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Does Norvasc (amlodipine besylate) cause side effects?
Norvasc (amlodipine) is a calcium channel blocker (CCB) used to treat and prevent angina resulting from coronary spasm as well as from exertion. Norvasc is also used to treat high blood pressure (hypertension).
Chest pain or heart pain (angina) occurs because of insufficient oxygen delivered to the heart muscles. Insufficient oxygen may be a result of coronary artery blockage or spasm, or because of exertion which increases the need of the heart for oxygen in patients with coronary artery narrowing (coronary artery disease or atherosclerosis).
Common side effects of Norvasc include:
Serious side effects of Norvasc include:
Use of Norvasc significantly increases blood levels of simvastatin.
The following, combined with Norvasc, results in excessive blood pressure reduction:
Generally, Norvasc is avoided in pregnancy, and by nursing mothers and children although there are no adequate studies of Norvasc use during pregnancy. It is unknown if Norvasc is excreted in breast milk.
What are the side effects of Norvasc (amlodipine besylate)?
Side effects of amlodipine are generally mild and reversible. The two most common side effects are:
Other side effects include:
More serious side effects include:
Increase in the frequency and severity of angina or heart attack due to amlodipine happens on rare occasions in patients with severe coronary artery disease when first starting amlodipine, or at the time of an increase in dosage.
Excessive lowering of blood pressure during initiation of amlodipine treatment can occur, especially in patients already taking other medications that lower blood pressure.
In rare instances, congestive heart failure has been associated with amlodipine, particularly in patients already taking a beta blocker.
Norvasc (amlodipine besylate) side effects list for healthcare professionals
Clinical Trials Experience
- Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
- Norvasc has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials.
- In general, treatment with Norvasc was well-tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with Norvasc were of mild or moderate severity.
- In controlled reactions reported during therapy with Norvasc were of mild or moderate severity.
- In controlled clinical trials directly comparing Norvasc (N=1730) at doses up to 10 mg to placebo (N=1250), discontinuation of Norvasc because of adverse reactions was required in only about 1.5% of patients and was not significantly different from placebo (about 1%).
- The most commonly reported side effects more frequent than placebo are reflected in the table below. The incidence (%) of side effects that occurred in a dose related manner are as follows:
Other adverse reactions that were not clearly dose related but were reported with an incidence greater than 1.0% in placebo-controlled clinical trials include the following:
For several adverse experiences that appear to be drug and dose related, there was a greater incidence in women than men associated with amlodipine treatment as shown in the following table:
The following events occurred in <1% but >0.1% of patients in controlled clinical trials or under conditions of open trials or marketing experience where a causal relationship is uncertain; they are listed to alert the physician to a possible relationship:
Respiratory System: dyspnea,1 epistaxis.
Urinary System: micturition frequency, micturition disorder, nocturia.
Hemopoietic: leukopenia, purpura, thrombocytopenia.
Norvasc therapy has not been associated with clinically significant changes in routine laboratory tests. No clinically relevant changes were noted in:
- serum potassium,
- serum glucose,
- total triglycerides,
- total cholesterol,
- HDL cholesterol,
- uric acid,
- blood urea nitrogen, or
In the CAMELOT and PREVENT studies, the adverse event profile was similar to that reported previously (see above), with the most common adverse event being peripheral edema.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following postmarketing event has been reported infrequently where a causal relationship is uncertain: gynecomastia. In postmarketing experience, jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis), in some cases severe enough to require hospitalization, have been reported in association with use of amlodipine.
Postmarketing reporting has also revealed a possible association between extrapyramidal disorder and amlodipine.
Norvasc has been used safely in patients with:
- chronic obstructive pulmonary disease,
- well-compensated congestive heart failure,
- coronary artery disease,
- peripheral vascular disease,
- diabetes mellitus, and
- abnormal lipid profiles.
1 These events occurred in less than 1% in placebo-controlled trials, but the incidence of these side effects was between 1% and 2% in all multiple dose studies.
What drugs interact with Norvasc (amlodipine besylate)?
Impact Of Other Drugs On Amlodipine
Co-administration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. Monitor for symptoms of hypotension and edema when amlodipine is co-administered with CYP3A inhibitors to determine the need for dose adjustment.
No information is available on the quantitative effects of CYP3A inducers on amlodipine. Blood pressure should be closely monitored when amlodipine is co-administered with CYP3A inducers.
Impact Of Amlodipine On Other Drugs
Co-administration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily.
Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered. Frequent monitoring of trough blood levels of cyclosporine and tacrolimus is recommended and adjust the dose when appropriate.
Norvasc (amlodipine) is a calcium channel blocker (CCB) used to treat and prevent angina resulting from coronary spasm as well as from exertion. Norvasc is also used to treat high blood pressure (hypertension). Common side effects of Norvasc include headache, swelling of the lower extremities, dizziness, flushing, fatigue, nausea, and palpitations. Generally, Norvasc is avoided in pregnancy, and by nursing mothers and children although there are no adequate studies of Norvasc use during pregnancy. It is unknown if Norvasc is excreted in breast milk.
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Hypertension-Related Kidney Disease
Second Source WebMD Medical Reference
Angina is chest pain due to inadequate blood supply to the heart. Angina symptoms may include chest tightness, burning, squeezing, and aching. Coronary artery disease is the main cause of angina but there are other causes. Angina is diagnosed by taking the patient's medical history and performing tests such as an electrocardiogram (EKG), blood test, stress test, echocardiogram, cardiac CT scan, and heart catheterization. Treatment of angina usually includes lifestyle modification, medication, and sometimes, surgery. The risk of angina can be reduced by following a heart healthy lifestyle.
High Blood Pressure (Hypertension) Signs, Causes, Diet, and Treatment
High blood pressure (hypertension) is a disease in which pressure within the arteries of the body is elevated. About 75 million people in the US have hypertension (1 in 3 adults), and only half of them are able to manage it. Many people do not know that they have high blood pressure because it often has no has no warning signs or symptoms. Systolic and diastolic are the two readings in which blood pressure is measured. The American College of Cardiology released new guidelines for high blood pressure in 2017. The guidelines now state that blood normal blood pressure is 120/80 mmHg. If either one of those numbers is higher, you have high blood pressure. The American Academy of Cardiology defines high blood pressure slightly differently. The AAC considers 130/80 mm Hg. or greater (either number) stage 1 hypertension. Stage 2 hypertension is considered 140/90 mm Hg. or greater. If you have high blood pressure you are at risk of developing life threatening diseases like stroke and heart attack.REFERENCE: CDC. High Blood Pressure. Updated: Nov 13, 2017.
Pulmonary hypertension is elevated pressure in the pulmonary arteries that carry blood from the lungs to the heart. The most common symptoms are fatigue and difficulty breathing. If the condition goes undiagnosed, more severe symptoms may occur. As pulmonary hypertension worsens, some people with the condition have difficulty performing any activities that require physical exertion. While there is no cure for pulmonary hypertension, it can be managed and treated with medications and supplemental oxygen to increase blood oxygen levels.
Hypertensive Kidney Disease
High blood pressure can damage the kidneys and is one of the leading causes of kidney failure (end-stage renal kidney disease). Kidney damage, like hypertension, can be unnoticeable and detected only through medical tests. If you have kidney disease, you should control your blood pressure. Other treatment options include prescription medications.
Herpangina is a contagious illness often seen in children. It is caused by a Coxsackievirus or an enterovirus. Symptoms and signs include mouth sores, fever, and sore throat. Treatment focuses on alleviating fever and pain with acetaminophen and ibuprofen. It is important for children to stay well hydrated, as children may be resistant to eating or drinking.
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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.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.