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What the FDA labels say about taking them together

Darunavir and sertraline

Darunavir's FDA label of August 29, 2025 names sertraline in its drug interactions section; the sertraline labels PlainMeds reads (3) do not name darunavir. The darunavir label: “If either sertraline or paroxetine is initiated in patients receiving PREZISTA/ritonavir, dose titrating the SSRI based on a clinical assessment of antidepressant response is recommended. …”

Check it at the source: the darunavir FDA label on DailyMed (effective August 29, 2025, Janssen Products LP); the sertraline FDA label on DailyMed (effective August 8, 2023, Viatris Specialty LLC).

What does the darunavir label say about sertraline?

Darunavir label, drug interactions

Concomitant Drug Class Drug Name Examples: paroxetine, sertraline; Effect on Concentration of Darunavir Or Concomitant Drug: ↓ paroxetine ↓ sertraline; Clinical Comment: If either sertraline or paroxetine is initiated in patients receiving PREZISTA/ritonavir, dose titrating the SSRI based on a clinical assessment of antidepressant response is recommended. Monitor for antidepressant response in patients on a stable dose of sertraline or paroxetine who start treatment with PREZISTA/ritonavir.

Source: FDA drug label (PREZISTA), Janssen Products LP, effective August 29, 2025 (SPL set 814301f9-c990-46a5-b481-2879a521a16f), via openFDA; the full label on DailyMed

What does the sertraline label say about darunavir?

Sertraline's label (effective August 8, 2023) and its 2 other brand-application labels do not name darunavir in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (Zoloft), Viatris Specialty LLC, effective August 8, 2023 (SPL set fda754f6-d0f3-4dce-a17a-927d64f912f7), via openFDA; the full label on DailyMed

These are the labels' own sentences. PlainMeds does not grade interactions; a pharmacist or prescriber can say what they mean for one person's medicines.

Both medicines on the record

13Darunavir generic labelers
47Sertraline generic labelers
DarunavirSertraline
Labeled forHIVDepression, Anxiety
Boxed warningNoYes
Pharmacy cost (NADAC)$1.16 per tablet 600 mg tablet$0.0507 per tablet 100 mg tablet
Shortage nowNo current entryNo current entry

Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)

What next?