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Table 5: Treatment-Emergent Adverse Reactions: Incidence of 2% or More in MDD andGAD Placebo-Controlled TrialsPercentage of Patients Reporting ReactionSystem Organ Class / Adverse ReactionCymbalta(N=2995)Placebo(N=1955)Cardiac DisordersPalpitations 2^ 2Eye DisordersVision blurred 3 2Gastrointestinal DisordersNausea 25 9Dry mouth 15 6Diarrhea 10 7Constipation* 10 4Abdominal pain a 4 4Vomiting 5 2General Disorders and Administration SiteConditionsFatigue b 10 6InvestigationsWeight decreased* 2
abcdefghIjkAlso includes abdominal pain upper, abdominal pain lower, abdominal tenderness, abdominaldiscomfort, and gastrointestinal painAlso includes astheniaAlso includes anorexiaAlso includes hypersomnia and sedationAlso includes middle insomnia, early morning awakening, and initial insomniaAlso includes feeling jittery, nervousness, restlessness, tension, and psychomotor agitationAlso includes loss of libidoAlso includes anorgasmiaAlso includes nightmareMales patients onlyAlso includes ejaculation failure and ejaculation dysfunctionDiabetic Peripheral Neuropathic Pain — Table 6 gives the incidence oftreatment-emergent adverse events that occurred in 2% or more of patients treated withCymbalta in the premarketing acute phase of DPNP placebo-controlled trials (doses of20 to 120 mg/day) and with an incidence greater than placebo.Table 6: Treatment-Emergent Adverse Reactions Incidence of 2% or Morein DPNP Placebo-Controlled TrialsPercentage of Patients Reporting ReactionSystem Organ Class /Adverse ReactionCymbalta20 mg oncedaily(N=115)Cymbalta60 mg oncedaily(N=228)Cymbalta60 mg twicedaily(N=225)Placebo(N=223)Gastrointestinal DisordersNausea 14 22 30 9Constipation 5 11 15 3Diarrhea 13 11 7 6Dry mouth 5 7 12 4Vomiting 6 5 5 4Dyspepsia 4 4 4 3Loose stools 2 3 2 1General Disorders andAdministrationSite ConditionsFatigue 2 10 12 5Asthenia 2 4 8 1Pyrexia 2 1 3 1Infections and InfestationsNasopharyngitis 9 7 9 5Metabolism and Nutrition DisordersDecreased appetite 3 4 11
Page 1 and 2: CYMBALTA ®(duloxetine hydrochlorid
Page 3 and 4: metabolites circulating in plasma a
Page 5 and 6: evaluation of efficacy of duloxetin
Page 7: diary, Brief Pain Inventory Severit
Page 12 and 13: those receiving antidepressants. Th
Page 14 and 15: Activation of ManiaIn placebo-contr
Page 16 and 17: Orthostatic Hypotension and Syncope
Page 18 and 19: maximum recommended dose. In rats r
Page 20 and 21: famotidine had no significant effec
Page 24 and 25: System Organ Class /Adverse Reactio
Page 26 and 27: Renal and Urinary DisordersCommon:
Page 28 and 29: Adverse Events - causality not esta
Page 30: PRESENTATIONCapsules containing 30

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