%
Tremor (see WARNINGS ) 56% 46% 48% 32%
Insomnia 64% 68% 32% 23%
Paresthesia 40% 30% 17% 17%
Gastrointestinal
Diarrhea 72% 47% 37% 27%
Nausea 46% 37% 32% 27%
Constipation 24% 27% 23% 21%
LFT Abnormal 36% 30% 6% 5%
Anorexia 34% 24% 7% 5%
Vomiting 27% 15% 14% 11%
Cardiovascula r
Hypertension (see PRECAUTIONS ) 47% 56% 38% 43%
Urogenital
Kidney Function Abnormal (see WARNINGS ) 40% 27% 36% 23%
Creatinine Increased (see WARNINGS ) 39% 25% 24% 19%
BUN Increased (see WARNINGS ) 30% 22% 12% 9%
Urinary Tract Infection 16% 18% 21% 19%
Oliguria 18% 15% 19% 12%
Metabolic and Nutritional
Hyperkalemia (see WARNINGS ) 45% 26% 13% 9%
Hypokalemia 29% 34% 13% 16%
Hyperglycemia (see WARNINGS ) 47% 38% 33% 22%
Hypomagnesemia 48% 45% 16% 9%
Hemic and Lymphatic
Anemia 47% 38% 5% 1%
Leukocytosis 32% 26% 8% 8%
Thrombocytopenia 24% 20% 14% 19%
Miscellaneous
Abdominal Pain 59% 54% 29% 22%
Pain 63% 57% 24% 22%
Fever 48% 56% 19% 22%
Asthenia 52% 48% 11% 7%
Back Pain 30% 29% 17% 17%
Ascites 27% 22% 7% 8%
Peripheral Edema 26% 26% 12% 14%
Respiratory System
Pleural Effusion 30% 32% 36% 35%
Atelectasis 28% 30% 5% 4%
Dyspnea 29% 23% 5% 4%
Skin and Appendages
Pruritus 36% 20% 15% 7%
Rash 24% 19% 10% 4%
Less frequently observed adverse reactions in both liver transplantation and kidney transplantation patients are described
under the subsection Less Frequently Reported Adverse Reactions below.
Kidney Transplantation
The most common adverse reactions reported were infection, tremor, hypertension, abnormal renal function, constipation,
diarrhea, headache, abdominal pain and insomnia.
Adverse events that occurred in ≥ 15% of kidney transplant patients treated with tacrolimus in conjunction with azathioprine
are presented below.
KIDNEY TRANSPLANTATION: ADVERSE EVENTS OCCURRING IN ≥ 15% OF PATIENTS TREATED WITH TACROLIMUS IN CONJUNCTION WITH AZATHIOPRINE
Tacrolimus
(N=205) CBIR
(N=207)
Nervous System
Tremor (see WARNINGS ) 54% 34%
Headache (see WARNINGS ) 44% 38%
Insomnia 32% 30%
Paresthesia 23% 16%
Dizziness 19% 16%
Gastrointestinal
Diarrhea 44% 41%
Nausea 38% 36%
Constipation 35% 43%
Vomiting 29% 23%
Dyspepsia 28% 20%
Cardiovascular
Hypertension (see PRECAUTIONS ) 50% 52%
Chest pain 19% 13%
Urogenital
Creatinine Increased (see WARNINGS ) 45% 42%
Urinary Tract Infection 34% 35%
Metabolic and Nutritional
Hypophosphatemia 49% 53%
Hypomagnesemia 34% 1
