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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.

PARAGARD 380A: 1,801 Adverse Event Reports & Safety Profile

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1,801
Total FAERS Reports
0
Deaths Reported
9
Hospitalizations
1,801
As Primary/Secondary Suspect
1
Disabilities

First Report: 2001 · Latest Report: 20141229

What Are the Most Common PARAGARD 380A Side Effects?

#1 Most Reported
Device expulsion
685 reports (38.0%)
#2 Most Reported
Device dislocation
479 reports (26.6%)
#3 Most Reported
Vaginal haemorrhage
186 reports (10.3%)

All PARAGARD 380A Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Device expulsion 685 38.0% 0 1
Device dislocation 479 26.6% 0 2
Vaginal haemorrhage 186 10.3% 0 1
Pelvic pain 177 9.8% 0 1
Device breakage 160 8.9% 0 0
Menorrhagia 128 7.1% 0 1
Metrorrhagia 115 6.4% 0 0
Embedded device 107 5.9% 0 2
Pain 107 5.9% 0 3
Medical device complication 91 5.1% 0 0
Muscle spasms 89 4.9% 0 0
Dysmenorrhoea 74 4.1% 0 0
Pregnancy with contraceptive device 72 4.0% 0 0
Discomfort 61 3.4% 0 0
Drug ineffective 58 3.2% 0 1
Complication of device insertion 46 2.6% 0 0
Menstruation delayed 46 2.6% 0 1
Abdominal pain 40 2.2% 0 0
Dyspareunia 37 2.1% 0 0
Abdominal pain lower 36 2.0% 0 2

Who Reports PARAGARD 380A Side Effects? Age & Gender Data

Average age: 29.8 years. Most reports from: US. View detailed demographics →

Is PARAGARD 380A Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 0
2003 4 0 0
2004 3 0 0
2006 2 0 0
2008 2 0 0
2009 4 0 0
2010 5 0 0
2011 5 0 0
2012 27 0 2
2013 373 0 6
2014 993 0 1

View full timeline →

What Is PARAGARD 380A Used For?

IndicationReports
Contraception 1,750
Post coital contraception 42

PARAGARD 380A vs Alternatives: Which Is Safer?

PARAGARD 380A vs PERAMPANEL PARAGARD 380A vs PERFLUTREN PARAGARD 380A vs PHENOBARBITAL PARAGARD 380A vs PHENYLEPHRINE PARAGARD 380A vs PHENYLEPHRINE\PHENYLEPHRINE PARAGARD 380A vs PHYTONADIONE PARAGARD 380A vs PLACEBO PARAGARD 380A vs PLAN B ONE-STEP PARAGARD 380A vs POLYETHYLENE GLYCOL 3350 PARAGARD 380A vs PRASTERONE

Official FDA Label for PARAGARD 380A

Official prescribing information from the FDA-approved drug label.