MIRENA IUD: 40 Adverse Event Reports & Safety Profile
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40
Total FAERS Reports
1 (2.5%)
Deaths Reported
12
Hospitalizations
40
As Primary/Secondary Suspect
4
Life-Threatening
11
Disabilities
First Report: 20081205 · Latest Report: 20140620
What Are the Most Common MIRENA IUD Side Effects?
#1 Most Reported
Alopecia
11 reports (27.5%)
#2 Most Reported
Depression
7 reports (17.5%)
#3 Most Reported
Muscle spasms
6 reports (15.0%)
All MIRENA IUD Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Alopecia | 11 | 27.5% | 0 | 2 |
| Depression | 7 | 17.5% | 0 | 0 |
| Device dislocation | 6 | 15.0% | 0 | 5 |
| Headache | 6 | 15.0% | 0 | 3 |
| Muscle spasms | 6 | 15.0% | 0 | 4 |
| Anxiety | 5 | 12.5% | 0 | 0 |
| Insomnia | 5 | 12.5% | 0 | 0 |
| Mood swings | 5 | 12.5% | 0 | 1 |
| Nausea | 5 | 12.5% | 0 | 1 |
Who Reports MIRENA IUD Side Effects? Age & Gender Data
Average age: 29.7 years. Most reports from: US. View detailed demographics →
Is MIRENA IUD Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2008 | 1 | 0 | 1 |
| 2009 | 2 | 0 | 0 |
| 2012 | 1 | 0 | 0 |
| 2013 | 11 | 0 | 4 |
| 2014 | 16 | 0 | 6 |
What Is MIRENA IUD Used For?
| Indication | Reports |
|---|---|
| Contraception | 7 |
Official FDA Label for MIRENA IUD
Official prescribing information from the FDA-approved drug label.