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Orthoclone Okt3 (Muromonab-CD3) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Orthoclone Okt3 (Muromonab-CD3) 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 (10)
Death (1)

Reports by Reaction Type

Abdominal Pain (2)Kidney Transplant Rejection (2)Constipation (2)Abdominal Tenderness (2)Abdominal Discomfort (2)Peritonitis Bacterial (2)Epstein-Barr Virus Associated Lymphoproliferative Disorder (2)Gastrointestinal Sounds Abnormal (2)Renal Graft Loss (2)Staphylococcal Skin Infection (2)Vomiting (2)Nausea (2)

Possible Orthoclone Okt3 side effects in female

Reported by a health professional (non-physician/pharmacist) from Portugal on 2012-05-04

Patient: female

Reactions: Abdominal Pain, Kidney Transplant Rejection, Constipation, Pallor, Abdominal Tenderness, Abdominal Discomfort, Peritonitis Bacterial, Renal Graft Loss, Gastrointestinal Sounds Abnormal, Decreased Appetite, Staphylococcal Skin Infection, Vomiting, Nausea, Cytolytic Hepatitis, Sclerosing Encapsulating Peritonitis, Appendicitis, Appendix Disorder, Renal Impairment, Staphylococcal Infection, Intestinal Dilatation, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclosporine
    Indication: Immunosuppressant Drug Therapy

Methylprednisolone Sandoz
    Indication: Immunosuppressant Drug Therapy

Anti-Thymocyte Globulin Equine NOS
    Indication: Immunosuppressant Drug Therapy

Orthoclone Okt3
    Indication: Immunosuppressant Drug Therapy

Other drugs received by patient: Steroids NOS; Mycophenolate Mofetil; Physiosol IN Plastic Container; Extraneal



Possible Orthoclone Okt3 side effects in female

Reported by a health professional (non-physician/pharmacist) from Portugal on 2012-05-04

Patient: female

Reactions: Abdominal Pain, Kidney Transplant Rejection, Constipation, Pallor, Abdominal Tenderness, Abdominal Discomfort, Peritonitis Bacterial, Gastrointestinal Sounds Abnormal, Renal Graft Loss, Decreased Appetite, Staphylococcal Skin Infection, Vomiting, Nausea, Cytolytic Hepatitis, Sclerosing Encapsulating Peritonitis, Appendicitis, Appendix Disorder, Renal Impairment, Staphylococcal Infection, Intestinal Dilatation, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Anti-Thymocyte Globulin Equine NOS
    Indication: Immunosuppressant Drug Therapy

Methylprednisolone
    Indication: Immunosuppressant Drug Therapy

Orthoclone Okt3
    Indication: Immunosuppressant Drug Therapy

Cyclosporine
    Indication: Immunosuppressant Drug Therapy

Other drugs received by patient: Extraneal; Mycophenolate Mofetil; Steroids NOS; Physiosol IN Plastic Container



Possible Orthoclone Okt3 side effects in 22 year old female

Reported by a physician from United States on 2012-03-13

Patient: 22 year old female

Reactions: Immune Reconstitution Syndrome, Meningitis Cryptococcal

Drug(s) suspected as cause:
Fluconazole
    Dosage: 200 mg, daily
    Indication: Meningitis Cryptococcal

Tacrolimus
    Indication: Immunosuppression

Orthoclone Okt3

Amphotericin B

Mycophenolate Mefetil
    Indication: Immunosuppression

Prednisone TAB
    Indication: Immunosuppression

Flucytosine



Possible Orthoclone Okt3 side effects in

Reported by a physician from United States on 2012-03-08

Patient:

Reactions: Blood Creatinine Increased

Drug(s) suspected as cause:
Anti-Thymocyte Globulin NOS
    Indication: Prophylaxis Against Transplant Rejection

Orthoclone Okt3
    Indication: Prophylaxis Against Transplant Rejection



Possible Orthoclone Okt3 side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-08

Patient:

Reactions: Myalgia, Cellulitis, Hyperglycaemia, Bone Marrow Failure, Pyrexia, Headache, Rash, Hypertension

Drug(s) suspected as cause:
Anti-Thymocyte Globulin NOS
    Dosage: over 4-6 hours
    Indication: Transplant

Orthoclone Okt3
    Indication: Transplant



Possible Orthoclone Okt3 side effects in

Reported by a physician from United States on 2012-03-08

Patient:

Reactions: Thrombophlebitis

Drug(s) suspected as cause:
Anti-Thymocyte Globulin NOS
    Indication: Prophylaxis Against Transplant Rejection

Orthoclone Okt3
    Indication: Prophylaxis Against Transplant Rejection



Possible Orthoclone Okt3 side effects in 55 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-01

Patient: 55 year old female

Reactions: Pleural Neoplasm, Fatigue, Pleural Effusion, Vascular Pseudoaneurysm, Protein Total Increased, Epstein-Barr Virus Associated Lymphoproliferative Disorder, Omentum Neoplasm, Haemobilia, Renal Neoplasm, Cytomegalovirus Hepatitis, Pneumonia, Dyspnoea, Plasmacytoma, Pancytopenia, Ascites, Globulins Increased, Asthenia, Herpes Virus Infection

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Prednisone TAB
    Dosage: unk
    Indication: Immunosuppression
    Start date: 1987-08-01
    End date: 1987-09-01

Methylpednisolone Sodium Succinate
    Dosage: unknown dosage, taken for one month
    Indication: Immunosuppression
    Start date: 1987-07-01
    End date: 1987-08-01

Prednisone TAB
    Dosage: 10 mg, daily
    Administration route: Oral
    Start date: 1987-09-01
    End date: 1988-02-01

Orthoclone Okt3
    Dosage: unk
    Indication: Immunosuppression

Prednisone TAB
    Dosage: 100 mg, x4 days
    Start date: 1988-02-01
    End date: 1988-02-01

Prednisone TAB
    Dosage: 20 mg, daily
    Start date: 1988-02-01
    End date: 1989-01-01

Cyclosporine
    Indication: Immunosuppression



Possible Orthoclone Okt3 side effects in 31 year old male

Reported by a physician from Brazil on 2011-11-18

Patient: 31 year old male

Reactions: Chronic Myeloid Leukaemia

Drug(s) suspected as cause:
Prednisone TAB
    Dosage: 0.25 mg/kg, daily

Cyclosporine
    Dosage: 4 mg/kg, daily
    Indication: Immunosuppression

Methylprednisolone
    Dosage: unk
    Indication: Immunosuppression

Azathioprine
    Dosage: 2 mg/kg, daily
    Indication: Immunosuppression

Prednisone TAB
    Dosage: 0.6 mg/kg, daily
    Indication: Immunosuppression

Orthoclone Okt3
    Dosage: unknown
    Indication: Immunosuppression



Possible Orthoclone Okt3 side effects in 31 year old male

Reported by a health professional (non-physician/pharmacist) from Brazil on 2011-11-08

Patient: 31 year old male

Reactions: Chronic Myeloid Leukaemia

Drug(s) suspected as cause:
Azathioprine
    Dosage: unknown
    Indication: Immunosuppression

Cyclosporine
    Dosage: unknown
    Indication: Immunosuppression

Orthoclone Okt3
    Dosage: unknown
    Indication: Immunosuppression

Prednisone
    Dosage: unknown
    Indication: Immunosuppression



Possible Orthoclone Okt3 side effects in 46 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-10-31

Patient: 46 year old female

Reactions: Anaemia, Epstein-Barr Virus Associated Lymphoproliferative Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tacrolimus
    Dosage: 4 to 6 ng/ml
    Indication: Renal and Pancreas Transplant Rejection

Orthoclone Okt3
    Indication: Renal and Pancreas Transplant Rejection

Mycophenolate Mofetil
    Administration route: Oral
    Indication: Renal and Pancreas Transplant Rejection

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