Side effects & safety considerations

SIDE EFFECTS &
SAFETY
CONSIDERATIONS

Possible side effects

The most common side effects for ORILISSA include:

  • Hot flashes or night sweats
  • Headaches
  • 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.

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.


ORILISSA can cause serious side effects including:

  • suicidal thoughts, suicidal behavior, and worsening of mood. ORILISSA may cause suicidal thoughts or actions. Call a doctor right away if you have any of these symptoms: 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

Why compare ORILISSA to a placebo?

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.

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.

Learn more about the clinical trials for ORILISSA.

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.