Maximum Dose of Cymbalta (Duloxetine)

The maximum recommended daily dose of duloxetine is 120 mg per day, administered as 60 mg twice daily. 1

FDA-Approved Maximum Dosing

The FDA label explicitly states that the maximum approved dose is 120 mg/day across all indications 1
Doses exceeding 120 mg daily should be avoided, as higher doses provide no additional therapeutic benefit and increase the risk of adverse effects 2
The studied dose range extends up to 400 mg/day (200 mg twice daily), but regulatory approval caps the maximum at 120 mg/day (60 mg twice daily) 3

While 120 mg/day has been shown effective, there is no evidence that doses greater than 60 mg/day confer any additional benefits for most patients with depression 1
The typical therapeutic dose remains 60 mg once daily 1

The maximum dose studied was 120 mg per day 1
For adults under 65 years: while 120 mg once daily was shown effective, no evidence supports additional benefit beyond 60 mg/day 1
For geriatric patients (≥65 years): start at 30 mg once daily for 2 weeks, then increase to 60 mg; may increase to 120 mg maximum if needed 1
For pediatric patients (7-17 years): maximum dose studied was 120 mg per day, though the recommended range is 30-60 mg once daily 1

Administer 60 mg once daily; there is no evidence that doses higher than 60 mg confer additional significant benefit, and higher dosages are clearly less well tolerated 1
In clinical trials, 120 mg/day achieved a number-needed-to-treat (NNT) of 4.9 for ≥50% pain reduction, compared to 5.2 for 60 mg/day—a clinically insignificant difference 2
Approximately 50% of patients achieve at least 50% pain reduction at 12 weeks with 60-120 mg daily 4, 2

60 mg once daily is the optimal dose; 120 mg provides no additional benefit 2
Higher doses increase adverse effects without improving pain outcomes 4

Start at 30 mg daily for one week, then increase to 60 mg daily 2
For suboptimal response after 7 weeks at 60 mg, may increase to 120 mg once daily 2
The maximum dose for these conditions is 120 mg/day 4

Increase in 30 mg increments, allowing at least 1-2 weeks at each dose level to assess response and tolerability 2
For geriatric patients: use smaller increments with longer observation periods (at least one week at each dose) 2
If no response after 4-8 weeks at 120 mg daily, switch to a different medication class rather than exceeding the maximum dose 2

Do not exceed 120 mg/day under any circumstances—this is the absolute ceiling for safety and efficacy 2, 1
Recognize that most indications achieve optimal benefit at 60 mg/day; escalation to 120 mg is appropriate only for specific pain conditions with inadequate response 1, 5
Doses above 60 mg/day are more poorly tolerated, with dose-dependent increases in nausea, dry mouth, constipation, dizziness, and fatigue 2
For diabetic neuropathy specifically, the FDA label emphasizes that 60 mg is the standard dose and higher doses are "clearly less well tolerated" without meaningful added benefit 1

Monitor blood pressure and heart rate, as duloxetine can cause modest hypertension, particularly at higher doses 4, 2
Watch for dose-dependent adverse effects: nausea (16-38%), dry mouth, headache, constipation, dizziness, decreased appetite, and somnolence 2
Number needed to harm for hepatotoxicity is 16, for nausea is 17, and for fatigue/constipation is 19 at therapeutic doses 6
Assess for adverse effects at each follow-up visit, especially when titrating to or maintaining the 120 mg maximum 2