Olandus/Olandus ODT Adverse Reactions

Olandus 5/Olandus 10: The most frequently reported adverse effects with Olanzapine are somnolence and weight gain. Olanzapine has been associated with a low incidence of extrapyramidal symptoms including tardive dyskinesia. Hyperprolactinaemia may occur but is usually asymptomatic. Other adverse effects include increased appetite, peripheral oedema, and rarely elevated creatine kinase concentrations.
Olandus ODT 5/Olandus ODT 10: Olanzapine may cause side effects: drowsiness, dizziness, restlessness, unusual behavior, depression, difficulty falling asleep or staying asleep, weakness, difficulty walking, constipation, weight gain, dry mouth, pain in arms, legs, back, or joints, breast enlargement or discharge, late or missed menstrual periods, decreased sexual ability.
Olandus ODT 15: Adverse events identified from clinical trials of olanzapine: Body as a whole: Very common (≥10%): weight gain: weight gain ≥7% baseline body weight. Common (≥1% and <10%): asthenia, fatigue, weight gain ≥15% baseline body weight. Uncommon (≥0.1% and <1%): photosensitivity reaction.
Cardiovascular system: Common (≥1% and <10%): orthostatic hypotension. Uncommon (≥0.1% and <1%): bradycardia.
Digestive system: Common (≥1% and <10%): constipation; dry mouth; increased appetite.
Metabolic: Common (≥1% and <10%): peripheral oedema. Rare (<0.l% and ≥0.01%): elevated creatinine phosphokinase levels.
Nervous system: Very common (≥10%): somnolence. Common (≥1% and <10%): dizziness; akathisia.
Clinical chemistry: Very common (≥10%): prolactin-increased, cholesterol-total (fasting borderline to high), triglycerides (fasting borderline to high), glucose (fasting borderline to high). Common (≥1% and <10%): alanine transferase (ALT)-increased; aspartate transferase (AST)-increased, cholesterol-total (fasting normal to high), triglycerides (fasting normal to high), glucose (fasting normal to high), glycosuria.
Hepatic Transaminases: Transient, asymptomatic elevations of hepatic transaminases, ALT and AST, have been seen occasionally.
Haematology: Common (≥1% and <10%): eosinophilia.
Eosinophilia: Asymptomatic eosinophilia was occasionally seen.
Undesirable Effects for Special Populations: Elderly Patients: Undesirable effects associated with the use of Olanzapine in clinical trials with elderly patients with dementia-related psychosis: Body as a whole: Very common (≥10%): falls.
Nervous system: Very common (≥10%): abnormal gait.
Urogenital system: Common (≥1% and <10%): urinary incontinence.
Respiratory system: Common (≥1% and <10%): pneumonia.
Adolescents (Ages 13-17 years): Body as a whole: Very common (≥10%): weight gain ≥7% of baseline body weight 40.6%.
Common (≥1% and <10%): weight gain ≥15% of baseline body weight 7.1%.
Digestive system: Very common (≥10%): increased appetite 24.0%.
Common (≥1% and <10%): dry mouth 6.1%.
Nervous system: Very common (≥10%): sedation (including hypersomnia, lethargy, sedation, somnolence) 44.1%.
Clinical chemistry: Very common (≥10%): ALT >3 x ULN (all randomised patients with ALT baseline ≤3 x ULN) 12.1%, AST-increased 27.6%, total bilirubin-decreased 22.1%, GGT-increased 10.1%, prolactin-increased 47.4%, cholesterol-total (fasting borderline to high) 38.9%, triglycerides (fasting normal to high) 26.9%, triglycerides (fasting borderline to high) 59.5%, glucose (fasting borderline to high) 14.3%.
Common (≥1% and <10%): cholesterol-total (fasting normal to high) 6.9%.
Very rare (<0.01%): glucose (fasting normal to high).
Adverse events based on post marketing spontaneous reports with oral olanzapine: Body as a whole: Very rare (<0.01%): allergic reaction (e.g. anaphylactoid reaction, angioedema, pruritis or urticaria); discontinuation reaction (acute symptoms such as sweating, insomnia, tremor, anxiety, nausea or vomiting have been reported very rarely when olanzapine is stopped suddenly).
Digestive system: Very rare (<0.01%): pancreatitis.
Hepatobiliary disorders: Rare (<0.1% and ≥0.01%): hepatitis.
Very rare (<0.01%): jaundice.
Metabolic: Rare (<0.1% and ≥0.01%): hyperglycaemia.
Very rare (<0.01%): diabetic coma; diabetic ketoacidosis; exacerbation of pre-existing diabetes; hypertriglyceridemia (random triglyceride levels of ≥11.29 mmol/L); hypercholesterolaemia (random cholesterol levels of ≥6.21 mmol/L).
Nervous system: Rare (<0.1% and ≥0.01%): seizures.
Very rare (<0.01%): neuroleptic malignant syndrome.
Skin and appendages: Rare (<0.1% and ≥0.01%): rash.
Very rare (<0.01%): alopecia.
Urogenital system: Very rare (<0.01%): priapism; urinary hesitation, urinary incontinence.
Haematology: Rare (<0.1% and ≥0.01%): leucopenia, including neutropenia.
Very rare (<0.01%): thrombocytopenia.
Cardiovascular: Very rare (<0.01%): venous thromboembolism, including pulmonary embolism and deep vein thrombosis. Cases of QT prolongation, ventricular arrhythmia, sudden unexplained death, cardiac arrest and torsades de pointes have been reported very rarely with the use of neuroleptics and may be considered a class effect.
Musculoskeletal System: Very rare (<0.01%): rhabdomyolysis.
Clinical chemistry: Very rare (<0.01%): alkaline phosphatase increased; total bilirubin increased, creatine phosphokinase increased.