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Fosamax

Last reviewed on RxList: 1/11/2021
Fosamax Side Effects Center

What Is Fosamax?

Fosamax (alendronate sodium) is a bisphosphonate that is a specific inhibitor of osteoclast-mediated bone resorption used to both treat and prevent osteoporosis, and to treat Paget's disease. Fosamax is available in generic form.

What Are Side Effects of Fosamax?

Common side effects of Fosamax include

Serious side effects of Fosamax include

  • severe pain (joints, bone, muscle, jaw, back or heartburn),
  • chest pain, difficulty swallowing,
  • bloody stools,
  • eye pain,
  • skin blisters, and
  • swelling of the face, tongue, or throat.

Dosage for Fosamax

Fosamax is available in a tablet or oral liquid form. Each bottle of the oral solution contains 91.35 mg of alendronate monosodium salt trihydrate, which is the molar equivalent to 70 mg of the drug. The recommended initial dosage is one 70 mg molar equivalent tablet or oral liquid bottle once weekly or one 10 mg molar equivalent tablet per day. Fosamax must be taken at least one-half hour before the first food, beverage, or medication of the day with plain water only to avoid any reduction in gastrointestinal adsorption.

What Drugs, Substances, or Supplements Interact with Fosamax?

Fosamax may interact with aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs). Tell your doctor all medications and supplements you use.

Fosamax During Pregnancy and Breastfeeding

There are no studies in pregnant or nursing women. Fosamax is not indicated for use in the pediatric population.

Additional Information

Our Fosamax Drug Center provides a comprehensive view of available drug information as well as related drugs, user reviews, supplements, and diseases, and conditions.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Fosamax Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; wheezing, difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using alendronate and call your doctor at once if you have:

  • chest pain, new or worsening heartburn;
  • difficulty or pain when swallowing;
  • pain or burning under the ribs or in the back;
  • severe heartburn, burning pain in your upper stomach, or coughing up blood;
  • new or unusual pain in your thigh or hip;
  • jaw pain, numbness, or swelling;
  • severe joint, bone, or muscle pain; or
  • low calcium levels--muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).

Common side effects may include:

  • heartburn, upset stomach;
  • stomach pain, nausea;
  • diarrhea, constipation; or
  • bone pain, muscle or joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Fosamax (Alendronate Sodium)

QUESTION

What is another medical term for osteoporosis? See Answer
Fosamax Professional Information

SIDE EFFECTS

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

Daily Dosing

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 preexisting 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 State s /Multinatio nal StudiesFracture Intervention Trial
FOSAMAX* %
(n=196)
Placebo %
(n=397)
FOSAMAX+ %
(n=3236)
Placebo %
(n=3223)
Gastrointestinal
  abdominal pain6.64.81.51.5
  nausea3.64.01.11.5
  dyspepsia3.63.51.11.2
  constipation3.11.80.00.2
  diarrhea3.11.80.60.3
  flatulence2.60.50.20.3
  acid regurgitation2.04.31.10.9
  esophageal ulcer1.50.00.10.1
  vomiting1.01.50.20.3
  dysphagia1.00.00.10.1
  abdominal distention1.00.80.00.0
gastritis0.51.30.60.7
Musculoskeletal
  musculoskeletal (bone, muscle or joint) pain4.12.50.40.3
  muscle cramp0.01.00.20.1
Nervous
System/Psychiatric
  headache2.61.50.20.2
  dizziness0.01.00.00.1
Special Senses
  taste perversion0.51.00.10.0
*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. [See WARNINGS AND PRECAUTIONS]

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.

Weekly Dosing

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 Women Adverse Reactions Considered Possibly, Probably, or Definitely Drug Related by the Investigators and Reported in Greater Than or Equal to 1% of Patients

Once Weekly FOSAMAX 70 mg %
(n=519)
FOSAMAX 10 mg/day %
(n=370)
Gastrointestinal
  abdominal pain3.73.0
  dyspepsia2.72.2
  acid regurgitation1.92.4
  nausea1.92.4
  abdominal distention1.01.4
  constipation0.81.6
  flatulence0.41.6
  gastritis0.21.1
  gastric ulcer0.01.1
Musculoskeletal
  musculoskeletal (bone, muscle, joint) pain2.93.2
  muscle cramp0.21.1

Prevention Of Osteoporosis In Postmenopausal Women

Daily Dosing

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.

Weekly Dosing

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 StudiesOne-Year Study
FOSAMAX 5 mg/day %
(n=642)
Placebo %
(n=648)
FOSAMAX 5 mg/day %
(n=361)
Once Weekly FOSAMAX 35 mg %
(n=362)
Gastrointestinal
dyspepsia1.91.42.21.7
abdominal pain1.73.44.22.2
acid regurgitation1.42.54.24.7
nausea1.41.42.51.4
diarrhea1.11.71.10.6
constipation0.90.51.70.3
abdominal distention0.20.31.41.1
Musculoskeletal
musculoskeletal (bone, muscle or joint) pain0.80.91.92.2

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 StudyOne-year Study
FOSAMAX 10 mg /day %
(n=146)
Placebo %
(n=95)
Once Weekly FOSAMAX 70 mg %
(n=109)
Placebo %
(n=58)
Gastrointestinal
  acid regurgitation4.13.20.00.0
  flatulence4.11.10.00.0
  gastroesophageal0.73.22.80.0
  reflux disease
  dyspepsia3.40.02.81.7
  diarrhea1.41.12.80.0
  abdominal pain2.11.10.93.4
  nausea2.10.00.00.0

Glucocorticoid-Induced Osteoporosis

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

FOSAMAX 10 mg /day%
(n=157)
FOSAMAX 5 mg/day %
(n=161)
Placebo%
(n=159)
Gastrointestinal
  abdominal pain3.21.90.0
  acid regurgitation2.51.91.3
  constipation1.30.60.0
  melena1.30.00.0
  nausea0.61.20.6
  diarrhea0.00.01.3

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.

Post-Marketing Experience

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 [see DOSAGE AND ADMINISTRATION; WARNINGS AND PRECAUTIONS].

Localized osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection with delayed healing, has been reported [see WARNINGS AND PRECAUTIONS].

Musculoskeletal: bone, joint, and/or muscle pain, occasionally severe, and incapacitating [see WARNINGS AND PRECAUTIONS]; joint swelling; low-energy femoral shaft and subtrochanteric fractures [see WARNINGS AND PRECAUTIONS].

Nervous System: dizziness and vertigo.

Pulmonary: acute asthma exacerbations.

Skin: rash (occasionally with photosensitivity), pruritus, alopecia, severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Special Senses: uveitis, scleritis or episcleritis. Cholesteatoma of the external auditory canal (focal osteonecrosis).

Read the entire FDA prescribing information for Fosamax (Alendronate Sodium)

Related Resources for Fosamax

Related Health

Read the Fosamax User Reviews »

© Fosamax Patient Information is supplied by Cerner Multum, Inc. and Fosamax Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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