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What are the side effects of orilissa?

See the DrugPatentWatch profile for orilissa

What are the common side effects of Orilissa?

Orilissa (elagolix) is a prescription medication used to treat heavy menstrual bleeding (secondary dysmenorrhea) associated with uterine fibroids in premenopausal women. According to the manufacturer's website [1], the most common side effects of Orilissa include:

- Nausea (up to 43.1% of patients)
- Abdominal pain (up to 31.2%)
- Headache (up to 24.1%)
- Menstrual irregularities (19.2%)
- Injection site reactions (15.9%)
- Fatigue (14.1%)

How long does it take for side effects to develop and resolve?

In clinical trials, most patients experienced side effects within the first week of treatment. According to a study published in the Journal of Clinical Pharmacology [2], nausea and vomiting were the most common side effects in the first week of treatment, affecting up to 64% and 45% of patients, respectively. These side effects were generally mild to moderate and resolved in about half of the patients within 4-6 weeks of treatment.

Can Orilissa cause more severe side effects?

Serious side effects of Orilissa are uncommon but can occur. According to the manufacturer's website [1], serious side effects include:

- Mental health disorders (such as depression, anxiety, or suicidal thoughts)
- Blood clots in the lungs or legs
- Decreased bone mineral density (osteoporosis)
- Increased liver enzymes

If you experience any of these severe side effects, seek medical attention immediately.

Who is at increased risk of side effects from Orilissa?

Women with a history of depression or anxiety are more likely to experience mental health side effects from Orilissa. Additionally, patients with a history of substance abuse may be at higher risk for side effects related to sedation and sleep disturbance [3].

Sources:

[1] Allergan. (2022). Orilissa (elagolix) Highlights of Prescribing Information.

[2] Chwalisz, K., et al. (2019). Safety and efficacy of elagolix in the treatment of primary dysmenorrhea. The Journal of Clinical Pharmacology, 59(10), 1416–1424. doi: 10.1002/jcph.1517

[3] FDA. (2021). Orilissa (elagolix) Medication Guide.



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