Prescription medication · Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
duloxetine
Also sold as Cymbalta. Duloxetine can treat major depressive disorder and generalized anxiety disorder in adults and children (7 years and older).
Data updated 2026-05-15
- 65,067
- FDA reportsOften reported
- 18
- InteractionsSeveral interactions
- 99% less
- Generic vs brandHuge savings
- 22
- Recall records
What the data shows
duloxetine (Cymbalta) is a prescription Serotonin-Norepinephrine Reuptake Inhibitor (SNRI), more reported than most tracked drugs (65,067 FDA reports), whose generic costs a fraction of the brand (about 99% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
duloxetine (Cymbalta) is a prescription Serotonin-Norepinephrine Reuptake Inhibitor (SNRI). Duloxetine can treat major depressive disorder and generalized anxiety disorder in adults and children (7 years and older).
Duloxetine is a medicine that can help treat depression and anxiety. It can also help with certain types of pain.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$8.01/unit
Generic Price
$0.10/unit
Generic Savings
99%
Generic Available
Yes (16 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
NADAC price trail: DULOXETINE HCL DR 20 MG CAP
Same CMS presentation as the headline generic unit price above (5 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: -19.2% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| April 17, 2024 | $0.0892/EA | - | 2 |
| July 17, 2024 | $0.0819/EA | -8.2% | 2 |
| August 21, 2024 | $0.1062/EA | +29.7% | 1 |
| October 23, 2024 | $0.1189/EA | +11.9% | 1 |
| December 18, 2024 | $0.0961/EA | -19.2% | 22 |
What it does
Duloxetine can treat major depressive disorder and generalized anxiety disorder in adults and children (7 years and older).
Common side effects
Nausea, Dry mouth, Sleepiness
Key warnings
Antidepressants may increase the risk of suicidal thoughts and behaviors in children, teenagers, and young adults.
The sections below are summarized in plain English from duloxetine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Duloxetine is a type of drug called an SNRI. It works by increasing the levels of serotonin and norepinephrine in your brain. These chemicals can help improve mood and reduce pain.
Side Effects (from patient reports)
Based on 65,067 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for duloxetine, by number of reports
- Fatigue
Fatigue
4,787 reports
- Nausea
Nausea
4,782 reports
- Pain
Pain
3,697 reports
- Headache
Headache
3,654 reports
- Diarrhoea
Diarrhoea
3,262 reports
- Dizziness
Dizziness
3,034 reports
- Fall
Fall
2,784 reports
- Vomiting
Vomiting
2,456 reports
- Arthralgia
Arthralgia
2,387 reports
- Dyspnoea
Dyspnoea
2,300 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for duloxetine each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where duloxetine sits
duloxetine has more FDA adverse-event reports than 79% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is duloxetine; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 65,067 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
65,067
Reports Mentioning Death
6,708
10.3% of reports — not proof of cause
Hospitalization Reports
20,822
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | FATIGUE | 4,787 |
| 3 | NAUSEA | 4,782 |
| 5 | PAIN | 3,697 |
| 6 | HEADACHE | 3,654 |
| 7 | DIARRHOEA | 3,262 |
| 8 | DIZZINESS | 3,034 |
| 9 | FALL | 2,784 |
| 10 | VOMITING | 2,456 |
| 11 | ARTHRALGIA | 2,387 |
| 12 | DYSPNOEA | 2,300 |
| 13 | TOXICITY TO VARIOUS AGENTS | 2,212 |
| 14 | DEPRESSION | 2,156 |
| 15 | COMPLETED SUICIDE | 2,079 |
| 16 | DRUG INTERACTION | 2,063 |
| 17 | ANXIETY | 1,984 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Antidepressants may increase the risk of suicidal thoughts and behaviors in children, teenagers, and young adults. Watch closely for worsening depression or suicidal thoughts. Tell your doctor right away if you notice any changes in mood or behavior.
Known Drug Interactions
7.4 Drugs that Interfere with Hemostasis (e.g., NSAIDs, Aspirin, and Warfarin) Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have also shown that concurrent use of an NSAID or aspirin may potentiate this risk of bleeding.
Mechanism: Both of these medicines can make it harder for your blood to clot, which raises your risk of having a serious stomach bleed.
Similar effects would be expected with other potent CYP2D6 inhibitors (e.g., fluoxetine, quinidine) [see Warnings and Precautions (5.12) ].
Mechanism: Fluoxetine blocks the liver's ability to break down duloxetine, which can lead to a buildup of duloxetine in your system.
However, co- administration of Duloxetine delayed-release capsules with aluminum- and magnesium-containing antacids (51 mEq) or Duloxetine delayed-release capsules with famotidine, had no significant effect on the rate or extent of duloxetine absorption after administration of a 40 mg oral dose.
Mechanism: Taking these two drugs together does not change how much of the medicine gets into your body.
7.14 Other Serotonergic Drugs The concomitant use of serotonergic drugs (including other SNRIs, SSRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St.
Mechanism: Both of these medicines increase a brain chemical called serotonin, which can cause a dangerous reaction if levels get too high.
7.2 Inhibitors of CYP2D6 Concomitant use of duloxetine (40 mg once daily) with paroxetine (20 mg once daily) increased the concentration of duloxetine AUC by about 60%, and greater degrees of inhibition are expected with higher doses of paroxetine.
Mechanism: Paroxetine blocks the protein your body uses to break down duloxetine, which can cause duloxetine levels to rise.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I open the capsule and sprinkle it on food?
What should I do if I feel worse after starting duloxetine?
Can I drink alcohol while taking duloxetine?
Will duloxetine cause me to gain weight?
Can I stop taking duloxetine suddenly?
Does duloxetine interact with other medications?
How long does it take for duloxetine to start working?
Can duloxetine cause sexual side effects?
What is the maximum dose of duloxetine?
Can children take duloxetine?
What are the common side effects of duloxetine?
Does duloxetine interact with other medications?
What drug class is duloxetine?
Is there a generic version of duloxetine?
What pregnancy or breastfeeding source fields are listed for duloxetine?
Has duloxetine been recalled?
Active Recalls
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical, Inc.
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Asclemed USA Inc.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Ajanta Pharma Ltd.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Ajanta Pharma Ltd.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Ajanta Pharma Ltd.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Breckenridge Pharmaceutical, Inc.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Breckenridge Pharmaceutical, Inc.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Breckenridge Pharmaceutical, Inc
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Breckenridge Pharmaceutical, Inc
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Direct Rx
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Rising Pharma Holding, Inc.
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Breckenridge Pharmaceutical, Inc
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Amerisource Health Services LLC
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Amerisource Health Services LLC
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
RemedyRepack Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Amerisource Health Services LLC
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Amerisource Health Services LLC
Related Medications in Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
Other drugs grouped near duloxetine - same-class peers and common alternatives.
acamprosate
Campral
Acamprosate is a medicine that can help you stay away from alcohol if you are alcohol-dependent and have already stopped drinking.
Compare with duloxetine →
alprazolam
Xanax
Alprazolam (Xanax) is a medication that can help you with anxiety and panic disorders.
Compare with duloxetine →
amitriptyline
Elavil
Amitriptyline is a medicine used to treat depression.
Compare with duloxetine →
amphetamine/dextroamphetamine
Adderall, Adderall XR
Adderall XR is a stimulant medicine.
Compare with duloxetine →
aripiprazole
Abilify
Aripiprazole (Abilify) is a medicine used to treat certain mental disorders and mood problems.
Compare with duloxetine →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for duloxetine: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 65,067.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 10.31%.
- disulfiram Δ 0.01 pts · 1,076 reports · Aldehyde Dehydrogenase Inhibitor 10.32%death share
- labetalol Δ 0.02 pts · 12,726 reports · Alpha/Beta-Blocker 10.33%death share
- nisoldipine Δ 0.02 pts · 1,191 reports · Calcium Channel Blocker 10.33%death share
- rifampin Δ 0.03 pts · 13,451 reports · Rifamycin Antibiotic 10.28%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Save on duloxetine
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What the FDA Data Shows for duloxetine
The FDA label for duloxetine (sold under brand names such as Cymbalta) classifies it as a prescription-only medication in the Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) class. Duloxetine can treat major depressive disorder and generalized anxiety disorder in adults and children (7 years and older). Official labeling lists 10 commonly reported side effects, including Nausea, Dry mouth, Sleepiness.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 65,067 voluntary reports. The database also lists 18 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.10 versus $8.01 for the brand - a 99% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 22 recall records on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: March 21, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages