Drug · FAERS side-effect profile with label screen
Sucralfate Oral side effects: what 14,133 FDA adverse event reports show
Brand names
Carafate
openFDA label
Who reports
14,133 reports · 71% serious · 1,409 with death outcome · 65% female
openFDA FAERS counts, all years, deduplication not applied
Used for
CARAFATE (sucralfate) Oral Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.
FDA label, Indications and Usage
What it is
DESCRIPTION CARAFATE Oral Suspension contains sucralfate and sucralfate is an α-D-glucopyranoside, β-D- fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex. CARAFATE Oral Suspension for oral administration contains 1 g of sucralfate per 10 mL.
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) 1Lab value / disease marker 1Not in label — unassessed 38
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.
- 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. 1,120 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 | 159 | 1,626.4 1,298.3–2,037.3ROR 1,644.9 · χ² 121,530 / p <1e-300 | 704.8 EB05 617.5 · IC025 +7.6 3/3 methods agree | Not in label — unassessed | serious n=159 · ♀ 100% (drug 65%) | no trial arm names this drug |
| Female genital tract fistula | 164 | 156.3 133.1–183.4ROR 158.1 · χ² 22,722 / p <1e-300 | 139.0 EB05 122.1 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=164 · ♀ 100% (drug 65%) | no trial arm names this drug |
| Radiculopathy | 166 | 99.6 85.2–116.5ROR 100.8 · χ² 15,085 / p <1e-300 | 92.4 EB05 81.2 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=166 · ♀ 100% (drug 65%) | no trial arm names this drug |
| Proctitis | 163 | 91.5 78.2–107.1ROR 92.6 · χ² 13,652 / p <1e-300 | 85.4 EB05 74.9 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=163 · ♀ 100% (drug 65%) | no trial arm names this drug |
| Chronic sinusitis | 151 | 62.3 53.0–73.2ROR 62.9 · χ² 8,674 / p <1e-300 | 59.3 EB05 51.8 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=149 · ♀ 100% (drug 65%) | no trial arm names this drug |
| Chronic kidney disease-mineral and bone disorder | 39 | 55.8 40.5–76.7ROR 55.9 · χ² 1,968 / p <1e-300 | 52.5 EB05 40.0 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=39 | no trial arm names this drug |
| Enterococcus test positive | 19 | 44.5 28.2–70.2ROR 44.5 · χ² 742 / p 1e-163 | 41.5 EB05 28.1 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=19 | no trial arm names this drug |
| Adenocarcinoma gastric | 23 | 38.0 25.1–57.4ROR 38.0 · χ² 771 / p 5e-170 | 36.0 EB05 25.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=23 | no trial arm names this drug |
| Nephrogenic anaemia | 116 | 37.7 31.4–45.3ROR 38.0 · χ² 4,008 / p <1e-300 | 36.6 EB05 31.3 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=116 | no trial arm names this drug |
| Reflux gastritis | 29 | 36.9 25.5–53.3ROR 37.0 · χ² 954 / p 1e-209 | 35.3 EB05 25.8 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=29 · ♀ 100% (drug 65%) | no trial arm names this drug |
| Hyperparathyroidism secondary | 58 | 34.8 26.8–45.1ROR 34.9 · χ² 1,825 / p <1e-300 | 33.6 EB05 27.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=58 | no trial arm names this drug |
| Rebound acid hypersecretion | 68 | 33.6 26.4–42.7ROR 33.8 · χ² 2,072 / p <1e-300 | 32.6 EB05 26.6 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=68 | no trial arm names this drug |
| Infective exacerbation of chronic obstructive airways disease | 14 | 33.0 19.4–56.0ROR 33.0 · χ² 394 / p 6e-88 | 31.0 EB05 19.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial arm names this drug |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 11 | 32.0 17.6–58.1ROR 32.0 · χ² 294 / p 4e-66 | 29.8 EB05 17.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial arm names this drug |
| Dizziness exertional | 15 | 30.5 18.3–50.9ROR 30.5 · χ² 391 / p 2e-87 | 28.9 EB05 18.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial arm names this drug |
| Early satiety | 38 | 30.1 21.9–41.5ROR 30.2 · χ² 1,021 / p 3e-224 | 29.2 EB05 22.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=38 · ♀ 100% (drug 65%) | no trial arm names this drug |
| Vaginal discharge | 168 | 25.2 21.7–29.3ROR 25.5 · χ² 3,818 / p <1e-300 | 24.7 EB05 21.8 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=165 · ♀ 100% (drug 65%) | no trial arm names this drug |
| Resorption bone increased | 12 | 22.0 12.5–38.9ROR 22.0 · χ² 217 / p 2e-49 | 20.8 EB05 12.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial arm names this drug |
| Oral candidiasis (oral thrush) | 190 | 22.0 19.1–25.3ROR 22.3 · χ² 3,728 / p <1e-300 | 21.6 EB05 19.2 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 24.1 · ♀ 90% (drug 65%) | no trial arm names this drug |
| Peptic ulcer | 45 | 20.4 15.2–27.3ROR 20.4 · χ² 798 / p 7e-176 | 19.9 EB05 15.5 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=45 | no trial arm names this drug |
| Oesophageal ulcer | 52 | 20.2 15.4–26.6ROR 20.3 · χ² 918 / p 6e-202 | 19.8 EB05 15.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=49 | no trial arm names this drug |
| Biliary dyskinesia | 23 | 20.1 13.4–30.4ROR 20.2 · χ² 394 / p 5e-88 | 19.5 EB05 13.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 100% (drug 65%) · 76% consumer | no trial arm names this drug |
| Macular degeneration | 151 | 19.0 16.2–22.3ROR 19.2 · χ² 2,529 / p <1e-300 | 18.8 EB05 16.4 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 16.4 · ♀ 97% (drug 65%) | no trial arm names this drug |
| Anaemia of chronic disease | 11 | 18.3 10.1–33.1ROR 18.3 · χ² 161 / p 4e-37 | 16.9 EB05 9.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial arm names this drug |
| Hypogonadism | 12 | 17.7 10.0–31.2ROR 17.7 · χ² 170 / p 3e-39 | 16.5 EB05 9.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial arm names this drug |
| Impaired gastric emptying | 141 | 16.6 14.1–19.6ROR 16.7 · χ² 2,026 / p <1e-300 | 16.4 EB05 14.2 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.7 · 78% consumer | no trial arm names this drug |
| Paraesthesia oral | 136 | 14.2 12.0–16.8ROR 14.3 · χ² 1,636 / p <1e-300 | 14.0 EB05 12.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 19.5 · ♀ 97% (drug 65%) | no trial arm names this drug |
| Gastrointestinal hypomotility | 21 | 14.1 9.2–21.6ROR 14.1 · χ² 240 / p 2e-54 | 13.4 EB05 8.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial arm names this drug |
| End stage renal disease | 172 | 14.0 12.0–16.2ROR 14.1 · χ² 2,041 / p <1e-300 | 13.8 EB05 12.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 | no trial arm names this drug |
| Vascular rupture | 14 | 13.5 8.0–22.8ROR 13.5 · χ² 148 / p 3e-34 | 12.1 EB05 7.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial arm names this drug |
| Crepitations | 27 | 13.5 9.2–19.6ROR 13.5 · χ² 296 / p 1e-66 | 12.9 EB05 9.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=27 | no trial arm names this drug |
| Gallbladder injury | 17 | 13.1 8.1–21.1ROR 13.1 · χ² 177 / p 1e-40 | 12.0 EB05 7.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial arm names this drug |
| Chronic kidney disease | 667 | 13.0 12.1–14.0ROR 13.6 · χ² 7,346 / p <1e-300 | 12.9 EB05 12.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial arm names this drug |
| Vertigo positional | 14 | 12.0 7.1–20.2ROR 12.0 · χ² 129 / p 4e-30 | 10.5 EB05 6.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial arm names this drug |
| Tendon injury | 29 | 11.6 8.0–16.7ROR 11.6 · χ² 268 / p 1e-60 | 10.9 EB05 7.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=29 · ♀ 100% (drug 65%) | no trial arm names this drug |
| Gastric ulcer | 145 | 11.4 9.7–13.4ROR 11.5 · χ² 1,353 / p 2e-296 | 11.2 EB05 9.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial arm names this drug |
| Infusion site discharge | 13 | 11.4 6.6–19.6ROR 11.4 · χ² 112 / p 2e-26 | 9.7 EB05 5.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial arm names this drug |
| Sputum increased | 16 | 11.3 6.9–18.5ROR 11.3 · χ² 139 / p 2e-32 | 10.0 EB05 6.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial arm names this drug |
| Oesophagitis | 82 | 11.2 9.0–13.9ROR 11.3 · χ² 746 / p 1e-164 | 10.9 EB05 9.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial arm names this drug |
| Frequent bowel movements | 200 | 11.1 9.7–12.7ROR 11.2 · χ² 1,817 / p <1e-300 | 11.0 EB05 9.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 13.1 · ♀ 93% (drug 65%) | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
ClinicalTrials.gov returned results-bearing trials mentioning Sucralfate only as a background or rescue medication (NCT00584922); 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 | 1,432 | 2.7 2.6–2.8ROR 2.9 · χ² 1,582 / p <1e-300 | 2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 | no trial arm names this drug |
| Fatigue (tiredness) | 1,033 | 2.0 1.9–2.1ROR 2.1 · χ² 514 / p 5e-114 | 2.0 EB05 1.9 · IC025 +0.9 | Not in label — unassessed | serious PRR 2.0 | no trial arm names this drug |
| Diarrhoea (diarrhea) | 1,030 | 2.4 2.2–2.5ROR 2.5 · χ² 845 / p 4e-186 | 2.4 EB05 2.3 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 | no trial arm names this drug |
| Pain | 929 | 2.2 2.1–2.4ROR 2.3 · χ² 656 / p 6e-145 | 2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | no trial arm names this drug |
| Headache | 911 | 2.2 2.0–2.3ROR 2.2 · χ² 583 / p 5e-129 | 2.2 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 |
| Off label use (used outside approved label) | 868 | 1.5 1.4–1.6ROR 1.5 · χ² 142 / p 4e-33 | 1.5 EB05 1.4 · IC025 +0.5 | Reporting / coding artifact | serious PRR 1.6 | no trial arm names this drug |
| Drug ineffective (drug did not work) | 821 | 0.9 0.9–1.0ROR 0.9 · χ² 5 / p 0.011 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.3 | no trial arm names this drug |
| Vomiting | 812 | 2.6 2.4–2.7ROR 2.7 · χ² 795 / p 4e-175 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | no trial arm names this drug |
| Dyspnoea (shortness of breath) | 802 | 2.1 2.0–2.3ROR 2.2 · χ² 476 / p 7e-106 | 2.1 EB05 2.0 · IC025 +1.0 | Labeled adverse reaction exact term | serious PRR 1.9 | no trial arm names this drug |
| Chronic kidney disease | 667 | 13.0 12.1–14.0ROR 13.6 · χ² 7,346 / p <1e-300 | 12.9 EB05 12.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial arm names this drug |
| Weight decreased (weight loss) | 639 | 3.4 3.2–3.7ROR 3.5 · χ² 1,094 / p 4e-240 | 3.4 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial arm names this drug |
| Dizziness | 633 | 1.9 1.7–2.0ROR 1.9 · χ² 269 / p 9e-61 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial arm names this drug |
| Malaise (feeling unwell) | 623 | 2.1 1.9–2.3ROR 2.2 · χ² 367 / p 4e-82 | 2.1 EB05 2.0 · IC025 +0.9 | Not in label — unassessed | serious PRR 2.3 | no trial arm names this drug |
| Abdominal pain | 623 | 4.0 3.7–4.3ROR 4.1 · χ² 1,401 / p <1e-300 | 4.0 EB05 3.7 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial arm names this drug |
| Constipation | 606 | 4.2 3.9–4.5ROR 4.3 · χ² 1,464 / p <1e-300 | 4.1 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | 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.
- Vaginal flatulence — n=159, PRR 1,626.4
- Female genital tract fistula — n=164, PRR 156.3
- Radiculopathy — n=166, PRR 99.6
- Proctitis — n=163, PRR 91.5
- Chronic sinusitis — n=151, PRR 62.3
- Chronic kidney disease-mineral and bone disorder — n=39, PRR 55.8
- Adenocarcinoma gastric — n=23, PRR 38.0
- Nephrogenic anaemia — n=116, PRR 37.7
- Reflux gastritis — n=29, PRR 36.9
- Hyperparathyroidism secondary — n=58, PRR 34.8
✓ A hand-written Bradford Hill causality assessment exists for this drug: Minoxidil (oral) ↔ Pericardial effusion.
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 Sucralfate?
In FDA FAERS, the most frequently co-reported reaction terms for Sucralfate are nausea, fatigue, diarrhoea, pain, headache, 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 Sucralfate have an FDA boxed warning?
No. The FDA label retrieved for Sucralfate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Sucralfate 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 0fb67b1c-b4c0-46f2-8a81-df1510e006aa, effective 20230608; matched on
openfda.generic_name.exact:"SUCRALFATE") - 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, 1,160 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
SUCRALFATE, 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.