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Zenapax (Daclizumab) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Zenapax (Daclizumab) 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 (20)
Death (8)

Reports by Reaction Type

Viith Nerve Paralysis (3)Cytomegalovirus Infection (3)Abdominal Pain (2)Arachnoiditis (2)Infection (2)Skin Toxicity (2)Tachycardia (2)Pyrexia (2)Fatigue (2)Neuropathy Peripheral (2)Adverse Event (2)Hallucination (2)

Possible Zenapax side effects in

Reported by a physician from United States on 2012-07-24

Patient:

Reactions: Bone Marrow Failure, Myelodysplastic Syndrome

Drug(s) suspected as cause:
Zenapax
    Indication: Hodgkin's Disease

Zenapax
    Dosage: initial dose of 10 or 15 mci
    Indication: Prophylaxis Against Transplant Rejection



Possible Zenapax side effects in

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-17

Patient:

Reactions: Viith Nerve Paralysis

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: on day 1 of 21 day cycle cycle
    Indication: Adult T-Cell Lymphoma / Leukaemia

Doxorubicin HCL
    Dosage: on day 1 of 21 day cycle

Doxorubicin HCL
    Dosage: on day 1 of 21 day cycle
    Indication: Adult T-Cell Lymphoma / Leukaemia

Prednisolone
    Dosage: on days 1-5 of 21 day cycle
    Administration route: Oral
    Indication: Adult T-Cell Lymphoma / Leukaemia

Vincristine
    Dosage: (maximum 2 mg) on day 1 of 21 day cycle,
    Indication: Adult T-Cell Lymphoma / Leukaemia

Zenapax
    Dosage: on days 7 and 14 for cycle 1 and only on day 1 for subsequent cycles 2-6 of 21 day cycle
    Indication: Adult T-Cell Lymphoma / Leukaemia

Other drugs received by patient: Cotrim; Thiabendazole; Acyclovir; Itraconazole



Possible Zenapax side effects in

Reported by a physician from United Kingdom on 2012-07-17

Patient:

Reactions: Arachnoiditis

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: on day 1 of 21 day cycle, (cycle 1-5)
    Indication: Adult T-Cell Lymphoma / Leukaemia

Doxorubicin HCL
    Dosage: on day 1 of 21 day, (cycle 1-5)
    Indication: Adult T-Cell Lymphoma / Leukaemia

Doxorubicin HCL
    Dosage: on day 1 of 21 day, (cycle 1-5)

Prednisolone
    Dosage: on days 1-5 of 21 day cycle, (cycle 1-5)
    Administration route: Oral
    Indication: Adult T-Cell Lymphoma / Leukaemia

Vincristine
    Dosage: (maximum 2 mg) on day 1 of 21 day cycle, (cycle 1-5)
    Indication: Adult T-Cell Lymphoma / Leukaemia

Zenapax
    Dosage: on days 7 and 14 on cycle 1 of 21 day cycle
    Indication: Adult T-Cell Lymphoma / Leukaemia

Other drugs received by patient: Cotrim; Acyclovir; Thiabendazole; Itraconazole



Possible Zenapax side effects in

Reported by a physician from United Kingdom on 2012-07-17

Patient:

Reactions: Abdominal Pain, Tachycardia, Skin Toxicity, Pyrexia, Fatigue, Neuropathy Peripheral, Hepatotoxicity, Adverse Event, Dizziness, Oedema, Hallucination, Vomiting, Nausea, Gastrointestinal Toxicity, Neutropenic Sepsis, Nephropathy Toxic, Hypotension, Condition Aggravated, Adult T-Cell Lymphoma / Leukaemia, Mucosal Inflammation, Lung Disorder, Infection, Infusion Related Reaction

Adverse event resulted in: death

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: on day 1 of 21 day cycle, (cycle 1-5)
    Indication: Adult T-Cell Lymphoma / Leukaemia

Cytarabine
    Indication: Adult T-Cell Lymphoma / Leukaemia

Doxorubicin HCL
    Dosage: on day 1 of 21 day, (cycle 1-5)

Doxorubicin HCL
    Dosage: on day 1 of 21 day, (cycle 1-5)
    Indication: Adult T-Cell Lymphoma / Leukaemia

Hydrocortisone
    Indication: Adult T-Cell Lymphoma / Leukaemia

Methotrexate
    Indication: Adult T-Cell Lymphoma / Leukaemia

Prednisolone
    Dosage: on days 1-5 of 21 day cycle, (cycle 1-5)
    Administration route: Oral
    Indication: Adult T-Cell Lymphoma / Leukaemia

Radiotherapy
    Indication: Adult T-Cell Lymphoma / Leukaemia

Vincristine
    Dosage: (maximum 2 mg) on day 1 of 21 day cycle, (cycle 1-5)
    Indication: Adult T-Cell Lymphoma / Leukaemia

Zenapax
    Dosage: on days 7 and 14 on cycle 1 of 21 day cycle
    Indication: Adult T-Cell Lymphoma / Leukaemia

Other drugs received by patient: Acyclovir; Thiabendazole; Cotrim; Itraconazole



Possible Zenapax side effects in

Reported by a physician from United Kingdom on 2012-07-17

Patient:

Reactions: Paraesthesia

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: on day 1 of 21 day cycle, (cycle 1-5)
    Indication: Adult T-Cell Lymphoma / Leukaemia

Doxorubicin HCL
    Dosage: on day 1 of 21 day, (cycle 1-5)

Doxorubicin HCL
    Dosage: on day 1 of 21 day, (cycle 1-5)
    Indication: Adult T-Cell Lymphoma / Leukaemia

Prednisolone
    Dosage: on days 1-5 of 21 day cycle, (cycle 1-5)
    Administration route: Oral
    Indication: Adult T-Cell Lymphoma / Leukaemia

Vincristine
    Dosage: (maximum 2 mg) on day 1 of 21 day cycle, (cycle 1-5)
    Indication: Adult T-Cell Lymphoma / Leukaemia

Zenapax
    Dosage: on days 7 and 14 on cycle 1 of 21 day cycle
    Indication: Adult T-Cell Lymphoma / Leukaemia

Other drugs received by patient: Cotrim; Itraconazole; Acyclovir; Thiabendazole



Possible Zenapax side effects in

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

Patient:

Reactions: Viith Nerve Paralysis

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: on day 1 of 21 day cycle cycle
    Indication: Adult T-Cell Lymphoma / Leukaemia

Doxorubicin HCL
    Dosage: on day 1 of 21 day cycle
    Indication: Adult T-Cell Lymphoma / Leukaemia

Prednisolone
    Dosage: on days 1-5 of 21 day cycle
    Administration route: Oral
    Indication: Adult T-Cell Lymphoma / Leukaemia

Vincristine
    Dosage: (maximum 2 mg) on day 1 of 21 day cycle,
    Indication: Adult T-Cell Lymphoma / Leukaemia

Zenapax
    Dosage: on days 7 and 14 for cycle 1 and only on day 1 for subsequent cycles 2-6 of 21 day cycle
    Indication: Adult T-Cell Lymphoma / Leukaemia

Other drugs received by patient: Cotrim; Itraconazole; Acyclovir; Thiabendazole



Possible Zenapax side effects in

Reported by a physician from United Kingdom on 2012-07-10

Patient:

Reactions: Abdominal Pain, Skin Toxicity, Tachycardia, Pyrexia, Fatigue, Neuropathy Peripheral, Hepatotoxicity, Adverse Event, Oedema, Dizziness, Hallucination, Vomiting, Gastrointestinal Toxicity, Nausea, Neutropenic Sepsis, Nephropathy Toxic, Hypotension, Adult T-Cell Lymphoma / Leukaemia, Condition Aggravated, Mucosal Inflammation, Lung Disorder, Infection, Infusion Related Reaction

Adverse event resulted in: death

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: on day 1 of 21 day cycle, (cycle 1-5)
    Indication: Adult T-Cell Lymphoma / Leukaemia

Cytarabine
    Indication: Adult T-Cell Lymphoma / Leukaemia

Doxorubicin HCL
    Dosage: on day 1 of 21 day, (cycle 1-5)
    Indication: Adult T-Cell Lymphoma / Leukaemia

Hydrocortisone
    Indication: Adult T-Cell Lymphoma / Leukaemia

Methotrexate
    Indication: Adult T-Cell Lymphoma / Leukaemia

Prednisolone
    Dosage: on days 1-5 of 21 day cycle, (cycle 1-5)
    Administration route: Oral
    Indication: Adult T-Cell Lymphoma / Leukaemia

Radiotherapy
    Indication: Adult T-Cell Lymphoma / Leukaemia

Vincristine
    Dosage: (maximum 2 mg) on day 1 of 21 day cycle, (cycle 1-5)
    Indication: Adult T-Cell Lymphoma / Leukaemia

Zenapax
    Dosage: on days 7 and 14 on cycle 1 of 21 day cycle
    Indication: Adult T-Cell Lymphoma / Leukaemia

Other drugs received by patient: Cotrim; Itraconazole; Thiabendazole; Acyclovir



Possible Zenapax side effects in

Reported by a physician from United Kingdom on 2012-07-10

Patient:

Reactions: Paraesthesia

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: on day 1 of 21 day cycle, (cycle 1-5)
    Indication: Adult T-Cell Lymphoma / Leukaemia

Doxorubicin HCL
    Dosage: on day 1 of 21 day, (cycle 1-5)
    Indication: Adult T-Cell Lymphoma / Leukaemia

Prednisolone
    Dosage: on days 1-5 of 21 day cycle, (cycle 1-5)
    Administration route: Oral
    Indication: Adult T-Cell Lymphoma / Leukaemia

Vincristine
    Dosage: (maximum 2 mg) on day 1 of 21 day cycle, (cycle 1-5)
    Indication: Adult T-Cell Lymphoma / Leukaemia

Zenapax
    Dosage: on days 7 and 14 on cycle 1 of 21 day cycle
    Indication: Adult T-Cell Lymphoma / Leukaemia

Other drugs received by patient: Cotrim; Itraconazole; Acyclovir; Thiabendazole



Possible Zenapax side effects in

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-10

Patient:

Reactions: Viith Nerve Paralysis

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: on day 1 of 21 day cycle cycle
    Indication: Adult T-Cell Lymphoma / Leukaemia

Doxorubicin HCL
    Dosage: on day 1 of 21 day cycle
    Indication: Adult T-Cell Lymphoma / Leukaemia

Prednisolone
    Dosage: on days 1-5 of 21 day cycle
    Administration route: Oral
    Indication: Adult T-Cell Lymphoma / Leukaemia

Vincristine
    Dosage: (maximum 2 mg) on day 1 of 21 day cycle,
    Indication: Adult T-Cell Lymphoma / Leukaemia

Zenapax
    Dosage: on days 7 and 14 for cycle 1 and only on day 1 for subsequent cycles 2-6 of 21 day cycle
    Indication: Adult T-Cell Lymphoma / Leukaemia

Other drugs received by patient: Acyclovir; Itraconazole; Thiabendazole; Cotrim



Possible Zenapax side effects in

Reported by a physician from United Kingdom on 2012-07-09

Patient:

Reactions: Arachnoiditis

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: on day 1 of 21 day cycle, (cycle 1-5)
    Indication: Adult T-Cell Lymphoma / Leukaemia

Doxorubicin HCL
    Dosage: on day 1 of 21 day, (cycle 1-5)
    Indication: Adult T-Cell Lymphoma / Leukaemia

Prednisolone
    Dosage: on days 1-5 of 21 day cycle, (cycle 1-5)
    Administration route: Oral
    Indication: Adult T-Cell Lymphoma / Leukaemia

Vincristine
    Dosage: (maximum 2 mg) on day 1 of 21 day cycle, (cycle 1-5)
    Indication: Adult T-Cell Lymphoma / Leukaemia

Zenapax
    Dosage: on days 7 and 14 on cycle 1 of 21 day cycle
    Indication: Adult T-Cell Lymphoma / Leukaemia

Other drugs received by patient: Cotrim; Itraconazole; Acyclovir; Thiabendazole



Possible Zenapax side effects in

Reported by a health professional (non-physician/pharmacist) from China on 2012-06-05

Patient:

Reactions: Pneumonia Bacterial, Fungal Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Basiliximab
    Dosage: on day 0 (2 hours before transplantation) and day +4
    Indication: Prophylaxis Against Graft Versus Host Disease

Cellcept
    Dosage: days +7 to +35
    Administration route: Oral
    Indication: Prophylaxis Against Graft Versus Host Disease

Cyclosporine
    Dosage: on day -1
    Indication: Prophylaxis Against Graft Versus Host Disease

Zenapax
    Dosage: on day 0 (2 hours before transplantation) and day +4
    Indication: Prophylaxis Against Graft Versus Host Disease

Other drugs received by patient: Methotrexate; Methotrexate



Possible Zenapax side effects in

Reported by a individual with unspecified qualification from United States on 2012-01-12

Patient:

Reactions: Palindromic Rheumatism

Drug(s) suspected as cause:
Zenapax



Possible Zenapax side effects in

Reported by a individual with unspecified qualification from Colombia on 2011-12-20

Patient:

Reactions: Acute Pulmonary Oedema, Pulmonary Tuberculosis, Lymphoproliferative Disorder, Nephrotic Syndrome, BK Virus Infection, Sepsis, Cytomegalovirus Infection, Septic Shock

Adverse event resulted in: death

Drug(s) suspected as cause:
Alemtuzumab
    Indication: Prophylaxis Against Transplant Rejection

Anti-Thymocyte Globulin NOS
    Indication: Prophylaxis Against Transplant Rejection

Azathioprine
    Indication: Prophylaxis Against Transplant Rejection

Cyclosporine
    Indication: Prophylaxis Against Transplant Rejection

Methylprednisolone
    Indication: Prophylaxis Against Transplant Rejection

Mycophenolate Mofetil (Cellcept)
    Indication: Prophylaxis Against Transplant Rejection

Tacrolimus
    Indication: Prophylaxis Against Transplant Rejection

Zenapax
    Indication: Prophylaxis Against Transplant Rejection



Possible Zenapax side effects in

Reported by a physician from China on 2011-12-14

Patient:

Reactions: Abdominal Infection, Intra-Abdominal Haemorrhage, Graft Dysfunction, Transplant Rejection, Graft Infection, Pneumonia Cytomegaloviral

Adverse event resulted in: death

Drug(s) suspected as cause:
Mycophenolate Mofetil (Cellcept)
    Indication: Small Intestine Transplant

Zenapax
    Indication: Small Intestine Transplant

Other drugs received by patient: Tacrolimus; Ganciclovir Sodium; Acyclovir; Acyclovir; Ganciclovir Sodium



Possible Zenapax side effects in

Reported by a individual with unspecified qualification from China on 2011-12-06

Patient:

Reactions: Fungal Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Mycophenolate Mofetil (Cellcept)
    Indication: Intestinal Transplant

Zenapax
    Indication: Intestinal Transplant

Other drugs received by patient: Tacrolimus



Possible Zenapax side effects in

Reported by a individual with unspecified qualification from China on 2011-12-01

Patient:

Reactions: Multi-Organ Failure, Lung Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Mycophenolate Mofetil (Cellcept)
    Indication: Liver Transplant

Zenapax
    Indication: Liver Transplant

Other drugs received by patient: Methylprednisolone



Possible Zenapax side effects in

Reported by a physician from China on 2011-11-28

Patient:

Reactions: Sepsis

Adverse event resulted in: death

Drug(s) suspected as cause:
Mycophenolate Mofetil (Cellcept)
    Indication: Liver Transplant

Zenapax
    Indication: Liver Transplant

Other drugs received by patient: Methylprednisolone



Possible Zenapax side effects in

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

Patient:

Reactions: Diabetes Mellitus, Urinary Tract Infection, Bacterial Infection, Cytomegalovirus Infection, Wound Infection

Drug(s) suspected as cause:
Mycophenolate Mofetil (Cellcept)
    Indication: Prophylaxis Against Transplant Rejection

Tacrolimus
    Indication: Renal Transplant

Zenapax
    Indication: Renal Transplant



Possible Zenapax side effects in 46 year old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2011-11-02

Patient: 46 year old female

Reactions: Pneumonia, Graft Dysfunction, Alopecia

Drug(s) suspected as cause:
Anti-Thymocyte Globulin NOS
    Dosage: 6 mg/kg, unk

Enbrel
    Dosage: 26 mg, unk
    Indication: Product Used FOR Unknown Indication

Enbrel
    Dosage: 50 mg, qd

Mycophenolate Mofetil
    Dosage: unk

Prograf
    Dosage: 2 mg, q12h
    Administration route: Oral

Prograf
    Dosage: unk

Rapamune
    Dosage: unk

Zenapax
    Dosage: unk



Possible Zenapax side effects in

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-28

Patient:

Reactions: Diabetes Mellitus, Urinary Tract Infection, Bacterial Infection, Cytomegalovirus Infection, Wound Infection

Drug(s) suspected as cause:
Mycophenolate Mofetil (Cellcept)
    Indication: Prophylaxis Against Transplant Rejection

Tacrolimus
    Indication: Renal Transplant

Zenapax
    Indication: Renal Transplant

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