UNDERSTANDING
SIDE EFFECTS

Take a closer look at the safety info

Because ORILISSA treats endometriosis pain by lowering estrogen, there are possible related side effects you may experience.

Most common side effects experienced by women in the clinical trials:

The percentage of women who experienced these side effects is shown below.

ORILISSA 150 mg once daily* ORILISSA 200 mg twice daily Placebo (a pill with no active medicine)


Hot flashes or night sweats

24% 46% 9%


Headache

17% 20% 12%


Nausea

11% 16% 13%


Insomnia (trouble sleeping)

6% 9% 3%


Mood altered, mood swings (mood changes)

6% 5% 3%


Amenorrhea (absence of periods)

4% 7% Less than 1% on placebo


Depressed mood, depression, depressive symptoms, and/or tearfulness

3% 6% 2%


Anxiety

3% 5% 3%


Arthralgia (joint pain)

3% 5% 3%

*Percentage based on 475 women taking ORILISSA 150 mg in 2 studies.
Percentage based on 477 women taking ORILISSA 200 mg in 2 studies.
Percentage based on 734 women taking placebo in 2 studies.

These are not all the possible side effects of ORILISSA. For more information, ask your gynecologist or pharmacist. Always tell your gynecologist if you have any side effect that bothers you or does not go away.

How many women stopped taking ORILISSA in the clinical trial program due to side effects?

In the ORILISSA clinical studies, about 10% or less stopped taking ORILISSA due to side effects.*†

*These women were in the ORILISSA clinical trials and had all taken ORILISSA for 6 months.

5.5% taking ORILISSA 150 mg once daily and 9.6% taking ORILISSA 200 mg twice daily stopped treatment because of side effects, compared to 6% taking placebo.

Some of the most common side effects for why women stopped taking it are shown below‖*:

hot flashes or night sweats

less than

2%

headaches

less than

1%

nausea

almost equal

1%

‖This is not a complete list of side effects that caused women to stop taking ORILISSA.
*Percentage based on 952 women taking ORILISSA in 2 studies.

 

Learn more about ORILISSA clinical trials

Want to learn more about the ORILISSA clinical trials?

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Got questions? We've got answers.

How many women in the clinical trials experienced hot flashes or night sweats?

Well, about 1 out of 4 women taking ORILISSA 150 mg and about 2 out of 4 women taking ORILISSA 200 mg experienced hot flashes or night sweats. Of these women, 94% reported that the hot flashes they had were mild or moderate (303 of 324 women).§ Less than 2% of women stopped taking ORILISSA because of hot flashes.*

§Mild/moderate were definitions used by the clinical researcher to rate the severity of each side effect. Mild was defined as temporary and easily tolerated. Moderate was defined as causing discomfort and interrupting usual activities.
*This is not the only side effect that caused women to stop taking ORILISSA.

Can ORILISSA put me into early menopause?
How can ORILISSA affect my bone health and what exactly is Bone Mineral Density (BMD)?
Will ORILISSA affect my period?
What do I do if I become pregnant while taking ORILISSA?
Why is it important to use effective birth control with ORILISSA?
Can I breastfeed while taking ORILISSA?
Who should not take ORILISSA?
What should I tell my doctor before starting ORILISSA?
What other serious side effects of ORILISSA should I know about?
What are the most common side effects of ORILISSA?
Discover the proven results of ORILISSA

Discover the proven results of ORILISSA

The benefits of ORILISSA were proven in the largest endometriosis clinical trial program to date.

See the results
Discover the proven results of ORILISSA

Hear women’s personal stories about ORILISSA

Amy had tried many treatments for her endometriosis pain. While they may have worked for others, they didn’t work for her. Find out why she and her GYN decided to try ORILISSA.

Watch Amy’s story
Get personalized support for questions before or during your ORILISSA treatment with the Ori for Me patient support program.

Questions? We're here to help.

An Ori for Me® nurse§ can help answer additional questions you may have.

 

§Remember to always ask your doctor for medical guidance. Ori for Me nurses do not offer medical advice.

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USE

ORILISSA® (elagolix) is a prescription medicine used to treat moderate to severe pain associated with endometriosis. It is not known if ORILISSA is safe and effective in children under 18 years of age.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ORILISSA?

ORILISSA may cause serious side effects, including bone loss and effects on pregnancy:

  • Bone Loss (decreased Bone Mineral Density [BMD])
    While you are taking ORILISSA, your estrogen levels will be low. This can lead to BMD loss. Your BMD may improve after stopping ORILISSA, but may not recover completely. It is unknown if these bone changes could increase your risk for broken bones as you age. Your healthcare provider (HCP) may order a DXA scan to check your BMD.
  • Effects on Pregnancy
    Do not take 
    ORILISSA if you are trying to become or are pregnant, as your risk for early pregnancy loss may increase. If you think you are pregnant, stop taking ORILISSA right away and call your HCP. ORILISSA may change your menstrual periods (irregular bleeding or spotting, a decrease in menstrual bleeding, or no bleeding at all), making it hard to know if you are pregnant. Watch for other signs of pregnancy, such as breast tenderness, weight gain, and nausea. ORILISSA does not prevent pregnancy. You will need to use effective hormone-free birth control (such as condoms or spermicide) while taking ORILISSA and for one week after stopping ORILISSA. Birth control pills that contain estrogen may make ORILISSA less effective. It is unknown how well ORILISSA works while on progestin-only birth control.

Do not take ORILISSA if you:

  • Are or may be pregnant, have osteoporosis, have severe liver disease, or take medicines known as strong OATP1B1 inhibitors, such as cyclosporine or gemfibrozil. If you are unsure if you are taking one of these medicines, ask your HCP.

What should I tell my HCP before taking ORILISSA?

Tell your HCP about all of your medical conditions, including if you:

  • Have or have had broken bones, have other conditions, or take medicines that may cause bone problems; have or have had depression, mood problems, or suicidal thoughts or behavior; have liver problems; think you may be pregnant; or are breastfeeding or plan to be. It is unknown if ORILISSA passes into breast milk. Talk to your HCP about the best way to feed your baby if you take ORILISSA.

Tell your HCP about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your HCP if you take birth control pills. Your HCP may advise you to change the pills you take or your method of birth control.

What are the possible side effects of ORILISSA?

ORILISSA can cause serious side effects including:

  • Suicidal thoughts, actions, or behavior, and worsening of mood. Call your HCP right away, or call 911 if an emergency, if you have any of these symptoms, especially if they are new, worse, or bother you: thoughts about suicide or dying, try to commit suicide, new or worse depression or anxiety, or other unusual changes in behavior or mood. You or your caregiver should pay attention to any changes, especially sudden changes in your mood, behaviors, thoughts, or feelings.
  • Abnormal liver tests. Call your HCP right away if you have any of these signs and symptoms of liver problems: yellowing of the skin or the whites of the eyes (jaundice), dark amber-colored urine, feeling tired, nausea and vomiting, generalized swelling, right upper stomach area pain, or bruising easily.

The most common side effects of ORILISSA include: hot flashes or night sweats, headache, nausea, difficulty sleeping, absence of periods, anxiety, joint pain, depression, and mood changes.

These are not all of the possible side effects of ORILISSA. This is the most important information to know about ORILISSA. For more information, talk to your doctor or HCP.

Take ORILISSA exactly as your HCP tells you. Tell your HCP if you have any side effect that bothers you or that does not go away. Call your HCP for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.


US-ORIL-200129

Please click here for Full Prescribing Information and Medication Guide.

 

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ORILISSA?

ORILISSA may cause serious side effects, including bone loss and effects on pregnancy:

USE

ORILISSA® (elagolix) is a prescription medicine used to treat moderate to severe pain associated with endometriosis. It is

USE

ORILISSA® (elagolix) is a prescription medicine used to treat moderate to severe pain associated with endometriosis. It is not known if ORILISSA is...

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ORILISSA?

ORILISSA may cause serious side effects, including bone loss and effects on pregnancy:

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ORILISSA?

ORILISSA may cause serious side effects, including bone loss and effects on pregnancy:

USE

ORILISSA® (elagolix) is a prescription medicine used to treat moderate to severe pain associated with endometriosis. It is

USE

ORILISSA® (elagolix) is a prescription medicine used to treat moderate to severe pain associated with endometriosis. It is not known if ORILISSA is...

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ORILISSA?

ORILISSA may cause serious side effects, including bone loss and effects on pregnancy:

USE

ORILISSA® (elagolix) is a prescription medicine used to treat moderate to severe pain associated with endometriosis. It is not known if ORILISSA is safe and effective in children under 18 years of age.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ORILISSA?

ORILISSA may cause serious side effects, including bone loss and effects on pregnancy:

  • Bone Loss (decreased Bone Mineral Density [BMD])
    While you are taking ORILISSA, your estrogen levels will be low. This can lead to BMD loss. Your BMD may improve after stopping ORILISSA, but may not recover completely. It is unknown if these bone changes could increase your risk for broken bones as you age. Your healthcare provider (HCP) may order a DXA scan to check your BMD.
  • Effects on Pregnancy
    Do not take 
    ORILISSA if you are trying to become or are pregnant, as your risk for early pregnancy loss may increase. If you think you are pregnant, stop taking ORILISSA right away and call your HCP. ORILISSA may change your menstrual periods (irregular bleeding or spotting, a decrease in menstrual bleeding, or no bleeding at all), making it hard to know if you are pregnant. Watch for other signs of pregnancy, such as breast tenderness, weight gain, and nausea. ORILISSA does not prevent pregnancy. You will need to use effective hormone-free birth control (such as condoms or spermicide) while taking ORILISSA and for one week after stopping ORILISSA. Birth control pills that contain estrogen may make ORILISSA less effective. It is unknown how well ORILISSA works while on progestin-only birth control.

Do not take ORILISSA if you:

  • Are or may be pregnant, have osteoporosis, have severe liver disease, or take medicines known as strong OATP1B1 inhibitors, such as cyclosporine or gemfibrozil. If you are unsure if you are taking one of these medicines, ask your HCP.

What should I tell my HCP before taking ORILISSA?

Tell your HCP about all of your medical conditions, including if you:

  • Have or have had broken bones, have other conditions, or take medicines that may cause bone problems; have or have had depression, mood problems, or suicidal thoughts or behavior; have liver problems; think you may be pregnant; or are breastfeeding or plan to be. It is unknown if ORILISSA passes into breast milk. Talk to your HCP about the best way to feed your baby if you take ORILISSA.

Tell your HCP about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your HCP if you take birth control pills. Your HCP may advise you to change the pills you take or your method of birth control.

What are the possible side effects of ORILISSA?

ORILISSA can cause serious side effects including:

  • Suicidal thoughts, actions, or behavior, and worsening of mood. Call your HCP right away, or call 911 if an emergency, if you have any of these symptoms, especially if they are new, worse, or bother you: thoughts about suicide or dying, try to commit suicide, new or worse depression or anxiety, or other unusual changes in behavior or mood. You or your caregiver should pay attention to any changes, especially sudden changes in your mood, behaviors, thoughts, or feelings.
  • Abnormal liver tests. Call your HCP right away if you have any of these signs and symptoms of liver problems: yellowing of the skin or the whites of the eyes (jaundice), dark amber-colored urine, feeling tired, nausea and vomiting, generalized swelling, right upper stomach area pain, or bruising easily.

The most common side effects of ORILISSA include: hot flashes or night sweats, headache, nausea, difficulty sleeping, absence of periods, anxiety, joint pain, depression, and mood changes.

These are not all of the possible side effects of ORILISSA. This is the most important information to know about ORILISSA. For more information, talk to your doctor or HCP.

Take ORILISSA exactly as your HCP tells you. Tell your HCP if you have any side effect that bothers you or that does not go away. Call your HCP for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.


US-ORIL-200129

Please click here for Full Prescribing Information and Medication Guide.