Tacrograf Adverse Reactions

Very common: Cardiovascular: angina pectoris, atrial fibrillation, atrial flutter, bradycardia, cardiac arrest, cardiac arrhythmia, cardiac failure, cardiorespiratory arrest, cerebral infarction, cerebral ischemia, chest pain, decreased heart rate, deep vein thrombophlebitis, deep vein thrombosis, ECG abnormality (QRS or ST segment or T wave), edema, flushing, hemorrhagic stroke, hypertension, hypertrophic cardiomyopathy, hypotension, ischemic heart disease, localized phlebitis, myocardial infarction, orthostatic hypotension, pericardial effusion, peripheral edema ((Calcineurin inhibitor-induced hemolytic uremic syndrome/thrombotic thrombocytopenic purpura/thrombotic microangiopathy (HUS/TTP/TMA) have been reported (with concurrent sirolimus)), peripheral vascular disease, phlebitis, syncope, tachycardia, thrombosis, vasodilatation, ventricular premature contractions.
Central nervous system (CNS): abnormal dreams, abnormality in thinking, agitation, amnesia, anxiety, aphasia, ataxia, brain disease, Carpal Tunnel syndrome, chills, confusion, convulsions, depression, dizziness, drowsiness, emotional lability, excessive crying, falling, fatigue, flaccid paralysis, hallucination, headache, hypertonia, hypoesthesia, insomnia, mental status changes, mood elevation, myasthenia, myoclonus, nervousness, neuropathy (including compression), neurotoxicity, nightmares, pain, paresis, paresthesia, peripheral neuropathy, psychosis, seizure, vertigo, voice disorder, writing difficulty.
Dermatologic: acne vulgaris, alopecia, cellulitis, condyloma acuminatum, dermal ulcer, dermatitis (including fungal), dermatological reaction, diaphoresis, exfoliative dermatitis, hypotrichosis, pruritus, skin discoloration, skin photosensitivity, skin rash, tinea versicolor.
Endocrine and metabolic: acidosis, albuminuria, alkalosis, anasarca, Cushing's syndrome, decreased serum bicarbonate, decreased serum iron, dehydration, diabetes mellitus, gout, hirsutism, hypercalcemia, hypercholesterolemia, hyperglycemia, hyperkalemia, hyperlipidemia, hypertriglyceridemia, hyperuricemia, hypervolemia, hypocalcemia, hypoglycemia, hypomagnesemia, hyponatremia, hypophosphatemia, increased gamma glutamyl transferase, increased lactate dehydrogenase, weight changes, weight gain.
Gastrointestinal (Gl): abdominal pain, anorexia, aphthous stomatitis, cholangitis, colitis, constipation, delayed gastric emptying, diarrhea, duodenitis, dyspepsia, dysphagia, enlargement of abdomen, esophagitis (including ulcerative), flatulence, gastric ulcer, gastritis, gastroesophageal reflux disease, gastrointestinal hemorrhage, gastrointestinal perforation, hernia, hiccups, increased appetite, intestinal obstruction, nausea, oral candidiasis, pancreatic disease (pseudocyst), pancreatitis (including hemorrhagic and necrotizing), peritonitis, rectal disease, stomach cramps, stomatitis, vomiting.
Genitourinary (GU): anuria, bladder spasm, cystitis, dysuria, hematuria, nocturia, oliguria, proteinuria, toxic nephrosis, urinary frequency, urinary incontinence, urinary retention, urinary tract infection, urinary urgency, vaginitis.
Hematologic and oncologic: anemia (hemoglobin <10 g/dL), blood coagulation disorder, bruise, decreased prothrombin time, hemolytic anemia, hemorrhage, hypochromic anemia, hypoproteinemia, increased hematocrit, increased INR, Kaposi's sarcoma, leukocytosis, leukopenia, malignant neoplasm of bladder, malignant neoplasm of thyroid, neutropenia, pancytopenia, polycythemia, skin neoplasm, thrombocytopenia.
Hepatic: abnormal hepatic function tests, ascites, cholestatic jaundice, hepatic injury, hepatitis (including acute, chronic, and granulomatous), hyperbilirubinemia, increased liver enzymes, increased serum alkaline phosphatase, jaundice.
Hypersensitivity: hypersensitivity reaction.
Immunologic: graft complications (kidney transplant).
Infection: abscess, bacterial infection, cytomegalovirus disease, Epstein-Barr infection, herpes simplex infection, infection, sepsis, serious infection.
Miscellaneous: fever, post-operative pain, post-operative wound complication, wound healing impairment.
Neuromuscular and skeletal: arthralgia, arthropathy, back pain, leg cramps, muscle spasm, muscle weakness of the extremities, myalgia, osteopenia, osteoporosis, tremor, weakness.
Ophthalmic: amblyopia, blurred vision, conjunctivitis, visual disturbance.
Otic: hearing loss, otalgia, ofitis externa, otitis media, tinnitus.
Renal: acute renal failure, hydronephrosis, increased blood urea nitrogen, increased serum creatinine, renal disease (BK nephropathy), renal function abnormality, renal tubular necrosis.
Respiratory: allergic rhinitis, asthma, atelectasis, bronchitis, cough, dyspnea, emphysema, flu-like symptoms, pharyngitis, pleural effusion, pneumonia, pneumothorax, pulmonary disease, pulmonary edema, pulmonary infiltrates, respiratory depression, respiratory failure, respiratory tract infection, rhinitis, sinusitis.
Common: Gastrointestinal (Gl): gastroenteritis.
Infection: polyoma virus infection.
Uncommon: Cardiovascular: Cerebrovascular accident, hepatic veno-occlusive disease, prolonged Q-T interval on ECG, supraventricular extrasystole, supraventricular tachycardia, torsades de pointes, venous thrombosis, ventricular fibrillation.
Central nervous system (CNS): coma, delirium, dysarthria, hemiparesis, leukoencephalopathy, mutism, progressive multifocal leukoencephalopathy, quadriplegia, reversible posterior leukoencephalopathy syndrome, status epilepticus.
Dermatologic: Hyperpigmentation, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), urticaria.
Endocrine and metabolic: decreased serum fibrinogen.
Gastrointestinal: biliary tract disease (stenosis).
Genitourinary: hemorrhagic cystitis.
Hematologic and oncologic: agranulocytosis, basal cell carcinoma, calcineurin inhibitor-induced hemolytic-uremic syndrome with concurrent sirolimus, calcineurin inhibitor-induced-thrombotic thrombocytopenic purpura concurrent sirolimus, disseminated intravascular coagulation, hemolytic-uremic syndrome, hepatosplenic T-cell lymphomas, immune thrombocytopenia, leukemia, lymphoproliferative disorder (post-transplant or related to EBV), malignant lymphoma, malignant melanoma, prolonged partial thromboplastin time, pure red cell aplasia, squamous cell carcinoma, thrombotic thrombocytopenic purpura.
Hepatic: hepatic cirrhosis, hepatic failure, hepatic necrosis, hepalotoxicity, liver steatosis.
Hypersensitivity: anaphylactoid reaction, anaphylaxis, angioedema.
Immunologic: graft versus host disease (acute and chronic).
Infection: septicemia.
Miscellaneous: multi-organ failure.
Neuromuscular and skeletal: osteomyelitis, polyarthritis, rhabdomyolysis.
Ophthalmic: blindness, optic atrophy, photophobia.
Otic: deafness.
Respiratory: adult respiratory distress syndrome, interstitial pulmonary disease, pulmonary hypertension.