Trazodone Hydrochloride (Page 3 of 6)

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)]
Discontinuation symptoms [see Warnings and Precautions (5.12)]

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 2× placebo
Trazodone
N = 202

Somnolence/Sedation

8 (4.0%)

Dizziness

7 (3.5%)

Confusional state

2 (1.0%)

Coordination abnormal

2 (1.0%)

Headache

2 (1.0%)

Nausea

2 (1.0%)

Balance disorder / Gait disturbance

2 (1.0%)

6.1 Clinical Studies Experience

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.

Table 3: Adverse Reactions: Percentage of Patients (>2%) as observed in controlled clinical studies
Inpatients Outpatients
Trazodone Placebo Trazodone Placebo
Occasional sinus bradycardia has occurred in long-term studies.
*
Incidence less than 1%

Number of Patients
% of Patients Reporting

142

95

157

158

Allergic

Skin Condition/Edema

2.8

1.1

7

1.3

Autonomic

Blurred Vision

6.3

4.2

14.7

3.8

Constipation

7

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

1.1

3.8

0

Shortness of Breath

*

1.1

1.3

0

Syncope

2.8

2.1

4.5

1.3

Tachycardia/Palpitations

0

0

7

7


CNS

Anger/Hostility

3.5

6.3

1.3

2.5

Confusion

4.9

0

5.7

7.6

Decreased Concentration

2.8

2.1

1.3

0

Disorientation

2.1

0

*

0

Dizziness/Light-headedness

19.7

5.3

28

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

Impaired Memory

1.4

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

Diarrhea

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

1.9

0

Paresthesia

1.4

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

*

Eyes Red/Tired/Itching

2.8

0

0

0

Head Full-Heavy

2.8

0

0

0

Malaise

2.8

0

0

0

Nasal/Sinus Congestion

2.8

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

*

Weight Gain

1.4

0

4.5

1.9

Weight Loss

*

3.2

5.7

2.5

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, hyper-salivation, hypomania, impaired speech, impotence, increased appetite, increased libido, increased urinary frequency, missed periods, muscle twitches, numbness, and retrograde ejaculation.

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