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azacitidine

Onureg, Vidaza · ATC code L01BC07

Also known as: Azacitidin · Brand names: Onureg, Vidaza, Azacitidin Hikma, Azacitidin Sandoz, Azacitidin Stada, Azacitidin Tillomed, Azacitidin Zentiva, Azatidine Aliud, Azadin, Azatu, Azavix, Azida, Vizadis

Key facts
Active substance
azacitidine
Drug class
Antimetabolite
ATC code
L01BC07
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Onureg 200 mg film-coated tablets / Onureg 300 mg film-coated tablets · Vidaza 25 mg/mL powder for suspension for injection
Marketing authorisation holder
Bristol-Myers Squibb Pharma EEIG
Information as of
2026-10-27

Key facts

Azacitidine is a pyrimidine analogue (antimetabolite) for certain myeloid neoplasms: as an injection (Vidaza) in MDS, CMML and AML, and as tablets (Onureg) for AML maintenance therapy.

What it is used for

  • Vidaza: adults not eligible for stem cell transplantation with intermediate-2 or high-risk MDS (IPSS)
  • Vidaza: CMML with 10-29% marrow blasts without myeloproliferative disorder, and AML with 20-30% blasts and multi-lineage dysplasia or with > 30% marrow blasts
  • Onureg: maintenance therapy in adults with AML in complete remission (CR/CRi) after induction who are not candidates for stem cell transplantation

Dosing

  • Vidaza: 75 mg/m² body surface area subcutaneously daily for 7 days, then 21 days rest (28-day cycle); minimum of 6 cycles recommended
  • Vidaza: dose reduction or delay based on nadir blood counts (scheme in full text)
  • Onureg: 300 mg orally once daily for 14 days, followed by 14 days off (28-day cycle)
  • Onureg: anti-emetic 30 minutes before each dose for the first 2 cycles; reduction to 200 mg possible for neutropenia
  • Oral and injectable forms must not be used interchangeably
  • Complete blood counts before starting and regularly before cycles

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Breast-feeding
  • Vidaza: advanced malignant hepatic tumours

Important warnings

  • Haematological toxicity (neutropenia, thrombocytopenia, anaemia, febrile neutropenia); fever and bleeding signs should be reported promptly
  • Vidaza: progressive hepatic coma and death reported with extensive hepatic tumour burden
  • Vidaza: renal abnormalities up to renal failure reported; creatinine and bicarbonate checked before each cycle
  • Onureg: more frequent monitoring in moderate and severe hepatic impairment
  • Differentiation syndrome possible (details in full text)

Side effects

  • Onureg, most common: nausea, vomiting, diarrhoea, neutropenia, fatigue, constipation, thrombocytopenia
  • Onureg, serious: febrile neutropenia and pneumonia
  • Vidaza: haematological reactions, nausea, vomiting and injection site reactions very frequent
  • Vidaza, serious: febrile neutropenia, infections (some fatal), haemorrhage

Interactions

  • No formal clinical interaction studies
  • Interactions via CYP enzymes are considered unlikely
  • Onureg: no dose change needed with proton pump inhibitors; caution with other antineoplastics

Pregnancy and breastfeeding

  • Effective contraception for women during and up to 6 months after, for men up to 3 months after treatment
  • Breast-feeding is contraindicated

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)

Source: European Medicines Agency (EMA), product information

Austria

  • Azacitidin HikmaHikma Farmacêutica (Portugal), S.A. · 1 register entry
  • Azacitidin SandozSandoz Gmbh · 2 register entries
  • Azacitidin StadaStada Arzneimittel Gmbh · 1 register entry
  • Azacitidin TillomedTillomed Pharma Gmbh · 1 register entry
  • Azacitidin ZentivaZentiva, K.S. · 1 register entry
  • Azatidine AliudAliud Pharma Gmbh · 1 register entry

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

Germany

  • AzacitidinStadapharm Gmbh, Pharmascience International Ltd, Bendalis Gmbh, Seacross Pharma (Europe) Ltd, Tillomed Pharma Gmbh, Onkovis Gmbh, Zentiva Pharma Gmbh, Aqvida Gmbh, Hexal Ag, Hikma Farmacêutica (Portugal), S.A., Eugia Pharma (Malta) Limited, Onko Pharmaceuticals · 13 register entries

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

Turkey

  • AzadinKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 1 register entry
  • AzatuONKO İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • AzavixTEVA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • AzidaFARMAKO ECZACILIK A.Ş. · 1 register entry
  • OnuregBRISTOL-MYERS SQUIBB İLAÇLARI INC. İSTANBUL ŞUBESİ · 4 register entries
  • VidazaBRISTOL-MYERS SQUIBB İLAÇLARI INC. İSTANBUL ŞUBESİ · 1 register entry
  • VizadisDEVA HOLDİNG A.Ş. · 1 register entry

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

Brand names in 27 more European countries
Belgium
Azacitidin Sandoz, Azacitidine Eugia, Azacitidine Eurogenerics, Azacitidine Hikma, Azacitidine Seacross
Bulgaria
Азацитидин
Croatia
Azacitidin Pharmascience, Azacitidin Sandoz, Azacitidin Stada, Etraga, Zassida
Cyprus
Azacitidine Koanaa, Azacitidine Sandoz, Azacitidine Stada
Czechia
Azacitidin Sandoz, Azacitidine Rompharm, Azacitidine Zentiva, Rendazvi
Denmark
Azacitidin "biogaran", Azacitidin "stada Arzneimittel Ag", Azacitidin Adalvo, Azacitidin Hikma, Azacitidin Sandoz, Azacitidin Stada, Azacitidin Tillomed, Azacitidine "stada", Azacitidine Lotus Pharma Bulgaria, Azacitidine Sandoz, Azacitidine Sun, Azacitidine Zentiva, Etraga, Rendazvi
Estonia
Azacitidine Auxilia
Finland
Azacitidine Hikma, Azacitidine Sandoz, Azacitidine Stada, Azacitidine Sun, Azacitidine Tillomed
France
Azacitidine Arrow, Azacitidine Biogaran, Azacitidine Eg, Azacitidine Ever Pharma, Azacitidine Hikma, Azacitidine Reddy Pharma, Azacitidine Sandoz, Azacitidine Seacross, Azacitidine Tillomed, Azacitidine Vivanta, Azacitidine Zentiva, Famotidine Msn Laboratories Europe Ltd Vivanta Generics S.R.O.
Greece
Azacitidine Sandoz, Azacitidine Stada, Azanex, Azida, Rendazvi
Hungary
Azacitidin Aliud, Azacitidin Sandoz, Azacitidin Stada Arzneimittel Ag, Azacitidine Oncoeurope, Azacitidine Stada, Azacitidine Zentiva, Etraga, Vidaculem
Iceland
Azacitidine Accord, Azacitidine Glenmark, Azacitidine Kabi, Azacitidine Mylan, Azacitidine Stada, Azacitidine Zentiva, Azida, Etraga, Onureg, Vidaza, Zassida
Ireland
Azacitdine Clonmel, Azacitidine Clonmel, Azacitidine Rowex, Azacitidine Seacross
Italy
Azacitidina Aurobindo, Azacitidina Eg Stada, Azacitidina Hikma, Azacitidina Sandoz, Azacitidina Seacross, Azacitidina Tillomed, Azacitidina Zentiva
Liechtenstein
Azacitidine Accord, Azacitidine Kabi, Azacitidine Mylan, Onureg, Vidaza
Lithuania
Azacitidine Auxilia, Azacitidine Icg Farma
Luxembourg
Azacitidine Eurogenerics
Malta
Azacitidine Adalvo, Azacitidine Lotus, Azacitidine Sandoz
Netherlands
Azacitidine, Laziros
Norway
Azacitidin Sun, Azacitidin Tillomed, Azacitidine Accord, Azacitidine Hikma, Azacitidine Kabi, Azacitidine Mylan, Azacitidine Sandoz, Azacitidine Stada, Azacitidine Zentiva, Etraga, Onureg, Vidaza
Poland
Azacitidine Eugia, Azacitidine Msn, Azacitidine Onko, Azacitidine Sandoz, Azacitidine Stada, Etraga
Portugal
Azacitidina Eugia, Azacitidina Hikma, Azacitidina Sandoz, Azacitidina Seacross, Azacitidina Zentiva
Romania
Azacitidine Zentiva, Azacitidină Aqvida, Azacitidină Dr. Reddy’s, Azacitidină Onko, Azacitidină Rompharm, Azacitidină Sandoz, Azacitidină Stada, Etraga, Laziros, Vidaculem
Slovakia
Azacitidine Glenmark, Azacitidine Sandoz, Azacitidine Stada, Azacitidine Zentiva, Zassida
Slovenia
Azacitidin Sandoz, Azacitidin Stada, Rendazvi, Vidaculem
Spain
Azacitidina Dr. Reddys, Azacitidina Eugia, Azacitidina Hikma, Azacitidina Sandoz, Azacitidina Seacross, Azacitidina Stadafarma, Azacitidina Zentiva
Sweden
Azacitidine Azacitidine Lotus Pharma, Azacitidine Hikma, Azacitidine Sandoz, Azacitidine Stada, Azacitidine Sun, Azacitidine Tillomed, Azacitidine Zentiva, Etraga

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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Another question about this substance?

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Sources

  1. European Medicines Agency. Onureg – 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/onureg-epar-product-information_en.pdf
  2. European Medicines Agency. Vidaza – 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/vidaza-epar-product-information_en.pdf
  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. 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
  5. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  6. Wikidata (CC0): ATC L01BC.

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.