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.
Kellyn
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.