Eprosartan Side Effects
Not all side effects for eprosartan may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to eprosartan: oral tablet
In addition to its needed effects, some unwanted effects may be caused by eprosartan. In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when taking eprosartan:Less common
- Burning or painful urination or changes in urinary frequency
- sore throat
- Dizziness, lightheadedness, or fainting
- swollen face, lips, limbs, or tongue
Some of the side effects that can occur with eprosartan may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:Less common or rare
- Abdominal or stomach pain
- joint pain
- unusual tiredness
For Healthcare Professionals
Applies to eprosartan: oral tablet
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 side effects have included anxiety, ataxia, insomnia, migraine, neuritis, nervousness, paresthesia, somnolence, tremor, vertigo, and tinnitus in less than 1% of patients.
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%).
Respiratory side effects have included upper respiratory tract infection (8%), rhinitis (4%), pharyngitis (4%), cough (4%), asthma (<1%), and epistaxis (<1%).
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 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 side effects reported in less than 1% of patients have included eczema, furunculosis, pruritus, rash, and maculopapular rash.
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 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 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 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 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 side effects have included increased sweating in less than 1% of patients.
Ocular side effects have included conjunctivitis, abnormal vision, and xerophthalmia in less than 1% of patients.
Psychiatric side effects have included depression (1%).
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.
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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