Endep Side Effects

Generic name: amitriptyline

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

Some side effects of Endep 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 amitriptyline: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking amitriptyline (the active ingredient contained in Endep) hives; difficulty 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 a serious side effect such as:

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

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

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

• pounding heartbeats or fluttering in your chest;

• feeling like you might pass out;

• confusion, hallucinations, seizures (convulsions);

• restless muscle movements in your eyes, tongue, jaw, or neck, uncontrollable shaking or tremor;

• extreme thirst with headache, nausea, vomiting, and weakness;

• numbness, burning pain, or tingly feeling;

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

• skin rash, bruising, severe tingling, numbness, pain, muscle weakness;

• urinating less than usual or not at all.

Less serious side effects of amitriptyline may include:

• constipation, diarrhea, loss of appetite;

• dry mouth, unpleasant taste;

• feeling dizzy, drowsy, or tired;

• trouble concentrating;

• nightmares;

• blurred vision, headache, 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 amitriptyline: compounding powder, intramuscular solution, oral tablet

Other

Anticholinergic effects have been reported in more than 50% of patients taking amitriptyline (the active ingredient contained in Endep) and include dry mouth, blurry vision, constipation and urinary retention. In one study, anticholinergic and antimuscarinic side effects occurred in 84% of patients.

Nervous system

Some investigators have estimated an incidence of 4 to 5 tricyclic- induced seizures per 1,000 treated patients.

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.

Nervous system side effects are among the most common. Drowsiness, dizziness, sedation and fatigue occur commonly. Delirium, tinnitus, sleep abnormalities, cognitive impairment (especially in the elderly), a tardive dyskinesia- like syndrome, dystonic reactions and seizures have also been reported.

Cardiovascular

Both antiarrhythmic and proarrhythmic effects have been associated with the use of tricyclic antidepressant therapy. Caution is recommended if amitriptyline (the active ingredient contained in Endep) must be used in patients with cardiovascular disease.

Cardiovascular side effects have included orthostatic hypotension, tachycardia, QRS widening, conduction abnormalities, malignant arrhythmias, and malignant hypertension. Very rare cases of cardiomyopathy have also been reported.

Psychiatric

Psychiatric side effects associated with the use of amitriptyline (the active ingredient contained in Endep) have included hypomania and visual hallucinations. Suicidal ideation, paradoxical aggressiveness, and mental status changes have also been reported with use of this and other tricyclic antidepressants.

Gastrointestinal

A study of 26,005 antidepressant users has reported 2.3 times more upper GI bleeding episodes with the use of non-SSRI's. Upper gastrointestinal tract bleeding was observed in 2.5 times more frequently in patients receiving amitriptyline (the active ingredient contained in Endep)

Gastrointestinal side effects are most likely due to the anticholinergic properties of the drug and commonly include dry mouth (79%) and constipation (55%). Nausea, vomiting, and diarrhea have also been reported. In addition, ischemic colitis has been associated with the use of amitriptyline.

General

Increased appetite and weight gain have been associated with use of amitriptyline (the active ingredient contained in Endep)

Other

Withdrawal symptoms, including nervousness, anxiety, restlessness, akathisia, nausea, malaise, sweating and salivation have been reported after abrupt discontinuation of other tricyclic antidepressants.

Genitourinary

Genitourinary side effects have included urinary retention and sexual dysfunction (including decreased penile circumference and decreased amplitude and duration of nocturnal erections).

Hematologic

Hematologic side effects are rare. Cases of reversible agranulocytosis and eosinophilia have been rarely associated with use of tricyclic antidepressants.

Endocrine

Endocrinologic problems associated with the use of amitriptyline (the active ingredient contained in Endep) are rare, and include hyponatremia in association with the syndrome of inappropriate secretion of antidiuretic hormone.

Hepatic

Hepatic side effects are rare. Elevated liver function tests, drug-induced hepatitis, and acute hepatic necrosis have been rarely reported.

Dermatologic

Dermatologic side effects have included rare cases of rashes and a single report of erythema annulare centrifigum.

Immunologic

Immunologic side effects of amitriptyline (the active ingredient contained in Endep) have included rare associated cases of a lupoid- like reaction.

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