BISACODYL: 3,465 Adverse Event Reports & Safety Profile

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3,465

Total FAERS Reports

414 (11.9%)

Deaths Reported

1,415

Hospitalizations

3,465

As Primary/Secondary Suspect

328

Life-Threatening

211

Disabilities

Wal-Mart Stores Inc

Manufacturer

Drug Class: Increased Large Intestinal Motility [PE] · Route: ORAL · Manufacturer: Wal-Mart Stores Inc · HUMAN OTC DRUG · FDA Label: Available

First Report: 1979 · Latest Report: 20250701

What Are the Most Common BISACODYL Side Effects?

#1 Most Reported

Drug ineffective

1,340 reports (38.7%)

#2 Most Reported

Constipation

966 reports (27.9%)

#3 Most Reported

Macular degeneration

764 reports (22.0%)

All BISACODYL Side Effects by Frequency

Side Effect	Reports	% of Total	Deaths	Hosp.
Drug ineffective	1,340	38.7%	60	441
Constipation	966	27.9%	208	769
Macular degeneration	764	22.1%	0	230
Pain	691	19.9%	27	637
Off label use	621	17.9%	194	475
Nausea	524	15.1%	198	363
Abdominal pain	473	13.7%	208	325
Fall	448	12.9%	1	426
Hypotension	445	12.8%	1	384
Cognitive disorder	423	12.2%	5	415
Balance disorder	385	11.1%	0	377
Orthostatic hypotension	382	11.0%	0	379
No adverse event	380	11.0%	2	1
Sedation	370	10.7%	0	364
Anaemia	361	10.4%	122	345
Toxicity to various agents	355	10.3%	7	327
Depressed level of consciousness	347	10.0%	1	340
Sedation complication	337	9.7%	0	335
Mobility decreased	328	9.5%	0	322
Vomiting	322	9.3%	203	157

Who Reports BISACODYL Side Effects? Age & Gender Data

Gender: 52.1% female, 47.9% male. Average age: 71.9 years. Most reports from: CA. View detailed demographics →

Is BISACODYL Getting Safer? Reports by Year

Year	Reports	Deaths	Hosp.
2001	1	1	0
2003	1	0	1
2004	2	0	1
2005	1	0	0
2006	3	0	0
2007	2	1	1
2008	10	0	7
2009	3	0	0
2010	8	1	5
2011	14	0	8
2012	12	0	7
2013	8	0	6
2014	28	3	13
2015	39	2	15
2016	54	3	29
2017	28	0	8
2018	63	0	32
2019	34	2	8
2020	87	61	65
2021	46	10	6
2022	21	2	10
2023	108	4	24
2024	54	1	7
2025	17	1	4

View full timeline →

What Is BISACODYL Used For?

Indication	Reports
Product used for unknown indication	1,618
Constipation	1,013
Drug therapy	151
Ventricular fibrillation	151
Colonoscopy	80
Dyspnoea	59
Off label use	57
Child abuse	37
Intentional product misuse	37
Chronic obstructive pulmonary disease	36

BISACODYL vs Alternatives: Which Is Safer?

BISACODYL vs BISACODYL OR DOCUSATE BISACODYL vs BISMUTH BISACODYL vs BISMUTH SUBCITRATE BISACODYL vs BISMUTH SUBCITRATE\METRONIDAZOLE\TETRACYCLINE BISACODYL vs BISMUTH SUBSALICYLATE BISACODYL vs BISMUTH SUBSALICYLATE\METRONIDAZOLE\TETRACYCLINE BISACODYL vs BISOPROLOL BISACODYL vs BISOPROLOL\BISOPROLOL BISACODYL vs BISOPROLOL\HYDROCHLOROTHIAZIDE BISACODYL vs BIVALIRUDIN

Other Drugs in Same Class: Increased Large Intestinal Motility [PE]

SODIUM (23,383) POTASSIUM (11,986) MAGNESIUM (9,739) SODIUM BICARBONATE (3,191) MAGNESIUM HYDROXIDE (1,970) POTASSIUM, DIBASIC (190) MAGNESIUM HEPTAHYDRATE (91) POTASSIUM CHLORATE (82) View all → Class side effects → Compare in class →

Official FDA Label for BISACODYL

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Directions - tear off one suppository from the strip - peel apart the wrapper - continue peeling apart to almost the full length of the suppository - gently remove the suppository from the wrapper - lie on your side and push suppository, with pointed end first, high into the rectum so it will not slip out - retain it for 15 to 20 minutes - Do not exceed recommended dose - if suppository seems soft, place in refrigerator for a short time before use. Adults and children 12 years and over 1 suppository once daily Children 6 to under 12 years 1/2 suppository once daily Children under 6 years Ask a doctor

Dosage & Administration

Directions tear off one suppository from the strip peel apart the wrapper continue peeling apart to almost the full length of the suppository (see illustration at the right) gently remove the suppository from the wrapper lie on your side and push suppository, with pointed end first, high into the rectum so it will not slip out retain it for about 15 to 20 minutes. Do not exceed recommended dose if suppository seems soft, place in refrigerator for a short time before use adults and children 12 years and over 1 suppository once daily children under 12 years Ask a doctor

Warnings

Warnings Do not use

if you cannot swallow without chewing Ask a doctor before use if you have
stomach pain, nausea or vomiting
noticed a sudden change in bowel habits that lasts more than 2 weeks When using this product
it may cause stomach discomfort, faintness and cramps
do not chew or crush tablet(s)
do not use within 1 hour after taking an antacid or milk Stop use and ask a doctor if
you have rectal bleeding or fail to have a bowel movement after using this product. These could be signs of a serious condition.
you need to use a laxative for more than 1 week If pregnant or b reast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Warnings Do not use

if you cannot swallow without chewing Ask a doctor before use if you have
stomach pain, nausea or vomiting
noticed a sudden change in bowel habits that lasts more than 2 weeks When using this product
it may cause stomach discomfort, faintness and cramps
do not chew or crush tablet(s)
do not use within 1 hour after taking an antacid or milk Stop use and ask a doctor if
you have rectal bleeding or fail to have a bowel movement after using this product. These could be signs of a serious condition.
you need to use a laxative for more than 1 week If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient

Active Ingredient (in each Suppository)

Active Ingredient

Purpose (in each Suppository)

Bisacodyl

10 mg.................................Stimulant Laxative

Inactive Ingredients

Inactive ingredients acacia senegal gum, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxides, lactose, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate