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Because ORILISSA treats endometriosis pain by lowering estrogen, there are possible related side effects you may experience.
The percentage of women who experienced these is shown in the table below.
| ORILISSA 150 mg once daily* | ORILISSA 200 mg twice daily† | Placebo (a pill with no active medicine)‡ | |
|---|---|---|---|
| Hot flash 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% | < 1% |
| 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 150 mg dose in 2 studies.
†Percentage based on 477 women taking 200 mg dose 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 doctor or pharmacist.
The majority of the women who stopped taking ORILISSA due to hot flashes or night sweats, or nausea did so within the first 2 months of treatment. Always tell your doctor if you have any side effect that bothers you or does not go away.
*This is not a complete list of side effects that caused women to stop taking ORILISSA.
These additional studies further evaluated safety considerations and how well it works.
ORILISSA can cause serious side effects including bone loss (decreased bone mineral density [BMD])
More information about BMD
Bone is a living tissue. And throughout the course of a person’s life, the body naturally loses old bone to make room for new bone. The following can cause women to experience bone loss:
Bone loss experienced in these instances may or may not fully recover over time.
ORILISSA may change your menstrual periods
With ORILISSA, you may have lighter, less frequent or irregular periods, or no periods at all, making it hard to know if you are pregnant. Watch for the signs of pregnancy such as breast tenderness, weight gain, and nausea. After finishing the 6-month clinical trials, the majority of women who took either dose of ORILISSA got their period within a month (~60%; and ~ 95% got it within 6-months).
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.
It’s important to use effective birth control
ORILISSA does not prevent pregnancy. You'll need to use effective methods of birth control while taking ORILISSA and for 1 week after you stop taking ORILISSA. So talk to your doctor about which birth control to use. Your doctor may change the birth control you were on before you start taking ORILISSA.
Birth control pills that contain estrogen may make ORILISSA less effective. It is not known how well ORILISSA will work while you are taking progestin-only birth control.
Talk to your doctor if you plan on breastfeeding
The impact of ORILISSA on breast milk and the nursing baby is not known. Talk to your doctor about the best way to feed your baby if you take ORILISSA.
† 2090 women were treated with ORILISSA in the Phase 2 and Phase 3 studies.
