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Brexpiprazole

Rxulti · ATC code N05AX16

Also known as: Brexpiprazol

Key facts
Active substance
Brexpiprazole
Drug class
Antipsychotics
ATC code
N05AX16
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
RXULTI 0.25 mg film-coated tablets / RXULTI 0.5 mg film-coated tablets / RXULTI 1 mg film-coated tablets
Marketing authorisation holder
Otsuka Pharmaceutical Netherlands B.V.
Information as of
2026-10-27

Key facts

Brexpiprazole is an antipsychotic used to treat schizophrenia in adults and adolescents aged 13 years and older.

What it is used for

  • Schizophrenia in adults
  • Schizophrenia in adolescents aged 13 years and older

Dosing

  • Adults: 1 mg once daily on days 1 to 4, then 2 mg on days 5 to 7, then 4 mg on day 8.
  • Adolescents: 0.5 mg once daily on days 1 to 4, then 1 mg on days 5 to 7, then 2 mg on day 8; weekly increases in 1 mg increments possible.
  • Target range 2 mg to 4 mg once daily; maximum 4 mg daily.
  • Moderate to severe renal or hepatic impairment: maximum 3 mg once daily.
  • CYP2D6 poor metabolisers: half the dose; a quarter of the dose when also taking strong or moderate CYP3A4 inhibitors.
  • Strong CYP3A4 inhibitors/inducers or strong CYP2D6 inhibitors: dose adjustment as in the full text.

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Suicidal behaviour, sometimes early after starting or switching treatment; closely supervise high-risk patients
  • Caution in cardiovascular or cerebrovascular disease and conditions predisposing to hypotension or hypertension
  • QT prolongation
  • Safety and efficacy in patients aged 65 years and older not established

Side effects

  • Most frequent in adults: akathisia (5.6%) and weight gain (3.9%)
  • Most frequent in adolescents: nausea (6.4%), somnolence (4.5%), akathisia (3.6%)
  • Others: dizziness, tremor, rash, parkinsonism
  • Uncommon or serious: seizures, neuroleptic malignant syndrome, impulse-control disorders such as gambling disorder

Interactions

  • Metabolised mainly by CYP3A4 and CYP2D6
  • Strong CYP3A4 inhibitors (itraconazole, ketoconazole, ritonavir, clarithromycin): half the brexpiprazole dose recommended
  • CYP3A4 inducers and CYP2D6 inhibitors require dose adjustment

Pregnancy and breastfeeding

  • Not recommended during pregnancy or in women of childbearing potential not using contraception.
  • Neonates exposed in the third trimester may show extrapyramidal and/or withdrawal symptoms.

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 →

Common questions – ask Medelix

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)

  • RxultiOtsuka Pharmaceutical Netherlands B.V. · EMEA/H/C/003841

Source: European Medicines Agency (EMA), product information

Turkey

  • RebexipNOBEL İLAÇ SAN. VE TİC. A.Ş. · 5 register entries
  • RexultiABDİ İBRAHİM OTSUKA İLAÇ SAN. VE TİC. A.Ş. · 5 register entries

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

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

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. Rxulti – 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/rxulti-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.