Label Changes for:

Carafate (sucralfate) Suspension

March 2013

Changes have been made to the CONTRAINDICATIONS and ADVERSE REACTIONS sections of the safety label.

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

 

March 2013

CONTRAINDICATIONS

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

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 

December 2010

 

Precautions

  • Episodes of hyperglycemia have been reported in diabetic patients. Close monitoring of glycemia in diabetic patients treated with sucralfate suspension is recommended. Adjustment of the antidiabetic treatment dose during the use of sucralfate suspension might be necessary.

Adverse Reactions

Other
  • Cases of hyperglycemia have been reported with sucralfate

 

 

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