Hydrochlorothiazide/Moexipril Side Effects

Please note - some side effects for Hydrochlorothiazide/Moexipril 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 Hydrochlorothiazide/Moexipril - for the Consumer

Hydrochlorothiazide/Moexipril

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 Hydrochlorothiazide/Moexipril:

Diarrhea; dizziness; dry cough; headache; nausea; tiredness.

Severe allergic reactions (rash; hives; itching; difficulty swallowing or breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); change in the amount or urine produced; chest pain; difficult or painful urination; drowsiness; dry mouth; eye pain; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; muscle pain, weakness, or cramps; numbness or tingling; one-sided weakness; red, swollen, blistered, or peeling skin; restlessness; severe or persistent dizziness or light-headedness; severe or persistent nausea or vomiting; shortness of breath; slurred speech; stomach pain (with or without nausea or vomiting); sudden, severe headache or vomiting; swelling of the hands, ankles, or feet; symptoms of liver problems (eg, dark urine; pale stools; unusual loss of appetite, tiredness, or stomach pain; yellowing of the skin or eyes); symptoms of low blood sodium (eg, confusion, mental or mood changes, seizures, sluggishness); unusual bruising or bleeding; unusual thirst, tiredness, or weakness; vision changes (eg, decreased vision clearness).

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.

Side Effects by Body System - for Healthcare Professionals

General

Moexipril-hydrochlorothiazide (HCTZ) has been evaluated for safety in more than 1,140 patients with hypertension with more than 120 treated for more than 1 year prior to its approval by the FDA. The overall incidence of adverse side effects was slightly less than in comparable patients treated with placebo. Adverse side effects were usually mild and transient, and there was no relationship between them and gender, race, age, or total daily dosage (except for serum potassium decreases associated with daily doses of HCTZ greater than 50 mg). In controlled trials, discontinuation of therapy was reported in 5.3% of treated patients due to adverse side effects, compared with 8.4% of patients who were taking placebo.

Renal

Rare cases of interstitial nephritis have been associated with the use of HCTZ. Although HCTZ 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.

Renal side effects including new or worsened renal insufficiency, defined as an increase in serum creatinine concentration to at least 140% of baseline values, has been reported in 2% of patients taking moexipril-HCTZ. The presence of the following risk factors may significantly increase the likelihood of nephrotoxicity: heart failure, intravascular hypovolemia or dehydration, renal artery stenosis, and underlying renal insufficiency.

Hypersensitivity

Patients with intestinal angioedema generally present with abdominal pain (with or without nausea or vomiting) and in some cases there was no prior history of facial angioedema, and C-1 esterase levels were normal. These symptoms resolve after stopping the ACE inhibitor..

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 was 44 minutes, women have a relative risk of 9:1, and the average age was 56 years. The mortality rate was 6%. Some experts consider this side effect grossly underreported.

Hypersensitivity reactions to angiotensin converting enzyme (ACE) inhibitors may be life threatening. Angioedema of the face, extremities, lips, tongue, glottis and/or pharynx have been reported rarely in patients receiving ACE inhibitors. In addition, intestinal angioedema has been reported in patients treated with ACE inhibitors. It is recommended that any patient with dyspnea, dysphagia, or significant facial angioedema stop therapy immediately and avoid ACE inhibitor therapy in general.

Urticaria, rash, pemphigus, pruritus, and photosensitivity have also been associated with moexipril.

Hypersensitivity reactions to HCTZ have included nausea, vomiting, diarrhea, and rash in less than 1% of patients. Acute pulmonary edema, interstitial cystitis, interstitial nephritis, and anaphylaxis have rarely been associated with the use of HCTZ.

Metabolic

Metabolic side effects including hypokalemia associated with the use of HCTZ is much less likely with the addition of moexipril because ACE inhibitors decrease serum aldosterone levels. By the same token, the mild hyperkalemia, although clinically insignificant, that often accompanies the use of moexipril, is much less likely due to HCTZ-induced kaliuresis. HCTZ can induce metabolic alkalosis, hyponatremia, hypomagnesemia, hypercalcemia, hyperglycemia, and elevated serum uric acid levels. It may also increase serum cholesterol.

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, caution is recommended when giving this drug to diabetic patients or those with hypercholesterolemia. Irreversible 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.

Cardiovascular

Cardiovascular side effects include dizziness, symptomatic hypotension, postural hypotension, or syncope in 0.5% to 1.0% of patients. Angina, myocardial infarction, palpitations, rhythm disturbances, and stroke have rarely been associated with the use of this drug or one of its components.

Hematologic

Hematologic side effects associated with either component of this combination drug have been extremely rare, but very serious in some cases. Rarely, the use of moexipril or other ACE inhibitors has been associated with the development of agranulocytosis, myelosuppression, or hemolytic anemia. Hematologic side effects have only rarely been associated with the use of ACE inhibitors in patients with uncomplicated hypertension, and have been almost exclusively been associated with the use of these drugs in patients with renal impairment and/or collagen-vascular disease (such as lupus erythematosus or scleroderma). Although more data are needed with regard to moexipril, monitoring of white blood cell counts is recommended in cases where these risk factors are present.

Respiratory

A retrospective study has revealed a significantly higher incidence of discontinuation of ACE inhibitor therapy due to cough among black patients compared with nonblack patients (9.6% vs. 2.4%).

Respiratory side effects including cough is associated with moexipril and other ACE inhibitors. It has been associated with the use of moexipril and moexipril-HCTZ in up to 6% and 3% of patients, respectively. Cough has been the most common reason patients on moexipril discontinue moexipril therapy. Dyspnea and wheezing have rarely been associated with the use of moexipril, and acute pulmonary edema, presumably due to hypersensitivity, has been associated with the use of HCTZ.

Gastrointestinal

Thiazide diuretics may increase serum cholesterol and triglycerides, resulting in an increased risk of cholesterol gallstone formation. Reports of bowel strictures associated with thiazide ingestion were reported in the 1960s (although patients in these reports were on a combination HCTZ-potassium product).

Gastrointestinal side effects are uncommon, and include abdominal pain, constipation, vomiting, appetite or weight changes, dry mouth, and rare cases of pancreatitis, hepatitis, and cholecystitis.

Dermatologic

Dermatologic reactions to thiazide-type diuretics have rarely included 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 has been associated with the use of HCTZ.

Nervous system

Nervous system side effects associated with the use of moexipril include drowsiness, sleep or taste disturbances, headache, nervousness, mood changes, tinnitus, and anxiety. Rarely, stroke due to cerebrovascular insufficiency and intravascular volume depletion has been associated with the use of HCTZ.

Immunologic

Immunologic side effects associated with the use of HCTZ have been rare, and have 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.

Endocrine

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.

Endocrinologic problems associated with the use of thiazide-type 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.

Musculoskeletal

Musculoskeletal side effects have rarely been associated with the use of thiazide-type diuretics and have included myalgias and chills.

Ocular

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

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