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Monopril Side Effects

Generic Name: fosinopril

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

For the Consumer

Applies to fosinopril: oral tablet

In addition to its needed effects, some unwanted effects may be caused by fosinopril (the active ingredient contained in Monopril). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when 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

Some of the side effects that can occur with fosinopril may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Monopril (fosinopril)." Bristol-Myers Squibb, Princeton, NJ.

Not all side effects for Monopril may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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