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: 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 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 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 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 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 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 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 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 2012-06-25
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 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 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 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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