Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS 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 (5.1) ] Hypotension in Volume- or Salt-Depleted Patients [see Warnings and Precautions (5.2) ] Impaired Renal Function [see Warnings and Precautions (5.3) ] Hypokalemia [see Warnings and Precautions (5.4) ] Hyperuricemia [see Warnings and Precautions (5.5) ] Most common adverse reactions (incidence ≥2%) are dizziness and fatigue ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc.
at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 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
Adverse Reactions Occurring at an Incidence of ≥2% of Edarbyclor-treated Patients and > Azilsartan medoxomil or Chlorthalidone Preferred Term Azilsartan medoxomil 20, 40, 80 mg (N=470) Chlorthalidone 12.5, 25 mg (N=316) Edarbyclor 40 / 12.5, 40 / 25 mg (N=302) Dizziness 1.7% 1.9% 8.9% Fatigue 0.6% 1.3% 2.0% 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%).
5 WARNINGS AND PRECAUTIONS In patients with an activated renin-angiotensin-aldosterone system (RAAS), such as volume- and/or salt-depleted patients, Edarbyclor can cause excessive hypotension.
Correct volume or salt depletion prior to administration of Edarbyclor ( 5.2 ) In patients with renal artery stenosis, Edarbyclor may cause renal failure ( 5.3 ) Monitor renal function in patients with renal impairment.
Consider discontinuing Edarbyclor with progressive renal impairment ( 5.3 ) Monitor serum electrolytes periodically ( 5.4 ) 5.1 Fetal Toxicity Azilsartan medoxomil Edarbyclor can cause fetal harm when administered to a pregnant woman.
Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.
Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations.
Like all medications, Edarbyclor can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: