Paxil Side Effects

What are the possible side effects of Paxil?

Body as a whole: Malaise (a vague feeling of bodily discomfort), pain.

Cardiovascular: Hypertension, syncope (a sudden loss of strength, a temporary suspension of consciousness due to cerebral anemia), tachycardia (excessive rapidity in the action of the heart).

Dermatological: Pruritus (Intense itching).

Gastrointestinal: Nausea and vomiting.

Metabolic and Nutritional: Weight gain, weight loss.

Respiratory: Cough increased, rhinitis (inflammation of the mucus membrane of the nose).

Nervous System: Central Nervous System stimulation, concentration impaired, depression, emotional lability (emotional instability), vertigo (a hallucination of movement; a sensation as if the external world were revolving around the patient or as if he himself were revolving in space), akinesia (the temporary paralysis of a muscle, can include intense pain), amnesia, ataxia (failure of muscular coordination or irregularity of muscle action), convulsion, depersonalization, hallucinations, hyperkinesias (abnormally increased motor function or activity), hypertonia (a condition of excessive tone, tension or activity, can include increased blood pressure), incoordination, lack of emotion, manic reaction, paranoid reaction, thinking abnormal.

In addition to the above, some people who take Paxil become aggressive, violent and even suicidal. There may be some early indications of a problem preceding these reactions, such as extreme agitation or unbearable inner restlessness (akathisia or hyperkinesia).

Commonly Observed Adverse Events

Major Depressive Disorder

The most commonly observed adverse events associated with the use of paroxetine (incidence of 5% or greater and incidence for PAXIL at least twice that for placebo, derived from Table 1) were: Asthenia, sweating, nausea, decreased appetite, somnolence, dizziness, insomnia, tremor, nervousness, ejaculatory disturbance, and other male genital disorders.

Obsessive Compulsive Disorder

The most commonly observed adverse events associated with the use of paroxetine (incidence of 5% or greater and incidence for PAXIL at least twice that of placebo, derived from Table 2) were: Nausea, dry mouth, decreased appetite, constipation, dizziness, somnolence, tremor, sweating, impotence, and abnrmal ejaculation.

Panic Disorder

The most commonly observed adverse events associated with the use of paroxetine (incidence of 5% or greater and incidence for PAXIL at least twice that for placebo, derived from Table 2) were: Asthenia, sweating, decreased appetite, libido decreased, tremor, abnormal ejaculation, female genital disorders, and impotence.

Social Anxiety Disorder

The most commonly observed adverse events associated with the use of paroxetine (incidence of 5% or greater and incidence for PAXIL at least twice that for placebo, derived from Table 2) were: Sweating, nausea, dry mouth, constipation, decreased appetite, somnolence, tremor, libido decreased, yawn, abnormal ejaculation, female genital disorders, and impotence.

Generalized Anxiety Disorder

The most commonly observed adverse events associated with the use of paroxetine (incidence of 5% or greater and incidence for PAXIL at least twice that for placebo, derived from Table 3) were: Asthenia, infection, constipation, decreased appetite, dry mouth, nausea, libido decreased, somnolence, tremor, sweating, and abnormal ejaculation.

Posttraumatic Stress Disorder

The most commonly observed adverse events associated with the use of paroxetine (incidence of 5% or greater and incidence for PAXIL at least twice that for placebo, derived from Table 3) were: Asthenia, sweating, nausea, dry mouth, diarrhea, decreased appetite, somnolence, libido decreased, abnormal ejaculation, female genital disorders, and impotence.

Incidence in Controlled Clinical Trials

The prescriber should be aware that the figures in the tables following cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence rate in the populations studied.

Major Depressive Disorder

Table 1 enumerates adverse events that occurred at an incidence of 1% or more among paroxetine-treated patients who participated in short-term (6-week) placebo-controlled trials in which patients were dosed in a range of 20 mg to 50 mg/day. Reported adverse events were classified using a standard COSTART-based Dictionary terminology.

Table 1. Treatment-Emergent Adverse Experience Incidence in Placebo-Controlled Clinical Trials for Major Depressive Disorder¹
Body System	Preferred Term	PAXIL	Placebo
		(n = 421)	(n = 421)
Body as a Whole	Headache	18%	17%
	Asthenia	15%	6%
Cardiovascular	Palpitation	3%	1%
	Vasodilation	3%	1%
Dermatologic	Sweating	11%	2%
	Rash	2%	1%
Gastrointestinal	Nausea	26%	9%
	Dry Mouth	18%	12%
	Constipation	14%	9%
	Diarrhea	12%	8%
	Decreased Appetite	6%	2%
	Flatulence	4%	2%
	Oropharynx Disorder²	2%	0%
	Dyspepsia	2%	1%
Musculoskeletal	Myopathy	2%	1%
	Myalgia	2%	1%
	Myasthenia	1%	0%
Nervous System	Somnolence	23%	9%
	Dizziness	13%	6%
	Insomnia	13%	6%
	Tremor	8%	2%
	Nervousness	5%	3%
	Anxiety	5%	3%
	Paresthesia	4%	2%
	Libido Decreased	3%	0%
	Drugged Feeling	2%	1%
	Confusion	1%	0%
Respiration	Yawn	4%	0%
Special Senses	Blurred Vision	4%	1%
	Taste Perversion	2%	0%
Urogenital System	Ejaculatory Disturbance^3,4	13%	0%
	Other Male Genital Disorders^3,5	10%	0%
	Urinary Frequency	3%	1%
	Urination Disorder⁶	3%	0%
	Female Genital Disorders^3,7	2%	0%
1. Events reported by at least 1% of patients treated with PAXIL are included, except the following events which had an incidence on placebo ³ PAXIL: Abdominal pain, agitation, back pain, chest pain, CNS stimulation, fever, increased appetite, myoclonus, pharyngitis, postural hypotension, respiratory disorder (includes mostly "cold symptoms" or "URI"), trauma, and vomiting.
2. Includes mostly "lump in throat" and "tightness in throat."
3. Percentage corrected for gender.
4. Mostly "ejaculatory delay."
5. Includes "anorgasmia," "erectile difficulties," "delayed ejaculation/orgasm," and "sexual dysfunction," and "impotence."
6. Includes mostly "difficulty with micturition" and "urinary hesitancy."
7. Includes mostly "anorgasmia" and "difficulty reaching climax/orgasm."

Obsessive Compulsive Disorder, Panic Disorder, and Social Anxiety Disorder

Table 2 enumerates adverse events that occurred at a frequency of 2% or more among OCD patients on PAXIL who participated in placebo-controlled trials of 12-weeks duration in which patients were dosed in a range of 20 mg to 60 mg/day or among patients with panic disorder on PAXIL who participated in placebo-controlled trials of 10- to 12-weeks duration in which patients were dosed in a range of 10 mg to 60 mg/day or among patients with social anxiety disorder on PAXIL who participated in placebo-controlled trials of 12-weeks duration in which patients were dosed in a range of 20 mg to 50 mg/day.

Table 2. Treatment-Emergent Adverse Experience Incidence in Placebo-Controlled Clinical Trials for Obsessive Compulsive Disorder, Panic Disorder, and Social Anxiety Disorder¹
		Obsessive Compulsive Disorder			Panic Disorder		Social Anxiety Disorder
		PAXIL		Placebo	PAXIL	Placebo	PAXIL	Placebo
Body System	Preferred Term	(n = 542)		(n = 265)	(n = 469)	(n = 324)	(n = 425)	(n = 339)
Body as a Whole	Asthenia	22%		14%	14%	5%	22%	14%
	Abdominal Pain	—		—	4%	3%	—	—
	Chest Pain	3%		2%	—	—	—	—
	Back Pain	—		—	3%	2%	—	—
	Chills	2%		1%	2%	1%	—	—
	Trauma	—		—	—	—	3%	1%
Cardiovascular	Vasodilation	4%		1%	—	—	—	—
	Palpitation	2%		0%	—	—	—	—
Dermatologic	Sweating	9%		3%	14%	6%	9%	2%
	Rash	3%		2%	—	—	—	—
Gastrointestinal	Nausea	23%		10%	23%	17%	25%	7%
	Dry Mouth	18%		9%	18%	11%	9%	3%
	Constipation	16%		6%	8%	5%	5%	2%
	Diarrhea	10%		10%	12%	7%	9%	6%
	Decreased
	Appetite	9%		3%	7%	3%	8%	2%
	Dyspepsia	—		—	—	—	4%	2%
	Flatulence	—		—	—	—	4%	2%
	Increased
	Appetite	4%		3%	2%	1%	—	—
	Vomiting	—		—	—	—	2%	1%
Musculoskeletal	Myalgia		—	—	—	—	4%	3%
Nervous System	Insomnia		24%	13%	18%	10%	21%	16%
	Somnolence		24%	7%	19%	11%	22%	5%
	Dizziness		12%	6%	14%	10%	11%	7%
	Tremor		11%	1%	9%	1%	9%	1%
	Nervousness		9%	8%	—	—	8%	7%
	Libido Decreased		7%	4%	9%	1%	12%	1%
	Agitation		—	—	5%	4%	3%	1%
	Anxiety		—	—	5%	4%	5%	4%
	Abnormal
	Dreams		4%	1%	—	—	—	—
	Concentration
	Impaired		3%	2%	—	—	4%	1%
	Depersonalization		3%	0%	—	—	—	—
	Myoclonus		3%	0%	3%	2%	2%	1%
	Amnesia		2%	1%	—	—	—	—
Respiratory System	Rhinitis		—	—	3%	0%	—	—
	Pharyngitis		—	—	—	—	4%	2%
	Yawn		—	—	—	—	5%	1%
Special Senses	Abnormal Vision		4%	2%	—	—	4%	1%
	Taste Perversion		2%	0%	—	—	—	—
Urogenital System	Abnormal
	Ejaculation²		23%	1%	21%	1%	28%	1%
	Dysmenorrhea		—	—	—	—	5%	4%
	Female Genital
	Disorder²		3%	0%	9%	1%	9%	1%
	Impotence²		8%	1%	5%	0%	5%	1%
	Urinary
	Frequency		3%	1%	2%	0%	—	—
	Urination
	Impaired		3%	0%	—	—	—	—
	Urinary Tract
	Infection		2%	1%	2%	1%	—	—
1.Events reported by at least 2% of OCD, panic disorder, and social anxiety disorder in patients treated with PAXIL are included, except the following events which had an incidence on placebo PAXIL: [OCD]: Abdominal pain, agitation, anxiety, back pain, cough increased, depression, headache, hyperkinesia, infection, paresthesia, pharyngitis, respiratory disorder, rhinitis, and sinusitis. [panic disorder]: Abnormal dreams, abnormal vision, chest pain, cough increased, depersonalization, depression, dysmenorrhea, dyspepsia, flu syndrome, headache, infection, myalgia, nervousness, palpitation, paresthesia, pharyngitis, rash, respiratory disorder, sinusitis, taste perversion, trauma, urination impaired, and vasodilation. [social anxiety disorder]: Abdominal pain, depression, headache, infection, respiratory disorder, and sinusitis.
2.Percentage corrected for gender.

Generalized Anxiety Disorder and Posttraumatic Stress Disorder

Table 3 enumerates adverse events that occurred at a frequency of 2% or more among GAD patients on PAXIL who participated in placebo-controlled trials of 8-weeks duration in which patients were dosed in a range of 10 mg/day to 50 mg/day or among PTSD patients on PAXIL who participated in placebo-controlled trials of 12-weeks duration in which patients were dosed in a range of 20 mg/day to 50 mg/day.

Table 3. Treatment-Emergent Adverse Experience Incidence in Placebo-Controlled Clinical Trials for Generalized Anxiety Disorder and Posttraumatic Stress Disorder¹
		Generalized Anxiety Disorder		Posttraumatic Stress Disorder
Body System	Preferred Term	PAXIL	Placebo	PAXIL	Placebo
		(n = 735)	(n = 529)	(n = 676)	(n = 504)
Body as a Whole	Asthenia	14%	6%	12%	4%
	Headache	17%	14%	—	—
	Infection	6%	3%	5%	4%
	Abdominal Pain			4%	3%
	Trauma			6%	5%
Cardiovascular	Vasodilation	3%	1%	2%	1%
Dermatologic	Sweating	6%	2%	5%	1%
Gastrointestinal	Nausea	20%	5%	19%	8%
	Dry Mouth	11%	5%	10%	5%
	Constipation	10%	2%	5%	3%
	Diarrhea	9%	7%	11%	5%
	Decreased Appetite	5%	1%	6%	3%
	Vomiting	3%	2%	3%	2%
	Dyspepsia	—	—	5%	3%
Nervous System	Insomnia	11%	8%	12%	11%
	Somnolence	15%	5%	16%	5%
	Dizziness	6%	5%	6%	5%
	Tremor	5%	1%	4%	1%
	Nervousness	4%	3%	—	—
	Libido Decreased	9%	2%	5%	2%
	Abnormal Dreams			3%	2%
Respiratory	Respiratory Disorder	7%	5%	—	—
System
	Sinusitis	4%	3%	—	—
	Yawn	4%	—	2%	<1%
Special Senses	Abnormal Vision	2%	1%	3%	1%
Urogenital	Abnormal	25%	2%	13%	2%
System	Ejaculation²
	Female Genital	4%	1%	5%	1%
	Disorder²
	Impotence²	4%	3%	9%	1%
1. Events reported by at least 2% of GAD and PTSD in patients treated with PAXIL are included, except the following events which had an incidence on placebo ³PAXIL [GAD]: Abdominal pain, back pain, trauma, dyspepsia, myalgia, and pharyngitis. [PTSD]: Back pain, headache, anxiety, depression, nervousness, respiratory disorder, pharyngitis, and sinusitis.
2. Percentage corrected for gender.

Dose Dependency of Adverse Events

A comparison of adverse event rates in a fixed-dose study comparing 10, 20, 30, and 40 mg/day of PAXIL with placebo in the treatment of major depressive disorder revealed a clear dose dependency for some of the more common adverse events associated with use of PAXIL, as shown in the following table:

Table 4 . Treatment-Emergent Adverse Experience Incidence in a Dose-Comparison Trial in the Treatment of Major Depressive Disorder*
	Placebo	PAXIL
		10 mg	20 mg	30 mg	40 mg
	n = 51	n = 102	n = 104	n = 101	n = 102
Body System/Preferred Term
Body as a Whole
Asthenia	0.0%	2.9%	10.6%	13.9%	12.7%
Dermatology
Sweating	2.0%	1.0%	6.7%	8.9%	11.8%
Gastrointestinal
Constipation	5.9%	4.9%	7.7%	9.9%	12.7%
Decreased Appetite	2.0%	2.0%	5.8%	4.0%	4.9%
Diarrhea	7.8%	9.8%	19.2%	7.9%	14.7%
Dry Mouth	2.0%	10.8%	18.3%	15.8%	20.6%
Nausea	13.7%	14.7%	26.9%	34.7%	36.3%
Nervous System
Anxiety	0.0%	2.0%	5.8%	5.9%	5.9%
Dizziness	3.9%	6.9%	6.7%	8.9%	12.7%
Nervousness	0.0%	5.9%	5.8%	4.0%	2.9%
Paresthesia	0.0%	2.9%	1.0%	5.0%	5.9%
Somnolence	7.8%	12.7%	18.3%	20.8%	21.6%
Tremor	0.0%	0.0%	7.7%	7.9%	14.7%
Special Senses
Blurred Vision	2.0%	2.9%	2.9%	2.0%	7.8%
Urogenital System
Abnormal Ejaculation	0.0%	5.8%	6.5%	10.6%	13.0%
Impotence	0.0%	1.9%	4.3%	6.4%	1.9%
Male Genital Disorders	0.0%	3.8%	8.7%	6.4%	3.7%
^*Rule for including adverse events in table: Incidence at least 5% for 1 of paroxetine groups and ³ twice the placebo incidence for at least 1 paroxetine group.

In a fixed-dose study comparing placebo and 20, 40, and 60 mg of PAXIL in the treatment of OCD, there was no clear relationship between adverse events and the dose of PAXIL to which patients were assigned. No new adverse events were observed in the group treated with 60 mg of PAXIL compared to any of the other treatment groups.

In a fixed-dose study comparing placebo and 10, 20, and 40 mg of PAXIL in the treatment of panic disorder, there was no clear relationship between adverse events and the dose of PAXIL to which patients were assigned, except for asthenia, dry mouth, anxiety, libido decreased, tremor, and abnormal ejaculation. In flexible-dose studies, no new adverse events were observed in patients receiving 60 mg of PAXIL compared to any of the other treatment groups.

In a fixed-dose study comparing placebo and 20, 40, and 60 mg of PAXIL in the treatment of social anxiety disorder, for most of the adverse events, there was no clear relationship between adverse events and the dose of PAXIL to which patients were assigned.

In a fixed-dose study comparing placebo and 20 and 40 mg of PAXIL in the treatment of generalized anxiety disorder, for most of the adverse events, there was no clear relationship between adverse events and the dose of PAXIL to which patients were assigned, except for the following adverse events: Asthenia, constipation, and abnormal ejaculation.

In a fixed-dose study comparing placebo and 20 and 40 mg of PAXIL in the treatment of posttraumatic stress disorder, for most of the adverse events, there was no clear relationship between adverse events and the dose of PAXIL to which patients were assigned, except for impotence and abnormal ejaculation.

Adaptation to Certain Adverse Events

Over a 4- to 6-week period, there was evidence of adaptation to some adverse events with continued therapy (e.g., nausea and dizziness), but less to other effects (e.g., dry mouth, somnolence, and asthenia).

Male and Female Sexual Dysfunction With SSRIs

Although changes in sexual desire, sexual performance, and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of pharmacologic treatment. In particular, some evidence suggests that selective serotonin reuptake inhibitors (SSRIs) can cause such untoward sexual experiences.

Reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance, and satisfaction are difficult to obtain, however, in part because patients and physicians may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in product labeling, are likely to underestimate their actual incidence.

In placebo-controlled clinical trials involving more than 3,200 patients, the ranges for the reported incidence of sexual side effects in males and females with major depressive disorder, OCD, panic disorder, social anxiety disorder, GAD, and PTSD are displayed in Table 5.

Table 5. Incidence of Sexual Adverse Events in Controlled Clinical Trials
	PAXIL	Placebo
n (males)	1446	1042
Decreased Libido	6-15%	0-5%
Ejaculatory Disturbance	13-28%	0-2%
Impotence	2-9%	0-3%
n (females)	1822	1340
Decreased Libido	0-9%	0-2%
Orgasmic Disturbance	2-9%	0-1%

There are no adequate and well-controlled studies examining sexual dysfunction with paroxetine treatment.

Paroxetine treatment has been associated with several cases of priapism. In those cases with a known outcome, patients recovered without sequelae.

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