Prescription Drug Information: Fluoxetine Hydrochloride (Page 7 of 11)

Incidence in Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Placebo-Controlled Clinical Trials (excluding data from extensions of trials)

Table 2 enumerates the most common treatment-emergent adverse events associated with the use of fluoxetine (incidence of at least 5% for fluoxetine and at least twice that for placebo within at least one of the indications) for the treatment of major depressive disorder, OCD, and bulimia in U.S. controlled clinical trials and panic disorder in U.S. plus non-U.S. controlled trials. Table 3 enumerates treatment-emergent adverse events that occurred in 2% or more patients treated with fluoxetine and with incidence greater than placebo who participated in U.S. major depressive disorder, OCD, and bulimia controlled clinical trials and U.S. plus non-U.S. panic disorder controlled clinical trials. Table 3 provides combined data for the pool of studies that are provided separately by indication in Table 2.

1 Includes U.S. data for major depressive disorder, OCD, bulimia, and panic disorder clinical trials, plus non-U.S. data for panic disorder clinical trials.

†Denominator used was for males only (N=690 fluoxetine major depressive disorder; N=410 placebo major depressive disorder; N=116 fluoxetine OCD; N=43 placebo OCD; N=14 fluoxetine bulimia; N=1 placebo bulimia; N=162 fluoxetine panic; N=121 placebo panic).

-Incidence less than 1%

Table 2 Most Common Treatment-Emergent Adverse Events: Incidence in Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Placebo-Controlled Clinical Trials 1
Percentage of Patients Reporting Event
Major Depressive Disorder OCD Bulimia Panic Disorder
Body System/ Adverse Event Fluoxetine (N=1728) Placebo (N=975) Fluoxetine (N=266) Placebo (N=89) Fluoxetine (N=450) Placebo (N=267) Fluoxetine (N=425) Placebo (N=342)
Body as a Whole
Asthenia 9 5 15 11 21 9 7 7
Flu Syndrome 3 4 10 7 8 3 5 5
Cardiovascular System
Vasodilatation 3 2 5 2 1 1
Digestive System
Nausea 21 9 26 13 29 11 12 7
Diarrhea 12 8 18 13 8 6 9 4
Anorexia 11 2 17 10 8 4 4 1
Dry Mouth 10 7 12 3 9 6 4 4
Dyspepsia 7 5 10 4 10 6 6 2
Nervous System
Insomnia 16 9 28 22 33 13 10 7
Anxiety 12 7 14 7 15 9 6 2
Nervousness 14 9 14 15 11 5 8 6
Somnolence 13 6 17 7 13 5 5 2
Tremor 10 3 9 1 13 1 3 1
Libido decreased 3 11 2 5 1 1 2
Abnormal dreams 1 1 5 2 5 3 1 1
Respiratory System
Pharyngitis 3 3 11 9 10 5 3 3
Sinusitis 1 4 5 2 6 4 2 3
Yawn 7 11 1
Skin and Appendages
Sweating 8 3 7 8 3 2 2
Rash 4 3 6 3 4 4 2 2
Urogenital System
Impotence† 2 7 1
Abnormal ejaculation† 7 7 2 1

1 Includes U.S data for major depressive disorder, OCD, bulimia, and panic disorder clinical trials, plus non-U.S. data for panic disorder clinical trials.

2 Included are events reported by at least 2% of patients taking fluoxetine, except the following events, which had an incidence on placebo ≥fluoxetine (major depressive disorder, OCD, bulimia, and panic disorder combined): abdominal pain, abnormal dreams, accidental injury, back pain, cough increased, major depressive disorder (includes suicidal thoughts), dysmenorrhea, infection, myalgia, pain, paresthesia, pharyngitis, rhinitis, sinusitis.

– Incidence less than 1%

Table 3 Treatment-Emergent Adverse Events; Incidence in Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Placebo-Controlled Clinical Trials 1
Percentage of Patients Reporting Event
Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Combined
Body System/Adverse Event 2 Fluoxetine (N=2869) Placebo (N=1673)
Body as a Whole
Headache 21 19
Asthenia 11 6
Flu syndrome 5 4
Fever 2 1
Cardiovascular System
Vasodilatation 2 1
Digestive System
Nausea 22 9
Diarrhea 11 7
Anorexia 10 3
Dry Mouth 9 6
Dyspepsia 8 4
Constipation 5 4
Flatulence 3 2
Vomiting 3 2
Metabolic and Nutritional Disorders
Weight loss 2 1
Nervous System
Insomnia 19 10
Nervousness 13 8
Anxiety 12 6
Somnolence 12 5
Dizziness 9 6
Tremor 9 2
Libido decreased 4 1
Thinking abnormal 2 1
Respiratory System
Yawn 3
Skin and Appendages
Sweating 7 3
Rash 4 3
Pruritus 3 2
Special Senses
Abnormal vision 2 1

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