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Efudex (Fluorouracil Topical) - Side Effect Reports to FDA

 
 



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)Blood Urine Present (5)Vomiting (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)Rash Generalised (1)Metabolic Acidosis (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 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 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 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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