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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