Azacitidine: uses, dosing, side effects & brands
Azacitidine is a nucleoside metabolic inhibitor sold in the U.S. under 3 brand and generic names, for refractory anemia, sideroblastic anemia and chronic myelomonocytic leukemia. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Nucleoside Metabolic Inhibitor
- Treats (across its forms)
- Refractory Anemia, Sideroblastic Anemia and Chronic Myelomonocytic Leukemia
- Available as
- Injectable · Tablet
- Sold as
- 3 products — Azacitidine, Onureg and Vidaza
- Prescription?
- Prescription only
- Generic available?
- Yes
How Azacitidine is dosed
From the FDA label for Azacitidine (application ANDA207518). Other azacitidine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Do not substitute Azacitidine for injection for oral azacitidine. The indications and dosing regimen for Azacitidine for injection differ from that of oral azacitidine ( 2.1 , 5.1 ). MDS: The recommended starting dosage for the first treatment cycle, for all patients regardless of baseline hematology values, is Azacitidine for injection 75 mg/m 2 daily for 7 days to be administered by subcutaneous injection or intravenous infusion. See full prescribing information for schedule for subsequent cycles. Premedicate for nausea and vomiting ( 2.2 ). Continue treatment as long as the patient continues to benefit ( 2.3 ). Monitor all patients for hematologic response and for renal toxicity; delay or reduce dosage as appropriate ( 2.3 , 2.6 , 2.7 ). 2.1 Important Administration Information Do not substitute Azacitidine for injection for oral azacitidine. The indications and dosing regimen for Azacitidine for injection differ from that of oral azacitidine [see Warnings and Precautions (5.1) ] 2.2 First Treatment Cycle for Adults The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m 2 subcutaneously or intravenously, daily for 7 days. Premedicate patients for nausea and vomiting. Obtain complete blood counts, liver chemistries and serum creatinine prior to the first dose. 2.3 Subsequent Treatment…
Everything below is the FDA label for Azacitidine (injectable). Azacitidine is also sold as tablet, and those are different medicines to take — follow the label for the one you were prescribed.
Azacitidine side effects
Most common adverse reactions (>30%) in adult patients with MDS by subcutaneous route are: nausea, anemia, thrombocytopenia, vomiting, pyrexia, leukopenia, diarrhea, injection site erythema, constipation, neutropenia and ecchymosis. Most common adverse reactions by intravenous route also included petechiae, rigors, weakness and hypokalemia ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Shilpa Medicare Limited 1-888-557-1212 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following adverse reactions are described in other labeling sections: Anemia, Neutropenia and Thrombocytopenia [ see Warnings and Precautions (5.2) ] Hepatotoxicity in Patients with Severe Pre-existing Hepatic Impairment [ see Warnings and Precautions (5.3) ] Renal Toxicity [ see Warnings and Precautions (5.4) ] Tumor Lysis Syndrome [ see Warnings and Precautions (5.5) ] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. MDS The data described below reflect exposure to Azacitidine in 443 patients with MDS from 4 clinical studies. Study 1 was a supportive-care controlled trial (subcutaneous administration), Studies 2 and 3 were single arm studies (one with…
Who shouldn’t take Azacitidine
Advanced Malignant Hepatic Tumors ( 4.1 ). Hypersensitivity to Azacitidine or Mannitol ( 4.2 ). 4.1 Advanced Malignant Hepatic Tumors Azacitidine is contraindicated in patients with advanced malignant hepatic tumors [ see Warnings and Precautions (5.3) ]. 4.2 Hypersensitivity to Azacitidine or Mannitol Azacitidine is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol.
Every azacitidine product we track (3)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Injectable | No data | — | View → | |
| 2 | Not yet rated | Prescription | Tablet | No data | — | View → | |
| 3 | Not yet rated | Prescription | Injectable | No data | — | View → |
What azacitidine pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Azacitidine recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Can you crush or split azacitidine?
At least one azacitidineproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each azacitidine label says about crushing, splitting and chewingHow long azacitidine keeps
No azacitidine label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does azacitidine expire? The in-use limits and storage rules from its labelsAzacitidine and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for azacitidine: levels in milk, effects in breastfed infants, and the drugs it would consider insteadMost sources consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy. It might be possible to breastfeed safely during intermittent azacitidine therapy with an appropriate period of breastfeeding abstinence; the manufacturer recommends an abstinence period of 1 week after the last dose. Chemotherapy may adversely affect the normal microbiome and chemical makeup of breastmilk. Women who receive chemotherapy during pregnancy are more likely to have difficulty nursing their infant.
National Institute of Child Health and Human Development, record revised June 15, 2024. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about azacitidine
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 18,861 reports naming azacitidine, and the FDA flagged 97% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- febrile neutropenia2,087 reports
- acute myeloid leukaemia1,376 reports
- neutropenia1,366 reports
- myelosuppression1,358 reports
- pneumonia1,171 reports
- pyrexia1,043 reports
- thrombocytopenia1,022 reports
- anaemia820 reports
Read these as a signal, not a rate. A report does not mean azacitidine caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
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Frequently asked questions
What is Azacitidine?
Azacitidine is a nucleoside metabolic inhibitor used to treat Refractory Anemia, Sideroblastic Anemia, Chronic Myelomonocytic Leukemia.
What kind of drug is azacitidine?
The FDA classifies azacitidine as a nucleoside metabolic inhibitor. Nucleoside metabolic inhibitors are fake DNA building blocks that fast-dividing cancer cells mistake for the real thing. Once inside, they get incorporated into the cell's DNA and also block enzymes such as ribonucleotide reductase, which together halt DNA copying and cause the cancer cell to die. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take azacitidine with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run azacitidine against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is azacitidine sold under?
We track 3 azacitidine-containing products in the U.S.: Azacitidine, Onureg and Vidaza. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does azacitidine come in?
Across the brands we track, azacitidine is currently marketed as injectable and tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic azacitidine?
Yes. Our catalog lists 1 generic azacitidine product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has azacitidine been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions azacitidine. The most recent: Azacitidine for Injection 100mg/Vial (Jun 24, 2026). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Azacitidine: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/azacitidine
- MLA
- “Azacitidine: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/azacitidine.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for azacitidine on DailyMed (NIH) ↗.