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Monopril

  • Generic Name: fosinopril sodium
  • Brand Name: Monopril

Monopril (Fosinopril Sodium) side effects drug center

PROFESSIONAL

CONSUMER

SIDE EFFECTS

Monopril Side Effects Center

Monopril (fosinopril sodium) is an ACE (angiotensin converting enzyme) inhibitor used to treat high blood pressure (hypertension) or heart failure. Monopril is available in generic form. Common side effects of Monopril include:

Other side effects of Monopril include:

Tell your doctor if you have unlikely but serious side effects of Monopril including:

  • fainting,
  • symptoms of high potassium blood levels (such as muscle weakness, slow or irregular heartbeat),
  • signs of infection (such as fever, chills, persistent sore throat), or
  • changes in the amount of urine.

The recommended initial adult dose of Monopril is 10 mg once a day. The usual dosage range is 20-40 mg but may be up to 80 mg. The recommended dose in children weighing more than 50 kg is 5 to 10 mg once daily. Monopril may interact with gold injections to treat arthritis, lithium, potassium supplement, salt substitutes that contain potassium, or diuretics (water pills). Tell your doctor all medications you are taking. Monopril is not recommended for use during pregnancy. It may harm a fetus. This medication passes into breast milk. Consult your doctor before breastfeeding.

Our Monopril (fosinopril sodium) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Monopril Consumer Information

Get emergency medical help if you have signs of an allergic reaction: 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--nausea, slow or unusual heart rate, weakness, loss of movement.

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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Monopril (Fosinopril Sodium)

 

Monopril Professional Information

SIDE EFFECTS

MONOPRIL (fosinopril sodium) 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 (fosinopril sodium) -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 (fosinopril sodium) -treated and placebo-treated patients, respectively. The most frequent reasons (0.4 to 0.9%) were headache, elevated transaminases, fatigue, cough (see PRECAUTIONS: General, Cough), diarrhea, and nausea and vomiting.

During clinical trials with any MONOPRIL (fosinopril sodium) 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 (fosinopril sodium) alone and at least as frequent on MONOPRIL (fosinopril sodium) as on placebo in placebo-controlled clinical trials are shown in the table below.

Clinical Adverse Events in Placebo-Controlled Trails (Hypertension)

  MONOPRIL (fosinopril sodium)
(N=688)
Incidence (Discontinuation)		 Placebo
(N=184)
Incidence (Discontinuation)
Cough 2.2 (0.4) 0.0 (0.0)
Dizziness 1.6 (0.0) 0.0 (0.0)
Nausea/Vomiting 1.2 (0.4) 0.5 (0.0)

The following events were also seen at > 1% on MONOPRIL (fosinopril sodium) 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 (fosinopril sodium) 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. (See WARNINGS: Head and Neck Angioedema and Intestinal 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 (fosinopril sodium) -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 (fosinopril sodium) -treated and placebo-treated patients, respectively. The most frequent reason for discontinuation of MONOPRIL (fosinopril sodium) was angina pectoris (1.1%). Significant hypotension after the first dose of MONOPRIL (fosinopril sodium) 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 (fosinopril sodium) and at least as common as the placebo group, in placebo-controlled trials are shown in the table below.

Clinical Adverse Events in Placebo-Controlled Trails (Heart Failure)

  MONOPRIL (fosinopril sodium)
(N=361)
Incidence (Discontinuation)		 Placebo
(N=373)
Incidence (Discontinuation)
Dizziness 11.9 (0.6) 5.4 (0.3)
Cough 9.7 (0.8) 5.1 (0.0)
Hypotension 4.4 (0.8) 0.8 (0.0)
Musculoskeletal Pain 3.3 (0.0) 2.7 (0.0)
Nausea/Vomiting 2.2 (0.6) 1.6 (0.3)
Diarrhea 2.2 (0.0) 1.3 (0.0)
Chest Pain (non-cardiac) 2.2 (0.0) 1.6 (0.0)
Upper Respiratory Infection 2.2 (0.0) 1.3 (0.0)
Orthostatic Hypotension 1.9 (0.0) 0.8 (0.0)
Subjective Cardiac Rhythm Disturbance 1.4 (0.6) 0.8 (0.3)
Weakness 1.4 (0.3) 0.5 (0.0)

The following events also occurred at a rate of 1% or more on MONOPRIL (fosinopril sodium) (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 (fosinopril sodium) 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 (see WARNINGS: Anaphylactoid and Possibly Related Reactions and PRECAUTIONS: Hemodialysis).

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, (see PRECAUTIONS); hyponatremia, (see PRECAUTIONS: DRUG INTERACTIONS, Diuretics).

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. (See PRECAUTIONS: General.)

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 (see WARNINGS), 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 (fosinopril sodium) on growth and development have not been studied.

Read the entire FDA prescribing information for Monopril (Fosinopril Sodium)

&Copy; Monopril Patient Information is supplied by Cerner Multum, Inc. and Monopril Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.