Drug · FAERS side-effect profile with label screen
Hyoscyamine side effects: what 9,124 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Hyoscyamine Sulfate (Hyoscyamine Sulfate)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
9,124 reports · 62% serious · 805 with death outcome · 75% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Hyoscyamine Sulfate Tablets, USP are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretions, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm and associated abdominal cramps.
FDA label, Indications and Usage
What it is
DESCRIPTION Hyoscyamine Sulfate Tablets, USP contain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids.
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) 2Likely indication confounding 9Reporting / coding artifact 3Not in label — unassessed 26
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.
- 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. 1,062 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 |
|---|---|---|---|---|---|---|
| Biliary dyskinesia | 56 | 77.5 59.4–101.1ROR 78.0 · χ² 4,016 / p <1e-300 | 73.2 EB05 58.5 · IC025 +5.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=56 · ♀ 100% (drug 75%) | no trial data cached |
| Cholecystitis chronic | 113 | 38.9 32.3–46.8ROR 39.4 · χ² 4,065 / p <1e-300 | 38.0 EB05 32.5 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 35.2 · ♀ 100% (drug 75%) | no trial data cached |
| Chronic kidney disease-mineral and bone disorder | 14 | 30.3 17.9–51.3ROR 30.3 · χ² 363 / p 4e-81 | 28.8 EB05 18.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Nephrogenic anaemia | 54 | 26.8 20.5–35.1ROR 27.0 · χ² 1,302 / p 2e-285 | 26.3 EB05 20.9 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=54 | no trial data cached |
| Hyperparathyroidism secondary | 28 | 25.7 17.7–37.2ROR 25.7 · χ² 632 / p 7e-140 | 25.0 EB05 18.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=28 | no trial data cached |
| Anticholinergic syndrome | 17 | 24.8 15.4–39.9ROR 24.8 · χ² 360 / p 1e-80 | 23.9 EB05 15.7 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious n=17 | no trial data cached |
| Gallbladder injury | 20 | 23.9 15.4–37.1ROR 24.0 · χ² 412 / p 6e-92 | 23.2 EB05 15.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=20 · ♀ 100% (drug 75%) | no trial data cached |
| Rebound acid hypersecretion | 27 | 20.4 14.0–29.8ROR 20.4 · χ² 474 / p 2e-105 | 19.9 EB05 14.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=27 | no trial data cached |
| Left atrial dilatation | 10 | 18.0 9.7–33.5ROR 18.0 · χ² 143 / p 3e-33 | 16.5 EB05 8.5 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Colonic polyp | 13 | 17.9 10.4–31.0ROR 18.0 · χ² 190 / p 2e-43 | 17.0 EB05 9.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Costochondritis | 11 | 15.6 8.6–28.2ROR 15.6 · χ² 135 / p 2e-31 | 14.1 EB05 7.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Mitral valve prolapse | 11 | 15.2 8.4–27.6ROR 15.3 · χ² 132 / p 9e-31 | 13.7 EB05 7.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Oesophageal spasm | 12 | 15.0 8.5–26.5ROR 15.1 · χ² 143 / p 3e-33 | 13.7 EB05 7.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Irritable bowel syndrome | 135 | 14.6 12.3–17.3ROR 14.8 · χ² 1,687 / p <1e-300 | 14.5 EB05 12.5 · IC025 +3.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 12.6 | no trial data cached |
| Pre-existing condition improved | 37 | 13.5 9.8–18.7ROR 13.6 · χ² 415 / p 2e-92 | 13.2 EB05 9.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Radiculopathy | 15 | 13.1 7.9–21.8ROR 13.2 · χ² 155 / p 6e-36 | 11.9 EB05 7.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Biliary colic | 16 | 12.9 7.9–21.0ROR 12.9 · χ² 162 / p 2e-37 | 11.7 EB05 7.0 · IC025 +2.4 3/3 methods agree | Likely indication confounding term in indications | serious n=16 | no trial data cached |
| Gallbladder disorder | 96 | 12.4 10.1–15.1ROR 12.5 · χ² 988 / p 4e-217 | 12.2 EB05 10.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 | no trial data cached |
| Narcolepsy | 10 | 12.2 6.6–22.8ROR 12.2 · χ² 92 / p 5e-22 | 10.1 EB05 5.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Impaired gastric emptying | 65 | 11.8 9.2–15.0ROR 11.8 · χ² 627 / p 1e-138 | 11.5 EB05 9.2 · IC025 +3.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 12.0 | no trial data cached |
| Abdominal adhesions | 15 | 10.9 6.6–18.1ROR 10.9 · χ² 125 / p 3e-29 | 9.5 EB05 5.7 · IC025 +2.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=15 | no trial data cached |
| Economic problem | 72 | 10.8 8.6–13.6ROR 10.9 · χ² 626 / p 2e-138 | 10.5 EB05 8.5 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 10.8 | no trial data cached |
| Abdominal rigidity | 12 | 10.2 5.8–18.1ROR 10.3 · χ² 91 / p 8e-22 | 8.5 EB05 4.8 · IC025 +1.9 3/3 methods agree | Likely indication confounding term in indications | serious n=6 | no trial data cached |
| Gastric polyps | 10 | 10.2 5.5–19.0ROR 10.2 · χ² 74 / p 5e-18 | 8.1 EB05 4.3 · IC025 +1.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=7 | no trial data cached |
| Cholecystectomy | 50 | 10.1 7.7–13.4ROR 10.2 · χ² 402 / p 1e-89 | 9.7 EB05 7.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 | no trial data cached |
| Crohn's disease | 30 | 10.0 7.0–14.2ROR 10.0 · χ² 232 / p 1e-52 | 9.2 EB05 6.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=23 | no trial data cached |
| Cancer pain | 11 | 9.9 5.5–17.9ROR 9.9 · χ² 79 / p 3e-19 | 8.0 EB05 4.4 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Duodenitis | 13 | 9.8 5.7–16.8ROR 9.8 · χ² 93 / p 2e-22 | 8.1 EB05 4.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Sinus operation | 10 | 9.7 5.2–18.0ROR 9.7 · χ² 69 / p 4e-17 | 7.6 EB05 4.1 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious n=10 | no trial data cached |
| Maculopathy | 15 | 9.7 5.8–16.1ROR 9.7 · χ² 108 / p 1e-25 | 8.3 EB05 5.0 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Chronic kidney disease | 319 | 9.6 8.6–10.7ROR 9.9 · χ² 2,446 / p <1e-300 | 9.5 EB05 8.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 | no trial data cached |
| Rhinitis allergic | 18 | 9.3 5.9–14.8ROR 9.4 · χ² 125 / p 2e-29 | 8.1 EB05 5.2 · IC025 +2.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=15 | no trial data cached |
| Product administration interrupted | 31 | 9.3 6.6–13.2ROR 9.3 · χ² 221 / p 3e-50 | 8.6 EB05 6.2 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious n=29 | no trial data cached |
| Abdominal tenderness | 20 | 9.3 6.0–14.4ROR 9.3 · χ² 139 / p 2e-32 | 8.2 EB05 5.4 · IC025 +2.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=13 | no trial data cached |
| Intervertebral disc disorder | 17 | 9.1 5.7–14.7ROR 9.1 · χ² 114 / p 5e-27 | 7.9 EB05 5.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Oesophageal disorder | 15 | 9.0 5.4–14.9ROR 9.0 · χ² 98 / p 2e-23 | 7.6 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Anxiety disorder | 13 | 8.9 5.2–15.4ROR 8.9 · χ² 83 / p 3e-20 | 7.3 EB05 4.4 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious n=13 | no trial data cached |
| Essential hypertension | 10 | 8.9 4.8–16.6ROR 8.9 · χ² 62 / p 2e-15 | 6.9 EB05 3.8 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| End stage renal disease | 71 | 8.9 7.0–11.2ROR 8.9 · χ² 487 / p 3e-108 | 8.6 EB05 7.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Hiatus hernia | 50 | 8.9 6.7–11.7ROR 8.9 · χ² 341 / p 2e-76 | 8.4 EB05 6.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | 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 |
|---|---|---|---|---|---|---|
| Nausea | 828 | 2.4 2.3–2.6ROR 2.6 · χ² 709 / p 2e-156 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 | no trial data cached |
| Diarrhoea (diarrhea) | 722 | 2.6 2.4–2.8ROR 2.7 · χ² 718 / p 2e-158 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 | no trial data cached |
| Fatigue (tiredness) | 650 | 1.9 1.8–2.1ROR 2.0 · χ² 298 / p 5e-67 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Pain | 647 | 2.4 2.2–2.6ROR 2.5 · χ² 552 / p 3e-122 | 2.4 EB05 2.3 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 | no trial data cached |
| Headache | 535 | 2.0 1.8–2.1ROR 2.0 · χ² 260 / p 1e-58 | 2.0 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Drug ineffective (drug did not work) | 531 | 0.9 0.9–1.0ROR 0.9 · χ² 3 / p 0.036 | 0.9 EB05 0.9 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.1 | no trial data cached |
| Dizziness | 529 | 2.4 2.2–2.7ROR 2.5 · χ² 460 / p 3e-102 | 2.4 EB05 2.3 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial data cached |
| Vomiting | 480 | 2.4 2.2–2.6ROR 2.4 · χ² 380 / p 6e-85 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | no trial data cached |
| Abdominal pain | 477 | 4.7 4.3–5.2ROR 4.9 · χ² 1,408 / p <1e-300 | 4.7 EB05 4.3 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 | no trial data cached |
| Dyspnoea (shortness of breath) | 430 | 1.7 1.6–1.9ROR 1.8 · χ² 140 / p 1e-32 | 1.7 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | serious PRR 1.8 | no trial data cached |
| Off label use (used outside approved label) | 396 | 1.0 1.0–1.2ROR 1.1 · χ² 1 / p 0.176 | 1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.0 | no trial data cached |
| Fall | 391 | 2.7 2.5–3.0ROR 2.8 · χ² 424 / p 1e-94 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Anxiety | 391 | 3.2 2.9–3.5ROR 3.2 · χ² 579 / p 3e-128 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 | no trial data cached |
| Weight decreased (weight loss) | 356 | 2.9 2.6–3.2ROR 3.0 · χ² 457 / p 1e-101 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Asthenia (weakness) | 353 | 2.2 1.9–2.4ROR 2.2 · χ² 222 / p 2e-50 | 2.2 EB05 2.0 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
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.
- Cholecystitis chronic — n=113, PRR 38.9
- Nephrogenic anaemia — n=54, PRR 26.8
- Hyperparathyroidism secondary — n=28, PRR 25.7
- Gallbladder injury — n=20, PRR 23.9
- Rebound acid hypersecretion — n=27, PRR 20.4
- Pre-existing condition improved — n=37, PRR 13.5
- Gallbladder disorder — n=96, PRR 12.4
- Cholecystectomy — n=50, PRR 10.1
- Crohn's disease — n=30, PRR 10.0
- Chronic kidney disease — n=319, PRR 9.6
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 Hyoscyamine?
In FDA FAERS, the most frequently co-reported reaction terms for Hyoscyamine are nausea, diarrhoea, fatigue, pain, headache, dizziness. 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 Hyoscyamine have an FDA boxed warning?
No. The FDA label retrieved for Hyoscyamine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Hyoscyamine 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 1f4b1ed7-bbba-4b2c-8139-b35cb428587d, effective 20250601; matched on
openfda.generic_name.exact:"HYOSCYAMINE SULFATE") - 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
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.