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Side Effects of Norvasc (Amlodipine Besylate) Drug Center - RxList



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8/18/2014
01:30 | Author: Caitlin White

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Side Effects of Norvasc (Amlodipine Besylate) Drug Center - RxList

Report Problems to the Food and Drug Administration.

Central and Peripheral Nervous System: hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo.

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

NORVASC (%) (N=1730) Placebo (%) (N=1250) Fatigue 4.5 2.8 Nausea 2.9 1.9 Abdominal Pain 1.6 0.3 Somnolence 1.4 0.6.

Gastrointestinal: anorexia, constipation, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia.

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Read the Norvasc User Reviews » Share this Article:

Medical Editor: Melissa Conrad Stöppler, MD.

General: allergic reaction, asthenia, 1 back pain, hot flushes, malaise, pain, rigors, weight gain, weight decrease.

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

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Our Norvasc Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

Respiratory System: dyspnea, 1 epistaxis.

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:

Metabolic and Nutritional: hyperglycemia, thirst.

Urinary System: micturition frequency, micturition disorder, nocturia.

What is Prescribing information?

This is not a complete list of side effects and others may occur. You may report side effects to FDA at 1-800-FDA-1088. Call your doctor for medical advice about side effects.

Get tips on handling your hypertension.

NORVASC Placebo Male=% (N=1218) Female=% (N=512) Male=% (N=914) Female=% (N=336) Edema 5.6 14.6 1.4 5.1 Flushing 1.5 4.5 0.3 0.9 Palpitations 1.4 3.3 0.9 0.9 Somnolence 1.3 1.6 0.8 0.3.

Musculoskeletal System: arthralgia, arthrosis, muscle cramps,1 myalgia.

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:

New Procedure May Aid Stubborn High Blood Pressure »

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. The following postmarketing event has been reported infrequently where a causal relationship is uncertain: gynecomastia.

Less serious side effects may include:

Special Senses: abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus.

Read the entire patient information overview for Norvasc (Amlodipine Besylate) ». If you notice other effects not listed above, contact your doctor or pharmacist. You may report side effects to Health Canada at. Many people using this medication do not have serious side effects. Get medical help right away if you experience: worsening chest pain, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating). 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. You may report side effects to FDA at 1-800-FDA-1088. To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. In the US - Call your doctor for medical advice about side effects. 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. In Canada - Call your doctor for medical advice about side effects. A very serious allergic reaction to this drug is rare. l your doctor immediay if any of these unlikely but serious side effects occur: fast/irregular/pounding heartbeat, fainting. Although this medication is effective in preventing chest pain (angina), some people who already have severe heart disease may rarely develop worsening chest pain or a heart attack after starting this medication or increasing the dose.

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.

What is Patient Information Overview?

What is Patient Information in Detail?

Skin and Appendages: angioedema, erythema multiforme, pruritus, 1 rash,1 rash erythematous, rash maculopapular.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This is not a complete list of side effects and others may occur.

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:

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

Read the entire FDA prescribing information for Norvasc (Amlodipine Besylate) »

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

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 creatinine.

Cardiovascular: arrhythmia (including ventricular tachycardia and atrial fibrillation ), bradycardia, chest pain, peripheral ischemia, syncope, tachycardia, vasculitis.

Call your doctor at once if you have a serious side effect such as:

and foreign clinical trials. NORVASC has been evaluated for safety in more than 11,000 patients in U.S. The incidence (%) of side effects that occurred in a dose related manner are as follows:. The most commonly reported side effects more frequent than placebo are reflected in the table below. 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 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%).

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 (amlodipine) is a medication that belongs to the calcium channel blockers (CCBs) class of drugs. Side effects of Norvasc are generally mild and reversible and include headache and swelling (edema) of the lower extremities. Norvasc is available as a generic drug, and is prescribed for the prevention and treatment of heart pain or chest pain from angina, and for the treatment of high blood pressure.

Psychiatric: sexual dysfunction (male1 and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization.

Hemopoietic: leukopenia, purpura, thrombocytopenia.

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.

Amlodipine Placebo N=520 2.5 mg N=275 5 mg N=296 10 mg N=268 Edema 1.8 3.0 10.8 0.6 Dizziness 1.1 3.4 3.4 1.5 Flushing 0.7 1.4 2.6 0.0 Palpitation 0.7 1.4 4.5 0.6.

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.

Here is a collection of user reviews for the medication Norvasc sorted by most helpful.

Drug interactions and warnings in patients with severe coronary artery disease can increase the frequency and severity of angina or actually cause a heart attack on rare occasions. Excessive lowering of blood pressure during initiation of Norvasc treatment can occur (especially in patients taking another blood pressure medication with Norvasc). Norvasc dosages may need to be lowered in patients with liver dysfunction. Norvasc is generally avoided during pregnancy and mothers nursing an infant. This reaction usually occurs when first starting Norvasc or at the time of dosage increase.

Read the entire detailed patient monograph for Norvasc (Amlodipine Besylate) »

Autonomic Nervous System: dry mouth, sweating increased.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.


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