Duloxetine Brand names: Drizalma; first approved as Cymbalta

What is duloxetine used for?

From the label: indications and usage

DRIZALMA SPRINKLE is indicated for the treatment of:

Major Depressive Disorder in adults

Generalized Anxiety Disorder in adults and pediatric patients 7 years of age and older

Diabetic Peripheral Neuropathy in adults

Fibromyalgia in adults

Chronic Musculoskeletal Pain in adults Additional pediatric use information is approved for Eli Lilly and Company, Inc.’s CYMBALTA (duloxetine delayed-release capsules). However, due to Eli Lilly and Company Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. […]

Conditions named in the indications of duloxetine's FDA labels, with every medicine labeled for each:

• Depression
• Anxiety
• Nerve pain and fibromyalgia
• Pain

FDA pharmacologic class: Serotonin and Norepinephrine Reuptake Inhibitor.

What does the patient leaflet for duloxetine say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about DRIZALMA SPRINKLE?

DRIZALMA SPRINKLE may cause serious side effects, including: • Increased risk of suicidal thoughts or actions. DRIZALMA SPRINKLE and other antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. •Depression and other serious mental illnesses are the most important causes of suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions? oPay close attention to any changes in mood, behavior, actions, thoughts, or feelings, especially sudden changes. This is very important when an antidepressant medicine is started or when the dose is changed.oCall your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.oKeep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms. Call your healthcare provider or get emergency help right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you: •attempts to commit suicide •acting on dangerous impulses •acting aggressive, being angry, or violent •thoughts about suicide or dying •new or worse depression •new or worse anxiety •panic attacks •feeling very agitated or restless •new or worse irritability •trouble sleeping •an extreme increase in activity or talking (mania) •other unusual changes in behavior or mood

From the patient leaflet: How should I store DRIZALMA SPRINKLE?

Store DRIZALMA SPRINKLE at room temperature between 68°F to 77°F (20°C to 25°C).•Store DRIZALMA SPRINKLE in a tightly closed container. Keep DRIZALMA SPRINKLE and all medicines out of the reach of children.

Is there a generic for duloxetine (Cymbalta)?

The FDA approved the first generic duloxetine on December 11, 2013. 23 generic applications are approved; 16 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 3 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.

FDA's NDC Directory lists duloxetine from 45 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

The Orange Book lists no patent for Cymbalta capsules; a patent listed only for Duloxetine Hydrochloride capsules runs to January 13, 2046. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

What do pharmacies pay for duloxetine (Cymbalta)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.102 per Duloxetine HCl DR 30 mg capsule, up 31% from $0.0782 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

Has duloxetine been recalled?

The FDA's Enforcement Report lists 57 recalls naming duloxetine since 2013: 0 Class I (the most serious), 51 Class II, 6 Class III; 40 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of duloxetine and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.

What does the duloxetine label say about other medicines?

The duloxetine label names 30 other medicines in its interaction, contraindication or warning sections. The labels of 12 other medicines name duloxetine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Every other medicine the duloxetine label names

Other labels that name duloxetine

• Almotriptan
• Clozapine
• Darifenacin
• Deferasirox
• Leflunomide
• Primaquine
• Teriflunomide

Check duloxetine against other medicines

What do FAERS reports show for duloxetine?

The FDA Adverse Event Reporting System holds 69,298 reports that list duloxetine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 7,118 are coded as a death and 22,135 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

• 3,021
• 3,872
• 5,224
• 6,099
• 6,546
• 6,176
• 6,775
• 6,668
• 6,900
• 7,660
• 3,924

• 2016
• 2017
• 2018
• 2019
• 2020
• 2021
• 2022
• 2023
• 2024
• 2025
• 2026

The most reported reactions

• Drug Ineffective (a use or a product term, not a reaction)5,438
• Nausea (named in the label)5,140
• Fatigue (named in the label)5,059
• Off Label Use (a use or a product term, not a reaction)4,390
• Pain (a use or a product term, not a reaction)3,916
• Headache (named in the label)3,913
• Diarrhoea (named in the label)3,508
• Dizziness (named in the label)3,223

Side effects: the label's list and every FAERS reaction

What else is labeled for the same conditions as duloxetine?

31 other medicines are given the same way (oral) and in the same FDA class as duloxetine or labeled mainly for the same use (depression), the same class first. Depression lists all 37 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Every medicine labeled for the same conditions as duloxetine

How does duloxetine compare with medicines for the same use?

21 side-by-side pages set duloxetine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.

• Amitriptyline
• Bupropion
• Buspirone
• Citalopram
• Clonazepam
• Desvenlafaxine
• Doxepin
• Escitalopram
• Fluoxetine
• Gabapentin
• Hydroxyzine
• Meloxicam
• Milnacipran
• Mirtazapine
• Nortriptyline
• Paroxetine
• Pregabalin
• Sertraline
• Tramadol
• Trazodone
• Venlafaxine

What next?

Alternatives to duloxetine

31 medicines for the same use

Other SNRIs

the pharmacologic class, with prices and generics

Duloxetine side effects

the label's list beside FAERS reports

Check an interaction

what two or more labels say about each other