Fluoride Action Network

Fluoride-Induced Gastric Symptoms in Human Clinical Trials

Fluoride Action Network | March 2012 | By Michael Connett

In studies where fluoride has been used (at doses of 18-34 mg/day) as an experimental drug for the treatment of osteoporosis, gastrointestinal disturbances are one of the two main side effects consistently encountered. The following are some of the accounts from the published literature:

“The use of fluoride in the prophylaxis or treatment of osteoporosis seems highly questionable for the following reasons: … (c) there are frequent gastrointestinal disturbancesand arthralgias…”
SOURCE: Inkovaara JA. (1991). Is fluoride treatment justified today? Calcified Tissue International 49 Suppl:S68-9.

“the fluoride-treated women (dose = 34 mg/day F) had about 3.0 times as many side effects as the women given placebo. The side effects fell into one of two major categories – those due to gastric irritation and those due to pain the lower extremities. The gastric symptoms consisted mainly of nausea or, less commonly, epigastric pain and vomiting, or both. The fluoride-treated women had these symptoms 2.9 times more frequently than the women given placebo.”
SOURCE: Riggs BL, et al. (1990). Effect of Fluoride treatment on the Fracture Rates in Postmenopausal Women with Osteoporosis. New England Journal of Medicine 322:802-809.

“Of 48 patients who began sodium fluoride therapy (dose = 9.0 – 27 mg/day F), 25 developed significant side-effects (10 with nausea and dyspepsia, 1 with gastrointestinal hemorrhage).”
SOURCE: Hodsman AB, Drost DJ. (1989). The response of vertebral bone mineral density during the treatment of osteoporosis with sodium fluoride. Journal of Clinical Endocrinology and Metabolism 69:932-8.

“Results from several large trials indicate that significant side effects attributable to treatment occur in about one-third to one-half of patients. Symptoms have been of two types–periarticular and gastrointestinal… Gastrointestinal symptoms consist of epigastric pain, nausea, vomiting, and occasionally, blood-loss anemia; these presumably result from the irritant effect of fluoride ion on gastric mucosa. The frequency of gastric side effects can be reduced by giving the calcium supplement concomitantly in the form of calcium carbonate, an effective antacid. Diarrhea occurs occasionally.”
SOURCE: Riggs BL. (1983). Treatment of osteoporosis with sodium fluoride: An appraisal. Bone and Mineral Research 2: 366-393.

“Twenty-three of the fluoride-treated patients (dose = 18-27mg/day) had adverse reactions (38 per cent), which caused five of them to discontinue therapy; 13 had rheumatic symptoms (joint pain and swelling or painful plantar fascial syndrome), nine had gastrointestinal symptoms (severe nausea and vomiting, peoptic ulcer, or blood-loss anemia), and one had both rheumatic and gastrointestinal symptoms.”
SOURCE: Riggs BL, et al. (1982). Effect of the fluoride/calcium regimen on vertebral fracture occurrence in postmenopausal osteoporosis. Comparison with conventional therapy. New England Journal of Medicine 306:446-50.

“Major gastrointestinal side effects also occurred (dose = 18-30 mg/day). Two patients had recurrent vomiting that could be controlled only when the dosage of sodium fluoride was reduced to 15 and 7.5 mg daily, respectively.”
SOURCE: Riggs BL, et al. (1980). Treatment of primary osteoporosis with fluoride and calcium: Clinical tolerance and fracture occurrence. Journal of the American Medical Association 243: 446-449.

“Treatment was ended in the fluoride group more frequently than in the controls (P < 0.001), usually because of abdominal discomfort.”
SOURCE: Inkovaara J, et al. (1975). Prophylactic fluoride treatment and aged bones. British Medical Journal 3(5975):73-4.

“Six (of 11) patients complained of occcasional epigastric dyspepsia.”
SOURCE: Jowsey J, et al. (1972). Effect of combined therapy with sodium fluoride, vitamin D and calcium in osteoporosis. The American Journal of Medicine 53: 43-49.

“Sodium fluoride in the dose used (dose = 23-68 mg/day F) often causes anorexia or epigastric pain.”
SOURCE: Rich C. (1966). Osteoporosis and fluoride therapy. Journal of the American Medical Association 196: 149.