Drug · FAERS side-effect profile with label screen
Loperamide HCL side effects: what 12,777 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Loperamide Hcl (Anti-Diarrheal, Caseys 4Good)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
12,777 reports · 66% serious · 1,415 with death outcome · 58% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Use Controls symptoms of diarrhea, including Travelers’ Diarrhea
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 2Lab value / disease marker 5No label text to screen 33
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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,062 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 |
|---|---|---|---|---|---|---|
| Vaginal flatulence | 105 | 861.8 680.5–1,091.4ROR 868.9 · χ² 58,330 / p <1e-300 | 510.0 EB05 433.2 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=105 · ♀ 100% (drug 58%) · 90% clinician | not reported in cached trials |
| Presbyacusis | 57 | 368.6 276.6–491.3ROR 370.3 · χ² 16,721 / p <1e-300 | 272.9 EB05 218.5 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=57 · ♀ 100% (drug 58%) | not reported in cached trials |
| Heart sounds | 15 | 299.4 172.6–519.3ROR 299.8 · χ² 3,517 / p <1e-300 | 191.5 EB05 123.2 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=15 | not reported in cached trials |
| Total lung capacity increased | 30 | 202.1 138.3–295.3ROR 202.6 · χ² 5,159 / p <1e-300 | 161.5 EB05 118.5 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=30 · ♀ 100% (drug 58%) · 100% clinician | not reported in cached trials |
| Stomatitis haemorrhagic | 11 | 160.2 86.3–297.7ROR 160.4 · χ² 1,442 / p <1e-300 | 116.9 EB05 69.6 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | not reported in cached trials |
| Pleural thickening | 45 | 115.9 85.7–156.7ROR 116.3 · χ² 4,675 / p <1e-300 | 103.5 EB05 80.5 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=45 · ♀ 100% (drug 58%) | not reported in cached trials |
| Female genital tract fistula | 112 | 114.1 94.3–138.1ROR 115.1 · χ² 11,625 / p <1e-300 | 104.8 EB05 89.5 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=112 · ♀ 100% (drug 58%) | not reported in cached trials |
| Stoma site ulcer | 11 | 107.8 58.6–198.4ROR 107.9 · χ² 993 / p 3e-218 | 86.4 EB05 51.5 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | not reported in cached trials |
| Blood magnesium increased | 52 | 100.1 75.7–132.4ROR 100.5 · χ² 4,711 / p <1e-300 | 91.2 EB05 72.3 · IC025 +5.2 3/3 methods agree | Lab value / disease marker | serious n=51 · ♀ 86% (drug 58%) | not reported in cached trials |
| Pleural fibrosis | 59 | 99.6 76.6–129.4ROR 100.0 · χ² 5,331 / p <1e-300 | 91.2 EB05 73.3 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=59 · ♀ 100% (drug 58%) | not reported in cached trials |
| Prolonged expiration | 15 | 98.6 58.6–166.0ROR 98.7 · χ² 1,275 / p 1e-279 | 83.4 EB05 53.7 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=15 | not reported in cached trials |
| Anticholinergic syndrome | 75 | 81.0 64.2–102.0ROR 81.4 · χ² 5,564 / p <1e-300 | 75.7 EB05 62.4 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=75 · 91% clinician | not reported in cached trials |
| Radiculopathy | 105 | 68.0 56.0–82.6ROR 68.5 · χ² 6,585 / p <1e-300 | 64.5 EB05 54.8 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=105 · ♀ 100% (drug 58%) · 90% clinician | not reported in cached trials |
| Proctitis | 111 | 67.5 55.9–81.6ROR 68.1 · χ² 6,923 / p <1e-300 | 64.2 EB05 54.8 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=111 · ♀ 100% (drug 58%) · 91% clinician | not reported in cached trials |
| Chronic sinusitis | 148 | 67.4 57.2–79.4ROR 68.2 · χ² 9,233 / p <1e-300 | 64.2 EB05 56.0 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=148 · ♀ 100% (drug 58%) | not reported in cached trials |
| Gastrointestinal stoma output increased | 16 | 58.7 35.6–96.6ROR 58.7 · χ² 820 / p 1e-180 | 53.3 EB05 34.8 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=16 | not reported in cached trials |
| Electrocardiogram qt interval abnormal | 12 | 40.6 22.9–72.0ROR 40.6 · χ² 414 / p 2e-92 | 37.5 EB05 22.8 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious n=11 | not reported in cached trials |
| Macular degeneration | 270 | 38.0 33.7–42.8ROR 38.8 · χ² 9,471 / p <1e-300 | 37.1 EB05 33.5 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.2 · ♀ 100% (drug 58%) | not reported in cached trials |
| Bone cyst | 21 | 37.4 24.3–57.7ROR 37.5 · χ² 693 / p 6e-153 | 35.5 EB05 24.5 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=21 | not reported in cached trials |
| Metastases to abdominal cavity | 11 | 37.3 20.5–67.8ROR 37.3 · χ² 345 / p 3e-77 | 34.5 EB05 20.5 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | not reported in cached trials |
| Incorrect product administration duration | 444 | 36.7 33.4–40.2ROR 37.9 · χ² 15,039 / p <1e-300 | 35.8 EB05 33.1 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious n=10 · 99% consumer | not reported in cached trials |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 11 | 35.4 19.5–64.2ROR 35.4 · χ² 327 / p 3e-73 | 32.8 EB05 19.5 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | not reported in cached trials |
| Hemianopia | 21 | 35.2 22.8–54.2ROR 35.2 · χ² 650 / p 1e-143 | 33.5 EB05 23.1 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=21 · 100% clinician | not reported in cached trials |
| Tumour pain | 27 | 34.1 23.3–50.0ROR 34.2 · χ² 818 / p 3e-180 | 32.8 EB05 23.6 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=27 | not reported in cached trials |
| Deafness neurosensory | 59 | 30.0 23.2–38.8ROR 30.2 · χ² 1,598 / p <1e-300 | 29.3 EB05 23.5 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=59 · ♀ 100% (drug 58%) | not reported in cached trials |
| Vanishing bile duct syndrome | 18 | 27.0 17.0–43.0ROR 27.0 · χ² 418 / p 3e-93 | 25.9 EB05 17.3 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=18 | not reported in cached trials |
| Epigastric discomfort | 62 | 26.3 20.5–33.8ROR 26.4 · χ² 1,461 / p <1e-300 | 25.7 EB05 20.8 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=59 · ♀ 100% (drug 58%) | not reported in cached trials |
| Acquired haemophilia | 15 | 25.3 15.2–42.1ROR 25.3 · χ² 321 / p 5e-72 | 24.2 EB05 15.4 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=15 | not reported in cached trials |
| Torsade de pointes | 118 | 25.0 20.8–29.9ROR 25.2 · χ² 2,651 / p <1e-300 | 24.5 EB05 21.0 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.7 · ♀ 38% (drug 58%) · 100% clinician | not reported in cached trials |
| Osteosclerosis | 21 | 22.1 14.4–34.0ROR 22.1 · χ² 397 / p 1e-88 | 21.4 EB05 14.7 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=21 | not reported in cached trials |
| Exposure to toxic agent | 36 | 18.5 13.3–25.7ROR 18.6 · χ² 573 / p 8e-127 | 18.1 EB05 13.6 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=36 · ♀ 36% (drug 58%) · 100% clinician | not reported in cached trials |
| Brugada syndrome | 11 | 17.8 9.8–32.2ROR 17.8 · χ² 156 / p 4e-36 | 16.5 EB05 8.8 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | not reported in cached trials |
| Gastric ph decreased | 11 | 17.7 9.8–32.1ROR 17.7 · χ² 155 / p 6e-36 | 16.3 EB05 8.8 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious n=11 | not reported in cached trials |
| Electrocardiogram qrs complex prolonged | 54 | 17.5 13.4–22.8ROR 17.5 · χ² 814 / p 2e-179 | 17.2 EB05 13.6 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious n=54 · ♀ 30% (drug 58%) · 100% clinician | not reported in cached trials |
| Vaginal discharge | 105 | 17.3 14.3–21.0ROR 17.4 · χ² 1,581 / p <1e-300 | 17.1 EB05 14.5 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=105 · ♀ 100% (drug 58%) · 90% clinician | not reported in cached trials |
| Intentional product use issue | 872 | 16.4 15.4–17.5ROR 17.5 · χ² 12,529 / p <1e-300 | 16.2 EB05 15.4 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 2.1 · 91% consumer | not reported in cached trials |
| Oral candidiasis (oral thrush) | 125 | 15.9 13.3–18.9ROR 16.0 · χ² 1,714 / p <1e-300 | 15.7 EB05 13.5 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.4 · ♀ 95% (drug 58%) · 90% clinician | not reported in cached trials |
| Waist circumference increased | 10 | 15.8 8.5–29.5ROR 15.8 · χ² 123 / p 6e-29 | 14.1 EB05 7.0 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | not reported in cached trials |
| Paraesthesia oral | 137 | 15.8 13.3–18.6ROR 15.9 · χ² 1,863 / p <1e-300 | 15.6 EB05 13.5 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.0 · ♀ 100% (drug 58%) | not reported in cached trials |
| Vascular device infection | 42 | 15.4 11.4–20.8ROR 15.4 · χ² 545 / p 6e-121 | 15.1 EB05 11.5 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=42 · 90% 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 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) | 1,710 | 4.4 4.2–4.6ROR 4.9 · χ² 4,565 / p <1e-300 | 4.4 EB05 4.2 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.5 | NCT02400476: 2/137 (1.5%) on Loperamide (serious AE) |
| Drug ineffective (drug did not work) | 1,369 | 1.7 1.6–1.8ROR 1.8 · χ² 425 / p 1e-94 | 1.7 EB05 1.6 · IC025 +0.7 | Reporting / coding artifact | serious PRR 1.7 | not reported in cached trials |
| Off label use (used outside approved label) | 1,016 | 1.9 1.8–2.0ROR 2.0 · χ² 466 / p 1e-103 | 1.9 EB05 1.8 · IC025 +0.8 | Reporting / coding artifact | serious PRR 1.8 | not reported in cached trials |
| Nausea | 953 | 2.0 1.9–2.1ROR 2.1 · χ² 480 / p 1e-106 | 2.0 EB05 1.9 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 2.8 | NCT02400476: 1/137 (0.7%) on Loperamide (serious AE) |
| Intentional product use issue | 872 | 16.4 15.4–17.5ROR 17.5 · χ² 12,529 / p <1e-300 | 16.2 EB05 15.4 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 2.1 · 91% consumer | not reported in cached trials |
| Fatigue (tiredness) | 800 | 1.7 1.6–1.8ROR 1.7 · χ² 233 / p 8e-53 | 1.7 EB05 1.6 · IC025 +0.6 | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | NCT02400476: 41/104 (39.4%) on Loperamide |
| Constipation | 611 | 4.6 4.3–5.0ROR 4.8 · χ² 1,754 / p <1e-300 | 4.6 EB05 4.3 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.8 | NCT02400476: 39/104 (37.5%) on Loperamide |
| Pyrexia (fever) | 587 | 2.8 2.6–3.0ROR 2.9 · χ² 679 / p 6e-150 | 2.8 EB05 2.6 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.0 | NCT02400476: 1/64 (1.6%) on Loperamide (serious AE) |
| Vomiting | 569 | 2.0 1.8–2.2ROR 2.0 · χ² 286 / p 2e-64 | 2.0 EB05 1.9 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 2.2 | NCT02400476: 25/104 (24.0%) on Loperamide |
| Weight decreased (weight loss) | 485 | 2.9 2.6–3.1ROR 2.9 · χ² 589 / p 2e-130 | 2.8 EB05 2.6 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.5 | NCT02400476: 4/104 (3.8%) on Loperamide |
| Abdominal pain | 479 | 3.4 3.1–3.7ROR 3.5 · χ² 809 / p 3e-178 | 3.4 EB05 3.1 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.6 | NCT02400476: 1/136 (0.7%) on Loperamide (serious AE) |
| Dyspnoea (shortness of breath) | 466 | 1.4 1.2–1.5ROR 1.4 · χ² 43 / p 2e-11 | 1.4 EB05 1.3 · IC025 +0.3 | No label text to screen label has no adverse-reaction text | serious PRR 1.5 | NCT02400476: 4/104 (3.8%) on Loperamide |
| Headache | 459 | 1.2 1.1–1.3ROR 1.2 · χ² 16 / p 3e-5 | 1.2 EB05 1.1 · IC025 +0.1 | No label text to screen label has no adverse-reaction text | serious PRR 1.9 | NCT02400476: 24/104 (23.1%) on Loperamide |
| Malaise (feeling unwell) | 456 | 1.7 1.6–1.9ROR 1.7 · χ² 134 / p 3e-31 | 1.7 EB05 1.6 · IC025 +0.6 | No label text to screen label has no adverse-reaction text | serious PRR 2.3 | not reported in cached trials |
| Pain | 444 | 1.2 1.1–1.3ROR 1.2 · χ² 13 / p 2e-4 | 1.2 EB05 1.1 · IC025 +0.1 | No label text to screen label has no adverse-reaction text | serious PRR 1.5 | NCT02400476: 1/136 (0.7%) on Loperamide (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?
In FDA FAERS, the most frequently co-reported reaction terms for Loperamide are diarrhoea, nausea, fatigue, constipation, pyrexia, vomiting. 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 have an FDA boxed warning?
No. The FDA label retrieved for Loperamide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Loperamide 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 043b0ab4-8fba-37d1-e063-6394a90a4cd4, effective 20241229; matched on
openfda.generic_name.exact:"LOPERAMIDE HCL") - 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, 1,102 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 2026-10-08. 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.