Alendronate Risks, Warnings, and Complications

ESOPHAGUS AND STOMACH IRRITATION: Alendronate and other oral bisphosphonates can cause local irritation of the esophagus (food pipe) and other upper gastrointestinal adverse events. People with gastrointestinal conditions such as dysphagia (difficulty swallowing), gastroesophageal reflux disease (GERD), Barrett's esophagus, some other esophageal disease, gastritis (stomach inflammation), and gastric or duodenal ulcers should take this medication with caution. Severe esophageal adverse effects, including esophagitis (inflammation), ulcers, erosions, and bleeding, and rarely, strictures (narrowing) and perforation have been reported in patients receiving alendronate and other oral bisphosphonates. These complications can be severe enough to require hospitalization. 

Take alendronate with a full glass of plain water (6-8 oz). Stay upright (do not lie down) for at least 30 minutes after taking the medicine. Stop taking alendronate and tell your doctor immediately or seek emergency medical attention if you develop signs and symptoms of esophageal irritation, such as trouble swallowing, pain with swallowing, new or worsening heartburn, or a burning pain in the chest. 

CALCIUM AND VITAMIN D: Your healthcare provider will check calcium and vitamin D levels before starting alendronate treatment. It is presumed that as alendronate increases bone mineral density, it causes a small, asymptomatic decrease in blood calcium and phosphate levels. The risk is especially high in patients with Paget's disease of bone and patients receiving concomitant therapy with glucocorticoids. 

If you have hypocalcemia (low calcium) or a vitamin D deficiency, these will need to be corrected with vitamin D and calcium supplements before starting alendronate therapy. Your provider will order blood tests to keep an eye on calcium and vitamin D levels during treatment with alendronate. 

MUSCLE PAIN AND JOINT PAIN: There are reports of muscle pain, joint pain, and bone pain in some patients taking bisphosphonates such as Fosamax (alendronate) for the prevention and treatment of osteoporosis. The risk of this side effect is higher in postmenopausal women. The muscle, joint, and bone pain can occur one day to several months after starting alendronate therapy. Your healthcare provider may ask you to discontinue alendronate if your muscle pain symptoms are severe. In most patients, the muscle pain goes away after stopping the medicine. However, some patients have a recurrence of these symptoms when they are treated with other bisphosphonates.

OSTEONECROSIS OF THE JAW: Patients taking bisphosphonates, including alendronate, are at risk of developing a serious complication of the jaw bone called osteonecrosis of the jaw (ONJ). This can occur spontaneously but known risk factors include poor oral hygiene, invasive dental procedures such as tooth extraction, dental implants, or bone surgery, pre-existing gum disease or other dental disease, ill-fitting dentures, a cancer diagnosis, treatment with corticosteroids, chemotherapy, and certain cancer medications, and medical conditions such as anemia, bleeding disorders, and infections. The risk of osteonecrosis of the jaw increases with long-term bisphosphonate treatment.

Tell your dentist you are on alendronate before any dental treatment. Your dentist may ask you to temporarily discontinue alendronate before a treatment. Tell your doctor right away if you develop pain or swelling in the gums, loosening of your teeth, poor healing of the gums, especially after dental procedures, or a sensation of heaviness or numbness in your jaw. If you develop osteonecrosis of the jaw while on alendronate therapy, you will need care from an oral surgeon. 

LEG FRACTURES: In most people receiving alendronate, this medicine increases bone mineral density and lowers the risk of fractures. However, there are reports of atypical leg fractures that occurred with minimal or no trauma in people treated with alendronate. The risk of bone fracture during bisphosphonate treatment is higher in people also receiving steroid medications. We cannot be sure that alendronate is the cause of these leg fractures, as fractures do also occur in patients with osteoporosis who have not been treated with bisphosphonates.

Tell your doctor immediately if you develop a dull, aching pain in the thigh bone, groin, or hip. If you are found to have a fracture, your doctor will perform a risk/benefit assessment and may recommend interrupting or discontinuing alendronate treatment. 

RENAL IMPAIRMENT: Alendronate is not recommended for people who have renal impairment (reduced kidney function). Tell your doctor if you have a history of kidney disease. Call your doctor without delay if you develop any urinary symptoms during treatment.