Gliadel Side Effects

Generic Name: carmustine

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

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

For the Consumer

Applies to carmustine: implantation implant

Along with its needed effects, carmustine (the active ingredient contained in Gliadel) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

More common
  • Blurred vision
  • change in ability to see colors, especially blue or yellow
  • confusion
  • fever
  • headache
  • nausea and vomiting
  • problems with movement, walking, or speech
  • seizures
  • trouble healing
Less common
  • Drowsiness
  • general feeling of illness
  • severe headache
  • stiff neck or back

Some side effects of carmustine 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
  • Abdominal or stomach pain
  • back pain
  • bladder pain
  • bloody or cloudy urine
  • difficult, burning, or painful urination
  • difficulty having a bowel movement (stool)
  • discouragement
  • feeling sad or empty
  • frequent urge to urinate
  • irritability
  • lack of appetite
  • lack or loss of strength
  • loss of interest or pleasure
  • lower back or side pain
  • tiredness
  • trouble concentrating
  • trouble sleeping
Less common
  • Chest pain

For Healthcare Professionals

Applies to carmustine: implant device, intravenous powder for injection

Respiratory

Most of the patients with respiratory toxicity received prolonged therapy with total doses greater than 1400 mg/m2, although respiratory problems have been reported in patients receiving as little as 600 mg/m2.

Delayed onset pulmonary fibrosis occurring up to 17 years after treatment has been reported in one long-term study (n=17) on patients who received carmustine (the active ingredient contained in Gliadel) in childhood and early adolescence combined with cranial radiotherapy (for intracranial tumors). Chest X-rays revealed pulmonary hypoplasia with upper zone contraction. Thoracic CT scans showed an unusual pattern of upper zone fibrosis. Some late reduction of pulmonary function was reported in all long-term survivors. In this long-term study, 8 of 17 died of delayed pulmonary lung fibrosis, including all those initially treated (5 of 17) at less than 5 years old.

Respiratory side effects including pulmonary infiltrates and/or fibrosis have been reported to occur from 9 days to 43 months after treatment with carmustine and related nitrosoureas. Cases of fatal respiratory toxicity have been reported.

Hematologic

Carmustine may produce cumulative myelosuppression. Thrombocytopenia has generally been reported to occur approximately four weeks after administration. Leukopenia has generally been reported to occur approximately five to six weeks after administration. Both have been reported to persist for one to two weeks.

Use of carmustine (the active ingredient contained in Gliadel) in combination with cimetidine has resulted in greater myelotoxicity (e.g., leucopenia, neutropenia).

Hematologic side effects including myelosuppression have been reported frequently. Thrombocytopenia, leukopenia, and less frequently, anemia have also been reported. Acute leukemia and bone marrow dysplasias have been reported following long-term nitrosourea therapy.

Gastrointestinal

Nausea and vomiting generally appear within two hours of dosing and last for four to six hours. Prior administration of antiemetics has been effective in diminishing and sometimes preventing these side effects.

Gastrointestinal side effects including nausea and vomiting have been reported frequently.

Hepatic

Hepatic side effects including increased transaminase, alkaline phosphatase, and bilirubin levels have been reported infrequently.

The increased levels are generally reversible.

Renal

Renal side effects including progressive azotemia, decrease in kidney size, and renal failure have been reported in patients after prolonged therapy and usually after large cumulative doses.

Cardiovascular

Cardiovascular side effects including hypotension and tachycardia have been reported. Three cases of myocardial ischemia during and immediately after high-dose carmustine (the active ingredient contained in Gliadel) infusion have been reported.

Local

Local side effects including burning and hyperpigmentation have been reported.

Other

Other side effects have included intensive flushing of the skin and suffusion of the conjunctiva following rapid intravenous infusion of carmustine (the active ingredient contained in Gliadel)

This effect usually has been reported to occur within two hours and last for approximately four hours.

Ocular

Ocular side effects including neuroretinitis have been reported.

General

General side effects including chest pain and headache have been reported.

Oncologic

Oncologic side effects have included spontaneous reports of cyst formation after gliadel wafer implantation. Carcinogenicity has been reported in animal studies.

Cyst formation occurred at varying time intervals postimplantation. Cyst formation has also been reported in patients following resection of malignant glioma who have not had gliadel implanted.

Carmustine has been reported in animal studies to produce a marked increase in tumor incidence at doses approximating clinical doses.

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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