pioglitazone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
peroxisome proliferator activating receptor-gamma (PPAR-gamma) agonists, thiazolidinedione derivatives	2179	111025-46-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: pioglitazone glustin sepioglin pioglitazone hydrochloride pioglitazone HCl	Pioglitazone is a thiazolidinedione that depends on the presence of insulin for its mechanism of action. Pioglitazone decreases insulin resistance in the periphery and in the liver resulting in increased insulin-dependent glucose disposal and decreased hepatic glucose output. Pioglitazone is not an insulin secretagogue. Pioglitazone is an agonist for peroxisome proliferator-activated receptor-gamma (PPAR-gamma). PPAR receptors are found in tissues important for insulin action such as adipose tissue, skeletal muscle, and liver. Activation of PPAR-gamma nuclear receptors modulates the transcription of a number of insulin responsive genes involved in the control of glucose and lipid metabolism. Molecular weight: 356.44 Formula: C19H20N2O3S CLOGP: 3.53 LIPINSKI: 0 HAC: 5 HDO: 1 TPSA: 68.29 ALOGS: -4.91 ROTB: 7 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

pioglitazone
glustin
sepioglin
pioglitazone hydrochloride
pioglitazone HCl

Pioglitazone is a thiazolidinedione that depends on the presence of insulin for its mechanism of action. Pioglitazone decreases insulin resistance in the periphery and in the liver resulting in increased insulin-dependent glucose disposal and decreased hepatic glucose output. Pioglitazone is not an insulin secretagogue. Pioglitazone is an agonist for peroxisome proliferator-activated receptor-gamma (PPAR-gamma). PPAR receptors are found in tissues important for insulin action such as adipose tissue, skeletal muscle, and liver. Activation of PPAR-gamma nuclear receptors modulates the transcription of a number of insulin responsive genes involved in the control of glucose and lipid metabolism.

Molecular weight: 356.44
Formula: C19H20N2O3S
CLOGP: 3.53
LIPINSKI: 0
HAC: 5
HDO: 1
TPSA: 68.29
ALOGS: -4.91
ROTB: 7

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
30	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0.50 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	1.80 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	83 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

Date	Agency	Company	Orphan
July 15, 1999	FDA	TAKEDA PHARMS USA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Bladder cancer	542.11	12.17	158	22194	4652	56265063
Hypoglycaemia	436.10	12.17	273	22079	55542	56214173
Blood glucose increased	403.12	12.17	291	22061	74860	56194855
Cardiac failure congestive	181.51	12.17	198	22154	87522	56182193
Glycosylated haemoglobin increased	136.03	12.17	73	22279	11092	56258623
Diabetes mellitus inadequate control	133.80	12.17	78	22274	13902	56255813
Blood glucose decreased	123.36	12.17	83	22269	19004	56250711
Diabetic ketoacidosis	117.05	12.17	80	22272	18791	56250924
Oedema peripheral	109.20	12.17	222	22130	171032	56098683
Rheumatoid arthritis	82.17	12.17	25	22327	382579	55887136
Diabetic metabolic decompensation	79.56	12.17	28	22324	1520	56268195
Cardiac failure	78.51	12.17	127	22225	81966	56187749
Pancreatitis	68.56	12.17	87	22265	44993	56224722
Lactic acidosis	68.20	12.17	77	22275	35269	56234446
Diabetes mellitus	60.83	12.17	89	22263	52646	56217069
Drug ineffective	60.65	12.17	177	22175	918812	55350903
Hyperglycaemia	59.99	12.17	75	22277	38206	56231509
Myocardial infarction	59.81	12.17	121	22231	92749	56176966
Systemic lupus erythematosus	59.10	12.17	3	22349	180075	56089640
Drug intolerance	57.35	12.17	17	22335	264801	56004914
Oedema	56.68	12.17	110	22242	81810	56187905
Bladder neoplasm	56.57	12.17	17	22335	556	56269159
Weight increased	55.82	12.17	209	22143	229494	56040221
Off label use	53.20	12.17	87	22265	556093	55713622
Bladder transitional cell carcinoma	50.81	12.17	16	22336	613	56269102
Macular oedema	49.58	12.17	26	22326	3768	56265947
Glossodynia	48.60	12.17	3	22349	152455	56117260
Infusion related reaction	47.87	12.17	12	22340	208919	56060796
Maternal exposure during pregnancy	47.25	12.17	9	22343	189544	56080171
Pancreatitis acute	45.53	12.17	53	22299	25071	56244644
Treatment failure	44.86	12.17	7	22345	170385	56099330
Contraindicated product administered	44.05	12.17	10	22342	186276	56083439
Weight decreased	43.50	12.17	200	22152	240514	56029201
Acute kidney injury	42.73	12.17	199	22153	240564	56029151
Coronary artery disease	41.48	12.17	56	22296	30740	56238975
Pancreatic carcinoma	38.62	12.17	28	22324	7213	56262502
Arthropathy	36.38	12.17	17	22335	200258	56069457
Wound	35.86	12.17	6	22346	138798	56130917
Diabetic retinopathy	33.99	12.17	17	22335	2232	56267483
Lower respiratory tract infection	31.89	12.17	4	22348	114790	56154925
Alopecia	31.79	12.17	42	22310	293416	55976299
Ureteric cancer	31.16	12.17	7	22345	69	56269646
Discomfort	30.84	12.17	9	22343	141752	56127963
Product complaint	30.49	12.17	30	22322	11730	56257985
Hypoglycaemic coma	30.30	12.17	16	22336	2351	56267364
Therapeutic product effect decreased	29.83	12.17	15	22337	169437	56100278
Renal failure	28.85	12.17	103	22249	110397	56159318
Chest pain	28.05	12.17	149	22203	189648	56080067
Joint swelling	27.93	12.17	45	22307	289755	55979960
Product use issue	27.81	12.17	20	22332	186021	56083694
Bladder trabeculation	27.20	12.17	6	22346	54	56269661
Bladder adenocarcinoma stage unspecified	26.99	12.17	5	22347	16	56269699
Blood glucose fluctuation	26.13	12.17	18	22334	4277	56265438
Asthenia	25.35	12.17	227	22125	342746	55926969
Myalgia	24.77	12.17	111	22241	131914	56137801
Angina unstable	24.73	12.17	21	22331	6800	56262915
Biopsy skin abnormal	24.21	12.17	6	22346	93	56269622
Pericarditis	23.53	12.17	7	22345	108916	56160799
Fall	23.12	12.17	230	22122	357280	55912435
Therapeutic product effect incomplete	22.57	12.17	7	22345	106024	56163691
Cholelithiasis	22.56	12.17	49	22303	39415	56230300
Pancreatitis chronic	22.47	12.17	13	22339	2281	56267434
Portal fibrosis	22.26	12.17	7	22345	267	56269448
General physical health deterioration	22.03	12.17	21	22331	169989	56099726
Blood triglycerides increased	21.77	12.17	25	22327	11652	56258063
Dehydration	21.65	12.17	122	22230	158703	56111012
Abdominal discomfort	21.51	12.17	49	22303	277225	55992490
Exposure during pregnancy	21.24	12.17	14	22338	136328	56133387
Diabetic neuropathy	21.15	12.17	15	22337	3733	56265982
Dyspnoea	20.70	12.17	340	22012	592237	55677478
Radius fracture	20.57	12.17	14	22338	3261	56266454
Musculoskeletal stiffness	20.53	12.17	19	22333	155988	56113727
Fasting	20.34	12.17	4	22348	19	56269696
Fluid retention	20.15	12.17	57	22295	54021	56215694
Ketoacidosis	20.02	12.17	15	22337	4060	56265655
Haematuria	19.58	12.17	37	22315	26950	56242765
Tibia fracture	18.11	12.17	15	22337	4693	56265022
Nasopharyngitis	18.00	12.17	38	22314	220921	56048794
Acute myocardial infarction	17.67	12.17	38	22314	30355	56239360
Pancreatic carcinoma metastatic	17.58	12.17	11	22341	2224	56267491
High density lipoprotein decreased	17.30	12.17	10	22342	1752	56267963
Incorrect dose administered	17.30	12.17	53	22299	52494	56217221
Ketosis	17.09	12.17	7	22345	577	56269138
Vomiting	17.05	12.17	285	22067	497943	55771772
Arteriosclerosis coronary artery	16.77	12.17	18	22334	7787	56261928
Infection	16.67	12.17	34	22318	200172	56069543
Transitional cell carcinoma	16.59	12.17	7	22345	621	56269094
Varicose vein ruptured	16.52	12.17	4	22348	56	56269659
Nicotinic acid deficiency	16.32	12.17	4	22348	59	56269656
Rash	16.20	12.17	122	22230	492925	55776790
Nausea	16.19	12.17	407	21945	763771	55505944
Decreased appetite	16.11	12.17	145	22207	219086	56050629
IIIrd nerve paralysis	16.11	12.17	7	22345	668	56269047
Retinal aneurysm	15.53	12.17	5	22347	206	56269509
Rhabdomyolysis	15.29	12.17	43	22309	40615	56229100
Ankle fracture	15.15	12.17	25	22327	16378	56253337
Shock	14.79	12.17	29	22323	21699	56248016
Left ventricular dysfunction	14.63	12.17	20	22332	11103	56258612
Visual acuity reduced	14.52	12.17	28	22324	20698	56249017
Renal impairment	14.48	12.17	67	22285	80646	56189069
Inflammatory bowel disease	14.48	12.17	12	22340	3756	56265959
Stomatitis	14.43	12.17	16	22336	120794	56148921
Unresponsive to stimuli	14.41	12.17	36	22316	31689	56238026
Blood glucose abnormal	14.37	12.17	16	22336	7212	56262503
Hepatic enzyme increased	14.35	12.17	29	22323	171355	56098360
Hypersensitivity	14.27	12.17	53	22299	256355	56013360
Euglycaemic diabetic ketoacidosis	14.05	12.17	11	22341	3178	56266537
Arteriosclerosis	13.98	12.17	18	22334	9435	56260280
Blood ketone body increased	13.97	12.17	5	22347	285	56269430
Swelling	13.71	12.17	49	22303	239722	56029993
Adult failure to thrive	13.70	12.17	4	22348	118	56269597
Postmortem blood drug level increased	13.67	12.17	6	22346	586	56269129
Acute coronary syndrome	13.51	12.17	18	22334	9750	56259965
Upper airway obstruction	13.49	12.17	6	22346	605	56269110
Product use in unapproved indication	13.42	12.17	22	22330	140800	56128915
Cerebrovascular accident	13.34	12.17	76	22276	99194	56170521
Pain	13.16	12.17	185	22167	662999	55606716
Contraindicated product prescribed	13.04	12.17	7	22345	1063	56268652
Face oedema	13.02	12.17	25	22327	18427	56251288
Hyperkalaemia	12.91	12.17	47	22305	50818	56218897
Salpingo-oophorectomy bilateral	12.89	12.17	4	22348	146	56269569
Cardiomegaly	12.47	12.17	23	22329	16444	56253271
Insulin resistance	12.26	12.17	6	22346	751	56268964
Retinal haemorrhage	12.22	12.17	12	22340	4679	56265036

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Bladder cancer	2347.53	12.22	738	24287	13987	31658332
Bladder transitional cell carcinoma	385.33	12.22	123	24902	2423	31669896
Blood glucose increased	258.27	12.22	278	24747	60805	31611514
Hypoglycaemia	231.51	12.22	241	24784	50705	31621614
Cardiac failure congestive	141.52	12.22	237	24788	79150	31593169
Diabetes mellitus inadequate control	135.31	12.22	98	24927	12643	31659676
Pancreatitis	134.07	12.22	153	24872	35618	31636701
Glycosylated haemoglobin increased	124.34	12.22	86	24939	10314	31662005
Oedema peripheral	100.89	12.22	249	24776	109590	31562729
Haematuria	97.14	12.22	149	24876	46165	31626154
Pancreatic carcinoma	86.44	12.22	64	24961	8536	31663783
Diabetic ketoacidosis	83.97	12.22	84	24941	16821	31655498
Bladder neoplasm	82.38	12.22	33	24992	1275	31671044
Blood glucose decreased	65.70	12.22	64	24961	12407	31659912
Myocardial infarction	61.39	12.22	213	24812	113241	31559078
Off label use	59.77	12.22	115	24910	347159	31325160
Transitional cell carcinoma	59.10	12.22	30	24995	2029	31670290
Macular oedema	54.48	12.22	31	24994	2637	31669682
Weight increased	49.50	12.22	161	24864	82786	31589533
Ureteric cancer	47.89	12.22	14	25011	202	31672117
Toxicity to various agents	47.53	12.22	44	24981	181443	31490876
Product use in unapproved indication	45.80	12.22	11	25014	99160	31573159
Malignant spinal cord compression	43.15	12.22	12	25013	143	31672176
Drug ineffective	43.11	12.22	164	24861	395409	31276910
Oedema	42.75	12.22	100	24925	42461	31629858
Hyperglycaemia	40.29	12.22	89	24936	36387	31635932
Pancreatitis acute	39.74	12.22	72	24953	25528	31646791
Genital infection fungal	36.92	12.22	11	25014	170	31672149
Bladder cancer recurrent	36.78	12.22	13	25012	353	31671966
Coronary artery disease	36.56	12.22	99	24926	45988	31626331
Bladder cancer stage 0, with cancer in situ	35.03	12.22	8	25017	39	31672280
Diabetic nephropathy	34.73	12.22	21	25004	2000	31670319
Diabetes mellitus	30.39	12.22	88	24937	42468	31629851
Meningitis eosinophilic	28.82	12.22	6	25019	17	31672302
Pemphigoid	28.64	12.22	34	24991	8237	31664082
Product complaint	28.44	12.22	28	24997	5496	31666823
Diabetic retinopathy	27.83	12.22	17	25008	1649	31670670
Acute myocardial infarction	27.06	12.22	95	24930	50728	31621591
Death	26.27	12.22	172	24853	360397	31311922
Gallbladder neoplasm	25.98	12.22	6	25019	31	31672288
Hypoglycaemic coma	25.68	12.22	18	25007	2203	31670116
General physical health deterioration	23.68	12.22	33	24992	113402	31558917
Euglycaemic diabetic ketoacidosis	23.65	12.22	19	25006	2855	31669464
Diabetic metabolic decompensation	22.80	12.22	15	25010	1654	31670665
Bladder transitional cell carcinoma stage III	22.13	12.22	5	25020	23	31672296
Treatment failure	22.10	12.22	3	25022	40789	31631530
Infectious mononucleosis	21.33	12.22	10	25015	568	31671751
Bladder papilloma	21.31	12.22	5	25020	28	31672291
Rheumatoid arthritis	20.73	12.22	6	25019	47803	31624516
Overdose	20.43	12.22	22	25003	84642	31587677
Renal cyst	20.39	12.22	29	24996	8387	31663932
Urethral cancer	20.24	12.22	6	25019	91	31672228
Pollakiuria	20.12	12.22	44	24981	17858	31654461
Pleural effusion	20.01	12.22	114	24911	74806	31597513
Intentional product use issue	19.96	12.22	7	25018	49340	31622979
Anti-insulin antibody positive	19.84	12.22	7	25018	189	31672130
Malignant neoplasm of renal pelvis	19.56	12.22	5	25020	42	31672277
Thrombocytopenia	19.04	12.22	54	24971	142693	31529626
Weight decreased	18.82	12.22	201	24824	159751	31512568
Cerebral infarction	18.81	12.22	54	24971	25923	31646396
Diabetic neuropathy	18.46	12.22	19	25006	3930	31668389
Urine cytology abnormal	18.44	12.22	3	25022	0	31672319
Cerebrovascular accident	18.08	12.22	116	24909	79368	31592951
Cardiac failure	18.07	12.22	123	24902	85830	31586489
Bladder transitional cell carcinoma stage II	17.87	12.22	5	25020	61	31672258
Hepatic cancer	17.68	12.22	26	24999	7749	31664570
Pulmonary oedema	17.04	12.22	75	24950	44427	31627892
Product use issue	17.02	12.22	12	25013	56747	31615572
Pyrexia	16.90	12.22	156	24869	303684	31368635
Blood glucose abnormal	16.87	12.22	21	25004	5342	31666977
Metastatic carcinoma of the bladder	16.67	12.22	6	25019	172	31672147
Abnormal weight gain	16.41	12.22	10	25015	966	31671353
Blood creatine phosphokinase increased	16.27	12.22	71	24954	41903	31630416
Type 2 diabetes mellitus	16.23	12.22	36	24989	14748	31657571
Prostate cancer	15.65	12.22	65	24960	37536	31634783
Drug intolerance	15.60	12.22	11	25014	52022	31620297
Bladder adenocarcinoma stage unspecified	15.14	12.22	3	25022	6	31672313
Post-thoracotomy pain syndrome	15.11	12.22	4	25021	39	31672280
Insulin resistance	14.77	12.22	8	25017	618	31671701
Neutropenia	14.68	12.22	59	24966	140305	31532014
Retinal aneurysm	14.61	12.22	5	25020	123	31672196
Isosporiasis	14.53	12.22	5	25020	125	31672194
Febrile neutropenia	14.19	12.22	49	24976	121800	31550519
Loss of consciousness	14.12	12.22	107	24918	77248	31595071
Sleep talking	13.81	12.22	7	25018	472	31671847
Angina pectoris	13.75	12.22	53	24972	29588	31642731
Interstitial lung disease	13.58	12.22	89	24936	61314	31611005
Intentional overdose	13.43	12.22	8	25017	41381	31630938
Aortic stenosis	13.20	12.22	16	25009	3960	31668359
Angina unstable	13.13	12.22	28	24997	11167	31661152
Hypoglycaemic unconsciousness	13.09	12.22	8	25017	776	31671543
Urogenital infection fungal	13.07	12.22	3	25022	15	31672304
Rectal cancer	12.93	12.22	12	25013	2189	31670130
Metastases to liver	12.87	12.22	30	24995	12697	31659622
Cholelithiasis	12.68	12.22	39	24986	19440	31652879
Blood urine present	12.61	12.22	26	24999	10131	31662188
Hepatic function abnormal	12.53	12.22	65	24960	41157	31631162

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Bladder cancer	2297.35	11.30	687	36833	16555	70874369
Hypoglycaemia	584.94	11.30	447	37073	93917	70797007
Blood glucose increased	485.92	11.30	416	37104	102566	70788358
Bladder transitional cell carcinoma	462.43	11.30	129	37391	2390	70888534
Cardiac failure congestive	248.07	11.30	331	37189	135126	70755798
Diabetes mellitus inadequate control	241.36	11.30	150	37370	22495	70868429
Diabetic ketoacidosis	205.32	11.30	154	37366	31358	70859566
Oedema peripheral	177.50	11.30	380	37140	227711	70663213
Glycosylated haemoglobin increased	167.33	11.30	108	37412	17283	70873641
Haematuria	137.73	11.30	169	37351	63404	70827520
Bladder neoplasm	133.99	11.30	45	37475	1580	70889344
Blood glucose decreased	131.15	11.30	106	37414	24053	70866871
Myocardial infarction	113.29	11.30	268	37252	171377	70719547
Pancreatitis	109.77	11.30	150	37370	62518	70828406
Pancreatic carcinoma	104.51	11.30	72	37448	12832	70878092
Diabetic metabolic decompensation	96.50	11.30	42	37478	3010	70887914
Rheumatoid arthritis	95.80	11.30	19	37501	291786	70599138
Off label use	92.73	11.30	157	37363	742903	70148021
Drug ineffective	91.59	11.30	229	37291	939523	69951401
Hyperglycaemia	84.67	11.30	135	37385	64537	70826387
Macular oedema	83.85	11.30	45	37475	5117	70885807
Ureteric cancer	81.62	11.30	21	37499	281	70890643
Cardiac failure	78.78	11.30	209	37311	143332	70747592
Oedema	78.59	11.30	171	37349	103410	70787514
Weight increased	76.94	11.30	292	37228	242039	70648885
Transitional cell carcinoma	72.84	11.30	32	37488	2345	70888579
Diabetes mellitus	68.02	11.30	130	37390	71694	70819230
Coronary artery disease	64.97	11.30	118	37402	62618	70828306
Drug intolerance	62.02	11.30	21	37499	225666	70665258
Diabetic retinopathy	60.77	11.30	30	37490	2867	70888057
Drug abuse	54.10	11.30	7	37513	147249	70743675
Acute myocardial infarction	53.76	11.30	119	37401	72768	70818156
Pancreatitis acute	53.23	11.30	90	37430	45134	70845790
Hypoglycaemic coma	51.86	11.30	31	37489	4330	70886594
Treatment failure	50.27	11.30	8	37512	144134	70746790
Malignant spinal cord compression	47.92	11.30	12	37508	143	70890781
Infusion related reaction	46.77	11.30	23	37497	197511	70693413
Bladder cancer stage 0, with cancer in situ	46.61	11.30	10	37510	56	70890868
Pemphigoid	43.56	11.30	45	37475	13977	70876947
Lactic acidosis	43.33	11.30	102	37418	64922	70826002
Bladder cancer recurrent	41.97	11.30	14	37506	481	70890443
Genital infection fungal	41.28	11.30	11	37509	170	70890754
Product use in unapproved indication	40.93	11.30	30	37490	207448	70683476
Euglycaemic diabetic ketoacidosis	40.54	11.30	30	37490	5977	70884947
Bladder adenocarcinoma stage unspecified	39.91	11.30	8	37512	30	70890894
Diabetic nephropathy	39.05	11.30	22	37498	2751	70888173
General physical health deterioration	37.19	11.30	42	37478	235989	70654935
Maternal exposure during pregnancy	36.80	11.30	8	37512	115337	70775587
Rhabdomyolysis	35.08	11.30	121	37399	95639	70795285
Diabetic neuropathy	34.56	11.30	27	37493	5831	70885093
Contraindicated product administered	34.48	11.30	14	37506	134598	70756326
Angina unstable	33.98	11.30	42	37478	15851	70875073
Lower respiratory tract infection	33.28	11.30	9	37511	111904	70779020
Toxicity to various agents	31.91	11.30	100	37420	382072	70508852
Product use issue	31.78	11.30	29	37491	179908	70711016
Cerebrovascular accident	31.66	11.30	155	37365	143315	70747609
Bladder papilloma	31.48	11.30	6	37514	16	70890908
Pleural effusion	31.10	11.30	146	37374	132718	70758206
Pulmonary oedema	31.04	11.30	105	37415	82173	70808751
Chest pain	30.84	11.30	233	37287	251027	70639897
Urine cytology abnormal	30.38	11.30	5	37515	3	70890921
Cerebral infarction	30.34	11.30	69	37451	42940	70847984
Glossodynia	29.70	11.30	5	37515	86482	70804442
Weight decreased	29.61	11.30	272	37248	310216	70580708
Retinal aneurysm	29.08	11.30	9	37511	242	70890682
Blood creatine phosphokinase increased	27.50	11.30	83	37437	61180	70829744
Dehydration	27.35	11.30	209	37311	225933	70664991
Pericarditis	26.76	11.30	6	37514	84699	70806225
Retinal haemorrhage	26.25	11.30	26	37494	7684	70883240
Exposure during pregnancy	26.18	11.30	7	37513	87710	70803214
Meningitis eosinophilic	25.80	11.30	5	37515	15	70890909
Product complaint	25.63	11.30	32	37488	12199	70878725
Intentional product use issue	25.52	11.30	16	37504	120126	70770798
Bladder trabeculation	25.10	11.30	6	37514	58	70890866
Urethral cancer	24.74	11.30	6	37514	62	70890862
Alopecia	23.66	11.30	43	37477	198447	70692477
Bladder transitional cell carcinoma stage III	23.62	11.30	5	37515	26	70890898
Hypersensitivity	23.00	11.30	55	37465	229757	70661167
Gallbladder neoplasm	23.00	11.30	6	37514	85	70890839
Blood triglycerides increased	22.95	11.30	39	37481	19625	70871299
Renal failure	22.44	11.30	174	37346	188896	70702028
Fluid retention	22.26	11.30	79	37441	63306	70827618
Visual acuity reduced	22.18	11.30	47	37473	27883	70863041
Ketoacidosis	21.99	11.30	23	37497	7246	70883678
Prostate cancer	21.98	11.30	50	37470	31113	70859811
Pain	21.44	11.30	221	37299	628595	70262329
Hepatic cancer	21.37	11.30	26	37494	9657	70881267
Wound	21.17	11.30	13	37507	98719	70792205
Cholelithiasis	21.12	11.30	64	37456	47276	70843648
Discomfort	21.10	11.30	15	37505	105421	70785503
Blood glucose fluctuation	21.09	11.30	21	37499	6246	70884678
Insulin resistance	20.72	11.30	11	37509	1223	70889701
Joint swelling	20.59	11.30	67	37453	253144	70637780
Arthropathy	20.22	11.30	30	37490	150027	70740897
Blood glucose abnormal	20.02	11.30	25	37495	9532	70881392
Hepatic function abnormal	19.95	11.30	80	37440	67916	70823008
Anti-insulin antibody positive	19.80	11.30	7	37513	287	70890637
Peripheral swelling	19.65	11.30	62	37458	236501	70654423
Febrile neutropenia	19.58	11.30	50	37470	204268	70686656
Therapeutic product effect incomplete	19.23	11.30	21	37499	119861	70771063
Acute kidney injury	19.18	11.30	355	37165	474269	70416655
Cardiomegaly	19.14	11.30	41	37479	24504	70866420
Renal cyst	19.04	11.30	29	37491	13316	70877608
Lacunar infarction	19.00	11.30	19	37501	5677	70885247
Coronary artery occlusion	18.83	11.30	30	37490	14315	70876609
Hydronephrosis	18.82	11.30	31	37489	15211	70875713
Pyrexia	18.81	11.30	218	37302	606734	70284190
IIIrd nerve paralysis	18.70	11.30	10	37510	1129	70889795
Bladder transitional cell carcinoma stage II	18.66	11.30	5	37515	79	70890845
Biopsy skin abnormal	18.54	11.30	6	37514	187	70890737
Musculoskeletal stiffness	18.52	11.30	31	37489	147729	70743195
Angina pectoris	18.47	11.30	62	37458	48321	70842603
Retinal exudates	18.44	11.30	10	37510	1160	70889764
High density lipoprotein decreased	18.08	11.30	16	37504	4103	70886821
Psoriatic arthropathy	17.82	11.30	6	37514	64765	70826159
Fatigue	17.53	11.30	319	37201	824000	70066924
Nasopharyngitis	17.24	11.30	60	37460	222146	70668778
Fall	17.19	11.30	330	37190	443766	70447158
Rash	17.15	11.30	180	37340	510382	70380542
Blood ketone body increased	17.11	11.30	8	37512	678	70890246
Fasting	17.09	11.30	4	37516	35	70890889
Ill-defined disorder	17.05	11.30	4	37516	54737	70836187
Pancreatic carcinoma metastatic	17.02	11.30	15	37505	3825	70887099
Stomatitis	17.02	11.30	26	37494	128485	70762439
Decreased appetite	16.79	11.30	240	37280	304540	70586384
Low density lipoprotein increased	16.74	11.30	21	37499	8044	70882880
Aortic stenosis	16.65	11.30	19	37501	6597	70884327
Ketosis	16.51	11.30	9	37511	1055	70889869
Malignant neoplasm of renal pelvis	16.50	11.30	5	37515	125	70890799
Arthralgia	16.29	11.30	179	37341	503211	70387713
Diabetic retinal oedema	15.95	11.30	7	37513	512	70890412
Blood urea increased	15.93	11.30	57	37463	45852	70845072
Transient ischaemic attack	15.91	11.30	57	37463	45887	70845037
Diabetic complication	15.49	11.30	9	37511	1192	70889732
Renal cell carcinoma	15.35	11.30	19	37501	7182	70883742
Pancreatitis chronic	15.33	11.30	14	37506	3740	70887184
Death	15.10	11.30	185	37335	509876	70381048
Microalbuminuria	15.06	11.30	8	37512	891	70890033
Portal fibrosis	15.04	11.30	7	37513	587	70890337
Radius fracture	14.97	11.30	13	37507	3253	70887671
Isosporiasis	14.90	11.30	5	37515	175	70890749
Face oedema	14.72	11.30	38	37482	25601	70865323
Hypoglycaemic encephalopathy	14.67	11.30	7	37513	621	70890303
Cardiac failure acute	14.55	11.30	30	37490	17457	70873467
Peripheral vascular disorder	14.47	11.30	19	37501	7613	70883311
Mucosal inflammation	14.45	11.30	9	37511	67841	70823083
Metastatic carcinoma of the bladder	14.43	11.30	5	37515	193	70890731
Abnormal weight gain	14.41	11.30	11	37509	2295	70888629
Multiple injuries	14.41	11.30	13	37507	3418	70887506
Cardiac disorder	14.41	11.30	66	37454	59349	70831575
Urogenital infection fungal	14.27	11.30	3	37517	15	70890909
Infectious mononucleosis	13.99	11.30	10	37510	1889	70889035
Helicobacter infection	13.91	11.30	6	37514	55650	70835274
Chronic gastritis	13.84	11.30	13	37507	3600	70887324
Treatment noncompliance	13.82	11.30	55	37465	46519	70844405
Pollakiuria	13.78	11.30	44	37476	33417	70857507
Blood pressure fluctuation	13.76	11.30	7	37513	59005	70831919
Therapeutic product effect decreased	13.70	11.30	35	37485	142983	70747941
Duodenal ulcer perforation	13.61	11.30	5	37515	51107	70839817
Folliculitis	13.48	11.30	3	37517	42567	70848357
Adenocarcinoma pancreas	13.44	11.30	10	37510	2008	70888916
Arteriosclerosis	13.21	11.30	28	37492	16610	70874314
Varicose vein ruptured	13.16	11.30	4	37516	101	70890823
Hypoglycaemic unconsciousness	13.16	11.30	8	37512	1152	70889772
Polydipsia	13.08	11.30	16	37504	5972	70884952
Rectal cancer	12.96	11.30	12	37508	3262	70887662
Salpingo-oophorectomy bilateral	12.95	11.30	3	37517	25	70890899
Sinusitis	12.91	11.30	46	37474	169149	70721775
Coma	12.72	11.30	18	37502	91826	70799098
Nocturia	12.68	11.30	23	37497	12181	70878743
Renal impairment	12.65	11.30	124	37396	143813	70747111
Urine ketone body present	12.64	11.30	12	37508	3367	70887557
Infection	12.57	11.30	63	37457	210722	70680202
Blood creatinine increased	12.47	11.30	123	37397	142878	70748046
Dilatation atrial	12.25	11.30	12	37508	3500	70887424
Loss of control of legs	12.11	11.30	9	37511	1805	70889119
Ventricular hypertrophy	11.88	11.30	16	37504	6568	70884356
Neuropathic arthropathy	11.88	11.30	5	37515	330	70890594
Cellulitis	11.70	11.30	91	37429	98837	70792087
Humerus fracture	11.66	11.30	18	37502	8360	70882564
Dyspnoea	11.66	11.30	508	37012	769552	70121372
Neutropenia	11.57	11.30	84	37436	257072	70633852
Asthenia	11.45	11.30	320	37200	457346	70433578
Sleep talking	11.35	11.30	7	37513	1034	70889890

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	A10BD05	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BD06	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BD09	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BD12	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BG03	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Thiazolidinediones
FDA CS	M0199111	PPAR alpha
FDA CS	M0199114	PPAR gamma
FDA CS	M0447306	Thiazolidinediones
FDA MoA	N0000175374	Peroxisome Proliferator-activated Receptor Activity
FDA EPC	N0000175596	Peroxisome Proliferator Receptor alpha Agonist
MeSH PA	D007004	Hypoglycemic Agents
CHEBI has role	CHEBI:35469	antidepressants
CHEBI has role	CHEBI:35526	antidiabetic
CHEBI has role	CHEBI:35703	Xenobiotic
CHEBI has role	CHEBI:50864	insulin sensitizers
CHEBI has role	CHEBI:71554	PPARgamma agonist
CHEBI has role	CHEBI:77194	ATP:pantothenate 4-phosphotransferase inhibitor
CHEBI has role	CHEBI:77307	cardioprotective agents
CHEBI has role	CHEBI:83157	EC 6.2.1.3 inhibitors
CHEBI has role	CHEBI:173084	ferroptosis inhibitors
CHEBI has role	CHEBI:176497	geroprotectors
FDA EPC	N0000180186	Peroxisome Proliferator Receptor gamma Agonist
FDA EPC	N0000180190	Thiazolidinedione

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Diabetes mellitus type 2	indication	44054006	DOID:9352
Alcoholism	contraindication	7200002
Asthenia	contraindication	13791008
Myocardial infarction	contraindication	22298006	DOID:5844
Acute vomiting	contraindication	23971007
Alcohol intoxication	contraindication	25702006
Shock	contraindication	27942005
Dehydration	contraindication	34095006
Macular retinal edema	contraindication	37231002	DOID:4449
Infectious disease	contraindication	40733004
Body fluid retention	contraindication	43498006
Chronic heart failure	contraindication	48447003
Hepatic porphyria	contraindication	55056006	DOID:3133
Ketoacidosis	contraindication	56051008
Metabolic acidosis	contraindication	59455009
Hemolytic anemia	contraindication	61261009	DOID:583
Glucose-6-phosphate dehydrogenase deficiency anemia	contraindication	62403005
Hypopituitarism	contraindication	74728003	DOID:9406
Cardiogenic shock	contraindication	89138009
Kidney disease	contraindication	90708001	DOID:557
Lactic acidosis	contraindication	91273001	DOID:3650
Fracture of bone	contraindication	125605004
Autonomic dysreflexia	contraindication	129618003
Liver function tests abnormal	contraindication	166603001
Cobalamin deficiency	contraindication	190634004
Decompensated cardiac failure	contraindication	195111005
Disease of liver	contraindication	235856003	DOID:409
Hypoglycemic disorder	contraindication	237630007
Sepsis syndrome	contraindication	238150007
Edema	contraindication	267038008
Primary adrenocortical insufficiency	contraindication	373662000
Adrenal cortical hypofunction	contraindication	386584007	DOID:10493
Fever	contraindication	386661006
Surgical procedure	contraindication	387713003
Malignant tumor of urinary bladder	contraindication	399326009	DOID:11054
Severe diarrhea	contraindication	409587002
Breastfeeding (mother)	contraindication	413712001
Traumatic injury	contraindication	417746004
Fever greater than 100.4 Fahrenheit	contraindication	426000000
Radiography with IV Iodinated Contrast Agent	contraindication
Severe Hypoxemia	contraindication

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	6.33	acidic
pKa2	7.15	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
EQ 12.5MG BASE;EQ 15MG BASE	OSENI	TAKEDA PHARMS USA	N022426	Jan. 25, 2013	DISCN	TABLET	ORAL	8173663	March 15, 2025	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
EQ 12.5MG BASE;EQ 30MG BASE	OSENI	TAKEDA PHARMS USA	N022426	Jan. 25, 2013	RX	TABLET	ORAL	8173663	March 15, 2025	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
EQ 12.5MG BASE;EQ 45MG BASE	OSENI	TAKEDA PHARMS USA	N022426	Jan. 25, 2013	DISCN	TABLET	ORAL	8173663	March 15, 2025	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
EQ 25MG BASE;EQ 15MG BASE	OSENI	TAKEDA PHARMS USA	N022426	Jan. 25, 2013	RX	TABLET	ORAL	8173663	March 15, 2025	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
EQ 25MG BASE;EQ 30MG BASE	OSENI	TAKEDA PHARMS USA	N022426	Jan. 25, 2013	RX	TABLET	ORAL	8173663	March 15, 2025	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
EQ 25MG BASE;EQ 45MG BASE	OSENI	TAKEDA PHARMS USA	N022426	Jan. 25, 2013	RX	TABLET	ORAL	8173663	March 15, 2025	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
EQ 12.5MG BASE;EQ 15MG BASE	OSENI	TAKEDA PHARMS USA	N022426	Jan. 25, 2013	DISCN	TABLET	ORAL	7807689	June 27, 2028	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN
EQ 12.5MG BASE;EQ 30MG BASE	OSENI	TAKEDA PHARMS USA	N022426	Jan. 25, 2013	RX	TABLET	ORAL	7807689	June 27, 2028	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN
EQ 12.5MG BASE;EQ 45MG BASE	OSENI	TAKEDA PHARMS USA	N022426	Jan. 25, 2013	DISCN	TABLET	ORAL	7807689	June 27, 2028	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN
EQ 25MG BASE;EQ 15MG BASE	OSENI	TAKEDA PHARMS USA	N022426	Jan. 25, 2013	RX	TABLET	ORAL	7807689	June 27, 2028	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN
EQ 25MG BASE;EQ 30MG BASE	OSENI	TAKEDA PHARMS USA	N022426	Jan. 25, 2013	RX	TABLET	ORAL	7807689	June 27, 2028	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN
EQ 25MG BASE;EQ 45MG BASE	OSENI	TAKEDA PHARMS USA	N022426	Jan. 25, 2013	RX	TABLET	ORAL	7807689	June 27, 2028	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Peroxisome proliferator-activated receptor gamma	Nuclear hormone receptor	P37231	PPARG_HUMAN	AGONIST	EC50	6.23	WOMBAT-PK	CHEMBL
Bile salt export pump	Transporter	O95342	ABCBB_HUMAN		IC50	6.52	CHEMBL
Amine oxidase [flavin-containing] B	Enzyme	P27338	AOFB_HUMAN		Ki	6.30	CHEMBL
Amine oxidase [flavin-containing] A	Enzyme	P21397	AOFA_HUMAN		IC50	4.46	DRUG MATRIX
Peroxisome proliferator-activated receptor alpha	Nuclear hormone receptor	Q07869	PPARA_HUMAN		EC50	5.18	CHEMBL
CDGSH iron-sulfur domain-containing protein 1	Unclassified	Q9NZ45	CISD1_HUMAN		Ki	6.43	CHEMBL
Carbonic anhydrase 2	Enzyme	P00918	CAH2_HUMAN		IC50	6.94	DRUG MATRIX
CDGSH iron-sulfur domain-containing protein 2	Unclassified	Q8N5K1	CISD2_HUMAN		IC50	5.32	CHEMBL
Aldose reductase	Enzyme		ALDR_RAT		IC50	4.88	DRUG MATRIX
Amine oxidase [flavin-containing] B	Enzyme		AOFB_RAT		Ki	5.68	CHEMBL
Peroxisome proliferator-activated receptor alpha	Transcription factor		PPARA_MOUSE		IC50	5.94	CHEMBL
Peroxisome proliferator-activated receptor gamma	Transcription factor		PPARG_MOUSE		IC50	6.15	CHEMBL
Peroxisome proliferator-activated receptor gamma	Transcription factor		PPARG_RAT		IC50	6.15	CHEMBL
Enoyl-[acyl-carrier-protein] reductase [NADH]	Enzyme		Q5NGQ3_FRATT		IC50	4.10	CHEMBL
Bile salt export pump	Transporter		ABCBB_RAT		IC50	5.70	CHEMBL
CDGSH iron-sulfur domain-containing protein 1	Unclassified		CISD1_RAT		IC50	6	CHEMBL

External reference:

ID	Source
4021165	VUID
N0000148616	NUI
D00945	KEGG_DRUG
112529-15-4	SECONDARY_CAS_RN
4021165	VANDF
4021166	VANDF
4029214	VANDF
C0071097	UMLSCUI
CHEBI:8228	CHEBI
8N6	PDB_CHEM_ID
CHEMBL595	ChEMBL_ID
DB01132	DRUGBANK_ID
CHEMBL1715	ChEMBL_ID
D000077205	MESH_DESCRIPTOR_UI
4829	PUBCHEM_CID
2694	IUPHAR_LIGAND_ID
6343	INN_ID
X4OV71U42S	UNII
259319	RXNORM
178611	MMSL
29092	MMSL
35713	MMSL
8258	MMSL
d04442	MMSL
007823	NDDF
007824	NDDF
116097005	SNOMEDCT_US
326058001	SNOMEDCT_US
395828009	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Pioglitazone	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7271	TABLET	15 mg	ORAL	ANDA	29 sections
Pioglitazone	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7271	TABLET	15 mg	ORAL	ANDA	29 sections
Pioglitazone	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7272	TABLET	30 mg	ORAL	ANDA	29 sections
Pioglitazone	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7272	TABLET	30 mg	ORAL	ANDA	29 sections
Pioglitazone	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7273	TABLET	45 mg	ORAL	ANDA	29 sections
Pioglitazone	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7273	TABLET	45 mg	ORAL	ANDA	29 sections
Pioglitazone	HUMAN PRESCRIPTION DRUG LABEL	1	0781-5420	TABLET	15 mg	ORAL	ANDA	28 sections
Pioglitazone	HUMAN PRESCRIPTION DRUG LABEL	1	0781-5421	TABLET	30 mg	ORAL	ANDA	28 sections
Pioglitazone	HUMAN PRESCRIPTION DRUG LABEL	1	0781-5422	TABLET	45 mg	ORAL	ANDA	28 sections
Pioglitazone and metformin	HUMAN PRESCRIPTION DRUG LABEL	2	0781-5626	TABLET, FILM COATED	15 mg	ORAL	ANDA	29 sections
Pioglitazone and metformin	HUMAN PRESCRIPTION DRUG LABEL	2	0781-5627	TABLET, FILM COATED	15 mg	ORAL	ANDA	29 sections
Pioglitazone hydrochloride and glimepiride	HUMAN PRESCRIPTION DRUG LABEL	2	0781-5634	TABLET	30 mg	ORAL	ANDA	28 sections
Pioglitazone hydrochloride and glimepiride	HUMAN PRESCRIPTION DRUG LABEL	2	0781-5635	TABLET	30 mg	ORAL	ANDA	28 sections
Pioglitazone	HUMAN PRESCRIPTION DRUG LABEL	1	0904-7090	TABLET	15 mg	ORAL	ANDA	30 sections
Pioglitazone	HUMAN PRESCRIPTION DRUG LABEL	1	0904-7090	TABLET	15 mg	ORAL	ANDA	30 sections
Pioglitazone	HUMAN PRESCRIPTION DRUG LABEL	1	0904-7096	TABLET	30 mg	ORAL	ANDA	30 sections
Pioglitazone	HUMAN PRESCRIPTION DRUG LABEL	1	0904-7096	TABLET	30 mg	ORAL	ANDA	30 sections
PIOGLITAZONEHYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	13668-119	TABLET	30 mg	ORAL	ANDA	26 sections
PIOGLITAZONEHYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	13668-120	TABLET	45 mg	ORAL	ANDA	26 sections
PIOGLITAZONEHYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	13668-140	TABLET	15 mg	ORAL	ANDA	26 sections
Pioglitazone HCL and Metformin HCL	HUMAN PRESCRIPTION DRUG LABEL	2	13668-280	TABLET	15 mg	ORAL	ANDA	28 sections
Pioglitazone HCL and Metformin HCL	HUMAN PRESCRIPTION DRUG LABEL	2	13668-281	TABLET	15 mg	ORAL	ANDA	28 sections
Pioglitazone	Human Prescription Drug Label	1	16714-645	TABLET	15 mg	ORAL	ANDA	30 sections
Pioglitazone	Human Prescription Drug Label	1	16714-646	TABLET	30 mg	ORAL	ANDA	30 sections
Pioglitazone	Human Prescription Drug Label	1	16714-647	TABLET	45 mg	ORAL	ANDA	30 sections
PIOGLITAZONE	HUMAN PRESCRIPTION DRUG LABEL	1	16729-020	TABLET	15 mg	ORAL	ANDA	29 sections
PIOGLITAZONE	HUMAN PRESCRIPTION DRUG LABEL	1	16729-021	TABLET	30 mg	ORAL	ANDA	29 sections
PIOGLITAZONE	HUMAN PRESCRIPTION DRUG LABEL	1	16729-022	TABLET	45 mg	ORAL	ANDA	29 sections
Actos	HUMAN PRESCRIPTION DRUG LABEL	1	21695-147	TABLET	15 mg	ORAL	NDA	31 sections
Actos	HUMAN PRESCRIPTION DRUG LABEL	1	21695-148	TABLET	30 mg	ORAL	NDA	31 sections