Uncommon (0.1% to 1%): Urinary tract infection Postmarketing reports: Pulmonary embolism Genitourinary Very rare (less than 0.01%): Respiratory/pulmonary embolus, asphyxia, laryngitis, pneumothorax, hiccupįrequency not reported: Pharyngitis, rhinitis Rare (0.01% to 0.1%): Epistaxis, bronchitis, asthma, pneumonia Uncommon (0.1% to 1%): Cough increased, sinusitis Postmarketing reports: Increased creatine kinase blood levels, rhabdomyolysis Respiratory Very rare (less than 0.01%): Pathologic fracture, osteoporosis fracture, bone pain, myositis, tendon rupture, arthrosis, bursitis Rare (0.01% to 0.1%): Neck rigidity, neck pain, arthritis, tenosynovitis Uncommon (0.1% to 1%): Myasthenia, arthralgia, twitching ![]() There was a mean increase in heart rate observed in patients given this drug compared to placebo (3.4 bpm versus 0.8 bpm, respectively) however, the clinical significance of this difference is unknown. Postmarketing reports: Ventricular arrhythmia, Torsades de pointes, generalized edema, localized edema Very rare (less than 0.01%): Chest pain substernal, atrial arrhythmia, bigeminy, cardiomegaly, phlebitis, left heart failureįrequency not reported: Chest pain, palpitation, tachycardia, postural hypotension, ECG changes Rare (0.01% to 0.1%): Angina pectoris, myocardial infarction, bradycardia, ventricular extrasystoles, hypotension ![]() Uncommon (0.1% to 1%): Hypertension, vasodilation, orthostatic hypotension Postmarketing reports: Psychomotor restlessness, drug withdrawal symptoms, paroniria CardiovascularĬommon (1% to 10%): Peripheral edema, edema Very rare (less than 0.01%): Drug dependence, psychotic depression, withdrawal syndrome, serotonin syndrome, aggressionįrequency not reported: Nervousness, decreased libido, suicidal ideation, suicidal behavior, somnambulism Rare (0.01% to 0.1%): Delirium, delusions, depersonalization, increased libido, hallucinations, manic reaction/mania, neurosis, hostility, emotional lability, euphoria, paranoid reaction, nightmares/vivid dreams Uncommon (0.1% to 1%): Apathy, depression, agitation, anxiety, insomnia Postmarketing reports: Hypercholesterolemia, hyperlipidemia PsychiatricĬommon (1% to 10%): Abnormal dreams, thinking abnormal, confusion Very rare (less than 0.01%): Gout, acid phosphatase increased, diabetes mellitus, hyponatremiaįrequency not reported: Hypertriglyceridemia Rare (0.01% to 0.1%): Dehydration, weight loss Very common (10% or more): Increased appetite (up to 17%), weight gain (up to 12%) Very rare (less than 0.01%): Tongue discoloration, ulcerative stomatitis, salivary gland enlargement, increased salivation, intestinal obstruction, pancreatitis, aphthous stomatitis, gastritis, gastroenteritis, oral moniliasis, tongue edemaįrequency not reported: Dyspepsia, flatulence, oral paresthesia, mouth edema Metabolic Rare (0.01% to 0.1%): Abdomen enlarged, eructation, glossitis, nausea and vomiting, gum hemorrhage, stomatitis, colitis, oral hypoesthesia Uncommon (0.1% to 1%): Abdominal pain, abdominal syndrome acute, vomiting, diarrhea Very common (10% or more): Dry mouth (up to 25%), constipation (up to 13%) Postmarketing reports: Impaired concentration, cerebrovascular disorder, movement disorders Gastrointestinal Very rare (less than 0.01%): Vascular headache, cerebral ischemia, aphasia, nystagmus, stupor, dementia, paralysis, grand mal convulsion, hypotonia, taste loss, myoclonus, parosmiaįrequency not reported: Hypertonia, taste perversion, convulsions (insults) Rare (0.01% to 0.1%): Syncope, migraine, ataxia, dyskinesia, extrapyramidal syndrome, coordination abnormal, dysarthria, dystonia, reflexes increased, restless legs, akathisia (psychomotor restlessness) Uncommon (0.1% to 1%): Hypesthesia, hypokinesia, vertigo, amnesia, hyperkinesia, paresthesia, lethargy Very common (10% or more): Somnolence (up to 54%)Ĭommon (1% to 10%): Dizziness, tremor, headache, sedation/drowsiness For Healthcare ProfessionalsĪpplies to mirtazapine: oral tablet, oral tablet disintegrating. Somnolence, increased appetite, weight gain, dizziness. (See Worsening of Depression and Suicidality Risk under Cautions.) a b ![]() a bĬlosely monitor pediatric patients who are started on mirtazapine therapy for clinical worsening, suicidality, or unusual changes in behavior involve family members and/or caregivers in this process. a b Mirtazapine is not approved for use in pediatric patients. Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children and adolescents with major depressive disorder and other psychiatric disorders (See Pediatric Use under Cautions) balance this risk with clinical need.
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