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Two medicines, side by side

Pioglitazone vs glimepiride

Pioglitazone and glimepiride are both labeled for type 2 diabetes. Drugs@FDA records approvals of pioglitazone since 1999 and of glimepiride since 1995. Pharmacies paid $0.0675 per pioglitazone HCl 15 mg tablet and $0.0507 per glimepiride 4 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, pioglitazone is a peroxisome proliferator receptor gamma agonist and glimepiride a sulfonylurea.

Check it at the source: the pioglitazone FDA label on DailyMed (effective March 28, 2025); the glimepiride FDA label on DailyMed (effective May 12, 2025).

Highlights of the pioglitazone record

Pioglitazone (Actos) · label of March 28, 2025

Boxed warning

CONGESTIVE HEART FAILURE

Thiazolidinediones, including ACTOS ® , cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions (5.1) ].

After initiation of ACTOS, and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema).

Used for

From the label: indications

Monotherapy and Combination Therapy ACTOS is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14) ]. Important Limitations of Use ACTOS exerts its antihyperglycemic effect only in the presence of endogenous insulin. […]

On the market

Earliest approval on file
July 15, 1999
Generic labelers
22 labelers
Pharmacy cost
$0.0675 per tablet

Supply and safety

Shortage
No current entry
Recalls
2

Highlights of the glimepiride record

Glimepiride (Amaryl) · label of May 12, 2025

Used for

From the label: indications

Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1) ]. Limitations of Use Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. […]

On the market

Earliest approval on file
November 30, 1995
Generic labelers
27 labelers
Pharmacy cost
$0.0507 per tablet

Supply and safety

Shortage
No current entry
Recalls
19

Source: FDA drug labels via openFDA (Pioglitazone label of March 28, 2025, Glimepiride label of May 12, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do pioglitazone and glimepiride differ on the record?

In FDA's classes, pioglitazone is a peroxisome proliferator receptor gamma agonist and glimepiride a sulfonylurea.

How each works, in its label's words: Pioglitazone, “ACTOS is a thiazolidinedione that depends on the presence of insulin for its mechanism of action.”; Glimepiride, “Glimepiride primarily lowers blood glucose by stimulating the release of insulin from pancreatic beta cells.”

Only the pioglitazone label carries a boxed warning.

Generics: pioglitazone since 2012; glimepiride since 2005 (Drugs@FDA).

PioglitazoneGlimepiride
Labeled forType 2 diabetesType 2 diabetes
Pharmacologic classPeroxisome Proliferator Receptor alpha Agonist, Peroxisome Proliferator Receptor gamma Agonist, ThiazolidinedioneSulfonylurea
How it works (label)ACTOS is a thiazolidinedione that depends on the presence of insulin for its mechanism of action.Glimepiride primarily lowers blood glucose by stimulating the release of insulin from pancreatic beta cells.
Half-life (label)The mean serum half-life (t 1/2 ) of pioglitazone and its metabolites (M-III and M-IV) range from three to seven hours and 16 to 24 hours, respectively.n/a
Earliest approval on file (Drugs@FDA)July 15, 1999November 30, 1995
First generic approvedAugust 17, 2012October 6, 2005
Generic labelers (NDC)22 labelers27 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$0.0675 per tablet (Pioglitazone HCl 15 mg tablet)$0.0507 per tablet (Glimepiride 4 mg tablet)
12-month price change-7%+4%
Boxed warningYesNo
Shortage nowNo current entryNo current entry
Recalls recorded219
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)44,18638,737
DEA schedulenonenone

Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)

What next?

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