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Index of reports
> Serious Reactions (1282)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Fluorouracil serious reactions. The selected reports were submitted to the FDA during the sample period of about a year. Reports 1 - 30 of 1282 Next >>
Possible Fluorouracil side effects in 73 year old male
Reported by a physician from France on 2012-08-27
Patient: 73 year old male, weighing 71.0 kg (156.2 pounds)
Reactions: Folliculitis, Rash
Drug(s) suspected as cause:
Avastin
Indication: Colorectal Cancer
Start date: 2012-05-22
End date: 2012-06-06
Fluorouracil
Indication: Colorectal Cancer
Start date: 2012-05-22
End date: 2012-06-27
Other drugs received by patient: Leucovorin Calcium
Possible Fluorouracil side effects in 64 year old female
Reported by a physician from Spain on 2012-08-24
Patient: 64 year old female
Reactions: Blood Alkaline Phosphatase Increased, Angina Pectoris, Gamma-Glutamyltransferase Increased, Blood Lactate Dehydrogenase Increased, Eczema, Sinus Tachycardia, Cutaneous Lupus Erythematosus
Drug(s) suspected as cause:
Fluorouracil
Dosage: 400 mg/m2, every two weeks
Fluorouracil
Dosage: 2400 mg/m2, over 48 hrs., every two weeks
Indication: Colorectal Cancer Metastatic
Leucovorin Calcium
Dosage: 200 mg/m2, every two weeks
Indication: Colorectal Cancer Metastatic
Oxaliplatin
Dosage: 85 mg/m2, every two weeks
Indication: Colorectal Cancer Metastatic
Other drugs received by patient: Granisetron; Dexamethasone
Possible Fluorouracil side effects in female
Reported by a physician from Japan on 2012-08-24
Patient: female
Reactions: Hyperammonaemia
Drug(s) suspected as cause:
Avastin
Indication: Colon Cancer
Fluorouracil
Dosage: dosage is uncertain.
Fluorouracil
Dosage: dosage is uncertain.
Indication: Colon Cancer
Other drugs received by patient: Oxaliplatin; Levoleucovorin Calcium
Possible Fluorouracil side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24
Patient: female
Reactions: Maternal Exposure During Pregnancy, Uterine Contractions During Pregnancy
Drug(s) suspected as cause:
Adriamycin PFS
Indication: Breast Cancer Stage I
Cytoxan
Indication: Breast Cancer Stage I
Fluorouracil
Indication: Breast Cancer Stage I
Paclitaxel
Indication: Breast Cancer Stage I
Possible Fluorouracil side effects in 61 year old female
Reported by a physician from Japan on 2012-08-24
Patient: 61 year old female, weighing 38.0 kg (83.6 pounds)
Reactions: White Blood Cell Count Decreased, Colonic Stenosis, Scar
Drug(s) suspected as cause:
Avastin
Dosage: dosage is uncertain.
Indication: Colon Cancer Metastatic
Fluorouracil
Dosage: dosage is uncertain.
Indication: Colon Cancer Metastatic
Fluorouracil
Dosage: dosage is uncertain.
Levoleucovorin Calcium
Dosage: dosage is uncertain.
Indication: Colon Cancer Metastatic
Oxaliplatin
Dosage: dosage is uncertain.
Indication: Colon Cancer Metastatic
Possible Fluorouracil side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24
Patient: , weighing 1.9 kg (4.3 pounds)
Reactions: Foetal Growth Restriction
Drug(s) suspected as cause:
Adriamycin PFS
Indication: Breast Cancer Stage I
Cytoxan
Indication: Breast Cancer Stage I
Fluorouracil
Indication: Breast Cancer Stage I
Paclitaxel
Indication: Breast Cancer Stage I
Possible Fluorouracil side effects in 77 year old female
Reported by a physician from Austria on 2012-08-24
Patient: 77 year old female
Reactions: Photosensitivity Reaction, Paraneoplastic Syndrome, Neoplasm Progression, Eczema, Erythema, Complement Factor C3 Decreased, Gastric Cancer, Gamma-Glutamyltransferase Increased, Rash Erythematous, Leukopenia, Cutaneous Lupus Erythematosus
Drug(s) suspected as cause:
Capecitabine
Dosage: 950 mg/m2, bid
Indication: Gastric Cancer
Start date: 2005-07-01
Etoposide
Dosage: unk
Indication: Gastric Cancer
Start date: 2005-03-01
Fluorouracil
Dosage: unk
Indication: Gastric Cancer
Start date: 2005-06-01
Fluorouracil
Dosage: unk
Start date: 2005-03-01
Irinotecan Hydrochloride
Dosage: unk
Indication: Gastric Cancer
Start date: 2005-06-01
Leucovorin Calcium
Dosage: unk
Indication: Gastric Cancer
Start date: 2005-06-01
Leucovorin Calcium
Dosage: unk
Start date: 2005-03-01
Other drugs received by patient: Cetirizine
Possible Fluorouracil side effects in 72 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-24
Patient: 72 year old male
Reactions: Leukoencephalopathy
Drug(s) suspected as cause:
Avastin
Fluorouracil
Fluorouracil
Leucovorin Calcium
Oxaliplatin
Possible Fluorouracil side effects in male
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-23
Patient: male
Reactions: Phlebitis, Malaise, Colon Cancer, B-Cell Lymphoma, Urinary Incontinence, Loss of Consciousness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fluorouracil
Dosage: 736 +2208 mg
Indication: Colon Cancer
Start date: 2012-05-02
Fluorouracil
Dosage: 736 mg, unk
Start date: 2012-05-03
Ondansetron
Dosage: 8 mg, unk
Indication: Prophylaxis of Nausea and Vomiting
Start date: 2012-05-02
Oxaliplatin
Dosage: 156 mg, unk
Indication: Colon Cancer
Start date: 2012-05-02
Tegretol
Dosage: 1 df, daily
Administration route: Oral
Indication: Epilepsy
Start date: 1983-01-01
Other drugs received by patient: Solu-Medrol; Bisoprolol Fumarate and Hydrochlorothiazide; Ramipril; Magnesium Sulfate; Leucovorin Calcium; Calcium Gluconate; Fluvastatin Sodium; Fraxodi
Possible Fluorouracil side effects in 56 year old female
Reported by a physician from United Kingdom on 2012-08-23
Patient: 56 year old female, weighing 86.4 kg (190.1 pounds)
Reactions: Gastrooesophageal Reflux Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cyclophosphamide
Start date: 2012-06-15
Dexamethasone
Start date: 2012-06-15
End date: 2012-06-15
Docetaxel
Start date: 2012-06-15
Epirubicin Hydrochloride
Start date: 2012-06-15
Fluorouracil
Start date: 2012-06-15
Ondansetron
Start date: 2012-06-15
End date: 2012-06-15
Other drugs received by patient: Acetaminophen; Filgrastim; Ibuprofen
Possible Fluorouracil side effects in 60 year old female
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-22
Patient: 60 year old female
Reactions: Disorientation
Drug(s) suspected as cause:
Fluorouracil
Possible Fluorouracil side effects in 60 year old female
Reported by a consumer/non-health professional from Germany on 2012-08-22
Patient: 60 year old female
Reactions: Disorientation
Drug(s) suspected as cause:
Fluorouracil
Possible Fluorouracil side effects in 71 year old male
Reported by a physician from Ireland on 2012-08-21
Patient: 71 year old male
Reactions: Photosensitivity Reaction, Skin Exfoliation, Erythema Annulare, Cutaneous Lupus Erythematosus, Skin Plaque
Drug(s) suspected as cause:
Fluorouracil
Possible Fluorouracil side effects in male
Reported by a physician from United States on 2012-08-20
Patient: male, weighing 101.0 kg (222.2 pounds)
Reactions: Death, Ataxia
Adverse event resulted in: death
Drug(s) suspected as cause:
Bevacizumab
Indication: Colorectal Cancer
Start date: 2007-01-17
End date: 2007-04-18
Fluorouracil
Indication: Colorectal Cancer
Start date: 2007-01-17
End date: 2007-04-18
Leucovorin Calcium
Indication: Colorectal Cancer
Start date: 2007-01-17
End date: 2007-04-18
Oxaliplatin
Indication: Colorectal Cancer
Start date: 2007-01-17
End date: 2007-01-17
Oxaliplatin
Start date: 2007-04-18
End date: 2007-04-18
Other drugs received by patient: Acyclovir; Docusate; Filgrastim; Hydrochlorothiazide; Phenergan HCL
Possible Fluorouracil side effects in 49 year old female
Reported by a physician from Japan on 2012-08-20
Patient: 49 year old female
Reactions: Hepatic Atrophy, Oesophageal Varices Haemorrhage, Splenomegaly
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Avastin
Dosage: dosage is uncertain.
Indication: Rectal Cancer
Start date: 2010-08-01
Fluorouracil
Dosage: dosage is uncertain.
Start date: 2010-08-01
Fluorouracil
Dosage: dosage is uncertain.
Indication: Rectal Cancer
Start date: 2010-08-01
Levoleucovorin Calcium
Dosage: dosage is uncertain.
Indication: Rectal Cancer
Start date: 2010-08-01
Oxaliplatin
Dosage: dosage is uncertain.
Indication: Rectal Cancer
Start date: 2010-08-01
Xeloda
Administration route: Oral
Indication: Rectal Cancer
Start date: 2009-09-01
Possible Fluorouracil side effects in
Reported by a health professional (non-physician/pharmacist) from Italy on 2012-08-20
Patient:
Reactions: Abdominal Pain, Vomiting, Hypersensitivity, Nausea, Skin Toxicity, Mucosal Inflammation, Fatigue, Diarrhoea, Hepatotoxicity, Neutropenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cyclophosphamide
Indication: Breast Cancer
Epirubicin
Indication: Breast Cancer
Fluorouracil
Indication: Breast Cancer
Herceptin
Dosage: loading dose
Indication: Breast Cancer
Herceptin
Dosage: maintenance dose
Lapatinib
Dosage: arm b
Administration route: Oral
Indication: Breast Cancer
Lapatinib
Dosage: arm c
Administration route: Oral
Paclitaxel
Indication: Breast Cancer
Possible Fluorouracil side effects in female
Reported by a physician from Portugal on 2012-08-20
Patient: female, weighing 59.0 kg (129.8 pounds)
Reactions: Diarrhoea, Dehydration, Blood Creatinine Increased
Drug(s) suspected as cause:
Avastin
Dosage: over 30-90 minutes
Indication: Colorectal Cancer
Start date: 2010-01-25
End date: 2010-03-08
Avastin
Fluorouracil
Dosage: over 46-48 hours.
Fluorouracil
Dosage: on every day 01. followed by 2400 mg/m2
Indication: Colorectal Cancer
Start date: 2010-01-25
End date: 2010-03-08
Oxaliplatin
Oxaliplatin
Dosage: on day 01 of every 14 days cycle.
Indication: Colorectal Cancer
Start date: 2010-01-25
End date: 2010-03-08
Other drugs received by patient: Albuterol Sulate; Leucovorin Calcium; Drill; Allopurinol; Acetaminophen; Altizide + Spironolactone; Leucovorin Calcium; Loperamide HCL
Possible Fluorouracil side effects in 72 year old male
Reported by a consumer/non-health professional from Japan on 2012-08-17
Patient: 72 year old male
Reactions: Leukoencephalopathy
Drug(s) suspected as cause:
Avastin
Fluorouracil
Dosage: regimen 1
Fluorouracil
Dosage: regimen 2
Leucovorin Calcium
Oxaliplatin
Possible Fluorouracil side effects in 63 year old male
Reported by a physician from Japan on 2012-08-17
Patient: 63 year old male
Reactions: Interstitial Lung Disease, Respiratory Failure, Enterocolitis
Adverse event resulted in: death
Drug(s) suspected as cause:
Avastin
Dosage: dosage is uncertain.
Indication: Rectal Cancer Metastatic
Start date: 2011-04-01
Fluorouracil
Dosage: dosage is uncertain.
Indication: Rectal Cancer Metastatic
Start date: 2011-04-01
Fluorouracil
Dosage: dosage is uncertain.
Start date: 2011-04-01
Levoleucovorin Calcium
Dosage: dosage is uncertain.
Indication: Rectal Cancer Metastatic
Start date: 2011-04-01
Oxaliplatin
Dosage: dosage is uncertain.
Indication: Rectal Cancer Metastatic
Start date: 2011-04-01
Possible Fluorouracil side effects in 64 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-17
Patient: 64 year old male
Reactions: Portal Hypertension, Intestinal Haemorrhage, Metastases To Liver, Bone Marrow Failure, Intestinal Varices, Thrombocytopenia
Drug(s) suspected as cause:
Fluorouracil
Indication: Adenocarcinoma
Oxaliplatin
Indication: Adenocarcinoma
Other drugs received by patient: Neupogen
Possible Fluorouracil side effects in 65 year old male
Reported by a individual with unspecified qualification from Japan on 2012-08-17
Patient: 65 year old male
Reactions: Neuropathy Peripheral, Hepatic Atrophy, Oesophageal Varices Haemorrhage, Splenomegaly
Drug(s) suspected as cause:
Avastin
Dosage: dosage is uncertain.
Indication: Colon Cancer Metastatic
Start date: 2010-06-01
Fluorouracil
Dosage: dosage is uncertain.
Start date: 2010-06-01
End date: 2010-12-01
Fluorouracil
Dosage: dosage is uncertain.
Indication: Colon Cancer Metastatic
Start date: 2010-06-01
End date: 2010-12-01
Fluorouracil
Dosage: dosage is uncertain.
Fluorouracil
Dosage: dosage is uncertain.
Levoleucovorin Calcium
Dosage: dosage is uncertain.
Indication: Colon Cancer Metastatic
Start date: 2010-06-01
End date: 2010-12-01
Levoleucovorin Calcium
Dosage: dosage is uncertain.
Oxaliplatin
Dosage: dosage is uncertain.
Indication: Colon Cancer Metastatic
Start date: 2010-06-01
End date: 2010-12-01
Possible Fluorouracil side effects in
Reported by a health professional (non-physician/pharmacist) from Austria on 2012-08-17
Patient:
Reactions: Cutaneous Lupus Erythematosus
Drug(s) suspected as cause:
Capecitabine
Dosage: unk
Fluorouracil
Dosage: unk
Possible Fluorouracil side effects in 48 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-16
Patient: 48 year old female
Reactions: Pulmonary Veno-Occlusive Disease
Drug(s) suspected as cause:
Adriamycin PFS
Indication: Anal Cancer
Fluorouracil
Indication: Anal Cancer
Mitomycin
Indication: Anal Cancer
Mitomycin
Possible Fluorouracil side effects in 65 year old male
Reported by a physician from Japan on 2012-08-16
Patient: 65 year old male
Reactions: Neuropathy Peripheral, Hepatic Atrophy, Oesophageal Varices Haemorrhage, Splenomegaly
Drug(s) suspected as cause:
Avastin
Dosage: dosage is uncertain.
Indication: Colon Cancer Metastatic
Start date: 2010-06-01
Fluorouracil
Dosage: dosage is uncertain.
Start date: 2010-06-01
End date: 2010-12-01
Fluorouracil
Dosage: dosage is uncertain.
Indication: Colon Cancer Metastatic
Start date: 2010-06-01
End date: 2010-12-01
Fluorouracil
Dosage: dosage is uncertain.
Fluorouracil
Dosage: dosage is uncertain.
Levoleucovorin Calcium
Dosage: dosage is uncertain.
Indication: Colon Cancer Metastatic
Start date: 2010-06-01
End date: 2010-12-01
Levoleucovorin Calcium
Dosage: dosage is uncertain.
Oxaliplatin
Dosage: dosage is uncertain.
Indication: Colon Cancer Metastatic
Start date: 2010-06-01
End date: 2010-12-01
Possible Fluorouracil side effects in 61 year old female
Reported by a physician from Japan on 2012-08-14
Patient: 61 year old female, weighing 38.0 kg (83.6 pounds)
Reactions: White Blood Cell Count Decreased, Colonic Stenosis, Scar
Drug(s) suspected as cause:
Avastin
Dosage: dosage is uncertain.
Indication: Colon Cancer Metastatic
Fluorouracil
Dosage: dosage is uncertain.
Indication: Colon Cancer Metastatic
Fluorouracil
Dosage: dosage is uncertain.
Levoleucovorin Calcium
Dosage: dosage is uncertain.
Indication: Colon Cancer Metastatic
Oxaliplatin
Dosage: dosage is uncertain.
Indication: Colon Cancer Metastatic
Possible Fluorouracil side effects in
Reported by a individual with unspecified qualification from Japan on 2012-08-14
Patient:
Reactions: Neutropenia, Haematotoxicity
Drug(s) suspected as cause:
Fluorouracil
Dosage: (df; everycycle intravenous (not otherwise specified)), (df; every cycle intravenous (not otherwise
Indication: Colorectal Cancer
Leucovorin Calcium
Dosage: (df; every cycle intravenous (not otherwise specified)
Indication: Colorectal Cancer
Oxaliplatin
Dosage: (df; every cycle intravenous (not otherwise specified)
Indication: Colorectal Cancer
Possible Fluorouracil side effects in 27 year old female
Reported by a physician from United States on 2012-08-14
Patient: 27 year old female
Reactions: Confusional State, Weight Decreased, Stomatitis, Cerebellar Ataxia, Pyrexia, Speech Disorder, Diarrhoea, Acquired Pyrimidine Metabolism Disorder, Alopecia, Depressed Level of Consciousness, Thrombocytopenia, Leukopenia
Drug(s) suspected as cause:
Fluorouracil
Dosage: 500 mg on day 8
Fluorouracil
Dosage: 500 mg, on days 1 and 8
Fluorouracil
Dosage: 800 mg (570 mg/m2), on day 1
Indication: Breast Cancer
Other drugs received by patient: Methotrexate Sodium; Cytoxan; Cytoxan
Possible Fluorouracil side effects in
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-14
Patient:
Reactions: Anaemia, Haematotoxicity
Drug(s) suspected as cause:
Fluorouracil
Dosage: (df; everycycle intravenous (not otherwise specified)), (df; every cycle intravenous (not otherwise
Indication: Colorectal Cancer
Leucovorin Calcium
Dosage: (df; every cycle intravenous (not otherwise specified))
Indication: Colorectal Cancer
Oxaliplatin
Dosage: (df; every cycle intravenous (not otherwise specified))
Indication: Colorectal Cancer
Possible Fluorouracil side effects in 59 year old
Reported by a physician from Canada on 2012-08-14
Patient: 59 year old
Reactions: Disease Progression
Drug(s) suspected as cause:
Avastin
Indication: Colorectal Cancer
Start date: 2011-11-02
Fluorouracil
Dosage: reported as folfox
Indication: Colorectal Cancer
Start date: 2011-11-02
Possible Fluorouracil side effects in
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-14
Patient:
Reactions: Neutropenia, Haematotoxicity
Drug(s) suspected as cause:
Fluorouracil
Dosage: (df; every cycle intravenous (not otherwise specified)), (df; every cycle intravenous (not otherwise
Indication: Colorectal Cancer
Leucovorin Calcium
Dosage: (df; every cycle intravenous (not otherwise specified))
Indication: Colorectal Cancer
Oxaliplatin
Dosage: (df; every cycle intravenous (not otherwise specified))
Indication: Colorectal Cancer
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