Silenor Side Effects

Generic name: doxepin

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

Some side effects of Silenor 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 doxepin: oral capsule, oral concentrate

Get emergency medical help if you have any of these signs of an allergic reaction while taking doxepin (the active ingredient contained in Silenor) 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:

• fast heart rate;

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

• feeling like you might pass out;

• tremors, restless muscle movements in your eyes, tongue, jaw, or neck;

• confusion, hallucinations, unusual thoughts, seizure (convulsions); or

• painful or difficult urination, urinating less than usual.

Other common side effects may include:

• feeling dizzy, drowsy, or tired;

• nausea, vomiting, constipation;

• dry mouth, blurred vision, ringing in your ears;

• weight gain, increased sweating;

• breast swelling (in men or women); or

• decreased sex drive.

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 doxepin: oral capsule, oral concentrate, oral tablet

Nervous system

Nervous system side effects have been reported more frequently with drowsiness as the most cited adverse effect. Dystonia, myoclonus, worsening of seizure control, hoarseness, aphonia, visual hallucinations, and tinnitus have also been reported. Mania can occur and is a particular risk in patients with bipolar disease.

Other

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

Although doxepin is not addicting, withdrawal symptoms after abrupt discontinuation may occur and include hypertension, tachycardia, restlessness, abdominal distress and emesis. A case of doxepin withdrawal mania has also been reported.

Gastrointestinal

Gastrointestinal side effects have included constipation and dry mouth and less frequently nausea and vomiting.

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 2.0 times more frequently in patients receiving doxepin.

Cardiovascular

The incidence of orthostatic hypotension is thought to be higher with doxepin (the active ingredient contained in Silenor) than with other tricyclic antidepressants. Both antiarrhythmic and proarrhythmic effects have been reported in association with doxepin therapy, however, the incidence of proarrhythmic effects may be lower with doxepin than other tricyclic antidepressants. Caution, however, should be exercised if doxepin must be used in patients with cardiovascular disease.

Cardiovascular side effects have included orthostatic hypotension, tachycardia, syncope, intracardiac conduction blocks, and ventricular arrhythmias. Torsades de pointes tachycardia has been reported in a woman who swallowed 6 g of doxepin in an attempt to commit suicide.

Endocrine

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.

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

Oncologic

Oncologic side effects have included a case of breast cancer occurring in a male taking doxepin (the active ingredient contained in Silenor)

Hematologic

Hematologic side effects have included immune hemolytic anemia and thrombocytopenia.

General

General side effects commonly reported have included weight gain. Anorexia has also been reported.

Hepatic

Hepatic side effects have included induction of cholestatic and hepatic reactions generally related to idiosyncratic hypersensitivity associated with the use of tricyclic antidepressants. Although these have generally been mild, severe injuries with fulminant hepatitis have been reported. A single case report has suggested that doxepin (the active ingredient contained in Silenor) may induce recurrent acute hepatitis.

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