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Understanding
Side Effects
I read about the potential side effects and pros and cons to it. That research is what helped me determine that I was going to try ORILISSA.
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Get the facts about ORILISSA safety info
Because ORILISSA reduces endometriosis pain by lowering estrogen, there are possible related side effects you may experience.
- Hot flashes/night sweats
- Headache
- Nausea
- Difficulty sleeping
- Absence of periods
- Anxiety
- Joint pain
- Depression
- Mood changes
Side effects experienced by at least 5% of women taking either dose of ORILISSA in the clinical trials
| Side effects | ORILISSA 150 mg once daily* | ORILISSA 200 mg twice daily† | Placebo (a pill with no active medicine)‡ |
| Hot flashes | 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% | < 1% |
| Depressed mood, depression, depressive symptoms, and/or tearfulness | 3% | 6% | 2% |
| Anxiety | 3% | 5% | 3% |
| Arthralgia (joint pain) |
3% | 5% | 3% |
These are not all the possible side effects of ORILISSA. The most common serious adverse events reported in the clinical studies included appendicitis (0.3%), abdominal pain (0.2%), and back pain (0.2%). 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.
*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.
About 1 in 10 women 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. 0.2% of subjects treated with ORILISSA 150 mg once daily and 0.2% treated with ORILISSA 200 mg twice daily stopped treatment due to serious adverse reactions compared to 0.5% with placebo.
Of all women taking ORILISSA in the clinical trials, fewer than 2% stopped taking ORILISSA due to hot flashes/night sweats, headache, or nausea.
This is not a complete list of side effects that caused women to stop taking ORILISSA.
Want to learn about ORILISSA’s clinical results?
Will ORILISSA stop my period or cause early menopause?
With ORILISSA, you may have lighter, less frequent, or irregular periods, or no periods at all. This can make it hard to know if you're pregnant. You shouldn’t take ORILISSA if you’re pregnant or trying to become pregnant, so watch for other signs of pregnancy such as breast tenderness, weight gain, and nausea.
You may not get your period while taking ORILISSA since it lowers estrogen. However, this does not mean ORILISSA will put you into early menopause. As a matter of fact, the majority of women (~60%) in clinical trials who took either dose of ORILISSA got their period within a month after they stopped taking ORILISSA. And about 95% got their period within 6 months.¶
¶These women had all taken ORILISSA for 6 months.
What other serious side effects of ORILISSA should I know about?
What exactly is bone mineral density (BMD) and what does it have to do with ORILISSA?
Is ORILISSA safe to take when pregnant or with other health conditions?
Does ORILISSA cause weight gain?
What are the most common side effects of ORILISSA?
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. If you have bone loss on ORILISSA, 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. For this reason, your healthcare provider (HCP) may limit the length of time you take ORILISSA. Your 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 28 days 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 pregnant, have osteoporosis, have severe liver disease, are taking medicines called organic anion transporting polypeptide (OATP) 1B1 inhibitors that are known or expected to significantly increase the blood levels of elagolix, the active ingredient in ORILISSA (ask your HCP if you are not sure if you are taking one of these medicines), or have had a serious allergic reaction to ORILISSA or any of the ingredients in ORILISSA. See the end of the Medication Guide for a complete list of ingredients in ORILISSA. Ask your HCP if you are not sure.
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 or other conditions 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 that contains hormones. Your HCP may advise you to change 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 or get emergency medical help right away if you have any of these symptoms, especially if they are new, worse, or bother you: thoughts about suicide or dying, attempts 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 and 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 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 doctor 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-210096
Please click here for Full Prescribing Information and Medication Guide.