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What the FDA labels say about taking them together

Colesevelam and ethinyl estradiol/levonorgestrel

Ethinyl estradiol/levonorgestrel's FDA label of August 27, 2026 names colesevelam in its drug interactions section; the colesevelam label PlainMeds reads does not name ethinyl estradiol/levonorgestrel. The ethinyl estradiol/levonorgestrel label: “Colesevelam Clinical effect Concomitant use of CHCs with colesevelam significantly decreases systemic exposure of ethinyl estradiol.”

Check it at the source: the colesevelam FDA label on DailyMed (effective December 28, 2023, A-S Medication Solutions); the ethinyl estradiol/levonorgestrel FDA label on DailyMed (effective August 27, 2026, Exeltis USA, Inc.).

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

Colesevelam's label (effective December 28, 2023) 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 (COLESEVELAM HYDROCHLORIDE), NDA021176 (Cosette), as published by A-S Medication Solutions, effective December 28, 2023 (SPL set 0127afae-8d8d-43f2-97f9-4f99f6947e81), via openFDA; the full label on DailyMed

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

Ethinyl estradiol/levonorgestrel label, drug interactions

Colesevelam Clinical effect Concomitant use of CHCs with colesevelam significantly decreases systemic exposure of ethinyl estradiol [see Clinical Pharmacology (12.3) ].

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

Colesevelam, a bile acid sequestrant, given together with a COC, has been shown to significantly decrease the AUC of ethinyl estradiol (EE).

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

15Colesevelam generic labelers
19Ethinyl estradiol/levonorgestrel generic labelers
ColesevelamEthinyl estradiol/levonorgestrel
Labeled forHigh cholesterol, Type 2 diabetesBirth control
Boxed warningNoYes
Pharmacy cost (NADAC)$0.262 per tablet 625 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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