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 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 2012-07-17
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 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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