Drug · FAERS side-effect profile with label screen

Dicyclomine side effects: what 14,155 FDA adverse event reports show

Dicyclomine Hydrochloride · 1,117 reaction terms · 68,214 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Dicyclomine Hydrochloride (Dicyclomine Hydrochloride)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

14,155 reports · 61% serious · 848 with death outcome · 75% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Dicyclomine hydrochloride tablets are indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine hydrochloride tablets are an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome ( 1 )

FDA label, Indications and Usage

What it is

Dicyclomine hydrochloride tablets USP, is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage form: • Dicyclomine hydrochloride tablets USP, for oral use contain 20 mg dicyclomine hydrochloride USP.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled (related wording) 1Likely indication confounding 1Reporting / coding artifact 1Lab value / disease marker 2Not in label — unassessed 35

What the badges mean

Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,077 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Cholesterosis	10	58.9 31.3–110.7ROR 58.9 · χ² 493 / p 2e-109	51.4 EB05 29.8 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=10	no trial arm names this drug
Biliary dyskinesia	65	58.3 45.5–74.6ROR 58.6 · χ² 3,465 / p <1e-300	55.2 EB05 44.9 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious n=66 · ♀ 100% (drug 75%)	no trial arm names this drug
Nephrogenic anaemia	132	43.0 36.2–51.1ROR 43.4 · χ² 5,220 / p <1e-300	41.6 EB05 35.9 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious n=132	no trial arm names this drug
Pigmentary maculopathy	13	40.5 23.3–70.2ROR 40.5 · χ² 449 / p 5e-100	37.4 EB05 23.3 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=13	no trial arm names this drug
Hyperparathyroidism secondary	59	35.3 27.3–45.7ROR 35.4 · χ² 1,887 / p <1e-300	34.1 EB05 27.4 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=59	no trial arm names this drug
Chronic kidney disease-mineral and bone disorder	25	35.2 23.7–52.3ROR 35.3 · χ² 778 / p 2e-171	33.6 EB05 23.9 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=25	no trial arm names this drug
Cholecystitis chronic	157	35.0 29.9–41.0ROR 35.4 · χ² 5,040 / p <1e-300	34.1 EB05 29.9 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 32.3 · ♀ 100% (drug 75%)	no trial arm names this drug
Gallbladder non-functioning	13	34.2 19.7–59.3ROR 34.2 · χ² 378 / p 2e-84	32.0 EB05 19.9 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=13	no trial arm names this drug
Rebound acid hypersecretion	67	33.0 26.0–42.1ROR 33.2 · χ² 2,005 / p <1e-300	32.1 EB05 26.1 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=67	no trial arm names this drug
Gallbladder injury	38	29.6 21.4–40.7ROR 29.6 · χ² 1,000 / p 9e-220	28.6 EB05 21.8 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=38 · ♀ 100% (drug 75%) · 70% consumer	no trial arm names this drug
Infusion site mass	18	25.4 15.9–40.4ROR 25.4 · χ² 390 / p 3e-87	24.4 EB05 16.2 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=15	no trial arm names this drug
Infusion site discharge	28	24.6 17.0–35.8ROR 24.7 · χ² 601 / p 5e-133	23.9 EB05 17.3 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=26 · ♀ 100% (drug 75%) · 86% consumer	no trial arm names this drug
Parotitis	17	21.9 13.6–35.4ROR 21.9 · χ² 314 / p 1e-70	21.1 EB05 13.8 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=17	no trial arm names this drug
Impaired gastric emptying	183	21.5 18.6–24.9ROR 21.8 · χ² 3,515 / p <1e-300	21.2 EB05 18.7 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 22.2 · 84% consumer	no trial arm names this drug
Gastrointestinal hypomotility	28	18.8 13.0–27.3ROR 18.8 · χ² 449 / p 7e-100	18.3 EB05 13.2 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=27	no trial arm names this drug
Hypogonadism	12	17.6 10.0–31.2ROR 17.7 · χ² 170 / p 4e-39	16.4 EB05 9.2 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=12	no trial arm names this drug
Discharge	16	17.5 10.7–28.7ROR 17.5 · χ² 230 / p 3e-52	16.7 EB05 10.4 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=15	no trial arm names this drug
Blood pressure diastolic abnormal	29	16.9 11.7–24.3ROR 16.9 · χ² 413 / p 4e-92	16.4 EB05 11.9 · IC025 +3.1 3/3 methods agree	Lab value / disease marker	serious n=29	no trial arm names this drug
Calcium deficiency	14	16.1 9.5–27.2ROR 16.1 · χ² 181 / p 1e-41	15.0 EB05 8.8 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious n=14	no trial arm names this drug
End stage renal disease	197	16.0 13.9–18.4ROR 16.2 · χ² 2,727 / p <1e-300	15.8 EB05 14.0 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 14.8	no trial arm names this drug
Infusion site pruritus	33	15.8 11.2–22.3ROR 15.9 · χ² 439 / p 9e-98	15.4 EB05 11.3 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=29 · 75% consumer	no trial arm names this drug
Infusion site bruising	22	15.5 10.2–23.5ROR 15.5 · χ² 280 / p 3e-63	14.8 EB05 10.0 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=18	no trial arm names this drug
Scleritis	16	15.0 9.2–24.5ROR 15.0 · χ² 193 / p 4e-44	14.0 EB05 8.5 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious n=16	no trial arm names this drug
Dry age-related macular degeneration	11	14.8 8.2–26.9ROR 14.9 · χ² 127 / p 8e-30	13.2 EB05 6.9 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious n=11	no trial arm names this drug
Rhinalgia	27	14.8 10.1–21.6ROR 14.8 · χ² 330 / p 6e-74	14.2 EB05 10.0 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=25 · ♀ 100% (drug 75%) · 100% clinician	no trial arm names this drug
Irritable bowel syndrome	208	14.5 12.7–16.7ROR 14.7 · χ² 2,587 / p <1e-300	14.4 EB05 12.8 · IC025 +3.6 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 12.5	no trial arm names this drug
Blood pressure systolic abnormal	24	14.4 9.6–21.5ROR 14.4 · χ² 283 / p 8e-64	13.8 EB05 9.4 · IC025 +2.8 3/3 methods agree	Lab value / disease marker	serious n=24 · ♀ 100% (drug 75%) · 100% clinician	no trial arm names this drug
Chronic kidney disease	719	14.0 13.0–15.0ROR 14.7 · χ² 8,623 / p <1e-300	13.9 EB05 13.0 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 13.2	no trial arm names this drug
Chronic sinusitis	35	13.9 10.0–19.5ROR 14.0 · χ² 404 / p 4e-90	13.5 EB05 10.0 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=33	no trial arm names this drug
Paranasal sinus discomfort	31	12.3 8.6–17.5ROR 12.3 · χ² 307 / p 4e-69	11.7 EB05 8.4 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=28 · ♀ 100% (drug 75%)	no trial arm names this drug
Pancreatic cyst	15	11.8 7.1–19.6ROR 11.8 · χ² 136 / p 9e-32	10.4 EB05 6.2 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious n=12	no trial arm names this drug
Infusion site haemorrhage	25	11.5 7.8–17.0ROR 11.5 · χ² 228 / p 1e-51	10.7 EB05 7.3 · IC025 +2.6 3/3 methods agree	Labeled (related wording) related wording	serious n=20 · ♀ 100% (drug 75%) · 72% consumer	no trial arm names this drug
Gallbladder disorder	138	11.5 9.7–13.6ROR 11.6 · χ² 1,302 / p 2e-285	11.3 EB05 9.8 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 11.5	no trial arm names this drug
Abdominal hernia	32	10.4 7.4–14.8ROR 10.5 · χ² 262 / p 3e-59	9.8 EB05 7.0 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=29	no trial arm names this drug
Product administration interrupted	52	10.1 7.7–13.3ROR 10.1 · χ² 414 / p 2e-92	9.7 EB05 7.5 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious n=49	no trial arm names this drug
Pre-existing condition improved	41	9.7 7.1–13.1ROR 9.7 · χ² 308 / p 3e-69	9.1 EB05 6.9 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=24	no trial arm names this drug
Bile duct stone	20	9.4 6.1–14.6ROR 9.4 · χ² 142 / p 6e-33	8.3 EB05 5.5 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious n=19	no trial arm names this drug
Lactose intolerance	16	9.3 5.7–15.1ROR 9.3 · χ² 109 / p 8e-26	7.9 EB05 4.9 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious n=14	no trial arm names this drug
Vitamin d deficiency	59	9.0 7.0–11.6ROR 9.0 · χ² 410 / p 2e-91	8.6 EB05 6.8 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 10.0	no trial arm names this drug
Abdominal rigidity	16	8.8 5.4–14.4ROR 8.8 · χ² 103 / p 2e-24	7.5 EB05 4.7 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious n=14	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Dicyclomine only as a background or rescue medication (NCT00614445); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Nausea	1,333	2.5 2.4–2.6ROR 2.7 · χ² 1,248 / p 1e-273	2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.9	no trial arm names this drug
Diarrhoea (diarrhea)	1,304	3.0 2.9–3.2ROR 3.2 · χ² 1,795 / p <1e-300	3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.1	no trial arm names this drug
Fatigue (tiredness)	1,172	2.2 2.1–2.4ROR 2.3 · χ² 828 / p 2e-182	2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.4	no trial arm names this drug
Pain	1,038	2.5 2.4–2.7ROR 2.6 · χ² 959 / p 6e-211	2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.8	no trial arm names this drug
Headache	909	2.2 2.0–2.3ROR 2.2 · χ² 575 / p 2e-127	2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.5	no trial arm names this drug
Drug ineffective (drug did not work)	892	1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.470	1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 1.2	no trial arm names this drug
Off label use (used outside approved label)	807	1.4 1.3–1.5ROR 1.4 · χ² 86 / p 7e-21	1.4 EB05 1.3 · IC025 +0.3	Reporting / coding artifact	serious PRR 1.6	no trial arm names this drug
Abdominal pain	743	4.7 4.4–5.1ROR 5.0 · χ² 2,209 / p <1e-300	4.7 EB05 4.4 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.5	no trial arm names this drug
Vomiting	741	2.3 2.2–2.5ROR 2.4 · χ² 581 / p 1e-128	2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.5	no trial arm names this drug
Dizziness	726	2.2 2.0–2.3ROR 2.2 · χ² 462 / p 1e-102	2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.4	no trial arm names this drug
Chronic kidney disease	719	14.0 13.0–15.0ROR 14.7 · χ² 8,623 / p <1e-300	13.9 EB05 13.0 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 13.2	no trial arm names this drug
Dyspnoea (shortness of breath)	659	1.7 1.6–1.9ROR 1.8 · χ² 206 / p 6e-47	1.7 EB05 1.6 · IC025 +0.7	Labeled adverse reaction exact term	serious PRR 1.6	no trial arm names this drug
Anxiety	604	3.1 2.9–3.4ROR 3.2 · χ² 888 / p 2e-195	3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 3.6	no trial arm names this drug
Abdominal pain upper	600	4.3 4.0–4.7ROR 4.5 · χ² 1,546 / p <1e-300	4.3 EB05 4.0 · IC025 +2.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.2 · 70% consumer	no trial arm names this drug
Fall	577	2.6 2.4–2.8ROR 2.6 · χ² 561 / p 3e-124	2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 2.4	no trial arm names this drug

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Biliary dyskinesia — n=65, PRR 58.3
Nephrogenic anaemia — n=132, PRR 43.0
Hyperparathyroidism secondary — n=59, PRR 35.3
Chronic kidney disease-mineral and bone disorder — n=25, PRR 35.2
Cholecystitis chronic — n=157, PRR 35.0
Rebound acid hypersecretion — n=67, PRR 33.0
Gallbladder injury — n=38, PRR 29.6
Infusion site discharge — n=28, PRR 24.6
Impaired gastric emptying — n=183, PRR 21.5
Gastrointestinal hypomotility — n=28, PRR 18.8

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Dicyclomine?

In FDA FAERS, the most frequently co-reported reaction terms for Dicyclomine are nausea, diarrhoea, fatigue, pain, headache, abdominal pain. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Dicyclomine have an FDA boxed warning?

No. The FDA label retrieved for Dicyclomine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Dicyclomine causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 0590c805-537e-46d3-9500-f4942c1df2ea, effective 20241019; matched on openfda.generic_name.exact:"DICYCLOMINE HYDROCHLORIDE")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 1,117 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath
ClinicalTrials.gov API v2 (query DICYCLOMINE, results-bearing studies sorted by enrollment)

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.