Decitabine Injection
Decitabine Injection is an intravenous (IV) chemotherapy-type medicine used to treat adults with myelodysplastic syndromes (MDS), a group of bone marrow disorders.
🧬 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 22 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 →
Decitabine Injection is an IV medicine for adults with myelodysplastic syndromes (MDS), bone marrow disorders that disrupt healthy blood cell production; it blocks an enzyme that tags DNA so abnormal cells may mature or die off, and it is a standard option alongside azacitidine, used for over a decade and available as a generic. It is usually gentler than intensive chemotherapy, but tiredness, nausea, fever and constipation or diarrhea are common. The thing to watch is low blood counts, most likely in the first two cycles and serious or fatal in some people, so call your care team the same day for fever, chills or unusual bleeding.
Clinical pearls
- Blood counts are checked before every cycle, and the next cycle may be delayed or the dose lowered until they recover.
- Women who could become pregnant need contraception through treatment and 6 months beyond; men with such partners, 3 months beyond.
- Do not breastfeed during treatment or for at least 2 weeks after the last dose.
- A new rash with fever, or a new cough or breathlessness, can signal rare skin or lung reactions worth reporting promptly.
Patient information guide A plain-language walkthrough of Decitabine Injection, written from its FDA label.
What Decitabine Injection is used for
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Decitabine Injection is used for one main condition in adults:
- Myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS
- All French-American-British subtypes, including refractory anemia and chronic myelomonocytic leukemia
- Intermediate-1, intermediate-2 and high-risk IPSS groups
How Decitabine Injection works
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Decitabine is a nucleoside metabolic inhibitor. After the body activates it, it is built into DNA and blocks DNA methyltransferase, an enzyme that adds methyl tags to DNA. This causes hypomethylation (fewer tags).
In abnormal cells, this may restore normal function to genes that control growth and maturation. It may also cause cells to mature or die. Cells that are not dividing are relatively insensitive.
Decitabine Injection dosage
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Decitabine Injection is given as an IV infusion by a healthcare professional. Your team uses one of two schedules and repeats cycles once your blood counts recover.
- 3-day regimen: infusions every 8 hours for 3 days, repeated about every 6 weeks.
- 5-day regimen: a 1-hour infusion daily for 5 days, repeated about every 4 weeks.
A response may take more than 4 cycles. Doses can be delayed or reduced for side effects. Follow your prescriber's plan.
Dosing details from the FDA-approved label
From the Decitabine Injection 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.
- Three Day Regimen
- 15 mg/m2 by continuous intravenous infusion over 3 hours repeated every 8 hours for 3 days
- Repeat cycles every 6 weeks upon hematologic recovery (ANC at least 1,000/mcL and platelets at least 50,000/mcL) for a minimum of 4 cycles
- A complete or partial response may take longer than 4 cycles; delay and reduce dose for hematologic toxicity.
- Five Day Regimen
- 20 mg/m2 by continuous intravenous infusion over 1 hour daily for 5 days
- Repeat cycles every 4 weeks upon hematologic recovery (ANC at least 1,000/mcL and platelets at least 50,000/mcL) for a minimum of 4 cycles
- A complete or partial response may take longer than 4 cycles; delay and reduce dose for hematologic toxicity.
- Hematologic recovery requiring more than 6, but less than 8 weeks
- Delay dosing for up to 2 weeks and reduce the dose temporarily to 11 mg/m2 every 8 hours (33 mg/m2/day, 99 mg/m2/cycle) upon restarting therapy
- Hematologic recovery requiring more than 8, but less than 10 weeks
- Perform bone marrow aspirate to assess for disease progression
- In the absence of progression, delay dosing for up to 2 more weeks and reduce the dose to 11 mg/m2 every 8 hours (33 mg/m2/day, 99 mg/m2/cycle) upon restarting therapy, then maintain or increase dose in subsequent cycles as clinically indicated
- Patients with pre-existing renal or severe hepatic impairment
- Not studied
- Consider the potential risks and benefits before initiating treatment
- No dose stated for renal or hepatic impairment
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Three Day Regimen : Administer Decitabine for Injection at a dose of 15 mg/m 2 by continuous intravenous infusion over 3 hours repeated every 8 hours for 3 days. Repeat cycle every 6 weeks. ( 2.1 ) Five Day Regimen : Administer Decitabine for Injection at a dose of 20 mg/m 2 by continuous intravenous infusion over 1 hour repeated daily for 5 days. Repeat cycle every 4 weeks. ( 2.1 ) 2.1 Recommended Dosage Pre-Medications and Baseline Testing Consider pre-medicating for nausea with antiemetics. Conduct baseline laboratory testing: complete blood count (CBC) with platelets, serum hepatic panel, and serum creatinine. Decitabine for Injection Regimen Options Three Day Regimen Administer Decitabine for Injection at a dose of 15 mg/m 2 by continuous intravenous infusion over 3 hours repeated every 8 hours for 3 days. Repeat cycles every 6 weeks upon hematologic recovery (ANC at least 1,000/mcL and platelets at least 50,000/mcL) for a minimum of 4 cycles. A complete or partial response may take longer than 4 cycles. Delay and reduce dose for hematologic toxicity [see Dosage and Administration ( 2.2 )] . Five Day Regimen Administer Decitabine for Injection at a dose of 20 mg/m 2 by continuous intravenous infusion over 1 hour daily for 5 days. Delay and reduce dose for hematologic toxicity [see Dosage and Administration ( 2.2 )] . Repeat cycles every 4 weeks upon hematologic recovery (ANC at least 1,000/mcL and platelets at least 50,000/mcL) for a minimum of 4 cycles. A complete or partial response may take longer than 4 cycles. Patients with Renal or Severe Hepatic Impairment Treatment with Decitabine for Injection has not been studied in patients with pre-existing renal or hepatic impairment. For patients with pre-existing renal or hepatic impairment, consider the potential risks and benefits before initiating treatment with Decitabine for Injection.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Decitabine Injection side effects
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The most common side effects are:
Common side effects
- Low white blood cells (neutropenia)
- Low platelets (thrombocytopenia)
- Anemia
- Fever
- Fatigue
- Nausea
- Constipation or diarrhea
- Cough
- High blood sugar
When to get medical help
- Fever, chills or signs of infection, since low white blood cells are very common and can be serious
- Unusual bleeding, bruising, or tiny red or purple spots on the skin (petechiae)
- Severe tiredness or paleness that may point to worsening anemia
- Allergic reaction signs such as swelling or trouble breathing
- Chest pain, irregular heartbeat or shortness of breath
- Rash with fever, or new cough or breathing problems (Sweet's syndrome, differentiation syndrome and interstitial lung disease have been reported after approval)
- Any pregnancy or suspected pregnancy during treatment
Decitabine Injection warnings and precautions
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- Myelosuppression: Serious and fatal low blood counts can occur, most often in the first or second cycles. Blood counts are monitored.
- Fetal harm: It can harm an unborn baby. Pregnancy testing and contraception are advised.
- Kidney or liver problems: Not studied, so doctors weigh risks and benefits and monitor closely.
- Infections: Treatment is delayed during active or uncontrolled infection.
Decitabine Injection interactions
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Interaction studies have not been done, but lab data suggest few expected problems.
- It is unlikely to affect cytochrome P450 liver enzymes.
- It is not broken down by those enzymes.
- It binds very little to blood proteins, so displacement of other drugs is not expected.
Interactions listed in the FDA-approved label
From the Decitabine Injection prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Drugs metabolized by or affecting cytochrome P450 enzymes: In vitro studies suggest decitabine is unlikely to inhibit or induce cytochrome P450 enzymes and is not a substrate for human liver cytochrome P450 enzymes.
- Highly protein-bound drugs: Plasma protein binding of decitabine is negligible (
Read the label’s full interactions text
7 DRUG INTERACTIONS Drug interaction studies with decitabine have not been conducted. In vitro studies in human liver microsomes suggest that decitabine is unlikely to inhibit or induce cytochrome P450 enzymes. In vitro metabolism studies have suggested that decitabine is not a substrate for human liver cytochrome P450 enzymes. As plasma protein binding of decitabine is negligible (< 1%), interactions due to displacement of more highly protein bound drugs from plasma proteins are not expected.
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.
Before taking Decitabine Injection
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- No contraindications are listed.
- Pregnancy: can cause fetal harm. A pregnancy test is done first.
- Contraception: women for 6 months and men for 3 months after the last dose.
- Breastfeeding: avoid during treatment and for at least 2 weeks after.
- Fertility: male fertility may be affected.
- Children: safety and effectiveness not established.
- Older adults: no overall differences seen, though some may be more sensitive.
- Kidney or liver problems: not studied; close monitoring is needed.
Decitabine Injection overdose
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There is no known antidote for decitabine overdose. Higher doses increase myelosuppression, including prolonged low neutrophils and platelets. Standard supportive care is used.
What Decitabine Injection does in the body
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Decitabine causes hypomethylation of DNA in lab studies and in the body. No studies have linked this effect to how the drug moves through the body.
How your body processes Decitabine Injection
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Decitabine leaves the blood quickly, with a half-life of roughly half an hour to under an hour. It does not build up with repeat doses. One elimination route appears to be breakdown by the enzyme cytidine deaminase, found mainly in the liver but also in white blood cells, the intestinal lining and blood. The exact route of elimination in humans is not known.
The 5-day schedule gave lower total exposure per cycle than the 3-day schedule. There are no data in people with kidney or liver impairment.
How to store Decitabine Injection
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Store vials at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F).
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Decitabine Injection: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Decitabine Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What is this medicine for?
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How will I receive it?
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What side effects should I expect?
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Why do I need so many blood tests?
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Can I use it if I could become pregnant or father a child?
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Can I breastfeed while on it?
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Is Decitabine Injection available over the counter?
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When was Decitabine Injection first available?
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Who makes Decitabine Injection?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Decitabine Injection on HelloPharmacist
Decitabine Injection forms and strengths (how it comes)
Decitabine Injection is available in 1 form. 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.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Decitabine Injection inactive ingredients by manufacturer.
Injection
How this form is used
- Decitabine for Injection is used to treat adults with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS.
- Decitabine for Injection is given by intravenous infusion, either as a 3-day regimen repeated about every 6 weeks or a 5-day regimen repeated about every 4 weeks.
- Decitabine for Injection must be reconstituted and diluted before use, and it is a cytotoxic drug requiring special handling and disposal.
- Decitabine for Injection treatment includes baseline blood, liver and kidney testing, and a blood count before each cycle.
Decitabine Injection on the U.S. market: products, makers and brands
How Decitabine Injection 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.
17 companies list 21 Decitabine Injection product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 2006. Brand names on the directory include Dacogen; the rest are generics.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Decitabine Injection is used (Medicaid data)
A general measure of how commonly Decitabine Injection 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 Decitabine Injection 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.
How commonly is Decitabine Injection prescribed? Of the 1,601 medications we measure, Decitabine Injection ranks #1,127 by Medicaid prescriptions — more than 30% of them.
Utilization by Decitabine Injection 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.
decitabine 50 MG Injection
Summed across the 11 of 34 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 636631
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 Decitabine Injection, 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 11 of 34 listed Decitabine Injection NDCs with Medicaid activity.
Compare Decitabine Injection products
A representative set of FDA-listed product records for Decitabine Injection — 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.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 50 mg/20 mL | Intravenous | Accord Healthcare Inc. | ANDA | View NDC → |
| 50 mg/20 mL | Intravenous | Amneal Pharmaceuticals LLC | ANDA | View NDC → |
| 50 mg | Intravenous | BluePoint Laboratories | ANDA | View NDC → |
| 50 mg/10 mL | Intravenous | BluePoint Laboratories × 2 listings | ANDA | View NDC → |
| 50 mg/20 mL | Intravenous | BluePoint Laboratories | ANDA | View NDC → |
| 50 mg/10 mL | Intravenous | Bryant Ranch Prepack | ANDA | View NDC → |
| 50 mg/10 mL | Intravenous | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 50 mg/10 mL | Intravenous | Dr. Reddy's Laboratories Inc. | ANDA | View NDC → |
| 50 mg/10 mL | Intravenous | Dr.Reddy's Laboratories Limited | ANDA | View NDC → |
| 50 mg/26 mL | Intravenous | Eugia US LLC | ANDA | View NDC → |
| 50 mg/10 mL | Intravenous | Gland Pharma Limited | ANDA | View NDC → |
| 50 mg | Intravenous | Hikma Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 50 mg/20 mL | Intravenous | Meitheal Pharmaceuticals Inc. | ANDA | View NDC → |
| 50 mg/20 mL | Intravenous | Mylan Institutional LLC | ANDA | View NDC → |
| 50 mg/20 mL | Intravenous | Nivagen Pharmaceuticals, Inc. | ANDA | View NDC → |
| 50 mg/10 mL | Intravenous | Northstar Rx LLC | ANDA | View NDC → |
| 50 mg/10 mL | Intravenous | Novadoz Pharmaceuticals LLC × 2 listings | ANDA | View NDC → |
| 50 mg/20 mL | Intravenous | Qilu Pharmaceutical Co., Ltd. | ANDA | View NDC → |
| 50 mg/20 mL | Intravenous | Sagent Pharmaceuticals | ANDA | View NDC → |
Showing 21 of 21 products — FDA National Drug Code Directory. See every product, package size and price: browse all 21 Decitabine Injection NDCs →
Decitabine Injection side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Decitabine Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Decitabine Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Decitabine Injection FDA approval history
How Decitabine Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Decitabine Injection 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 no Decitabine recalls since July 2021.
✅No Decitabine recalls on record since July 2021Source: 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.
RxCUI 15657 1 dose form · 1 strength
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Dose form (SCDF) Injection RxCUI 1806907In current FDA listingsClinical drug / strength (SCD) 50 MGRxCUI 636631
Look up RxCUI 15657 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.
Decitabine Injection supply and shortage status
Whether Decitabine Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Decitabine Injection brand names
Decitabine Injection is sold under one brand name in the FDA directory — Dacogen. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Decitabine Injection: manufacturers and labelers
17 companies list Decitabine Injection products with the FDA. By number of product records, the largest are BluePoint Laboratories, Novadoz Pharmaceuticals LLC, Accord Healthcare Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Decitabine Injection drug class (RxNorm)
Decitabine Injection belongs to the Nucleoside Metabolic Inhibitor class.
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 Decitabine Injection 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.
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. BluePoint Laboratories 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 →