Hydrochlorothiazide / irbesartan Side Effects

Some side effects of hydrochlorothiazide / irbesartan 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 hydrochlorothiazide / irbesartan: oral tablet

Along with its needed effects, hydrochlorothiazide / irbesartan may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking hydrochlorothiazide / irbesartan:

Less common
  • Abdominal or stomach pain
  • bladder pain
  • bloody or cloudy urine
  • chest pain
  • confusion
  • difficult with breathing
  • difficult, burning, or painful urination
  • fast, pounding, or irregular heartbeat or pulse
  • frequent urge to urinate
  • lower back or side pain
  • nausea or vomiting
  • nervousness
  • numbness or tingling in the hands, feet, or lips
  • shortness of breath
  • swelling
  • weakness or heaviness of the legs
Rare
  • Blurred vision
  • convulsions
  • decreased urine
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • increased thirst
  • loss of appetite
  • muscle pain or cramps
  • sweating
  • unusual tiredness or weakness
Incidence not known
  • Dark-colored urine
  • fever
  • general tiredness and weakness
  • hives or welts
  • itching
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • muscle spasms or stiffness
  • redness of the skin
  • skin rash
  • upper right abdominal or stomach pain
  • yellow eyes and skin

Some side effects of hydrochlorothiazide / irbesartan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Headache
Less common
  • Acid or sour stomach
  • belching
  • body aches or pain
  • bone pain
  • chills
  • congestion
  • cough
  • diarrhea
  • dry cough
  • dryness or soreness of the throat
  • ear congestion
  • fear
  • heartburn
  • hoarseness
  • indigestion
  • joint pain
  • loss of appetite
  • loss of voice
  • shivering
  • sneezing
  • stomach discomfort or upset
  • stuffy or runny nose
  • tender, swollen glands in the neck
  • trouble with sleeping
  • trouble with swallowing
  • voice changes

For Healthcare Professionals

Applies to hydrochlorothiazide / irbesartan: oral tablet

General

In general, the safety and efficacy of hydrochlorothiazide-irbesartan has been tested in over 700 patients. Side effects associated with the use of hydrochlorothiazide-irbesartan have generally been mild and transient.

Cardiovascular

Cardiovascular side effects associated with hydrochlorothiazide-irbesartan have been reported rarely and have occurred at a rate less than or equal to placebo. These have included chest pain, edema, dizziness, sinus arrhythmia, tachycardia, and cardiac arrhythmias (including ventricular ectopy and complete AV heart block). Arrhythmias in the absence of HCTZ-induced electrolyte disturbances have been reported rarely. Orthostatic hypotension has been reported rarely.

Cardiovascular side effects associated with irbesartan including flushing, hypertension, cardiac murmur, myocardial infarction, angina pectoris, arrhythmias, cardiorespiratory arrest, and hypertensive crisis have been reported in less than 1% of patients in controlled trials. Bradycardia has been reported in less than 1% of patients in postmarketing experience.

Gastrointestinal

Gastrointestinal side effects associated with HCTZ have rarely included pancreatitis and acute cholecystitis. Bowel strictures have been reported.

Gastrointestinal side effects associated with irbesartan have been reported the most frequently. Diarrhea (3% vs. 2% in placebo) and dyspepsia (2% vs. 1% in placebo) have been reported. Abdominal pain, nausea, and vomiting have been reported in 1% or greater among patients and at least as frequent or more frequent in patients receiving placebo. Constipation, gastroenteritis, flatulence, and abdominal distension have been reported in less than 1% of patients in controlled trials. Dry mouth, pyrosis, and epigastralgia have been reported in less than 1% of patients in postmarketing experience.

Reports of bowel strictures associated with thiazide ingestion have been reported, although these patients were on a combination hydrochlorothiazide-potassium product.

Hypersensitivity

There have been approximately 34 known cases of thiazide-induced pulmonary edema, encompassing 52 episodes of pulmonary edema. 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.

Hypersensitivity side effects associated with thiazide-type diuretics have been reported rarely. Anaphylaxis and approximately 30 cases of acute pulmonary edema have been reported.

Hypersensitivity side effects associated with irbesartan including allergic reactions have been reported in less than 1% of patients in postmarketing experience.

Nervous system

Nervous system side effects including headache have been reported in patients receiving hydrochlorothiazide-irbesartan (11.9%) compared to HCTZ-placebo (7.5%). Extremely rare cases of stroke have been associated with HCTZ-induced plasma volume contraction.

Nervous system side effects associated with irbesartan have been reported rarely. These have included dizziness, numbness, somnolence, paresthesias, tremor, transient ischemic attack, and stroke at a frequency less than or similar to placebo. Fatigue has been reported in 4% of patients compared to 3% in placebo. Lethargy and paresis has been reported in less than 1% of patients in postmarketing experience.

Metabolic

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.

Hypokalemia, which is typically associated with the use of HCTZ, is much less likely with the addition of irbesartan because A-II inhibitors decrease serum aldosterone levels. (The risk of hypokalemia associated with HCTZ monotherapy is significantly increased when daily HCTZ doses exceed 50 mg.) In addition, the mild hyperkalemia, although usually clinically insignificant, that may accompany the use of irbesartan is much less likely due to HCTZ-induced kaliuresis.

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

True glucose intolerance is typically reversible within six months after discontinuation of therapy.

Metabolic side effects associated with the use of thiazide-type diuretics have included glucose intolerance (3%), hyperuricemia, hypophosphatemia, hypomagnesemia, and reduced insulin secretion. Metabolic side effects associated with HCTZ have included metabolic alkalosis, hyponatremia, hypercalcemia, hyperglycemia, and hypokalemia. Increased (by 11%) total serum cholesterol, increased (by 12%) LDL lipoprotein cholesterol, and increased (by 50%) VLDL lipoprotein cholesterol have been reported.

Metabolic side effects associated with some A-II inhibitors have included greater than 20% increases in baseline serum potassium (4.4% vs. 2.9% in placebo). Gouty arthritis associated with irbesartan has been reported in less than 1% of patients in controlled trials.

Dermatologic

Dermatologic side effects associated with thiazide-type diuretics have been reported rarely. These have included erythema annular centrifugum, acute eczematous dermatitis, morbilliform and leukocytoclastic vasculitis. Phototoxic dermatitis has been reported. Rarely, distinct entity with clinical and laboratory features indistinguishable from those of subacute cutaneous lupus erythematosus has been reported with the use of HCTZ.

Dermatologic side effects associated with irbesartan have included pruritus, dermatitis, ecchymosis, facial erythema, and urticaria in less than 1% of patients in controlled trials. Rash has been reported in less than 1% of patients and at a rate similar to placebo. Facial edema and sweating have been reported in less than 1% of patients in postmarketing experience.

Respiratory

Respiratory side effects associated with irbesartan that have occurred in treated patients at rates less than or similar to placebo have included pharyngitis, rhinitis, tracheobronchitis, pulmonary congestion, dyspnea, and wheezing. A causal association has not been proven. Cough is a relatively common and obnoxious side effect associated with the use of angiotensin converting enzyme inhibitors. However, the use of irbesartan has not been associated with an increased incidence of dry cough.

Renal

Preexisting hypovolemia could predispose a patient to the risk of developing azotemia associated with the use of this combination drug.

Renal side effects associated with hydrochlorothiazide-irbesartan have included azotemia. Renal side effects associated with HCTZ have frequently included new or worsened renal insufficiency. Rarely, interstitial nephritis has been reported.

Renal side effects associated with irbesartan have rarely included new or worsened renal insufficiency.

Musculoskeletal

Musculoskeletal side effects associated with hydrochlorothiazide-irbesartan have included aches and pains, chills, and cramps. Joint stiffness, bursitis, and weakness have been reported rarely.

Musculoskeletal side effects associated with irbesartan have included myalgia in less than 1% of patients in postmarketing experience. Rhabdomyolysis has been reported during postmarketing experience in patients receiving angiotensin II receptor blockers.

Immunologic

Immunologic side effects associated with the use of HCTZ have rarely included allergic vasculitis and hemolytic anemia. There have been numerous case reports of patients developing a rash histologically identical to subacute cutaneous lupus following HCTZ administration.

Genitourinary

Genitourinary side effects have been reported extremely rarely in controlled trials. Sexual dysfunction, abnormal urination and prostate problems have been reported with the use of irbesartan in less than 1% of patients in controlled trials. Rarely, interstitial cystitis has been reported. Urinary retention and oliguria have been reported in less than 1% of patients in postmarketing experience. Most genitourinary side effects during therapy probably reflect underlying disease. At least one case of penile angioedema has also been reported with the use of irbesartan.

Hematologic

Hematologic side effects associated with HCTZ have rarely included immune-complex hemolytic anemia.

Hematologic side effects associated with the use of irbesartan have not been reported. Decreases (greater than 20%) in hematocrit (0.8%) and hemoglobin (0.4%) have been reported in the use of a similar product, valsartan. Neutropenia (1.9% vs. 0.8% in placebo) associated with valsartan has been reported in controlled trials.

Hepatic

Hepatic side effects associated with irbesartan have rarely included cholestatic jaundice. Hepatitis has been reported during postmarketing experience.

Psychiatric

Psychiatric side effects rarely associated with the use of irbesartan and at a frequency less than or similar to placebo have included anxiety, nervousness, sleep disturbances, emotional problems, and depression. Alterations in libido have been reported in less than 1% of patients in controlled trials. Nightmares and hallucinations have been reported in less than 1% of patients in postmarketing experience.

Other

Other side effects associated with irbesartan including general discomfort have been reported in less than 1% of patients in postmarketing experience.

Ocular

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

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