From the Guidelines
Trazodone is associated with a range of side effects, including drowsiness, dizziness, dry mouth, headache, nausea, and blurred vision, as well as more serious effects like priapism, irregular heartbeat, and serotonin syndrome, as reported in a study published in the Journal of Clinical Sleep Medicine 1. The most common side effects of trazodone include:
- Drowsiness
- Dizziness
- Dry mouth
- Headache
- Nausea
- Blurred vision More serious side effects can include:
- Priapism (prolonged, painful erection requiring emergency treatment)
- Irregular heartbeat
- Fainting
- Serotonin syndrome (characterized by confusion, rapid heart rate, fever, and muscle rigidity) According to a study published in the Journal of Clinical Sleep Medicine, 60% of patients who continued trazodone experienced some side effect, particularly daytime sedation or dizziness 1. Other studies have also reported similar side effects, including somnolence, sexual adverse events, and gastrointestinal disturbances 1. It is essential to monitor patients taking trazodone for these potential side effects and adjust the dosage or discontinue treatment if necessary to minimize the risk of adverse events, as recommended by the American College of Physicians 1.
From the FDA Drug Label
ADVERSE REACTIONS ... 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 ...
Table 2
- T=Trazodone HCl † P=Placebo ‡ Incidence less than 1 % Treatment Emergent Symptom Incidence Inpatients Outpatients T* P† T* P† ... 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. 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 ...
The side effects of trazodone include:
- Common side effects:
- Dizziness/Lightheadedness (19.7% - 28.0%)
- Drowsiness (23.9% - 40.8%)
- Dry Mouth (14.8% - 33.8%)
- Headache (9.9% - 19.8%)
- Nausea/Vomiting (9.9% - 12.7%)
- Fatigue (11.3% - 5.7%)
- Insomnia (9.9% - 12.0%)
- Nervousness (14.8% - 8.2%)
- Less common side effects:
- Allergic Skin Condition/Edema (2.8% - 7.0%)
- Blurred Vision (6.3% - 14.7%)
- Constipation (7.0% - 7.6%)
- Confusion (4.9% - 5.7%)
- Decreased Concentration (2.8% - 1.3%)
- Disorientation (2.1% - 0.0%)
- Excitement (1.4% - 5.7%)
- Impaired Memory (1.4% - 0.0%)
- Incoordination (4.9% - 1.9%)
- Paresthesia (1.4% - 0.0%)
- Tremors (2.8% - 5.1%)
- Decreased Libido (less than 1% - 1.3%)
- Decreased Appetite (3.5% - 0.0%)
- Eyes Red/Tired/Itching (2.8% - 0.0%)
- Head Full-Heavy (2.8% - 0.0%)
- Malaise (2.8% - 0.0%)
- Nasal/Sinus Congestion (2.8% - 5.7%)
- Nightmares/Vivid Dreams (less than 1% - 5.7%)
- Sweating/Clamminess (1.4% - less than 1%)
- Tinnitus (1.4% - 0.0%)
- Weight Gain (1.4% - 4.5%)
- Weight Loss (less than 1% - 5.7%) 2
From the Research
Side Effects of Trazodone
The side effects of trazodone are generally mild, with the most common being:
- Sedation or drowsiness (somnolence) 3, 4, 5, 6, 7
- Headache 4, 5, 7
- Dizziness 4, 7
- Dry mouth (xerostomia) 4, 7
- Orthostatic hypotension, particularly in elderly patients or those with heart disease 4, 6, 7
- Minimal anticholinergic activity 4, 7
- Corrected QT interval prolongation and torsade de pointes, cardiac arrhythmias 4
- Rare occurrences of priapism and suicidal ideation 4
- Weight changes and gastrointestinal effects such as nausea and vomiting 5
- Sweating 5
Special Considerations
Trazodone is relatively safe in overdose compared to other antidepressants 3, 6. However, it may be associated with rare but serious side effects, and patients should be closely monitored for these adverse effects. The safety and toxicology of trazodone should be examined under current standards of drug development before exposure to new patient populations 5.
Patient Populations
In elderly patients, maximum tolerated doses of trazodone are 300 to 400 mg/day, although higher doses of up to 600 mg/day are tolerated by younger patients 6. Trazodone may be of use in elderly patients in whom anxiety and insomnia are problematic, and in those patients who are unresponsive to or cannot tolerate therapy with other agents 6.