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

Applies to fosinopril: oral tablet.

Serious side effects of Monopril

Along with its needed effects, fosinopril (the active ingredient contained in Monopril) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking fosinopril:

Less common

• Blurred vision
• chest pain or discomfort
• chills
• cold sweats
• confusion
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• fast, slow, or irregular heartbeat
• pounding or rapid pulse
• sweating
• unusual tiredness or weakness

Other side effects of Monopril

Some side effects of fosinopril may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Cough

Less common

• Body aches or pain
• diarrhea
• difficult breathing
• ear congestion
• fever
• headache
• loss of voice
• muscle or bone pain
• nasal congestion
• nausea and vomiting
• runny nose
• sneezing
• sore throat
• weakness

For Healthcare Professionals

Applies to fosinopril: oral tablet.

General

Adverse events were generally mild and transient, and their frequency was not prominently related to dose within the recommended daily dosage range.^[Ref]

Dermatologic

Common (1% to 10%): Rash, angioedema, dermatitis

Uncommon (0.1% to 1%): Urticaria, photosensitivity, pruritus, excessive sweating/hyperhidrosis

Rare (less than 0.1%): Ecchymosis

Frequency not reported: Bullous pemphigus, exfoliative dermatitis^[Ref]

Cardiovascular

Common (1% to 10%): Orthostatic hypotension, angina pectoris, hypotension, atrial/cardiac rhythm disturbances, tachycardia

Uncommon (0.1% to 1%): Myocardial infarction, hypertensive crisis, palpitations, flushing, claudication, cardiorespiratory arrest, shock, non-anginal chest pain, hypertension, conduction disorder, bradycardia, cardiac arrest, conduction disturbances, transitory ischemia

Rare (less than 0.1%): Hemorrhage, peripheral vascular disease

Frequency not reported: Vasculitis^[Ref]

Nervous system

Very common (10% or more): Dizziness (up to 11.9%)

Common (1% to 10%): Headache

Uncommon (0.1% to 1%): Tremor, paresthesia, drowsiness, cerebrovascular accident, syncope, memory disturbance, taste disturbance/dysgeusia, cerebral infarction, transient ischemic attack (TIA), numbness, somnolence, stroke

Rare (less than 0.1%): Dysphasia^[Ref]

Respiratory

Common (1% to 10%): Cough, dyspnea, upper respiratory infection

Uncommon (0.1% to 1%): Bronchospasm, pharyngitis, sinusitis, rhinitis, laryngitis/hoarseness, epistaxis, abnormal vocalization, sinus abnormality, abnormal breathing, pleuritic chest pain, tracheobronchitis

Rare (less than 0.1%): Pneumonia, pulmonary congestion

Frequency not reported: Eosinophilic pneumonitis^[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting, diarrhea, abdominal pain

Uncommon (0.1% to 1%): Pancreatitis, dysphagia, abdominal distention, flatulence, constipation, heartburn, appetite changes, dry mouth

Rare (0.01% to 0.1%): Oral lesions, swollen tongue

Very rare (less than 0.01%): Intestinal angioedema, sub-ileus^[Ref]

Metabolic

Common (1% to 10%): Elevated alkaline phosphatase, elevated lactate dehydrogenase

Uncommon (0.1% to 1%): Gout, hyperkalemia, increased blood urea, decreased appetite, weight increase

Rare (less than 0.1%): Hyponatremia

Frequency not reported: Symptomatic hyponatremia^[Ref]

Renal

Uncommon (0.1% to 1%): Renal insufficiency, kidney pain, renal failure, increased serum creatinine

Very rare (less than 0.01%): Acute renal failure

Frequency not reported: Elevated BUN^[Ref]

Hepatic

Common (1% to 10%): Increased serum bilirubin, elevated transaminases

Uncommon (0.1% to 1%): Hepatitis, hepatomegaly

Very rare (less than 0.01%): Hepatic failure

Frequency not reported: Hepatocellular jaundice, cholestatic jaundice^[Ref]

Genitourinary

Common (1% to 10%): Sexual dysfunction

Uncommon (0.1% to 1%): Urinary frequency, abnormal urination, proteinuria

Rare (less than 0.1%): Prostatic disorders^[Ref]

Hematologic

Uncommon (0.1% to 1%): Lymphadenopathy, transient decreased hemoglobin, decreased hematocrit

Rare (0.01% to 0.1%): Eosinophilia, leukopenia, neutropenia, thrombocytopenia, transient anemia

Very rare (less than 0.01%): Agranulocytosis

Frequency not reported: pancytopenia, hemolytic anemia, aplastic anemia, leukocytosis, elevated erythrocyte sedimentation rate (ESR)^[Ref]

Psychiatric

Common (1% to 10%): Insomnia

Uncommon (0.1% to 1%): Mood change, decreased libido, confusion, sleep disturbance, depression, behavior change

Rare (less than 0.1%): Disorientation^[Ref]

Musculoskeletal

Common (1% to 10%): Muscle cramp, musculoskeletal pain

Uncommon (0.1% to 1%): Arthralgia, myalgia, muscle ache, weakness of an extremity

Rare (less than 0.1%): Arthritis^[Ref]

Ocular

Uncommon (0.1% to 1%): Vision disturbance, eye irritation^[Ref]

Other

Common (1% to 10%): Fatigue, edema, non-cardiac chest pain, weakness, viral infection

Uncommon (0.1% to 1%): Vertigo, tinnitus, ear ache, fever, influenza-like syndrome, weight gain, sensation of cold, fall, pain, sudden death, lower extremity edema, swelling of extremity, peripheral edema, thoracic pain

Rare (less than 0.1%): Weakness in one extremity

Frequency not reported: Serositis^[Ref]

Immunologic

Frequency not reported: Anaphylactoid reactions, positive antinuclear antibodies (ANA)^[Ref]