Ziprasidon Actavis (Ziprasidone)
Atypical antipsychotic for schizophrenia and bipolar disorder
Ziprasidon Actavis contains the active substance ziprasidone, an atypical (second-generation) antipsychotic medication. It is primarily prescribed for schizophrenia in adults and for manic or mixed episodes in bipolar disorder in adults and adolescents aged 10 to 17. Ziprasidone works by modulating dopamine and serotonin pathways in the brain, helping to reduce psychotic symptoms and stabilize mood. This capsule must always be taken with food to ensure proper absorption.
Quick Facts
Key Takeaways
- Ziprasidone is an atypical antipsychotic used for schizophrenia and bipolar mania, taken as capsules twice daily with meals.
- Capsules must be taken with food — absorption decreases by up to 50% on an empty stomach, reducing effectiveness.
- It has a lower risk of metabolic side effects (weight gain, diabetes) compared to many other antipsychotics, but may prolong the QT interval.
- Do not use if you have known heart problems, recent heart attack, or are taking other QT-prolonging medications.
- Common side effects include drowsiness, insomnia, headache, dizziness, and nausea — most are mild and temporary.
What Is Ziprasidon Actavis and What Is It Used For?
Quick Answer: Ziprasidon Actavis is an atypical antipsychotic medication containing ziprasidone. It treats schizophrenia in adults and manic/mixed episodes in bipolar disorder in adults and adolescents (10–17 years). It modulates brain dopamine and serotonin to reduce psychotic symptoms and mood instability.
Ziprasidon Actavis belongs to the pharmacological class of atypical (second-generation) antipsychotics. Unlike older first-generation antipsychotics, ziprasidone has a more favorable side effect profile, particularly regarding metabolic disturbances. Its pharmacological mechanism involves antagonism at dopamine D2 and serotonin 5-HT2A receptors, combined with agonist activity at serotonin 5-HT1A receptors and inhibition of norepinephrine and serotonin reuptake. This unique profile contributes to both antipsychotic and mood-stabilizing effects.
Schizophrenia
In adults, Ziprasidon Actavis is indicated for the treatment of schizophrenia, a chronic and severe mental health disorder characterized by disturbances in thought, perception, and behavior. Symptoms may include hearing, seeing, or feeling things that are not real (hallucinations), believing things that are not true (delusions), unusual suspiciousness, social withdrawal, nervousness, depression, or anxiety. Clinical trials have demonstrated that ziprasidone effectively reduces both positive symptoms (such as hallucinations and delusions) and negative symptoms (such as social withdrawal and flattened affect) of schizophrenia.
The evidence supporting ziprasidone's efficacy in schizophrenia comes from multiple randomized controlled trials and is well-documented in guidelines from the American Psychiatric Association (APA) and the National Institute for Health and Care Excellence (NICE). The CATIE trial (Clinical Antipsychotic Trials of Intervention Effectiveness) provided important comparative data showing that while all antipsychotics had high discontinuation rates, ziprasidone had a notably better metabolic profile than alternatives like olanzapine.
Bipolar Disorder — Manic and Mixed Episodes
Ziprasidon Actavis is also used to treat manic or mixed episodes associated with bipolar disorder in adults, as well as in children and adolescents aged 10 to 17 years. Bipolar disorder is characterized by alternating periods of elevated mood (mania) and depression. During manic episodes, individuals may experience euphoria, exaggerated self-confidence, increased energy, reduced need for sleep, poor concentration, hyperactivity, and repeated episodes of high-risk behavior.
In mixed episodes, patients may simultaneously experience features of both mania and depression, which can be particularly distressing and difficult to manage. Ziprasidone has demonstrated efficacy in rapidly controlling acute manic symptoms while providing mood stabilization. The International College of Neuro-Psychopharmacology (CINP) guidelines support the use of ziprasidone as a monotherapy or adjunctive therapy in the management of acute bipolar mania.
Ziprasidone may also be approved for other conditions not described in this leaflet. Always follow your prescribing doctor's instructions and consult them or your pharmacist if you have questions about your specific treatment.
What Should You Know Before Taking Ziprasidon Actavis?
Quick Answer: Do not take Ziprasidon Actavis if you are allergic to ziprasidone, have heart problems or recent heart attack, or take medications that affect heart rhythm (QT interval). Inform your doctor about all medications, pregnancy plans, and pre-existing conditions before starting treatment.
Contraindications
You must not use Ziprasidon Actavis in any of the following circumstances:
- Allergy to ziprasidone or any other ingredient in the capsules. Allergic reactions may manifest as rash, itching, facial or lip swelling, or breathing difficulties.
- Heart problems — if you have or have had cardiac conditions, including a recent myocardial infarction (heart attack), uncompensated heart failure, or known QT prolongation.
- QT-prolonging medications — if you are taking medications known to prolong the QT interval, including Class IA and III antiarrhythmics, arsenic trioxide, halofantrin, levomethadyl acetate, mesoridazine, thioridazine, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, dolasetron mesylate, mefloquine, sertindole, or cisapride.
Ziprasidone may prolong the QT interval, which can lead to serious and potentially life-threatening cardiac arrhythmias including Torsades de Pointes. An ECG should be performed before and during treatment. If you experience rapid or irregular heartbeat, fainting, or dizziness upon standing, seek immediate medical attention.
Warnings and Precautions
Speak to your doctor or pharmacist before taking Ziprasidon Actavis if any of the following apply to you:
- You or a family member have a history of blood clots (venous thromboembolism), as antipsychotic medications have been associated with clot formation.
- You have liver problems — dose adjustment may be necessary.
- You have or have had seizures or epilepsy.
- You are over 65 years old with dementia — elderly patients with dementia-related psychosis treated with antipsychotics have an increased risk of stroke and death.
- You have a low resting heart rate and/or may have electrolyte imbalances from prolonged diarrhea, vomiting, or diuretic use.
- You experience rapid or irregular heartbeat, fainting, collapse, or dizziness when standing up, which may indicate abnormal cardiac function.
Contact your doctor immediately if you experience any of the following during treatment:
- Severe skin reactions such as blistering rash that may involve mouth sores, peeling skin, fever, and round skin lesions, which may be symptoms of Stevens-Johnson syndrome. These reactions can be life-threatening.
- Neuroleptic Malignant Syndrome (NMS) — symptoms include fever, shortness of breath, sweating, muscle rigidity, tremors, difficulty swallowing, and altered consciousness. This is a medical emergency requiring immediate treatment.
- Serotonin Syndrome — confusion, agitation, elevated temperature, sweating, difficulty coordinating muscles, and muscle twitching, especially if taking other serotonergic medications concurrently.
Ziprasidone may cause drowsiness, blood pressure drops when standing (orthostatic hypotension), dizziness, and gait disturbance, which can increase the risk of falls. Exercise particular caution if you are elderly or physically frail. Inform your doctor that you are taking ziprasidone before undergoing any laboratory tests, as the medication may affect results.
Children and Adolescents
The safety and efficacy of ziprasidone for treating schizophrenia have not been established in children and adolescents. For bipolar mania, ziprasidone is approved for use in patients aged 10 to 17 years under medical supervision.
Pregnancy and Breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning a pregnancy, consult your doctor before using this medication.
Pregnancy: You should not use Ziprasidon Actavis during pregnancy unless specifically prescribed by your doctor, as there is a risk that the medication may affect your baby. Newborns exposed to antipsychotics during the third trimester may experience withdrawal symptoms including tremors, muscle rigidity and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your baby develops any of these symptoms after birth, contact your doctor immediately.
Breastfeeding: Do not breastfeed while taking ziprasidone, as small amounts of the drug may pass into breast milk. Consult your doctor about alternative feeding options before starting treatment.
Contraception: Women of childbearing potential should use effective contraception throughout treatment with ziprasidone.
Driving and Operating Machinery
Ziprasidone may cause drowsiness and dizziness. If you experience these effects, do not drive, use tools, or operate machinery until the symptoms resolve. You are personally responsible for assessing whether you are fit to drive or perform tasks requiring alertness.
This medicine contains less than 1 mmol (23 mg) sodium per capsule, meaning it is essentially sodium-free.
How Does Ziprasidon Actavis Interact with Other Drugs?
Quick Answer: Ziprasidone has significant interactions with QT-prolonging drugs (absolutely contraindicated), certain antibiotics, antiepileptics, antidepressants, and Parkinson's medications. Always inform your doctor and pharmacist about all medications you take, including herbal products.
Drug interactions with ziprasidone can be clinically significant and in some cases dangerous. The most critical interactions relate to medications that also prolong the QT interval, as the combined effect can lead to life-threatening cardiac arrhythmias. Additionally, drugs that alter ziprasidone's metabolism through the cytochrome P450 enzyme system (particularly CYP3A4) can affect blood levels of ziprasidone, potentially leading to reduced efficacy or increased toxicity.
Major Interactions — Contraindicated
The following medications must never be taken together with ziprasidone due to the risk of dangerous QT prolongation:
| Drug/Class | Examples | Risk |
|---|---|---|
| Class IA Antiarrhythmics | Quinidine, procainamide | Additive QT prolongation — risk of Torsades de Pointes |
| Class III Antiarrhythmics | Amiodarone, sotalol, dofetilide | Additive QT prolongation — risk of Torsades de Pointes |
| Other Antipsychotics | Thioridazine, mesoridazine, pimozide, sertindole | Additive QT prolongation and CNS effects |
| Certain Antibiotics | Sparfloxacin, gatifloxacin, moxifloxacin | Additive QT prolongation |
| Antimalarials | Halofantrin, mefloquine | Additive QT prolongation |
| Other | Arsenic trioxide, cisapride, dolasetron mesylate, levomethadyl acetate | Additive QT prolongation |
Clinically Significant Interactions
Inform your doctor or pharmacist if you are taking or have recently taken any of the following medications:
| Category | Examples | Effect |
|---|---|---|
| Macrolide antibiotics | Erythromycin, clarithromycin | May increase ziprasidone levels via CYP3A4 inhibition |
| Antiepileptics | Carbamazepine, phenytoin, phenobarbital | May decrease ziprasidone levels via CYP3A4 induction |
| Mood stabilizers | Lithium, valproate | Monitor closely; may potentiate CNS effects |
| SSRI antidepressants | Fluoxetine, paroxetine, sertraline | Risk of serotonin syndrome |
| Parkinson's medications | Levodopa, bromocriptine, ropinirole, pramipexole | Ziprasidone may oppose dopaminergic effects |
| CYP3A4 inhibitors | Ketoconazole, itraconazole, ritonavir | May increase ziprasidone blood levels |
| CYP3A4 inducers | Rifampin, St. John's Wort | May decrease ziprasidone blood levels significantly |
| Calcium channel blockers | Verapamil | May increase ziprasidone levels |
Food and Alcohol
Capsules MUST be taken during a main meal. Food significantly increases the absorption of ziprasidone. Taking the capsules without food may reduce absorption by approximately 50%, potentially leading to subtherapeutic blood levels and reduced efficacy.
Alcohol should be avoided during treatment with ziprasidone, as it increases the risk of side effects such as drowsiness, dizziness, and impaired cognitive function. The combination of alcohol and ziprasidone may also exacerbate orthostatic hypotension.
What Is the Correct Dosage of Ziprasidon Actavis?
Quick Answer: Adults with schizophrenia typically take 40–80 mg twice daily with meals (maximum 160 mg/day). For bipolar mania in adolescents (10–17), the starting dose is 20 mg with food, adjusted up to 80 mg/day (≤45 kg) or 160 mg/day (>45 kg). Capsules must be swallowed whole, not chewed.
Always use this medicine exactly as your doctor or pharmacist has instructed. Consult them if you are unsure. Capsules should be swallowed whole — do not chew them, as this can reduce the amount of medication absorbed by the gut. Take capsules twice daily: one capsule in the morning with breakfast and one in the evening with dinner. Take the medication at the same times each day.
Adults — Schizophrenia
Standard Adult Dosing
The recommended dose is 40–80 mg twice daily, taken with a main meal. Your doctor may adjust the dose based on your individual response. The maximum daily dose is 160 mg (80 mg twice daily). During long-term treatment, your doctor may periodically re-evaluate the dosage to ensure the lowest effective dose is maintained.
Adults — Bipolar Mania
Bipolar Mania Dosing
Ziprasidone is taken twice daily with meals for manic or mixed episodes. Your doctor will determine the appropriate dose, typically starting at a moderate level and adjusting based on clinical response and tolerability. The maximum daily dose is 160 mg.
Children and Adolescents (10–17 years) — Bipolar Mania
Pediatric Dosing
The recommended starting dose is 20 mg once daily taken with food. Your doctor will determine the appropriate dose based on your child's weight and clinical response:
- Body weight ≤45 kg: Maximum dose is 80 mg per day
- Body weight >45 kg: Maximum dose is 160 mg per day
Elderly (Over 65 Years)
Elderly Dosing
Lower doses may be necessary for patients over 65. Your doctor will determine an appropriate dose based on your individual health status, kidney and liver function, and other medications you are taking. Elderly patients may be more susceptible to orthostatic hypotension and other side effects.
Patients with Liver Problems
Hepatic Impairment
If you have liver problems, you may need a lower dose. Your doctor will determine the correct dose based on the severity of your liver impairment and your clinical response to treatment.
Missed Dose
It is important to take your medication regularly at the same times each day. If you miss a dose, take it as soon as you remember — unless it is nearly time for your next dose. In that case, skip the missed dose and take your next dose at the usual time. Do not take a double dose to make up for a forgotten one.
Overdose
If you take more Ziprasidon Actavis than prescribed, contact your doctor immediately or go to the nearest emergency department. Bring the medication packaging with you. Overdose symptoms may include drowsiness, tremors, seizures, and involuntary movements of the head and neck. In case of suspected overdose, call your local poison control center or emergency services immediately.
Stopping Treatment
Your doctor will tell you how long to continue taking Ziprasidon Actavis. Do not stop taking the medication without consulting your doctor, even if you feel better. Abruptly stopping treatment may cause symptoms to return. If your doctor decides to discontinue ziprasidone, the dose may be gradually reduced to minimize the risk of withdrawal symptoms.
What Are the Side Effects of Ziprasidon Actavis?
Quick Answer: Very common side effects include insomnia, drowsiness, and headache. Common effects include dizziness, nausea, dry mouth, restlessness, and involuntary movements. Rare but serious effects include QT prolongation, neuroleptic malignant syndrome, and severe allergic reactions. Most side effects are mild and temporary.
Like all medicines, Ziprasidon Actavis can cause side effects, although not everyone experiences them. Most side effects are short-lived. It can sometimes be difficult to distinguish between symptoms of the underlying condition and medication side effects.
- Swelling of face, lips, tongue, or throat; difficulty swallowing or breathing; hives (signs of a serious allergic reaction/angioedema)
- Fever, breathlessness, sweating, muscle rigidity, tremors, and altered consciousness (signs of Neuroleptic Malignant Syndrome)
- Rapid or irregular heartbeat, fainting (signs of potentially life-threatening cardiac arrhythmia)
- Confusion, agitation, fever, sweating, muscle twitching (signs of Serotonin Syndrome)
- Severe skin reactions with blistering, mouth sores, peeling skin (signs of Stevens-Johnson syndrome or DRESS)
- Persistent, abnormal, and painful erection (priapism)
Very Common
May affect more than 1 in 10 people
- Difficulty sleeping (insomnia)
- Abnormal sleepiness or excessive daytime drowsiness
- Headache
Common
May affect up to 1 in 10 people
- Runny nose
- High energy, abnormal thought patterns, hyperactivity, agitation, anxiety
- Restlessness (akathisia)
- Involuntary movements, muscle stiffness, slow movements
- Dizziness, drowsiness
- Blurred or impaired vision
- High blood pressure
- Constipation, diarrhea, nausea, vomiting, indigestion
- Dry mouth or increased saliva
- Skin rash
- Sexual problems in men
- Fever, pain, fatigue, general malaise
- Weight loss or weight gain
Uncommon
May affect up to 1 in 100 people
- High prolactin levels in blood, increased appetite
- Panic anxiety, nervousness, depression, decreased libido
- Loss of consciousness, restless legs syndrome
- Seizures, involuntary eye movements, speech disorders, numbness, tingling
- Palpitations, shortness of breath
- Light sensitivity, dry eyes, tinnitus, ear pain
- Throat tightness, nightmares, drooling
- Sore throat, gas, stomach discomfort, acid reflux
- Itchy rash, acne, hair loss
- Muscle cramps, stiff or swollen joints
- Urinary incontinence, painful urination, difficulty urinating
- Abnormal breast milk production, breast enlargement in men
- Cessation of menstruation
- Abnormal ECG results, abnormal liver function tests
Rare
May affect up to 1 in 1,000 people
- Decreased blood calcium levels, cognitive slowing, emotional blunting
- Facial paralysis, general paralysis
- Partial or complete vision loss in one eye, itchy eyes
- Speech difficulties, hiccups, loose stools
- Skin irritation, difficulty opening mouth (trismus)
- Difficulty emptying bladder, decreased orgasm
- Newborn withdrawal symptoms (when used in third trimester)
- Changes in white blood cell counts
- Psoriasis flares
- Angioedema, Neuroleptic Malignant Syndrome, Torsades de Pointes
- Serotonin syndrome, DRESS (drug reaction with eosinophilia)
Frequency Not Known
Cannot be estimated from available data
- In elderly patients with dementia, a small increase in deaths has been reported with antipsychotic use
- Blood clots in veins, particularly the legs (deep vein thrombosis), which can travel to the lungs causing chest pain and breathing difficulty (pulmonary embolism)
Reporting suspected side effects after a medicine has been authorized is important. It allows continued monitoring of the medicine's benefit-risk balance. Healthcare professionals and patients are encouraged to report any suspected adverse reactions through their national adverse drug reaction reporting system.
How Should You Store Ziprasidon Actavis?
Quick Answer: Store below 30°C (86°F), out of sight and reach of children. Do not use after the expiry date on the packaging. Dispose of unused medicines through your pharmacy — never throw them in household waste or flush them down the drain.
Keep this medicine out of the sight and reach of children at all times. Do not use Ziprasidon Actavis after the expiry date stated on the carton, blister, or bottle label. The expiry date refers to the last day of the stated month. Store at temperatures not exceeding 30°C (86°F). Keep the capsules in their original packaging to protect from moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist about how to safely dispose of medicines that are no longer needed. These measures help to protect the environment and reduce the risk of accidental exposure.
What Does Ziprasidon Actavis Contain?
Quick Answer: Each capsule contains ziprasidone (as ziprasidone hydrochloride) in strengths of 20 mg, 40 mg, 60 mg, or 80 mg. Inactive ingredients include magnesium stearate, colloidal anhydrous silica, croscarmellose sodium, and pregelatinized maize starch, in gelatin capsule shells.
Active Substance
The active substance is ziprasidone. Each capsule contains 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone as ziprasidone hydrochloride.
Inactive Ingredients
Capsule contents: Magnesium stearate, colloidal anhydrous silica, croscarmellose sodium, pregelatinized maize starch.
Gelatin capsule shells:
- 20 mg capsules: White body and blue cap — titanium dioxide (E171), indigocarmine (E132), gelatin
- 40 mg capsules: Blue body and blue cap — indigocarmine (E132), titanium dioxide (E171), gelatin
- 60 mg capsules: White body and white cap — titanium dioxide (E171), gelatin
- 80 mg capsules: White body and blue cap — titanium dioxide (E171), indigocarmine (E132), gelatin
Appearance and Pack Sizes
Ziprasidon Actavis capsules are hard gelatin capsules available in the following sizes:
- 20 mg: Size 4 capsule, white body with blue cap
- 40 mg: Size 4 capsule, blue body with blue cap
- 60 mg: Size 3 capsule, white body with white cap
- 80 mg: Size 2 capsule, white body with blue cap
Available in blister packs of 14, 20, 28, 30, 50, 56, 60, 90, 98, and 100 hard capsules, as well as in tablet bottles containing 100 hard capsules. Not all pack sizes may be marketed in your country.
Frequently Asked Questions About Ziprasidon Actavis
Ziprasidon Actavis (ziprasidone) is an atypical antipsychotic used to treat schizophrenia in adults and manic or mixed episodes in bipolar disorder in adults and adolescents aged 10 to 17 years. It works by modulating dopamine and serotonin activity in the brain, helping to reduce hallucinations, delusions, and mood instability. Your doctor may also prescribe it for other conditions based on their clinical judgment.
Ziprasidone's absorption from the gut is highly dependent on food intake. Studies have shown that taking ziprasidone capsules with a meal of at least 500 calories increases absorption by approximately 100% compared to taking it on an empty stomach. Without food, blood levels may be too low for the medication to work effectively. Always take your capsules during breakfast and dinner.
The most frequently reported side effects include difficulty sleeping (insomnia), excessive drowsiness or daytime sleepiness, and headache. Common side effects also include dizziness, nausea, constipation, dry mouth, restlessness, involuntary movements, and weight changes. Most of these effects are mild to moderate and tend to improve over time as your body adjusts to the medication. If side effects persist or become bothersome, consult your doctor.
Ziprasidone can prolong the QT interval on an electrocardiogram (ECG), which in rare cases may lead to serious heart rhythm disturbances such as Torsades de Pointes. This is why ziprasidone is contraindicated in patients with known heart disease, recent heart attack, or uncompensated heart failure. It must not be combined with other QT-prolonging drugs. Your doctor may perform an ECG before and periodically during treatment to monitor your heart rhythm. Report any palpitations, fainting, or dizziness to your doctor immediately.
Ziprasidon Actavis should generally not be used during pregnancy unless the potential benefits outweigh the risks, as determined by your doctor. Newborns whose mothers took antipsychotics during the third trimester may experience withdrawal symptoms such as tremors, muscle rigidity, weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If you are pregnant or planning a pregnancy, discuss treatment options with your doctor. Women of childbearing potential should use reliable contraception during treatment.
If you miss a dose, take it as soon as you remember — but only if it is not nearly time for your next scheduled dose. If it is close to your next dose, simply skip the missed dose and continue with your regular dosing schedule. Never take a double dose to compensate for a missed one. To help remember, try setting alarms or taking your medication at the same times each day alongside your regular mealtimes.
References and Sources
This article is based on the following peer-reviewed sources and international guidelines:
- European Medicines Agency (EMA). Ziprasidone Summary of Product Characteristics (SmPC). EMA, 2023.
- U.S. Food and Drug Administration (FDA). Geodon (ziprasidone) Prescribing Information. FDA, 2024.
- National Institute for Health and Care Excellence (NICE). Psychosis and schizophrenia in adults: prevention and management. Clinical guideline CG178. NICE, 2014 (updated 2024).
- American Psychiatric Association (APA). Practice Guidelines for the Treatment of Patients with Schizophrenia. 3rd edition. APA, 2020.
- Lieberman JA, Stroup TS, McEvoy JP, et al. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia (CATIE). N Engl J Med. 2005;353(12):1209-1223.
- World Health Organization (WHO). WHO Model List of Essential Medicines. 23rd edition. WHO, 2023.
- International College of Neuro-Psychopharmacology (CINP). Treatment Guidelines for Bipolar Disorder. CINP, 2022.
- Leucht S, Cipriani A, Spineli L, et al. Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis. Lancet. 2013;382(9896):951-962.
- British National Formulary (BNF). Ziprasidone. National Institute for Health and Care Excellence, 2024.
- Strom BL, Faich GA, Reynolds RF, et al. The Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC). Am J Psychiatry. 2011;168(11):1136-1145.
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