Norpramin Side Effects

Generic name: desipramine

Note: This document contains side effect information about desipramine. Some of the dosage forms listed on this page may not apply to the brand name Norpramin.

Some side effects of Norpramin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to desipramine: compounding powder, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking desipramine (the active ingredient contained in Norpramin) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• feeling like you might pass out;

• new or worsening chest pain, pounding heartbeats or fluttering in your chest;

• sudden numbness or weakness, problems with vision, speech, or balance;

• fever, sore throat;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• confusion, hallucinations, unusual thoughts or behavior;

• very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors;

• painful or difficult urination;

• seizure (convulsions); or

• upper stomach pain, loss of appetite, jaundice (yellowing of the skin or eyes).

Other common side effects may include:

• tingly feeling, weakness, lack of coordination;

• dry mouth, nausea, vomiting, constipation, diarrhea;

• blurred vision, ringing in your ears;

• breast swelling (in men or women); or

• decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to desipramine: compounding powder, oral tablet

Other

Anticholinergic effects have been reported frequently and include dry mouth, blurry vision, constipation and urinary retention.

Nervous system

Nervous system side effects are common. General stimulation (manifested by insomnia and subjective and objective evidence of increased activity) have been reported frequently. Drowsiness, lightheadedness, dizziness, sleep abnormalities, myoclonus, jitteriness, tremor, delirium, cognitive impairment (especially in the elderly), and seizures have also been reported.

Nearly all selective serotonin reuptake inhibitors, mixed serotonin/norepinephrine reuptake inhibitors, and tricyclic antidepressants cause sleep abnormalities to some extent. These antidepressants have marked dose-dependent effects on rapid eye movement (REM) sleep, causing reductions in the overall amount of REM sleep over the night and delays the first entry into REM sleep (increased REM sleep onset latency (ROL)), both in healthy subjects and depressed patients. The antidepressants that increase serotonin function appear to have the greatest effect on REM sleep. The reduction in REM sleep is greatest early in treatment, but gradually returns towards baseline during long-term therapy; however, ROL remains long. Following discontinuation of therapy the amount of REM sleep tends to rebound. Some of these drugs (i.e., bupropion, mirtazapine, nefazodone, trazodone, trimipramine) appear to have a modest or minimal effect on REM sleep.

Cardiovascular

Orthostatic hypotension, tachycardia, PR interval prolongation, QRS widening, other conduction abnormalities and ventricular arrhythmias have been reported. One study has found a the relative risk of myocardial infarction to be 2.2 times greater in patients receiving tricyclic antidepressants including desipramine (the active ingredient contained in Norpramin)

Both antiarrhythmic and proarrhythmic effects have been reported in association with tricyclic therapy. One case report of a patient who experienced cardiac ischemia while taking desipramine has suggested that genetic differences in drug metabolizing activity may predispose some patients to desipramine- induced cardiotoxicity. Caution should be exercised if desipramine must be used in patients with cardiovascular disease.

General

Weight gain, and less frequently, hair loss have been reported.

Endocrine

Hyponatremia in association with the syndrome of inappropriate secretion of antidiuretic hormone has been reported.

Gastrointestinal

Dry mouth and constipation have been reported most frequently although nausea, vomiting and diarrhea have also occurred.

Other

Although tricyclic antidepressants are not addicting, withdrawal symptoms (such as nervousness, anxiety, restlessness, akathisia, nausea, malaise, sweating and salivation) after abrupt discontinuation of tricyclics may occur. However, withdrawal from desipramine (the active ingredient contained in Norpramin) has been reported less frequently than with other tricyclics.

Hematologic

A case of reversible eosinophilia with neutropenia has been reported.

Hypersensitivity

Hypersensitivity reactions, particularly drug eruptions, have been reported. Bronchospasm has also occurred.

Hepatic

Drug-induced hepatitis and liver function test abnormalities have been rarely reported.

Genitourinary

Urinary retention and male and female sexual dysfunction have been reported.

Dermatologic

A single case of desipramine- induced photosensitive blue- gray pigmentation has been reported.

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