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 the possible side effects of ORILISSA. For more information, ask your doctor or pharmacist.
| COMMON SIDE EFFECTS | 150 MG ONCE DAILY* | 200 MG TWICE DAILY† | PLACEBO‡ |
|---|---|---|---|
| Hot flash or night sweats | 24% | 46% | 9% |
| Headache | 17% | 20% | 12% |
| Nausea | 11% | 16% | 13% |
| Difficulty sleeping | 6% | 9% | 3% |
| Absence of periods | 4% | 7% | Less than 1% |
| Anxiety | 3% | 5% | 3% |
| Joint pain | 3% | 5% | 3% |
| Depression | 3% | 6% | 2% |
| Mood changes | 6% | 5% | 3% |
The safety, efficacy and side effects of ORILISSA were studied in clinical trials involving 1,686 women with moderate to severe endometriosis pain. In these trials, researchers compared the effects of ORILISSA against a placebo. This is how researchers can show if any benefits or side effects that occur are caused by the medicine being studied. The placebo serves as a starting point so researchers can see what happened without the treatment.
Learn more about the clinical trials of ORILISSA, what was studied, and how many women participated.
While you are taking ORILISSA, your estrogen levels will be low. Low estrogen levels can lead to bone mineral density loss. 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.
