Orilissa Lawsuit: Bone Loss, Mental Health & Side Effect Claims

Orilissa and Its Known Side Effects

Orilissa works by suppressing estrogen production, reducing the estrogen-driven tissue growth that causes endometriosis pain. The estrogen suppression is effective for pain management but creates significant side effects related to menopause-like estrogen deficiency, including bone mineral density (BMD) loss, hot flashes, and mood changes.

The FDA approved Orilissa with a REMS (Risk Evaluation and Mitigation Strategy) due to concerns about bone density loss and fetal harm (teratogenicity). However, plaintiffs allege that the degree of bone density loss experienced by many patients, and the risk of mental health consequences including suicidal thoughts, were not adequately communicated to prescribers and patients relative to the actual risk profile observed in post-market use.

Bone Density Loss Claims

Clinical trials showed dose-dependent bone mineral density decreases in women taking Orilissa -- losses of 2-3% in the spine and hip over 6-12 months of treatment. Plaintiffs allege that these losses, for some women on long-term treatment, have resulted in permanent bone density reductions that increase fracture risk and that in some cases have caused osteopenia or osteoporosis requiring ongoing management.

AbbVie's labeling warned of BMD decreases and recommended limiting treatment duration. Plaintiffs argue that the warnings were insufficient in describing the likelihood and extent of permanent BMD effects for individual patients and that some patients continued treatment beyond recommended durations without adequate monitoring.

Mental Health and Suicidality Claims

Post-market reporting identified a signal for mood changes, depression, and suicidal ideation in some Orilissa patients. The FDA issued updated safety communications addressing these mental health risks. Plaintiffs who experienced significant mood disturbance, depression, or suicidal thoughts while on Orilissa and whose prescribers were not adequately warned of these risks may have failure-to-warn claims.

Who Qualifies

Women who took Orilissa and experienced: significant bone mineral density loss documented by DEXA scan; fractures attributable to medication-induced bone loss; serious mood disturbance, depression, or suicidal ideation; or other serious adverse events -- may have claims. Medical documentation establishing the adverse event and its temporal correlation with Orilissa use is essential. Related: Singulair Lawsuit.

Status 2026

Orilissa personal injury litigation is developing. Claims are being evaluated and filed in multiple jurisdictions. No class action settlement has been announced. The litigation is in relatively early stages.

How to Get Legal Help

If you believe you qualify based on the eligibility criteria described above, the next step is a free consultation with an experienced attorney. Most plaintiff-side attorneys handling these cases work on contingency -- meaning you pay nothing unless your case results in a recovery. Bring any relevant documentation including receipts, correspondence, or evidence of the harm you experienced.

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