Carafate Side Effects

Generic Name: sucralfate

Please note - some side effects for Carafate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Carafate - for the Consumer

Carafate

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Carafate:

Constipation; dizziness; feeling of a whirling motion.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

Carafate Suspension

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Carafate Suspension:

Constipation; dizziness; feeling of a whirling motion.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

Carafate Side Effects - for the Professional

Carafate

Adverse reactions to sucralfate tablets in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2700 patients treated with sucralfate, adverse effects were reported in 129 (4.7%).

Constipation was the most frequent complaint (2%). Other adverse effects reported in less than 0.5% of the patients are listed below by body system:

Gastrointestinal: diarrhea, dry mouth, flatulence, gastric discomfort, indigestion, nausea, vomiting

Dermatological: pruritus, rash

Nervous System: dizziness, insomnia, sleepiness, vertigo

Other: back pain, headache

Postmarketing reports of hypersensitivity reactions, including urticaria (hives), angioedema, respiratory difficulty, rhinitis, laryngospasm, and facial swelling have been reported in patients receiving sucralfate tablets. Similar events were reported with sucralfate suspension. However, a causal relationship has not been established.

Bezoars have been reported in patients treated with sucralfate. The majority of patients had underlying medical conditions that may predispose to bezoar formation (such as delayed gastric emptying) or were receiving concomitant enteral tube feedings.

Inadvertent injection of insoluble sucralfate and its insoluble excipients has led to fatal complications, including pulmonary and cerebral emboli. Sucralfate is not intended for intravenous administration.

Carafate Tablets

Adverse reactions to sucralfate in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2700 patients treated with sucralfate tablets, adverse effects were reported in 129 (4.7%).

Constipation was the most frequent complaint (2%). Other adverse effects reported in less than 0.5% of the patients are listed below by body system:

Gastrointestinal: diarrhea, nausea, vomiting, gastric discomfort, indigestion, flatulence, dry mouth

Dermatological: pruritus, rash

Nervous System: dizziness, insomnia, sleepiness, vertigo

Other: back pain, headache

Postmarketing reports of hypersensitivity reactions, including urticaria (hives), angioedema, respiratory difficulty, rhinitis, laryngospasm, and facial swelling have been reported in patients receiving sucralfate tablets. Similar events were reported with sucralfate suspension. However, a causal relationship has not been established.

Bezoars have been reported in patients treated with sucralfate. The majority of patients had underlying medical conditions that may predispose to bezoar formation (such as delayed gastric emptying) or were receiving concomitant enteral tube feedings.

Inadvertent injection of insoluble sucralfate and its insoluble excipients has led to fatal complications, including pulmonary and cerebral emboli. Sucralfate is not intended for intravenous administration.

Side Effects by Body System

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 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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