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cariprazine

Reagila · ATC code N05AX15

Also known as: Cariprazin

Key facts
Active substance
cariprazine
Drug class
Antipsychotics
ATC code
N05AX15
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Reagila 1.5 mg hard capsules / Reagila 3 mg hard capsules / Reagila 4.5 mg hard capsules · Reagila 1.5 mg orodispersible tablets / Reagila 3 mg orodispersible tablets / Reagila 4.5 mg orodispersible tablets
Marketing authorisation holder
Gedeon Richter
Information as of
2026-10-27

Key facts

Cariprazine is an antipsychotic metabolised mainly by CYP3A4. It is indicated for the treatment of schizophrenia in adult patients.

What it is used for

  • Treatment of schizophrenia in adult patients

Dosing

  • Starting dose 1.5 mg once daily; if needed, increase slowly in 1.5 mg increments to a maximum of 6 mg/day
  • Maintain the lowest effective dose; because of the long half-life, monitor response and adverse reactions for several weeks after each dose change
  • Taken once daily at the same time, with or without food (hard capsules or orodispersible tablets)
  • Mild to moderate renal or hepatic impairment: no dose adjustment; severe impairment: not recommended
  • Elderly: more cautious dose selection; children and adolescents: safety not established

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Concomitant strong CYP3A4 inhibitors
  • Concomitant strong or moderate CYP3A4 inducers

Important warnings

  • Suicidality: close supervision of high-risk patients, especially early after initiation or switch
  • Akathisia and restlessness develop early; use cautiously in prone patients; slow up-titration
  • Tardive dyskinesia: consider discontinuation; may worsen Parkinson's disease
  • Neuroleptic malignant syndrome, potentially fatal, may occur
  • Orthostatic hypotension and hypertension; monitor blood pressure
  • Elderly patients with dementia: not recommended due to increased overall mortality

Side effects

  • Most frequent: akathisia (19%) and parkinsonism (17.5%), mostly mild to moderate
  • Other reported reactions include sleep disorders, anxiety, weight increase, dyslipidaemia and blood pressure changes
  • Rare or serious: suicidal behaviour, tardive dyskinesia, neuroleptic malignant syndrome

Interactions

  • Strong CYP3A4 inhibitors (e.g. ketoconazole) increase cariprazine exposure; co-administration contraindicated
  • Strong or moderate CYP3A4 inducers: co-administration contraindicated

Pregnancy and breastfeeding

  • Not recommended during pregnancy; women of childbearing potential must use highly effective contraception during treatment and for at least 10 weeks after the last dose
  • Breast-feeding should be discontinued during treatment

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)

  • ReagilaGedeon Richter · EMEA/H/C/002770

Source: European Medicines Agency (EMA), product information

Turkey

  • KaprazdiDEVA HOLDİNG A.Ş. · 4 register entries

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

Brand names in 3 more European countries
Iceland
Reagila
Liechtenstein
Reagila
Norway
Reagila

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

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Reagila – 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/reagila-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  3. Wikidata (CC0): ATC N05AX.

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.