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Fematrol Side Effects

Generic Name: bisacodyl

Note: This document contains side effect information about bisacodyl. Some of the dosage forms listed on this page may not apply to the brand name Fematrol.

For the Consumer

Applies to bisacodyl: oral tablets delayed-release, rectal suppositories, rectal suspension

Side effects include:

Some degree of abdominal discomfort, nausea, cramps, griping, and/or faintness with therapeutic doses.

Diarrhea, GI irritation, and fluid and electrolyte depletion.

Gastric irritation and the possibility of vomiting if enteric coating of tablets is disrupted. (See Advice to Patients.)

Rectal administration of bisacodyl (the active ingredient contained in Fematrol) suspensions or suppositories may cause irritation and a sensation of burning of the rectal mucosa and mild proctitis.

Hepatotoxicity if sufficient tannic acid is absorbed from bisacodyl tannex.

For Healthcare Professionals

Applies to bisacodyl: compounding powder, oral delayed release tablet, rectal enema, rectal suppository

General

ENEMA: The most commonly reported side effects included abdominal discomfort, faintness, mild cramps, and rectal burning.

SUPPOSITORY: The most commonly reported side effects included abdominal discomfort, faintness, mild cramps, and rectal burning.

TABLET: The most commonly reported side effects included cramps, faintness, and stomach discomfort.[Ref]

Gastrointestinal

Prolonged use of this drug may result in diarrhea with excessive water and electrolyte loss, especially potassium.

Colic was treated with atropine derivatives.[Ref]

ENEMA:

Rare (0.01% to 0.1%): Vomiting

Frequency not reported: Abdominal discomfort, abdominal pain, colic, cramping, diarrhea, epigastralgia, nausea, proctitis, mild cramps, tenesmus

SUPPOSITORY:

Common (1% to 10%): Abdominal cramps, abdominal pain, diarrhea, nausea

Uncommon (0.1% to 1%): Abdominal discomfort, blood in stool/hematochezia, vomiting

Rare (0.01% to 0.1%): Colitis, ischemic colitis

Frequency not reported: Abdominal spasm, atonic, nonfunctioning colon, defecation, diarrhea with excessive water and electrolyte loss, mild cramps, proctitis

TABLET:

Common (1% to 10%): Abdominal cramps, abdominal pain, diarrhea, nausea

Uncommon (0.1% to 1%): Abdominal discomfort, anorectal discomfort, blood in stool/ hematochezia, vomiting

Rare (0.01% to 0.1%): Colitis, ischemic colitis

Frequency not reported: Abdominal spasm, colic, cramps/cramping, defecation, epigastralgia, proctitis, stomach discomfort, tenesmus[Ref]

Nervous system

ENEMA:

Frequency not reported: Faintness, syncope

SUPPOSITORY:

Uncommon (0.1% to 1%): Dizziness

Rare (0.01% to 0.1%): Syncope

Frequency not reported: Faintness, vasovagal response

TABLET:

Uncommon (0.1% to 1%): Dizziness

Rare (0.01% to 0.1%): Syncope

Frequency not reported: Faintness, vasovagal response[Ref]

Local

ENEMA:

Frequency not reported: Local rectal irritation, rectal burning

SUPPOSITORY:

Uncommon (0.1% to 1%): Anorectal discomfort, rectal irritation

Frequency not reported: Rectal burning[Ref]

Hypersensitivity

ENEMA:

Rare (0.01% to 0.1%): Anaphylactoid reactions, angioedema, hypersensitivity reactions

SUPPOSITORY:

Rare (0.01% to 0.1%): Anaphylactic reactions, angioedema, hypersensitivity

TABLET:

Rare (0.01% to 0.1%): Anaphylactic reactions, anaphylactoid reactions, angioedema, hypersensitivity reactions/hypersensitivity[Ref]

Dermatologic

ENEMA:

Rare (0.01% to 0.1%): Mild, transient skin reactions

SUPPOSITORY:

Frequency not reported: Sloughing of the epithelium

TABLET:

Rare (0.01% to 0.1%): Mild, transient skin reactions[Ref]

Metabolic

SUPPOSITORY:

Rare (0.01% to 0.1%): Dehydration

TABLET:

Rare (0.01% to 0.1%): Dehydration[Ref]

Immunologic

ENEMA:

Frequency not reported: Slight indisposition

TABLET:

Frequency not reported: Slight indisposition[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Dulcolax (bisacodyl)." Ciba Self-Medication Inc, Woodbridge, NJ.

3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Related questions

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