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Sandimmune (Cyclosporine) - Thrombotic Microangiopathy - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Thrombotic Microangiopathy (16)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Sandimmune (Cyclosporine) where reactions include thrombotic microangiopathy. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Sandimmune side effects in male

Reported by a physician from France on 2012-08-27

Patient: male

Reactions: Multi-Organ Failure, Thrombotic Microangiopathy

Adverse event resulted in: death

Drug(s) suspected as cause:
Albumin (Human)
    End date: 2012-03-06

Clorazepate Dipotassium
    Dosage: unknown dose daily
    Administration route: Oral
    Indication: Anxiety
    Start date: 2012-03-13
    End date: 2012-03-16

Delursan
    Indication: Cholestasis

Effexor
    Start date: 2012-03-13
    End date: 2012-03-22

Folic Acid
    Indication: Vitamin B12 Deficiency
    End date: 2012-04-05

Heparin Calcium
    Indication: Prophylaxis
    End date: 2012-03-21

Levothyroxine Sodium
    Indication: Hypothyroidism

Nicardipine HCL
    Administration route: Oral
    Indication: Hypertension
    End date: 2012-04-15

Omeprazole
    Indication: Prophylaxis
    End date: 2012-05-11

Phenoxymethyl Penicillin
    Dosage: 2 m iu daily
    Administration route: Oral
    Indication: Prophylaxis
    End date: 2012-03-22

Plitican
    Indication: Prophylaxis
    Start date: 2012-03-14
    End date: 2012-03-19

Sandimmune
    Indication: Prophylaxis
    Start date: 2012-01-23

Solu-Medrol
    Indication: Immunosuppression

Sulfamethoxazole and Trimethoprim
    Administration route: Oral
    Indication: Prophylaxis
    End date: 2012-04-05

Tiorfan
    Administration route: Oral
    Indication: Prophylaxis Against Diarrhoea
    End date: 2012-04-25

Valganciclovir
    Indication: Prophylaxis
    Start date: 2012-03-10
    End date: 2012-03-16

Vfend
    Indication: Prophylaxis

Zolpidem
    Administration route: Oral
    Indication: Insomnia
    End date: 2012-03-18

Other drugs received by patient: Vidaza; Cytarabine; Idarubicin HCL



Possible Sandimmune side effects in male

Reported by a physician from France on 2012-08-27

Patient: male

Reactions: Thrombotic Microangiopathy

Adverse event resulted in: death

Drug(s) suspected as cause:
Albumin (Human)
    Indication: Product Used FOR Unknown Indication
    End date: 2012-03-06

Bactrim DS
    Administration route: Oral
    Indication: Prophylaxis
    End date: 2012-04-05

Delursan
    Administration route: Oral
    Indication: Cholestasis

Effexor
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-13
    End date: 2012-03-22

Folic Acid
    Indication: Vitamin B12 Deficiency
    End date: 2012-04-05

Heparin Calcium
    Indication: Prophylaxis
    End date: 2012-03-21

Levothyroxine Sodium
    Indication: Product Used FOR Unknown Indication

Nicardipine HCL
    Administration route: Oral
    Indication: Hypertension
    End date: 2012-04-15

Omeprazole
    Indication: Prophylaxis

Phenoxymethyl Penicillin
    Administration route: Oral
    Indication: Prophylaxis
    End date: 2012-03-22

Plitican
    Indication: Prophylaxis
    Start date: 2012-03-14
    End date: 2012-03-19

Sandimmune
    Indication: Prophylaxis
    Start date: 2012-01-23
    End date: 2012-04-04

Solu-Medrol
    Indication: Immunosuppression

Tiorfan
    Administration route: Oral
    Indication: Prophylaxis
    End date: 2012-04-25

Tranxene
    Administration route: Oral
    Indication: Anxiety
    Start date: 2012-03-13
    End date: 2012-03-16

Valganciclovir
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2012-03-10
    End date: 2012-03-16

Vfend
    Indication: Prophylaxis

Zolpidem
    Administration route: Oral
    Indication: Insomnia
    End date: 2012-03-18



Possible Sandimmune side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-24

Patient: male

Reactions: Confusional State, Graft Versus Host Disease, RED Blood Cell Schistocytes Present, Haptoglobin Abnormal, Thrombotic Microangiopathy, Hyperuricaemia, Graft Versus Host Disease in Liver, Multi-Organ Failure, Thrombocytopenic Purpura, Thrombocytopenia, Kussmaul Respiration, Haemolysis, Haematotoxicity, Epstein-Barr Virus Infection, Renal Failure, Renal Impairment, Cytomegalovirus Infection, Nervous System Disorder, Human Herpesvirus 6 Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Albumin (Human)
    Dosage: 20 g, qd
    End date: 2012-03-06

Bactrim DS
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: Prophylaxis
    End date: 2012-04-05

Delursan
    Dosage: 1.5 g, unk
    Administration route: Oral
    Indication: Cholestasis

Effexor
    Administration route: Oral
    Start date: 2012-03-13
    End date: 2012-03-22

Folic Acid
    Indication: Vitamin Supplementation
    End date: 2012-04-05

Heparin Calcium
    Dosage: 7500 (units unknown), once daily
    Indication: Prophylaxis
    End date: 2012-03-21

Levothyroxine Sodium
    Dosage: 150 ug, qd
    Indication: Hypothyroidism

Nicardipine HCL
    Dosage: 50 mg, qd
    Administration route: Oral
    Indication: Hypertension
    End date: 2012-04-15

Omeprazole
    Indication: Prophylaxis

Phenoxymethyl Penicillin
    Dosage: 2 miu, qd
    Administration route: Oral
    Indication: Prophylaxis
    End date: 2012-03-22

Plitican
    Indication: Prophylaxis
    Start date: 2012-03-14
    End date: 2012-03-19

Sandimmune
    Indication: Prophylaxis
    Start date: 2012-01-23
    End date: 2012-04-04

Solu-Medrol
    Indication: Immunosuppression

Tiorfan
    Dosage: 600 mg, qd
    Administration route: Oral
    Indication: Prophylaxis Against Diarrhoea
    End date: 2012-04-25

Tranxene
    Administration route: Oral
    Indication: Anxiety
    Start date: 2012-03-13
    End date: 2012-03-16

Valganciclovir
    Dosage: 900 mg, qd
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2012-03-10
    End date: 2012-03-16

Vfend
    Dosage: 400 ukn, qd
    Indication: Prophylaxis

Zolpidem
    Dosage: 10 mg, qd
    Administration route: Oral
    Indication: Insomnia
    End date: 2012-03-18

Other drugs received by patient: Ganciclovir Sodium; Vidaza; Mycophenolate Mofetil (Cellcept)



Possible Sandimmune side effects in male

Reported by a physician from France on 2012-08-17

Patient: male

Reactions: Thrombotic Microangiopathy

Adverse event resulted in: death

Drug(s) suspected as cause:
Albumin (Human)
    Indication: Product Used FOR Unknown Indication
    End date: 2012-03-06

Bactrim DS
    Administration route: Oral
    Indication: Prophylaxis
    End date: 2012-04-05

Delursan
    Administration route: Oral
    Indication: Cholestasis

Effexor
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-13
    End date: 2012-03-22

Folic Acid
    Indication: Vitamin B12 Deficiency
    End date: 2012-04-05

Heparin Calcium
    Indication: Prophylaxis
    End date: 2012-03-21

Levothyroxine Sodium
    Indication: Product Used FOR Unknown Indication

Nicardipine HCL
    Administration route: Oral
    Indication: Hypertension
    End date: 2012-04-15

Omeprazole
    Indication: Prophylaxis

Phenoxymethyl Penicillin
    Administration route: Oral
    Indication: Prophylaxis
    End date: 2012-03-22

Plitican
    Indication: Prophylaxis
    Start date: 2012-03-14
    End date: 2012-03-19

Sandimmune
    Indication: Prophylaxis
    Start date: 2012-01-23
    End date: 2012-04-04

Solu-Medrol
    Indication: Immunosuppression

Tiorfan
    Administration route: Oral
    Indication: Prophylaxis
    End date: 2012-04-25

Tranxene
    Administration route: Oral
    Indication: Anxiety
    Start date: 2012-03-13
    End date: 2012-03-16

Valganciclovir
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2012-03-10
    End date: 2012-03-16

Vfend
    Indication: Prophylaxis

Zolpidem
    Administration route: Oral
    Indication: Insomnia
    End date: 2012-03-18



Possible Sandimmune side effects in 66 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-13

Patient: 66 year old male

Reactions: Thrombotic Microangiopathy

Adverse event resulted in: death

Drug(s) suspected as cause:
Albumin
    Dosage: form: solution
    End date: 2012-03-06

Bactrim DS
    Administration route: Oral
    End date: 2012-03-22

Delursan
    Administration route: Oral
    Indication: Cholestasis
    End date: 2012-05-11

Effexor
    Administration route: Oral
    Start date: 2012-03-13
    End date: 2012-03-22

Folic Acid
    Administration route: Oral
    Indication: Vitamin B12 Deficiency
    End date: 2012-04-05

Heparin
    End date: 2012-03-21

Levothyroxine Sodium
    Administration route: Oral
    Indication: Hypothyroidism
    End date: 2012-05-11

Nicardipine HCL
    Administration route: Oral
    Indication: Hypertension
    End date: 2012-04-15

Omeprazole
    Administration route: Oral
    End date: 2012-05-11

Phenoxymethyl Penicillin
    Dosage: 2 millions iu daily
    End date: 2012-03-22

Plitican
    Start date: 2012-03-14
    End date: 2012-03-19

Sandimmune
    Start date: 2012-01-23
    End date: 2012-04-04

Solu-Medrol
    Indication: Immunosuppression
    End date: 2012-05-11

Tiorfan
    Administration route: Oral
    End date: 2012-04-25

Tranxene
    Administration route: Oral
    Start date: 2012-03-13
    End date: 2012-03-16

Valganciclovir
    Administration route: Oral
    Start date: 2012-03-10
    End date: 2012-03-16

Vfend
    Dosage: powder for solution for perfusion
    End date: 2012-05-11

Zolpidem Tartrate
    Administration route: Oral
    Indication: Insomnia
    End date: 2012-03-18



Possible Sandimmune side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-10

Patient: male

Reactions: Confusional State, Graft Versus Host Disease, RED Blood Cell Schistocytes Present, Haptoglobin Abnormal, Thrombotic Microangiopathy, Hyperuricaemia, Multi-Organ Failure, Thrombocytopenic Purpura, Thrombocytopenia, Kussmaul Respiration, Haematotoxicity, Haemolysis, Renal Impairment, Renal Failure, Cytomegalovirus Infection, Nervous System Disorder, Human Herpesvirus 6 Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Albumin (Human)
    Dosage: 20 g, qd
    End date: 2012-03-06

Bactrim DS
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: Prophylaxis
    End date: 2012-04-05

Delursan
    Dosage: 1.5 g, unk
    Administration route: Oral
    Indication: Cholestasis

Effexor
    Dosage: unk
    Administration route: Oral
    Start date: 2012-03-13
    End date: 2012-03-22

Folic Acid
    Dosage: unk
    Indication: Vitamin Supplementation
    End date: 2012-04-05

Heparin Calcium
    Dosage: 7500 (units unknown), once daily
    Indication: Prophylaxis
    End date: 2012-03-21

Levothyroxine Sodium
    Dosage: 150 ug, qd
    Indication: Hypothyroidism

Nicardipine HCL
    Dosage: 50 mg, qd
    Administration route: Oral
    Indication: Hypertension
    End date: 2012-04-15

Omeprazole
    Dosage: unk
    Indication: Prophylaxis

Phenoxymethyl Penicillin
    Dosage: 2 miu, qd
    Administration route: Oral
    Indication: Prophylaxis
    End date: 2012-03-22

Plitican
    Dosage: unk
    Indication: Prophylaxis
    Start date: 2012-03-14
    End date: 2012-03-19

Sandimmune
    Indication: Prophylaxis
    Start date: 2012-01-23
    End date: 2012-04-04

Solu-Medrol
    Dosage: unk
    Indication: Immunosuppression

Tiorfan
    Dosage: 600 mg, qd
    Administration route: Oral
    Indication: Prophylaxis Against Diarrhoea
    End date: 2012-04-25

Tranxene
    Dosage: unk
    Administration route: Oral
    Indication: Anxiety
    Start date: 2012-03-13
    End date: 2012-03-16

Valganciclovir
    Dosage: 900 mg, qd
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2012-03-10
    End date: 2012-03-16

Vfend
    Dosage: 400 unk, qd
    Indication: Prophylaxis

Zolpidem Tartrate
    Dosage: 10 mg, qd
    Administration route: Oral
    Indication: Insomnia
    End date: 2012-03-18

Other drugs received by patient: Ganciclovir Sodium; Cellcept; Vidaza



Possible Sandimmune side effects in 66 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-10

Patient: 66 year old male

Reactions: Thrombotic Microangiopathy

Adverse event resulted in: death

Drug(s) suspected as cause:
Albumin (Human)
    Dosage: 20 g daily
    End date: 2012-03-06

Bactrim DS
    Dosage: 1 df, 1x/day
    Administration route: Oral
    Indication: Prophylaxis
    End date: 2012-04-05

Delursan
    Dosage: 1.5 g daily
    Administration route: Oral
    Indication: Cholestasis

Effexor XR
    Dosage: variable dose
    Administration route: Oral
    Start date: 2012-03-13
    End date: 2012-03-22

Folic Acid
    Dosage: 5 (unspecified unit) daily
    Indication: Vitamin B12 Deficiency
    End date: 2012-04-05

Heparin Calcium
    Dosage: 7500 (unspecified unit) daily
    Indication: Prophylaxis
    End date: 2012-03-21

Levothyroxine Sodium
    Dosage: 150 ug daily
    Indication: Hypothyroidism

Nicardipine HCL
    Dosage: 1 df daily
    Administration route: Oral
    Indication: Hypertension
    End date: 2012-04-15

Omeprazole
    Dosage: variable dose
    Indication: Prophylaxis

Phenoxymethyl Penicillin
    Dosage: 2 miu daily
    Administration route: Oral
    Indication: Prophylaxis
    End date: 2012-03-22

Plitican
    Dosage: variable dose
    Indication: Prophylaxis
    Start date: 2012-03-14
    End date: 2012-03-19

Sandimmune
    Dosage: variable dose
    Indication: Prophylaxis
    Start date: 2012-01-23
    End date: 2012-04-04

Solu-Medrol
    Dosage: variable dose
    Indication: Immunosuppression

Tiorfan
    Dosage: 600 mg daily
    Administration route: Oral
    Indication: Diarrhoea
    End date: 2012-04-25

Tranxene
    Dosage: variable dose
    Administration route: Oral
    Indication: Anxiety
    Start date: 2012-03-13
    End date: 2012-03-16

Valganciclovir
    Dosage: 900 mg daily
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2012-03-10
    End date: 2012-03-16

Vfend
    Dosage: 400 (unspecified unit) daily
    Indication: Prophylaxis

Zolpidem Tartrate
    Dosage: 1 dosage form (df) daily
    Administration route: Oral
    Indication: Insomnia
    End date: 2012-03-18



Possible Sandimmune side effects in 66 year old male

Reported by a physician from France on 2012-08-10

Patient: 66 year old male

Reactions: Multi-Organ Failure, Thrombotic Microangiopathy

Adverse event resulted in: death

Drug(s) suspected as cause:
Albumin (Human)
    End date: 2012-03-06

Clorazepate Dipotassium
    Dosage: unknown dose daily
    Administration route: Oral
    Indication: Anxiety
    Start date: 2012-03-13
    End date: 2012-03-16

Effexor
    Start date: 2012-03-13
    End date: 2012-03-22

Folic Acid
    Indication: Vitamin B12 Deficiency
    End date: 2012-04-05

Heparin Calcium
    Indication: Prophylaxis
    End date: 2012-03-21

Levothyroxine Sodium
    Indication: Hypothyroidism

Nicardipine HCL
    Administration route: Oral
    Indication: Hypertension
    End date: 2012-04-15

Omeprazole
    Indication: Prophylaxis

Phenoxymethyl Penicillin
    Dosage: 2 m iu daily
    Administration route: Oral
    Indication: Prophylaxis
    End date: 2012-03-22

Plitican
    Indication: Prophylaxis
    Start date: 2012-03-14
    End date: 2012-03-19

Sandimmune
    Indication: Prophylaxis
    Start date: 2012-01-23

Solu-Medrol
    Indication: Immunosuppression

Sulfamethoxazole and Trimethoprim
    Administration route: Oral
    Indication: Prophylaxis
    End date: 2012-04-05

Tiorfan
    Administration route: Oral
    Indication: Prophylaxis Against Diarrhoea
    End date: 2012-04-25

Ursodiol
    Administration route: Oral
    Indication: Cholestasis

Valganciclovir
    Indication: Prophylaxis
    Start date: 2012-03-10
    End date: 2012-03-16

Vfend
    Indication: Prophylaxis

Zolpidem Tartrate
    Administration route: Oral
    Indication: Insomnia
    End date: 2012-03-18

Other drugs received by patient: Idarubicin HCL; Vidaza; Cytarabine



Possible Sandimmune side effects in 65 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-31

Patient: 65 year old male

Reactions: Blood Bilirubin Increased, Venoocclusive Liver Disease, Abdominal Distension, Thrombotic Microangiopathy, Blood Pressure Decreased, Melaena, Ileus Paralytic

Adverse event resulted in: death

Drug(s) suspected as cause:
Busulfex
    Dosage: 45 mg milligram(s), intravenous ; 45 mg milligram(s), qid, intravenous
    Indication: Stem Cell Transplant
    Start date: 2008-11-04
    End date: 2008-11-07

Sandimmune
    Dosage: 100 mg milligram(s), bid, intravenous
    Indication: Immunosuppression
    Start date: 2007-11-08
    End date: 2007-11-08

Other drugs received by patient: Fludara; Cellcept; Maxipime; Omegacin (Biapenem); Urso 250; G-CSF-Priming-ARA-C (G-CSF-Priming-ARA-C); Hibon (Riboflavin Tetrabutyrate); Filgrastim (Filgrastin); Famotidine; Epadel (Elcosapentaenoic Acid Ethyl Ester); Neutrogin (Lenograstim); Soldactone (Potassium Canrenoate); Diflucan; Zovirax; Neuquinon (Ubidecarenone)



Possible Sandimmune side effects in 65 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-27

Patient: 65 year old male

Reactions: Venoocclusive Liver Disease, Thrombotic Microangiopathy

Adverse event resulted in: death

Drug(s) suspected as cause:
Busulfex
    Dosage: 45 mg milligram(s), intravenous, 45 mg milligram(s), qid, intravenous
    Indication: Stem Cell Transplant
    Start date: 2008-11-04
    End date: 2008-11-07

Sandimmune
    Dosage: 100 mg milligram(s), bid, intravenous
    Indication: Immunosuppression
    Start date: 2007-11-08
    End date: 2007-12-05

Other drugs received by patient: Filgrastim (Filgrastim); Cellcept; Urso 250; G-CSF-Priming-ARA-C (G-CSF-Priming-ARA-C); Maxipime; Epadel (Eicosapentaenoic Acid Ethyl Ester); Fludara; Famotidine; Soldactone (Potassium Canrenoate); Zovirax; Diflucan; Hibon (Riboflavin Tetrabutyrate); Omegacin (Biapenem); Neutrogin (Lenograstim); Neuquinon (Ubidecarenone)



Possible Sandimmune side effects in 56 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-05-03

Patient: 56 year old female

Reactions: Acute Graft Versus Host Disease, Autoimmune Hepatitis, Thrombotic Microangiopathy

Drug(s) suspected as cause:
Neoral
    Indication: Bone Marrow Transplant

Sandimmune

Other drugs received by patient: Vincristine; Fludarabine Phosphate; Doxorubicin HCL; Methotrexate; Melphalan Hydrochloride; Radiation Therapy; Adriamycin PFS; Dexamethasone; Bortezomib



Possible Sandimmune side effects in 56 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-05-03

Patient: 56 year old female

Reactions: Acute Graft Versus Host Disease, Autoimmune Hepatitis, Thrombotic Microangiopathy

Drug(s) suspected as cause:
Neoral
    Indication: Bone Marrow Transplant

Sandimmune

Other drugs received by patient: Bortezomib; Fludarabine Phosphate; Adriamycin PFS; Dexamethasone; Vincristine; Radiation Therapy; Melphalan Hydrochloride; Doxorubicin HCL; Methotrexate



Possible Sandimmune side effects in 56 year old male

Reported by a health professional (non-physician/pharmacist) from Swaziland on 2012-03-06

Patient: 56 year old male

Reactions: Gout, Acne, Urine Output Decreased, Toxicity To Various Agents, Thrombotic Microangiopathy, Hepatic Enzyme Increased, Haemoglobin Decreased, Fatigue, Lung Adenocarcinoma, Diarrhoea, Renal Tubular Necrosis, Acute Prerenal Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Colchicine
    Dosage: 1 or 2 mg
    Administration route: Oral

Sandimmune
    Dosage: 125 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 1994-01-01
    End date: 2012-01-01

Tarceva
    Dosage: 150 mg, unk
    Administration route: Oral
    Start date: 2011-10-01
    End date: 2012-01-23

Other drugs received by patient: Cardura CR; Aspirin; Torsemide; Prednisone TAB; Enoxaparin Sodium; Lercanidipine; Nitroderm; Metoprolol Tartrate and Hydrochlorothiazide; Calcimagon-D3; Azathioprine Sodium



Possible Sandimmune side effects in 56 year old male

Reported by a physician from Switzerland on 2012-03-02

Patient: 56 year old male

Reactions: Diarrhoea, Gout, Acne, Renal Tubular Necrosis, Thrombotic Microangiopathy, Hepatic Enzyme Increased, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Colchicine
    Dosage: 1 mg, uid/qd/prn
    Administration route: Oral
    Indication: Gout
    Start date: 2012-01-19
    End date: 2012-01-19

Erlotinib Hydrochloride
    Dosage: 150 mg, uid/qd
    Administration route: Oral
    Indication: Lung Neoplasm Malignant
    Start date: 2011-10-01
    End date: 2012-01-23

Sandimmune
    Dosage: 125 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 1994-01-01

Other drugs received by patient: Nitroderm; Torsemide; Enoxaparin Sodium; Calcimagon-D3; Minocin; Azathioprine Sodium; Metoprolol Tartrate and Hydrochlorothiazide; Cardura; Aspirin; Lercanidipine; Prednisone TAB



Possible Sandimmune side effects in male

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-11-18

Patient: male, weighing 65.0 kg (143.0 pounds)

Reactions: Jaundice, Systemic Candida, Hepatic Function Abnormal, Histiocytosis Haematophagic, Neutrophil Count Increased, Cytomegalovirus Test Positive, Hepatic Failure, Thrombotic Microangiopathy, Ascites, Weight Increased, Venoocclusive Liver Disease, Pleural Effusion, Bilirubin Conjugated Increased

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Busulfex
    Dosage: 208 mg, unk
    Indication: Bone Marrow Transplant
    Start date: 2010-07-07
    End date: 2010-07-10

Cyclophosphamide
    Dosage: 3900 mg, unk
    Indication: Bone Marrow Transplant
    Start date: 2010-07-11
    End date: 2010-07-12

Neoral
    Dosage: unk ukn, unk

Sandimmune
    Dosage: 150 mg, unk
    Indication: Bone Marrow Transplant
    Start date: 2010-07-13
    End date: 2010-07-29

Other drugs received by patient: Recomodulin; Vfend; Methotrexate; Thrombomodulin Alfa; Solu-Medrol; Funguard



Possible Sandimmune side effects in male

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-11-18

Patient: male, weighing 65.0 kg (143.0 pounds)

Reactions: Systemic Candida, Jaundice, Hepatic Function Abnormal, Histiocytosis Haematophagic, Neutrophil Count Increased, Cytomegalovirus Test Positive, Hepatic Failure, Thrombotic Microangiopathy, Ascites, Weight Increased, Venoocclusive Liver Disease, Pleural Effusion, Bilirubin Conjugated Increased

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Busulfex
    Dosage: 208 mg, unk
    Indication: Bone Marrow Transplant
    Start date: 2010-07-07
    End date: 2010-07-10

Cyclophosphamide
    Dosage: 3900 mg, unk
    Indication: Bone Marrow Transplant
    Start date: 2010-07-11
    End date: 2010-07-12

Neoral
    Dosage: unk ukn, unk

Sandimmune
    Dosage: 150 mg, unk
    Indication: Bone Marrow Transplant
    Start date: 2010-07-13
    End date: 2010-07-29

Other drugs received by patient: Thrombomodulin Alfa; Recomodulin; Funguard; Methotrexate; Vfend; Solu-Medrol

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