Azacitidine
Pyrimidine Analogues
Sold as VIDAZA · ONUREG
- Drug class
- Pyrimidine Analogues
- Availability
- Prescription only
- Routes
- Oral, Subcutaneous, Intravenous
- Markets covered
- 4
- Products on record
- 57
- FDA reports (12 mo)
- 2,516
Overview
Plain-language summary, compiled from the cited regulatory records
Azacitidine is a nucleoside metabolic inhibitor [1]. It belongs to the drug class of pyrimidine analogues [1].
Azacitidine is approved for treating adult patients with certain myelodysplastic syndrome (MDS) subtypes [1]. These include refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS), particularly when accompanied by neutropenia or thrombocytopenia, or if transfusions are required [1]. It is also indicated for refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMML) [1].
This medication is available under various brand names, including ONUREG [1]. In the past 12 months, there have been 2516 adverse event reports associated with azacitidine [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 36 | May 29, 2026 |
| CA Canada | Health Canada | 12 | March 12, 2026 |
| EU European Union | EMA | 6 | January 9, 2026 |
| US United States | FDA | 3 | April 9, 2026 |
GBUnited Kingdom· MHRA
36 products
Uses
Azacitidine is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with: • intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS), • chronic myelomonocytic leukaemia (CMML) with 10-29% marrow blasts without myeloproliferative disorder, • acute myeloid leukaemia (AML) with 20-30% blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification, • AML with > 30% marrow blasts according to the WHO classification.
How to take
CACanada· Health Canada
12 products
Uses
1 Pediatrics The safety and effectiveness of azacitidine for injection in children and adolescents (<18 yrs) have not been established. 2 Geriatrics No overall differences in safety or effectiveness of azacitidine for injection were observed between younger patients and patients ≥ 65 years of age.
Greater sensitivity of some older individuals cannot be ruled out. Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function.
How to take
EUEuropean Union· EMA
6 products
Uses
Onureg is indicated as maintenance therapy in adult patients with acute myeloid leukaemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (HSCT).
How to take
USUnited States· FDA
3 products
Uses
1 INDICATIONS AND USAGE ONUREG is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy.
ONUREG is a nucleoside metabolic inhibitor indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy ( 1 ).
How to take
Drug interactions
Known interactions involving Azacitidine. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL587130021 · revised May 29, 2026
- [2]Health Canada (DPD) · 02564998 · revised March 4, 2026
- [3]European Medicines Agency · EMEA/H/C/004761 · revised January 9, 2026
- [4]FDA DailyMed · 0e95e33f-8aba-4f… · revised April 9, 2026 [PDF]
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.