Moexipril Side Effects

Brand Names: Univasc

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

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 Moexipril:

Diarrhea; dizziness; fatigue; flu-like symptoms; light-headedness when sitting or standing; persistent, dry cough.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); chest pain; confusion; decreased urination; fainting; fast, slow, or irregular heartbeat; mental or mood changes; numbness of an arm or leg; one-sided weakness; severe or persistent dizziness or light-headedness; 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 infection (eg, fever, chills, persistent sore throat); symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, yellowing of the skin or eyes); vision changes.

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.

Moexipril/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 Moexipril/Hydrochlorothiazide:

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

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

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.

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Moexipril Side Effects - for the Professional

Moexipril

Moexipril hydrochloride has been evaluated for safety in more than 2500 patients with hypertension; more than 250 of these patients were treated for approximately one year. The overall incidence of reported adverse events was only slightly greater in patients treated with Moexipril hydrochloride than patients treated with placebo.

Reported adverse experiences were usually mild and transient, and there were no differences in adverse reaction rates related to gender, race, age, duration of therapy, or total daily dosage within the range of 3.75 mg to 60 mg. Discontinuation of therapy because of adverse experiences was required in 3.4% of patients treated with Moexipril hydrochloride and in 1.8% of patients treated with placebo. The most common reasons for discontinuation in patients treated with Moexipril hydrochloride were cough (0.7%) and dizziness (0.4%).

All adverse experiences considered at least possibly related to treatment that occurred at any dose in placebo-controlled trials of once-daily dosing in more than 1% of patients treated with Moexipril hydrochloride alone and that were at least as frequent in the Moexipril hydrochloride group as in the placebo group are shown in the following table:

ADVERSE EVENTS IN PLACEBO-CONTROLLED STUDIES

ADVERSE EVENT	Moexipril HYDROCHLORIDE (N=674)	PLACEBO (N=226)
	N (%)	N (%)
Cough Increased	41 (6.1)	5 (2.2)
Dizziness	29 (4.3)	5 (2.2)
Diarrhea	21 (3.1)	5 (2.2)
Flu Syndrome	21 (3.1)	0 (0)
Fatigue	16 (2.4)	4 (1.8)
Pharyngitis	12 (1.8)	2 (0.9)
Flushing	11 (1.6)	0 (0)
Rash	11 (1.6)	2 (0.9)
Myalgia	9 (1.3)	0 (0)

Other adverse events occurring in more than 1% of patients on Moexipril that were at least as frequent on placebo include: headache, upper respiratory infection, pain, rhinitis, dyspepsia, nausea, peripheral edema, sinusitis, chest pain, and urinary frequency. See WARNINGS and PRECAUTIONS for discussion of anaphylactoid reactions, angioedema, hypotension, neutropenia/agranulocytosis, second and third trimester fetal/neonatal morbidity and mortality, hyperkalemia, and cough.

Other potentially important adverse experiences reported in controlled or uncontrolled clinical trials in less than 1% of Moexipril patients or that have been attributed to other ACE inhibitors include the following:

Cardiovascular:

Symptomatic hypotension, postural hypotension, or syncope were seen in 9/1750 (0.51%) patients; these reactions led to discontinuation of therapy in controlled trials in 3/1254 (0.24%) patients who had received Moexipril hydrochloride monotherapy and in 1/344 (0.3%) patients who had received Moexipril hydrochloride with hydrochlorothiazide. Other adverse events included angina/myocardial infarction, palpitations, rhythm disturbances, and cerebrovascular accident.

Renal:

Of hypertensive patients with no apparent preexisting renal disease, 1% of patients receiving Moexipril hydrochloride alone and 2% of patients receiving Moexipril hydrochloride with hydrochlorothiazide experienced increases in serum creatinine to at least 140% of their baseline values.

Gastrointestinal:

Abdominal pain, constipation, vomiting, appetite/weight change, dry mouth, pancreatitis, hepatitis.

Respiratory:

Bronchospasm, dyspnea, eosinophilic pneumonitis.

Urogenital:

Renal insufficiency, oliguria.

Dermatologic:

Apparent hypersensitivity reactions manifested by urticaria, rash, pemphigus, pruritus, photosensitivity, alopecia.

Neurological and Psychiatric:

Drowsiness, sleep disturbances, nervousness, mood changes, anxiety.

Other:

Angioedema, taste disturbances, tinnitus, sweating, malaise, arthralgia, hemolytic anemia.

Clinical Laboratory Test Findings

Serum Electrolytes:

Hyperkalemia, hyponatremia.

Creatinine and Blood Urea Nitrogen:

As with other ACE inhibitors, minor increases in blood urea nitrogen or serum creatinine, reversible upon discontinuation of therapy, were observed in approximately 1% of patients with essential hypertension who were treated with Moexipril hydrochloride. Increases are more likely to occur in patients receiving concomitant diuretics and in patients with compromised renal function.

Other (causal relationship unknown):

Clinically important changes in standard laboratory tests were rarely associated with Moexipril hydrochloride administration.

Elevations of liver enzymes and uric acid have been reported. In trials, less than 1% of Moexipril-treated patients discontinued Moexipril hydrochloride treatment because of laboratory abnormalities. The incidence of abnormal laboratory values with Moexipril was similar to that in the placebo-treated group.

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Side Effects by Body System - for Healthcare Professionals

General

Based on limited data, moexipril appears to be generally well-tolerated. Moexipril has been evaluated for safety in more than 2,500 patients with hypertension; more than 250 of these patients were treated for approximately one year. The overall incidence of reported adverse events was only slightly greater in patients treated with moexipril than patients treated with placebo. Less than 4% of patients discontinued therapy due to adverse events.

Cardiovascular

Cardiovascular side effects include symptomatic hypotension, postural hypotension, or syncope in 0.5% of patients. Less commonly associated with moexipril are angina/myocardial infarction, palpitations, rhythm disturbances, and cerebrovascular accidents. Angioedema is a rare side effect that indicates a need to discontinue therapy.

Renal

Renal side effects have included new or worsened renal insufficiency, defined as an increase in serum creatinine to at least 140% of baseline value, reported in 1% and 2% of patients taking moexipril and hydrochlorothiazide-moexipril, respectively.

Gastrointestinal

Gastrointestinal side effects are uncommon, and include abdominal pain, constipation, vomiting, appetite or weight changes, dry mouth, and rare cases of pancreatitis and hepatitis. While elevations of liver enzymes have been reported, the overall incidence of abnormal laboratory values associated with moexipril has been similar to that in placebo-treated groups.

Respiratory

Respiratory side effects have commonly included cough in up to 6% of patients. Cough is the most common reason patients have discontinued therapy. Other respiratory system side effects have included dyspnea and wheezing.

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

Several agents have been studied for treating cough with ACE inhibitors. No long term trials exist to allow a definitive treatment option. Cromolyn has the most data showing some benefit. Other agents studied include baclofen, theophylline, sulindac, and benzonatate.

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.

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.

Nervous system

Nervous system side effects include drowsiness, sleep or taste disturbances, headache, nervousness, mood changes, tinnitus, and anxiety.

Hematologic

Hematologic problems include rare cases of hemolytic anemia. The use of some ACE inhibitors has been associated with agranulocytosis and bone marrow depression.

At least one other ACE inhibitor has been shown to cause agranulocytosis and bone marrow depression. This has only rarely been seen in patients with uncomplicated hypertension, and appears to be more likely in patients with renal insufficiency and/or collagen-vascular disease (such as systemic lupus erythematosus or scleroderma). Although there have been no reported instances of severe neutropenia (absolute neutrophil count < 500/mm3) among treated patients, monitoring of white blood cells should be considered for those patients at higher risk.

Hepatic

Hepatic side effects associated with the use of ACE inhibitors have included a rare syndrome that begins with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. Experts recommend discontinuation of therapy with this drug if jaundice or markedly elevated hepatic serum enzymes develop.

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