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| __NOTOC__
| | #REDIRECT [[Amlodipine#Adverse Reactions]] |
| {{Amlodipine}}
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| {{CMG}}; {{AE}} {{AK}}
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| == Adverse Reactions==
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| === Clinical Trials Experience===
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| 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.
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| 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 clinical trials directly comparing NORVASC (N=1730) at doses up to 10 mg to placebo (N=1250), discontinuation of NORVASC due to adverse reactions was required in only about 1.5% of patients and was not significantly different from placebo (about 1%). The most common side effects are headache and edema. The incidence (%) of side effects that occurred in a dose related manner are as follows:
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| {|
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| |[[image:norvasc1.png|600px|thumb]]
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| Other adverse experiences that were not clearly dose related but were reported with an incidence greater than 1.0% in placebo-controlled clinical trials include the following:
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| |[[image:norvasc2.png|600px|thumb]]
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| 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:
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| |[[image:norvasc3.png|600px|thumb]]
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| 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:
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| '''Cardiovascular:''' arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, hypotension, peripheral ischemia, syncope, tachycardia, postural dizziness, postural hypotension, vasculitis.
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| '''Central and Peripheral Nervous:''' [[hypoesthesia]], [[neuropathy]] peripheral, [[paresthesia]], [[tremor]], [[vertigo]].
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| '''Gastrointestinal:''' [[anorexia]], [[constipation]], [[dyspepsia]],<sup>1</sup> [[dysphagia]], [[diarrhea]], [[flatulence]], [[pancreatitis]], [[vomiting]], [[gingival hyperplasia]].
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| '''General:''' allergic reaction, [[asthenia]],<sup>2</sup> [[back pain]],[[ hot flushes]], [[malaise]], pain, [[rigors]], [[weight gain]], [[weight decrease]].
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| '''Musculoskeletal System:''' [[arthralgia]], [[arthrosis]], [[muscle cramps]],<sup>3</sup> [[myalgia]].
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| '''Psychiatric:'''[[ sexual dysfunction]] (male<sup>4</sup> and female), [[insomnia]], [[nervousness]], [[depression]], abnormal dreams, [[anxiety]], [[depersonalization]].
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| '''Respiratory System:''' [[dyspnea]],<sup>5</sup> [[epistaxis]].
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| '''Skin and Appendages:''' [[angioedema]], [[erythema multiforme]], [[pruritus]],<sup>6</sup> [[rash]],<sup>7</sup> rash [[erythematous]], rash [[maculopapular]].
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| '''Special Senses:''' abnormal vision, [[conjunctivitis]], [[diplopia]], [[eye pain]], [[tinnitus]].
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| '''Urinary System:''' [[micturition]] frequency, micturition disorder, [[nocturia]].
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| '''Autonomic Nervous System:''' dry mouth, sweating increased.
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| '''Metabolic and Nutritional:''' [[hyperglycemia]], [[thirst]].
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| '''Hemopoietic:''' [[leukopenia]], [[purpura]], [[thrombocytopenia]].
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| The following events occurred in <0.1% of patients: [[cardiac failure]], pulse irregularity, [[extrasystoles]], skin discoloration, [[urticaria]], [[skin dryness]], [[alopecia]], [[dermatitis]],[[ muscle weakness]], [[twitching]], [[ataxia]], [[hypertonia]], [[migraine]], cold and clammy skin, [[apathy]], [[agitation]], [[amnesia]], [[gastritis]], increased appetite, loose stools, [[coughing]], [[rhinitis]], [[dysuria]], [[polyuria]], [[parosmia]], [[taste perversion]], abnormal visual accommodation, and [[xerophthalmia]].
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| Other reactions occurred sporadically and cannot be distinguished from medications or concurrent disease states such as [[myocardial infarction]] and [[angina]].
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| 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.
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| In the CAMELOT and PREVENT studies [see [[Amlodipine clinical studies|Clinical Studies (14.4)]]], the adverse event profile was similar to that reported previously (see above), with the most common adverse event being peripheral edema.
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| <sup>1</sup>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.
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| <sup>2</sup>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.
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| <sup>3</sup>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.
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| <sup>4</sup>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.
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| <sup>5</sup>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.
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| <sup>6</sup>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.
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| <sup>7</sup>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.
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| === Postmarketing Experience===
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| 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.
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| 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.
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| 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.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = NORVASC (AMLODIPINE BESYLATE) TABLET [CARDINAL HEALTH] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=44e5ad27-e062-461a-bdf4-192d852fbc49#nlm42230-3 | publisher = | date = | accessdate = 6 March 2014 }}</ref>
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| ==References==
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| {{Reflist|2}}
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| [[Category:Cardiovascular Drugs]] | | [[Category:Cardiovascular Drugs]] |
| [[Category:Drugs]] | | [[Category:Drugs]] |