drowsiness, dizziness, dry mouth, blurred vision, constipation, weight gain, or trouble urinating, myocardial infarction, arrhythmia, hypotension, hypertension, palpitation, tachycardia, coma, seizures, hallucinations; delusions, confused states; disorientation, incoordination, tremors, peripheral neuropathy, abnormal involuntary movements, tardive dyskinesia, dysarthria, disturbed concentration, anxiety, insomnia, restlessness, nightmares, drowsiness, dizziness, weakness, fatigue, headache, syndrome of inappropriate ADH secretion, tinnitus, hyperpyrexia, urinary retention, dilation of urinary tract, constipation, blurred vision, increased ocular pressure, skin rash, urticarial, edema of face and tongue, bone marrow depression, nausea, vomiting, anorexia, stomatitis; peculiar taste, diarrhea, black tongue, testicular swelling, breast enlargement – female, increased or decreased libido, impotence, elevation and lowering of blood sugar levels, alopecia, weight gain or loss, urinary frequency, increased perspiration

The safety and efficacy of amitriptyline (ELAVIL) for the treatment of depression have not been established in children less than 12 years of age. In October 2004, the FDA directed manufacturers of all antidepressants to include a boxed warning detailing the risk of suicide in pediatric patients, including children and adolescents less than 18 years of age, as well as young adults. A causal role has been established for antidepressants in inducing suicidality in pediatric patients. The risk of suicidality for these drugs was identified in a pooled analysis of 24 placebo-controlled trials (n = 4400) 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 (SSRIs and others). 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 SSRIs and other 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 children 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 at the time of dose increase or decrease; such observation would generally include at least weekly face-to-face contact with patients during the first 4 weeks of treatment, then every other week visits for the next 4 weeks, then at 12 weeks, and as clinically indicated beyond 12 weeks; additional contact by telephone may be appropriate between visits. It is unknown if the suicidality risk in children and young adults extends to longer-term therapy (i.e., beyond several months). 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 psychiatric disorder. All patients with a history of suicidal ideation or behaviors and those with a prominence of suicidal ideation prior to treatment are considered at an increased risk for suicidal ideation or attempts, and should be closely monitored during treatment with amitriptyline. In patients who exhibit changes in symptoms, worsening of depression or suicidality, a decision should be made to change or discontinue treatment. If discontinuing, medication should be tapered as rapidly as possible, but with recognition that abrupt discontinuation can also cause adverse symptoms. Antidepressants should be prescribed in the smallest quantity consistent with good patient management in order to reduce the risk of overdose.