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Alendronate / cholecalciferol Side Effects

In Summary

Commonly reported side effects of alendronate/cholecalciferol include: hypocalcemia and hypophosphatemia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to alendronate / cholecalciferol: oral tablet

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

  • Chest pain, discomfort, or burning
  • difficulty with swallowing
  • heartburn
  • muscle or bone pain
  • pain with swallowing
  • vomiting blood

Rare

  • Abdominal or stomach cramps
  • blistering, peeling, or loosening of the skin
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • chills
  • confusion
  • convulsions
  • cough
  • diarrhea
  • difficulty with breathing
  • fever
  • irregular heartbeats
  • itching
  • joint pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • mood or mental changes
  • muscle cramps in the hands, arms, feet, legs, or face
  • numbness and tingling around the mouth, fingertips, or feet
  • rapid weight gain
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • shortness of breath
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • swelling of the neck
  • tremor
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • vomiting

Incidence Not Known

  • Burning upper abdominal or stomach pain
  • difficulty with moving
  • heavy jaw feeling
  • loosening of a tooth
  • loss of appetite
  • muscle aching or cramping
  • muscle pains or stiffness
  • pain or burning in the throat
  • pain, swelling, or numbness in the mouth or jaw
  • severe bone, joint, or muscle pain
  • stomach bloating, burning, cramping, or pain
  • swollen joints
  • weight loss

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

  • Acid or sour stomach
  • belching
  • constipation
  • excess air or gas in the stomach or intestines
  • full feeling
  • headache
  • indigestion
  • passing gas
  • pressure in the stomach
  • stomach discomfort, upset, or pain
  • swelling of the abdominal or stomach area

Rare

  • Blurred vision or other change in vision
  • decreased vision
  • eye pain
  • eye redness
  • eye tenderness
  • flushing or redness of the skin
  • increased tearing
  • rash
  • redness of the eye
  • sensitivity of the eye to light
  • severe eye pain
  • tearing
  • unusually warm skin

Incidence Not Known

  • Dizziness or lightheadedness
  • feeling of constant movement of self or surroundings
  • general feeling of discomfort or illness
  • hair loss
  • hives or welts
  • lack or loss of strength
  • sensation of spinning
  • thinning of the hair

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. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Fosamax Plus D (alendronate-cholecalciferol)." Merck & Company Inc, West Point, PA.

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.

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