Benefits and Risks of SSRI Antidepressants Above Placebo Demonstrated in Short-Term Controlled Clinical Trials

Benefits1

Risks2

 

Improvement in response to depression questionnaire

 

6%

 

Nervous Sys / Psychiatric

Somnolence

Insomnia

Dizziness

Tremor

Anxiety

Nervousness

Suicidality3

Agitation

Confusion

Thinking abnormal

 

Cardiovascular

Vasodilation

Palpitation

Fatigue /weakness

 

Gastrointestinal

Nausea

Diarrhea

Weight loss/ anorexia

Dry Mouth

Dyspepsia

Taste perversion

Vomiting

 

Sexual / Urogenital

Ejaculation dysfunction

Anorgasmic

Libido decreased

Urinary disorder

 

Dermatologic

Excessive Sweating

Burning sensation

Rash

 

 

6-14%

7-10%

6-7%

6-7%

1-6%

1-5%

2%

2%

1%

1%

 

 

1-2%

2%

3-6%

 

 

13-17%

4-10%

1-7%

3-6%

1-4%

2%

1-2%

 

 

13%

1-9%

3-4%

3%

 

 

4-9%

1-2%

1%

1. Benefits reported by ACNP from its Task Force Report on SSRIs and Suicidal Behavior in Youth (2005) analysis of randomized controlled clinical trials submitted to FDA. http://www.nature.com/npp/journal/vaop/ncurrent/full/1300958a.html

2. Risks are those events that occurred in excess of background and disclosed in product labels for three top-selling antidepressants (Prozac, Zoloft, Paxil). Excess risks were calculated by subtracting the risk in the placebo group from the risk in the antidepressant group.

3. Disclosed in FDA Black Box warning following meta-analysis of pediatric trials.