Mirenalevonorgestrel

Name: MIRENA (levonorgestrel) — FDA Adverse Event Reports
Creator: PillSignal
License: https://open.fda.gov/license/

According to the FDA label: Use for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)

135,699 adverse event reports submitted to the FDA (2004–2026)

This data reflects voluntary reports submitted to the FDA's Adverse Event Monitoring System (AEMS), formerly the FDA Adverse Event Reporting System (FAERS). A report does not mean the medication caused the event. Data may be incomplete or contain errors. Learn more about AEMS. New to this data? Read our guide on how to interpret FDA adverse event reports →

New to FDA adverse event data? Here's how to read these reports →

Top Reported Adverse Events

The most frequently reported events in association with Mirena in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.

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Device Expulsion 36,648 reports
Device Dislocation 17,057 reports
Genital Haemorrhage 9,891 reports
Abdominal Pain Lower 7,516 reports
Pain 6,815 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →
Vaginal Haemorrhage 6,747 reports
Vaginal bleeding, particularly heavy or unexpected bleeding. Also spelled hemorrhage in American English.
Full definition in the glossary →
Uterine Perforation 6,721 reports
Abdominal Pain 6,674 reports
Pain in the belly or stomach area.
Full definition in the glossary → See all drugs reporting this event →
Procedural Pain 5,979 reports
Intra-uterine Contraceptive Device Expelled 5,573 reports
Pregnancy With Contraceptive Device 4,910 reports
Complication Of Device Insertion 4,684 reports
Injury 4,592 reports
A general report of physical harm to the body, used when no more specific type is given.
Full definition in the glossary →
Depression 4,545 reports
A persistent low mood, loss of interest, or feelings of sadness. If you are struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary → See all drugs reporting this event →
Anxiety 4,433 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →

Browse the full glossary →

Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.

Who Is Reporting

Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.

By Sex

View reporter sex data as a table

Mirena adverse event reports by reporter sex
Sex	Reports
Female	133,289
Male	1,564
Unknown	41

By Age Group

View age group data as a table

Mirena adverse event reports by reporter age group
Age group	Reports
0-17	1,921
18-34	53,652
35-49	31,229
50-64	2,663
65-74	75
75+	30

This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.

Reported Outcomes

Outcomes recorded in FAERS reports that included Mirena. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.

View outcome data as a table

Mirena adverse event reports by reported outcome
Outcome	Reports
Non-Serious	78,789
Other Serious	49,657
Hospitalization	10,078
Disability	1,944
Life-Threatening	1,809
Death	249

Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.

Report Volume Over Time

Number of FAERS reports received per quarter for Mirena. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.

View report trend as a table

Mirena adverse event reports by year
Year	Reports
2004	313
2005	505
2006	655
2007	867
2008	10,604
2009	8,233
2010	3,123
2011	16,021
2012	10,282
2013	8,743
2014	8,338
2015	7,366
2016	6,713
2017	8,989
2018	7,599
2019	6,146
2020	6,285
2021	5,458
2022	4,735
2023	4,651
2024	4,846
2025	4,173
2026 (partial)	1,054

The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.

Other medications with similar adverse event profiles in FDA FAERS reports.

Data Source

This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.

View this data on the FDA website →

Data last updated: June 2026