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Gefitinib

Warning

Gefitinib has rarely caused very serious (possibly fatal) liver disease. Get medical help right away if you develop symptoms of liver disease, including stomach/abdominal pain, unusual tiredness, dark urine, yellowing eyes/skin.

Gefitinib has also rarely caused very serious (possibly fatal) tears in the wall of the stomach or intestines. Get medical help right away if you develop stomach/abdominal pain, black/bloody stools, or vomit that looks like coffee grounds.

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 (such as 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.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using gefitinib. Gefitinib may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for 2 weeks after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if gefitinib passes into breast milk. Because of possible risk to the infant, breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

Side Effects

See also Warning section.

Diarrhea, rash, acne, dry skin, nausea, vomiting, loss of appetite, nail problems, hair loss, red/sore mouth or throat, or unusual weakness may occur. If any of these effects last or get worse, tell your doctor or pharmacist right away.

Diarrhea is a common side effect. Drink plenty of fluids as directed by your doctor to reduce your risk of dehydration. Your doctor may prescribe anti-diarrhea medication to control your symptoms. Tell your doctor right away if you develop diarrhea that is severe or doesn't stop, or signs of dehydration (such as extreme thirst, dizziness, decreased urination).

Remember that this medication has been prescribed because your doctor 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.

Tell your doctor right away if you have any serious side effects, including: signs of kidney problems (such as change in the amount of urine), 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 right away if you develop shortness of breath, cough, or fever.

Gefitinib can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe 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 or at www.fda.gov/medwatch.

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

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Drug information is selected from data included with permission and copyrighted by First DataBank, Inc. This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your healthcare professional. Always seek the advice of your healthcare professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your healthcare professional. This information does not contain any assurances that this product is safe, effective or appropriate for you.

This information is intended only for residents of the United States. Products sold under the same brand names in other countries may contain different ingredients.

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Information expires December 2024.