Ziprasidone Side Effects

Some side effects of ziprasidone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to ziprasidone: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking ziprasidone: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking ziprasidone and call your doctor at once if you have a serious side effect such as:

• dizziness, feeling light-headed, fainting, fast or pounding heartbeat;

• fever, stiff muscles, confusion, sweating, fast or uneven heartbeats;

• fever, chills, body aches, flu symptoms;

• white patches or sores inside your mouth or on your lips;

• tremor (uncontrolled shaking), restless muscle movements in your eyes, tongue, jaw, or neck;

• agitation, hostility, confusion;

• increased thirst or urination, weakness, extreme hunger; or

• penis erection that is painful or lasts 4 hours or longer.

Less serious side effects of ziprasidone may include:

• mild skin rash;

• anxiety, headache, depressed mood;

• dizziness, drowsiness;

• muscle pain or twitching;

• nausea, vomiting, loss of appetite;

• runny or stuffy nose, cough, sore throat; or

• weight gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to ziprasidone: intramuscular powder for injection, oral capsule

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.

Ziprasidone has been associated with improvement on cognitive test performance in patients in the early stages of schizophrenia.

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.

Lower (worse) baseline scores predicted greater cognitive improvement. Change In cognitive performance was weakly related to change in symptom scores.

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, thrombocythemia, neutropenia, and agranulocytosis 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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