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Renal and Urinary DisordersCommon: Urinary frequency.Uncommon: nocturia, urinary hesitation, urinary retention, dysuria, polyuria.Rare: urine odour abnormal, urine flow decreased.Reproductive System and Breast DisordersUncommon: ejaculation disorder (includes ejaculation dysfunction, ejaculation failure),sexual dysfunction, menopausal symptoms, testicular pain.Rare: Menstrual disorderRespiratory, Thoracic and Mediastinal DisordersCommon: yawning, oropharyngeal pain.Uncommon: throat tightnessSkin and Subcutaneous Tissue DisordersCommon: PruritusUncommon: night sweats, photosensitivity reaction, cold sweats, dermatitis contact,increased tendency to bruise.Vascular DisordersUncommon: flushing, peripheral coldness, orthostatic hypotension.Glucose Regulation—In three clinical trials of duloxetine for the treatment of diabeticneuropathic pain, the mean duration of diabetes was approximately 12 years, the meanbaseline fasting blood glucose was 176 mg/dL (9.78 mmol/L), and the mean baselinehaemoglobin A1c (HbA1c) was 7.81%. In the 12 week acute treatment phase of thesestudies, small increases in fasting blood glucose were observed in duloxetine-treatedpatients. HbA1c was stable in both duloxetine-treated and placebo-treated patients. Inthe extension phase of these studies, which lasted up to 52 weeks, there was an increasein HbA1c in both the duloxetine and routine care groups, but the mean increase was 0.3%greater in the duloxetine-treated group. There was also a small increase in fasting bloodglucose and in total cholesterol in duloxetine-treated patients while those laboratory testsshowed a slight decrease in the routine care group.Spontaneous DataThe following list of adverse drug reactions is based on post-marketing spontaneousreports involving use of duloxetine for any indication, and corresponding reporting rateshave been provided. Rare events are defined as those occurring in less than 1/1000patients; very rare events are those occurring in less than 1/10,000 patients.Endocrine disordersVery rare: Syndrome of inappropriate antidiuretic hormone (SIADH).Cardiac disordersVery rare: Supraventricular arrhythmia.Cymbalta PI Nov 2012 v8.0 26