ADVERSE REACTIONS
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 trazodone. 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 trazodone hydrochloride.
The figures cited cannot be used to predict concisely 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. |
| T | P | T | P |
| 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 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 trazodone 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, cholestasis, 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 (see WARNINGS and PRECAUTIONS, Information for Patients; some patients have required surgical intervention), 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 (see WARNINGS).
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