BUSULFAN

N/A

Manufactured by Otsuka America Pharmaceutical, Inc.

36,413 FDA adverse event reports analyzed

Last updated: 2026-04-14

About BUSULFAN

BUSULFAN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Otsuka America Pharmaceutical, Inc.. The most commonly reported adverse reactions for BUSULFAN include OFF LABEL USE, PRODUCT USE IN UNAPPROVED INDICATION, MUCOSAL INFLAMMATION, DRUG INEFFECTIVE, GRAFT VERSUS HOST DISEASE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BUSULFAN.

Top Adverse Reactions

OFF LABEL USE2,038 reports
PRODUCT USE IN UNAPPROVED INDICATION1,659 reports
MUCOSAL INFLAMMATION1,184 reports
DRUG INEFFECTIVE1,052 reports
GRAFT VERSUS HOST DISEASE1,049 reports
ACUTE GRAFT VERSUS HOST DISEASE1,035 reports
VENOOCCLUSIVE LIVER DISEASE1,031 reports
CYTOMEGALOVIRUS INFECTION976 reports
FEBRILE NEUTROPENIA957 reports
PYREXIA902 reports
CHRONIC GRAFT VERSUS HOST DISEASE758 reports
SEPSIS713 reports
ACUTE GRAFT VERSUS HOST DISEASE IN SKIN648 reports
DIARRHOEA636 reports
INFECTION618 reports
THROMBOCYTOPENIA599 reports
VENOOCCLUSIVE DISEASE597 reports
PNEUMONIA583 reports
CYTOMEGALOVIRUS INFECTION REACTIVATION575 reports
RESPIRATORY FAILURE523 reports
CYSTITIS HAEMORRHAGIC493 reports
THROMBOTIC MICROANGIOPATHY480 reports
PANCYTOPENIA474 reports
NEUTROPENIA450 reports
NAUSEA419 reports
STOMATITIS401 reports
BK VIRUS INFECTION388 reports
CYTOMEGALOVIRUS VIRAEMIA374 reports
DEATH372 reports
GRAFT VERSUS HOST DISEASE IN SKIN366 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME363 reports
HYPERTENSION358 reports
VOMITING343 reports
GRAFT VERSUS HOST DISEASE IN GASTROINTESTINAL TRACT342 reports
SEPTIC SHOCK335 reports
EPSTEIN BARR VIRUS INFECTION323 reports
ACUTE MYELOID LEUKAEMIA RECURRENT321 reports
ACUTE GRAFT VERSUS HOST DISEASE IN INTESTINE310 reports
DISEASE PROGRESSION305 reports
ACUTE KIDNEY INJURY304 reports
POST TRANSPLANT LYMPHOPROLIFERATIVE DISORDER291 reports
RENAL FAILURE284 reports
BACTERAEMIA280 reports
POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME280 reports
TRANSPLANT FAILURE263 reports
BONE MARROW FAILURE254 reports
APLASTIC ANAEMIA249 reports
ADENOVIRUS INFECTION248 reports
ACUTE MYELOID LEUKAEMIA245 reports
ANAEMIA237 reports
BRONCHOPULMONARY ASPERGILLOSIS230 reports
TOXICITY TO VARIOUS AGENTS228 reports
DYSPNOEA225 reports
ASCITES222 reports
INTENTIONAL PRODUCT USE ISSUE211 reports
VIRAL HAEMORRHAGIC CYSTITIS209 reports
STAPHYLOCOCCAL INFECTION203 reports
ACUTE RESPIRATORY DISTRESS SYNDROME196 reports
RENAL IMPAIRMENT196 reports
PLEURAL EFFUSION184 reports
BLOOD BILIRUBIN INCREASED182 reports
EPSTEIN BARR VIRUS INFECTION REACTIVATION177 reports
MULTI ORGAN FAILURE177 reports
MALAISE176 reports
SEIZURE173 reports
PLATELET COUNT DECREASED171 reports
HEPATIC FAILURE168 reports
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY166 reports
HERPES SIMPLEX165 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION162 reports
HEADACHE162 reports
PERICARDIAL EFFUSION161 reports
FUNGAL INFECTION160 reports
ABDOMINAL PAIN159 reports
HUMAN HERPESVIRUS 6 INFECTION158 reports
BACTERIAL INFECTION157 reports
DISEASE RECURRENCE156 reports
MYELODYSPLASTIC SYNDROME156 reports
RASH155 reports
CONDITION AGGRAVATED153 reports
GASTROINTESTINAL HAEMORRHAGE151 reports
ACUTE GRAFT VERSUS HOST DISEASE IN LIVER150 reports
PRODUCT USE ISSUE148 reports
INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION146 reports
PULMONARY HAEMORRHAGE146 reports
RESPIRATORY DISTRESS138 reports
ANOREXIA136 reports
CHRONIC GRAFT VERSUS HOST DISEASE IN SKIN136 reports
CARDIAC FAILURE135 reports
FATIGUE135 reports
DRUG RESISTANCE134 reports
ALANINE AMINOTRANSFERASE INCREASED133 reports
HYPOTENSION133 reports
PAIN133 reports
COUGH131 reports
CLOSTRIDIUM DIFFICILE COLITIS130 reports
DRUG INTERACTION130 reports
HEPATOTOXICITY129 reports
MENINGITIS TUBERCULOUS128 reports
WEIGHT INCREASED128 reports

Report Outcomes

Out of 17,639 classified reports for BUSULFAN:

Serious 95.3%Non-Serious 4.7%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male7,335 (55.6%)
Female5,476 (41.5%)
Unknown380 (2.9%)

Reports by Age

Age 4412 reports
Age 3394 reports
Age 5355 reports
Age 9348 reports
Age 7347 reports
Age 15321 reports
Age 2305 reports
Age 6300 reports
Age 16288 reports
Age 8274 reports
Age 60256 reports
Age 1249 reports
Age 10240 reports
Age 12233 reports
Age 13232 reports
Age 64219 reports
Age 14208 reports
Age 55206 reports
Age 59202 reports
Age 11195 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with BUSULFAN?

This profile reflects 36,413 FDA FAERS reports that mention BUSULFAN. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BUSULFAN?

Frequently reported terms in FAERS include OFF LABEL USE, PRODUCT USE IN UNAPPROVED INDICATION, MUCOSAL INFLAMMATION, DRUG INEFFECTIVE, GRAFT VERSUS HOST DISEASE, ACUTE GRAFT VERSUS HOST DISEASE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BUSULFAN?

Labeling and FAERS entries often list Otsuka America Pharmaceutical, Inc. in connection with BUSULFAN. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.