Carlson D

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).

You should not use cholecalciferol if you have ever had an allergic reaction to vitamin D, or if you have:

• high levels of calcium in your blood (hypercalcemia);

• high levels of vitamin D in your body (hypervitaminosis D); or

• any condition that makes it hard for your body to absorb nutrients from food (malabsorption).

To make sure cholecalciferol is safe for you, tell your doctor if you have:

• heart disease;

• kidney disease; or

• an electrolyte imbalance.

Your cholecalciferol dose needs may change if you are pregnant or breast-feeding. Tell your doctor if you are pregnant or plan to become pregnant during treatment, or if you are breast-feeding a baby.

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.

Ask a doctor or pharmacist if it is safe for you to use cholecalciferol if you are also using any of the following drugs:

• seizure medication;

• cholestyramine, colestipol;

• steroids;

• digoxin; or

• a diuretic or "water pill."

This list is not complete. Other drugs may interact with cholecalciferol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Applies to cholecalciferol: oral capsule, oral capsule liquid filled, oral solution, oral tablet, oral tablet chewable, oral wafer

Along with its needed effects, cholecalciferol (the active ingredient contained in Carlson D) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking cholecalciferol:

• Cough
• difficulty swallowing
• dizziness
• fast heartbeat
• hives or itching
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• skin rash
• tightness in the chest
• unusual tiredness or weakness

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