Hepatotoxicity: Hepatic failure, sometimes fatal, has been reported in patients treated with duloxetine delayed-release capsules. Duloxetine delayed-release capsules should be discontinued in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established.      Duloxetine delayed-release capsules should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease (5.2)
Orthostatic Hypotension, Falls and Syncope: Cases have been reported with duloxetine therapy (5.3)
Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including with duloxetine delayed-release capsules, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines and St. John's Wort). If such symptoms occur, discontinue duloxetine and initiate supportive treatment. If concomitant use of duloxetine delayed-release capsules with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases (5.4)
Abnormal Bleeding: Duloxetine delayed-release capsules may increase the risk of bleeding events. Patients should be cautioned about the risk of bleeding associated with the concomitant use of duloxetine and NSAIDs, aspirin, or other drugs that affect coagulation (5.5, 7.4)
Severe Skin Reactions: Severe skin reactions, including erythema multiforme and Stevens-Johnson Syndrome (SJS), can occur with duloxetine delayed-release capsules. Duloxetine delayed-release capsules should be discontinued at the first appearance of blisters, peeling rash, mucosal erosions, or any other sign of hypersensitivity if no other etiology can be identified. (5.6)
Discontinuation: May result in symptoms, including dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue (5.7)
Activation of mania or hypomania has occurred (5.8)
Angle-Closure Glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. (5.9)
Seizures: Prescribe with care in patients with a history of seizure disorder (5.10)
Blood Pressure: Monitor blood pressure prior to initiating treatment and periodically throughout treatment (5.11)
Inhibitors of CYP1A2 or Thioridazine: Should not administer with duloxetine delayed-release capsules (5.12)
Hyponatremia: Cases of hyponatremia have been reported (5.13)
Glucose Control in Diabetes: In diabetic peripheral neuropathic pain patients, small increases in fasting blood glucose, and HbA1chave been observed (5.14)
Conditions that Slow Gastric Emptying: Use cautiously in these patients (5.14)
Urinary Hesitation and Retention (5.15)

ADVERSE REACTIONS

Most common adverse reactions (≥5% and at least twice the incidence of placebo patients): nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis (6.3).

To report SUSPECTED ADVERS