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

Applies to gefitinib: oral tablet.

Serious side effects of Iressa

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:

More common

• Abdominal or stomach pain or tenderness
• clay colored stools
• dark urine
• decreased appetite
• diarrhea, severe
• fever
• headache
• itching or skin rash
• loss of appetite
• nausea and vomiting
• swelling of the feet or lower legs
• unusual tiredness or weakness
• yellow eyes or skin

Less common

• Burning, dry, or itching eyes
• chest pain
• chills
• cough
• difficult breathing
• discharge or excessive tearing
• dry eyes
• general feeling of discomfort or illness
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• thickening of bronchial secretions
• troubled breathing
• troubled or quick, shallow breathing

Rare

• Blistering, peeling, or loosening of the skin
• bloody, black, or tarry stools
• eye redness, irritation, or pain
• heartburn
• indigestion
• joint or muscle pain
• red skin lesions, often with a purple center
• severe abdominal or stomach pain, cramping, or burning
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• vomiting of material that looks like coffee grounds, severe and continuing

Other side effects of Iressa

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:

Less common

• Redness or soreness around fingernails or loosening of the fingernails

For Healthcare Professionals

Applies to gefitinib: oral tablet.

Respiratory

Common (1% to 10%): Interstitial lung disease or ILD-like adverse reactions^[Ref]

Hepatic

Very common (10% or more): Increased AST (up to 40%), increased ALT (up to 38%)

Common (1% to 10%): Increased bilirubin

Uncommon (0.1% to 1%): Hepatitis/hepatic failure

Rare (less than 0.1%): Fatal hepatotoxicity^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 29%), nausea (up to 18%), vomiting (up to 14%)

Common (1% to 10%): Stomatitis, dry mouth, pancreatitis, dehydration (secondary to diarrhea, nausea, vomiting, or anorexia)

Uncommon (0.1% to 1%): GI perforation^[Ref]

Ocular

Common (1% to 10%): Keratitis, conjunctivitis, blepharitis, dry eye

Uncommon (0.1% to 1%): Corneal erosion/aberrant eyelash growth^[Ref]

Nervous system

Rare (less than 0.1%): CNS hemorrhage

Frequency not reported: Cerebrovascular events^[Ref]

Dermatologic

Very common (10% or more): Skin reactions (up to 47%)

Common (1% to 10%): Nail disorder, alopecia

Rare (less than 0.1%): Bullous conditions (including toxic epidermal necrolysis, Stevens Johnson syndrome, erythema multiforme), cutaneous vasculitis^[Ref]

Reported skin reactions: acne/acne pustular, dermatitis (acneiform and exfoliative), drug eruption, dry skin, erythema, folliculitis, pruritus, rash (erythematous, exfoliative, generalized, macular, maculo-papular, papular, pruritic, pustular, vesicular), skin exfoliation, skin toxicity, and xeroderma.^[Ref]

Renal

Very common (10% or more): Proteinuria (up to 35%)

Common (1% to 10%): Elevated blood creatinine, cystitis

Rare (less than 0.1%): Hemorrhagic cystitis

Frequency not reported: Renal failure^[Ref]

Metabolic

Very common (10% or more): Decreased appetite (up to 17%), anorexia (10%)^[Ref]

Other

Very common (10% or more): Asthenia (up to 17%)

Common (1% to 10%): Pyrexia^[Ref]

Hematologic

Common (1% to 10%): Hemorrhage (including epistaxis and hematuria)^[Ref]

Immunologic

Common (1% to 10%): Allergic reactions (including angioedema and urticaria)^[Ref]