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How EDARBI may affect you

EDARBI® (azilsartan medoxomil) was well tolerated in clinical studies. In fact, 4814 patients took EDARBI in clinical studies designed to see what the side effects of the medicine might be. Most found that EDARBI side effects were similar to placebo ("sugar pill"). Side effects were generally mild, with the most common side effect being diarrhea (2.0% of patients).

If you are taking EDARBI and experience side effects that concern you, call your doctor for medical advice. You are also encouraged to report negative side effects of prescription medicines to the FDA at www.fda.gov/medwatch or by calling 1-800-FDA-1088.

Important Safety Information

WARNING: EDARBI and EDARBYCLOR can cause harm or death to your unborn baby. If you become pregnant while taking EDARBI or EDARBYCLOR, tell your doctor right away. If you plan to become pregnant, talk to your doctor about other treatments to lower blood pressure.

  • Before taking EDARBI or EDARBYCLOR, tell your doctor if you are breastfeeding or plan to breastfeed. Discuss with your doctor other ways to lower your blood pressure. It is not known if EDARBYCLOR passes into breast milk. You and your doctor should decide if you will take EDARBI or EDARBYCLOR or breastfeed. You should not do both.
  • Do not take EDARBYCLOR if you make less urine because of kidney problems (anuria).
  • Do not take aliskiren-containing products with EDARBI or EDARBYCLOR if you have diabetes.
  • Tell your doctor about all your medical conditions, including if you have heart problems or stroke, have gout, or have liver or kidney problems. Kidney problems may become worse in people that already have kidney disease. If you have kidney problems, you may need blood tests, and your doctor may need to lower your dose or may need to stop treatment with EDARBYCLOR.
  • Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other medicines to treat your high blood pressure or heart problem; water pills (diuretics); lithium; or digoxin.
  • EDARBI and EDARBYCLOR may cause serious side-effects including low blood pressure (hypotension) which may cause you to feel faint and dizzy. Vomiting and diarrhea, a low salt diet, sweating a lot, or not drinking enough fluid can also lead to low blood pressure.
  • If you feel faint or dizzy, lie down and call your doctor right away. If you pass out (faint) have someone call your doctor or get medical help. Stop taking EDARBYCLOR.
  • If you have fluid and body salt (electrolytes) problems, tell your doctor if you experience any of the following symptoms: dry mouth, confusion, thirst, lack of energy/weakness, drowsiness, passing very little urine or passing large amounts of urine, seizures, muscle pain/cramps, restlessness, muscle tiredness (fatigue), fast or abnormal heartbeat, nausea and vomiting, or constipation.
  • People who have increased levels of uric acid in the blood may develop gout. If you already have gout tell your doctor about worsening of your gout symptoms.
  • In clinical studies, the most common side effect seen with EDARBI was diarrhea (2.0%).
  • In clinical studies, the side effects seen with EDARBYCLOR included dizziness (8.9%) and tiredness (2.0%).

Please talk to your healthcare professional and see complete Prescribing Information for EDARBI and EDARBYCLOR.

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

Indications

EDARBI and EDARBYCLOR are prescription medicines used to treat high blood pressure (hypertension). Your doctor may prescribe other medicines for you to take along with EDARBI or EDARBYCLOR to treat your high blood pressure. EDARBYCLOR is used when one medicine is not enough or as the first medicine if your doctor decides you are likely to need more than one medicine. Medicines that lower your blood pressure may lower your chances of having a stroke or heart attack, but they don't work alone. They should be part of a complete treatment plan.