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Busulfan Side Effects

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Common Busulfan Side Effects


The most commonly reported Busulfan side effects (click to view or check a box to report):

Diarrhoea (66)
Acute Graft Versus Host Disease (56)
Anorexia (54)
Graft Versus Host Disease (50)
Nausea (45)
Sepsis (41)
Stomatitis (39)
Malaise (34)
Febrile Neutropenia (34)
Venoocclusive Liver Disease (29)
Cytomegalovirus Infection (27)
Pyrexia (27)
Multi-organ Failure (25)
Staphylococcal Sepsis (24)
Bone Marrow Transplant (23)
Renal Failure (21)
Pneumonia (20)
Liver Disorder (20)
Stem Cell Transplant (19)
Mucosal Inflammation (18)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Busulfan Side Effects Reported to FDA



Busulfan Side Effect Report#9712778
Pancytopenia, Febrile Neutropenia, Blood Culture Positive, Escherichia Infection, Graft Versus Host Disease In Skin, Bone Marrow Failure, Transplant Failure, Respiratory Disorder, Stenotrophomonas Test Positive
This is a report of a 15-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: NA, who was treated with Busulfan (dosage: NA, start time: NS), combined with:
  • Fludarabine
  • Lymphocyte Immune Globulin
and developed a serious reaction and side effect(s): Pancytopenia, Febrile Neutropenia, Blood Culture Positive, Escherichia Infection, Graft Versus Host Disease In Skin, Bone Marrow Failure, Transplant Failure, Respiratory Disorder, Stenotrophomonas Test Positive after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Busulfan treatment in female patients, resulting in Pancytopenia side effect.
Busulfan Side Effect Report#9563573
Fluid Overload, Pseudomonal Bacteraemia, Renal Failure, Mucosal Inflammation, Venoocclusive Liver Disease, Respiratory Disorder, Pleural Effusion, Hypotension
This report suggests a potential Busulfan Fluid Overload side effect(s) that can have serious consequences. A 18-year-old male patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: NA and used Busulfan (dosage: NA) starting NS. After starting Busulfan the patient began experiencing various side effects, including: Fluid Overload, Pseudomonal Bacteraemia, Renal Failure, Mucosal Inflammation, Venoocclusive Liver Disease, Respiratory Disorder, Pleural Effusion, HypotensionAdditional drugs used concurrently:
  • Cyclophosphamide
  • Lymphocyte Immune Globulin
  • Mesna
  • Methotrexate
The patient was hospitalized. Although Busulfan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Fluid Overload, may still occur.
Busulfan Side Effect Report#9533315
Cytomegalovirus Infection
This Cytomegalovirus Infection problem was reported by a consumer or non-health professional from US. A 2-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: bone marrow conditioning regimen. On NS this consumer started treatment with Busulfan (dosage: NA). The following drugs were being taken at the same time:
  • Cyclpphosphamide(cyclophosphamide)
  • Eltoposide(etoposide)
  • Orthoclone Okt 3(moromonab-cd3)
  • Fluconazole(fluconazole)
  • Acyclovir(aciclover)
  • Ciprofloxacin(ciprofloxacin Hydrochloride)
  • Trimetoprim +sulfametoxazol(sulfamethoxazole, Trimethoprim)
  • Immunoglobulin(immunoglobulin)
When using Busulfan, the patient experienced the following unwanted symptoms/side effects: Cytomegalovirus InfectionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cytomegalovirus Infection, may become evident only after a product is in use by the general population.
Busulfan Side Effect Report#9416466
Primary Adrenal Insufficiency, Graft Versus Host Disease
This Primary Adrenal Insufficiency side effect was reported by a health professional from TR. A 9-year-old female patient (weight:NA) experienced the following symptoms/conditions: graft versus host disease.The patient was prescribed Busulfan (drug dosage: In 4 Days Bu), which was initiated on NS. Concurrently used drugs: NA..After starting to take Busulfan the consumer reported adverse symptoms, such as: Primary Adrenal Insufficiency, Graft Versus Host DiseaseThese side effects may potentially be related to Busulfan.
Busulfan Side Effect Report#9388011
Pulmonary Hypertension, Venoocclusive Disease, Toxicity To Various Agents, Pulmonary Haemorrhage
This is a report of a 10-year-old patient (weight: NA) from US, suffering from the following health symptoms/conditions: bone marrow conditioning regimen, who was treated with Busulfan (dosage: NA, start time: NS), combined with:
  • Cyclophosphamide
  • Antithymocyte Globulin
and developed a serious reaction and side effect(s): Pulmonary Hypertension, Venoocclusive Disease, Toxicity To Various Agents, Pulmonary Haemorrhage after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Busulfan treatment in patients, resulting in Pulmonary Hypertension side effect.
Busulfan Side Effect Report#9380405
Pulmonary Hypertension, Off Label Use, Pulmonary Haemorrhage, Serratia Test Positive, Epstein-barr Virus Test Positive, Adenovirus Test Positive, Post Procedural Complication
This report suggests a potential Busulfan Pulmonary Hypertension side effect(s) that can have serious consequences. A 1-year-old patient (weight: NA) from US was diagnosed with the following symptoms/conditions: bone marrow transplant and used Busulfan (dosage: NA) starting NS. After starting Busulfan the patient began experiencing various side effects, including: Pulmonary Hypertension, Off Label Use, Pulmonary Haemorrhage, Serratia Test Positive, Epstein-barr Virus Test Positive, Adenovirus Test Positive, Post Procedural ComplicationAdditional drugs used concurrently:
  • Cyclophosphamide (cyclophosphamide)
  • Antithymocyte Immunoglobulin
Although Busulfan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pulmonary Hypertension, may still occur.
Busulfan Side Effect Report#9378701
Multi-organ Failure
This Multi-organ Failure problem was reported by a health professional from IT. A 19-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Busulfan (dosage: NA). The following drugs were being taken at the same time:
  • Melphalan
When using Busulfan, the patient experienced the following unwanted symptoms/side effects: Multi-organ FailureAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Multi-organ Failure, may become evident only after a product is in use by the general population.
Busulfan Side Effect Report#9366988
Multi-organ Failure
This Multi-organ Failure side effect was reported by a physician from IT. A 19-year-old male patient (weight:NA) experienced the following symptoms/conditions: ewing^s sarcoma.The patient was prescribed Busulfan (drug dosage: 1mgk Per Day), which was initiated on NS. Concurrently used drugs:
  • Melphalan (140mgk Per Day)
.After starting to take Busulfan the consumer reported adverse symptoms, such as: Multi-organ FailureThese side effects may potentially be related to Busulfan.
Busulfan Side Effect Report#9337360
Lymphopenia, Hypogammaglobulinaemia, Bk Virus Infection, Blood Creatinine Increased, Thrombocytopenia, Neutropenia, Thrombotic Microangiopathy, Polyomavirus-associated Nephropathy, Renal Impairment
This is a report of a 10-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Busulfan (dosage: 3mgk Per Day, start time: NS), combined with:
  • Melphalan (50mgm2 Per Day)
  • Thiotepa (250mgm2 Per Day)
  • Stem Cell Transplant
and developed a serious reaction and side effect(s): Lymphopenia, Hypogammaglobulinaemia, Bk Virus Infection, Blood Creatinine Increased, Thrombocytopenia, Neutropenia, Thrombotic Microangiopathy, Polyomavirus-associated Nephropathy, Renal Impairment after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Busulfan treatment in female patients, resulting in Lymphopenia side effect.
Busulfan Side Effect Report#9332681
Neurotoxicity, Wheelchair User, Speech Disorder, Fatigue, Fibula Fracture, Tibia Fracture, Myelitis Transverse, Fall, Cerebellar Syndrome
This report suggests a potential Busulfan Neurotoxicity side effect(s) that can have serious consequences. A 28-year-old female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: acute myeloid leukaemia and used Busulfan (dosage: NA) starting
Aug 28, 1999. After starting Busulfan the patient began experiencing various side effects, including: Neurotoxicity, Wheelchair User, Speech Disorder, Fatigue, Fibula Fracture, Tibia Fracture, Myelitis Transverse, Fall, Cerebellar SyndromeAdditional drugs used concurrently:
  • Aracytine
  • Idarubicine (cyclophosphamide)
  • Endoxan (cyclophosphamide)
  • Mitoxantrone (mitoxantrone)
  • Amsacrine (amsacrine)
  • Vp16 (etoposide)
  • Levothyrox (levothyroxine Sodium) Infusion
The patient was hospitalized and became disabled. Although Busulfan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Neurotoxicity, may still occur.
Busulfan Side Effect Report#9332678
Tooth Hypoplasia
This Tooth Hypoplasia problem was reported by a consumer or non-health professional from GB. A 12-year-old patient (weight: NA) was diagnosed with the following symptoms/conditions: bone marrow conditioning regimen. On NS this consumer started treatment with Busulfan (dosage: 2-4 Mg/kg/day On Days -9 To -6). The following drugs were being taken at the same time:
  • Cyclophosphamide (cyclophosphamide) (50 Mg/kg/ Day On Days -5 To -1)
When using Busulfan, the patient experienced the following unwanted symptoms/side effects: Tooth HypoplasiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Tooth Hypoplasia, may become evident only after a product is in use by the general population.
Busulfan Side Effect Report#9332668
Tooth Hypoplasia, Tooth Hypoplasia, Toxicity To Various Agents
This Tooth Hypoplasia side effect was reported by a health professional from GB. A 8-year-old patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Busulfan (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Cyclophosphamide (cyclophosphamide) (On Days -5 To -1 (50 Mg/kg, 1 In 1 Day) Transplacental)
.After starting to take Busulfan the consumer reported adverse symptoms, such as: Tooth Hypoplasia, Tooth Hypoplasia, Toxicity To Various AgentsThese side effects may potentially be related to Busulfan.
Busulfan Side Effect Report#9332652
Acute Graft Versus Host Disease In Skin, Candida Pneumonia, Engraft Failure, Stem Cell Transplant, Surgical Procedure Repeated
This is a report of a 5-year-old patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Busulfan (dosage: NA, start time: NS), combined with:
  • Alemtuzumab
  • Ciclosporin
  • Cyclophosphamide
  • Itraconazole
and developed a serious reaction and side effect(s): Acute Graft Versus Host Disease In Skin, Candida Pneumonia, Engraft Failure, Stem Cell Transplant, Surgical Procedure Repeated after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Busulfan treatment in patients, resulting in Acute Graft Versus Host Disease In Skin side effect.
Busulfan Side Effect Report#9332649
Haematemesis, Melaena, Blood Urea Increased
This report suggests a potential Busulfan Haematemesis side effect(s) that can have serious consequences. A 82-year-old female patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: thrombocytosis and used Busulfan (dosage: NA) starting
Mar 23, 2010. After starting Busulfan the patient began experiencing various side effects, including: Haematemesis, Melaena, Blood Urea IncreasedAdditional drugs used concurrently:
  • Cardioaspirin
  • Solosa
The patient was hospitalized. Although Busulfan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Haematemesis, may still occur.
Busulfan Side Effect Report#9331908
Epstein-barr Virus Infection, Fungal Infection, Pneumocystis Jirovecii Infection, Sepsis
This Epstein-barr Virus Infection problem was reported by a health professional from GB. A 5-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: familial haemophagocytic lymphohistiocytosis. On NS this consumer started treatment with Busulfan (dosage: NA). The following drugs were being taken at the same time:
  • Fludarabine (fludarabine)
  • Prednisolone (prednisolone)
  • Tacrolimus (tacrolimus)
  • Antithymocyte Globulin (antithymocyte Globulin)
When using Busulfan, the patient experienced the following unwanted symptoms/side effects: Epstein-barr Virus Infection, Fungal Infection, Pneumocystis Jirovecii Infection, SepsisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Epstein-barr Virus Infection, may become evident only after a product is in use by the general population.
Busulfan Side Effect Report#9331907
Venoocclusive Liver Disease
This Venoocclusive Liver Disease side effect was reported by a health professional from GB. A 3-year-old male patient (weight:NA) experienced the following symptoms/conditions: bone marrow failure.The patient was prescribed Busulfan (drug dosage: NA), which was initiated on
Jan 16, 2011. Concurrently used drugs:
  • Cyclophosphamide
.After starting to take Busulfan the consumer reported adverse symptoms, such as: Venoocclusive Liver DiseaseThese side effects may potentially be related to Busulfan.
Busulfan Side Effect Report#9331906
Adenovirus Infection, Graft Versus Host Disease In Skin
This is a report of a 12-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: histiocytosis haematophagic, who was treated with Busulfan (dosage: NA, start time: NS), combined with:
  • Campath (alemtuzumab)
  • Cyclophosphamide (cyclophosphamide)
  • Fludarabine (fludarabine)
and developed a serious reaction and side effect(s): Adenovirus Infection, Graft Versus Host Disease In Skin after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Busulfan treatment in male patients, resulting in Adenovirus Infection side effect.
Busulfan Side Effect Report#9331899
Pseudomonal Sepsis
This report suggests a potential Busulfan Pseudomonal Sepsis side effect(s) that can have serious consequences. A 6-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: familial haemophagocytic lymphohistiocytosis and used Busulfan (dosage: NA) starting NS. After starting Busulfan the patient began experiencing various side effects, including: Pseudomonal SepsisAdditional drugs used concurrently:
  • Methotrexate (methotrexate)
  • Mycophenolate Mofetil (mycophenolic Acid)
  • Prednisolone (prednisolone)
Although Busulfan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pseudomonal Sepsis, may still occur.
Busulfan Side Effect Report#9331886
Multi-organ Failure, Nephropathy Toxic, Venoocclusive Disease
This Multi-organ Failure problem was reported by a health professional from GB. A 3-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: familial haemophagocytic lymphohistiocytosis. On NS this consumer started treatment with Busulfan (dosage: NA). The following drugs were being taken at the same time:
  • Antithymocyte Globulin (antithymocyte Globulin)
  • Cyclophosphamide (cyclophosphamide)
When using Busulfan, the patient experienced the following unwanted symptoms/side effects: Multi-organ Failure, Nephropathy Toxic, Venoocclusive DiseaseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Multi-organ Failure, may become evident only after a product is in use by the general population.
Busulfan Side Effect Report#9331875
Venoocclusive Disease, Malaise, Pneumonia Cytomegaloviral, Cytomegalovirus Infection, Acidosis, Toxicity To Various Agents
This Venoocclusive Disease side effect was reported by a health professional from GB. A 3-year-old male patient (weight:NA) experienced the following symptoms/conditions: thalassaemia beta.The patient was prescribed Busulfan (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Cyclophosphamide
.After starting to take Busulfan the consumer reported adverse symptoms, such as: Venoocclusive Disease, Malaise, Pneumonia Cytomegaloviral, Cytomegalovirus Infection, Acidosis, Toxicity To Various AgentsThese side effects may potentially be related to Busulfan.
Busulfan Side Effect Report#9331867
Respiratory Failure, Pneumonia, Cystitis Haemorrhagic, Odynophagia, Mucosal Inflammation, Pulmonary Mass
This is a report of a 21-year-old female patient (weight: NA) from BR, suffering from the following health symptoms/conditions: hodgkin^s disease, who was treated with Busulfan (dosage: 56 Mg At 6h, 54 Mg At 12h, 18h, And 24h, start time:
Feb 10, 2011), combined with:
  • Cyclophosphamide
  • Antithymocyte Globulin (antithymocyte Immunoglobulin (rabbit)
  • Cefepime (cefepime)
  • Norethisterone (norethisterone)
  • Ondansetron (ondansetron)
  • Human Immunoglobulin (immunoglobulins, Normal Human)
  • Allopurinol
  • Ursodeoxycholic Acid (ursodeoxycholic Acid)
and developed a serious reaction and side effect(s): Respiratory Failure, Pneumonia, Cystitis Haemorrhagic, Odynophagia, Mucosal Inflammation, Pulmonary Mass after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Busulfan treatment in female patients, resulting in Respiratory Failure side effect.
Busulfan Side Effect Report#9331781
Alanine Aminotransferase Increased
This report suggests a potential Busulfan Alanine Aminotransferase Increased side effect(s) that can have serious consequences. A 7-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: acute myeloid leukaemia,clostridial infection and used Busulfan (dosage: NA) starting NS. After starting Busulfan the patient began experiencing various side effects, including: Alanine Aminotransferase IncreasedAdditional drugs used concurrently:
  • Metronidazole
  • Clofarabine (clofarabine)
  • Thiotepa (thiotepa)
  • Rabbit Antithymocyte Globulin (antithymocyte Immunoglobulin (rabbit))
  • Lorazepam (lorazepam)
  • Tacrolimus (tacrolimus)
  • Mycophenolate Mofetil (mycophenolic Acid)
Although Busulfan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Alanine Aminotransferase Increased, may still occur.
Busulfan Side Effect Report#9264973
Hepatic Vein Occlusion, Depressed Mood, Suicidal Ideation, Pancreatitis Acute, Off Label Use
This Hepatic Vein Occlusion problem was reported by a physician from KR. A 40-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: stem cell transplant,prophylaxis against graft versus host disease. On NS this consumer started treatment with Busulfan (dosage: Day-6 To -5). The following drugs were being taken at the same time:
  • Tacrolimus
  • Fludarabine (On Days -7 To -3)
  • Heparin (Continuous Infusion Of Low Dose Heparin)
  • Ursodeoxycholic Acid
  • Methotrexate (Days 1, 3, 6, 11)
  • Antithymocyte Immunoglobulin (From Day -4 To -1)
When using Busulfan, the patient experienced the following unwanted symptoms/side effects: Hepatic Vein Occlusion, Depressed Mood, Suicidal Ideation, Pancreatitis Acute, Off Label UseThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hepatic Vein Occlusion, may become evident only after a product is in use by the general population.
Busulfan Side Effect Report#9204889
Cardio-respiratory Arrest, Renal Failure Acute, Acute Hepatic Failure
This Cardio-respiratory Arrest side effect was reported by a physician from US. A 54-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Busulfan (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Fludarabine Phosphate
  • Methotrexate
  • Tacrolimus
  • Blood Stem Cells (5.1 N/a)
  • Antithymocyte Globulin
.After starting to take Busulfan the consumer reported adverse symptoms, such as: Cardio-respiratory Arrest, Renal Failure Acute, Acute Hepatic FailureThese side effects may potentially be related to Busulfan. The patient was hospitalized.
Busulfan Side Effect Report#9171709
Graft Versus Host Disease, Pneumonitis, Acute Respiratory Distress Syndrome, Multi-organ Failure
This is a report of a 14-year-old patient (weight: NA) from US, suffering from the following health symptoms/conditions: bone marrow transplant, who was treated with Busulfan (dosage: NA, start time: NS), combined with:
  • Etoposide
  • Cyclophosphamide
  • Anti-thymocyte Globulin (rabbit) Nos
and developed a serious reaction and side effect(s): Graft Versus Host Disease, Pneumonitis, Acute Respiratory Distress Syndrome, Multi-organ Failure after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Busulfan treatment in patients, resulting in Graft Versus Host Disease side effect.


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The appearance of Busulfan on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Busulfan Side Effects for Men?

Men Side EffectsReports
Diarrhoea 37
Acute Graft Versus Host Disease 32
Anorexia 32
Graft Versus Host Disease 26
Nausea 24
Stomatitis 24
Malaise 20
Pyrexia 20
Sepsis 19
Venoocclusive Liver Disease 18

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    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Busulfan reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Side Effects reported to FDA: 494

    Busulfan safety alerts: No

    Reported deaths: 134

    Reported hospitalizations: 124

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