Drug · FAERS side-effect profile with label screen
Loperamide Hydrochloride Oral side effects: what 10,143 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Loperamide Hydrochloride Oral (Loperamide 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
10,143 reports · 62% serious · 966 with death outcome · 60% female
openFDA FAERS counts, all years, deduplication not applied
Used for
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 3Lab value / disease marker 6No label text to screen 31
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. 1,014 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 | 1,085.9 857.6–1,374.9ROR 1,097.2 · χ² 73,532 / p <1e-300 | 627.1 EB05 532.8 · IC025 +7.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=105 · ♀ 100% (drug 60%) · 90% clinician | no trial data cached |
| Presbyacusis | 56 | 454.5 340.4–606.9ROR 457.0 · χ² 20,350 / p <1e-300 | 329.9 EB05 263.5 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=56 · ♀ 100% (drug 60%) | no trial data cached |
| Heart sounds | 15 | 377.3 217.5–654.3ROR 377.8 · χ² 4,437 / p <1e-300 | 226.8 EB05 145.9 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=15 | no trial data cached |
| Total lung capacity increased | 30 | 254.7 174.3–372.0ROR 255.4 · χ² 6,514 / p <1e-300 | 198.1 EB05 145.4 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=30 · ♀ 100% (drug 60%) · 100% clinician | no trial data cached |
| Stomatitis haemorrhagic | 11 | 201.9 108.7–375.0ROR 202.1 · χ² 1,822 / p <1e-300 | 139.8 EB05 83.3 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | no trial data cached |
| Pleural thickening | 44 | 142.5 105.0–193.3ROR 143.1 · χ² 5,647 / p <1e-300 | 126.1 EB05 97.8 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=44 · ♀ 100% (drug 60%) | no trial data cached |
| Female genital tract fistula | 111 | 142.4 117.6–172.5ROR 144.0 · χ² 14,437 / p <1e-300 | 130.2 EB05 111.1 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=111 · ♀ 100% (drug 60%) | no trial data cached |
| Prolonged expiration | 15 | 124.2 73.8–209.1ROR 124.4 · χ² 1,614 / p <1e-300 | 102.3 EB05 65.8 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=15 | no trial data cached |
| Pleural fibrosis | 58 | 123.2 94.6–160.5ROR 123.9 · χ² 6,515 / p <1e-300 | 112.0 EB05 89.9 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=58 · ♀ 100% (drug 60%) | no trial data cached |
| Blood magnesium increased | 48 | 115.9 86.7–154.9ROR 116.4 · χ² 5,064 / p <1e-300 | 105.2 EB05 82.5 · IC025 +5.2 3/3 methods agree | Lab value / disease marker | serious n=47 · ♀ 91% (drug 60%) | no trial data cached |
| Anticholinergic syndrome | 73 | 99.1 78.5–125.3ROR 99.9 · χ² 6,671 / p <1e-300 | 92.4 EB05 75.9 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=73 · 90% clinician | no trial data cached |
| Radiculopathy | 105 | 85.6 70.5–104.0ROR 86.5 · χ² 8,349 / p <1e-300 | 81.0 EB05 68.9 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=105 · ♀ 100% (drug 60%) · 90% clinician | no trial data cached |
| Proctitis | 111 | 85.1 70.5–102.8ROR 86.0 · χ² 8,777 / p <1e-300 | 80.6 EB05 68.8 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=111 · ♀ 100% (drug 60%) · 91% clinician | no trial data cached |
| Chronic sinusitis | 148 | 84.9 72.1–100.0ROR 86.2 · χ² 11,706 / p <1e-300 | 80.8 EB05 70.4 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=148 · ♀ 100% (drug 60%) | no trial data cached |
| Gastrointestinal stoma output increased | 16 | 73.9 44.9–121.7ROR 74.0 · χ² 1,041 / p 9e-229 | 66.0 EB05 43.1 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious n=16 | no trial data cached |
| Electrocardiogram qt interval abnormal | 12 | 51.1 28.9–90.7ROR 51.2 · χ² 528 / p 5e-117 | 46.5 EB05 28.3 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious n=11 | no trial data cached |
| Macular degeneration | 270 | 47.9 42.5–53.9ROR 49.2 · χ² 12,067 / p <1e-300 | 46.6 EB05 42.2 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 46.9 · ♀ 100% (drug 60%) | no trial data cached |
| Bone cyst | 21 | 47.2 30.6–72.7ROR 47.3 · χ² 883 / p 2e-194 | 44.4 EB05 30.6 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=21 | no trial data cached |
| Incorrect product administration duration | 444 | 46.2 42.1–50.6ROR 48.3 · χ² 19,170 / p <1e-300 | 45.1 EB05 41.7 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious n=10 · 99% consumer | no trial data cached |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 11 | 44.6 24.5–80.9ROR 44.6 · χ² 417 / p 6e-93 | 40.8 EB05 24.3 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | no trial data cached |
| Tumour pain | 27 | 43.0 29.4–62.9ROR 43.1 · χ² 1,044 / p 2e-229 | 41.0 EB05 29.6 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=27 · ♀ 86% (drug 60%) | no trial data cached |
| Metastases to abdominal cavity | 10 | 42.6 22.8–79.7ROR 42.7 · χ² 358 / p 3e-80 | 38.9 EB05 22.6 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Hemianopia | 20 | 42.2 27.1–65.6ROR 42.3 · χ² 748 / p 6e-165 | 39.9 EB05 27.3 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=20 | no trial data cached |
| Deafness neurosensory | 58 | 37.2 28.7–48.2ROR 37.4 · χ² 1,971 / p <1e-300 | 36.1 EB05 29.0 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=58 · ♀ 100% (drug 60%) | no trial data cached |
| Epigastric discomfort | 61 | 32.6 25.3–42.0ROR 32.8 · χ² 1,809 / p <1e-300 | 31.8 EB05 25.7 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=58 · ♀ 100% (drug 60%) | no trial data cached |
| Acquired haemophilia | 14 | 29.7 17.5–50.3ROR 29.7 · χ² 355 / p 2e-79 | 28.2 EB05 17.8 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | no trial data cached |
| Torsade de pointes | 109 | 29.0 24.1–35.0ROR 29.3 · χ² 2,882 / p <1e-300 | 28.5 EB05 24.3 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.7 · ♀ 36% (drug 60%) · 100% clinician | no trial data cached |
| Osteosclerosis | 20 | 26.5 17.1–41.2ROR 26.6 · χ² 460 / p 3e-102 | 25.6 EB05 17.5 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=20 | no trial data cached |
| Exposure to toxic agent | 36 | 23.3 16.8–32.4ROR 23.4 · χ² 739 / p 5e-163 | 22.8 EB05 17.2 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=36 · ♀ 36% (drug 60%) · 100% clinician | no trial data cached |
| Brugada syndrome | 11 | 22.4 12.4–40.6ROR 22.5 · χ² 202 / p 4e-46 | 21.2 EB05 12.1 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | no trial data cached |
| Gastric ph decreased | 11 | 22.3 12.3–40.4ROR 22.3 · χ² 201 / p 7e-46 | 21.1 EB05 12.1 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious n=11 | no trial data cached |
| Vaginal discharge | 105 | 21.8 18.0–26.4ROR 22.0 · χ² 2,043 / p <1e-300 | 21.5 EB05 18.3 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=105 · ♀ 100% (drug 60%) · 90% clinician | no trial data cached |
| Electrocardiogram qrs complex prolonged | 53 | 21.6 16.5–28.3ROR 21.7 · χ² 1,011 / p 4e-222 | 21.3 EB05 16.9 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious n=53 · ♀ 31% (drug 60%) · 100% clinician | no trial data cached |
| Intentional product use issue | 868 | 20.6 19.3–21.9ROR 22.4 · χ² 16,056 / p <1e-300 | 20.4 EB05 19.3 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 · 91% consumer | no trial data cached |
| Paraesthesia oral | 136 | 19.7 16.7–23.3ROR 20.0 · χ² 2,377 / p <1e-300 | 19.5 EB05 16.9 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.9 · ♀ 100% (drug 60%) | no trial data cached |
| Vascular device infection | 41 | 18.9 13.9–25.7ROR 19.0 · χ² 672 / p 2e-148 | 18.6 EB05 14.2 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=41 · 90% clinician | no trial data cached |
| Oral candidiasis (oral thrush) | 118 | 18.9 15.8–22.6ROR 19.1 · χ² 1,965 / p <1e-300 | 18.7 EB05 16.0 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.4 · ♀ 97% (drug 60%) | no trial data cached |
| Vanishing bile duct syndrome | 10 | 18.8 10.1–35.0ROR 18.8 · χ² 149 / p 1e-34 | 17.3 EB05 9.0 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Forced expiratory volume decreased | 23 | 16.9 11.2–25.4ROR 16.9 · χ² 325 / p 6e-73 | 16.4 EB05 11.2 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious n=23 · ♀ 100% (drug 60%) · 91% clinician | no trial data cached |
| Gastrointestinal stoma complication | 12 | 16.0 9.1–28.2ROR 16.0 · χ² 153 / p 2e-35 | 14.7 EB05 8.0 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious n=12 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 1,286 | 2.0 1.9–2.1ROR 2.2 · χ² 703 / p 3e-155 | 2.0 EB05 1.9 · IC025 +0.9 | Reporting / coding artifact | serious PRR 2.1 | no trial data cached |
| Diarrhoea (diarrhea) | 1,274 | 4.1 3.9–4.3ROR 4.5 · χ² 3,068 / p <1e-300 | 4.1 EB05 3.9 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.5 | no trial data cached |
| Off label use (used outside approved label) | 976 | 2.3 2.2–2.5ROR 2.5 · χ² 766 / p 6e-169 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.2 | no trial data cached |
| Intentional product use issue | 868 | 20.6 19.3–21.9ROR 22.4 · χ² 16,056 / p <1e-300 | 20.4 EB05 19.3 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 · 91% consumer | no trial data cached |
| Nausea | 759 | 2.0 1.9–2.1ROR 2.1 · χ² 386 / p 3e-86 | 2.0 EB05 1.9 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 3.0 · ♀ 82% (drug 60%) | no trial data cached |
| Fatigue (tiredness) | 636 | 1.7 1.6–1.8ROR 1.7 · χ² 186 / p 1e-42 | 1.7 EB05 1.6 · IC025 +0.6 | No label text to screen label has no adverse-reaction text | serious PRR 2.3 | no trial data cached |
| Constipation | 552 | 5.3 4.9–5.7ROR 5.5 · χ² 1,926 / p <1e-300 | 5.2 EB05 4.9 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.8 | no trial data cached |
| Pyrexia (fever) | 458 | 2.7 2.5–3.0ROR 2.8 · χ² 510 / p 3e-113 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.1 | no trial data cached |
| Incorrect product administration duration | 444 | 46.2 42.1–50.6ROR 48.3 · χ² 19,170 / p <1e-300 | 45.1 EB05 41.7 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious n=10 · 99% consumer | no trial data cached |
| Weight decreased (weight loss) | 407 | 3.0 2.7–3.3ROR 3.1 · χ² 553 / p 1e-122 | 3.0 EB05 2.8 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.9 | no trial data cached |
| Vomiting | 402 | 1.8 1.6–1.9ROR 1.8 · χ² 137 / p 5e-32 | 1.8 EB05 1.6 · IC025 +0.7 | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | no trial data cached |
| Abdominal pain | 394 | 3.5 3.2–3.9ROR 3.6 · χ² 709 / p 1e-156 | 3.5 EB05 3.2 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.0 | no trial data cached |
| Headache | 389 | 1.3 1.2–1.4ROR 1.3 · χ² 25 / p 3e-7 | 1.3 EB05 1.2 · IC025 +0.2 | No label text to screen label has no adverse-reaction text | serious PRR 2.2 | no trial data cached |
| Malaise (feeling unwell) | 387 | 1.8 1.6–2.0ROR 1.9 · χ² 145 / p 1e-33 | 1.8 EB05 1.7 · IC025 +0.7 | No label text to screen label has no adverse-reaction text | serious PRR 2.7 | no trial data cached |
| Pain | 375 | 1.3 1.1–1.4ROR 1.3 · χ² 20 / p 3e-6 | 1.3 EB05 1.2 · IC025 +0.2 | No label text to screen label has no adverse-reaction text | serious PRR 1.6 | no trial data cached |
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, 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 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 4bd0939e-c172-d962-e063-6394a90a44b5, effective 20260227; matched on
openfda.generic_name.exact:"LOPERAMIDE HYDROCHLORIDE ORAL") - 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, 1,054 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
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.