Sucralfate Oral Suspension side effects: what 14,174 FDA adverse event reports show

Sucralfate Oral Suspension · Carafate · 1,159 reaction terms · 69,198 drug–reaction co-reports · data 2026-09-14

Drug class

Aluminum Complex

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Carafate

openFDA label

Who reports

14,174 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. 1,119 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Vaginal flatulence	159	1,621.7 1,294.6–2,031.5ROR 1,640.1 · χ² 121,178 / p <1e-300	702.9 EB05 615.9 · 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	155.8 132.8–182.9ROR 157.6 · χ² 22,655 / p <1e-300	138.6 EB05 121.7 · 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	99.3 85.0–116.2ROR 100.5 · χ² 15,041 / p <1e-300	92.1 EB05 80.9 · 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	91.3 78.0–106.8ROR 92.3 · χ² 13,611 / p <1e-300	85.1 EB05 74.7 · 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	62.1 52.8–73.0ROR 62.7 · χ² 8,648 / p <1e-300	59.2 EB05 51.7 · 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	55.6 40.4–76.5ROR 55.8 · χ² 1,962 / p <1e-300	52.3 EB05 39.9 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=39	no trial arm names this drug
Enterococcus test positive	19	44.3 28.1–70.0ROR 44.4 · χ² 740 / p 4e-163	41.4 EB05 28.0 · IC025 +3.6 3/3 methods agree	Lab value / disease marker	serious n=19	no trial arm names this drug
Adenocarcinoma gastric	23	37.9 25.0–57.3ROR 37.9 · χ² 769 / p 1e-169	35.9 EB05 25.2 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=23	no trial arm names this drug
Nephrogenic anaemia	116	37.6 31.3–45.2ROR 37.9 · χ² 3,996 / p <1e-300	36.5 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	36.8 25.5–53.2ROR 36.9 · χ² 951 / p 4e-209	35.2 EB05 25.7 · 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	34.7 26.7–44.9ROR 34.8 · χ² 1,819 / p <1e-300	33.5 EB05 26.9 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=58	no trial arm names this drug
Rebound acid hypersecretion	68	33.5 26.4–42.6ROR 33.7 · χ² 2,066 / p <1e-300	32.5 EB05 26.5 · 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	32.9 19.4–55.8ROR 32.9 · χ² 393 / p 1e-87	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	31.9 17.6–58.0ROR 31.9 · χ² 293 / p 7e-66	29.7 EB05 17.6 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=11	no trial arm names this drug
Dizziness exertional	15	30.4 18.3–50.7ROR 30.5 · χ² 390 / p 4e-87	28.8 EB05 18.5 · 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 21.8–41.4ROR 30.1 · χ² 1,018 / p 1e-223	29.1 EB05 22.1 · 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	25.1 21.6–29.3ROR 25.4 · χ² 3,807 / p <1e-300	24.7 EB05 21.7 · 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 12.4–38.8ROR 22.0 · χ² 216 / p 3e-49	20.8 EB05 12.2 · 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	21.9 19.0–25.3ROR 22.2 · χ² 3,716 / p <1e-300	21.6 EB05 19.1 · 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	20.3 15.1–27.2ROR 20.4 · χ² 796 / p 2e-175	19.9 EB05 15.4 · 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 15.3–26.5ROR 20.2 · χ² 915 / p 3e-201	19.8 EB05 15.6 · 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 13.3–30.3ROR 20.1 · χ² 393 / p 1e-87	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 2,521 / p <1e-300	18.7 EB05 16.3 · 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	18.2 10.1–33.0ROR 18.2 · χ² 160 / p 5e-37	16.9 EB05 9.1 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious n=10	no trial arm names this drug
Hypogonadism	12	17.6 10.0–31.1ROR 17.6 · χ² 170 / p 4e-39	16.4 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	16.5 14.0–19.5ROR 16.7 · χ² 2,020 / p <1e-300	16.3 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	14.1 11.9–16.7ROR 14.2 · χ² 1,630 / p <1e-300	13.9 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	14.0 9.1–21.6ROR 14.1 · χ² 239 / p 3e-54	13.3 EB05 8.7 · 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	13.9 12.0–16.2ROR 14.1 · χ² 2,034 / 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	13.4 7.9–22.7ROR 13.4 · χ² 147 / p 3e-34	12.1 EB05 6.9 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious n=13	no trial arm names this drug
Crepitations	27	13.4 9.2–19.6ROR 13.4 · χ² 295 / p 2e-66	12.8 EB05 8.9 · 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 176 / p 2e-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 12.0–14.0ROR 13.6 · χ² 7,322 / 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	11.9 7.1–20.2ROR 11.9 · χ² 128 / p 4e-30	10.5 EB05 6.0 · 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 267 / p 2e-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	11.3 9.6–13.3ROR 11.5 · χ² 1,348 / p 2e-295	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	11.3 6.6–19.5ROR 11.3 · χ² 111 / 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 6.9–18.4ROR 11.3 · χ² 138 / p 3e-32	9.9 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 11.2 · χ² 743 / p 5e-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 9.6–12.7ROR 11.2 · χ² 1,810 / p <1e-300	10.9 EB05 9.7 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 13.0 · ♀ 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	1,439	2.7 2.6–2.8ROR 2.9 · χ² 1,597 / 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
Diarrhoea (diarrhea)	1,040	2.4 2.3–2.5ROR 2.5 · χ² 868 / p 5e-191	2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.4	no trial arm names this drug
Fatigue (tiredness)	1,033	2.0 1.9–2.1ROR 2.0 · χ² 509 / p 5e-113	2.0 EB05 1.9 · IC025 +0.9	Not in label — unassessed	serious PRR 2.0	no trial arm names this drug
Pain	930	2.2 2.1–2.4ROR 2.3 · χ² 653 / p 2e-144	2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.3	no trial arm names this drug
Headache	912	2.2 2.0–2.3ROR 2.2 · χ² 581 / p 1e-128	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)	870	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)	824	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	820	2.6 2.4–2.8ROR 2.7 · χ² 815 / p 1e-179	2.6 EB05 2.4 · IC025 +1.3 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 2.0–2.2ROR 2.2 · χ² 472 / p 5e-105	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 12.0–14.0ROR 13.6 · χ² 7,322 / 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)	641	3.4 3.2–3.7ROR 3.5 · χ² 1,097 / p 6e-241	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	634	1.9 1.7–2.0ROR 1.9 · χ² 268 / p 1e-60	1.9 EB05 1.8 · IC025 +0.8	Labeled adverse reaction exact term	serious PRR 1.8	no trial arm names this drug
Abdominal pain	625	4.0 3.7–4.3ROR 4.1 · χ² 1,406 / 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
Malaise (feeling unwell)	623	2.1 1.9–2.3ROR 2.1 · χ² 364 / p 2e-81	2.1 EB05 2.0 · IC025 +0.9	Not in label — unassessed	serious PRR 2.3	no trial arm names this drug
Constipation	608	4.2 3.9–4.5ROR 4.3 · χ² 1,470 / 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 1,621.7
Female genital tract fistula — n=164, PRR 155.8
Radiculopathy — n=166, PRR 99.3
Proctitis — n=163, PRR 91.3
Chronic sinusitis — n=151, PRR 62.1
Chronic kidney disease-mineral and bone disorder — n=39, PRR 55.6
Adenocarcinoma gastric — n=23, PRR 37.9
Nephrogenic anaemia — n=116, PRR 37.6
Reflux gastritis — n=29, PRR 36.8
Hyperparathyroidism secondary — n=58, PRR 34.7

✓ 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, diarrhoea, fatigue, 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, field patient.drug.openfda.generic_name.exact, 1,159 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.