All About Orilissa

What are Orilissa’s side effects?

Like most drugs, Orilissa may cause mild or serious side effects. The lists below describe some of the more common side effects that Orilissa may cause. These lists don’t include all possible side effects.

Keep in mind that side effects of a drug can depend on:

• your age
• other health conditions you have
• other medications you’re taking

Your doctor or pharmacist can tell you more about the potential side effects of Orilissa. They can also suggest ways to help 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 prescribing information.

Mild side effects of Orilissa that have been reported include:

• night sweats
• hot flashes
• headache
• nausea
• insomnia (trouble sleeping)
• joint pain
• diarrhea
• stopped periods
• weight gain

Mild side effects of many drugs may go away within a few days or a couple of weeks. But if they become bothersome, talk with your doctor or pharmacist.

Serious side effects

Serious side effects of Orilissa can occur, but they aren’t common. If you have serious side effects of Orilissa, call your doctor right away. But if you think you’re having a medical emergency, call 911 or your local emergency number.

Serious side effects of Orilissa that have been reported include:

• mood changes, including feeling anxious or depressed, and in rare cases, thoughts of suicide
• liver injury
• bone loss
• allergic reaction*

In addition to the information above, you can also refer to this article about Orilissa’s side effects.

* For more information about this side effect, see the “Allergic reaction” section below.

Allergic reaction

Some people may have an allergic reaction to Orilissa.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (temporary warmth, redness, or deepening of skin color)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include swelling under your skin, typically in your eyelids, lips, hands, or feet. They can also include swelling of your tongue, mouth, or throat, which can cause trouble breathing.

Call your doctor right away if you have an allergic reaction to Orilissa. But if you think you’re having a medical emergency, call 911 or your local emergency number.

What does Orilissa cost?

Whether you have health insurance or not, cost may be a factor when you’re considering Orilissa. What you’ll pay for Orilissa may depend on several things, such as your treatment plan and the pharmacy you use.

Here are a few things to consider regarding cost:

• Cost information and savings coupons: You can visit Optum Perks* to get price estimates of what you’d pay for Orilissa when using coupons from the site.
• Savings program: If you have questions about how to pay for your prescription, talk with your doctor or pharmacist. Savings options may also be available on the Orilissa manufacturer’s website.

You can also check out this article to learn more about saving money on prescriptions.

* Optum Perks is a sister site of Healthline. Optum Perks coupons cannot be used with any insurance copays or benefits.

What is Orilissa’s dosage?

Your doctor will recommend the dosage of Orilissa that’s right for you. Below is the commonly used dosage, but always take the dosage your doctor prescribes.

Form and strengths

Orilissa comes as a tablet that you swallow. It’s available in two strengths:

• 150 milligrams (mg)
• 200 mg

Recommended dosage

To treat moderate or severe pain caused by endometriosis, you’ll likely take Orilissa once or twice each day.

You should not take Orilissa for more than 24 months. If you take Orilissa twice each day or have liver problems, you should not take the drug for more than 6 months.

Questions about taking Orilissa

Below are some common questions about taking Orilissa.

• 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.
• Is there a best time of day to take Orilissa? You may take Orilissa once or twice per day. Taking this drug around the same time or times each day helps to keep a steady level of the drug in your body. This helps Orilissa work effectively. If you take the drug twice per day, try to take it about 12 hours apart (for example, once at 8 a.m. and once at 8 p.m.).
• What if I miss a dose of Orilissa? If you miss a dose of Orilissa and it’s still the day the dose was due, take it as soon as you remember. Then, go back to your regular dosing schedule. But if you miss the dose and it’s the next day, skip the missed dose. Take your regular dose at your usual time.
• Will I need to take Orilissa long term? Because of the risk of bone loss, you should not take Orilissa for more than 24 months. If you take Orilissa twice per day or have liver problems, you should not take the drug for more than 6 months. See “What are Orilissa’s uses?” below for details.

Overdose

Do not take more Orilissa than your doctor prescribes. Taking more than this can lead to 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 America’s Poison 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.

What are some frequently asked questions about Orilissa?

Find answers to some commonly asked questions about Orilissa.

Does stopping Orilissa cause withdrawal symptoms?

No, stopping Orilissa isn’t known to cause withdrawal symptoms. (Withdrawal symptoms can occur when you stop taking a drug your body depends on to function like usual.) Some people’s endometriosis symptoms get worse after stopping Orilissa treatment, though.

If you have questions about stopping Orilissa, talk with your doctor. Do not stop taking the drug unless they tell you to do so.

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 “What is Orilissa used for?” below.

If you have more questions about how Orilissa works, talk with your pharmacist or doctor.

What should I know about Orilissa vs. Lupron?

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 Lupron and Lupron Depot, talk with your doctor. You can also check out this side-by-side comparison of Orilissa and Lupron.

What is Orilissa used for?

Orilissa is used in adult females* to treat moderate or severe pain caused by endometriosis.

Endometriosis is a condition that causes tissue usually found lining the uterus to grow outside the uterus. The tissue may grow on surrounding organs, such as your ovaries, fallopian tubes, and the lining of your pelvis. The most common symptoms of endometriosis 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. These 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.

Your doctor may recommend taking Orilissa by itself, or with other drugs. For example, your doctor may recommend taking a nonsteroidal anti-inflammatory drug (NSAID), such as ibuprofen (Advil, Motrin), as needed.

* 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.

Limit of use

You should not take Orilissa for more than 24 months, due to the risk of bone loss. If you take Orilissa twice each day or have liver problems, you should not take the drug for more than 6 months.

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.

Taking a higher dosage of Orilissa increases your risk of bone loss. And the longer you take Orilissa, the more this risk increases. Your doctor may recommend that you take a vitamin D and calcium supplement while you’re taking Orilissa. 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. Your doctor may order an X-ray to check your bone health.

What should be considered before taking Orilissa?

Below is important information you should consider before taking Orilissa.

Interactions

Taking a medication with certain vaccines, foods, and other things can affect how the medication works. These effects are called interactions.

Orilissa can interact with several other medications, as well as some supplements and possibly certain foods.

Before taking Orilissa, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

Drug interactions

Below is a list of medications that can interact with Orilissa. This list does not contain all drugs that may interact with Orilissa. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Other interactions

Orilissa can also interact with other substances, such as:

• Vitamins or supplements: Orilissa can interact with the herbal supplement St. John’s wort. Taking them together can decrease Orilissa levels in your body, causing it not to work as well.
• Foods: 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 to consume while you’re taking Orilissa.
• Alcohol: Alcohol isn’t known to interact with Orilissa. But it’s possible that consuming alcohol may make certain side effects of Orilissa worse. These include hot flashes, headache, nausea, and mood changes. Also, alcohol can sometimes worsen symptoms of endometriosis, which Orilissa is used to treat. If you drink alcohol, ask your doctor how much is safe for you to consume while taking Orilissa.

Pregnancy and breastfeeding

It’s not safe to take Orilissa while pregnant. Doing so can lead to pregnancy loss.

Taking Orilissa can cause changes to your menstrual cycle, which can make it harder to know if you’re pregnant or not. If you think you may be pregnant, contact your doctor right away. If you’re pregnant, you’ll need to stop taking Orilissa right away.

If you take Orilissa during pregnancy, you can sign up for the drug’s pregnancy registry by calling 833-782-7241. You can also visit the registry website for details and ways to sign up. Your doctor can give you more information about this registry.

It’s not known whether Orilissa is safe to take while breastfeeding, or whether the drug passes into breast milk. Talk with your doctor about the best way to feed your child while taking Orilissa.

Birth control

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. Condoms and diaphragms are two types of nonhormonal birth control methods.

It’s not recommended to use birth control that contains estrogen or oral birth control that contains progestin 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 “Drug interactions” section above 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.

Other warnings

Orilissa can sometimes cause harmful effects in people who have certain conditions. This is known as a drug-condition interaction. Other factors may also affect whether Orilissa is a good treatment option for you.

Talk with your doctor about your health history before you take Orilissa. Be sure to tell them if any of the following factors apply to you:

• osteoporosis
• depression
• severe liver problems
• previous allergic reaction to Orilissa
• pregnancy
• breastfeeding

Similar drugs

Other drugs are available that can treat your condition. If you’d like to explore an alternative to Orilissa, talk with your doctor. They can tell you about other medications that might work well for you.

The following drugs are similar to Orilissa:

• aromatase inhibitors, such as:
  • letrozole (Femara)
  • anastrozole (Arimidex)
• gonadotropic-releasing hormone (GnRH) agonists, such as:
  • leuprolide (Lupron Depot)
• progestins, such as:
  • dienogest (Visanne)
  • norethindrone

Note: Some of these medications may be prescribed off-label for endometriosis. Off-label use is when a drug is used to treat a condition other than what it’s approved for.