Fluorouracil (Fluorouracil) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Stomatitis and esophagopharyngitis (which may lead to sloughing and ulceration), diarrhea, anorexia, nausea and emesis are commonly seen during therapy.

Leukopenia usually follows every course of adequate therapy with fluorouracil. The lowest white blood cell counts are commonly observed between the 9 ^th and 14^th days after the first course of treatment, although uncommonly the maximal depression may be delayed for as long as 20 days. By the 30^th day the count has usually returned to the normal range.

Alopecia and dermatitis may be seen in a substantial number of cases. The dermatitis most often seen is a pruritic maculopapular rash usually appearing on the extremities and less frequently on the trunk. It is generally reversible and usually responsive to symptomatic treatment.

Other adverse reactions are:

Hematologic: pancytopenia, thrombocytopenia, agranulocytosis, anemia.

Cardiovascular: myocardial ischemia, angina.

Gastrointestinal: gastrointestinal ulceration and bleeding.

Allergic Reactions: anaphylaxis and generalized allergic reactions.

Neurologic: acute cerebellar syndrome (which may persist following discontinuance of treatment), nystagmus, headache.

Dermatologic: dry skin; fissuring; photosensitivity, as manifested by erythema or increased pigmentation of the skin; vein pigmentation; palmar-plantar erythrodysesthesia syndrome, as manifested by tingling of the hands and feet followed by pain, erythema and swelling.

Ophthalmic: lacrimal duct stenosis, visual changes, lacrimation, photophobia.

Psychiatric: disorientation, confusion, euphoria.

Miscellaneous: thrombophlebitis, epistaxis, nail changes (including loss of nails).

REPORTS OF SUSPECTED FLUOROURACIL SIDE EFFECTS / ADVERSE REACTIONS

Possible Fluorouracil side effects / adverse reactions in 64 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-10-03

Patient: 64 year old female

Reactions: Dyspnoea, Neoplasm Progression, Pyrexia, Interstitial Lung Disease, Respiratory Failure, Platelet Count Decreased, Crepitations, Leukopenia, Cough

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Leucovorin Calcium
    Start date: 2008-03-01

Fluorouracil
    Start date: 2008-03-01

Bevacizumab
    Start date: 2008-03-01

Irinotecan Hydrochloride
    Start date: 2008-03-01

Possible Fluorouracil side effects / adverse reactions in 77 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-10-03

Patient: 77 year old male weighing 66.0 kg (145.2 pounds)

Reactions: Dermatitis Acneiform, Hypomagnesaemia, Hypocalcaemia, Convulsion

Adverse event resulted in: hospitalization

Suspect drug(s):
Panitumumab
    Dosage: 6 mg/kg, q2wk
    Start date: 2011-03-08

Panitumumab
    Dosage: 6 mg/kg, q2wk
    Start date: 2011-02-08

Panitumumab
    Dosage: 6 mg/kg, q2wk
    Indication: Colorectal Cancer
    Start date: 2010-07-20
    End date: 2010-11-16

Fluorouracil
    Indication: Colorectal Cancer
    Start date: 2010-09-07
    End date: 2010-11-16

Other drugs received by patient: Irinotecan HCL; Levoleucovorin Calcium

Possible Fluorouracil side effects / adverse reactions in 65 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-10-03

Patient: 65 year old male weighing 55.0 kg (121.0 pounds)

Reactions: Glossodynia, Stomatitis, Colorectal Cancer

Adverse event resulted in: death

Suspect drug(s):
Panitumumab
    Dosage: 4.8 mg/kg, q2wk
    Start date: 2010-10-28
    End date: 2010-12-09

Fluorouracil
    Indication: Colorectal Cancer
    Start date: 2010-09-16

Panitumumab
    Dosage: 4.8 mg/kg, q2wk
    Start date: 2011-03-03
    End date: 2011-04-14

Topotecan
    Indication: Colorectal Cancer
    Start date: 2010-09-16

Fluorouracil
    Start date: 2010-09-16

Panitumumab
    Dosage: 6 mg/kg, q2wk
    Indication: Colorectal Cancer
    Start date: 2010-09-16
    End date: 2010-09-16

Panitumumab
    Dosage: 4.8 mg/kg, q2wk
    Start date: 2011-05-12

Panitumumab
    Dosage: 4.8 mg/kg, q2wk
    Start date: 2011-01-13
    End date: 2011-02-03

Other drugs received by patient: Antihistamines; Minocycline HCL; Decadron; Polaramine; Corticosteroids; Aloxi; Levoleucovorin Calcium