Seroquel

Seroquel
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Indicate All Seroquel Side Effects You Have or Add a New Seroquel Side Effect

Reporting Your Seroquel Side Effect can play a very important role by raising awareness for other seroquel users and can help identify an unknown side effect and inform other users and health care professionals. If you think you may have a medical emergency due to a serious side effect, call your doctor or 911 immediately.

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>>Compare seroquel side effects | View FDA-reported seroquel side effects



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    WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA See Full Prescribing Information for complete boxed warning. • Antipsychotic drugs are associated with an increased risk of death (5.1) • Quetiapine is not approved for elderly patients with Dementia-Related Psychosis (5.1)
    WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS See Full Prescribing Information for complete boxed warning. • Increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants for major depressive disorder and other psychiatric disorders (5.2)

    ———–WARNINGS AND PRECAUTIONS—-•
    Increased Mortality in Elderly Patients with Dementia-Related Psychoses: Atypical antipsychotic drugs, including quetiapine, are associated with an increased risk of death; causes of death are variable. (5.1)

    Suicidality and Antidepressant Drugs: Increased the risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants for major depressive disorder and other psychiatric disorders.
    (5.2)

    Neuroleptic Malignant Syndrome (NMS): Manage with immediate discontinuation and close monitoring (5.3)

    Hyperglycemia and Diabetes Mellitus (DM): Ketoacidosis, hyperosmolar coma and death have been reported in patients treated with atypical antipsychotics, including quetiapine. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. When starting treatment,
    _____________________________________________________________________________________________________________________
    patients with diabetes or risk factors for diabetes should undergo blood glucose testing before and during treatment. (5.3)

    Hyperlipidemia: Undesirable alterations in lipids have been observed. Increases in total cholesterol, LDL-cholesterol and triglycerides and decreases in HDL-cholesterol have been reported in clinical trials. Appropriate clinical monitoring is recommended, including fasting blood lipid testing at the beginning of, and periodically during treatment. (5.5)

    Weight Gain: Patients should receive regular monitoring of weight. (5.6)

    Tardive Dyskinesia: Discontinue if clinically appropriate (5.7)

    Orthostatic Hypotension: Associated dizziness, tachycardia and syncope may occur especially during the initial dose titration period. (5.8)

    Increased Blood Pressure in Children and Adolescents: Blood pressure should be measured at the beginning of, and periodically during treatment in children and adolescents (5.9)

    Leukopenia, Neutropenia and Agranulocytosis have been reported with atypical antipsychotics including SEROQUEL. Patients with a pre-existing low white cell count (WBC) or a history of leukopenia/neutropenia should have complete blood count (CBC) monitored frequently during the first few months of treatment and should discontinue SEROQUEL at the first sign of a decline in WBC in absence of other causative factors. (5.10)

    Cataracts: Lens changes have been observed in patients during long-term quetiapine treatment. Lens examination is recommended when starting treatment and at 6-month intervals during chronic treatment. (5.11)

    Suicide: The possibility of a suicide attempt is inherent in schizophrenia and bipolar disorder, and close supervision of high risk patients should accompany drug therapy. (5.20)

    See Full Prescribing Information for additional WARNINGS and
    PRECAUTIONS.
    ———————–ADVERSE REACTIONS——Most common adverse reactions (incidence ≥5% and twice placebo):
    Adults: somnolence, dry mouth, dizziness, constipation, asthenia, abdominal pain,
    postural hypotension, pharyngitis, weight gain, lethargy, ALT increased, dyspepsia.
    (6.1)
    Children and Adolescents: somnolence, dizziness, fatigue, increased appetite, nausea, vomiting, dry mouth, tachycardia, weight increased (6.1)
    To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. ———————–DRUG INTERACTIONS———————-•
    P450 3A Inhibitors: May decrease the clearance of quetiapine. Lower doses of quetiapine may be required. (7.1)

    Hepatic Enzyme Inducers: May increase the clearance of quetiapine. Higher doses of quetiapine may be required with phenytoin or other inducers.
    (7.1)

    Centrally Acting Drugs: Caution should be used when quetiapine is used in combination with other CNS acting drugs. (7)

    Antihypertensive Agents: Quetiapine may add to the hypotensive effects of these agents. (7)

    Levodopa and Dopamine Agents: Quetiapine may antagonize the effect of these drugs. (7)

    http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020639s045s046lbl.pdf

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