Onzapin OD Adverse Reactions

The frequency of the undesirable effects in this section is defined as: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Very common undesirable effects associated with the use of olanzapine in clinical trials were somnolence and weight gain.
In clinical trials in elderly patients with dementia, olanzapine treatment was associated with a higher incidence of death and cebrebrovascular adverse events compared to placebo (see also Precautions). Very common undesirable effects associated with the use of olanzapine in this patient group were abnormal gait and falls. Pneumonia, increased body temperature, lethargy, erythema, visual hallucinations and urinary incontinence were observed commonly.
In clinical trials in patients with drug-induced (dopamine agonist) psychosis associated with Parkinson's disease, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo.
In one clinical trial in patients with bipolar mania, valproate combination therapy with olanzapine resulted in an incidence of neutropenia of 4.1%; a potential contributing factor could be high plasma valproate levels. Olanzapine administered with lithium or valproate resulted in increased levels of tremor, dry mouth, increased appetite, and weight gain. Speech disorder was also reported commonly. During treatment with olanzapine in combination with lithium or divalproex, an increase of ≥ 7% from baseline body weight occurred in 17.4% of patients during acute treatment (up to 6 weeks). Long-term olanzapine treatment (up to 12 months) for recurrence prevention in patients with bipolar disorder was associated with an increase of ≥ 7% from baseline body weight in 39.9% of patients.
The following list of undesirable effects is based on adverse event reporting and laboratory investigations from clinical trials: Investigations: Very common: Elevated plasma prolactin levels, but associated clinical manifestations (e.g., gynaecomastia, galactorrhoea, and breast enlargement) were rare. In most patients, levels returned to normal ranges without cessation of treatment.
Uncommon: High creatine phosphokinase.
Cardiac disorders: Uncommon: Bradycardia with or without hypotension or syncope, QT prolongation (see also Precautions).
Blood and lymphatic system disorders: Common: Eosinophilia.
Nervous system disorders: Very common: Somnolence.
Common: Dizziness, akathisia, parkinsonism, dyskinesia. (See also note 2 as follows.)
Gastrointestinal disorders: Common: Mild, transient anticholinergic effects including constipation and dry mouth.
Skin and subcutaneous tissue disorders: Uncommon: Photosensitivity reaction.
Metabolism and nutrition disorders: Very common: Weight gain.
Common: Increased appetite. Elevated glucose levels (see note 1 as follows). Elevated triglyceride levels.
Vascular disorders: Common: Orthostatic hypotension.
General disorders and administration site conditions: Common: Asthenia, oedema.
Hepatobiliary disorders: Common: Transient, asymptomatic elevations of hepatic transaminases (ALT, AST), especially in early treatment (see also Precautions).
¹In clinical trials with olanzapine in over 5000 patients with baseline non-fasting glucose levels ≤ 7.8 mmol/l, the incidence of non-fasting plasma glucose levels ≥ 11 mmol/l (suggestive of diabetes) was 1.0%, compared to 0.9% with placebo. The incidence of non-fasting plasma glucose levels ≥ 8.9 mmol/l but < 11 mmol/l (suggestive of hyperglycaemia) was 2.0%, compared to 1.6% with placebo. Hyperglycaemia is also reported as a very rare spontaneous event.
²In clinical trials, the incidence of parkinsonism and dystonia in olanzapine-treated patients was numerically higher, but not statistically significantly different from placebo.
Olanzapine-treated patients had a lower incidence of parkinsonism, akathisia and dystonia compared with titrated doses of haloperidol. In the absence of detailed information on the pre-existing history of individual acute and tardive extrapyramidal movement disorders, it cannot be concluded at present that olanzapine produces less tardive dyskinesia and/or other tardive extrapyramidal syndromes.
The following list of undesirable effects is based on post-marketing spontaneous reports: Investigations: Increased transaminases.
Very rare: Increased alkaline phosphatase. Increased total bilirubin.
Cardiac disorders: Very rare: QTc prolongation, ventricular tachycardia/fibrillation and sudden death. (See also Precautions.)
Blood and lymphatic system disorders: Rare: Leukopenia.
Very rare: Thrombocytopenia. Neutropenia.
Nervous system disorders: Rare: Seizures have been reported to occur rarely in patients treated with olanzapine. In most of these cases, a history of seizures or risk factors for seizures were reported.
Very rare: Cases reported as Neuroleptic Malignant Syndrome (NMS) have been received in association with olanzapine. (See also Precautions.) Parkinsonism, dystonia and tardive dyskinesia have been reported very rarely with olanzapine.
Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported very rarely when olanzapine is stopped abruptly.
Gastrointestinal disorders: Very rare: Pancreatitis.
Renal and urinary disorders: Very rare: Urinary hesitation.
Skin and subcutaneous tissue disorders: Rare: Rash.
Musculoskeletal and connective tissue and bone disorders: Very rare: Rhabdomyolysis.
Metabolism and nutrition disorders: Very rare: Hyperglycaemia and/or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma has been spontaneously reported very rarely, including some fatal cases (see also note 1 as previously mentioned and Precautions).
Hypertriglyceridaemia, hypercholesterolaemia and hypothermia.
Vascular disorders: Very rare: Venous thromboembolism (including pulmonary embolism and deep vein thrombosis).
Immune system disorders: Very rare: Allergic reaction (e.g. anaphylactoid reaction, angioedema, pruritus or urticaria).
Hepatobiliary disorders: Rare: Hepatitis (including hepatocellular, cholestatic or mixed liver injury).
Reproductive system and breast disorders: Very rare: Priapism.