This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Nulojix (Belatacept) 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 (51)
Death (6)
Life Threatening Events (5)
Reports by Reaction Type
Thrombocytopenia (6),
Pancytopenia (5),
Transplant Rejection (5),
Cardiac Failure Congestive (4),
Haemorrhage (3),
Renal Artery Thrombosis (3),
Death (3),
Disseminated Intravascular Coagulation (2),
Kidney Transplant Rejection (2),
Haemolytic Uraemic Syndrome (2),
Blood Creatinine Increased (2),
Graft Loss (2)
Below are a few examples of reports where side effects / adverse reactions may be related to Nulojix (Belatacept). For a complete list or a specific selection of reports, please use the links above.
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
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
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
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