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 →
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.
How to Take It
Take duloxetine capsules once a day, with or without food. Swallow the capsules whole. Do not crush, chew, or open them. If you miss a dose, take it as soon as you remember unless it is almost time for your next dose.
This is a plain-language summary of duloxetine's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Using duloxetine in the last month of pregnancy may cause problems in the newborn. Talk to your doctor about the risks and benefits of taking duloxetine during pregnancy. Women who stop taking antidepressants during pregnancy are more likely to experience a relapse of depression.
This is a plain-language summary of duloxetine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time.
This is a plain-language summary of duloxetine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store duloxetine capsules at room temperature (between 59°F and 86°F).
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
- Tiredness
Tiredness
4,788 reports
- Feeling sick to your stomach
Feeling sick to your stomach
4,783 reports
- Aches or soreness
Aches or soreness
3,698 reports
- Head pain
Head pain
3,653 reports
- Loose stools
Loose stools
3,262 reports
- Feeling lightheaded
Feeling lightheaded
3,034 reports
- Accidental fall
Accidental fall
2,785 reports
- Throwing up
Throwing up
2,457 reports
- Joint pain
Joint pain
2,387 reports
- Difficulty breathing
Difficulty breathing
2,299 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) 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.
What to do: Use caution when taking these together and tell your doctor immediately if you notice unusual bruising or bleeding.
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.
What to do: Your doctor may need to adjust your duloxetine dose or monitor you more closely for side effects.
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.
What to do: You can take these medications together without any special changes to your routine.
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.
What to do: Your doctor should watch you closely for symptoms like confusion, sweating, or a fast heart rate.
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.
What to do: Your doctor may need to lower your dose of duloxetine to avoid side effects.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
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?
Is duloxetine safe during pregnancy?
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
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alprazolam
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amitriptyline
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amphetamine/dextroamphetamine
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aripiprazole
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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
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: March 21, 2025
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 and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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