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What the FDA labels say about taking them together

Colesevelam and pioglitazone

Colesevelam's FDA label of December 28, 2023 names pioglitazone in its warnings and precautions section; the pioglitazone label PlainMeds reads does not name colesevelam. The colesevelam label: “… monotherapy and when colesevelam hydrochloride was used in combination with pioglitazone, sulfonylureas, and insulin. Obtain lipid parameters, including TG levels, before starting colesevelam hydrochloride and …”

Check it at the source: the colesevelam FDA label on DailyMed (effective December 28, 2023, A-S Medication Solutions); the pioglitazone FDA label on DailyMed (effective March 28, 2025, Takeda Pharmaceuticals America, Inc.).

What does the colesevelam label say about pioglitazone?

Colesevelam label, warnings and precautions

In trials in patients with type 2 diabetes, greater increases in TG levels occurred when colesevelam hydrochloride was used as monotherapy (median increase 9.7% compared to placebo) and when colesevelam hydrochloride was used in combination with pioglitazone (median increase 11% compared to placebo in combination with pioglitazone), sulfonylureas (median increase 18% compared to placebo in combination with sulfonylureas), and insulin (median increase 22% compared to placebo in combination with insulin) [see Adverse Reactions (6.1) ]. Obtain lipid parameters, including TG levels, before starting colesevelam hydrochloride and periodically thereafter.

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 pioglitazone label say about colesevelam?

Pioglitazone's label (effective March 28, 2025) does not name colesevelam in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (Actos), Takeda Pharmaceuticals America, Inc., effective March 28, 2025 (SPL set d2ddc491-88a9-4063-9150-443b4fa4330c), 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
22Pioglitazone generic labelers
ColesevelamPioglitazone
Labeled forHigh cholesterol, Type 2 diabetesType 2 diabetes
Boxed warningNoYes
Pharmacy cost (NADAC)$0.262 per tablet 625 mg tablet$0.0675 per tablet 15 mg 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)

What next?