See Tables A and B.
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Discontinuation symptoms have been reported when stopping duloxetine. The most commonly reported symptoms following abrupt or tapered discontinuation of duloxetine in clinical trials have included dizziness, nausea, headache, paresthesia, fatigue, vomiting, irritability, nightmares, insomnia, diarrhea, anxiety, hyperhidrosis, vertigo and somnolence.
Duloxetine treatment in clinical trials was associated with numerically significant, but not clinically related increases in ALT, AST, creatinine phosphokinase-CPK, and potassium; transient, abnormal values of these enzymes were infrequently observed in duloxetine-treated patients, compared with placebo-treated patients. Duloxetine is in a class of drugs known to affect urethral resistance. In placebo-controlled trials, urinary hesitation was reported rarely (<1%) in male patients only. If symptoms of urinary hesitation develop during treatment with duloxetine, consideration should be given that they might be drug-related.
Electrocardiograms were obtained from 1139 duloxetine treated patients and 777 placebo-treated patients in 8-week clinical trials. The heart rate-corrected QT interval in duloxetine-treated patients did not differ from that seen in placebo-treated patients.
Cases of suicidal ideation and suicidal behaviors have been reported during duloxetine therapy or early after treatment discontinuation (see Precautions).
Glucose Regulation: In three clinical trials of duloxetine for the treatment of diabetic neuropathic pain, the mean duration of diabetes was approximately 12 years, the mean baseline fasting blood glucose was 176 mg/dL, and the mean baseline hemoglobin A1c (HbA1c) was 7.81%. In the 12 week acute treatment phase of these studies, small increases in fasting blood glucose were observed in duloxetine-treated patients. HbA1c was stable in both duloxetine-treated and placebo-treated patients. In the extension phase of these studies, which lasted up to 52 weeks, there was an increase in HbA1c in both the duloxetine and the routine care groups, but the mean increase was 0.3% greater in the duloxetine-treated group. There was also a small increase in fasting blood glucose and in total cholesterol in duloxetine-treated patients while those laboratory tests showed a slight decrease in the routine care group.
Spontaneous Data: Adverse drug reactions for all indications: The following list of undesirable effects (adverse drug reactions) is based on post-marketing spontaneous reports, and corresponding reporting rates have been provided.
Endocrine disorders: Very rarely (<0.01%): Syndrome of Inappropriate Antidiuretic Hormone (SIADH).
Cardiac disorders: Very rarely (<0.01%): Supraventricular arrhythmia.
Ear and Labyrinth Disorders: Very rarely (<0.01%): Tinnitus upon treatment discontinuation.
Eye disorders: Very rarely (<0.01%): Glaucoma.
Gastrointestinal Disorders: Very rarely (<0.01%): Microscopic colitis.
Hepatobiliary disorders: Very rarely (<0.01%): Hepatitis, jaundice.
Immune system disorders: Very rarely (<0.01%): Anaphylactic reaction, hypersensitivity.
Investigations: Very rarely (<0.01%): Alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, bilirubin increased.
Metabolism and nutrition disorders: Very rarely (<0.01%): Hyponatremia, hyperglycemia (reported especially in diabetic patients).
Musculoskeletal and connective tissue disorders: Very rarely (<0.01%): Trismus.
Nervous system disorders: Very rarely (<0.01%): Extrapyramidal disorder, restless leg syndrome, serotonin syndrome, seizures, seizures upon treatment discontinuation.
Psychiatric disorders: Rarely (≥0.01%-<0.1%): Hallucinations.
Very rarely (<0.01%): Mania, aggression and anger (particularly early in treatment or after treatment discontinuation).
Renal and urinary disorders: Rarely (≥0.01%-<0.1%): Urinary retention.
Reproductive system and breast disorders: Very rarely (<0.01%): Gynecological bleeding, galactorrhea, hyperprolactinemia.
Skin and subcutaneous tissue disorders: Rarely (≥0.01%-<0.1%): Rash.
Very rarely (<0.01%): Angioneurotic edema, contusion, ecchymosis, Stevens-Johnson Syndrome, urticaria.
Vascular disorders: Very rarely (<0.01%): Orthostatic hypotension (especially at the initiation of treatment), syncope (especially at initiation of treatment), hypertensive crisis.