Cymbalta | European Medicines Agency (2024)

Overview

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

Cymbalta is a medicine that contains the active substance duloxetine. It is available as gastroresistant capsules (white and blue: 30 mg; green and blue: 60 mg). ‘Gastroresistant’ means that the capsules’ contents pass through the stomach without being broken down until they reach the intestine.

This prevents the active substance being destroyed by the acid in the stomach.

Cymbalta is used to treat adults with the following diseases:

  • major depression;
  • pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes);
  • generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).

The medicine can only be obtained with a prescription.

For major depression, the recommended dose of Cymbalta is 60 mg once a day. A response is usually seen in two to four weeks. In patients who respond to Cymbalta, treatment should continue for several months to prevent the disease coming back, or for longer in patients who have had repeated periods of depression in the past.

For diabetic neuropathic pain, the recommended dose is 60 mg per day but some patients may need a higher dose of 120 mg per day. The response to treatment should be assessed regularly.

For generalised anxiety disorder, the recommended starting dose is 30 mg once a day, but the dose can be increased to 60, 90 or 120 mg depending on the patient’s response. Most patients will need to take 60 mg per day. Patients who also have major depression should start with 60 mg once a day. In patients who respond to Cymbalta, treatment should continue for several months, to prevent the disorder coming back.

The dose of Cymbalta should be reduced gradually when stopping treatment.

The active substance in Cymbalta, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor. It works by preventing the neurotransmitters 5-hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.

Neurotransmitters are chemicals that allow nerve cells to communicate with one another. By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters in the spaces between these nerve cells, increasing the level of communication between the cells. Since these neurotransmitters are involved in maintaining high mood and reducing the sensation of pain, blocking their re-uptake into nerve cells can improve the symptoms of depression, anxiety and neuropathic pain.

For major depression, Cymbalta has been compared with placebo (a dummy treatment) in eight main studies involving a total of 2,544 patients. Six of the studies looked at the treatment of depression and measured the change in symptoms over up to six months. The other two studies looked at how long it took for symptoms to return in patients who had initially responded to Cymbalta, including 288 patients with a history of repeated episodes of depression for up to five years.

For neuropathic pain, Cymbalta has been compared with placebo in two 12-week studies in 809 diabetic adults. The main measure of effectiveness was the change in the severity of pain each week. For generalised anxiety disorder, Cymbalta has been compared with placebo in five studies involving a total of 2,337 patients. Four studies looked at the treatment of the disorder by measuring the reduction in symptoms after nine to 10 weeks. The fifth study looked at how long it took for symptoms to return in 429 patients who had initially responded to Cymbalta.

Although the results of the depression studies varied, Cymbalta was more effective than placebo in four of the studies. In the two studies where the approved dose of Cymbalta was compared with placebo, Cymbalta was more effective. It also took longer for symptoms to return in patients taking Cymbalta than in those taking placebo.

For the treatment of diabetic neuropathic pain, Cymbalta was more effective at reducing pain than placebo. In both studies, pain reduction was seen from the first week of treatment for up to 12 weeks.

For generalised anxiety disorder, Cymbalta was also more effective than placebo at treating the disorder and preventing symptoms returning.

The most common side effects with Cymbalta (seen in more than 1 patient in 10) are nausea (feeling sick), headache, dry mouth, somnolence (sleepiness) and dizziness. Most of these were mild or moderate, starting early in treatment and getting milder as treatment continued. For the full list of all side effects reported with Cymbalta, see the package leaflet.

Cymbalta should not be used in people who may be hypersensitive (allergic) to duloxetine or any of the other ingredients. Cymbalta must not be used together with monoamine-oxidase inhibitors (another group of antidepressants), fluvoxamine (another antidepressant), or ciprofloxacin or enoxacin (types of antibiotic). Cymbalta must also not be used in patients with certain types of liver disease or patients with severe kidney disease. Treatment must not be started in patients with uncontrolled hypertension (high blood pressure), because of a risk of hypertensive crisis (sudden, dangerously high blood pressure). As with other antidepressants, isolated cases of suicidal thoughts and behaviour have been seen in patients taking Cymbalta, particularly in the first few weeks of treatment for depression. Any patients taking Cymbalta who have distressing thoughts or experiences at any time should tell their doctor immediately.

The Committee for Medicinal Products for Human Use (CHMP) decided that Cymbalta’s benefits are greater than its risks and recommended that it be given marketing authorisation.

The European Commission granted a marketing authorisation valid throughout the European Union for Cymbalta to Eli Lilly Nederland BV on 17 December 2004. The marketing authorisation is valid for an unlimited period.

Cymbalta : EPAR - Summary for the public

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Cymbalta : EPAR - Risk-management-plan summary

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Cymbalta : EPAR - Risk-management-plan

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Product information

Cymbalta : EPAR - Product Information

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Latest procedure affecting product information: PSUSA/00001187/202308

20/06/2024

Cymbalta | European Medicines Agency (1)

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

  • summary of product characteristics(annex I);
  • manufacturing authorisationholder responsible for batch release (annex IIA);
  • conditions of themarketing authorisation(annex IIB);
  • labelling(annex IIIA);
  • package leaflet(annex IIIB).

Cymbalta : EPAR - All Authorised presentations

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Product details

Name of medicine

Cymbalta

Active substance

duloxetine

International non-proprietary name (INN) or common name

duloxetine

Therapeutic area (MeSH)
  • Anxiety Disorders
  • Diabetic Neuropathies
  • Depressive Disorder, Major

Anatomical therapeutic chemical (ATC) code

N06AX21

Pharmacotherapeutic group

Psychoanaleptics

Therapeutic indication

Treatment of major depressive disorder.

Treatment of diabetic peripheral neuropathic pain.

Treatment of generalised anxiety disorder.

Cymbalta is indicated in adults.

Authorisation details

EMA product number

EMEA/H/C/000572

Marketing authorisation holder

Eli Lilly Nederland B.V.

Papendorpseweg 83
3528 BJ Utrecht
Netherlands

Opinion adopted

16/09/2004

Marketing authorisation issued

17/12/2004

Revision

33

Assessment history

Cymbalta : EPAR - Procedural steps taken and scientific information after authorisation

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Cymbalta-H-C-PSUSA-00001187-202308 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/314979/2024

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Cymbalta-H-C-PSUSA-00001187-201408 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/PRAC/154100/2015

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Cymbalta-H-C-572-P46-0044 : EPAR - Assessment Report

AdoptedReference Number: EMA/121591/2013

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Cymbalta-H-C-572-P46-0039 : EPAR - Assessment Report

AdoptedReference Number: EMA/18171/2013

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Cymbalta-H-C-572-WS-0076: EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/285264/2012

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Cymbalta-H-C-572-II-0036: EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/812385/2009

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CHMP post-authorisation summary of positive opinion for Cymbalta on 22 October 2009

AdoptedReference Number: EMEA/CHMP/656849/2009

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Cymbalta-H-C-572-II-0026 : EPAR - Refusal assessment report - Variation

Reference Number: EMEA/590296/2008

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CHMP post-authorisation summary of positive opinion for Cymbalta on 26 June 2008

AdoptedReference Number: EMEA/CHMP/335965/2008

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Cymbalta-H-C-572-II-0003 : EPAR - Scientific Discussion - Variation

Adopted

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Cymbalta : EPAR - Procedural steps taken before authorisation

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Cymbalta : EPAR - Scientific Discussion

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News on Cymbalta

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 November 2011

More information on Cymbalta

  • EMEA-000420-PIP01-10 - paediatric investigation plan

Topics

  • Medicines

This page was last updated on

Cymbalta | European Medicines Agency (2024)

FAQs

What pharmaceutical company makes Cymbalta? ›

Cymbalta comes in delayed-release capsules and is part of a drug class called serotonin and norepinephrine reuptake inhibitors, or SNRIs. Eli Lilly and Company manufactures the medication.

What's the difference between Cymbalta and duloxetine? ›

Cymbalta is a brand name for duloxetine, a medication that's been approved by the FDA since 2004 to treat depression and anxiety, as well as other conditions. Other brand names for duloxetine include Irenka and Drizalma Sprinkle.

What drug class is the medication Cymbalta? ›

It is in the Serotonin and norepinephrine reuptake inhibitors (SNRIs) class of medications. This activity describes the indications, mechanism of action, and contraindications for duloxetine as a valuable agent in treating multiple health conditions.

What class of drug is Cymbalta DEA? ›

Duloxetine is in a class of medications called selective serotonin and norepinephrine reuptake inhibitors (SNRIs). It works by increasing the amounts of serotonin and norepinephrine, natural substances in the brain that help maintain mental balance and stop the movement of pain signals in the brain.

What is the controversy with Cymbalta? ›

NEW YORK (Reuters) - Eli Lilly & Co on Tuesday will confront the first U.S. trial over allegations it failed to warn users of its popular antidepressant Cymbalta that they could suffer severe withdrawal symptoms, including suicidal thoughts and electric shock-like sensations.

Why is Cymbalta so expensive? ›

Years of research and testing are needed to ensure that brand-name drugs are safe and effective. This testing can make the drugs expensive. The manufacturer of a brand-name drug can sell the drug for up to 20 years. After that, other drugmakers can create generic versions.

Why does Cymbalta have a bad reputation? ›

Cymbalta comes with a Black Box Warning,7 one of the most serious medicine label warnings the FDA can impose. It indicates that this drug can cause withdrawals, suicidal thoughts, and suicidal behaviors. Suicidality is especially prominent when Cymbalta is prescribed to teenagers and young adults.

What is the downside of Cymbalta? ›

Downsides

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include: Drowsiness, insomnia, nausea, headache, dry mouth, constipation, and dizziness.

Why is Cymbalta so hard to get off of? ›

Stopping any medication suddenly and completely — including Cymbalta treatment — can be dangerous. This is because your body is used to having a certain amount of the drug in its system. Suddenly removing it could cause severe withdrawal symptoms, antidepressant discontinuation syndrome, or other health issues.

Does Cymbalta thin your hair? ›

One very, very rare side effect is hair loss. While most patients on the antidepressant duloxetine don't experience hair issues, it's not impossible.

What to avoid on Cymbalta? ›

Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). If you have diabetes, duloxetine may affect your blood sugar.

What organ does duloxetine affect? ›

Duloxetine therapy can be associated with transient asymptomatic elevations in serum aminotransferase levels and has been linked to rare instances of clinically apparent acute liver injury.

Is Cymbalta like an opioid? ›

No, Cymbalta isn't a controlled substance or a narcotic. “Narcotics” is another term for opioids, which are a type of pain reliever. Controlled substances are medications that could cause either physical or mental dependence. With dependence, your body needs the drug to function as usual.

Is duloxetine stronger than gabapentin? ›

The results showed that, at the end of the study, duloxetine was significantly superior to gabapentin in terms of the incidence of adverse reactions (RR = 0.59, 95% CI: 0.45–0.79, P < 0.01), sleep interference score (SMD = −0.35, 95% CI: −0.63 to −0.08, P < 0.05), but no significant differences in VAS score (SMD = − ...

What drug is most like Cymbalta? ›

Lexapro (escitalopram) is an alternative to Cymbalta that might be good for people who are concerned about Cymbalta's effects when used long-term. Lexapro is in the class of drugs called selective serotonin reuptake inhibitors (SSRIs), which work by increasing serotonin levels in the brain to enhance mood.

Why was Cymbalta recalled? ›

According to a recent FDA announcement, tens of millions of duloxetine tablets sold by Breckenridge Pharmaceutical, Inc. are being recalled because they are apparently contaminated with a carcinogen in the nitrosamine family. Drug regulators consider nitrosamines as “high potency mutagenic carcinogens.”

Is Cymbalta brand better than generic? ›

Cymbalta generic

The generic is considered to be as safe and effective as the original drug. Generics tend to cost less than brand-name drugs.

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