Slideshows Images Quizzes

Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. See additional information.

Geodon

Last reviewed on RxList: 5/28/2020
Geodon Side Effects Center

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

Serious side effects of Geodon include

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 Answer
Geodon Consumer Information

Get 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, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. This reaction may occur several weeks after you began using ziprasidone.

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;
  • nausea, vomiting;
  • trouble swallowing;
  • feeling restless;
  • tremors;
  • 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 Slideshow
Geodon Professional Information

SIDE 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 ReactionPercentage of Patients Reporting Reaction
Ziprasidone
(N=702)
Placebo
(N=273)
Body as a Whole
  Asthenia53
  Accidental Injury42
  Chest Pain32
Cardiovascular
  Tachycardia21
Digestive
  Nausea107
  Constipation98
  Dyspepsia87
  Diarrhea54
  Dry Mouth42
  Anorexia21
Nervous
  Extrapyramidal Symptoms*148
  Somnolence147
  Akathisia87
  Dizziness**86
Respiratory
  Respiratory Tract Infection83
  Rhinitis42
  Cough Increased31
Skin and Appendages
  Rash43
  Fungal Dermatitis21
Special Senses
  Abnormal Vision32
* 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 ReactionPercentage of Patients Reporting Reaction
Ziprasidone
(N=279)
Placebo
(N=136)
Body as a Whole
  Headache1817
  Asthenia62
  Accidental Injury41
Cardiovascular
  Hypertension32
Digestive
  Nausea107
  Diarrhea54
  Dry Mouth54
  Vomiting52
  Increased Salivation40
  Tongue Edema31
  Dysphagia20
Musculoskeletal
  Myalgia20
Nervous
  Somnolence3112
  Extrapyramidal Symptoms*3112
  Dizziness**167
  Akathisia105
  Anxiety54
  Hypesthesia21
  Speech Disorder20
Respiratory
  Pharyngitis31
  Dyspnea21
Skin and Appendages
  Fungal Dermatitis21
Special Senses
  Abnormal Vision63
* 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 ReactionPercentage of Patients Reporting Reaction
Ziprasidone 2 mg (N=92)Ziprasidone 10 mg (N=63)Ziprasidone 20 mg (N=41)
Body as a Whole
  Headache3135
  Injection Site Pain987
  Asthenia200
  Abdominal Pain020
  Flu Syndrome100
  Back Pain100
Cardiovascular
  Postural Hypotension005
  Hypertension200
  Bradycardia002
  Vasodilation100
Digestive
  Nausea4812
  Rectal Hemorrhage002
  Diarrhea330
  Vomiting030
  Dyspepsia132
  Anorexia020
  Constipation002
  Tooth Disorder100
  Dry Mouth100
Nervous
  Dizziness3310
  Anxiety200
  Insomnia300
  Somnolence8820
  Akathisia020
  Agitation220
  Extrapyramidal Syndrome200
  Hypertonia100
  Cogwheel Rigidity100
  Paresthesia020
  Personality Disorder020
  Psychosis100
  Speech Disorder020
Respiratory
  Rhinitis100
Skin and Appendages
  Furunculosis020
  Sweating002
Urogenital
  Dysmenorrhea020
  Priapism100

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)

Health Solutions From Our Sponsors

CONTINUE SCROLLING FOR RELATED SLIDESHOW