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.

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]