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: OFP 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: OFP

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
S (Water solubility)	50 mg/mL	Bocci G, Oprea TI, Benet LZ

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	860.04	10.98	699	63910	83057	63341356
Hypoglycaemia	658.18	10.98	521	64088	59544	63364869
Pancreatitis	601.68	10.98	455	64154	48600	63375813
Diabetes mellitus inadequate control	554.00	10.98	282	64327	14844	63409569
Pancreatic carcinoma	444.88	10.98	196	64413	7432	63416981
Carotid artery thrombosis	350.88	10.98	125	64484	2669	63421744
Neurologic neglect syndrome	335.16	10.98	120	64489	2601	63421812
Lactic acidosis	325.55	10.98	287	64322	38000	63386413
Glycosylated haemoglobin increased	313.93	10.98	181	64428	12217	63412196
Personality disorder	302.75	10.98	138	64471	5673	63418740
Adjustment disorder	288.34	10.98	112	64497	3066	63421347
Hemiplegia	279.28	10.98	152	64457	9171	63415242
Pancreatic carcinoma metastatic	264.29	10.98	95	64514	2083	63422330
Diabetic ketoacidosis	250.77	10.98	190	64419	20315	63404098
Acute kidney injury	224.26	10.98	682	63927	262733	63161680
Affect lability	223.24	10.98	140	64469	11011	63413402
Pemphigoid	198.76	10.98	112	64497	7232	63417181
Sensory loss	191.15	10.98	123	64486	10115	63414298
Motor dysfunction	187.98	10.98	124	64485	10637	63413776
Systemic lupus erythematosus	178.69	10.98	8	64601	208910	63215503
Pancreatitis acute	177.60	10.98	176	64433	26990	63397423
Contraindicated product administered	169.16	10.98	14	64595	217634	63206779
Blood glucose abnormal	167.90	10.98	103	64506	7789	63416624
Pemphigus	167.85	10.98	4	64605	183722	63240691
Coordination abnormal	167.02	10.98	127	64482	13646	63410767
Hyperglycaemia	161.45	10.98	206	64403	41661	63382752
Drug intolerance	158.64	10.98	58	64551	308603	63115810
Off label use	155.70	10.98	281	64328	674181	62750232
Glossodynia	143.25	10.98	10	64599	178866	63245547
Synovitis	142.58	10.98	13	64596	186905	63237508
Muscle spasticity	140.24	10.98	140	64469	21654	63402759
Hemiparesis	139.67	10.98	144	64465	23138	63401275
Treatment failure	138.85	10.98	19	64590	199024	63225389
Maternal exposure during pregnancy	135.96	10.98	29	64580	220033	63204380
Aphasia	134.59	10.98	167	64442	32833	63391580
Drug ineffective	131.10	10.98	584	64025	1044181	62380232
Euglycaemic diabetic ketoacidosis	130.13	10.98	67	64542	3607	63420806
Eating disorder	127.63	10.98	125	64484	18891	63405522
Ketoacidosis	127.30	10.98	70	64539	4308	63420105
Therapeutic product effect decreased	126.65	10.98	22	64587	193165	63231248
No adverse event	125.11	10.98	181	64428	41224	63383189
Lung diffusion test abnormal	122.04	10.98	34	64575	309	63424104
Arthropathy	117.44	10.98	46	64563	234746	63189667
Infusion related reaction	111.90	10.98	55	64554	245466	63178947
Blood glucose decreased	103.58	10.98	117	64492	20835	63403578
Product use issue	102.62	10.98	48	64561	220472	63203941
Bile duct stent insertion	100.69	10.98	21	64588	42	63424371
Dysarthria	100.03	10.98	166	64443	42545	63381868
Product dose omission issue	98.27	10.98	485	64124	233828	63190585
Adenocarcinoma pancreas	97.82	10.98	38	64571	1040	63423373
Joint swelling	97.47	10.98	114	64495	327552	63096861
Product residue present	95.17	10.98	56	64553	3923	63420490
Blood glucose fluctuation	92.96	10.98	58	64551	4518	63419895
Hand deformity	92.55	10.98	24	64585	159433	63264980
Muscular weakness	92.12	10.98	304	64305	122049	63302364
Cerebrovascular accident	88.22	10.98	276	64333	107748	63316665
Hyperkalaemia	85.81	10.98	178	64431	54025	63370388
Lipase increased	85.67	10.98	75	64534	9825	63414588
Dysphagia	85.33	10.98	240	64369	88345	63336068
Pancreaticoduodenectomy	83.19	10.98	16	64593	16	63424397
Arterial occlusive disease	79.06	10.98	58	64551	5900	63418513
Gangrene	77.64	10.98	58	64551	6065	63418348
Exposure during pregnancy	76.87	10.98	31	64578	155516	63268897
Skin haemorrhage	76.56	10.98	71	64538	10023	63414390
Duodenal ulcer perforation	75.64	10.98	3	64606	87206	63337207
Wrong technique in product usage process	74.42	10.98	183	64426	62157	63362256
Sinus congestion	74.34	10.98	92	64517	18031	63406382
Pain	72.33	10.98	450	64159	740178	62684235
Wound	67.89	10.98	41	64568	163222	63261191
Product use in unapproved indication	67.71	10.98	50	64559	179030	63245383
Eosinophilic myocarditis	67.62	10.98	25	64584	595	63423818
Lower respiratory tract infection	65.98	10.98	26	64583	132281	63292132
Pericarditis	65.38	10.98	26	64583	131553	63292860
Alopecia	64.63	10.98	156	64453	337380	63087033
Hypoglycaemic coma	63.59	10.98	37	64572	2538	63421875
Rhinorrhoea	62.48	10.98	177	64432	65400	63359013
Musculoskeletal stiffness	61.84	10.98	58	64551	184560	63239853
Hypersensitivity	60.29	10.98	130	64479	292555	63131858
Swelling	59.51	10.98	119	64490	275259	63149154
Discomfort	59.15	10.98	50	64559	167324	63257089
Metabolic acidosis	56.67	10.98	135	64474	44934	63379479
Helicobacter infection	55.70	10.98	13	64596	92772	63331641
Hepatic enzyme increased	55.29	10.98	75	64534	202253	63222160
Respiratory tract congestion	51.02	10.98	76	64533	17756	63406657
MELAS syndrome	50.27	10.98	14	64595	127	63424286
Metastases to liver	50.22	10.98	88	64521	23551	63400862
Toxicity to various agents	49.93	10.98	111	64498	247139	63177274
Sneezing	48.38	10.98	75	64534	18143	63406270
Sinus disorder	47.81	10.98	88	64521	24465	63399948
Abdominal discomfort	47.76	10.98	167	64442	320718	63103695
Psoriatic arthropathy	47.27	10.98	17	64592	91503	63332910
Temperature perception test abnormal	43.84	10.98	9	64600	16	63424397
Pancreatectomy	42.51	10.98	9	64600	20	63424393
Pneumobilia	42.23	10.98	12	64597	118	63424295
Pancreatitis chronic	41.87	10.98	28	64581	2456	63421957
Bursitis infective	40.50	10.98	22	64587	1321	63423092
Product packaging quantity issue	40.26	10.98	22	64587	1337	63423076
Irritable bowel syndrome	39.77	10.98	17	64592	82395	63342018
Impaired healing	39.56	10.98	28	64581	102514	63321899
Drug hypersensitivity	39.01	10.98	173	64436	310514	63113899
Diabetic neuropathy	38.31	10.98	32	64577	3932	63420481
Diabetic metabolic decompensation	38.12	10.98	23	64586	1687	63422726
Skin exfoliation	37.84	10.98	113	64496	42989	63381424
Renal cyst	37.05	10.98	49	64560	10253	63414160
Nausea	36.14	10.98	1130	63479	853341	62571072
Cerebral infarction	36.10	10.98	77	64532	23816	63400597
Hypoglycaemic encephalopathy	35.58	10.98	13	64596	299	63424114
Intentional product use issue	35.33	10.98	47	64562	127845	63296568
Neutropenia	34.95	10.98	79	64530	174926	63249487
Dehydration	34.76	10.98	298	64311	173056	63251357
Urine ketone body present	34.65	10.98	25	64584	2478	63421935
Haemoglobin increased	34.34	10.98	29	64580	3617	63420796
Pancreatic mass	33.07	10.98	17	64592	912	63423501
Acetonaemia	32.87	10.98	10	64599	127	63424286
Radiotherapy	32.47	10.98	13	64596	386	63424027
Injury	32.44	10.98	17	64592	73230	63351183
Fibromyalgia	32.30	10.98	21	64588	80399	63344014
Blister	31.67	10.98	52	64557	129762	63294651
Arthralgia	31.55	10.98	400	64209	569310	62855103
Condition aggravated	31.50	10.98	260	64349	401957	63022456
Angina pectoris	31.43	10.98	84	64525	29994	63394419
Completed suicide	31.39	10.98	63	64546	145610	63278803
Palpitations	31.12	10.98	209	64400	112561	63311852
Genital infection female	31.09	10.98	9	64600	95	63424318
Anuria	31.02	10.98	50	64559	12501	63411912
Therapy non-responder	30.24	10.98	20	64589	75881	63348532
Tubulointerstitial nephritis	29.90	10.98	64	64545	19839	63404574
Cataract	29.72	10.98	126	64483	56927	63367486
Injection site erythema	29.18	10.98	25	64584	83149	63341264
Product prescribing error	29.09	10.98	75	64534	26214	63398199
Stomatitis	29.04	10.98	61	64548	138664	63285749
Pruritus genital	28.97	10.98	23	64586	2631	63421782
Oedema peripheral	28.68	10.98	307	64302	189204	63235209
Renal disorder	28.52	10.98	86	64523	32888	63391525
Small fibre neuropathy	27.32	10.98	12	64597	451	63423962
Tubulointerstitial nephritis and uveitis syndrome	27.17	10.98	10	64599	235	63424178
Liver injury	26.87	10.98	14	64595	60506	63363907
Asthenia	26.75	10.98	543	64066	383061	63041352
Pancreatic duct dilatation	26.74	10.98	10	64599	246	63424167
Diabetes mellitus	26.59	10.98	120	64489	55690	63368723
Diarrhoea	26.56	10.98	932	63677	714434	62709979
Drug abuse	26.43	10.98	21	64588	72497	63351916
Hepatic steatosis	25.79	10.98	76	64533	28693	63395720
Pancreatic stent placement	25.52	10.98	5	64604	6	63424407
Tonsillectomy	25.46	10.98	14	64595	861	63423552
Cystitis	25.28	10.98	117	64492	54874	63369539
Anaemia vitamin B12 deficiency	25.18	10.98	11	64598	408	63424005
Febrile neutropenia	24.86	10.98	52	64557	118397	63306016
Hip arthroplasty	24.34	10.98	9	64600	47637	63376776
Joint noise	24.26	10.98	26	64583	4366	63420047
Decreased vibratory sense	24.01	10.98	10	64599	329	63424084
Gastric disorder	23.88	10.98	88	64521	37281	63387132
Prevertebral soft tissue swelling of cervical space	23.71	10.98	6	64603	36	63424377
Splenic vein occlusion	23.57	10.98	4	64605	0	63424413
Angioedema	23.50	10.98	104	64505	47861	63376552
Glomerular filtration rate decreased	23.48	10.98	46	64563	13395	63411018
Circumstance or information capable of leading to medication error	23.32	10.98	24	64585	3846	63420567
Peripheral artery haematoma	23.30	10.98	6	64603	39	63424374
Blood pressure inadequately controlled	23.25	10.98	27	64582	4951	63419462
Full blood count abnormal	23.12	10.98	78	64531	31639	63392774
Altered state of consciousness	22.95	10.98	67	64542	25163	63399250
Seronegative arthritis	22.86	10.98	24	64585	3935	63420478
Insulin-requiring type 2 diabetes mellitus	22.65	10.98	7	64602	94	63424319
Mixed liver injury	22.65	10.98	26	64583	4709	63419704
Foetal exposure during pregnancy	22.38	10.98	3	64606	31959	63392454
Infection	22.35	10.98	139	64470	229034	63195379
Mobility decreased	22.35	10.98	57	64552	121102	63303311
Cardiospasm	21.84	10.98	17	64592	1890	63422523
Adverse event	21.60	10.98	130	64479	67429	63356984
Bladder trabeculation	21.59	10.98	6	64603	54	63424359
Pancreatic pseudocyst	21.45	10.98	11	64598	587	63423826
Embolic cerebellar infarction	21.43	10.98	5	64604	20	63424393
Abdominal pain	21.30	10.98	418	64191	293038	63131375
Dizziness	21.19	10.98	580	64029	429345	62995068
Exercise tolerance decreased	21.10	10.98	27	64582	5470	63418943
Tri-iodothyronine free decreased	21.09	10.98	9	64600	315	63424098
Palmoplantar keratoderma	21.07	10.98	17	64592	1990	63422423
Amylase increased	21.02	10.98	29	64580	6316	63418097
Metastases to lymph nodes	20.85	10.98	33	64576	8125	63416288
Intensive care unit acquired weakness	20.81	10.98	12	64597	809	63423604
Inability to afford medication	20.75	10.98	18	64591	2329	63422084
Ill-defined disorder	20.64	10.98	32	64577	81723	63342690
Rhabdomyolysis	20.56	10.98	94	64515	43857	63380556
Fear-related avoidance of activities	20.55	10.98	7	64602	130	63424283
Impaired work ability	20.52	10.98	51	64558	17424	63406989
Renal impairment	20.46	10.98	157	64452	88198	63336215
Intestinal transit time abnormal	20.19	10.98	6	64603	70	63424343
Aortic arteriosclerosis	20.01	10.98	28	64581	6181	63418232
Flatulence	19.94	10.98	79	64530	34623	63389790
Diabetic complication	19.63	10.98	12	64597	901	63423512
Abdominal pain upper	19.61	10.98	307	64302	206137	63218276
Endometrial disorder	19.26	10.98	11	64598	728	63423685
Internal haemorrhage	19.25	10.98	25	64584	5140	63419273
Vomiting	19.23	10.98	723	63886	558894	62865519
Mucosal inflammation	19.19	10.98	12	64597	46916	63377497
Blood creatinine increased	19.19	10.98	154	64455	87690	63336723
Explorative laparotomy	19.19	10.98	6	64603	84	63424329
Multiple drug therapy	19.11	10.98	21	64588	3625	63420788
Splenectomy	19.09	10.98	10	64599	558	63423855
Acidosis	19.08	10.98	38	64571	11195	63413218
Multiple sclerosis relapse	19.01	10.98	13	64596	48465	63375948
Rheumatoid arthritis	18.97	10.98	166	64443	253653	63170760
General physical health deterioration	18.94	10.98	299	64310	201103	63223310
Incisional hernia repair	18.56	10.98	4	64605	10	63424403
Adverse drug reaction	18.46	10.98	33	64576	79681	63344732
Renal failure	18.45	10.98	192	64417	117460	63306953
Hysterectomy	18.43	10.98	34	64575	9465	63414948
Blood cholesterol increased	18.32	10.98	43	64566	93989	63330424
Radioallergosorbent test positive	18.30	10.98	5	64604	42	63424371
Pancreatic cyst	17.99	10.98	14	64595	1556	63422857
Leukopenia	17.89	10.98	32	64577	77258	63347155
Cholelithiasis	17.70	10.98	90	64519	43835	63380578
Radiotherapy to pancreas	17.67	10.98	3	64606	0	63424413
Peripheral vascular disorder	17.66	10.98	26	64583	6009	63418404
Micturition disorder	17.62	10.98	17	64592	2521	63421892
Biliary obstruction	17.39	10.98	18	64591	2903	63421510
Muscle atrophy	17.36	10.98	28	64581	7005	63417408
Portal vein cavernous transformation	17.30	10.98	6	64603	118	63424295
Migraine	17.28	10.98	51	64558	103295	63321118
Sedation	17.19	10.98	9	64600	38800	63385613
Haematochezia	17.09	10.98	103	64506	53441	63370972
Sinusitis	17.04	10.98	148	64461	226505	63197908
Sleep disorder due to a general medical condition	16.96	10.98	38	64571	12150	63412263
Diabetic retinopathy	16.94	10.98	16	64593	2311	63422102
Pancreatitis necrotising	16.92	10.98	14	64595	1698	63422715
Enterococcus test positive	16.89	10.98	12	64597	1161	63423252
Increased appetite	16.87	10.98	33	64576	9597	63414816
Sleep terror	16.84	10.98	17	64592	2663	63421750
Tongue oedema	16.78	10.98	22	64587	4564	63419849
Flushing	16.57	10.98	32	64577	75055	63349358
Cholangitis	16.34	10.98	24	64585	5537	63418876
Myalgia	16.31	10.98	224	64385	146305	63278108
Carcinoid crisis	16.04	10.98	7	64602	259	63424154
Knee arthroplasty	15.92	10.98	19	64590	54187	63370226
Influenza	15.91	10.98	175	64434	108547	63315866
Urosepsis	15.72	10.98	48	64561	18476	63405937
Glycosylated haemoglobin abnormal	15.70	10.98	6	64603	157	63424256
Dysuria	15.66	10.98	72	64537	33666	63390747
Injection site reaction	15.66	10.98	22	64587	58502	63365911
Weight decreased	15.53	10.98	380	64229	276418	63147995
Mesenteric arterial occlusion	15.52	10.98	6	64603	162	63424251
Serotonin syndrome	15.37	10.98	5	64604	28677	63395736
Peripheral swelling	15.32	10.98	185	64424	265757	63158656
Product colour issue	15.07	10.98	9	64600	648	63423765
Urine albumin/creatinine ratio increased	15.04	10.98	7	64602	302	63424111
Premature delivery	15.00	10.98	6	64603	30275	63394138
Myelosuppression	14.87	10.98	3	64606	23700	63400713
Gout	14.82	10.98	38	64571	13233	63411180
Device dislocation	14.65	10.98	4	64605	25701	63398712
Rash	14.63	10.98	447	64162	560424	62863989
Red blood cell sedimentation rate increased	14.49	10.98	14	64595	43968	63380445
Vision blurred	14.40	10.98	150	64459	91774	63332639
Peripheral sensorimotor neuropathy	14.25	10.98	12	64597	1491	63422922
Vitamin B12 decreased	14.24	10.98	18	64591	3602	63420811
Infusion site scar	14.20	10.98	8	64601	516	63423897
Bile duct stone	14.10	10.98	18	64591	3638	63420775
Product size issue	14.02	10.98	7	64602	353	63424060
Pancreatic neoplasm	14.02	10.98	9	64600	737	63423676
Upper respiratory tract irritation	13.98	10.98	6	64603	213	63424200
Fatigue	13.88	10.98	751	63858	887277	62537136
Therapeutic product effect incomplete	13.71	10.98	73	64536	124983	63299430
Coma acidotic	13.68	10.98	5	64604	115	63424298
Anaemia	13.63	10.98	393	64216	293037	63131376
Glycosylated haemoglobin decreased	13.63	10.98	8	64601	558	63423855
Transient ischaemic attack	13.60	10.98	75	64534	37678	63386735
Acquired mitochondrial DNA mutation	13.52	10.98	3	64606	9	63424404
Atrial tachycardia	13.48	10.98	19	64590	4221	63420192
Influenza like illness	13.44	10.98	115	64494	66709	63357704
Blood creatine phosphokinase increased	13.44	10.98	64	64545	30366	63394047
Blood lactic acid increased	13.30	10.98	25	64584	7061	63417352
Cardiac failure	13.28	10.98	144	64465	88998	63335415
Hyperlipidaemia	13.28	10.98	47	64562	19524	63404889
Meibomianitis	13.21	10.98	4	64605	50	63424363
Foot deformity	13.03	10.98	6	64603	27847	63396566
Injection site pain	13.02	10.98	78	64531	129722	63294691
Pancreatic neuroendocrine tumour	12.83	10.98	7	64602	424	63423989
Seizure	12.64	10.98	81	64528	132553	63291860
Product monitoring error	12.56	10.98	19	64590	4497	63419916
Acute coronary syndrome	12.37	10.98	30	64579	10096	63414317
Portal fibrosis	12.31	10.98	6	64603	287	63424126
Immunisation	12.30	10.98	10	64599	1183	63423230
Renal cancer metastatic	12.25	10.98	6	64603	290	63424123
Drug ineffective for unapproved indication	12.24	10.98	10	64599	34053	63390360
Stent placement	12.20	10.98	17	64592	3738	63420675
Disease progression	12.20	10.98	74	64535	122684	63301729
Fulminant type 1 diabetes mellitus	12.19	10.98	7	64602	468	63423945
Splenic granuloma	12.15	10.98	3	64606	16	63424397
Hyperthermia	12.13	10.98	28	64581	9128	63415285
Reperfusion injury	12.13	10.98	4	64605	67	63424346
Systemic infection	12.12	10.98	19	64590	4641	63419772
Nephroangiosclerosis	12.11	10.98	5	64604	161	63424252
Cerebral reperfusion injury	12	10.98	3	64606	17	63424396
Tension headache	11.93	10.98	20	64589	5166	63419247
Oesophageal mucosal tear	11.86	10.98	3	64606	18	63424395
Gastrooesophageal reflux disease	11.80	10.98	149	64460	95490	63328923
Pancreatic atrophy	11.80	10.98	5	64604	172	63424241
Intraductal papillary mucinous neoplasm	11.79	10.98	6	64603	315	63424098
Genital infection	11.77	10.98	5	64604	173	63424240
Adrenal mass	11.77	10.98	9	64600	975	63423438
Disease recurrence	11.69	10.98	7	64602	28023	63396390
Basal cell carcinoma	11.66	10.98	7	64602	27984	63396429
Sopor	11.64	10.98	4	64605	22160	63402253
Hepatic function abnormal	11.57	10.98	71	64538	37071	63387342
Infrequent bowel movements	11.54	10.98	10	64599	1292	63423121
Pseudomonal bacteraemia	11.48	10.98	11	64598	1617	63422796
Gallbladder enlargement	11.47	10.98	8	64601	751	63423662
Pancreatic enzymes increased	11.45	10.98	8	64601	754	63423659
Hunger	11.39	10.98	20	64589	5359	63419054
Fall	11.39	10.98	498	64111	391836	63032577
Infusion site rash	11.36	10.98	12	64597	1982	63422431
Sciatica	11.22	10.98	11	64598	34313	63390100
Non-alcoholic steatohepatitis	11.18	10.98	11	64598	1670	63422743
Oral mucosal discolouration	11.13	10.98	6	64603	355	63424058
Pollakiuria	11.09	10.98	57	64552	27880	63396533
Skin turgor decreased	11.07	10.98	7	64602	558	63423855
Disability assessment scale score increased	11.05	10.98	15	64594	3218	63421195

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	634.20	10.95	516	56080	38375	34861960
Hypoglycaemia	552.74	10.95	554	56042	54086	34846249
Blood glucose increased	437.07	10.95	539	56057	66179	34834156
Pancreatic carcinoma	419.17	10.95	229	56367	8672	34891663
Diabetes mellitus inadequate control	401.84	10.95	258	56338	13206	34887129
Pancreatic carcinoma metastatic	338.32	10.95	140	56456	2800	34897535
Glycosylated haemoglobin increased	237.86	10.95	175	56421	11185	34889150
Pancreatitis acute	221.53	10.95	250	56346	27891	34872444
Lactic acidosis	188.37	10.95	256	56340	34516	34865819
Diabetic ketoacidosis	182.30	10.95	183	56413	17849	34882486
Adenocarcinoma pancreas	173.69	10.95	70	56526	1304	34899031
Pancreaticoduodenectomy	160.05	10.95	34	56562	36	34900299
Product monitoring error	145.82	10.95	90	56506	4291	34896044
Drug abuse	141.89	10.95	4	56592	99092	34801243
Off label use	135.35	10.95	300	56296	419224	34481111
Hyperglycaemia	124.84	10.95	227	56369	39253	34861082
Metastases to liver	122.46	10.95	130	56466	13533	34886802
Pemphigoid	114.44	10.95	102	56494	8564	34891771
Toxicity to various agents	114.43	10.95	94	56502	200268	34700067
Bile duct stent insertion	112.13	10.95	27	56569	70	34900265
Lipase increased	109.09	10.95	103	56493	9313	34891022
No adverse event	108.11	10.95	158	56438	22769	34877566
Pancreatectomy	103.28	10.95	21	56575	14	34900321
Ketoacidosis	99.40	10.95	70	56526	4173	34896162
General physical health deterioration	99.27	10.95	441	56155	127828	34772507
Interstitial lung disease	98.75	10.95	280	56316	65002	34835333
Radiotherapy	94.45	10.95	33	56563	405	34899930
Blood glucose abnormal	92.70	10.95	77	56519	5875	34894460
Euglycaemic diabetic ketoacidosis	82.16	10.95	56	56540	3166	34897169
Hyperkalaemia	69.87	10.95	259	56337	69130	34831205
Pancreatitis chronic	69.46	10.95	44	56552	2196	34898139
Acute kidney injury	67.93	10.95	773	55823	304215	34596120
Product use in unapproved indication	67.15	10.95	55	56541	117444	34782891
Pancreatic stent placement	60.96	10.95	12	56584	5	34900330
Hyperlipidaemia	58.41	10.95	93	56503	14436	34885899
Seronegative arthritis	58.12	10.95	30	56566	1009	34899326
Glycosylated haemoglobin abnormal	56.32	10.95	18	56578	164	34900171
Product dose omission issue	55.12	10.95	357	56239	119354	34780981
Bladder cancer	53.21	10.95	95	56501	16183	34884152
Explorative laparotomy	53.03	10.95	12	56584	21	34900314
Cerebral infarction	52.96	10.95	129	56467	27326	34873009
Blood glucose decreased	52.21	10.95	84	56512	13153	34887182
Metabolic acidosis	51.68	10.95	172	56424	43508	34856827
Renal cyst	49.28	10.95	67	56529	9026	34891309
Drug ineffective	49.22	10.95	488	56108	456263	34444072
Blood glucose fluctuation	46.39	10.95	44	56552	4000	34896335
Neutropenia	44.09	10.95	120	56476	156658	34743677
Biliary sphincterotomy	43.68	10.95	9	56587	7	34900328
Cholelithiasis	43.62	10.95	102	56494	21046	34879289
Febrile neutropenia	42.94	10.95	99	56497	136750	34763585
Dyslipidaemia	41.83	10.95	56	56540	7432	34892903
Diabetic foetopathy	41.53	10.95	15	56581	204	34900131
Prostatomegaly	41.23	10.95	47	56549	5294	34895041
Diverticulum intestinal	40.97	10.95	41	56555	3980	34896355
Amylase increased	40.23	10.95	49	56547	5919	34894416
Pancreatitis necrotising	39.49	10.95	34	56562	2724	34897611
Insulin-requiring type 2 diabetes mellitus	38.90	10.95	13	56583	138	34900197
Circumstance or information capable of leading to medication error	38.57	10.95	28	56568	1751	34898584
Product residue present	37.60	10.95	33	56563	2713	34897622
Pancreatic enzymes increased	36.98	10.95	19	56577	633	34899702
Therapeutic drug monitoring analysis not performed	36.55	10.95	18	56578	547	34899788
Cholecystectomy	36.35	10.95	33	56563	2837	34897498
Diabetic nephropathy	36.23	10.95	29	56567	2099	34898236
Mucosal inflammation	34.22	10.95	10	56586	38612	34861723
Pancreatic cyst	33.60	10.95	19	56577	769	34899566
Glycosylated haemoglobin decreased	33.26	10.95	15	56581	372	34899963
Dizziness	32.39	10.95	515	56081	218006	34682329
Splenectomy	31.59	10.95	15	56581	420	34899915
Weight decreased	31.41	10.95	429	56167	175872	34724463
Death	31.03	10.95	456	56140	397593	34502742
Thirst	30.99	10.95	50	56546	7845	34892490
Disease progression	30.90	10.95	82	56514	107995	34792340
Large for dates baby	30.90	10.95	19	56577	899	34899436
Metastases to lymph nodes	30.55	10.95	38	56558	4690	34895645
Gastrointestinal tube insertion	30.33	10.95	21	56575	1218	34899117
Wrong technique in product usage process	30.27	10.95	127	56469	35859	34864476
Diabetes mellitus	29.52	10.95	152	56444	46721	34853614
Hypoglycaemic coma	28.94	10.95	27	56569	2404	34897931
Autoimmune pancreatitis	28.84	10.95	13	56583	322	34900013
Gastroenterostomy	28.37	10.95	8	56588	45	34900290
Pancreatic disorder	27.95	10.95	23	56573	1731	34898604
Diabetic neuropathy	27.55	10.95	34	56562	4163	34896172
Pancreatic mass	26.16	10.95	17	56579	887	34899448
Renal failure	25.87	10.95	324	56272	130233	34770102
Renal impairment	25.83	10.95	250	56346	94263	34806072
Oedema peripheral	25.77	10.95	302	56294	119510	34780825
Vomiting projectile	25.57	10.95	15	56581	651	34899684
Pollakiuria	25.55	10.95	80	56516	19594	34880741
Pemphigus	25.19	10.95	21	56575	1610	34898725
Alcoholic ketoacidosis	25.07	10.95	6	56590	15	34900320
Inability to afford medication	24.96	10.95	20	56576	1450	34898885
Electrolyte imbalance	24.94	10.95	65	56531	14347	34885988
Hypomagnesaemia	24.91	10.95	85	56511	21766	34878569
Rhabdomyolysis	24.74	10.95	192	56404	67971	34832364
Pancreatic pseudocyst	24.68	10.95	16	56580	831	34899504
Gastrooesophageal reflux disease	24.59	10.95	124	56472	37800	34862535
Dysuria	24.55	10.95	98	56498	27054	34873281
Drug resistance	24.32	10.95	6	56590	25921	34874414
Polyuria	24.21	10.95	47	56549	8527	34891808
Treatment failure	24.09	10.95	24	56572	46673	34853662
Drug intolerance	24.03	10.95	37	56559	59533	34840802
Hyperlipasaemia	23.73	10.95	13	56583	494	34899841
Pyrexia	23.71	10.95	388	56208	332625	34567710
Pneumocystis jirovecii infection	23.70	10.95	21	56575	1749	34898586
Body mass index abnormal	23.03	10.95	9	56587	154	34900181
Metastases to peritoneum	22.95	10.95	21	56575	1823	34898512
Food aversion	22.89	10.95	12	56584	417	34899918
Therapeutic drug monitoring analysis incorrectly performed	22.87	10.95	11	56585	317	34900018
Seizure	22.71	10.95	90	56506	104767	34795568
Type 2 diabetes mellitus	22.51	10.95	67	56529	15965	34884370
Biliary dilatation	22.30	10.95	16	56580	982	34899353
Pyelitis	22.07	10.95	8	56588	110	34900225
Prostatic calcification	21.75	10.95	8	56588	115	34900220
Radiotherapy to pancreas	21.71	10.95	4	56592	0	34900335
Intestinal adhesion lysis	21.71	10.95	4	56592	0	34900335
Completed suicide	21.42	10.95	84	56512	98084	34802251
Angioedema	21.35	10.95	118	56478	37256	34863079
Diabetic retinopathy	21.28	10.95	20	56576	1797	34898538
Drug ineffective for unapproved indication	21.27	10.95	6	56590	23709	34876626
Adverse event	21.14	10.95	73	56523	18804	34881531
Product packaging quantity issue	21.00	10.95	15	56581	914	34899421
Cytomegalovirus infection	21.00	10.95	8	56588	26127	34874208
Pancreatolithiasis	20.97	10.95	7	56589	74	34900261
Prohormone brain natriuretic peptide increased	20.81	10.95	7	56589	76	34900259
Tonsillectomy	20.52	10.95	11	56585	400	34899935
Aortic arteriosclerosis	20.48	10.95	31	56565	4605	34895730
Lower respiratory tract infection	20.41	10.95	13	56583	31624	34868711
Musculoskeletal pain	20.36	10.95	104	56492	31859	34868476
Urine ketone body present	20.30	10.95	16	56580	1132	34899203
Haematochezia	20.30	10.95	137	56459	46397	34853938
Therapeutic product effect decreased	20.15	10.95	16	56580	34727	34865608
Vena cava filter insertion	19.99	10.95	5	56591	16	34900319
Urticaria chronic	19.81	10.95	7	56589	89	34900246
Malignant ascites	19.59	10.95	11	56585	439	34899896
Phlebolith	19.48	10.95	4	56592	3	34900332
Suicide attempt	19.17	10.95	21	56575	39095	34861240
Staphylococcal infection	19.11	10.95	15	56581	32745	34867590
Hyperlactacidaemia	19.10	10.95	24	56572	2992	34897343
Urinary hesitation	18.88	10.95	23	56573	2779	34897556
Psychotic disorder	18.80	10.95	8	56588	24444	34875891
Diverticulum	18.72	10.95	38	56558	7121	34893214
Labelled drug-drug interaction medication error	18.71	10.95	60	56536	14879	34885456
Nephropathy	18.65	10.95	34	56562	5883	34894452
Electrocardiogram abnormal	18.41	10.95	44	56552	9203	34891132
Insulin C-peptide increased	18.28	10.95	6	56590	60	34900275
Foetal exposure during pregnancy	18.07	10.95	21	56575	38080	34862255
Diabetic metabolic decompensation	17.98	10.95	18	56578	1748	34898587
Brain contusion	17.95	10.95	13	56583	810	34899525
Peripancreatic fluid collection	17.90	10.95	5	56591	27	34900308
Alopecia universalis	17.85	10.95	7	56589	121	34900214
Pancreatic carcinoma recurrent	17.85	10.95	6	56590	65	34900270
Psoriatic arthropathy	17.77	10.95	5	56591	19793	34880542
Bile duct cancer	17.69	10.95	12	56584	673	34899662
Pseudohyponatraemia	17.60	10.95	6	56590	68	34900267
Intentional product use issue	17.38	10.95	45	56551	59771	34840564
Pancreatic duct dilatation	17.37	10.95	6	56590	71	34900264
Suicidal ideation	17.35	10.95	24	56572	40364	34859971
Neurotoxicity	17.22	10.95	4	56592	18006	34882329
Metastases to lung	17.13	10.95	43	56553	9277	34891058
Knee operation	17.12	10.95	19	56577	2078	34898257
Pancreatic neoplasm	16.81	10.95	13	56583	895	34899440
Vitamin B1 decreased	16.75	10.95	9	56587	329	34900006
Vitamin B1 deficiency	16.72	10.95	9	56587	330	34900005
Pneumobilia	16.45	10.95	6	56590	84	34900251
Hypoxia	16.35	10.95	41	56555	55054	34845281
Ductal adenocarcinoma of pancreas	16.33	10.95	5	56591	39	34900296
Bile duct adenocarcinoma	16.28	10.95	3	56593	0	34900335
Biliary neoplasm	16.28	10.95	3	56593	0	34900335
Duodenal sphincterotomy	16.28	10.95	3	56593	0	34900335
Biopsy pancreas	16.28	10.95	3	56593	0	34900335
Choledochoenterostomy	16.28	10.95	3	56593	0	34900335
Pancreatic sphincterotomy	16.28	10.95	3	56593	0	34900335
Splenic vein occlusion	16.28	10.95	3	56593	0	34900335
Infusion related reaction	16.12	10.95	39	56557	53018	34847317
Colon cancer	16.08	10.95	40	56556	8581	34891754
Coma	16.02	10.95	31	56565	45647	34854688
Genital swelling	16.01	10.95	7	56589	161	34900174
Blood triglycerides abnormal	15.89	10.95	8	56588	255	34900080
COVID-19	15.88	10.95	68	56528	77482	34822853
Thrombocytopenia	15.86	10.95	169	56427	156078	34744257
Cardiac failure	15.79	10.95	221	56375	91027	34809308
Sprue-like enteropathy	15.71	10.95	10	56586	503	34899832
Hypercapnic coma	15.66	10.95	7	56589	170	34900165
Product prescribing error	15.59	10.95	76	56520	22851	34877484
Eczema asteatotic	15.53	10.95	8	56588	268	34900067
Urogenital infection fungal	15.50	10.95	4	56592	15	34900320
Dependence on respirator	15.50	10.95	6	56590	100	34900235
Bile duct stenosis	15.48	10.95	14	56582	1197	34899138
Groin abscess	15.45	10.95	11	56585	667	34899668
Oscillopsia	15.32	10.95	5	56591	49	34900286
Amaurosis	15.25	10.95	11	56585	681	34899654
Gastrointestinal mucosal necrosis	15.11	10.95	7	56589	185	34900150
Large intestine polyp	15.06	10.95	37	56559	7877	34892458
Nephroangiosclerosis	14.97	10.95	7	56589	189	34900146
Respiratory arrest	14.94	10.95	14	56582	28029	34872306
Romberg test positive	14.89	10.95	5	56591	54	34900281
Nephrolithiasis	14.88	10.95	92	56504	30241	34870094
Osteonecrosis	14.86	10.95	3	56593	14887	34885448
Blood creatinine increased	14.85	10.95	226	56370	94750	34805585
Palindromic rheumatism	14.77	10.95	7	56589	195	34900140
Asthma-chronic obstructive pulmonary disease overlap syndrome	14.75	10.95	14	56582	1273	34899062
Spinal osteoarthritis	14.70	10.95	36	56560	7647	34892688
Nephrogenic anaemia	14.65	10.95	18	56578	2193	34898142
Anaemia	14.56	10.95	487	56109	232848	34667487
Stent placement	14.54	10.95	28	56568	5050	34895285
Biliary obstruction	14.53	10.95	20	56576	2725	34897610
Unresponsive to stimuli	14.41	10.95	14	56582	27555	34872780
Unevaluable event	14.37	10.95	19	56577	32571	34867764
Thyroid neoplasm	14.30	10.95	9	56587	444	34899891
Renal mass	14.13	10.95	16	56580	1788	34898547
Bile duct stone	13.98	10.95	19	56577	2558	34897777
Umbilical hernia repair	13.97	10.95	4	56592	24	34900311
Thrombosis	13.87	10.95	39	56557	50419	34849916
Subdural hygroma	13.75	10.95	8	56588	342	34899993
Bladder irrigation	13.65	10.95	5	56591	71	34900264
Weight increased	13.64	10.95	219	56377	92814	34807521
Hypercholesterolaemia	13.63	10.95	38	56558	8724	34891611
Drug eruption	13.56	10.95	66	56530	19832	34880503
Oedematous pancreatitis	13.54	10.95	9	56587	488	34899847
Dehydration	13.50	10.95	290	56306	129679	34770656
Intentional product misuse	13.49	10.95	34	56562	45577	34854758
Pancreatic fistula	13.40	10.95	5	56591	75	34900260
Hallucination	13.29	10.95	41	56555	51457	34848878
Generalised tonic-clonic seizure	13.25	10.95	9	56587	21165	34879170
Encephalopathy	13.25	10.95	23	56573	35296	34865039
Agitation	13.24	10.95	48	56548	57351	34842984
Aggression	13.18	10.95	27	56569	38937	34861398
Genital lesion	13.15	10.95	7	56589	251	34900084
Thrombotic cerebral infarction	13.14	10.95	8	56588	372	34899963
Sedation	13.05	10.95	9	56587	20997	34879338
Pulmonary mass	13.02	10.95	48	56548	12764	34887571
Fracture	13.01	10.95	32	56564	6817	34893518
Gallbladder disorder	12.89	10.95	31	56565	6511	34893824
Adrenal mass	12.86	10.95	10	56586	694	34899641
Superinfection	12.80	10.95	18	56578	2501	34897834
Toe amputation	12.78	10.95	18	56578	2506	34897829
Dementia	12.73	10.95	50	56546	13698	34886637
Acute respiratory distress syndrome	12.66	10.95	14	56582	25955	34874380
Procedural headache	12.56	10.95	4	56592	36	34900299
Heart rate decreased	12.53	10.95	20	56576	31725	34868610
Abdominal pain	12.47	10.95	350	56246	163268	34737067
Pseudocyst	12.44	10.95	6	56590	174	34900161
Retinopathy	12.40	10.95	16	56580	2048	34898287
Intraductal papillary-mucinous carcinoma of pancreas	12.40	10.95	3	56593	8	34900327
Campylobacter infection	12.39	10.95	11	56585	918	34899417
Cyst removal	12.37	10.95	4	56592	38	34900297
Arthroscopy	12.27	10.95	5	56591	96	34900239
Renal stone removal	12.10	10.95	4	56592	41	34900294
Bladder transitional cell carcinoma	12.08	10.95	18	56578	2637	34897698
Blood ketone body increased	12.01	10.95	8	56588	435	34899900
Gastrostomy	11.98	10.95	10	56586	768	34899567
Accidental exposure to product	11.93	10.95	3	56593	12799	34887536
Malignant neoplasm of ampulla of Vater	11.90	10.95	3	56593	10	34900325
Duodenitis	11.89	10.95	25	56571	4803	34895532
Hepatic steatosis	11.87	10.95	60	56536	18302	34882033
Pneumonitis	11.87	10.95	23	56573	33855	34866480
Anion gap increased	11.87	10.95	15	56581	1881	34898454
Ketonuria	11.86	10.95	9	56587	602	34899733
Toxic skin eruption	11.86	10.95	43	56553	11342	34888993
Synovitis	11.82	10.95	4	56592	14062	34886273
Nodular rash	11.81	10.95	5	56591	106	34900229
Cervicobrachial syndrome	11.64	10.95	7	56589	318	34900017
Injection site nodule	11.64	10.95	14	56582	1669	34898666
Metastases to spleen	11.60	10.95	8	56588	461	34899874
Arthropathy	11.54	10.95	16	56580	26891	34873444
Alanine aminotransferase increased	11.51	10.95	80	56516	80735	34819600
Hypoglycaemic seizure	11.45	10.95	7	56589	328	34900007
Proteinuria	11.42	10.95	60	56536	18582	34881753
Flushing	11.37	10.95	22	56574	32398	34867937
Pain	11.27	10.95	249	56347	204426	34695909
Abdominal hernia repair	11.24	10.95	4	56592	52	34900283
Nasal neoplasm	11.24	10.95	5	56591	120	34900215
Loss of personal independence in daily activities	11.22	10.95	23	56573	33156	34867179
Post streptococcal glomerulonephritis	11.16	10.95	5	56591	122	34900213
High density lipoprotein abnormal	11.10	10.95	4	56592	54	34900281

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
Hypoglycaemia	998.04	10.32	885	94342	100709	79548452
Blood glucose increased	893.18	10.32	879	94348	114096	79535065
Diabetes mellitus inadequate control	682.34	10.32	401	94826	23863	79625298
Pancreatitis	650.45	10.32	586	94641	67989	79581172
Lactic acidosis	522.03	10.32	525	94702	69834	79579327
Diabetic ketoacidosis	418.31	10.32	338	94889	33784	79615377
Glycosylated haemoglobin increased	381.76	10.32	255	94972	19005	79630156
Pancreatic carcinoma	364.94	10.32	218	95009	13359	79635802
Pancreatitis acute	322.57	10.32	345	94882	49259	79599902
Carotid artery thrombosis	317.04	10.32	124	95103	2929	79646232
Pemphigoid	311.33	10.32	206	95021	15109	79634052
Neurologic neglect syndrome	305.16	10.32	119	95108	2788	79646373
Acute kidney injury	285.44	10.32	1301	93926	518103	79131058
Personality disorder	268.47	10.32	136	95091	6010	79643151
Hyperglycaemia	263.06	10.32	370	94857	69965	79579196
Adjustment disorder	246.17	10.32	112	95115	3888	79645273
Hemiplegia	222.23	10.32	166	95061	14773	79634388
Euglycaemic diabetic ketoacidosis	210.64	10.32	120	95107	6724	79642437
Ketoacidosis	208.18	10.32	125	95102	7729	79641432
Off label use	197.00	10.32	502	94725	906713	78742448
Affect lability	192.24	10.32	136	95091	11123	79638038
Lipase increased	186.86	10.32	156	95071	16310	79632851
Hyperkalaemia	182.03	10.32	414	94813	113984	79535177
Blood glucose abnormal	176.64	10.32	126	95101	10440	79638721
General physical health deterioration	165.51	10.32	709	94518	274529	79374632
Product monitoring error	155.35	10.32	109	95118	8797	79640364
Sensory loss	147.24	10.32	123	95104	12868	79636293
Motor dysfunction	145.66	10.32	129	95098	14604	79634557
Drug intolerance	143.39	10.32	68	95159	264051	79385110
Synovitis	141.25	10.32	10	95217	150724	79498437
Drug ineffective	137.90	10.32	745	94482	1080168	78568993
Drug abuse	136.03	10.32	17	95210	162674	79486487
Coordination abnormal	135.32	10.32	133	95094	17179	79631982
Systemic lupus erythematosus	126.42	10.32	4	95223	121145	79528016
Toxicity to various agents	125.87	10.32	193	95034	421347	79227814
Interstitial lung disease	122.43	10.32	353	94874	112247	79536914
Muscle spasticity	121.64	10.32	139	95088	21336	79627825
Metabolic acidosis	120.66	10.32	289	94938	82240	79566921
Therapeutic product effect decreased	117.35	10.32	26	95201	163837	79485324
Blood glucose decreased	111.65	10.32	147	95080	26087	79623074
Treatment failure	108.89	10.32	34	95193	170452	79478709
Product residue present	108.82	10.32	62	95165	3474	79645687
Lung diffusion test abnormal	108.07	10.32	33	95194	357	79648804
Eating disorder	107.28	10.32	128	95099	20569	79628592
Arthropathy	101.75	10.32	42	95185	177069	79472092
Product use in unapproved indication	101.15	10.32	90	95137	250269	79398892
Hemiparesis	98.29	10.32	158	95069	33575	79615586
Cerebral infarction	98.04	10.32	187	95040	45489	79603672
Maternal exposure during pregnancy	93.17	10.32	24	95203	136514	79512647
Hypoglycaemic coma	91.85	10.32	62	95165	4698	79644463
Glossodynia	90.91	10.32	9	95218	103328	79545833
Infusion related reaction	89.18	10.32	86	95141	230151	79419010
Aphasia	85.51	10.32	179	95048	46553	79602608
Product use issue	84.06	10.32	76	95151	209746	79439415
Gangrene	77.87	10.32	73	95154	8891	79640270
Joint swelling	75.21	10.32	144	95083	288502	79360659
Contraindicated product administered	74.66	10.32	48	95179	157490	79491671
Seronegative arthritis	69.47	10.32	52	95175	4640	79644521
Blood glucose fluctuation	69.04	10.32	60	95167	6622	79642539
Muscular weakness	68.28	10.32	375	94852	160354	79488807
Lower respiratory tract infection	65.99	10.32	36	95191	129184	79519977
Hypersensitivity	64.73	10.32	135	95092	262104	79387057
Hand deformity	64.09	10.32	22	95205	103897	79545264
Pemphigus	61.56	10.32	21	95206	99561	79549600
Dysarthria	61.31	10.32	199	95028	67423	79581738
Bladder cancer	60.39	10.32	94	95133	19432	79629729
Duodenal ulcer perforation	60.29	10.32	5	95222	66206	79582955
Dysphagia	60.18	10.32	297	94930	121839	79527322
Diabetes mellitus	59.14	10.32	217	95010	78173	79570988
Sinus congestion	59.07	10.32	94	95133	19802	79629359
Arterial occlusive disease	58.82	10.32	61	95166	8395	79640766
Skin haemorrhage	58.67	10.32	72	95155	11909	79637252
Pain	55.57	10.32	555	94672	703247	78945914
Rhabdomyolysis	55.31	10.32	257	94970	102874	79546287
Exposure during pregnancy	54.88	10.32	26	95201	101106	79548055
Amylase increased	54.31	10.32	67	95160	11142	79638019
Musculoskeletal stiffness	53.22	10.32	79	95148	174929	79474232
Sneezing	53.03	10.32	89	95138	19594	79629567
Glycosylated haemoglobin abnormal	52.84	10.32	17	95210	221	79648940
Pancreatitis necrotising	52.77	10.32	41	95186	3867	79645294
Neutropenia	52.03	10.32	173	95054	287537	79361624
Urine ketone body present	51.65	10.32	39	95188	3526	79645635
Drug hypersensitivity	51.18	10.32	184	95043	298732	79350429
Haematochezia	50.42	10.32	223	95004	87422	79561739
Product prescribing error	50.13	10.32	142	95085	44671	79604490
Cerebrovascular accident	49.27	10.32	336	94891	154956	79494205
Psoriatic arthropathy	48.99	10.32	16	95211	77983	79571178
Dizziness	48.77	10.32	891	94336	525550	79123611
Renal impairment	48.65	10.32	339	94888	157444	79491717
Mucosal inflammation	48.37	10.32	15	95212	75565	79573596
Wrong technique in product usage process	47.95	10.32	195	95032	73680	79575481
Eosinophilic myocarditis	47.49	10.32	25	95202	1197	79647964
Febrile neutropenia	47.41	10.32	131	95096	230868	79418293
Alopecia	46.89	10.32	132	95095	231223	79417938
Renal failure	46.54	10.32	404	94823	200564	79448597
Helicobacter infection	46.13	10.32	13	95214	69691	79579470
Folliculitis	45.75	10.32	6	95221	55374	79593787
Completed suicide	45.66	10.32	146	95081	245621	79403540
Swelling	44.39	10.32	123	95104	216588	79432573
Dehydration	43.72	10.32	471	94756	247716	79401445
Diabetic metabolic decompensation	42.93	10.32	34	95193	3298	79645863
Oedema peripheral	42.70	10.32	475	94752	251813	79397348
MELAS syndrome	42.70	10.32	14	95213	194	79648967
Temperature perception test abnormal	42.41	10.32	9	95218	16	79649145
Irritable bowel syndrome	42.33	10.32	11	95216	62230	79586931
Hypoglycaemic encephalopathy	42.23	10.32	19	95208	642	79648519
Dysuria	41.80	10.32	145	95082	50806	79598355
Cardiac failure	41.07	10.32	321	94906	154521	79494640
Sinus disorder	41.03	10.32	86	95141	22378	79626783
Wound	40.91	10.32	47	95180	116132	79533029
C-reactive protein abnormal	40.54	10.32	5	95222	48362	79600799
Adenocarcinoma pancreas	40.47	10.32	27	95200	2006	79647155
Pericarditis	40.25	10.32	39	95188	104197	79544964
No adverse event	39.81	10.32	116	95111	37076	79612085
Pancreatic carcinoma metastatic	39.38	10.32	34	95193	3719	79645442
Discomfort	38.87	10.32	56	95171	125561	79523600
Stomatitis	38.38	10.32	73	95154	146684	79502477
Rhinorrhoea	38.18	10.32	186	95041	75888	79573273
Product dose omission issue	37.84	10.32	457	94770	247080	79402081
Fibromyalgia	37.35	10.32	15	95212	64325	79584836
Injury	36.18	10.32	24	95203	77472	79571689
Pollakiuria	35.81	10.32	112	95115	37205	79611956
Pancreatitis chronic	35.43	10.32	33	95194	3986	79645175
Respiratory tract congestion	34.84	10.32	75	95152	19879	79629282
Injection site erythema	34.16	10.32	26	95201	78171	79570990
Angioedema	34.02	10.32	180	95047	75855	79573306
Intentional product use issue	33.69	10.32	83	95144	152029	79497132
Thirst	33.68	10.32	71	95156	18548	79630613
Genital infection female	32.58	10.32	9	95218	66	79649095
Diarrhoea	32.55	10.32	1322	93905	879167	78769994
Serotonin syndrome	32.51	10.32	7	95220	45020	79604141
Therapeutic drug monitoring analysis not performed	32.16	10.32	23	95204	1913	79647248
Weight decreased	32.07	10.32	599	94628	354599	79294562
Hepatic function abnormal	31.98	10.32	172	95055	72935	79576226
Dyslipidaemia	31.87	10.32	53	95174	11580	79637581
Anaemia	31.82	10.32	725	94502	444290	79204871
Pancreatic enzymes increased	31.78	10.32	20	95207	1345	79647816
Polyuria	31.63	10.32	61	95166	14953	79634208
Hepatic enzyme increased	30.84	10.32	113	95114	182497	79466664
Arthralgia	30.42	10.32	490	94737	571313	79077848
Autoimmune pancreatitis	29.77	10.32	15	95212	655	79648506
Pancreatic mass	29.68	10.32	20	95207	1511	79647650
Impaired healing	29.22	10.32	37	95190	87618	79561543
Nephroangiosclerosis	28.74	10.32	12	95215	337	79648824
Therapy non-responder	28.70	10.32	41	95186	92264	79556897
Altered state of consciousness	28.69	10.32	116	95111	43706	79605455
Sedation	28.68	10.32	13	95214	51882	79597279
Angina pectoris	28.52	10.32	130	95097	51602	79597559
Labelled drug-drug interaction medication error	28.41	10.32	85	95142	27565	79621596
Diabetic retinopathy	28.34	10.32	26	95201	3080	79646081
Blood cholesterol increased	28.26	10.32	35	95192	83685	79565476
Hyperlipasaemia	28.26	10.32	18	95209	1236	79647925
Gastric disorder	27.70	10.32	103	95124	37330	79611831
Mobility decreased	27.58	10.32	66	95161	122109	79527052
Alcoholic ketoacidosis	26.89	10.32	6	95221	15	79649146
Asthenia	26.79	10.32	800	94427	510889	79138272
Abdominal pain	26.70	10.32	631	94596	388938	79260223
Flushing	26.67	10.32	40	95187	88228	79560933
Pancreatic pseudocyst	26.49	10.32	18	95209	1379	79647782
Red blood cell sedimentation rate increased	26.20	10.32	11	95216	45931	79603230
Drug ineffective for unapproved indication	25.11	10.32	15	95212	51223	79597938
Electrocardiogram abnormal	24.86	10.32	59	95168	16678	79632483
Hyperlactacidaemia	24.81	10.32	32	95195	5563	79643598
Electrolyte imbalance	24.57	10.32	87	95140	30794	79618367
Pancreatic disorder	24.49	10.32	25	95202	3377	79645784
Micturition disorder	24.39	10.32	27	95200	4001	79645160
Drug resistance	24.24	10.32	10	95217	42203	79606958
Fall	24.08	10.32	757	94470	486872	79162289
Diabetic nephropathy	23.70	10.32	23	95204	2924	79646237
Small fibre neuropathy	23.60	10.32	12	95215	534	79648627
Neurotoxicity	23.59	10.32	5	95222	32513	79616648
Glycosylated haemoglobin decreased	23.48	10.32	13	95214	689	79648472
Blood creatinine increased	23.12	10.32	285	94942	154772	79494389
Respiratory depression	22.81	10.32	3	95224	27627	79621534
Prevertebral soft tissue swelling of cervical space	22.76	10.32	6	95221	36	79649125
Tubulointerstitial nephritis and uveitis syndrome	22.59	10.32	10	95217	325	79648836
Acetonaemia	22.39	10.32	10	95217	332	79648829
Blood pressure inadequately controlled	22.34	10.32	32	95195	6145	79643016
Infection	22.31	10.32	183	95044	241529	79407632
Osteonecrosis	22.11	10.32	5	95222	31090	79618071
Body mass index abnormal	21.95	10.32	9	95218	241	79648920
Depression	21.94	10.32	160	95067	216630	79432531
Glomerular filtration rate decreased	21.65	10.32	68	95159	22634	79626527
Hip arthroplasty	21.31	10.32	8	95219	35748	79613413
Adverse drug reaction	21.13	10.32	29	95198	66363	79582798
Flatulence	21.10	10.32	104	95123	42620	79606541
Full blood count abnormal	21.05	10.32	100	95127	40374	79608787
Vomiting	21.04	10.32	984	94243	664844	78984317
Fear-related avoidance of activities	21.03	10.32	7	95220	102	79649059
Multiple sclerosis relapse	20.93	10.32	15	95212	46518	79602643
Food aversion	20.88	10.32	14	95213	1049	79648112
Diabetic neuropathy	20.74	10.32	31	95196	6185	79642976
Embolic cerebellar infarction	20.63	10.32	5	95222	20	79649141
Bursitis infective	20.54	10.32	15	95212	1289	79647872
Urosepsis	20.52	10.32	74	95153	26421	79622740
Renal disorder	20.45	10.32	102	95125	42003	79607158
Pneumocystis jirovecii infection	20.35	10.32	21	95206	2873	79646288
Bladder trabeculation	20.26	10.32	6	95221	58	79649103
Disease progression	20.17	10.32	133	95094	184229	79464932
Bladder transitional cell carcinoma	20.04	10.32	20	95207	2630	79646531
Insulin C-peptide increased	20.03	10.32	7	95220	119	79649042
Migraine	19.95	10.32	47	95180	87446	79561715
Systemic infection	19.79	10.32	39	95188	9713	79639448
Cystitis	19.73	10.32	119	95108	52613	79596548
Basal cell carcinoma	19.68	10.32	10	95217	37365	79611796
Haemoglobin increased	19.63	10.32	30	95197	6102	79643059
Endometrial disorder	19.47	10.32	11	95216	606	79648555
Exercise tolerance decreased	19.29	10.32	37	95190	9034	79640127
Intestinal transit time abnormal	19.24	10.32	6	95221	70	79649091
Posterior reversible encephalopathy syndrome	19.15	10.32	4	95223	26277	79622884
Abdominal pain upper	18.99	10.32	374	94853	223445	79425716
Gamma-glutamyltransferase increased	18.95	10.32	121	95106	54559	79594602
Cytomegalovirus infection	18.85	10.32	14	95213	42630	79606531
Bile duct stone	18.83	10.32	28	95199	5561	79643600
Skin exfoliation	18.53	10.32	121	95106	54979	79594182
Anuria	18.37	10.32	61	95166	20902	79628259
Tri-iodothyronine free decreased	18.34	10.32	9	95218	371	79648790
Colon cancer	18.21	10.32	48	95179	14475	79634686
Groin abscess	18.20	10.32	15	95212	1540	79647621
Therapeutic drug monitoring analysis incorrectly performed	17.96	10.32	11	95216	705	79648456
Seizure	17.86	10.32	142	95085	188692	79460469
Upper gastrointestinal haemorrhage	17.85	10.32	97	95130	41283	79607878
Psychotic disorder	17.78	10.32	14	95213	41388	79607773
Vitamin B1 decreased	17.67	10.32	10	95217	553	79648608
Brain contusion	17.67	10.32	14	95213	1359	79647802
Radioallergosorbent test positive	17.61	10.32	5	95222	41	79649120
Injection site reaction	17.36	10.32	24	95203	54761	79594400
Carcinoid tumour of the pancreas	17.20	10.32	3	95224	0	79649161
Hypokinesia	17.18	10.32	56	95171	19004	79630157
Sinusitis	17.14	10.32	150	95077	195351	79453810
Hypomagnesaemia	17	10.32	105	95122	46806	79602355
Knee arthroplasty	16.90	10.32	16	95211	43232	79605929
Acidosis	16.87	10.32	57	95170	19705	79629456
Wrong patient received product	16.81	10.32	24	95203	4594	79644567
Sleep disorder due to a general medical condition	16.71	10.32	46	95181	14231	79634930
Injection site pain	16.67	10.32	89	95138	129749	79519412
Nausea	16.60	10.32	1342	93885	955854	78693307
Multiple congenital abnormalities	16.60	10.32	6	95221	113	79649048
Inflammation	16.49	10.32	57	95170	93696	79555465
Joint noise	16.49	10.32	22	95205	3952	79645209
Encephalopathy	16.35	10.32	35	95192	67362	79581799
Generalised tonic-clonic seizure	16.29	10.32	17	95210	43893	79605268
Pyelitis	16.19	10.32	8	95219	335	79648826
Fracture	16.14	10.32	60	95167	21741	79627420
Urogenital infection fungal	16.13	10.32	4	95223	18	79649143
Testicular swelling	16.09	10.32	13	95214	1297	79647864
Portal vein cavernous transformation	16.08	10.32	6	95221	124	79649037
Tubulointerstitial nephritis	16.07	10.32	89	95138	38146	79611015
Anion gap increased	16.06	10.32	21	95206	3699	79645462
Peripheral artery haematoma	16.04	10.32	6	95221	125	79649036
Gastrointestinal mucosal necrosis	15.94	10.32	7	95220	223	79648938
Blister	15.84	10.32	81	95146	119395	79529766
Pseudohyponatraemia	15.78	10.32	6	95221	131	79649030
Hepatotoxicity	15.78	10.32	23	95204	51329	79597832
Infusion site scar	15.76	10.32	8	95219	355	79648806
Bladder irrigation	15.61	10.32	5	95222	64	79649097
Cerebral haemorrhage	15.52	10.32	120	95107	57553	79591608
Melaena	15.45	10.32	125	95102	60765	79588396
Increased appetite	15.44	10.32	40	95187	11938	79637223
Myocardial infarction	15.39	10.32	307	94920	183822	79465339
Intensive care unit acquired weakness	15.38	10.32	15	95212	1918	79647243
Blood ketone body increased	15.37	10.32	10	95217	712	79648449
Acute myocardial infarction	15.35	10.32	150	95077	76886	79572275
Hepatic steatosis	15.30	10.32	87	95140	37651	79611510
Palpitations	15.27	10.32	224	95003	126386	79522775
Impaired work ability	15.27	10.32	55	95172	19626	79629535
Gastric cancer	15.25	10.32	36	95191	10143	79639018
Device dislocation	15.16	10.32	6	95221	25964	79623197
Paraesthesia	15.14	10.32	136	95091	176187	79472974
Hypoglycaemic unconsciousness	15.09	10.32	12	95215	1171	79647990
Therapeutic product effect incomplete	15.08	10.32	103	95124	141542	79507619
Amaurosis	15.02	10.32	12	95215	1179	79647982
Wound infection	14.92	10.32	5	95222	23986	79625175
Thrombotic cerebral infarction	14.89	10.32	9	95218	563	79648598
Urine albumin/creatinine ratio increased	14.88	10.32	9	95218	564	79648597
Ketonuria	14.87	10.32	12	95215	1196	79647965
Diabetic foetopathy	14.77	10.32	4	95223	27	79649134
Pancreatectomy	14.77	10.32	4	95223	27	79649134
Anaemia vitamin B12 deficiency	14.58	10.32	10	95217	778	79648383
Proteinuria	14.57	10.32	77	95150	32425	79616736
Multiple drug therapy	14.56	10.32	21	95206	4057	79645104
Ill-defined disorder	14.53	10.32	36	95191	65839	79583322
Prohormone brain natriuretic peptide increased	14.53	10.32	7	95220	277	79648884
Pancreaticoduodenectomy	14.52	10.32	4	95223	29	79649132
Cataract	14.42	10.32	125	95102	61995	79587166
Procedural headache	14.32	10.32	6	95221	170	79648991
Alopecia universalis	14.21	10.32	7	95220	291	79648870
Suicide attempt	14.20	10.32	51	95176	82881	79566280
Pain of skin	14.15	10.32	44	95183	14569	79634592
Dystonia	14.14	10.32	4	95223	21395	79627766
Nephropathy	14.11	10.32	34	95193	9704	79639457
Internal haemorrhage	14.06	10.32	32	95195	8801	79640360
Condition aggravated	14.02	10.32	474	94753	500650	79148511
Campylobacter infection	13.98	10.32	14	95213	1849	79647312
Tongue oedema	13.89	10.32	28	95199	7089	79642072
Urinary hesitation	13.84	10.32	21	95206	4245	79644916
Mixed liver injury	13.83	10.32	29	95198	7549	79641612
Nephrogenic anaemia	13.80	10.32	20	95207	3882	79645279
Toxic skin eruption	13.79	10.32	58	95169	22235	79626926
Toe amputation	13.76	10.32	20	95207	3891	79645270
Product packaging quantity issue	13.71	10.32	12	95215	1337	79647824
Blood ketone body present	13.70	10.32	5	95222	97	79649064
Pulmonary tumour thrombotic microangiopathy	13.70	10.32	5	95222	97	79649064
Peripheral swelling	13.65	10.32	233	94994	269384	79379777
Thrombosis	13.57	10.32	53	95174	84047	79565114
Lymphopenia	13.55	10.32	10	95217	30547	79618614
Decreased vibratory sense	13.55	10.32	9	95218	664	79648497
Body temperature increased	13.54	10.32	20	95207	44400	79604761
Psoriasis	13.49	10.32	165	95062	89422	79559739
Blood calcium decreased	13.37	10.32	11	95216	31808	79617353
Foot deformity	13.35	10.32	6	95221	24068	79625093
Vitamin B1 deficiency	13.25	10.32	9	95218	689	79648472
Subdural hygroma	13.23	10.32	8	95219	501	79648660
Pseudocyst	13.18	10.32	7	95220	341	79648820
Sopor	13.15	10.32	12	95215	32998	79616163
Prerenal failure	13.14	10.32	19	95208	3679	79645482
Impaired insulin secretion	13.12	10.32	4	95223	43	79649118
Oedematous pancreatitis	13.11	10.32	11	95216	1157	79648004
Acquired mitochondrial DNA mutation	13.05	10.32	3	95224	9	79649152
Hyperthermia	12.82	10.32	49	95178	17988	79631173
Vaginal haemorrhage	12.80	10.32	5	95222	21812	79627349
Loss of personal independence in daily activities	12.79	10.32	71	95156	102509	79546652
Premature delivery	12.78	10.32	6	95221	23461	79625700
Testicular pain	12.78	10.32	14	95213	2051	79647110
Cholelithiasis	12.77	10.32	107	95120	52557	79596604
Pneumocystis jirovecii pneumonia	12.74	10.32	12	95215	32496	79616665
Fulminant type 1 diabetes mellitus	12.73	10.32	12	95215	1471	79647690
Drug eruption	12.71	10.32	93	95134	43842	79605319
Death	12.52	10.32	551	94676	565963	79083198
Vomiting projectile	12.48	10.32	13	95214	1798	79647363
Post streptococcal glomerulonephritis	12.48	10.32	5	95222	126	79649035
Incorrect route of product administration	12.43	10.32	14	95213	34915	79614246
Pulmonary haematoma	12.41	10.32	5	95222	128	79649033
Vitamin B12 deficiency	12.39	10.32	27	95200	7214	79641947
Coma acidotic	12.33	10.32	5	95222	130	79649031
Decreased appetite	12.31	10.32	513	94714	341905	79307256
Embolic cerebral infarction	12.31	10.32	11	95216	1260	79647901
Abdominal discomfort	12.27	10.32	218	95009	250509	79398652
Type 2 diabetes mellitus	12.26	10.32	113	95114	57009	79592152
Bile duct cancer	12.24	10.32	10	95217	1014	79648147
Mesenteric arterial occlusion	12.23	10.32	6	95221	247	79648914
Emotional distress	12.18	10.32	18	95209	39951	79609210
Transplant rejection	12.18	10.32	4	95223	19433	79629728
Neuropathy peripheral	12.12	10.32	109	95118	141196	79507965
Nephrotic syndrome	12.10	10.32	35	95192	11139	79638022
Upper respiratory tract irritation	12.01	10.32	6	95221	257	79648904
Blood lactic acid increased	11.99	10.32	38	95189	12706	79636455
Haemorrhage subcutaneous	11.97	10.32	21	95206	4788	79644373
Therapy partial responder	11.97	10.32	3	95224	17394	79631767
Urticaria chronic	11.95	10.32	8	95219	598	79648563
Device related infection	11.93	10.32	14	95213	34280	79614881
Agitation	11.90	10.32	70	95157	99645	79549516
Hypercapnic coma	11.89	10.32	7	95220	417	79648744
Unevaluable event	11.78	10.32	31	95196	55554	79593607
Leukopenia	11.78	10.32	86	95141	116427	79532734
Erythema multiforme	11.77	10.32	47	95180	17604	79631557
Palindromic rheumatism	11.71	10.32	7	95220	429	79648732
Oesophageal mucosal tear	11.68	10.32	3	95224	16	79649145
Multiple sclerosis	11.67	10.32	6	95221	22276	79626885
Photophobia	11.57	10.32	5	95222	20523	79628638
Brain oedema	11.55	10.32	8	95219	25255	79623906
Hypoxia	11.53	10.32	74	95153	103169	79545992
Disease recurrence	11.47	10.32	22	95205	44087	79605074
Exostosis	11.42	10.32	3	95224	16855	79632306
Sleep disorder	11.40	10.32	58	95169	85619	79563542
Chronic kidney disease	11.37	10.32	125	95102	66029	79583132
Haemophagocytic lymphohistiocytosis	11.26	10.32	6	95221	21831	79627330
Cervicobrachial syndrome	11.26	10.32	10	95217	1136	79648025
Blood testosterone decreased	11.18	10.32	14	95213	2363	79646798
Magnetic resonance imaging head abnormal	11.17	10.32	15	95212	2711	79646450
Pancreatic neuroendocrine tumour	11.17	10.32	8	95219	667	79648494
Joint range of motion decreased	11.14	10.32	14	95213	33268	79615893
Inability to afford medication	10.97	10.32	15	95212	2758	79646403
Blood triglycerides abnormal	10.92	10.32	7	95220	486	79648675
Meibomianitis	10.84	10.32	4	95223	80	79649081
Genital swelling	10.73	10.32	6	95221	324	79648837
Myalgia	10.72	10.32	294	94933	185347	79463814
Jaundice	10.69	10.32	104	95123	53245	79595916
Bone erosion	10.62	10.32	4	95223	17843	79631318
Putamen haemorrhage	10.62	10.32	7	95220	510	79648651
Polydipsia	10.60	10.32	24	95203	6581	79642580
Renal cancer metastatic	10.60	10.32	8	95219	723	79648438
Myelosuppression	10.57	10.32	20	95207	40276	79608885
Suicidal ideation	10.55	10.32	51	95176	76289	79572872
Carcinoid crisis	10.54	10.32	7	95220	516	79648645
Blood creatine phosphokinase increased	10.51	10.32	123	95104	65967	79583194
Genital infection	10.49	10.32	5	95222	193	79648968
Pruritus genital	10.41	10.32	19	95208	4467	79644694
Oral candidiasis	10.41	10.32	12	95215	29616	79619545
Miosis	10.34	10.32	3	95224	15786	79633375
Community acquired infection	10.32	10.32	3	95224	27	79649134

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	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	MSD SUB MERCK	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	MSD SUB MERCK	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	MSD SUB MERCK	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	MSD SUB MERCK	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	MSD SUB MERCK	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	MSD SUB MERCK	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	MSD SUB MERCK	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	MSD SUB MERCK	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	MSD SUB MERCK	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	MSD SUB MERCK	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	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	MSD SUB MERCK	N022044	March 30, 2007	RX	TABLET	ORAL	Feb. 12, 2023	PEDIATRIC EXCLUSIVITY
500MG;EQ 50MG BASE	JANUMET	MSD SUB MERCK	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	MSD SUB MERCK	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	MSD SUB MERCK	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	MSD SUB MERCK	N022044	March 30, 2007	RX	TABLET	ORAL	June 4, 2024	PEDIATRIC EXCLUSIVITY
500MG;EQ 50MG BASE	JANUMET	MSD SUB MERCK	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	MSD SUB MERCK	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	MSD SUB MERCK	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
22317	MMSL
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	0006-0078	TABLET, FILM COATED, EXTENDED RELEASE	50 mg	ORAL	NDA	30 sections
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	0006-0080	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
JANUMET XR	HUMAN PRESCRIPTION DRUG LABEL	2	0006-0081	TABLET, FILM COATED, EXTENDED RELEASE	100 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	0006-0112	TABLET, FILM COATED	50 mg	ORAL	NDA	27 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	0006-0221	TABLET, FILM COATED	25 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
JANUVIA	HUMAN PRESCRIPTION DRUG LABEL	1	0006-0277	TABLET, FILM COATED	100 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	0006-0575	TABLET, FILM COATED	50 mg	ORAL	NDA	29 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
JANUMET	HUMAN PRESCRIPTION DRUG LABEL	2	0006-0577	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	0006-5367	TABLET, FILM COATED	100 mg	ORAL	NDA	28 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
STEGLUJAN	HUMAN PRESCRIPTION DRUG LABEL	2	0006-5368	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