Dacarbazine

Mechanism-of-action class: Alkylating Activity.

• Dacarbazine for Injection, USP is indicated in the treatment of metastatic malignant melanoma. In addition, dacarbazine is also indicated for Hodgkin's disease as a second-line therapy when used in combination with other effective agents.ICD-10: C43.9

• Dacarbazine is contraindicated in patients who have demonstrated a hypersensitivity to it in the past.contraindicated

Malignant Melanoma The recommended dosage is 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 The recommended dosage of dacarbazine 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. 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. Dacarbazine 200 mg/vial is reconstituted with 19.7 mL of Sterile Water for Injection. 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.

Hemopoietic depression is the most common toxicity with dacarbazine and involves primarily the leukocytes and platelets, although, anemia may sometimes occur. Leukopenia and thrombocytopenia may be severe enough to cause death. The possible bone marrow depression requires careful monitoring of white blood cells, red blood cells, and platelet levels. Hemopoietic toxicity may warrant temporary suspension or cessation of therapy with dacarbazine. Hepatic toxicity accompanied by hepatic vein thrombosis and hepatocellular necrosis resulting in death, has been reported. The incidence of such reactions has been low; approximately 0.01% of patients treated. This toxicity has been observed mostly when dacarbazine has been administered concomitantly with other anti-neoplastic drugs; however, it has also been reported in some patients treated with dacarbazine alone. Anaphylaxis can occur following the administration of dacarbazine.

Symptoms of anorexia, nausea, and vomiting are the most frequently noted of all toxic reactions. Over 90% of patients are affected with the initial few doses. The vomiting lasts 1 to 12 hours and is incompletely and unpredictably palliated with phenobarbital and/or prochlorperazine. Rarely, intractable nausea and vomiting have necessitated discontinuance of therapy with dacarbazine. Rarely, dacarbazine has caused diarrhea. Some helpful suggestions include restricting the patient’s oral intake of food for 4 to 6 hours prior to treatment. The rapid toleration of these symptoms suggests that a central nervous system mechanism may be involved, and usually these symptoms subside after the first 1 or 2 days. There are a number of minor toxicities that are infrequently noted. Patients have experienced an influenza-like syndrome of fever to 39°C, myalgias and malaise. These symptoms occur usually after large single doses, may last for several days, and they may occur with successive treatments. Alopecia has been noted as has facial flushing and facial paresthesia. There have been few reports of significant liver or renal function test abnormalities in man. However, these abnormalities have been observed more frequently in animal studies. Erythematous and urticarial rashes have been observed infrequently after administration of dacarbazine. Rarely, photosensitivity reactions may occur. OVERDOSAGE Give supportive treatment and monitor blood cell counts.

Pregnancy Teratogenic effects; Pregnancy Category C Dacarbazine has been shown to be teratogenic in rats when given in doses 20 times the human daily dose on day 12 of gestation. Dacarbazine when administered in 10 times the human daily dose to male rats (twice weekly for 9 weeks) did not affect the male libido, although female rats mated to male rats had higher incidence of resorptions than controls. In rabbits, dacarbazine daily dose 7 times the human daily dose given on Days 6 to 15 of gestation resulted in fetal skeletal anomalies. There are no adequate and well-controlled studies in pregnant women. Dacarbazine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for tumorigenicity shown for dacarbazine in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Give supportive treatment and monitor blood cell counts.

• Aug 27, 1998ANDAANDA075259Meitheal
• Aug 27, 1999ANDAANDA075371Fresenius Kabi Usa
• Jun 15, 2001ANDAANDA075812Hikma

1. 1Febrile Neutropenia6248.6%
2. 2Off Label Use5958.2%
3. 3Neutropenia4916.8%
4. 4Pyrexia3835.3%
5. 5Drug Ineffective3254.5%
6. 6Disease Progression3054.2%
7. 7Neuropathy Peripheral2914.0%
8. 8Nausea2733.8%
9. 9Anaemia2443.4%
10. 10Product Use In Unapproved Indication2393.3%
11. 11Vomiting2293.2%
12. 12Diarrhoea2233.1%
13. 13Thrombocytopenia2183.0%
14. 14Sepsis2062.8%
15. 15Malignant Neoplasm Progression2052.8%

Recent PubMed references pinned to Dacarbazine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Ferulic Acid Increases Temozolomide Sensitivity in Glioblastoma Cells, Causing DNA Damage and Inhibiting Cell Proliferation.
  Turkish neurosurgery · 2026 · Ulutabanca H, Hamurcu Z, Albayrak S, et al.
  PMID 42227838DOI 10.5137/1019-5149.JTN.49811-25.3
• Hsa-miR-25-3p Inhibition Sensitizes Patient-Derived Glioblastoma Cells to Temozolomide via β-catenin Downregulation.
  Cellular and molecular neurobiology · 2026 · Richter K, Markmann H, Kaps P, et al.
  PMID 42218313DOI 10.1007/s10571-026-01750-6
• Implications of the Cuproptosis Protein SLC31A1 for the Immune Microenvironment and Temozolomide Sensitivity in Glioblastoma.
  Anticancer research · 2026 · Xu D, DU G, Sun J, et al.
  PMID 42203322DOI 10.21873/anticanres.18188
• Real-World Effectiveness of Capecitabine and Temozolomide Across Endocrine and Neuroendocrine Neoplasm Subtypes (ENENs): A Population-Based Cohort Study from Alberta, Canada (2011-2021).
  Current oncology (Toronto, Ont.) · 2026 · Aleksi A, Jobin KD, Hannouf MB, et al.
  PMID 42187606DOI 10.3390/curroncol33050289
• Stress granule assembly represents a therapeutic vulnerability in super-enhancer-driven circMLB-mediated glioblastoma temozolomide resistance.
  Cancer letters · 2026 · Huang R, Yang Z, Dong Y, et al.
  PMID 42167397DOI 10.1016/j.canlet.2026.218601
• [(177)Lu]Lu-DOTATATE PRRT and CAPTEM chemotherapy for pancreas and small bowel neuroendocrine tumours: The AGITG CONTROL NETS Multi-centre randomized trial.
  European journal of cancer (Oxford, England : 1990) · 2026 · Chan DL, Sjoquist KM, Ransom DT, et al.
  PMID 42142431DOI 10.1016/j.ejca.2026.116781
• Prolonged sequential temozolomide in glioblastoma: A systematic review with exploratory quantitative synthesis.
  Cancer treatment and research communications · 2026 · Pasqualetti F, Ius T, Montemurro N, et al.
  PMID 42114299DOI 10.1016/j.ctarc.2026.101231
• Temozolomide reconsidered: Real-World evidence in resistant melanoma cases.
  The oncologist · 2026 · Maselli-Schoueri JH, Martinez E, Lagos E, et al.
  PMID 42105220DOI 10.1093/oncolo/oyag184

The 10 most recently updated of 1,151 ClinicalTrials.gov registrations naming Dacarbazine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Study of Olutasidenib and Temozolomide in HGG
  Recruiting · Phase 2 · Interventional · 60 enrolled · Rigel Pharmaceuticals
  NCT06161974updated 2026-06-12
• A Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma
  Recruiting · Phase 1 · Phase 2 · Interventional · 116 enrolled · Debiopharm International SA
  NCT05765812updated 2026-06-12
• Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
  Recruiting · Phase 3 · Interventional · 478 enrolled · National Cancer Institute (NCI)
  NCT06172296updated 2026-06-12
• A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma
  Recruiting · Phase 2 · Phase 3 · Interventional · 2,250 enrolled · Global Coalition for Adaptive Research
  NCT03970447updated 2026-06-12
• A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab
  Recruiting · Phase 3 · Interventional · 1,875 enrolled · National Cancer Institute (NCI)
  NCT05675410updated 2026-06-12
• Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness
  Recruiting · Phase 1 · Phase 2 · Interventional · 42 enrolled · National Cancer Institute (NCI)
  NCT05691491updated 2026-06-11
• Natural Killer Cell Therapy (UD TGFbetai NK Cells) and Temozolomide for the Treatment of Stage IV Melanoma Metastatic to the Brain
  Recruiting · Phase 1 · Phase 2 · Interventional · 24 enrolled · Kari Kendra
  NCT05588453updated 2026-06-11
• Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII
  Recruiting · Phase 2 · Interventional · 162 enrolled · Black Diamond Therapeutics, Inc.
  NCT07326566updated 2026-06-11
• Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
  Active not recruiting · Phase 2 · Phase 3 · Interventional · 447 enrolled · National Cancer Institute (NCI)
  NCT02152982updated 2026-06-11
• NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial
  Recruiting · Phase 2 · Interventional · 62 enrolled · New Approaches to Neuroblastoma Therapy Consortium
  NCT06450041updated 2026-06-10

Frequently asked questions

How does Dacarbazine work?

Mechanism-of-action class: Alkylating Activity.

What is Dacarbazine used for?

According to FDA labeling, Dacarbazine carries indications including: Dacarbazine for Injection, USP is indicated in the treatment of metastatic malignant melanoma. In addition, dacarbazine is also indicated for Hodgkin's disease as a second-line therapy when used in combination with other effective agents.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Dacarbazine?

Dacarbazine is classified as Other alkylating agents, Alkylating Drug, Alkylating Activity, Decreased DNA Integrity, Decreased Protein Synthesis, Decreased RNA Integrity.

What are the contraindications for Dacarbazine?

Dacarbazine labeling lists contraindications including: Dacarbazine is contraindicated in patients who have demonstrated a hypersensitivity to it in the past.. Always consult the full prescribing information and a clinician.