AVANZA WITHDRAWAL SYMPTOMS MAY INCLUDE:

aggression, anxiety, balance issues , blurred vision, brain zaps, concentration impairment, constipation, crying spells, depersonalization, diarrhea, dizziness. electric shock sensations, fatigue, flatulence, flu-like symptoms, hallucinations, hostility, highly emotional, indigestion, irritability, impaired speech, insomnia, jumpy nerves, lack of coordination, lethargy, migraine headaches / increased headaches, nausea, nervousness, over-reacting to situations, paranoia, repetitive thoughts or songs, sensory & sleep disturbances, severe internal restlessness (akathisia), stomach cramps, tremors, tinnitus (ear ringing or buzzing), tingling sensations, troubling thoughts, visual hallucinations / illusions, vivid dreams, speech or visual changes, worsened depression

AVANZA SIDE EFFECTS MAY INCLUDE: 

abdominal pain, Chills, Fever, Face Edema, Ulcer, Neck rigidity, Neck pain, Chest pain, Hypertension, Angina, Migraine, Goiter, Hypothyroidism, Thirst or dehydration, Weight loss, Abnormal healing, Diabetes, Arthritis or bursitis, Anxiety, Agitation, Twitching, Hostility, Reflexes increased, Convulsions, Sinusitis, Cough increased, Rash, Acne, Urinary retention

AVANZA ADVERSE REACTIONS MAY INCLUDE: per PDR  

Severe: cholecystitis, bronchospasm, bradycardia, myocardial infarction, exfoliative dermatitis, ocular hypertension, keratoconjunctivitis, hearing loss, muscle paralysis, seizures, GI obstruction, pancreatitis, cirrhosis, tendon rupture, bone fractures, asphyxia, pneumothorax, pulmonary embolism, heart failure, pancytopenia, serotonin syndrome, suicidal ideation, habdomyolysis, ventricular fibrillation, torsade de pointes, agranulocytosis, diabetic ketoacidosis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis

Moderate: hypercholesterolemia, constipation, hypertriglyceridemia, confusion, elevated hepatic enzymes, peripheral edema, hyperreflexia, delirium, dysarthria, ataxia, migraine, mania, hostility, hallucinations, depression, euphoria, dyskinesia, dystonic reaction, stomatitis, colitis, glossitis, dyspnea, angina, hypotension, dehydration, dysuria, hematuria, cystitis, urinary incontinence, impotence (erectile dysfunction), vaginitis, nephrolithiasis, urinary retention, hyperacusis, conjunctivitis, edema, aphasia, nystagmus, myoclonia, hypotonia, gastritis, oral ulceration, candidiasis, bone pain, phlebitis, lymphadenopathy, lymphocytosis, thrombocytopenia, leukopenia, anemia, gout, hyponatremia, diabetes mellitus, skin ulcer, ejaculation dysfunction, goiter, hypothyroidism, blepharitis, withdrawal, amnesia, myasthenia, peripheral vasodilation, hypertension, orthostatic hypotension, QT prolongation, neutropenia, hyperglycemia, bullous rash  

Mild: drowsiness, weight gain, xerostomia, appetite stimulation, asthenia, dizziness, influenza, abnormal dreams, tremor, back pain, myalgia, increased urinary frequency, libido increase, emotional lability, paranoia, eructation, weight loss, nausea, epistaxis, syncope, fever, acne vulgaris, alopecia, xerosis, mastalgia, amenorrhea , dysmenorrhea, leukorrhea, otalgia, ocular pain, chills, headache, diplopia, tongue discoloration, hypersalivation, laryngitis, hiccups, petechiae, seborrhea, urticaria, polyuria, urinary urgency, breast enlargement, menorrhagia, parosmia, dysgeusia, paresthesias, hyperkinesis, hypoesthesia, vertigo, agitation, anxiety, abdominal pain, vomiting, anorexia, arthralgia, sinusitis, cough, polydipsia, rash, pruritus, photosensitivity, malaise, restlessness, infection 

AVANZA BOXED WARNINGS: per PDR:

Children, suicidal ideation

Remeron (Mirtazapine, Avanza) is not FDA-approved for the treatment of depression in adolescents or children; safety and efficacy have not been established. Two manufacturer-sponsored, randomized, double-blind, placebo-controlled clinical trials in pediatric patients 7 to 18 years of age with major depressive disorder (n = 259) failed to demonstrate significant differences between mirtazapine and placebo with regard to the primary endpoint and all secondary endpoints. In October 2004, the FDA directed manufacturers of all antidepressants to add a boxed warning to their product labels detailing the risk of suicide in pediatric patients. The risk of suicidality for these drugs was identified in a pooled analysis of 24 placebo-controlled trials (n = 4,400) lasting up to 16 weeks in pediatric patients with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders. The analysis showed a greater risk of suicidality during the first few months of treatment in those receiving antidepressants. The average risk of such events on drug was 4% and 2% for placebo; however, no suicides occurred in these trials. Pooled analysis of short-term clinical trials during early phase treatment with antidepressants in young adults (18 to 24 years) also showed an increased risk of suicidal thinking and behavior. The clinical need for an antidepressant in pediatrics or young adults for any use must be weighed against the risk of increased suicidality; patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior, particularly within the first few months of starting therapy or during dose changes. It is unknown if the suicidality risk in children or young adults extends to longer-term therapy. The possibility of a suicide attempt is inherent in patients with depressive symptoms, whether these occur in primary depression or in association with another primary disorder. All patients with a history of suicidal ideation or behaviors and those with a prominence of suicidal ideation prior to treatment should be closely monitored during treatment with mirtazapine. In patients who exhibit worsening of depression or suicidality, a decision should be made to change or discontinue treatment. If discontinuing, the medication should be tapered as rapidly as possible, but with recognition that abrupt discontinuation can also cause adverse symptoms. All antidepressants should be prescribed in the smallest quantity consistent with good patient management to reduce the risk of overdose.

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