|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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