Summary

Commonly reported side effects of ziprasidone include: drowsiness, weight gain, dizziness, headache, and nausea. Other side effects include: respiratory system disorder, extrapyramidal reaction, orthostatic hypotension, and pain at injection site. Continue reading for a comprehensive list of adverse effects.

Applies to ziprasidone: oral capsule. Other dosage forms:

• intramuscular powder for solution

Serious side effects of Ziprasidone

Along with its needed effects, ziprasidone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ziprasidone:

More common

• Cough
• difficulty with speaking
• drooling
• fear or nervousness
• fever
• inability to sit still
• loss of balance control
• muscle trembling, jerking, or stiffness
• need to keep moving
• restlessness
• shuffling walk
• sneezing
• sore throat
• stiffness of the limbs
• twisting movements of the body
• uncontrolled movements, especially of the face, neck, and back

Less common

• Blurred vision
• body aches or pain
• chest pain
• congestion
• dizziness
• fast, pounding, or irregular heartbeat or pulse
• headache
• hoarseness
• pounding in the ears
• runny nose
• slow or fast heartbeat
• swelling of the tongue
• tender, swollen glands in the neck
• trouble with swallowing
• voice changes

Rare

• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• persistent, painful erection
• seizures

Incidence not known

• Inability to move the eyes
• increased blinking or spasms of the eyelid
• sticking out of tongue
• trouble with breathing
• uncontrolled twisting movements of the neck, trunk, arms, or legs
• unusual facial expressions

Other side effects of Ziprasidone

Some side effects of ziprasidone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach
• belching
• constipation
• diarrhea
• heartburn
• indigestion
• lack or loss of strength
• nausea
• rash
• stomach discomfort, upset, or pain
• weakness
• weight gain

Less common

• Blistering, crusting, irritation, itching, or reddening of the skin
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in vision
• cracked, dry, or scaly skin
• depression
• difficulty with moving
• dry mouth
• increase in salivation
• itching or reddening of the skin
• joint pain
• loss of appetite
• muscle ache
• muscle pains or stiffness
• muscle tightness
• stuffy nose
• swelling
• swollen joints
• vomiting
• weakness of the arms and legs
• weight loss

For Healthcare Professionals

Applies to ziprasidone: intramuscular powder for injection, oral capsule.

General

The most commonly reported adverse events included somnolence, respiratory tract infections, extrapyramidal symptoms, dizziness, akathisia, abnormal vision, asthenia, vomiting, headache, and nausea.^[Ref]

Metabolic

Uncommon (0.1% to 1%): Thirst, increased appetite, hypercholesteremia, dehydration, hyperglycemia, hypokalemia

Rare (less than 0.1%): Hypocalcemia, hyperlipidemia, hyperkalemia, hypochloremia, hypoglycemia, hyponatremia, hypoproteinemia, gout, hyperchloremia, hyperuricemia, hypomagnesemia, ketosis^[Ref]

Weight gain of 7% or more was statistically significantly greater among patients with schizophrenia receiving ziprasidone in a pooled analysis of four 4 and 6 week placebo-controlled trials (10% versus 4%). The median weight gain was 0.5 kg among all ziprasidone patients compared with no weight gain in the placebo patients.^[Ref]

Nervous system

Very common (10% or more): Headache (18%), extrapyramidal symptoms (31%), somnolence (14%)

Common (1% to 10%): Akathisia, dizziness, dyskinesia, dystonia, headache, sedation, tremor, hypertonia, speech disorder

Uncommon (0.1% to 1%): Ataxia, bradykinesia, cogwheel rigidity, disturbance in attention, dizziness postural, drooling, dysarthria, generalized tonic-clonic seizures, hyperkinesia, hypersomnia, hypoesthesia, lethargy, oculogyric crisis, paresthesia, tardive dyskinesia, amnesia, buccoglossal syndrome, choreoathetosis, diplopia, incoordination, neuropathy

Rare (less than 0.1%): Akinesis, paresis, restless legs syndrome, torticollis, paralysis

Postmarketing reports: Facial droop, neuroleptic malignant syndrome, serotonin syndrome (alone or in combination with serotonergic products), tardive dyskinesia^[Ref]

Gastrointestinal

Common (1% to 10%): Constipation, dry mouth, nausea, thick tongue, vomiting, dyspepsia, diarrhea, anorexia

Uncommon (0.1% to 1%): Gastrointestinal discomfort, salivary hypersecretion, dysphagia, flatulence, gastritis, rectal hemorrhage, tongue edema

Rare (less than 0.1%): Gastroesophageal reflux, loose stools, gum hemorrhage, fecal impaction, hematemesis, leukoplakia of mouth, melena

Postmarketing reports: Dysphagia, swollen tongue^[Ref]

Respiratory

Common (1% to 10%): Respiratory tract infection, increased cough, rhinitis

Uncommon (0.1% to 1%): Dyspnea, sore throat, pneumonia, epistaxis

Rare (less than 0.1%): Hiccups, hemoptysis, laryngismus^[Ref]

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.^[Ref]

Cardiovascular

Common (1% to 10%): Chest pain, tachycardia, postural hypotension, hypertension

Uncommon (0.1% to 1%): Right bundle branch block, palpitation, bradycardia, angina pectoris, atrial fibrillation, peripheral edema

Rare (less than 0.1%): ECG QTc prolonged, increased pulse, first degree AV block, bundle branch block, phlebitis, pulmonary embolism, cardiomegaly, cerebral infarct, cerebrovascular accident, deep thrombophlebitis, myocarditis, thrombophlebitis

Postmarketing reports: Torsades de pointes, postural hypotension, hypotension, syncope, venous thromboembolism^[Ref]

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 indicated for use in the treatment of behavioral disorders in elderly patients with dementia.

In a study evaluating the QT prolonging effect of oral ziprasidone with other drugs used in the treatment of schizophrenia, the mean increase in QTc from baseline ranged from 9 to 14 seconds which was greater than 4 of the comparator drugs (risperidone, olanzapine, quetiapine, and haloperidol) but was approximately 14 seconds less than thioridazine.^[Ref]

Hypersensitivity

Postmarketing reports: Allergic reaction^[Ref]

Dermatologic

Common (1% to 10%): Rash, fungal dermatitis, face edema, photosensitivity reaction, sweating

Uncommon (0.1% to 1%): Acne, maculopapular rash, urticaria, eczema, exfoliative dermatitis, vesiculobullous rash

Rare (less than 0.1%): Alopecia, dermatitis allergic, erythema, psoriasis, skin irritation, swelling face, rash papular

Frequency not reported: Severe cutaneous adverse reactions, such as Stevens-Johnson syndrome

Postmarketing reports: Angioedema, rash, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)^[Ref]

Psychiatric

Common (1% to 10%): Restlessness, insomnia, agitation

Uncommon (0.1% to 1%): Anxiety, throat tightness, nightmare

Rare (less than 0.1%): Anorgasmia, bradyphrenia, flat affect, panic attack, sleep walking

Postmarketing reports: Mania/hypomania^[Ref]

Ocular

Common (1% to 10%): Blurred vision, abnormal vision

Uncommon (0.1% to 1%): Photophobia, conjunctivitis, dry eyes, blepharitis, cataract

Rare (less than 0.1%): Amblyopia, eye pruritus, visual disturbance, eye hemorrhage, visual field defect, keratitis, keratoconjunctivitis^[Ref]

Endocrine

Uncommon (0.1% to 1%): Impotence, abnormal ejaculation, female lactation,

Rare (less than 0.1%): Erectile dysfunction, increased erection, galactorrhea, gynecomastia, hypothyroidism, hyperthyroidism, thyroiditis, female sexual dysfunction

Postmarketing reports: Priapism^[Ref]

Musculoskeletal

Common (1% to 10%): Musculoskeletal stiffness, myalgia

Uncommon (0.1% to 1%): Joint stiffness, muscle cramps, extremity pain, tenosynovitis

Rare (less than 0.1%): Arthropathy, musculoskeletal discomfort, trismus, myopathy^[Ref]

Genitourinary

Uncommon (0.1% to 1%): Dysuria, urinary incontinence, amenorrhea, hematuria, menorrhagia, polyuria, urinary retention metrorrhagia

Rare (less than 0.1%): vaginal hemorrhage, nocturia, oliguria, uterine hemorrhage

Postmarketing reports: Enuresis, urinary incontinence^[Ref]

Hematologic

Uncommon (0.1% to 1%): Anemia, ecchymosis, leukocytosis, leukopenia, eosinophilia, lymphadenopathy

Rare (less than 0.1%): Lymphopenia, increased eosinophil count, abnormal eosinophil count, thrombocytopenia, hypochromic anemia, lymphocytosis, monocytosis, basophilia, lymphedema, polycythemia, thrombocythemia^[Ref]

Hepatic

Uncommon (0.1% to 1%): Hepatic enzyme increased, alkaline phosphatase increased, Rare (less than 0.1%): Abnormal liver function test, jaundice, gamma glutamyl transpeptidase increased, cholestatic jaundice, hepatitis, hepatomegaly, fatty liver deposit^[Ref]

Other

Common (1% to 10%): Asthenia, accidental injury, fatigue, fever, chills, hypothermia

Uncommon (0.1% to 1%): Abnormal gait, tinnitus

Rare (less than 0.1%): Ear pain, vertigo positional, body temperature increased^[Ref]

Local

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

Immunologic

Common (1% to 10%): Flu syndrome^[Ref]