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Gefitinib Side Effects

Not all side effects for gefitinib 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. 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
  • 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

If any of the following symptoms of overdose occur while taking gefitinib, get emergency help immediately:

  • Diarrhea
  • 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
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).[Ref]

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.[Ref]


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.[Ref]


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.[Ref]

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


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


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


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.[Ref]


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

Nervous system

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

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.[Ref]


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


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


1. "Product Information. Iressa (gefitinib)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

2. Sagara R, Kitami A, Nakada T, Iijima M "Adverse reactions to gefitinib (Iressa(R)): Revealing sycosis- and pyoderma gangrenosum-like lesions." Int J Dermatol 45 (2006): 1002-3

3. Kim SY, Choi HJ, Park HJ, Lee JY, Cho BK "An unusual terminal hair growth on the nose tip associated with gefitinib therapy." Br J Dermatol (2007):

4. Razis E, Karina M, Karanastassi S, Fountzilas G "Three case reports of hand-foot syndrome with gefitinib." Cancer Invest 24 (2006): 514-6

5. Graves JE, Jones BF, Lind AC, Heffernan MP "Nonscarring inflammatory alopecia associated with the epidermal growth factor receptor inhibitor gefitinib." J Am Acad Dermatol 55 (2006): 349-53

6. Shih HC, Hsiao YP, Wu MF, Yang JH "Gefitinib-induced acute generalized exanthematous pustulosis in two patients with advanced non-small-cell lung cancer." Br J Dermatol 155 (2006): 1101-2

7. High WA "Gefitinib: a cause of pyogenic granulomalike lesions of the nail." Arch Dermatol 142 (2006): 939

8. Donovan JC, Ghazarian DM, Shaw JC "Scarring alopecia associated with use of the epidermal growth factor receptor inhibitor gefitinib." Arch Dermatol 144 (2008): 1524-5

9. Kumasaka R, Nakamura N, Shirato K, et al. "Side Effects of Therapy: CASE 1. Nephrotic Syndrome Associated With Gefitinib Therapy." J Clin Oncol 22 (2004): 2504-5

10. Stulberg DL, Crandell B, Fawcett RS "Diagnosis and treatment of basal cell and squamous cell carcinomas." Am Fam Physician 70 (2004): 1481-8

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