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Updated: Apr 6, 2026

Intracranial Pressure Monitoring In Nontraumatic Intraventricular Hemorrhage Rodent Model
Published on: February 8, 2022
Risk of intracranial hypertension with intrauterine levonorgestrel
Mahyar Etminan1, Hao Luo2, Paul Gustafson2
1Therapeutic Evaluation Unit, Child and Family Research Institute of British Columbia, Faculty of Medicine, University of British Columbia, A4-198 WS 2, 709-650 West 28th Avenue, Vancouver, BC, Canada.
Objectives:
The objective of this study was to quantify the risk of intracranial hypertension (ICH) with the intrauterine levonorgestrel (IUL) device Mirena(®).
Methods:
We used the United States Food and Drug Administration's Adverse Events Reporting System (FAERS) database to quantify a reporting odds ratio (ROR) for ICH and Mirena(®). We also conducted a retrospective cohort study using the IMS LifeLink(®) database, comparing the risk of two oral contraceptives ethinyl estradiol (EE) with Mirena(®). A Bayesian sensitivity analysis was performed to account for the effect of body mass index (BMI).
Results:
The reported odds ratios (ORs) for ICH and papilledema with Mirena(®) were 1.78 (95% confidence interval [CI] 1.41-2.25) and 1.50 (95% CI 1.10-2.05), respectively. In the cohort study, the OR for ICH and EE-norgestimate and EE-norethindrone compared with Mirena(®) were 1.29 (95% CI 0.83-2.00) and 0.31 (95% CI 0.04-2.29), respectively. The presence of a strong confounder BMI did not affect the estimated OR (OR = 1.31, 95% CI 0.73-2.41 for EE-norgestimate; OR = 0.18, 95% CI 0.01-1.27 for EE-norethindrone).
Conclusion:
We found a higher than expected number of reports of ICH with Mirena(®) in the FAERS database. We also found a similar risk of ICH with Mirena(®) compared with the oral contraceptive EE-norgestimate. The higher risk of ICH with EE-norethindrone, another oral contraceptive should be further investigated.
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