Gefitinib Side Effects

Brand Names: Iressa

Please note - some side effects for Gefitinib may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Gefitinib - for the Consumer

Gefitinib

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Gefitinib:

Acne; diarrhea; dry skin; loss of appetite; mouth ulcers; nausea; unusual weakness; vision problems; vomiting; weight loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the eyelids, mouth, face, lips, or tongue); cough; dark urine; dizziness; eye irritation or pain; extreme fatigue; fever; persistent diarrhea; stomach pain; swelling of the ankles or feet; yellowing of the skin or eyes.

Side Effects by Body System

Respiratory

Patients with ILD usually present with the acute onset of dyspnea which is sometimes associated with cough or low grade fever. The condition often becomes severe within a short time and requires hospitalization. ILD has been reported in patients who have received prior radiation (31% of reported cases), prior chemotherapy (57% of reported cases), and no previous therapy (12% of reported cases).

Respiratory side effects including interstitial lung disease (ILD) (approximately 1%) has been reported in patients receiving gefitinib. Approximately 1/3 of these cases have been fatal. ILD has been reported at a rate of approximately 2% in Japan in postmarketing experience. ILD has been reported at a rate of about 0.3% in approximately 23,000 patients treated in a US expanded access program and about 1% in the studies of first-line use in non-small cell lung cancer. (but with similar rates in both treatment and placebo groups). Reports have described ILD as interstitial pneumonia, pneumonitis, and alveolitis. Dyspnea (2%) and epistaxis have also been reported.

Gastrointestinal

Gastrointestinal side effects including diarrhea (up to 67%), nausea (up to 18%), vomiting (up to 12 %) and mouth ulceration (1%) have been reported. Pancreatitis has been reported rarely.

Dermatologic

Dermatologic side effects including rash (up to 54%), acne (up to 33%), dry skin (up to 26%), pruritus (up to 9%), and vesiculobullous rash (1%) have been reported. Toxic epidermal necrolysis and erythema multiforme have been reported very rarely. Three cases of hand-foot syndrome recall have been reported. Two cases of acute generalized exanthematous pustulosis have been reported. A case of terminal hair growth on the nose tip, a case of nonscarring inflammatory alopecia, a case of scarring alopecia, a case of sycosis with pyoderma gangrenosum-like lesions, and a case of pyogenic granuloma-like lesions of the nail have also been reported.

Hand-foot syndrome can occur in patients who have been previously exposed to agents know to cause hand-foot syndrome.

General

General side effects including anorexia (up to 10%), asthenia (up to 6%) and weight loss (up to 5%) have been reported.

Cardiovascular

Cardiovascular side effects including peripheral edema (2%) have been reported.

Ocular

Ocular side effects including amblyopia (2%) and conjunctivitis (1%) have been reported. Eye pain and corneal erosion/ulcer (sometimes associated with aberrant eyelash growth) have also been reported. Corneal membrane sloughing and ocular ischemia/hemorrhage have been reported very rarely.

Hypersensitivity

Hypersensitivity side effects including angioedema and urticaria have been reported very rarely.

Nervous system

There is insufficient data in pediatric patients to establish a causal relationship. Furthermore, there is no evidence to suggest an increased risk of cerebral hemorrhage in adult patients with NSCLC receiving gefitinib.

Nervous system side effects have included cases of CNS hemorrhage and death in pediatric patients with primary central nervous system tumors.

Renal

Renal side effects including hematuria have been reported. A case of nephrotic syndrome has also been reported.

Other

Other side effects including a case of trichomegaly have also been reported.

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 information does not endorse drugs, diagnose patients, or recommend therapy. This drug 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 drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information 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 drugs you are taking, check with your doctor, nurse, or pharmacist.