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What the FDA labels say about taking them together

Darunavir and ethinyl estradiol/levonorgestrel

Ethinyl estradiol/levonorgestrel's FDA label of August 27, 2026 names darunavir in its drug interactions section; the darunavir label PlainMeds reads does not name ethinyl estradiol/levonorgestrel. The ethinyl estradiol/levonorgestrel label: “Significant changes (increase or decrease) in the plasma concentrations of estrogen and/or progestin have been noted in some cases of co-administration with HIV/HCV protease inhibitors and non-nucleoside reverse …”

Check it at the source: the darunavir FDA label on DailyMed (effective August 29, 2025, Janssen Products LP); the ethinyl estradiol/levonorgestrel FDA label on DailyMed (effective August 27, 2026, Exeltis USA, Inc.).

What does the darunavir label say about ethinyl estradiol/levonorgestrel?

Darunavir's label (effective August 29, 2025) does not name ethinyl estradiol/levonorgestrel in these sections. A label lists what its studies and reports found; it is not a complete list.

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 ethinyl estradiol/levonorgestrel label say about darunavir?

Ethinyl estradiol/levonorgestrel label, drug interactions

Significant decreases in systemic exposure of the estrogen and/or progestin have been noted when CHCs are co-administered with some HIV protease inhibitors (e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir), some HCV protease inhibitors (e.g., boceprevir and telaprevir), and some non-nucleoside reverse transcriptase inhibitors (e.g., nevirapine).

Balcoltra label (Avion Pharmaceuticals, December 5, 2025), drug interactions

Significant changes (increase or decrease) in the plasma concentrations of estrogen and/or progestin have been noted in some cases of co-administration with HIV/HCV protease inhibitors and non-nucleoside reverse transcriptase inhibitors (decrease [e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, tipranavir/ritonavir, boceprevir, telaprevir, nevirapine and efavirenz] or increase [e.g., indinavir, atazanavir/ritonavir and etravirine]).

Source: FDA drug label (Balcoltra, NDA208612), Avion Pharmaceuticals, effective December 5, 2025 (SPL set 752ab698-4b48-4614-8016-d1d33ee7c007), via openFDA

Source: FDA drug label (Tyblume), Exeltis USA, Inc., effective August 27, 2026 (SPL set b2482d51-d606-4aaa-8af4-19e4fe2f8872), 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
19Ethinyl estradiol/levonorgestrel generic labelers
DarunavirEthinyl estradiol/levonorgestrel
Labeled forHIVBirth control
Boxed warningNoYes
Pharmacy cost (NADAC)$1.16 per tablet 600 mg tablet$0.154 per tablet 28 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)

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