Index of reports
> Cases with Complications of Transplanted Kidney (9)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Simulect (Basiliximab) where reactions include complications of transplanted kidney. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Simulect side effects in male
Reported by a physician from Peru on 2012-08-16
Patient: male
Reactions: Complications of Transplanted Kidney, Hypotension, Haematuria, Renal Vein Thrombosis, Kidney Transplant Rejection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Simulect
Other drugs received by patient: Mycophenolic Acid; Antihypertensive Drugs; Corticosteroids
Possible Simulect side effects in 36 year old male
Reported by a physician from India on 2012-07-26
Patient: 36 year old male
Reactions: Complications of Transplanted Kidney, Blood Lactate Dehydrogenase Increased, Kidney Transplant Rejection, Blood Creatinine Increased, Thrombocytopenia
Drug(s) suspected as cause:
Neoral
Simulect
Dosage: 20 mg, unk
Indication: Renal Transplant
Possible Simulect side effects in male
Reported by a physician from Peru on 2012-07-17
Patient: male
Reactions: Complications of Transplanted Kidney, Hypotension, Haematuria, Renal Vein Thrombosis, Kidney Transplant Rejection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Simulect
Possible Simulect side effects in 36 year old male
Reported by a consumer/non-health professional from India on 2012-07-11
Patient: 36 year old male
Reactions: Complications of Transplanted Kidney, Blood Lactate Dehydrogenase Increased, Kidney Transplant Rejection, Thrombocytopenia, Blood Creatinine Increased
Drug(s) suspected as cause:
Simulect
Dosage: 20 mg, unk
Indication: Renal Transplant
Neoral
Possible Simulect side effects in female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-05-22
Patient: female
Reactions: Complications of Transplanted Kidney, Renal and Pancreas Transplant Rejection, Pancreatic Leak, Kidney Fibrosis, Cytomegalovirus Infection, Urinary Anastomotic Leak, Renal Atrophy
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Simulect
Other drugs received by patient: Cellcept; Tacrolimus; Prograf; Prednisolone
Possible Simulect side effects in female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-04-23
Patient: female
Reactions: Complications of Transplanted Kidney, Renal and Pancreas Transplant Rejection, Pancreatic Leak, Kidney Fibrosis, Cytomegalovirus Infection, Urinary Anastomotic Leak, Renal Atrophy
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Simulect
Other drugs received by patient: Prednisolone; Tacrolimus; Mycophenolate Mofetil (Cellcept)
Possible Simulect side effects in female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-04-09
Patient: female
Reactions: Complications of Transplanted Kidney, Pancreatic Leak, Urinary Anastomotic Leak
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Simulect
Other drugs received by patient: Mycophenolate Mofetil (Cellcept); Tacrolimus; Prednisolone
Possible Simulect side effects in 69 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-03-09
Patient: 69 year old female
Reactions: Complications of Transplanted Kidney, Kidney Transplant Rejection, Renal Impairment, Respiratory Failure, Oral Candidiasis, Oral Disorder, Pneumonia Herpes Viral, Dermatitis Bullous, Acute Respiratory Distress Syndrome, Vasculitis, Infection
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Mycophenolate Mofetil (Cellcept)
Dosage: 1 gm daily
Administration route: Oral
Indication: Renal Transplant
Start date: 2008-11-01
Neoral
Dosage: 250 mg, unk
Administration route: Oral
Indication: Renal Transplant
Start date: 2008-11-01
Steroids NOS
Dosage: 15 mg daily
Administration route: Oral
Indication: Renal Transplant
Start date: 2008-11-01
Simulect
Dosage: 20 mg
Indication: Renal Transplant
Start date: 2008-11-01
End date: 2008-11-01
Other drugs received by patient: Adrenal Hormone Preparations
Possible Simulect side effects in female
Reported by a physician from Japan on 2011-10-28
Patient: female, weighing 38.0 kg (83.6 pounds)
Reactions: Blood Pressure Increased, Renal Disorder, Blood Urea Increased, Renal Impairment, Complications of Transplanted Kidney, Toxicity To Various Agents, Blood Creatinine Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prograf
Dosage: 8 mg, unk
Administration route: Oral
Start date: 2009-02-04
Prograf
Dosage: 8 mg, unk
Administration route: Oral
Indication: Renal Transplant
Start date: 2009-01-29
Mycophenolate Mofetil (Cellcept)
Dosage: 1000 mg, unk
Administration route: Oral
Indication: Renal Transplant
Start date: 2009-01-20
Simulect
Dosage: 20 mg, unk
Start date: 2009-02-07
End date: 2009-02-07
Prednisolone
Dosage: 10 mg, unk
Administration route: Oral
Start date: 2009-01-20
End date: 2009-02-02
Prednisolone
Dosage: 10 mg, unk
Administration route: Oral
Start date: 2009-02-04
Simulect
Dosage: 20 mg, unk
Indication: Renal Transplant
Start date: 2009-02-03
End date: 2009-02-03
Mycophenolate Mofetil (Cellcept)
Dosage: 1000 mg, unk
Administration route: Oral
Start date: 2009-02-04
Prograf
Dosage: 2 mg, unk
Start date: 2009-02-04
Other drugs received by patient: Prednisolone
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