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Gefitinib Side Effects

Medically reviewed by Last updated on Feb 8, 2023.

Applies to gefitinib: oral tablet.

Serious side effects of Gefitinib

Along with its needed effects, gefitinib 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

Other side effects of Gefitinib

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.


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]


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]


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. 2003.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.