Geodon Side Effects

Generic Name: ziprasidone

Please note - some side effects for Geodon may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Geodon - for the Consumer

Geodon

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Geodon:

Constipation; diarrhea; dizziness; drowsiness; dry mouth; feeling unusually tired or sleepy; headache; increased cough or runny nose; loss of appetite; nausea; pain at the injection site; upset stomach.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); altered mental abilities, including lack of response to your surroundings; change in amount of urine; change in vision; difficulty swallowing; fainting or loss of consciousness; fast or irregular heartbeat; fever; high blood sugar (increased thirst, increased urination, confusion, flushing, rapid breathing, or fruity breath odor); inability to move; increased body heat; muscle rigidity; muscle spasms or twitching; pounding in the chest; prolonged or painful erection; seizures; sweating; uncontrolled movements (especially of face or tongue); unusual mood or mental changes.

Geodon Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Geodon Capsules:

Constipation; diarrhea; dizziness; drowsiness; dry mouth; feeling unusually tired or sleepy; headache; increased cough or runny nose; loss of appetite; nausea; upset stomach.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); altered mental abilities, including lack of response to your surroundings; change in amount of urine; change in vision; difficulty swallowing; fainting or loss of consciousness; fast or irregular heartbeat; fever; high blood sugar (increased thirst, increased urination, confusion, flushing, rapid breathing, or fruity breath odor); inability to move; increased body heat; muscle rigidity; muscle spasms or twitching; pounding in the chest; prolonged or painful erection; seizures; sweating; uncontrolled movements (especially of face or tongue); unusual mood or mental changes.

Geodon Side Effects - for the Professional

Geodon

Premarketing experience

The premarketing development program 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. The conditions and duration of treatment with ziprasidone included open-label and double-blind studies, inpatient and outpatient studies, and short-term and longer-term exposure.

The premarketing development program for intramuscular ziprasidone included 570 patients and/or normal subjects who received one or more injections of ziprasidone. Over 325 of these subjects participated in trials involving the administration of multiple doses.

Adverse events during exposure were obtained by collecting voluntarily reported adverse experiences, as well as results of physical examinations, vital signs, weights, laboratory analyses, ECGs, and results of ophthalmologic examinations. Adverse experiences were recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and tabulations that follow, standard COSTART dictionary terminology has been used to classify reported adverse events.

The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the side effect incidence rate in the population studied.

Adverse Findings Observed in Short-Term, Placebo-Controlled Trials with Oral Ziprasidone

The following findings are based on the short-term placebo-controlled premarketing trials for schizophrenia (a pool of two 6-week, and two 4-week fixed-dose trials) and bipolar mania (a pool of two 3-week flexible-dose trials) in which ziprasidone was administered in doses ranging from 10 to 200 mg/day.

Adverse Events Associated with Discontinuation of Treatment in Short-Term, Placebo-Controlled Trials of Oral Ziprasidone

Approximately 4.1% (29/702) of ziprasidone-treated patients in short-term, placebo-controlled studies discontinued treatment due to an adverse event, compared with about 2.2% (6/273) on placebo. The most common event associated with dropout was rash, including 7 dropouts for rash among ziprasidone patients (1%) compared to no placebo patients.

Approximately 6.5% (18/279) of ziprasidone-treated patients in short-term, placebo-controlled studies discontinued treatment due to an adverse event, compared with about 3.7% (5/136) on placebo. The most common events associated with dropout in the ziprasidone-treated patients were akathisia, anxiety, depression, dizziness, dystonia, rash and vomiting, with 2 dropouts for each of these events among ziprasidone patients (1%) compared to one placebo patient each for dystonia and rash (1%) and no placebo patients for the remaining adverse events.

The most commonly observed adverse events associated with the use of ziprasidone (incidence of 5% or greater) and not observed at an equivalent incidence among placebo-treated patients (ziprasidone incidence at least twice that for placebo) are shown in Tables 1 and 2.

Adverse Events Occurring at an Incidence of 2% or More Among Ziprasidone-Treated Patients in Short-Term, Oral, Placebo-Controlled Trials

Table 3 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred during acute therapy (up to 6 weeks) in predominantly patients with schizophrenia, including only those events that occurred in 2% or more of patients treated with ziprasidone and for which the incidence in patients treated with ziprasidone was greater than the incidence in placebo-treated patients.

Table 4 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred during acute therapy (up to 3 weeks) in patients with bipolar mania, including only those events that occurred in 2% or more of patients treated with ziprasidone and for which the incidence in patients treated with ziprasidone was greater than the incidence in placebo-treated patients.

Explorations for interactions on the basis of gender did not reveal any clinically meaningful differences in the adverse event occurrence on the basis of this demographic factor.

Dose Dependency of Adverse Events in Short-Term, Fixed-Dose, Placebo-Controlled Trials

An analysis for dose response in the schizophrenia 4-study pool revealed an apparent relation of adverse event to dose for the following events: asthenia, postural hypotension, anorexia, dry mouth, increased salivation, arthralgia, anxiety, dizziness, dystonia, hypertonia, somnolence, tremor, rhinitis, rash, and abnormal vision.

The incidence of reported EPS (which included the adverse event terms extrapyramidal syndrome, hypertonia, dystonia, dyskinesia, hypokinesia, tremor, paralysis and twitching) for ziprasidone-treated patients in the short-term, placebo-controlled schizophrenia trials was 14% vs. 8% for placebo. Objectively collected data from those trials on the Simpson-Angus Rating Scale (for EPS) and the Barnes Akathisia Scale (for akathisia) did not generally show a difference between ziprasidone and placebo.

Class Effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.

Ziprasidone is associated with orthostatic hypotension.

The proportions of patients meeting a weight gain criterion of ≥7% of body weight were compared in a pool of four 4- and 6- week placebo-controlled schizophrenia clinical trials, revealing a statistically significantly greater incidence of weight gain for ziprasidone (10%) compared to placebo (4%). A median weight gain of 0.5 kg was observed in ziprasidone patients compared to no median weight change in placebo patients. In this set of clinical trials, weight gain was reported as an adverse event in 0.4% and 0.4% of ziprasidone and placebo patients, respectively. During long-term therapy with ziprasidone, a categorization of patients at baseline on the basis of body mass index (BMI) revealed the greatest mean weight gain and highest incidence of clinically significant weight gain (>7% of body weight) in patients with low BMI (<23) compared to normal (23–27) or overweight patients (>27). There was a mean weight gain of 1.4 kg for those patients with a "low" baseline BMI, no mean change for patients with a "normal" BMI, and a 1.3 kg mean weight loss for patients who entered the program with a "high" BMI.

Ziprasidone is associated with an increase in the QTc interval. In the schizophrenia trials, ziprasidone was associated with a mean increase in heart rate of 1.4 beats per minute compared to a 0.2 beats per minute decrease among placebo patients.

Other Adverse Events Observed During the Premarketing Evaluation of Oral Ziprasidone

Following is a list of COSTART terms that reflect treatment-emergent adverse events as defined in the introduction to the ADVERSE REACTIONS section reported by patients treated with ziprasidone in schizophrenia trials at multiple doses >4 mg/day within the database of 3834 patients. All reported events are included except those already listed in Table 3 or elsewhere in labeling, those event terms that were so general as to be uninformative, events reported only once and that did not have a substantial probability of being acutely life-threatening, events that are part of the illness being treated or are otherwise common as background events, and events considered unlikely to be drug-related. It is important to emphasize that, although the events reported occurred during treatment with ziprasidone, they were not necessarily caused by it.

Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring in at least 1/100 patients (only those not already listed in the tabulated results from placebo-controlled trials appear in this listing); infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients.

Body as a Whole: Frequent: abdominal pain, flu syndrome, fever, accidental fall, face edema, chills, photosensitivity reaction, flank pain, hypothermia, motor vehicle accident.

Cardiovascular System: Frequent: tachycardia, hypertension, postural hypotension; Infrequent: bradycardia, angina pectoris, atrial fibrillation; Rare: first degree AV block, bundle branch block, phlebitis, pulmonary embolus, cardiomegaly, cerebral infarct, cerebrovascular accident, deep thrombophlebitis, myocarditis, thrombophlebitis.

Digestive System: Frequent: anorexia, vomiting; Infrequent: rectal hemorrhage, dysphagia, tongue edema; Rare: gum hemorrhage, jaundice, fecal impaction, gamma glutamyl transpeptidase increased, hematemesis, cholestatic jaundice, hepatitis, hepatomegaly, leukoplakia of mouth, fatty liver deposit, melena.

Endocrine: Rare: hypothyroidism, hyperthyroidism, thyroiditis.

Hemic and Lymphatic System: Infrequent: anemia, ecchymosis, leukocytosis, leukopenia, eosinophilia, lymphadenopathy; Rare: thrombocytopenia, hypochromic anemia, lymphocytosis, monocytosis, basophilia, lymphedema, polycythemia, thrombocythemia.

Metabolic and Nutritional Disorders: Infrequent: thirst, transaminase increased, peripheral edema, hyperglycemia, creatine phosphokinase increased, alkaline phosphatase increased, hypercholesteremia, dehydration, lactic dehydrogenase increased, albuminuria, hypokalemia; Rare: BUN increased, creatinine increased, hyperlipemia, hypocholesteremia, hyperkalemia, hypochloremia, hypoglycemia, hyponatremia, hypoproteinemia, glucose tolerance decreased, gout, hyperchloremia, hyperuricemia, hypocalcemia, hypoglycemic reaction, hypomagnesemia, ketosis, respiratory alkalosis.

Musculoskeletal System: Frequent: myalgia; Infrequent: tenosynovitis; Rare: myopathy.

Nervous System: Frequent: agitation, extrapyramidal syndrome, tremor, dystonia, hypertonia, dyskinesia, hostility, twitching, paresthesia, confusion, vertigo, hypokinesia, hyperkinesia, abnormal gait, oculogyric crisis, hypesthesia, ataxia, amnesia, cogwheel rigidity, delirium, hypotonia, akinesia, dysarthria, withdrawal syndrome, buccoglossal syndrome, choreoathetosis, diplopia, incoordination, neuropathy; Infrequent: paralysis; Rare: myoclonus, nystagmus, torticollis, circumoral paresthesia, opisthotonos, reflexes increased, trismus.

Respiratory System: Frequent: dyspnea; Infrequent: pneumonia, epistaxis; Rare: hemoptysis, laryngismus.

Skin and Appendages: Infrequent: maculopapular rash, urticaria, alopecia, eczema, exfoliative dermatitis, contact dermatitis, vesiculobullous rash.

Special Senses: Frequent: fungal dermatitis; Infrequent: conjunctivitis, dry eyes, tinnitus, blepharitis, cataract, photophobia; Rare: eye hemorrhage, visual field defect, keratitis, keratoconjunctivitis.

Urogenital System: Infrequent: impotence, abnormal ejaculation, amenorrhea, hematuria, menorrhagia, female lactation, polyuria, urinary retention, metrorrhagia, male sexual dysfunction, anorgasmia, glycosuria; Rare: gynecomastia, vaginal hemorrhage, nocturia, oliguria, female sexual dysfunction, uterine hemorrhage.

Adverse Findings Observed in Trials of Intramuscular Ziprasidone

Table 5 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred during acute therapy with intramuscular ziprasidone in 1% or more of patients.

In these studies, the most commonly observed adverse events associated with the use of intramuscular ziprasidone (incidence of 5% or greater) and observed at a rate on intramuscular ziprasidone (in the higher dose groups) at least twice that of the lowest intramuscular ziprasidone group were headache (13%), nausea (12%), and somnolence (20%).

Other Events Observed During Post-marketing Use

Adverse event reports not listed above that have been received since market introduction include rare occurrences of the following (no causal relationship with ziprasidone has been established): Cardiac Disorders: Tachycardia, torsade de pointes (in the presence of multiple confounding factors - see WARNINGS); Digestive System Disorders: Swollen tongue; Nervous System Disorders: Facial droop, neuroleptic malignant syndrome, serotonin syndrome (alone or in combination with serotonergic medicinal products), tardive dyskinesia; Psychiatric Disorders: Insomnia, mania/hypomania; Reproductive System and Breast Disorders: Galactorrhea, priapism; Skin and subcutaneous Tissue Disorders: Allergic reaction (such as allergic dermatitis, angioedema, orofacial edema, urticaria), rash; Urogenital System Disorders: Enuresis, urinary incontinence; Vascular Disorders: Postural hypotension, syncope.

Side Effects by Body System

Nervous system

Nervous system side effects have frequently included extrapyramidal symptoms encompassing hypertonia, dystonia, dyskinesia, hypokinesia, tremor, paralysis, and twitching. Extrapyramidal side effects have been reported in 14% and 31% of patients with schizophrenia and bipolar mania, respectively, though no one effect occurred individually at an incidence greater than 10% in the bipolar mania trials. Headache (18%), somnolence (14% to 31%), dizziness/lightheadedness (8% to 16%), akathisia (8% to 10%), anxiety (5%), asthenia (5%), insomnia (3%), hypesthesia (2%), speech disorder (2%), agitation, hostility, paresthesia, confusion, vertigo, hyperkinesia, abnormal gait, oculogyric crisis, hypesthesia, ataxia, amnesia, cogwheel rigidity, delirium, hypotonia, akinesia, dysarthria, withdrawal syndrome, buccoglossal syndrome, choreoathetosis, diplopia, incoordination, and neuropathy have also been reported frequently. Paralysis has been reported infrequently. Myoclonus, nystagmus, torticollis, circumoral paresthesia, opisthotonos, increased reflexes, neuromalignant syndrome, and trismus have been reported rarely. Single cases of tardive dystonia and parkinsonism have been reported. Syncope, serotonin syndrome (alone or in combination with other serotonergic agents), and facial droop have been observed in postmarketing use.

A 20-year-old male with a history of auditory hallucinations, paranoid delusions, flat affect, and social withdrawal, showed signs of mania following 7 days of ziprasidone therapy at a final dose of 80 mg once at bedtime. Symptoms resolved approximately 48 hours following discontinuation of ziprasidone therapy.

A 53-year-old male diagnosed with schizoaffective disorder at 12 years of age was admitted from the emergency room with a diagnosis of schizophrenia, paranoid type. The patient denied receiving pharmacological treatment in the previous 3 month time period. Ziprasidone therapy was initiated with 40 mg orally twice a day on Day 1 followed by a dosage adjustment to 80 mg twice a day on Day 2. The patient demonstrated notable torticollis and dystonic posturing of his left carpus approximately four hours following his sixth 80 mg dose. Palpitation of his musculature revealed spasm. The patient had normal lab values and was deemed to be without general medical conditions. Muscular contraction was relieved with injectable diphenhydramine. Ziprasidone was discontinued and the patient showed no signs of recurrence during a subsequent 24-hour observation period. Soon thereafter the patient left the facility against medical advice and without further pharmacologic treatment. The rapid increase in dosage may have contributed to the observed dystonia.

A 12-year-old male with a history of schizoaffective disorder was switched from risperidone orally 2 mg once a day (because of facial twitching) to ziprasidone orally 80 mg once a day. Approximately 8-weeks after initiation of ziprasidone therapy the patient presented to the emergency room as rigid, diaphoretic, tremulous, difficult to arouse, and with tactile fever, urinary incontinence, and incoherent speech. Ziprasidone was discontinued and the patient was treated for neuroleptic malignant syndrome (NMS). The patient was assessed approximately 2 months after the incident and was deemed to have made a full neurologic and physical recovery.

Five female patients with bipolar disorder receiving ziprasidone (80 to 160 mg/day) developed severe and abrupt akathisia following a dose reduction. In each case, akathisia resolved following treatment and/or discontinuation of ziprasidone.

Gastrointestinal

Gastrointestinal side effects have frequently included nausea (10%), constipation (9%), dyspepsia (8%), diarrhea (5%), vomiting (5%), increased salivation (4%), dry mouth (4%), tongue edema (3%), dysphagia (2%), anorexia (2%), tooth disorder, abdominal pain, and dry mouth. Rectal hemorrhage has been reported infrequently. Gum hemorrhage, fecal impaction, hematemesis, leukoplakia of mouth, melena, and swollen tongue have also been reported.

Respiratory

Collective data gathered from 17 placebo-controlled clinical studies (n=5106) involving the use of atypical antipsychotic agents for the treatment of behavioral disorders in the elderly patient with dementia showed a risk of death 1.6 to 1.7 times greater in the drug- treated patient than in the placebo-treated patient. The average length of duration for the trials was 10 weeks with the cause of death in the majority of cases, though not all, reported as either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Although ziprasidone was not included in these studies, the consistent findings across all three relevant chemical classes support the opinion that these findings are likely to be applicable to all atypical antipsychotic agents. Ziprasidone is not approved by the FDA for use in the treatment of behavioral disorders in elderly patients with dementia.

Respiratory side effects have frequently included respiratory tract infections (8%), rhinitis (4%), increased cough (3%), pharyngitis (3%), and dyspnea (2%). Pneumonia and epistaxis have also been reported. Hemoptysis and laryngismus have been reported rarely.

Dermatologic

Dermatologic side effects have frequently included rash (4%), fungal dermatitis (2%), furunculosis, and sweating. Maculopapular rash, urticaria, alopecia, eczema, exfoliative dermatitis, contact dermatitis, and vesiculobullous rash have also been reported.

The manufacturer reports the most common event associated with dropout in two short-term placebo-controlled studies involving patients receiving oral ziprasidone was rash (1%).

Ocular

Ocular side effects have frequently included abnormal vision in up to 6% of patients. Conjunctivitis, dry eyes, blepharitis, cataract, and photophobia have also been reported. Eye hemorrhage, visual field defects, keratitis, and keratoconjunctivitis have been reported rarely.

Cardiovascular

In schizophrenia trials, oral ziprasidone was associated with a mean increase in heart rate of 1.4 beats per minute compared to a 0.2 beats per minute decrease in placebo patients.

Collective data gathered from 17 placebo-controlled clinical studies (n=5106) involving the use of atypical antipsychotic agents for the treatment of behavioral disorders in the elderly patient with dementia showed a risk of death 1.6 to 1.7 times greater in the drug- treated patient than in the placebo- treated patient. The average length of duration for the trials was 10 weeks with the cause of death in the majority of cases, though not all, reported as either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Although ziprasidone was not included in these studies, the consistent findings across all three relevant chemical classes support the opinion that these findings are likely to be applicable to all atypical antipsychotic agents. Ziprasidone is not approved by the FDA for use in the treatment of behavioral disorders in elderly patients with dementia.

Cardiovascular side effects have frequently included tachycardia (2%), hypertension (3%), chest pain (3%), postural hypotension (1%), bradycardia, and vasodilation. Increase in QTc interval, angina pectoris, atrial fibrillation have also been reported. First degree AV block, bundle branch block, phlebitis, pulmonary embolus, cardiomegaly, cerebral infarct, cerebrovascular accident, deep thrombophlebitis, myocarditis, thrombophlebitis, and Torsade de Pointes have been reported rarely.

Endocrine

Endocrine side effects have included hyperprolactinemia, hyperglycemia, and diabetes mellitus. Hypothyroidism, hyperthyroidism, thyroiditis, hypoglycemia, decreased glucose tolerance, hypoglycemic reaction, and ketosis have been reported rarely. A significant reduction in serum cholesterol and triglycerides has been reported in one study (n=37).

Hyperprolactinemia in some patients may cause sexual dysfunction and menstrual irregularities. In addition, as many as one-third of human breast cancers may be prolactin-dependent in vitro.

Studies have demonstrated that patients receiving atypical antipsychotics (i.e., clozapine, risperidone, olanzapine, quetiapine, ziprasidone) are at an increased risk of developing hyperglycemia and/or diabetes mellitus.

Musculoskeletal

Musculoskeletal side effects have included myalgia (2%) and tenosynovitis (less than 1%). Myopathy has been reported rarely.

Metabolic

A one year study reported clinically significant weight gain, as defined by an increase in body weight of greater than or equal to 7%, in 5% to 11% of ziprasidone recipients. However, median weight actually decreased from baseline by 1, 2, and 3 kg in recipients of ziprasidone 20 mg, 40 mg, and 80 mg twice daily, respectively.

Ziprasidone had a negligible effect on body weight in two short-term studies.

Hyperglycemia has been reported in patients treated with atypical antipsychotics. In some cases, the hyperglycemia has been extreme and associated with ketoacidosis or hyperosmolar coma and death. There have been a few reports of hyperglycemia and diabetes in patients treated with ziprasidone.

Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population. Epidemiological studies (which did not include ziprasidone) suggest an increased risk of treatment-emergent hyperglycemia- related adverse events in patients treated with the atypical antipsychotics included in the studies.

Metabolic side effects have frequently included weight gain (10%). Increased transaminase, increased creatinine phosphokinase, increased alkaline phosphatase, increased lactic dehydrogenase, albuminuria, hypokalemia have also been reported. Increased BUN, increased creatinine, hyperlipemia, hypocholesteremia, hyperkalemia, hypochloremia, hyponatremia, hypoproteinemia, gout, hyperchloremia, hyperuricemia, hypocalcemia, hypomagnesemia, and respiratory alkalosis.

Oncologic

Oncologic side effects have been reported in animal studies. These animal studies have revealed dose-related increases in the incidence of pituitary gland adenoma and carcinoma, and gland adenocarcinoma.

Genitourinary

A 32-year-old male with a history of schizophrenia reported unwanted penile erections lasting a duration of approximately 1 hour. The patient reported this effect starting approximately 10 weeks after initiation of ziprasidone therapy and occurring at a rate of approximately 3 episodes per week. The patient mentioned this adverse effect to his clinician at a regular office visit approximately 1-month later. The problem resolved without recurrence following discontinuation of ziprasidone therapy.

Genitourinary side effects have included impotence, abnormal ejaculation, amenorrhea, hematuria, menorrhagia, female lactation, polyuria, urinary retention, metrorrhagia, male sexual dysfunction, anorgasmia, dysmenorrhea, and glycosuria. Gynecomastia, vaginal hemorrhage, nocturia, oliguria, female sexual dysfunction, and uterine hemorrhage have been reported rarely. Enuresis, urinary incontinence, and priapism have also been reported.

Hematologic

Hematologic side effects have infrequently included anemia, ecchymosis, leukocytosis, leukopenia, eosinophilia, and lymphadenopathy. Thrombocytopenia, hypochromic anemia, lymphocytosis, monocytosis, basophilia, lymphedema, polycythemia, and thrombocythemia have been reported rarely.

Hepatic

Hepatic side effects have rarely included jaundice, increased gamma glutamyl transpeptidase, cholestatic jaundice, hepatitis, hepatomegaly, and fatty liver deposit.

Hypersensitivity

Hypersensitivity side effects have rarely included allergic reactions (such as allergic dermatitis, angioedema, orofacial edema, and urticaria) and rash.

Other

Other side effects have frequently included accidental injury (4%), flu syndrome, fever, accidental fall, face edema, chills, photosensitivity reaction, flank pain, hypothermia, peripheral edema, thirst, dehydration, tinnitus, and motor vehicle accident.

Psychiatric

Psychiatric side effects reported in the short-term trials with intramuscular ziprasidone have included personality disorder and psychosis. Mania/hypomania and depression have also been reported rarely.

Local

Local side effects associated with intramuscular ziprasidone have frequently included pain at the injection site.

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