All About Orilissa
If you have endometriosis that causes you moderate or severe pain, your doctor may suggest treatment with Orilissa.
Endometriosis is a condition that causes tissue normally found lining the uterus to grow in your belly, outside the uterus. Orilissa is prescribed for adults to treat moderate or severe pain caused by endometriosis.
Because of the risk of bone loss, you shouldn’t take Orilissa for more than 24 months. But in some cases, your doctor may recommend that you only take it for 6 months. They will recommend which option is best for you. See “What are Orilissa’s side effects?” just below for more information.
To learn more about how Orilissa treats endometriosis, see “How does Orilissa work?” in the “What are some frequently asked questions about Orilissa?” section below.
Orilissa has a drug called elagolix. It is a tablet that you take with your mouth.
It’s not currently available as a generic drug. Instead, elagolix only comes as the brand-name drug Orilissa.
Orilissa has side effects, costs, uses, and more, so keep reading.
Orilissa may cause mild or serious side effects. Some of the more common side effects of Orilissa are described in the lists below. All possible side effects are not included in these lists.
Side effects of a drug can depend on other factors.
- Your age.
- You have other health conditions.
- You are taking other medications.
“The doctor or the pharmacy can tell you more about Orilissa’s side effects. They can suggest ways to reduce side effects.”
Mild side effects
Here’s a short list of some of the mild side effects that Orilissa can cause. To learn about other mild side effects, talk with your doctor or pharmacist, or read Orilissa’s medication guide.
There are some mild side effects of Orilissa that have been reported.
- The night sweats on.
- There were There were hot flashes..
- There is a throbbing head.
- insomnia (trouble sleeping)
- Joint pain.
- There is a lot of diarrhea.
- stopped periods*
- weight gain
Many drugs can have mild side effects that go away in a few days or weeks. If they become intolerable, talk to your doctor or pharmacist.
The side effect focus section gives more information about this side effect.
Serious side effects
Orilissa can have serious side effects, but they are not common. If you have serious side effects, call your doctor. If you think you have a medical emergency, call the emergency number.
Orilissa has been reported to have serious side effects.
- Mood changes., including feeling anxious or depressed, and in rare cases, thoughts of suicide
- There is an injury to the liver.
- bone loss*
- allergic reaction*
The side effect focus section gives more information about this side effect.
If you think someone is at risk of self-injury or hurting another person.
- You can call your local emergency number.
- Stay with the person until help arrives.
- Guns, knives, medications, and other things should be removed.
- “Don’t judge, argue, threaten, or yell.”
If you or someone you know is considering suicide, you should get help from a hotline. The National Suicide Prevention Hotline is 800-273-8255.
Side effect focus
Orilissa may cause some side effects.
Taking Orilissa could cause your periods to stop. You may also bleed less or for a shorter length of time during your periods.
This side effect was more common than others reported in studies. People taking a higher dosage of Orilissa were more likely to have this side effect.
Most people who stopped Orilissa had their periods resume within 1 to 6 months. How long it takes for your period to return depends on a number of factors, such as your dosage and Orilissa.
What can help?
If you have stopped periods, you should talk to your doctor about it. They can help you with your treatment plan.
Keep in mind that changes in periods caused by Orilissa may make it hard to tell if you’re pregnant. So, if your periods stop while taking Orilissa, watch for other signs of pregnancy, such as nausea and breast tenderness. This drug is not safe to take while pregnant. (For more information, see the “Can I take Orilissa while I’m pregnant or breastfeeding?” section below).
Although it’s not common, you may experience weight gain while taking Orilissa. This was reported by people taking the drug in studies, but it wasn’t common.
What can help?
If you have questions about your weight, talk to your doctor. They can help you maintain a healthy weight.
Orilissa is known to cause bone loss. In studies, people who took the drug lost bone mineral density (BMD). The degree of BMD loss varied, but it was severe in some people. (BMD indicates the strength of your bones.)
Orilissa has a higher risk of bone loss. The risk increases with the length of Orilissa.
It isn’t known whether bone loss caused by Orilissa is completely reversible, even if you stop taking the drug. And it isn’t known if this bone loss increases the risk of broken bones as you age.
What can help?
Because of the risk of bone loss, you shouldn’t take Orilissa for more than 24 months. But, if you take Orilissa twice each day or have liver problems, you shouldn’t take the drug for more than 6 months.
While you’re taking Orilissa, your healthcare professional may recommend that you take a vitamin D and calcium supplement. They may also suggest other ways to support your bone health.
Before you begin taking Orilissa, tell your doctor if you’ve ever broken a bone. You should also tell them about all the medications you take, so they can see if any cause bone loss. If you’ve ever broken a bone or you’re taking another medication that causes bone loss, your doctor may order an X-ray to check your bone health.
You shouldn’t take Orilissa if you have osteoporosis. Instead, ask your doctor about other treatment options for your condition.
Some people may have an allergic reaction to Orilissa.
A mild allergic reaction can include some symptoms.
- There is a skin rash.
- It is itchy.
- flushing (temporary warmth, redness, or deepening of skin color)
A more severe allergic reaction is not uncommon. A severe allergic reaction can cause swelling under your skin, which can be seen in your eyes, lips, hands, and feet. They can include swelling of your mouth, throat, and tongue, which can cause trouble breathing.
If you have an allergic reaction to Orilissa, call your doctor. If you think you have a medical emergency, call the emergency number.
Costs of prescription drugs can vary, depending on many factors. These factors include what your insurance plan covers and which pharmacy you use.
If you have questions about how to pay for your prescription, talk with your doctor or pharmacist. You can also visit the Orilissa manufacturer’s website to see if they have support options.
Your doctor will recommend the correct Orilissa dose for you. Always take the dosages your doctor prescribes.
Form and strengths
Orilissa is a tablet that you swallow. It is available in two strengths.
- 150 milligrams is a drug.
- 200 tablets
To treat moderate or severe pain caused by endometriosis, you’ll likely take Orilissa once or twice each day.
You shouldn’t take Orilissa for more than 24 months. If you take Orilissa twice each day or have liver problems, you shouldn’t take the drug for more than 6 months.
If you miss a dose of Orilissa, you should take it as soon as possible. Then, return to your regular schedule. If you miss the dose, skip it. Take your regular dose at your usual time.
Questions about Orilissa’s dosage
There are a couple questions related to Orilissa.
- Will I need to take Orilissa long term? Because of the risk of bone loss, you shouldn’t take Orilissa for more than 24 months. If you take Orilissa twice each day or have liver problems, you shouldn’t take the drug for more than 6 months. See the “Bone loss” section under “What are Orilissa’s side effects?” above for more information.
- How long does Orilissa take to work? In studies of the drug, it took up to 3 months for some people to feel a decrease in their endometriosis pain. Some people had pain relief sooner, though.
Find out what the questions are about Orilissa.
Are there reviews of Orilissa?
Yes, the manufacturer of Orilissa has a video library of patient stories and reviews on its website.
If you want to learn more about Orilissa reviews, you can talk to your healthcare professional.
Will Orilissa cause menopause, weight loss, acne, or hair loss?
Menopause, weight loss, acne, and hair loss weren’t reported as side effects by people taking Orilissa in studies.
Orilissa can cause amenorrhea (stopped periods), but this isn’t the same as menopause. Menopause begins when you haven’t had a period for 12 months in a row. And after menopause, you’re also no longer able to become pregnant naturally.
Orilissa may cause some side effects similar to symptoms of menopause, such as The night sweats on. and There were There were hot flashes... Talk with your doctor or pharmacist if these side effects are bothersome or become severe.
For more information about side effects that Orilissa may cause, see “What are Orilissa’s side effects?” above. If you have more questions, talk with your doctor or pharmacist.
Does stopping Orilissa cause withdrawal symptoms?
No, stopping Orilissa isn’t known to cause withdrawal symptoms. Some people’s endometriosis gets worse after they stop the treatment, though.
“If you have questions about Orilissa, you should talk to your healthcare professional. Unless they tell you to stop, don’t stop taking the drug.”
How does Orilissa work?
Orilissa’s mechanism of action (how it works) for treating endometriosis pain is to block the release of certain hormones made by your body. These hormones include follicle-stimulating hormone and luteinizing hormone.
Blocking these hormones decreases the levels of estrogen and progesterone in your body. This decreases tissue buildup outside your uterus.
For more information about how estrogen, progesterone, and endometriosis are related, see “Is Orilissa used for endometriosis?” below.
If you have more questions about Orilissa, you can talk to your doctor.
When was Orilissa approved by the FDA? Is it approved for fibroids or PCOS?
The Food and Drug Administration (FDA) approved Orilissa in 2018 to treat moderate or severe pain caused by endometriosis.
Orilissa isn’t currently approved to treat fibroids or polycystic ovary syndrome (PCOS). This drug may be prescribed off-label for these conditions, though. Off-label use is when a drug is used to treat a condition other than what it’s approved for.
“If you have questions about Orilissa’s uses, talk to your doctor or pharmacist.”
Orilissa and Lupron are both prescription medications used to treat pain caused by endometriosis. They belong to different groups of drugs. But they both work to decrease levels of certain hormones in your body, such as estrogen and progesterone.
Orilissa and Lupron have some differences. The only form of Lupron available is Lupron Depot. It’s given as an injection into a muscle by a healthcare professional every 3 months. Orilissa, on the other hand, is a tablet that you swallow once or twice each day.
To learn more about this alternative medication, talk with your doctor. You can also check out this side-by-side comparison of Orilissa and Lupron.
Yes. If you have endometriosis, your doctor may suggest treatment with Orilissa. It’s used in adult females* to treat moderate or severe pain caused by endometriosis.
Endometriosis is a condition that causes tissue normally found lining the uterus to grow in the belly, outside the uterus. It’s most common in people between the ages of 25 and 29 years. The most common symptoms are pelvic pain and infertility.
It’s not fully understood why endometriosis develops. But it’s known that the hormones estrogen and progesterone are involved.
Estrogen and progesterone are sex hormones that your body makes naturally. They play a major role in your menstrual cycle, including sending signals that make the lining of your uterus grow. Orilissa works by blocking these signals from being sent. This helps stop the growth of both the lining of your uterus and endometriosis tissue.
Note: You shouldn’t take Orilissa for more than 24 months. If you take Orilissa twice each day or have liver problems, you shouldn’t take the drug for more than 6 months. For more information, see “Bone loss” in the “What are Orilissa’s side effects?” section above.
* In this article, we use the term “female” to refer to someone’s sex assigned at birth. For information about the difference between sex and gender, see this article.
“Alcohol isn’t known to interact with Orilissa. It is possible that consuming alcohol may make Orilissa worse.”
Also, alcohol can sometimes worsen symptoms of endometriosis, which Orilissa is used to treat. If you drink alcohol, ask your doctor how much alcohol is safe for you to consume while taking Orilissa.
It is not safe to take Orilissa while pregnant. Doing so can lead to miscarriage (pregnancy loss)..
It’s recommended that you use nonhormonal birth control to help prevent pregnancy while you’re taking Orilissa. And you should keep using birth control for at least 28 days after stopping the drug. Check with your doctor about which birth control method is right for you.
Taking Orilissa can cause changes to your menstrual cycle, making it harder to know if you’re pregnant or not. Consider taking a pregnancy test if you think you may be pregnant. If you’re pregnant, you’ll need to stop taking Orilissa right away.
It is not known if Orilissa is safe to use while breastfeeding or if it is present in breast milk. Talk to your doctor about the best way to feed your child while taking Orilissa.
It’s recommended that you use nonhormonal birth control to help prevent pregnancy while you’re taking Orilissa. And you should keep using birth control for at least 28 days after stopping Orilissa treatment.
It’s not recommended to use birth control that contains estrogen while taking Orilissa. These methods can make Orilissa less effective and may increase the risk of serious problems related to estrogen, such as blood clots or a stroke. See the “Does Orilissa have any interactions?” section below for examples of birth control methods that can interact with Orilissa.
You can see this article to learn about birth control options that don’t contain estrogen. And your doctor can help you choose the birth control method that’s best for you.
Can I take Orilissa with birth control injections such as Depo-Provera or Mirena?
It’s not known if birth control injections (such as Depo-Provera) or an intrauterine device (IUD) (such as Mirena) affect how well Orilissa will work. Be sure to check with your doctor about which birth control method is right for you. You may need to change the birth control you use before you begin taking this drug.
“Your doctor will explain how Orilissa works. They will explain how much to take and how often. Follow your doctor’s instructions.”
Orilissa is a tablet that you swallow.
Taking Orilissa with other drugs
Orilissa can be used alone or with other drugs to treat moderate or severe pain caused by endometriosis.
For example, your doctor may have you take a nonsteroidal anti-inflammatory drug (NSAID), such as ibuprofen (Advil, Motrin). You can use an NSAID as needed to treat any breakthrough endometriosis pain while you’re taking Orilissa. (Breakthrough pain is pain that happens even while you’re taking a medication to treat it.)
If Orilissa works well, you can take the drug on its own.
Questions about taking Orilissa
Some questions about Orilissa are below.
- Can Orilissa be chewed, crushed, or split? The manufacturer of Orilissa hasn’t stated whether their drug may be chewed, crushed, or split. Talk with your doctor or pharmacist if you’re struggling to swallow Orilissa tablets. They may suggest other treatment options for you.
- Should I take Orilissa with food? You may take Orilissa with or without food.
Questions for your doctor
You may have questions about Orilissa. Discuss your concerns with your doctor.
Here are a few tips that might help you.
- Before your appointment, write down questions, such as:
- How will Orilissa affect me?
- Bring someone with you to your appointment to make you feel more comfortable.
- “If you don’t understand something, ask your doctor to explain it.”
“Your doctor and other healthcare professionals are available to help you. They want you to get the best care possible. Don’t be afraid to ask questions or give feedback about your treatment”
Taking medications or having vaccines, foods, or other things with a certain drug can affect how the drug works. These effects are called interactions.
Before taking Orilissa, you should tell your doctor about all the drugs you take. You should also describe any vitamins, herbs, or supplements you use. Your doctor or pharmacist can tell you about Orilissa interactions.
Interactions with drugs or supplements
Orilissa can interact with a lot of drugs. These include:
- certain birth control pills that contain estrogen, such as:
- Ethinyl estradiol and drospirenone are used for anesthesia.
- Norethindrone and ethinyl estradiol are used in medicine.
- ethinyl estradiol and levonorgestrel (Altavera, Amethia, Daysee, Lessina, Seasonique, and others)
- the birth control vaginal ring, ethinyl estradiol and etonogestrel (NuvaRing)
- the antibiotic clarithromycin
- the antifungals itraconazole (Sporanox) and ketoconazole
- The transplant drug cyclosporine is used for transplants.
- The drug gemfibrozil is used for cholesterol.
- The drug carbamazepine was seized.
- The drugs digoxin and rivaroxaban are used for the heart.
- the blood pressure drug amlodipine (Norvasc)
- the statin drug rosuvastatin (Crestor)
- the sleep drug zolpidem (Ambien)
The list does not include all the drugs that may interact with Orilissa. Your doctor or pharmacist can tell you more about these interactions.
Orilissa can interact with the supplement St. John’s wort. Taking them together can decrease Orilissa levels in your body, causing it to not work as well.
Also, eating grapefruit or drinking grapefruit juice while taking Orilissa could lead to increased levels of the drug in your body. Talk with your doctor or pharmacist about how much, if any, grapefruit is safe for you to consume while you’re taking Orilissa.
If you have a medical condition that affects your health, Orilissa may not be right for you. Before you take Orilissa, you should talk to your doctor about your health history. The factors to consider are listed below.
- Osteoporosis. You shouldn’t take Orilissa if you have low bone mineral density due to osteoporosis. Orilissa can cause bone loss and may make your condition worse. Your doctor can give you more information about other treatment options for your condition.
- Depression. If you’ve ever had depression, you may be more likely to experience depression, Mood changes., and suicidal thoughts while taking Orilissa. These symptoms may need to be treated while you’re taking Orilissa, which could include stopping Orilissa treatment.
- Severe liver problems. You should not take Orilissa if you have a severe liver problem. People with severe liver problems have a higher risk of bone loss as a side effect of Orilissa. Your doctor can tell you whether your liver is safe enough for Orilissa. If it isn’t, talk with them about other medications that may be better options for you.
- Allergic reaction. If you’ve had an allergic reaction to Orilissa or any of its ingredients, you shouldn’t take this drug. Ask your doctor what other medications are better options for you.
“Don’t take more Orilissa than your doctor tells you to. Taking more than this can cause serious side effects.”
What to do in case you take too much Orilissa
Call your doctor if you think you’ve taken too much Orilissa. You can also call 800-222-1222 to reach the American Association of Poison Control Centers, or use its online resource. However, if you have severe symptoms, immediately call 911 (or your local emergency number) or go to the nearest emergency room.
If you have questions about taking Orilissa, talk with your doctor. It’s a prescription medication used in adults who have moderate or severe pain caused by endometriosis.
Here are a few questions you can ask your doctor.
- I like to do activities that may put me at risk of broken bones. Is it still safe for me to take Orilissa?
- Is it safe to take Orilissa if I have an intrauterine device (IUD)?
- Orilissa is a surgical treatment option for endometriosis pain.
You may want to ask your doctor about other treatments. There are a few articles you can find helpful.
- Is it Endometriosis pain? There are identification, treatment, and more.
- Considering surgery for Endometriosis? Here is what you need to know.
- Home remedies for menstruation.
You can also learn more by subscribing to Healthline’s endometriosis newsletter.
I have pain during sex, which my doctor says could be caused by endometriosis. Is there a certain dosage of Orilissa I should take for this?
Yes. For pain during sex that may be related to endometriosis, it’s recommended to take 200 milligrams (mg) of Orilissa twice per day. When taken twice daily, you should not take Orilissa for more than 6 months. Be sure to follow the dosage that your doctor prescribes for you, however.
If you have questions about Orilissa, you should talk to your healthcare professional.
The Healthline Pharmacist TeamAnswers represent the opinions of our medical experts. All content is strictly informational and should not be considered medical advice.
Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.