SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| ACTOS 15MG TABLET | 15 mg | Tablet · Oral use | 30 Blister | SAR 51.70 | NCE · Prescription | APM | Valid |
| ACTOS 30MG TAB | 30 mg | Tablet · Oral use | 30 Bottle | SAR 87.75 | NCE · Prescription | APM | Valid |
| GLACERA 15MG TABLET | 15 mg | Tablet · Oral use | 30 Blister | SAR 37.80 | Generic · Prescription | RIYADH PHARMA | Valid |
| GLACERA 30MG TABLET | 30 mg | Tablet · Oral use | 30 Blister | SAR 64.15 | Generic · Prescription | RIYADH PHARMA | Valid |
| GLADOS 15MG TABLET | 15 mg | Tablet · Oral use | 30 Bottle | SAR 42.00 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| GLADOS 30MG TABLET | 30 mg | Tablet · Oral use | 30 Bottle | SAR 71.30 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| GLERAN 15MG TABLET | 15 mg | Tablet · Oral use | 30 Jar | SAR 22.60 | Generic · Prescription | UNITED PHARMACEUTICAL CO. | Valid |
| GLERAN 30MG TABLET | 30 mg | Tablet · Oral use | 30 Jar | SAR 45.20 | Generic · Prescription | UNITED PHARMACEUTICAL CO. | Valid |
| OGLITON 15 MG Tablet | 15 mg | Tablet · Oral use | 30 Blister | SAR 34.00 | Generic · Prescription | ACTAVIS | Valid |
| OGLITON 30 MG Tablet | 30 mg | Tablet · Oral use | 30 Blister | SAR 57.75 | Generic · Prescription | ACTAVIS | Valid |
| OGLITON 45 MG Tablet | 45 mg | Tablet · Oral use | 30 Blister | SAR 74.90 | Generic · Prescription | ACTAVIS | Valid |
| GLACERA 45MG TABLET | 45 mg | Tablet · Oral use | 30 Blister | SAR 83.25 | Generic · Prescription | RIYADH PHARMA | Withdrawn by MAH · Not Marketed |
| GLADOS 45MG TABLET | 45 mg | Tablet · Oral use | 30 Bottle | SAR 92.50 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Withdrawn by MAH · Not Marketed |
| GLUSTIN 15MG TAB | 15 mg | Tablet · Oral use | 30 Blister | SAR 64.65 | Generic · Prescription | Eli Lilly and Company | Withdrawn by regulatory authority · Not Marketed |
| GLUSTIN 30MG TAB | 30 mg | Tablet · Oral use | 30 Blister | SAR 87.75 | Generic · Prescription | Eli Lilly and Company | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
DIABETES MELLITUS TYPE 2
US FDA United States — FDA approvals (Drugs@FDA)
EMA European Union — centrally authorised medicines
Actos CHEPLAPHARM Arzneimittel GmbH · Authorised · authorised 13 Oct 2000 · ATC A10BG03
Therapeutic indication (EMA)
Pioglitazone is indicated in the treatment of type-2 diabetes mellitus: as monotherapy: in patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance; as dual oral therapy in combination with: metformin, in patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin; a sulphonylurea, only in patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea; as triple oral therapy in combination with: metformin and a sulphonylurea, in patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. Pioglitazone is also indicated for combination with insulin in type-2 diabetes mellitus patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance.
Pioglitazone Actavis Actavis Group PTC ehf · Authorised · authorised 15 Mar 2012 · ATC A10BG03
Therapeutic indication (EMA)
Pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below: as monotherapy in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. as dual oral therapy in combination with metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin. a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea. as triple oral therapy in combination with metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4). After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained (see section 4.4).
Pioglitazone Accord Accord Healthcare S.L.U. · Authorised · authorised 21 Mar 2012 · ATC A10BG03
Therapeutic indication (EMA)
Pioglitazone is indicated in the treatment of type-2 diabetes mellitus: as monotherapy in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.
Pioglitazone ratio Ratiopharm GmbH · Application withdrawn
Pioglitazone Teva Generics Teva Pharma B.V. · Application withdrawn · ATC A10BG03
Therapeutic indication (EMA)
Treatment of type 2 diabetes mellitus
Glustin Takeda Pharma A/S · Withdrawn · authorised 11 Oct 2000 · ATC A10BG03
Therapeutic indication (EMA)
Pioglitazone is indicated as second or third line treatment of type-2 diabetes mellitus as described below: as monotherapy: in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. as dual oral therapy in combination with: metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin; a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea; as triple oral therapy in combination with: metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. Pioglitazone is also indicated for combination with insulin in type-2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance. After initiation of therapy with pioglitazone, patients should be reviewed after three to six months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.
Sepioglin Vaia S.A. · Withdrawn · authorised 9 Mar 2012 · ATC A10BG03
Therapeutic indication (EMA)
Pioglitazone is indicated as second- or third-line treatment of type-2 diabetes mellitus as described below: as monotherapy: in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance; as dual oral therapy in combination with: metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin; a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea; as triple oral therapy in combination with: metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. Pioglitazone is also indicated for combination with insulin in type-2-diabetes-mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4). After initiation of therapy with pioglitazone, patients should be reviewed after three to six months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained (see section 4.4).
Therapeutic indication (EMA)
Pioglitazone is indicated as second or third line treatment of type-2 diabetes mellitus as described below: as monotherapy: in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance; as dual oral therapy in combination with: metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin; a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea; as triple oral therapy in combination with: metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. Pioglitazone is also indicated for combination with insulin in type-2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance. After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.
Paglitaz Krka, d.d., Novo mesto · Lapsed · authorised 21 Mar 2012 · ATC A10BG03
Therapeutic indication (EMA)
Pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below: as monotherapy in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance; as dual oral therapy in combination with metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin; a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea; as triple oral therapy in combination with metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus in adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance. After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.
Pioglitazone Krka Krka, d.d., Novo mesto · Withdrawn · authorised 21 Mar 2012 · ATC A10BG03
Therapeutic indication (EMA)
Pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below: as monotherapy - in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance; as dual oral therapy in combination with - a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea; Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus in adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance. After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.
Pioglitazone Teva Teva B.V. · Withdrawn · authorised 26 Mar 2012 · ATC A10BG03
Therapeutic indication (EMA)
Pioglitazone is indicated in the treatment of type 2 diabetes mellitus: as monotherapy- in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance as dual oral therapy in combination with- metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin- a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea as triple oral therapy in combination with- metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance. After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.
Pioglitazone Teva Pharma Teva Pharma B.V. · Withdrawn · authorised 26 Mar 2012 · ATC A10BG03
Therapeutic indication (EMA)
Pioglitazone is indicated in the treatment of type-2 diabetes mellitus as monotherapy: in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance. After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.
Canada Canada — marketed products (Health Canada)
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|
| US NADAC | PIOGLITAZONE HCL 15 MG TABLET | $0.06749 | per EA | 30 Sep 2026 |
| US NADAC | PIOGLITAZONE HCL 30 MG TABLET | $0.09301 | per EA | 30 Sep 2026 |
| US NADAC | PIOGLITAZONE HCL 45 MG TABLET | $0.11448 | per EA | 30 Sep 2026 |
| NHS Drug Tariff | Pioglitazone 15mg tablets | £1.78 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Pioglitazone 30mg tablets | £2.00 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Pioglitazone 45mg tablets | £8.10 | 28 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 11 Aug 2026 ACTOPLUS MET — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 28 Jun 2024 OSENI — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 21 Dec 2017 ACTOPLUS MET XR — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 21 Dec 2017 ACTOS — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 21 Dec 2017 DUETACT — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - MHRA 11 Dec 2014 Pioglitazone: risk of bladder cancer
Use of pioglitazone is associated with a small increased risk of bladder cancer. Healthcare professionals should be aware of new warnings and precautions for use in at-risk patients
All safety entries for pioglitazone →
Combinations containing Pioglitazone
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.