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Dicyclomine

ATC code A03AA07

Also known as: Disiklomin

Key facts
Active substance
Dicyclomine
ATC code
A03AA07
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Key facts

Dicyclomine is, per the US prescribing information, an anticholinergic/antispasmodic agent used to treat functional bowel/irritable bowel syndrome.

What it is used for

  • Treatment of patients with functional bowel/irritable bowel syndrome.

Dosing

  • Adults: initial dose 20 mg four times a day, adjusted to individual needs.
  • After one week the dose may be increased to 40 mg four times a day unless side effects limit escalation.
  • Discontinue if efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day; no documented safety data exist for doses above 80 mg daily for longer than 2 weeks.
  • Use with caution in hepatic or renal impairment and in elderly patients.

Contraindications

  • Infants less than 6 months of age and nursing mothers.
  • Unstable cardiovascular status in acute hemorrhage, myasthenia gravis, glaucoma, obstructive uropathy.
  • Obstructive disease of the gastrointestinal tract, severe ulcerative colitis, reflux esophagitis.

Important warnings

  • Cardiovascular: caution in tachyarrhythmia (e.g. thyrotoxicosis, congestive heart failure), coronary heart disease and hypertension.
  • Anticholinergic effects such as dry mouth, mydriasis, loss of accommodation; heat prostration from decreased sweating in high environmental temperature.
  • Central nervous system effects up to delirium; drowsiness, dizziness and blurred vision may impair driving.
  • Diarrhea may be an early symptom of incomplete intestinal obstruction; in ulcerative colitis, risk of paralytic ileus and toxic megacolon.
  • Caution in prostatic enlargement (urinary retention).

Side effects

  • In controlled trials (40 mg four times a day): dizziness 40%, dry mouth 33%, blurred vision 27%, nausea 14%, somnolence 9%, asthenia 7%.
  • The most serious adverse reactions involve cardiovascular and central nervous system symptoms (e.g. tachyarrhythmias, delirium, hallucinations).
  • Postmarketing include palpitations, constipation, hypersensitivity up to anaphylactic shock, suppressed lactation.

Interactions

  • Other drugs with anticholinergic activity (e.g. amantadine, antihistamines, phenothiazines, tricyclic antidepressants) may increase effects and side effects.
  • Antagonizes antiglaucoma agents and drugs that alter gastrointestinal motility, such as metoclopramide.
  • Antacids may interfere with absorption; avoid simultaneous use.

Pregnancy and breastfeeding

  • Epidemiologic studies showed no increased risk of malformations at doses up to 40 mg/day; studies at recommended doses are lacking.
  • Contraindicated in breastfeeding because it is excreted in human milk.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

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For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Brand names in 1 more European countries
Latvia
Trigan-Sp

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. U.S. Food and Drug Administration. Dicyclomine Hydrochloride (Lannett Company, LLC) – Prescribing Information, 2026-08-06. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=bd2cba10-70ec-4d1f-b46c-53d1de2ee130

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.