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Byclomine Side Effects

Generic Name: dicyclomine

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

For the Consumer

Applies to dicyclomine: oral capsules and tablets, oral solution, parenteral injection

Side effects include:

Most adverse effects are manifestations of pharmacologic effects at muscarinic-cholinergic receptors and usually are reversible when therapy is discontinued.

Severity and frequency of adverse effects are dose related and individual intolerance varies greatly; although adverse effects occasionally may be obviated by a reduction in dosage, this also will likely eliminate potential therapeutic effects. If dosage of ≥80 mg daily cannnot be achieved because of intolerance, discontinue dicyclomine (the active ingredient contained in Byclomine)

Dry mouth, dizziness, blurred vision, nausea, light-headedness (especially with the injectable form), drowsiness, weakness, nervousness.

For Healthcare Professionals

Applies to dicyclomine: compounding powder, intramuscular solution, oral capsule, oral syrup, oral tablet

General

-The most serious adverse reactions include cardiovascular and central nervous system symptoms.
-The most common adverse reactions are dizziness, dry mouth, vision blurred, nausea, somnolence, asthenia and nervousness, fever, tachycardia, agitation, and dry skin/mucous membranes.[Ref]

Gastrointestinal

Very common (10% or more): Dry mouth (33%), nausea (14%)
Rare (less than 0.1%): Constipation, anorexia
Frequency not reported: Thirst, delayed gastric emptying time, reduced gastric acid secretion, gastroesophageal reflux
Postmarketing reports: Abdominal distension, abdominal pain, dyspepsia, constipation, dry mouth, nausea, vomiting[Ref]

Nervous system

Very common (10% or more): Dizziness (40%)
Common (1% to 10%): Somnolence, nervousness
Rare (less than 0.1%): Sedation, headache
Postmarketing reports: Dizziness, headache, somnolence, syncope[Ref]

Ocular

Very common (10% or more): Blurred vision (27%)
Frequency not reported: Follicular conjunctivitis, all muscarinic antagonists can precipitate glaucoma
Postmarketing reports: Cycloplegia, mydriasis, blurred vision[Ref]

Other

Common (1% to 10%): Asthenia
Frequency not reported: Fatigue
Postmarketing reports: Malaise, fatigue[Ref]

Dermatologic

Rare (less than 0.1%): Rash
Postmarketing reports: Allergic dermatitis, erythema, rash[Ref]

Renal

Rare (less than 0.1%): Dysuria[Ref]

Genitourinary

Frequency not reported: Urinary retention, impotence in male patients
Postmarketing reports: Suppressed lactation[Ref]

Cardiovascular

Postmarketing reports: Palpitations, tachyarrhythmias, thrombosis, thrombophlebitis[Ref]

Hypersensitivity

Postmarketing reports: Face edema, angioedema, anaphylactic shock[Ref]

Local

Postmarketing reports: Local pain, edema, skin color change, reflex sympathetic dystrophy syndrome (caused by inadvertent IV injection)[Ref]

Psychiatric

Postmarketing reports: Delirium or symptoms of delirium such as amnesia (or transient global amnesia), nervousness, agitation, confusional state, delusion, disorientation, hallucination (including visual hallucination), and mania, mood (altered and pseudodementia).[Ref]

Respiratory

Postmarketing reports: Dyspnea, nasal congestion[Ref]

References

1. Kagan G, Huddlestone L, Wolstencroft P "Comparison of dicyclomine with antacid and without antacid in dyspepsia." J Int Med Res 12 (1984): 174-8

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

3. "Product Information. Bentyl (dicyclomine)." Aventis Pharmaceuticals, Kansas City, MO.

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.

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