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Paxil

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Paxil

Paxil Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Paxil (paroxetine hydrochloride) is a selective serotonin reuptake inhibitor (SSRI) used to treat depression, panic attacks, obsessive-compulsive disorder (OCD), anxiety disorders, post-traumatic stress disorder, and a severe form of premenstrual syndrome (premenstrual dysphoric disorder). Paxil is available as a generic drug, and dosing is usually once daily or as directed by your doctor. The most common side effects of Paxil are nervous feelings, drowsiness, dizziness, nasal irritation, insomnia, or mild nausea. Call your doctor immediately if you are experiencing suicidal thoughts.

Drug interactions and warnings include: Do not take paroxetine together with pimozide (Orap), thioridazine (Mellaril), or a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate). Patients taking Paxil should be advised to notify their physician if they become pregnant or are breast feeding. This medication may cause withdrawal reactions.

Our Paxil Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Paxil in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have a serious side effect such as:

  • unusual bone pain or tenderness, swelling or bruising;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), coughing up blood;
  • agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, feeling unsteady, loss of coordination, fainting;
  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, overactive reflexes, feeling like you might pass out;
  • headache, trouble concentrating, memory problems, weakness, confusion, hallucinations, fainting, seizure, shallow breathing or breathing that stops; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • mild headache, drowsiness, dizziness, sleep problems (insomnia), feeling restless or nervous;
  • mild nausea, constipation, weight changes;
  • decreased sex drive, impotence, or difficulty having an orgasm; or
  • dry mouth, yawning, or ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Paxil (Paroxetine Hydrochloride) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Paxil Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Nausea, drowsiness, dizziness, trouble sleeping, loss of appetite, weakness, dry mouth, sweating, blurred vision, and yawning may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: shaking (tremor), restlessness, inability to keep still, decreased interest in sex, changes in sexual ability, numbness/tingling, easy bruising/bleeding, fast/irregular heartbeat, muscle weakness/spasm, seizures.

Get medical help right away if you have any very serious side effects, including: black stools, vomit that looks like coffee grounds.

This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Paxil (Paroxetine Hydrochloride)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Paxil FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 Ejaculationa 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%
Impotencea 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.
a Incidence corrected for gender.

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 2) 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 3) were: Nausea, dry mouth, decreased appetite, constipation, dizziness, somnolence, tremor, sweating, impotence, and abnormal 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 3) 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 3) 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 4) 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 4) 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 2 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 2: Treatment-Emergent Adverse Experience Incidence in Placebo-Controlled Clinical Trials for Major Depressive Disordera

Body System Preferred Term PAXIL
(n = 421)
Placebo
(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 Disorderb 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 Disturbancec,d 13% 0%
Other Male Genital Disordersc,e 10% 0%
Urinary Frequency 3% 1%
Urination Disorderf 3% 0%
Female Genital Disordersc,g 2% 0%
a Events reported by at least 1% of patients treated with PAXIL are included, except the following events which had an incidence on placebo ≥ 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.
b Includes mostly “lump in throat” and “tightness in throat.”
c Percentage corrected for gender.
d Mostly “ejaculatory delay.”
e Includes “anorgasmia,” “erectile difficulties,” “delayed ejaculation/orgasm,” and “sexual dysfunction,” and “impotence.”
f Includes mostly “difficulty with micturition” and “urinary hesitancy.”
g Includes mostly “anorgasmia” and “difficulty reaching climax/orgasm.”

Obsessive Compulsive Disorder, Panic Disorder, and Social Anxiety Disorder

Table 3 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 3: Treatment-Emergent Adverse Experience Incidence in Placebo-Controlled Clinical Trials for Obsessive Compulsive Disorder, Panic Disorder, and Social Anxiety Disordera

Body System Preferred Term Obsessive Compulsive Disorder Panic Disorder Social Anxiety Disorder
PAXIL
(n = 542)
Placebo
(n = 265)
PAXIL
(n = 469)
Placebo
(n = 324)
PAXIL
(n = 425)
Placebo
(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
Ejaculationb 23% 1% 21% 1% 28% 1%
Dysmenorrhea 5% 4%
Female Genital Disorderb 3% 0% 9% 1% 9% 1%
Impotenceb 8% 1% 5% 0% 5% 1%
Urinary Frequency 3% 1% 2% 0%
Urination Impaired 3% 0%
Urinary Tract Infection 2% 1% 2% 1%
a 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.
b Percentage corrected for gender.

Generalized Anxiety Disorder and Posttraumatic Stress Disorder

Table 4 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 4: Treatment-Emergent Adverse Experience Incidence in Placebo-Controlled Clinical Trials for Generalized Anxiety Disorder and Posttraumatic Stress Disordera

Body System Preferred Term Generalized Anxiety Disorder Posttraumatic Stress Disorder
PAXIL
(n = 735)
Placebo
(n = 529)
PAXIL
(n = 676)
Placebo
(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 System Respiratory Disorder 7% 5%
Sinusitis 4% 3%
Yawn 4% 2% < 1%
Special Senses Abnormal Vision 2% 1% 3% 1%
Urogenital System Abnormal Ejaculation b 25% 2% 13% 2%
. Female Genital Disorderb 4% 1% 5% 1%
Impotenceb 4% 3% 9% 1%
a 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 ≥ PAXIL [GAD]: Abdominal pain, back pain, trauma, dyspepsia, myalgia, and pharyngitis. [PTSD]: Back pain, headache, anxiety, depression, nervousness, respiratory disorder, pharyngitis, and sinusitis.
b 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 Table 5:

Table 5: Treatment-Emergent Adverse Experience Incidence in a Dose-Comparison Trial in the Treatment of Major Depressive Disordera

Body System/Preferred Term Placebo
n = 51
PAXIL
10 mg
n = 102
20 mg
n = 104
30 mg
n = 101
40 mg
n = 102
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%
a Rule for including adverse events in table: Incidence at least 5% for 1 of paroxetine groups and ≥ 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 6.

Table 6: 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.

While it is difficult to know the precise risk of sexual dysfunction associated with the use of SSRIs, physicians should routinely inquire about such possible side effects.

Weight and Vital Sign Changes

Significant weight loss may be an undesirable result of treatment with PAXIL for some patients but, on average, patients in controlled trials had minimal (about 1 pound) weight loss versus smaller changes on placebo and active control. No significant changes in vital signs (systolic and diastolic blood pressure, pulse and temperature) were observed in patients treated with PAXIL in controlled clinical trials.

ECG Changes

In an analysis of ECGs obtained in 682 patients treated with PAXIL and 415 patients treated with placebo in controlled clinical trials, no clinically significant changes were seen in the ECGs of either group.

Liver Function Tests

In placebo-controlled clinical trials, patients treated with PAXIL exhibited abnormal values on liver function tests at no greater rate than that seen in placebo-treated patients. In particular, the PAXIL-versus-placebo comparisons for alkaline phosphatase, SGOT, SGPT, and bilirubin revealed no differences in the percentage of patients with marked abnormalities.

Hallucinations

In pooled clinical trials of immediate-release paroxetine hydrochloride, hallucinations were observed in 22 of 9089 patients receiving drug and 4 of 3187 patients receiving placebo.

Other Events Observed During The Premarketing Evaluation Of PAXIL

During its premarketing assessment in major depressive disorder, multiple doses of PAXIL were administered to 6,145 patients in phase 2 and 3 studies. The conditions and duration of exposure to PAXIL varied greatly and included (in overlapping categories) open and double-blind studies, uncontrolled and controlled studies, inpatient and outpatient studies, and fixed-dose, and titration studies. During premarketing clinical trials in OCD, panic disorder, social anxiety disorder, generalized anxiety disorder, and posttraumatic stress disorder, 542, 469, 522, 735, and 676 patients, respectively, received multiple doses of PAXIL. Untoward events associated with this exposure were recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of untoward events into a smaller number of standardized event categories.

In the tabulations that follow, reported adverse events were classified using a standard COSTART-based Dictionary terminology. The frequencies presented, therefore, represent the proportion of the 9,089 patients exposed to multiple doses of PAXIL who experienced an event of the type cited on at least 1 occasion while receiving PAXIL. All reported events are included except those already listed in Tables 2 to 5, those reported in terms so general as to be uninformative and those events where a drug cause was remote. It is important to emphasize that although the events reported occurred during treatment with paroxetine, they were not necessarily caused by it.

Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: Frequent adverse events are those occurring on 1 or more occasions in at least 1/100 patients (only those not already listed in the tabulated results from placebo-controlled trials appear in this listing); Infrequent adverse events are those occurring in 1/100 to 1/1,000 patients; rare events are those occurring in fewer than 1/1,000 patients. Events of major clinical importance are also described in the PRECAUTIONS section.

Body as a Whole: Infrequent: Allergic reaction, chills, face edema, malaise, neck pain; rare: Adrenergic syndrome, cellulitis, moniliasis, neck rigidity, pelvic pain, peritonitis, sepsis, ulcer.

Cardiovascular System: Frequent: Hypertension, tachycardia; Infrequent: Bradycardia, hematoma, hypotension, migraine, postural hypotension, syncope; rare: Angina pectoris, arrhythmia nodal, atrial fibrillation, bundle branch block, cerebral ischemia, cerebrovascular accident, congestive heart failure, heart block, low cardiac output, myocardial infarct, myocardial ischemia, pallor, phlebitis, pulmonary embolus, supraventricular extrasystoles, thrombophlebitis, thrombosis, varicose vein, vascular headache, ventricular extrasystoles.

Digestive System: Infrequent: Bruxism, colitis, dysphagia, eructation, gastritis, gastroenteritis, gingivitis, glossitis, increased salivation, liver function tests abnormal, rectal hemorrhage, ulcerative stomatitis; rare: Aphthous stomatitis, bloody diarrhea, bulimia, cardiospasm, cholelithiasis, duodenitis, enteritis, esophagitis, fecal impactions, fecal incontinence, gum hemorrhage, hematemesis, hepatitis, ileitis, ileus, intestinal obstruction, jaundice, melena, mouth ulceration, peptic ulcer, salivary gland enlargement, sialadenitis, stomach ulcer, stomatitis, tongue discoloration, tongue edema, tooth caries.

Endocrine System: Rare: Diabetes mellitus, goiter, hyperthyroidism, hypothyroidism, thyroiditis.

Hemic and Lymphatic Systems: Infrequent: Anemia, leukopenia, lymphadenopathy, purpura; rare: Abnormal erythrocytes, basophilia, bleeding time increased, eosinophilia, hypochromic anemia, iron deficiency anemia, leukocytosis, lymphedema, abnormal lymphocytes, lymphocytosis, microcytic anemia, monocytosis, normocytic anemia, thrombocythemia, thrombocytopenia.

Metabolic and Nutritional: Frequent: Weight gain; Infrequent: Edema, peripheral edema, SGOT increased, SGPT increased, thirst, weight loss; rare: Alkaline phosphatase increased, bilirubinemia, BUN increased, creatinine phosphokinase increased, dehydration, gamma globulins increased, gout, hypercalcemia, hypercholesteremia, hyperglycemia, hyperkalemia, hyperphosphatemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, ketosis, lactic dehydrogenase increased, non-protein nitrogen (NPN) increased.

Musculoskeletal System: Frequent: Arthralgia; Infrequent: Arthritis, arthrosis; rare: Bursitis, myositis, osteoporosis, generalized spasm, tenosynovitis, tetany.

Nervous System: Frequent: Emotional lability, vertigo; Infrequent: Abnormal thinking, alcohol abuse, ataxia, dystonia, dyskinesia, euphoria, hallucinations, hostility, hypertonia, hypesthesia, hypokinesia, incoordination, lack of emotion, libido increased, manic reaction, neurosis, paralysis, paranoid reaction; rare: Abnormal gait, akinesia, antisocial reaction, aphasia, choreoathetosis, circumoral paresthesias, convulsion, delirium, delusions, diplopia, drug dependence, dysarthria, extrapyramidal syndrome, fasciculations, grand mal convulsion, hyperalgesia, hysteria, manic-depressive reaction, meningitis, myelitis, neuralgia, neuropathy, nystagmus, peripheral neuritis, psychotic depression, psychosis, reflexes decreased, reflexes increased, stupor, torticollis, trismus, withdrawal syndrome.

Respiratory System: Infrequent: Asthma, bronchitis, dyspnea, epistaxis, hyperventilation, pneumonia, respiratory flu; rare: Emphysema, hemoptysis, hiccups, lung fibrosis, pulmonary edema, sputum increased, stridor, voice alteration.

Skin and Appendages: Frequent: Pruritus; Infrequent: Acne, alopecia, contact dermatitis, dry skin, ecchymosis, eczema, herpes simplex, photosensitivity, urticaria; rare: Angioedema, erythema nodosum, erythema multiforme, exfoliative dermatitis, fungal dermatitis, furunculosis; herpes zoster, hirsutism, maculopapular rash, seborrhea, skin discoloration, skin hypertrophy, skin ulcer, sweating decreased, vesiculobullous rash.

Special Senses: Frequent: Tinnitus; Infrequent: Abnormality of accommodation, conjunctivitis, ear pain, eye pain, keratoconjunctivitis, mydriasis, otitis media; rare: Amblyopia, anisocoria, blepharitis, cataract, conjunctival edema, corneal ulcer, deafness, exophthalmos, eye hemorrhage, glaucoma, hyperacusis, night blindness, otitis externa, parosmia, photophobia, ptosis, retinal hemorrhage, taste loss, visual field defect.

Urogenital System: Infrequent: Amenorrhea, breast pain, cystitis, dysuria, hematuria, menorrhagia, nocturia, polyuria, pyuria, urinary incontinence, urinary retention, urinary urgency, vaginitis; rare: Abortion, breast atrophy, breast enlargement, endometrial disorder, epididymitis, female lactation, fibrocystic breast, kidney calculus, kidney pain, leukorrhea, mastitis, metrorrhagia, nephritis, oliguria, salpingitis, urethritis, urinary casts, uterine spasm, urolith, vaginal hemorrhage, vaginal moniliasis.

Postmarketing Reports

Voluntary reports of adverse events in patients taking PAXIL that have been received since market introduction and not listed above that may have no causal relationship with the drug include acute pancreatitis, elevated liver function tests (the most severe cases were deaths due to liver necrosis, and grossly elevated transaminases associated with severe liver dysfunction), Guillain-Barré syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, priapism, syndrome of inappropriate ADH secretion, symptoms suggestive of prolactinemia and galactorrhea; extrapyramidal symptoms which have included akathisia, bradykinesia, cogwheel rigidity, dystonia, hypertonia, oculogyric crisis which has been associated with concomitant use of pimozide; tremor and trismus; status epilepticus, acute renal failure, pulmonary hypertension, allergic alveolitis, anaphylaxis, eclampsia, laryngismus, optic neuritis, porphyria, restless legs syndrome (RLS), ventricular fibrillation, ventricular tachycardia (including torsade de pointes), thrombocytopenia, hemolytic anemia, events related to impaired hematopoiesis (including aplastic anemia, pancytopenia, bone marrow aplasia, and agranulocytosis), vasculitic syndromes (such as Henoch-Schönlein purpura), and premature births in pregnant women. There has been a case report of an elevated phenytoin level after 4 weeks of PAXIL and phenytoin coadministration. There has been a case report of severe hypotension when PAXIL was added to chronic metoprolol treatment.

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).

Read the entire FDA prescribing information for Paxil (Paroxetine Hydrochloride) »

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