Mycophenolic Acid

Common brands: Myfortic, Prograf, Envarsus Xr, Tacrolimus, Prednisone

Top reporter: Novartis Pharmaceuticals Corporation

Antimetabolite Immunosuppressant [EPC]Calcineurin Inhibitor Immunosuppressant [EPC]Corticosteroid [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Loop Diuretic [EPC]
31,034
Total Reports
16,806
Serious Reports
4,350
Death Reports
30
Reported Reactions
Death Report Ratio: High (14.02%)

Patient Demographics

Male
14,905
Female
13,132

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Mycophenolic Acid.

# Reaction Reports % of Total
1 OFF LABEL USE 2,743
9.2%
2 DIARRHOEA 1,935
6.5%
3 DRUG INEFFECTIVE 1,774
6.0%
4 DEATH 1,404
4.7%
5 PYREXIA 1,328
4.5%
6 ACUTE KIDNEY INJURY 1,268
4.3%
7 NAUSEA 1,129
3.8%
8 COVID-19 1,037
3.5%
9 FATIGUE 971
3.3%
10 VOMITING 953
3.2%
11 PRODUCT USE IN UNAPPROVED INDICATION 942
3.2%
12 PNEUMONIA 933
3.1%
13 HEADACHE 891
3.0%
14 DYSPNOEA 889
3.0%
15 DRUG INTERACTION 879
3.0%
16 BLOOD CREATININE INCREASED 863
2.9%
17 CYTOMEGALOVIRUS INFECTION 806
2.7%
18 URINARY TRACT INFECTION 751
2.5%
19 MALAISE 731
2.5%
20 RENAL IMPAIRMENT 716
2.4%
21 TRANSPLANT REJECTION 714
2.4%
22 SEPSIS 710
2.4%
23 ANAEMIA 709
2.4%
24 KIDNEY TRANSPLANT REJECTION 708
2.4%
25 COUGH 700
2.4%
26 ASTHENIA 673
2.3%
27 CONDITION AGGRAVATED 670
2.3%
28 ABDOMINAL PAIN 639
2.2%
29 HYPERTENSION 610
2.1%
30 LEUKOPENIA 593
2.0%

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.