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U.S. Department of Health and Human Services

Safety

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Carafate (sucralfate) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

March 2013

Summary View

CONTRAINDICATIONS

  • Carafate is contraindicated for patients with known hypersensitivity reactions to the active substance or to any of the excipients.

PRECAUTIONS

  • Isolated reports of sucralfate tablet aspiration with accompanying respiratory complications have been received. Therefore, sucralfate tablets should be used with caution by patients who have known conditions that may impair swallowing, such as recent or prolonged intubation, tracheostomy, prior history of aspiration, dysphagia, or any other conditions that may alter gag and cough reflexes, or diminish oropharyngeal coordination or motility.

ADVERSE REACTIONS

Post-marketing
  • Cases of hypersensitivity have been reported with the use of sucralfate suspension, including anaphylactic reactions, dyspnea, lip swelling, edema of the mouth, pharyngeal edema, pruritus, rash, swelling of the face and urticaria