SIDE EFFECTS: Nausea may occur. If this effect persists or worsens, tell your doctor or pharmacist promptly. 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. As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including: unexplained weight loss, severe tiredness, muscle aches/weakness that doesn't go away, headaches that are severe or don't go away, joint pain, numbness/tingling of the hands/feet/arms/legs, vision changes, signs of infection (such as fever, chills, swollen lymph nodes, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre syndrome (such as trouble breathing/swallowing/moving your eyes, drooping face, paralysis, trouble speaking). Tell your doctor right away if any of these unlikely but serious side effects occur: increased thirst/urination, signs of kidney problems (such as change in the amount of urine), mental/mood changes (e.g., nervousness, confusion), seizures. Get medical help right away if any of these rare but very serious side effects occur: chest/jaw/left arm pain. Changes in body fat may occur while you are taking this medication (e.g., increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible role of exercise to reduce this side effect. 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. Etravirine can commonly cause a mild rash that is usually not serious. The rash usually occurs during the second week of treatment and goes away in 1 to 2 weeks. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, get medical help right away if you develop any rash, especially with symptoms such as fever, tiredness, muscle/joint pain, blisters, mouth sores, or red/swollen eyes. 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.

PRECAUTIONS: Before taking etravirine, 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: liver disease (e.g., hepatitis B, hepatitis C). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Children may be more sensitive to the side effects of this drug, especially rash. During pregnancy, this medication should be used only when clearly needed. Treatment can lower the risk of passing HIV infection to your baby, and etravirine may be part of that treatment. Discuss the risks and benefits with your doctor. It is not known if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: certain anti-seizure medicines (carbamazepine, phenobarbital, phenytoin, primidone), other HIV NNRTIs (e.g., efavirenz, nevirapine, delavirdine), certain HIV protease inhibitors (atazanavir, fosamprenavir, tipranavir/ritonavir), orlistat, rifampin, rifapentine, St John's wort. Make sure your doctor is aware of all the HIV drugs you are taking. This medication may interact with other HIV medications. Your doctor may need to change your treatment or monitor you more closely if you are taking a certain combination of HIV medications. Consult your doctor or pharmacist for more details. Other medications can affect the removal of etravirine from your body, which may affect how etravirine works. Examples include rifabutin, azole antifungals (such as itraconazole), macrolide antibiotics (such as erythromycin, clarithromycin), among others. This drug can speed up or slow down the removal of other drugs from your body by affecting certain liver enzymes. These affected drugs include clopidogrel, cobicistat, medications for heart rhythm (e.g., amiodarone, disopyramide, quinidine), "blood thinners" (e.g., warfarin), certain "statin" cholesterol medications (atorvastatin, fluvastatin, lovastatin, simvastatin), drugs to treat erectile dysfunction-ED or pulmonary hypertension (e.g., sildenafil, tadalafil), among others.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.