pantoprazole Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
antiulcer, benzimidazole derivatives	2054	102625-70-7

Description:

Molecule

Description

Molfile Inchi Smiles Synonyms: pantoprazole pantozol pantoprazole sodium controloc control pantoprazole sodium hydrate pantoprazole sodium sesquihydrate

Pantoprazole sodium is a proton pump inhibitor (PPI) that suppresses the final step in gastric acid production by covalently binding to the (H+, K+)-ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. The binding to the (H+, K+)-ATPase results in a duration of antisecretory effect that persists longer than 24 hours. Molecular weight: 383.37 Formula: C16H15F2N3O4S CLOGP: 2.11 LIPINSKI: 0 HAC: 7 HDO: 1 TPSA: 86.33 ALOGS: -2.89 ROTB: 7 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

Dose	Unit	Route
40	mg	O
40	mg	P

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	1.74 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution)	0.17 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	2.20 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.02 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	1.90 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Feb. 2, 2000	FDA	WYETH PHARMS INC

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
General physical health deterioration	730.52	9.73	2153	332896	113616	46237397
Chronic kidney disease	603.79	9.73	1066	333983	39805	46311208
Completed suicide	497.63	9.73	212	334837	145708	46205305
Drug ineffective	423.66	9.73	2992	332057	674846	45676167
Toxicity to various agents	394.10	9.73	568	334481	211198	46139815
Exposure during pregnancy	297.71	9.73	206	334843	108006	46243007
Maternal exposure during pregnancy	291.84	9.73	188	334861	102361	46248652
Haematochezia	271.98	9.73	734	334315	36759	46314254
Acute kidney injury	228.33	9.73	2642	332407	233213	46117800
Anaemia	190.01	9.73	2729	332320	253050	46097963
Product prescribing error	184.79	9.73	430	334619	19617	46331396
End stage renal disease	177.14	9.73	215	334834	5671	46345342
Death	168.00	9.73	1569	333480	333979	46017034
Rheumatoid arthritis	167.80	9.73	1023	334026	239192	46111821
Renal injury	156.77	9.73	261	334788	9280	46341733
Device expulsion	154.94	9.73	11	335038	27531	46323482
Pemphigus	153.82	9.73	66	334983	45208	46305805
Hyponatraemia	141.39	9.73	1225	333824	100107	46250906
Drug intolerance	135.81	9.73	568	334481	146481	46204532
Drug hypersensitivity	135.68	9.73	1109	333940	242716	46108297
Treatment failure	135.43	9.73	291	334758	92796	46258217
Abortion spontaneous	133.99	9.73	73	334976	43573	46307440
Off label use	132.23	9.73	1925	333124	377916	45973097
Hypomagnesaemia	127.52	9.73	400	334649	21810	46329203
Systemic lupus erythematosus	126.85	9.73	169	334880	65011	46286002
Injection site erythema	124.55	9.73	214	334835	74213	46276800
Intentional overdose	109.34	9.73	186	334863	64758	46286255
Abdominal pain upper	109.12	9.73	1554	333495	143751	46207262
Alopecia	108.98	9.73	700	334349	161714	46189299
Injection site pain	107.75	9.73	400	334649	106752	46244261
Injection site reaction	102.67	9.73	115	334934	47734	46303279
Tubulointerstitial nephritis	101.72	9.73	284	334765	14504	46336509
Hypokalaemia	100.64	9.73	1020	334029	87004	46264009
Orthostatic intolerance	96.35	9.73	74	334975	1080	46349933
Melaena	92.45	9.73	420	334629	27352	46323661
Drug abuse	89.10	9.73	202	334847	63206	46287807
Hand deformity	85.86	9.73	73	334976	34501	46316512
Abdominal pain	83.36	9.73	2201	332848	227830	46123183
Haematemesis	82.39	9.73	417	334632	28389	46322624
Asthenia	80.28	9.73	2855	332194	308220	46042793
Gastrointestinal haemorrhage	78.80	9.73	876	334173	76497	46274516
Hepatic function abnormal	75.75	9.73	81	334968	34340	46316673
Foetal exposure during pregnancy	73.84	9.73	67	334982	30680	46320333
Glossodynia	72.93	9.73	129	334920	44244	46306769
Cardio-respiratory arrest	70.84	9.73	208	334841	59661	46291352
Agranulocytosis	70.51	9.73	331	334718	21854	46329159
Injection site swelling	70.19	9.73	113	334936	40214	46310799
Renal failure	69.22	9.73	1173	333876	112421	46238592
Hypocalcaemia	69.21	9.73	377	334672	26408	46324605
Wrong technique in product usage process	68.90	9.73	183	334866	54239	46296774
Dyspnoea	68.70	9.73	4431	330618	511117	45839896
Respiratory arrest	64.44	9.73	89	334960	33727	46317286
No adverse event	64.33	9.73	91	334958	34140	46316873
Leukopenia	62.98	9.73	759	334290	67584	46283429
Gastritis	62.49	9.73	442	334607	33936	46317077
Subacute cutaneous lupus erythematosus	60.99	9.73	72	334977	1843	46349170
Arthropathy	60.96	9.73	357	334692	84343	46266670
Product monitoring error	60.65	9.73	73	334976	1908	46349105
Injection site pruritus	60.51	9.73	121	334928	39622	46311391
Blood loss anaemia	53.69	9.73	159	334890	8398	46342615
Product dose omission issue	50.72	9.73	877	334172	167643	46183370
Gastrooesophageal reflux disease	50.61	9.73	782	334267	73562	46277451
Drug resistance	49.15	9.73	32	335017	17336	46333677
Pneumonia viral	48.33	9.73	130	334919	6494	46344519
Overdose	48.23	9.73	483	334566	101496	46249517
Foetal death	47.74	9.73	4	335045	8739	46342274
Gastroenteritis clostridial	47.63	9.73	35	335014	476	46350537
Therapeutic product effect incomplete	45.42	9.73	351	334698	77802	46273211
Pregnancy	45.40	9.73	78	334971	27059	46323954
Therapeutic response decreased	44.70	9.73	159	334890	42986	46308027
Accidental exposure to product	43.77	9.73	52	334997	21029	46329984
Suicidal ideation	43.08	9.73	233	334816	56149	46294864
Rash	42.34	9.73	2109	332940	354403	45996610
Labelled drug-drug interaction medication error	42.10	9.73	152	334897	8909	46342104
Folliculitis	41.55	9.73	118	334931	6085	46344928
Anti-cyclic citrullinated peptide antibody positive	41.08	9.73	46	335003	19099	46331914
Hypertensive nephropathy	41.01	9.73	29	335020	370	46350643
Faecaloma	40.32	9.73	135	334914	7617	46343396
Premature delivery	40.16	9.73	60	334989	22009	46329004
Loss of personal independence in daily activities	40.09	9.73	243	334806	56940	46294073
Caesarean section	40.08	9.73	36	335013	16567	46334446
Anaphylactic reaction	39.74	9.73	221	334828	52891	46298122
Soft tissue disorder	38.80	9.73	90	334959	4096	46346917
Atrial fibrillation	38.54	9.73	995	334054	102595	46248418
Seizure	37.78	9.73	638	334411	122416	46228597
Clostridium difficile colitis	37.57	9.73	245	334804	18308	46332705
Angina pectoris	37.45	9.73	324	334725	26451	46324562
Abdominal discomfort	36.86	9.73	815	334234	150350	46200663
Live birth	36.81	9.73	14	335035	10316	46340697
Swelling	35.85	9.73	653	334396	123858	46227155
Injection site bruising	35.81	9.73	133	334916	35503	46315510
Rebound acid hypersecretion	35.76	9.73	23	335026	248	46350765
Hypoaesthesia	35.62	9.73	619	334430	118250	46232763
Haemoglobin decreased	35.52	9.73	1193	333856	127756	46223257
Dehydration	35.47	9.73	1441	333608	158099	46192914
Pallor	35.42	9.73	286	334763	22880	46328133
Stillbirth	35.36	9.73	3	335046	6488	46344525
Polyneuropathy	35.02	9.73	171	334878	11473	46339540
Muscle injury	35	9.73	95	334954	4771	46346242
Product quality issue	34.56	9.73	135	334914	35513	46315500
Electrolyte imbalance	33.98	9.73	226	334823	17000	46334013
Infusion related reaction	33.64	9.73	517	334532	100691	46250322
Breast cancer	33.19	9.73	191	334858	45327	46305686
Fall	33.17	9.73	2767	332282	326330	46024683
Intentional self-injury	33.12	9.73	78	334971	24088	46326925
Hypoparathyroidism secondary	33.06	9.73	13	335036	41	46350972
Blood pressure systolic increased	32.11	9.73	332	334717	28455	46322558
Injection site warmth	31.90	9.73	31	335018	13741	46337272
Eructation	31.90	9.73	120	334929	7175	46343838
Muscle spasticity	31.59	9.73	164	334885	11276	46339737
Therapeutic product effect decreased	31.31	9.73	411	334638	82190	46268823
Product used for unknown indication	31.29	9.73	28	335021	511	46350502
Intentional product misuse	31.11	9.73	204	334845	46924	46304089
Irritability	31.11	9.73	105	334944	28841	46322172
Musculoskeletal stiffness	31.08	9.73	505	334544	97488	46253525
Neuropathy peripheral	30.99	9.73	462	334587	90431	46260582
Genital haemorrhage	30.91	9.73	5	335044	6561	46344452
Drug dependence	30.80	9.73	60	334989	19841	46331172
Hip arthroplasty	30.35	9.73	52	334997	18060	46332953
Eosinophilia	30.34	9.73	239	334810	18978	46332035
Psoriasis	30.21	9.73	390	334659	78214	46272799
Dyspepsia	30.10	9.73	673	334376	67799	46283214
Product use in unapproved indication	30.04	9.73	461	334588	89812	46261201
Pulmonary embolism	30.00	9.73	1005	334044	107580	46243433
Painful respiration	29.76	9.73	60	334989	2477	46348536
Feeling abnormal	29.70	9.73	677	334372	124383	46226630
Ear pain	29.69	9.73	265	334784	21827	46329186
Hiatus hernia	29.66	9.73	229	334820	18073	46332940
Device issue	29.42	9.73	62	334987	19918	46331095
Restlessness	29.25	9.73	296	334753	25228	46325785
Synovitis	28.98	9.73	289	334760	60786	46290227
Gestational diabetes	28.87	9.73	8	335041	7211	46343802
Colitis ulcerative	28.81	9.73	222	334827	17510	46333503
Vomiting	28.11	9.73	3684	331365	449110	45901903
Therapy non-responder	27.74	9.73	177	334872	40975	46310038
Gamma-glutamyltransferase increased	27.71	9.73	349	334700	31391	46319622
Pancytopenia	27.66	9.73	803	334246	84255	46266758
Cholestasis	27.59	9.73	305	334744	26588	46324425
Diabetic nephropathy	27.42	9.73	41	335008	1327	46349686
Body temperature increased	27.39	9.73	286	334763	24575	46326438
Adverse event	27.38	9.73	139	334910	34045	46316968
Uterine perforation	27.34	9.73	9	335040	7258	46343755
Cardiac arrest	27.31	9.73	470	334579	89929	46261084
Cholecystitis chronic	27.27	9.73	148	334901	10351	46340662
Cardiac failure	27.17	9.73	759	334290	79189	46271824
Body temperature decreased	27.10	9.73	177	334872	13232	46337781
Depression	26.91	9.73	974	334075	169130	46181883
White blood cell count decreased	26.80	9.73	607	334442	111624	46239389
Haematoma	26.79	9.73	348	334701	31524	46319489
Pre-eclampsia	26.60	9.73	12	335037	7982	46343031
Dystonia	26.47	9.73	25	335024	11232	46339781
Hypotension	26.41	9.73	1974	333075	230615	46120398
Internal haemorrhage	26.27	9.73	81	334968	4374	46346639
Device use error	25.97	9.73	3	335046	5078	46345935
Hepatitis acute	25.69	9.73	122	334927	8092	46342921
Therapeutic drug monitoring analysis not performed	25.61	9.73	24	335025	466	46350547
Thrombocytopenia	25.57	9.73	1132	333917	125449	46225564
Premature baby	25.19	9.73	58	334991	18054	46332959
Knee arthroplasty	24.65	9.73	87	334962	23578	46327435
Nephrogenic anaemia	24.57	9.73	47	335002	1866	46349147
Duodenitis	24.53	9.73	65	334984	3218	46347795
Adverse drug reaction	24.49	9.73	202	334847	44160	46306853
Night sweats	24.38	9.73	301	334748	26949	46324064
Rapid eye movement sleep behaviour disorder	24.27	9.73	15	335034	150	46350863
Colitis erosive	24.23	9.73	12	335037	74	46350939
Coagulation test abnormal	24.17	9.73	27	335022	650	46350363
Febrile infection	24.11	9.73	37	335012	1226	46349787
Diarrhoea	23.98	9.73	4460	330589	555142	45795871
Gastric haemorrhage	23.81	9.73	95	334954	5839	46345174
Urinary tract infection enterococcal	23.53	9.73	53	334996	2365	46348648
Nausea	23.39	9.73	5418	329631	682036	45668977
Oesophagitis	23.35	9.73	173	334876	13478	46337535
Coma	23.35	9.73	287	334762	58062	46292951
Hepatitis cholestatic	22.98	9.73	102	334947	6575	46344438
Abnormal behaviour	22.89	9.73	76	334973	20982	46330031
Acute abdomen	22.66	9.73	40	335009	1492	46349521
Food allergy	22.44	9.73	104	334945	6829	46344184
Lactic acidosis	22.42	9.73	355	334694	33554	46317459
Device difficult to use	22.30	9.73	15	335034	7989	46343024
Somatic symptom disorder	22.17	9.73	45	335004	1867	46349146
Haematotoxicity	22.16	9.73	11	335038	6922	46344091
Device dislocation	22.15	9.73	81	334968	21721	46329292
Urosepsis	22.11	9.73	187	334862	15166	46335847
Neutrophil count decreased	22.08	9.73	202	334847	43224	46307789
Cerebral ischaemia	22.06	9.73	97	334952	6228	46344785
Malaise	22.03	9.73	2062	332987	329170	46021843
Peripheral swelling	21.89	9.73	1364	333685	156707	46194306
Hypertensive crisis	21.86	9.73	170	334879	13445	46337568
Hyperkalaemia	21.84	9.73	497	334552	50212	46300801
Drug reaction with eosinophilia and systemic symptoms	21.73	9.73	315	334734	29233	46321780
Injection site rash	21.70	9.73	51	334998	15762	46335251
Abortion induced	21.63	9.73	25	335024	10235	46340778
Nephritis allergic	21.61	9.73	14	335035	153	46350860
Gastric ulcer	21.54	9.73	246	334803	21617	46329396
Rectal haemorrhage	21.47	9.73	390	334659	37865	46313148
Trimethylaminuria	21.46	9.73	14	335035	155	46350858
Injection site urticaria	21.32	9.73	33	335016	11934	46339079
Brain contusion	21.28	9.73	23	335026	533	46350480
Reactive gastropathy	21.13	9.73	19	335030	349	46350664
Prothrombin time shortened	21.11	9.73	42	335007	1717	46349296
Neutropenic sepsis	21.00	9.73	35	335014	12289	46338724
Injection site haemorrhage	20.99	9.73	77	334972	20632	46330381
Breath sounds abnormal	20.87	9.73	111	334938	7704	46343309
Pancreatitis	20.83	9.73	434	334615	43193	46307820
Hypochromic anaemia	20.62	9.73	37	335012	1398	46349615
Prerenal failure	20.58	9.73	37	335012	1400	46349613
Dysuria	20.58	9.73	297	334752	27536	46323477
Product storage error	20.55	9.73	33	335016	11759	46339254
Drug withdrawal syndrome	20.45	9.73	114	334935	27270	46323743
Suicide attempt	20.43	9.73	275	334774	54761	46296252
Monoparesis	20.43	9.73	38	335011	1477	46349536
Synovial fluid analysis	20.39	9.73	36	335013	1343	46349670
Urinary tract obstruction	20.26	9.73	41	335008	1697	46349316
Glomerulonephropathy	20.16	9.73	11	335038	85	46350928
Irritable bowel syndrome	20.13	9.73	194	334855	16321	46334692
Product use issue	20.09	9.73	521	334528	94123	46256890
Tachyarrhythmia	20.09	9.73	76	334973	4556	46346457
Hepatitis	20.08	9.73	334	334715	31881	46319132
Device breakage	20.02	9.73	24	335025	9668	46341345
Syncope	20.02	9.73	932	334117	103871	46247142
Substance abuse	20.01	9.73	3	335046	4164	46346849
Dyspnoea exertional	19.86	9.73	487	334562	49802	46301211
Fracture	19.84	9.73	193	334856	16278	46334735
Neuropathy vitamin B12 deficiency	19.72	9.73	5	335044	0	46351013
Somnolence	19.68	9.73	920	334129	155601	46195412
Pharyngeal dystonia	19.55	9.73	6	335043	6	46351007
Pleural effusion	19.52	9.73	754	334295	82198	46268815
Chronic gastritis	19.42	9.73	49	335000	2354	46348659
Poisoning	19.31	9.73	45	335004	13949	46337064
Drug-induced liver injury	19.27	9.73	272	334777	25096	46325917
Peripheral arterial occlusive disease	19.21	9.73	65	334984	3687	46347326
Therapeutic drug monitoring analysis incorrectly performed	19.19	9.73	13	335036	154	46350859
Haemarthrosis	19.14	9.73	56	334993	2937	46348076
Arthralgia	19.11	9.73	2308	332741	362295	45988718
Hyperkinesia	19.09	9.73	41	335008	1771	46349242
Platelet count decreased	19.07	9.73	559	334490	99465	46251548
Underdose	19.00	9.73	74	334975	19484	46331529
Hepatic cyst	18.88	9.73	76	334973	4690	46346323
Flushing	18.85	9.73	338	334711	64276	46286737
Gastritis erosive	18.78	9.73	82	334967	5248	46345765
Pseudomembranous colitis	18.76	9.73	58	334991	3137	46347876
Tetany	18.57	9.73	40	335009	1731	46349282
Cellulitis	18.57	9.73	374	334675	69914	46281099
Nephropathy	18.41	9.73	78	334971	4927	46346086
Abdominal distension	18.28	9.73	671	334378	72680	46278333
Drug interaction	18.16	9.73	1693	333356	201401	46149612
Temperature regulation disorder	17.91	9.73	59	334990	3301	46347712
Biliary dyskinesia	17.85	9.73	52	334997	2721	46348292
Total lung capacity decreased	17.77	9.73	30	335019	1079	46349934
Disease progression	17.72	9.73	509	334540	90791	46260222
Clostridium test positive	17.72	9.73	41	335008	1863	46349150
Diverticulum intestinal	17.66	9.73	88	334961	5953	46345060
Hepatocellular injury	17.64	9.73	304	334745	29218	46321795
Joint stiffness	17.56	9.73	118	334931	26990	46324023
Incorrect dosage administered	17.51	9.73	38	335011	1653	46349360
Bradycardia	17.39	9.73	610	334439	65688	46285325
Gastrointestinal inflammation	17.37	9.73	69	334980	4232	46346781
Pain	17.32	9.73	3086	331963	473862	45877151
Blood parathyroid hormone decreased	17.25	9.73	5	335044	4376	46346637
Bursitis	17.25	9.73	218	334831	19624	46331389
Solar urticaria	17.19	9.73	8	335041	42	46350971
Pancreatic steatosis	17.19	9.73	28	335021	977	46350036
Haematocrit decreased	17.15	9.73	350	334699	34707	46316306
Disseminated intravascular coagulation	17.15	9.73	74	334975	18931	46332082
Deep vein thrombosis	17.13	9.73	718	334331	79055	46271958
Treatment noncompliance	17.04	9.73	134	334915	29597	46321416
Anxiety	17.04	9.73	1101	333948	180856	46170157
Arterial occlusive disease	17.00	9.73	74	334975	4730	46346283
Contraindicated product administered	16.99	9.73	440	334609	79507	46271506
Hepatitis B	16.97	9.73	3	335046	3690	46347323
Clostridium colitis	16.94	9.73	40	335009	1842	46349171
Drug eruption	16.92	9.73	87	334962	21242	46329771
Sensory level abnormal	16.91	9.73	12	335037	154	46350859
Carcinoid tumour of the stomach	16.85	9.73	12	335037	155	46350858
Paresis	16.82	9.73	42	335007	2004	46349009
Arterial stenosis	16.76	9.73	22	335027	629	46350384
Dysphoria	16.72	9.73	6	335043	4583	46346430
Neurotoxicity	16.70	9.73	47	335002	13670	46337343
Sedation complication	16.66	9.73	3	335046	3642	46347371
Vertigo	16.54	9.73	490	334559	51558	46299455
Clostridium difficile infection	16.29	9.73	262	334787	24841	46326172
Hepatic vein dilatation	16.26	9.73	6	335043	15	46350998
Subileus	16.25	9.73	53	334996	2950	46348063
Iron deficiency anaemia	16.24	9.73	192	334857	17014	46333999
Intestinal haemorrhage	16.05	9.73	54	334995	3054	46347959
Tenosynovitis stenosans	16.02	9.73	40	335009	1909	46349104
Neutrophil function disorder	15.98	9.73	6	335043	16	46350997
Therapeutic reaction time decreased	15.94	9.73	28	335021	1040	46349973
Maternal drugs affecting foetus	15.84	9.73	10	335039	5508	46345505
Strangury	15.82	9.73	5	335044	6	46351007
Shock	15.74	9.73	92	334957	21753	46329260
Systemic infection	15.74	9.73	22	335027	669	46350344
Sopor	15.63	9.73	214	334835	19614	46331399
Pseudarthrosis	15.62	9.73	17	335032	397	46350616
Abdominal wall wound	15.56	9.73	8	335041	54	46350959
Device malfunction	15.43	9.73	47	335002	13327	46337686
Presyncope	15.41	9.73	254	334795	24200	46326813
Amenorrhoea	15.40	9.73	25	335024	8870	46342143
Blood creatinine increased	15.36	9.73	683	334366	75720	46275293
Epigastric discomfort	15.36	9.73	81	334968	5603	46345410
Headache	15.35	9.73	3115	331934	475237	45875776
Anuria	15.30	9.73	137	334912	11294	46339719
Metabolic surgery	15.22	9.73	26	335023	944	46350069
Sedation	15.20	9.73	99	334950	22811	46328202
Vision blurred	15.06	9.73	446	334603	79262	46271751
Carotid arteriosclerosis	15.03	9.73	26	335023	954	46350059
Flatulence	15.03	9.73	291	334758	28587	46322426
Sleep disorder due to general medical condition, insomnia type	15.01	9.73	76	334973	5173	46345840
Renal haemangioma	15.01	9.73	7	335042	37	46350976
Hypertransaminasaemia	14.94	9.73	57	334992	3431	46347582
Hypochloraemia	14.93	9.73	38	335011	1835	46349178
Folate deficiency	14.91	9.73	36	335013	1682	46349331
Transaminases increased	14.87	9.73	281	334768	27480	46323533
Oedema peripheral	14.82	9.73	1335	333714	158371	46192642
Cachexia	14.81	9.73	71	334978	4728	46346285
Faecal calprotectin increased	14.77	9.73	37	335012	1769	46349244
Feeling jittery	14.77	9.73	132	334917	10876	46340137
Oesophageal dilatation	14.68	9.73	15	335034	325	46350688
Complication associated with device	14.63	9.73	59	334990	15382	46335631
Pulmonary renal syndrome	14.63	9.73	16	335033	376	46350637
Bicytopenia	14.58	9.73	35	335014	1629	46349384
Lipoedema	14.53	9.73	11	335038	157	46350856
Spinal pain	14.52	9.73	121	334928	9771	46341242
Mydriasis	14.51	9.73	34	335015	10519	46340494
Maternal exposure before pregnancy	14.49	9.73	7	335042	4474	46346539
Confusional state	14.45	9.73	1334	333715	158558	46192455
Gastric polyps	14.41	9.73	42	335007	2198	46348815
Productive cough	14.41	9.73	471	334578	50244	46300769
Glomerulonephritis chronic	14.35	9.73	11	335038	160	46350853
Agitation	14.29	9.73	296	334753	55119	46295894
Occupational asthma	14.18	9.73	10	335039	127	46350886
Tuberculosis	14.17	9.73	33	335016	10232	46340781
Type I hypersensitivity	14.16	9.73	43	335006	2303	46348710
Disorientation	14.12	9.73	356	334693	36562	46314451
Jaundice	14.12	9.73	288	334761	28557	46322456
Oesophageal candidiasis	13.98	9.73	74	334975	5126	46345887
Rapid correction of hyponatraemia	13.92	9.73	10	335039	131	46350882
Dermatitis allergic	13.89	9.73	145	334904	12458	46338555
Cerebellar ataxia	13.88	9.73	24	335025	880	46350133
Hyperplastic cholecystopathy	13.84	9.73	9	335040	99	46350914
Retroperitoneal haematoma	13.75	9.73	46	335003	2594	46348419
Complication of device removal	13.71	9.73	4	335045	3486	46347527
Atelectasis	13.69	9.73	200	334849	18590	46332423
Blood iron abnormal	13.67	9.73	3	335046	3167	46347846
Pruritus	13.64	9.73	1961	333088	240391	46110622
Mycotic allergy	13.60	9.73	18	335031	519	46350494
Inappropriate antidiuretic hormone secretion	13.59	9.73	158	334891	13944	46337069
Hypergastrinaemia	13.47	9.73	9	335040	104	46350909
Pain in jaw	13.43	9.73	194	334855	38178	46312835
Wound infection fungal	13.38	9.73	8	335041	75	46350938
Injection site discolouration	13.35	9.73	18	335031	6892	46344121
Sacroiliitis	13.32	9.73	40	335009	2129	46348884
Vitamin B12 decreased	13.27	9.73	47	335002	2728	46348285
Decreased appetite	13.25	9.73	1587	333462	192249	46158764
Spontaneous haemorrhage	13.23	9.73	11	335038	181	46350832
Infective pulmonary exacerbation of cystic fibrosis	13.18	9.73	37	335012	10770	46340243
Duodenal polyp	13.11	9.73	8	335041	78	46350935
Mood swings	13.06	9.73	66	334983	16186	46334827
Vaginal haemorrhage	13.06	9.73	119	334930	25485	46325528
Skin test positive	13.01	9.73	21	335028	727	46350286
Drug ineffective for unapproved indication	12.99	9.73	67	334982	16346	46334667
Food aversion	12.98	9.73	16	335033	429	46350584
Hypophysitis	12.97	9.73	30	335019	1363	46349650
International normalised ratio increased	12.96	9.73	434	334615	46449	46304564
Bacterial test	12.95	9.73	28	335021	1215	46349798
Respiratory disorder	12.84	9.73	271	334778	27029	46323984
Complication of device insertion	12.82	9.73	10	335039	4934	46346079
Enthesopathy	12.79	9.73	9	335040	4681	46346332
Blood pressure diastolic abnormal	12.67	9.73	83	334966	6211	46344802
Haemoptysis	12.66	9.73	261	334788	25928	46325085
Abdominal pain lower	12.62	9.73	218	334831	20963	46330050
Cholangitis acute	12.55	9.73	16	335033	444	46350569
Juvenile idiopathic arthritis	12.55	9.73	7	335042	4125	46346888
White blood cell count abnormal	12.54	9.73	11	335038	5121	46345892
Patent ductus arteriosus	12.54	9.73	6	335043	3856	46347157
Aortic valve stenosis	12.53	9.73	50	334999	3074	46347939
Pathogen resistance	12.52	9.73	15	335034	6045	46344968
Eosinophils urine present	12.44	9.73	5	335044	17	46350996
Spigelian hernia	12.39	9.73	6	335043	35	46350978
Thrombosis	12.34	9.73	506	334543	55563	46295450
Renal cyst	12.25	9.73	106	334943	8653	46342360
Device related bacteraemia	12.22	9.73	5	335044	18	46350995
Neuroleptic malignant syndrome	12.19	9.73	40	335009	11082	46339931
Glomerular filtration rate decreased	12.17	9.73	133	334916	11561	46339452
Intentional product use issue	12.16	9.73	287	334762	52493	46298520
Inflammatory marker increased	12.14	9.73	74	334975	5401	46345612
Enterochromaffin cell hyperplasia	12.13	9.73	7	335042	61	46350952
Surgery	12.12	9.73	140	334909	28645	46322368
Squamous cell carcinoma of the oral cavity	12.11	9.73	13	335036	299	46350714
Device deployment issue	12.07	9.73	5	335044	3498	46347515
Musculoskeletal disorder	12	9.73	64	334985	15481	46335532
Acute graft versus host disease	11.99	9.73	7	335042	4023	46346990
Application site pain	11.95	9.73	7	335042	4016	46346997
Deafness	11.94	9.73	67	334982	16001	46335012
Wheelchair user	11.87	9.73	7	335042	4001	46347012
Lethargy	11.86	9.73	278	334771	50893	46300120
Automatism epileptic	11.83	9.73	3	335046	0	46351013
Low density lipoprotein	11.83	9.73	3	335046	0	46351013
Arterial haemorrhage	11.82	9.73	33	335016	1685	46349328
Low birth weight baby	11.72	9.73	13	335036	5421	46345592
Escherichia infection	11.71	9.73	124	334925	10693	46340320
Pharyngitis	11.66	9.73	76	334973	17507	46333506
Vascular stent stenosis	11.63	9.73	17	335032	539	46350474
Blood pressure increased	11.62	9.73	1058	333991	125608	46225405
Myeloblast percentage decreased	11.61	9.73	6	335043	41	46350972
Dysphagia	11.60	9.73	672	334377	76640	46274373
Lung opacity	11.58	9.73	26	335023	1158	46349855
Grunting	11.56	9.73	11	335038	218	46350795
Frequent bowel movements	11.50	9.73	140	334909	12492	46338521
Ureteric stenosis	11.50	9.73	18	335031	607	46350406
Nightmare	11.38	9.73	71	334978	16527	46334486
Administration site discomfort	11.38	9.73	8	335041	101	46350912
Natural killer cell count decreased	11.37	9.73	6	335043	43	46350970
Dysentery	11.35	9.73	20	335029	745	46350268
Erysipelas	11.35	9.73	87	334962	6851	46344162
Micturition disorder	11.34	9.73	32	335017	1644	46349369
Arrhythmia	11.34	9.73	329	334720	34512	46316501
Bile duct stone	11.21	9.73	52	334997	3415	46347598
Pneumonia	11.17	9.73	2949	332100	373371	45977642
Gait deviation	11.16	9.73	7	335042	72	46350941
Wound treatment	11.15	9.73	10	335039	183	46350830
Neurofibrosarcoma	11.08	9.73	9	335040	143	46350870
Blood pressure diastolic decreased	11.05	9.73	153	334896	14058	46336955
Metabolic alkalosis	11.01	9.73	43	335006	2617	46348396
Upper gastrointestinal haemorrhage	10.98	9.73	175	334874	16563	46334450
Sputum discoloured	10.94	9.73	140	334909	12638	46338375
Gastrointestinal toxicity	10.93	9.73	9	335040	4322	46346691
Hypoparathyroidism	10.91	9.73	18	335031	635	46350378
Epstein-Barr virus infection	10.89	9.73	20	335029	6764	46344249
Foetal growth restriction	10.87	9.73	19	335030	6548	46344465
SJS-TEN overlap	10.83	9.73	9	335040	148	46350865
Faeces discoloured	10.82	9.73	175	334874	16612	46334401
Product administered to patient of inappropriate age	10.76	9.73	3	335046	2693	46348320
Lip erosion	10.72	9.73	20	335029	779	46350234
Psoriatic arthropathy	10.71	9.73	190	334859	36189	46314824
Red blood cell sedimentation rate increased	10.57	9.73	109	334940	22780	46328233
Pulmonary tuberculosis	10.56	9.73	11	335038	4720	46346293
Cholecystitis	10.55	9.73	154	334895	14312	46336701
Cushingoid	10.49	9.73	79	334970	6187	46344826
Neurosensory hypoacusis	10.48	9.73	12	335037	297	46350716
Constipation	10.43	9.73	1414	333635	172683	46178330
Head banging	10.41	9.73	14	335035	410	46350603
Leukoplakia oral	10.40	9.73	8	335041	117	46350896
Rectal cancer metastatic	10.38	9.73	11	335038	249	46350764
Hypersensitivity pneumonitis	10.35	9.73	39	335010	2334	46348679
C-reactive protein increased	10.33	9.73	517	334532	58073	46292940
Synovial cyst	10.33	9.73	89	334960	7257	46343756
Bronchitis chronic	10.33	9.73	58	334991	4109	46346904
Microgenia	10.32	9.73	4	335045	12	46351001
Lung adenocarcinoma stage III	10.32	9.73	4	335045	12	46351001
Osteochondrosis	10.28	9.73	22	335027	948	46350065
Right atrial enlargement	10.26	9.73	7	335042	84	46350929
Lymphatic fistula	10.25	9.73	21	335028	877	46350136
Soft tissue swelling	10.25	9.73	21	335028	877	46350136
Genital herpes simplex	10.25	9.73	9	335040	160	46350853
Intracranial mass	10.24	9.73	25	335024	1176	46349837
Pericarditis	10.22	9.73	116	334933	23811	46327202
Suspected suicide	10.22	9.73	11	335038	4650	46346363
Colitis	10.13	9.73	345	334704	37002	46314011
Serotonin syndrome	10.12	9.73	118	334931	24102	46326911
Medication error	10.09	9.73	292	334757	30619	46320394
Device dependence	10.08	9.73	4	335045	13	46351000
Intraocular pressure increased	10.08	9.73	17	335032	5940	46345073
Femoral hernia incarcerated	10.08	9.73	21	335028	888	46350125
Vibratory sense increased	10.07	9.73	5	335044	31	46350982
Stenosis	10.06	9.73	20	335029	817	46350196
Mixed liver injury	10.06	9.73	47	335002	3096	46347917
Pneumocystis jirovecii pneumonia	10.06	9.73	66	334983	15182	46335831
Laboratory test abnormal	10.06	9.73	110	334939	22737	46328276
Conjunctivitis	10.02	9.73	161	334888	15263	46335750
Multiple sclerosis relapse	10.00	9.73	228	334821	41897	46309116
White matter lesion	10.00	9.73	24	335025	1117	46349896
Swelling face	9.99	9.73	297	334752	52762	46298251
N-terminal prohormone brain natriuretic peptide increased	9.99	9.73	31	335018	1680	46349333
Mucous stools	9.97	9.73	40	335009	2465	46348548
Autoimmune nephritis	9.96	9.73	12	335037	314	46350699
Thiopurine methyltransferase decreased	9.96	9.73	12	335037	314	46350699
Gingivitis ulcerative	9.94	9.73	9	335040	167	46350846
Abnormal dreams	9.91	9.73	39	335010	10240	46340773
Panniculitis	9.91	9.73	16	335033	5688	46345325
Gastrointestinal wall thickening	9.90	9.73	21	335028	899	46350114
Musculoskeletal pain	9.85	9.73	606	334443	69522	46281491
Ulcer haemorrhage	9.84	9.73	50	334999	3408	46347605
Product complaint	9.80	9.73	49	335000	12052	46338961
Abnormal faeces	9.80	9.73	56	334993	3993	46347020
Retrograde portal vein flow	9.77	9.73	3	335046	3	46351010
Peripheral nerve paresis	9.77	9.73	3	335046	3	46351010
Tinea capitis	9.77	9.73	3	335046	3	46351010
Blood pressure ambulatory abnormal	9.77	9.73	3	335046	3	46351010
Cephalhaematoma	9.77	9.73	3	335046	3	46351010
Intestinal mucosal atrophy	9.77	9.73	3	335046	3	46351010
Poisoning deliberate	9.77	9.73	27	335022	7899	46343114
Oesophageal discomfort	9.76	9.73	9	335040	171	46350842
Helicobacter gastritis	9.74	9.73	28	335021	1454	46349559

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
General physical health deterioration	696.07	10.55	1997	225692	97947	29626842
Toxicity to various agents	426.64	10.55	431	227258	176752	29548037
Completed suicide	394.74	10.55	132	227557	99360	29625429
Chronic kidney disease	312.73	10.55	806	226883	37032	29687757
Drug ineffective	311.27	10.55	1432	226257	338955	29385834
Drug abuse	264.89	10.55	147	227542	81925	29642864
Hypomagnesaemia	210.25	10.55	419	227270	16179	29708610
Product prescribing error	173.19	10.55	389	227300	16344	29708445
End stage renal disease	141.05	10.55	224	227465	7211	29717578
Death	139.67	10.55	1897	225792	355386	29369403
Anaemia	138.27	10.55	2284	225405	205708	29519081
Haematochezia	133.56	10.55	565	227124	33657	29691132
Hypocalcaemia	121.15	10.55	398	227291	20978	29703811
Hepatic function abnormal	98.44	10.55	104	227585	41841	29682948
Acute kidney injury	97.23	10.55	2746	224943	271096	29453693
Foetal exposure during pregnancy	96.36	10.55	83	227606	36788	29688001
Renal injury	82.93	10.55	236	227453	11493	29713296
Cholestasis	82.35	10.55	392	227297	24558	29700231
Overdose	78.24	10.55	352	227337	83985	29640804
Intentional product misuse	77.98	10.55	89	227600	34578	29690211
Product monitoring error	77.18	10.55	80	227609	1661	29723128
Intentional overdose	74.74	10.55	125	227564	41356	29683433
Melaena	67.98	10.55	451	227238	31986	29692803
Electrolyte imbalance	67.75	10.55	217	227472	11283	29713506
Haematemesis	66.66	10.55	383	227306	25820	29698969
Blood loss anaemia	63.49	10.55	163	227526	7464	29717325
Erysipelas	61.89	10.55	118	227571	4406	29720383
Hypokalaemia	61.71	10.55	618	227071	49574	29675215
Syncope	59.80	10.55	942	226747	83961	29640828
Respiratory arrest	59.64	10.55	81	227608	29177	29695612
Agranulocytosis	55.34	10.55	320	227369	21622	29703167
Abdominal pain	54.13	10.55	1382	226307	134272	29590517
Dyspnoea	53.99	10.55	3071	224618	330224	29394565
Gastrointestinal haemorrhage	50.39	10.55	903	226786	82543	29642246
Abdominal pain upper	49.86	10.55	709	226980	61842	29662947
Off label use	49.81	10.55	1479	226210	247811	29476978
Neuropathy peripheral	49.40	10.55	323	227366	70152	29654637
Cardiac arrest	49.01	10.55	460	227229	92390	29632399
Cardio-respiratory arrest	47.99	10.55	248	227441	57058	29667731
Hepatitis cholestatic	46.79	10.55	149	227540	7723	29717066
Drug resistance	46.02	10.55	51	227638	20082	29704707
Treatment failure	45.39	10.55	125	227564	34554	29690235
Irritability	44.80	10.55	66	227623	22984	29701805
Type I hypersensitivity	44.64	10.55	45	227644	903	29723886
Rectal haemorrhage	44.29	10.55	433	227256	34506	29690283
Hypoparathyroidism secondary	43.27	10.55	21	227668	115	29724674
Abnormal behaviour	42.74	10.55	81	227608	25542	29699247
Gastrointestinal bacterial overgrowth	41.73	10.55	17	227672	56	29724733
Musculoskeletal pain	40.48	10.55	386	227303	30554	29694235
Haematoma muscle	39.26	10.55	34	227655	558	29724231
Therapeutic product effect incomplete	39.22	10.55	129	227560	33705	29691084
Drug withdrawal syndrome	39.21	10.55	56	227633	19753	29705036
Subileus	39.16	10.55	78	227611	3009	29721780
Pallor	38.99	10.55	284	227405	20765	29704024
Feeling abnormal	38.32	10.55	263	227426	56493	29668296
Abdominal pain lower	38.06	10.55	150	227539	8648	29716141
Leukopenia	37.60	10.55	618	227071	55541	29669248
Hypoparathyroidism	37.52	10.55	30	227659	438	29724351
Shock haemorrhagic	37.02	10.55	161	227528	9704	29715085
Lower respiratory tract infection	36.69	10.55	94	227595	26620	29698169
Hypertensive nephropathy	36.64	10.55	29	227660	417	29724372
Product dose omission issue	36.45	10.55	484	227205	91147	29633642
Mucosal haemorrhage	36.42	10.55	50	227639	1408	29723381
Immune reconstitution inflammatory syndrome	36.17	10.55	12	227677	9089	29715700
Tachyarrhythmia	34.89	10.55	74	227615	2987	29721802
Therapeutic drug monitoring analysis not performed	34.71	10.55	27	227662	378	29724411
Interstitial lung disease	34.48	10.55	292	227397	59905	29664884
Insomnia	34.27	10.55	501	227188	92835	29631954
Neutrophil count decreased	34.27	10.55	186	227503	42268	29682521
Systemic infection	33.98	10.55	34	227655	676	29724113
Febrile infection	33.67	10.55	52	227637	1633	29723156
Malaise	33.67	10.55	989	226700	165973	29558816
Premature baby	33.22	10.55	47	227642	16644	29708145
Acute abdomen	33.10	10.55	53	227636	1718	29723071
Suicidal ideation	32.70	10.55	152	227537	35962	29688827
Drug hypersensitivity	32.58	10.55	348	227341	68171	29656618
Stomatitis	31.96	10.55	160	227529	37119	29687670
Gastritis	31.58	10.55	262	227427	19936	29704853
Gastrooesophageal reflux disease	31.28	10.55	379	227310	31876	29692913
Platelet count decreased	31.01	10.55	594	227095	105535	29619254
Agitation	30.65	10.55	263	227426	53810	29670979
Seizure	30.06	10.55	547	227142	97928	29626861
C-reactive protein increased	29.69	10.55	480	227209	42993	29681796
Asthenia	29.57	10.55	2006	225683	219284	29505505
Nephrogenic anaemia	29.52	10.55	56	227633	2083	29722706
Suicide attempt	29.49	10.55	161	227528	36536	29688253
Haematoma	29.45	10.55	295	227394	23658	29701131
Labelled drug-drug interaction medication error	29.44	10.55	158	227531	10380	29714409
Hyperlipasaemia	29.42	10.55	27	227662	480	29724309
Pathogen resistance	28.67	10.55	14	227675	8396	29716393
Tetanus	28.29	10.55	12	227677	45	29724744
Fracture	28.11	10.55	105	227584	5901	29718888
Intentional self-injury	28.04	10.55	37	227652	13495	29711294
Exposure during pregnancy	27.86	10.55	18	227671	9243	29715546
Drug dependence	27.68	10.55	77	227612	21218	29703571
Visual acuity reduced	27.39	10.55	49	227640	15797	29708992
Rash	26.79	10.55	1189	226500	190700	29534089
Liver disorder	26.38	10.55	126	227563	29596	29695193
Psychotic disorder	26.36	10.55	80	227609	21435	29703354
Wrong technique in product usage process	25.97	10.55	135	227554	31020	29693769
Polyneuropathy	25.74	10.55	166	227523	11657	29713132
Aggression	25.42	10.55	170	227519	36737	29688052
Vitamin B12 deficiency	25.22	10.55	59	227630	2546	29722243
Thrombocytopenia	25.09	10.55	1278	226411	135766	29589023
Myocardial infarction	25.09	10.55	745	226944	124880	29599909
Cardiac failure congestive	24.47	10.55	473	227216	83934	29640855
Cytomegalovirus infection	24.29	10.55	95	227594	23579	29701210
Oedema peripheral	24.13	10.55	1009	226680	104823	29619966
Occupational dermatitis	24.12	10.55	12	227677	70	29724719
Colitis microscopic	24.01	10.55	45	227644	1658	29723131
Atrial fibrillation	24.00	10.55	1028	226661	107096	29617693
Hyponatraemia	23.71	10.55	674	227015	66528	29658261
Solar lentigo	23.51	10.55	20	227669	320	29724469
Hepatocellular injury	23.28	10.55	296	227393	25175	29699614
Synovitis	23.23	10.55	24	227665	9759	29715030
Bradyarrhythmia	23.19	10.55	48	227641	1904	29722885
Fear of disease	23.02	10.55	17	227672	219	29724570
Product use in unapproved indication	22.90	10.55	408	227281	73285	29651504
Acute graft versus host disease	22.84	10.55	8	227681	5856	29718933
Dysplastic naevus	22.52	10.55	20	227669	340	29724449
Headache	22.19	10.55	1146	226543	181160	29543629
Rebound acid hypersecretion	22.17	10.55	10	227679	45	29724744
Hydrocholecystis	22.00	10.55	16	227673	201	29724588
Vertigo	21.96	10.55	266	227423	22369	29702420
Psoriasis	21.80	10.55	212	227477	42294	29682495
Tetany	21.80	10.55	28	227661	738	29724051
Injection site pain	21.69	10.55	138	227551	30172	29694617
Serum ferritin decreased	21.56	10.55	22	227667	448	29724341
Chronic graft versus host disease	21.28	10.55	3	227686	4116	29720673
Upper gastrointestinal haemorrhage	21.00	10.55	258	227431	21770	29703019
Low birth weight baby	20.89	10.55	10	227679	6066	29718723
Sedation	20.69	10.55	60	227629	16313	29708476
Paresis	20.45	10.55	44	227645	1794	29722995
Depression	20.44	10.55	527	227162	89910	29634879
Troponin increased	20.30	10.55	126	227563	8731	29716058
Accidental overdose	20.27	10.55	71	227618	18204	29706585
Injection site haemorrhage	20.13	10.55	18	227671	7837	29716952
Cerebral infarction	19.95	10.55	118	227571	26255	29698534
Poisoning	19.85	10.55	35	227654	11347	29713442
Drug interaction	19.84	10.55	1768	225921	197800	29526989
Dyspnoea exertional	19.82	10.55	379	227310	35051	29689738
Joint swelling	19.75	10.55	245	227444	46701	29678088
Anxiety	19.71	10.55	526	227163	89345	29635444
Rheumatoid arthritis	19.67	10.55	209	227480	40988	29683801
Microcytic anaemia	19.65	10.55	48	227641	2130	29722659
Foetal malformation	19.62	10.55	13	227676	139	29724650
Respiratory depression	19.50	10.55	36	227653	11467	29713322
Cardiac failure	19.39	10.55	797	226892	82621	29642168
Arrhythmia	19.31	10.55	357	227332	32812	29691977
Photodermatosis	19.30	10.55	20	227669	415	29724374
Abnormal dreams	19.16	10.55	20	227669	8095	29716694
Peritoneal dialysis complication	19.14	10.55	4	227685	4123	29720666
Urticaria	19.04	10.55	296	227393	54310	29670479
Neuroleptic malignant syndrome	18.97	10.55	62	227627	16233	29708556
Gamma-glutamyltransferase increased	18.90	10.55	321	227368	29029	29695760
Drug reaction with eosinophilia and systemic symptoms	18.87	10.55	313	227376	28175	29696614
Injection site erythema	18.75	10.55	49	227640	13785	29711004
Normocytic anaemia	18.58	10.55	37	227652	1427	29723362
Nightmare	18.58	10.55	40	227649	12036	29712753
Gravitational oedema	18.47	10.55	23	227666	587	29724202
Occupational exposure to air contaminants	18.30	10.55	9	227680	51	29724738
Serotonin syndrome	18.22	10.55	72	227617	17819	29706970
Cerebellar ischaemia	18.18	10.55	11	227678	99	29724690
Intestinal angioedema	18.17	10.55	13	227676	159	29724630
Subacute cutaneous lupus erythematosus	18.05	10.55	24	227665	655	29724134
Mania	17.99	10.55	26	227663	9128	29715661
Drug screen false positive	17.94	10.55	25	227664	714	29724075
Therapeutic response decreased	17.86	10.55	110	227579	24239	29700550
Mood swings	17.78	10.55	19	227670	7607	29717182
Dizziness	17.60	10.55	1715	225974	193194	29531595
Memory impairment	17.58	10.55	189	227500	36985	29687804
Eosinophilia	17.57	10.55	251	227438	21909	29702880
Lactic acidosis	17.50	10.55	334	227355	30879	29693910
Infective exacerbation of chronic obstructive airways disease	17.50	10.55	36	227653	1422	29723367
Mean cell haemoglobin concentration	17.23	10.55	8	227681	39	29724750
Urinary hesitation	17.17	10.55	47	227642	2237	29722552
Disorganised speech	17.11	10.55	21	227668	528	29724261
Cold sweat	17.08	10.55	123	227566	8959	29715830
Cachexia	17.05	10.55	97	227592	6514	29718275
Product quality issue	17.00	10.55	79	227610	18695	29706094
Base excess decreased	16.93	10.55	14	227675	215	29724574
Peripheral arterial occlusive disease	16.90	10.55	81	227608	5087	29719702
Disease progression	16.86	10.55	470	227219	79404	29645385
Accidental exposure to product	16.84	10.55	32	227657	10083	29714706
Hypersensitivity	16.82	10.55	299	227390	53729	29671060
Perihepatic abscess	16.81	10.55	10	227679	87	29724702
Osteochondrosis	16.75	10.55	24	227665	704	29724085
Burns second degree	16.44	10.55	17	227672	352	29724437
Post transplant lymphoproliferative disorder	16.39	10.55	10	227679	5296	29719493
Injection site swelling	16.24	10.55	26	227663	8754	29716035
Trisomy 18	16.20	10.55	14	227675	229	29724560
Mean cell haemoglobin decreased	16.10	10.55	31	227658	1166	29723623
Fall	16.08	10.55	1598	226091	180274	29544515
Lower gastrointestinal haemorrhage	16.01	10.55	109	227580	7795	29716994
Glomerular filtration rate decreased	15.99	10.55	144	227545	11218	29713571
No adverse event	15.95	10.55	73	227616	17346	29707443
Erectile dysfunction	15.91	10.55	77	227612	18025	29706764
Withdrawal syndrome	15.90	10.55	39	227650	11211	29713578
Jaundice	15.69	10.55	340	227349	32146	29692643
Renal haemangioma	15.60	10.55	7	227682	31	29724758
Chest injury	15.57	10.55	33	227656	1331	29723458
Duodenogastric reflux	15.55	10.55	4	227685	0	29724789
Adverse event	15.46	10.55	62	227627	15279	29709510
Anaphylactic reaction	15.45	10.55	137	227552	27845	29696944
Respiratory tract haemorrhage	15.35	10.55	25	227664	822	29723967
Apparent death	15.30	10.55	4	227685	3538	29721251
Serum ferritin abnormal	15.28	10.55	13	227676	208	29724581
Hallucination	15.11	10.55	272	227417	48787	29676002
Pulpitis dental	15.09	10.55	17	227672	389	29724400
Gastrointestinal pain	15.03	10.55	50	227639	2652	29722137
Dermatitis infected	15.01	10.55	10	227679	108	29724681
Angina pectoris	14.92	10.55	311	227378	29207	29695582
Polypectomy	14.90	10.55	19	227670	497	29724292
Gastritis erosive	14.90	10.55	83	227606	5530	29719259
Procalcitonin abnormal	14.86	10.55	10	227679	110	29724679
Mastitis	14.80	10.55	12	227677	179	29724610
Upper motor neurone lesion	14.78	10.55	10	227679	111	29724678
Pulmonary embolism	14.76	10.55	731	226958	77404	29647385
Granulomatous dermatitis	14.73	10.55	13	227676	219	29724570
Thrombocytosis	14.61	10.55	58	227631	3355	29721434
Altered state of consciousness	14.61	10.55	90	227599	19829	29704960
Osteonecrosis	14.55	10.55	68	227621	16067	29708722
Wound haemorrhage	14.53	10.55	38	227651	1760	29723029
Body temperature decreased	14.43	10.55	124	227565	9531	29715258
Flushing	14.33	10.55	149	227540	29343	29695446
Ascites	14.30	10.55	366	227323	35555	29689234
Injection site bruising	14.27	10.55	21	227668	7317	29717472
Jugular vein distension	14.22	10.55	19	227670	521	29724268
Injection site phlebitis	14.18	10.55	7	227682	40	29724749
Faecal calprotectin increased	14.12	10.55	29	227660	1144	29723645
Pancreatitis acute	14.08	10.55	274	227415	25421	29699368
Drug abuser	14.01	10.55	8	227681	4393	29720396
Presyncope	14.00	10.55	185	227504	15871	29708918
Sexual dysfunction	13.94	10.55	15	227674	5986	29718803
Product use issue	13.90	10.55	256	227433	45760	29679029
Anger	13.87	10.55	41	227648	11079	29713710
Disseminated intravascular coagulation	13.86	10.55	105	227584	22066	29702723
Faeces pale	13.81	10.55	33	227656	1444	29723345
Thrombophlebitis	13.74	10.55	50	227639	2774	29722015
Product storage error	13.73	10.55	17	227672	6374	29718415
Urinary straining	13.70	10.55	5	227684	11	29724778
Puncture site haematoma	13.68	10.55	11	227678	162	29724627
Device issue	13.66	10.55	24	227665	7792	29716997
Rash maculo-papular	13.57	10.55	270	227419	25148	29699641
Iron deficiency anaemia	13.54	10.55	116	227573	8908	29715881
Hypertransaminasaemia	13.52	10.55	62	227627	3823	29720966
Uveitis	13.50	10.55	13	227676	5464	29719325
Drug eruption	13.48	10.55	78	227611	17448	29707341
Leptospirosis	13.48	10.55	6	227683	26	29724763
Autoimmune colitis	13.45	10.55	23	227666	788	29724001
Food aversion	13.42	10.55	14	227675	293	29724496
Drug use disorder	13.41	10.55	4	227685	3244	29721545
Multiple-drug resistance	13.33	10.55	3	227686	2938	29721851
Myelocyte count increased	13.32	10.55	8	227681	71	29724718
Arteriosclerotic gangrene	13.32	10.55	8	227681	71	29724718
Muscular weakness	13.30	10.55	375	227314	63270	29661519
Benign gastrointestinal neoplasm	13.22	10.55	10	227679	134	29724655
Atrial septal defect	13.20	10.55	19	227670	6682	29718107
Gastrooesophageal sphincter insufficiency	13.13	10.55	8	227681	73	29724716
Post procedural haemorrhage	13.12	10.55	104	227585	7806	29716983
Product prescribing issue	13.00	10.55	23	227666	810	29723979
Jejunostomy	12.96	10.55	6	227683	29	29724760
Drug ineffective for unapproved indication	12.94	10.55	41	227648	10839	29713950
Substance abuse	12.87	10.55	21	227668	7019	29717770
Thrombotic microangiopathy	12.85	10.55	29	227660	8581	29716208
Lethargy	12.85	10.55	217	227472	39302	29685487
Device leakage	12.82	10.55	6	227683	3688	29721101
Therapy partial responder	12.80	10.55	6	227683	3685	29721104
Hiatus hernia	12.75	10.55	95	227594	6995	29717794
Hyperkinesia	12.73	10.55	40	227649	2058	29722731
Erythropenia	12.73	10.55	12	227677	221	29724568
Hepatorenal syndrome	12.68	10.55	45	227644	2466	29722323
Hyperreflexia	12.66	10.55	3	227686	2836	29721953
Bladder tamponade	12.65	10.55	16	227673	415	29724374
Diverticulum intestinal	12.65	10.55	54	227635	3228	29721561
Blood pressure fluctuation	12.60	10.55	195	227494	17308	29707481
Cytomegalovirus viraemia	12.56	10.55	15	227674	5714	29719075
Rhythm idioventricular	12.54	10.55	13	227676	270	29724519
Renal cyst	12.53	10.55	103	227586	7814	29716975
Phlebitis infective	12.40	10.55	10	227679	148	29724641
Eosinophilic pneumonia	12.36	10.55	47	227642	2664	29722125
Failure to suspend medication	12.36	10.55	8	227681	82	29724707
Hospitalisation	12.34	10.55	250	227439	44069	29680720
Hypochromic anaemia	12.29	10.55	22	227667	782	29724007
Chronic kidney disease-mineral and bone disorder	12.28	10.55	15	227674	375	29724414
Tuberculosis	12.22	10.55	27	227662	8050	29716739
Weight decreased	12.18	10.55	1318	226371	149603	29575186
Paranasal sinus discomfort	12.18	10.55	19	227670	602	29724187
Seroma	12.18	10.55	19	227670	602	29724187
Alveolar lung disease	12.16	10.55	15	227674	379	29724410
Acute coronary syndrome	12.09	10.55	157	227532	13416	29711373
Bicytopenia	12.01	10.55	35	227654	1727	29723062
Acute graft versus host disease in skin	12.00	10.55	10	227679	4506	29720283
Arteriovenous fistula	11.95	10.55	19	227670	612	29724177
Prolonged expiration	11.87	10.55	11	227678	198	29724591
Pulmonary sepsis	11.87	10.55	38	227651	1975	29722814
Haemorrhagic disorder	11.85	10.55	18	227671	557	29724232
Intestinal haemorrhage	11.82	10.55	52	227637	3149	29721640
Confabulation	11.81	10.55	9	227680	122	29724667
Macrocytosis	11.78	10.55	23	227666	874	29723915
Miosis	11.76	10.55	26	227663	7750	29717039
Splenic thrombosis	11.74	10.55	5	227684	19	29724770
Dyspnoea at rest	11.73	10.55	45	227644	2561	29722228
Bronchial obstruction	11.73	10.55	31	227658	1445	29723344
Treatment noncompliance	11.70	10.55	129	227560	25124	29699665
Resting tremor	11.68	10.55	18	227671	564	29724225
Bladder diverticulitis	11.66	10.55	3	227686	0	29724789
Spinal cord herniation	11.66	10.55	3	227686	0	29724789
Pulmonary fistula	11.66	10.55	6	227683	38	29724751
Saliva altered	11.65	10.55	10	227679	162	29724627
Renal impairment	11.64	10.55	522	227167	83662	29641127
Hypovolaemic shock	11.63	10.55	87	227602	6413	29718376
Status epilepticus	11.63	10.55	44	227645	11028	29713761
Haematoma infection	11.63	10.55	24	227665	950	29723839
Generalised tonic-clonic seizure	11.57	10.55	94	227595	19457	29705332
Lymphoedema	11.56	10.55	55	227634	3444	29721345
Graft versus host disease	11.55	10.55	39	227650	10111	29714678
Degenerative aortic valve disease	11.54	10.55	5	227684	20	29724769
Peripheral paralysis	11.53	10.55	6	227683	39	29724750
Helicobacter gastritis	11.51	10.55	22	227667	823	29723966
Tricuspid valve incompetence	11.48	10.55	108	227581	8515	29716274
Xyphoid retraction	11.45	10.55	10	227679	166	29724623
Peritonitis bacterial	11.45	10.55	46	227643	11332	29713457
Cardiotoxicity	11.45	10.55	10	227679	4404	29720385
Chronic actinic dermatitis	11.35	10.55	5	227684	21	29724768
Neoplasm malignant	11.31	10.55	84	227605	17730	29707059
Oxygen consumption decreased	11.31	10.55	10	227679	169	29724620
Hypogammaglobulinaemia	11.26	10.55	14	227675	5238	29719551
Lip ulceration	11.24	10.55	21	227668	772	29724017
Inflammatory marker increased	11.18	10.55	51	227638	3137	29721652
Therapy non-responder	11.18	10.55	157	227532	29296	29695493
Painful respiration	11.16	10.55	28	227661	1264	29723525
Road traffic accident	11.08	10.55	80	227609	16991	29707798
Adenocarcinoma gastric	11.07	10.55	26	227663	1125	29723664
Renal artery thrombosis	11.06	10.55	13	227676	312	29724477
Listeria encephalitis	11.05	10.55	6	227683	43	29724746
Meralgia paraesthetica	11.02	10.55	10	227679	175	29724614
Hyperferritinaemia	11.01	10.55	14	227675	365	29724424
Ureteric dilatation	11.00	10.55	9	227680	136	29724653
Suture rupture	10.99	10.55	14	227675	366	29724423
Renal failure	10.93	10.55	1130	226559	127836	29596953
Electrocardiogram QT prolonged	10.91	10.55	353	227336	35482	29689307
Oesophageal infection	10.90	10.55	11	227678	221	29724568
Bone marrow failure	10.87	10.55	160	227529	29625	29695164
Euphoric mood	10.79	10.55	10	227679	4280	29720509
Influenza virus test positive	10.77	10.55	8	227681	104	29724685
Myalgia	10.67	10.55	475	227214	76192	29648597
Vasculitis	10.60	10.55	100	227589	7890	29716899
Pneumonia cytomegaloviral	10.57	10.55	4	227685	2792	29721997
Pancreatic duct stenosis	10.57	10.55	10	227679	185	29724604

Pharmacologic Action:

Source	Code	Description
ATC	A02BC02	ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) Proton pump inhibitors
ATC	A02BD04	ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) Combinations for eradication of Helicobacter pylori
ATC	A02BD11	ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) Combinations for eradication of Helicobacter pylori
FDA MoA	N0000000147	Proton Pump Inhibitors
FDA EPC	N0000175525	Proton Pump Inhibitor
MeSH PA	D000897	Anti-Ulcer Agents
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D005765	Gastrointestinal Agents
MeSH PA	D054328	Proton Pump Inhibitors
CHEBI has role	CHEBI:35703	xenobiotic
CHEBI has role	CHEBI:49200	proton pump inhibitors
CHEBI has role	CHEBI:49201	anti-ulcer agents
CHEBI has role	CHEBI:78298	environmental contaminants

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Peptic ulcer	indication	13200003	DOID:750
Erosive esophagitis	indication	40719004
Zollinger-Ellison syndrome	indication	53132006	DOID:0050782
Multiple endocrine adenomas	indication	60549007
Gastroesophageal reflux disease	indication	235595009	DOID:8534
Maintenance of Healing Erosive Esophagitis	indication
Gastric Hypersecretory Conditions	indication
Upper gastrointestinal hemorrhage	off-label use	37372002
Duodenal ulcer disease	off-label use	51868009	DOID:1724
Gastric ulcer	off-label use	397825006	DOID:10808
Pathological Gastric Hypersecretory Condition	off-label use
Duodenal Ulcer due to H. Pylori	off-label use
Prevention of NSAID-Induced Gastric Ulcer	off-label use
Osteoporosis	contraindication	64859006	DOID:11476
Pernicious anemia	contraindication	84027009	DOID:13381
Fracture of bone	contraindication	125605004
Hypomagnesemia	contraindication	190855004

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.42	acidic
pKa2	3.58	Basic
pKa3	2.32	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
EQ 40MG BASE	PANTOPRAZOLE SODIUM	SUN PHARM	A213725	June 30, 2020	RX	FOR SUSPENSION, DELAYED RELEASE	ORAL	Feb. 9, 2021	PATENT CHALLENGE

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Potassium-transporting ATPase	Transporter	P20648 P51164	ATP4A_HUMAN ATP4B_HUMAN	INHIBITOR				CHEMBL	CHEMBL
Solute carrier family 22 member 2	Transporter	O15244	S22A2_HUMAN		IC50	5.82		CHEMBL
Multidrug and toxin extrusion protein 2	Transporter	Q86VL8	S47A2_HUMAN		IC50	4.36		CHEMBL
Multidrug and toxin extrusion protein 1	Transporter	Q96FL8	S47A1_HUMAN		IC50	5.55		CHEMBL
Sodium/potassium-transporting ATPase subunit alpha-1	Transporter	P05023	AT1A1_HUMAN					WOMBAT-PK
Fatty acid synthase	Enzyme	P49327	FAS_HUMAN		Ki	5.39		CHEMBL
Indoleamine 2,3-dioxygenase 2	Enzyme		I23O2_MOUSE		IC50	4.90		CHEMBL
Potassium-transporting ATPase	Enzyme		ATP4A_RABIT ATP4B_RABIT		IC50	6		SCIENTIFIC LITERATURE

External reference:

ID	Source
4021208	VUID
N0000148654	NUI
D02593	KEGG_DRUG
164579-32-2	SECONDARY_CAS_RN
4021208	VANDF
4021209	VANDF
C0081876	UMLSCUI
CHEBI:7915	CHEBI
CHEMBL1502	ChEMBL_ID
CHEMBL1200408	ChEMBL_ID
CHEMBL3989559	ChEMBL_ID
D000077402	MESH_DESCRIPTOR_UI
DB00213	DRUGBANK_ID
4679	PUBCHEM_CID
7260	IUPHAR_LIGAND_ID
6548	INN_ID
D8TST4O562	UNII
236632	RXNORM
130104	MMSL
8654	MMSL
d04514	MMSL
006006	NDDF
006493	NDDF
009120	NDDF
116510001	SNOMEDCT_US
317317009	SNOMEDCT_US
395821003	SNOMEDCT_US
432408008	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Protonix Delayed-Release	HUMAN PRESCRIPTION DRUG LABEL	1	0008-0841	TABLET, DELAYED RELEASE	40 mg	ORAL	NDA	30 sections
Protonix Delayed-Release	HUMAN PRESCRIPTION DRUG LABEL	1	0008-0843	TABLET, DELAYED RELEASE	20 mg	ORAL	NDA	30 sections
Protonix Delayed-Release	HUMAN PRESCRIPTION DRUG LABEL	1	0008-0844	GRANULE, DELAYED RELEASE	40 mg	ORAL	NDA	30 sections
Protonix I.V.	HUMAN PRESCRIPTION DRUG LABEL	1	0008-0923	INJECTION, POWDER, FOR SOLUTION	40 mg	INTRAVENOUS	NDA	28 sections
Protonix I.V.	HUMAN PRESCRIPTION DRUG LABEL	1	0008-2001	INJECTION, POWDER, FOR SOLUTION	40 mg	INTRAVENOUS	NDA	27 sections
Protonix I.V.	HUMAN PRESCRIPTION DRUG LABEL	1	0008-4001	INJECTION, POWDER, FOR SOLUTION	40 mg	INTRAVENOUS	NDA	28 sections
Pantoprazole Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9284	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	40 mg	INTRAVENOUS	NDA	26 sections
Pantoprazole Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9300	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	40 mg	INTRAVENOUS	NDA	26 sections
Pantoprazole Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0378-6688	TABLET, DELAYED RELEASE	20 mg	ORAL	ANDA	28 sections
Pantoprazole Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0378-6689	TABLET, DELAYED RELEASE	40 mg	ORAL	ANDA	28 sections
Pantoprazole Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0615-7629	TABLET, DELAYED RELEASE	40 mg	ORAL	ANDA	28 sections
Pantoprazole Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0615-7916	TABLET, DELAYED RELEASE	20 mg	ORAL	ANDA	29 sections
Pantoprazole Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8113	TABLET, DELAYED RELEASE	20 mg	ORAL	ANDA	27 sections
Pantoprazole Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8308	TABLET, DELAYED RELEASE	40 mg	ORAL	ANDA	29 sections
Pantoprazole Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3232	INJECTION, POWDER, FOR SOLUTION	40 mg	INTRAVENOUS	ANDA	28 sections
Pantoprazole Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6474	TABLET, DELAYED RELEASE	40 mg	ORAL	ANDA	27 sections
Pantoprazole Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6870	TABLET, DELAYED RELEASE	40 mg	ORAL	ANDA	27 sections
Pantoprazole Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	13668-096	TABLET, DELAYED RELEASE	20 mg	ORAL	ANDA	27 sections
Pantoprazole Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	13668-429	TABLET, DELAYED RELEASE	40 mg	ORAL	ANDA	27 sections
PANTOPRAZOLE SODIUMDELAYED RELEASE	HUMAN PRESCRIPTION DRUG LABEL	1	16590-635	TABLET, DELAYED RELEASE	20 mg	ORAL	NDA	30 sections
PROTONIXDELAYED-RELEASE	HUMAN PRESCRIPTION DRUG LABEL	1	16590-939	TABLET, DELAYED RELEASE	20 mg	ORAL	NDA	30 sections
Protonix	HUMAN PRESCRIPTION DRUG LABEL	1	21695-108	TABLET, DELAYED RELEASE	40 mg	ORAL	NDA	27 sections
Pantoprazole Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	21695-771	TABLET, DELAYED RELEASE	40 mg	ORAL	ANDA	28 sections
PANTOPRAZOLE SODIUM	HUMAN PRESCRIPTION DRUG LABEL	1	31722-712	TABLET, DELAYED RELEASE	20 mg	ORAL	ANDA	26 sections
PANTOPRAZOLE SODIUM	HUMAN PRESCRIPTION DRUG LABEL	1	31722-713	TABLET, DELAYED RELEASE	40 mg	ORAL	ANDA	26 sections
Pantoprazole Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	33261-629	TABLET, DELAYED RELEASE	40 mg	ORAL	ANDA	29 sections
Pantoprazole Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	33358-536	TABLET, DELAYED RELEASE	20 mg	ORAL	ANDA	28 sections
Pantoprazole Sodium	Human Prescription Drug Label	1	35573-428	TABLET, DELAYED RELEASE	40 mg	ORAL	ANDA	27 sections
PANTOPRAZOLE SODIUM	HUMAN PRESCRIPTION DRUG LABEL	1	42254-124	TABLET, DELAYED RELEASE	40 mg	ORAL	ANDA	27 sections
PANTOPRAZOLE SODIUM	HUMAN PRESCRIPTION DRUG LABEL	1	42291-765	TABLET, DELAYED RELEASE	40 mg	ORAL	ANDA	26 sections