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lurasidone

Latuda · ATC code N05AE05

Also known as: Lurasidon · Brand names: Latuda, Lurasidon G.L., Lurasidon Genericon, Lurasidon Elpen, Feradon, Ledason, Luigon, Lunivex, Luradin, Sizolock

Key facts
Active substance
lurasidone
Drug class
Antipsychotics
ATC code
N05AE05
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Latuda 18.5 mg film-coated tablets / Latuda 37 mg film-coated tablets / Latuda 74 mg film-coated tablets
Marketing authorisation holder
Aziende Chimiche Riunite Angelini Francesco S.p.A.
Information as of
2026-10-27

Key facts

Lurasidone is an atypical antipsychotic used to treat schizophrenia in adults and adolescents aged 13 years and over.

What it is used for

  • Schizophrenia in adults and adolescents aged 13 years and over

Dosing

  • Adults: starting dose 37 mg once daily, no titration; effective at 37 to 148 mg once daily; maximum 148 mg
  • Adolescents: starting dose 37 mg once daily; effective at 37 to 74 mg; maximum 74 mg
  • Moderate CYP3A4 inhibitors: starting dose 18.5 mg, maximum 74 mg once daily
  • Moderate to severe renal impairment: starting dose 18.5 mg, maximum 74 mg; hepatic: moderate maximum 74 mg, severe maximum 37 mg
  • Take once daily with a meal, as exposure is significantly lower without food

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Concomitant strong CYP3A4 inhibitors (e.g. clarithromycin, itraconazole, ketoconazole, ritonavir, voriconazole)
  • Concomitant strong CYP3A4 inducers (e.g. carbamazepine, phenytoin, rifampicin, St John's wort)

Important warnings

  • Suicidal behaviour may occur, sometimes early after starting or switching; closely supervise high-risk patients
  • Extrapyramidal symptoms and tardive dyskinesia; may worsen Parkinson's disease
  • Increased mortality in elderly dementia patients with other atypical antipsychotics; lurasidone not studied there
  • Caution with QT-prolonging medicines

Side effects

  • Very common: akathisia, nausea and insomnia
  • Common include somnolence, parkinsonism, dizziness, agitation, anxiety, weight increase

Interactions

  • Strong CYP3A4 inhibitors and inducers contraindicated; moderate CYP3A4 inhibitors require dose limits
  • Other centrally acting medicines and alcohol: caution
  • Serotonergic agents (e.g. SSRIs, SNRIs, MAO inhibitors, opioids): increased risk of serotonin syndrome

Pregnancy and breastfeeding

  • Should not be used during pregnancy unless clearly necessary
  • Breast-feeding only if the potential benefit justifies the potential risk to the child

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. 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

Package leaflet, verbatim

Package leaflet for patients →

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.

EU – centrally authorised (all member states)

  • LatudaAziende Chimiche Riunite Angelini Francesco S.p.A. · EMEA/H/C/002713

Source: European Medicines Agency (EMA), product information

Austria

  • Lurasidon G.L.G.L. Pharma Gmbh · 1 register entry
  • Lurasidon GenericonGenericon Pharma Gesellschaft M.B.H. · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • Lurasidon ElpenElpen Pharmaceutical Co. Inc. · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • FeradonNOBEL İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • LedasonSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 5 register entries
  • LuigonGENVEON İLAÇ SAN. VE TİC. A.Ş. · 5 register entries
  • LunivexSANTA FARMA İLAÇ SAN. A.Ş. · 5 register entries
  • LuradinALİ RAİF İLAÇ SAN. A.Ş. · 5 register entries
  • SizolockGEN İLAÇ VE SAĞLIK ÜRÜNLERİ SAN. VE TİC. A.Ş. · 5 register entries

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

Brand names in 16 more European countries
Bulgaria
Lurasidone Accord, Луразидон Тева
Croatia
Lurasidon Teva
Czechia
Isaq, Lurasidon G.L. Pharma, Lurasidon Teva, Lurasidone +pharma, Lurasidone Accord
Denmark
Elgera, Lurasidone Accord, Lurasidone Orifarm, Lurasidonhydrochlorid Elpen
Finland
Lurasidone Accord
Greece
Elgera, Latomno, Lurasidone Pharmazac, Rellunta
Iceland
Latuda
Italy
Lurasidone Accord, Lurasidone Doc, Lurasidone Liconsa, Lurasidone Teva
Liechtenstein
Latuda
Netherlands
Lurasidon Teva
Norway
Latuda, Lurasidone Accord
Poland
Alurazen, Asil, Lurasidone +pharma, Lurasidone G.L. Pharma, Lurasidone Teva, Lurobran, Polur
Portugal
Latomno, Lurasidona Farmoz, Lurasidona Tecnigen
Slovenia
Lurasidon Teva
Spain
Lurasidona Cinfa, Lurasidona Tecnigen, Lurasidona Teva, Lurobran
Sweden
Lurasidon G.L. Pharma, Lurasidone Accord, Lurasidone Liconsa, Lurasidone Orifarm, Lurobran, Polur

EMA – Article 57 product data (EU/EEA), 2026-10-28

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Sources

  1. European Medicines Agency. Latuda – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/latuda-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. 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), 2026-10-28. 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 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.