POSSIBLE SIDE EFFECTS


It's smart to think about side effects. Here are the side effects for ORILISSA.

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%
*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.

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.


ORILISSA can cause serious side effects including:

  • suicidal thoughts, suicidal behavior, and worsening of mood. ORILISSA may cause suicidal thoughts or actions. Call your doctor right away if you have any of these symptoms, or call 911 if an emergency, especially if they are new, worse, or bother you: thoughts about suicide or dying, try to commit suicide, new or worse depression or 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.
  • abnormal liver tests. Call your doctor right away if you have any of these signs and symptoms of liver problems: yellowing of the skin or the 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.

Things you should know about bone mineral density (BMD)

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.

What can you do about your BMD?

  • Tell your doctor if you have or have had broken bones and if you have other conditions or take medicine that may cause bone problems.
  • Your doctor may advise you to take vitamin D and calcium supplements as part of a healthy lifestyle that promotes bone health.
  • 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, your doctor may order an X-ray test called a DXA scan to check your bone mineral density.
Get personalized support Not sure what to expect while taking ORILISSA? We’ll help provide one-on-one support for questions you might have about ORILISSA.**
**Remember to always talk to your doctor for medical guidance. Ori for Me nurses do not offer medical advice.