Duloxetine is a serotonin and norepinephrine reuptake inhibitor sold in the U.S. under 2 brand and generic names, for anxiety disorders, major depressive disorder and diabetic neuropathies. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Cymbalta (application NDA021733). Other duloxetine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Take CYMBALTA once daily, with or without food. Swallow whole; do not crush, chew, or open capsule ( 2.1 ) Indication Starting Dose Target Dose Maximum Dose MDD ( 2.2 ) 40 mg/day to 60 mg/day Acute Treatment: 40 mg/day (20 mg twice daily) to 60 mg/day (once daily or as 30 mg twice daily); Maintenance Treatment: 60 mg/day 120 mg/day GAD ( 2.3 ) Adults 60 mg/day 60 mg/day (once daily) 120 mg/day Geriatric 30 mg/day 60 mg/day (once daily) 120 mg/day Pediatrics (7 to 17 years of age) 30 mg/day 30 to 60 mg/day (once daily) 120 mg/day DPNP ( 2.4 ) 60 mg/day 60 mg/day (once daily) 60 mg/day FM ( 2.5 ) 30 mg/day 60 mg/day (once daily) 60 mg/day Adults and Pediatrics (13 to 17 years of age) Chronic Musculoskeletal Pain ( 2.6 ) 30 mg/day 60 mg/day (once daily) 60 mg/day Discontinuing CYMBALTA: Gradually reduce dosage to avoid discontinuation symptoms ( 2.8 , 5.7 ) 2.1 Important Administration Instructions Administer CYMBALTA orally (with or without meals) and swallow whole. Do not chew or crush, and do not open the delayed-release capsule and sprinkle its contents on food or mix with liquids because these actions might affect the enteric coating. If a dose of CYMBALTA is missed, take the missed dose as soon as it is remembered. 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 CYMBALTA at the same time. 2.2…
The following serious adverse reactions are described below and elsewhere in the labeling: Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [see Boxed Warning and Warnings and Precautions ( 5.1 )] Hepatotoxicity [see Warnings and Precautions ( 5.2 )] Orthostatic Hypotension, Falls and Syncope [see Warnings and Precautions ( 5.3 )] Serotonin Syndrome [see Warnings and Precautions ( 5.4 )] Increased Risk of Bleeding [see Warnings and Precautions ( 5.5 )] Severe Skin Reactions [see Warnings and Precautions ( 5.6 )] Discontinuation Syndrome [see Warnings and Precautions ( 5.7 )] Activation of Mania/Hypomania [see Warnings and Precautions ( 5.8 )] Angle-Closure Glaucoma [see Warnings and Precautions ( 5.9 )] Seizures [see Warnings and Precautions ( 5.10 )] Increases in Blood Pressure [see Warnings and Precautions ( 5.11 )] Clinically Important Drug Interactions [see Warnings and Precautions ( 5.12 )] Hyponatremia [see Warnings and Precautions ( 5.13 )] Urinary Hesitation and Retention [see Warnings and Precautions ( 5.15 )] Sexual Dysfunction [see Warnings and Precautions ( 5.16 )] Most common adverse reactions (≥5% and at least twice the incidence of placebo-treated patients): ( 6.1 ) Adults : nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis Pediatric Patients : decreased weight, decreased appetite, nausea, vomiting,…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
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| 1 | Not yet rated | Prescription | Capsule | Generic | $3 | View → | |
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Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| B;748 | 60 mg | green, yellow | capsule | — |
| 156;A | 20 mg | green | capsule | — |
| 157;A | 30 mg | blue, white | capsule | — |
| 158;A | 60 mg | blue, green | capsule | — |
| 156;A | 20 mg | green | capsule | — |
| 157;A | 30 mg |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
DULOXETINE D/R
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Direct Rx · Jun 22, 2026
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical, Inc. · Jun 4, 2026
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical, Inc. · Jun 4, 2026
Duloxetine DR Capsules
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Asclemed USA Inc. · May 14, 2026
Duloxetine Delayed-Release Capsules
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. · Apr 29, 2026
The elimination half-life of duloxetine is about 12 hours (typically 8 to 17 hours). Duloxetine has no pharmacologically active major metabolites, so nothing extends its effect; however, the half-life is prolonged roughly 3-fold in people with moderate liver impairment (cirrhosis), and it runs somewhat longer in older adults.
CYMBALTA (duloxetine hydrochloride) delayed-release capsule — FDA prescribing information via DailyMed ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
The use of MAOIs intended to treat psychiatric disorders with CYMBALTA or within 5 days of stopping treatment with CYMBALTA is contraindicated because of an increased risk of serotonin syndrome. The use of CYMBALTA within 14 days of stopping an MAOI intended to treat psychiatric disorders is contraindicated [see Dosage and Administration ( 2.8 ) and Warnings and Precautions ( 5.4 )] . Starting CYMBALTA in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and Administration ( 2.9 ) and Warnings and Precautions ( 5.4 )] . Concomitant use of an MAOI antidepressant with CYMBALTA is contraindicated Use of CYMBALTA within 14 days of stopping an MAOI antidepressant is contraindicated In linezolid- or intravenous methylene blue-treated patients, initiation of CYMBALTA is contraindicated ( 4 )
Both CYP1A2 and CYP2D6 are responsible for duloxetine metabolism. Potent inhibitors of CYP1A2 should be avoided ( 7.1 ) Potent inhibitors of CYP2D6 may increase CYMBALTA concentrations ( 7.2 ) CYMBALTA is a moderate inhibitor of CYP2D6 ( 7.9 ) 7.1 Inhibitors of CYP1A2 When CYMBALTA 60 mg was co-administered with fluvoxamine 100 mg, a potent CYP1A2 inhibitor, to male subjects (n=14) duloxetine AUC was increased approximately 6-fold, the C max was increased about 2.5-fold, and duloxetine t 1/2 was increased approximately 3-fold. Other drugs that inhibit CYP1A2 metabolism include cimetidine and quinolone antimicrobials such as ciprofloxacin and enoxacin [see Warnings and Precautions ( 5.12 )] . 7.2 Inhibitors of CYP2D6 Concomitant use of CYMBALTA (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. Similar effects would be expected with other potent CYP2D6 inhibitors (e.g., fluoxetine, quinidine) [see Warnings and Precautions ( 5.12 )] . 7.3 Dual Inhibition of CYP1A2 and CYP2D6 Concomitant administration of CYMBALTA 40 mg twice daily with fluvoxamine 100 mg, a potent CYP1A2 inhibitor, to CYP2D6 poor metabolizer subjects (n=14) resulted in a 6-fold increase in duloxetine AUC and C max . 7.4 Drugs that Interfere with Hemostasis (e.g., NSAIDs,…
| Not yet rated |
| Prescription |
| Capsule |
| Generic |
| $3 |
| View → |
| blue, white |
| capsule |
| — |
| 158;A | 60 mg | blue, green | capsule | — |
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| B;746 | 20 mg | yellow | capsule | — |
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| Y203;60mg | 60 mg | yellow, blue | capsule | — |
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| Y202;30mg | 30 mg | white, blue | capsule | — |
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| Y201;20mg | 20 mg | yellow | capsule | — |
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