Medication Guide App

Carafate Side Effects

Generic Name: sucralfate

Note: This page contains information about the side effects of sucralfate. Some of the dosage forms included on this document may not apply to the brand name Carafate.

Not all side effects for Carafate may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to sucralfate: oral suspension, oral tablet

Along with its needed effects, sucralfate (the active ingredient contained in Carafate) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking sucralfate:

Signs of aluminum toxicity
  • Drowsiness
  • convulsions (seizures)

Some side effects of sucralfate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Constipation
Less common or rare
  • Backache
  • diarrhea
  • dizziness or lightheadedness
  • dryness of mouth
  • indigestion
  • nausea
  • skin rash, hives, or itching
  • stomach cramps or pain

For Healthcare Professionals

Applies to sucralfate: compounding powder, oral suspension, oral tablet

General

Sucralfate (the active ingredient contained in Carafate) is generally very well tolerated, only 2% to 3% of patients experience side effects. Constipation and other gastrointestinal effects are the most commonly reported. Patients with renal dysfunction may be at increased risk for more serious side effects such as hypophosphatemia and aluminum intoxication.

Gastrointestinal

Gastrointestinal side effects have included constipation (1% to 3%), dry mouth, nausea, vomiting, indigestion, gastric mucosal calcinosis, and rare case reports of gastroesophageal bezoars.

Case reports of gastroesophageal and esophageal bezoars have been reported in the literature. Sucralfate was usually given crushed and suspended in water. In addition, several patients were also receiving concomitant enteral feedings via a nasogastric tube. Two patients had Guillain-Barre syndrome. These factors may have contributed to bezoar formation.

In one study, calcified aluminum phosphate deposits in the gastric mucosa were present in gastric biopsies of 32.7% (18/55) of organ transplant patients taking aluminum-containing antacids or sucralfate for gastritis. This was observed in only 5.1% (3/59) of non-transplant patients. These three patients all had chronic renal failure and were on long-term aluminum-containing antacid therapy. The clinical relevance of these findings is not known.

Musculoskeletal

Osteomalacia was reported in a 42-year-old female with normal renal and hepatic function. Chronic treatment of peptic ulcer disease with sucralfate (the active ingredient contained in Carafate) resulted in severe hypophosphatemia, elevated alkaline phosphatase levels, and elevated 1,25-dihydroxyvitamin D levels. Subsequent osteomalacia and microfractures occurred.

Another report involves a 13-year-old with end-stage renal disease secondary to hemolytic uremic syndrome. This patient developed aluminum intoxication with encephalopathy as well as osteomalacia with surface stainable aluminum noted on bone biopsy.

Musculoskeletal side effects have included rare reports of bone pain and osteomalacia secondary to hypophosphatemia and aluminum toxicity.

Metabolic

Metabolic side effects have included hypophosphatemia and aluminum toxicity. Sucralfate (the active ingredient contained in Carafate) has been reported to decrease the absorption of thyroxine (T4). Sucralfate suspension has been associated with hyperglycemia in diabetic patients.

Sucralfate has phosphate binding properties for which the drug is sometimes used therapeutically. However, hypophosphatemia may occur in some patients, regardless of renal function status.

In addition, each 1 gram dose of sucralfate contains approximately 200 mg of aluminum which may be absorbed. Aluminum intoxication leading to mental status changes, confusion, seizures, and encephalopathy may occur, especially in patients on concomitant aluminum-containing antacids, on chronic sucralfate, or with renal dysfunction.

Nervous system

Nervous system side effects have included headache, vertigo, dizziness, and rare reports of encephalopathy secondary to aluminum accumulation.

Dermatologic

Dermatologic side effects have included pruritus, rash, and urticaria.

Hypersensitivity

Hypersensitivity side effects have included urticaria, angioedema, rhinitis, and respiratory difficulty. Sucralfate (the active ingredient contained in Carafate) suspension has been associated with postmarketing reports of hypersensitivity including anaphylactic reactions, dyspnea, lip swelling, edema of the mouth, pharyngeal edema, pruritus, rash, swelling of the face and urticaria.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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