Рефераты. Такролимус

|Constipation |24 |27 |23 |21 |

|LFT Abnormal |36 |30 |6 |5 |

|Anorexia |34 |24 |7 |5 |

|Vomiting |27 |15 |14 |11 |

|Cardiovascular | | | | |

|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, decreased renal function, constipation, diarrhea, headache,

abdominal pain and insomnia.

Adverse events that occurred in > 15 % of Prograf-treated kidney transplant

patients are presented below:

KIDNEY TRANSPLANTATION: ADVERSE EVENTS OCCURRING IN > 15% OF PROGRAF-

TREATED PATIENTS

| |Prograf |CBIR |

| |(N=205) |(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 |17 |

|Hyperlipemia |31 |38 |

|Hyperkalemia (see WARNINGS) |31 |32 |

|Diabetes Mellitus (see WARNINGS) |24 |9 |

|Hypokalemia |22 |25 |

|Hyperglycemia (see WARNINGS) |22 |16 |

|Edema |18 |19 |

|Hemic and Lymphatic | | |

|Anemia |30 |24 |

|Leukopenia |15 |17 |

|Miscellaneous | | |

|Infection |45 |49 |

|Peripheral Edema |36 |48 |

|Asthenia |34 |30 |

|Abdominal Pain |33 |31 |

|Pain |32 |30 |

|Fever |29 |29 |

|Back Pain |24 |20 |

|Respiratory System | | |

|Dyspnea |22 |18 |

|Cough Increased |18 |15 |

|Musculoskeletal | | |

|Arthralgia |25 |24 |

|Skin | | |

|Rash |17 |12 |

|Pruritis |15 |7 |

Less frequently observed adverse reactions in both liver transplantion and

kidney transplantation patients are described under the subsection Less

Frequently Reported Adverse Reactions shown below.

Less Frequently Reported Adverse Reactions

The following adverse events were reported in the range of 3% to less than

15% incidence in either liver or kidney transplant recipients who were

treated with tacrolimus in the Phase 3 comparative trials.

NERVOUS SYSTEM: (see WARNINGS) abnormal dreams, agitation, amnesia,

anxiety, confusion, convulsion, depression, dizziness, emotional lability,

encephalopathy, hallucinations, hypertonia, incoordination, myoclonus,

nervousness, neuropathy, psychosis, somnolence, thinking abnormal; SPECIAL

SENSES: abnormal vision, amblyopia, ear pain, otitis media, tinnitus;

GASTROINTESTINAL: anorexia, cholangitis, cholestatic jaundice, dyspepsia,

dysphagia, esophagitis, flatulence, gastritis, gastrointestinal hemorrhage,

GGT increase, GI perforation, hepatitis, ileus, increased appetite,

jaundice, liver damage, liver function test abnormal, oral moniliasis,

rectal disorder, stomatitis; CARDIOVASCULAR: angina pectoris, chest pain,

deep thrombophlebitis, abnormal ECG, hemorrhage, hypotension, postural

hypotension, peripheral vascular disorder, phlebitis, tachycardia,

thrombosis, vasodilatation; UROGENITAL: (see WARNINGS) albuminuria,

cystitis, dysuria, hematuria, hydronephrosis, kidney failure, kidney

tubular necrosis, nocturia, pyuria, toxic nephropathy, oliguria, urinary

frequency, urinary incontinence, vaginitis; METABOLIC/NUTRITIONAL:

acidosis, alkaline phosphatase increased, alkalosis, ALT (SGPT) increased,

AST (SGOT) increased, bicarbonate decreased, bilirubinemia, BUN increased,

dehydration, GGT increased, healing abnormal, hypercalcemia,

hypercholesterolemia, hyperlipemia, hyperphosphatemia, hyperuricemia,

hypervolemia, hypocalcemia, hypoglycemia, hyponatremia, hypophosphatemia,

hypoproteinemia, lactic dehydrogenase increase, weight gain; ENDOCRINE:

(see PRECAUTIONS) Cushing's syndrome, diabetes mellitus; HEMIC/LYMPHATIC:

coagulation disorder, ecchymosis, hypochromic anemia, leukocytosis,

leukopenia, polycythemia, prothrombin decreased, serum iron decreased,

thrombocytopenia; MISCELLANEOUS: abdomen enlarged, abscess, accidental

injury, allergic reaction, cellulitis, chills, flu syndrome, generalized

edema, hernia, peritonitis, photosensitivity reaction, sepsis;

MUSCULOSKELETAL: arthralgia, cramps, generalized spasm, joint disorder, leg

cramps, myalgia, myasthenia, osteoporosis; RESPIRATORY: asthma, bronchitis,

cough increased, lung disorder, pneumothorax, pulmonary edema, pharyngitis,

pneumonia, respiratory disorder, rhinitis, sinusitis, voice alteration;

SKIN: acne, alopecia, exfoliative dermatitis, fungal dermatitis, herpes

simplex, hirsutism, skin discoloration, skin disorder, skin ulcer,

sweating.

There have been rare spontaneous reports of myocardial hypertrophy

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