Understanding
Side Effects
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?
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.
To understand BMD, first let’s chat about bone. Bone’s a living tissue. Throughout one’s life, estrogen helps the body break down old bone to replace it with new bone. When estrogen levels are lower, the body may break down old bone faster than it replaces it—causing bone loss (or decreased BMD). This can happen anytime estrogen levels are lower—while breastfeeding, throughout pregnancy, during endurance exercise, or if you're taking medications that lower estrogen.
Since ORILISSA works by lowering estrogen, it can cause BMD loss. If you have bone loss on ORILISSA, your bone density may improve after you stop taking ORILISSA but complete recovery may not occur. It is unknown if these bone changes could increase your risk for broken bones as you age. For this reason, your healthcare provider may limit the length of time you take ORILISSA.
So, what can you do about BMD while taking ORILISSA? Start by talking to your gynecologist. They may advise you to take vitamin D and calcium supplements as part of a healthy lifestyle that promotes bone health. They may also order a DXA scan (a type of X-ray) to check your BMD. Lastly, don't forget to tell your doctor if you have conditions or take other medicines that can cause bone loss, or if you have broken a bone with minimal or no injury.
Do not take ORILISSA if you are trying to become or are pregnant. If you think you are pregnant, stop taking ORILISSA right away and call your doctor. If you become pregnant while taking ORILISSA, we encourage you to enroll in the Pregnancy Registry. The purpose of the pregnancy registry is to collect information about the health of you and your baby. Talk to your doctor or call 1-833-782-7241 to enroll in this registry. You can also visit www.bloompregnancyregistry.com to learn more.
ORILISSA is also not right for you if you have certain conditions or are taking certain medications. You should not take ORILISSA if you:
- are or may be pregnant
- have osteoporosis
- have severe liver disease
- are taking medicines known as strong OATP1B1 inhibitors that are known or expected to significantly increase the blood levels of elagolix (the active ingredient in ORILISSA). Ask your healthcare provider if you are not sure if you are taking one of these medicines.
- 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 healthcare provider if you are not sure.
In addition to decreased bone mineral density and effects on pregnancy, ORILISSA can also cause the following serious side effects:
- ORILISSA may cause suicidal thoughts or actions. We understand how serious this is, so we want to tell you a bit more about what happened in the clinical trials and why this warning exists. See, out of the 2090 women studied,** 4 experienced suicidal thoughts. Two of these women stopped taking ORILISSA because of this. One woman from the clinical trials committed suicide. Investigators determined she was experiencing life stressors. We want you to know about it because you should have all the facts when deciding if a medication is right for you.
- Your safety is important. So please call your healthcare provider or get emergency medical help right away if you have any of the following symptoms, especially if they are new, worse, or bother you: thoughts about suicide or dying, attempts to commit suicide, new or worse depression, new or worse 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.
- It's important to share any conditions you have with your doctor, including depression, and talk about any mood problems or suicidal thoughts or behaviors before starting ORILISSA. Women with depression are not restricted from taking ORILISSA but it's important to call your gynecologist if these symptoms appear or worsen while taking ORILISSA. In the ORILISSA clinical trial program, 19% of women had a history of depression and 13% were taking antidepressants when they entered the study.‡‡
- Abnormal liver tests. Call your gynecologist right away if you have any of these signs and symptoms of liver problems: yellowing of the skin or whites of the eyes (jaundice), dark amber-colored urine, feeling tired (fatigue or exhaustion), nausea and vomiting, generalized swelling, right upper stomach area (abdomen) pain, bruising easily.
**2090 women were treated with ORILISSA in the Phase 2 and Phase 3 studies.
‡‡Percentages based on 324 women with a history of depression and 217 women taking antidepressants in clinical studies.
Weight gain was one of the less common side effects reported by women in the ORILISSA clinical trial program. Other less common side effects included decreased sex drive, diarrhea, abdominal pain, dizziness, constipation, and irritability.
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 the possible side effects of ORILISSA. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.