SIDE EFFECTS: See also Warning and Drug Interactions sections. Diarrhea, nausea, drowsiness, dizziness, headache or vomiting may occur. If any of these effects persist or worsen, notify 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: depression, increased thirst, signs of kidney problems (such as change in the amount of urine). Seek immediate medical attention if any of these rare but serious side effects occur: symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating). 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 therapy 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 unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. Tipranavir can commonly cause a mild 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 allergic reaction. Therefore, seek immediate medical attention if you develop a rash. Taking estrogen (in birth control or hormone therapy) may increase your risk of developing this rash. 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 tipranavir, tell your doctor or pharmacist if you are allergic to it; or to sulfa drugs; 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: diabetes, heart problems (coronary artery disease, heart attack), blood or bleeding disorders (e.g., hemophilia), other conditions causing an increased risk of bleeding (e.g., injury, surgery), high blood fat levels (cholesterol/triglyceride), other viral infections (chronic hepatitis B or hepatitis C), liver disease (including abnormal liver function tests). This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana. This drug may rarely make your blood sugar rise, which can cause or worsen diabetes. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet. This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. During pregnancy, this medication should be used only when clearly needed. Treatment can lower the risk of passing HIV infection to your baby, and tipranavir 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: See also How to Use section. 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: antiplatelet drugs (e.g., clopidogrel), artemether, "blood thinners" (anticoagulants such as warfarin, heparins), NSAIDs (e.g., ibuprofen, naproxen, sulindac, indomethacin), disulfiram, estrogens (e.g., ethinyl estradiol), garlic supplements, vitamin E, lumefantrine, metronidazole, orlistat. Other medications can affect the removal of tipranavir from your body, which may affect how tipranavir works. Examples include macrolide antibiotics (such as erythromycin), rifampin, St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others. Tipranavir with ritonavir can both speed up and slow down the removal of other drugs from your body, thereby affecting how they work. Examples of affected drugs include alfuzosin, certain benzodiazepines (e.g., midazolam, triazolam), certain heart rhythm drugs (amiodarone, bepridil, flecainide, propafenone, quinidine), cisapride, colchicine, eletriptan, eplerenone, ergot-containing drugs (e.g., ergotamine), fluticasone, other HIV medications (such as etravirine, other protease inhibitors including fosamprenavir, lopinavir, saquinavir), meperidine, pimozide, ranolazine, rifabutin, salmeterol, certain "statin" cholesterol drugs (such as atorvastatin, lovastatin, simvastatin), drugs to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, vardenafil), among others. Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details. This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Talk to your doctor about additional or alternative reliable forms of birth control, and always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity to decrease the risk of spreading HIV to others. Tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your hormonal birth control is not working well.

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.