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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

MIRENA: 3,769 Adverse Event Reports & Safety Profile

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3,769
Total FAERS Reports
8 (0.2%)
Deaths Reported
597
Hospitalizations
3,769
As Primary/Secondary Suspect
80
Life-Threatening
41
Disabilities

First Report: 2000 · Latest Report: 20140624

What Are the Most Common MIRENA Side Effects?

#1 Most Reported
Device expulsion
1,300 reports (34.5%)
#2 Most Reported
Injury
788 reports (20.9%)
#3 Most Reported
Pain
685 reports (18.2%)

All MIRENA Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Device expulsion 1,300 34.5% 0 10
Injury 788 20.9% 0 467
Pain 685 18.2% 0 296
Device dislocation 677 18.0% 0 182
Uterine perforation 644 17.1% 0 395
Emotional distress 577 15.3% 0 363
Genital haemorrhage 410 10.9% 0 75
Abdominal pain lower 342 9.1% 0 89
Device difficult to use 307 8.2% 0 77
Device issue 292 7.8% 0 205
Abdominal pain 286 7.6% 0 119
Anxiety 281 7.5% 0 209
Depression 239 6.3% 0 166
Procedural pain 217 5.8% 0 49
Drug ineffective 203 5.4% 0 82
Pelvic pain 186 4.9% 0 81
Pregnancy with contraceptive device 162 4.3% 0 58
Embedded device 159 4.2% 0 44
Device misuse 155 4.1% 0 47
Menorrhagia 145 3.9% 0 61

Who Reports MIRENA Side Effects? Age & Gender Data

Average age: 31.0 years. Most reports from: US. View detailed demographics →

Is MIRENA Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 2 0 0
2002 2 0 2
2003 4 0 4
2004 5 0 2
2005 10 0 3
2006 18 0 13
2007 40 0 25
2008 57 0 34
2009 63 1 33
2010 106 1 69
2011 155 1 101
2012 185 0 100
2013 553 0 74
2014 1,220 0 26

View full timeline →

What Is MIRENA Used For?

IndicationReports
Contraception 2,813
Menorrhagia 383
Endometriosis 12
Menstrual cycle management 12
Product used for unknown indication 12
Dysmenorrhoea 10
Adenomyosis 6
Genital haemorrhage 6
Uterine leiomyoma 6
Menstruation irregular 5

MIRENA vs Alternatives: Which Is Safer?

MIRENA vs MIRIKIZUMAB-MRKZ MIRENA vs MIRTAZAPINE MIRENA vs MIRVETUXIMAB SORAVTANSINE-GYNX MIRENA vs MISOPROSTOL MIRENA vs MITAPIVAT MIRENA vs MITOMYCIN MIRENA vs MITOTANE MIRENA vs MITOXANTRONE MIRENA vs MITRAGYNINE\HERBALS MIRENA vs MIZORIBINE

Official FDA Label for MIRENA

Official prescribing information from the FDA-approved drug label.