Eprosartan Side Effects

Some side effects of eprosartan 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 eprosartan: oral tablet

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

In rare cases, eprosartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

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:

• cold symptoms such as stuffy nose, sneezing, sore throat, cough;

• joint pain;

• nausea, stomach pain, diarrhea;

• headache, dizziness; or

• tired feeling.

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 eprosartan: oral tablet

General

In general, eprosartan has been well tolerated. Prior to FDA approval data have shown that the incidence of adverse drug events (ADEs) associated the use of eprosartan was similar to the incidence of ADEs associated with the use of placebo. The most frequently occurring ADEs that were considered to be associated with the use of eprosartan (but as prevalent among placebo patients) included headache, dizziness, myalgia, sinusitis, diarrhea, bronchitis, dyspepsia, edema, and chest pain. The majority of ADEs were mild to moderate in severity. In placebo-controlled trials, 4% of treated patients discontinued therapy due to an ADE, compared with 6.5% of patients given placebo.

Nervous system

Nervous system side effects have included anxiety, ataxia, insomnia, migraine, neuritis, nervousness, paresthesia, somnolence, tremor, vertigo, and tinnitus in less than 1% of patients.

Respiratory

Respiratory side effects have included upper respiratory tract infection (8%), rhinitis (4%), pharyngitis (4%), cough (4%), asthma (<1%), and epistaxis (<1%).

Angiotensin II receptor blockade, unlike ACE inhibition, has no impact on the processing of peptides such as bradykinin and substance P, two peptides able to induce cough.

The incidence of cough was not significantly different and averaged 3.5% and 2.6%, respectively, in patients who were given eprosartan and placebo. In comparative studies, the average incidence of cough among patients enalapril ranged from 6.1% to 12.8%, nearly two to three times the incidence of cough among patients given eprosartan (1.5% to 6.5%).

Cardiovascular

Cardiovascular side effects of eprosartan reported in less than 1% of patients have included angina pectoris, bradycardia, abnormal ECG, extrasystoles, atrial fibrillation, hypotension (including orthostatic hypotension), tachycardia, palpitations, and peripheral ischemia.

Metabolic

Metabolic side effects have included hypertriglyceridemia (1%); and increased creatine phosphokinase, diabetes mellitus, glycosuria, gout, hypercholesterolemia, hyperglycemia, hyperkalemia, hypokalemia, and hyponatremia in less than 1% of patients.

Dermatologic

Dermatologic side effects reported in less than 1% of patients have included eczema, furunculosis, pruritus, rash, and maculopapular rash.

Gastrointestinal

Gastrointestinal side effects have included abdominal pain (2%). Anorexia, constipation, dry mouth, esophagitis, flatulence, gastritis, gastroenteritis, gingivitis, nausea, periodontitis, toothache, and vomiting have been reported in less than 1% of patients. A case of dysgeusia and burning mouth syndrome has been reported.

Musculoskeletal

Musculoskeletal side effects have included arthralgia (2%), arthritis, arthrosis, skeletal pain, tendonitis, leg cramps, and back pain in less than 1% of patients. In addition, rare reports of rhabdomyolysis have been reported during postmarketing experience in patients receiving angiotensin II receptor blockers.

Hematologic

Hematologic side effects have included anemia and purpura in less than 1% of patients, decrease in hemoglobin of more than 20% (0.1%), leukopenia (0.3%), neutropenia (1.3%), and thrombocytopenia (0.3%).

Hepatic

Hepatic side effects have included minor increases in AST (SGOT), ALT (SGPT), and alkaline phosphatase in less than 1% of patients. One case of elevated ALT >3.5 times ULN has been reported.

Renal

Renal side effects have included minor increases in creatinine (0.6%) and BUN (1.3%). The use of angiotensin II receptor antagonists in patients whose renal function depends on the renin-angiotensin-aldosterone system (i.e., congestive heart failure) has been associated with oliguria and/or progressive azotemia and rarely acute renal failure and/or death. Increases in serum creatinine and BUN have been reported with other angiotensin II receptor antagonists in patients with unilateral or bilateral renal artery stenosis.

Endocrine

Endocrine side effects have included increased sweating in less than 1% of patients.

Ocular

Ocular side effects have included conjunctivitis, abnormal vision, and xerophthalmia in less than 1% of patients.

Psychiatric

Psychiatric side effects have included depression (1%).

Genitourinary

Genitourinary side effects have included urinary tract infection (1%). Albuminuria, cystitis, hematuria, micturition frequency, polyuria, renal calculus, and urinary incontinence have been reported in less than 1% of patients.

Other

Side effects affecting the body as a whole have included viral infection (2%), injury (2%), and fatigue (2%). Alcohol intolerance, asthenia, substernal chest pain, peripheral edema, fever, hot flushes, influenza-like symptoms, malaise, rigors, pain, herpes simplex, otitis externa, and otitis media have been reported in less than 1% of patients.

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