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Edarbyclor Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Edarbyclor (azilsartan medoxomil and chlorthalidone) is a combination of azilsartan, an angiotensin II receptor blocker (ARB) and chlorthalidone, a diuretic, used to treat high blood pressure (hypertension). Common side effects include dizziness and fatigue.
The recommended starting dose of Edarbyclor is 40/12.5 mg taken orally once daily. Edarbyclor may interact with nonsteroidal anti-inflammatory drugs (NSAIDs), other angiotensin receptor blockers, ACE inhibitors, aliskiren, or lithium. Tell your doctor all medications and supplements you use. Edarbyclor is not recommended for use during pregnancy. It may harm a fetus. It is unknown if azilsartan passes into breast milk, but because of the potential for adverse effects on the nursing infant, consult your doctor before breastfeeding.
Our Edarbyclor (azilsartan medoxomil and chlorthalidone) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Edarbyclor FDA Prescribing Information: Side Effects
The following potential adverse reactions with Edarbyclor, azilsartan medoxomil, or chlorthalidone and similar agents are included in more detail in the WARNINGS AND PRECAUTIONS section of the label:
- Fetal toxicity [see WARNINGS AND PRECAUTIONS]
- Hypotension in Volume-or Salt-Depleted Patients [see WARNINGS AND PRECAUTIONS]
- Impaired Renal Function [see WARNINGS AND PRECAUTIONS]
- Hypokalemia [see WARNINGS AND PRECAUTIONS]
- Hyperuricemia [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Edarbyclor has been evaluated for safety in more than 3900 patients with hypertension; more than 700 patients were treated for at least 6 months and more than 280 for at least 1 year. Adverse reactions have generally been mild and transient in nature.
Common adverse reactions that occurred in the 8-week factorial design trial in at least 2% of Edarbyclor-treated patients and greater than azilsartan medoxomil or chlorthalidone are presented in Table 1.
Table 1: Adverse Reactions Occurring at an Incidence
of ≥ 2% of Edarbyclor-treated Patients and > Azilsartan medoxomil or
|Preferred Term||Azilsartan medoxomil 20, 40, 80 mg
|Chlorthalidone 12.5, 25 mg
|Edarbyclor 40 / 12.5, 40 / 25 mg
Hypotension and syncope were reported in 1.7% and 0.3%, respectively, of patients treated with Edarbyclor.
Study discontinuation because of adverse reactions occurred in 8.3% of patients treated with the recommended doses of Edarbyclor compared with 3.2% of patients treated with azilsartan medoxomil and 3.2% of patients treated with chlorthalidone. The most common reasons for discontinuation of therapy with Edarbyclor were serum creatinine increased (3.6%) and dizziness (2.3%).
The adverse reaction profile obtained from 52 weeks of open-label combination therapy with azilsartan medoxomil plus chlorthalidone or Edarbyclor was similar to that observed during the double-blind, active controlled trials.
In 3 double-blind, active controlled, titration studies, in which Edarbyclor was titrated to higher doses in a step-wise manner, adverse reactions and discontinuations for adverse events were less frequent than in the fixed-dose factorial trial.
A total of 4814 patients were evaluated for safety when treated with azilsartan medoxomil at doses of 20, 40 or 80 mg in clinical trials. This includes 1704 patients treated for at least 6 months, of these, 588 were treated for at least 1 year. Generally, adverse reactions were mild, not dose related and similar regardless of age, gender and race.
Adverse reactions with a plausible relationship to treatment that have been reported with an incidence of ≥ 0.3% and greater than placebo in more than 3300 patients treated with azilsartan medoxomil in controlled trials are listed below:
Gastrointestinal Disorders: diarrhea, nausea
General Disorders and Administration Site Conditions: asthenia, fatigue
Musculoskeletal and Connective Tissue Disorders: muscle spasm
Nervous System Disorders: dizziness, dizziness postural
Respiratory, Thoracic and Mediastinal Disorders: cough
Clinical Laboratory Findings with Edarbyclor
In the factorial design trial, clinically relevant changes in standard laboratory parameters were uncommon with administration of the recommended doses of Edarbyclor.
Increased blood creatinine is a known pharmacologic effect of renin-angiotensin aldosterone system (RAAS) blockers, such as ARBs and ACE inhibitors, and is related to the magnitude of blood pressure reduction. The incidence of consecutive increases of creatinine ≥ 50% from baseline and > ULN was 2.0% in patients treated with the recommended doses of Edarbyclor compared with 0.4% and 0.3% with azilsartan medoxomil and chlorthalidone, respectively. Elevations of creatinine were typically transient, or non-progressive and reversible, and associated with large blood pressure reductions.
Mean increases in blood urea nitrogen (BUN) were observed with Edarbyclor (5.3 mg/dL) compared with azilsartan medoxomil (1.5 mg/dL) and with chlorthalidone (2.5 mg/dL).
The following adverse reactions have been identified during the postmarketing use of EDARBYCLOR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Read the entire FDA prescribing information for Edarbyclor (Azilsartan Medoxomil and Chlorthalidone Tablets) »
Additional Edarbyclor Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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