This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
Dicyclomine hydrochloride tablets are 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 ( 1 )
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 gastrointestinal tract [see Warnings and Precautions ( 5.5 )] severe ulcerative colitis [see Warnings and Precautions ( 5.7 )] reflux esophagitis Infants less than 6 months of age ( 4 ) Glaucoma ( 4 ) Nursing mothers ( 4 ) Obstructive uropathy ( 4 ) Unstable cardiovascular status in the acute hemorrhage ( 4 ) Obstructive disease of gastrointestinal tract ( 4 ) Myasthenia gravis ( 4 ) Severe ulcerative colitis ( 4 ) Reflux esophagitis ( 4 )
Cardiovascular conditions : worsening of conditions ( 5.2 ) Peripheral and central nervous system : heat prostration can occur with drug use (fever and heat stroke due to decreased sweating); drug should be discontinued and supportive measures instituted ( 5.3 ) Psychosis and delirium have been reported in patients sensitive to anticholinergic drugs (such as elderly patients and/or in patients with mental illness): signs and symptoms resolve within 12 to 24 hours after discontinuation of dicyclomine hydrochloride tablets ( 5.3 ) Myasthenia Gravis : overdose may lead to muscular weakness and paralysis. Dicyclomine hydrochloride tablets should be given to patients with myasthenia gravis only to reduce adverse muscarinic effects of an anticholinesterase ( 5.4 ) Incomplete intestinal obstruction : diarrhea may be an early symptom especially in patients with ileostomy or colostomy. Treatment with dicyclomine hydrochloride tablets would be inappropriate and possibly fatal ( 5.5 ) Salmonella dysenteric patients : due to risk of toxic megacolon ( 5.6 ) Ulcerative colitis : Dicyclomine hydrochloride tablets should be used with caution in these patients; large doses may suppress intestinal m...
The pattern of adverse effects seen with dicylomine 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. 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 Advagen Pharma Ltd, at 866-488-0312 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...
RECENT MAJOR CHANGES Warnings and Precautions, Peripheral and Central Nervous System ( 5.3 ) 07/2012
Source: FDA SPL label for Dicyclomine hydrochloride (Northwind Health Company, LLC), effective 20260101. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 1,976 | 1,850 | 1,535 | 1,334 | 1,304 | 1,185 | 1,532 | 775 |
1,480 reports blaming this drug for every million Medicare prescriptions filled, which is 0.5× the typical drug on this site. (3,480 reports in 2024–2026, against 2,350,765 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 07/2026 | Class II | Aurobindo Pharma USA Inc | shortfill; reports of empty capsules. |
| 01/2022 | Class II | CARDINAL HEALTHCARE | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $0 in payments to US physicians and hospitals tied to this drug across 0 transactions.
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Dicyclomine HCl | 2,350,747 | $18 |
| Bentyl | 18 | $1,207 |
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.