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Filgrastim Side Effects submitted to FDA

Total Filgrastim reports: 15.
Filgrastim FDA safety alerts: 2001 .
Reported deaths: 2    Reported hospitalizations: 15.
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FDA Reported Filgrastim Side Effects: pulmonary fibrosis, interstitial lung disease, anaphylactic reaction, lactic acidosis, cardiac output decreased, pancytopenia, infection, pneumonitis, pyrexia, pulmonary haemorrhage, lung infiltration,
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Filgrastim Side Effects Report #5443267-3
Health Professional from UNITED KINGDOM reported FILGRASTIM problem on Aug 24, 2007. Male patient, 78 years of age, was diagnosed with myelodysplastic syndrome and was treated with FILGRASTIM. After drug was administered, patient experienced the following problems/side effects: cardiac output decreased, lactic acidosis. FILGRASTIM dosage: unknown. During the same period patient was treated with ATENOLOL, CLOPIDOGREL, ISOSORBIDE MONONITRATE, OMEPRAZOLE, ASPIRIN. Patient died.



Filgrastim Side Effects Report #5416685-7
FILGRASTIM problem was reported by a Health Professional from UNITED KINGDOM on Aug 01, 2007. Male patient, 39 years of age, was treated with FILGRASTIM. After drug was administered, patient experienced the following problems/side effects: pneumonitis, pulmonary fibrosis. FILGRASTIM dosage: unknown. During the same period patient was treated with NEUPOGEN, CYCLOPHOSPHAMIDE, RITUXIMAB, METHOTREXATE, PREDNISOLONE, RANITIDINE, VINCRISTINE. Patient was hospitalized. Patient recovered.



Filgrastim Side Effects Report #5425935-2
Health Professional from UNITED KINGDOM reported FILGRASTIM problem on Aug 15, 2007. Female patient, 51 years of age, was treated with FILGRASTIM. After drug was administered, patient experienced the following problems/side effects: infection, pancytopenia. FILGRASTIM dosage: unknown. During the same period patient was treated with CYTARABINE, FLUDARABINE. Patient died on 06/15/2007.



Filgrastim Side Effects Report #5377553-2
FILGRASTIM problem was reported by a Health Professional from UNITED KINGDOM on June 20, 2007. Male patient, 39 years of age, was treated with FILGRASTIM. After drug was administered, patient experienced the following problems/side effects: interstitial lung disease, pulmonary fibrosis. FILGRASTIM dosage: unknown. During the same period patient was treated with RITUXIMAB, CYCLOPHOSPHAMIDE, VINCRISTINE. Patient was hospitalized. Patient recovered.




Filgrastim Side Effects Report #5378883-0
Health Professional from UNITED KINGDOM reported FILGRASTIM problem on June 25, 2007. Female patient, weighting 133.6 lb, was treated with FILGRASTIM. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, oedema mouth, pharyngeal oedema, swollen tongue, vomiting, wheezing. FILGRASTIM dosage: unknown. During the same period patient was treated with DEXAMETHASONE. Patient recovered.



Filgrastim Side Effects Report #5389751-2
FILGRASTIM problem was reported by a Health Professional from UNITED KINGDOM on July 05, 2007. Male patient, 39 years of age, was treated with FILGRASTIM. After drug was administered, patient experienced the following problems/side effects: interstitial lung disease, pulmonary fibrosis. FILGRASTIM dosage: unknown. During the same period patient was treated with RITUXIMAB, CYCLOPHOSPHAMIDE, METHOTREXATE, NEUPOGEN, VINCRISTINE, PREDNISOLONE, RANITIDINE. Patient was hospitalized. Patient recovered.



Filgrastim Side Effects Report #5400329-4
Physician from GERMANY reported FILGRASTIM problem on July 18, 2007. Male patient, 49 years of age, was diagnosed with blood stem cell harvest and was treated with FILGRASTIM. After drug was administered, patient experienced the following problems/side effects: chest discomfort, cough, haemoptysis, lung infiltration, pulmonary haemorrhage, pyrexia. FILGRASTIM dosage: unknown. Patient was hospitalized. Patient recovered.



Filgrastim Side Effects Report #5377553-2
FILGRASTIM problem was reported by a Health Professional from UNITED KINGDOM on June 20, 2007. Male patient, 39 years of age, was treated with FILGRASTIM. After drug was administered, patient experienced the following problems/side effects: interstitial lung disease, pulmonary fibrosis. FILGRASTIM dosage: unknown. During the same period patient was treated with RITUXIMAB, CYCLOPHOSPHAMIDE, VINCRISTINE. Patient was hospitalized. Patient recovered.



Filgrastim Side Effects Report #5378883-0
Health Professional from UNITED KINGDOM reported FILGRASTIM problem on June 25, 2007. Female patient, weighting 133.6 lb, was treated with FILGRASTIM. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, oedema mouth, pharyngeal oedema, swollen tongue, vomiting, wheezing. FILGRASTIM dosage: unknown. During the same period patient was treated with DEXAMETHASONE. Patient recovered.




Filgrastim Side Effects Report #5389751-2
FILGRASTIM problem was reported by a Health Professional from UNITED KINGDOM on July 05, 2007. Male patient, 39 years of age, was treated with FILGRASTIM. After drug was administered, patient experienced the following problems/side effects: interstitial lung disease, pulmonary fibrosis. FILGRASTIM dosage: unknown. During the same period patient was treated with RITUXIMAB, CYCLOPHOSPHAMIDE, METHOTREXATE, NEUPOGEN, VINCRISTINE, PREDNISOLONE, RANITIDINE. Patient was hospitalized. Patient recovered.



Filgrastim Side Effects Report #5400329-4
Physician from GERMANY reported FILGRASTIM problem on July 18, 2007. Male patient, 49 years of age, was diagnosed with blood stem cell harvest and was treated with FILGRASTIM. After drug was administered, patient experienced the following problems/side effects: chest discomfort, cough, haemoptysis, lung infiltration, pulmonary haemorrhage, pyrexia. FILGRASTIM dosage: unknown. Patient was hospitalized. Patient recovered.



Filgrastim Side Effects Report #5762358-0
FILGRASTIM problem was reported by a Physician from SPAIN on May 28, 2008. Female patient, 65 years of age, weighting 126.8 lb, was diagnosed with blood stem cell harvest and was treated with FILGRASTIM. After drug was administered, patient experienced the following problems/side effects: iron metabolism disorder, myelodysplastic syndrome, thrombocytopenia. FILGRASTIM dosage: unknown. Patient recovered.



Filgrastim Side Effects Report #5762359-2
Physician from SPAIN reported FILGRASTIM problem on May 28, 2008. Male patient, 47 years of age, was diagnosed with blood stem cell harvest and was treated with FILGRASTIM. After drug was administered, patient experienced the following problems/side effects: lung cancer metastatic. FILGRASTIM dosage: unknown. Patient recovered.



Filgrastim Side Effects Report #5762360-9
FILGRASTIM problem was reported by a Physician from SPAIN on May 28, 2008. Male patient, 45 years of age, weighting 147.7 lb, was diagnosed with blood stem cell harvest and was treated with FILGRASTIM. After drug was administered, patient experienced the following problems/side effects: colon cancer, iron deficiency anaemia. FILGRASTIM dosage: unknown. Patient recovered.




Filgrastim Side Effects Report #5341872-6
Consumer or non-health professional from UNITED STATES reported FILGRASTIM problem on May 29, 2007. Female patient, 49 years of age, was diagnosed with breast cancer and was treated with FILGRASTIM. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction. FILGRASTIM dosage: 480 MCG/ 0.8 ML SUBCUTANEOUS INJECTION. Patient recovered.




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