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Azacitidine

Azacitidine is a cancer-fighting medicine used to treat certain bone marrow disorders — including myelodysplastic syndromes and juvenile myelomonocytic leukemia — and, as the tablet form Onureg, to help maintain remission in acute myeloid leukemia.

Brand names OnuregVidaza
Drug class Nucleoside Metabolic Inhibitor
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 26 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

How we combine label and product data →
Other forms & routes:
Injection
Azacitidine at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Azacitidine is a chemotherapy medicine for myelodysplastic syndromes (MDS, bone marrow disorders where blood cells do not form normally), a rare childhood leukemia (JMML) and, as Onureg tablets, keeping acute myeloid leukemia in remission. It turns growth-control genes back on and kills fast-dividing abnormal cells. On the market since about 2004, it is a standard first treatment for higher-risk MDS, and the injection is available generically. It is usually gentler than intensive chemotherapy, though nausea, constipation or diarrhea, tiredness and sore, red injection sites are common. The main risk is low blood counts, so call your care team right away about fever, chills, or unusual bruising or bleeding.

Clinical pearls

  • Never swap the injection and Onureg tablets, because they are not interchangeable and have different approved uses and schedules.
  • Expect frequent blood tests during treatment, because doses are often delayed or adjusted based on your counts.
  • Swallow Onureg tablets whole without cutting, crushing or chewing, and take the anti-nausea medicine beforehand as prescribed.
  • Use effective contraception during treatment and for months afterward, men included, because azacitidine can seriously harm an unborn baby.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asInjection, Tablet
Earliest FDA record2004
Companies listing it with the FDA42
FDA label last updatedJan 29, 2024
FDA’s strongest warning (boxed)None on the label

Patient information guide — a plain-language walkthrough of Azacitidine, written from its FDA label.

What Azacitidine is used for

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Azacitidine is used across two product types — injectables and an oral tablet — to treat serious blood and bone marrow cancers. The approved uses depend on the specific product and patient population.

  • Azacitidine injection and Vidaza treat adults with the following subtypes of myelodysplastic syndromes (MDS): refractory anemia (RA), refractory anemia with ringed sideroblasts (RARS, when accompanied by low neutrophil or platelet counts, or need for transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).
  • Vidaza specifically is approved for pediatric patients aged 1 month and older with newly diagnosed juvenile myelomonocytic leukemia (JMML).
  • Onureg (the oral tablet) is approved for continued treatment of adults with acute myeloid leukemia (AML) who achieved their first complete remission or complete remission with incomplete blood count recovery after intensive induction chemotherapy and cannot complete intensive curative therapy.

How Azacitidine works

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Azacitidine is a nucleoside metabolic inhibitor — a molecule that mimics a natural building block of DNA and RNA. Once it enters cancer cells, it gets built into their genetic machinery and blocks enzymes called DNA and RNA methyltransferases. These enzymes normally attach chemical tags (methyl groups) to genes, sometimes silencing important genes that control healthy cell growth. By blocking this process — called DNA hypomethylation — azacitidine can reawaken suppressed genes involved in normal cell differentiation and tumor suppression. It also directly causes rapid cell death (apoptosis) in actively dividing abnormal cells, while relatively sparing non-dividing cells.

In pediatric patients with JMML, measurable reductions in DNA methylation in bone marrow cells have been confirmed as early as the first treatment cycle, supporting azacitidine's mechanism in this patient population as well.

Azacitidine dosage

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How azacitidine is taken depends entirely on which product is prescribed — do not switch between them without your doctor's guidance.

  • Azacitidine injection / Vidaza: Given by subcutaneous injection (under the skin) or intravenous infusion (into a vein), once daily for 7 days in a row, repeated every 4 weeks. Anti-nausea medicine is given before each dose. Treatment continues as long as you are benefiting; at least 4 to 6 cycles are recommended.
  • Onureg tablets: Taken by mouth once daily, on days 1–14 of each 28-day cycle, with or without food. Swallow whole — never cut, crush, or chew. Take at the same time each day. If you miss a dose, take it as soon as possible that same day; never take two doses in one day. If you vomit a dose, do not retake it — resume your normal schedule the next day.

Dosing details from the FDA-approved label

From the Azacitidine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • MDS (adults), first treatment cycle (Vidaza)
    • 75 mg/m2 subcutaneously or intravenously, daily for 7 days
    • Same starting dose for all patients regardless of baseline hematology laboratory values; premedicate for nausea and vomiting
  • MDS (adults), subsequent treatment cycles (Vidaza)
    • Repeat cycles every 4 weeks
    • The dose may be increased to 100 mg/m2 if no beneficial effect is seen after 2 treatment cycles and if no toxicity other than nausea and vomiting has occurred
    • Maximum: 100 mg/m2
    • Treat for a minimum of 4 to 6 cycles; reduce dose for hematologic or renal/electrolyte findings per label
  • Pediatric patients with JMML, age 1 month to less than 1 year OR weighing less than 10 kg (Vidaza)
    • 2.5 mg/kg as an intravenous infusion daily for 7 days in a 28-day cycle
    • Minimum of 3 cycles and maximum of 6 cycles
  • Pediatric patients with JMML, age 1 year and older AND weighing 10 kg or greater (Vidaza)
    • 75 mg/m2 as an intravenous infusion daily for 7 days in a 28-day cycle
    • Minimum of 3 cycles and maximum of 6 cycles
  • Adults on Onureg (oral azacitidine), recommended dosage
    • 300 mg orally once daily with or without food on Days 1 through 14 of each 28-day cycle
    • Continue until disease progression or unacceptable toxicity
    • Give an antiemetic 30 minutes prior to each dose for the first 2 cycles; do not give if ANC is less than 0.5 Gi/L on Day 1 of a cycle
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION • Do not substitute VIDAZA for oral azacitidine. The indications and dosing regimen for VIDAZA 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 VIDAZA 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 ). • JMML: See full prescribing information for recommended dosage and schedule. • Continue treatment as long as the patient continues to benefit; up to 6 cycles for pediatric patients with JMML ( 2.3 , 2.4 ). • Monitor all patients for hematologic response and for renal toxicity; delay or reduce dosage as appropriate ( 2.3 , 2.4 , 2.6 , 2.7 ). 2.1 Important Administration Information Do not substitute VIDAZA for oral azacitidine. The indications and dosing regimen for VIDAZA 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 Cycles for Adults Repeat cycles every 4 weeks. The dose may be increased to 100 mg/m 2 if no beneficial effect is seen after 2 treatment cycles and if no toxicity other than nausea and vomiting has occurred. It is recommended that patients be treated for a minimum of 4 to 6 cycles. However, complete or partial response may require additional treatment cycles. Treatment may be continued as long as the patient continues to benefit. Monitor patients for hematologic response and renal toxicities [see Warnings and Precautions ( 5.4 )], and delay or reduce dosage if necessary [see Dosage and Administration ( 2.6 )].

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Azacitidine side effects

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Common side effects

  • Nausea and vomiting
  • Low red blood cell count (anemia), causing tiredness
  • Low platelet count (thrombocytopenia), increasing bruising and bleeding risk
  • Low white blood cell count (neutropenia or leukopenia), raising infection risk
  • Diarrhea or constipation
  • Fever (pyrexia)
  • Injection site redness, pain, or bruising (with injectable forms)
  • Bruising under the skin (ecchymosis)

When to get medical help

  • Call your doctor right away if you develop signs of serious infection: fever, chills, or unusual fatigue — your white blood cell count may be dangerously low.
  • Get emergency help for signs of tumor lysis syndrome: sudden muscle pain or weakness, nausea, vomiting, confusion, fast or irregular heartbeat, or very little urination.
  • Contact your doctor if you notice yellowing of the skin or eyes, or severe stomach pain — these could be signs of liver toxicity.
  • Report any significant decrease in urination, leg swelling, or rising creatinine levels — azacitidine can affect kidney function.
  • Tell your doctor immediately if you are pregnant or plan to become pregnant — azacitidine can seriously harm an unborn baby.
  • Seek help for signs of a severe allergic reaction: hives, swelling of the face or throat, or trouble breathing.

Azacitidine commonly affects blood counts and the digestive system. The most frequently reported side effects include:

  • Nausea and vomiting
  • Anemia (low red blood cells) — causing fatigue and weakness
  • Thrombocytopenia (low platelets) — causing easy bruising and bleeding
  • Neutropenia and leukopenia (low white blood cells) — raising infection risk
  • Diarrhea or constipation
  • Fever (pyrexia)
  • Injection site reactions: redness, pain, bruising (with injectable forms)
  • Skin bruising (ecchymosis) and small red or purple spots (petechiae)

More serious reactions — including severe infections, tumor lysis syndrome, liver or kidney toxicity, and dangerously low blood counts — require prompt medical attention. Contact your care team right away if you develop high fever, unusual bleeding, signs of infection, or sudden changes in how much you urinate.

Azacitidine warnings and precautions

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The most important risks with azacitidine involve low blood counts. Treatment regularly reduces white blood cells, red blood cells, and platelets — sometimes to dangerously low levels — which increases the risk of serious infections and bleeding. Blood counts are monitored closely throughout treatment, and your dose may be delayed or reduced based on results.

  • Tumor lysis syndrome: Azacitidine injection can cause this potentially fatal condition, where dying cancer cells release substances into the bloodstream too quickly. It can happen even in MDS patients. Signs include muscle weakness, nausea, irregular heartbeat, and reduced urination.
  • Liver toxicity: Patients with severe pre-existing liver disease are at higher risk for serious liver complications. Azacitidine injection is contraindicated in patients with advanced malignant liver tumors.
  • Kidney toxicity: Azacitidine and its byproducts leave the body through the kidneys. Patients with kidney problems need close monitoring; serious kidney effects including kidney failure have been reported.
  • Do not substitute forms: Injecting the dose intended for tablets — or vice versa — can cause fatal toxicity or treatment failure. These are completely different regimens.
  • Fetal harm: Azacitidine can cause serious harm to an unborn baby. Effective contraception is required during and for months after treatment.

Azacitidine interactions

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The FDA labeling for azacitidine does not identify specific drug-drug interactions, but there are important clinical considerations to discuss with your care team:

  • Other chemotherapy agents: Serious kidney toxicity (including kidney failure) has been reported when intravenous azacitidine was combined with other chemotherapy drugs — inform your doctor of all cancer treatments you are receiving.
  • Drugs that affect kidney function: Since azacitidine is cleared mainly through the kidneys, other medicines that stress the kidneys may increase the risk of renal toxicity.

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿17 supplements and herbs with documented Azacitidine interactions, ranked by severity Check Azacitidine against a supplement or herb →

Before taking Azacitidine

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  • Advanced liver cancer: Azacitidine injection is contraindicated — it must not be used — in patients with advanced malignant hepatic (liver) tumors.
  • Allergy to azacitidine or mannitol: Do not take if you have a known hypersensitivity to either ingredient.
  • Severe liver disease: Patients with serious pre-existing liver conditions are at higher risk for liver toxicity; close monitoring is required.
  • Kidney disease: Azacitidine is mainly cleared by the kidneys; patients with impaired kidney function need extra monitoring and possible dose adjustments.
  • Pregnancy: Azacitidine can cause fetal death and birth defects. Pregnancy must be ruled out before starting treatment. Women of reproductive potential must use effective contraception during treatment and for 6 months after the last injectable dose.
  • Breastfeeding: Women should not breastfeed during treatment or for 1 week after the last dose due to the risk of serious harm to the infant.
  • Male patients: Men with female partners who could become pregnant should use effective contraception during treatment and for 3 months after the last injectable dose.
  • Older adults: Older patients are more likely to have reduced kidney function; renal monitoring is especially important.
  • Children: Vidaza is approved for JMML in children aged 1 month and older. Safety and effectiveness of the injectable azacitidine generics in pediatric MDS have not been established.

Azacitidine overdose

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One case of azacitidine injection overdose was reported in clinical trials, where a patient received nearly four times the recommended starting dose and experienced diarrhea, nausea, and vomiting — all of which resolved without lasting harm. There is no specific antidote for azacitidine overdose. If an overdose is suspected, medical monitoring of blood counts and supportive care are recommended.

What Azacitidine does in the body

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Azacitidine works by reducing the chemical tagging (methylation) of DNA in abnormal bone marrow and cancer cells. In pediatric patients with JMML, measurable reductions in genome-wide DNA methylation in bone marrow granulocytes (a type of white blood cell) were confirmed during the first treatment cycle, showing the drug is actively changing how genes are expressed. This hypomethylating effect is thought to reactivate genes that control normal cell development and growth suppression.

How your body processes Azacitidine

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When given as a subcutaneous (under-the-skin) injection, azacitidine is rapidly absorbed — peak blood levels are reached in about 30 minutes. The bioavailability of the subcutaneous route is approximately 89% compared to intravenous administration, meaning nearly all of the drug reaches the bloodstream either way. The drug has a short half-life of roughly 40 minutes after subcutaneous dosing and does not build up in the body with repeated cycles. Azacitidine is broken down primarily through natural hydrolysis (breakdown by water) and an enzyme called cytidine deaminase — not by the liver's cytochrome P450 enzymes — and is eliminated mainly in the urine, accounting for about 85% of the dose.

How to store Azacitidine

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Store unreconstituted vials at 20º to 25ºC (68º to 77ºF); excursions permitted between 15º to 30ºC (59º to 86ºF).

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

17

Supplements & herbs that interact with Azacitidine

17 supplements and herbal products have documented interactions with Azacitidine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 7
  • Minor · 9
ACTIVATED CHARCOAL Major COFFEE CHARCOAL Moderate EUROPEAN MANDRAKE Moderate GLUCOMANNAN Moderate GUAR GUM Moderate GUM ARABIC Moderate SLIPPERY ELM Moderate TRAGACANTH Moderate +9 more
Every supplement checked against Azacitidine — ranked by severity The full interaction hub: 1 major · 7 moderate · 9 minor · every one linked to its full report. Check Azacitidine against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Azacitidine: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Azacitidine — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is azacitidine treating — is it chemotherapy?

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Yes, azacitidine is a type of cancer treatment, though it works a bit differently from traditional chemotherapy. Instead of just killing cancer cells outright, it also reprograms how abnormal cells behave by reactivating genes that help control normal growth. The injectable forms (Vidaza and generic azacitidine) are used for bone marrow disorders called myelodysplastic syndromes in adults, and Vidaza is also used for a childhood condition called juvenile myelomonocytic leukemia. The tablet form, Onureg, is used to help maintain remission in certain adults with acute myeloid leukemia.

Can I take the Onureg tablet instead of getting injections — they're the same drug, right?

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They contain the same active ingredient, but you absolutely cannot swap one for the other. Onureg tablets and the injectable forms are approved for completely different conditions, and the dosing schedules are different too. Using the wrong form at the wrong dose could be seriously harmful — even fatal. Your prescriber will choose the right product for your specific diagnosis, and that's the one you should stick with.

What side effects should I watch out for most closely?

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The biggest concern is that azacitidine lowers your blood counts — white blood cells, red blood cells, and platelets. Low white blood cells mean you're more vulnerable to serious infections, so call your doctor right away if you develop a fever, chills, or feel unusually unwell. Low platelets can cause unusual bleeding or bruising. Nausea and vomiting are also very common, but your care team will give you anti-nausea medicine to help. You'll have regular blood tests throughout treatment to keep a close eye on all of these.

Is it safe to get pregnant or father a child while on this medication?

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No — azacitidine can cause serious harm to a developing baby, including birth defects and fetal death, even at low doses. If you're a woman who could become pregnant, you need to use reliable contraception during treatment and for 6 months after your last injection dose. Men with partners who could get pregnant should use contraception during treatment and for 3 months after the last injection. If pregnancy occurs during treatment, contact your doctor immediately. Breastfeeding is also not recommended during treatment or for 1 week after the last dose.

How many treatment cycles will I need before we know if it's working?

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It can take time to see a response — you're typically treated for a minimum of 4 to 6 cycles before your doctor fully evaluates how you're responding. Some people need even more cycles to get a complete or partial response. Treatment continues as long as you're benefiting. If no helpful effect is seen after 2 cycles and you haven't had significant side effects, your doctor may adjust your dose. Patience is important with this medicine — staying the course through at least several cycles gives it the best chance to work.

My kidneys aren't in great shape — is azacitidine safe for me?

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Your care team will need to monitor your kidney function closely throughout treatment. Azacitidine and its breakdown products leave the body mainly through the kidneys, so any pre-existing kidney problems can increase your risk of side effects. Your doctor will check your kidney labs before treatment starts and regularly during each cycle, and they may need to adjust or delay your dose if needed. Make sure your full medical history is on the table before you begin.

Is Azacitidine available over the counter?

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No. Azacitidine is a prescription medicine: every Azacitidine product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Azacitidine first available?

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The earliest FDA record we hold for Azacitidine is from 2004: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Azacitidine was first used.

Who makes Azacitidine?

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42 companies list Azacitidine products in the FDA's NDC Directory, including Dr. Reddy's Laboratories Inc., BluePoint Laboratories, Celgene Corporation. That count includes repackagers and distributors as well as manufacturers, so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Azacitidine on HelloPharmacist

📊Azacitidine supplement interactions17 checked — ranked by severity 🌿Drug & Supplement CheckerAzacitidine vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Azacitidine NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Azacitidine Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Azacitidine forms and strengths (how it comes)

Azacitidine is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

By injection · Into a vein · Under the skin
Brands Vidaza
How this form is used
What it may be used for
  • Azacitidine and Vidaza treat adults with specific subtypes of myelodysplastic syndromes (MDS), including refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia.
  • Vidaza is approved for infants and children aged 1 month and older with newly diagnosed juvenile myelomonocytic leukemia (JMML).
Important instructions
  • Azacitidine and Vidaza injections are given either under the skin (subcutaneously) or into a vein (intravenously), typically once daily for 7 consecutive days per treatment cycle.
  • Treatment cycles repeat every 4 weeks; patients are generally treated for a minimum of 4 to 6 cycles and may continue as long as they are benefiting.
  • Anti-nausea (antiemetic) medication should be given before each dose to reduce nausea and vomiting.
  • Do not substitute Vidaza or azacitidine injection for Onureg oral tablets — the indications and dosing are different.
Available strengths 5 strengths
100 mg 100 mg/4 mL 100 mg/30 mL 100 mg/50 mL 1 g/g
68 FDA-listed product records ⓘ

Tablet

By mouth
Brands Onureg
How this form is used
What it may be used for
  • Onureg is used for continued treatment of adults with acute myeloid leukemia (AML) who achieved their first complete remission following intensive induction chemotherapy and cannot complete intensive curative therapy.
Important instructions
  • Onureg is taken by mouth once daily on days 1 through 14 of each 28-day cycle, with or without food.
  • Swallow Onureg tablets whole — do not cut, crush, or chew them.
  • Take an anti-nausea medicine 30 minutes before each Onureg dose for at least the first 2 cycles; if no nausea or vomiting occurs after 2 cycles, antiemetic prevention may be stopped.
  • Do not substitute Onureg for injectable azacitidine (Vidaza or generic) — they have different approved uses and dosing schedules.
Available strengths 2 strengths
200 mg 300 mg
6 FDA-listed product records ⓘ

Azacitidine on the U.S. market: products, makers and brands

How Azacitidine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

42 companies list 93 Azacitidine product records with the FDA, mostly as injection, tablet; the earliest marketing or approval year on record is 2004. Brand names on the directory include Onureg, Vidaza; the rest are generics.

2
Dose forms ⓘ
42
Labelers (makers, repackagers, distributors)
5
Brand names
93
FDA-listed product records ⓘ
2004
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (19) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Dr. Reddy's Laboratories Inc.11%
BluePoint Laboratories7%
Celgene Corporation7%
Meitheal Pharmaceuticals Inc.7%
Sandoz Inc5%
NorthStar RxLLC5%
Other makers58%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Azacitidine is used (Medicaid data)

A general measure of how commonly Azacitidine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Azacitidine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

14,325
Medicaid prescriptions filled (Q1–Q4 2025)
$4.5M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Azacitidine prescribed? Of the 1,601 medications we measure, Azacitidine ranks #863 by Medicaid prescriptions — more than 46% of them.

Where Azacitidine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #863 of 1,601
#858 Etoposide 14,672 Rx #859 Desmopressin Nasal 14,664 Rx #860 Hydrocortisone Injecti... 14,630 Rx #861 Abiraterone 14,531 Rx #862 Etoposide Injection 14,504 Rx #863 Azacitidine 14,325 Rx #864 Teriparatide Injection 14,225 Rx #865 Etelcalcetide Injectio... 14,185 Rx #866 Azacitidine Injection 14,177 Rx #867 Cevimeline 14,121 Rx #868 Natalizumab Injection 14,035 Rx

Utilization by Azacitidine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 100 mg injection is the most-dispensed Azacitidine product — about 99% of these Medicaid prescriptions.

azacitidine 100 MG Injection Most dispensed

14,177 Medicaid prescriptions (Q1–Q4 2025) 99% of Azacitidine prescriptions shown $750,982 gross reimbursement (before rebates) ≈ $53 per prescription (gross)

Summed across the 17 of 37 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 485246

azacitidine 300 MG Oral Tablet

148 Medicaid prescriptions (Q1–Q4 2025) 1% of Azacitidine prescriptions shown $3.7M gross reimbursement (before rebates) ≈ $25,082 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2396772

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Azacitidine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 18 of 40 listed Azacitidine NDCs with Medicaid activity.

Compare Azacitidine products

A representative set of FDA-listed product records for Azacitidine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 93 of 93 products — FDA National Drug Code Directory. See every product, package size and price: browse all 93 Azacitidine NDCs →

Azacitidine recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 2 Azacitidine recalls since July 2021, covering 3 product listings. None of them is still listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Class III Jul 22, 2022 · Terminated · Teva Pharmaceuticals USA Inc
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
  • Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56 Lots: Lot: FE22001A, Exp 01/2024 FDA record D-1334-2022 →
Class III Jan 19, 2022 · Terminated · Dr. Reddy's Laboratories, Inc.
Failed stability specifications
  • Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-465-62 Lots: Lot#: H200107, Exp 8/1/2023; H200154, Exp 9/1/2023; H210020, Exp 11/1/2023; H210055, Exp 12/1/2023; H210129, Exp 1/1/2024, H210288, Exp 4/1/2024. FDA record D-0576-2022 →
  • Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-305-62 Lots: Lot #: H200101, H200102, H200099, H200100 & H200106, Exp 8/1/2023; H210015, H210014 & H210013, Exp 11/1/2023; H210086, Exp 12/1/2023; H210130, Exp 1/1/2024; H210171, H210172, H210173, H210174, Exp 2/1/2024; H210196 & H210197, Exp 3/1/2024;… FDA record D-0575-2022 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Azacitidine RxCUI 1251 2 dose forms · 3 strengths
  1. Dose form (SCDF) Injection RxCUI 1726497 In current FDA listings
    Clinical drug / strength (SCD) 100 MG RxCUI 485246
  2. Dose form (SCDF) Oral Tablet RxCUI 2396763 In current FDA listings
    Clinical drug / strength (SCD) 200 MG RxCUI 2396764 300 MG RxCUI 2396772

Look up RxCUI 1251 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Azacitidine brand names

Azacitidine is sold under 2 brand names in the FDA directory — Onureg, Vidaza. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Onureg Vidaza

Who makes Azacitidine: manufacturers and labelers

42 companies list Azacitidine products with the FDA. By number of product records, the largest are Dr. Reddy's Laboratories Inc., BluePoint Laboratories, Celgene Corporation. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Dr. Reddy's Laboratories Inc. 10 BluePoint Laboratories 6 Celgene Corporation 6 Meitheal Pharmaceuticals Inc. 6 Sandoz Inc 5 NorthStar RxLLC 5 Amneal Pharmaceuticals LLC 3 Apotex Corp 3 Armas Pharmaceuticals Inc. 3 Accord Healthcare Inc. 3 Cipla USA Inc. 3 Fresenius Kabi USA, LLC 2 Hikma Pharmaceuticals USA Inc. 2 Jiangsu Hansoh Pharmaceutical Group Co., Ltd. 2 Laurus Labs Limited 2 Msn Laboratories Private Limited 2 Shilpa Pharma Lifesciences Limited 2 Eugia US LLC 2 Excella GmbH & Co. KG 2 Breckenridge Pharmaceutical, Inc. 2 Wuhan Biocause Pharmaceutical Development Co., Ltd 1 Valary Lab Private Limited 1 Sun Pharmaceutical Industries, Inc. 1 Somerset Therapeutics LLC 1

…and 18 more on the FDA NDC directory.

Azacitidine drug class (RxNorm)

Azacitidine belongs to the Nucleoside Metabolic Inhibitor class.

Pharmacologic class Nucleoside Metabolic Inhibitor
Drug family (ATC) Pyrimidine analogues
How it works Nucleic Acid Synthesis Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Azacitidine page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jan 29, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Azacitidine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Azacitidine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
26
Finished products in the current FDA directory
93
Companies listing them (makers, repackagers, distributors)
42
Linked representative label ⓘ
Celgene Corporation
Linked label effective
Jan 29, 2024
Composite sections available
23
Linked SPL Set ID
3495a71a-cc04-4776-851f-f185956f32af
Linked SPL Document ID
8cba79e2-11fa-4eb9-87e7-827ca781fbf3
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Celgene Corporation is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →