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Overview: Orilissa is commonly used to treat endometriosis. Common side effects include hot flashes, night sweats, and headaches. Serious side effects are rare but include bone loss and suicidal thoughts. Orilissa is a tablet you will swallow.

Uses

What is Orilissa used for?

Orilissa (elagolix) is commonly used to treat pain caused by endometriosis.

Orilissa may also be used for other conditions as determined by your healthcare provider.

How does Orilissa work (mechanism of action)?

Orilissa is a type of medicine called a gonadotropin-releasing hormone (GnRH) antagonist. It blocks a specific hormone, called estrogen, from being produced. Estrogen is responsible for causing pain associated with endometriosis. 

How is Orilissa supplied (dosage forms)?

Brands and other names

  • Orilissa

Dosage forms and strengths

  • 150 mg, 200 mg oral tablets

How should I store Orilissa?

Orilissa should be stored at room temperature or in the refrigerator, between 36 F to 86 F (2 C to 30 C). Store in a cool, dry place.

Side Effects

What are the most common side effects of Orilissa?

The most common side effects of Orilissa are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

  • Hot flashes
  • Night sweats
  • Headache
  • Nausea
  • Trouble sleeping
  • Lack of a period
  • Anxiety
  • Joint pain
  • Depression and mood changes

There may be other side effects of Orilissa that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Orilissa?

While less common, the most serious side effects of Orilissa are described below, along with what to do if they happen.

Severe Allergic Reactions. Orilissa may cause allergic reactions, which can be serious. Stop taking Orilissa and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Weak Bones. Using Orilissa for a long time may cause your bones to become weaker, leading to reduced bone density (osteopenia). It may also cause a more serious condition called osteoporosis, which can cause your bones to break (fracture) more easily. Tell your healthcare provider if you break a bone, and get a bone mineral density test if one is ordered for you.    

Suicidal Thoughts and Actions. Orilissa may cause suicidal thoughts or actions in a small number of people. It may also cause depression and mood changes. People who have had depression, anxiety, or other mood changes in the past may be at higher risk. If you are about to harm yourself, call 911 or call or text 988, the Suicide & Crisis Lifeline. Call your healthcare provider right away if you have any of the following symptoms.

  • New or increased thoughts of suicide or death
  • Suicide attempt
  • New or increased feelings of anxiety, depression, or other unusual changes in mood or behavior

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Orilissa. Call your healthcare provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Warnings & Precautions

Who should not use Orilissa?

Allergies to Ingredients. People who are allergic to any of the following should not take Orilissa.

  • Elagolix
  • Orilissa
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Orilissa.

Osteoporosis. Orilissa should not be taken by people who have osteoporosis. Osteoporosis is a condition where your bones become thin and weak and may break more easily.

Severe Liver Problems. Orilissa should not be taken by people who have severe liver problems. Tell your healthcare provider if you have any current or prior liver problems. 

Pregnancy. Do not take Orilissa if you are pregnant or planning to become pregnant. If you become pregnant while taking Orilissa, contact your healthcare provider right away. See the Pregnancy section for more details.

Drug Interactions. Orilissa should not be used or taken while you are using certain other medicines. Before using Orilissa, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

What should I know about Orilissa before using it?

Do not take Orilissa unless it has been prescribed to you by a healthcare provider. Take it as prescribed.

Do not share Orilissa with other people, even if they have the same condition as you. It may harm them.

Keep Orilissa out of the reach of children. If this medicine is kept in a refrigerator, take special precautions to keep it away from children who also use the refrigerator.

If you need to get rid of Orilissa, you should not flush it down the toilet. Instead, take it to your pharmacy or visit www.fda.gov/drugdisposal to learn how to throw away the medicine safely. 

What should I tell my healthcare provider before using Orilissa?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Orilissa is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your healthcare provider if you have or have had any of the following.

  • Any bone problems, including osteoporosis or broken bones in the past
  • Liver problems
  • Mental health problems, including depression, mood swings, or suicidal thoughts or behavior

Pregnancy. Do not take Orilissa while you are pregnant as it may increase the risk of a pregnancy loss. Your healthcare provider will give you a test to make sure you are not pregnant before you start Orilissa. You should use nonhormonal contraception, such as condoms, while taking Orilissa and for 28 days after stopping it. Tell your healthcare provider if you are, think you are, or plan to become pregnant. 

Orilissa can cause your period to stop or cause you to have irregular periods. This may make it hard to know if you are pregnant. Watch for other signs of pregnancy, such as nausea, weight gain, or breast tenderness. 

If you think you are pregnant, stop taking Orilissa right away and contact your healthcare provider. If you become pregnant while taking Orilissa, you can enroll in a Pregnancy Registry by calling 833-782-7241 or at www.bloompregnancyregistry.com. This registry collects safety information about the use of Orilissa during pregnancy.

Breastfeeding. It is not known if Orilissa passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Orilissa?

For more information about Orilissa, you can visit the manufacturer’s website at orilissa.com or call them at 844-674-3676.

Interactions

Does Orilissa interact with foods or drinks?

While taking Orilissa, you should not eat grapefruit or drink anything that has grapefruit juice. Grapefruit can block your body’s ability to break down Orilissa, causing too much of the medicine to stay in your body and increasing your risk for side effects.

It is unknown if drinking alcohol will affect Orilissa.

Does Orilissa interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before using Orilissa.

  • A medicine known as an organic anion transporting polypeptide (OATP)1B1 inhibitor, such as cyclosporine or gemfibrozil
  • A birth control pill, patch, vaginal ring, implant, injection, or intrauterine device (IUD)
  • Digoxin (Lanoxin), which is a medicine used to treat irregular heartbeat and some types of heart failure
  • A benzodiazepine, such as midazolam, clonazepam (Klonopin), diazepam (Valium and others), or lorazepam (Ativan and others), which is a medicine used for anxiety, muscle spasms, or seizures
  • A statin, such as or rosuvastatin (Crestor), which is a medicine to lower cholesterol
  • A proton pump inhibitor (PPI), such as esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), or rabeprazole (Aciphex)
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis

Many other medicines may alter the blood levels of Orilissa, and vice versa. Tell your healthcare provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Orilissa. Always check with your healthcare provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Orilissa?

If you or someone else has used too much Orilissa, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Orilissa?

If you miss a dose, take it as soon as you remember, as long as it is on the same day. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses. 

If you take Orilissa once a day, you should not take more than one tablet each day. If you take Orilissa two times a day, you should not take more than two tablets each day.