Paxil Withdrawal Symptoms

 

 

DRUG ABUSE AND DEPENDENCE

Controlled Substance Class

PAXIL is not a controlled substance.

Physical and Psychologic Dependence

PAXIL has not been systematically studied in animals or humans for its potential for abuse, tolerance or physical dependence. While the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, patients should be evaluated carefully for history of drug abuse, and such patients should be observed closely for signs of misuse or abuse of PAXIL (e.g., development of tolerance, incrementations of dose, drug-seeking behavior).

What are the possible withdrawal effects of Paxil?

Based on the available scientific evidence, Paxil causes dependency/withdrawal syndrome in a significant percentage of those who take it. Individuals trying to come off of Paxil usually experience one or more of the following complaints:

“jolting electric ‘zaps,’ dizziness, light headedness, crying spells, vertigo, coordination problems, gait disturbances, sweating, extreme nausea, vomiting, high fever, abdominal discomfort, flu symptoms, anorexia, diarrhea, agitation, tremulousness, irritability, aggression, sleep disturbance, nightmares, tremor, confusion, memory and concentration difficulties, lethargy, malaise, weakness and general fatigue.”

 

SIDE EFFECTS

Associated With Discontinuation of Treatment

Twenty percent (1,199/6,145) of patients treated with PAXIL in worldwide clinical trials in major depressive disorder and 16.1% (84/522), 11.8% (64/542), 9.4% (44/469), 10.7% (79/735), and 11.7% (79/676) of patients treated with PAXIL in worldwide trials in social anxiety disorder, OCD, panic disorder, GAD, and PTSD, respectively, discontinued treatment due to an adverse event. The most common events (1%) associated with discontinuation and considered to be drug related (i.e., those events associated with dropout at a rate approximately twice or greater for PAXIL compared to placebo) included the following:

 

Major Depressive Disorder

OCD

Panic Disorder

Social Anxiety Disorder

Generalized Anxiety Disorder

PTSD

PAXIL

Placebo

PAXIL

Placebo

PAXIL

Placebo

PAXIL

Placebo

PAXIL

Placebo

PAXIL

Placebo

CNS

                       

Somnolence

2.3%

0.7%

—

 

1.9%

0.3%

3.4%

0.3%

2.0%

0.2%

2.8%

0.6%

Insomnia

—

—

1.7%

0%

1.3%

0.3%

3.1%

0%

   

—

—

Agitation

1.1%

0.5%

—

             

—

—

Tremor

1.1%

0.3%

—

     

1.7%

0%

   

1.0%

0.2%

Anxiety

—

—

—

     

1.1%

0%

   

—

—

Dizziness

—

—

1.5%

0%

   

1.9%

0%

1.0%

0.2%

—

—

Gastroin-

                       

testinal

                       

Constipation

—

 

1.1%

0%

           

—

—

Nausea

3.2%

1.1%

1.9%

0%

3.2%

1.2%

4.0%

0.3%

2.0%

0.2%

2.2%

0.6%

Diarrhea

1.0%

0.3%

—

                 

Dry mouth

1.0%

0.3%

—

             

—

—

Vomiting

1.0%

0.3%

—

     

1.0%

0%

   

—

—

Flatulence

           

1.0%

0.3%

   

—

—

Other

                       

Asthenia

1.6%

0.4%

1.9%

0.4%

   

2.5%

0.6%

1.8%

0.2%

1.6%

0.2%

Abnormal

                       

ejaculation1

1.6%

0%

2.1%

0%

   

4.9%

0.6%

2.5%

0.5%

—

—

Sweating

1.0%

0.3%

—

     

1.1%

0%

1.1%

0.2%

—

—

Impotence1

—

 

1.5%

0%

           

—

—

Libido

                       

Decreased

           

1.0%

0%

   

—

—

Where numbers are not provided the incidence of the adverse events in patients treated with PAXIL was not >1% or was not greater than or equal to 2 times the incidence of placebo.

1. Incidence corrected for gender.

 

 

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