Two medicines, side by side
Pioglitazone vs sitagliptin
Pioglitazone and sitagliptin are both labeled for type 2 diabetes. Drugs@FDA records approvals of pioglitazone since 1999 and of sitagliptin since 2006. Pharmacies paid $0.0675 per pioglitazone HCl 15 mg tablet and $3.77 per sitagliptin phosphate 100 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 sitagliptin a dipeptidyl peptidase 4 inhibitor.
Check it at the source: the pioglitazone FDA label on DailyMed (effective March 28, 2025); the sitagliptin FDA label on DailyMed (effective November 14, 2024).
Highlights of the pioglitazone record
Pioglitazone (Actos) · label of March 28, 2025
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: indicationsMonotherapy 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 sitagliptin record
Sitagliptin (Januvia) · label of November 14, 2024
Used for
From the label: indicationsJANUVIA ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. JANUVIA is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. […]
On the market
- Earliest approval on file
- October 16, 2006
- Generic labelers
- 4 labelers
- Pharmacy cost
- $3.77 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 1
Source: FDA drug labels via openFDA (Pioglitazone label of March 28, 2025, Sitagliptin label of November 14, 2024); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do pioglitazone and sitagliptin differ on the record?
In FDA's classes, pioglitazone is a peroxisome proliferator receptor gamma agonist and sitagliptin a dipeptidyl peptidase 4 inhibitor.
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.”; Sitagliptin, “Sitagliptin is a DPP-4 inhibitor, which is believed to exert its actions in patients with type 2 diabetes mellitus by slowing the inactivation of incretin hormones.”
Half-life, in each label's words: Pioglitazone, “The mean serum half-life (t 1/2 ) of pioglitazone and its metabolites (M-III and M-IV) range from three to seven hours …”; Sitagliptin, “Following a single oral 100-mg dose to healthy volunteers, mean plasma AUC of sitagliptin was 8.52 μM•hr, C max was 950 …”
Only the pioglitazone label carries a boxed warning.
Generics: pioglitazone since 2012; sitagliptin since 2025 (Drugs@FDA).
| Pioglitazone | Sitagliptin | |
|---|---|---|
| Labeled for | Type 2 diabetes | Type 2 diabetes |
| Pharmacologic class | Peroxisome Proliferator Receptor alpha Agonist, Peroxisome Proliferator Receptor gamma Agonist, Thiazolidinedione | Dipeptidyl Peptidase 4 Inhibitor |
| How it works (label) | ACTOS is a thiazolidinedione that depends on the presence of insulin for its mechanism of action. | Sitagliptin is a DPP-4 inhibitor, which is believed to exert its actions in patients with type 2 diabetes mellitus by slowing the inactivation of incretin hormones. |
| 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. | Following a single oral 100-mg dose to healthy volunteers, mean plasma AUC of sitagliptin was 8.52 μM•hr, C max was 950 nM, and apparent terminal half-life (t 1/2 ) was 12.4 hours. |
| Earliest approval on file (Drugs@FDA) | July 15, 1999 | October 16, 2006 |
| First generic approved | August 17, 2012 | December 29, 2025 |
| Generic labelers (NDC) | 22 labelers | 4 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.0675 per tablet (Pioglitazone HCl 15 mg tablet) | $3.77 per tablet (Sitagliptin phosphate 100 mg tablet) |
| 12-month price change | -7% | n/a |
| Boxed warning | Yes | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 2 | 1 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 44,186 | 74,197 |
| DEA schedule | none | none |
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?
- Alternatives to pioglitazone
- every medicine labeled for the same conditions