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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

In addition to its needed effects, some unwanted effects may be caused by alendronate / cholecalciferol. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking alendronate / cholecalciferol:

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

Minor Side Effects

Some of the side effects that can occur with alendronate / cholecalciferol may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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
  • 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


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


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


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]


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]


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]


Common (1% to 10%): Vertigo, asthenia, peripheral edema
Uncommon (0.1% to 1%): Myalgia, malaise
Rare (less than 0.1%): Fever[Ref]


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


Rare (less than 0.1%): Hypersensitivity reactions including urticaria and angioedema
Frequency not reported: Rash, erythema[Ref]


Postmarketing reports: Acute asthma exacerbations[Ref]


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

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

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

Not all side effects for alendronate / cholecalciferol may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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