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What is Fosamax (alendronate)?
Common side effects of Fosamax include:
- stomach pain,
- black stool (due to intestinal bleeding),
- change in taste perception,
- and muscle or joint pain.
Serious side effects of Fosamax include femoral fractures.
Drug interactions of Fosamax include:
- calcium supplements and antacids,
- intravenous ranitidine,
- and aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).
What are the important side effects of Fosamax (alendronate)?
The most common side effect of alendronate is stomach pain.
Other important side effects are:
Fosamax (alendronate) side effects list for healthcare professionals
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Treatment Of Osteoporosis In Postmenopausal Women
- The safety of Fosamax in the treatment of postmenopausal osteoporosis was assessed in four clinical trials that enrolled 7453 women aged 44-84 years.
- Study 1 and Study 2 were identically designed, three-year, placebo-controlled, double-blind, multicenter studies (United States and Multinational n=994); Study 3 was the three-year vertebral fracture cohort of the Fracture Intervention Trial [FIT] (n=2027) and Study 4 was the four-year clinical fracture cohort of FIT (n=4432).
- Overall, 3620 patients were exposed to placebo and 3432 patients exposed to Fosamax.
- Patients with pre-existing gastrointestinal disease and concomitant use of non-steroidal anti-inflammatory drugs were included in these clinical trials. In Study 1 and Study 2 all women received 500 mg elemental calcium as carbonate.
- In Study 3 and Study 4 all women with dietary calcium intake less than 1000 mg per day received 500 mg calcium and 250 international units Vitamin D per day.
- Among patients treated with alendronate 10 mg or placebo in Study 1 and Study 2, and all patients in Study 3 and Study 4, the incidence of all-cause mortality was 1.8% in the placebo group and 1.8% in the Fosamax group.
- The incidence of serious adverse event was 30.7% in the placebo group and 30.9% in the Fosamax group.
- The percentage of patients who discontinued the study due to any clinical adverse event was 9.5% in the placebo group and 8.9% in the Fosamax group.
- Adverse reactions from these studies considered by the investigators as possibly, probably, or definitely drug related in greater than or equal to 1% of patients treated with either Fosamax or placebo are presented in Table 1.
Table 1: Osteoporosis Treatment Studies in Postmenopausal Women Adverse Reactions Considered Possibly, Probably, or Definitely Drug Related by the Investigators and Reported in Greater Than or Equal to 1% of Patients
|United States/ Multinational Studies||Fracture Intervention Trial|
|musculoskeletal (bone, muscle or joint) pain||4.1||2.5||0.4||0.3|
|* 10 mg/day for three years|
† 5 mg/day for 2 years and 10 mg/day for either 1 or 2 additional years
Rash and erythema have occurred.
Gastrointestinal Adverse Reactions
One patient treated with Fosamax (10 mg/day), who had a history of peptic ulcer disease and gastrectomy and who was taking concomitant aspirin, developed an anastomotic ulcer with mild hemorrhage, which was considered drug related. Aspirin and Fosamax were discontinued and the patient recovered.
In the Study 1 and Study 2 populations, 49-54% had a history of gastrointestinal disorders at baseline and 54-89% used nonsteroidal anti-inflammatory drugs or aspirin at some time during the studies.
Laboratory Test Findings
In double-blind, multicenter, controlled studies, asymptomatic, mild, and transient decreases in serum calcium and phosphate were observed in approximately 18% and 10%, respectively, of patients taking Fosamax versus approximately 12% and 3% of those taking placebo. However, the incidences of decreases in serum calcium to less than 8.0 mg/dL (2.0 mM) and serum phosphate to less than or equal to 2.0 mg/dL (0.65 mM) were similar in both treatment groups.
The safety of Fosamax 70 mg once weekly for the treatment of postmenopausal osteoporosis was assessed in a one-year, double-blind, multicenter study comparing Fosamax 70 mg once weekly and Fosamax 10 mg daily. The overall safety and tolerability profiles of once weekly Fosamax 70 mg and Fosamax 10 mg daily were similar. The adverse reactions considered by the investigators as possibly, probably, or definitely drug related in greater than or equal to 1% of patients in either treatment group are presented in Table 2.
Table 2: Osteoporosis Treatment Studies in Postmenopausal WomenAdverse Reactions Considered Possibly, Probably, or Definitely Drug Relatedby the Investigators and Reported in Greater Than or Equal to 1% of Patients
|Once Weekly Fosamax|
|musculoskeletal (bone, muscle, joint) pain||2.9||3.2|
Prevention Of Osteoporosis In Postmenopausal Women
The safety of Fosamax 5 mg/day in postmenopausal women 40-60 years of age has been evaluated in three double-blind, placebo-controlled studies involving over 1,400 patients randomized to receive Fosamax for either two or three years.
In these studies the overall safety profiles of Fosamax 5 mg/day and placebo were similar. Discontinuation of therapy due to any clinical adverse event occurred in 7.5% of 642 patients treated with Fosamax 5 mg/day and 5.7% of 648 patients treated with placebo.
The safety of Fosamax 35 mg once weekly compared to Fosamax 5 mg daily was evaluated in a one-year, double-blind, multicenter study of 723 patients. The overall safety and tolerability profiles of once weekly Fosamax 35 mg and Fosamax 5 mg daily were similar.
The adverse reactions from these studies considered by the investigators as possibly, probably, or definitely drug related in greater than or equal to 1% of patients treated with either once weekly Fosamax 35 mg, Fosamax 5 mg/day or placebo are presented in Table 3.
Table 3: Osteoporosis Prevention Studies in Postmenopausal Women Adverse Reactions Considered Possibly, Probably, or Definitely Drug Related by the Investigators and Reported in Greater Than or Equal to 1% of Patients
|Two/Three-Year Studies||One-Year Study|
|musculoskeletal (bone, muscle or joint) pain||0.8||0.9||1.9||2.2|
Concomitant Use With Estrogen/Hormone Replacement Therapy
In two studies (of one and two years’ duration) of postmenopausal osteoporotic women (total: n=853), the safety and tolerability profile of combined treatment with Fosamax 10 mg once daily and estrogen ± progestin (n=354) was consistent with those of the individual treatments.
Osteoporosis In Men
In two placebo-controlled, double-blind, multicenter studies in men (a two-year study of Fosamax 10 mg/day and a one-year study of once weekly Fosamax 70 mg) the rates of discontinuation of therapy due to any clinical adverse event were 2.7% for Fosamax 10 mg/day vs. 10.5% for placebo, and 6.4% for once weekly Fosamax 70 mg vs. 8.6% for placebo.
The adverse reactions considered by the investigators as possibly, probably, or definitely drug related in greater than or equal to 2% of patients treated with either Fosamax or placebo are presented in Table 4.
Table 4: Osteoporosis Studies in Men Adverse Reactions Considered Possibly, Probably, or Definitely Drug Related by the Investigators and Reported in Greater Than or Equal to 2% of Patients
|Two-year Study||One-year Study|
Fosamax 70 mg
|gastroesophageal reflux disease||0.7||3.2||2.8||0.0|
In two, one-year, placebo-controlled, double-blind, multicenter studies in patients receiving glucocorticoid treatment, the overall safety and tolerability profiles of Fosamax 5 and 10 mg/day were generally similar to that of placebo. The adverse reactions considered by the investigators as possibly, probably, or definitely drug related in greater than or equal to 1% of patients treated with either Fosamax 5 or 10 mg/day or placebo are presented in Table 5.
Table 5: One-Year Studies in Glucocorticoid-Treated Patients Adverse Reactions Considered Possibly, Probably, or Definitely Drug Related by the Investigators and Reported in Greater Than or Equal to 1% of Patients
The overall safety and tolerability profile in the glucocorticoid-induced osteoporosis population that continued therapy for the second year of the studies (Fosamax: n=147) was consistent with that observed in the first year.
Paget's Disease Of Bone
- In clinical studies (osteoporosis and Paget's disease), adverse events reported in 175 patients taking Fosamax 40 mg/day for 3-12 months were similar to those in postmenopausal women treated with Fosamax 10 mg/day.
- However, there was an apparent increased incidence of upper gastrointestinal adverse reactions in patients taking Fosamax 40 mg/day (17.7% Fosamax vs. 10.2% placebo). One case of esophagitis and two cases of gastritis resulted in discontinuation of treatment.
- Additionally, musculoskeletal (bone, muscle or joint) pain, which has been described in patients with Paget's disease treated with other bisphosphonates, was considered by the investigators as possibly, probably, or definitely drug related in approximately 6% of patients treated with Fosamax 40 mg/day versus approximately 1% of patients treated with placebo, but rarely resulted in discontinuation of therapy.
- Discontinuation of therapy due to any clinical adverse events occurred in 6.4% of patients with Paget's disease treated with Fosamax 40 mg/day and 2.4% of patients treated with placebo.
The following adverse reactions have been identified during post-approval use of Fosamax. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Body as a Whole: hypersensitivity reactions including urticaria and angioedema. Transient symptoms of myalgia, malaise, asthenia and fever have been reported with Fosamax, typically in association with initiation of treatment. Symptomatic hypocalcemia has occurred, generally in association with predisposing conditions. Peripheral edema.
Gastrointestinal: esophagitis, esophageal erosions, esophageal ulcers, esophageal stricture or perforation, and oropharyngeal ulceration. Gastric or duodenal ulcers, some severe and with complications, have also been reported.
Localized osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection with delayed healing, has been reported.
Pulmonary: acute asthma exacerbations.
What drugs interact with Fosamax (alendronate)?
Co-administration of Fosamax and calcium, antacids, or oral medications containing multivalent cations will interfere with absorption of Fosamax. Therefore, instruct patients to wait at least one-half hour after taking Fosamax before taking any other oral medications.
In clinical studies, the incidence of upper gastrointestinal adverse events was increased in patients receiving concomitant therapy with daily doses of Fosamax greater than 10 mg and aspirin-containing products.
Nonsteroidal Anti-Inflammatory Drugs
Fosamax may be administered to patients taking nonsteroidal anti-inflammatory drugs (NSAIDs). In a 3-year, controlled, clinical study (n=2027) during which a majority of patients received concomitant NSAIDs, the incidence of upper gastrointestinal adverse events was similar in patients taking Fosamax 5 or 10 mg/day compared to those taking placebo. However, since NSAID use is associated with gastrointestinal irritation, caution should be used during concomitant use with Fosamax.
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Related Disease Conditions
Multiple myeloma is a form of cancer that develops in plasma cells, the white blood cells that make antibodies. Symptoms include bone pain, weakness, extreme thirst, nausea, frequent urination, and broken bones. Treatment of multiple myeloma depends upon the staging and symptoms of the disease.
Learn about osteoporosis, a condition characterized by the loss of bone density, which leads to an increased risk of bone fracture. Unless one experiences a fracture, a person may have osteoporosis for decades without knowing it. Treatment for osteoporosis may involve medications that stop bone loss and increase bone strength and bone formation, as well as quitting smoking, regular exercise, cutting back on alcohol intake, and eating a calcium- and vitamin D-rich balanced diet.
Osteoarthritis vs. Osteoporosis Differences and Similarities
Arthritis is defined as painful inflammation and joint stiffness. Osteoarthritis is a type of arthritis and the most common cause of chronic joint pain, affecting over 25 million Americans. Osteoarthritis is a type of arthritis that involves the entire joint. Osteoporosis is not a type of arthritis. It is a disease that mainly is caused by a loss of bone tissue that is not limited to the joint areas. It is possible for one person to have both osteoarthritis and osteoporosis. The differences in the signs and symptoms of osteoarthritis and osteoporosis include; pain, stiffness, and joint swelling, joint deformity, crackle sounds when the joint is moving, and walking with a limp. Osteoporosis is called the "silent disease" because it can progress for years without signs and symptoms before it is diagnosed, severe back pain, bone fractures, height loss, and difficulty or inability to walk. The differences in the causes of osteoarthritis and osteoporosis are that osteoarthritis usually is caused by wear and tear on the joints. Osteoporosis usually is caused by one or more underlying problems, for example, calcium and vitamin D deficiencies. Treatment for osteoarthritis and osteoporosis are not the same. There is no cure for osteoarthritis or osteoporosis.
Paget's disease, also called Paget's disease of bone, is a chronic bone disorder due to irregular breakdown and formation of bone tissue. Paget's disease symptoms include bone pain, headaches and hearing loss, pressure on nerves, increased head size, hip pain, and damage to cartilage of joints.
Paget Disease of the Breast (Paget's Disease of the Nipple)
Paget's disease is a rare form of cancer that forms in or around the nipple and frequently coexists with breast cancer. The exact cause of Paget's disease is unknown. Symptoms and signs include redness, scaling, and flaking of the nipple skin. A biopsy and imaging studies are needed to diagnose the disease. Treatment may include surgery, radiation, and adjuvant therapy.
Treatment & Diagnosis
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.