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PlainMeds

What the label lists and what reports show

Busulfan side effects

Busulfan's FDA label: “Most common adverse reactions (incidence >60%) were: myelosuppression, nausea, stomatitis, vomiting, anorexia, diarrhea, insomnia, fever, hypomagnesemia, abdominal pain, anxiety, headache, hyperglycemia and hypokalemia ( 6.1 ) To report SUSPECTED ADVERSE …” FAERS holds 15,644 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is mucosal inflammation (1,113 reports).

  • Generic listed
  • A presentation discontinued
  • Boxed warning

Check it at the source: the busulfan FDA label on DailyMed (effective June 27, 2024, Eugia US LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Most common adverse reactions (incidence >60%) were: myelosuppression, nausea, stomatitis, vomiting, anorexia, diarrhea, insomnia, fever, hypomagnesemia, abdominal pain, anxiety, headache, hyperglycemia and hypokalemia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eugia US LLC at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Table 1: Summary of the Incidence (greater than or equal to 20%) of Non-Hematologic Adverse Reactions through BMT Day +28 in Patients who Received Busulfan Prior to Allogeneic Hematopoietic Progenitor Cell…

Non-Hematological Adverse Reactions 11. Includes all reported adverse reactions regardless of severity (toxicity grades 1 to 4) Percent Incidence
Fever80
Headache69
Asthenia51
Chills46
Pain44
Edema General28
Allergic Reaction26
Chest Pain26
Inflammation at Injection Site25
Back Pain23
Tachycardia44
Hypertension36
Thrombosis33
Vasodilation25
Nausea98
Stomatitis (Mucositis)97
Vomiting95
Anorexia85
Diarrhea84
Abdominal Pain72
Dyspepsia44
Constipation38
Dry Mouth26
Rectal Disorder25
Abdominal Enlargement23

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

From the label: adverse reactions, continued

The following adverse reactions are discussed in more detail in other sections of the labeling: Myelosuppression [see Warnings and Precautions (5.1) ] Seizures [see Warnings and Precautions (5.2) ] Hepatic Veno-Occlusive Disease (HVOD) [see Warnings and Precautions (5.3) ] Embryo-fetal Toxicity [see Warnings and Precautions (5.4) ] Cardiac Tamponade [see Warnings and Precautions (5.5) ] Bronchopulmonary Dysplasia [see Warnings and Precautions (5.6) ] Cellular Dysplasia [see Warnings and Precautions (5.7) ] Most common adverse reactions (incidence >60%) were: myelosuppression, nausea, stomatitis, vomiting, anorexia, diarrhea, insomnia, fever, hypomagnesemia, abdominal pain, anxiety, headache, hyperglycemia and hypokalemia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eugia US LLC at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …

Source: FDA drug label, Eugia US LLC, effective June 27, 2024 (SPL set 06883ac0-4b2a-4f26-89bf-512d37b9ba7f), via openFDA; the full label on DailyMed

What do FAERS reports show?

15,644 reports list busulfan among the medicines taken, each a report of something that happened, not proof the medicine caused it; 4,592 are coded as a death and 3,233 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Off Label Use (a use or a product term, not a reaction)2,019
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)1,723
  • Mucosal Inflammation1,113
  • Drug Ineffective (a use or a product term, not a reaction)1,076
  • Graft Versus Host Disease (named in the label)915
  • Venoocclusive Liver Disease875
  • Cytomegalovirus Infection873
  • Febrile Neutropenia (named in the label)863
  • Acute Graft Versus Host Disease824
  • Pyrexia816
  • Chronic Graft Versus Host Disease645
  • Cytomegalovirus Infection Reactivation595
  • Acute Graft Versus Host Disease In Skin585
  • Thrombocytopenia (named in the label)566
  • Infection (named in the label)533
  • Sepsis (named in the label)531
  • Venoocclusive Disease525
  • Pneumonia (named in the label)497
  • Diarrhoea (named in the label)490
  • Respiratory Failure476
  • Pancytopenia450
  • Cystitis Haemorrhagic436
  • Neutropenia (named in the label)430
  • Bk Virus Infection379
  • Thrombotic Microangiopathy (named in the label)377

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Busulfan: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions