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Sandimmune (Cyclosporine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Sandimmune (Cyclosporine) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (165)
Death (38)
Life Threatening Events (20)
Disability (4)

Reports by Reaction Type

Thrombotic Microangiopathy (16)Renal Impairment (13)Pyrexia (11)Cytomegalovirus Infection (11)Renal Failure Acute (10)Renal Failure (9)Diarrhoea (9)Multi-Organ Failure (8)Blood Lactate Dehydrogenase Increased (8)Atrial Fibrillation (8)Weight Increased (7)Rash Pustular (7)

Below are a few examples of reports where side effects / adverse reactions may be related to Sandimmune (Cyclosporine). For a complete list or a specific selection of reports, please use the links above.

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 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 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 female

Reported by a physician from Germany on 2012-08-20

Patient: female

Reactions: Personality Change, Abnormal Behaviour, Screaming, Aggression

Drug(s) suspected as cause:
Sandimmune



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 female

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

Patient: female, weighing 54.0 kg (118.8 pounds)

Reactions: Blood Creatine Phosphokinase Increased, Rhabdomyolysis, Pruritus, Pain, Weight Increased, Myalgia, Acute Respiratory Distress Syndrome, Engraft Failure, Oxygen Saturation Decreased, Blood Urea Increased, Blood Lactate Dehydrogenase Increased, Muscular Weakness, Febrile Neutropenia, Cardiac Failure, Aspartate Aminotransferase Increased, Toxic Skin Eruption

Adverse event resulted in: death, life threatening event, disablity

Drug(s) suspected as cause:
Sandimmune
    Dosage: 110 mg, unk
    Start date: 2012-03-21
    End date: 2012-03-21

Sandimmune
    Indication: Prophylaxis Against Graft Versus Host Disease
    Start date: 2012-03-12
    End date: 2012-03-20

Other drugs received by patient: Neutrogin; Azactam / SCH /; Acyclovir; Alkeran; Furosemide; Solu-Cortef; M.v.i.-12; Humulin R; Lactec; Fluconazole; Prograf; Prograf; Methotrexate; Neutrogin; Heparin Sodium; Sodium Bicarbonate; Miya-BM; Dobutamine; Methylprednisolone Sodium Succinate; Promac; Clostridium Butyricum; Fludarabine Phosphate; Atarax; Hirudoid; Fulmeta; Acetaminophen; Artificial Tears =; Meropenem; Doripenem Monohydrate; Amino Acids; Epinastine Hydrochloride; Oxycodone Hydrochloride; Omeprazole; Azactam; Alloid; Xylocaine; Celecoxib; Levofloxacin; Furosemide; Dopamine HCL; Acetaminophen; Mucosta; Sodium Bicarbonate; Potassium; Lidomex



Possible Sandimmune side effects in 82 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-16

Patient: 82 year old male

Reactions: Pneumonia, General Physical Health Deterioration, Cytomegalovirus Infection, Aspergillosis, Cholecystitis

Drug(s) suspected as cause:
Sandimmune
    Dosage: 20 to 100mg,daily
    Indication: Immunosuppressant Drug Therapy
    Start date: 2011-11-11
    End date: 2011-12-16

Sandimmune
    Indication: Acquired Haemophilia

Other drugs received by patient: Factor Viii, Recombinant



Possible Sandimmune side effects in 82 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-16

Patient: 82 year old male

Reactions: Pneumonia, General Physical Health Deterioration, Aspergillosis, Cytomegalovirus Infection, Cholecystitis

Drug(s) suspected as cause:
Sandimmune
    Dosage: 20 to 100mg,daily
    Indication: Immunosuppressant Drug Therapy
    Start date: 2011-11-11
    End date: 2011-12-16

Sandimmune
    Indication: Acquired Haemophilia

Other drugs received by patient: Factor Viii, Recombinant



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 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 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 male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-01

Patient: male

Reactions: Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bredinin
    Dosage: unk
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-01-01

Bredinin
    Dosage: unk
    Administration route: Oral
    End date: 2012-01-01

Imuran
    Dosage: unk
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-01-01

Imuran
    Dosage: unk
    Administration route: Oral
    End date: 2012-01-01

Rapaflo
    Dosage: 4 mg, daily
    Administration route: Oral
    Indication: Dysuria
    Start date: 2012-05-01

Sandimmune
    Dosage: unk
    Indication: Renal Transplant
    Start date: 2012-01-01

Sandimmune
    Dosage: unk
    End date: 2012-01-01

Other drugs received by patient: Eviprostat



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 female

Reported by a consumer/non-health professional from Mexico on 2012-07-25

Patient: female

Reactions: Scleral Oedema, Scleral Hyperaemia

Drug(s) suspected as cause:
Sandimmune

Other drugs received by patient: Enalapril Maleate; Prednisone



Possible Sandimmune side effects in 13 year old female

Reported by a physician from Germany on 2012-07-24

Patient: 13 year old female

Reactions: Blood Triglycerides Increased, Grand MAL Convulsion, Malignant Hypertension, Psychotic Disorder, Visual Impairment, Proteinuria, Posterior Reversible Encephalopathy Syndrome, Antithrombin III Increased, Immunosuppressant Drug Level Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sandimmune
    Dosage: 5 mg/kg, per day
    Administration route: Oral
    Indication: Glomerulonephritis Membranoproliferative
    End date: 2012-07-01

Sandimmune
    Dosage: 3 mg/kg, per day
    Administration route: Oral
    End date: 2012-07-06

Other drugs received by patient: Cellcept; Immune Globulin NOS; Prednisone



Possible Sandimmune side effects in male

Reported by a consumer/non-health professional from Mexico on 2012-07-23

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Sandimmune



Possible Sandimmune side effects in male

Reported by a consumer/non-health professional from Japan on 2012-07-19

Patient: male

Reactions: Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bredinin
    Dosage: unk
    Administration route: Oral
    Indication: Renal Transplant

Imuran
    Dosage: unk
    Administration route: Oral
    Indication: Renal Transplant

Rapaflo
    Dosage: 4 mg, daily
    Administration route: Oral
    Indication: Dysuria
    Start date: 2012-05-01

Sandimmune
    Dosage: unk
    Indication: Renal Transplant

Other drugs received by patient: Eviprostat



Possible Sandimmune side effects in male

Reported by a lawyer from Germany on 2012-07-18

Patient: male

Reactions: Multi-Organ Failure, Skin Discolouration, Skin Ulcer, Oedema Peripheral, Oedema, Testicular Swelling, Rash Generalised, Drug Intolerance, General Physical Health Deterioration, Chronic Graft Versus Host Disease, Rash, Penile Swelling, Nasal Mucosal Disorder, Oral Disorder, Skin Erosion, Blood Disorder, Gait Disturbance, Multi-Organ Disorder

Adverse event resulted in: death

Drug(s) suspected as cause:
Sandimmune
    Dosage: 25 mg/day
    Administration route: Oral
    Indication: Bone Marrow Transplant
    Start date: 2010-03-01

Simulect
    Dosage: 20 mg, unk
    Start date: 2010-11-19

Simulect
    Dosage: 20 mg, unk
    Start date: 2010-11-11

Simulect
    Dosage: 20 mg, unk
    Start date: 2010-11-04

Simulect
    Dosage: once every week, total for 4 times
    Indication: Bone Marrow Transplant
    Start date: 2010-10-15
    End date: 2010-11-19

Other drugs received by patient: Corticosteroids; Corticosteroids; Cellcept



Possible Sandimmune side effects in male

Reported by a physician from Japan on 2012-07-17

Patient: male

Reactions: Neutrophil Count Decreased

Drug(s) suspected as cause:
Cellcept
    Dosage: 500 mg
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2010-07-01

Cellcept
    Dosage: 2000 mg
    Administration route: Oral
    Start date: 2010-07-28

Cellcept
    Dosage: 1500 mg
    Administration route: Oral
    Start date: 2010-08-12

Neoral
    Dosage: 450 mg
    Administration route: Oral
    Start date: 2010-08-05

Neoral
    Dosage: 120 mg, daily dose
    Administration route: Oral
    Start date: 2011-04-19
    End date: 2011-08-30

Neoral
    Dosage: 400 mg
    Administration route: Oral
    Start date: 2010-08-10

Neoral
    Dosage: 500 mg
    Administration route: Oral
    Start date: 2010-08-01

Neoral
    Dosage: 150 mg, daily dose
    Administration route: Oral
    Start date: 2011-03-02

Neoral
    Dosage: 500 mg
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2010-07-16
    End date: 2010-07-27

Sandimmune
    Dosage: 100 mg
    Start date: 2010-07-28
    End date: 2010-08-01

Valganciclovir
    Dosage: 450 mg
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2010-08-27
    End date: 2010-09-06

Other drugs received by patient: Methylprednisolone Sodium Succinate; Methylprednisolone Sodium Succinate; Pravastatin; Itraconazole; Simulect; Rituxan; Medrol; Medrol; Methylprednisolone Sodium Succinate; Methylprednisolone Sodium Succinate; Methylprednisolone Sodium Succinate; Medrol; Medrol; Simvastatin; Medrol; Lansoprazole; Sulfamethoxazole and Trimethoprim; Medrol; Medrol; Methylprednisolone Sodium Succinate; Urinorm; Amlodipine



Possible Sandimmune side effects in 61 year old male

Reported by a consumer/non-health professional from United States on 2012-07-14

Patient: 61 year old male

Reactions: Bladder Cancer

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Enbrel
    Indication: Arthritis

Enbrel
    Dosage: 50 mg, qw
    Indication: Psoriasis
    Start date: 2010-03-01
    End date: 2012-04-01

Methotrexate
    Dosage: 15 mg, qw
    Administration route: Oral
    Indication: Psoriasis
    Start date: 2005-06-01
    End date: 2005-12-01

Methotrexate
    Indication: Arthritis

Sandimmune
    Indication: Arthritis

Sandimmune
    Dosage: 300 mg, per day
    Administration route: Oral
    Indication: Psoriasis
    Start date: 2008-01-01
    End date: 2008-06-01



Possible Sandimmune side effects in 51 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-06

Patient: 51 year old female

Reactions: RED Blood Cell Abnormality, Blood Lactate Dehydrogenase Increased, Platelet Count Increased, Anxiety, Renal Impairment, Platelet Count Decreased, Renal Tubular Necrosis, Haemolytic Uraemic Syndrome, Haemolytic Anaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Neoral
    Dosage: 400 mg, daily
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2010-06-08
    End date: 2010-06-09

Sandimmune
    Dosage: 200 mg, daily
    Start date: 2010-06-11
    End date: 2010-06-11

Sandimmune
    Dosage: 175 mg, daily
    Indication: Renal Transplant
    End date: 2010-06-11

Other drugs received by patient: Cefaclor; Adalat; Atarax; Pancreaze; Gamofa; Prednisolone Sodium Succinate INJ; Prograf; Tacrolimus; Amlodipine; Sucralfate; Alosenn; Gamofa; Prednisolone Sodium Succinate INJ; Prednisolone Sodium Succinate INJ; Prograf; Prograf; Allegra; Doxazosin Mesylate; Cefazolin Sodium; Nicardipine HCL; Simulect; Simulect; Doxazosin Mesylate; Aspirin; Sodium Picosulfate; Rabeprazole Sodium; Prednisolone Sodium Succinate INJ; Prednisolone Sodium Succinate INJ; Lasix; Spanidin; Venilon; Cellcept; Nafamostat; Medrol; Carvedilol; Alosenn; Buscopan



Possible Sandimmune side effects in 60 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-29

Patient: 60 year old female

Reactions: Drug Level Decreased

Drug(s) suspected as cause:
Argatroban
    Dosage: 50 mg, daily
    Indication: Heparin-Induced Thrombocytopenia
    Start date: 2012-06-01
    End date: 2012-06-03

Sandimmune
    Dosage: 100 mg, 1x/day
    Administration route: Oral
    Start date: 2012-06-03
    End date: 2012-06-03

Sandimmune
    Dosage: 200 mg, 1x/day
    Administration route: Oral
    Start date: 2012-06-05
    End date: 2012-06-05

Sandimmune
    Dosage: 75 mg, 1x/day
    Administration route: Oral
    Indication: Heart Transplant
    Start date: 2012-05-12
    End date: 2012-06-02

Sandimmune
    Dosage: 150 mg, 1x/day
    Administration route: Oral
    Start date: 2012-06-04
    End date: 2012-06-04



Possible Sandimmune side effects in female

Reported by a physician from France on 2012-06-26

Patient: female

Reactions: Overdose, Immunosuppressant Drug Level Decreased, Drug Interaction

Drug(s) suspected as cause:
Sandimmune

Other drugs received by patient possibly interacting with the suspect drug:
Argatroban
    Dosage: 50 mg, qd
    Start date: 2012-06-01
    End date: 2012-06-03

Sandimmune
    Dosage: 200 mg, qd
    Start date: 2012-06-05

Sandimmune
    Dosage: 150 mg, qd
    Start date: 2012-06-04
    End date: 2012-06-05

Sandimmune
    Dosage: 100 mg, qd
    Start date: 2012-06-03
    End date: 2012-06-04

Sandimmune
    Dosage: 50 mg, qd

Other drugs received by patient: Heparin



Possible Sandimmune side effects in 49 year old male

Reported by a physician from Germany on 2012-06-25

Patient: 49 year old male, weighing 90.0 kg (198.0 pounds)

Reactions: Pancreatic Abscess, Tachyarrhythmia, Urinary Retention Postoperative, Cystitis Klebsiella, Pancreas Transplant Rejection

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Mycophenolic Acid
    Dosage: 720 mg, bid
    Administration route: Oral
    Indication: Pancreas Transplant
    Start date: 2011-11-15
    End date: 2011-12-18

Sandimmune
    Dosage: 100 mg, bid
    Administration route: Oral
    Start date: 2011-12-19

Other drugs received by patient: Prograf; Anti-Thymocyte Globulin NOS; Prednisolone; Prograf



Possible Sandimmune side effects in male

Reported by a consumer/non-health professional from France on 2012-06-25

Patient: male

Reactions: Urticaria, Hypertension, Decreased Appetite, Renal Failure Acute

Drug(s) suspected as cause:
Atgam
    Dosage: 2 g, daily
    Indication: Bone Marrow Failure
    Start date: 2011-12-28
    End date: 2011-12-31

Neoral
    Indication: Bone Marrow Failure
    End date: 2011-12-28

Sandimmune
    Dosage: 2 df
    Start date: 2011-12-28

Other drugs received by patient: Polaramine; Acetaminophen; Valacyclovir Hydrochloride; Solu-Medrol; Bactrim



Possible Sandimmune side effects in 49 year old male

Reported by a physician from Germany on 2012-06-21

Patient: 49 year old male, weighing 90.0 kg (198.0 pounds)

Reactions: Pancreatic Abscess, Tachyarrhythmia, Urinary Tract Infection, Urinary Retention, Pancreas Transplant Rejection

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Mycophenolic Acid
    Dosage: 720 mg, bid
    Administration route: Oral
    Indication: Pancreas Transplant
    Start date: 2011-11-15
    End date: 2011-12-18

Sandimmune
    Dosage: 100 mg, bid
    Administration route: Oral
    Start date: 2011-12-19

Other drugs received by patient: Prograf; Prograf; Anti-Thymocyte Globulin NOS; Prednisolone



Possible Sandimmune side effects in 18 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-06-21

Patient: 18 year old female

Reactions: Pruritus, Post Transplant Distal Limb Syndrome, Pain in Extremity

Drug(s) suspected as cause:
Sandimmune

Other drugs received by patient: Methotrexate



Possible Sandimmune side effects in 48 year old male

Reported by a physician from Germany on 2012-06-20

Patient: 48 year old male, weighing 93.5 kg (205.7 pounds)

Reactions: Graft Haemorrhage, Complications of Transplanted Kidney, Staphylococcal Sepsis, Renal Aneurysm

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mycophenolic Acid
    Dosage: 1440 mg, unk
    Administration route: Oral
    Indication: Prophylaxis Against Transplant Rejection
    Start date: 2011-01-02

Prednisone TAB
    Dosage: 85 mg, unk
    Administration route: Oral
    Indication: Prophylaxis Against Transplant Rejection
    Start date: 2011-01-02

Sandimmune
    Dosage: 550 mg, unk
    Administration route: Oral
    Indication: Prophylaxis Against Transplant Rejection
    Start date: 2011-01-02

Other drugs received by patient: Moxonidine; Aranesp; Valcyte; Furosemide; Metoprolol Tartrate; Fosamax; Clonidine; Felodipine; Pantoprazole; Folsan

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