Alendronate / cholecalciferol Side Effects

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.

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.

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
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 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
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

Gastrointestinal

Gastrointestinal side effects have included abdominal pain, nausea, dyspepsia, constipation, melena, diarrhea, flatulence, acid regurgitation, esophagitis, esophageal erosion, esophageal ulcer, vomiting, dysphagia, abdominal distension, gastritis, gastroesophageal ulcer, duodenal ulcer, and gastric ulcer. Rarely, esophageal stricture or perforation has been reported.[Ref]

Musculoskeletal

Musculoskeletal side effects have included muscle cramp and bone, muscle and/or joint pain which were occasionally severe and rarely incapacitating. Localized osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection, often with delayed healing, has been reported rarely. Joint swelling has been reported in postmarketing experience. Also, low-energy femoral shaft and subtrochanteric fractures have been reported in postmarketing experience.[Ref]

Nervous system

Nervous system side effects have included headache, dizziness, and taste perversion. Dizziness and vertigo have been reported in postmarketing experience.[Ref]

Dermatologic

Dermatologic side effects have included rash (occasionally with photosensitivity), pruritus, rare severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis. Postmarketing reports have included alopecia.[Ref]

Other

Other side effects have included uveitis, scleritis and episcleritis.[Ref]

Hypersensitivity

Hypersensitivity side effects have included urticaria, and rarely angioedema.[Ref]

General

General side effects have included transient symptoms of myalgia, malaise, and rarely fever. Asthenia and rare instances of peripheral edema have been reported in postmarketing experience.[Ref]

Respiratory

Postmarketing side effects have included exacerbations of asthma.

References

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

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