Dacarbazine: adverse event reports filed with FDA

6,431

reports as suspect product

0% of all reports · about 286 a year

511

reports, 12 months to June 2026

681 in the 12 months before

96.3%

marked serious by the reporter

93.5% across the class

17.1%

record death among outcomes, as reported

1,102 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Dacarbazine reports recording the termmedian drug in alkylating drug

1. Febrile neutropeniafever with low white blood cells9.4%607
2. Off label useused for a purpose or in a way not on the label8%515
3. Neutropenialow neutrophils, a type of white blood cell7%451
4. Pyrexiafever5.1%329
5. Drug ineffectivethe medicine did not work as expected4.3%279
6. Disease progressionthe disease advanced4.3%275
7. Neuropathy peripheralnerve damage in hands or feet4.1%265
8. Nauseafeeling sick3.7%235
9. Anaemialow red blood cells3.5%222
10. Product use in unapproved indicationused for a purpose not on the label3.4%217
11. Vomitingbeing sick3.3%210
12. Thrombocytopenialow platelets3%196
13. Diarrhoealoose or frequent stools3%192
14. Sepsisa severe body-wide response to infection3%192
15. Acute myeloid leukaemia2.8%183
16. Malignant neoplasm progression2.6%169
17. Pneumonialung infection2.6%166
18. Abdominal painstomach or belly pain2.6%165
19. Fatiguetiredness2.6%165
20. Pulmonary toxicity2.4%156
21. Hodgkin's disease2.4%154
22. Second primary malignancy2.4%154
23. Dyspnoeashortness of breath2.3%150
24. Leukopenialow white blood cells1.9%120
25. Deaththe patient died; cause not stated by this term1.9%119
26. Neutrophil count decreased1.7%109
27. Respiratory failurethe lungs could not supply enough oxygen1.7%109
28. Pancytopenialow counts of all blood cells1.7%108
29. White blood cell count decreasedlow white cell count1.7%107
30. Infectionan infection, type not specified1.6%103

Top 30 of 1,000 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 23 drugs in the alkylating drug class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 253,205 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 32% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 6,431 reports.

Drugs most often listed in the same reports

Other products listed in reports where Dacarbazine is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the alkylating drug class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Dacarbazine as a suspect or interacting product; reports listing it only as a concomitant medication (1,085) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.