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Fluorouracil Side Effects summary

Total Fluorouracil reports: 565.
Fluorouracil FDA safety alerts: 2005 .
Reported deaths: 83    Reported hospitalizations: 422.
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Fluorouracil Side Effects: dehydration, diarrhoea, nausea, neutropenia, vomiting, abdominal pain upper, asthenia, febrile neutropenia, haemoglobin decreased, pyrexia, mucosal inflammation,
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Fluorouracil Side Effects reported to FDA

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Fluorouracil Side Effects Report #5496920-X
Consumer or non-health professional from GERMANY reported FLUOROURACIL problem on Oct 08, 2007. Male patient, 62 years of age, was diagnosed with colorectal cancer metastatic and was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: intestinal obstruction. FLUOROURACIL dosage: (3200 MG/M2, 2 IN 1 WK) INTRAVENOUS (NOT OTHERWISE SPECIFIED). During the same period patient was treated with FOLINIC ACID, IRINOTECAN, CETUXIMAB, OXALIPLATIN. Patient was hospitalized. Patient recovered.



Fluorouracil Side Effects Report #5498633-7
FLUOROURACIL problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 24, 2007. Male patient, weighting 152.3 lb, was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: fatigue, nausea, proctalgia, vomiting. FLUOROURACIL dosage: 12632 MG. During the same period patient was treated with BEVACIZUMAB, LEUCOVORIN CALCIUM, ELOXATIN. Patient was hospitalized. Patient recovered.



Fluorouracil Side Effects Report #5500372-0
Consumer or non-health professional from UNITED STATES reported FLUOROURACIL problem on Oct 25, 2007. Male patient, weighting 161.8 lb, was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: diarrhoea, disease progression, fatigue, feeling abnormal, liver disorder, myocardial infarction, myocardial ischaemia. FLUOROURACIL dosage: 9615 MG. During the same period patient was treated with BEVACIZUMAB, CAMPTOSAR, LEUCOVORIN CALCIUM. Patient recovered.



Fluorouracil Side Effects Report #5500376-8
FLUOROURACIL problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 25, 2007. Male patient, weighting 233.5 lb, was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: pulmonary embolism. FLUOROURACIL dosage: 20000 MG. During the same period patient was treated with BEVACIZUMAB, CAMPTOSAR, LEUCOVORIN CALCIUM. Patient recovered.




Fluorouracil Side Effects Report #5500383-5
Consumer or non-health professional from UNITED STATES reported FLUOROURACIL problem on Oct 24, 2007. Female patient, weighting 119.0 lb, was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia. FLUOROURACIL dosage: 6300 MG. During the same period patient was treated with CISPLATIN, ERBITUX, ELLENCE. Patient was hospitalized. Patient recovered.



Fluorouracil Side Effects Report #5500685-2
FLUOROURACIL problem was reported by a Physician from UNITED STATES on Oct 18, 2007. Female patient, 31 years of age, was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: cardiac failure congestive, cardiotoxicity, dyspnoea, ejection fraction decreased. FLUOROURACIL dosage: 225 MG/M2/DAY 5 DAYS A WEEK X 6 W. Patient was hospitalized. Patient recovered.



Fluorouracil Side Effects Report #5501426-5
Health Professional from UNITED STATES reported FLUOROURACIL problem on Oct 26, 2007. Male patient, 71 years of age, was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: burning sensation, pruritus, rash maculo-papular. FLUOROURACIL dosage: 780MG BOLUS/4680MG OVER 46?. During the same period patient was treated with ELOXATIN, LEUCOVORIN, ZOFRAN, DECADRON. Patient recovered.



Fluorouracil Side Effects Report #5501713-0
FLUOROURACIL problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 26, 2007. Female patient, weighting 166.9 lb, was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: neutropenia. FLUOROURACIL dosage: 4970 MG. During the same period patient was treated with LEUCOVORIN CALCIUM, ELOXATIN. Patient recovered.



Fluorouracil Side Effects Report #5503153-7
Consumer or non-health professional from UNITED STATES reported FLUOROURACIL problem on Oct 29, 2007. Female patient, weighting 116.2 lb, was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: intestinal obstruction, oral intake reduced, thirst. FLUOROURACIL dosage: 4200 MG. During the same period patient was treated with BEVACIZUMAB, LEUCOVORIN CALCIUM, ELOXATIN. Patient was hospitalized. Patient recovered.




Fluorouracil Side Effects Report #5503158-6
FLUOROURACIL problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 29, 2007. Male patient, weighting 174.4 lb, was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: type iv hypersensitivity reaction. FLUOROURACIL dosage: 5180 MG. During the same period patient was treated with BEVACIZUMAB, LEUCOVORIN CALCIUM, ELOXATIN. Patient was hospitalized. Patient recovered.



Fluorouracil Side Effects Report #5504038-2
Health Professional from UNITED STATES reported FLUOROURACIL problem on Oct 17, 2007. Female patient, 56 years of age, was diagnosed with colorectal cancer metastatic and was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: small intestinal obstruction. FLUOROURACIL dosage: EVERY TWO WEEKS (2693 MG), INTRAVENOUS (NOT OTHERWISE SPECIFIED). During the same period patient was treated with FOLINIC ACID, CETUXIMAB, BEVACIZUMAB, DIPHENHYDRAMINE HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE, DEXAMETHASONE, WARFARIN. Patient was hospitalized. Patient recovered.



Fluorouracil Side Effects Report #5504798-0
FLUOROURACIL problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 31, 2007. Male patient, weighting 152.3 lb, was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: fatigue, nausea, proctalgia, rectal tenesmus, vomiting. FLUOROURACIL dosage: 12632 MG. During the same period patient was treated with BEVACIZUMAB, LEUCOVORIN CALCIUM, ELOXATIN. Patient was hospitalized. Patient recovered.



Fluorouracil Side Effects Report #5442052-6
Consumer or non-health professional from GERMANY reported FLUOROURACIL problem on Aug 27, 2007. Male patient, 43 years of age, was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: colitis. FLUOROURACIL dosage: unknown. During the same period patient was treated with LEUCOVORIN CALCIUM, MITOMYCIN, OXALIPLATIN. Patient recovered.



Fluorouracil Side Effects Report #5442071-X
FLUOROURACIL problem was reported by a Health Professional from JAPAN on Aug 31, 2007. Male patient, weighting 125.7 lb, was diagnosed with rectal cancer and was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: leukopenia, neutropenia, pneumonia, thrombocytopenia. FLUOROURACIL dosage: 650 MG/BODY=406.3 MG/M2 IN BOLUS THEN 975 MG/BODY=609.4 MG/M2 AS CONTINUOUS INFUSION. During the same period patient was treated with VENOGLOBULIN, OXALIPLATIN, PENTCILLIN, LEUCOVORIN CALCIUM, FLOMOXEF. Patient died on 11/28/2005.




Fluorouracil Side Effects Report #5444147-X
Pharmacist from UNITED STATES reported FLUOROURACIL problem on Sept 04, 2007. Male patient, weighting 165.0 lb, was diagnosed with colorectal cancer and was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: infusion related reaction. FLUOROURACIL dosage: 3950 MG OVER 46 HRS IV. Patient recovered.



Fluorouracil Side Effects Report #5445716-3
FLUOROURACIL problem was reported by a Health Professional from UNITED STATES on Aug 21, 2007. Female patient, 64 years of age, was diagnosed with colon cancer and was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, diffuse alveolar damage, eye injury, eye penetration, fall, pulmonary congestion, pulmonary fibrosis, respiratory failure. FLUOROURACIL dosage: (5600 MG), INTRAVENOUS. During the same period patient was treated with FOLINIC ACID, OXALIPLATIN. Patient was hospitalized. Patient died on 07/15/2007.



Fluorouracil Side Effects Report #5448360-7
Consumer or non-health professional from GERMANY reported FLUOROURACIL problem on Aug 27, 2007. Female patient, 65 years of age, was diagnosed with metastatic gastric cancer, hypercalcaemia and was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: hypocalcaemia, trousseau's syndrome. FLUOROURACIL dosage: (200 MG/M2,CYCLICAL), INTRAVENOUS (NOT OTHERWISE SPECIFIED). During the same period patient was treated with FOLINIC ACID, IRINOTECAN, CETUXIMAB, ZOMETA. Patient was hospitalized. Patient recovered.



Fluorouracil Side Effects Report #5449593-6
FLUOROURACIL problem was reported by a Consumer or non-health professional from GERMANY on Aug 27, 2007. Male patient, 55 years of age, was diagnosed with metastatic gastric cancer and was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: pelvic venous thrombosis. FLUOROURACIL dosage: 1500 MG/M2 (ON DAYS, 1, 8, 15, 22, 29, 36, OF 6 WEEK CYCLE) (1500 MG/M2) INTRAVENOUS. During the same period patient was treated with FOLINIC ACID, IRINOTECAN, CETUXIMAB. Patient was hospitalized. Patient recovered.



Fluorouracil Side Effects Report #5449883-7
Consumer or non-health professional from UNITED STATES reported FLUOROURACIL problem on Sept 10, 2007. Female patient, weighting 210.3 lb, was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: dermatitis exfoliative, diarrhoea, haemoglobin abnormal, pain, platelet count abnormal, radiation skin injury, white blood cell count abnormal. FLUOROURACIL dosage: 7800 MG. During the same period patient was treated with CISPLATIN, ERBITUX. Patient was hospitalized. Patient recovered.




Fluorouracil Side Effects Report #5449895-3
FLUOROURACIL problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 10, 2007. Female patient, weighting 154.3 lb, was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: neutrophil count decreased, platelet count decreased, white blood cell count decreased. FLUOROURACIL dosage: 1810 MG. During the same period patient was treated with MITOMYCIN. Patient recovered.



Fluorouracil Side Effects Report #5449988-0
Consumer or non-health professional from GERMANY reported FLUOROURACIL problem on Sept 07, 2007. Male patient, 43 years of age, was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: colitis. FLUOROURACIL dosage: DOSE: 350 MG/M2 OVER 24 HOURS ON DAYS 1-5 AND 8-12. During the same period patient was treated with LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM, MITOMYCIN, OXALIPLATIN. Patient recovered.



Fluorouracil Side Effects Report #5450275-5
FLUOROURACIL problem was reported by a Pharmacist from GERMANY on Sept 03, 2007. Male patient, 63 years of age, was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: alcohol interaction, fall, lower limb fracture. FLUOROURACIL dosage: unknown. During the same period patient was treated with ELOXATIN, ALCOHOL. Patient recovered.



Fluorouracil Side Effects Report #5451265-9
Consumer or non-health professional from UNITED STATES reported FLUOROURACIL problem on Sept 11, 2007. Male patient, weighting 173.7 lb, was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, anorexia, asthenia, diarrhoea, haemoglobin decreased, small intestinal obstruction, weight decreased. FLUOROURACIL dosage: 6750 MG. During the same period patient was treated with ELOXATIN. Patient was hospitalized. Patient recovered.



Fluorouracil Side Effects Report #5451359-8
FLUOROURACIL problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 11, 2007. Female patient, weighting 210.3 lb, was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: blood phosphorus abnormal, dermatitis exfoliative, diarrhoea, fatigue, haemoglobin abnormal, painful defaecation, platelet count abnormal, platelet disorder, radiation skin injury. FLUOROURACIL dosage: 7800 MG. During the same period patient was treated with CISPLATIN. Patient was hospitalized. Patient recovered.



Fluorouracil Side Effects Report #5452229-1
Consumer or non-health professional from UNITED STATES reported FLUOROURACIL problem on Sept 12, 2007. Female patient, weighting 210.3 lb, was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: blood phosphorus abnormal, dermatitis exfoliative, diarrhoea, fatigue, haemoglobin abnormal, pain, platelet count abnormal, radiation skin injury, white blood cell count abnormal. FLUOROURACIL dosage: 7800 MG. During the same period patient was treated with CISPLATIN. Patient was hospitalized. Patient recovered.



Fluorouracil Side Effects Report #5452761-0
FLUOROURACIL problem was reported by a Health Professional from JAPAN on Sept 05, 2007. Male patient, weighting 88.18 lb, was diagnosed with colon cancer, stomatitis and was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: gastric ulcer. FLUOROURACIL dosage: unknown. During the same period patient was treated with ALLOPURINOL, LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM, OXALIPLATIN. Patient recovered.



Fluorouracil Side Effects Report #5455732-3
Health Professional from UNITED STATES reported FLUOROURACIL problem on Sept 05, 2007. Male patient, 82 years of age, was diagnosed with colorectal cancer metastatic and was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: anaemia, asthenia, dehydration, electrolyte imbalance, mental status changes, metabolic acidosis, mucosal inflammation, neutropenic sepsis, oxygen saturation decreased. FLUOROURACIL dosage: unknown. During the same period patient was treated with FOLINIC ACID, OXALIPLATIN, BEVACIZUMAB, WARFARIN, LOSARTAN POTASSIUM, DILTIAZEM, FAMOTIDINE, DIGOXIN. Patient was hospitalized. Patient died on 07/31/2007.



Fluorouracil Side Effects Report #5456621-0
FLUOROURACIL problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 17, 2007. Female patient, weighting 125.7 lb, was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: abdominal pain, atrial fibrillation, bacterial infection, blood culture positive, confusional state, dehydration, diarrhoea, disseminated intravascular coagulation, faecal incontinence. FLUOROURACIL dosage: 1520 MG. During the same period patient was treated with MITOMYCIN. Patient was hospitalized. Patient recovered.



Fluorouracil Side Effects Report #5458177-5
Consumer or non-health professional from UNITED KINGDOM reported FLUOROURACIL problem on Sept 07, 2006. Female patient, 56 years of age, was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: peripheral ischaemia. FLUOROURACIL dosage: unknown. During the same period patient was treated with METHOTREXATE, CYCLOPHOSPHAMIDE. Patient was hospitalized. Patient recovered.



Fluorouracil Side Effects Report #5462928-3
FLUOROURACIL problem was reported by a Consumer or non-health professional from ISRAEL on Sept 10, 2007. Male patient, 20 years of age, was diagnosed with rectal cancer and was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: colitis ischaemic. FLUOROURACIL dosage: unknown. During the same period patient was treated with AVASTIN, CAMPTO, LEUCOVORIN CALCIUM. Patient was hospitalized. Patient recovered.



Fluorouracil Side Effects Report #5463783-8
Health Professional from UNITED STATES reported FLUOROURACIL problem on Sept 05, 2007. Male patient, 62 years of age, was diagnosed with metastatic gastric cancer and was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: anaemia, asthenia, atelectasis, beta haemolytic streptococcal infection, biliary tract disorder, depression, diarrhoea, dilatation intrahepatic duct acquired, erosive oesophagitis. FLUOROURACIL dosage: CYCLE 1, DAY 1-5 EVERY 28 DAYS (1780 MG), INTRAVENOUS (NOT OTHERWISE SPECIFIED). During the same period patient was treated with CISPLATIN, APREPITANT, LORAZEPAM, ONDANSETRON, PROCHLORPERAZINE EDISYLATE, HYDROCODONE BITARTRATE. Patient was hospitalized. Patient recovered.



Fluorouracil Side Effects Report #5463785-1
FLUOROURACIL problem was reported by a Physician from UNITED STATES on Sept 05, 2007. Female patient, 31 years of age, was diagnosed with squamous cell carcinoma of the cervix and was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: cardiotoxicity, chest pain, dyspnoea, ejection fraction decreased. FLUOROURACIL dosage: 225 MG/M2/DAY (1 IN 1 D). Patient was hospitalized. Patient recovered.



Fluorouracil Side Effects Report #5465395-9
Consumer or non-health professional from UNITED STATES reported FLUOROURACIL problem on Sept 20, 2007. Male patient, 81 years of age, was diagnosed with colon cancer and was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: conjunctivitis, iritis, mucosal inflammation, photosensitivity reaction, sjogren's syndrome. FLUOROURACIL dosage: 4080MG OTHER IV. Patient was hospitalized. Patient recovered.



Fluorouracil Side Effects Report #5467066-1
FLUOROURACIL problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 24, 2007. Male patient, weighting 253.5 lb, was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, fall, unresponsive to stimuli. FLUOROURACIL dosage: 690 MG. During the same period patient was treated with CISPLATIN, ERBITUX, EPIRUBICIN. Patient was hospitalized. Patient recovered.



Fluorouracil Side Effects Report #5469251-1
Physician from MEXICO reported FLUOROURACIL problem on July 23, 2007. Male patient was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: erythema, oedema, scab, skin exfoliation. FLUOROURACIL dosage: unknown. Patient recovered.



Fluorouracil Side Effects Report #5469726-5
FLUOROURACIL problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 26, 2007. Female patient, weighting 171.1 lb, was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: diarrhoea, dysuria, hypokalaemia, hypomagnesaemia, muscle spasms, nausea, urinary tract infection, vomiting. FLUOROURACIL dosage: 7360 MG. During the same period patient was treated with CISPLATIN, ERBITUX. Patient was hospitalized. Patient recovered.



Fluorouracil Side Effects Report #5470245-0
Physician from UNITED STATES reported FLUOROURACIL problem on Sept 10, 2007. Female patient, 64 years of age, weighting 179.9 lb, was diagnosed with colorectal cancer and was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: bundle branch block right, cardiac arrest, convulsion, diarrhoea, febrile neutropenia, hypotension, lethargy, myocardial infarction, respiratory arrest. FLUOROURACIL dosage: 1000 MG DAY AND DAY 8 CYCLIC (1000 MG), INTRAVENOUS (NOT OTHWERWISE SPECIFIED). During the same period patient was treated with FOLINIC ACID, IRINOTECAN, ATENOLOL, HYZAAR, AMITRIPTYLINE HYDROCHLORIDE. Patient was hospitalized. Patient died on 11/23/2003.



Fluorouracil Side Effects Report #5472418-X
FLUOROURACIL problem was reported by a Consumer or non-health professional from ISRAEL on Sept 12, 2007. Male patient, 20 years of age, was diagnosed with rectal cancer and was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: colitis ischaemic, impaired healing. FLUOROURACIL dosage: unknown. During the same period patient was treated with BEVACIZUMAB, FOLINIC ACID. Patient was hospitalized. Patient recovered.



Fluorouracil Side Effects Report #5474490-X
Consumer or non-health professional from UNITED STATES reported FLUOROURACIL problem on Sept 28, 2007. Male patient, weighting 179.5 lb, was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: dehydration, diarrhoea, hypokalaemia, hypotension. FLUOROURACIL dosage: 4884 MG. During the same period patient was treated with BEVACIZUMAB, LEUCOVORIN CALCIUM, ELOXATIN. Patient was hospitalized. Patient recovered.



Fluorouracil Side Effects Report #5474499-6
FLUOROURACIL problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 28, 2007. Female patient, weighting 165.3 lb, was treated with FLUOROURACIL. After drug was administered, patient experienced the following problems/side effects: diverticular perforation, diverticulitis, dysuria. FLUOROURACIL dosage: 2642 MG. During the same period patient was treated with BEVACIZUMAB, CAMPTOSAR, LEUCOVORIN CALCIUM. Patient was hospitalized. Patient recovered.



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