Infections and infestations:
Cellulitis, herpes zoster.
Neoplasms benign, malignant and unspecified (incl cysts and polyps):
Malignant melanoma, myelodysplastic syndrome.
Blood and lymphatic system disorders:
Anemia, idiopathic thrombocytopenic purpura, leukocytosis/leukopenia, neutropenia, pancytopenia, splenomegaly, thrombocytopenia.
Immune system disorders:
Anaphylaxis, hypersensitivity, rare serious reactions including anaphylactic reaction/shock.
Metabolism and nutrition disorders:
Anorexia, decreased/increased appetite, cow's milk intolerance, decreased/increased weight, dehydration, diabetes mellitus, dyslipidemia, gout, gout flares, hypercholesterolemia, hyperglycemia, hyperlipidemia, hypertriglyceridemia, hypokalemia.
Agitation, anxiety, decreased libido, depression, insomnia, irritability, nervousness, panic attack, psychotic behavior including aggressive thoughts.
Nervous system disorders:
Altered taste, amnesia, balance disorder, burning sensation, cerebrovascular accident, dizziness, Guillain-Barre syndrome, headache, hemiparesis, hypoesthesia, hyposmia, lacunar infarction, lethargy, mental impairment, migraine, paresthesia, peripheral neuropathy, somnolence, transient ischemic attack, tremor.
Blurred vision, cataract.
Ear and labyrinth disorders:
Deafness, tinnitus, vertigo.
Abnormal electrocardiogram (ECG), angina pectoris, atrial fibrillation/flutter, cardiac murmur, cardiovascular thromboembolic events [e.g., cardiovascular death, myocardial infarction (some fatal) and non-fatal stroke], palpitations, sinus bradycardia, tachycardia.
flushing, hot flush, hypertension, hypotension.
Respiratory, thoracic and mediastinal disorders:
Bronchitis, cough, dyspnea, epistaxis, nasal dryness, paranasal sinus hypersecretion, pharyngeal edema, respiratory tract congestion, sinusitis, sneezing, throat irritation, upper respiratory tract infection, wheezing.
Abdominal distention, abdominal pain, colitis, constipation, dry mouth, dyspepsia, esophageal stenosis, flatulence, frequent stools, gastritis, gastroenteritis, gastroesophageal reflux disease, gastrointestinal discomfort, gingival pain, hematemesis, hematochezia, hyperchlorhydria, mouth ulceration, nausea, pancreatitis, peptic ulcer, rectal hemorrhage, vomiting.
Cholelithiasis/cholecystitis, hepatic failure (some fatal), hepatic steatosis, hepatitis, hepatomegaly, jaundice, liver disorder/injury, serious cases of abnormal liver function test results.
Skin and subcutaneous tissue disorders:
Abnormal hair growth, abnormal skin odor, alopecia, angioedema, dermatitis, dermographism, drug reaction with eosinophilia and systemic symptoms (DRESS), ecchymosis, eczema, erythema, exfoliative rash, hair color changes, hyperhidrosis, peeling skin, petechiae, photosensitivity, pruritus, purpura, rash follicular, rash erythematous, rash macular, rash maculopapular, rash morbilliform, rash papular, rash pustular, rash vesicular, skin discoloration/altered pigmentation, skin hypersensitivity reactions, skin lesion, tinea pedis, toxic epidermal necrolysis (TEN), urticaria.
Musculoskeletal and connective tissue disorders:
Arthralgia, arthritis, bunion, bursitis, costochondritis, gouty tophus, joint stiffness, joint swelling, muscle spasms/twitching/tightness/weakness, musculoskeletal pain/stiffness, myalgia, rhabdomyolysis.
Renal and urinary disorders:
Hematuria, incontinence, kidney infection, micturition urgency, nephrolithiasis, pollakiuria, proteinuria, renal failure, renal insufficiency, tubulointerstitial nephritis, urgency, urinary tract infection.
Reproductive system and breast disorders:
Breast pain, erectile dysfunction, gynecomastia, mastitis.
General disorders and administration site conditions:
Asthenia, chest pain/discomfort, edema, fatigue, feeling abnormal, gait disturbance, influenza-like symptoms, mass, pain, thirst.
Activated partial thromboplastin time prolonged, abnormal electroencephalogram (EEG), abnormal coagulation test, alkaline phosphatase increased, amylase increased, bicarbonate decreased, blood urea nitrogen/creatinine ratio increased, blood urea increased, cholesterol increased, creatine phosphokinase (CPK) increased, creatine increased, glucose increased, hematocrit decreased, hemoglobin decreased, lactate dehydrogenase increased, low density lipoprotein increased, lymphocyte count decreased, mean corpuscular volume increased, neutrophil count decreased, platelet count decreased, potassium increased, prothrombin time prolonged, prostate specific antigen increased, red blood cell count decreased, sodium increased, thyroid stimulating hormone increased, triglycerides increased, urinary casts, urine output decreased/increased, urine positive for white blood cells and protein, white blood cell count decreased/increased.
Injury, poisoning and procedural complications: