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:
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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