Is Carafate (Sucralfate) Safe to Use?
Yes, Carafate (sucralfate) is generally safe for most patients, with minimal side effects due to its lack of systemic absorption, though it requires specific precautions in patients with chronic renal failure and those taking multiple medications. 1
Safety Profile
Sucralfate is particularly well tolerated because only 3-5% of an oral dose is absorbed systemically, with over 90% excreted unchanged in feces. 2 This minimal absorption accounts for its excellent safety profile compared to systemically absorbed medications.
Common Side Effects
- Constipation is the most frequent adverse effect, occurring in only 2-4% of patients 2, 3
- Dry mouth (xerostomia) occurs in approximately 1% of patients 2
- Skin eruptions are rare, affecting 0.6% of patients 2
- No evidence of carcinogenicity was found in 24-month animal studies at doses up to 12 times the human dose 1
Critical Safety Considerations
Patients with Renal Impairment
Sucralfate should be used with caution in patients with chronic renal failure or those on dialysis due to aluminum accumulation risk. 1
- Small amounts of aluminum are absorbed from the gastrointestinal tract 1
- Patients with normal renal function adequately excrete aluminum in urine 1
- Patients with impaired renal function cannot adequately excrete absorbed aluminum, leading to potential aluminum toxicity (osteodystrophy, osteomalacia, encephalopathy) 1
- Aluminum does not cross dialysis membranes because it binds to albumin and transferrin 1
Aspiration Risk
Sucralfate tablets should be used cautiously in patients with conditions that impair swallowing. 1 This includes:
- Recent or prolonged intubation 1
- Tracheostomy 1
- Prior history of aspiration 1
- Dysphagia 1
- Conditions that alter gag/cough reflexes or diminish oropharyngeal coordination 1
Drug Interactions
Sucralfate can reduce absorption of multiple medications through nonsystemic binding in the gastrointestinal tract. 1 Affected medications include:
- Cimetidine, ranitidine 1
- Fluoroquinolone antibiotics 1
- Digoxin 1
- Levothyroxine 1
- Phenytoin 1
- Quinidine 1
- Tetracycline 1
- Theophylline 1
- Ketoconazole 1
To avoid these interactions, administer other medications at least 2 hours before sucralfate. 1 This timing eliminates the interaction in all documented cases 1
Sucralfate should be administered at least 2 hours apart from PPIs or H2-blockers to avoid interaction. 4
Special Populations
Pregnancy
Sucralfate is Pregnancy Category B. 1
- Animal studies at doses up to 50 times the human dose showed no evidence of fetal harm 1
- No adequate well-controlled studies exist in pregnant women 1
- Should be used during pregnancy only if clearly needed 1
Nursing Mothers
Caution should be exercised when administering sucralfate to nursing women, as it is unknown whether the drug is excreted in human milk. 1
Pediatric Patients
Safety and effectiveness in pediatric patients have not been established. 1
Elderly Patients
Dose selection for elderly patients should be cautious, starting at the low end of the dosing range. 1
- Elderly patients are more likely to have decreased renal function 1
- Monitor renal function in this population 1
- The drug is substantially excreted by the kidney, increasing risk of toxic reactions in patients with impaired renal function 1
Clinical Context
While sucralfate is safe, it is generally recommended as a second-line agent rather than first-line therapy. 5, 4, 6
- PPIs are preferred first-line agents for treating and preventing gastrointestinal ulcers 5, 4
- For stress ulcer prophylaxis, PPIs or H2-blockers are first-line, with sucralfate as second-line 6
- Sucralfate may offer lower risk of ventilator-associated pneumonia compared to acid-suppressive therapies in select ICU populations 6
Long-Term Safety
Sucralfate has been shown safe for maintenance therapy up to 12 months. 7