What the FDA labels say about taking them together
Darunavir and midazolam
Darunavir's FDA label of August 29, 2025 names midazolam in its contraindications section; the midazolam labels PlainMeds reads (4) do not name darunavir. The darunavir label: “… increased sedation or respiratory depression. Triazolam and orally administered midazolam are extensively metabolized by CYP3A. Co-administration of triazolam or orally administered midazolam with PREZISTA may cause …”
Check it at the source: the darunavir FDA label on DailyMed (effective August 29, 2025, Janssen Products LP); the midazolam FDA label on DailyMed (effective January 1, 2024, Fresenius Kabi USA, LLC).
What does the darunavir label say about midazolam?
Darunavir label, contraindicationsSt. John's wort ( Hypericum perforatum ) Hepatitis C direct acting antiviral: elbasvir/grazoprevir Lipid modifying agents: lomitapide, lovastatin, simvastatin Opioid Antagonist: naloxegol PDE-5 inhibitor: sildenafil when used for treatment of pulmonary arterial hypertension Sedatives/hypnotics: orally administered midazolam, triazolam Co-administration of PREZISTA/ritonavir is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events (narrow therapeutic index).
Darunavir label, drug interactionsConcomitant Drug Class Drug Name Examples: orally administered midazolam, triazolam; Effect on Concentration of Darunavir Or Concomitant Drug: ↑ midazolam ↑ triazolam; Clinical Comment: Co-administration is contraindicated due to potential for serious and/or life-threatening reactions such as prolonged or increased sedation or respiratory depression. Triazolam and orally administered midazolam are extensively metabolized by CYP3A. Co-administration of triazolam or orally administered midazolam with PREZISTA may cause large increases in the concentrations of these benzodiazepines.
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 midazolam label say about darunavir?
Midazolam's label (effective January 1, 2024) and its 3 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 (Midazolam), Fresenius Kabi USA, LLC, effective January 1, 2024 (SPL set 1cc9ba6e-fa1b-405e-9de8-720c567b2a73), 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
| Darunavir | Midazolam | |
|---|---|---|
| Labeled for | HIV | n/a |
| Boxed warning | No | Yes |
| Pharmacy cost (NADAC) | $1.16 per tablet 600 mg tablet | $0.233 per mL 2 mg/2 mL vial |
| Shortage now | No current entry | In shortage |
Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)
What next?
- Check more medicines together
- up to five at once