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Cymbalta (duloxetine hydrochloride) is a popular antidepressant designed to control neurotransmitters and hormones in order to improve moods and alleviate pain. Eli Lilly manufactures this multiuse, billion-dollar drug, which comes with FDA warnings and reprimands.

Cymbalta 60 mg capsule

Active Ingredient: Duloxetine hydrochloride

Related Drugs: Effexor, Celexa and Lexapro

Manufacturer: Eli Lilly and Company

Black Box Warnings: Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants

FDA Approval Status: Approved Aug. 3, 2004

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*Please seek the advice of a medical professional before discontinuing the use of this drug.

Cymbalta is part of a class of antidepressant drugs known as serotonin and norepinephrine reuptake inhibitor (SNRI) medications. This class of drugs is used to treat depression, anxiety and other mood disorders. SNRIs are referred to as dual inhibitors because they work on both norepinephrine and serotonin. This type of drug works by blocking certain nerve cells in the brain from reabsorbing (reuptake) norepinephrine and serotonin. By doing so, this leaves more serotonin and norepinephrine available, which in turn improves mood and alleviates pain.

The U.S. Food and Drug Administration (FDA) first approved Cymbalta in 2004. Within five years of the drug’s hitting the market, doctors prescribed 2.8 million patients Cymbalta, according to an FDA staff report. Of these prescriptions, 400,000 were prescribed for off-label uses like nerve pain, musculoskeletal pain and headaches. In 2008, the FDA approved Cymbalta for Fibromyalgia. Analgesic, or painkilling, properties make the drug also suitable for osteoarthritis. By 2010, about 30 million people had used Cymbalta, despite its being more expensive than many antidepressants on the market. The brand-name drug sells for retail prices of more than $180 a month. For 30 of the 20 mg delayed-release capsules, a consumer can expect to pay about $186. The same number of capsules but in 30 mg doses go for about $216. And 30 of the 60 mg capsules cost about $193 a month.

Cymbalta 20mg capsule
Cymbalta 30mg capsule
Cymbalta 60mg capsule
Cymabalta comes in three capsule sizes - 20mg, 30mg and 60mg

With its above-average prices, Cymbalta generated $29 billion in sales in the drug’s first decade on the market. At its peak in 2013, Cymbalta had annual sales of $5 billion. However, Eli Lilly lost the U.S. patent exclusivity for Cymbalta in December 2013. This “resulted in the immediate entry of generic competitors and rapid and severe decline in revenue,” according to the company’s 2015 annual report, the most recent available. In 2015, Cymbalta brought in $144.6 million in U.S. Cymbalta sales —a 66 percent decrease from the previous year. In 2014, that figure was $420.5 million — an 89 percent decrease from the previous year. Even so, Cymbalta earned status as the most-prescribed antidepressant medication in the U.S., with nearly 10.07 million prescriptions monthly.

FDA-Approved Cymbalta Uses

The FDA initially approved Cymbalta for treating depression. Over the years, Cymbalta indications have expanded to include anxiety, diabetic neuropathy, fibromyalgia and chronic muscle pain. Internationally, the drug is also approved for treating stress urinary incontinence.

  • 2004Major Depressive Disorder

    Treatment of Major Depressive Disorder (also referred to as “depression”) became the first indicated use for Cymbalta in 2004. It is a common but serious mood disorder. Symptoms must be present for at least two weeks to be diagnosed as depression.

  • 2004Diabetic Peripheral Neuropathy

    The FDA approved Cymbalta for treatment of diabetic neuropathy in 2004. Diabetic neuropathy is a type of nerve damage that can occur in people with diabetes. For diabetic neuropathy, Cymbalta treats pain and tingling from nerve damage.

  • 2007Generalized Anxiety Disorder

    In 2007, generalized anxiety disorder — a condition that more than six million Americans suffer from every year — joined the list of indicated uses for Cymbalta. Years later, on October 16, 2014, the FDA approved Cymbalta for the treatment of GAD in children and adolescents ages 7 to 17.

  • 2008Fibromyalgia

    The FDA approved adding the treatment of fibromyalgia to Cymbalta’s label in 2008. This common, chronic and often debilitating syndrome is characterized by muscle pain, trouble sleeping and tiredness. Researchers say duloxetine, the generic name for Cymbalta, may effectively diminish pain and increase physical function in some, not all, patients.

  • 2010Chronic Musculoskeletal Pain

    The most recent FDA-approved use of Cymbalta is treatment of chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain. “Up to three quarters of the population experience chronic pain at some time in their lives,” Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research said in a 2010 press release. “This approval means that many of those people now have another treatment option.”

How to Take Cymbalta

A prescription medication, Cymbalta is available in 20 mg opaque green delayed-release capsules, 30 mg white and blue delayed-release capsules and 60 mg green and blue delayed-release capsules. You should only take the amount of Cymbalta prescribed by your doctor, and you should follow the instructions on the prescription label.

The drug’s label instructs patients:

  • Take Cymbalta once daily, with or without food
  • If you miss a dose, take the missed dose as soon as you remember
  • If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time
  • Do not take two doses of the drug at once

The label further states that users should swallow Cymbalta whole. They should not crush the capsule, chew the capsule, open the capsule and sprinkle its contents on food, or open the capsule and mix the contents with liquids. A month or longer may pass before symptoms improve. Be sure to store Cymbalta at room temperature away from moisture and heat.

Cymbalta Side Effects & Potential Risks

Potential risks and side effects of using Cymbalta include birth defects, skin disease, suicidal thoughts, liver toxicity and complications for pregnant women. Stopping use of the drug can also cause life-altering effects, known as withdrawal symptoms, which include abrupt electrical shocks (brain zaps), dizziness, anger, weight gain and burning sensation.

The most common side effects of Cymbalta use are:

  • Nausea
  • Dry mouth
  • Sleepiness
  • Fatigue
  • Constipation
  • Loss of appetite
  • Increased sweating
  • Dizziness

FDA Warnings, Reviews and Reprimands

The FDA has become increasingly aware of risks and side effects associated with Cymbalta use. As a result, the agency has taken steps to make those risks known to the public, including requiring changes to the drug’s label. The agency, for example, required labels of antidepressant drugs, including Cymbalta, to include a black box warning, the agency’s strictest warning, regarding the risk of suicidal thinking and behavior in children, adolescents and adults.Other actions include:

Liver Disease Warning

In 2005, the FDA notified healthcare professionals of its recommendation that Cymbalta not be administered to patients with any liver issues. “Postmarketing reports of hepatic injury (including hepatitis and cholestatic jaundice) suggest that patients with preexisting liver disease who take duloxetine may have an increased risk for further liver damage. The new labeling extends the Precaution against using Cymbalta in patients with substantial alcohol use to include those patients with chronic liver disease,” a post on the agency’s website said.

Misleading Portion of Ads

Also in 2005, the FDA censured Eli Lilly regarding professional journal ads that provided misleading information about Cymbalta. It sent a letter to Eli Lilly describing the misleading portion of ads as failing to disclose important risks and side effects. Although the ads were discontinued, the dangers remained.

Urinary Retention Warning

During a 2008 review of Cymbalta adverse events, the FDA discovered that there were many cases of urinary retention, some with serious outcome. The FDA required the “Warnings and Precautions” section of the drug’s label be updated to reflect the new information.

Withdrawal Symptoms Complaints

In a 2009 assessment of the drug’s warning label, the FDA found that Eli Lilly failed to adequately warn consumers of the seriousness of withdrawal symptoms. As a result, the agency created several objectives, including requiring Cymbalta to provide an auditable email system to collect comments and complaints related to Cymbalta. Roughly 1,300 people have filed about 140 lawsuits in various federal and state courts alleging injuries arising from the discontinuation of Cymbalta use.

Advisory Committee Review

Because of reports of serious side effects like liver damage and skin disease, an FDA advisory committee met in 2010 to review whether or not the benefits outweighed the risks in the use of Cymbalta for treating chronic pain. Despite the dangers, the drug was approved months later for chronic musculoskeletal pain, including osteoarthritis.

Blood Pressure Warning

The FDA approved changes to Cymbalta’s label in November 2014 that added information about orthostatic hypotension (low blood pressure when standing), falls and syncope (temporary loss of consciousness caused by a fall in blood pressure). According to the warning, syncope and orthostatic hypotension tend to happen within the first week of Cymbalta treatment but can occur at any time while using the drug, especially after increasing dosage.

Serotonin Syndrome Warning

In January 2017, the FDA approved an updated label for Cymbalta that includes new safety information regarding the risk for serotonin syndrome. The agency released a drug safety communication in March 2016 that warned antidepressants, like Cymbalta, can interact with opioids to cause serotonin syndrome, a serious central nervous system reaction in which levels of the chemical serotonin build up in the brain and cause toxicity.

Drugwatch.com Author


Emily is a former journalist with experience in health care writing. She graduated from the University of Florida with a bachelor’s degree in journalism.

View Sources
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