Iressa Side Effects
Generic Name: gefitinib
Note: This page contains information about the side effects of gefitinib. Some of the dosage forms included on this document may not apply to the brand name Iressa.
Not all side effects for Iressa may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to gefitinib: oral tablet
In addition to its needed effects, some unwanted effects may be caused by gefitinib (the active ingredient contained in Iressa). In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when taking gefitinib:Less common
- bloating or swelling of face, arms, hands, lower legs, or feet
- burning, dry or itching eyes
- change in vision
- difficult or labored breathing
- eye discharge or excessive tearing
- redness, pain, swelling of eye, eyelid, or inner lining of eyelid
- shortness of breath
- tightness in chest
- tingling of hands or feet
- unusual weight gain or loss
- abnormal eyelash growth
- blistering, peeling, loosening of skin
- bloating of stomach
- blood in urine
- bloody nose
- darkened urine
- fainting or loss of consciousness
- fast heartbeat
- fast or irregular breathing
- joint or muscle pain
- large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
- loss of appetite
- pains in stomach, side, or abdomen, possibly radiating to the back
- redness, tenderness, itching, or burning of skin
- seeing floating spots before the eyes
- severe stinging of the eye
- skin rash
- sore throat
- sores, ulcers, or white spots in mouth or on lips
- unusual tiredness or weakness
- yellow eyes or skin
If any of the following symptoms of overdose occur while taking gefitinib, get emergency help immediately:
- skin rash
Some of the side effects that can occur with gefitinib may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:More Common
- blemishes on the skin, pimples
- lack or loss of strength
- dry skin
- irritation or soreness of mouth
- blisters under the skin, large, hard skin blisters
For Healthcare Professionals
Applies to gefitinib: oral tablet
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 side effects including diarrhea (up to 67%), nausea (up to 18%), vomiting (up to 12%) and mouth ulceration (1%) have been reported. Pancreatitis (0.1%) has been reported rarely.
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 side effects including anorexia (up to 10%), asthenia (up to 6%) and weight loss (up to 5%) have been reported.
Cardiovascular side effects including peripheral edema (2%) have been reported.
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 side effects including angioedema and urticaria have been reported very rarely.
Nervous system side effects have included cases of CNS hemorrhage and death in pediatric patients with primary central nervous system tumors.
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.
Renal side effects including hematuria have been reported. A case of nephrotic syndrome has also been reported.
Other side effects including a case of trichomegaly have also been reported.
More about Iressa (gefitinib)
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