Prograf (Page 8 of 12)

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 Prograf in conjunction with azathioprine are presented below:

KIDNEY TRANSPLANTATION: ADVERSE EVENTS OCCURRING IN ≥ 15% OF PATIENTS TREATED WITH PROGRAF IN CONJUNCTION WITH AZATHIOPRINE

Prograf

CBIR

Nervous System

Tremor (see WARNINGS)

Headache (see WARNINGS)

Insomnia

Paresthesia

Dizziness

54%

44%

32%

23%

19%

34%

38%

30%

16%

16%

Gastrointestinal

Diarrhea

Nausea

Constipation

Vomiting

Dyspepsia

44%

38%

35%

29%

28%

41%

36%

43%

23%

20%

Cardiovascular

Hypertension (see PRECAUTIONS)

Chest pain

50%

19%

52%

13%

Urogenital

Creatinine Increased (see WARNINGS)

Urinary Tract Infection

45%

34%

42%

35%

Metabolic and Nutritional

Hypophosphatemia

Hypomagnesemia

Hyperlipemia

Hyperkalemia (see WARNINGS)

Diabetes Mellitus (see WARNINGS)

Hypokalemia

Hyperglycemia (see WARNINGS)

Edema

49%

34%

31%

31%

24%

22%

22%

18%

53%

17%

38%

32%

9%

25%

16%

19%

Hemic and Lymphatic

Anemia

Leukopenia

30%

15%

24%

17%

Miscellaneous

Infection

Peripheral Edema

Asthenia

Abdominal Pain

Pain

Fever

Back Pain

45%

36%

34%

33%

32%

29%

24%

49%

48%

30%

31%

30%

29%

20%

Respiratory System

Dyspnea

Cough Increased

22%

18%

18%

15%

Musculoskeletal

Arthralgia

25%

24%

Skin

Rash

17%

12%

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

*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.
KIDNEY TRANSPLANTATION: ADVERSE EVENTS OCCURRING IN ≥ 10% OF PROGRAF-TREATED PATIENTS
Prograf (Group C) Cyclosporine (Group A) Cyclosporine (Group B)
(N=403) (N=384) (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%

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

KIDNEY TRANSPLANTATION: ADVERSE EVENTS OCCURRING IN ≥ 15% OF PROGRAF-TREATED PATIENTS
Prograf Cyclosporine
(N=212) (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 shown below.

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