Darunavir and cobicistat and Midazolam interaction

Darunavir and cobicistat and Midazolam: both prescribing labels flag this combination with the strongest language, such as a contraindication, a boxed warning, or an instruction to avoid it.

Major

Do not combine without a prescriber's guidance. The label language below is the strongest FDA uses.

What the FDA labels say

From the Darunavir and cobicistat (PREZCOBIX) label · effective 2026-02-01

Major

…lovastatin, simvastatin Opioid Antagonist: naloxegol PDE-5 inhibitor: sildenafil when used for treatment of pulmonary arterial hypertension Sedatives/hypnotics: orally administered midazolam, triazolam PREZCOBIX or PREZCOBIX PED is contraindicated in patients receiving certain co-administered drugs for which altered plasma concentrations are associated with serious…

Contraindicationsnames MidazolamView label on DailyMed
Major

Sedatives/hypnotics: orally administered midazolam, triazolam ↑ midazolam ↑ triazolam Co-administration is contraindicated due to potential for serious and/or life-threatening reactions such as prolonged or increased sedation or respiratory depression.

Drug interactionsnames MidazolamView label on DailyMed
Moderate

Dose reduction for parenteral midazolam should be considered, especially if more than a single dose of midazolam is administered.

Drug interactionsnames MidazolamView label on DailyMed
Moderate

Co-administration of triazolam or orally administered midazolam with PREZCOBIX or PREZCOBIX PED may cause large increases in the concentrations of these benzodiazepines. metabolized by CYP3A: e.g. buspirone, diazepam, estazolam, zolpidem ↑ sedatives/hypnotics With concomitant use, titration is recommended with sedatives/hypnotics metabolized by CYP3A and a lower…

Drug interactionsby drug classView label on DailyMed
Minor

Triazolam and orally administered midazolam are extensively metabolized by CYP3A.

Drug interactionsnames MidazolamView label on DailyMed

From the Midazolam (Midazolam in Sodium Chloride) label · effective 2025-03-02

Moderate

Cytochrome P450-3A4 Inhibitors: May result in prolonged sedation due to decreased plasma clearance of midazolam.

Drug interactionsby drug classView label on DailyMed
Moderate

Cytochrome P450-3A4 Inhibitors Concomitant administration with drugs that are known to inhibit the P450-3A4 enzyme system, such as cimetidine (not ranitidine), erythromycin, diltiazem, verapamil, ketoconazole and itraconazole, may result in prolonged sedation due to a decrease in plasma clearance of midazolam.

Drug interactionsby drug classView label on DailyMed

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Not medical advice. Interaction Checker quotes FDA label text and NIH fact sheets. Whether an interaction matters for you depends on doses, timing, kidney and liver function, and other conditions. Confirm with a pharmacist or prescriber.