Applies to fluorouracil: solution.

Serious side effects of Fluorouracil

Along with its needed effects, fluorouracil may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.

Check with your doctor immediately if any of the following side effects occur while taking fluorouracil:

More common

• Diarrhea
• heartburn
• sores in mouth and on lips

Less common

• Black, tarry stools
• cough or hoarseness, accompanied by fever or chills
• fever or chills
• lower back or side pain, accompanied by fever or chills
• nausea and vomiting (severe)
• painful or difficult urination, accompanied by fever or chills
• stomach cramps

Rare

• Blood in urine or stools
• pinpoint red spots on skin
• unusual bleeding or bruising

Check with your doctor as soon as possible if any of the following side effects occur while taking fluorouracil:

Rare

• Chest pain
• cough
• shortness of breath
• tingling of hands and feet, followed by pain, redness, and swelling
• trouble with balance

Other side effects of Fluorouracil

Some side effects of fluorouracil may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Loss of appetite
• nausea and vomiting
• skin rash and itching
• weakness

Less common

• Dry or cracked skin

This medicine often causes a temporary loss of hair. After treatment with fluorouracil has ended, normal hair growth should return.

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, Check with your doctor immediately if you notice the following side effects:

• Black, tarry stools
• blood in urine or stools
• cough or hoarseness, accompanied by fever or chills
• fever or chills
• lower back or side pain, accompanied by fever or chills
• painful or difficult urination, accompanied by fever or chills
• pinpoint red spots on skin
• unusual bleeding or bruising

For Healthcare Professionals

Applies to fluorouracil: compounding powder, intravenous solution.

Cardiovascular

Very common (10% or more): Ischemic ECG abnormalities

Common (1% to 10%): Angina pectoris-like chest pain

Uncommon (0.1% to 1%): Arrhythmia, myocardial infarction, myocardial ischemia myocarditis, heart insufficiency, dilative cardiomyopathy, cardiac shock, hypotension

Rare (0.01% to 0.1%): Cerebral, intestinal and peripheral ischemia, Raynaud's syndrome, thromboembolism

Very rare (less than 0.01%): Cardiac arrest, sudden cardiac death

Frequency not reported: Tachycardia^[Ref]

Dermatologic

Very common (10% or more): Palmar-plantar erythrodysesthesia syndrome (hand-foot syndrome), alopecia

Uncommon (0.1% to 1%): Dermatitis, skin alterations (e.g., dry skin, fissure erosion, erythema, pruritic maculopapular rash), exanthema, urticaria, photosensitivity, hyperpigmentation, streaky hyperpigmentation or depigmentation near the veins, changes in nails (e.g., diffuse superficial blue pigmentation, hyperpigmentation, nail dystrophy, pain and thickening of the nail bed, paronychia), onycholysis^[Ref]

Endocrine

Rare (less than 0.1%): Total thyroxin (T4) increased, total triiodothyronine (T3) increased^[Ref]

Gastrointestinal

Very common (10% or more): Mucositis (stomatitis, esophagitis, pharyngitis, proctitis), anorexia, watery diarrhea, nausea, vomiting

Uncommon (0.1% to 1%): Dehydration, GI ulceration, GI bleeding, GI sloughing

Frequency not reported: Dysphagia^[Ref]

Genitourinary

Uncommon (0.1% to 1%): Spermatogenesis, ovulation disorder

Frequency not reported: Urinary tract infection^[Ref]

Hematologic

Very common (10% or more): Myelosuppression, neutropenia, thrombocytopenia, leucopenia, agranulocytosis, anemia, pancytopenia

Rare (less than 0.1%): Thrombophlebitis/vein tracking^[Ref]

Hepatic

Uncommon (0.1% to 1%): Liver cell damage

Very rare (less than 0.01%): Liver necrosis, biliary sclerosis, cholecystitis^[Ref]

Hypersensitivity

Rare (less than 0.1%): Generalized allergic reactions, anaphylaxis, anaphylactic shock^[Ref]

Immunologic

Very common (10% or more): Immunosuppression with an increased risk of infection

Frequency not reported: Sepsis, septic shock, neutropenic sepsis, super infection, cellulitis^[Ref]

Nervous system

Uncommon (0.1% to 1%): Headache, dizziness, Parkinson's disease like symptoms, pyramidal signs

Very rare (less than 0.01%): Symptoms of leukoencephalopathy (including ataxia, acute cerebellar syndrome, dysarthria, confusion, disorientation, myasthenia, aphasia, convulsion, or coma in patients receiving high doses and in patients with dihydropyrimidine dehydrogenase deficiency)

Frequency not reported: Peripheral neuropathy, acute cerebellar syndrome^[Ref]

Ocular

Uncommon (0.1% to 1%): Nystagmus, excessive lacrimation, blurred vision, eye movement disturbance, optic neuritis, diplopia, decrease in visual acuity, photophobia, conjunctivitis, blepharitis, ectropion, dacryostenosis^[Ref]

Renal

Very rare (less than 0.01%): Kidney failure^[Ref]

Psychiatric

Uncommon (0.1% to 1%): Euphoria, somnolence

Rare (0.01% to 0.1%): Confusion

Very rare (less than 0.01%): Disorientation^[Ref]

Respiratory

Very common (10% or more): Bronchospasm, epistaxis

Frequency not reported: Breathlessness, pneumonia, pharyngitis^[Ref]