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February 10, 2012

imipramine, Tofranil, Tofranil-PM (cont.)

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PREGNANCY: Use of imipramine during pregnancy has not been adequately evaluated.

NURSING MOTHERS: Available evidence suggests that imipramine may be excreted in breast milk and may be harmful to the infant.

SIDE EFFECTS: The most common side effects of imipramine are nausea, vomiting, weakness, confusion, anxiety, insomnia, increased heart rate, heart palpitations, blurred vision, difficulty urinating, dry mouth, constipation, weight gain or loss, rash, hives, and impotence.

Serious side effects include high blood pressure, low blood pressure when standing (orthostatic hypotension), fainting, heart attack, stroke, seizures, hepatitis, and abnormal heart beats (arrhythmia).

Imipramine also can cause elevated pressure in the eyes of some patients with glaucoma.

Following prolonged therapy with high doses, abrupt discontinuation of TCAs, including imipramine, could lead to withdrawal symptoms such as nausea, vomiting, diarrhea, or restlessness. Therefore, many experts recommend gradually reducing the dose of drug if the drug is to be discontinued.

Antidepressants increased the risk of suicidal thinking and behavior in short-term studies in children and adolescents with depression and other psychiatric disorders. Anyone considering the use of imipramine  or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be closely observed for clinical worsening, suicidal thinking or behavior, and unusual changes in behavior.

Reference: FDA Prescribing Information


Last Editorial Review: 2/2/2012



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