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.
Warning
Oral route (Tablet)
When pregnancy is detected, discontinue fosinopril sodium tablets as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
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]
