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more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest,
and death.
5.11
Potential for Cognitive and Motor Impairment
Trazodone hydrochloride tablets may cause somnolence or sedation and may impair the mental and/or
physical ability required for the performance of potentially hazardous tasks. Patients should be
cautioned about operating hazardous machinery, including automobiles, until they are reasonably
certain that the drug treatment does not affect them adversely.
5.12 Angle-Closure Glaucoma
The pupillary dilation that occurs following use of many antidepressant drugs including trazodone
hydrochloride may trigger an angle closure attack in a patient with anatomically narrow angles who does
not have a patent iridectomy.
5.13
Discontinuation Symptoms
Withdrawal symptoms including anxiety, agitation and sleep disturbances, have been reported with
trazodone. Clinical experience suggests that the dose should be gradually reduced before complete
discontinuation of the treatment.
6 ADVERSE REACTIONS
The following serious adverse reactions are described elsewhere in the labeling:
• Clinical Worsening and Suicide Risk [see Boxed Warning and Warnings and Precautions (5.1)]
• Serotonin Syndrome or NMS-Like Reactions [see Warnings and Precautions (5.2)]
• QT Prolongation and Risk of Sudden Death [see Warnings and Precautions (5.4)]
• Orthostatic Hypotension [see Warnings and Precautions (5.6)]
• Abnormal Bleeding Events [see Warnings and Precautions (5.7)]
• Priapism [see Warnings and Precautions (5.9)]
• Hyponatremia [see Warnings and Precautions (5.10)]
• Cognitive and Motor Impairment [see Warnings and Precautions (5.11)]
• Angle-Closure Glaucoma [see Warnings and Precautions (5.12)]
• Discontinuation Symptoms [see Warnings and Precautions (5.13)]
The most common adverse reactions (reported in ≥ 5% and at twice the rate of placebo) are:
Somnolence/sedation, dizziness, constipation, vision blurred.
Table 2 presents the summary of adverse events (AEs) leading to discontinuation of trazodone
hydrochloride tablets treatment with an incidence of at least 1% and at least twice that for placebo.
Table 2: Adverse Reactions With Discontinuation as
Action Taken (≥ 1%) Incidence and Incidence 2x
Placebo
Trazodone
N = 202
Somnolence/Sedation
8 (4%)