Asendin Side Effects

Generic name: amoxapine

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

Some side effects of Asendin 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 amoxapine: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking amoxapine (the active ingredient contained in Asendin) 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.

Stop taking amoxapine and call your doctor at once if you have a serious side effect such as:

• very stiff (rigid) muscles, high fever, sweating, confusion, tremors, feeling like you might pass out;

• pounding heartbeats or fluttering in your chest;

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

• sudden numbness or weakness, especially on one side of the body; or

• sudden severe headache, confusion, problems with vision, speech, or balance.

Less serious side effects of amoxapine may include:

• drowsiness, dizziness, headache, tired feeling;

• feeling restless or nervous;

• dry mouth, blurred vision;

• mild nausea, constipation;

• increased appetite, weight changes;

• increased sweating; or

• sleep problems (insomnia), night mares.

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 amoxapine: oral tablet

Nervous system

Nervous system side effects have included drowsiness (14%), anxiety, dizziness, headache, fatigue, weakness, insomnia, sleep abnormalities, restlessness, nervousness, tremors, confusion, excitement, nightmares, and alterations in the EEG patterns.

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.

Gastrointestinal

Gastrointestinal side effects have included dry mouth (14%), constipation (12%), nausea, and excessive appetite.

Ocular

Ocular side effects have included blurred vision (7%).

Cardiovascular

Cardiovascular side effects have included palpitations.

Musculoskeletal

Musculoskeletal side effects have included ataxia.

Hypersensitivity

Hypersensitivity side effects have included edema.

Dermatologic

Dermatologic side effects have included excessive perspiration and skin rash.

Endocrine

Endocrine side effects have included elevation of prolactin levels and hyponatremia (in association with the syndrome of inappropriate secretion of antidiuretic hormone).

A retrospective register study of the World Health Organization (WHO) database for spontaneous reporting of adverse drug reactions (n=668) suggests that the risk of hyponatremia during treatment with antidepressants seems to be highest in women, in the elderly, during the summer season, and during the first weeks of therapy.

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