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Monopril

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Monopril

Monopril

Monopril Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Monopril (fosinopril sodium) is used to treat high blood pressure (hypertension) or heart failure. It is an ACE (angiotensin converting enzyme) inhibitor. This medication is available in generic form. Common side effects include dizziness or lightheadedness as your body adjusts to the medication. Dry cough may also occur.

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 breast-feeding.

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.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Monopril in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these 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 any of these serious side effects:

  • feeling light-headed, fainting;
  • urinating less than usual, or not at all;
  • fever, chills, body aches, flu symptoms;
  • severe blistering, peeling, and red skin rash;
  • pale skin, easy bruising or bleeding, unusual weakness;
  • pounding or uneven heartbeats;
  • slow heart rate, weak pulse, muscle weakness, tingly feeling;
  • jaundice (yellowing of the skin or eyes);
  • chest pain; or
  • swelling, rapid weight gain.

Less serious side effects may include:

  • cough;
  • muscle or joint pain;
  • dizziness, headache, tired feeling;
  • runny or stuffy nose;
  • 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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Monopril Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness or lightheadedness may occur as your body adjusts to the medication. Dry cough may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: fainting, muscle weakness, signs of infection (such as fever, chills, persistent sore throat), change in the amount of urine.

This drug may rarely cause serious (possibly fatal) liver problems. Tell your doctor right away if you notice any of the following rare but serious side effects: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Monopril (Fosinopril Sodium)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Monopril FDA Prescribing Information: Side Effects
(Adverse Reactions)

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) »

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Monopril - User Reviews

Monopril User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Monopril sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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