Duloxetine (Page 6 of 16)

6.5 Adverse Reactions Occurring at an Incidence of 2% or More Among Duloxetine-Treated Patients in Adult Placebo-Controlled Trials


Pooled MDD and GAD Trials — Table 3 gives the incidence of treatment-emergent adverse reactions in MDD and GAD placebo-controlled trials for approved indications that occurred in 2% or more of patients treated with duloxetine and with an incidence greater than placebo. Table 3: Treatment-Emergent Adverse Reactions: Incidence of 2% or More and Greater than Placebo in MDD and GAD Placebo-Controlled Trialsa

System Organ Class / Adverse Reaction Percentage of Patients Reporting Reaction
Duloxetine Delayed-Release Capsules (N=4,797) Placebo (N=3,303)
Cardiac Disorders Palpitations 2 1
Eye Disorders Vision blurred 3 1
Gastrointestinal Disorders Nauseac Dry mouth Constipationc DiarrheaAbdominal paind Vomiting 23149954 866442
General Disorders and Administration Site Conditions Fatiguee 9 5
Metabolism and Nutrition Disorders Decreased appetitec 6 2
Nervous System Disorders HeadacheDizzinessc Somnolencef Tremor 1499 3 1453 1
Psychiatric Disorders Insomniag Agitationh Anxiety 9 43 52 2
Reproductive System and Breast Disorders Erectile dysfunctionEjaculation delayedc Libido decreasedi Orgasm abnormalj 4 2 32 1 1 1< 1
Respiratory, Thoracic, and Mediastinal Disorders Yawning 2 < 1
Skin and Subcutaneous Tissue Disorders Hyperhidrosis 6 2

a The inclusion of an event in the table is determined based on the percentages before rounding; however, the percentages displayed in the table are rounded to the nearest integer.
b For GAD, there were no adverse events that were significantly different between treatments in adults ≥65 years that were also not significant in the adults <65 years.
c Events for which there was a significant dose-dependent relationship in fixed-dose studies, excluding three MDD studies which did not have a placebo lead-in period or dose titration.
d Also includes abdominal pain upper, abdominal pain lower, abdominal tenderness, abdominal discomfort, and gastrointestinal pain
e Also includes asthenia
f Also includes hypersomnia and sedation
g Also includes initial insomnia, middle insomnia, and early morning awakening
h Also includes feeling jittery, nervousness, restlessness, tension, and psychomotor hyperactivity
i Also includes loss of libido
j Also includes anorgasmia
DPNP, another indication, OA, and CLBP — Table 4 gives the incidence of treatment-emergent adverse events that occurred in 2% or more of patients treated with duloxetine delayed-release capsules (determined prior to rounding) in the premarketing acute phase of DPNP, another indication, OA, and CLBP placebo-controlled trials and with an incidence greater than placebo. Table 4: Treatment-Emergent Adverse Reactions: Incidence of 2% or More and Greater than Placebo in DPNP, another indication, OA, and CLBP Placebo-Controlled Trialsa

System Organ Class / Adverse Reaction Percentage of Patients Reporting Reaction
Duloxetine Delayed-Release Capsules (N=3,303) Placebo (N=2,352)
Gastrointestinal Disorders Nausea Dry Mouthb Constipationb Diarrhea Abdominal Painc Vomiting Dyspepsia 23 11 10 95 3 2 7 3 3 5 4 21
General Disorders and Administration Site Conditions Fatigued 11 5
Infections and Infestations Nasopharyngitis Upper Respiratory Tract Infection Influenza 4 3 2 4 3 2
Metabolism and Nutrition Disorders Decreased Appetiteb 8 1
Musculo ske letal and Co nnecti ve Tissue Musculoskeletal Paine Muscle Spasms 3 2 3 2
Nervous System Disorders Headache Somnolenceb,f Dizziness Paraesthesiag Tremorb 13 11 92 2 8 3 5 2 < 1
Psychiatric Disorders Insomniab,h Agitationi 10 3 5 1
Reproductive System and Breast Disorders Erectile Dysfunctionb Ejaculation Disorderj 4 2 < 1 < 1
Respiratory, Thoracic,and Mediastinal Disorders Cough 2 2
Skin and Subcutaneous Tissue Disorders Hyperhidrosis 6 1
Vascular Disorders Flushingk Blood pressure increased1 3 2 1 1

a The inclusion of an event in the table is determined based on the percentages before rounding; however, the percentages displayed in the table are rounded to the nearest integer.
b Incidence of 120 mg/day is significantly greater than the incidence for 60 mg/day.
c Also includes abdominal discomfort, abdominal pain lower, abdominal pain upper, abdominal tenderness and gastrointestinal pain
d Also includes asthenia
e Also includes myalgia and neck pain
f Also includes hypersomnia and sedation
g Also includes hypoaesthesia, hypoaesthesia facial, genital hypoaesthesia and paraesthesia oral
h Also includes initial insomnia middle insomnia, and early morning awakening
i Also includes feeling jittery, nervousness, restlessness, tension and psychomotor hyperactivity
j Also includes ejaculation failure
k Also includes hot flushl Also includes blood pressure diastolic increased, blood pressure systolic increased, diastolic hypertension, essential hypertension, hypertension, hypertensive crisis, labile hypertension, orthostatic hypertension, secondary hypertension, and systolic hypertension

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