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

Stem definition	Drug id	CAS RN
dipeptidyl aminopeptidase-IV inhibitors	2448	486460-32-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: sitagliptin sitagliptin phosphate januvia ristaben sitagliptin phosphate hydrate sitagliptin phosphate monohydrate MK-0431 MK 0431 sitagliptin monophosphate monohydrate sitagliptin phosphate anhydrous sitagliptin hydrochloride monohydrate	A pyrazine-derived DIPEPTIDYL-PEPTIDASE IV INHIBITOR and HYPOGLYCEMIC AGENT that increases the levels of the INCRETIN hormones GLUCAGON-LIKE PEPTIDE-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). It is used in the treatment of TYPE 2 DIABETES. Molecular weight: 407.32 Formula: C16H15F6N5O CLOGP: 0.69 LIPINSKI: 0 HAC: 6 HDO: 1 TPSA: 77.04 ALOGS: -4.08 ROTB: 5 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

sitagliptin
sitagliptin phosphate
januvia
ristaben
sitagliptin phosphate hydrate
sitagliptin phosphate monohydrate
MK-0431
MK 0431
sitagliptin monophosphate monohydrate
sitagliptin phosphate anhydrous
sitagliptin hydrochloride monohydrate

A pyrazine-derived DIPEPTIDYL-PEPTIDASE IV INHIBITOR and HYPOGLYCEMIC AGENT that increases the levels of the INCRETIN hormones GLUCAGON-LIKE PEPTIDE-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). It is used in the treatment of TYPE 2 DIABETES.

Molecular weight: 407.32
Formula: C16H15F6N5O
CLOGP: 0.69
LIPINSKI: 0
HAC: 6
HDO: 1
TPSA: 77.04
ALOGS: -4.08
ROTB: 5

Status: ONP

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

Drug dosage:

Dose	Unit	Route
0.10	g	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	78 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.35 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	87 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	2.80 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	6 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.62 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	12 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
March 20, 2007	EMA	MERCK SHARP DOHME
Oct. 16, 2006	FDA	MERCK SHARP DOHME

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
Blood glucose increased	823.17	11.24	660	55382	70664	50478418
Pancreatitis	595.38	11.24	442	55600	42172	50506910
Hypoglycaemia	563.51	11.24	470	55572	53111	50495971
Diabetes mellitus inadequate control	484.46	11.24	253	55789	12892	50536190
Pancreatic carcinoma	464.31	11.24	195	55847	6019	50543063
Glycosylated haemoglobin increased	290.93	11.24	168	55874	10438	50538644
Carotid artery thrombosis	263.13	11.24	88	55954	1411	50547671
Pancreatic carcinoma metastatic	258.70	11.24	94	55948	1948	50547134
Neurologic neglect syndrome	253.58	11.24	85	55957	1373	50547709
Lactic acidosis	250.20	11.24	242	55800	33113	50515969
Personality disorder	217.93	11.24	103	55939	4221	50544861
Adjustment disorder	215.66	11.24	82	55960	1937	50547145
Diabetic ketoacidosis	211.29	11.24	168	55874	17704	50531378
Hemiplegia	197.33	11.24	115	55927	7266	50541816
Pemphigoid	195.87	11.24	106	55936	5801	50543281
Acute kidney injury	178.07	11.24	606	55436	227452	50321630
Pancreatitis acute	173.36	11.24	170	55872	23642	50525440
Blood glucose abnormal	173.22	11.24	102	55940	6570	50542512
Affect lability	149.96	11.24	104	55938	8894	50540188
Contraindicated product administered	142.71	11.24	5	56037	148953	50400129
Sensory loss	125.59	11.24	88	55954	7650	50541432
Motor dysfunction	124.94	11.24	89	55953	7942	50541140
Systemic lupus erythematosus	124.18	11.24	8	56034	140614	50408468
Hyperglycaemia	123.86	11.24	176	55866	36229	50512853
No adverse event	118.19	11.24	165	55877	33413	50515669
Product dose omission issue	115.06	11.24	455	55587	183383	50365699
Drug intolerance	114.00	11.24	50	55992	219054	50330028
Treatment failure	112.69	11.24	11	56031	137626	50411456
Off label use	112.11	11.24	223	55819	474203	50074879
Ketoacidosis	107.60	11.24	62	55980	3833	50545249
Coordination abnormal	102.48	11.24	92	55950	11442	50537640
Bile duct stent insertion	98.92	11.24	21	56021	42	50549040
Maternal exposure during pregnancy	97.52	11.24	28	56014	159750	50389332
Blood glucose decreased	96.84	11.24	110	55932	18101	50530981
Synovitis	96.08	11.24	12	56030	123853	50425229
Muscle spasticity	93.43	11.24	105	55937	17079	50532003
Adenocarcinoma pancreas	93.17	11.24	37	56005	985	50548097
Glossodynia	92.62	11.24	10	56032	115559	50433523
Product residue present	92.34	11.24	55	55987	3617	50545465
Euglycaemic diabetic ketoacidosis	89.06	11.24	49	55993	2770	50546312
Blood glucose fluctuation	88.68	11.24	56	55986	4090	50544992
Therapeutic product effect decreased	88.44	11.24	21	56021	136029	50413053
Hemiparesis	86.71	11.24	109	55933	19939	50529143
Lipase increased	85.67	11.24	73	55969	8468	50540614
Eating disorder	85.22	11.24	95	55947	15314	50533768
Drug ineffective	84.19	11.24	548	55494	818785	49730297
Aphasia	82.88	11.24	128	55914	28366	50520716
Infusion related reaction	80.11	11.24	44	55998	169513	50379569
Pain	78.21	11.24	353	55689	578550	49970532
Pancreaticoduodenectomy	77.76	11.24	15	56027	13	50549069
Joint swelling	74.00	11.24	98	55944	245188	50303894
Arthropathy	73.12	11.24	42	56000	157864	50391218
Wrong technique in product usage process	72.84	11.24	178	55864	55332	50493750
Hyperkalaemia	69.37	11.24	160	55882	47929	50501153
Pericarditis	67.91	11.24	5	56037	78684	50470398
Product use issue	67.45	11.24	41	56001	149434	50399648
Lung diffusion test abnormal	59.84	11.24	17	56025	152	50548930
Hand deformity	58.51	11.24	19	56023	100180	50448902
Exposure during pregnancy	57.73	11.24	31	56011	120984	50428098
Cerebrovascular accident	55.66	11.24	230	55812	94450	50454632
Toxicity to various agents	55.25	11.24	94	55948	212405	50336677
Dysarthria	54.55	11.24	125	55917	37278	50511804
Muscular weakness	52.89	11.24	227	55815	94786	50454296
Metastases to liver	52.52	11.24	86	55956	20018	50529064
Dysphagia	51.76	11.24	196	55846	77322	50471760
Lower respiratory tract infection	50.61	11.24	21	56021	95180	50453902
Alopecia	48.89	11.24	126	55916	244921	50304161
Gangrene	46.85	11.24	40	56002	4652	50544430
Hypoglycaemic coma	46.15	11.24	30	56012	2303	50546779
Arterial occlusive disease	43.99	11.24	39	56003	4769	50544313
Drug abuse	43.57	11.24	7	56035	59839	50489243
Product packaging quantity issue	43.27	11.24	22	56020	1058	50548024
Temperature perception test abnormal	43.09	11.24	9	56033	16	50549066
Pancreatitis chronic	42.58	11.24	28	56014	2192	50546890
Wound	42.41	11.24	33	56009	105761	50443321
MELAS syndrome	42.07	11.24	12	56030	109	50548973
Pneumobilia	41.88	11.24	12	56030	111	50548971
Rhinorrhoea	41.79	11.24	139	55903	51444	50497638
Adverse event	41.01	11.24	124	55918	43639	50505443
Product use in unapproved indication	40.57	11.24	41	56001	115778	50433304
Musculoskeletal stiffness	39.03	11.24	51	55991	128430	50420652
Skin haemorrhage	38.85	11.24	43	55999	6875	50542207
Pancreatectomy	37.36	11.24	8	56034	17	50549065
Sinus congestion	36.81	11.24	60	55982	13911	50535171
Hypersensitivity	36.78	11.24	119	55923	215042	50334040
Metabolic acidosis	35.43	11.24	109	55933	38716	50510366
Swelling	35.10	11.24	110	55932	200762	50348320
Seronegative arthritis	34.75	11.24	24	56018	2037	50547045
Completed suicide	34.56	11.24	58	55984	131831	50417251
Diabetic metabolic decompensation	34.20	11.24	21	56021	1459	50547623
Haemoglobin increased	34.09	11.24	28	56014	3087	50545995
Neutropenia	32.73	11.24	72	55970	147893	50401189
Nausea	32.71	11.24	1016	55026	704382	49844700
Renal cyst	32.53	11.24	44	55998	8643	50540439
Bursitis infective	32.38	11.24	19	56023	1215	50547867
Injection site erythema	31.81	11.24	22	56020	74914	50474168
Radiotherapy	30.99	11.24	12	56030	298	50548784
Discomfort	30.93	11.24	45	55997	108335	50440747
Renal disorder	30.69	11.24	83	55959	27422	50521660
Genital infection female	30.60	11.24	9	56033	92	50548990
Cerebral infarction	30.18	11.24	71	55971	21533	50527549
Abdominal discomfort	30.08	11.24	143	55899	231498	50317584
Tubulointerstitial nephritis and uveitis syndrome	29.57	11.24	10	56032	166	50548916
Pancreatic mass	28.72	11.24	15	56027	763	50548319
Diabetic neuropathy	28.70	11.24	27	56015	3564	50545518
Anuria	27.89	11.24	47	55995	11197	50537885
Urine ketone body present	27.71	11.24	22	56020	2311	50546771
Mixed liver injury	27.68	11.24	26	56016	3425	50545657
Drug hypersensitivity	27.56	11.24	164	55878	250846	50298236
Diabetes mellitus	27.15	11.24	117	55925	48916	50500166
Multiple drug therapy	26.80	11.24	20	56022	1917	50547165
Decreased vibratory sense	26.38	11.24	10	56032	234	50548848
Helicobacter infection	26.35	11.24	11	56031	49691	50499391
Tonsillectomy	25.95	11.24	14	56028	761	50548321
Oedema peripheral	25.80	11.24	278	55764	157683	50391399
Tubulointerstitial nephritis	25.76	11.24	54	55988	15157	50533925
Hepatic enzyme increased	25.59	11.24	73	55969	137307	50411775
Circumstance or information capable of leading to medication error	25.53	11.24	24	56018	3164	50545918
Diarrhoea	25.49	11.24	841	55201	587635	49961447
Hypoglycaemic encephalopathy	25.12	11.24	10	56032	268	50548814
Pancreatic stent placement	25.10	11.24	5	56037	6	50549076
Arthralgia	24.67	11.24	340	55702	438362	50110720
Insulin-requiring type 2 diabetes mellitus	24.41	11.24	7	56035	65	50549017
Abdominal pain	24.35	11.24	382	55660	235846	50313236
Product prescribing error	24.14	11.24	64	55978	20897	50528185
Explorative laparotomy	23.96	11.24	6	56036	31	50549051
General physical health deterioration	23.41	11.24	251	55791	142183	50406899
Irritable bowel syndrome	23.34	11.24	14	56028	51427	50497655
Splenic vein occlusion	23.23	11.24	4	56038	0	50549082
Dizziness	23.22	11.24	524	55518	345845	50203237
Prevertebral soft tissue swelling of cervical space	23.21	11.24	6	56036	36	50549046
Joint noise	23.14	11.24	24	56018	3563	50545519
Intentional product use issue	22.87	11.24	31	56011	76887	50472195
Anaemia vitamin B12 deficiency	22.81	11.24	10	56032	343	50548739
Peripheral artery haematoma	22.80	11.24	6	56036	39	50549043
Hepatic steatosis	22.75	11.24	69	55973	24315	50524767
Amylase increased	22.64	11.24	29	56013	5401	50543681
Blood pressure inadequately controlled	22.51	11.24	26	56016	4354	50544728
Impaired healing	21.91	11.24	27	56015	69759	50479323
Sinus disorder	21.91	11.24	57	55985	18401	50530681
Flatulence	21.77	11.24	77	55965	29381	50519701
Pancreatic pseudocyst	21.52	11.24	11	56031	535	50548547
Respiratory tract congestion	21.30	11.24	48	55994	14151	50534931
Aortic arteriosclerosis	21.28	11.24	28	56014	5354	50543728
Bladder trabeculation	21.09	11.24	6	56036	54	50549028
Metastases to lymph nodes	21.04	11.24	32	56010	6992	50542090
Hysterectomy	20.94	11.24	34	56008	7856	50541226
Migraine	20.75	11.24	32	56010	75248	50473834
Tri-iodothyronine free decreased	20.74	11.24	9	56033	301	50548781
Internal haemorrhage	20.68	11.24	25	56017	4392	50544690
Pancreatic duct dilatation	20.58	11.24	8	56034	201	50548881
Asthenia	20.54	11.24	480	55562	318562	50230520
Sneezing	20.54	11.24	47	55995	13997	50535085
Multiple sclerosis relapse	20.48	11.24	11	56031	42953	50506129
Glomerular filtration rate decreased	20.48	11.24	42	56000	11610	50537472
Febrile neutropenia	20.39	11.24	49	55993	97618	50451464
Abdominal pain upper	20.13	11.24	267	55775	159042	50390040
Infection	20.04	11.24	111	55931	172843	50376239
Intestinal transit time abnormal	19.76	11.24	6	56036	69	50549013
Dehydration	19.47	11.24	256	55786	152193	50396889
Condition aggravated	19.37	11.24	223	55819	296835	50252247
Splenectomy	19.29	11.24	10	56032	501	50548581
Incisional hernia repair	19.19	11.24	4	56038	7	50549075
Intensive care unit acquired weakness	19.00	11.24	11	56031	686	50548396
Rheumatoid arthritis	18.86	11.24	139	55903	202411	50346671
Pancreatic cyst	18.79	11.24	14	56028	1339	50547743
Exercise tolerance decreased	18.72	11.24	25	56017	4849	50544233
Blood creatinine increased	18.49	11.24	146	55896	76014	50473068
Leukopenia	18.33	11.24	29	56013	67499	50481583
Haematochezia	18.25	11.24	90	55952	39792	50509290
Peripheral vascular disorder	17.95	11.24	26	56016	5441	50543641
Therapy non-responder	17.93	11.24	18	56024	51004	50498078
Cholelithiasis	17.60	11.24	86	55956	37887	50511195
Seizure	17.58	11.24	69	55973	117805	50431277
Injury	17.49	11.24	17	56025	48908	50500174
Radiotherapy to pancreas	17.42	11.24	3	56039	0	50549082
Biliary obstruction	17.25	11.24	17	56025	2376	50546706
Weight decreased	17.15	11.24	342	55700	220903	50328179
Muscle atrophy	17.10	11.24	27	56015	6094	50542988
Flushing	17.06	11.24	30	56012	66985	50482097
Endometrial disorder	16.98	11.24	10	56032	644	50548438
Increased appetite	16.95	11.24	32	56010	8329	50540753
Infusion site scar	16.92	11.24	8	56034	328	50548754
Altered state of consciousness	16.82	11.24	58	55984	21852	50527230
Micturition disorder	16.77	11.24	15	56027	1856	50547226
Mucosal inflammation	16.75	11.24	12	56030	40130	50508952
Urine albumin/creatinine ratio increased	16.69	11.24	7	56035	215	50548867
Fear-related avoidance of activities	16.66	11.24	6	56036	121	50548961
Dysuria	16.54	11.24	69	55973	28435	50520647
Myalgia	16.39	11.24	210	55832	124109	50424973
Ill-defined disorder	16.28	11.24	22	56020	54632	50494450
Injection site reaction	16.08	11.24	19	56023	50013	50499069
Impaired work ability	16.06	11.24	42	56000	13598	50535484
Psoriatic arthropathy	16.06	11.24	17	56025	47015	50502067
Vision blurred	16.04	11.24	145	55897	78502	50470580
Angina pectoris	15.67	11.24	64	55978	26124	50522958
Skin exfoliation	15.49	11.24	76	55966	33536	50515546
Stomatitis	15.32	11.24	59	55983	101285	50447797
Gastric disorder	15.21	11.24	69	55973	29479	50519603
Renal impairment	15.17	11.24	139	55903	75522	50473560
Cataract	15.17	11.24	97	55945	47203	50501879
Diabetic complication	15.15	11.24	10	56032	788	50548294
Sinusitis	14.95	11.24	119	55923	170439	50378643
Pancreatic neuroendocrine tumour	14.94	11.24	7	56035	281	50548801
Peripheral swelling	14.85	11.24	151	55891	205785	50343297
Acidosis	14.71	11.24	34	56008	10193	50538889
Injection site pain	14.70	11.24	68	55974	110956	50438126
Pancreatitis necrotising	14.47	11.24	12	56030	1341	50547741
Bile duct stone	14.33	11.24	18	56024	3289	50545793
Radioallergosorbent test positive	14.26	11.24	4	56038	34	50549048
Glycosylated haemoglobin decreased	14.19	11.24	8	56034	474	50548608
Glycosylated haemoglobin abnormal	14.16	11.24	5	56037	95	50548987
Hyperlipidaemia	14.04	11.24	47	55995	17443	50531639
Meibomianitis	13.96	11.24	4	56038	37	50549045
Hyperthermia	13.83	11.24	28	56014	7668	50541414
Pancreatic neoplasm	13.73	11.24	9	56033	701	50548381
Tongue oedema	13.70	11.24	19	56023	3820	50545262
Hunger	13.60	11.24	20	56022	4243	50544839
Rash pruritic	13.47	11.24	95	55947	47751	50501331
Coma acidotic	13.40	11.24	5	56037	112	50548970
Blister	13.38	11.24	49	55993	85369	50463713
Acquired mitochondrial DNA mutation	13.27	11.24	3	56039	9	50549073
Disease recurrence	13.23	11.24	3	56039	20078	50529004
Vomiting	13.19	11.24	630	55412	460128	50088954
Carcinoid crisis	13.19	11.24	6	56036	225	50548857
Oedema	13.11	11.24	127	55915	70054	50479028
Peripheral sensorimotor neuropathy	13.09	11.24	11	56031	1251	50547831
Fatigue	13.03	11.24	646	55396	706955	49842127
Palpitations	13.03	11.24	161	55881	94345	50454737
Sedation	12.97	11.24	9	56033	30601	50518481
Product colour issue	12.96	11.24	8	56034	561	50548521
Adverse drug reaction	12.93	11.24	26	56016	55196	50493886
Hepatic cancer	12.89	11.24	17	56025	3258	50545824
Pulmonary haematoma	12.87	11.24	4	56038	50	50549032
Diabetic retinopathy	12.87	11.24	14	56028	2196	50546886
Adrenal mass	12.83	11.24	9	56033	783	50548299
Hip arthroplasty	12.82	11.24	9	56033	30420	50518662
Renal failure	12.75	11.24	177	55865	106456	50442626
Device dislocation	12.72	11.24	4	56038	21542	50527540
Nephroangiosclerosis	12.59	11.24	5	56037	133	50548949
Pancreatic carcinoma stage IV	12.53	11.24	6	56036	253	50548829
Infusion site rash	12.51	11.24	11	56031	1331	50547751
Rhabdomyolysis	12.49	11.24	80	55962	38947	50510135
Enterococcus test positive	12.48	11.24	10	56032	1064	50548018
Loss of personal independence in daily activities	12.47	11.24	38	56004	70012	50479070
Reperfusion injury	12.39	11.24	4	56038	57	50549025
Portal fibrosis	12.29	11.24	6	56036	264	50548818
Gout	12.18	11.24	34	56008	11436	50537646
Pancreatic atrophy	12.09	11.24	5	56037	148	50548934
Renal cancer metastatic	12.07	11.24	6	56036	275	50548807
Infrequent bowel movements	11.97	11.24	10	56032	1128	50547954
Angioedema	11.92	11.24	77	55965	37599	50511483
Splenic granuloma	11.90	11.24	3	56039	16	50549066
Oral mucosal discolouration	11.87	11.24	6	56036	285	50548797
Pancreatic enzymes increased	11.79	11.24	8	56034	660	50548422
Vitamin B12 decreased	11.68	11.24	15	56027	2800	50546282
Metastases to peritoneum	11.61	11.24	15	56027	2818	50546264
Oesophageal mucosal tear	11.60	11.24	3	56039	18	50549064
Fibromyalgia	11.57	11.24	20	56022	44958	50504124
Cardiac failure	11.56	11.24	132	55910	75908	50473174
Product size issue	11.49	11.24	6	56036	305	50548777
Intraductal papillary mucinous neoplasm	11.47	11.24	6	56036	306	50548776
Premature delivery	11.36	11.24	6	56036	23657	50525425
Appendicectomy	11.36	11.24	14	56028	2508	50546574
Vitamin D deficiency	11.33	11.24	33	56009	11369	50537713
Cholecystectomy	11.32	11.24	29	56013	9274	50539808
Inability to afford medication	11.27	11.24	11	56031	1519	50547563

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
Pancreatitis	648.66	10.88	512	50794	34002	29489219
Hypoglycaemia	510.84	10.88	518	50788	47828	29475393
Pancreatic carcinoma	439.92	10.88	225	51081	6925	29516296
Blood glucose increased	411.53	10.88	509	50797	58475	29464746
Pancreatic carcinoma metastatic	336.08	10.88	139	51167	2582	29520639
Diabetes mellitus inadequate control	324.79	10.88	223	51083	11911	29511310
Pancreatitis acute	217.53	10.88	239	51067	24146	29499075
Glycosylated haemoglobin increased	214.66	10.88	157	51149	9269	29513952
Adenocarcinoma pancreas	176.47	10.88	70	51236	1161	29522060
Diabetic ketoacidosis	174.53	10.88	175	51131	15898	29507323
Pancreaticoduodenectomy	158.20	10.88	34	51272	35	29523186
Lactic acidosis	136.74	10.88	212	51094	30035	29493186
Drug abuse	124.26	10.88	3	51303	79880	29443341
Metastases to liver	121.25	10.88	125	51181	11731	29511490
Bile duct stent insertion	116.13	10.88	27	51279	51	29523170
No adverse event	110.80	10.88	144	51162	17334	29505887
Lipase increased	109.83	10.88	101	51205	8236	29514985
Pemphigoid	108.05	10.88	96	51210	7485	29515736
Toxicity to various agents	107.91	10.88	86	51220	173575	29349646
Hyperglycaemia	104.65	10.88	202	51104	34085	29489136
Pancreatectomy	101.83	10.88	21	51285	14	29523207
Radiotherapy	99.47	10.88	33	51273	317	29522904
Product monitoring error	96.30	10.88	59	51247	2586	29520635
Off label use	92.34	10.88	245	51061	300555	29222666
Blood glucose abnormal	90.16	10.88	73	51233	5010	29518211
General physical health deterioration	88.38	10.88	383	50923	102474	29420747
Bladder cancer	82.97	10.88	95	51211	10032	29513189
Interstitial lung disease	80.02	10.88	251	51055	57467	29465754
Ketoacidosis	76.97	10.88	58	51248	3581	29519640
Euglycaemic diabetic ketoacidosis	71.91	10.88	49	51257	2581	29520640
Pancreatitis chronic	70.69	10.88	44	51262	1984	29521237
Hyperlipidaemia	60.75	10.88	91	51215	12499	29510722
Product dose omission issue	60.46	10.88	328	50978	96055	29427166
Pancreatic stent placement	60.13	10.88	12	51294	5	29523216
Glycosylated haemoglobin abnormal	53.95	10.88	16	51290	102	29523119
Explorative laparotomy	53.75	10.88	12	51294	17	29523204
Renal cyst	53.01	10.88	67	51239	7840	29515381
Product use in unapproved indication	51.43	10.88	45	51261	86830	29436391
Blood glucose decreased	50.92	10.88	82	51224	11987	29511234
Cerebral infarction	49.70	10.88	123	51183	24552	29498669
Hyperkalaemia	48.43	10.88	223	51083	61169	29462052
Cholelithiasis	46.30	10.88	101	51205	18571	29504650
Biliary sphincterotomy	43.06	10.88	9	51297	7	29523214
Febrile neutropenia	42.80	10.88	81	51225	112159	29411062
Seronegative arthritis	42.56	10.88	24	51282	900	29522321
Prostatomegaly	42.07	10.88	46	51260	4615	29518606
Neutropenia	42	10.88	105	51201	131606	29391615
Diverticulum intestinal	41.67	10.88	39	51267	3251	29519970
Amylase increased	40.68	10.88	48	51258	5232	29517989
Diabetic foetopathy	40.59	10.88	15	51291	203	29523018
Blood glucose fluctuation	40.57	10.88	40	51266	3557	29519664
Insulin-requiring type 2 diabetes mellitus	39.84	10.88	13	51293	118	29523103
Cholecystectomy	39.28	10.88	33	51273	2384	29520837
Circumstance or information capable of leading to medication error	38.39	10.88	27	51279	1497	29521724
Product residue present	37.87	10.88	33	51273	2506	29520715
Therapeutic drug monitoring analysis not performed	37.80	10.88	18	51288	472	29522749
Pancreatic enzymes increased	37.71	10.88	19	51287	565	29522656
Metabolic acidosis	37.60	10.88	147	51159	37515	29485706
Diabetic nephropathy	35.27	10.88	28	51278	1867	29521354
Acute kidney injury	34.66	10.88	649	50657	264618	29258603
Pancreatic cyst	33.53	10.88	19	51287	719	29522502
Metastases to lymph nodes	33.43	10.88	38	51268	3979	29519242
Splenectomy	31.62	10.88	15	51291	390	29522831
Electrolyte imbalance	31.45	10.88	64	51242	11210	29512011
Thirst	31.43	10.88	47	51259	6444	29516777
Diabetes mellitus	30.89	10.88	144	51162	39687	29483534
Wrong technique in product usage process	30.83	10.88	122	51184	31306	29491915
Glycosylated haemoglobin decreased	30.81	10.88	14	51292	329	29522892
Dizziness	30.50	10.88	480	50826	189204	29334017
Large for dates baby	30.30	10.88	19	51287	868	29522353
Death	29.61	10.88	417	50889	341667	29181554
Dyslipidaemia	29.51	10.88	44	51262	6017	29517204
Autoimmune pancreatitis	29.48	10.88	13	51293	284	29522937
Pancreatic disorder	29.15	10.88	23	51283	1520	29521701
Gastroenterostomy	28.28	10.88	8	51298	42	29523179
Mucosal inflammation	27.82	10.88	10	51296	31585	29491636
Weight decreased	27.01	10.88	389	50917	150516	29372705
Pancreatitis necrotising	26.28	10.88	26	51280	2321	29520900
Hypoglycaemic coma	26.17	10.88	25	51281	2138	29521083
Drug ineffective	25.95	10.88	459	50847	362711	29160510
Gastrooesophageal reflux disease	25.26	10.88	115	51191	31381	29491840
Metastases to peritoneum	25.21	10.88	21	51285	1499	29521722
Pyrexia	25.07	10.88	350	50956	287272	29235949
Disease progression	24.79	10.88	67	51239	81849	29441372
Alcoholic ketoacidosis	24.66	10.88	6	51300	15	29523206
Pancreatic pseudocyst	24.51	10.88	16	51290	784	29522437
Polyuria	24.46	10.88	45	51261	7317	29515904
Pancreatic carcinoma recurrent	24.38	10.88	6	51300	16	29523205
Pancreatic mass	23.81	10.88	16	51290	823	29522398
Adverse event	23.51	10.88	69	51237	15222	29507999
Biliary dilatation	23.48	10.88	15	51291	708	29522513
Hyperlipasaemia	23.38	10.88	13	51293	474	29522747
Pyelitis	22.52	10.88	8	51298	96	29523125
Diabetic neuropathy	22.35	10.88	30	51276	3723	29519498
Angioedema	22.31	10.88	112	51194	31803	29491418
Completed suicide	22.24	10.88	81	51225	90165	29433056
Tonsillectomy	21.99	10.88	11	51295	322	29522899
Knee operation	21.69	10.88	19	51287	1453	29521768
Aortic arteriosclerosis	21.59	10.88	30	51276	3846	29519375
Food aversion	21.53	10.88	11	51295	337	29522884
Intestinal adhesion lysis	21.44	10.88	4	51302	0	29523221
Radiotherapy to pancreas	21.44	10.88	4	51302	0	29523221
Pemphigus	21.19	10.88	17	51289	1151	29522070
Pancreatolithiasis	21.03	10.88	7	51299	68	29523153
Vomiting projectile	20.87	10.88	13	51293	587	29522634
Alopecia universalis	20.85	10.88	7	51299	70	29523151
Malignant ascites	20.70	10.88	11	51295	366	29522855
Drug resistance	20.40	10.88	6	51300	21534	29501687
Diverticulum	20.15	10.88	38	51268	6294	29516927
Seizure	20.15	10.88	88	51218	93035	29430186
Rhabdomyolysis	20.14	10.88	177	51129	60631	29462590
Hyperlactacidaemia	20.06	10.88	24	51282	2654	29520567
Pneumobilia	19.87	10.88	6	51300	41	29523180
Vena cava filter insertion	19.65	10.88	5	51301	16	29523205
Cytomegalovirus infection	19.35	10.88	8	51298	23207	29500014
Urticaria chronic	19.34	10.88	7	51299	89	29523132
Lower respiratory tract infection	19.26	10.88	11	51295	26491	29496730
Phlebolith	19.20	10.88	4	51302	3	29523218
Ductal adenocarcinoma of pancreas	19.19	10.88	5	51301	18	29523203
Metastases to lung	18.91	10.88	42	51264	7813	29515408
Renal impairment	18.88	10.88	220	51086	81113	29442108
Prostatic calcification	18.79	10.88	7	51299	97	29523124
Staphylococcal infection	18.72	10.88	14	51292	29226	29493995
Eczema asteatotic	18.61	10.88	8	51298	164	29523057
Urine ketone body present	18.47	10.88	15	51291	1033	29522188
Diabetic metabolic decompensation	18.35	10.88	17	51289	1399	29521822
Drug intolerance	18.34	10.88	35	51271	48344	29474877
Insulin C-peptide increased	18.14	10.88	6	51300	57	29523164
Oedema peripheral	18.12	10.88	266	51040	103291	29419930
Bile duct cancer	18.07	10.88	12	51294	605	29522616
Weight increased	18.07	10.88	208	51098	76459	29446762
Product packaging quantity issue	17.99	10.88	13	51293	752	29522469
Type 2 diabetes mellitus	17.82	10.88	58	51248	13523	29509698
Product prescribing error	17.80	10.88	70	51236	17906	29505315
Therapeutic product effect decreased	17.72	10.88	15	51291	29436	29493785
Peripancreatic fluid collection	17.56	10.88	5	51301	27	29523194
Treatment failure	17.53	10.88	23	51283	36916	29486305
Renal failure	17.49	10.88	296	51010	118303	29404918
Colon cancer	17.39	10.88	40	51266	7615	29515606
Dysuria	17.30	10.88	81	51225	22359	29500862
Hypomagnesaemia	17.28	10.88	68	51238	17400	29505821
Foetal exposure during pregnancy	17.22	10.88	20	51286	33847	29489374
Pseudohyponatraemia	17.20	10.88	6	51300	68	29523153
Nephrolithiasis	17.07	10.88	88	51218	25246	29497975
Psychotic disorder	16.99	10.88	7	51299	20347	29502874
Pancreatic neoplasm	16.89	10.88	13	51293	828	29522393
Groin abscess	16.65	10.88	11	51295	550	29522671
Sprue-like enteropathy	16.49	10.88	10	51296	430	29522791
Stent placement	16.47	10.88	28	51278	4278	29518943
Spinal osteoarthritis	16.46	10.88	35	51271	6321	29516900
Suicide attempt	16.43	10.88	21	51285	34089	29489132
Biopsy pancreas	16.08	10.88	3	51303	0	29523221
Choledochoenterostomy	16.08	10.88	3	51303	0	29523221
Splenic vein occlusion	16.08	10.88	3	51303	0	29523221
Bile duct adenocarcinoma	16.08	10.88	3	51303	0	29523221
Duodenal sphincterotomy	16.08	10.88	3	51303	0	29523221
Biliary neoplasm	16.08	10.88	3	51303	0	29523221
Pancreatic sphincterotomy	16.08	10.88	3	51303	0	29523221
Pollakiuria	16.05	10.88	65	51241	16851	29506370
Pulmonary mass	16.04	10.88	48	51258	10700	29512521
Genital swelling	15.91	10.88	7	51299	152	29523069
Dependence on respirator	15.86	10.88	6	51300	87	29523134
Oscillopsia	15.77	10.88	5	51301	41	29523180
Respiratory arrest	15.74	10.88	13	51293	25820	29497401
Amaurosis	15.65	10.88	11	51295	609	29522612
Drug eruption	15.62	10.88	64	51242	16677	29506544
Vitamin B1 decreased	15.57	10.88	8	51298	248	29522973
Gastrointestinal mucosal necrosis	15.54	10.88	7	51299	161	29523060
Coma	15.43	10.88	28	51278	39422	29483799
Vitamin B1 deficiency	15.37	10.88	8	51298	255	29522966
Drug ineffective for unapproved indication	15.34	10.88	3	51303	14211	29509010
Renal mass	15.31	10.88	16	51290	1524	29521697
Bile duct stenosis	15.17	10.88	14	51292	1146	29522075
Nephroangiosclerosis	15.12	10.88	7	51299	172	29523049
Suicidal ideation	15.10	10.88	23	51283	34693	29488528
Romberg test positive	14.98	10.88	5	51301	49	29523172
Abdominal pain	14.88	10.88	323	50983	135034	29388187
Large intestine polyp	14.77	10.88	34	51272	6475	29516746
Thrombocytopenia	14.77	10.88	156	51150	134667	29388554
Adrenal mass	14.74	10.88	10	51296	523	29522698
Palindromic rheumatism	14.55	10.88	7	51299	188	29523033
Subdural hygroma	14.41	10.88	8	51298	291	29522930
Osteonecrosis	14.29	10.88	3	51303	13516	29509705
Thyroid neoplasm	14.24	10.88	9	51297	417	29522804
Pancreatic fistula	14.23	10.88	5	51301	58	29523163
Aggression	14.10	10.88	25	51281	35516	29487705
Psoriatic arthropathy	14.08	10.88	4	51302	14687	29508534
Toe amputation	14.03	10.88	18	51288	2137	29521084
Malignant neoplasm of ampulla of Vater	14.00	10.88	3	51303	3	29523218
Brain contusion	13.98	10.88	11	51295	724	29522497
Pancreatic duct dilatation	13.92	10.88	5	51301	62	29523159
Biliary obstruction	13.92	10.88	19	51287	2395	29520826
Respiratory failure	13.88	10.88	105	51201	97026	29426195
Generalised tonic-clonic seizure	13.82	10.88	8	51298	19131	29504090
Oedematous pancreatitis	13.80	10.88	9	51297	440	29522781
Unevaluable event	13.75	10.88	19	51287	29832	29493389
Unresponsive to stimuli	13.70	10.88	14	51292	25112	29498109
Umbilical hernia repair	13.69	10.88	4	51302	24	29523197
Pneumocystis jirovecii pneumonia	13.64	10.88	6	51300	16773	29506448
Nephrogenic anaemia	13.59	10.88	17	51289	1968	29521253
Gastrointestinal tube insertion	13.57	10.88	13	51293	1116	29522105
Superinfection	13.48	10.88	17	51289	1984	29521237
Bile duct stone	13.47	10.88	18	51288	2224	29520997
Bladder irrigation	13.44	10.88	5	51301	69	29523152
Intentional product use issue	13.43	10.88	34	51272	42464	29480757
Duodenitis	13.39	10.88	25	51281	4110	29519111
Pancytopenia	13.30	10.88	87	51219	83081	29440140
Infusion related reaction	13.19	10.88	36	51270	43850	29479371
Genital lesion	13.12	10.88	7	51299	235	29522986
Diabetic retinopathy	13.07	10.88	15	51291	1587	29521634
Fracture	13.06	10.88	31	51275	6022	29517199
Inability to afford medication	13.03	10.88	12	51294	980	29522241
Haematochezia	12.95	10.88	109	51197	36874	29486347
Musculoskeletal pain	12.74	10.88	90	51216	28863	29494358
Hypoxia	12.69	10.88	41	51265	47338	29475883
Metastases to spleen	12.63	10.88	8	51298	372	29522849
Blood ketone body increased	12.59	10.88	8	51298	374	29522847
Nephropathy	12.51	10.88	28	51278	5235	29517986
Intraductal papillary-mucinous carcinoma of pancreas	12.48	10.88	3	51303	7	29523214
Campylobacter infection	12.39	10.88	10	51296	683	29522538
Pseudocyst	12.31	10.88	6	51300	166	29523055
Hepatic steatosis	12.30	10.88	55	51251	14891	29508330
Renal stone removal	12.29	10.88	4	51302	36	29523185
Procedural headache	12.29	10.88	4	51302	36	29523185
Hypercapnic coma	12.27	10.88	6	51300	167	29523054
Arthroscopy	12.23	10.88	5	51301	90	29523131
Toxic skin eruption	12.21	10.88	41	51265	9716	29513505
Bladder transitional cell carcinoma	12.17	10.88	18	51288	2443	29520778
Encephalopathy	12.17	10.88	22	51284	31021	29492200
Cyst removal	12.10	10.88	4	51302	38	29523183
Gallbladder disorder	12.09	10.88	29	51277	5671	29517550
Intentional overdose	12.03	10.88	31	51275	38497	29484724
Agitation	12.01	10.88	47	51259	51257	29471964
Alanine aminotransferase increased	11.97	10.88	73	51233	70871	29452350
Flushing	11.86	10.88	20	51286	28972	29494249
Pneumonitis	11.80	10.88	19	51287	28025	29495196
Thrombosis	11.71	10.88	37	51269	43008	29480213
Nodular rash	11.52	10.88	5	51301	105	29523116
Pancreatic carcinoma stage III	11.18	10.88	4	51302	49	29523172
Abdominal hernia repair	11.18	10.88	4	51302	49	29523172
Acute respiratory distress syndrome	11.17	10.88	14	51292	22921	29500300
Discoloured vomit	11.15	10.88	8	51298	458	29522763
Pain	11.14	10.88	220	51086	171212	29352009
Hallucination	11.09	10.88	40	51266	44672	29478549
Chronic gastritis	11.05	10.88	12	51294	1194	29522027
Nasal neoplasm	11.02	10.88	5	51301	117	29523104
Tachycardia	10.95	10.88	77	51229	72333	29450888
Appendicectomy	10.95	10.88	10	51296	808	29522413

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
Blood glucose increased	868.79	10.25	832	81879	97241	64318780
Hypoglycaemia	867.96	10.25	800	81911	89092	64326929
Pancreatitis	653.13	10.25	570	82141	59037	64356984
Diabetes mellitus inadequate control	567.76	10.25	349	82362	20972	64395049
Pancreatic carcinoma	394.05	10.25	214	82497	10159	64405862
Lactic acidosis	389.68	10.25	436	82275	60974	64355047
Diabetic ketoacidosis	373.01	10.25	308	82403	29537	64386484
Glycosylated haemoglobin increased	346.40	10.25	230	82481	15789	64400232
Pancreatitis acute	313.37	10.25	328	82383	42527	64373494
Pemphigoid	299.17	10.25	194	82517	12792	64403229
Carotid artery thrombosis	234.99	10.25	88	82623	1707	64414314
Neurologic neglect syndrome	232.70	10.25	85	82626	1533	64414488
Hyperglycaemia	209.50	10.25	320	82391	60648	64355373
Acute kidney injury	197.15	10.25	1112	81599	448128	63967893
Personality disorder	192.39	10.25	102	82609	4609	64411412
Lipase increased	186.96	10.25	152	82559	14250	64401771
Adjustment disorder	182.87	10.25	83	82628	2662	64413359
Blood glucose abnormal	178.38	10.25	122	82589	8791	64407230
Ketoacidosis	164.16	10.25	105	82606	6758	64409263
Euglycaemic diabetic ketoacidosis	163.22	10.25	96	82615	5314	64410707
General physical health deterioration	162.16	10.25	603	82108	203822	64212199
Hemiplegia	155.80	10.25	130	82581	12638	64403383
Drug abuse	147.29	10.25	5	82706	132369	64283652
Hyperkalaemia	137.57	10.25	360	82351	100769	64315252
Affect lability	131.95	10.25	102	82609	8888	64407133
Toxicity to various agents	129.30	10.25	166	82545	363347	64052674
Off label use	127.43	10.25	403	82308	632403	63783618
Product residue present	107.02	10.25	61	82650	3181	64412840
Blood glucose decreased	105.47	10.25	139	82572	22984	64393037
Product monitoring error	105.24	10.25	73	82638	5381	64410640
Interstitial lung disease	104.58	10.25	319	82392	97413	64318608
Drug intolerance	103.54	10.25	56	82655	187936	64228085
Bladder cancer	98.62	10.25	94	82617	10880	64405141
Sensory loss	95.01	10.25	89	82622	10080	64405941
Synovitis	94.33	10.25	9	82702	99081	64316940
Motor dysfunction	93.92	10.25	93	82618	11280	64404741
Cerebral infarction	89.18	10.25	176	82535	40868	64375153
Muscle spasticity	83.55	10.25	105	82606	16564	64399457
Systemic lupus erythematosus	82.73	10.25	4	82707	77608	64338413
Coordination abnormal	82.66	10.25	99	82612	14865	64401156
Metabolic acidosis	81.96	10.25	238	82473	70720	64345301
Therapeutic product effect decreased	80.37	10.25	24	82687	115327	64300694
Treatment failure	80.13	10.25	25	82686	116791	64299230
Drug ineffective	79.98	10.25	692	82019	839555	63576466
Seronegative arthritis	75.79	10.25	46	82665	2697	64413324
Hypoglycaemic coma	75.03	10.25	54	82657	4220	64411801
Eating disorder	70.50	10.25	97	82614	16708	64399313
Product use in unapproved indication	69.85	10.25	74	82637	176544	64239477
Arthropathy	63.76	10.25	38	82673	120929	64295092
Blood glucose fluctuation	63.23	10.25	56	82655	5899	64410122
Maternal exposure during pregnancy	61.46	10.25	23	82688	95861	64320160
Diabetes mellitus	61.10	10.25	206	82505	66268	64349753
Hemiparesis	60.14	10.25	124	82587	29703	64386318
Infusion related reaction	59.52	10.25	74	82637	164393	64251628
Pain	58.88	10.25	442	82269	553069	63862952
Product use issue	58.40	10.25	65	82646	151650	64264371
Amylase increased	56.68	10.25	66	82645	9619	64406402
Glossodynia	56.29	10.25	8	82703	64688	64351333
Lung diffusion test abnormal	53.81	10.25	16	82695	145	64415876
Product dose omission issue	53.59	10.25	430	82281	194317	64221704
Gangrene	53.30	10.25	56	82655	7282	64408739
Dizziness	53.21	10.25	810	81901	429353	63986668
Contraindicated product administered	52.56	10.25	37	82674	107792	64308229
Lower respiratory tract infection	50.88	10.25	29	82682	94585	64321436
Wrong technique in product usage process	50.01	10.25	190	82521	64784	64351237
Joint swelling	49.12	10.25	129	82582	215253	64200768
Aphasia	48.96	10.25	139	82572	40767	64375254
Neutropenia	48.44	10.25	152	82559	239472	64176549
Product prescribing error	48.36	10.25	126	82585	35143	64380878
Completed suicide	47.76	10.25	139	82572	224275	64191746
Glycosylated haemoglobin abnormal	46.69	10.25	14	82697	131	64415890
Diabetic metabolic decompensation	44.56	10.25	33	82678	2695	64413326
Febrile neutropenia	43.86	10.25	111	82600	187546	64228475
Urine ketone body present	43.12	10.25	35	82676	3272	64412749
Haematochezia	42.26	10.25	183	82528	66190	64349831
Temperature perception test abnormal	41.77	10.25	9	82702	16	64416005
Rhabdomyolysis	40.60	10.25	228	82483	91498	64324523
Therapeutic drug monitoring analysis not performed	40.53	10.25	23	82688	1189	64414832
Muscular weakness	40.52	10.25	291	82420	127047	64288974
Mucosal inflammation	40.12	10.25	15	82696	62569	64353452
Pancreatic carcinoma metastatic	39.53	10.25	34	82677	3444	64412577
Serotonin syndrome	38.93	10.25	3	82708	39279	64376742
Exposure during pregnancy	38.72	10.25	26	82685	77649	64338372
Adenocarcinoma pancreas	38.33	10.25	26	82685	1847	64414174
Pemphigus	38.17	10.25	15	82696	60686	64355335
No adverse event	38.10	10.25	101	82610	28460	64387561
Thirst	37.43	10.25	66	82645	14071	64401950
Hypersensitivity	37.35	10.25	128	82583	196324	64219697
MELAS syndrome	37.18	10.25	12	82699	146	64415875
Hand deformity	37.09	10.25	17	82694	62754	64353267
Renal impairment	37.05	10.25	298	82413	134719	64281302
Pericarditis	36.83	10.25	17	82694	62499	64353522
Diarrhoea	36.75	10.25	1198	81513	721506	63694515
Pancreatitis chronic	36.64	10.25	33	82678	3553	64412468
Dysuria	35.73	10.25	127	82584	41930	64374091
Drug hypersensitivity	35.73	10.25	170	82541	237645	64178376
Dysphagia	35.68	10.25	247	82464	106565	64309456
Pancreatitis necrotising	35.65	10.25	31	82680	3186	64412835
Injection site erythema	34.89	10.25	24	82687	70776	64345245
Oedema peripheral	34.55	10.25	417	82294	209900	64206121
Dysarthria	34.21	10.25	159	82552	59247	64356774
Duodenal ulcer perforation	33.33	10.25	3	82708	34622	64381399
Hypoglycaemic encephalopathy	33.03	10.25	16	82695	596	64415425
Pancreatic enzymes increased	32.82	10.25	20	82691	1181	64414840
Weight decreased	32.58	10.25	531	82180	285208	64130813
Cardiac failure	32.51	10.25	285	82426	132088	64283933
Genital infection female	32.19	10.25	9	82702	64	64415957
Alopecia	32.14	10.25	107	82604	165583	64250438
Abdominal pain	31.81	10.25	570	82141	311805	64104216
Renal failure	31.50	10.25	364	82347	181324	64234697
Autoimmune pancreatitis	30.47	10.25	15	82696	579	64415442
Musculoskeletal stiffness	30.25	10.25	71	82640	123135	64292886
Arterial occlusive disease	30.11	10.25	41	82670	6992	64409029
Sinus congestion	29.73	10.25	63	82648	15376	64400645
Skin haemorrhage	29.37	10.25	45	82666	8540	64407481
Sneezing	29.10	10.25	62	82649	15189	64400832
Nephroangiosclerosis	29.10	10.25	12	82699	303	64415718
Polyuria	28.41	10.25	55	82656	12588	64403433
Cerebrovascular accident	28.18	10.25	285	82426	137298	64278723
Rhinorrhoea	27.82	10.25	151	82560	59818	64356203
Flushing	27.80	10.25	36	82675	78612	64337409
Pancreatic pseudocyst	26.74	10.25	18	82693	1263	64414758
Hyperlactacidaemia	26.67	10.25	32	82679	4812	64411209
Micturition disorder	26.47	10.25	26	82685	3122	64412899
Alcoholic ketoacidosis	26.47	10.25	6	82705	15	64416006
Wound	26.02	10.25	36	82675	76441	64339580
Pancreatic disorder	25.97	10.25	25	82686	2929	64413092
Angioedema	25.60	10.25	151	82560	61670	64354351
Swelling	25.56	10.25	112	82599	160106	64255915
Pollakiuria	24.91	10.25	93	82618	31437	64384584
Neurotoxicity	24.77	10.25	3	82708	27401	64388620
Altered state of consciousness	24.50	10.25	105	82606	37797	64378224
Diabetic nephropathy	24.35	10.25	23	82688	2631	64413390
Electrolyte imbalance	23.87	10.25	79	82632	25164	64390857
Gastric cancer	23.59	10.25	35	82676	6458	64409563
Tubulointerstitial nephritis and uveitis syndrome	23.49	10.25	10	82701	274	64415747
Flatulence	23.20	10.25	99	82612	35567	64380454
Pancreatic mass	23.19	10.25	17	82694	1367	64414654
Hyperlipasaemia	23.04	10.25	15	82696	995	64415026
Dyslipidaemia	23.00	10.25	42	82669	9200	64406821
Arthralgia	22.98	10.25	414	82297	441846	63974175
Food aversion	22.68	10.25	13	82698	685	64415336
Stomatitis	22.49	10.25	69	82642	109536	64306485
Prevertebral soft tissue swelling of cervical space	22.33	10.25	6	82705	36	64415985
Irritable bowel syndrome	22.26	10.25	10	82701	37359	64378662
C-reactive protein abnormal	22.21	10.25	5	82706	29042	64386979
Sedation	21.87	10.25	13	82698	41449	64374572
Dehydration	21.85	10.25	395	82316	216368	64199653
Helicobacter infection	21.73	10.25	11	82700	38351	64377670
Multiple drug therapy	21.58	10.25	20	82691	2234	64413787
Injury	21.52	10.25	24	82687	55968	64360053
Glycosylated haemoglobin decreased	21.44	10.25	12	82699	604	64415417
Folliculitis	21.41	10.25	6	82705	30071	64385950
Gastric disorder	21.33	10.25	84	82627	29113	64386908
Osteonecrosis	21.31	10.25	5	82706	28224	64387797
Peripheral artery haematoma	21.18	10.25	6	82705	45	64415976
Bladder transitional cell carcinoma	21.01	10.25	20	82691	2310	64413711
Blood pressure inadequately controlled	20.98	10.25	30	82681	5354	64410667
Hepatic function abnormal	20.46	10.25	147	82564	64166	64351855
Intentional product use issue	20.31	10.25	59	82652	95305	64320716
Haemoglobin increased	20.30	10.25	29	82682	5172	64410849
Seizure	20.27	10.25	128	82583	166764	64249257
Abdominal pain upper	20.19	10.25	326	82385	174704	64241317
Multiple sclerosis relapse	20.19	10.25	14	82697	41121	64374900
Respiratory depression	20.15	10.25	3	82708	23440	64392581
Insulin C-peptide increased	20.11	10.25	7	82704	109	64415912
Colon cancer	20.08	10.25	48	82663	12691	64403330
Respiratory arrest	20.04	10.25	23	82688	52962	64363059
Asthenia	19.99	10.25	703	82008	427341	63988680
Drug resistance	19.98	10.25	10	82701	35092	64380929
Infection	19.87	10.25	147	82564	184733	64231288
Migraine	19.86	10.25	31	82680	62646	64353375
Bladder trabeculation	19.83	10.25	6	82705	58	64415963
Nausea	19.70	10.25	1212	81499	784588	63631433
Psoriatic arthropathy	19.61	10.25	16	82695	43265	64372756
Depression	19.57	10.25	146	82565	183145	64232876
Groin abscess	19.20	10.25	15	82696	1327	64414694
Renal disorder	19.15	10.25	93	82618	35272	64380749
Exercise tolerance decreased	19.14	10.25	35	82676	7675	64408346
Gamma-glutamyltransferase increased	19.13	10.25	117	82594	48393	64367628
Mixed liver injury	19.13	10.25	29	82682	5452	64410569
Vitamin B1 decreased	19.07	10.25	9	82702	316	64415705
Intestinal transit time abnormal	18.90	10.25	6	82705	69	64415952
Sinus disorder	18.83	10.25	56	82655	16852	64399169
Discomfort	18.75	10.25	48	82663	80830	64335191
Angina pectoris	18.59	10.25	110	82601	44971	64371050
Urine albumin/creatinine ratio increased	18.48	10.25	9	82702	339	64415682
Bile duct stone	18.32	10.25	27	82684	4951	64411070
Glomerular filtration rate decreased	18.28	10.25	61	82650	19511	64396510
Tri-iodothyronine free decreased	18.17	10.25	9	82702	352	64415669
Blood creatinine increased	18.01	10.25	259	82452	135523	64280498
Vomiting	17.93	10.25	871	81840	550246	63865775
Endometrial disorder	17.91	10.25	10	82701	501	64415520
Infusion site scar	17.61	10.25	8	82703	257	64415764
Posterior reversible encephalopathy syndrome	17.45	10.25	4	82707	22942	64393079
Anaemia	17.44	10.25	621	82090	378059	64037962
Fear-related avoidance of activities	17.38	10.25	6	82705	91	64415930
Injection site pain	17.09	10.25	79	82632	111329	64304692
Alopecia universalis	16.97	10.25	7	82704	177	64415844
Pyelitis	16.95	10.25	8	82703	281	64415740
Multiple congenital abnormalities	16.92	10.25	6	82705	99	64415922
Injection site reaction	16.86	10.25	21	82690	46643	64369378
Increased appetite	16.83	10.25	39	82672	10107	64405914
Cytomegalovirus infection	16.55	10.25	14	82697	37185	64378836
Generalised tonic-clonic seizure	16.54	10.25	16	82695	39841	64376180
Gastrointestinal mucosal necrosis	16.37	10.25	7	82704	194	64415827
Red blood cell sedimentation rate increased	16.18	10.25	10	82701	31225	64384796
Adverse event	16.06	10.25	96	82615	39393	64376628
Death	16.04	10.25	484	82227	482221	63933800
Diabetic retinopathy	16.04	10.25	19	82692	2820	64413201
Blood ketone body increased	15.94	10.25	10	82701	622	64415399
Anuria	15.88	10.25	57	82654	18907	64397114
Basal cell carcinoma	15.80	10.25	10	82701	30828	64385193
Fall	15.76	10.25	669	82042	416157	63999864
Joint noise	15.73	10.25	20	82691	3191	64412830
Amaurosis	15.66	10.25	12	82699	1032	64414989
Pneumocystis jirovecii pneumonia	15.54	10.25	8	82703	27626	64388395
Pancreatectomy	15.50	10.25	4	82707	20	64416001
Bladder irrigation	15.41	10.25	5	82706	62	64415959
Blood ketone body present	15.41	10.25	5	82706	62	64415959
Psychotic disorder	15.40	10.25	13	82698	34565	64381456
Fracture	15.39	10.25	56	82655	18699	64397322
Pseudohyponatraemia	15.36	10.25	6	82705	131	64415890
Fibromyalgia	15.23	10.25	14	82697	35717	64380304
Encephalopathy	15.16	10.25	33	82678	58786	64357235
Pancreaticoduodenectomy	15.03	10.25	4	82707	23	64415998
Ketonuria	14.94	10.25	12	82699	1105	64414916
Drug eruption	14.79	10.25	88	82623	36048	64379973
Impaired healing	14.72	10.25	35	82676	60438	64355583
Therapy non-responder	14.60	10.25	40	82671	65859	64350162
Diabetic foetopathy	14.49	10.25	4	82707	27	64415994
Internal haemorrhage	14.43	10.25	31	82680	7636	64408385
Toe amputation	14.38	10.25	20	82691	3480	64412541
Mobility decreased	14.30	10.25	59	82652	85781	64330240
Product packaging quantity issue	14.26	10.25	11	82700	955	64415066
Liver disorder	14.21	10.25	117	82594	53234	64362787
Bursitis infective	14.19	10.25	12	82699	1188	64414833
Disease progression	14.12	10.25	115	82596	141565	64274456
Anaemia vitamin B12 deficiency	14.08	10.25	9	82702	578	64415443
Intensive care unit acquired weakness	14.03	10.25	14	82697	1713	64414308
Decreased vibratory sense	13.99	10.25	9	82702	585	64415436
Nephrotic syndrome	13.96	10.25	35	82676	9532	64406489
Pulmonary tumour thrombotic microangiopathy	13.96	10.25	5	82706	85	64415936
Brain contusion	13.85	10.25	12	82699	1227	64414794
Radioallergosorbent test positive	13.79	10.25	4	82707	33	64415988
Vitamin B12 deficiency	13.78	10.25	25	82686	5447	64410574
Device dislocation	13.70	10.25	5	82706	21173	64394848
Toxic skin eruption	13.70	10.25	55	82656	19229	64396792
Intentional overdose	13.66	10.25	64	82647	89880	64326141
Urticaria chronic	13.60	10.25	8	82703	443	64415578
Lymphopenia	13.59	10.25	8	82703	25649	64390372
Cerebral haemorrhage	13.58	10.25	112	82599	50978	64365043
Drug ineffective for unapproved indication	13.50	10.25	12	82699	31121	64384900
Subdural hygroma	13.48	10.25	8	82703	450	64415571
Impaired insulin secretion	13.48	10.25	4	82707	36	64415985
Electrocardiogram abnormal	13.47	10.25	43	82668	13438	64402583
Diabetic neuropathy	13.37	10.25	25	82686	5576	64410445
Decreased appetite	13.36	10.25	463	82248	280826	64135195
Cholelithiasis	13.33	10.25	102	82609	45404	64370617
Pseudocyst	13.31	10.25	7	82704	311	64415710
Transplant rejection	13.30	10.25	3	82708	17398	64398623
Hyperthermia	13.24	10.25	47	82664	15503	64400518
Hypokinesia	13.15	10.25	49	82662	16547	64399474
Tubulointerstitial nephritis	13.12	10.25	76	82635	30833	64385188
Thrombotic cerebral infarction	13.10	10.25	8	82703	474	64415547
Palindromic rheumatism	13.07	10.25	7	82704	323	64415698
Device related infection	13.05	10.25	12	82699	30614	64385407
Respiratory tract congestion	13.04	10.25	48	82663	16117	64399904
Adverse drug reaction	13.01	10.25	24	82687	45440	64370581
Dystonia	13.00	10.25	4	82707	18861	64397160
Impaired work ability	12.96	10.25	46	82665	15173	64400848
Oedematous pancreatitis	12.87	10.25	10	82701	878	64415143
Acquired mitochondrial DNA mutation	12.83	10.25	3	82708	9	64416012
Hypoglycaemic unconsciousness	12.82	10.25	11	82700	1110	64414911
Pulmonary haematoma	12.68	10.25	5	82706	112	64415909
Procedural headache	12.68	10.25	5	82706	112	64415909
Acute myocardial infarction	12.66	10.25	141	82570	69577	64346444
Prerenal failure	12.62	10.25	18	82693	3204	64412817
Myalgia	12.61	10.25	279	82432	158338	64257683
Joint injury	12.38	10.25	7	82704	22940	64393081
Hepatic steatosis	12.36	10.25	75	82636	30932	64385089
Hyperglycaemic hyperosmolar nonketotic syndrome	12.27	10.25	13	82698	1706	64414315
Emotional distress	12.22	10.25	17	82694	36021	64380000
Bile duct cancer	12.20	10.25	10	82701	948	64415073
Sopor	12.20	10.25	12	82699	29649	64386372
Nephrogenic anaemia	12.19	10.25	18	82693	3307	64412714
Type 2 diabetes mellitus	12.14	10.25	80	82631	33940	64382081
Thrombosis	12.11	10.25	48	82663	70594	64345427
Leukopenia	12.10	10.25	78	82633	101164	64314857
Coma acidotic	11.99	10.25	5	82706	130	64415891
Hepatic enzyme increased	11.82	10.25	108	82603	129835	64286186
Vaginal haemorrhage	11.80	10.25	5	82706	19339	64396682
Pyrexia	11.77	10.25	591	82120	558053	63857968
Vitamin B1 deficiency	11.75	10.25	8	82703	572	64415449
Sinusitis	11.72	10.25	125	82586	145803	64270218
Hypomagnesaemia	11.64	10.25	85	82626	37291	64378730
Urogenital infection fungal	11.63	10.25	3	82708	15	64416006
Campylobacter infection	11.61	10.25	11	82700	1263	64414758
Deep vein thrombosis	11.60	10.25	83	82628	105099	64310922
Sprue-like enteropathy	11.57	10.25	10	82701	1019	64415002
Disease recurrence	11.57	10.25	14	82697	31496	64384525
Oesophageal mucosal tear	11.46	10.25	3	82708	16	64416005
Meibomianitis	11.39	10.25	4	82707	64	64415957
Multiple sclerosis	11.39	10.25	5	82706	18936	64397085
Loss of personal independence in daily activities	11.33	10.25	51	82660	72403	64343618
Intentional product misuse	11.24	10.25	51	82660	72244	64343777
Coronavirus infection	11.16	10.25	23	82688	5507	64410514
Haemorrhage subcutaneous	11.08	10.25	20	82691	4341	64411680
Oral mucosal discolouration	11.06	10.25	6	82705	284	64415737
Putamen haemorrhage	11.03	10.25	7	82704	444	64415577
Proteinuria	11.02	10.25	67	82644	27656	64388365
Neuropathy peripheral	10.99	10.25	97	82614	117428	64298593
Infusion site rash	10.95	10.25	10	82701	1096	64414925
Unevaluable event	10.92	10.25	31	82680	50458	64365563
Chronic kidney disease	10.91	10.25	118	82593	57801	64358220
Blood calcium decreased	10.90	10.25	10	82701	25544	64390477
Peripheral swelling	10.77	10.25	196	82515	208957	64207064
Eczema asteatotic	10.74	10.25	7	82704	465	64415556
Respiratory failure	10.67	10.25	144	82567	161039	64254982
Genital swelling	10.61	10.25	6	82705	308	64415713
Immune-mediated myositis	10.55	10.25	15	82696	2663	64413358
Erythema multiforme	10.54	10.25	44	82667	15657	64400364
Renal cancer metastatic	10.51	10.25	8	82703	681	64415340
Oscillopsia	10.50	10.25	5	82706	179	64415842
Suicide attempt	10.50	10.25	51	82660	70956	64345065
Idiopathic pulmonary fibrosis	10.39	10.25	18	82693	3782	64412239
Ill-defined disorder	10.32	10.25	26	82685	44026	64371995

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	A10BD07	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	A10BD24	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BH01	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Dipeptidyl peptidase 4 (DPP-4) inhibitors
ATC	A10BH51	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Dipeptidyl peptidase 4 (DPP-4) inhibitors
MeSH PA	D054873	Dipeptidyl-Peptidase IV Inhibitors
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D006728	Hormones
MeSH PA	D007004	Hypoglycemic Agents
MeSH PA	D054795	Incretins
MeSH PA	D011480	Protease Inhibitors
FDA MoA	N0000175912	Dipeptidyl Peptidase 4 Inhibitors
FDA EPC	N0000175913	Dipeptidyl Peptidase 4 Inhibitor
CHEBI has role	CHEBI:35526	antidiabetic
CHEBI has role	CHEBI:35703	Xenobiotic
CHEBI has role	CHEBI:48353	serine proteinase inhibitors
CHEBI has role	CHEBI:68612	dipeptidyl peptidase-4 inhibitors
CHEBI has role	CHEBI:78298	environmental contaminants

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
Infectious disease	contraindication	40733004
Ketoacidosis	contraindication	56051008
Metabolic acidosis	contraindication	59455009
Hypopituitarism	contraindication	74728003	DOID:9406
Cardiogenic shock	contraindication	89138009
Kidney disease	contraindication	90708001	DOID:557
Lactic acidosis	contraindication	91273001	DOID:3650
Cobalamin deficiency	contraindication	190634004
Decompensated cardiac failure	contraindication	195111005
Acute pancreatitis	contraindication	197456007	DOID:2913
Impaired renal function disorder	contraindication	197663003
Disease of liver	contraindication	235856003	DOID:409
Hypoglycemic disorder	contraindication	237630007
Sepsis syndrome	contraindication	238150007
Adrenal cortical hypofunction	contraindication	386584007	DOID:10493
Fever	contraindication	386661006
Surgical procedure	contraindication	387713003
Severe diarrhea	contraindication	409587002
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	8.1	Basic
pKa2	2.67	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
10MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Oct. 7, 2011	DISCN	TABLET	ORAL	8168637	June 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
10MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Sept. 18, 2012	DISCN	TABLET	ORAL	8168637	June 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
20MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Oct. 7, 2011	DISCN	TABLET	ORAL	8168637	June 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
20MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Sept. 18, 2012	DISCN	TABLET	ORAL	8168637	June 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
40MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Oct. 7, 2011	DISCN	TABLET	ORAL	8168637	June 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
40MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Sept. 18, 2012	DISCN	TABLET	ORAL	8168637	June 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
EQ 100MG BASE	JANUVIA	MERCK SHARP DOHME	N021995	Oct. 16, 2006	RX	TABLET	ORAL	6699871	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
EQ 100MG BASE	JANUVIA	MERCK SHARP DOHME	N021995	Oct. 16, 2006	RX	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH INSULIN
EQ 100MG BASE	JANUVIA	MERCK SHARP DOHME	N021995	Oct. 16, 2006	RX	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH METFORMIN AND A PPAR-GAMMA AGONIST
EQ 100MG BASE	JANUVIA	MERCK SHARP DOHME	N021995	Oct. 16, 2006	RX	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH A PPAR-GAMMA AGONIST
EQ 100MG BASE	JANUVIA	MERCK SHARP DOHME	N021995	Oct. 16, 2006	RX	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND/OR A SULFONYLUREA
EQ 25MG BASE	JANUVIA	MERCK SHARP DOHME	N021995	Oct. 16, 2006	RX	TABLET	ORAL	6699871	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
EQ 25MG BASE	JANUVIA	MERCK SHARP DOHME	N021995	Oct. 16, 2006	RX	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH INSULIN
EQ 25MG BASE	JANUVIA	MERCK SHARP DOHME	N021995	Oct. 16, 2006	RX	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH METFORMIN AND A PPAR-GAMMA AGONIST
EQ 25MG BASE	JANUVIA	MERCK SHARP DOHME	N021995	Oct. 16, 2006	RX	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH A PPAR-GAMMA AGONIST
EQ 25MG BASE	JANUVIA	MERCK SHARP DOHME	N021995	Oct. 16, 2006	RX	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND/OR A SULFONYLUREA
EQ 50MG BASE	JANUVIA	MERCK SHARP DOHME	N021995	Oct. 16, 2006	RX	TABLET	ORAL	6699871	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
EQ 50MG BASE	JANUVIA	MERCK SHARP DOHME	N021995	Oct. 16, 2006	RX	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH INSULIN
EQ 50MG BASE	JANUVIA	MERCK SHARP DOHME	N021995	Oct. 16, 2006	RX	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH METFORMIN AND A PPAR-GAMMA AGONIST
EQ 50MG BASE	JANUVIA	MERCK SHARP DOHME	N021995	Oct. 16, 2006	RX	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH A PPAR-GAMMA AGONIST
EQ 50MG BASE	JANUVIA	MERCK SHARP DOHME	N021995	Oct. 16, 2006	RX	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND/OR A SULFONYLUREA
1GM;EQ 50MG BASE	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	6699871	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
1GM;EQ 50MG BASE	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH INSULIN
1GM;EQ 50MG BASE	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH METFORMIN AND A PPAR-GAMMA AGONIST
1GM;EQ 50MG BASE	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN
500MG;EQ 50MG BASE	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	6699871	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
500MG;EQ 50MG BASE	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH INSULIN
500MG;EQ 50MG BASE	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH METFORMIN AND A PPAR-GAMMA AGONIST
500MG;EQ 50MG BASE	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN
1GM;EQ 100MG BASE	JANUMET XR	MERCK SHARP DOHME	N202270	Feb. 2, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	6699871	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
1GM;EQ 100MG BASE	JANUMET XR	MERCK SHARP DOHME	N202270	Feb. 2, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
1GM;EQ 50MG BASE	JANUMET XR	MERCK SHARP DOHME	N202270	Feb. 2, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	6699871	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
1GM;EQ 50MG BASE	JANUMET XR	MERCK SHARP DOHME	N202270	Feb. 2, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
500MG;EQ 50MG BASE	JANUMET XR	MERCK SHARP DOHME	N202270	Feb. 2, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	6699871	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
500MG;EQ 50MG BASE	JANUMET XR	MERCK SHARP DOHME	N202270	Feb. 2, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
10MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Oct. 7, 2011	DISCN	TABLET	ORAL	6699871	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
10MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Oct. 7, 2011	DISCN	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A PPAR-GAMMA AGONIST (SUCH AS PIOGLITAZONE AND ROSIGLITAZONE)
10MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Oct. 7, 2011	DISCN	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A SULFONYLUREA (SUCH AS GLIPIZIDE, GLIMEPIRIDE AND GLYBURIDE)
10MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Oct. 7, 2011	DISCN	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH INSULIN
10MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Oct. 7, 2011	DISCN	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH METFORMIN
10MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Sept. 18, 2012	DISCN	TABLET	ORAL	6699871	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
10MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Sept. 18, 2012	DISCN	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A PPAR-GAMMA AGONIST (SUCH AS PIOGLITAZONE AND ROSIGLITAZONE)
10MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Sept. 18, 2012	DISCN	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A SULFONYLUREA (SUCH AS GLIPIZIDE, GLIMEPIRIDE AND GLYBURIDE)
10MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Sept. 18, 2012	DISCN	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH INSULIN
10MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Sept. 18, 2012	DISCN	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH METFORMIN
20MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Oct. 7, 2011	DISCN	TABLET	ORAL	6699871	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
20MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Oct. 7, 2011	DISCN	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A PPAR-GAMMA AGONIST (SUCH AS PIOGLITAZONE AND ROSIGLITAZONE)
20MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Oct. 7, 2011	DISCN	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A SULFONYLUREA (SUCH AS GLIPIZIDE, GLIMEPIRIDE AND GLYBURIDE)
20MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Oct. 7, 2011	DISCN	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH INSULIN
20MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Oct. 7, 2011	DISCN	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH METFORMIN
20MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Sept. 18, 2012	DISCN	TABLET	ORAL	6699871	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
20MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Sept. 18, 2012	DISCN	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A PPAR-GAMMA AGONIST (SUCH AS PIOGLITAZONE AND ROSIGLITAZONE)
20MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Sept. 18, 2012	DISCN	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A SULFONYLUREA (SUCH AS GLIPIZIDE, GLIMEPIRIDE AND GLYBURIDE)
20MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Sept. 18, 2012	DISCN	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH INSULIN
20MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Sept. 18, 2012	DISCN	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH METFORMIN
40MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Oct. 7, 2011	DISCN	TABLET	ORAL	6699871	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
40MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Oct. 7, 2011	DISCN	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A PPAR-GAMMA AGONIST (SUCH AS PIOGLITAZONE AND ROSIGLITAZONE)
40MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Oct. 7, 2011	DISCN	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A SULFONYLUREA (SUCH AS GLIPIZIDE, GLIMEPIRIDE AND GLYBURIDE)
40MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Oct. 7, 2011	DISCN	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH INSULIN
40MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Oct. 7, 2011	DISCN	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH METFORMIN
40MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Sept. 18, 2012	DISCN	TABLET	ORAL	6699871	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
40MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Sept. 18, 2012	DISCN	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A PPAR-GAMMA AGONIST (SUCH AS PIOGLITAZONE AND ROSIGLITAZONE)
40MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Sept. 18, 2012	DISCN	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A SULFONYLUREA (SUCH AS GLIPIZIDE, GLIMEPIRIDE AND GLYBURIDE)
40MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Sept. 18, 2012	DISCN	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH INSULIN
40MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Sept. 18, 2012	DISCN	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH METFORMIN
15MG;EQ 100MG BASE	STEGLUJAN	MERCK SHARP DOHME	N209805	Dec. 19, 2017	RX	TABLET	ORAL	6699871	July 26, 2022	AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES
5MG;EQ 100MG BASE	STEGLUJAN	MERCK SHARP DOHME	N209805	Dec. 19, 2017	RX	TABLET	ORAL	6699871	July 26, 2022	AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES
10MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Oct. 7, 2011	DISCN	TABLET	ORAL	7326708	April 11, 2026	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
10MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Sept. 18, 2012	DISCN	TABLET	ORAL	7326708	April 11, 2026	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
20MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Oct. 7, 2011	DISCN	TABLET	ORAL	7326708	April 11, 2026	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
20MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Sept. 18, 2012	DISCN	TABLET	ORAL	7326708	April 11, 2026	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
40MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Oct. 7, 2011	DISCN	TABLET	ORAL	7326708	April 11, 2026	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
40MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JUVISYNC	MERCK SHARP DOHME	N202343	Sept. 18, 2012	DISCN	TABLET	ORAL	7326708	April 11, 2026	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
EQ 100MG BASE	JANUVIA	MERCK SHARP DOHME	N021995	Oct. 16, 2006	RX	TABLET	ORAL	7326708	Nov. 24, 2026	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
EQ 25MG BASE	JANUVIA	MERCK SHARP DOHME	N021995	Oct. 16, 2006	RX	TABLET	ORAL	7326708	Nov. 24, 2026	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
EQ 50MG BASE	JANUVIA	MERCK SHARP DOHME	N021995	Oct. 16, 2006	RX	TABLET	ORAL	7326708	Nov. 24, 2026	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
1GM;EQ 50MG BASE	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	7326708	Nov. 24, 2026	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
500MG;EQ 50MG BASE	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	7326708	Nov. 24, 2026	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
1GM;EQ 100MG BASE	JANUMET XR	MERCK SHARP DOHME	N202270	Feb. 2, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	7326708	Nov. 24, 2026	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
1GM;EQ 50MG BASE	JANUMET XR	MERCK SHARP DOHME	N202270	Feb. 2, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	7326708	Nov. 24, 2026	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
500MG;EQ 50MG BASE	JANUMET XR	MERCK SHARP DOHME	N202270	Feb. 2, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	7326708	Nov. 24, 2026	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
15MG;EQ 100MG BASE	STEGLUJAN	MERCK SHARP DOHME	N209805	Dec. 19, 2017	RX	TABLET	ORAL	7326708	Nov. 24, 2026	AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES
5MG;EQ 100MG BASE	STEGLUJAN	MERCK SHARP DOHME	N209805	Dec. 19, 2017	RX	TABLET	ORAL	7326708	Nov. 24, 2026	AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES
1GM;EQ 50MG BASE	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	8414921	July 21, 2028	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH INSULIN
500MG;EQ 50MG BASE	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	8414921	July 21, 2028	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH INSULIN
15MG;EQ 100MG BASE	STEGLUJAN	MERCK SHARP DOHME	N209805	Dec. 19, 2017	RX	TABLET	ORAL	8080580	July 13, 2030	AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES
5MG;EQ 100MG BASE	STEGLUJAN	MERCK SHARP DOHME	N209805	Dec. 19, 2017	RX	TABLET	ORAL	8080580	July 13, 2030	AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES
15MG;EQ 100MG BASE	STEGLUJAN	MERCK SHARP DOHME	N209805	Dec. 19, 2017	RX	TABLET	ORAL	9439901	Oct. 21, 2030	AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES
5MG;EQ 100MG BASE	STEGLUJAN	MERCK SHARP DOHME	N209805	Dec. 19, 2017	RX	TABLET	ORAL	9439901	Oct. 21, 2030	AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
EQ 100MG BASE	JANUVIA	MERCK SHARP DOHME	N021995	Oct. 16, 2006	RX	TABLET	ORAL	Aug. 12, 2022	INFORMATION ADDED TO THE LABELING REGARDING EFFICACY AND SAFETY OF THE CONTINUATION OF SITAGLIPTIN COMPARED WITH THE WITHDRAWAL OF SITAGLIPTIN DURING INITIATION AND TITRATION OF INSULIN GLARGINE IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
EQ 25MG BASE	JANUVIA	MERCK SHARP DOHME	N021995	Oct. 16, 2006	RX	TABLET	ORAL	Aug. 12, 2022	INFORMATION ADDED TO THE LABELING REGARDING EFFICACY AND SAFETY OF THE CONTINUATION OF SITAGLIPTIN COMPARED WITH THE WITHDRAWAL OF SITAGLIPTIN DURING INITIATION AND TITRATION OF INSULIN GLARGINE IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
EQ 50MG BASE	JANUVIA	MERCK SHARP DOHME	N021995	Oct. 16, 2006	RX	TABLET	ORAL	Aug. 12, 2022	INFORMATION ADDED TO THE LABELING REGARDING EFFICACY AND SAFETY OF THE CONTINUATION OF SITAGLIPTIN COMPARED WITH THE WITHDRAWAL OF SITAGLIPTIN DURING INITIATION AND TITRATION OF INSULIN GLARGINE IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
1GM;EQ 50MG BASE	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	Aug. 12, 2022	INFORMATION ADDED TO THE LABELING REGARDING EFFICACY AND SAFETY OF THE CONTINUATION OF SITAGLIPTIN COMPARED WITH THE WITHDRAWAL OF SITAGLIPTIN DURING INITIATION AND TITRATION OF INSULIN GLARGINE IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
500MG;EQ 50MG BASE	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	Aug. 12, 2022	INFORMATION ADDED TO THE LABELING REGARDING EFFICACY AND SAFETY OF THE CONTINUATION OF SITAGLIPTIN COMPARED WITH THE WITHDRAWAL OF SITAGLIPTIN DURING INITIATION AND TITRATION OF INSULIN GLARGINE IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
1GM;EQ 100MG BASE	JANUMET XR	MERCK SHARP DOHME	N202270	Feb. 2, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	Aug. 12, 2022	INFORMATION ADDED TO THE LABELING REGARDING EFFICACY AND SAFETY OF THE CONTINUATION OF SITAGLIPTIN COMPARED WITH THE WITHDRAWAL OF SITAGLIPTIN DURING INITIATION AND TITRATION OF INSULIN GLARGINE IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
1GM;EQ 50MG BASE	JANUMET XR	MERCK SHARP DOHME	N202270	Feb. 2, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	Aug. 12, 2022	INFORMATION ADDED TO THE LABELING REGARDING EFFICACY AND SAFETY OF THE CONTINUATION OF SITAGLIPTIN COMPARED WITH THE WITHDRAWAL OF SITAGLIPTIN DURING INITIATION AND TITRATION OF INSULIN GLARGINE IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
500MG;EQ 50MG BASE	JANUMET XR	MERCK SHARP DOHME	N202270	Feb. 2, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	Aug. 12, 2022	INFORMATION ADDED TO THE LABELING REGARDING EFFICACY AND SAFETY OF THE CONTINUATION OF SITAGLIPTIN COMPARED WITH THE WITHDRAWAL OF SITAGLIPTIN DURING INITIATION AND TITRATION OF INSULIN GLARGINE IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
15MG;EQ 100MG BASE	STEGLUJAN	MERCK SHARP DOHME	N209805	Dec. 19, 2017	RX	TABLET	ORAL	Dec. 19, 2022	NEW CHEMICAL ENTITY
5MG;EQ 100MG BASE	STEGLUJAN	MERCK SHARP DOHME	N209805	Dec. 19, 2017	RX	TABLET	ORAL	Dec. 19, 2022	NEW CHEMICAL ENTITY
EQ 100MG BASE	JANUVIA	MERCK SHARP DOHME	N021995	Oct. 16, 2006	RX	TABLET	ORAL	Feb. 12, 2023	PEDIATRIC EXCLUSIVITY
EQ 25MG BASE	JANUVIA	MERCK SHARP DOHME	N021995	Oct. 16, 2006	RX	TABLET	ORAL	Feb. 12, 2023	PEDIATRIC EXCLUSIVITY
EQ 50MG BASE	JANUVIA	MERCK SHARP DOHME	N021995	Oct. 16, 2006	RX	TABLET	ORAL	Feb. 12, 2023	PEDIATRIC EXCLUSIVITY
1GM;EQ 50MG BASE	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	Feb. 12, 2023	PEDIATRIC EXCLUSIVITY
500MG;EQ 50MG BASE	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	Feb. 12, 2023	PEDIATRIC EXCLUSIVITY
1GM;EQ 100MG BASE	JANUMET XR	MERCK SHARP DOHME	N202270	Feb. 2, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	Feb. 12, 2023	PEDIATRIC EXCLUSIVITY
1GM;EQ 50MG BASE	JANUMET XR	MERCK SHARP DOHME	N202270	Feb. 2, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	Feb. 12, 2023	PEDIATRIC EXCLUSIVITY
500MG;EQ 50MG BASE	JANUMET XR	MERCK SHARP DOHME	N202270	Feb. 2, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	Feb. 12, 2023	PEDIATRIC EXCLUSIVITY
EQ 100MG BASE	JANUVIA	MERCK SHARP DOHME	N021995	Oct. 16, 2006	RX	TABLET	ORAL	Dec. 4, 2023	ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
EQ 25MG BASE	JANUVIA	MERCK SHARP DOHME	N021995	Oct. 16, 2006	RX	TABLET	ORAL	Dec. 4, 2023	ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
EQ 50MG BASE	JANUVIA	MERCK SHARP DOHME	N021995	Oct. 16, 2006	RX	TABLET	ORAL	Dec. 4, 2023	ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
1GM;EQ 50MG BASE	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	Dec. 4, 2023	ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
500MG;EQ 50MG BASE	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	Dec. 4, 2023	ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
1GM;EQ 50MG BASE	JANUMET XR	MERCK SHARP DOHME	N202270	Feb. 2, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	Dec. 4, 2023	ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
500MG;EQ 50MG BASE	JANUMET XR	MERCK SHARP DOHME	N202270	Feb. 2, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	Dec. 4, 2023	ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
EQ 100MG BASE	JANUVIA	MERCK SHARP DOHME	N021995	Oct. 16, 2006	RX	TABLET	ORAL	June 4, 2024	PEDIATRIC EXCLUSIVITY
EQ 25MG BASE	JANUVIA	MERCK SHARP DOHME	N021995	Oct. 16, 2006	RX	TABLET	ORAL	June 4, 2024	PEDIATRIC EXCLUSIVITY
EQ 50MG BASE	JANUVIA	MERCK SHARP DOHME	N021995	Oct. 16, 2006	RX	TABLET	ORAL	June 4, 2024	PEDIATRIC EXCLUSIVITY
1GM;EQ 50MG BASE	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	June 4, 2024	PEDIATRIC EXCLUSIVITY
500MG;EQ 50MG BASE	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	June 4, 2024	PEDIATRIC EXCLUSIVITY
1GM;EQ 50MG BASE	JANUMET XR	MERCK SHARP DOHME	N202270	Feb. 2, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	June 4, 2024	PEDIATRIC EXCLUSIVITY
500MG;EQ 50MG BASE	JANUMET XR	MERCK SHARP DOHME	N202270	Feb. 2, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	June 4, 2024	PEDIATRIC EXCLUSIVITY
15MG;EQ 100MG BASE	STEGLUJAN	MERCK SHARP DOHME	N209805	Dec. 19, 2017	RX	TABLET	ORAL	Sept. 17, 2024	REVISION TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY, MK-8835-004/B1521021, VERTIS CV
5MG;EQ 100MG BASE	STEGLUJAN	MERCK SHARP DOHME	N209805	Dec. 19, 2017	RX	TABLET	ORAL	Sept. 17, 2024	REVISION TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY, MK-8835-004/B1521021, VERTIS CV

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Dipeptidyl peptidase 4	Enzyme	P27487	DPP4_HUMAN	INHIBITOR	Ki	7.77	WOMBAT-PK	CHEMBL
Angiotensin-converting enzyme	Enzyme	P12821	ACE_HUMAN		IC50	4.96	CHEMBL
Prolyl endopeptidase FAP	Enzyme	Q12884	SEPR_HUMAN		IC50	5.23	CHEMBL
Dipeptidyl peptidase 8	Enzyme	Q6V1X1	DPP8_HUMAN		IC50	4.96	CHEMBL
Dipeptidyl peptidase 9	Enzyme	Q86TI2	DPP9_HUMAN		IC50	4.70	CHEMBL
Dipeptidyl peptidase 2	Enzyme	Q9UHL4	DPP2_HUMAN		IC50	4.22	CHEMBL
Dipeptidyl peptidase 4	Enzyme		DPP4_MOUSE		IC50	7.16	CHEMBL
Dipeptidyl peptidase 4	Enzyme		DPP4_RAT		IC50	7.48	CHEMBL
Dipeptidyl peptidase IV	Unclassified		O31048_PORGN		IC50	4.75	CHEMBL

External reference:

ID	Source
4025780	VUID
N0000179787	NUI
D06645	KEGG_DRUG
654671-77-9	SECONDARY_CAS_RN
4025780	VANDF
4025781	VANDF
C1667080	UMLSCUI
CHEBI:40237	CHEBI
715	PDB_CHEM_ID
CHEMBL1422	ChEMBL_ID
CHEMBL1201174	ChEMBL_ID
D000068900	MESH_DESCRIPTOR_UI
DB01261	DRUGBANK_ID
4369359	PUBCHEM_CID
6286	IUPHAR_LIGAND_ID
8692	INN_ID
654671-78-0	SECONDARY_CAS_RN
862156-92-1	SECONDARY_CAS_RN
QFP0P1DV7Z	UNII
593411	RXNORM
23649	MMSL
89034	MMSL
d05896	MMSL
011790	NDDF
011791	NDDF
423307000	SNOMEDCT_US
424106006	SNOMEDCT_US
425508009	SNOMEDCT_US
CHEMBL393336	ChEMBL_ID

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
JANUMET XR	HUMAN PRESCRIPTION DRUG LABEL	2	0006-0078	TABLET, FILM COATED, EXTENDED RELEASE	50 mg	ORAL	NDA	30 sections
JANUMET XR	HUMAN PRESCRIPTION DRUG LABEL	2	0006-0080	TABLET, FILM COATED, EXTENDED RELEASE	50 mg	ORAL	NDA	30 sections
JANUMET XR	HUMAN PRESCRIPTION DRUG LABEL	2	0006-0081	TABLET, FILM COATED, EXTENDED RELEASE	100 mg	ORAL	NDA	30 sections
JANUVIA	HUMAN PRESCRIPTION DRUG LABEL	1	0006-0112	TABLET, FILM COATED	50 mg	ORAL	NDA	27 sections
JANUVIA	HUMAN PRESCRIPTION DRUG LABEL	1	0006-0221	TABLET, FILM COATED	25 mg	ORAL	NDA	27 sections
JANUVIA	HUMAN PRESCRIPTION DRUG LABEL	1	0006-0277	TABLET, FILM COATED	100 mg	ORAL	NDA	27 sections
JANUMET	HUMAN PRESCRIPTION DRUG LABEL	2	0006-0575	TABLET, FILM COATED	50 mg	ORAL	NDA	29 sections
JANUMET	HUMAN PRESCRIPTION DRUG LABEL	2	0006-0577	TABLET, FILM COATED	50 mg	ORAL	NDA	29 sections
STEGLUJAN	HUMAN PRESCRIPTION DRUG LABEL	2	0006-5367	TABLET, FILM COATED	100 mg	ORAL	NDA	28 sections
STEGLUJAN	HUMAN PRESCRIPTION DRUG LABEL	2	0006-5368	TABLET, FILM COATED	100 mg	ORAL	NDA	28 sections
JANUVIA	HUMAN PRESCRIPTION DRUG LABEL	1	50090-1036	TABLET, FILM COATED	100 mg	ORAL	NDA	27 sections
JANUVIA	HUMAN PRESCRIPTION DRUG LABEL	1	50090-3472	TABLET, FILM COATED	50 mg	ORAL	NDA	27 sections
JANUVIA	HUMAN PRESCRIPTION DRUG LABEL	1	50090-3527	TABLET, FILM COATED	25 mg	ORAL	NDA	26 sections
JANUVIA	HUMAN PRESCRIPTION DRUG LABEL	1	50090-4084	TABLET, FILM COATED	100 mg	ORAL	NDA	27 sections
JANUVIA	HUMAN PRESCRIPTION DRUG LABEL	1	50090-4086	TABLET, FILM COATED	50 mg	ORAL	NDA	27 sections
JANUVIA	HUMAN PRESCRIPTION DRUG LABEL	1	50090-4087	TABLET, FILM COATED	25 mg	ORAL	NDA	27 sections
JANUMET XR	HUMAN PRESCRIPTION DRUG LABEL	2	50090-4411	TABLET, FILM COATED, EXTENDED RELEASE	50 mg	ORAL	NDA	30 sections
JANUVIA	HUMAN PRESCRIPTION DRUG LABEL	1	50090-5517	TABLET, FILM COATED	50 mg	ORAL	NDA	27 sections
JANUVIA	HUMAN PRESCRIPTION DRUG LABEL	1	50090-5517	TABLET, FILM COATED	50 mg	ORAL	NDA	27 sections
JANUVIA	HUMAN PRESCRIPTION DRUG LABEL	1	50090-5547	TABLET, FILM COATED	25 mg	ORAL	NDA	27 sections
JANUVIA	HUMAN PRESCRIPTION DRUG LABEL	1	50090-5585	TABLET, FILM COATED	100 mg	ORAL	NDA	27 sections
JANUMET	HUMAN PRESCRIPTION DRUG LABEL	2	50090-5618	TABLET, FILM COATED	50 mg	ORAL	NDA	29 sections
JANUVIA	HUMAN PRESCRIPTION DRUG LABEL	1	54868-5840	TABLET, FILM COATED	100 mg	ORAL	NDA	27 sections
JANUVIA	HUMAN PRESCRIPTION DRUG LABEL	1	54868-6031	TABLET, FILM COATED	50 mg	ORAL	NDA	27 sections
JANUVIA	HUMAN PRESCRIPTION DRUG LABEL	1	55154-5040	TABLET, FILM COATED	50 mg	ORAL	NDA	28 sections
JANUVIA	HUMAN PRESCRIPTION DRUG LABEL	1	55154-5040	TABLET, FILM COATED	50 mg	ORAL	NDA	28 sections
JANUVIA	HUMAN PRESCRIPTION DRUG LABEL	1	55154-5042	TABLET, FILM COATED	100 mg	ORAL	NDA	28 sections
JANUVIA	HUMAN PRESCRIPTION DRUG LABEL	1	58118-0277	TABLET, FILM COATED	100 mg	ORAL	NDA	27 sections
JANUMET	HUMAN PRESCRIPTION DRUG LABEL	2	70518-2548	TABLET, FILM COATED	50 mg	ORAL	NDA	29 sections
JANUMET	HUMAN PRESCRIPTION DRUG LABEL	2	70518-2548	TABLET, FILM COATED	50 mg	ORAL	NDA	29 sections