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The most common side effects for ORILISSA include:
These are not all the possible side effects of ORILISSA. For more information, ask your doctor or pharmacist.
In clinical trials, less than 3% of women stopped taking ORILISSA due to hot flashes or night sweats or nausea. The majority of the women who stopped taking ORILISSA due to these side effects did so within the first 2 months of treatment. Always tell your doctor if you have any side effect that bothers you or that does not go away.
| Common Side effects | 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.
In these trials, researchers compared the effects of ORILISSA against a placebo. This is how researchers could determine whether any benefits or side effects that occurred were caused by ORILISSA.
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.
