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Nulojix (Belatacept) - Side Effect Reports to FDA

 
 



Index of reports > All Cases (51)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Nulojix (Belatacept) all cases. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 51   Next >>

Possible Nulojix side effects in 67 year old female

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

Patient: 67 year old female, weighing 48.0 kg (105.6 pounds)

Reactions: Pancytopenia, Thrombocytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nulojix
    Dosage: decreased to 250mg-16may12
    Indication: Renal Transplant
    Start date: 2012-03-24

Azathioprine Sodium
    Dosage: interr 19apr12, restart 25apr12
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-03-20
    End date: 2012-04-19

Other drugs received by patient: Atovaquone; Hyperium; Mycophenolate Mofetil (Cellcept); Prednisone TAB; Valganciclovir; Omeprazole; Eupressyl



Possible Nulojix side effects in 64 year old male

Reported by a physician from France on 2012-08-22

Patient: 64 year old male, weighing 74.0 kg (162.8 pounds)

Reactions: Pancytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nulojix
    Indication: Renal Transplant
    Start date: 2012-04-05

Azathioprine Sodium
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-11-17
    End date: 2012-05-29

Other drugs received by patient: Prednisone TAB; Hyperium; Omeprazole; Calcium Carbonate; Amlodipine Besylate



Possible Nulojix side effects in 67 year old female

Reported by a consumer/non-health professional from France on 2012-08-21

Patient: 67 year old female, weighing 48.0 kg (105.6 pounds)

Reactions: Pancytopenia, Thrombocytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nulojix
    Dosage: decreased to 250mg-16may12
    Indication: Renal Transplant
    Start date: 2012-03-24

Azathioprine Sodium
    Dosage: interr 19apr12, restart 25apr12
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-03-20
    End date: 2012-04-19

Other drugs received by patient: Mycophenolate Mofetil (Cellcept); Eupressyl; Omeprazole; Hyperium; Atovaquone; Prednisone TAB; Valganciclovir



Possible Nulojix side effects in

Reported by a physician from United States on 2012-07-19

Patient:

Reactions: Transplant Rejection

Drug(s) suspected as cause:
Nulojix



Possible Nulojix side effects in 25 year old male

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

Patient: 25 year old male

Reactions: Transplant Rejection

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Nulojix



Possible Nulojix side effects in

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

Patient: , weighing 100.0 kg (220.0 pounds)

Reactions: Circumstance or Information Capable of Leading To Medication Error

Drug(s) suspected as cause:
Nulojix



Possible Nulojix side effects in male

Reported by a pharmacist from United States on 2012-07-19

Patient: male

Reactions: Kidney Transplant Rejection

Drug(s) suspected as cause:
Nulojix



Possible Nulojix side effects in female

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

Patient: female

Reactions: Blood Prolactin Increased

Drug(s) suspected as cause:
Nulojix



Possible Nulojix side effects in female

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

Patient: female

Reactions: Rash Papular

Drug(s) suspected as cause:
Nulojix



Possible Nulojix side effects in male

Reported by a consumer/non-health professional from France on 2012-07-16

Patient: male

Reactions: Pancytopenia, Thrombocytopenia

Drug(s) suspected as cause:
Nulojix

Other drugs received by patient: Cellcept



Possible Nulojix side effects in male

Reported by a physician from France on 2012-07-16

Patient: male

Reactions: Pancytopenia

Drug(s) suspected as cause:
Nulojix



Possible Nulojix side effects in male

Reported by a physician from France on 2012-07-13

Patient: male

Reactions: Gastrointestinal Perforation

Adverse event resulted in: death

Drug(s) suspected as cause:
Nulojix



Possible Nulojix side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-13

Patient: male, weighing 79.0 kg (173.8 pounds)

Reactions: Abdominal Pain, Vomiting, Nausea, Pyrexia, Leukocytosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cellcept
    Dosage: 1,000 mg bid po
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-05-25

Nulojix
    Dosage: 841 mg q 4 weeks iv
    Indication: Renal Transplant
    Start date: 2012-06-21

Other drugs received by patient: Alentuzumab; Prednisone; Solu-Medrol



Possible Nulojix side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-03

Patient: male, weighing 75.2 kg (165.4 pounds)

Reactions: Post Procedural Discharge, Hydronephrosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nulojix
    Dosage: 841 mg q 4weeks iv last dose
    Indication: Renal Transplant
    End date: 2012-06-21

Cellcept
    Dosage: 1,000 mg bid po
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-05-25

Other drugs received by patient: Prednisone; Solu-Medrol; Alemtuzumab



Possible Nulojix side effects in 69 year old male

Reported by a consumer/non-health professional from Germany on 2012-06-08

Patient: 69 year old male, weighing 80.0 kg (176.0 pounds)

Reactions: Haemorrhage, Thrombocytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nulojix



Possible Nulojix side effects in 65 year old male

Reported by a pharmacist from United States on 2012-05-16

Patient: 65 year old male, weighing 82.4 kg (181.3 pounds)

Reactions: Cardiac Flutter

Drug(s) suspected as cause:
Nulojix



Possible Nulojix side effects in 49 year old female

Reported by a consumer/non-health professional from United States on 2012-05-07

Patient: 49 year old female, weighing 54.0 kg (118.8 pounds)

Reactions: Venous Thrombosis, Renal Artery Thrombosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mycophenolate Mofetil (Cellcept)
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-03-28

Campath
    Indication: Renal Transplant
    Start date: 2012-03-28
    End date: 2012-03-28

Medrol
    Dosage: inj
    Indication: Renal Transplant
    Start date: 2012-03-28
    End date: 2012-04-01

Nulojix
    Dosage: 10mg/kg,650mg single 28mar12-28mar12 01apr12-01apr12
    Indication: Renal Transplant
    Start date: 2012-03-28
    End date: 2012-04-01

Other drugs received by patient: Lopressor; Aspirin



Possible Nulojix side effects in 63 year old male

Reported by a physician from Germany on 2012-05-03

Patient: 63 year old male

Reactions: Haemorrhage, Thrombocytopenia

Drug(s) suspected as cause:
Nulojix



Possible Nulojix side effects in 35 year old female

Reported by a consumer/non-health professional from United States on 2012-05-01

Patient: 35 year old female

Reactions: Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nulojix

Other drugs received by patient: Mycophenolate Mofetil (Cellcept); Metoprolol Tartrate



Possible Nulojix side effects in

Reported by a consumer/non-health professional from Germany on 2012-04-30

Patient:

Reactions: Haemorrhage, Thrombocytopenia

Drug(s) suspected as cause:
Nulojix



Possible Nulojix side effects in 49 year old female

Reported by a consumer/non-health professional from United States on 2012-04-24

Patient: 49 year old female, weighing 51.0 kg (112.2 pounds)

Reactions: Renal Artery Thrombosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Medrol
    Dosage: inj
    Indication: Renal Transplant
    Start date: 2012-03-28
    End date: 2012-04-01

Mycophenolate Mofetil (Cellcept)
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-03-28

Nulojix
    Dosage: 10mg/kg
    Indication: Renal Transplant
    Start date: 2012-03-28
    End date: 2012-03-28

Campath
    Indication: Renal Transplant
    Start date: 2012-03-28
    End date: 2012-03-28



Possible Nulojix side effects in 49 year old female

Reported by a consumer/non-health professional from United States on 2012-04-19

Patient: 49 year old female, weighing 51.0 kg (112.2 pounds)

Reactions: Renal Artery Thrombosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Campath
    Indication: Renal Transplant
    Start date: 2012-03-28
    End date: 2012-03-28

Nulojix
    Indication: Renal Transplant
    Start date: 2012-03-28

Mycophenolate Mofetil (Cellcept)
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-03-28

Medrol
    Dosage: inj
    Indication: Renal Transplant
    Start date: 2012-03-28
    End date: 2012-03-28



Possible Nulojix side effects in 60 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-13

Patient: 60 year old female, weighing 69.0 kg (151.8 pounds)

Reactions: Disseminated Intravascular Coagulation, Renal Vein Thrombosis, Graft Loss

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Medrol
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-12-27
    End date: 2011-12-27

Nulojix
    Indication: Renal Transplant
    Start date: 2011-12-27
    End date: 2011-12-27

Mycophenolate Mofetil (Cellcept)
    Dosage: reg 2, 1gm bid, 29dec-29dec11.
    Indication: Renal Transplant
    Start date: 2011-12-27
    End date: 2011-12-29

Campath
    Indication: Renal Transplant
    Start date: 2011-12-27
    End date: 2011-12-27

Other drugs received by patient: Lasix



Possible Nulojix side effects in

Reported by a pharmacist from United States on 2012-04-12

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Nulojix



Possible Nulojix side effects in 31 year old male

Reported by a consumer/non-health professional from United States on 2012-04-06

Patient: 31 year old male

Reactions: Blood Creatinine Increased

Drug(s) suspected as cause:
Nulojix



Possible Nulojix side effects in

Reported by a consumer/non-health professional from United States on 2012-04-06

Patient:

Reactions: Extravasation

Drug(s) suspected as cause:
Nulojix



Possible Nulojix side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-06

Patient: male

Reactions: Transplant Rejection

Drug(s) suspected as cause:
Nulojix



Possible Nulojix side effects in

Reported by a consumer/non-health professional from United States on 2012-04-06

Patient:

Reactions: Transplant Rejection

Drug(s) suspected as cause:
Nulojix



Possible Nulojix side effects in male

Reported by a physician from United States on 2012-04-06

Patient: male

Reactions: Kidney Transplant Rejection

Drug(s) suspected as cause:
Nulojix



Possible Nulojix side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-06

Patient: male

Reactions: BK Virus Infection

Drug(s) suspected as cause:
Nulojix



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