Eprosartan / hydrochlorothiazide Side Effects

Not all side effects for eprosartan / hydrochlorothiazide 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 / hydrochlorothiazide: oral tablet

In addition to its needed effects, some unwanted effects may be caused by eprosartan / hydrochlorothiazide. 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 / hydrochlorothiazide:

Rare
  • Abdominal or stomach pain
  • ankle, knee, or great toe joint pain
  • arm, back, or jaw pain
  • bladder pain
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody or cloudy urine
  • blurred vision
  • chest pain or discomfort
  • chest tightness or heaviness
  • confusion
  • convulsions
  • decreased urine output
  • difficulty breathing
  • difficult, burning, or painful urination
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • fast, pounding, or irregular heartbeat or pulse
  • feeling of warmth
  • fever
  • flushed or dry skin
  • frequent urination
  • fruit-like breath odor
  • headache
  • increased hunger
  • increased thirst
  • increased volume of pale, dilute urine
  • itching of the skin
  • joint stiffness or swelling
  • loss of appetite
  • loss of bladder control
  • loss of consciousness
  • lower back or side pain
  • muscle pain or cramps
  • nausea or vomiting
  • nervousness
  • numbness and tingling of the face, fingers, or toes
  • pale, bluish-colored, or cold hands or feet
  • pinpoint red or purple spots on the skin
  • rapid weight gain
  • sudden decrease in the amount of urine
  • sudden sweating
  • unexplained weight loss
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • weakness or heaviness of the legs
Incidence not known
  • Back, leg, or stomach pains
  • black, tarry stools
  • bleeding gums
  • blistering, peeling, or loosening of the skin
  • bloody or cloudy urine
  • chills
  • constipation
  • cough or hoarseness
  • coughing up blood
  • darkened urine
  • decreased frequency or amount of urine
  • diarrhea
  • difficulty with swallowing
  • drowsiness
  • fever with or without chills
  • general body swelling
  • general feeling of tiredness or weakness
  • hives
  • indigestion
  • irritability
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • nosebleeds
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • skin rash
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen or painful glands
  • thickening of bronchial secretions
  • unusual weight loss
  • vision changes
  • weak pulse
  • weight gain
  • yellow eyes or skin

Some of the side effects that can occur with eprosartan / hydrochlorothiazide 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:

Rare
  • Acid or sour stomach
  • belching
  • body aches or pain
  • bone pain
  • burning feeling in the chest or stomach
  • burning or stinging of the skin
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • burning, dry, or itching eyes
  • change in hearing
  • cold or flu-like symptoms
  • congestion
  • continuing ringing or buzzing or other unexplained noise in the ears
  • cough producing mucus
  • depression
  • difficulty moving
  • ear drainage
  • earache
  • excess air or gas in the stomach or intestines
  • fear or nervousness
  • feeling of constant movement of self or surroundings
  • feeling unusually cold
  • full feeling
  • headache, severe and throbbing
  • hearing loss
  • heartburn
  • increased sweating
  • irritation in the mouth
  • itching ears
  • lack or loss of strength
  • loose teeth
  • loss of voice
  • multiple swollen and inflamed skin lesions
  • muscle stiffness
  • pain, inflammation, or swelling in the calves, shoulders, or hands
  • painful cold sores or blisters on the lips, nose, eyes, or genitals
  • passing gas
  • persistent breath odor or bad taste in your mouth
  • rash with flat lesions or small raised lesions on the skin
  • redness and swelling of the gums
  • redness or swelling of the ears
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • runny or stuffy nose
  • sensation of spinning
  • shakiness in the legs, arms, hands, or feet
  • shivering
  • skin rash, encrusted, scaly, and oozing
  • sleepiness or unusual drowsiness
  • sneezing
  • tender, swollen glands in the neck
  • tenderness in the stomach area
  • toothache
  • trembling or shaking of the hands or feet
  • trouble sleeping
  • voice changes
  • weight loss
Incidence not known
  • Decreased interest in sexual intercourse
  • hair loss or thinning of the hair
  • hives or welts
  • inability to have or keep an erection
  • increased sensitivity of the skin to sunlight
  • loss in sexual ability, desire, drive, or performance
  • muscle spasm
  • redness of the skin
  • redness or other discoloration of the skin
  • severe sunburn
  • tenderness of the salivary glands

For Healthcare Professionals

Applies to eprosartan / hydrochlorothiazide: oral tablet

Respiratory

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%).[Ref]

Respiratory side effects of eprosartan have included upper respiratory tract infection (8%), rhinitis (4%), pharyngitis (4%), cough (4%), asthma (<1%), and epistaxis (<1%). Respiratory side effects associated with HCTZ are rare, and include approximately 30 case reports of acute noncardiogenic pulmonary edema. These cases are thought to be due to idiosyncrasy or a hypersensitivity mechanism.[Ref]

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. The risk of orthostatic hypotension is greater in patients with intravascular salt or volume depletion. Cardiac arrhythmias, including ventricular ectopy and complete AV heart block, are associated with hypokalemia and hyponatremia due to HCTZ. Hypotension has been reported in association with HCTZ-induced pulmonary edema. Orthostatic hypotension may occur and may rarely be associated with syncope, particularly in the elderly.[Ref]

Endocrine

A prospective study of 34 patients who received oral thiazide-type diuretics for 14 years without interruption revealed an increased average fasting blood glucose level after treatment. Withdrawal of thiazide therapy for 7 months in 10 of the patients resulted in average reductions of 10% in the fasting blood glucose and 25% in the 2-hour glucose tolerance test values. A control group was not reported.[Ref]

Endocrine side effects of eprosartan have included increased sweating in less than 1% of patients. Endocrinologic problems associated with thiazide diuretics include glucose intolerance and a potentially deleterious effect on the lipid profile. This may be important in some patients with or who are at risk for diabetes or coronary artery disease. A single case of recurrent parathyroid adenoma is reported, although the association is probably coincidental.[Ref]

Gastrointestinal

Gastrointestinal side effects of eprosartan 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. Gastrointestinal side effects associated with HCTZ are unusual, and include case reports of pancreatitis and acute cholecystitis.[Ref]

Thiazide diuretics may increase serum cholesterol and triglycerides, resulting in increased risk of cholesterol gallstone formation. Reports of bowel strictures associated with thiazide ingestion have been reported in the 1960's although these patients were on a combination HCTZ-potassium product.[Ref]

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 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.[Ref]

Genitourinary

Genitourinary side effects associated with eprosartan 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.[Ref]

Hematologic

Hematologic side effects of eprosartan 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%). Hematologic side effects associated with HCTZ are rare. Cases of immune-complex hemolytic anemia, aplastic anemia, and thrombocytopenia have been reported.[Ref]

Hepatic

Hepatic side effects of eprosartan 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.[Ref]

Metabolic

Metabolic side effects associated with eprosartan have included hypertriglyceridemia (1%); and increased creatine phosphokinase, diabetes mellitus, glycosuria, gout, hypercholesterolemia, hyperglycemia, hyperkalemia, hypokalemia, and hyponatremia in less than 1% of patients. Metabolic side effects associated with HCTZ are common, especially when doses greater than 50 mg per day are used. Mild hypokalemia (decrease of 0.5 mEq/L) occurs in up to 50% of patients, and may predispose patients to cardiac arrhythmias. Metabolic alkalosis, hyponatremia, hypomagnesemia, hypercalcemia, hyperglycemia, and elevated serum uric acid levels are also relatively common. Hydrochlorothiazide (HCTZ) may increase serum cholesterol.[Ref]

Since HCTZ may increase total serum cholesterol by 11%, LDL lipoprotein cholesterol by 12%, and VLDL lipoprotein cholesterol levels by 50%, and may reduce insulin secretion, it should be used with caution in diabetic patients and in those with hypercholesterolemia. True glucose intolerance may develop in approximately 3% of patients. It is typically reversible within six months after discontinuation of therapy.

Hyperuricemia may be an important consideration in patients with a history of gout. Hypophosphatemia and low serum magnesium concentrations may occur, but are usually clinically insignificant except in malnourished patients.[Ref]

Musculoskeletal

Musculoskeletal side effects of eprosartan 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. Musculoskeletal side effects associated with HCTZ are unusual, and include case reports of myalgias and chills. Preservation of mineral bone density has also been observed in older patients.[Ref]

Nervous system

Nervous system side effects of eprosartan have included anxiety, ataxia, insomnia, migraine, neuritis, nervousness, paresthesia, somnolence, tremor, vertigo, and tinnitus in less than 1% of patients. A nervous system side effect, cerebrovascular insufficiency, has been associated with HCTZ-induced plasma volume contraction.[Ref]

Ocular

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

Ocular side effects have included idiosyncratic reactions to the hydrochlorothiazide component resulting in acute transient myopia and acute angle-closure glaucoma.[Ref]

Other

Other side effects associated with eprosartan 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.[Ref]

Psychiatric

Psychiatric side effects of eprosartan have included depression (1%).[Ref]

Renal

Renal side effects of eprosartan 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. Renal insufficiency, manifest as an increase in serum creatinine and BUN may occur due to HCTZ-induced intravascular volume depletion. Rare cases of interstitial nephritis have been reported.[Ref]

Although hydrochlorothiazide has been used to treat nephrogenic diabetes insipidus, a case report in which the drug was believed to have caused this condition has been reported.[Ref]

Dermatologic

Dermatologic side effects reported in less than 1% of patients taking eprosartan have included eczema, furunculosis, pruritus, rash, and maculopapular rash. Dermatologic reactions of HCTZ include case reports of erythema annular centrifugum, acute eczematous dermatitis, and morbilliform and leukocytoclastic vasculitis. Thiazides may induce phototoxic dermatitis. In addition, a rare, distinct entity with clinical and laboratory features indistinguishable from those of subacute cutaneous lupus erythematosus is associated with HCTZ.[Ref]

A 67-year-old woman with hypothyroidism, hypercalcemia, depression, and hypertension developed facial erythema, headaches, tremors, confusion and personality changes associated with a new positive ANA and anti-nRNP, and a skin biopsy consistent with lupus erythematosus while taking hydrochlorothiazide (HCTZ), levothyroxine, and amitriptyline. The eruption resolved upon discontinuation of HCTZ, but she later developed a higher ANA titer associated with symptomatic diffuse interstitial pulmonary infiltrates. She was successfully treated with corticosteroids.[Ref]

Hypersensitivity

Hypersensitivity (usually nausea, vomiting, diarrhea, and rash) has been reported in less than 1% of patients taking HCTZ. Rare cases of acute pulmonary edema, interstitial cystitis, and interstitial nephritis, and anaphylaxis have been reported.[Ref]

There have been approximately 34 known cases of thiazide-induced pulmonary edema, encompassing 52 episodes of pulmonary edema, as of 1991 (per a 1996 review). In some cases, doses as small as 12.5 mg were associated with the development of pulmonary edema. The average time to onset of this adverse reaction is 44 minutes, women carry a relative risk of 9:1, and the average age is 56 years. The mortality rate is 6%. Some experts consider this side effect grossly underreported.[Ref]

Immunologic

There are rare case reports of hydrochlorothiazide-induced immune hemolytic anemia. The following illustrates a fatal case:

A 53-year-old man with hypertension developed nausea, vomiting, diarrhea, and progressive anorexia and weakness associated with scleral icterus, anemia with spherocytosis, dark red urine with proteinuria, bilirubinuria, hemoglobinuria, and elevated lactic dehydrogenase levels 18 months after beginning hydrochlorothiazide and methyldopa. Haptoglobin was less than 50 mg per dl. Direct and indirect Coombs tests were positive. The patient died suddenly; autopsy revealed no obvious cause of death, left ventricular hypertrophy, and mild coronary atherosclerosis.[Ref]

Immunologic side effects associated with HCTZ are rare, and include case reports of allergic vasculitis and hemolytic anemia. There are numerous case reports of patients developing a rash histologically identical to subacute cutaneous lupus following HCTZ administration.[Ref]

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