Adverse events that occurred in ≥ 10% of kidney transplant patients treated with tacrolimus in conjunction with MMF in Study 1* are presented below:

KIDNEY TRANSPLANTATION: ADVERSE EVENTS OCCURRING IN ≥ 10% OF TACROLIMUS-TREATED PATIENTS 
  Tacrolimus
(Group C)
(N=403)  Cyclosporine
(Group A)
(N=384)  Cyclosporine
( Group B)
(N=408) 
Anemia  17% 19% 17%
Leucopenia  13% 10% 10%
Diarrhea  25% 16% 13%
Edema peripheral  11% 12% 13%
Urinary tract infection 24% 28% 24%
Hyperlipidemia  10% 15% 13%
Hypertension (see PRECAUTIONS )  13% 14% 12%

* Study 1 was conducted entirely outside of the United States. Such studies often report a lower incidence of adverse events in comparison to US studies.

Adverse events that occurred in ≥15% of kidney transplant patients treated with tacrolimus in conjunction with MMF in Study 2 are presented below:

KIDNEY TRANSPLANTATION: ADVERSE EVENTS OCCURRING IN ≥ 15% OF TACROLIMUS-TREATED PATIENTS 
   Tacrolimus (N=212)  Cyclosporine (N=212) 
Gastrointestinal Disorders    
Diarrhea  44%   26%
Nausea  39% 47%
Constipation 36% 41%
Vomiting 26% 25%
Dyspepsia  18% 15%
Injury, Poisoning, and Procedural Complications   
Post Procedural Pain 29% 27%
Incision Site Complication 28% 23%
Graft Dysfunction 24% 18%
Metabolism and Nutrition Disorders   
Hypomagnesemia  28%  22%
Hypophosphatemia  28%  21%
Hyperkalemia (see WARNINGS )  26%  19%
Hyperglycemia (see WARNINGS )  21%  15%
Hyperlipidemia  18%  25%
Hypokalemia  16%  18%
Nervous System Disorders     
Tremor  34%  20%
Headache  24%  25%
Blood and Lymphatic System Disorders     
Anemia  30%  28%
Leukopenia  16%  12%
Miscellaneous     
Edema Peripheral  35%  46%
Hypertension (see PRECAUTIONS )  32%  35%
Insomnia  30%  21%
Urinary Tract Infection  26%  22%
Blood creatinine increased  23%  23%

Less frequently observed adverse reactions in both liver transplantation and kidney transplantation patients are described under the subsection Less Frequently Reported Adverse Reactions sh