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Because ORILISSA treats endometriosis pain by lowering estrogen, there are possible related side effects you may experience.
The percentage of women who experienced these side effects is shown below.
ORILISSA 150 mg once daily* ORILISSA 200 mg twice daily† Placebo (a pill with no active medicine)‡
*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.
These are not all the possible side effects of ORILISSA. 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.
In the ORILISSA clinical studies, about 10% or less 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.
‖This is not a complete list of side effects that caused women to stop taking ORILISSA.
*Percentage based on 952 women taking ORILISSA in 2 studies.
Well, about 1 out of 4 women taking ORILISSA 150 mg and about 2 out of 4 women taking ORILISSA 200 mg experienced hot flashes or night sweats. Of these women, 94% reported that the hot flashes they had were mild or moderate (303 of 324 women).§ Less than 2% of women stopped taking ORILISSA because of hot flashes.*
§Mild/moderate were definitions used by the clinical researcher to rate the severity of each side effect. Mild was defined as temporary and easily tolerated. Moderate was defined as causing discomfort and interrupting usual activities.
*This is not the only side effect that caused women to stop taking ORILISSA.
The benefits of ORILISSA were proven in the largest endometriosis clinical trial program to date.
See the resultsSee how Sara realized her pain was not normal and decided she owed it to herself to try ORILISSA.
Watch Sara’s storyRegardless of your insurance coverage, you’ll have access to an Orilissa® Complete Insurance Specialist to help you understand your coverage and identify possible ways to save* on your prescription.
*Eligibility restrictions apply. Click here to view them in full.
Get supportORILISSA® (elagolix) is a prescription medicine used to treat moderate to severe pain associated with endometriosis. It is not known if ORILISSA is safe and effective in children under 18 years of age.
ORILISSA may cause serious side effects, including bone loss and effects on pregnancy:
Tell your HCP about all of your medical conditions, including if you:
Tell your HCP about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Especially tell your HCP if you take birth control pills. Your HCP may advise you to change the pills you take or your method of birth control.
ORILISSA can cause serious side effects including:
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 of the possible side effects of ORILISSA. This is the most important information to know about ORILISSA. For more information, talk to your doctor or HCP.
Take ORILISSA exactly as your HCP tells you. Tell your HCP if you have any side effect that bothers you or that does not go away. Call your HCP for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.
If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.
US-ORIL-200129
Please click here for Full Prescribing Information and Medication Guide.