Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
Adverse Reactions The following serious adverse reactions are described below and elsewhere in the labeling: Suicidal Thoughts and Behaviors in Children, Adolescents and Young Adults [see Boxed Warning and Warnings and Precautions (5.1)] Hepatotoxicity [see Warnings and Precautions (5.2)] Orthostatic Hypotension, Falls and Syncope [see Warnings and Precautions (5.3)] Serotonin Syndrome [see Warnings and Precautions (5.4)] Increased Risk of Bleeding [see Warnings and Precautions (5.5)] Severe Skin Reactions [see Warnings and Precautions (5.6)] Discontinuation Syndrome [see Warnings and Precautions (5.7)] Activation of Mania/Hypomania [see Warnings and Precautions (5.8)] Angle-Closure Glaucoma [see Warnings and Precautions (5.9)] Seizures [see Warnings and Precautions (5.10)] Increases in Blood Pressure [see Warnings and Precautions (5.11)] Clinically Important Drug Interactions [see Warnings and Precautions (5.12)] Hyponatremia [see Warnings and Precautions (5.13)] Urinary Hesitation and Retention [see Warnings and Precautions (5.15)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The stated frequencies of adverse reactions represent the proportion of patients who experienced, at least once, one treatment-emergent adverse reaction of the type listed.
A reaction was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.
Adverse Reactions in Adults Adult Clinical Trial Database The data described below reflect exposure to duloxetine delayed-release capsules in placebo-controlled adult trials for MDD (N=3779), GAD (N=1018), OA (N=503), CLBP (N=600), DPNP (N=906), and FM (N=1294).
The age range in this pooled population was 17 to 89 years of age.
In this pooled population, 66%, 61%, 61%, 43%, and 94% of adult patients were female;
and 82%, 73%, 85%, 74%, and 86% of adult patients were Caucasian in the MDD, GAD, OA and CLBP, DPNP, and FM populations, respectively.
Most patients received duloxetine dosages of a total of 60 to 120 mg per day [see Clinical Studies (14)].
The data below do not include results of the trial that evaluated the efficacy of duloxetine for the treatment of GAD in patients ≥65 years old (Study GAD-5) [see Clinical Studies (14.3)];
however, the adverse reactions observed in this geriatric population were generally similar to adverse reactions in the overall adult population.
Warnings and Precautions 5.1 Suicidal Thoughts and Behaviors in Children, Adolescents and Young Adults Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs.
Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.
There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment.
Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) with major depressive disorder (MDD) and other psychiatric disorders.
Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24;
Like all medications, Duloxetine Hcl Dr can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: