Sucralfate Side Effects

Some side effects of sucralfate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to sucralfate: oral suspension, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking sucralfate: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects of sucralfate may include:

• nausea, vomiting, upset stomach;

• stomach pain;

• constipation, diarrhea;

• mild itching or skin rash;

• sleep problems (insomnia);

• dizziness, drowsiness, spinning sensation;

• headache; or

• back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

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

General

Sucralfate 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 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 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.

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