Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Commonly observed adverse reactions (incidence ≥5% and at least twice the incidence for placebo) were: Schizophrenia : Somnolence, respiratory tract infection.
( 6.1 ) Manic and Mixed Episodes Associated with Bipolar Disorder : Somnolence, extrapyramidal symptoms, dizziness, akathisia, abnormal vision, asthenia, vomiting.
( 6.1 ) Intramuscular administration (≥5% and at least twice the lowest intramuscular ziprasidone group): Headache, nausea, somnolence.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Steriscience at 1-888-278-1784 or www.steri-science.com or FDA at 1-800-332-1088 or www.fda.gov/medwatch.
The following adverse reactions are described in more detail in other sections of the prescribing information: • Increased Mortality in Elderly Patients with Dementia-Related Psychosis [ see Boxed Warning and Warnings and Precautions (5.1) ] • Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis [ see Warnings and Precautions (5.2) ] • QT Prolongation and Risk of Sudden Death [ see Contraindications (4.2), Warnings and Precautions (5.3) ] • Serotonin Syndrome [ see Contraindications (4.3), Warnings and Precautions (5.4), Drug Interactions (7.1) ] • Neuroleptic Malignant Syndrome (NMS) [ see Warnings and Precautions (5.5) ] • Severe Cutaneous Adverse Reactions [ see Warnings and Precautions (5.6) ] • Tardive Dyskinesia [ see Warnings and Precautions (5.7) ] • Metabolic Changes [ see Warnings and Precautions (5.8) ] • Rash [ see Warnings and Precautions (5.9) ] • Orthostatic Hypotension [ see Warnings and Precautions (5.10) ] • Falls [ see Warnings and Precautions (5.11) ] • Leukopenia, Neutropenia, and Agranulocytosis [ see Warnings and Precautions (5.12) ] • Seizures [ see Warnings and Precautions (5.13) ] • Dysphagia [ see Warnings and Precautions (5.14) ] • Hyperprolactinemia [ see Warnings and Precautions (5.15) ] • Potential for Cognitive and Motor Impairment [ see Warnings and Precautions (5.16) ] • Priapism [ see Warnings and Precautions (5.17) ] • Body Temperature Regulation [ see Warnings and Precautions (5.18) ] • Suicide [ see Warnings and Precautions (5.19) ] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Clinical trials in adults for oral ziprasidone included approximately 5700 patients and/or normal subjects exposed to one or more doses of ziprasidone.
Of these 5700, over 4800 were patients who participated in multiple-dose effectiveness trials, and their experience corresponded to approximately 1831 patient-years.
These patients include: (1) 4331 patients who participated in multiple-dose trials, predominantly in schizophrenia, representing approximately 1698 patient-years of exposure as of February 5, 2000;
and (2) 472 patients who participated in bipolar mania trials representing approximately 133 patient-years of exposure.
An additional 127 patients with bipolar disorder participated in a long-term maintenance treatment study representing approximately 74.7 patient-years of exposure to ziprasidone.
5 WARNINGS AND PRECAUTIONS Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack).
( 5.2 ) QT Interval Prolongation :Ziprasidone mesylate for injection use should be avoided in patients with bradycardia, hypokalemia or hypomagnesemia, congenital prolongation of the QT interval, or in combination with other drugs that have demonstrated QT prolongation.
( 5.3 ) Serotonin Syndrome : Increased risk when co-administered with other serotonergic agents, but also when taken alone.
If it occurs, discontinue Ziprasidone mesylate for injection and serotonergic agents and initiate supportive treatment.
(5.4) Neuroleptic Malignant Syndrome (NMS): Potentially fatal symptom complex has been reported with antipsychotic drugs.
Like all medications, Ziprasidone Mesylate can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: