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Serious side effects may occur with DIOVAN
and DIOVAN HCT, such as:

• Harm to an unborn baby causing injury and even death

• Low blood pressure (hypotension), especially if you take water pills, are on a low-salt diet, get dialysis treatments, have heart problems, get sick with vomiting or diarrhea, or drink alcohol. Lie down if you feel faint or dizzy and call your doctor right away

• Kidney problems. Call your doctor if you have swelling in your feet, ankles, or hands or have unexplained weight gain

Serious side effects may occur with DIOVAN HCT. Call your doctor for any of the following:

• Allergic reactions

• Worsening of lupus

• Fluid and electrolyte (salt) problems, such as dry mouth, thirst, weakness, lack of energy, drowsiness, restlessness, confusion, seizures, muscle pain or cramps, muscle fatigue, low blood pressure, very low urine output, fast heartbeat, or nausea or vomiting

• Kidney problems, such as swelling in your feet, ankles, hands, or unexplained weight gain

• Skin rash. Call your doctor right away if you get an unusual rash

• Eye problems. Call your doctor right away if you have eye pain or decrease in vision

Protect your skin from the sun and undergo regular skin cancer screening, as one of the medicines in DIOVAN HCT may cause non-melanoma skin cancer.

Tell your doctor about all your medical conditions including if:

• you are pregnant or plan to become pregnant

• you are breastfeeding. Do not breastfeed while you are taking DIOVAN or DIOVAN HCT

• you have allergies, have liver or kidney problems, have or have had gallstones, have lupus, low potassium, high calcium, high uric acid

• you have ever had a reaction called angioedema to another blood pressure medicine. Angioedema causes swelling of the face, lips, tongue and/or throat, and may cause difficulty breathing

• People with and without allergy problems or asthma who take DIOVAN HCT may get allergic reactions

Tell your doctor about all the medicines you take. If you are taking DIOVAN or DIOVAN HCT, especially tell your doctor if you take other medicines for high blood pressure or a heart problem; water pills (diuretics); potassium supplements or a salt substitute containing potassium; or aspirin or other medicines called non-steroidal anti-inflammatory drugs (NSAIDs, like ibuprofen or naproxen); diabetes medicine, including insulin; narcotic pain medicines; sleeping pills; lithium; digoxin or other digitalis glycosides (a heart medicine); muscle relaxants (medicines used during operations); certain cancer medicines, like cyclophosphamide or methotrexate; or certain antibiotics (rifamycin group); a drug used to protect against transplant rejection (cyclosporine); or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may increase the effect of valsartan.

The most common side effects seen with DIOVAN in people with high blood pressure are headache, dizziness, flu symptoms, tiredness, and stomach (abdominal) pain.

The most common side effect with DIOVAN HCT is cold-like symptoms.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-10881-800-FDA-1088.

Please see full Prescribing Information and Patient Information, including IMPORTANT WARNING, for DIOVAN

Please see full Prescribing Information and Patient Information, including IMPORTANT WARNING, for DIOVAN HCT