Prescription medication · Anticholinergic / Antispasmodic

dicyclomine

Also sold as Bentyl. Dicyclomine treats irritable bowel syndrome (IBS).

Data updated 2026-05-15

13,367
FDA reportsModerately reported
3
InteractionsFew interactions
1
Recall record

What the data shows

dicyclomine (Bentyl) is a prescription Anticholinergic / Antispasmodic, reported less often than most tracked drugs (13,367 FDA reports), with 3 documented drug interactions.

Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.

dicyclomine (Bentyl) is a prescription Anticholinergic / Antispasmodic. Dicyclomine treats irritable bowel syndrome (IBS).

Dicyclomine is a medicine that helps with irritable bowel syndrome. It reduces muscle spasms in the gut.

Drug Pricing (NADAC)

Generic Price

$0.08/unit

Generic Available

Yes (29 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

View Alternatives → Compare with Another Drug → Full Side Effects Report →

What it does

Dicyclomine treats irritable bowel syndrome (IBS).

Common side effects

Dizziness, Dry mouth, Blurred vision

Key warnings

Dicyclomine can worsen heart problems.

The sections below are summarized in plain English from dicyclomine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

How It Works

Dicyclomine works by blocking a substance called acetylcholine. This substance tells the muscles in your gut to contract. By blocking acetylcholine, dicyclomine helps to relax these muscles and reduce spasms.

Side Effects (from patient reports)

Based on 13,367 FDA adverse event reports.

Most-reported reactions

Adverse reactions in FAERS for dicyclomine, by number of reports

reports

What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.

Source FDA Adverse Event Reporting System (FAERS) As of 2025

Reports over time

Adverse-event reports filed for dicyclomine each year to the FDA Adverse Event Reporting System (FAERS).

05001,0001,500 20042007201020132016201920222025 1,250

Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.

Where dicyclomine sits

dicyclomine has more FDA adverse-event reports than 46% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.

fewest reports most reports

Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is dicyclomine; the line is the median (50th percentile).

FDA Adverse Event Report Analysis

Detailed analysis of 13,367 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.

Total Reports

13,367

Reports Mentioning Death

790

5.9% of reports — not proof of cause

Hospitalization Reports

4,021

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 9,529 (75%)
Male 3,141 (25%)

Age Distribution

0–17 265
18–44 1,942
45–64 3,356
65–74 1,766
75+ 1,127

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 NAUSEA 1,251
2 DIARRHOEA 1,193
3 FATIGUE 1,119
4 PAIN 1,003
5 HEADACHE 861
8 CHRONIC KIDNEY DISEASE 716
9 DIZZINESS 688
10 VOMITING 682
11 ABDOMINAL PAIN 681
12 DYSPNOEA 618
13 ANXIETY 586
14 ABDOMINAL PAIN UPPER 565
15 FALL 553
16 ARTHRALGIA 528
17 ACUTE KIDNEY INJURY 527

Reactions in Death Reports

DEATH 374
COMPLETED SUICIDE 90
ACUTE KIDNEY INJURY 62
CHRONIC KIDNEY DISEASE 60
TOXICITY TO VARIOUS AGENTS 54
RENAL FAILURE 50
NAUSEA 33
PNEUMONIA 30
DIARRHOEA 29
END STAGE RENAL DISEASE 26

Reactions in Hospitalization Reports

NAUSEA 457
DIARRHOEA 433
PAIN 404
FATIGUE 338
VOMITING 330
ABDOMINAL PAIN 326
FALL 310
DYSPNOEA 285
PNEUMONIA 271
HEADACHE 265

Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Dicyclomine can worsen heart problems. It can also cause heat stroke because it reduces sweating. Some people, especially older adults or those with mental illness, may get psychosis or delirium. Overdose can cause muscle weakness and paralysis, especially in people with myasthenia gravis. This medicine may not be safe if you have a bowel obstruction, ulcerative colitis, or an enlarged prostate.

Known Drug Interactions

minor digoxin

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.

Mechanism: Dicyclomine slows down the movement of the gut, which gives the body more time to absorb digoxin into the blood.

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.

Mechanism: Both drugs have similar effects on the body, so taking them together can increase the risk of side effects like dry mouth or constipation.

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.

Mechanism: These two drugs work in opposite ways on how the stomach moves, which means they can cancel each other out. One drug tries to speed up the gut while the other tries to slow it down.

This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.

Common Questions

Can I take dicyclomine if I have glaucoma?
No, you should not take dicyclomine if you have glaucoma.
Can I take dicyclomine if I am breastfeeding?
No, you should not take dicyclomine if you are breastfeeding.
What should I do if I get a fever while taking dicyclomine?
Stop taking dicyclomine and seek medical attention immediately.
Can dicyclomine be used for children?
Dicyclomine is not recommended for infants under 6 months old.
Can I drive while taking dicyclomine?
Dicyclomine may cause drowsiness or blurred vision, so use caution when driving or operating machinery.
What should I avoid while taking dicyclomine?
Avoid becoming overheated or dehydrated in hot weather.
Can I take antacids with dicyclomine?
Avoid taking antacids at the same time as dicyclomine.
What if dicyclomine doesn't seem to be working?
Talk to your doctor if your symptoms do not improve after two weeks.
Can I drink alcohol while taking dicyclomine?
Alcohol may increase drowsiness, so use caution when drinking alcohol while taking dicyclomine.
What are the signs of an overdose?
Signs of overdose include muscle weakness, paralysis, and confusion. Seek immediate medical attention if you suspect an overdose.
What are the common side effects of dicyclomine?
The registry lists Dizziness, Dry mouth, Blurred vision, Nausea, Sleepiness among the most-reported FAERS reaction terms for dicyclomine. The compiled record contains 13,367 FDA adverse-event reports. These counts are not an individual symptom assessment.
Does dicyclomine interact with other medications?
The registry has 3 documented interaction rows for dicyclomine. Notable source-record pairings include digoxin, meperidine, metoclopramide. These rows are not a complete medication review.
What drug class is dicyclomine?
dicyclomine belongs to the Anticholinergic / Antispasmodic drug class. It requires a prescription (Rx). Dicyclomine treats irritable bowel syndrome (IBS).
What pregnancy or breastfeeding source fields are listed for dicyclomine?
The FDA label for dicyclomine contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.
Has dicyclomine been recalled?
There is 1 recall associated with dicyclomine products. CGMP Deviations: Firm went out of business and could no longer continue stability studies. Check the recalls section below for full details and affected products.

Active Recalls

Class II April 26, 2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc.

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Compare beyond drug class

Nationwide peers by FAERS volume & death-report share

Two PlainMeds-derived comparison paths for dicyclomine: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.

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What the FDA Data Shows for dicyclomine

The FDA label for dicyclomine (sold under brand names such as Bentyl) classifies it as a prescription-only medication in the Anticholinergic / Antispasmodic class. Dicyclomine treats irritable bowel syndrome (IBS). Official labeling lists 7 commonly reported side effects, including Dizziness, Dry mouth, Blurred vision.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 13,367 voluntary reports. The database also lists 3 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $0.08.

Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.

Last updated: July 24, 2023

PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.

Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.

All federal data sources used on this page