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Gefitinib Side Effects

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.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when 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
  • 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

Minor Side Effects

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:

Less common:
  • Redness or soreness around fingernails or loosening of the fingernails

For Healthcare Professionals

Applies to gefitinib: oral tablet


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


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]


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]


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]


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]

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]


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]


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


Very common (10% or more): Asthenia (up to 17%)
Common (1% to 10%): Pyrexia[Ref]


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


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


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

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.

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 material does not endorse drugs, diagnose patients, or recommend therapy. This 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 combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials 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 substances you are taking, check with your doctor, nurse, or pharmacist.