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Iressa Side Effects

Generic Name: gefitinib

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

Not all side effects for Iressa 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 (the active ingredient contained in Iressa). 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


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.

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