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Efudex (Fluorouracil Topical) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The most frequent adverse reactions to Efudex occur locally and are often related to an extension of the pharmacological activity of the drug. These include burning, crusting, allergic contact dermatitis, pruritus, scarring, rash, soreness, and ulceration. Ulcerations, other local reactions, cases of miscarriage and a birth defect (ventricular septal defect) have been reported when Efudex was applied to mucous membrane areas. Leukocytosis is the most frequent hematological side effect.

Although a causal relationship is remote, other adverse reactions which have been reported infrequently are:

Central Nervous System: Emotional upset, insomnia, irritability.

Gastrointestinal: Medicinal taste, stomatitis.

Hematological: Eosinophilia, thrombocytopenia, toxic granulation.

Integumentary: Alopecia, blistering, bullous pemphigoid, discomfort, ichthyosis, scaling, suppuration, swelling, telangiectasia, tenderness, urticaria, skin rash.

Special Senses: Conjunctival reaction, corneal reaction, lacrimation, nasal irritation.

Miscellaneous: Herpes simplex.



REPORTS OF SUSPECTED EFUDEX SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Efudex. The information is not vetted and should not be considered as verified clinical evidence.

Possible Efudex side effects / adverse reactions 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

Suspect drug(s):
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



Possible Efudex side effects / adverse reactions 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

Suspect drug(s):
Efudex



Possible Efudex side effects / adverse reactions 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

Suspect drug(s):
Efudex



See index of all Efudex side effect reports >>

Drug label data at the top of this Page last updated: 2014-05-05

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