Monopril Side Effects

Generic Name: fosinopril

Please note - some side effects for Monopril may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Monopril - for the Consumer

Monopril HCT

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 Monopril HCT:

Dizziness or lightheadedness when sitting up or standing; dry cough.

Severe allergic reactions (rash; hives; itching; difficulty swallowing or breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); blurred vision or other vision changes; change in the amount of urine produced; chest pain; confusion; dark urine; dry mouth; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; increase in thirst, hunger, or urination; joint pain or swelling, especially in the big toe; loss of coordination; mental or mood changes (eg, depression); muscle cramps, pain, or weakness; numbness or tingling; one-sided weakness; red, swollen, blistered, or peeling skin; severe or persistent cough; severe or persistent headache, dizziness, or lightheadedness; severe or persistent nausea, vomiting, or stomach pain; slurred speech; tremor; unusual bruising or bleeding; unusual weakness; yellowing of the skin or eyes.

Monopril

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 Monopril:

Cough; dizziness; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the hands, eyes, mouth, face, lips, or tongue; unusual hoarseness); chest pain; confusion; dark urine; decreased urination; difficulty swallowing; fast, slow, or irregular heartbeat; mental or mood changes; muscle pain or cramping; numbness of an arm or leg; one-sided weakness; slurred speech; stomach pain (with or without nausea or vomiting); symptoms of infection (eg, fever, chills, persistent sore throat); symptoms of low blood pressure (eg, fainting, severe dizziness, lightheadedness); vision changes; yellowing of the skin or eyes.

Monopril Side Effects - for the Professional

Monopril

Monopril has been evaluated for safety in more than 2100 individuals in hypertension and heart failure trials, including approximately 530 patients treated for a year or more. Generally adverse events were mild and transient, and their frequency was not prominently related to dose within the recommended daily dosage range.

Hypertension

In placebo-controlled clinical trials (688 Monopril-treated patients), the usual duration of therapy was 2 to 3 months. Discontinuations due to any clinical or laboratory adverse event were 4.1% and 1.1% in Monopril-treated and placebo-treated patients, respectively. The most frequent reasons (0.4 to 0.9%) were headache, elevated transaminases, fatigue, cough, diarrhea, and nausea and vomiting.

During clinical trials with any Monopril regimen, the incidence of adverse events in the elderly (≥65 years old) was similar to that seen in younger patients.

Clinical adverse events probably or possibly related or of uncertain relationship to therapy, occurring in at least 1% of patients treated with Monopril alone and at least as frequent on Monopril as on placebo in placebo-controlled clinical trials are shown in the table below.

The following events were also seen at >1% on Monopril but occurred in the placebo group at a greater rate: headache, diarrhea, fatigue, and sexual dysfunction. Other clinical events probably or possibly related, or of uncertain relationship to therapy occurring in 0.2 to 1.0% of patients (except as noted) treated with Monopril in controlled or uncontrolled clinical trials (N=1479) and less frequent, clinically significant events include (listed by body system):

General: Chest pain, edema, weakness, excessive sweating.

Cardiovascular: Angina/myocardial infarction, cerebrovascular accident, hypertensive crisis, rhythm disturbances, palpitations, hypotension, syncope, flushing, claudication.

Orthostatic hypotension occurred in 1.4% of patients treated with fosinopril monotherapy. Hypotension or orthostatic hypotension was a cause for discontinuation of therapy in 0.1% of patients.

Dermatologic: Urticaria, rash, photosensitivity, pruritus.

Endocrine/Metabolic: Gout, decreased libido.

Gastrointestinal: Pancreatitis, hepatitis, dysphagia, abdominal distention, abdominal pain, flatulence, constipation, heartburn, appetite/weight change, dry mouth.

Hematologic: Lymphadenopathy.

Immunologic: Angioedema.

Musculoskeletal: Arthralgia, musculoskeletal pain, myalgia/muscle cramp.

Nervous/Psychiatric: Memory disturbance, tremor, confusion, mood change, paresthesia, sleep disturbance, drowsiness, vertigo.

Respiratory: Bronchospasm, pharyngitis, sinusitis/rhinitis, laryngitis/hoarseness, epistaxis. A symptom-complex of cough, bronchospasm, and eosinophilia has been observed in two patients treated with fosinopril.

Special Senses: Tinnitus, vision disturbance, taste disturbance, eye irritation.

Urogenital: Renal insufficiency, urinary frequency.

Heart Failure

In placebo-controlled clinical trials (361 Monopril-treated patients), the usual duration of therapy was 3-6 months. Discontinuations due to any clinical or laboratory adverse event, except for heart failure, were 8.0% and 7.5% in Monopril-treated and placebo-treated patients, respectively. The most frequent reason for discontinuation of Monopril was angina pectoris (1.1%). Significant hypotension after the first dose of Monopril occurred in 14/590 (2.4%) of patients; 5/590 (0.8%) patients discontinued due to first dose hypotension.

Clinical adverse events probably or possibly related or of uncertain relationship to therapy, occurring in at least 1% of patients treated with Monopril and at least as common as the placebo group, in placebo-controlled trials are shown in the table below.

The following events also occurred at a rate of 1% or more on Monopril (fosinopril sodium tablets) but occurred on placebo more often: fatigue, dyspnea, headache, rash, abdominal pain, muscle cramp, angina pectoris, edema, and insomnia.

The incidence of adverse events in the elderly (≥65 years old) was similar to that seen in younger patients.

Other clinical events probably or possibly related, or of uncertain relationship to therapy occurring in 0.4 to 1.0% of patients (except as noted) treated with Monopril in controlled clinical trials (N=516) and less frequent, clinically significant events include (listed by body system):

General: Fever, influenza, weight gain, hyperhidrosis, sensation of cold, fall, pain.

Cardiovascular: Sudden death, cardiorespiratory arrest, shock (0.2%), atrial rhythm disturbance, cardiac rhythm disturbances, non-anginal chest pain, edema lower extremity, hypertension, syncope, conduction disorder, bradycardia, tachycardia.

Dermatologic: Pruritus.

Endocrine/Metabolic: Gout, sexual dysfunction.

Gastrointestinal: Hepatomegaly, abdominal distention, decreased appetite, dry mouth, constipation, flatulence.

Immunologic: Angioedema (0.2%).

Musculoskeletal: Muscle ache, swelling of an extremity, weakness of an extremity.

Nervous/Psychiatric: Cerebral infarction, TIA, depression, numbness, paresthesia, vertigo, behavior change, tremor.

Respiratory: Abnormal vocalization, rhinitis, sinus abnormality, tracheobronchitis, abnormal breathing, pleuritic chest pain.

Special Senses: Vision disturbance, taste disturbance.

Urogenital: Abnormal urination, kidney pain.

Fetal/Neonatal Morbidity and Mortality

See WARNINGS: Fetal/Neonatal Morbidity and Mortality.

Potential Adverse Effects Reported with ACE Inhibitors

Body as a whole: Anaphylactoid reactions.

Other medically important adverse effects reported with ACE inhibitors include: Cardiac arrest; eosinophilic pneumonitis; neutropenia/agranulocytosis, pancytopenia, anemia (including hemolytic and aplastic), thrombocytopenia; acute renal failure; hepatic failure, jaundice (hepatocellular or cholestatic); symptomatic hyponatremia; bullous pemphigus, exfoliative dermatitis; a syndrome which may include: arthralgia/arthritis, vasculitis, serositis, myalgia, fever, rash or other dermatologic manifestations, a positive ANA, leukocytosis, eosinophilia, or an elevated ESR.

Laboratory Test Abnormalities

Serum Electrolytes: Hyperkalemia,; hyponatremia,.

BUN/Serum Creatinine: Elevations, usually transient and minor, of BUN or serum creatinine have been observed. In placebo-controlled clinical trials, there were no significant differences in the number of patients experiencing increases in serum creatinine (outside the normal range or 1.33 times the pre-treatment value) between the fosinopril and placebo treatment groups. Rapid reduction of longstanding or markedly elevated blood pressure by any antihypertensive therapy can result in decreases in the glomerular filtration rate, and in turn, lead to increases in BUN or serum creatinine.

Hematology: In controlled trials, a mean hemoglobin decrease of 0.1 g/dL was observed in fosinopril-treated patients. In individual patients decreases in hemoglobin or hematocrit were usually transient, small, and not associated with symptoms. No patient was discontinued from therapy due to the development of anemia. Other: Neutropenia, leukopenia and eosinophilia.

Liver Function Tests: Elevations of transaminases, LDH, alkaline phosphatase, and serum bilirubin have been reported. Fosinopril therapy was discontinued because of serum transaminase elevations in 0.7% of patients. In the majority of cases, the abnormalities were either present at baseline or were associated with other etiologic factors. In those cases which were possibly related to fosinopril therapy, the elevations were generally mild and transient and resolved after discontinuation of therapy.

Pediatric Patients

The adverse experience profile for pediatric patients is similar to that seen in adult patients with hypertension. The long-term effects of Monopril on growth and development have not been studied.

Side Effects by Body System

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 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, 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. Rare reports of decreased white blood cell counts have been reported.

Immunologic

An 83-year-old lady taking fosinopril 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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