Alendronic acid 10mg tablets

In clinical studies, ≥3% of patients experience abdominal pain, acid regurgitation, constipation, diarrhea, dyspepsia, musculoskeletal pain, and nausea[FDA Label].

No information for treatment of overdose is available, however patients should be given milk or antacids to bind alendronic acid and vomiting should not be induced[FDA Label]. Patients may experience hypocalcemia, hypophosphatemia, and upper gastrointestinal events.[FDA Label].

There are currently no studies for safety and efficacy in pregnancy, though studies in pregnant rats show fetal and maternal complications at 4 times the clinical dose and pregnant rabbits do not show complications at as high as 10 times the clincal dose[FDA Label].

Excretion in breast milk, and therefore safety in lactation, is unknown[FDA Label].

Alendronic acid has been studied for use in pediatric patients[FDA Label]. The oral bioavailability is similar to that in adult patients, but an increase in the portion of patients experiencing vomiting[FDA Label].

There is no significant difference in efficacy or safety of alendronic acid in geriatric populations, though there is potential for even greater sensitivity in patients at a further advanced age than those in the study[FDA Label].

Alendronic acid is not recommended for patients with creatinine clearance <35mL/min, but no dosage adjustment is necessary in hepatic impairment[FDA Label].