Desyrel Side Effects

Generic Name: trazodone

Please note - some side effects for Desyrel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Desyrel - for the Consumer

Desyrel

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Desyrel:

Blurred vision; constipation; decreased appetite; dizziness; drowsiness; dry mouth; general body discomfort; headache; incoordination; light-headedness; muscle aches/pains; nausea; nervousness; sleeplessness; stomach pain; stuffy nose; swelling of the skin; tiredness; tremors.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in urine; chest pain; fainting; hallucinations; irregular heartbeat; light-headedness when rising from a lying or seated position; prolonged, inappropriate, or painful erections; seizures; shortness of breath; stroke; vomiting.

Desyrel Side Effects - for the Professional

Desyrel

Because the frequency of adverse drug effects is affected by diverse factors (eg, drug dose, method of detection, physician judgment, disease under treatment, etc.) a single meaningful estimate of adverse event incidence is difficult to obtain. This problem is illustrated by the variation in adverse event incidence observed and reported from the inpatients and outpatients treated with Desyrel. It is impossible to determine precisely what accounts for the differences observed.

Clinical Trial Reports

The table below is presented solely to indicate the relative frequency of adverse events reported in representative controlled clinical studies conducted to evaluate the safety and efficacy of Desyrel® (trazodone hydrochloride).

The figures cited cannot be used to predict precisely the incidence of untoward events in the course of usual medical practice where patient characteristics and other factors often differ from those which prevailed in the clinical trials. These incidence figures, also, cannot be compared with those obtained from other clinical studies involving related drug products and placebo as each group of drug trials is conducted under a different set of conditions.

Occasional sinus bradycardia has occurred in long-term studies.

In addition to the relatively common (ie, greater than 1%) untoward events enumerated above, the following adverse events have been reported to occur in association with the use of Desyrel® (trazodone hydrochloride) in the controlled clinical studies: akathisia, allergic reaction, anemia, chest pain, delayed urine flow, early menses, flatulence, hallucinations/delusions, hematuria, hypersalivation, hypomania, impaired speech, impotence, increased appetite, increased libido, increased urinary frequency, missed periods, muscle twitches, numbness, and retrograde ejaculation.

Post-Introduction Reports

Although the following adverse reactions have been reported in Desyrel users, the causal association has neither been confirmed nor refuted.

Voluntary reports received since market introduction include the following: abnormal dreams, agitation, alopecia, anxiety, aphasia, apnea, ataxia, breast enlargement or engorgement, cardiospasm, cerebrovascular accident, chills, cholestatis, clitorism, congestive heart failure, diplopia, edema, extrapyramidal symptoms, grand mal seizures, hallucinations, hemolytic anemia, hirsutism, hyperbilirubinemia, increased amylase, increased salivation, insomnia, leukocytosis, leukonychia, jaundice, lactation, liver enzyme alterations, methemoglobinemia, nausea/vomiting (most frequently), paresthesia, paranoid reaction, priapism, pruritus, psoriasis, psychosis, rash, stupor, inappropriate ADH syndrome, tardive dyskinesia, unexplained death, urinary incontinence, urinary retention, urticaria, vasodilation, vertigo and weakness.

Cardiovascular system effects which have been reported include the following: conduction block, orthostatic hypotension and syncope, palpitations, bradycardia, atrial fibrillation, myocardial infarction, cardiac arrest, arrhythmia, and ventricular ectopic activity, including ventricular tachycardia.

Side Effects by Body System

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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