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 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%).
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.