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Review Zenapax Safety Reports submitted to FDA

Total Zenapax reports: 27.
Zenapax FDA safety alerts: 2003 .
Reported deaths: 6    Reported hospitalizations: 17.
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FDA Reported Zenapax Side Effects: pyrexia, acute respiratory distress syndrome, interstitial lung disease, hepatic enzyme increased, cardio-respiratory arrest, cytomegalovirus infection, renal failure acute, meningitis aseptic, meningitis, dehydration, human herpesvirus 8 infection.
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Zenapax Side Effects Report #5534274-0
Health Professional from UNITED STATES reported ZENAPAX problem on Nov 26, 2007. Male patient, 53 years of age, was treated with ZENAPAX. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, convulsion. ZENAPAX dosage: unknown. During the same period patient was treated with ACYCLOVIR, ASPIRIN, CLONIDINE, DOCUSATE, FAMOTIDINE, HEPARIN, KEPPRA, CELLCEPT. Patient was hospitalized. Patient recovered.

Zenapax Side Effects Report #5483737-5
ZENAPAX problem was reported by a Physician from UNITED STATES on Oct 09, 2007. Male patient, weighting 183.0 lb, was diagnosed with human t-cell lymphotropic virus infection and was treated with ZENAPAX. After drug was administered, patient experienced the following problems/side effects: condition aggravated, conjunctival hyperaemia, conjunctival oedema, dysphagia, no therapeutic response, perivascular dermatitis, photosensitivity reaction, rash, rash macular. ZENAPAX dosage: 708MG (8MG/KG) EVERY 3 WEEKS IV. During the same period patient was treated with LORTADINE, BENADRYL, PEPCID, MEDROL, KETOCONAZOLE, KERI LOTION, AVEENO OATMEAL BATH. Patient recovered.

Zenapax Side Effects Report #5499713-2
Consumer or non-health professional from INDIA reported ZENAPAX problem on Oct 18, 2007. Female patient, child 11 years of age, weighting 66.14 lb, was diagnosed with prophylaxis against transplant rejection and was treated with ZENAPAX. After drug was administered, patient experienced the following problems/side effects: anaemia, renal tubular necrosis, thrombocytopenia. ZENAPAX dosage: unknown. During the same period patient was treated with STEROID NOS, MYCOPHENOLATE MOFETIL. Patient was hospitalized. Patient recovered.

Zenapax Side Effects Report #5729133-4
ZENAPAX problem was reported by a Physician from FRANCE on Apr 30, 2008. Male patient, weighting 94.80 lb, was diagnosed with prophylaxis against transplant rejection and was treated with ZENAPAX. After drug was administered, patient experienced the following problems/side effects: acute pulmonary oedema, acute respiratory distress syndrome, toxoplasmosis. ZENAPAX dosage: unknown. During the same period patient was treated with CELLCEPT, SANDIMMUNE, LOXEN, PLITICAN, VANCOCIN. Patient died on 01/30/2008.


Zenapax Side Effects Report #5735018-X
Physician from FRANCE reported ZENAPAX problem on May 06, 2008. Male patient, weighting 94.80 lb, was diagnosed with graft versus host disease, bone marrow transplant and was treated with ZENAPAX. After drug was administered, patient experienced the following problems/side effects: acute pulmonary oedema, acute respiratory distress syndrome, toxoplasmosis. ZENAPAX dosage: unknown. During the same period patient was treated with CELLCEPT, SANDIMMUNE, LOXEN, PLITICAN, VANCOCIN. Patient died on 01/30/2008.

Zenapax Side Effects Report #5739228-7
ZENAPAX problem was reported by a Physician from FRANCE on Apr 30, 2008. Male patient, weighting 94.80 lb, was diagnosed with graft versus host disease, bone marrow transplant and was treated with ZENAPAX. After drug was administered, patient experienced the following problems/side effects: acute pulmonary oedema, acute respiratory distress syndrome, toxoplasmosis. ZENAPAX dosage: unknown. During the same period patient was treated with CELLCEPT, SANDIMMUNE, LOXEN, PLITICAN, VANCOCIN. Patient died on 01/30/2008.

Zenapax Side Effects Report #5746212-6
Physician from FRANCE reported ZENAPAX problem on May 16, 2008. Male patient, weighting 94.80 lb, was diagnosed with graft versus host disease, prophylaxis against transplant rejection and was treated with ZENAPAX. After drug was administered, patient experienced the following problems/side effects: acute pulmonary oedema, acute respiratory distress syndrome, toxoplasmosis. ZENAPAX dosage: unknown. During the same period patient was treated with CELLCEPT, SANDIMMUNE, LOXEN, PLITICAN, VANCOCIN, FORTUM, CANCIDAS. Patient died on 01/30/2008.

Zenapax Side Effects Report #5699668-1
ZENAPAX problem was reported by a Consumer or non-health professional from FRANCE on Apr 04, 2008. Male patient, child 11 years of age, weighting 94.80 lb, was diagnosed with bone marrow transplant and was treated with ZENAPAX. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, cough, dyspnoea, graft versus host disease, multi-organ failure, pulmonary oedema, toxoplasmosis. ZENAPAX dosage: unknown. During the same period patient was treated with CELLCEPT, LOXEN, PLITICAN, VANCOMYCIN, FORTUM, CANCIDAS, ZOVIRAX. Patient died on 01/30/2008.

Zenapax Side Effects Report #5284619-4
Physician from FRANCE reported ZENAPAX problem on Mar 23, 2007. Male patient, 34 years of age, was diagnosed with prophylaxis and was treated with ZENAPAX. After drug was administered, patient experienced the following problems/side effects: septic shock. ZENAPAX dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL, TACROLIMUS, METHYLPREDNISOLONE, PREDNISONE, PIPERILLINE. Patient was hospitalized. Patient recovered.


Zenapax Side Effects Report #5286829-9
ZENAPAX problem was reported by a Physician from SWEDEN on Mar 29, 2007. Male patient, 59 years of age, was treated with ZENAPAX. After drug was administered, patient experienced the following problems/side effects: abdominal distension, abdominal pain, atelectasis, cardiovascular disorder, gastrointestinal haemorrhage, haemoglobin decreased, hepatic haematoma, hypopnoea, platelet count decreased. ZENAPAX dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL, TACROLIMUS, METHYLPREDNISOLONE. Patient recovered.

Zenapax Side Effects Report #5286830-5
Physician from FRANCE reported ZENAPAX problem on Mar 23, 2007. Male patient, 60 years of age, was treated with ZENAPAX. After drug was administered, patient experienced the following problems/side effects: chest pain, cytomegalovirus infection, dyspnoea, fatigue. ZENAPAX dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL, METHYLPREDNISOLONE. Patient was hospitalized. Patient recovered.

Zenapax Side Effects Report #5288260-9
ZENAPAX problem was reported by a Physician from CANADA on Mar 29, 2007. Male patient, 53 years of age, weighting 162.7 lb, was treated with ZENAPAX. After drug was administered, patient experienced the following problems/side effects: anastomotic complication, gastroenteritis viral, haematoma, renal failure acute, urinary tract infection. ZENAPAX dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL, CYCLOSPORINE. Patient was hospitalized. Patient recovered.

Zenapax Side Effects Report #5288688-7
Consumer or non-health professional from UNITED STATES reported ZENAPAX problem on Mar 27, 2007. Female patient, 38 years of age, weighting 138.9 lb, was diagnosed with multiple sclerosis and was treated with ZENAPAX. After drug was administered, patient experienced the following problems/side effects: breast cancer. ZENAPAX dosage: unknown. During the same period patient was treated with AMBIEN, IBUPROFEN, REBIF, QUININE, GABAPENTIN, ZANAFLEX, INTERFERON BETA. Patient recovered.

Zenapax Side Effects Report #5300916-8
ZENAPAX problem was reported by a Physician from INDIA on Apr 09, 2007. Male patient, 50 years of age, was diagnosed with tuberculosis and was treated with ZENAPAX. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock. ZENAPAX dosage: unknown. During the same period patient was treated with RIFAMPICIN, ISONIAZID, ETHAMBUTOL HYDROCHLORIDE. Patient recovered.


Zenapax Side Effects Report #5303198-6
Physician from INDIA reported ZENAPAX problem on Apr 12, 2007. Male patient, 50 years of age, was diagnosed with tuberculosis, renal transplant and was treated with ZENAPAX. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock. ZENAPAX dosage: unknown. During the same period patient was treated with RIFAMPICIN, ISONIAZID, ETHAMBUTOL HYDROCHLORIDE, PREDNISOLONE, MYCOPHENOLATE MOFETIL, CYCLOSPORINE. Patient was hospitalized. Patient recovered.

Zenapax Side Effects Report #5253311-4
ZENAPAX problem was reported by a Physician from BELGIUM on Feb 21, 2007. Male patient, 61 years of age, was treated with ZENAPAX. After drug was administered, patient experienced the following problems/side effects: intervertebral discitis, osteopenia. ZENAPAX dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL. Patient was hospitalized. Patient recovered.

Zenapax Side Effects Report #5254156-1
Pharmacist from UNITED KINGDOM reported ZENAPAX problem on Feb 19, 2007. Female patient, child 12 years of age, was treated with ZENAPAX. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome. ZENAPAX dosage: unknown. Patient recovered.

Zenapax Side Effects Report #5257159-6
ZENAPAX problem was reported by a Physician from NETHERLANDS on Feb 28, 2007. Male patient, 47 years of age, was diagnosed with liver transplant and was treated with ZENAPAX. After drug was administered, patient experienced the following problems/side effects: hyperkalaemia. ZENAPAX dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL, TACROLIMUS. Patient recovered.

Zenapax Side Effects Report #5258643-1
Physician from NETHERLANDS reported ZENAPAX problem on Feb 28, 2007. Male patient, 59 years of age, was diagnosed with liver transplant and was treated with ZENAPAX. After drug was administered, patient experienced the following problems/side effects: renal failure acute. ZENAPAX dosage: unknown. Patient was hospitalized. Patient recovered.


Zenapax Side Effects Report #5263589-9
ZENAPAX problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 06, 2007. Female patient, 50 years of age, weighting 137.8 lb, was diagnosed with multiple sclerosis and was treated with ZENAPAX. After drug was administered, patient experienced the following problems/side effects: rectocele. ZENAPAX dosage: unknown. During the same period patient was treated with COLACE, AMITRIPTYLINE, ZYPREXA, LIPITOR, IBUPROFEN, LYRICA. Patient was hospitalized. Patient recovered.

Zenapax Side Effects Report #5263592-9
Consumer or non-health professional from UNITED STATES reported ZENAPAX problem on Mar 06, 2007. Female patient, 50 years of age, weighting 137.8 lb, was diagnosed with multiple sclerosis and was treated with ZENAPAX. After drug was administered, patient experienced the following problems/side effects: anxiety, back pain, blood potassium decreased, clostridium difficile toxin test positive, constipation, dehydration, dental caries, depressed level of consciousness, ear pain. ZENAPAX dosage: unknown. During the same period patient was treated with INTERFERON BETA, ALERTEC, OMEGA, VITAMIN D, VITAMIN B, MSM JOINTMULA, DOCUSATE, GABAPENTIN. Patient was hospitalized. Patient recovered.

Zenapax Side Effects Report #5263593-0
ZENAPAX problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 01, 2007. Female patient, 33 years of age, weighting 242.5 lb, was diagnosed with multiple sclerosis and was treated with ZENAPAX. After drug was administered, patient experienced the following problems/side effects: cardio-respiratory arrest, interstitial lung disease, meningitis, pyrexia. ZENAPAX dosage: unknown. During the same period patient was treated with INTERFERON BETA, CLORAZEPATE, MICRODIOL, ORLISTAT. Patient was hospitalized. Patient recovered.

Zenapax Side Effects Report #5266298-5
Consumer or non-health professional from UNITED STATES reported ZENAPAX problem on Mar 01, 2007. Female patient, 33 years of age, weighting 242.5 lb, was diagnosed with multiple sclerosis and was treated with ZENAPAX. After drug was administered, patient experienced the following problems/side effects: cardio-respiratory arrest, interstitial lung disease, meningitis, pyrexia. ZENAPAX dosage: unknown. During the same period patient was treated with INTERFERON BETA, CLORAZEPATE, MICRODIOL, ORLISTAT. Patient was hospitalized. Patient recovered.

Zenapax Side Effects Report #5266308-5
ZENAPAX problem was reported by a Consumer or non-health professional from AUSTRALIA on Mar 06, 2007. Female patient, 43 years of age, was treated with ZENAPAX. After drug was administered, patient experienced the following problems/side effects: back pain, chills, hyperhidrosis, malaise, nausea, pollakiuria, pyelonephritis, vomiting. ZENAPAX dosage: unknown. During the same period patient was treated with PROGRAF, RAMIPRIL, SIMVASTATIN, PREDNISONE. Patient was hospitalized. Patient recovered.

Zenapax Side Effects Report #5269643-X
Physician from FRANCE reported ZENAPAX problem on Nov 10, 2006. Male patient, 43 years of age, was treated with ZENAPAX. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, pneumothorax. ZENAPAX dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL, TACROLIMUS, METHYLPREDNISOLONE, PREDNISONE, GANCICLOVIR, OMEPRAZOLE. Patient was hospitalized. Patient recovered.

Zenapax Side Effects Report #5273848-1
ZENAPAX problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 13, 2007. Female patient, 33 years of age, weighting 242.5 lb, was diagnosed with multiple sclerosis and was treated with ZENAPAX. After drug was administered, patient experienced the following problems/side effects: cardio-respiratory arrest, interstitial lung disease, meningitis, pyrexia. ZENAPAX dosage: unknown. During the same period patient was treated with INTERFERON BETA, CLORAZEPATE, MICRODIOL, ORLISTAT. Patient was hospitalized. Patient recovered.

Zenapax Side Effects Report #5280219-0
Physician from NETHERLANDS reported ZENAPAX problem on Mar 23, 2007. Female patient, 58 years of age, was treated with ZENAPAX. After drug was administered, patient experienced the following problems/side effects: sepsis. ZENAPAX dosage: unknown. During the same period patient was treated with HYDROCORTISON. Patient recovered.


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