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What the label lists and what reports show

Sucralfate side effects

Sucralfate's FDA label lists its adverse reactions in its own words. FAERS holds 23,820 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (2,353 reports).

  • Generic listed

Check it at the source: the sucralfate FDA label on DailyMed (effective September 2, 2026, Preferred Pharmaceuticals Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Adverse reactions to sucralfate in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2,700 patients treated with sucralfate tablets, adverse effects were reported in 129 (4.7%). Constipation was the most frequent complaint (2%). Other adverse effects reported in less than 0.5% of the patients are listed below by body system: Gastrointestinal: diarrhea, nausea, vomiting, gastric discomfort, indigestion, flatulence, dry mouth Dermatological: pruritus, rash Nervous System: dizziness, insomnia, sleepiness, vertigo Other: back pain, headache Post-marketing: cases of hypersensitivity have been reported with the use of sucralfate tablets, including dyspnea, lip swelling, pruritus, rash, and urticaria. …

Source: FDA drug label, NDA018333 (Abbvie), as published by Preferred Pharmaceuticals Inc., effective September 2, 2026 (SPL set 536b8c00-13ab-4397-a754-63a1c92bf883), via openFDA; the full label on DailyMed

What do FAERS reports show?

23,820 reports list sucralfate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,309 are coded as a death and 9,251 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Sucralfate: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions