This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Efudex (Fluorouracil Topical) 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 (13)
Death (2)
Life Threatening Events (1)
Disability (1)
Reports by Reaction Type
Abdominal Pain Upper (6),
Vomiting (5),
Blood Urine Present (5),
Diffuse Large B-Cell Lymphoma (4),
Incorrect Route of Drug Administration (2),
Pain (2),
Death (2),
Disseminated Intravascular Coagulation (1),
Drug Administration Error (1),
Metabolic Acidosis (1),
Rash Generalised (1),
Nausea (1)
Possible Efudex side effects in 64 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-26
Patient: 64 year old male
Reactions: Blood Urine Present, Vomiting, Diffuse Large B-Cell Lymphoma, Abdominal Pain Upper
Drug(s) suspected as cause:
Efudex
Other drugs received by patient: Morphine; Laxatives
Possible Efudex side effects in 64 year old male
Reported by a consumer/non-health professional from United Kingdom on 2012-08-10
Patient: 64 year old male
Reactions: Blood Urine Present, Vomiting, Diffuse Large B-Cell Lymphoma, Abdominal Pain Upper
Drug(s) suspected as cause:
Efudex
Other drugs received by patient: Morphine; Laxatives
Possible Efudex side effects in 64 year old male
Reported by a consumer/non-health professional from United Kingdom on 2012-08-10
Patient: 64 year old male
Reactions: Blood Urine Present, Vomiting, Diffuse Large B-Cell Lymphoma, Abdominal Pain Upper
Drug(s) suspected as cause:
Efudex
Other drugs received by patient: Laxatives; Morphine
Possible Efudex side effects in 64 year old male
Reported by a consumer/non-health professional from United Kingdom on 2012-08-09
Patient: 64 year old male
Reactions: Vomiting, Blood Urine Present, Diffuse Large B-Cell Lymphoma, Abdominal Pain Upper
Drug(s) suspected as cause:
Efudex
Other drugs received by patient: Morphine; Laxatives
Possible Efudex side effects in 84 year old male
Reported by a pharmacist from United Kingdom on 2012-07-13
Patient: 84 year old male
Reactions: Pain, Drug Administration Error, Conjunctival Scar
Drug(s) suspected as cause:
Efudex
Possible Efudex side effects in 64 year old male
Reported by a individual with unspecified qualification from United Kingdom on 2012-06-15
Patient: 64 year old male
Reactions: Vomiting, Blood Urine Present, Lymphoma, Abdominal Pain Upper
Drug(s) suspected as cause:
Efudex
Other drugs received by patient: Laxatives; Morphine
Possible Efudex side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-08
Patient: male
Reactions: Bedridden, Abdominal Pain Upper, Terminal State
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Efudex
Possible Efudex side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-08
Patient: female
Reactions: Death, Incorrect Route of Drug Administration
Adverse event resulted in: death
Drug(s) suspected as cause:
Efudex
Possible Efudex side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-08
Patient: female
Reactions: Death, Incorrect Route of Drug Administration
Adverse event resulted in: death
Drug(s) suspected as cause:
Efudex
Possible Efudex side effects in 66 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-04-05
Patient: 66 year old male
Reactions: Rash Generalised, Rash Pruritic
Drug(s) suspected as cause:
Efudex
Other drugs received by patient: Cetirizine
Possible Efudex side effects in 36 year old male
Reported by a consumer/non-health professional from United States on 2012-03-01
Patient: 36 year old male, weighing 86.2 kg (189.6 pounds)
Reactions: Gastrointestinal Haemorrhage, Pain, Toxicity To Various Agents, Gastric Disorder, Tremor
Drug(s) suspected as cause:
Efudex
Possible Efudex side effects in 52 year old male
Reported by a consumer/non-health professional from United States on 2012-01-06
Patient: 52 year old male, weighing 98.9 kg (217.5 pounds)
Reactions: Hypersensitivity, Nausea, Sinus Disorder, Immune System Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Efudex
Possible Efudex side effects in 79 year old male
Reported by a physician from Japan on 2011-10-04
Patient: 79 year old male, weighing 51.0 kg (112.2 pounds)
Reactions: Metabolic Acidosis, Hypotension, Disseminated Intravascular Coagulation, Respiratory Alkalosis, Pyrexia, Ileus Paralytic, Haemoglobin Decreased, Respiratory Failure, Neutropenia, Thrombocytopenia, Leukopenia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Camptosar
Dosage: 140 mg/body (95.2 mg/m2), unk
Start date: 2010-01-05
End date: 2010-01-05
Camptosar
Dosage: 224 mg/body (152.4 mg/m2), unk
Indication: Colorectal Cancer
Start date: 2009-09-03
End date: 2009-09-03
Efudex
Dosage: 600 mg/body, (408.2 mg/m2)
Indication: Colorectal Cancer
Start date: 2009-09-03
End date: 2009-09-03
Efudex
Dosage: 3600 mg/body/d1-2, (2449 mg/m2/d1-2)
Start date: 2009-09-03
End date: 2009-09-03
Erbitux
Dosage: 605 mg/body (411.6 mg/m2), unk
Indication: Colorectal Cancer
Start date: 2009-09-03
End date: 2009-09-03
Erbitux
Dosage: 375 mg/body (255.1 mg/m2), unk
Start date: 2009-09-10
End date: 2009-09-10
Erbitux
Dosage: 280 mg/body (190.5 mg/m2), unk
Start date: 2010-01-05
End date: 2010-01-12
Other drugs received by patient: Albumin Normal Human Serum; Levoleucovorin Calcium; Midazolam HCL; RED Blood Cells, Leucocyte Depleted
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