Trazodone Side Effects

Some side effects of trazodone 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 trazodone: oral tablet, oral tablet extended release

Stop taking trazodone and call your doctor at once if you have a penis erection that is painful or lasts 6 hours or longer. This is a medical emergency and could lead to a serious condition that must be corrected with surgery.

Get emergency medical help if you have any of these signs of an allergic reaction while taking trazodone: 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:

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

• agitation, hallucinations, overactive reflexes, nausea, diarrhea, loss of coordination;

• headache with chest pain and severe dizziness, fainting;

• slurred speech, vomiting, severe weakness, muscle cramps, feeling unsteady, seizure (convulsions), shallow breathing (breathing may stop); or

• chest pain or pressure, tight feeling in your neck or jaw, sweating, pain spreading to your arm or shoulder.

Common side effects may include:

• drowsiness, dizziness, memory problems

• mild headache, tired feeling;

• stomach pain, constipation;

• dry mouth, altered sense of taste;

• back pain; or

• blurred vision.

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 trazodone: compounding powder, oral tablet, oral tablet extended release

Nervous system

Nervous system side effects are common and include drowsiness and sedation in as many as 50% of treated patients. Dizziness (10% to 30%), sleep abnormalities, headache, fatigue and, more rarely, seizures, dystonia, akathisia, myoclonus, palinopsia (persistence or reappearance of an image of a recently viewed object), and extrapyramidal symptoms have been reported. One case of serotonin syndrome has been reported which is believed to have been precipitated by the combination of venlafaxine and trazodone.

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.

Psychiatric

Psychiatric side effects have been reported and include mania, paranoia, hypomania (during and following therapy), increased libido, delirium, agitation, psychosis, hallucinations and self- destructive behavior.

Cardiovascular

Cardiovascular side effects including arrhythmias, hypotension, peripheral edema, postural hypotension, ventricular ectopy, ventricular tachycardia, torsades de pointes, rapid atrial fibrillation, heart block, and other conduction abnormalities have been reported.

Some investigators have suggested that trazodone exerts fewer adverse cardiovascular effects than many other antidepressants.

Genitourinary

Genitourinary side effects including priapism, clitoral priapism, ejaculatory inhibition, and anorgasmia have been reported.

Priapism has been rarely reported (0.01% to 0.1%). Priapism has occurred with doses of 50 to 150 mg daily and typically within the first 28 days of treatment. Approximately one-third of affected individuals have required surgical intervention. It has been suggested that trazodone's alpha-adrenergic blocking properties may contribute to the induction of priapism.

One case of spontaneous orgasms in an elderly postmenopausal woman has also been reported.

Other

Anticholinergic (and possibly alpha-adrenergic blocking) side effects have been reported, although much less frequently than with many other antidepressants. The effects reported include dry mouth, blurred vision, constipation, and urinary retention.

Hepatic

Hepatic side effects including cases of chronic active hepatitis and drug-induced hepatotoxicity have been reported rarely.

One case of severe hepatotoxicity followed a four day course of trazodone therapy.

Dermatologic

Dermatologic side effects including erythema multiforme, leukocytoclastic vasculitis, pustular psoriasis, drug eruptions, and acute peripheral edema have been reported rarely.

Hematologic

Hematologic side effects have included alterations in laboratory studies such as significant decreases in hematocrit, hemoglobin, red blood cell count, serum cholesterol, serum calcium, and serum albumin levels. Pseudoanemia (laboratory findings suggestive of anemia without pathologic significance) has been reported in 36% of treated patients.

Endocrine

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

Gastrointestinal

Gastrointestinal side effects have included dry mouth (up to 34%) and constipation.

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