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| __NOTOC__
| | #REDIRECT [[Mexiletine#Adverse Reactions]] |
| {{Mexiletine}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Adverse Reactions==
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| Mexiletine hydrochloride commonly produces reversible gastrointestinal and nervous system adverse reactions but is otherwise well tolerated. Mexiletine has been evaluated in 483 patients in one month and three month controlled studies and in over 10,000 patients in a large compassionate use program. Dosages in the controlled studies ranged from 600 to 1200 mg/day; some patients (8%) in the compassionate use program were treated with higher daily doses (1600 to 3200 mg/day). In the three month controlled trials comparing mexiletine to[[quinidine]], [[procainamide]] and [[disopyramide]], the most frequent adverse reactions were upper gastrointestinal distress (41%), [[lightheadedness]] (10.5%), [[tremor]](12.6%) and coordination difficulties (10.2%). Similar frequency and incidence were observed in the one month placebo-controlled trial. Although these reactions were generally not serious, and were dose-related and reversible with a reduction in dosage, by taking the drug with food or antacid or by therapy discontinuation, they led to therapy discontinuation in 40% of patients in the controlled trials. Table 1 presents the adverse events reported in the one-month placebo-controlled trial.
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| Table 1: Comparative Incidence (%) of Adverse Events Among Patients Treated With Mexiletine and Placebo in the 4 Week, Double-Blind Crossover Trial
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| Table 2 presents the adverse reactions occurring in one percent or more of patients in the three month controlled studies.
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| Table 2: Comparative Incidence (%) of Adverse Events Among Patients Treated With Mexiletine or Control Drugs in the 12 Week Double-Blind Trials
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| Less than 1%: [[Syncope]], [[edema]], hot flashes, [[hypertension]], short-term memory loss, loss of consciousness, other psychological changes, [[diaphoresis]], [[urinary hesitancy]]/retention, [[malaise]], impotence/decreased libido, [[pharyngitis]], [[congestive heart failure]].
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| An additional group of over 10,000 patients has been treated in a program allowing administration of mexiletine hydrochloride under compassionate use circumstances. These patients were seriously ill with the large majority on multiple drug therapy. Twenty-four percent of the patients continued in the program for one year or longer. Adverse reactions leading to therapy discontinuation occurred in 15 percent of patients (usually upper gastrointestinal system or nervous system effects). In general, the more common adverse reactions were similar to those in the controlled trials. Less common adverse events possibly related to mexiletine use include:
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| ===Cardiovascular System===
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| [[Syncope]] and [[hypotension]], each about 6 in 1000; [[bradycardia]], about 4 in 1000; angina/angina-like pain, about 3 in 1000; edema, atrioventricular block/conduction disturbances and hot flashes, each about 2 in 1000; atrial [[arrhythmias]], [[hypertension]] and cardiogenic shock, each about 1 in 1000.
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| ===Central Nervous System===
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| Short-term memory loss, about 9 in 1000 patients; hallucinations and other psychological changes, each about 3 in 1000; psychosis and [[convulsions]]/[[seizures]], each about 2 in 1000; loss of consciousness, about 6 in 10,000.
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| ===Digestive===
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| Dysphagia, about 2 in 1000; peptic ulcer, about 8 in 10,000; upper gastrointestinal bleeding, about 7 in 10,000; esophageal ulceration, about 1 in 10,000. Rare cases of severe hepatitis/acute hepatic necrosis.
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| ===Skin===
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| Rare cases of exfoliative dermatitis and [[Stevens-Johnson syndrome]] with mexiletine treatment have been reported.
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| ===Laboratory===
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| Abnormal liver function tests, about 5 in 1000; positive ANA and thrombocytopenia, each about 2 in 1000; leukopenia (including neutropenia and agranulocytosis), about 1 in 1000; myelofibrosis, about 2 in 10,000 patients.
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| ===Other===
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| [[Diaphoresis]], about 6 in 1000; altered taste, about 5 in 1000; salivary changes, hair loss and impotence/decreased libido, each about 4 in 1000; malaise, about 3 in 1000; urinary hesitancy/retention, each about 2 in 1000; hiccups, dry skin, laryngeal and pharyngeal changes and changes in oral mucous membranes, each about 1 in 1000; SLE syndrome, about 4 in 10,000.
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| ===Hematology===
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| Blood dyscrasias were not seen in the controlled trials but did occur among 10,867 patients treated with mexiletine in the compassionate use program (seePRECAUTIONS).
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| [[Myelofibrosis]] was reported in two patients in the compassionate use program; one was receiving long-term thiotepa therapy and the other had pretreatment myeloid abnormalities.
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| In postmarketing experience, there have been isolated, spontaneous reports of pulmonary changes including pulmonary infiltration and pulmonary fibrosis during mexiletine therapy with or without other drugs or diseases that are known to produce pulmonary toxicity. A causal relationship to mexiletine therapy has not been established. In addition, there have been isolated reports of [[drowsiness]], [[nystagmus]], [[ataxia]], [[dyspepsia]], [[hypersensitivity reaction]], and exacerbation of congestive [[heart failure]] in patients with preexisting compromised ventricular function. There have been rare reports of [[pancreatitis]] associated with mexiletine treatment.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = MEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=693da40b-26d4-40d6-87d1-158e256f40ab | publisher = | date = | accessdate = 3 March 2014 }}</ref>
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| ==References==
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| {{Reflist}}
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| {{Antiarrhythmic agents}}
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| [[Category:Sodium channel blockers]]
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| [[Category:Phenol ethers]]
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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