Central nervous system: >10%: Insomnia (2% to 14%).
1% to 10%: Headache (3% to 10%), pain (3% to 9%), fatigue (1% to 8%), dizziness (2% to 8%), abnormal dreams (3%), hostility (3%), nervousness (1% to 3%), hallucinations (3%), depression (2% to 3%), emotional lability (2%), personality disorder (2%), confusion (2%), fever (2%), somnolence (2%), abnormal crying, aggression, agitation, anxiety, aphasia, delusions, irritability, restlessness, seizure, vertigo.
Gastrointestinal: >10%: Nausea (3% to 19%; dose related), diarrhea (5% to 15%; dose related).
1% to 10%: Anorexia (2% to 8%), vomiting (3% to 9%: dose related), weight loss (3% to 5%: dose related), abdominal pain, bloating, constipation, dyspepsia, epigastric pain, fecal incontinence, gastroenteritis, GI bleeding, toothache.
Cardiovascular: 1% to 10%: Hypertension (3%), chest pain (2%), hemorrhage (2%), syncope (2%), hypotension, atrial fibrillation, bradycardia, ECG abnormal, edema, peripheral edema, heart failure, hot flashes, vasodilation.
Dermatologic: 1% to 10%: Bruising (4% to 5%), eczema (3%), pruritus, rash, skin ulcer, urticaria.
Endocrine & metabolic: 1% to 10%: Dehydration (1% to 2%), hyper-lipemia (2%), libido increased.
Genitourinary: 1% to 10%: Urinary frequency (2%), urinary incontinence (1% to 3%), cystitis, hematuria, glycosuria, nocturia, UTI.
Hematologic: 1% to 10%: Contusion (<2%), anemia.
Hepatic: 1% to 10%: Alkaline phosphatase increased.
Neuromuscular & skeletal: 1% to 10%: Muscle cramps (3% to 8%), back pain (3%), CPK increased (3%), arthritis (1% to 2%), ataxia, bone fracture, gait abnormal, lactate dehydrogenase increased, paresthesia, tremor, weakness (1% to 2%).
Ocular: 1% to 10%: Blurred vision, cataract, eye irritation.
Respiratory: 1% to 10%: Bronchitis, cough increased, dyspnea, pharyngitis, pneumonia, sore throat.
Miscellaneous: >10%: Accident (7% to 13%), infection (11%).
1% to 10%: Diaphoresis, fungal infection, flu symptoms.
<1% (Limited to important or life-threatening): Angina, cardiomegaly, cerebrovascular accident, cholecystitis, conjunctival hemorrhage, deep vein thrombosis, diabetes mellitus, diverticulitis, gastrointestinal ulcer, glaucoma, heart block, heart failure, hemolytic anemia, hepatitis, hyperglycemia, hypertonia, hypokalemia, hypokinesia, hyponatremia, hypoxia, intracranial hemorrhage, jaundice, LFTs increased, MI, neuroleptic malignant syndrome, pancreatitis, pleurisy, pulmonary collapse, pulmonary congestion, pyelonephritis, renal failure, retinal hemorrhage, SVT, thrombocythemia, thrombocytopenia, tongue edema, transient ischemic attack.