Levonorgestrel Intrauterine System Psychiatric Adverse Effects
Liletta (levonorgestrel-releasing intrauterine system) is labeled to cause mood-related adverse reactions, including “mood changes,” “depression,” and “anxiety.” [1] Emotional instability such as increased tearfulness is not specifically listed as a discrete adverse reaction, but tearfulness can occur within the labeled spectrum of mood changes and depression. [1]
Evidence From Liletta Prescribing Information
In the Liletta phase 3 contraception study (N = 1,751), adverse reactions occurring in ≥5% included: [1]
- Depression: 9.1% [1]
- Anxiety: 9.6% [1]
- Mood changes: 6.5% [1]
In the same study, adverse reactions leading to premature discontinuation included “mood swings” (0.8%). [1]
Interpretation of “Increased Tearfulness”
The Liletta label does not enumerate “tearfulness” as an individual symptom in the adverse-reaction table. [1] The labeled categories that align most closely with emotional instability are “mood changes,” “depression,” and “anxiety.” [1]
Observational and Review-Level Evidence on Psychiatric Symptoms
A systematic review evaluating psychiatric symptoms with levonorgestrel IUDs concluded that psychiatric symptoms, predominantly depression, have been reported across studies, while the available data were considered unreliable for estimating absolute risk. [2]
Clinical Clarifications and Practical Next Steps
Clinical evaluation is recommended when mood symptoms are new, worsening, or associated with significant distress or functional impairment. [1] In cases of severe mood symptoms, discontinuation of the device may be considered based on clinical judgment and patient safety. [1]
Common Pitfalls to Avoid
Assuming the absence of “tearfulness” as a labeled term excludes clinically meaningful mood effects is inaccurate. [1] Attributing all mood symptoms solely to the device without assessment of alternative causes (including baseline mood disorder and other temporal factors) is not supported by the available evidence base. [2]
When to Seek Urgent Care
Urgent care is recommended for severe depression symptoms, suicidal thoughts, or behavior suggesting imminent risk. [1]