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bisacodyl Side Effects

Also known as: Dulcolax

Analysis of 13,500 adverse event reports submitted to the FDA from 2002 to 2025.

Total Reports

13,500

Death-Related

2,363

17.5% of reports

Hospitalizations

6,915

51.2% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

CONSTIPATION
1,509
NAUSEA
1,358
DRUG INEFFECTIVE
1,344
PAIN
1,115
OFF LABEL USE
1,096
VOMITING
985
FALL
837
DYSPNOEA
827
PNEUMONIA
783
FATIGUE
773
MACULAR DEGENERATION
772
ABDOMINAL PAIN
770
DEATH
770
PYREXIA
752
ANAEMIA
678
HYPOTENSION
677
HEADACHE
668
DIARRHOEA
633
ASTHENIA
624
CONDITION AGGRAVATED
572

Who Reports Side Effects

Gender Distribution

Female 7,086 (57%)
Male 5,390 (43%)
Unknown 14

Age Distribution

0-17 348 (4%)
18-44 999 (10%)
45-64 3,090 (32%)
65-74 2,458 (25%)
75+ 2,831 (29%)

Reporting Trend by Year

2002 2025

Reactions in Death Reports

Top reactions reported in 2,363 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 770
SEPSIS 297
CONSTIPATION 269
GENERAL PHYSICAL HEALTH DETERIORATION 269
NAUSEA 260
VOMITING 260
OFF LABEL USE 234
MULTIPLE ORGAN DYSFUNCTION SYNDROME 226
ABDOMINAL PAIN 220
HYPONATRAEMIA 218
CONDITION AGGRAVATED 217
DYSPNOEA 214
ASCITES 209
ABDOMINAL DISTENSION 205
CARDIOGENIC SHOCK 191
PNEUMONIA 188
APPENDICITIS 186
STRESS 186
APPENDICOLITH 181
ANAEMIA 179

Reactions in Hospitalization Reports

Top reactions in 6,915 reports where hospitalization was an outcome.

Reaction Reports
CONSTIPATION 1,013
NAUSEA 943
PAIN 849
OFF LABEL USE 716
FALL 703
PNEUMONIA 697
VOMITING 687
DYSPNOEA 642
PYREXIA 638
ANAEMIA 577
ABDOMINAL PAIN 548
HYPOTENSION 523
DRUG INEFFECTIVE 515
HEADACHE 436
ASTHENIA 429
CONDITION AGGRAVATED 429
WEIGHT DECREASED 421
COGNITIVE DISORDER 409
FATIGUE 400
MALAISE 397

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What the FAERS Data Reveals About bisacodyl Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 13,500 voluntary reports linked to bisacodyl and its brand equivalents (Dulcolax), spanning 2002 through 2025. Of those, 2,363 (17.5%) listed death as an outcome and 6,915 (51.2%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 57% were female and 43% male; age distribution skews toward 45-64, with 3,090 reports in that bracket. The single most reported reaction is constipation with 1,509 submissions, followed by nausea and drug ineffective.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.