Alendronate/Cholecalciferol Side Effects

Please note - some side effects for 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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Alendronate/Cholecalciferol - for the Consumer

Alendronate/Cholecalciferol

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Alendronate/Cholecalciferol:

Bone, muscle, or joint pain; constipation; diarrhea; dizziness; feeling bloated or full; flu-like symptoms at the start of treatment; gas; headache; mild stomach pain; nausea; taste changes; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; chest pain; coughing or vomiting blood; difficult or painful swallowing; mouth sores; new, worsening, or severe heartburn; red, swollen, blistered, or peeling skin; severe bone, muscle, or joint pain; severe or persistent sore throat or stomach pain; swelling of the hands, legs, or joints; swelling or pain in the jaw.

Side Effects by Body System

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.

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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