Tacrolimus

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

Top reporter: Astellas Pharma Us, Inc.

Calcineurin Inhibitor Immunosuppressant [EPC]Corticosteroid [EPC]Kinase Inhibitor [EPC]Azole Antifungal [EPC]Antimetabolite Immunosuppressant [EPC]
152,098
Total Reports
75,124
Serious Reports
25,252
Death Reports
30
Reported Reactions
Death Report Ratio: High (16.60%)

Patient Demographics

Male
74,247
Female
58,418

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Tacrolimus.

# Reaction Reports % of Total
1 OFF LABEL USE 14,690
11.4%
2 DRUG INEFFECTIVE 10,088
7.8%
3 DRUG INTERACTION 6,334
4.9%
4 PRODUCT USE IN UNAPPROVED INDICATION 6,247
4.8%
5 ACUTE KIDNEY INJURY 5,968
4.6%
6 DIARRHOEA 5,843
4.5%
7 TRANSPLANT REJECTION 4,979
3.9%
8 DEATH 4,968
3.9%
9 PYREXIA 4,802
3.7%
10 CYTOMEGALOVIRUS INFECTION 4,559
3.5%
11 PNEUMONIA 4,461
3.5%
12 COVID-19 3,926
3.0%
13 TOXICITY TO VARIOUS AGENTS 3,811
3.0%
14 RENAL IMPAIRMENT 3,626
2.8%
15 SEPSIS 3,462
2.7%
16 NAUSEA 3,224
2.5%
17 CONDITION AGGRAVATED 3,058
2.4%
18 VOMITING 2,982
2.3%
19 ANAEMIA 2,951
2.3%
20 POST TRANSPLANT LYMPHOPROLIFERATIVE DISORDER 2,948
2.3%
21 BLOOD CREATININE INCREASED 2,915
2.3%
22 RENAL FAILURE 2,886
2.2%
23 THROMBOTIC MICROANGIOPATHY 2,834
2.2%
24 RESPIRATORY FAILURE 2,775
2.2%
25 HEADACHE 2,513
1.9%
26 SEPTIC SHOCK 2,475
1.9%
27 URINARY TRACT INFECTION 2,475
1.9%
28 DYSPNOEA 2,453
1.9%
29 FATIGUE 2,378
1.8%
30 IMMUNOSUPPRESSANT DRUG LEVEL INCREASED 2,364
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.