Decitabine
Pyrimidine Analogues
Sold as INQOVI · DACOGEN · DEMYLOCAN
- Drug class
- Pyrimidine Analogues
- Availability
- Prescription only
- Routes
- Oral, Intravenous
- Markets covered
- 4
- Products on record
- 7
- FDA reports (12 mo)
- 547
Overview
Plain-language summary, compiled from the cited regulatory records
Decitabine is a medication classified as a pyrimidine analogue [1]. It is approved for the treatment of adult patients diagnosed with myelodysplastic syndromes (MDS) [1]. This includes various subtypes of MDS, such as refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia [1]. It is also indicated for intermediate-1, intermediate-2, and high-risk International classifications of MDS [1].
In the past 12 months, there have been 547 adverse event reports associated with decitabine [2]. The most frequently reported adverse events include myelosuppression, off-label use, death, decreased platelet count, and fatigue [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| CA Canada | Health Canada | 3 | June 18, 2025 |
| US United States | FDA | 2 | August 5, 2025 |
| EU European Union | EMA | 1 | December 9, 2025 |
| GB United Kingdom | MHRA | 1 | January 24, 2025 |
CACanada· Health Canada
3 products
Uses
DemylocanTM is indicated for the treatment of adult patients with: Myelodysplastic Syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System (IPSS) groups.
1 Pediatrics Pediatrics (< 18 years of age): No clinical efficacy and safety data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use (see WARNINGS AND PRECAUTIONS, Special Populations).
2 Geriatrics Geriatrics (≥ 65 years of age): The majority of patients with MDS in the clinical trials were ≥ 65 years of age. No overall differences in safety and efficacy have been identified between younger patients and those ≥ 65 years of age although greater sensitivity of some older individuals cannot be ruled out (see WARNINGS AND PRECAUTIONS, Special Populations).
USUnited States· FDA
2 products
Uses
1 INDICATIONS AND USAGE Decitabine for Injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.
Decitabine for Injection is a nucleoside metabolic inhibitor indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.
EUEuropean Union· EMA
1 product
Uses
Dacogen is indicated for the treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organisation (WHO) classification, who are not candidates for standard induction chemotherapy.
How to take
GBUnited Kingdom· MHRA
1 product
Uses
Dacogen is indicated for the treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organisation (WHO) classification, who are not candidates for standard induction chemotherapy.
How to take
Drug interactions
Known interactions involving Decitabine. 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]Health Canada (DPD) · 02484811 · revised March 22, 2025
- [2]FDA DailyMed · 00caa305-fef4-47… · revised August 5, 2025 [PDF]
- [3]European Medicines Agency · EMEA/H/C/002221 · revised December 9, 2025
- [4]MHRA (UK) · PLGB002420662 · revised January 24, 2025
- [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.