total Reports
65,469
Serious Reports
19,320
Death Reports
30
Reported Reactions
Death Report Ratio: High (15.99%)

Patient Demographics

Male
58,825
Female
44,937

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Tacrolimus Extended-.

# Reaction Reports % of Total
1 OFF LABEL USE 12,173
11.5%
2 DRUG INEFFECTIVE 8,572
8.1%
3 PRODUCT USE IN UNAPPROVED INDICATION 5,942
5.6%
4 DRUG INTERACTION 5,465
5.2%
5 ACUTE KIDNEY INJURY 5,221
4.9%
6 DIARRHOEA 4,412
4.2%
7 TRANSPLANT REJECTION 4,033
3.8%
8 CYTOMEGALOVIRUS INFECTION 3,919
3.7%
9 PYREXIA 3,753
3.5%
10 COVID-19 3,684
3.5%
11 TOXICITY TO VARIOUS AGENTS 3,551
3.3%
12 PNEUMONIA 3,457
3.3%
13 DEATH 3,359
3.2%
14 POST TRANSPLANT LYMPHOPROLIFERATIVE DISORDER 2,802
2.6%
15 SEPSIS 2,783
2.6%
16 RENAL IMPAIRMENT 2,771
2.6%
17 CONDITION AGGRAVATED 2,598
2.5%
18 NAUSEA 2,397
2.3%
19 THROMBOTIC MICROANGIOPATHY 2,342
2.2%
20 RESPIRATORY FAILURE 2,338
2.2%
21 ANAEMIA 2,208
2.1%
22 BLOOD CREATININE INCREASED 2,143
2.0%
23 VOMITING 2,143
2.0%
24 MULTIPLE ORGAN DYSFUNCTION SYNDROME 2,137
2.0%
25 SEPTIC SHOCK 2,118
2.0%
26 RENAL FAILURE 2,012
1.9%
27 URINARY TRACT INFECTION 1,984
1.9%
28 NEUTROPENIA 1,949
1.8%
29 DYSPNOEA 1,894
1.8%
30 INFECTION 1,880
1.8%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.