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Ziprasidone

Zeldox, Ziprasidon Krka, Ziprasidon Stada, Ziprasidon Viatris · ATC code N05AE04

Also known as: Ziprasidon · Brand names: Zeldox, Ziprasidon Krka, Ziprasidon Stada, Ziprasidon Viatris, Zipsilan

Key facts
Active substance
Ziprasidone
Drug class
Antipsychotics
ATC code
N05AE04
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Boxed warning

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Ziprasidone capsules are not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1)] .

Key facts

Ziprasidone is an atypical antipsychotic. Per the US prescribing information, it is used for schizophrenia and bipolar I disorder (acute manic or mixed episodes and maintenance treatment).

What it is used for

  • Schizophrenia in adults
  • Monotherapy for acute manic or mixed episodes of bipolar I disorder
  • Maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate
  • Its greater capacity to prolong the QT/QTc interval than several other antipsychotics should be considered when choosing treatment

Dosing

  • Take with food; swallow capsules whole, do not open, crush or chew
  • Schizophrenia: start with 20 mg twice daily, up to 80 mg twice daily if needed; adjust at intervals of not less than 2 days
  • Doses above 80 mg twice daily are not generally recommended
  • Bipolar mania: start with 40 mg twice daily, increase to 60 mg or 80 mg twice daily on the second day, then 40 mg to 80 mg twice daily
  • Maintenance (with lithium or valproate): continue the stabilizing dose within 40 mg to 80 mg twice daily

Contraindications

  • Known history of QT prolongation (including congenital long QT syndrome), recent acute myocardial infarction, uncompensated heart failure
  • Concomitant other QT-prolonging drugs (e.g. dofetilide, sotalol, quinidine, thioridazine, pimozide, moxifloxacin, arsenic trioxide)
  • Taking MAOIs (including linezolid and intravenous methylene blue) or within 14 days of stopping them

Important warnings

  • Boxed warning: increased mortality in elderly patients with dementia-related psychosis; not approved for this use
  • QT prolongation and risk of sudden death
  • Neuroleptic malignant syndrome, tardive dyskinesia, serotonin syndrome
  • Severe cutaneous reactions including DRESS, sometimes fatal
  • Metabolic changes, orthostatic hypotension, leukopenia/agranulocytosis, seizures, hyperprolactinemia, priapism

Side effects

  • Schizophrenia: somnolence, respiratory tract infection
  • Bipolar disorder: somnolence, extrapyramidal symptoms, dizziness, akathisia, abnormal vision, asthenia, vomiting
  • Rash, falls, dysphagia

Interactions

  • Other QT-prolonging drugs: contraindicated
  • Ketoconazole and other CYP3A4 inhibitors: increase ziprasidone exposure by about 35 to 40%
  • Carbamazepine: decreases exposure by approximately 35%
  • MAOIs and serotonergic drugs: serotonin syndrome

Pregnancy and breastfeeding

  • Neonates exposed in the third trimester may have extrapyramidal or withdrawal symptoms; a risk of major birth defects has not been established

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

  • ZeldoxViatris Austria Gmbh, Viatris Healthcare Limited · 2 register entries
  • Ziprasidon KrkaKrka, D.D., Novo Mesto · 1 register entry
  • Ziprasidon StadaStada Arzneimittel Gmbh · 1 register entry
  • Ziprasidon ViatrisUpjohn Eesv, Viatris Healthcare Limited · 2 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • ZeldoxViatris Pharma Gmbh · 2 register entries
  • Ziprasidon1 A Pharma Gmbh, Neuraxpharm Arzneimittel Gmbh, Puren Pharma Gmbh & Co. Kg, Hormosan Pharma Gmbh, Teva B.V, Viatris Germany Gmbh, Stadapharm Gmbh, Betapharm Arzneimittel Gmbh · 11 register entries
  • ZipsilanTad Pharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • ZeldoxVİATRİS İLAÇLARI LİMİTED ŞİRKETİ · 4 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 22 more European countries
Bulgaria
Зелдокс, Зипсила, Зипуел
Croatia
Zeldox
Cyprus
Geodon
Czechia
Zeldox, Zypsilan
Denmark
Zeldox, Ziprasidon Krka, Ziprasidon Stada, Ziprasidone "sandoz"
Finland
Zeldox, Ziprasidon Krka, Ziprasidon Viatris
Greece
Geodon, Ziprasidone Actavis
Hungary
Ypsila, Zeldox
Iceland
Zeldox, Ziprasidon Actavis
Ireland
Geodon
Italy
Zeldox, Ziprasidone Sandoz
Latvia
Ypsila, Zeldox
Lithuania
Zeldox, Zypsilan
Malta
Ziprasidone Aurobindo
Norway
Zeldox, Ziprasidon Actavis
Poland
Zypsila
Portugal
Zeldox, Ziprasidona Aurobindo, Ziprasidona Ciclum, Ziprasidona Mylan
Romania
Zypsila
Slovakia
Zeldox, Zipwell, Zypsilan
Slovenia
Zeldox, Zypsila
Spain
Zeldox, Ziprasidona Aurovitas, Ziprasidona Cinfa, Ziprasidona Krka, Ziprasidona Sandoz, Ziprasidona Stada, Ziprasidone Viatris
Sweden
Zeldox, Ziprasidon Actavis, Ziprasidon Krka, Ziprasidon Stada, Ziprasidon Upjohn, Ziprasidone Sandoz

EMA – Article 57 product data (EU/EEA), 2026-10-29

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Sources

  1. U.S. Food and Drug Administration. ziprasidone hydrochloride (Apotex Corp.) – Prescribing Information, 2026-07-20. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ccfd5ba2-7271-f3dd-4c98-7418c1a4b54a
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. Wikidata (CC0): ATC N05AE.

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.