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Iressa

Disclaimer

Iressa Consumer (continued)

SIDE EFFECTS: See also Warning section.

Diarrhea, rash, acne, nausea, vomiting, loss of appetite, nail problems, hair loss, red/sore mouth or throat, or unusual weakness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist immediately.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Persistent nausea, vomiting, diarrhea, or loss of appetite may result in a serious loss of body water (dehydration) and kidney problems. Contact your doctor promptly if you notice any symptoms of dehydration, such as: unusual decreased urination, unusual dry mouth/thirst, fast heartbeat, dizziness/lightheadedness.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual bleeding (coughing up blood, blood in urine), eye irritation/pain, swelling of the ankles/feet.

Gefitinib may cause rare (possibly fatal) lung disease (interstitial lung disease-ILD). Tell your doctor immediately if you develop trouble breathing, cough or fever.

If you have persistent diarrhea or skin rashes contact your doctor. Your doctor may temporarily stop gefitinib (for up to 14 days) which may help reverse those side effects. Treatment is then resumed with the same dosage.

An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: severe rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Iressa (getfitinib) Side Effects Center for a complete guide to possible side effects

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: lung disease (e.g., pulmonary fibrosis), severe kidney disease, eye problems, stomach/intestinal ulcers, other stomach/intestinal problems (such as diverticulitis, blockage, bowel disease), smoking, cancer that has spread to the bowels.

Gefitinib is not recommended for use during pregnancy. It may cause harm to an unborn baby. Consult your doctor for more details.

It is not known whether this drug passes into breast milk. Due to the potential risk to the infant, breast-feeding while using gefitinib is not recommended.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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