Thera-D 2000

Cholecalciferol is a vitamin D3. Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.

Cholecalciferol is used to treat or prevent many conditions caused by a lack of vitamin D, especially conditions of the skin or bones.

Cholecalciferol may also be used for purposes not listed in this medication guide.

You should not use cholecalciferol if you have high levels of calcium or vitamin D in your blood, or if you have any condition that makes it hard for your body to absorb nutrients from food (malabsorption).

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of vitamin D can cause serious or life-threatening side effects.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking cholecalciferol and call your doctor at once if you have:

• thinking problems, changes in behavior, feeling irritable;

• urinating more than usual;

• chest pain, feeling short of breath; or

• early signs of vitamin D overdose (weakness, metallic taste in your mouth, weight loss, muscle or bone pain, constipation, nausea, and vomiting).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Applies to cholecalciferol: compounding crystal, oral capsule, oral liquid, oral solution, oral tablet, oral tablet chewable, oral tablet disintegrating, oral wafer

Metabolic

Metabolic side effects have included hypercalcemia.[Ref]

Renal

Uncommon (0.1% to 1%): Hypercalciuria[Ref]

Dermatologic

Rare (less than 0.1%): Pruritus, rash, urticaria[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions such as angioedema or laryngeal edema[Ref]

Gastrointestinal

Frequency not reported: Nausea, vomiting[Ref]

Some side effects of Thera-D 2000 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.