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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.

INDOMETHACIN\INDOMETHACIN: 131 Adverse Event Reports & Safety Profile

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131
Total FAERS Reports
5 (3.8%)
Deaths Reported
22
Hospitalizations
131
As Primary/Secondary Suspect
3
Life-Threatening
1
Disabilities

Active Ingredient: INDOMETHACIN\INDOMETHACIN SODIUM ·

First Report: 1960 · Latest Report: 20160821

What Are the Most Common INDOMETHACIN\INDOMETHACIN Side Effects?

#1 Most Reported
Drug hypersensitivity
50 reports (38.2%)
#2 Most Reported
Drug ineffective
11 reports (8.4%)
#3 Most Reported
Gastrointestinal haemorrhage
8 reports (6.1%)

All INDOMETHACIN\INDOMETHACIN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug hypersensitivity 50 38.2% 0 1
Drug ineffective 11 8.4% 0 0
Gastrointestinal haemorrhage 8 6.1% 0 5
Off label use 7 5.3% 2 2
Blood creatinine increased 5 3.8% 0 0
Gout 5 3.8% 0 2

Who Reports INDOMETHACIN\INDOMETHACIN Side Effects? Age & Gender Data

Gender: 57.7% female, 42.3% male. Average age: 54.2 years. Most reports from: US. View detailed demographics →

Is INDOMETHACIN\INDOMETHACIN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2005 1 0 0
2007 1 0 1
2008 1 0 0
2009 3 0 0
2010 3 0 0
2011 3 1 1
2012 6 0 3
2013 2 0 2
2014 12 1 8
2015 7 1 4
2016 1 0 0

View full timeline →

What Is INDOMETHACIN\INDOMETHACIN Used For?

IndicationReports
Product used for unknown indication 33
Gout 15

INDOMETHACIN\INDOMETHACIN vs Alternatives: Which Is Safer?

INDOMETHACIN\INDOMETHACIN vs INEBILIZUMAB-CDON INDOMETHACIN\INDOMETHACIN vs INEXIUM INDOMETHACIN\INDOMETHACIN vs INFLIXIMAB INDOMETHACIN\INDOMETHACIN vs INFLIXIMAB-ABDA INDOMETHACIN\INDOMETHACIN vs INFLIXIMAB-AXXQ INDOMETHACIN\INDOMETHACIN vs INFLIXIMAB-DYYB INDOMETHACIN\INDOMETHACIN vs INFLIXIMAB-QBTX INDOMETHACIN\INDOMETHACIN vs INFLIXIMAB, RECOMBINANT INDOMETHACIN\INDOMETHACIN vs INFLUENZA A VIRUS A/CALIFORNIA/7/2009 LIVE ANTIGEN\INFLUENZA A VIRUS A/TEXAS/50/2012 LIVE ANTIGEN\INFLUENZA B VIRUS B/BRISBANE/60/2008 LIVE ANTIGEN\INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 LIVE ANTIGEN INDOMETHACIN\INDOMETHACIN vs INFLUENZA VIRUS VACCINE

Official FDA Label for INDOMETHACIN\INDOMETHACIN

Official prescribing information from the FDA-approved drug label.