Olza-5 Adverse Reactions

Unless otherwise noted, adverse events are reported for placebo-controlled trials in adult patients on monotherapy.
>10%: Central Nervous System: Somnolence (dose dependent: 20-39%; adolescents: 39-48%), extrapyramidal symptoms (dose dependent: <32%), dizziness (11-18%), headache (adolescents: 17%), fatigue (adolescents: 3-14%), insomnia (12%).
Endocrine and Metabolic: Increased prolactin (30%; adolescents: 17%).
Gastrointestinal: Weight gain (5-6%, has been reported as high as 40%; adolescents: 29-31%), increased appetite (3-6%; adolescents: 17-29%), xerostomia (dose dependent: 3-22%), constipation (9-11%), dyspepsia (7-11%).
Hepatic: ALT increased >3 x upper limit of normal (adolescents: 12%; adults: 5%).
Neuromuscular and Skeletal: Weakness (dose dependent: 8-20%).
Miscellaneous: Accidental injury (12%).
1% to 10%: Cardiovascular: Chest pain, hypertension, peripheral edema, postural hypotension, tachycardia.
Central Nervous System: Fever, personality changes, restlessness (adolescents).
Dermatologic: Bruising.
Endocrine and Metabolic: Breast-related events in adolescents (discharge, enlargement, galactorrhea, gynecomastia, lactation disorder), menstrual-related events (amenorrhea, hypomenorrhea, delayed menstruation, oligomenorrhea), sexual function-related events (anorgasmia, delayed ejaculation, erectile dysfunction, changes in libido, abnormal orgasm, sexual dysfunction).
Gastrointestinal: Abdominal pain (adolescents), diarrhea (adolescents), flatulence, nausea (dose dependent), vomiting.
Genitourinary: Incontinence, UTI.
Hepatic: Increased hepatic enzymes.
Neuromuscular and Skeletal: Abnormal gait, akathisia, articulation impairment, back pain, falling, hypertonia, joint/extremity pain, muscle stiffness (adolescents), tremor (dose dependent).
Ocular: Amblyopia.
Respiratory: Cough, epistaxis (adolescents), pharyngitis, respiratory tract infection (adolescents), rhinitis, sinusitis (adolescents).
<1% (limited to important life-threatening): Acidosis, agranulocytosis, anaphylactoid reaction, angioedema, apnea, atelectasis, atrial fibrillation, cerebrovascular accident, congestive heart failure, deafness, diabetes mellitus, diabetic ketoacidosis, diabetic coma, dystonia, encephalopathy, facial paralysis, glaucoma, heart arrest, heart failure, hemorrhage (eye, rectal, subarachnoid, vaginal), hepatitis, hypercholesterolemia, hyper-/hypoglycemia, hyper-/hypokalemia, hyperlipidemia, hyper-/hyponatremia, hypertriglyceridemia, hyperuricemia, hyper-/hypoventilation, hypoproteinemia, hypoxia, jaundice, ileus, ketosis, leukocytosis, (eosinophilia), leucopenia, liver damage (cholestatic or mixed), liver fatty deposit, lung edema, lymphadenopathy, myasthenia, myopathy, neuralgia, neuroleptic malignant syndrome, neutropenia, pancreatitis, paralysis, pulmonary embolus, rash, rhabdomyolysis, seizure, sudden death, suicide attempt, syncope, tardive dyskinesia, thrombocytopenia, transient ischemic attack, venous thrombotic events.