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Adrucil Side Effects

Generic Name: fluorouracil

Note: This document contains side effect information about fluorouracil. Some of the dosage forms listed on this page may not apply to the brand name Adrucil.

For the Consumer

Applies to fluorouracil: injectable, solution

Along with its needed effects, fluorouracil (the active ingredient contained in Adrucil) 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

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]

References

1. "Product Information. Fluorouracil (fluorouracil)." BluePoint Laboratories, Norwich, NY.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Some side effects of Adrucil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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