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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