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| __NOTOC__
| | #REDIRECT [[Guanfacine#Adverse Reactions]] |
| {{Guanfacine}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Adverse Reactions==
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| Adverse reactions noted with Tenex (guanfacine hydrochloride) are similar to those of other drugs of the central α2-adrenoreceptor agonist class: dry mouth, sedation (somnolence), weakness (asthenia), dizziness, constipation, and impotence. While the reactions are common, most are mild and tend to disappear on continued dosing.
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| Skin rash with exfoliation has been reported in a few cases; although clear cause and effect relationships to Tenex could not be established, should a rash occur, Tenex should be discontinued and the patient monitored appropriately.
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| In the dose-response monotherapy study described under CLINICAL PHARMACOLOGY, the frequency of the most commonly observed adverse reactions showed a dose relationship from 0.5 to 3 mg as follows:
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| {|
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| |[[File:TENEX01.jpg|thumb|800px]]
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| name="Table_4" style="color: rgb(0, 0, 0); font-family: 'Arial Unicode MS'; font-size: 16px; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: normal; orphans: auto; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: auto; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255);"
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| The percent of patients who dropped out because of adverse reactions are shown below for each dosage group.
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| {|
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| |[[File:TENEX02.jpg|thumb|800px]]
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| The most common reasons for dropouts among patients who received guanfacine were dry mouth, somnolence, dizziness, fatigue, weakness, and constipation.
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| In the 12-week, placebo-controlled, dose-response study of guanfacine administered with 25 mg chlorthalidone at bedtime, the frequency of the most commonly observed adverse reactions showed a clear dose relationship from 0.5 to 3 mg as follows:
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| {|
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| |[[File:TENEX05.jpg|thumb|800px]]
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| There were 41 premature terminations because of adverse reactions in this study. The percent of patients who dropped out and the dose at which the dropout occurred were as follows:
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| {|
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| |[[File:TENEX06.jpg|thumb|800px]]
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| Reasons for dropouts among patients who received guanfacine were: somnolence, headache, weakness, dry mouth, dizziness, impotence, insomnia, constipation, syncope, urinary incontinence, conjunctivitis, paresthesia, and dermatitis.
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| In a second 12-week placebo-controlled combination therapy study in which the dose could be adjusted upward to 3 mg per day in 1-mg increments at 3-week intervals, i.e., a setting more similar to ordinary clinical use, the most commonly recorded reactions were: dry mouth, 47%; constipation, 16%; fatigue, 12%; somnolence, 10%; asthenia, 6%; dizziness, 6%; headache, 4%; and insomnia, 4%.
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| Reasons for dropouts among patients who received guanfacine were: somnolence, dry mouth, dizziness, impotence, constipation, confusion, depression, and palpitations.
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| In the clonidine/guanfacine comparison described in CLINICAL PHARMACOLOGY, the most common adverse reactions noted were as follows:
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| {|
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| |[[File:TENEX03.jpg|thumb|800px]]
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| Adverse reactions occurring in 3% or less of patients in the three controlled trials of Tenex (guanfacine hydrochloride) with a [[diuretic]]were:
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| '''Cardiovascular'''- [[bradycardia]], [[palpitations]], substernal pain
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| '''Gastrointestinal'''- abdominal pain, [[diarrhea]], [[dyspepsia]], [[dysphagia]], [[nausea]]
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| '''CNS'''- [[amnesia]], [[confusion]], [[depression]], [[insomnia]], libido decrease
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| '''ENT disorders'''- [[rhinitis]], taste perversion, [[tinnitus]]
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| '''Eye disorders'''- [[conjunctivitis]], [[iritis]], vision disturbance
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| '''Musculoskeletal'''- leg cramps, [[hypokinesia]]
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| '''Respiratory'''- [[dyspnea]]
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| '''Dermatologic'''- [[dermatitis]], [[pruritus]], [[purpura]], sweating
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| '''Urogenital'''- testicular disorder, urinary incontinence
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| '''Other'''- [[malaise]], [[paresthesia]], [[paresis]]
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| Adverse reaction reports tend to decrease over time. In an open-label trial of one year's duration, 580 hypertensive subjects were given guanfacine, titrated to achieve goal blood pressure, alone (51%), with [[diuretic]](38%), with [[beta blocker]] (3%), with [[diuretic]]plus [[beta blocker]] (6%), or with [[diuretic]]plus vasodilator (2%). The mean daily dose of guanfacine reached was 4.7 mg.
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| {|
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| |[[File:TENEX04.jpg|thumb|800px]]
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| There were 52 (8.9%) dropouts due to adverse effects in this 1-year trial. The causes were: dry mouth (n = 20), weakness (n = 12), [[constipation]] (n = 7), [[somnolence]] (n = 3), [[nausea]] (n = 3), orthostatic [[hypotension]] (n = 2), [[insomnia]] (n = 1), [[rash]] (n = 1), nightmares (n = 1), headache (n = 1), and depression (n = 1).
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| ===Postmarketing Experience===
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| An open-label postmarketing study involving 21,718 patients was conducted to assess the safety of Tenex (guanfacine hydrochloride) 1 mg/day given at bedtime for 28 days. Tenex was administered with or without other antihypertensive agents. Adverse events reported in the postmarketing study at an incidence greater than 1% included dry mouth, [[dizziness]], [[somnolence]], [[fatigue]], [[headache]] and [[nausea]]. The most commonly reported adverse events in this study were the same as those observed in controlled clinical trials.
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| Less frequent, possibly Tenex-related events observed in the postmarketing study and/or reported spontaneously include:
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| '''BODY AS A WHOLE''' [[asthenia]], chest pain, [[edema]], [[malaise]], [[tremor]]
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| '''CARDIOVASCULAR''' [[bradycardia]], [[palpitations]], [[syncope]], [[tachycardia]]
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| '''CENTRAL NERVOUS SYSTEM''' [[paresthesias]], [[vertigo]]
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| '''EYE DISORDERS''' blurred vision
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| '''GASTROINTESTINAL SYSTEM''' abdominal pain, [[constipation]], [[diarrhea]], [[dyspepsia]]
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| '''LIVER AND BILLIARY SYSTEM''' abnormal liver function tests
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| '''MUSCULO-SKELETAL SYSTEM''' [[arthralgia]], leg cramps, leg pain, [[myalgia]]
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| '''PSYCHIATRIC''' [[agitation]], [[anxiety]], [[confusion]], [[depression]], [[insomnia]], [[nervousness]]
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| '''RREPRODUCTIVE SYSTEM''', Male- impotence
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| '''RESPIRATORY SYSTEM''' [[dyspnea]]
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| '''SKIN AND APPENDAGES''' [[alopecia]], [[dermatitis]], exfoliative dermatitis, [[pruritus]], [[rash]]
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| '''SPECIAL SENSES''' alterations in taste
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| '''URINARY SYSTEM''' [[nocturia]], urinary frequency
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| Rare, serious disorders with no definitive cause and effect relationship to Tenex have been reported spontaneously and/or in the postmarketing study. These events include [[acute renal failure]], cardiac fibrillation, cerebrovascular accident, congestive heart failure, heart block, and [[myocardial infarction]].<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = TENEX (GUANFACINE HYDROCHLORIDE) TABLET [PROMIUS PHARMA, LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=886e050c-dd22-4f35-ac3b-243f091125c3#nlm34067-9 | publisher = | date = | accessdate = 25 February 2014 }}</ref>
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| ==References==
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| {{reflist|2}}
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| {{Antihypertensives and diuretics}}
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| {{Antihyperkinetics}}
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| {{Adrenergics}}
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| [[Category:Antihypertensive agents]]
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| [[Category:Guanidines]]
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| [[Category:Alpha-adrenergic agonists]]
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| [[Category:Acetamides]]
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| [[Category:Organochlorides]]
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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