Safety experience with sucralfate in Japan.
Three major documentary sources attest to the clinical safety of sucralfate in Japan. Two double-blind trials evaluated the safety and efficacy of sucralfate in 163 sucralfate-treated patients compared to 154 patients who received lactose placebo. The low indicence of side effects was comparable in both groups: constipation, 3.7% and 3.9%; oral dryness, 1.2% and 0%; skin eruption, 0.6% and 0.6%, respectively. Laboratory findings were within normal limits in sucralfate-treated patients. Side effects were monitored by 137 medical institutions over 4 years and reported under regulation to the Japanese health authorities. Follow-up of 2,298 patients yielded the following: constipation, 2.3%; oral dryness, 0.7%; nausea, 0.2%; stomach discomfort, 0.1%; increased upper GI complaints, 0.1%; and dizziness, 0.4%. Ninety-one papers from the literature were reviewed to further evaluate the safety of sucralfate treatment. Of 2.306 patients studied, constipation was noted in 2.2%, oral dryness in 0.7%, and nausea in 0.4%. More constipation and oral dryness were reported when anticholinergics were administered concomitantly with sucralfate. Laboratory tests in about 500 patients revealed no significant abnormalities. Experience has established a solid basis for the safety, efficacy, and tolerability of sucralfate. The only side effect of note was constipation; however, this symptom occurred in similarly low numbers of patients receiving either sucralfate or placebo.
D000535:Aluminum / Q000009:adverse effects / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D003248:Constipation / Q000139:chemically induced; D004311:Double-Blind Method; D003875:Drug Eruptions; D006801:Humans; D007564:Japan; D013392:Sucralfate; D014987:Xerostomia / Q000139:chemically induced
D000897:Anti-Ulcer Agents; D013392:Sucralfate; D000535:Aluminum