Dacarbazine
Dacarbazine is a chemotherapy drug used intravenously to treat metastatic malignant melanoma and Hodgkin's disease.
🧬 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 3 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 →
Dacarbazine (DTIC-Dome) is an IV chemotherapy for metastatic melanoma (skin cancer that has spread) and, with other drugs, a second-line option for Hodgkin's disease, thought to work by damaging DNA or blocking how cancer cells copy it; an older standby, around since about 1975 and available as a generic, it is used less for melanoma now that newer immune treatments exist. It is hard on the stomach, with nausea and vomiting worst in the first doses, plus flu-like aches and hair loss. The boxed warning covers bone marrow suppression (dangerously low blood counts) and rare but serious liver damage, so a cancer specialist oversees it, with regular blood tests.
Clinical pearls
- Anti-nausea medicine is usually given before each infusion, and vomiting that stops you keeping fluids down needs a call.
- Flu-like fever can follow a dose, but with low white cells, always report fever rather than assuming it is harmless.
- Yellow skin or eyes, dark urine or severe stomach pain could signal liver damage and needs immediate medical help.
- Animal studies showed cancer and fetal harm, so settle pregnancy plans and breastfeeding with your team before the first cycle.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Dacarbazine carries serious risks and must be given only by or under the direct supervision of a cancer specialist. The most common dangerous side effect is bone marrow suppression — meaning the drug can severely lower your blood cell counts, which can be life-threatening. Serious liver damage (including liver cell death) has also been reported. Animal studies have shown this drug can cause cancer and harm a fetus. Every patient's potential benefit must be carefully weighed against these risks before and during treatment.
Patient information guide A plain-language walkthrough of Dacarbazine, written from its FDA label.
What Dacarbazine is used for
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Dacarbazine is a chemotherapy drug given by IV for two main cancer types:
- Metastatic malignant melanoma — advanced skin cancer that has spread beyond the original site
- Hodgkin's disease — a type of lymphoma (cancer of the lymphatic system); dacarbazine is used here as a second-line treatment (when first-choice therapy hasn't been enough) and is always combined with other effective cancer drugs
How Dacarbazine works
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Dacarbazine works by interfering with cancer cells' ability to grow and divide. Researchers believe it may act in more than one way: it can block DNA replication by mimicking purines (the natural building blocks of DNA), it can act as an alkylating agent by directly damaging the DNA strand so cancer cells can't copy themselves, or it may disrupt key chemical groups within the cell. By targeting DNA, dacarbazine slows or stops tumor growth.
After an IV dose, dacarbazine distributes widely in the body — concentrating especially in the liver — and is broken down extensively before being cleared mainly through the kidneys.
Dacarbazine dosage
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Dacarbazine is given as an intravenous infusion in a clinical or hospital setting by trained healthcare professionals. It is never taken by mouth or self-administered at home. Treatment follows a cycle schedule — a set number of days on treatment followed by a rest period of several weeks — and the schedule differs depending on whether it is being used for melanoma or Hodgkin's disease.
- For melanoma, treatment cycles may run over 5 or 10 days and repeat every 3 to 4 weeks
- For Hodgkin's disease, cycles may be 5-day courses or single-day doses repeated every 2 to 4 weeks, always alongside other cancer drugs
Your oncology team will set your exact schedule. Do not adjust it on your own.
Dosing details from the FDA-approved label
From the Dacarbazine 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.
- Malignant Melanoma
- 2 to 4.5 mg/kg/day for 10 days
- Treatment may be repeated at 4 week intervals
- An alternate recommended dosage is 250 mg/square meter body surface/day I.V. for 5 days
- Treatment may be repeated every 3 weeks
- Hodgkin's Disease
- 150 mg/square meter body surface/day for 5 days, in combination with other effective drugs
- Treatment may be repeated every 4 weeks
- An alternative recommended dosage is 375 mg/square meter body surface on day 1, in combination with other effective drugs, to be repeated every 15 days
Read the label’s full dosing text
DOSAGE AND ADMINISTRATION Malignant Melanoma The recommended dosage is 2 to 4.5 mg/kg/day for 10 days. Treatment may be repeated at 4 week intervals. 2 An alternate recommended dosage is 250 mg/square meter body surface/day I.V. for 5 days. Treatment may be repeated every 3 weeks. 3,4 Hodgkin's Disease The recommended dosage of Dacarbazine for Injection, USP in the treatment of Hodgkin’s disease is 150 mg/square meter body surface/day for 5 days, in combination with other effective drugs. Treatment may be repeated every 4 weeks. 5 An alternative recommended dosage is 375 mg/square meter body surface on day 1, in combination with other effective drugs, to be repeated every 15 days. 6 Dacarbazine for Injection, USP 100 mg/vial and 200 mg/vial are reconstituted with 9.9 mL and 19.7 mL, respectively, of Sterile Water for Injection, USP. The resulting solution contains 10 mg/mL of dacarbazine having a pH of 3.0 to 4.0. The calculated dose of the resulting solution is drawn into a syringe and administered only intravenously. The reconstituted solution may be further diluted with 5% Dextrose Injection or Sodium Chloride Injection and administered as an intravenous infusion. After reconstitution and prior to use, the solution in the vial may be stored at 4°C for up to 72 hours or at normal room conditions (temperature and light) for up to 8 hours. If the reconstituted solution is further diluted in 5% Dextrose Injection or Sodium Chloride Injection, the resulting solution may be stored at 4°C for up to 24 hours or at normal room conditions for up to 8 hours. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published. 7-13 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Malignant Melanoma The recommended dosage is 2 to 4.5 mg/kg/day for 10 days. Treatment may be repeated at 4 week intervals. 2 An alternate recommended dosage is 250 mg/square meter body surface/day I.V. for 5 days. Treatment may be repeated every 3 weeks.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Dacarbazine side effects
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Most people on dacarbazine experience some side effects — here are the most commonly reported ones:
Common side effects
- Nausea and vomiting (very common, especially with first few doses)
- Loss of appetite
- Diarrhea (less common)
- Flu-like symptoms: fever, muscle aches, and feeling run-down
- Hair loss (alopecia)
- Facial flushing or tingling
- Skin rashes (red or hive-like)
- Nausea and vomiting — affects more than 90% of patients, especially with the first few doses; tends to improve after the first day or two
- Flu-like symptoms: fever up to 39°C (102°F), muscle aches, and fatigue — often after larger doses
- Facial flushing and tingling around the face
- Skin rashes (red or hive-like); rarely, sensitivity to sunlight
When to get medical help
- Call your doctor if you notice unusual bruising or bleeding — this can signal dangerous drops in blood platelets
- Watch for signs of serious infection (fever, chills, sores) — low white blood cell counts make infection more likely
- Seek immediate help if you develop yellowing of the skin or eyes, severe stomach pain, or dark urine — these can be signs of liver damage
- Tell your care team right away if you develop difficulty breathing, swelling, or hives — this may be a severe allergic reaction (anaphylaxis)
- Notify your doctor if nausea and vomiting become so severe you can't keep anything down
Dacarbazine warnings and precautions
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- Bone marrow suppression: The most common serious risk. Dacarbazine can cause dangerous drops in white blood cells, platelets, and red blood cells. This raises your risk of serious infection and bleeding. Blood counts must be monitored regularly, and treatment may need to be paused or stopped.
- Liver toxicity: Serious liver damage — including blockage of liver veins and death of liver cells — has been reported and can be fatal. Though rare (about 0.01% of patients), it can happen with dacarbazine alone or combined with other drugs.
- Anaphylaxis: Severe allergic reactions are possible. Seek emergency care immediately if you develop sudden difficulty breathing, hives, or swelling.
- Cancer and fetal harm risk: Animal studies show dacarbazine can cause cancer and harm a developing fetus. These risks must be discussed with your doctor before starting treatment.
- Specialist supervision required: This drug must be given only under the care of a physician experienced in cancer chemotherapy.
Dacarbazine interactions
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The FDA label for dacarbazine specifically notes the following interaction concern:
- Other antineoplastic (cancer-fighting) drugs: Serious liver toxicity has been reported more often when dacarbazine is combined with other cancer drugs — your care team will monitor liver function carefully during combination therapy
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 Dacarbazine
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- Prior allergic reaction to dacarbazine: Do not use — this is a contraindication
- Kidney or liver problems: The drug stays in your body longer if these organs aren't working well; tell your doctor about any kidney or liver disease
- Pregnancy: Animal studies show this drug can cause fetal harm — discuss reliable contraception and the risks with your doctor before starting treatment
- Breastfeeding: Talk to your doctor — the potential risks need to be considered
- All patients: Treatment must be supervised by an oncology specialist experienced with chemotherapy agents
Dacarbazine overdose
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If too much dacarbazine is given, the focus is on supportive care — managing symptoms and keeping the patient stable. Blood cell counts must be monitored closely, as bone marrow suppression is the most likely serious consequence. Contact a poison control center or emergency services immediately in the event of an overdose.
What Dacarbazine does in the body
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Dacarbazine's primary measurable effect in the body is suppression of rapidly dividing cells — most critically, cancer cells. It does this by interfering with DNA so cells cannot replicate properly. This same effect on the bone marrow (where blood cells are made) is why drops in white blood cells, red blood cells, and platelets are the most common serious toxicity seen during treatment.
How your body processes Dacarbazine
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After an IV dose, dacarbazine distributes widely — its volume of distribution exceeds total body water, suggesting it concentrates in tissues, especially the liver. It clears from the blood in two phases: a fast initial phase (half-life of about 19 minutes) and a slower terminal phase (half-life of about 5 hours). In patients with kidney or liver problems, these half-lives are significantly longer, meaning the drug stays active in the body longer. About 40% of the dose is excreted unchanged in the urine within 6 hours, and the drug is cleared by the kidneys via tubular secretion rather than simple filtration.
How to store Dacarbazine
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Store in a refrigerator 2° to 8°C (36° to 46°F). Protect from light.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Dacarbazine
24 supplements and herbal products have documented interactions with Dacarbazine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 14
- Minor · 9
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.
Nutrient depletion considerations
Dacarbazine has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Dacarbazine: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Dacarbazine — the kind of thing our pharmacy team would talk through with you at the counter.
What is dacarbazine actually used for?
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How is dacarbazine given — do I take it at home?
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What side effects should I expect — and which ones should make me call someone right away?
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Why does my doctor keep ordering blood tests during treatment?
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Is dacarbazine safe if I'm pregnant or planning to become pregnant?
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What if I have kidney or liver problems — does that change anything?
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Is Dacarbazine available over the counter?
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When was Dacarbazine first available?
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Who makes Dacarbazine?
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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 Dacarbazine on HelloPharmacist
Dacarbazine forms and strengths (how it comes)
Dacarbazine 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.
Injection
How this form is used
- Dacarbazine Injection is used to treat metastatic malignant melanoma
- Dacarbazine Injection is used as second-line therapy for Hodgkin's disease, always in combination with other effective cancer drugs
- Dacarbazine Injection is given only intravenously (into a vein) by a healthcare professional — never self-administered
- The powder must be reconstituted (mixed) with Sterile Water for Injection before use, then may be further diluted in dextrose or saline solution for IV infusion
- Treatment is given in repeated cycles with rest periods in between; your oncology team sets the exact schedule based on your condition
- The prepared solution should be inspected for particles or unusual color before administration and must be stored properly — refrigerated or at room temperature — within strict time limits
Dacarbazine on the U.S. market: products, makers and brands
How Dacarbazine 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.
3 companies list 4 Dacarbazine product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 1975. Brand names on the directory include DTIC-Dome; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Dacarbazine is used (Medicaid data)
A general measure of how commonly Dacarbazine 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 Dacarbazine 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 Dacarbazine prescribed? Of the 1,601 medications we measure, Dacarbazine ranks #1,213 by Medicaid prescriptions — more than 24% of them.
Utilization by Dacarbazine 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.
dacarbazine 200 MG Injection Most dispensed
Summed across the 2 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1731338
dacarbazine 100 MG Injection
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1731340
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 Dacarbazine, 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 3 of 10 listed Dacarbazine NDCs with Medicaid activity.
Compare Dacarbazine products
A representative set of FDA-listed product records for Dacarbazine — 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 | ||||
| 10 mg/mL | Intravenous | Fresenius Kabi USA, LLC × 2 listings | ANDA | View NDC → |
| 200 mg | Intravenous | Hikma Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 200 mg/20 mL | Intravenous | Meitheal Pharmaceuticals Inc. | ANDA | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Dacarbazine NDCs →
Dacarbazine 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 Dacarbazine — 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 Dacarbazine 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.
Dacarbazine FDA approval history
How Dacarbazine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Dacarbazine 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 Dacarbazine recalls since July 2021.
✅No Dacarbazine 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 3098 1 dose form · 2 strengths
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Dose form (SCDF) Injection RxCUI 1731337In current FDA listings
Look up RxCUI 3098 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.
Dacarbazine supply and shortage status
Whether Dacarbazine 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.
Dacarbazine brand names
Dacarbazine is sold under one brand name in the FDA directory — DTIC-Dome. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Dacarbazine: manufacturers and labelers
3 companies list Dacarbazine products with the FDA. By number of product records, the largest are Fresenius Kabi USA, LLC, Hikma Pharmaceuticals USA Inc., Meitheal Pharmaceuticals Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Dacarbazine drug class (RxNorm)
Dacarbazine belongs to the Alkylating Drug 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 Dacarbazine 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. Fresenius Kabi USA, LLC 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 →