Sucralfate Side Effects

It is possible that some side effects of sucralfate may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to sucralfate: oral suspension, oral tablet

As well as its needed effects, sucralfate may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking sucralfate, check with your doctor immediately:

Signs of aluminum toxicity
  • Drowsiness
  • convulsions (seizures)

Some sucralfate side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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 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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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

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.[Ref]

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.[Ref]

Nervous system

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

Dermatologic

Dermatologic side effects have included pruritus, rash, and urticaria.[Ref]

Hypersensitivity

Hypersensitivity side effects have included urticaria, angioedema, rhinitis, and respiratory difficulty. Sucralfate 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.[Ref]

References

1. "Product Information. Carafate (sucralfate)." Hoechst Marion-Roussel Inc, Kansas City, MO.

2. Fisher RS "Sucralfate: a review of drug tolerance and safety." J Clin Gastroenterol 3 (1981): 181-4

3. McCarthy DM "Sucralfate." N Engl J Med 325 (1991): 1017-25

4. Greenson JK, Trinidad SB, Pfeil SA, Brainard JA, McBride PT, Colijn HO, Tesi RJ, Lucas JG "Gastric mucosal calcinosis. Calcified aluminum phosphate deposits secondary to aluminum-containing antacids or sucralfate therapy in organ transplant patients." Am J Surg Pathol 17 (1993): 45-50

5. Hart RS, Levin B, Gholson CF "Esophageal obstruction caused by sucralfate impaction ." Gastrointest Endosc 35 (1989): 474-5

6. Carrougher JG, Barrilleaux CN "Esophageal bezoars: the sucralith." Crit Care Med 19 (1991): 837-9

7. Rowbottom SJ, Wilson J, Samuel L, Grant IS "Total oesophageal obstruction in association with combined enteral feed and sucralfate therapy." Anaesth Intensive Care 21 (1993): 372-4

8. Anderson W, Weatherstone G, Veal C "Esophageal medication bezoar in a patient receiving enteral feedings and sucralfate." Am J Gastroenterol 84 (1989): 205-6

9. Algozzine GJ, Hill G, Scoggins WG, Marr MA "Sucralfate bezoar." N Engl J Med 309 (1983): 1387

10. Chines A, Pacifici R "Antacid and sucralfate-induced hypophosphatemic osteomalacia: a case report and review of the literature." Calcif Tissue Int 47 (1990): 291-5

11. Robertson JA, Salusky IB, Goodman WG, Norris KC, Coburn JW "Sucralfate, intestinal aluminum absorption, and aluminum toxicity in a patient on dialysis." Ann Intern Med 111 (1989): 179-81

12. Pai S, Melethil S, Cuddy P, Hall T "Elevation of serum aluminum in humans on a two-day sucralfate regimen." J Clin Pharmacol 27 (1987): 213-5

13. Campistol JM, Cases A, Botey A, Revert A "Acute aluminum encephalopathy in an uremic patient." Nephron 51 (1989): 103-6

14. Withers DJ, Woolf AS, Kingswood JC, Tsang WN, Mansell MA "Encephalopathy in patient taking aluminium-containing agents, including sucralfate ." Lancet 2 (1989): 674

15. Min DI, D'Elia JA "Sucralfate-associated aluminum toxicity in a patient with renal failure: treatment with deferoxamine." Clin Pharm 11 (1992): 636-9

16. Surks MI, Sievert R "Drugs and thyroid function." N Engl J Med 333 (1995): 1688-94

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