Iressa Side Effects

Generic Name: gefitinib

Note: This page contains side effects data for the generic drug gefitinib. It is possible that some of the dosage forms included below may not apply to the brand name Iressa.

It is possible that some side effects of Iressa may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to gefitinib: oral tablet

Along with its needed effects, gefitinib (the active ingredient contained in Iressa) 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 immediately if any of the following side effects occur while 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
  • wheezing
Incidence unknown
  • abnormal eyelash growth
  • blistering, peeling, loosening of skin
  • bloating of stomach
  • blood in urine
  • bloody nose
  • chills
  • constipation
  • cough
  • darkened urine
  • diarrhea
  • fainting or loss of consciousness
  • fast heartbeat
  • fast or irregular breathing
  • fever
  • indigestion
  • joint or muscle pain
  • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
  • loss of appetite
  • nausea
  • 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
  • vomiting
  • yellow eyes or skin
Symptoms of Overdose

Get emergency help immediately if any of the following symptoms of overdose occur while taking gefitinib:

  • Diarrhea
  • skin rash

Some side effects of gefitinib 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
  • blemishes on the skin, pimples
  • lack or loss of strength
  • dry skin
Less common
  • 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

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 (the active ingredient contained in Iressa)

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


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.

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