Duloxetine
CYMBALTA
Pronunciation: doo-LOX-e-teen (sim-BAWL-ta)
“Dueling Cymbals”
Rare liver toxicity
Blue cloud → serotonin reuptake inhibitor (SRI)
What it isSerotonin and norepinephrine reuptake inhibitor; depression, generalized anxiety, diabetic neuropathy and fibromyalgia.
Why this oneAmong antidepressants, it has labeled efficacy across diabetic neuropathy, fibromyalgia and chronic musculoskeletal pain.
What limits itBlood-pressure rise, nausea and discontinuation symptoms limit it; avoid substantial hepatic disease or heavy alcohol use.
FDA-approved for
- depression (2004)
- diabetic neuropathy (2004)
- GAD (2007)
- fibromyalgia (2008)
- chronic musculoskeletal pain (2010)
Off-label
- stress urinary incontinence
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Major depressive disorder | Adults | 40-60 mg/day | 60 mg/day QD | 120 mg/day |
| Generalized anxiety disorder | Adults <65 yr | 60 mg QD (or 30 mg QD x1 wk) | 60 mg QD | 120 mg/day |
| Generalized anxiety disorder | Geriatric | 30 mg QD x2 wk | 60 mg QD | 120 mg/day |
| Generalized anxiety disorder | Pediatric 7-17 yr | 30 mg QD x2 wk | 30-60 mg QD | 120 mg/day |
| Diabetic peripheral neuropathic pain | Adults | 60 mg QD | 60 mg QD | 60 mg QD |
| Fibromyalgia | Adults | 30 mg QD x1 wk | 60 mg QD | 60 mg QD |
| Fibromyalgia | Pediatric 13-17 yr | 30 mg QD | 60 mg QD | 60 mg QD |
| Chronic musculoskeletal pain | Adults | 30 mg QD x1 wk | 60 mg QD | 60 mg QD |
Titration Where started at 30 mg, increase to 60 mg after 1 week (2 weeks in geriatric/pediatric GAD)
Renal Avoid in severe renal impairment (GFR <30 mL/min)
Hepatic Avoid in chronic liver disease or cirrhosis
Instructions
- Swallow whole; do not crush, chew, or open
- Take with or without food
- Taper gradually to discontinue
Available strengths
- DR cap 20, 30, 40, 60 mg
Contraindications
- MAOIs (concurrently or within 14 days of stopping MAOI); allow 5 days after stopping duloxetine before starting an MAOI due to risk of serotonin syndrome
Cautions
- Hepatotoxicity
- Orthostatic hypotension, falls, syncope
- Serotonin syndrome
- Increased bleeding risk
- Severe skin reactions (erythema multiforme, SJS)
- Activation of mania/hypomania
- Angle-closure glaucoma
- Seizures
- Blood pressure increases
- Hyponatremia/SIADH
- Glucose control in diabetes
- Sexual dysfunction
Adverse reactions
- Nausea
- Dry mouth
- Somnolence
- Constipation
- Decreased appetite
- Hyperhidrosis
- Pediatric: decreased weight, decreased appetite, nausea, vomiting, fatigue, diarrhea
Pregnancy Use near delivery may raise postpartum hemorrhage risk; third-trimester exposure may cause neonatal complications.
Lactation Present in human milk (~<1% of maternal dose); monitor infant for sedation, poor feeding, and poor weight gain.
Cost
Generic entry2013
⚠ BOXED WARNING
- Suicidal thoughts and behaviors in patients under 25
Classes and tags
Clinical profile
Legacy pregnancy categoryC
Defining liabilitySexual/GI effects, hyponatremia, discontinuation and serotonin toxicity; overdose danger varies substantially by agent.
Serotonin and MAOI
Provisional washout figures
Elevating mechanismSRI
Non-elevating actionNone recorded
Exposure dependenceTherapeutic exposure; severe toxicity requires meaningful MAO-A inhibition
Washout BEFORE an MAOI5 days
Evidence confidenceHigh
InterpretationClinically significant SRI. A second SRI generally represents therapeutic duplication/additive adverse effects, not the classic life-threatening interaction.
Open Duloxetine in the interactive console ↗
