Dicyclomine hydrochloride

What Dicyclomine hydrochloride is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome

— FDA label: Dicyclomine Hydrochloride, Major Pharmaceuticals, effective August 20, 2026. Read the full label on DailyMed →

Label quoted: the one for the most common form (tablet, oral), Dicyclomine Hydrochloride, Major Pharmaceuticals; it covers 2 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

The FDA has 114 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Related medical specialties

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 114 FDA labels for this medicine have a boxed warning.

Dicyclomine hydrochloride side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

The pattern of adverse effects seen with dicyclomine is mostly related to its pharmacological actions at muscarinic receptors [see Clinical Pharmacology (12)]. They are a consequence of the inhibitory effect on muscarinic receptors within the autonomic nervous system. These effects are dose-related and are usually reversible when treatment is discontinued.

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The most serious adverse reactions reported with dicyclomine hydrochloride include cardiovascular and central nervous system symptoms [see Warnings and Precautions (5.2, 5.3)]. The most serious adverse reactions include cardiovascular and central nervous system symptoms. The most common adverse reactions (> 5% of patients) are dizziness, dry mouth, vision blurred, nausea, somnolence, asthenia and nervousness (6) To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. at 1-844-834-0530 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure in controlled clinical trials involving over 100 patients treated for functional bowel/irritable bowel syndrome with dicyclomine hydrochloride at initial doses of 160 mg daily (40 mg four times a day). In these trials most of the side effects were typically anticholinergic in nature and were reported by 61% of the patients. Table 1 presents adverse reactions (MedDRA 13.0 preferred terms) by decreasing order of frequency in a side-by-side comparison with placebo. Table 1: Adverse reactions experienced in controlled clinical trials with decreasing order of frequency MedDRA Preferred Term Dicyclomine Hydrochloride (40 mg four times a day) Placebo % % Dry Mouth 33 5 Dizziness 40 5 Vision blurred 27 2 Nausea 14 6 Somnolence 9 1 Asthenia 7 1 Nervousness 6 2 Nine percent (9%) of patients were discontinued from dicyclomine hydrochloride because of one or more of these side effects (compared with 2% in the placebo group). In 41% of the patients with side effects, side effects disappeared or were tolerated at the 160 mg daily dose without reduction. A dose reduction from 160 mg daily to an average daily dose of 90 mg was required in 46% of the patients with side effects who then continued to experience a favorable clinical response; their side effects either disappeared or were tolerated. 6.2 Postmarketing Experience The following adverse reactions, presented by system organ class in alphabetical order, have been identified during post approval use of dicyclomine hydrochloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

— FDA label: Dicyclomine Hydrochloride, Major Pharmaceuticals, effective August 20, 2026. This is part of the section. Read the full label on DailyMed →

Dicyclomine hydrochloride drug interactions

Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.

• Antiglaucoma agents: anticholinergics antagonize antiglaucoma agents and may increase intraoccular pressure (7)
• Anticholinergic agents: may affect the gastrointestinal absorption of various drugs; may also increase certain actions or side effects of other anticholinergic drugs (7)
• Antacids: interfere with the absorption of anticholinergic agents (7) 7.1 Antiglaucoma Agents Anticholinergics antagonize the effects of antiglaucoma agents.

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Anticholinergic drugs in the presence of increased intraocular pressure may be hazardous when taken concurrently with agents such as corticosteroids. Use of dicyclomine hydrochloride in patients with glaucoma is not recommended [see Contraindications (4)]. 7.2 Other Drugs with Anticholinergic Activity The following agents may increase certain actions or side effects of anticholinergic drugs including dicyclomine hydrochloride: amantadine, antiarrhythmic agents of Class I (e.g., quinidine), antihistamines, antipsychotic agents (e.g., phenothiazines), benzodiazepines, MAO inhibitors, narcotic analgesics (e.g., meperidine), nitrates and nitrites, sympathomimetic agents, tricyclic antidepressants, and other drugs having anticholinergic activity. 7.3 Other Gastrointestinal Motility Drugs Interaction with other gastrointestinal motility drugs may antagonize the effects of drugs that alter gastrointestinal motility, such as metoclopramide. 7.4 Effect of Antacids Because antacids may interfere with the absorption of anticholinergic agents including dicyclomine hydrochloride, simultaneous use of these drugs should be avoided. 7.5 Effect on Absorption of Other Drugs Anticholinergic agents may affect gastrointestinal absorption of various drugs by affecting on gastrointestinal motility, such as slowly dissolving dosage forms of digoxin; increased serum digoxin concentration may result. 7.6 Effect on Gastric Acid Secretion The inhibiting effects of anticholinergic drugs on gastric hydrochloric acid secretion are antagonized by agents used to treat achlorhydria and those used to test gastric secretion.

— FDA label: Dicyclomine Hydrochloride, Major Pharmaceuticals, effective August 20, 2026. Read the full label on DailyMed →

Dicyclomine hydrochloride dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

Dosage must be adjusted to individual patient needs. Dosage for dicyclomine hydrochloride must be adjusted to individual patient needs (2). If a dose is missed, patients should continue the normal dosing schedule (2). Oral in adults (2.1):

• Starting dose: 20 mg four times a day.

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After a week treatment with the starting dose, the dose may be escalated to 40 mg four times a day, unless side effects limit dosage escalation

• Discontinue dicyclomine hydrochloride if efficacy not achieved or side effects require doses less than 80 mg per day after two weeks of treatment 2.1 Oral Dosage and Administration in Adults The recommended initial dose is 20 mg four times a day. After one week treatment with the initial dose, the dose may be increased to 40 mg four times a day unless side effects limit dosage escalation. If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued. Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.

— FDA label: Dicyclomine Hydrochloride, Major Pharmaceuticals, effective August 20, 2026. Read the full label on DailyMed →

Dicyclomine hydrochloride in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.

Pregnancy Category B Adequate and well-controlled studies have not been conducted with dicyclomine hydrochloride in pregnant women at the recommended doses of 80 to 160 mg/day. However, epidemiologic studies did not show an increased risk of structural malformations among babies born to women who took products containing dicyclomine hydrochloride at doses up to 40 mg/day during the first trimester of pregnancy.

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Reproduction studies have been performed in rats and rabbits at doses up to 33 times the maximum recommended human dose based on 160 mg/day (3 mg/kg) and have revealed no evidence of harm to the fetus due to dicyclomine. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

— FDA label: Dicyclomine Hydrochloride, Major Pharmaceuticals, effective August 20, 2026. Read the full label on DailyMed →

Dicyclomine hydrochloride and breastfeeding

Quoted from the nursing mothers / lactation part of the FDA-approved label.

Dicyclomine hydrochloride is contraindicated in women who are breastfeeding. Dicyclomine hydrochloride is excreted in human milk. Because of the potential for serious adverse reactions in breast-fed infants from dicyclomine hydrochloride, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother [see Use in Specific Populations (8.4)].

— FDA label: Dicyclomine Hydrochloride, Major Pharmaceuticals, effective August 20, 2026. Read the full label on DailyMed →

When Dicyclomine hydrochloride should not be used

Quoted from the “Contraindications” section of the FDA-approved label.

Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [see Use in Specific Populations (8.4)], nursing mothers [see Use in Specific Populations (8.3)], and in patients with:

• unstable cardiovascular status in acute hemorrhage
• myasthenia gravis [see Warnings and Precautions (5.4)]
• glaucoma [see Adverse Reactions (6.3) and Drug Interactions (7.1)]
• obstructive uropathy [see Warnings and Precautions (5.8)]
• obstructive disease of the …

— FDA label: Dicyclomine Hydrochloride, Major Pharmaceuticals, effective August 20, 2026. This is part of the section. Read the full label on DailyMed →

Dicyclomine hydrochloride overdose

Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).

In case of an overdose, patients should contact a physician, poison control center (1-800-222-1222), or emergency room. The signs and symptoms of overdosage include: headache; nausea; vomiting; blurred vision; dilated pupils; hot, dry skin; dizziness; dryness of the mouth; difficulty in swallowing; and CNS stimulation including convulsion. A curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis).

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One reported event included a 37-year-old who reported numbness on the left side, cold fingertips, blurred vision, abdominal and flank pain, decreased appetite, dry mouth, and nervousness following ingestion of 320 mg daily (four 20 mg tablets four times daily). These events resolved after discontinuing the dicyclomine. The acute oral LD 50 of the drug is 625 mg/kg in mice. The amount of drug in a single dose that is ordinarily associated with symptoms of overdosage or that is likely to be life-threatening, has not been defined. The maximum human oral dose recorded was 600 mg by mouth in a 10-month-old child and approximately 1500 mg in an adult, each of whom survived. In three of the infants who died following administration of dicyclomine hydrochloride [see Warnings and Precautions (5)], the blood concentrations of drug were 200, 220, and 505 ng/mL. It is not known if dicyclomine hydrochloride is dialyzable. Treatment should consist of gastric lavage, emetics, and activated charcoal. Sedatives (e.g., short-acting barbiturates, benzodiazepines) may be used for management of overt signs of excitement. If indicated, an appropriate parenteral cholinergic agent may be used as an antidote.

— FDA label: Dicyclomine Hydrochloride, Major Pharmaceuticals, effective August 20, 2026. Read the full label on DailyMed →

Forms and how it is given

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• NuCare Pharmaceuticals, Inc.14 products
• Bryant Ranch Prepack11 products
• A-S Medication Solutions11 products
• PD-Rx Pharmaceuticals, Inc.8 products
• Redpharm Drug7 products
• Remedyrepack Inc.6 products
• Hikma Pharmaceuticals USA Inc.6 products
• Northwind Health Company, LLC5 products
• Proficient Rx LP4 products
• Preferred Pharmaceuticals Inc.4 products
• St. Mary's Medical Park Pharmacy3 products
• Advagen Pharma Ltd3 products
• Coupler LLC3 products
• NCS HealthCare of KY, LLC dba Vangard Labs2 products
• Rising Pharma Holdings, Inc.2 products
• Aurobindo Pharma Limited2 products
• Chartwell RX, LLC2 products
• Aphena Pharma Solutions - Tennessee, LLC2 products
• Golden State Medical Supply, Inc.2 products
• Solaris Pharma Corporation2 products
• Actavis Pharma, Inc.2 products
• Cardinal Health 107, LLC2 products
• Major Pharmaceuticals2 products
• American Health Packaging2 products
• Somerset Therapeutics, LLC2 products
• Camber Pharmaceuticals, Inc.2 products
• Lannett Company, LLC2 products
• Upsher-Smith Laboratories, LLC2 products
• American Regent, Inc.1 product
• Atlantic Biologicals Corp.1 product
• Bionpharma Inc.1 product
• Fosun Pharma USA Inc.1 product
• Par Health USA, LLC1 product
• AvPAK1 product
• Slate Run Pharmaceuticals, LLC1 product
• Trifluent Pharma, LLC1 product
• Fresenius Kabi USA, LLC1 product
• Novitium Pharma LLC1 product
• QPharma, Inc.1 product
• Unit Dose Solutions, Inc.1 product
• Solco Healthcare US, LLC1 product
• HF Acquisition Co LLC, DBA HealthFirst1 product

FDA approval history

• ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (30)

• ANDA084285Lannett · September 30, 1974
• ANDA085082Watson Labs · July 28, 1976
• ANDA085223Watson Labs · August 17, 1976
• ANDA040161Hikma · October 1, 1996
• ANDA040204Hikma · February 28, 1997
• ANDA040230Lannett · February 26, 1999
• ANDA040317Aurobindo Pharma USA · September 7, 1999
• ANDA040319Aurobindo Pharma USA · September 7, 1999
• ANDA040465Hikma · June 30, 2003
• ANDA040169Ph Health · March 24, 2005
• ANDA208353Am Regent · February 17, 2017
• ANDA210979Fosun Pharma · July 2, 2018
• ANDA207076Slate Run Pharma · November 2, 2018
• ANDA210257Fresenius Kabi USA · January 25, 2019
• ANDA212286Hikma · May 22, 2020
• ANDA214721Novitium Pharma · April 23, 2021
• ANDA216760Solgen · November 28, 2022
• ANDA216736Rubicon Research · December 14, 2022
• ANDA217054Twi Pharms · December 27, 2022
• ANDA216639Solgen · March 24, 2023
• ANDA216782Twi Pharms · June 1, 2023
• ANDA217916Bionpharma · August 4, 2023
• ANDA217531Prinston Inc · August 30, 2023
• ANDA217566Annora Pharma · May 7, 2024
• ANDA218018Annora Pharma · July 1, 2024
• ANDA214332Somerset Theraps LLC · November 1, 2024
• ANDA214333Somerset Theraps LLC · November 1, 2024
• ANDA218952Rising · November 15, 2024
• ANDA219242Rising · June 23, 2025
• ANDA216515Rubicon Research · July 17, 2026

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

1. July 23, 2026 · Class II · Ongoing · D-0733-2026

   shortfill; reports of empty capsules.

   Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-719-99 — Aurobindo Pharma USA Inc

2. January 26, 2022 · Class II · Terminated · D-0175-2024

   CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

   Dicyclomine Hydrochloride Tablets, USP 20 mg, 100 Tablets, Rx only, Manufactured For: Teva Pharmaceuticals USA, Parsippany, NJ 07054. NDC: 0591-0795-01 — CARDINAL HEALTHCARE

Official identifiers

Next steps

• Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
• Latest FDA drug recallsAll medicines, newest first
• Irritable bowel syndrome (IBS)Condition named on the label: hospitals that treat it
• NuCare Pharmaceuticals, Inc.Maker or distributor
• Bryant Ranch PrepackMaker or distributor
• A-S Medication SolutionsMaker or distributor
• All prescription drugs A to ZSearch by generic, brand or Spanish name

Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Dicyclomine Hydrochloride, Major Pharmaceuticals, effective August 20, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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