Alendronate / cholecalciferol Side Effects

Some side effects of alendronate / cholecalciferol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to alendronate / cholecalciferol: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking alendronate / cholecalciferol: 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 of alendronate / cholecalciferol 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.

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.

Musculoskeletal

Musculoskeletal side effects have included muscle cramp and bone, muscle and/or joint pain which was 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.

Nervous system

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

Dermatologic

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

Other

Other side effects have included uveitis, scleritis and episcleritis.

Hypersensitivity

Hypersensitivity side effects have included urticaria, and rarely angioedema.

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.

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