Monopril Side Effects

Generic name: fosinopril

Note: This document contains side effect information about fosinopril. Some of the dosage forms listed on this page may not apply to the brand name Monopril.

Some side effects of Monopril 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 fosinopril: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking fosinopril (the active ingredient contained in Monopril) hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• sudden weakness or ill feeling, fever, chills, sore throat, painful mouth sores, cough, trouble breathing;

• little or no urinating; or

• high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling).

Common side effects may include:

• cough, runny or stuffy nose;

• muscle or joint pain;

• dizziness, headache, tired feeling;

• nausea, vomiting, diarrhea; or

• mild skin itching or rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to fosinopril: oral tablet

General

General side effects including headache (3.2%) have been reported. Other general side effects including fatigue, weakness, weight gain, sensation of cold, fall, pain and excessive sweating have been reported.

Nervous system

Nervous system side effects have included dizziness (2% to 12%) and headache (up to 3%). Rare nervous system side effects have included lightheadedness, paresthesia, lightheadedness, fatigue, transient ischemic attacks, cerebral infarction, tinnitus, dysgeusia, and sleep disturbance.

Gastrointestinal

Gastrointestinal side effects have occurred in approximately 1% to 2% of patients and have included nausea, general abdominal pain, diarrhea, dysgeusia, and dry mouth. Rare gastrointestinal problems that have been rarely associated with the use of fosinopril (the active ingredient contained in Monopril) have included pancreatitis, dysphagia, abdominal distention, flatulence, constipation, heartburn, and appetite/weight changes.

Cardiovascular

Cardiovascular side effects have most commonly included mild first dose hypotension (2.4%) and orthostatic hypotension (1.4%). Shock (0.2%) has rarely been associated with the use of this drug. Rare cardiovascular problems associated with the use of fosinopril (the active ingredient contained in Monopril) but without clear causal effect, have included angina, myocardial infarction, cerebrovascular accident, hypertensive crisis, rhythm disturbances, palpitations, flushing, sudden death, cardiorespiratory arrest, conduction disorders, syncope, and claudication.

Metabolic

Metabolic effects have included hyperkalemia in 2% of patients and rare reports of gout.

Risk factors for the development of hyperkalemia include preexisting renal disease, diabetes mellitus, and the concomitant use of potassium-sparing diuretics.

Data show that total serum cholesterol and lipoprotein A levels are significantly decreased during fosinopril therapy relative to placebo.

Respiratory

Respiratory side effects have included an idiosyncratic cough in approximately 2% to 10% of patients. Rare cases of asthma, bronchospasm, tracheobronchitis, abnormal breathing, pleuritic chest pain, abnormal vocalization, pharyngitis, sinusitis/rhinitis and laryngitis/hoarseness have been reported.

A rare syndrome of cough, bronchospasm, and eosinophilia is reported in two patients treated with fosinopril.

A retrospective study has revealed a significantly higher incidence of discontinuation of angiotensin converting enzyme inhibitor therapy due to cough among black patients compared to 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.

Renal

Renal impairment is very rare. Essentially no changes in serum creatinine have been reported except for rare cases associated with fosinopril-induced hypotension. Fosinopril-induced renal insufficiency is more likely in patients with a history of congestive heart failure, preexisting renal insufficiency, renal artery stenosis, sodium or intravascular volume depletion or who are on concurrent antihypertensives.

Hepatic

Experts recommend discontinuation of therapy with this drug if jaundice or markedly elevated hepatic serum enzymes develop.

Hepatic side effects associated with the use of fosinopril or other ACE inhibitors have included a rare syndrome that begins with cholestatic jaundice and progresses to fulminant hepatic necrosis and sometimes death. Rare hepatic side effects have included hepatomegaly and hepatitis.

Genitourinary

Genitourinary complaints have included impotence in 1% of male patients. More rare genitourinary complaints have included abnormal urination, kidney pain, renal insufficiency and urinary frequency.

Hematologic

Hematologic side effects including lymphadenopathy, decreases in hematocrit, and increases in the blood urea nitrogen, serum creatinine and serum potassium have been reported. Agranulocytosis and neutropenia, which have occurred with other ACE inhibitors, have not been associated with fosinopril (the active ingredient contained in Monopril) Rare reports of decreased white blood cell counts have been reported.

Immunologic

An 83-year-old lady taking fosinopril (the active ingredient contained in Monopril) 20 mg/day was diagnosed with scleroderma six months after beginning fosinopril therapy and a 59-year-old female taking 20 mg/day was diagnosed with eosinophilic fasciitis five months after beginning therapy. Although it can not be proved, the physician felt that the appearance of these illnesses pointed to fosinopril therapy in each case due to (1) both scleroderma and eosinophilic fasciitis are rare disorders, (2) in both cases, the symptoms appeared a few months after therapy initiation with fosinopril, (3) the second patient with eosinophilic fasciitis presented with a cough one month after beginning fosinopril therapy, (4) the onset in both cases was sudden and progressed rapidly; the clinical course stabilized once the fosinopril was discontinued.

Immunologic side effects including one case of scleroderma and eosinophilic fasciitis has been reported.

Psychiatric

Psychiatric symptoms have included memory disturbances, tremor, confusion, behavior and mood changes, and depression.

Musculoskeletal

Musculoskeletal side effects have included musculoskeletal pain in approximately 3% of patients. Rarely, arthralgias, myalgias/muscle cramp, swelling of an extremities and weakness of an extremity have been reported.

Ocular

Ocular side effects have included vision disturbance and eye irritation.

Dermatologic

Dermatological side effects have included urticaria, rash, photosensitivity, and pruritus.

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