cymbalta - Drivetime Radio
cymbalta - Drivetime Radio cymbalta - Drivetime Radio
System Organ Class /Adverse ReactionPercentage of Patients Reporting ReactionCymbalta Cymbalta60 mg once 60 mg twicedaily daily(N=228) (N=225)Cymbalta20 mg oncedaily(N=115)Placebo(N=223)Nervous System DisordersSomnolence 7 15 21 5Headache 13 13 15 10Dizziness 6 14 17 6Tremor 0 1 5 0Psychiatric DisordersInsomnia 9 8 13 7Renal and Urinary DisordersPolyuria 3 1 5 2Reproductive System and BreastDisordersErectile dysfunction 1 0 1 4 0Respiratory, Thoracic andMediastinalDisordersCough 6 3 5 4Pharyngolaryngeal pain 3 1 6 1Skin and SubcutaneousTissue DisordersHyperhidrosis 6 6 8 21 Male patients only.The following additional adverse events were reported during placebo-controlled clinicaltrials of duloxetine for MDD or other indications in 8504 patients. Very common eventsare defined as those occurring in ≥10% of patients, common events are defined as thoseoccurring in ≥1% and
Gastrointestinal DisordersCommon: dyspepsia (including stomach discomfort), abdominal pain.Uncommon: eructation, gastroenteritis, stomatitis, halitosis, gastritis, flatulence,gastrointestinal haemorrhage, dysphagia.General Disorders and Administration Site ConditionsCommon: chills (including rigors).Uncommon: feeling abnormal, feeling hot and/or cold, malaise, thirst, falls (morecommon in the elderly (≥65 years old))..Rare: Gait disturbanceInfections and InfestationsUncommon: laryngitis.InvestigationsUncommon: blood pressure increased (including blood pressure systolic increased, bloodpressure diastolic increased), hepatic lab related findings (including alanineaminotransferase increased, hepatic enzyme increased, aspartate aminotransferaseincreased, liver function test abnormal, gamma-glutamyltransferase increased, bloodalkaline phosphatise increased, blood bilirubin increased), weight increased, bloodcholesterol increased.Duloxetine treatment in placebo-controlled clinical trials was associated with small meanincreases from baseline to endpoint in ALT, AST, CPK, and potassium; infrequent,transient, abnormal values were observed for these analytes in duloxetine-treated patients,compared with placebo-treated patients (see PRECAUTIONS).Metabolism and Nutrition DisordersUncommon: dehydration.Musculoskeletal and Connective Tissue DisordersCommon: musculoskeletal pain (including myalgia, neck pain), muscle spasm.Uncommon: muscle tightness (including musculoskeletal stiffness), muscle twitching.Nervous System DisordersVery common: headache (placebo rate was more than duloxetine rate in MDD trials).Common: lethargy, paraesthesia (including hypoaesthesia, hypoaesthesia facia andparasthesia oral).Uncommon: dysgeusia, disturbance in attention, dyskinesia, poor quality sleep.Rare: myoclonus.Psychiatric DisordersCommon: anxiety, sleep disorder, agitation (including feeling jittery, nervousness,restlessness, tension, psychomotor agitation).Uncommon: bruxism, disorientation (including confusional state), apathy, abnormaldreams (including nightmares).Cymbalta PI Nov 2012 v8.0 25
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Gastrointestinal DisordersCommon: dyspepsia (including stomach discomfort), abdominal pain.Uncommon: eructation, gastroenteritis, stomatitis, halitosis, gastritis, flatulence,gastrointestinal haemorrhage, dysphagia.General Disorders and Administration Site ConditionsCommon: chills (including rigors).Uncommon: feeling abnormal, feeling hot and/or cold, malaise, thirst, falls (morecommon in the elderly (≥65 years old))..Rare: Gait disturbanceInfections and InfestationsUncommon: laryngitis.InvestigationsUncommon: blood pressure increased (including blood pressure systolic increased, bloodpressure diastolic increased), hepatic lab related findings (including alanineaminotransferase increased, hepatic enzyme increased, aspartate aminotransferaseincreased, liver function test abnormal, gamma-glutamyltransferase increased, bloodalkaline phosphatise increased, blood bilirubin increased), weight increased, bloodcholesterol increased.Duloxetine treatment in placebo-controlled clinical trials was associated with small meanincreases from baseline to endpoint in ALT, AST, CPK, and potassium; infrequent,transient, abnormal values were observed for these analytes in duloxetine-treated patients,compared with placebo-treated patients (see PRECAUTIONS).Metabolism and Nutrition DisordersUncommon: dehydration.Musculoskeletal and Connective Tissue DisordersCommon: musculoskeletal pain (including myalgia, neck pain), muscle spasm.Uncommon: muscle tightness (including musculoskeletal stiffness), muscle twitching.Nervous System DisordersVery common: headache (placebo rate was more than duloxetine rate in MDD trials).Common: lethargy, paraesthesia (including hypoaesthesia, hypoaesthesia facia andparasthesia oral).Uncommon: dysgeusia, disturbance in attention, dyskinesia, poor quality sleep.Rare: myoclonus.Psychiatric DisordersCommon: anxiety, sleep disorder, agitation (including feeling jittery, nervousness,restlessness, tension, psychomotor agitation).Uncommon: bruxism, disorientation (including confusional state), apathy, abnormaldreams (including nightmares).Cymbalta PI Nov 2012 v8.0 25
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