This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.1) ] . In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.1) ]. Duloxetine Delayed-release Capsules are not approved for use in pediatric patients [see Use in Specific Populations (8.4) ]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. • Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants ( 5.1 ) • Monitor for worsening and emergence of suicidal thoughts and behaviors ( 5.1 ) • Duloxetine Delayed-release Capsules a...
Duloxetine, milnacipran and venlafaxine are serotonin and noradrenaline (norepinephrine) reuptake inhibitors (SNRIs) that, as well as provoking the adverse effects of SSRI antidepressants, carry a risk of cardiac disorders due to their noradrenergic activity, including hypertension, tachycardia, arrhythmias, and QT prolongation. Compared with SSRIs, venlafaxine carries a higher risk of withdrawal symptoms following discontinuation, and a higher risk of cardiac arrest in cases of overdose (Prescrire Int n° 131, 170, 206, 250, 270; Rev Prescrire n° 338; Interactions Médicamenteuses Prescrire). D...
Prescrire is a French independent review funded only by subscribers, with no industry money. Its annual "drugs to avoid" list (2026 edition, section: Haematology) names drugs it judges more harmful than useful in every authorised indication. Its view is one expert opinion, reached without a conflict of interest.
1. INDICATIONS AND USAGE Duloxetine Delayed-release Capsules is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: • Major Depressive Disorder (MDD) ( 1.1 ) • Generalized Anxiety Disorder (GAD) ( 1.2 ) • Diabetic Peripheral Neuropathic Pain (DPNP) ( 1.3 ) • Chronic Musculoskeletal Pain ( 1.5 ) 1.1 Major Depressive Disorder Duloxetine Delayed-release Capsules are indicated for the treatment of major depressive disorder (MDD). The efficacy of Duloxetine Delayed-release Capsules was established in four short-term and one maintenance trial in adults [see Clinical Studies (14.1) ] . A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation. 1.2 Generalized Anxiety Disorder Duloxe...
4. CONTRAINDICATIONS • Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with Duloxetine Delayed-release Capsules or within 5 days of stopping treatment with Duloxetine Delayed-release Capsules. Do not use Duloxetine Delayed-release Capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start Duloxetine Delayed-release Capsules in a patient who is treated with linezolid or intravenous methylene blue ( 4.1 ) • Use in patients with uncontrolled narrow-angle glaucoma ( 4.2 ) 4.1 Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with Duloxetine Delayed-release Capsules or within 5 days of stopping treatment with Duloxetine Delayed-release Capsules is contraindicated because of an increased risk of serotonin syndrome. The use of Duloxetine Delayed-release Capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see Dosage and Administration (2.5) and Warnings and Precautions (5.4) ]. Starting Duloxetine Delayed-release Capsules in a patient who is being treated with MAOIs such as linezolid or intravenous me...
5. WARNINGS AND PRECAUTIONS • Suicidality: Monitor for clinical worsening and suicide risk ( 5.1 ) • Hepatotoxicity: Hepatic failure, sometimes fatal, has been reported in patients treated with Duloxetine Delayed-release Capsules. Duloxetine Delayed-release Capsules should be discontinued in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. Duloxetine Delayed-release Capsules should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease ( 5.2 ) • Orthostatic Hypotension and Syncope: Cases have been reported with duloxetine therapy ( 5.3 ) • Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including with Duloxetine Delayed-release Capsules, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone and St. John's Wort). If such symptoms occur, discontinue Duloxetine Delayed-release Capsules and initiate supportive treatment. If concomitant use of Duloxetine Delayed-release Capsu...
6. ADVERSE REACTIONS • Most common adverse reactions (≥5% and at least twice the incidence of placebo patients): nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis ( 6.3 ). To report SUSPECTED ADVERSE REACTIONS, contact Breckenridge Pharmaceutical, Inc. at 1-800-367-3395 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Data Sources The data described below reflect exposure to duloxetine in placebo-controlled trials for MDD (N=2489), GAD (N=910), OA (N=239), CLBP (N=600), and DPNP (N=906). The population studied was 17 to 91 years of age; 65.5%, 62.5%, 61.5%, and 42.9% female; and 86.5%, 81.2%, 86.2%, and 74.0% Caucasian for MDD, GAD, OA and CLBP, DPNP, respectively. Most patients received doses of a total of 60 to 120 mg per day [see Clinical Studies (14) ] . The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. Reactions reported during the studies were not necessarily...
Dosage and Administration: Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders ( 2.5 ) 10/2012 Use of Duloxetine Delayed-release Capsules with Other MAOIs such as Linezolid or Methylene Blue ( 2.6 ) 10/2012 Contraindications – Monoamine Oxidase Inhibitors ( 4.1 ) 10/2012 Warnings and Precautions: Serotonin Syndrome ( 5.4 ) 10/2012 Discontinuation of Treatment with Duloxetine Delayed-release Capsules ( 5.7 ) 08/2012
Source: FDA SPL label for DULOXETINE DELAYED-RELEASE (Proficient Rx LP), effective 20221001. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 13,519 | 12,781 | 10,802 | 10,281 | 9,325 | 9,314 | 9,895 | 4,828 |
1,804 reports blaming this drug for every million Medicare prescriptions filled, which is 0.7× the typical drug on this site. (23,682 reports in 2024–2026, against 13,124,600 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 06/2026 | Class II | Breckenridge Pharmaceutical, Inc. | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit |
| 06/2026 | Class II | Breckenridge Pharmaceutical, Inc. | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit |
| 05/2026 | Class II | Asclemed USA Inc. | CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit. |
| 04/2026 | Class II | 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. |
| 04/2026 | Class II | 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. |
| 04/2026 | Class II | 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. |
| 04/2026 | Class II | Breckenridge Pharmaceutical, Inc. | CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit |
| 11/2025 | Class II | Breckenridge Pharmaceutical, Inc. | CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit |
| 11/2025 | Class II | Breckenridge Pharmaceutical, Inc. | CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit |
| 10/2025 | Class II | Breckenridge Pharmaceutical, Inc. | CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm. |
| 08/2025 | Class II | Breckenridge Pharmaceutical, Inc. | CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit. |
| 07/2025 | Class II | Breckenridge Pharmaceutical, Inc. | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $0 in payments to US physicians and hospitals tied to this drug across 0 transactions.
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Duloxetine HCl | 13,094,360 | $24 |
| Cymbalta | 23,811 | $667 |
| Drizalma Sprinkle | 6,429 | $185 |
No same-class alternatives found in RxClass.