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Combination hormone treatment increases the risk of blood clot problems, including clots in the legs, lungs, and heart. Do not use this medication if you smoke cigarettes/use tobacco and are over 35 years old. Smoking raises your risk of stroke, heart attack, blood clots, and high blood pressure from this product. The risk of these serious problems increases with age and with the number of cigarettes you smoke. Do not smoke or use tobacco.

Hot flashes, headache, tiredness, or menstrual period changes may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Hair thinning and hair loss may occur. It is unknown if normal hair growth will return after treatment has ended. 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. This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Tell your doctor right away if you have any serious side effects, including: lumps in the breast, mental/mood changes (such as new or worsening depression, anxiety, unusual changes in behavior), signs of liver damage (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding), symptoms of high blood sugar (such as increased thirst/urination). Get medical help right away if you have any very serious side effects, including: thoughts of suicide. The elagolix in this medication lowers estrogen levels in your body. Low estrogen levels can lead to bone loss (osteoporosis). The risk is increased with higher doses or with longer use of this medication. Some bone loss may be permanent. Talk with your doctor about the risks and benefits of taking this medication, and ask about taking calcium supplements and vitamin D for bone health. This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs). Get medical help right away if you have: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, trouble speaking, weakness on one side of the body, sudden vision changes. 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.

Some products that may interact with this drug are: aromatase inhibitors (such as anastrozole, exemestane, letrozole), fezolinetant, ospemifene, tamoxifen, tranexamic acid. Other medications can affect the removal of this medication from your body, which may affect how it works. Examples include asciminib, belumosudil, cyclosporine, encorafenib, gemfibrozil, letermovir, resmetirom, vadadustat, voclosporin, among others. This medication can speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include daridorexant, elacestrant, certain drugs for hepatitis C (such as asunaprevir, ombitasvir/paritaprevir/ritonavir), mavacamten, quizartinib, revumenib, among others.