Calcium carbonate / risedronate Side Effects
Applies to calcium carbonate / risedronate: oral kit
During phase 3 clinical studies of risedronate, patients with a history of upper gastrointestinal (GI) disease or abnormalities were not excluded. Severe upper GI side effects were not noted. Patients using NSAIDs or aspirin were also included in phase 3 clinical studies. GI side effects in patient using concomitant NSAIDs or aspirin were higher than in non users.
Rebound hyperacidity has been associated with calcium salt antacids. This side effect does not appear to be due to the acid buffering capacity of calcium carbonate, but is a consequence of a specific action of calcium on the parietal cell. Rare cases of calcium carbonate gallstones have been reported in the pediatric literature.[Ref]
There were no deaths in a 1 year, double-blind, placebo-controlled study of risedronate 35 mg once a week for prevention of bone loss in 278 postmenopausal women without osteoporosis. More treated subjects on risedronate experienced arthralgia (risedronate 13.9%; placebo 7.8%), myalgia (risedronate 5.1%; placebo 2.1%), and nausea (risedronate 7.3%; placebo 4.3%) than subjects on placebo.[Ref]
Oncologic side effects of risedronate have included neoplasms which have occurred in 3% of patients receiving risedronate therapy.[Ref]
Prolonged ingestion of large amounts of calcium carbonate and other sources of exogenous calcium can rarely result in the "milk alkali syndrome" and calcinosis. The milk alkali syndrome is characterized by the triad of hypercalcemia, metabolic alkalosis, and renal insufficiency.[Ref]
Metabolic side effects of calcium carbonate have rarely included hypercalcemia and hypophosphatemia. Other metabolic side effects have rarely included "mild alkali syndrome", calcinosis, and irreversible renal damage.[Ref]
Hematologic side effects of risedronate have included ecchymosis and anemia.[Ref]
Renal side effects of calcium carbonate have included renal failure, formation of renal calcium, and a single case report of a calcium carbonate and calcium phosphate-filled renal cyst.[Ref]
1. "Multum Information Services, Inc. Expert Review Panel"
Some side effects may not be reported. You may report them to the FDA.