Side Effects of Carafate (sucralfate)

Carafate (sucralfate) is an anti-ulcer medication used to treat peptic ulcer disease and to prevent recurrent ulcers after healing of the ulcer has been achieved; to relieve or prevent ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs), but is less effective than misoprostol; and to treat patients with gastroesophageal reflux disease (GERD). 

Off-label uses of Carafate are to prevent stress ulcers, which are ulcers associated with high degrees of physical stress (for example, extensive burns, surgery, and overwhelming infection) in hospitalized patients.

Common side effects of Carafate include

• constipation,
• headache,
• dizziness,
• insomnia,
• diarrhea,
• nausea,
• spinning sensation (vertigo),
• indigestion,
• dry mouth,
• dizziness,
• vomiting, and
• gas (flatulence).

Drug interactions of Carafate include other drugs taken orally at the same time, because Carafate may bind to the drugs in the stomach and reduce absorption of the drugs.

• Carafate reduces the absorption of dolutegravir, cimetidine, digoxin, ketoconazole, levothyroxine, phenytoin, quinidine, ranitidine, tetracycline, theophylline, and fluoroquinolone antibiotics.
• All these medications should be taken at least two hours prior to Carafate.
• It is possible, if not likely, that many other drugs will interact similarly with Carafate.
• Therefore, it probably is prudent to take all medications at least 2 hours prior to Carafate. 

All human data show no ill-effect of Carafate on the fetus. Carafate is considered safe during pregnancy. 

Minimal if any Carafate penetrates into breast milk because so little is absorbed from the gastrointestinal tract. Although there are no data, Carafate is considered safe in breastfeeding mothers. Consult your doctor before breastfeeding.

Carafate is well tolerated. Constipation is the most frequent side effect.

Other side effects include:

• Headache
• Dizziness
• Insomnia
• Diarrhea
• Nausea
• Vertigo
• Indigestion
• Dry mouth
• Dizziness
• Vomiting
• Flatulence

Adverse reactions to sucralfate tablets in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2,700 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
• Post-marketing cases of hypersensitivity have been reported with the use of sucralfate oral suspension, including anaphylactic reactions, dyspnea, lip swelling, edema of the mouth, pharyngeal edema, pruritus, rash, swelling of the face and urticaria.
• Cases of bronchospasm, laryngeal edema and respiratory tract edema have been reported with an unknown oral formulation of sucralfate.
• Cases of hyperglycemia have been reported with sucralfate. 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.

Some studies have shown that simultaneous sucralfate administration in healthy volunteers reduced the extent of absorption (bioavailability) of single doses of the following:

• cimetidine,
• digoxin,
• fluoroquinolone antibiotics,
• ketoconazole,
• l-thyroxine,
•  phenytoin,
• quinidine,
• ranitidine,
• tetracycline, and
• theophylline.

Subtherapeutic prothrombin times with concomitant warfarin and sucralfate therapy have been reported in spontaneous and published case reports. However, two clinical studies have demonstrated no change in either serum warfarin concentration or prothrombin time with the addition of sucralfate to chronic warfarin therapy.

The mechanism of these interactions appears to be nonsystemic in nature, presumably resulting from sucralfate binding to the concomitant agent in the gastrointestinal tract. In all cases studied to date (cimetidine, ciprofloxacin, digoxin, norfloxacin, ofloxacin, and ranitidine), dosing the concomitant medication 2 hours before sucralfate eliminated the interaction.

Due to Carafate Oral Suspension's potential to alter the absorption of some drugs, Carafate Oral Suspension should be administered separately from other drugs when alterations in bioavailability are felt to be critical. In these cases, patients should be monitored appropriately.