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Fosamax Plus D Side Effects

Generic name: alendronate / cholecalciferol

Medically reviewed by Drugs.com. Last updated on Dec 26, 2023.

Note: This document contains side effect information about alendronate / cholecalciferol. Some dosage forms listed on this page may not apply to the brand name Fosamax Plus D.

Applies to alendronate / cholecalciferol: oral tablet.

Serious side effects of Fosamax Plus D

Along with its needed effects, alendronate/cholecalciferol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking alendronate / cholecalciferol:

Less common

Rare

Incidence not known

Other side effects of Fosamax Plus D

Some side effects of alendronate / cholecalciferol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Rare

Incidence not known

For Healthcare Professionals

Applies to alendronate / cholecalciferol: oral tablet.

General

The most commonly reported adverse reactions are upper gastrointestinal adverse reactions including abdominal pain, dyspepsia, esophageal ulcer, dysphagia, abdominal distension and acid regurgitation.[Ref]

Metabolic

Very common (10% or more): Decrease in serum calcium (18%), decrease in serum phosphate (10%)[Ref]

Musculoskeletal

Very common (10% or more): Bone, muscle, or join pain (sometimes severe)

Common (1% to 10%): Joint swelling

Rare (less than 0.1%): Osteonecrosis of the Jaw, atypical subtrochanteric and diaphyseal femoral fractures

Postmarketing reports: Transient symptoms of myalgia (at the beginning of treatment); low-energy femoral shaft and subtrochanteric fractures[Ref]

Dermatologic

Common (1% to 10%): Alopecia, pruritus

Uncommon (0.1% to 1%): Rash erythema

Rare (less than 0.1%): Rash with photosensitivity, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis

Postmarketing reports: Rash (occasionally with photosensitivity)[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal pain, nausea, dyspepsia, constipation, diarrhea, flatulence, acid regurgitation, esophageal ulcer, vomiting, dysphagia, abdominal distensions

Uncommon (0.1% to 1%): Gastritis, esophagitis, esophageal erosions, melena

Rare (less than 0.1%): Esophageal stricture, oropharyngeal ulceration, upper gastrointestinal perforation, ulcers, bleeding

Postmarketing reports: Gastric or duodenal ulcers (some severe and with complications)[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness

Uncommon (0.1% to 1%): Taste perversion (dysgeusia)[Ref]

Other

Common (1% to 10%): Vertigo, asthenia, peripheral edema

Uncommon (0.1% to 1%): Myalgia, malaise

Rare (less than 0.1%): Fever[Ref]

Ocular

Uncommon (0.1% to 1%): Eye inflammation, uveitis, scleritis, episcleritis[Ref]

Hypersensitivity

Rare (less than 0.1%): Hypersensitivity reactions including urticaria and angioedema

Frequency not reported: Rash, erythema[Ref]

Respiratory

Postmarketing reports: Acute asthma exacerbations[Ref]

References

1. Product Information. Fosamax Plus D (alendronate-cholecalciferol). Merck & Co., Inc. 2005.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

3. Cerner Multum, Inc. Australian Product Information.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.