SIDE EFFECTS: Since darunavir is always taken with other HIV medications, it may be difficult to tell whether darunavir is causing certain side effects. However, darunavir is known to cause diarrhea, nausea, vomiting, stomach pain, and headache. If any of these effects persist or worsen, 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). This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet. Get medical help right away 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), easy bruising/bleeding. This drug may rarely cause serious (possibly fatal) liver problems. Tell your doctor right away if you notice any of the following rare but very serious side effects: persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing eyes/skin. Changes in body fat may occur while you are taking this medication (such as 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 use 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. Darunavir 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, 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 darunavir, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Since darunavir must be taken with ritonavir, tell your doctor if you are allergic to ritonavir. 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 problems (such as hepatitis B or C), diabetes, a certain bleeding problem (hemophilia), lipid problems (high cholesterol or triglycerides/fats), heart problems (coronary artery disease, heart attack). 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 before using this medication. Treatment can lower the risk of passing HIV infection to your baby. Discuss the risks and benefits with your doctor. It is unknown 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 of the products that may interact with this drug include: orlistat, certain hepatitis C virus protease inhibitors (such as boceprevir, simeprevir, telaprevir), certain drugs used to treat seizures (such as carbamazepine, phenytoin, primidone), barbiturates (such as phenobarbital, secobarbital), a certain combination HIV medication (elvitegravir/cobicistat/emtricitabine/tenofovir). Darunavir can slow down the removal of other drugs from your body, which may affect how they work. Examples of affected drugs include certain alpha blockers (such as alfuzosin, tamsulosin), certain benzodiazepines (midazolam, triazolam), "blood thinners" (such as apixaban, rivaroxaban), bosutinib, dronedarone, ergot alkaloids (such as dihydroergotamine, ergotamine), certain drugs to treat erectile dysfunction-ED or pulmonary hypertension (such as avanafil, sildenafil), lomitapide, pimozide, ranolazine, salmeterol, certain "statin" cholesterol drugs (such as lovastatin, simvastatin), tolvaptan, among others. Other medications can affect the removal of darunavir from your body, which may affect how darunavir works. Examples include garlic supplements, certain rifamycins (rifampin, rifapentine), St. John's Wort, among others. 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. Do not take this medication with other products that contain darunavir.

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.