Trazodone Hydrochloride (Page 3 of 7)

6 ADVERSE REACTIONS

The following serious adverse reactions are described elsewhere in the labeling:

  • Suicidal Thoughts and Behavior in Children, Adolescents and Young Adults [see Boxed Warning and Warnings and Precautions (5.1)]

  • Serotonin Syndrome [see Warnings and Precautions (5.2)]

  • Cardiac Arrythmias (see Warnings and Precautions (5.3)]

  • Orthostatic Hypotension and Syncope [see Warnings and Precautions (5.4)]

  • Increased Risk of Bleeding [see Warnings and Precautions (5.5)]

  • Priapism [see Warnings and Precautions (5.6)]

  • Activation of Mania or Hypomania [see Warnings and Precautions (5.7)]

  • Discontinuation Syndrome [see Warnings and Precautions (5.8)]

  • Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.9) ]

  • Angle-Closure Glaucoma [see Warnings and Precautions (5.10)]

  • Hyponatremia [see Warnings and Precautions (5.11)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Table 2: Common Adverse Reactions Occurring in ≥ 2% of Trazodone Hydrochloride Tablets-treated Patients and Greater than the Rate of Placebo- Treated Patients as Observed in Controlled Clinical Studies

Inpatients

Outpatients

Trazodone Hydrochloride Tablets

Placebo

Trazodone Hydrochloride Tablets

Placebo

N =142

N=95

N =157

N=158

Allergic

3%

1%

7%

1%

Skin Condition/Edema

Autonomic

Blurred Vision

6%

4%

15%

4%

Constipation

7%

4%

8%

6%

Dry Mouth

15%

8%

34%

20%

Cardiovascular

Hypertension

20%

1%

1%

*

Hypotension

7%

1%

4%

0

Syncope

3%

2%

5%

1%

CNS

Confusion

5%

0

6%

8%

Decreased Concentration

3%

2%

1%

0

Disorientation

2%

0

*

0

Dizziness/Light-Headedness

20%

5%

28%

15%

Drowsiness

24%

6%

41%

20%

Fatigue

11%

4%

6%

3%

Headache

10%

5%

20%

16%

Nervousness

15%

11%

6%

8%

Gastrointestinal

Abdominal/Gastric Disorder

4%

4%

6%

4%

Diarrhea

0

1%

5%

1%

Nausea/Vomiting

10%

1%

13%

10%

Musculoskeletal

Aches/Pains

6%

3%

5%

3%

Neurological

Incoordination

5%

0

2%

*

Tremors

3%

1%

5%

4%

Other

Eyes Red/Tired/Itching

3%

0

0

0

Head Full-Heavy

3%

0

0

0

Malaise

3%

0

0

0

Nasal/Sinus Congestion

3%

0

6%

3%

Weight Gain

1%

0

5%

2%

Weight Loss

*

3%

6%

3%

Other adverse reactions occurring at an incidence of <2% 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 memory, impaired speech, impotence, increased appetite, increased libido, increased urinary frequency, missed periods, muscle twitches, numbness, paresthesia, retrograde ejaculation, shortness of breath, and tachycardia/palpitations. Occasional sinus bradycardia has occurred in long-term studies.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.