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Side Effects > Desyrel

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).


For the consumer

For the professional

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Desyrel:

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.

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For the professional


Desyrel

Because the frequency of adverse drug effects is affected by diverse factors (e.g., 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.

Treatment-Emergent Symptom Incidence
Inpts. Outpts.
D P D P
* Incidence less than 1%
D = Desyrel P = PLACEBO
Number of Patients 142 95 157 158
% of Patients Reporting
Allergic
   Skin Condition/Edema 2.8 1.1 7.0 1.3
Autonomic
   Blurred Vision 6.3 4.2 14.7 3.8
   Constipation 7.0 4.2 7.6 5.7
   Dry Mouth 14.8 8.4 33.8 20.3
Cardiovascular
   Hypertension 2.1 1.1 1.3 *
   Hypotension 7.0 1.1 3.8 0.0
   Shortness of Breath * 1.1 1.3 0.0
   Syncope 2.8 2.1 4.5 1.3
   Tachycardia/Palpitations 0.0 0.0 7.0 7.0
CNS
   Anger/Hostility 3.5 6.3 1.3 2.5
   Confusion 4.9 0.0 5.7 7.6
   Decreased Concentration 2.8 2.1 1.3 0.0
   Disorientation 2.1 0.0 * 0.0
   Dizziness/Lightheadedness 19.7 5.3 28.0 15.2
   Drowsiness 23.9 6.3 40.8 19.6
   Excitement 1.4 1.1 5.1 5.7
   Fatigue 11.3 4.2 5.7 2.5
   Headache 9.9 5.3 19.8 15.8
   Insomnia 9.9 10.5 6.4 12.0
   Impaired Memory 1.4 0.0 * *
   Nervousness 14.8 10.5 6.4 8.2
Gastrointestinal
   Abdominal/Gastric Disorder 3.5 4.2 5.7 4.4
   Bad Taste in Mouth 1.4 0.0 0.0 0.0
   Diarrhea 0.0 1.1 4.5 1.9
   Nausea/Vomiting 9.9 1.1 12.7 9.5
Musculoskeletal
   Musculoskeletal Aches/Pains 5.6 3.2 5.1 2.5
Neurological
   Incoordination 4.9 0.0 1.9 0.0
   Paresthesia 1.4 0.0 0.0 *
   Tremors 2.8 1.1 5.1 3.8
Sexual Function
   Decreased Libido * 1.1 1.3 *
Other
   Decreased Appetite 3.5 5.3 0.0 *
   Eyes Red/Tired/Itching 2.8 0.0 0.0 0.0
   Head Full-Heavy 2.8 0.0 0.0 0.0
   Malaise 2.8 0.0 0.0 0.0
   Nasal/Sinus Congestion 2.8 0.0 5.7 3.2
   Nightmares/Vivid Dreams * 1.1 5.1 5.7
   Sweating/Clamminess 1.4 1.1 * *
   Tinnitus 1.4 0.0 0.0 *
   Weight Gain 1.4 0.0 4.5 1.9
   Weight Loss * 3.2 5.7 2.5

Occasional sinus bradycardia has occurred in long-term studies.

In addition to the relatively common (i.e., 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.

PostIntroduction 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.

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