What the FDA labels say about taking them together
Elafibranor and levonorgestrel
Elafibranor's FDA label of August 11, 2026 names levonorgestrel in its drug interactions section; the levonorgestrel labels PlainMeds reads (4) do not name elafibranor. The elafibranor label: “… contraceptive failure and/or an increase in breakthrough bleeding, while levonorgestrel exposure remained unaffected.”
Check it at the source: the elafibranor FDA label on DailyMed (effective August 11, 2026, Ipsen Biopharmaceuticals, Inc.); the levonorgestrel FDA label on DailyMed (effective January 31, 2023, Foundation Consumer Healthcare LLC).
What does the elafibranor label say about levonorgestrel?
Elafibranor label, drug interactionsClinical Impact; IQIRVO is a weak CYP3A4 inducer [see ]. A clinical interaction study demonstrated that co-administration of IQIRVO and a combined oral hormonal contraceptive produced a decrease of ethinylestradiol which may lead to contraceptive failure and/or an increase in breakthrough bleeding, while levonorgestrel exposure remained unaffected.
Elafibranor label, warnings and precautionsAdvise females of reproductive potential to avoid use of hormonal contraceptives containing ethinyl estradiol and to use alternative contraception, including progestin-only contraceptives containing levonorgestrel/norgestrel, intrauterine systems, or effective non-hormonal contraceptives during treatment with IQIRVO and for 3 weeks after the last dose of IQIRVO [see Drug Interactions (7.1), Use in Specific Populations (8.3) ].
Source: FDA drug label (IQIRVO), Ipsen Biopharmaceuticals, Inc., effective August 11, 2026 (SPL set d78aa14f-6ec1-4b1d-a4ae-e48658137a25), via openFDA; the full label on DailyMed
What does the levonorgestrel label say about elafibranor?
Levonorgestrel's label (effective January 31, 2023) and its 3 other brand-application labels do not name elafibranor in these sections. A label lists what its studies and reports found; it is not a complete list.
Source: FDA drug label (Plan B One-Step), Foundation Consumer Healthcare LLC, effective January 31, 2023 (SPL set 6ce6b40e-14ac-47bd-a648-ddf9e452e559), 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
| Elafibranor | Levonorgestrel | |
|---|---|---|
| Labeled for | n/a | Birth control |
| Boxed warning | No | No |
| Pharmacy cost (NADAC) | n/a | $6.33 per tablet 1.5 mg tablet |
| Shortage now | No current entry | No 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?
- Check more medicines together
- up to five at once