Eprosartan Side Effects

Brand Names: Teveten

Please note - some side effects for Eprosartan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Eprosartan - for the Consumer

Eprosartan

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Eprosartan:

Dizziness; upper respiratory tract infection.

Seek medical attention right away if any of these SEVERE side effects occur when using Eprosartan:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; hoarseness); change in the amount of urine produced; chest pain; difficulty swallowing; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; muscle pain or cramps; swelling of the hands, ankles, or feet; symptoms of low blood pressure (eg, fainting, light-headedness, severe dizziness); unusual bruising or bleeding.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Eprosartan/Hydrochlorothiazide

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Eprosartan/Hydrochlorothiazide:

Dizziness or light-headedness, especially when sitting up or standing.

Seek medical attention right away if any of these SEVERE side effects occur when using Eprosartan/Hydrochlorothiazide:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; confusion; decrease in sexual ability; decreased urination; depression; drowsiness; eye pain; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; muscle pain, tenderness, or cramps; red, swollen, blistered, or peeling skin; restlessness; seizures; severe or persistent dizziness or light-headedness; severe or persistent dry mouth, nausea, or stomach pain; shortness of breath; sluggishness; swelling of the arms or legs; unusual bruising or bleeding; unusual thirst, tiredness, or weakness; vision changes (eg, decreased vision clearness); vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Eprosartan Side Effects - for the Professional

Eprosartan

Eprosartan mesylate has been evaluated for safety in more than 3,300 healthy volunteers and patients worldwide, including more than 1,460 patients treated for more than 6 months and more than 980 patients treated for one year or longer. Eprosartan mesylate was well tolerated at doses up to 1200 mg daily. Most adverse events were of mild or moderate severity and did not require discontinuation of therapy. The overall incidence of adverse experiences and the incidences of specific adverse events reported with Eprosartan were similar to placebo.

Adverse experiences were similar in patients regardless of age, gender or race. Adverse experiences were not dose related.

In placebo-controlled clinical trials, about 4% of 1,202 patients treated with Eprosartan mesylate discontinued therapy due to clinical adverse experiences, compared to 6.5% of 352 patients given placebo.

Adverse Events Occurring at an Incidence of 1% or More Among Eprosartan-treated Patients

The following table lists adverse events that occurred at an incidence of 1% or more among Eprosartan-treated patients who participated in placebo-controlled trials of 8 to 13 weeks' duration, using doses of 25 mg to 400 mg twice daily and 400 mg to 1200 mg once daily. The overall incidence of adverse events reported with Eprosartan mesylate (54.4%) was similar to placebo (52.8%).

Table 1. Adverse Events Reported by ≥ 1% of Patients Receiving Eprosartan Mesylate and Were More Frequent on Eprosartan than Placebo

Event	Eprosartan (n = 1,202) %	Placebo (n = 352) %
Body as a Whole
Infection viral	2	1
Injury	2	1
Fatigue	2	1
Gastrointestinal
Abdominal pain	2	1
Metabolic and Nutritional
Hypertriglyceridemia	1	0
Musculoskeletal
Arthralgia	2	1
Nervous System
Depression	1	0
Respiratory
Upper respiratory tract infection	8	5
Rhinitis	4	3
Pharyngitis	4	3
Coughing	4	3
Urogenital
Urinary tract infection	1	0

 

The following adverse events were also reported at a rate of 1% or greater in patients treated with Eprosartan, but were as or more, frequent in the placebo group: headache, myalgia, dizziness, sinusitis, diarrhea, bronchitis, dependent edema, dyspepsia and chest pain.

Facial edema was reported in five patients receiving Eprosartan. Angioedema has been reported with other angiotensin II antagonists. Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers.

In addition to the adverse events above, potentially important events that occurred in at least two patients/subjects exposed to Eprosartan or other adverse events that occurred in < 1% of patients in clinical studies are listed below. It cannot be determined whether events were causally related to Eprosartan:

Body as a Whole: alcohol intolerance, asthenia, substernal chest pain, peripheral edema, fatigue, fever, hot flushes, influenza-like symptoms, malaise, rigors, pain;

Cardiovascular: angina pectoris, bradycardia, abnormal ECG, specific abnormal ECG, extrasystoles, atrial fibrillation, hypotension (including orthostatic hypotension), tachycardia, palpitations;

Gastrointestinal: anorexia, constipation, dry mouth, esophagitis, flatulence, gastritis, gastroenteritis, gingivitis, nausea, periodontitis, toothache, vomiting;

Hematologic: anemia, purpura;

Liver and Biliary: increased SGOT, increased SGPT;

Metabolic and Nutritional: increased creatine phosphokinase, diabetes mellitus, glycosuria, gout, hypercholesterolemia, hyperglycemia, hyperkalemia, hypokalemia, hyponatremia;

Musculoskeletal: arthritis, aggravated arthritis, arthrosis, skeletal pain, tendinitis, back pain;

Nervous System/Psychiatric: anxiety, ataxia, insomnia, migraine, neuritis, nervousness, paresthesia, somnolence, tremor, vertigo;

Resistance Mechanism: herpes simplex, otitis externa, otitis media, upper respiratory tract infection;

Respiratory: asthma, epistaxis;

Skin and Appendages: eczema, furunculosis, pruritus, rash, maculopapular rash, increased sweating;

Special Senses: conjunctivitis, abnormal vision, xerophthalmia, tinnitus;

Urinary: albuminuria, cystitis, hematuria, micturition frequency, polyuria, renal calculus, urinary incontinence;

Vascular: leg cramps, peripheral ischemia.

Laboratory Test Findings

In placebo-controlled studies, clinically important changes in standard laboratory parameters were rarely associated with administration of Eprosartan mesylate. Patients were rarely withdrawn from Eprosartan mesylate because of laboratory test results.

Creatinine, Blood Urea Nitrogen

Minor elevations in creatinine and in BUN occurred in 0.6% and 1.3%, respectively, of patients taking Eprosartan mesylate and 0.9% and 0.3%, respectively, of patients given placebo in controlled clinical trials. Two patients were withdrawn from clinical trials for elevations in serum creatinine and BUN and three additional patients were withdrawn for increases in serum creatinine.

Liver Function Tests

Minor elevations of ALAT, ASAT and alkaline phosphatase occurred for comparable percentages of patients taking Eprosartan mesylate or placebo in controlled clinical trials. An elevated ALAT of > 3.5 x ULN occurred in 0.1% of patients taking Eprosartan mesylate (one patient) and in no patient given placebo in controlled clinical trials. Four patients were withdrawn from clinical trials for an elevation in liver function tests.

Hemoglobin

A greater than 20% decrease in hemoglobin was observed in 0.1% of patients taking Eprosartan mesylate (one patient) and in no patient given placebo in controlled clinical trials. Two patients were withdrawn from clinical trials for anemia.

Leukopenia

A WBC count of ≤ 3 x 103/mm3 occurred in 0.3% of patients taking Eprosartan mesylate and in 0.3% of patients given placebo in controlled clinical trials. One patient was withdrawn from clinical trials for leukopenia.

Neutropenia

A neutrophil count of ≤ 1.5 x 103/mm3 occurred in 1.3% of patients taking Eprosartan mesylate and in 1.4% of patients given placebo in controlled clinical trials. No patient was withdrawn from any clinical trial for neutropenia.

Thrombocytopenia

A platelet count of ≤ 100 x 109/L occurred in 0.3% of patients taking Eprosartan mesylate (one patient) and in no patient given placebo in controlled clinical trials. Four patients receiving Eprosartan mesylate in clinical trials were withdrawn for thrombocytopenia. In one case, thrombocytopenia was present prior to dosing with Eprosartan mesylate.

Serum Potassium

A potassium value of ≥ 5.6 mmol/L occurred in 0.9% of patients taking Eprosartan mesylate and 0.3% of patients given placebo in controlled clinical trials. One patient was withdrawn from clinical trials for hyperkalemia and three for hypokalemia.

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Side Effects by Body System - for Healthcare Professionals

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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