Paroxetine (Page 3 of 8)

6 ADVERSE REACTIONS

The following adverse reactions are included in more detail in other sections of the prescribing information:

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.

Safety data for paroxetine extended-release tablets is from 11 short-term, placebo-controlled clinical trials including 3 studies in patients with major depressive disorder (MDD) (Studies 1, 2, and 3), 3 studies in patients with panic disorder (PD) (Studies 4, 5, and 6), 1 study in patients with social anxiety disorder (SAD) (Study 7), and 4 studies in female patients with premenstrual dysphoric disorder (PMDD) (Studies 8, 9, 10, and 11) [see Clinical Studies (14)]. These 11 trials included 1,627 patients treated with paroxetine extended-release tablets.

  • Studies 1 and 2 were 12-week studies that enrolled patients 18 to 65 years old who received paroxetine extended-release tablets at doses ranging from 25 mg to 62.5 mg once daily. Study 3 was a 12-week study in patients 60 to 88 years old who received paroxetine extended-release tablets at doses ranging from 12.5 mg to 50 mg once daily.
  • Studies 4, 5, and 6 were 10-week studies in patients 19 to 72 years old who received paroxetine extended-release tablets at doses ranging from 12.5 mg to 75 mg once daily.
  • Study 7 was a 12-week study that enrolled adult patients who received paroxetine extended-release tablets at doses ranging from 12.5 mg to 37.5 mg once daily.
  • Studies 8, 9, and 10 were 12-week, placebo-controlled trials in female patients 18 to 46 years old who received paroxetine extended-release tablets at doses of 12.5 mg or 25 mg once daily. Study 11 was a 12-week placebo-controlled trial in patients 18 to 46 years old who received paroxetine extended-release tablets 2 weeks prior to the onset of menses (luteal phase dosing) at doses of 12.5 mg or 25 mg once daily.

Adverse Reactions Leading to Discontinuation in Patients with MDD, PD, SAD, and PMDD

In pooled studies in patients with MDD, PD and SAD, the most common adverse reactions leading to study withdrawal were: nausea (up to 4% of patients), asthenia, headache, depression, insomnia, and abnormal liver function tests (each occurring in up to 2% of patients), and dizziness, somnolence, and diarrhea (each occurring in up to 1% of patients).

In pooled studies for PMDD, the most common adverse reactions leading to study withdrawal were: nausea (occurring in up to 6% of patients), asthenia (occurring in up to 5% of patients), somnolence (occurring in up to 4% of patients), insomnia (occurring in approximately 2% of patients); and impaired concentration, dry mouth, dizziness, decreased appetite, sweating, tremor, yawn and diarrhea (occurring in less than or equal to 2% of patients).

Adverse Reactions in MDD, PD, and SAD

Table 3 presents the most common adverse reactions in paroxetine extended-release tablets-treated patients (incidence ≥ 5% and greater than placebo within at least 1 of the indications) in controlled trials in patients with MDD, PD, and SAD.

Table 3. Adverse Reactions (≥ 5% of Patients Treated with Paroxetine Extended-Release Tablets and Greater than Placebo) in 10 to 12 Week Studies of MDD, PD, and SAD
MDD 18 to 65 year olds MDD≥ 60 years old Panic Disorder Social Anxiety Disorder
Body System/ Adverse Reaction Paroxetine Extended-Release Tablets(N = 212)% Placebo(N = 211)% Paroxetine Extended-Release Tablets(N = 104)% Placebo(N = 109)% Paroxetine Extended-Release Tablets(N = 444)% Placebo(N = 445)% Paroxetine Extended-Release Tablets(N = 186)% Placebo(N = 184)%
Hyphen = the reaction listed occurred in < 5% of patients treated with paroxetine extended-release tablets NA = the adverse reaction listed did not occur in this group of patients
*
Mostly blurred vision
Based on the number of males or females
Mostly anorgasmia or delayed ejaculation
§
Mostly anorgasmia or delayed orgasm
Body as a Whole
Headache 27 20 17 13 NA NA 23 17
Asthenia 14 9 15 14 15 10 18 7
Abdominal Pain 7 4 6 4 5 4
Back Pain 5 3 NA NA 4 1
Digestive System
Nausea 22 10 23 17 22 6
Diarrhea 18 7 15 9 12 9 9 8
Dry Mouth 15 8 18 7 13 9 3 2
Constipation 10 4 13 5 9 6 5 2
Flatulence 6 4 NA NA NA NA
Decreased Appetite 2 12 5 8 6 1 < 1
Dyspepsia NA NA 13 10 NA NA 2 < 1
Musculoskeletal System
Myalgia NA NA 5 3 NA NA
Nervous System
Somnolence 22 8 21 12 20 9 9 4
Insomnia 17 9 10 8 20 11 9 4
Dizziness 14 4 9 5 NA NA 7 4
Libido Decreased 7 3 8 < 1 9 4 1
Nervousness NA NA 8 7 NA NA
Tremor 7 1 7 0 8 2 4 2
Anxiety NA NA 5 4 2 1
Respiratory System
Sinusitis NA NA 8 5 NA NA
Yawn 0 3 0 2 0
Skin and Appendages
Sweating 6 2 10 < 1 7 2 14 3
Special Senses
Abnormal Vision * 5 1 3 < 1 2 0
Urogenital System
Abnormal Ejaculation , 26 1 17 3 27 3 15 1
Female Genital Disorder , § 10 < 1 7 1 3 0
Impotence 5 3 9 3 10 1 9 0

Other Adverse Reactions Observed During the Premarketing Evaluation of Paroxetine Extended-Release Tablets

Adverse reactions from studies in MDD (not including Study 3 in elderly patients), PD, and SAD that occurred between 1% and 5% of patients treated with paroxetine extended-release tablets and at a rate greater than in placebo-treated patients include: allergic reaction, tachycardia, vasodilatation, hypertension, migraine, vomiting, weight loss, weight gain, hypertonia, paresthesia, agitation, confusion, myoclonus, concentration impaired, depression, rhinitis, cough increased, bronchitis, photosensitivity, eczema, taste perversion, UTI, menstrual disorder, urinary frequency, urination impaired, and vaginitis.

Adverse Reactions in Patients with PMDD

Table 4 displays adverse reactions that occurred (incidence of 5% or more and greater than placebo within at least 1 of the studies) in patients treated with paroxetine extended-release tablets in Studies 8, 9, 10, and 11.

Table 4. Adverse Reactions (≥ 5% of Patients Treated with Paroxetine Extended-Release Tablets and Greater than Placebo) in Pooled Studies PMDD (Studies 8, 9, 11), and in Study 10*, ,
Body System/Adverse Reaction % Reporting Adverse Reaction
Continuous Dosing Studies 8, 9, and 10 Luteal Phase Dosing Study 11
Paroxetine Extended-Release Tablets(n = 681)% Placebo(n = 349)% Paroxetine Extended-Release Tablets(n = 246)% Placebo(n = 120)%
NA = the adverse reaction information is not available in this population.
*
< 1% means greater than zero and less than 1%.
The luteal phase and continuous dosing PMDD trials were not designed for making direct comparisons between the 2 dosing regimens.
Mostly anorgasmia or difficulty achieving orgasm.
Body as a Whole
Asthenia 17 6 15 4
Headache 15 12 NA NA
Infection 6 4 NA NA
Digestive System
Nausea 17 7 18 2
Diarrhea 6 2 6 0
Constipation 5 1 2 <1
Nervous System
Libido Decreased 12 5 9 6
Somnolence 9 2 3 <1
Insomnia 8 2 7 3
Dizziness 7 3 6 3
Tremor 4 < 1 5 0
Skin and Appendages
Sweating 7 < 1 6 <1
Urogenital System
Female Genital Disorders 8 1 2 0

Dose Dependent Adverse Reactions

Comparison of the incidence of adverse reactions (placebo vs. 12.5 mg paroxetine extended-release tablets vs. 25 mg paroxetine extended-release tablets) from studies 8, 9, 10 showed the following adverse reactions to be dose-related: Nausea, somnolence, sweating, dry mouth, dizziness, decreased appetite, tremor, impaired concentration, yawn, paresthesia, hyperkinesia, and vaginitis.

Male and Female Sexual Dysfunction

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 SSRI treatment. However, reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance, and satisfaction are difficult to obtain, in part because patients and healthcare providers may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in labeling may underestimate their actual incidence.

The percentage of patients reporting symptoms of sexual dysfunction in the Studies 1 and 2 (nonelderly patients with MDD), 4, 5, 6, 7, 8, 9, 10, and 11 are presented in Table 5:

Table 5. Adverse Reactions Related To Sexual Dysfunction In Patients Treated With Paroxetine Extended-Release Tablets in Pooled 10 to 12 Week Studies of MDD, PD, SAD, and PMDD
Studies 1 and 2 % Studies 4, 5, and 6 % Study 7 % Studies 8, 9, and 11 (Continuous Dosing) % Study 10 (Luteal Phase Dosing) %
Paroxetine Extended-Release Tablets Placebo Paroxetine Extended-Release Tablets Placebo Paroxetine Extended-Release Tablets Placebo Paroxetine Extended-Release Tablets Placebo Paroxetine Extended-Release Tablets Placebo
NA = the adverse reaction listed did not occur in this group of patients.Paroxetine treatment has been associated with several cases of priapism. In those cases with a known outcome, patients recovered without sequelae.
n (males) 78 78 162 194 88 97 NA NA NA NA
Decreased Libido 10 5 9 6 13 1 NA NA NA NA
Abnormal Ejaculation 26 1 27 3 15 1 NA NA NA NA
Impotence 5 3 10 1% 9 0 NA NA NA NA
n (females) 134 133 282 251 98 87 681 349 246 120
Decreased Libido 4 2 8 2 4 1 12 5 9 6
Orgasmic Disturbance 10 < 1 7 1 3 0 8 1 2 0

Less Common Adverse Reactions

The following adverse reactions occurred during the clinical studies of paroxetine extended-release tablets and are not included elsewhere in the labeling.

Reactions are categorized by body system and listed in order of decreasing frequency according to the following definitions: Frequent adverse reactions are those occurring on 1 or more occasions in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1,000 patients; rare reactions are those occurring in fewer than 1/1,000 patients.

Cardiovascular System: Infrequent was postural hypotension.

Hemic and Lymphatic System: Rare was thrombocytopenia.

Metabolic and Nutritional Disorders: Infrequent were generalized edema and hypercholesteremia.

Nervous System: Infrequent were convulsion, akathisia, and manic reaction.

Psychiatric: Infrequent were hallucinations.

Skin and Appendages: Frequent was rash; infrequent was urticaria; rare was angioedema and erythema multiforme.

Urogenital System: Infrequent was urinary retention; rare was urinary incontinence.

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