Drug · FAERS side-effect profile with label screen
Loperamide and Dimethicone side effects: what 31,840 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Loperamide Hydrochloride And Dimethicone (Imodium Multi-Symptom Relief)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
31,840 reports · 59% serious · 2,527 with death outcome · 63% female
openFDA FAERS counts, all years, deduplication not applied
Used for
relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas
FDA label, Indications and Usage
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
Reporting / coding artifact 13Lab value / disease marker 9No label text to screen 18
What the badges mean
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,154 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Blood mercury abnormal | 41 | 474.6 317.2–709.9ROR 475.2 · calibrated p 8e-13 ✓ | 243.3 EB05 187.0 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious n=41 · ♀ 0% (drug 63%) | not reported in cached trials |
| 5-hydroxyindolacetic acid in urine increased | 21 | 400.3 232.4–689.7ROR 400.6 · calibrated p 2e-11 ✓ | 202.4 EB05 139.7 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious n=21 · ♀ 0% (drug 63%) | not reported in cached trials |
| Total lung capacity increased | 95 | 351.9 274.2–451.6ROR 352.9 · calibrated p 4e-12 ✓ | 218.4 EB05 184.0 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=95 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| 5-hydroxyindolacetic acid increased | 22 | 347.8 207.2–583.8ROR 348.0 · calibrated p 4e-11 ✓ | 189.6 EB05 132.0 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=22 · ♀ 0% (drug 63%) | not reported in cached trials |
| Product difficult to swallow | 231 | 190.7 164.8–220.8ROR 192.1 · calibrated p 7e-10 ✓ | 145.8 EB05 130.7 · IC025 +6.6 3/3 methods agree | Reporting / coding artifact | serious n=18 · ♀ 85% (drug 63%) · 100% consumer | not reported in cached trials |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 95 | 147.0 117.7–183.6ROR 147.4 · calibrated p 8e-9 ✓ | 117.2 EB05 98.7 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=95 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Gastrointestinal procedural complication | 36 | 103.7 73.0–147.4ROR 103.8 · calibrated p 2e-7 ✓ | 85.6 EB05 64.6 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious n=36 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Arteriovenous fistula occlusion | 22 | 93.8 60.0–146.7ROR 93.9 · calibrated p 6e-7 ✓ | 76.8 EB05 53.5 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=22 · ♀ 100% (drug 63%) | not reported in cached trials |
| Product coating issue | 104 | 74.8 61.1–91.6ROR 75.1 · calibrated p 1e-6 ✓ | 66.4 EB05 56.4 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious n=24 · 100% consumer | not reported in cached trials |
| Product blister packaging issue | 102 | 72.4 59.0–88.8ROR 72.6 · calibrated p 1e-6 ✓ | 64.5 EB05 54.6 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | ♀ 84% (drug 63%) · 100% consumer | not reported in cached trials |
| Calcium ionised decreased | 23 | 68.7 44.7–105.6ROR 68.8 · calibrated p 4e-6 ✓ | 59.3 EB05 41.6 · IC025 +4.1 3/3 methods agree | Lab value / disease marker | serious n=21 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Product size issue | 458 | 62.0 56.4–68.2ROR 62.9 · calibrated p 3e-6 ✓ | 56.5 EB05 52.3 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious n=53 · 100% consumer | not reported in cached trials |
| Vaginal flatulence | 25 | 58.5 38.9–88.1ROR 58.5 · calibrated p 1e-5 ✓ | 51.7 EB05 36.9 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=24 · ♀ 100% (drug 63%) | not reported in cached trials |
| Fibrous histiocytoma | 26 | 51.9 34.8–77.3ROR 51.9 · calibrated p 2e-5 ✓ | 46.6 EB05 33.4 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=26 · ♀ 0% (drug 63%) | not reported in cached trials |
| Product package associated injury | 143 | 45.3 38.3–53.7ROR 45.5 · calibrated p 3e-5 ✓ | 42.2 EB05 36.7 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | 100% consumer | not reported in cached trials |
| Blood follicle stimulating hormone increased | 24 | 42.6 28.2–64.4ROR 42.7 · calibrated p 7e-5 ✓ | 38.9 EB05 27.5 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious n=24 · ♀ 0% (drug 63%) | not reported in cached trials |
| Foreign body | 243 | 42.0 36.9–47.8ROR 42.3 · calibrated p 4e-5 ✓ | 39.4 EB05 35.4 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=29 · 100% consumer | not reported in cached trials |
| Blue toe syndrome | 23 | 41.3 27.1–62.9ROR 41.3 · calibrated p 9e-5 ✓ | 37.8 EB05 26.5 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=22 · ♀ 100% (drug 63%) | not reported in cached trials |
| Gastrointestinal stoma output increased | 25 | 37.5 25.1–56.1ROR 37.5 · calibrated p 1e-4 ✓ | 34.7 EB05 24.7 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious n=25 | not reported in cached trials |
| Product packaging difficult to open | 121 | 33.8 28.2–40.6ROR 34.0 · calibrated p 1e-4 ✓ | 32.1 EB05 27.5 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | 100% consumer | not reported in cached trials |
| Bronchial wall thickening | 35 | 33.3 23.7–46.8ROR 33.3 · calibrated p 2e-4 ✓ | 31.3 EB05 23.5 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=35 · ♀ 100% (drug 63%) | not reported in cached trials |
| Bacterial disease carrier | 35 | 33.2 23.6–46.6ROR 33.2 · calibrated p 2e-4 ✓ | 31.1 EB05 23.4 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious n=35 · ♀ 100% (drug 63%) | not reported in cached trials |
| Hypomania | 176 | 32.9 28.3–38.3ROR 33.1 · calibrated p 2e-4 ✓ | 31.3 EB05 27.6 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=176 · ♀ 100% (drug 63%) · 94% clinician | not reported in cached trials |
| Jaundice cholestatic | 167 | 32.5 27.9–38.0ROR 32.7 · calibrated p 2e-4 ✓ | 30.9 EB05 27.2 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=167 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Product packaging issue | 437 | 32.5 29.5–35.7ROR 32.9 · calibrated p 2e-4 ✓ | 30.9 EB05 28.6 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious n=35 · 100% consumer | not reported in cached trials |
| Pouchitis | 32 | 25.3 17.8–36.0ROR 25.4 · calibrated p 9e-4 ✓ | 24.1 EB05 17.9 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=32 | not reported in cached trials |
| Infrequent bowel movements | 80 | 21.8 17.4–27.2ROR 21.8 · calibrated p 0.001 ✓ | 21.0 EB05 17.4 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=18 · 88% consumer | not reported in cached trials |
| Gastrointestinal stoma complication | 48 | 20.8 15.6–27.8ROR 20.9 · calibrated p 0.002 ✓ | 20.1 EB05 15.7 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious n=47 | not reported in cached trials |
| Stoma complication | 31 | 20.6 14.4–29.4ROR 20.6 · calibrated p 0.002 ✓ | 19.7 EB05 14.5 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious n=30 | not reported in cached trials |
| Bronchial secretion retention | 38 | 20.4 14.7–28.1ROR 20.4 · calibrated p 0.002 ✓ | 19.6 EB05 14.9 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=38 · ♀ 100% (drug 63%) | not reported in cached trials |
| Foreign body in respiratory tract | 39 | 19.9 14.5–27.4ROR 20.0 · calibrated p 0.003 ✓ | 19.2 EB05 14.6 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | not reported in cached trials |
| Low density lipoprotein decreased | 41 | 19.6 14.3–26.7ROR 19.6 · calibrated p 0.003 ✓ | 18.8 EB05 14.4 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious n=41 · ♀ 0% (drug 63%) | not reported in cached trials |
| Product lot number issue | 57 | 17.7 13.6–23.0ROR 17.7 · calibrated p 0.004 ✓ | 17.1 EB05 13.7 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | 100% consumer | not reported in cached trials |
| Rhinitis allergic | 115 | 17.5 14.5–21.0ROR 17.5 · calibrated p 0.004 ✓ | 17.0 EB05 14.5 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=111 · ♀ 100% (drug 63%) | not reported in cached trials |
| Product label issue | 169 | 17.0 14.6–19.8ROR 17.1 · calibrated p 0.004 ✓ | 16.5 EB05 14.6 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | 100% consumer | not reported in cached trials |
| Blood pressure diastolic abnormal | 64 | 16.8 13.1–21.5ROR 16.8 · calibrated p 0.005 ✓ | 16.3 EB05 13.2 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious n=64 · 100% clinician | not reported in cached trials |
| Therapeutic reaction time decreased | 71 | 16.2 12.8–20.6ROR 16.3 · calibrated p 0.006 ✓ | 15.8 EB05 12.9 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious n=67 | not reported in cached trials |
| Hemianopia | 23 | 15.5 10.2–23.4ROR 15.5 · calibrated p 0.008 ✓ | 14.7 EB05 10.0 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=23 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Blood pressure systolic abnormal | 57 | 15.4 11.8–20.0ROR 15.4 · calibrated p 0.007 ✓ | 14.9 EB05 11.9 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious n=57 · 100% clinician | not reported in cached trials |
| Sarcoidosis | 102 | 14.4 11.8–17.5ROR 14.5 · calibrated p 0.009 ✓ | 14.0 EB05 11.9 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=102 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Loperamide and Dimethicone as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT02400476 — An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ (N=563, PHASE2; 91 AE terms posted; arms: Loperamide; Budesonide and Loperamide; Colestipol and Loperamide; Colestipol With Loperamide as Needed)
- NCT02008565 — Controlling Anal Incontinence by Performing Anal Exercises With Biofeedback or Loperamide (CAPABLe) (N=300, PHASE3; 36 AE terms posted; arms: Loperamide - Exercise Plus Biofeedback; Placebo - Exercise Plus Biofeedback; Loperamide - Education Only; Placebo - Education Only)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 |
|---|---|---|---|---|---|---|
| Diarrhoea (diarrhea) | 6,489 | 6.7 6.6–6.8ROR 8.2 · calibrated p 0.063 | 6.6 EB05 6.5 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.4 | NCT02400476: 2/137 (1.5%) on Loperamide and Dimethicone (serious AE) |
| Drug ineffective (drug did not work) | 3,147 | 1.6 1.5–1.6ROR 1.6 · calibrated p 0.730 | 1.6 EB05 1.5 · IC025 +0.6 | Reporting / coding artifact | serious PRR 1.3 · 77% consumer | not reported in cached trials |
| Nausea | 3,101 | 2.6 2.5–2.7ROR 2.8 · calibrated p 0.708 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.6 | NCT02400476: 1/137 (0.7%) on Loperamide and Dimethicone (serious AE) |
| Fatigue (tiredness) | 2,617 | 2.2 2.1–2.3ROR 2.3 · calibrated p 0.889 | 2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.9 | NCT02400476: 41/104 (39.4%) on Loperamide and Dimethicone |
| Off label use (used outside approved label) | 2,257 | 1.7 1.6–1.8ROR 1.8 · calibrated p 0.810 | 1.7 EB05 1.7 · IC025 +0.7 | Reporting / coding artifact | serious PRR 2.1 | not reported in cached trials |
| Vomiting | 2,126 | 3.0 2.9–3.1ROR 3.1 · calibrated p 0.584 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.6 | NCT02400476: 25/104 (24.0%) on Loperamide and Dimethicone |
| Constipation | 1,778 | 5.4 5.2–5.7ROR 5.7 · calibrated p 0.171 | 5.4 EB05 5.2 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.4 | NCT02400476: 39/104 (37.5%) on Loperamide and Dimethicone |
| Weight decreased (weight loss) | 1,518 | 3.6 3.4–3.8ROR 3.7 · calibrated p 0.433 | 3.6 EB05 3.4 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.3 | NCT02400476: 4/104 (3.8%) on Loperamide and Dimethicone |
| Incorrect dose administered | 1,402 | 4.1 3.9–4.3ROR 4.3 · calibrated p 0.332 | 4.1 EB05 3.9 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 2.1 · 91% consumer | not reported in cached trials |
| Headache | 1,361 | 1.4 1.4–1.5ROR 1.5 · calibrated p 0.609 | 1.4 EB05 1.4 · IC025 +0.4 | No label text to screen label has no adverse-reaction text | serious PRR 1.9 | NCT02400476: 24/104 (23.1%) on Loperamide and Dimethicone |
| Dyspnoea (shortness of breath) | 1,361 | 1.6 1.5–1.7ROR 1.6 · calibrated p 0.713 | 1.6 EB05 1.5 · IC025 +0.6 | No label text to screen label has no adverse-reaction text | serious PRR 1.8 | NCT02400476: 4/104 (3.8%) on Loperamide and Dimethicone |
| Abdominal pain | 1,353 | 3.8 3.6–4.1ROR 4.0 · calibrated p 0.383 | 3.8 EB05 3.7 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.2 | NCT02400476: 1/136 (0.7%) on Loperamide and Dimethicone (serious AE) |
| Asthenia (weakness) | 1,317 | 2.3 2.2–2.4ROR 2.4 · calibrated p 0.873 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.7 | NCT02400476: 4/104 (3.8%) on Loperamide and Dimethicone |
| Dehydration | 1,234 | 6.1 5.8–6.5ROR 6.3 · calibrated p 0.130 | 6.1 EB05 5.8 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.4 | NCT02400476: 1/104 (1.0%) on Loperamide and Dimethicone (serious AE) |
| Decreased appetite (loss of appetite) | 1,224 | 3.5 3.3–3.7ROR 3.6 · calibrated p 0.463 | 3.5 EB05 3.3 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.9 | NCT02400476: 1/137 (0.7%) on Loperamide and Dimethicone (serious AE) |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
✓ A hand-written Bradford Hill causality assessment exists for this drug: Loperamide ↔ QT prolongation.
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 Loperamide and Dimethicone?
In FDA FAERS, the most frequently co-reported reaction terms for Loperamide and Dimethicone are diarrhoea, nausea, fatigue, vomiting, constipation, weight decreased. 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 Loperamide and Dimethicone have an FDA boxed warning?
No. The FDA label retrieved for Loperamide and Dimethicone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Loperamide and Dimethicone 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 ecb91e47-2b0c-47c8-9256-4623d8bc825e, effective 20260825; matched on
openfda.generic_name.exact:"LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE") - 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, fieldpatient.drug.openfda.generic_name.exact, 1,194 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
LOPERAMIDE, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.