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Fosamax Plus D

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Overall, most people with osteoporosis, a loss of bone density over time"...

Fosamax Plus D

Fosamax Plus D Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Fosamax Plus D (alendronate sodium & cholecalciferol) is used to treat and prevent osteoporosis. Alendronate is a bisphosphonate, and cholecalciferol is a form of vitamin D. Common side effects include stomach pain, constipation, diarrhea, gas, or nausea.

The recommended dosage of Fosamax Plus D is one 70 mg alendronate/2800 IU vitamin D3 or one 70 mg alendronate/5600 IU vitamin D3 tablet once weekly. Fosamax Plus D may interact with antacids, supplements, or medicines that contain aluminum, calcium, magnesium, or other minerals. It may also interact with aspirin or other NSAIDs (nonsteroidal anti-inflammatory drugs). Other drugs can interact with Fosamax Plus D. Tell your doctor all prescription and over-the-counter medications and supplements you use. Caution is advised if you are pregnant or planning to become pregnant in the future. Alendronate may stay in your body for many years. Its effects on a fetus are unknown. Consult your doctor before starting treatment with this medication. Cholecalciferol (vitamin D3) in this medication passes into breast milk. It is unknown if alendronate passes into breast milk. Consult your doctor before breastfeeding.

Our Fosamax Plus D (alendronate sodium & cholecalciferol) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Fosamax Plus D in Detail - Patient Information: Side Effects

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

Stop using alendronate and cholecalciferol and call your doctor at once if you have a serious side effect such as:

  • chest pain;
  • difficulty or pain when swallowing;
  • pain or burning under the ribs or in the back;
  • new or worsening heartburn;
  • severe joint, bone, or muscle pain;
  • new or unusual pain in your thigh or hip; or
  • jaw pain, numbness, or swelling.

Less serious side effects may include:

  • mild heartburn, stomach upset;
  • diarrhea, gas, constipation;
  • mild joint or back pain; or
  • headache.

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 Plus D (Alendronate Sodium and Cholecalciferol) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Fosamax Plus D Overview - Patient Information: Side Effects

SIDE EFFECTS: Stomach pain, constipation, diarrhea, gas, or nausea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: jaw pain, swelling of joints/hands/ankles/feet, increased or severe bone/joint/muscle pain, new or unusual hip/thigh/groin pain, black/tarry stools, vomit that looks like coffee grounds.

This medication may infrequently cause serious irritation and ulcers of the esophagus. If you notice any of the following unlikely but very serious side effects, stop taking alendronate and talk to your doctor or pharmacist right away: new or worsening heartburn, chest pain, pain or difficulty when swallowing.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Fosamax Plus D (Alendronate Sodium and Cholecalciferol)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Fosamax Plus D FDA Prescribing Information: Side Effects
(Adverse Reactions)

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.

FOSAMAX

Treatment of Osteoporosis in Postmenopausal Women

FOSAMAX Daily

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
FOSAMAX*%
(n=196)
Placebo%
(n=397)
FOSAMAX† %
(n=3236)
Placebo %
(n=3223)
Gastrointestinal
  abdominal pain 6.6 4.8 1.5 1.5
  nausea 3.6 4.0 1.1 1.5
  dyspepsia 3.6 3.5 1.1 1.2
  constipation 3.1 1.8 0.0 0.2
  diarrhea 3.1 1.8 0.6 0.3
  flatulence 2.6 0.5 0.2 0.3
  acid regurgitation 2.0 4.3 1.1 0.9
  esophageal ulcer 1.5 0.0 0.1 0.1
  vomiting 1.0 1.5 0.2 0.3
  dysphagia 1.0 0.0 0.1 0.1
  abdominal distention 1.0 0.8 0.0 0.0
  gastritis 0.5 1.3 0.6 0.7
Musculoskeletal
  musculoskeletal (bone, muscle or joint) pain 4.1 2.5 0.4 0.3
  muscle cramp 0.0 1.0 0.2 0.1
Nervous
  System/Psychiatric 2.6 1.5 0.2 0.2
  headache 0.0 1.0 0.0 0.1
  dizziness        
Special Senses
  taste perversion 0.5 1.0 0.1 0.0
* 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.

FOSAMAX Once-Weekly

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 pain 3.7 3.0
  dyspepsia 2.7 2.2
  acid regurgitation 1.9 2.4
  nausea 1.9 2.4
  abdominal distention 1.0 1.4
  constipation 0.8 1.6
  flatulence 0.4 1.6
  gastritis 0.2 1.1
  gastric ulcer 0.0 1.1
Musculoskeletal
  musculoskeletal (bone,muscle, joint) pain 2.9 3.2
  muscle cramp 0.2 1.1

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 3.

Table 3: Osteoporosis Studies in Men Adverse Reactions Considered Possibly, Probably, or Definitely Drug Related by the Investigators and Reported in Greater Than or Equal to2% of Patients

  Two-year Study One-year Study
FOSAMAX 10 mg/day %
(n=146)
Placebo %
(n=95)
Once Weekly FOSAMAX 70 mg %
(n=109)
Placebo %
(n=58)
Gastrointestinal
  acid regurgitation 4.1 3.2 0.0 0.0
  flatulence 4.1 1.1 0.0 0.0
  gastroesophageal reflux disease 0.7 3.2 2.8 0.0
  dyspepsia 3.4 0.0 2.8 1.7
  diarrhea 1.4 1.1 2.8 0.0
  abdominal pain 2.1 1.1 0.9 3.4
  nausea 2.1 0.0 0.0 0.0

FOSAMAX PLUS D

In a fifteen-week double-blind, multinational study in osteoporotic postmenopausal women (n=682) and men (n=35), the safety profile of FOSAMAX PLUS D (70 mg/2800 international units) was similar to that of FOSAMAX once weekly 70 mg. In the 24-week double-blind extension study in women (n=619) and men (n=33), the safety profile of FOSAMAX PLUS D (70 mg/2800 international units) administered with an additional 2800 international units vitamin D3 was similar to that of FOSAMAX PLUS D (70 mg/2800 international units).

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of FOSAMAX and FOSAMAX PLUS D. 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 rarely, fever have been reported with alendronate, 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 and 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.

Read the entire FDA prescribing information for Fosamax Plus D (Alendronate Sodium and Cholecalciferol) »

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Fosamax Plus D - User Reviews

Fosamax Plus D User Reviews

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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.


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