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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.

DULCOLAX: 60 Adverse Event Reports & Safety Profile

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60
Total FAERS Reports
2 (3.3%)
Deaths Reported
29
Hospitalizations
60
As Primary/Secondary Suspect
3
Life-Threatening
1
Disabilities

First Report: 2003 · Latest Report: 20140519

What Are the Most Common DULCOLAX Side Effects?

#1 Most Reported
Nausea
12 reports (20.0%)
#2 Most Reported
Diarrhoea
11 reports (18.3%)
#3 Most Reported
Renal failure chronic
10 reports (16.7%)

All DULCOLAX Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Nausea 12 20.0% 0 6
Diarrhoea 11 18.3% 0 8
Renal failure chronic 10 16.7% 0 5
Renal failure acute 9 15.0% 0 7
Abdominal pain 7 11.7% 0 4
Abdominal pain upper 7 11.7% 0 2
Hypokalaemia 6 10.0% 0 4
Nephrogenic anaemia 6 10.0% 0 3
Off label use 6 10.0% 0 1
Vomiting 6 10.0% 0 4
Acute phosphate nephropathy 5 8.3% 0 4
Dehydration 5 8.3% 0 3
Drug ineffective 5 8.3% 0 1

Who Reports DULCOLAX Side Effects? Age & Gender Data

Average age: 62.1 years. Most reports from: US. View detailed demographics →

Is DULCOLAX Getting Safer? Reports by Year

YearReportsDeathsHosp.
2003 1 0 1
2006 1 0 0
2007 6 0 4
2008 6 1 3
2009 2 0 1
2010 1 0 0
2012 2 1 2
2013 14 0 9
2014 12 0 6

View full timeline →

What Is DULCOLAX Used For?

IndicationReports
Constipation 23
Colonoscopy 14
Product used for unknown indication 9

Official FDA Label for DULCOLAX

Official prescribing information from the FDA-approved drug label.