Stimulant Laxative side effects compared: 5 drugs, 41,585 FDA adverse event reports
Members
| Drug | FAERS reports | Serious | Death outcome | Boxed warning | Top labeled signals | Unlabeled (unassessed) |
|---|---|---|---|---|---|---|
| Bisacodyl (Laxative) | 13,995 | 86% | 2,457 | – | – | – |
| Biscodyl (Bisacodyl) | 12,983 | 88% | 2,318 | – | – | – |
| Bisacodyl Suppositories (Bisacodyl) | 12,866 | 88% | 2,302 | – | – | – |
| Bisacodyl 5Mg | 875 | 62% | 134 | – | – | – |
| Laxative | 866 | 62% | 133 | – | – | – |
Class-wide signals (flagged in at least 3 of 5 members)
| Reaction | Members flagged | Median PRR | Reports (sum) | In label |
|---|---|---|---|---|
| Hypokinetic dysarthria | 3/5 | 3,641.3 | 48 | 0/3 members' labels |
| Vaginal flatulence | 3/5 | 2,554.4 | 560 | 0/3 members' labels |
| Appendicolith | 3/5 | 1,763.1 | 592 | 0/3 members' labels |
| Total lung capacity increased | 3/5 | 937.1 | 300 | 0/3 members' labels |
| Congenital hiatus hernia | 3/5 | 534.3 | 165 | 0/3 members' labels |
| Malignant melanoma stage 0 | 3/5 | 519.2 | 132 | 0/3 members' labels |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 3/5 | 384.8 | 300 | 0/3 members' labels |
| Bacteroides infection | 3/5 | 286.3 | 117 | 0/3 members' labels |
| Ivth nerve paralysis | 3/5 | 285.1 | 102 | 0/3 members' labels |
| Epidural lipomatosis | 3/5 | 283.7 | 157 | 0/3 members' labels |
| Cerebral hypoperfusion | 3/5 | 271.7 | 198 | 0/3 members' labels |
| Capillaritis | 3/5 | 218.8 | 96 | 0/3 members' labels |
| Female genital tract fistula | 3/5 | 207.7 | 590 | 0/3 members' labels |
| Bronchopulmonary aspergillosis allergic | 3/5 | 200.1 | 303 | 0/3 members' labels |
| Binocular eye movement disorder | 3/5 | 179.1 | 84 | 0/3 members' labels |
| Total lung capacity abnormal | 3/5 | 173.9 | 112 | 0/3 members' labels |
| Pulmonary vasculitis | 3/5 | 135.8 | 124 | 0/3 members' labels |
| Radiculopathy | 3/5 | 131.2 | 597 | 0/3 members' labels |
| Cerebellar stroke | 3/5 | 130.4 | 84 | 0/3 members' labels |
| Colonic pseudo-obstruction | 3/5 | 123.0 | 60 | 0/3 members' labels |
| Proctitis | 3/5 | 118.7 | 578 | 0/3 members' labels |
| Chronic sinusitis | 3/5 | 118.5 | 770 | 0/3 members' labels |
| Macular degeneration | 3/5 | 114.2 | 2,363 | 0/3 members' labels |
| Mite allergy | 3/5 | 113.8 | 127 | 0/3 members' labels |
| Hyperphosphataemia | 3/5 | 101.2 | 381 | 0/3 members' labels |
| Total lung capacity decreased | 3/5 | 87.1 | 246 | 0/3 members' labels |
Member-specific signals (flagged in exactly one drug)
No strong single-member signals (n ≥ 50) in this class.
Common questions
Which stimulant laxative has the most FDA adverse event reports?
Bisacodyl has the most FAERS co-reports in this class (13,995), followed by Biscodyl (12,983). Report volume tracks how widely and how long a drug has been used, and how much attention it has had, far more than its risk.
Which side effects are shared across stimulant laxative drugs?
Reaction terms flagged in at least half of the 5 members include hypokinetic dysarthria, vaginal flatulence, appendicolith, total lung capacity increased, congenital hiatus hernia. A term shared across a class usually reflects the shared mechanism (or the shared patient population) rather than one product.
Does a FAERS signal mean the drug causes the reaction?
No. These are disproportionality signals from voluntary reports with no denominator. Each is screened against the FDA label (known vs unlabeled) on the drug pages; causality needs temporality, dose-response, plausibility and trial or cohort evidence.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, seriousness and death counts from openFDA count queries. Generated 2026-10-08. Not medical advice.