From the Guidelines
Fosamax (alendronate) should be taken with caution due to potential side effects, and patients should be aware of the risks of severe esophageal problems, osteonecrosis of the jaw, atypical femur fractures, and hypocalcemia, as reported in studies such as 1 and 1.
Administration Guidelines
- Fosamax (alendronate) should be taken first thing in the morning with a full glass of plain water (6-8 oz) at least 30 minutes before consuming any food, beverages, or other medications.
- Patients must remain upright (sitting or standing) for at least 30 minutes after taking the medication to prevent esophageal irritation.
Common Side Effects
- Stomach pain
- Nausea
- Heartburn
- Muscle or joint pain
- Headache
Serious Side Effects
- Severe esophageal problems
- Osteonecrosis of the jaw
- Atypical femur fractures
- Hypocalcemia
Dosing and Contraindications
- Dosing typically ranges from 5-10 mg daily or 35-70 mg once weekly depending on the condition being treated, as outlined in 1.
- Patients should ensure adequate calcium and vitamin D intake while on this medication.
- Those with severe kidney problems (creatinine clearance less than 35 mL/min), hypocalcemia, or esophageal abnormalities should not take Fosamax, as noted in 1 and 1.
Mechanism of Action and Precautions
- The medication works by inhibiting bone breakdown (resorption) by osteoclasts, helping to maintain bone density and reduce fracture risk.
- Dental work should ideally be completed before starting therapy to reduce jaw osteonecrosis risk, and patients should report any thigh or groin pain which could indicate an atypical femur fracture, as recommended in 1 and 1.
From the FDA Drug Label
Alendronate sodium tablets, USP can cause serious side effects including: Esophagus problems Low calcium levels in your blood (hypocalcemia) Bone, joint, or muscle pain Severe jaw bone problems (osteonecrosis) Unusual thigh bone fractures The most common side effects of alendronate sodium tablets, USP are: Stomach area (abdominal) pain Heartburn Constipation Diarrhea Upset stomach Pain in your bones, joints, or muscles Nausea
The side effects of Fosamax (alendronate) include:
- Esophagus problems
- Low calcium levels in the blood
- Bone, joint, or muscle pain
- Severe jaw bone problems (osteonecrosis)
- Unusual thigh bone fractures
- Stomach area pain
- Heartburn
- Constipation
- Diarrhea
- Upset stomach
- Pain in bones, joints, or muscles
- Nausea The administration guidelines for Fosamax (alendronate) are:
- Take on an empty stomach
- Take after getting up for the day and before taking the first food, drink, or other medicine
- Take while sitting or standing
- Swallow with a full glass of plain water only
- Wait at least 30 minutes before lying down or taking other medicines 2 2
From the Research
Side Effects of Fosamax (Alendronate)
- Esophagitis: Alendronate can cause chemical esophagitis, including severe ulcerations, in some patients 3.
- Gastric ulcers: Alendronate has been associated with gastric ulceration, suggesting that its use may be associated with ulcer complications such as acute upper gastrointestinal bleeding 4.
- Esophageal injury: Alendronate can damage the esophagus both by toxicity from the medication itself and by nonspecific irritation secondary to contact between the pill and the esophageal mucosa 5.
- Severe esophagitis: Alendronate-induced severe esophagitis is a rare and severe reversible side-effect, characterized by oesophageal ulceration with discoloured exudate, a narrowed lumen, and denuded, haemorrhagic mucosa 6.
Administration Guidelines
- To reduce the risk of esophagitis, patients should swallow alendronate with 180 to 240 ml (6 to 8 oz) of water on arising in the morning 3.
- Patients should remain upright for at least 30 minutes after swallowing the tablet and until the first food of the day has been ingested 3.
- The drug should be discontinued promptly if esophageal symptoms develop 3.
- Patients with a history of swallowing problems should be treated with caution 6.
Upper Gastrointestinal Toxicity
- Some studies suggest that alendronate may be associated with significant predictable esophageal and gastric mucosal toxicity, similar to that of aspirin and nonsteroidal anti-inflammatory drugs 4, 7.
- However, other studies have found that alendronate does not cause predictable esophageal, gastric, or duodenal mucosal damage when used as directed 7.