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AZOR® has been shown to help lower blood pressure for a full 24 hours.

INDICATION

AZOR is a prescription drug used to lower high blood pressure (hypertension). Medicines that lower blood pressure lower the chance of having a stroke or heart attack. AZOR is not for use as the first medicine to treat high blood pressure for people who are 75 years of age and older or have liver problems.

Patients may require more than one type of blood pressure lowering medication. Along with lowering blood pressure, a complete treatment plan to lower the chance of a stroke or heart attack may include exercise, a diet low in sodium, stopping smoking, controlling cholesterol, treatment or prevention of blood clots, and controlling blood sugar.

Important Safety Information for AZOR®

WARNING: DO NOT TAKE AZOR DURING PREGNANCY

  • AZOR can cause harm or death to an unborn baby
  • Talk with your doctor about other ways to lower your blood pressure if you become pregnant
  • If you get pregnant while taking AZOR, tell your doctor immediately

Please see the WARNINGS AND PRECAUTIONS section of the Full Product Information about Fetal Toxicity.

Do not take AZOR if you:

  • Take medicine that contains aliskiren and you have diabetes or kidney problems

Before taking AZOR, tell your doctor if you are pregnant or plan to become pregnant. Also tell your doctor if you are breast-feeding or plan to breast-feed. You and your doctor should decide if you will take AZOR or breast-feed. You should not do both.

Let your doctor know about any health conditions you may have
Tell your doctor if you are allergic to any of the ingredients in AZOR. Also let your doctor know if you have any of the health conditions listed below:

Before you take AZOR: Let your doctor know if you have these, or any other, medical conditions:
  • Kidney or liver problems
  • Heart problems (including coronary heart disease and narrowing of the aortic valve)
  • A lot of diarrhea or are vomiting

Tell your doctor about all the medicines you take
Some of your other medicines and AZOR could affect each other. This may cause serious side effects.

These medicines may include prescription and nonprescription medicines, vitamins, and herbal supplements:

If you take AZOR, tell your doctor if you also take:


  • Water pills (diuretics)
  • Other medicines for high blood pressure or a heart problem
  • Potassium supplements or a salt substitute that contains potassium
  • Pain or arthritis medicines, such as aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Welchol® (colesevelam hydrochloride)
  • Simvastatin, a cholesterol-lowering medicine

Know about possible side effects of AZOR
Serious side effects may include injury or death to an unborn baby; low blood pressure (hypotension), which may cause you to feel faint or dizzy; and kidney problems, which may get worse in people with kidney disease. If you have kidney problems, you may need blood tests, and your doctor may need to lower your dose. Tell your doctor if you get swelling in your feet, ankles, or hands, or have unexplained weight gain. These may be signs of kidney problems. If you have heart failure, your doctor should also check your kidney function before prescribing these medicines. Tell your doctor if you are experiencing these symptoms.

Serious side effects may also include severe, chronic diarrhea with considerable weight loss, which may develop months to years after starting AZOR. Tell your doctor if you are experiencing these symptoms.

Additional side effects for AZOR
Because of amlodipine, an ingredient in AZOR, other serious side effects may include worsening chest pain or heart attack. Get medical help right away if you have chest pain that gets worse or does not go away.

The most common side effect of AZOR was swelling from fluid buildup in the body. Other less common side effects were blood pressure that is too low; blood pressure that becomes too low after standing up too quickly; rash; itching; pounding or racing heartbeat; more frequent urination; and excessive urination at night. Other side effects may include headache, dizziness, and redness of the face and neck (flushing).

Do not take AZOR as your first medicine for the treatment of your high blood pressure if you have liver problems or if you are 75 years of age and older.

Tell your doctor if you have any side effect that bothers you or does not go away. Not all the possible side effects of AZOR have been mentioned in the Important Safety Information. For more information, talk with your doctor or pharmacist. Call your doctor for medical advice about side effects.

To report side effects, contact Daiichi Sankyo, Inc., at 1-877-437-7763 or the FDA at 1-800-332-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information for AZOR, including Boxed WARNING regarding Fetal Toxicity.

The photos depict models, not actual patients or healthcare professionals.