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The following information outlines important safety considerations for those using erlotinib (Tarceva). It is crucial to understand these warnings and discuss any concerns with your healthcare provider.

• Severe Lung or Breathing Problems: Erlotinib (Tarceva) has been associated with interstitial lung disease (ILD), a rare yet serious condition characterized by lung scarring. Symptoms may appear between 5 days to 9 months after starting treatment. Contact your healthcare provider immediately if you experience new or worsening breathing issues, chest discomfort, a persistent dry cough, or fever. Treatment may need to be paused or discontinued to determine the underlying cause.

• Kidney or Liver Damage: This medication can lead to severe kidney issues. Regular monitoring of kidney function through lab tests is essential. Notify your healthcare provider if you notice any changes in urination frequency or if blood appears in your urine. Those with a history of liver problems or dehydration are at increased risk.

• Gastrointestinal Perforation: Although extremely rare, erlotinib (Tarceva) can cause tears in the stomach, intestines, or bowel lining, which can be life-threatening. The risk is higher if you are taking medications that affect blood vessel formation, corticosteroids, NSAIDs, or taxane chemotherapy. Seek immediate medical attention if you experience severe abdominal pain, fever, chills, nausea, or vomiting.

• Severe Skin Problems: Skin reactions such as blisters, dry or cracking skin, nail changes, and excessive hair growth may occur. Rarely, severe skin reactions or infections can happen, which require urgent medical care. Report any painful blisters, skin wounds, or peeling skin to your healthcare provider promptly.

• Stroke Risk: Blood clots in the brain leading to a stroke have occurred rarely in those taking erlotinib (Tarceva). Seek emergency medical help if you experience a severe headache, sudden confusion, weakness on one side of your body, or difficulty speaking or walking.

• Eye Problems: Possible side effects include reduced tear production, dry eyes, abnormal eyelash growth, and eye tissue inflammation. These can sometimes lead to more severe issues. Contact your healthcare provider if you have any eye pain or vision changes.

• Serious Bleeding with Warfarin: When taken with warfarin (Coumadin), there is an increased risk of bleeding. Regular blood tests will be conducted to ensure safe dosing. If you notice unusual bleeding, such as blood in your urine or dark stools, or if bleeding from a wound does not stop, seek immediate medical attention.

• Potential Harm to an Unborn Baby: Animal studies suggest that erlotinib (Tarceva) may harm an unborn baby or increase miscarriage risk. Women who are able to become pregnant should use effective birth control during treatment and for one month after the last dose. Inform your healthcare provider immediately if you become pregnant.

These safety considerations are vital for ensuring the safe use of erlotinib (Tarceva). Always communicate with your healthcare provider if you have any questions or experience adverse effects.

When taking this medication, you may experience some common side effects. These can include rash, diarrhea, loss of appetite, extreme tiredness, cough, difficulty breathing, nausea, and infections. While these are typically mild, it is important to consult your healthcare provider if they persist or worsen. Additionally, some individuals may notice dry skin, back pain, chest pain, itching, nail changes or infections, joint pain, muscle pain, or eye inflammation.

However, there are also serious side effects that require immediate medical attention. These include stroke symptoms such as severe headaches, visual changes, sudden confusion, weakness on one side of the body, dizziness, and trouble speaking or walking. Serious lung problems may manifest as extreme tiredness, dry cough, trouble catching your breath, fast and shallow breathing, or chest discomfort. Kidney issues can present as blood in the urine, painful urination, or dark urine. Liver damage symptoms include dark urine, right-sided stomach pain, yellowing of the eyes or skin, tiredness, loss of appetite, nausea, and vomiting. Gut damage symptoms involve fevers, chills, nausea, vomiting, bloating, and intense stomach pain. Severe skin reactions may appear as painful blisters, skin wounds, peeling skin, or painful sores in your mouth or around your eyes. Serious bleeding could manifest as persistent bleeding or bruising, large amounts of bleeding, blood in the urine, vomiting blood, or bloody or black, tarry stools.

A rash, while often mild, can sometimes indicate a serious allergic reaction. If you develop a rash, seek medical attention promptly. Although rare, a serious allergic reaction can occur, with symptoms such as itching, swelling (especially of the face, tongue, or throat), severe dizziness, and trouble breathing. Always contact your healthcare provider if you notice any other unusual effects.

Erlotinib (Tarceva) can interact with various medications and substances. It's important to inform your doctor and pharmacist about any other medications or supplements you are taking, including prescription, over-the-counter drugs, vitamins, and herbal products.

Some drugs that may interact with Erlotinib include those that reduce stomach acid, such as proton pump inhibitors like omeprazole, and medications that increase bleeding risk, such as antiplatelet drugs (e.g., clopidogrel), NSAIDs (e.g., ibuprofen, naproxen), and blood thinners (e.g., warfarin, dabigatran). Using aspirin alongside Erlotinib may also heighten bleeding risk, but if your doctor has prescribed low-dose aspirin (81-162 mg daily) for heart attack or stroke prevention, continue as advised unless instructed otherwise by your doctor. Consult your healthcare provider for more guidance.

Additionally, smoking can lower the effectiveness of Erlotinib by decreasing its blood levels. Inform your doctor if you smoke or have recently quit smoking.

Other potential interactions include a wide range of medications such as acenocoumarol, amiodarone, various antivirals and antibiotics (e.g., clarithromycin, ciprofloxacin), certain antifungals (e.g., itraconazole, ketoconazole), and more. If these drugs are necessary alongside Erlotinib, your doctor may adjust dosages or treatment schedules to mitigate interaction risks.