SIDE EFFECTS: Dizziness, lightheadedness, or headache may occur as your body adjusts to the medication. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

The hydrochlorothiazide in this product may cause a loss of too much body water (dehydration) and salt/minerals. Tell your doctor immediately if you have any of these unlikely but serious symptoms of dehydration or mineral loss: very dry mouth, extreme thirst, muscle cramps, weakness, fast/irregular heartbeat, nausea/vomiting, severe dizziness, confusion, fainting, seizures.

Tell your doctor immediately if any of these unlikely but serious side effects occur: joint pain, swelling hands/ankles/feet, decrease in vision, eye pain.

Tell your doctor immediately if any of these rare but very serious side effects occur: signs of infection (such as fever, chills, persistent sore throat), unusual change in the amount of urine (not including the normal increase in urine when you first start this drug), muscle pain/tenderness, yellowing eyes/skin, dark urine, severe stomach/abdominal pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Exforge HCT (amlodipine valsartan hydrochlorothiazide tablets) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to either amlodipine, valsartan, or hydrochlorothiazide; or to other angiotensin receptor blockers (such as losartan); or to ACE inhibitors (such as lisinopril); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: an inability to make urine (anuria), kidney disease (such as renal artery stenosis), liver disease, severe loss of body water and/or minerals (volume depletion, dehydration), bile duct blockage, heart valve disorder (such aortic/mitral stenosis), untreated mineral imbalance (such as high/low potassium, low magnesium, high calcium), lupus, gout, high levels of fats in the blood (cholesterol/triglycerides).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

If you have diabetes, this product may change your blood sugar levels. Check your blood glucose levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar such as increased thirst and urination. Your anti-diabetic medication or diet may need to be adjusted.

Before having surgery or a procedure, tell your doctor or dentist that you are taking this medication.

This product may increase or decrease the potassium levels in your blood. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Too much sweating, diarrhea, or vomiting may cause you to feel lightheaded. Report prolonged diarrhea or vomiting to your doctor.

Older adults may be more sensitive to the effects of this product, especially dizziness, kidney effects.

This medication is not recommended for use during pregnancy due to the risk for harm to an unborn baby. Consult your doctor for more details. (See also Warning section.)

It is unknown if amlodipine or valsartan pass into breast milk. Hydrochlorothiazide passes into breast milk. Discuss the risks and benefits with your doctor before breast-feeding.