Medical Editor: Melissa Conrad Stöppler, MD
What Is Geodon?
Geodon (ziprasidone HCl and ziprasidone mesylate) is an atypical antipsychotic used to treat symptoms of schizophrenia and acute manic or mixed episodes associated with bipolar disorder. Geodon also can be used as maintenance treatment of bipolar disorder when added to lithium or valproate.
What Are Side Effects of Geodon?
Common side effects of Geodon include
- feeling unusually tired or sleepy;
- nausea,
- vomiting,
- upset stomach,
- loss of appetite;
- constipation;
- dizziness,
- drowsiness;
- restlessness;
- anxiety,
- headache,
- depression;
- abnormal muscle movements,
- such as tremor,
- shuffling, and
- uncontrolled involuntary movements,
- muscle pain or twitching;
- diarrhea;
- skin rash;
- weight gain, and
- increased cough or runny or stuffy nose.
Serious side effects of Geodon include
- fainting or
- loss of consciousness or
- heart palpitations.
This is not a complete list of side effects, and others may occur.
Dosage for Geodon
Geodon (ziprasidone HCl) is available as capsules and Geodon (ziprasidone mesylate) is available as an injection for intramuscular use. Geodon Capsules should be administered at an initial daily dose of 20 mg twice daily with food. For intramuscular dosing, the recommended dose of Geodon is 10 mg to 20 mg administered as required up to a maximum dose of 40 mg per day.
What Drugs, Substances, or Supplements Interact with Geodon?
Geodon may interact with other medicines that make you sleepy (such as cold or allergy medicines, narcotics, sleeping pills, muscle relaxers, and medicines for seizures, depression, or anxiety), diuretics (water pills), blood pressure medicines, heart rhythm medicines, carbamazepine, cisapride, haloperidol, or medicines used to treat Parkinson's Disease.
Tell your doctor all medications and supplements you use.
Geodon During Pregnancy and Breastfeeding
Geodon should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Women receiving Geodon should not breastfeed. Taking antipsychotic medication such as Geodon during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking Geodon during pregnancy. If you become pregnant while taking Geodon, do not stop taking it without your doctor's advice.
Additional Information
Our Geodon Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION
Another term that has been previously used for bipolar disorder is ___________________. See AnswerGet emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).
Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.
Stop using ziprasidone and call your doctor at once if you have:
- fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
- uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
- any skin rash, no matter how mild;
- low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing;
- high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor; or
- severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, agitation.
Common side effects may include:
- dizziness, drowsiness, weakness;
- headache;
- nausea, vomiting;
- trouble swallowing;
- weight gain;
- feeling restless or being unable to sit still;
- tremors, involuntary muscle movements;
- vision problems; or
- runny nose, new or worsening cough.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Geodon (Ziprasidone)

SLIDESHOW
Bipolar Disorder: Symptoms, Testing for Bipolar Depression See SlideshowSIDE EFFECTS
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 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. 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.
Clinical trials 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 reactions 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.
The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.
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.
Commonly Observed Adverse Reactions In Short Term-Placebo-Controlled Trials
The following adverse reactions were the most commonly observed adverse reactions 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): Schizophrenia trials (see Table 11)
- Somnolence
- Respiratory Tract Infection Bipolar trials (see Table 12)
- Somnolence
- Extrapyramidal Symptoms which includes the following adverse reaction terms: extrapyramidal syndrome, hypertonia, dystonia, dyskinesia, hypokinesia, tremor, paralysis and twitching. None of these adverse reactions occurred individually at an incidence greater than 10% in bipolar mania trials.
- Dizziness which includes the adverse reaction terms dizziness and lightheadedness.
- Akathisia
- Abnormal Vision
- Asthenia
- Vomiting
SCHIZOPHRENIA
Adverse Reactions 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 reaction, compared with about 2.2% (6/273) on placebo. The most common reaction associated with dropout was rash, including 7 dropouts for rash among ziprasidone patients (1%) compared to no placebo patients [see WARNINGS AND PRECAUTIONS].
Adverse Reactions Occurring at an Incidence of 2% or More Among Ziprasidone-Treated Patients in Short-Term, Oral, Placebo-Controlled Trials
Table 11 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse reactions that occurred during acute therapy (up to 6 weeks) in predominantly patients with schizophrenia, including only those reactions 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 11: Treatment-Emergent Adverse Reaction Incidence In Short-Term Oral Placebo-Controlled Trials – Schizophrenia
Body System/Adverse Reaction | Percentage of Patients Reporting Reaction | |
Ziprasidone (N=702) | Placebo (N=273) | |
Body as a Whole | ||
Asthenia | 5 | 3 |
Accidental Injury | 4 | 2 |
Chest Pain | 3 | 2 |
Cardiovascular | ||
Tachycardia | 2 | 1 |
Digestive | ||
Nausea | 10 | 7 |
Constipation | 9 | 8 |
Dyspepsia | 8 | 7 |
Diarrhea | 5 | 4 |
Dry Mouth | 4 | 2 |
Anorexia | 2 | 1 |
Nervous | ||
Extrapyramidal Symptoms* | 14 | 8 |
Somnolence | 14 | 7 |
Akathisia | 8 | 7 |
Dizziness** | 8 | 6 |
Respiratory | ||
Respiratory Tract Infection | 8 | 3 |
Rhinitis | 4 | 2 |
Cough Increased | 3 | 1 |
Skin and Appendages | ||
Rash | 4 | 3 |
Fungal Dermatitis | 2 | 1 |
Special Senses | ||
Abnormal Vision | 3 | 2 |
* Extrapyramidal Symptoms includes the following adverse reaction terms: extrapyramidal syndrome, hypertonia, dystonia, dyskinesia, hypokinesia, tremor, paralysis and twitching. None of these adverse reactions occurred individually at an incidence greater than 5% in schizophrenia trials. ** Dizziness includes the adverse reaction terms dizziness and lightheadedness. |
Dose Dependency Of Adverse Reactions 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 reaction to dose for the following reactions: asthenia, postural hypotension, anorexia, dry mouth, increased salivation, arthralgia, anxiety, dizziness, dystonia, hypertonia, somnolence, tremor, rhinitis, rash, and abnormal vision.
Extrapyramidal Symptoms (EPS)
The incidence of reported EPS (which included the adverse reaction 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.
Dystonia
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.
Vital Sign Changes
Ziprasidone is associated with orthostatic hypotension [see WARNINGS AND PRECAUTIONS]
ECG Changes
Ziprasidone is associated with an increase in the QTc interval [see WARNINGS AND PRECAUTIONS]. 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 Reactions Observed During The Premarketing Evaluation Of Oral Ziprasidone
Following is a list of COSTART terms that reflect treatment-emergent adverse reactions 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 reactions are included except those already listed in Table 11 or elsewhere in labeling, those reaction terms that were so general as to be uninformative, reactions reported only once and that did not have a substantial probability of being acutely life-threatening, reactions that are part of the illness being treated or are otherwise common as background reactions, and reactions considered unlikely to be drug-related. It is important to emphasize that, although the reactions reported occurred during treatment with ziprasidone, they were not necessarily caused by it.
Adverse reactions are further categorized by body system and listed in order of decreasing frequency according to the following definitions:
Frequent -adverse reactions occurring in at least 1/100 patients (≥1.0% of patients) (only those not already listed in the tabulated results from placebo-controlled trials appear in this listing);
Infrequent -adverse reactions occurring in 1/100 to 1/1000 patients (in 0.1-1.0% of patients)
Rare – adverse reactions occurring in fewer than 1/1000 patients (<0.1% of 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, hypoglycemicreaction, 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
Biplar Disorder
Acute Treatment of Manic or Mixed Episodes
Adverse Reactions Associated with Discontinuation of Treatment in Short Term, Placebo-Controlled Trials
Approximately 6.5% (18/279) of ziprasidone-treated patients in short-term, placebo-controlled studies discontinued treatment due to an adverse reaction, compared with about 3.7% (5/136) on placebo. The most common reactions associated with dropout in the ziprasidone-treated patients were akathisia, anxiety, depression, dizziness, dystonia, rash and vomiting, with 2 dropouts for each of these reactions among ziprasidone patients (1%) compared to one placebo patient each for dystonia and rash (1%) and no placebo patients for the remaining adverse reactions.
Adverse Reactions Occurring at an Incidence of 2% or More Among Ziprasidone-Treated Patients in Short-Term, Oral, Placebo-Controlled Trials
Table 12 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse reactions that occurred during acute therapy (up to 3 weeks) in patients with bipolar mania, including only those reactions 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 12: Treatment-Emergent Adverse Reactions Incidence In Short-Term Oral Placebo-Controlled Trials – Manic and Mixed Episodes Associated with Bipolar Disorder
Body System/Adverse Reaction | Percentage of Patients Reporting Reaction | |
Ziprasidone (N=279) | Placebo (N=136) | |
Body as a Whole | ||
Headache | 18 | 17 |
Asthenia | 6 | 2 |
Accidental Injury | 4 | 1 |
Cardiovascular | ||
Hypertension | 3 | 2 |
Digestive | ||
Nausea | 10 | 7 |
Diarrhea | 5 | 4 |
Dry Mouth | 5 | 4 |
Vomiting | 5 | 2 |
Increased Salivation | 4 | 0 |
Tongue Edema | 3 | 1 |
Dysphagia | 2 | 0 |
Musculoskeletal | ||
Myalgia | 2 | 0 |
Nervous | ||
Somnolence | 31 | 12 |
Extrapyramidal Symptoms* | 31 | 12 |
Dizziness** | 16 | 7 |
Akathisia | 10 | 5 |
Anxiety | 5 | 4 |
Hypesthesia | 2 | 1 |
Speech Disorder | 2 | 0 |
Respiratory | ||
Pharyngitis | 3 | 1 |
Dyspnea | 2 | 1 |
Skin and Appendages | ||
Fungal Dermatitis | 2 | 1 |
Special Senses | ||
Abnormal Vision | 6 | 3 |
* Extrapyramidal Symptoms includes the following adverse reaction terms: extrapyramidal syndrome, hypertonia, dystonia, dyskinesia, hypokinesia, tremor, paralysis and twitching. None of these adverse reactions occurred individually at an incidence greater than 10% in bipolar mania trials. ** Dizziness includes the adverse reaction terms dizziness and lightheadedness. |
Explorations for interactions on the basis of gender did not reveal any clinically meaningful differences in the adverse reaction occurrence on the basis of this demographic factor.
Intramuscular Ziprasidone
Adverse Reactions Occurring at an Incidence of 1% or More Among Ziprasidone-Treated Patients in Short-Term Trials of Intramuscular Ziprasidone
Table 13 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse reactions that occurred during acute therapy with intramuscular ziprasidone in 1% or more of patients.
In these studies, the most commonly observed adverse reactions 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%).
Table 13: Treatment-Emergent Adverse Reaction Incidence In Short-Term Fixed-Dose Intramuscular Trials
Body System/Adverse Reaction | Percentage of Patients Reporting Reaction | ||
Ziprasidone 2 mg (N=92) | Ziprasidone 10 mg (N=63) | Ziprasidone 20 mg (N=41) | |
Body as a Whole | |||
Headache | 3 | 13 | 5 |
Injection Site Pain | 9 | 8 | 7 |
Asthenia | 2 | 0 | 0 |
Abdominal Pain | 0 | 2 | 0 |
Flu Syndrome | 1 | 0 | 0 |
Back Pain | 1 | 0 | 0 |
Cardiovascular | |||
Postural Hypotension | 0 | 0 | 5 |
Hypertension | 2 | 0 | 0 |
Bradycardia | 0 | 0 | 2 |
Vasodilation | 1 | 0 | 0 |
Digestive | |||
Nausea | 4 | 8 | 12 |
Rectal Hemorrhage | 0 | 0 | 2 |
Diarrhea | 3 | 3 | 0 |
Vomiting | 0 | 3 | 0 |
Dyspepsia | 1 | 3 | 2 |
Anorexia | 0 | 2 | 0 |
Constipation | 0 | 0 | 2 |
Tooth Disorder | 1 | 0 | 0 |
Dry Mouth | 1 | 0 | 0 |
Nervous | |||
Dizziness | 3 | 3 | 10 |
Anxiety | 2 | 0 | 0 |
Insomnia | 3 | 0 | 0 |
Somnolence | 8 | 8 | 20 |
Akathisia | 0 | 2 | 0 |
Agitation | 2 | 2 | 0 |
Extrapyramidal Syndrome | 2 | 0 | 0 |
Hypertonia | 1 | 0 | 0 |
Cogwheel Rigidity | 1 | 0 | 0 |
Paresthesia | 0 | 2 | 0 |
Personality Disorder | 0 | 2 | 0 |
Psychosis | 1 | 0 | 0 |
Speech Disorder | 0 | 2 | 0 |
Respiratory | |||
Rhinitis | 1 | 0 | 0 |
Skin and Appendages | |||
Furunculosis | 0 | 2 | 0 |
Sweating | 0 | 0 | 2 |
Urogenital | |||
Dysmenorrhea | 0 | 2 | 0 |
Priapism | 1 | 0 | 0 |
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of GEODON. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Adverse reaction reports not listed above that have been received since market introduction include rare occurrences of the following :
Cardiac Disorders: Tachycardia, torsade de pointes (in the presence of multiple confounding factors), [see WARNINGS AND PRECAUTIONS];
Digestive System Disorders: Swollen Tongue;
Reproductive System and Breast Disorders: Galactorrhea, priapism;
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;
Skin and subcutaneous Tissue Disorders: Allergic reaction (such as allergic dermatitis, angioedema, orofacial edema, urticaria), rash, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS);
Urogenital System Disorders: Enuresis, urinary incontinence;
Vascular Disorders: Postural hypotension, syncope.
Read the entire FDA prescribing information for Geodon (Ziprasidone)
Read the Geodon User Reviews »
© Geodon Patient Information is supplied by Cerner Multum, Inc. and Geodon Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
