DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Cymbalta (Duloxetine Hydrochloride) - Summary



Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions ()] 5.1 .

In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions ()] 5.1 .

Cymbalta is not approved for use in pediatric patients [see Use in Specific Populations ()] 8.4 .



Cymbalta (Duloxetine Delayed-Release Capsules) is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-()- -methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride.

Major Depressive Disorder

Cymbalta is indicated for the treatment of major depressive disorder (MDD). The efficacy of Cymbalta was established in four short-term and one maintenance trial in adults. [see Clinical Studies ()] 14.1

A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation.

Generalized Anxiety Disorder

Cymbalta is indicated for the treatment of generalized anxiety disorder (GAD). The efficacy of Cymbalta was established in three short-term trials and one maintenance trial in adults. [see Clinical Studies ()] 14.2

Generalized anxiety disorder is defined by the DSM-IV as excessive anxiety and worry, present more days than not, for at least 6 months. The excessive anxiety and worry must be difficult to control and must cause significant distress or impairment in normal functioning. It must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and/or sleep disturbance.

Diabetic Peripheral Neuropathic Pain

Cymbalta is indicated for the management of neuropathic pain (DPNP) associated with diabetic peripheral neuropathy. [see Clinical Studies ()] 14.3


Cymbalta is indicated for the management of fibromyalgia (FM). [see Clinical Studies ()] 14.4

Chronic Musculoskeletal Pain

Cymbalta is indicated for the management of chronic musculoskeletal pain. This has been established in studies in patients with chronic low back pain (CLBP) and chronic pain due to osteoarthritis. [see Clinical Studies ()] 14.5

See all Cymbalta indications & dosage >>


Published Studies Related to Cymbalta (Duloxetine)

Pharmacokinetics of orally administered duloxetine in children and adolescents with major depressive disorder. [2014]
pharmacokinetics in the pediatric population with those characterized in adults... CONCLUSIONS: Duloxetine pharmacokinetics was similar in children and adolescents

Efficacy of duloxetine versus alternative oral therapies: an indirect comparison of randomised clinical trials in chronic low back pain. [2013]
chronic low back pain... CONCLUSION: The available evidence shows that there does not seem to be any

Effect of duloxetine on pain, function, and quality of life among patients with chemotherapy-induced painful peripheral neuropathy: a randomized clinical trial. [2013]
IMPORTANCE: There are no known effective treatments for painful chemotherapy-induced peripheral neuropathy... CONCLUSION AND RELEVANCE: Among patients with painful chemotherapy-induced peripheral neuropathy, the use of duloxetine compared with placebo for 5 weeks resulted in a greater reduction in pain.

Responsiveness of the Intermittent and Constant Osteoarthritis Pain (ICOAP) scale in a trial of duloxetine for treatment of osteoarthritis knee pain. [2013]
this study... CONCLUSION: The study demonstrated efficacy of duloxetine compared with placebo

Safety and tolerability of duloxetine in elderly patients with major depressive disorder: a pooled analysis of two placebo-controlled studies. [2013]
The objective of this study was to examine the safety and tolerability of duloxetine hydrochloride, a serotonin-norepinephrine reuptake inhibitor, in a large cohort of elderly patients with major depressive disorder. Data were pooled from 8-week and 12-week, double-blind, randomized, placebo-controlled trials of duloxetine 60 mg/day (duloxetine=456; placebo=225)...

more studies >>

Clinical Trials Related to Cymbalta (Duloxetine)

The Cymbalta Pregnancy Registry [Recruiting]
The Cymbalta Pregnancy Registry is a U. S. based Registry designed to monitor women who are exposed to Cymbalta (duloxetine) during pregnancy. This is an observational, exposure-registration and follow-up registry.

Study of Duloxetine in the Reduction of Pain in Patient With Systemic Lupus Erythematosus [Completed]
The purpose of this study is to determine whether Duloxetine (cymbalta) can reduce pain severity in patient with Systemic Lupus Erythematosus.

Feasibility Study of Duloxetine in the Treatment of Depression in Patients With Traumatic Brain Injury [Terminated]
The primary objective of the study is to compare the efficacy of duloxetine 60 mg by mouth daily with placebo in the prevention of depression associated with mild/moderate traumatic brain injury and to enhance cognitive function.

Duloxetine for Social Anxiety Disorder: Prediction of Long Term Outcome [Completed]

A Study for the Treatment of Diabetic Peripheral Neuropathic Pain [Completed]
The purpose of the study is to determine if duloxetine can help patients with painful diabetic neuropathy.

more trials >>

Reports of Suspected Cymbalta (Duloxetine) Side Effects

Nausea (263)Dizziness (233)Drug Ineffective (224)Pain (179)Drug Withdrawal Syndrome (173)Depression (169)Insomnia (166)Headache (163)Feeling Abnormal (158)Fatigue (155)more >>


Based on a total of 42 ratings/reviews, Cymbalta has an overall score of 6.81. The effectiveness score is 7.62 and the side effect score is 7.19. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.

Cymbalta review by 55 year old female patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
Treatment Info
Condition / reason:   fybromyalgia
Dosage & duration:   120mg taken once a day for the period of one year
Other conditions:   none
Other drugs taken:   synthroid, allegra, topamax, and Meloxicam
Reported Results
Benefits:   for severe pain and acheness
Side effects:   none
Comments:   I had severe pain from stiffness, achyness, nerve pain in the muscles in my whole body. In the morning it would take me ten minutes to get from my bed to the bathroom and I would be crying all the way because of the pain. Cymbalta is a miracle drug. When added to my other medications for pain it made all the difference in the world and I was able to function pretty normal. Thank God!


Cymbalta review by 40 year old female patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Moderate Side Effects
Treatment Info
Condition / reason:   fibromyalgia
Dosage & duration:   40 mg taken once daily for the period of three months
Other conditions:   undifferentiated connective tissue disease
Other drugs taken:   prednisone, leflunomide
Reported Results
Benefits:   Considerable reduction in muscle pain and increased energy
Side effects:   panic attacks for the first few weeks, followed by mild tachycardia, moderate diarrhea, mild tinnitus
Comments:   Cymbalta was started at 20 mg for two weeks, then increased to 40 mg. Dropped again to 20 mg after about a month in hopes of reducing side effects, but 40 mg turned out to be the effective does.


Cymbalta review by 26 year old female patient

Overall rating:  
Effectiveness:   Ineffective
Side effects:   Extremely Severe Side Effects
Treatment Info
Condition / reason:   depression/anxiety
Dosage & duration:   60mg taken once a day for the period of 3 days
Other conditions:   n/a
Other drugs taken:   n/a
Reported Results
Benefits:   No treatment benefits
Side effects:   Confusion, memory loss,blurred vision,extreamly hot,chills,dizzy,shaking,out of body experience.
Comments:   I took 60mg sunday evening...everything was fine that night. Monday do not remeber what I cooked for diner lunch and I was careing for my two small children. Monday night took my dose again.....I dont remeber doing this but my medication was counted for. Tuesday morning I was severly sleepy, dizzy and felt like I was in space all day. Tuesday night I took my regular 60 mg does and with in 1 hr I was extremly stoned...I was confusd, dizzy extreme heat sensation running threw my feet,neck and arms. I got chill and goose bumps in between. I habe high anxiety. Tingly feeling runing up and down my legs. Felt like and out of body experience because I was so stoned. Withdrall from only 3 days of meds is very uncomfortable....migraine Cymbalta should be off the market. People should be more informed about the side effects and withdral of this drug.

See all Cymbalta reviews / ratings >>

Page last updated: 2015-08-10

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017