Percentages show how often each reaction appears relative to total reports for busulfan.
2 Product Use In Unapproved Indication 9.2% 1,667
3 Mucosal Inflammation 5.8% 1,044
5 Venoocclusive Liver Disease 4.8% 865
6 Febrile Neutropenia 4.5% 810
7 Cytomegalovirus Infection 4.4% 796
8 Graft Versus Host Disease 4.0% 723
10 Acute Graft Versus Host Disease 3.8% 691
11 Cytomegalovirus Infection Reactivation 3.2% 577
12 Chronic Graft Versus Host Disease 3.0% 550
15 Venoocclusive Disease 2.8% 500
These are voluntary reports and do not establish that busulfan caused these reactions.
Report severity
95.4% Serious 17,275 reports
20.5% Hospitalizations 3,716 reports
31.4% Fatal 5,696 reports
Seriousness is determined by the reporter, not by OpenClaim.
Busulfan drug interactions
Other drugs that appear in adverse event reports alongside busulfan. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.
Also suspected
1 Fludarabine-phosphate 40.9% 7,402
2 Cyclophosphamide 34.3% 6,220
14 Vincristine-sulfate 4.9% 882
15 Methylprednisolone 4.8% 868
Taken alongside
1 Fludarabine-phosphate 14.8% 2,686
2 Cyclophosphamide 14.2% 2,577
8 Methylprednisolone 5.6% 1,015
Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.
Who reports busulfan side effects
31.2% of busulfan adverse event reports involve female patients and 41.7% involve male patients. The largest age group is adult at 53%. These figures reflect who reports side effects, not underlying risk.
Sex
Female 31.2%
Male 41.7%
Unknown 27.0%
Age group
< 2 9.1%
2–11 22.7%
12–17 9.8%
18–64 52.9%
65+ 5.6%
What is busulfan used for
Conditions and purposes for which patients were taking busulfan when the adverse event was reported.
Accidental Exposure Acute Biphenotypic Leukaemia Acute Haemorrhagic Leukoencephalitis Acute Leukaemia Acute Lymphocytic Leukaemia Acute Lymphocytic Leukaemia Recurrent Acute Monocytic Leukaemia Acute Myeloid Leukaemia Acute Myeloid Leukaemia Recurrent Acute Myeloid Leukaemia Refractory Acute Myeloid Leukemia Acute Myelomonocytic Leukaemia Acute Promyelocytic Leukaemia Adjuvant Therapy Adrenoleukodystrophy
Showing 15 of 533 indications
ACCIDENTAL EXPOSURE ACUTE BIPHENOTYPIC LEUKAEMIA ACUTE HAEMORRHAGIC LEUKOENCEPHALITIS ACUTE LEUKAEMIA ACUTE LYMPHOCYTIC LEUKAEMIA ACUTE LYMPHOCYTIC LEUKAEMIA RECURRENT ACUTE MONOCYTIC LEUKAEMIA ACUTE MYELOID LEUKAEMIA ACUTE MYELOID LEUKAEMIA RECURRENT ACUTE MYELOID LEUKAEMIA REFRACTORY ACUTE MYELOID LEUKEMIA ACUTE MYELOMONOCYTIC LEUKAEMIA ACUTE PROMYELOCYTIC LEUKAEMIA ADJUVANT THERAPY ADRENOLEUKODYSTROPHY ADULT T-CELL LYMPHOMA/LEUKAEMIA ALLOGENIC BONE MARROW TRANSPLANTATION THERAPY ALLOGENIC STEM CELL TRANSPLANTATION ALVEOLAR RHABDOMYOSARCOMA AMYLOIDOSIS AMYOTROPHIC LATERAL SCLEROSIS ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA ANTIFUNGAL PROPHYLAXIS APLASIA PURE RED CELL APLASTIC ANAEMIA ASPARTATE AMINOTRANSFERASE INCREASED ASPIRATION BONE MARROW ABNORMAL ATYPICAL MYCOBACTERIAL INFECTION AUTOIMMUNE DISORDER AUTOLOGOUS BONE MARROW TRANSPLANTATION THERAPY AUTOLOGOUS HAEMATOPOIETIC STEM CELL TRANSPLANT Acute biphenotypic leukaemia Acute graft versus host disease Acute graft versus host disease in skin Acute leukaemia Acute lymphocytic leukaemia Acute lymphocytic leukaemia recurrent Acute lymphocytic leukaemia refractory Acute megakaryocytic leukaemia Acute myeloid leukaemia Acute myeloid leukaemia (in remission) Acute myeloid leukaemia recurrent Acute myeloid leukaemia refractory Acute myelomonocytic leukaemia Acute promyelocytic leukaemia Adrenal gland cancer Adrenoleukodystrophy Adult T-cell lymphoma/leukaemia Age-related macular degeneration Allogenic bone marrow transplantation therapy Allogenic stem cell transplantation Alpha-mannosidosis Alveolar rhabdomyosarcoma Amegakaryocytic thrombocytopenia Angiocentric lymphoma Angioimmunoblastic T-cell lymphoma Angioimmunoblastic T-cell lymphoma stage IV Antifungal prophylaxis Antifungal treatment Aplastic anaemia Aspergillus infection Atypical teratoid/rhabdoid tumour of CNS Autoinflammatory disease Autologous haematopoietic stem cell transplant B PRECURSOR TYPE ACUTE LEUKAEMIA B precursor type acute leukaemia B-CELL LYMPHOMA B-CELL LYMPHOMA RECURRENT B-CELL LYMPHOMA REFRACTORY B-CELL TYPE ACUTE LEUKAEMIA B-cell lymphoma B-cell type acute leukaemia BENIGN NEOPLASM BING-NEEL SYNDROME BLAST CRISIS IN MYELOGENOUS LEUKAEMIA BLASTIC PLASMACYTOID DENDRITIC CELL NEOPLASIA BLOOD COUNT ABNORMAL BLOOD DISORDER BONE GRAFT BONE MARROW CONDITIONING REGIMEN BONE MARROW DISORDER BONE MARROW FAILURE BONE MARROW TRANSPLANT BONE NEOPLASM MALIGNANT BRAIN NEOPLASM MALIGNANT BREAST CANCER FEMALE BURKITT^S LYMPHOMA STAGE IV Behcet^s syndrome Bipolar II disorder Blastic plasmacytoid dendritic cell neoplasia Bone graft Bone marrow conditioning regimen Bone marrow disorder Bone marrow failure Bone marrow transplant Burkitt^s lymphoma CENTRAL NERVOUS SYSTEM LYMPHOMA CERVIX CARCINOMA CHEMOTHERAPY CHEMOTHERAPY SIDE EFFECT PROPHYLAXIS CHEST WALL TUMOUR CHLOROMA CHROMOSOME ANALYSIS ABNORMAL CHRONIC GRAFT VERSUS HOST DISEASE CHRONIC GRANULOMATOUS DISEASE CHRONIC INFANTILE NEUROLOGICAL CUTANEOUS AND ARTICULAR SYNDROME CHRONIC LYMPHOCYTIC LEUKAEMIA CHRONIC LYMPHOCYTIC LEUKAEMIA TRANSFORMATION CHRONIC MYELOID LEUKAEMIA CHRONIC MYELOID LEUKAEMIA TRANSFORMATION CHRONIC MYELOMONOCYTIC LEUKAEMIA CNS GERMINOMA CNS germinoma COELIAC DISEASE COLONY STIMULATING FACTOR THERAPY COMBINED IMMUNODEFICIENCY CONGENITAL ANAEMIA CONGENITAL APLASTIC ANAEMIA CONGENITAL DISORDER OF GLYCOSYLATION CONGENITAL DYSERYTHROPOIETIC ANAEMIA CORD BLOOD TRANSPLANT THERAPY CROHN^S DISEASE CYTOGENETIC ABNORMALITY Central nervous system lymphoma Cerebrovascular disorder Chediak-Higashi syndrome Chemotherapy Chemotherapy side effect prophylaxis Chloroma Chronic active Epstein-Barr virus infection Chronic disease Chronic graft versus host disease Chronic graft versus host disease oral Chronic granulomatous disease Chronic leukaemia Chronic lymphocytic leukaemia Chronic myeloid leukaemia Chronic myelomonocytic leukaemia Clear cell sarcoma of the kidney Coeliac disease Colony stimulating factor therapy Combined immunodeficiency Congenital anaemia Congenital aplastic anaemia Congenital dyserythropoietic anaemia Congenital dyskeratosis Congenital rubella infection Cord blood transplant therapy Cytogenetic abnormality Cytomegalovirus infection Cytopenia DEAFNESS DESMOPLASTIC SMALL ROUND CELL TUMOUR DIFFUSE LARGE B-CELL LYMPHOMA DIFFUSE LARGE B-CELL LYMPHOMA RECURRENT DIFFUSE LARGE B-CELL LYMPHOMA REFRACTORY DISEASE PROGRESSION DISEASE RECURRENCE DONOR ORGAN TISSUE PREPARATION ISSUE DRUG THERAPY DRUG USE FOR UNKNOWN INDICATION Desmoplastic small round cell tumour Diffuse large B-cell lymphoma Diffuse large B-cell lymphoma recurrent Diffuse large B-cell lymphoma refractory Diffuse large B-cell lymphoma stage III Diffuse large B-cell lymphoma stage IV Disseminated trichosporonosis Donor organ tissue preparation issue Drug therapy ENZYME LEVEL DECREASED EOSINOPHILIA EPILEPSY EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER EPSTEIN-BARR VIRUS INFECTION ESSENTIAL THROMBOCYTHAEMIA EWING'S SARCOMA EWING^S SARCOMA EWING^S SARCOMA METASTATIC EX VIVO GENE THERAPY Epstein-Barr virus infection Essential thrombocythaemia Evans syndrome Ewing^s sarcoma Ex vivo gene therapy Extragonadal primary germ cell tumour FAMILIAL HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS FLT3 gene mutation FOETAL EXPOSURE DURING PREGNANCY FOLLICLE CENTRE LYMPHOMA, FOLLICULAR GRADE I, II, III FOLLICLE CENTRE LYMPHOMA, FOLLICULAR GRADE I, II, III STAGE IV FOLLICULAR LYMPHOMA FOLLICULAR LYMPHOMA STAGE III Familial haemophagocytic lymphohistiocytosis Feeling abnormal Follicle centre lymphoma, follicular grade I, II, III Follicle centre lymphoma, follicular grade I, II, III stage IV Follicular lymphoma GANGLIONEUROBLASTOMA GASTROINTESTINAL TOXICITY GATA2 deficiency GENE MUTATION GERM CELL CANCER GRAFT COMPLICATION GRAFT VERSUS HOST DISEASE GRANULOMA Gatad2b associated neurodevelopmental disorder Gaucher^s disease type I Gaucher^s disease type III Gene mutation Genotoxicity Glanzmann^s disease Glioblastoma Glutaric acidaemia type I Graft versus host disease Graft versus host disease in gastrointestinal tract Graft versus host disease in skin Granulocyte percentage decreased HAEMATOLOGICAL MALIGNANCY HAEMATOPOIETIC NEOPLASM HAEMATOPOIETIC STEM CELL MOBILISATION HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS HEPATITIS C HEPATOCELLULAR CARCINOMA HEPATOSPLENIC T-CELL LYMPHOMA HEREDITARY SIDEROBLASTIC ANAEMIA HISTIOCYTOSIS HAEMATOPHAGIC HISTOLOGY HODGKIN'S DISEASE HODGKIN'S DISEASE STAGE II HODGKIN^S DISEASE HODGKIN^S DISEASE NODULAR SCLEROSIS HODGKIN^S DISEASE RECURRENT HYPER IGE SYNDROME HYPER IGM SYNDROME Haematological malignancy Haematopoietic neoplasm Haematopoietic stem cell mobilisation Haemophagocytic lymphohistiocytosis Hepatoblastoma Hepatosplenic T-cell lymphoma Hereditary sideroblastic anaemia High frequency ablation Histiocytic sarcoma Hodgkin^s disease Hodgkin^s disease nodular sclerosis Hodgkin^s disease nodular sclerosis stage II Hodgkin^s disease nodular sclerosis stage IV Hodgkin^s disease recurrent Hyper IgM syndrome Hypertension Hypertrophic osteoarthropathy ILL-DEFINED DISORDER IMMUNE SYSTEM DISORDER IMMUNE TOLERANCE INDUCTION IMMUNODEFICIENCY IMMUNODEFICIENCY CONGENITAL IMMUNOSUPPRESSANT DRUG THERAPY IMMUNOSUPPRESSION INFANTILE GENETIC AGRANULOCYTOSIS INFECTION PROPHYLAXIS INFLAMMATORY BOWEL DISEASE INTRACRANIAL GERM CELL TUMOUR IPEX SYNDROME IPEX syndrome Immune system disorder Immune thrombocytopenia Immune tolerance induction Immunochemotherapy Immunodeficiency Immunosuppressant drug therapy Immunosuppression In vivo gene therapy Infantile genetic agranulocytosis Inflammatory bowel disease Intentional product use issue Interferon gamma receptor deficiency Interstitial lung disease JUVENILE CHRONIC MYELOMONOCYTIC LEUKAEMIA Juvenile chronic myelomonocytic leukaemia Krabbe^s disease LEUKAEMIA LEUKAEMIA MONOCYTIC LEUKAEMIA RECURRENT LUNG DISORDER LUNG NEOPLASM LYMPHADENITIS LYMPHADENOPATHY LYMPHOCYTIC LEUKAEMIA LYMPHOMA LYMPHOPENIA Leukaemia Leukaemia cutis Leukocyte adhesion deficiency type I Leukodystrophy Leukoencephalopathy Lymphocytic leukaemia Lymphocytic lymphoma Lymphodepletion Lymphoma Lymphoproliferative disorder MALIGNANT LYMPHOID NEOPLASM MANTLE CELL LYMPHOMA MANTLE CELL LYMPHOMA STAGE III MANTLE CELL LYMPHOMA STAGE IV MDS MEDULLOBLASTOMA MEDULLOBLASTOMA RECURRENT METABOLIC DISORDER METASTASES TO BONE METASTASES TO BONE MARROW METASTASES TO CENTRAL NERVOUS SYSTEM METASTASES TO LIVER METASTASES TO LUNG METASTASES TO SPINE METASTASIS METASTATIC NEOPLASM MISMATCHED DONOR BONE MARROW TRANSPLANTATION THERAPY MOTOR DYSFUNCTION MUCOCUTANEOUS CANDIDIASIS MUCOPOLYSACCHARIDOSIS MUCOPOLYSACCHARIDOSIS I MUCORMYCOSIS MULTIPLE MYELOMA MULTIPLE SCLEROSIS MYCOSIS FUNGOIDES MYELOBLAST PRESENT MYELODYSPLASTIC SYNDROME MYELOFIBROSIS MYELOID LEUKAEMIA MYELOPROLIFERATIVE DISORDER MYELOPROLIFERATIVE NEOPLASM MYELOSUPPRESSION MYH9-related disease Malignant lymphoid neoplasm Mantle cell lymphoma Mantle cell lymphoma stage IV McLeod neuroacanthocytosis syndrome Medulloblastoma Metachromatic leukodystrophy Metastases to bone Metastases to bone marrow Metastases to lung Mevalonate kinase deficiency Mismatched donor bone marrow transplantation therapy Monoclonal B-cell lymphocytosis Mucopolysaccharidosis I Mucopolysaccharidosis II Mucopolysaccharidosis VII Myasthenia gravis Mycobacterial infection Myelodysplastic syndrome Myelodysplastic syndrome transformation Myelodysplastic syndrome unclassifiable Myelodysplastic syndrome with excess blasts Myelodysplastic syndrome/myeloproliferative neoplasm overlap syndrome Myelofibrosis Myeloid leukaemia Myeloproliferative neoplasm Myelosuppression NASOPHARYNGITIS NATURAL KILLER-CELL LYMPHOBLASTIC LYMPHOMA NEOPLASM NEOPLASM MALIGNANT NEPHROPATHY NEUROBLASTOMA NEUROBLASTOMA RECURRENT NEUROECTODERMAL NEOPLASM NEUROFIBROMATOSIS NEURONAL CEROID LIPOFUSCINOSIS NIJMEGEN BREAKAGE SYNDROME NON-HODGKIN'S LYMPHOMA NON-HODGKIN'S LYMPHOMA RECURRENT NON-HODGKIN^S LYMPHOMA NON-HODGKIN^S LYMPHOMA RECURRENT NON-HODGKIN^S LYMPHOMA STAGE IV Neoplasm Neoplasm malignant Neuroblastoma Nijmegen breakage syndrome Non-Hodgkin^s lymphoma Non-Hodgkin^s lymphoma recurrent Non-Hodgkin^s lymphoma stage IV OFF LABEL USE OMENN SYNDROME ORAL CANDIDIASIS OSTEOPETROSIS OVARIAN CANCER OVARIAN CANCER METASTATIC Ocular lymphoma Off label use Oocyte harvest Organ transplant Osteopetrosis Osteosarcoma Ovarian cancer PANCYTOPENIA PERIPHERAL HAEMOPOIETIC STEM CELL TRANSPLANT PERIPHERAL HEMOPOIETIC STEM CELL TRANSPLANT PERIPHERAL T-CELL LYMPHOMA UNSPECIFIED PHILADELPHIA CHROMOSOME NEGATIVE PLASMA CELL MYELOMA PLASMA CELL MYELOMA RECURRENT PLASMABLASTIC LYMPHOMA PLASMACYTOMA PLATELET STORAGE POOL DEFICIENCY PLEUROPULMONARY BLASTOMA POLYCYTHAEMIA POLYCYTHAEMIA VERA PORPHYRIA NON-ACUTE PRADER-WILLI SYNDROME PRECURSOR T-LYMPHOBLASTIC LYMPHOMA/LEUKAEMIA PRECURSOR T-LYMPHOBLASTIC LYMPHOMA/LEUKAEMIA REFRACTORY PRECURSOR T-LYMPHOBLASTIC LYMPHOMA/LEUKAEMIA STAGE I PREMEDICATION PREOPERATIVE CARE PRIMARY IMMUNODEFICIENCY SYNDROME PRIMARY MEDIASTINAL LARGE B-CELL LYMPHOMA PRIMARY MYELOFIBROSIS PRIMITIVE NEUROECTODERMAL TUMOUR PRODUCT PREPARATION ERROR PRODUCT USED FOR UNKNOWN INDICATION PROPHYLACTIC CHEMOTHERAPY PROPHYLAXIS PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE PROPHYLAXIS AGAINST TRANSPLANT REJECTION PROSTATIC ADENOMA PULMONARY FIBROSIS Palliative care Pancytopenia Paroxysmal nocturnal haemoglobinuria Pearson^s syndrome Peripheral T-cell lymphoma unspecified Philadelphia chromosome negative Philadelphia positive acute lymphocytic leukaemia Pinealoblastoma Plasma cell myeloma Plasma cell myeloma refractory Platelet disorder Polyarthritis Polycythaemia Porphyria acute Porphyria non-acute Post procedural complication Post transplant lymphoproliferative disorder Prader-Willi syndrome Precursor T-lymphoblastic lymphoma/leukaemia Premedication Preoperative care Primary immunodeficiency syndrome Primary mediastinal large B-cell lymphoma Primary mediastinal large B-cell lymphoma stage IV Primary myelofibrosis Primitive neuroectodermal tumour Product used for unknown indication Prophylaxis Prophylaxis against graft versus host disease Prophylaxis against transplant rejection Purine nucleoside phosphorylase deficiency Pyrexia REFRACTORY CANCER RETINOBLASTOMA RETINOBLASTOMA BILATERAL Rhabdoid tumour Richter^s syndrome SALVAGE THERAPY SARCOMA SEIZURE SHWACHMAN-DIAMOND SYNDROME SICKLE CELL ANAEMIA SICKLE CELL ANAEMIA WITH CRISIS SICKLE CELL DISEASE SIDEROBLASTIC ANAEMIA SPEECH DISORDER STEM CELL THERAPY STEM CELL TRANSPLANT STILL^S DISEASE SURGERY SURGICAL PRECONDITIONING SYSTEMIC LUPUS ERYTHEMATOSUS SYSTEMIC MASTOCYTOSIS Second primary malignancy Shwachman-Diamond syndrome Sickle cell anaemia Sickle cell disease Sideroblastic anaemia Small cell carcinoma Squamous cell carcinoma Stem cell therapy Stem cell transplant Still^s disease Surgical preconditioning Symptomatic treatment T-CELL LYMPHOMA T-CELL LYMPHOMA RECURRENT T-CELL LYMPHOMA REFRACTORY T-CELL LYMPHOMA STAGE IV T-CELL PROLYMPHOCYTIC LEUKAEMIA T-CELL TYPE ACUTE LEUKAEMIA T-cell lymphoma T-cell prolymphocytic leukaemia T-cell type acute leukaemia THALASSAEMIA THALASSAEMIA BETA THERAPEUTIC PROCEDURE THROMBOCYTOPENIA THROMBOCYTOSIS TRANSPLANT TRANSPLANT REJECTION TRANSPLANTATION COMPLICATION Testicular swelling Thalassaemia Thalassaemia beta Therapeutic procedure Thrombocytopenia Transferrin decreased Transfusion Transplant Transplant failure Transplant rejection Tropical spastic paresis UNEVALUABLE EVENT UNRELATED DONOR BONE MARROW TRANSPLANTATION THERAPY Unrelated donor bone marrow transplantation therapy VENOOCCLUSIVE LIVER DISEASE WALDENSTROM^S MACROGLOBULINAEMIA WISKOTT-ALDRICH SYNDROME Waldenstrom^s macroglobulinaemia White blood cell disorder Wiskott-Aldrich syndrome X-LINKED LYMPHOPROLIFERATIVE SYNDROME X-linked lymphoproliferative syndrome XANTHOGRANULOMA Busulfan brand names and reporting trend
Busulfan is sold under the brand name Myleran.
Quarterly reports (2004–2025) An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.
Taking busulfan with another medication? Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.
