Olmesartan Side Effects

Some side effects of olmesartan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to olmesartan: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking olmesartan: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• little or no urinating;

• chest pain, fast heart rate; or

• swelling in your hands or feet.

Common side effects may include:

• dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to olmesartan: oral tablet

Nervous system

Nervous system side effects have included dizziness (3% vs. 1% with placebo), vertigo (0.5% to 1% with placebo), and insomnia (0.5% to 1% with placebo). Asthenia has been reported in postmarketing experience.

Respiratory

Respiratory side effects have included cough (0.9% vs. 0.7% with placebo), bronchitis, rhinitis, pharyngitis, sinusitis, and upper respiratory tract infection.

Gastrointestinal

Gastrointestinal side effects including abdominal pain, dyspepsia, gastroenteritis, and nausea have been reported in 0.5% to 1% of patients. Vomiting has been reported in postmarketing experience. Diarrhea has been reported in more than 1% of patients but at the same or greater incidence than placebo.

Cardiovascular

Cardiovascular side effects including tachycardia, chest pain, and peripheral edema have been reported in 0.5% to 1% of patients. At least 5 cases of facial edema and at least one case of olmesartan-induced angioedema, which resolved over 7 to 10 days after discontinuing olmesartan, have been reported.

Metabolic

Metabolic side effects have included hyperglycemia and hypertriglyceridemia. Hyperkalemia has been reported in postmarketing experience.

Musculoskeletal

Musculoskeletal side effects including arthralgia, arthritis, myalgia, and skeletal pain have been reported in 0.5% to 1% of patients. Rhabdomyolysis have been reported during postmarketing experience in patients receiving angiotensin II receptor blockers.

Dermatologic

Dermatologic side effects have included rash (0.5% to 1%), alopecia, pruritus, and urticaria.

Genitourinary

Genitourinary side effects including urinary tract infection have been reported in 0.5% to 1% of patients. Hematuria has been reported in more than 1% of patients but at the same or greater incidence than placebo.

Hematologic

Hematologic side effects have included decreased hemoglobin and hematocrit.

Hepatic

Hepatic side effects have rarely included liver enzyme and serum bilirubin elevations.

Other

Other side effects including back pain, increased creatine phosphokinase, headache, inflicted injury, influenza-like symptoms, and have been reported in more than 1% of patients but at the same or greater incidence than placebo. Fatigue and pain have been reported in 0.5% to 1% of patients.

Renal

Renal side effects associated with ACE inhibitors have included increases in serum creatinine or BUN in patients with renal artery stenosis. Acute renal failure and increased serum creatinine levels have been reported in postmarketing experience.

Hypersensitivity

Hypersensitivity side effects including rare cases of angioedema and anaphylactic reactions have been reported in patients receiving olmesartan.

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