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

Stem definition	Drug id	CAS RN
antiulcer, benzimidazole derivatives	1547	103577-45-3

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: prevacid lansoprazole A-65006 AG 1749 AG-1749	A 2,2,2-trifluoroethoxypyridyl derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS. Lansoprazole is a racemic mixture of (R)- and (S)-isomers. Molecular weight: 369.36 Formula: C16H14F3N3O2S CLOGP: 2.79 LIPINSKI: 0 HAC: 5 HDO: 1 TPSA: 67.87 ALOGS: -3.17 ROTB: 6 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

prevacid
lansoprazole
A-65006
AG 1749
AG-1749

A 2,2,2-trifluoroethoxypyridyl derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS. Lansoprazole is a racemic mixture of (R)- and (S)-isomers.

Molecular weight: 369.36
Formula: C16H14F3N3O2S
CLOGP: 2.79
LIPINSKI: 0
HAC: 5
HDO: 1
TPSA: 67.87
ALOGS: -3.17
ROTB: 6

Status: OFP

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

Drug dosage:

Dose	Unit	Route
30	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.00 mg/mL	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)	1.35 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	81 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.28 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	4.40 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 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
May 10, 1995	FDA	TAKEDA PHARMS USA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Chronic kidney disease	911.70	9.14	921	206207	44477	63237417
Drug ineffective	725.08	9.14	1454	205674	1043311	62238583
Colitis microscopic	425.96	9.14	304	206824	9035	63272859
Hyponatraemia	400.34	9.14	1026	206102	110874	63171020
Renal injury	398.05	9.14	293	206835	9146	63272748
Acute kidney injury	318.06	9.14	1696	205432	261719	63020175
Completed suicide	304.23	9.14	54	207074	145619	63136275
End stage renal disease	298.65	9.14	215	206913	6478	63275416
Product dose omission issue	211.95	9.14	272	206856	234041	63047853
Therapeutic product effect incomplete	207.93	9.14	74	207054	124982	63156912
Drug intolerance	203.47	9.14	440	206688	308221	62973673
Hypomagnesaemia	202.33	9.14	348	206780	28389	63253505
Fatigue	191.25	9.14	1916	205212	886112	62395782
Contraindicated product administered	182.38	9.14	267	206861	217381	63064513
Death	171.20	9.14	636	206492	373745	62908149
Pain	171.10	9.14	1570	205558	739058	62542836
Off label use	159.50	9.14	1421	205707	673041	62608853
Subacute cutaneous lupus erythematosus	158.64	9.14	102	207026	2541	63279353
Renal failure	148.17	9.14	767	206361	116885	63165009
Arthropathy	147.04	9.14	344	206784	234448	63047446
Treatment failure	135.85	9.14	278	206850	198765	63083129
Neutropenic sepsis	130.35	9.14	210	206918	16228	63265666
Synovitis	126.76	9.14	262	206866	186656	63095238
Joint swelling	125.33	9.14	596	206532	327070	62954824
Pemphigus	124.19	9.14	258	206870	183468	63098426
Hypertensive nephropathy	122.78	9.14	54	207074	598	63281296
Alopecia	122.74	9.14	625	206503	336911	62944983
Maternal exposure during pregnancy	113.95	9.14	354	206774	219708	63062186
Toxicity to various agents	112.90	9.14	420	206708	246830	63035064
Chest pain	111.68	9.14	1136	205992	214823	63067071
Therapeutic product effect decreased	109.31	9.14	298	206830	192889	63089005
Interstitial lung disease	107.85	9.14	444	206684	61464	63220430
Systemic lupus erythematosus	106.80	9.14	338	206790	208580	63073314
Swollen tongue	104.15	9.14	299	206829	34501	63247393
Angioedema	103.28	9.14	368	206760	47597	63234297
Cerebral infarction	101.24	9.14	234	206894	23659	63258235
Hepatic function abnormal	100.59	9.14	308	206820	36834	63245060
Electric shock	99.74	9.14	59	207069	1261	63280633
Exposure during pregnancy	98.84	9.14	226	206902	155321	63126573
Injection site pain	98.46	9.14	170	206958	129630	63152264
Tubulointerstitial nephritis	95.66	9.14	205	206923	19698	63262196
Product use issue	95.25	9.14	383	206745	220137	63061757
Melaena	91.95	9.14	262	206866	30103	63251791
Subarachnoid haemorrhage	91.53	9.14	166	206962	14117	63267777
Lip swelling	91.14	9.14	265	206863	30798	63251096
Haematemesis	88.79	9.14	259	206869	30153	63251741
Device expulsion	84.71	9.14	8	207120	34914	63246980
Glossodynia	84.15	9.14	300	206828	178576	63103318
Hand deformity	81.45	9.14	258	206870	159199	63122695
Abdominal pain	80.20	9.14	1374	205754	292082	62989812
Renal impairment	78.16	9.14	525	206603	87830	63194064
Swelling	77.34	9.14	553	206575	274825	63007069
Hypokalaemia	76.90	9.14	591	206537	103213	63178681
Cardiospasm	75.49	9.14	57	207071	1850	63280044
Diabetic nephropathy	74.88	9.14	51	207077	1403	63280491
Nephrogenic anaemia	73.38	9.14	59	207069	2103	63279791
Palmoplantar keratoderma	72.90	9.14	57	207071	1950	63279944
Pruritus genital	70.70	9.14	63	207065	2591	63279303
Cholecystitis chronic	68.41	9.14	122	207006	10239	63271655
Reaction to excipient	67.54	9.14	48	207080	1416	63280478
Arthralgia	66.50	9.14	1386	205742	568324	62713570
Sinusitis	66.15	9.14	450	206678	226203	63055691
Hypocalcaemia	62.95	9.14	237	206891	31476	63250418
Confusional state	62.46	9.14	1101	206027	235279	63046615
Sleep terror	62.40	9.14	59	207069	2621	63279273
Abdominal discomfort	62.24	9.14	708	206420	320177	62961717
Intervertebral discitis	62.03	9.14	64	207064	3164	63278730
Deep vein thrombosis postoperative	61.56	9.14	123	207005	11246	63270648
Lower respiratory tract infection	61.31	9.14	681	206447	131626	63150268
Labile blood pressure	61.10	9.14	49	207079	1740	63280154
Electrocardiogram QT prolonged	60.85	9.14	367	206761	59163	63222731
Drug abuse	60.62	9.14	89	207039	72429	63209465
Nephropathy	60.11	9.14	88	207040	6253	63275641
Hepatic enzyme increased	58.89	9.14	402	206726	201926	63079968
Loss of personal independence in daily activities	58.88	9.14	145	206983	97145	63184749
Infective pulmonary exacerbation of cystic fibrosis	58.44	9.14	104	207024	8713	63273181
Rebound acid hypersecretion	57.87	9.14	26	207102	304	63281590
Infusion related reaction	57.84	9.14	517	206611	245004	63036890
Sopor	55.59	9.14	179	206949	21985	63259909
Urticaria	54.55	9.14	801	206327	165001	63116893
Lip dry	54.35	9.14	141	206987	15329	63266565
Agranulocytosis	54.24	9.14	193	206935	24941	63256953
Atrial tachycardia	54.13	9.14	68	207060	4172	63277722
Weight increased	53.90	9.14	567	206561	260225	63021669
Hepatocellular injury	53.82	9.14	204	206924	27177	63254717
Swelling face	53.06	9.14	372	206756	63103	63218791
Cholestasis	51.96	9.14	212	206916	29222	63252672
Accidental exposure to product	51.35	9.14	13	207115	27392	63254502
Therapy interrupted	50.93	9.14	21	207107	32434	63249460
Psoriasis	50.76	9.14	132	206996	86825	63195069
Facet joint syndrome	50.46	9.14	118	207010	12020	63269874
Tension headache	49.20	9.14	72	207056	5114	63276780
Faeces discoloured	48.72	9.14	152	206976	18357	63263537
Rectal haemorrhage	48.67	9.14	300	206828	48730	63233164
Dry mouth	48.34	9.14	426	206702	77437	63204457
Foetal exposure during pregnancy	48.06	9.14	22	207106	31940	63249954
Hyperglycaemia	47.93	9.14	266	206862	41601	63240293
Wound	46.69	9.14	326	206802	162937	63118957
International normalised ratio increased	46.67	9.14	285	206843	46140	63235754
Injection site pruritus	46.56	9.14	47	207081	45069	63236825
Brain stem glioma	46.46	9.14	19	207109	173	63281721
Anti-cyclic citrullinated peptide antibody positive	46.33	9.14	208	206920	116004	63165890
Injection site reaction	45.88	9.14	75	207053	58449	63223445
Drug hypersensitivity	45.86	9.14	725	206403	309962	62971932
Vomiting	45.47	9.14	2246	204882	557371	62724523
Peripheral venous disease	45.36	9.14	132	206996	15345	63266549
Pemphigoid	45.34	9.14	84	207044	7260	63274634
Post-traumatic stress disorder	44.27	9.14	69	207059	5182	63276712
Gastritis	44.04	9.14	239	206889	37064	63244830
Immunisation	43.59	9.14	34	207094	1159	63280735
Injection site erythema	43.56	9.14	133	206995	83041	63198853
Lethargy	43.21	9.14	322	206806	55685	63226209
Dysphagia	42.88	9.14	460	206668	88125	63193769
Carotid artery occlusion	42.85	9.14	64	207064	4630	63277264
Coordination abnormal	42.82	9.14	120	207008	13653	63268241
Asthma	42.63	9.14	618	206510	126943	63154951
Injection site swelling	42.14	9.14	56	207072	47516	63234378
Jaundice	41.97	9.14	198	206930	29053	63252841
Liver function test abnormal	41.82	9.14	285	206843	47896	63233998
Autoimmune disorder	41.52	9.14	137	206991	17040	63264854
Macular degeneration	41.22	9.14	14	207114	24362	63257532
Inappropriate schedule of product administration	40.30	9.14	188	206940	103777	63178117
Biliary dyskinesia	40.10	9.14	47	207081	2682	63279212
Wrong technique in product usage process	40.04	9.14	90	207038	62250	63219644
Transient ischaemic attack	40.02	9.14	235	206893	37518	63244376
Upper respiratory tract inflammation	39.68	9.14	45	207083	2478	63279416
Post cholecystectomy syndrome	39.53	9.14	22	207106	417	63281477
Peripheral swelling	39.43	9.14	620	206508	265322	63016572
Liver disorder	39.37	9.14	305	206823	53382	63228512
Coma scale abnormal	38.37	9.14	64	207064	5089	63276805
Hepatic ischaemia	38.31	9.14	25	207103	639	63281255
Red blood cell sedimentation rate abnormal	37.82	9.14	9	207119	19773	63262121
Skin candida	37.70	9.14	36	207092	1619	63280275
Abdominal pain upper	37.20	9.14	909	206219	205535	63076359
Blood alkaline phosphatase increased	37.19	9.14	254	206874	42713	63239181
Circulatory collapse	37.14	9.14	156	206972	21782	63260112
Facial pain	36.84	9.14	96	207032	10465	63271429
Basilar artery occlusion	36.81	9.14	14	207114	103	63281791
Drug reaction with eosinophilia and systemic symptoms	36.76	9.14	212	206916	33624	63248270
Suicide attempt	36.69	9.14	91	207037	60827	63221067
Anaphylactic reaction	36.66	9.14	353	206775	65747	63216147
Discomfort	36.57	9.14	359	206769	167015	63114879
Demyelination	36.43	9.14	74	207054	6846	63275048
Nasopharyngitis	35.94	9.14	598	206530	253659	63028235
Therapy cessation	35.91	9.14	28	207100	30429	63251465
Anaemia	35.79	9.14	1230	205898	292200	62989694
Neutrophil count decreased	35.73	9.14	310	206818	56096	63225798
Nephrocalcinosis	35.70	9.14	29	207099	1049	63280845
Oesophagitis	35.66	9.14	119	207009	14889	63267005
Rheumatoid arthritis	35.54	9.14	598	206530	253221	63028673
Mixed liver injury	35.52	9.14	59	207069	4676	63277218
Hospitalisation	35.29	9.14	150	206978	84931	63196963
Crohn's disease	35.23	9.14	60	207068	4853	63277041
Hypersensitivity	35.23	9.14	708	206420	291977	62989917
Device dislocation	35.20	9.14	20	207108	25685	63256209
Reflux gastritis	35.12	9.14	30	207098	1165	63280729
Hepatorenal syndrome	34.79	9.14	37	207091	1895	63279999
Abortion spontaneous	34.69	9.14	63	207065	47132	63234762
Gastrooesophageal reflux disease	34.63	9.14	470	206658	95169	63186725
Hypophosphataemic osteomalacia	34.39	9.14	16	207112	204	63281690
Decreased appetite	34.12	9.14	1066	206062	249986	63031908
Hallucination	34.07	9.14	300	206828	54517	63227377
Somatic delusion	33.45	9.14	22	207106	570	63281324
Muscle twitching	33.40	9.14	140	206988	19528	63262366
Renal tubular acidosis	33.33	9.14	34	207094	1658	63280236
Urine magnesium decreased	33.10	9.14	7	207121	0	63281894
Condition aggravated	32.98	9.14	1030	206098	401187	62880707
Disseminated intravascular coagulation	32.66	9.14	136	206992	18915	63262979
Deep vein thrombosis	32.49	9.14	417	206711	83383	63198511
Cholecystitis acute	31.85	9.14	78	207050	8182	63273712
Temperature intolerance	31.80	9.14	82	207046	8882	63273012
Adrenal insufficiency	31.59	9.14	129	206999	17786	63264108
Hepatotoxicity	31.41	9.14	45	207083	36996	63244898
COVID-19	31.27	9.14	228	206900	112875	63169019
Drug interaction	31.15	9.14	973	206155	228158	63053736
Erythema multiforme	31.03	9.14	88	207040	10081	63271813
Progressive multifocal leukoencephalopathy	30.95	9.14	103	207025	12868	63269026
Coronary artery disease	30.81	9.14	196	206932	32181	63249713
Mobility decreased	30.80	9.14	250	206878	120909	63160985
Palpitations	30.72	9.14	528	206600	112242	63169652
Hyperkalaemia	30.32	9.14	290	206838	53913	63227981
Altered state of consciousness	30.02	9.14	162	206966	25068	63256826
Anosmia	29.96	9.14	68	207060	6792	63275102
Hypergastrinaemia	29.66	9.14	12	207116	106	63281788
Post viral fatigue syndrome	28.86	9.14	16	207112	301	63281593
Injury	28.61	9.14	365	206763	72882	63209012
Urine phosphorus decreased	28.37	9.14	6	207122	0	63281894
Blood sodium decreased	28.37	9.14	155	206973	24097	63257797
Dehydration	27.91	9.14	752	206376	172602	63109292
Total lung capacity decreased	27.85	9.14	35	207093	2148	63279746
Haemorrhage subcutaneous	27.70	9.14	41	207087	2942	63278952
Sedation	27.47	9.14	53	207075	38756	63243138
Urine potassium decreased	27.34	9.14	7	207121	9	63281885
No adverse event	27.22	9.14	59	207069	41346	63240548
Drug resistance	27.14	9.14	21	207107	22912	63258982
Pituitary tumour benign	27.08	9.14	33	207095	1962	63279932
Pneumonia bacterial	27.04	9.14	80	207048	9385	63272509
Rectal ulcer	26.33	9.14	26	207102	1219	63280675
Gastric polyps	26.31	9.14	43	207085	3362	63278532
Blood immunoglobulin A increased	25.91	9.14	21	207107	757	63281137
Hyperchlorhydria	25.84	9.14	31	207097	1813	63280081
Lung opacity	25.84	9.14	41	207087	3127	63278767
Influenza	25.54	9.14	229	206899	108493	63173401
Granulocyte count increased	25.50	9.14	22	207106	866	63281028
Syncope	25.23	9.14	530	206598	116855	63165039
Urine output decreased	25.12	9.14	88	207040	11282	63270612
Multiple sclerosis relapse	25.04	9.14	78	207050	48400	63233494
Aspiration	24.86	9.14	85	207043	10766	63271128
Erythema dyschromicum perstans	24.81	9.14	9	207119	57	63281837
Genital ulceration	24.65	9.14	19	207109	636	63281258
Product storage error	24.58	9.14	9	207119	14947	63266947
Toxic skin eruption	24.50	9.14	95	207033	12790	63269104
Wrong patient received product	24.44	9.14	33	207095	2174	63279720
Wheezing	24.40	9.14	443	206685	95152	63186742
Iron deficiency anaemia	24.29	9.14	129	206999	19840	63262054
Renal atrophy	24.28	9.14	27	207101	1455	63280439
Aspartate aminotransferase	24.11	9.14	16	207112	421	63281473
Nightmare	24.03	9.14	125	207003	19069	63262825
Inappropriate antidiuretic hormone secretion	23.91	9.14	107	207021	15355	63266539
Rheumatoid factor positive	23.89	9.14	169	206959	84237	63197657
Bronchopulmonary aspergillosis allergic	23.85	9.14	33	207095	2225	63279669
Dermatitis exfoliative	23.71	9.14	54	207074	5405	63276489
Full blood count decreased	23.70	9.14	30	207098	25994	63255900
Medication error	23.69	9.14	268	206860	52016	63229878
Diarrhoea	23.54	9.14	2671	204457	712695	62569199
Pancreatitis	23.39	9.14	254	206874	48801	63233093
Cerebral haemorrhage	23.32	9.14	176	206952	30553	63251341
Blood lactic acid decreased	23.18	9.14	11	207117	147	63281747
Chromaturia	23.14	9.14	112	207016	16605	63265289
Vasculitis	23.09	9.14	119	207009	18090	63263804
Foetal death	23.06	9.14	4	207124	10976	63270918
Blood pressure increased	22.93	9.14	381	206747	161681	63120213
Hyperparathyroidism secondary	22.79	9.14	26	207102	1441	63280453
Haematuria	22.69	9.14	168	206960	28989	63252905
Injection site bruising	22.67	9.14	66	207062	41844	63240050
Hypersensitivity pneumonitis	22.59	9.14	35	207093	2615	63279279
Dermatitis bullous	22.51	9.14	70	207058	8438	63273456
Neuropathy, ataxia, retinitis pigmentosa syndrome	22.42	9.14	8	207120	48	63281846
Deja vu	22.39	9.14	9	207119	78	63281816
Rhinorrhoea	22.33	9.14	124	207004	65453	63216441
Neoplasm progression	22.26	9.14	54	207074	36374	63245520
Device difficult to use	22.25	9.14	7	207121	12789	63269105
Excessive eye blinking	22.15	9.14	24	207104	1256	63280638
C-reactive protein	22.00	9.14	49	207079	4833	63277061
Hiatus hernia	21.98	9.14	133	206995	21461	63260433
Joint stiffness	21.88	9.14	67	207061	41802	63240092
Muscle relaxant therapy	21.88	9.14	11	207117	168	63281726
Foot deformity	21.54	9.14	36	207092	27817	63254077
Laryngeal pain	21.23	9.14	46	207082	4452	63277442
Rheumatoid nodule	21.22	9.14	15	207113	17140	63264754
Bursitis	21.12	9.14	199	206929	36842	63245052
Platelet count decreased	21.10	9.14	512	206616	115610	63166284
Blood uric acid increased	21.04	9.14	51	207077	5316	63276578
Deformity	21.03	9.14	6	207122	11678	63270216
Cardiac failure	20.99	9.14	408	206720	88734	63193160
Pain in extremity	20.99	9.14	876	206252	330610	62951284
Oesophageal mucosal tear	20.90	9.14	6	207122	15	63281879
Hyperprolactinaemia	20.88	9.14	42	207086	3858	63278036
Nasal congestion	20.84	9.14	127	207001	65533	63216361
Fluid retention	20.79	9.14	112	207016	59574	63222320
Gastrointestinal haemorrhage	20.65	9.14	376	206752	80800	63201094
Dysuria	20.63	9.14	184	206944	33554	63248340
Abnormal loss of weight	20.62	9.14	53	207075	5729	63276165
Sleep disorder due to a general medical condition	20.61	9.14	7	207121	12181	63269713
Blood lactic acid	20.60	9.14	9	207119	98	63281796
Injection site warmth	20.55	9.14	12	207116	15183	63266711
Amnesia	20.46	9.14	274	206854	55311	63226583
Gallbladder disorder	20.43	9.14	118	207010	18724	63263170
Hypoxic-ischaemic encephalopathy	20.42	9.14	44	207084	4243	63277651
Upper gastrointestinal haemorrhage	20.40	9.14	118	207010	18734	63263160
Haemoptysis	20.39	9.14	162	206966	28564	63253330
Gastric ulcer	20.15	9.14	141	206987	23896	63257998
Lung disorder	20.14	9.14	300	206828	61961	63219933
Vitamin B1 decreased	20.12	9.14	11	207117	201	63281693
Angina pectoris	19.94	9.14	167	206961	29911	63251983
Oedema peripheral	19.82	9.14	781	206347	188730	63093164
Oropharyngeal oedema	19.80	9.14	13	207115	336	63281558
Carcinoid tumour of the stomach	19.64	9.14	10	207118	157	63281737
Gastric dysplasia	19.64	9.14	6	207122	20	63281874
Glomerular filtration rate increased	19.45	9.14	19	207109	879	63281015
Premature delivery	19.21	9.14	44	207084	30237	63251657
Cholecystitis	19.16	9.14	100	207028	15277	63266617
Pneumocystis jirovecii pneumonia	19.04	9.14	107	207021	16807	63265087
Ventricular tachycardia	19.04	9.14	121	207007	19858	63262036
Genital pain	19.01	9.14	14	207114	437	63281457
Flashback	18.99	9.14	10	207118	169	63281725
Human herpesvirus 6 infection reactivation	18.98	9.14	13	207115	361	63281533
Infection	18.96	9.14	586	206542	228587	63053307
Blood urea increased	18.86	9.14	149	206979	26230	63255664
Immunodeficiency	18.81	9.14	23	207105	20231	63261663
Obesity	18.65	9.14	164	206964	29788	63252106
Musculoskeletal disorder	18.59	9.14	24	207104	20620	63261274
Red blood cell sedimentation rate increased	18.57	9.14	77	207051	43905	63237989
Hypocalciuria	18.52	9.14	5	207123	9	63281885
Anal prolapse	18.48	9.14	8	207120	85	63281809
Panniculitis	18.46	9.14	7	207121	11378	63270516
Malaise	18.44	9.14	1586	205542	414368	62867526
Intestinal ischaemia	18.44	9.14	60	207068	7408	63274486
Face oedema	18.40	9.14	121	207007	20091	63261803
Enthesopathy	18.39	9.14	3	207125	8611	63273283
Stoma site haemorrhage	18.39	9.14	20	207108	1051	63280843
Pain of skin	18.36	9.14	81	207047	11553	63270341
Dopamine transporter scintigraphy abnormal	18.32	9.14	8	207120	87	63281807
Seasonal allergy	18.21	9.14	25	207103	20925	63260969
Tinnitus	18.17	9.14	187	206941	35441	63246453
Device issue	18.15	9.14	31	207097	23750	63258144
Acne	18.11	9.14	30	207098	23263	63258631
Rheumatoid factor increased	18.02	9.14	26	207102	1823	63280071
Therapeutic response decreased	17.99	9.14	122	207006	61403	63220491
Respiratory arrest	17.96	9.14	51	207077	32594	63249300
Hypoglycaemic coma	17.88	9.14	31	207097	2544	63279350
Bradycardia	17.87	9.14	337	206791	72890	63209004
Enterochromaffin cell hyperplasia	17.80	9.14	7	207121	57	63281837
Hypochloraemia	17.78	9.14	27	207101	1982	63279912
Chronic kidney disease-mineral and bone disorder	17.70	9.14	8	207120	95	63281799
Activated partial thromboplastin time prolonged	17.58	9.14	56	207072	6837	63275057
Dialysis	17.53	9.14	74	207054	10353	63271541
Nervous system disorder	17.48	9.14	113	207015	18653	63263241
Mediastinitis	17.41	9.14	10	207118	202	63281692
Genitourinary symptom	17.38	9.14	7	207121	61	63281833
Stress	17.33	9.14	138	206990	67029	63214865
Gastrointestinal motility disorder	17.31	9.14	46	207082	5073	63276821
Aphasia	17.20	9.14	174	206954	32826	63249068
Single functional kidney	17.19	9.14	12	207116	344	63281550
Infusion site streaking	17.13	9.14	14	207114	511	63281383
Generalised bullous fixed drug eruption	17.12	9.14	8	207120	103	63281791
Biliary sepsis	17.07	9.14	18	207110	913	63280981
Intentional overdose	17.06	9.14	157	206971	73995	63207899
Pancreatitis acute	17.04	9.14	149	206979	27017	63254877
Hip fracture	16.99	9.14	45	207083	29429	63252465
Pressure of speech	16.93	9.14	16	207112	710	63281184
Hypophosphataemia	16.87	9.14	78	207050	11348	63270546
Protein-losing gastroenteropathy	16.85	9.14	10	207118	215	63281679
Vulvovaginal candidiasis	16.77	9.14	34	207094	3141	63278753
Non-economic loss	16.76	9.14	5	207123	15	63281879
Device dependence	16.76	9.14	5	207123	15	63281879
Orthostatic hypotension	16.67	9.14	186	206942	35974	63245920
Enterocolitis	16.66	9.14	60	207068	7798	63274096
Product use in unapproved indication	16.54	9.14	451	206677	178629	63103265
Colon cancer	16.53	9.14	70	207058	9808	63272086
Eosinophilia	16.52	9.14	129	206999	22627	63259267
Hyponatraemic syndrome	16.45	9.14	14	207114	541	63281353
Parosmia	16.37	9.14	51	207077	6155	63275739
Alanine aminotransferase increased	16.36	9.14	449	206679	103321	63178573
Purpura	16.28	9.14	77	207051	11308	63270586
Hyperhidrosis	16.27	9.14	464	206664	107372	63174522
Skin necrosis	16.22	9.14	13	207115	13937	63267957
Pneumonia aspiration	16.08	9.14	178	206950	34362	63247532
Azotaemia	15.96	9.14	41	207087	4430	63277464
Limb discomfort	15.92	9.14	47	207081	29669	63252225
Blood parathyroid hormone decreased	15.91	9.14	6	207122	9785	63272109
Multiple allergies	15.88	9.14	13	207115	13789	63268105
Vitamin B12 increased	15.87	9.14	19	207109	1109	63280785
Infusion site pain	15.83	9.14	19	207109	16850	63265044
Respiratory tract congestion	15.78	9.14	21	207107	17811	63264083
Rapid eye movement sleep behaviour disorder	15.76	9.14	11	207117	315	63281579
Intentional self-injury	15.75	9.14	38	207090	25649	63256245
Hepatic cytolysis	15.75	9.14	95	207033	15312	63266582
Joint injury	15.68	9.14	47	207081	29525	63252369
Product quality issue	15.64	9.14	62	207066	35803	63246091
Acute coronary syndrome	15.60	9.14	70	207058	10056	63271838
Neuropathy peripheral	15.50	9.14	483	206645	113184	63168710
Maternal exposure before pregnancy	15.47	9.14	3	207125	7600	63274294
Pyrexia	15.47	9.14	1757	205371	468721	62813173
Narrow anterior chamber angle	15.45	9.14	6	207122	47	63281847
Pulmonary embolism	15.44	9.14	494	206634	116190	63165704
Psoriatic arthropathy	15.41	9.14	208	206920	91312	63190582
Complication of device insertion	15.36	9.14	3	207125	7561	63274333
Eosinophilic pneumonia chronic	15.35	9.14	9	207119	189	63281705
Gallbladder injury	15.34	9.14	21	207107	1402	63280492
Product substitution issue	15.32	9.14	97	207031	15899	63265995
White blood cell count increased	15.32	9.14	233	206895	48328	63233566
Enteritis infectious	15.31	9.14	26	207102	2098	63279796
Stevens-Johnson syndrome	15.22	9.14	136	206992	24814	63257080
Bone pain	15.17	9.14	110	207018	54531	63227363
Superinfection	15.08	9.14	29	207099	2578	63279316
Unevaluable event	14.97	9.14	102	207026	51284	63230610
Cholangitis	14.94	9.14	46	207082	5515	63276379
Myocardial ischaemia	14.91	9.14	82	207046	12777	63269117
Vascular skin disorder	14.89	9.14	4	207124	7	63281887
Injection site rash	14.84	9.14	24	207104	18785	63263109
Diplopia	14.81	9.14	130	206998	23598	63258296
Drug ineffective for unapproved indication	14.78	9.14	59	207069	34004	63247890
Inflammatory bowel disease	14.77	9.14	37	207091	3936	63277958
Oral mucosal discolouration	14.76	9.14	11	207117	350	63281544
Blood triglycerides increased	14.73	9.14	80	207048	12408	63269486
Cardioactive drug level increased	14.65	9.14	26	207102	2174	63279720
Oesophageal food impaction	14.59	9.14	9	207119	208	63281686
Palmar erythema	14.59	9.14	23	207105	1744	63280150
Musculoskeletal stiffness	14.56	9.14	475	206653	184143	63097751
Paramnesia	14.55	9.14	4	207124	8	63281886
Gastrointestinal stoma output decreased	14.54	9.14	6	207122	56	63281838
Gastric cancer	14.54	9.14	41	207087	4682	63277212
Injection site mass	14.53	9.14	24	207104	18632	63263262
Phyllodes tumour	14.45	9.14	5	207123	27	63281867
Blood pressure decreased	14.43	9.14	295	206833	64727	63217167
Muscle spasticity	14.37	9.14	31	207097	21763	63260131
Bronchiectasis	14.31	9.14	96	207032	16046	63265848
Oesophageal carcinoma recurrent	14.30	9.14	5	207123	28	63281866
Gastroenteritis	14.25	9.14	141	206987	26449	63255445
Renal cyst	14.24	9.14	69	207059	10233	63271661
Erythema annulare	14.22	9.14	7	207121	102	63281792
Urine output	14.19	9.14	3	207125	0	63281894
Pre-eclampsia	14.18	9.14	6	207122	9127	63272767
Cardiac output increased	14.11	9.14	9	207119	221	63281673
Eye haemorrhage	14.06	9.14	60	207068	8436	63273458
Hypophagia	14.05	9.14	160	206968	31099	63250795
Dizziness	14.05	9.14	1605	205523	428320	62853574
Abortion induced	13.98	9.14	8	207120	10234	63271660
Catarrh	13.97	9.14	21	207107	1528	63280366
Femoral neck fracture	13.96	9.14	60	207068	8463	63273431
Ileus	13.92	9.14	89	207039	14636	63267258
Rhabdomyolysis	13.91	9.14	211	206917	43740	63238154
Haemodialysis	13.90	9.14	62	207066	8885	63273009
Finger deformity	13.90	9.14	4	207124	7741	63274153
Device malfunction	13.89	9.14	23	207105	17834	63264060
Oesophageal achalasia	13.87	9.14	12	207116	474	63281420
Blood creatinine increased	13.82	9.14	380	206748	87464	63194430
Secondary adrenocortical insufficiency	13.80	9.14	20	207108	1408	63280486
Lactic acidosis	13.78	9.14	188	206940	38099	63243795
Metastases to bone	13.78	9.14	30	207098	20989	63260905
Oropharyngeal swelling	13.76	9.14	16	207112	905	63280989
Tooth hypoplasia	13.76	9.14	6	207122	65	63281829
Lower limb fracture	13.75	9.14	130	206998	24091	63257803
Arthritis	13.74	9.14	281	206847	115640	63166254
Urine calcium/creatinine ratio increased	13.58	9.14	7	207121	113	63281781
Bile duct stone	13.54	9.14	34	207094	3622	63278272
Mouth swelling	13.48	9.14	40	207088	4700	63277194
Renal haemangioma	13.36	9.14	5	207123	35	63281859
Laryngotracheal oedema	13.36	9.14	5	207123	35	63281859
Spleen congestion	13.31	9.14	7	207121	118	63281776
Haematotoxicity	13.27	9.14	7	207121	9369	63272525
Ejection fraction decreased	13.25	9.14	121	207007	22211	63259683
General physical health deterioration	13.20	9.14	530	206598	200872	63081022
Aplastic anaemia	13.17	9.14	64	207064	9505	63272389
Morbid thoughts	13.16	9.14	13	207115	610	63281284
Basal cell carcinoma	13.11	9.14	47	207081	27944	63253950
Illness	13.03	9.14	100	207028	48959	63232935
Multiple injuries	12.95	9.14	22	207106	1776	63280118
Multiple sclerosis	12.94	9.14	129	206999	24243	63257651
Atypical fracture	12.93	9.14	13	207115	623	63281271
Dermatitis psoriasiform	12.91	9.14	25	207103	2234	63279660
Bradyphrenia	12.90	9.14	51	207077	6929	63274965
Throat clearing	12.89	9.14	26	207102	2393	63279501
Mucosal inflammation	12.87	9.14	220	206908	46708	63235186
Ulcer	12.82	9.14	136	206992	25971	63255923
Delirium	12.81	9.14	234	206894	50307	63231587
Cholelithiasis	12.81	9.14	208	206920	43717	63238177
Aortic valve calcification	12.80	9.14	12	207116	527	63281367
Food allergy	12.80	9.14	11	207117	11390	63270504
Urinary straining	12.79	9.14	5	207123	40	63281854
Pleuritic pain	12.75	9.14	56	207072	7973	63273921
Laboratory test abnormal	12.73	9.14	45	207083	26867	63255027
Immune thrombocytopenia	12.70	9.14	68	207060	10488	63271406
Cystitis noninfective	12.67	9.14	16	207112	987	63280907
Sinus bradycardia	12.58	9.14	86	207042	14465	63267429
Vulval haemorrhage	12.53	9.14	4	207124	16	63281878
Mouth ulceration	12.30	9.14	163	206965	32821	63249073
Herpes zoster	12.28	9.14	192	206936	82270	63199624
Drug tolerance decreased	12.25	9.14	24	207104	17449	63264445
Muscle tension dysphonia	12.21	9.14	8	207120	206	63281688
Disability	12.18	9.14	26	207102	18321	63263573
Osteonecrosis	12.15	9.14	128	207000	24402	63257492
Obstructive nephropathy	12.12	9.14	3	207125	3	63281891
Hepatic failure	12.00	9.14	173	206955	35483	63246411
Subdural haematoma	11.98	9.14	84	207044	14244	63267650
Pancreatic carcinoma recurrent	11.97	9.14	6	207122	91	63281803
Breast cancer female	11.97	9.14	16	207112	13543	63268351
Oligohydramnios	11.97	9.14	3	207125	6363	63275531
Rash erythematous	11.92	9.14	200	206928	42310	63239584
Hiccups	11.91	9.14	24	207104	2207	63279687
Vaginal cellulitis	11.86	9.14	6	207122	93	63281801
Wheelchair user	11.83	9.14	3	207125	6316	63275578
Emotional distress	11.79	9.14	160	206968	32389	63249505
Hydronephrosis	11.71	9.14	67	207061	10595	63271299
Degenerative mitral valve disease	11.65	9.14	4	207124	21	63281873
Joint destruction	11.65	9.14	3	207125	6249	63275645
Myelosuppression	11.64	9.14	39	207089	23664	63258230
Rash papulosquamous	11.63	9.14	6	207122	97	63281797
Pharyngotonsillitis	11.53	9.14	7	207121	157	63281737
Dactylitis	11.53	9.14	26	207102	2586	63279308
Physical deconditioning	11.45	9.14	14	207114	835	63281059
Unintended pregnancy	11.44	9.14	3	207125	6176	63275718
Bronchitis	11.44	9.14	315	206813	124620	63157274
Gastrointestinal perforation	11.43	9.14	31	207097	3460	63278434
Tongue discolouration	11.40	9.14	29	207099	3114	63278780
Transplant rejection	11.39	9.14	11	207117	10769	63271125
Multiple fractures	11.38	9.14	7	207121	8611	63273283
Overdose	11.36	9.14	287	206841	114791	63167103
Anxiety disorder	11.35	9.14	34	207094	4016	63277878
Dilatation atrial	11.34	9.14	22	207106	1969	63279925
Renal cyst haemorrhage	11.32	9.14	5	207123	56	63281838
Secretion discharge	11.24	9.14	14	207114	12217	63269677
Poisoning deliberate	11.22	9.14	12	207116	11206	63270688
Post cardiac arrest syndrome	11.21	9.14	4	207124	24	63281870
Blood phosphorus decreased	11.20	9.14	36	207092	4417	63277477
Gambling	11.20	9.14	8	207120	238	63281656
Staphylococcus test positive	11.20	9.14	33	207095	3863	63278031
Splenic vein thrombosis	11.16	9.14	9	207119	322	63281572
Multiple organ dysfunction syndrome	11.15	9.14	253	206875	56499	63225395
Large intestine perforation	11.15	9.14	56	207072	8426	63273468
Hepatitis acute	11.15	9.14	59	207069	9061	63272833
Chronic gastritis	11.14	9.14	27	207101	2814	63279080
Adjustment disorder with depressed mood	11.13	9.14	64	207064	10140	63271754
Knee arthroplasty	11.11	9.14	118	207010	54088	63227806
Cytomegalovirus test positive	11.11	9.14	28	207100	2990	63278904
Hospice care	11.11	9.14	6	207122	7926	63273968
Tachypnoea	11.09	9.14	25	207103	17277	63264617
Abdominal rigidity	11.08	9.14	22	207106	2002	63279892
Presyncope	11.08	9.14	139	206989	27646	63254248
Nasal polyps	11.06	9.14	3	207125	6036	63275858
Depression	10.97	9.14	763	206365	195729	63086165
Sinus congestion	10.96	9.14	27	207101	18096	63263798
Photodermatosis	10.95	9.14	10	207118	425	63281469
Cardiotoxicity	10.94	9.14	7	207121	8431	63273463
Dyspnoea	10.93	9.14	2377	204751	658936	62622958
Creatinine renal clearance decreased	10.92	9.14	23	207105	16285	63265609
Bronchogenic cyst	10.91	9.14	3	207125	6	63281888
Pleural effusion	10.90	9.14	389	206739	92821	63189073
Cold sweat	10.89	9.14	72	207056	11975	63269919
Hypoproteinaemia	10.89	9.14	22	207106	2027	63279867
Blood albumin decreased	10.88	9.14	84	207044	14682	63267212
Discoloured vomit	10.88	9.14	14	207114	880	63281014
Autonomic neuropathy	10.86	9.14	16	207112	1143	63280751
Hemiparesis	10.84	9.14	120	207008	23162	63258732
Aortic aneurysm rupture	10.81	9.14	11	207117	535	63281359
Prothrombin time ratio increased	10.68	9.14	6	207122	116	63281778
Inadequate diet	10.66	9.14	7	207121	181	63281713
Gingival bleeding	10.65	9.14	74	207054	12513	63269381
Enterocolitis haemorrhagic	10.64	9.14	18	207110	1448	63280446
Lacunar infarction	10.61	9.14	29	207099	3251	63278643
Joint dislocation	10.61	9.14	29	207099	18771	63263123
Optic neuritis	10.61	9.14	55	207073	8380	63273514
Gastrointestinal amyloidosis	10.59	9.14	5	207123	66	63281828
Joint noise	10.59	9.14	35	207093	4357	63277537
Small intestinal haemorrhage	10.58	9.14	22	207106	2070	63279824
Coagulopathy	10.55	9.14	108	207020	20436	63261458
Hyperuricaemia	10.54	9.14	40	207088	5330	63276564
Bleeding time prolonged	10.53	9.14	12	207116	664	63281230
Adrenal suppression	10.51	9.14	14	207114	910	63280984
Road traffic accident	10.51	9.14	173	206955	36459	63245435
Blood cholinesterase decreased	10.50	9.14	6	207122	120	63281774
Occult blood positive	10.47	9.14	31	207097	3639	63278255
Rectocele	10.46	9.14	15	207113	1046	63280848
Blood electrolytes abnormal	10.46	9.14	15	207113	1046	63280848
Bradyarrhythmia	10.41	9.14	22	207106	2093	63279801
Nasal mucosal erosion	10.40	9.14	5	207123	69	63281825
Hypoglycaemia	10.36	9.14	263	206865	59802	63222092
Uraemic encephalopathy	10.35	9.14	8	207120	269	63281625
Poisoning	10.33	9.14	18	207110	13682	63268212
Product dose omission in error	10.31	9.14	6	207122	7606	63274288
Hypercapnic coma	10.30	9.14	7	207121	192	63281702
Gallbladder hypofunction	10.29	9.14	11	207117	567	63281327
Pathogen resistance	10.27	9.14	4	207124	6394	63275500
Fasciitis	10.22	9.14	11	207117	571	63281323
Apraxia	10.22	9.14	20	207108	1801	63280093
Blood pressure systolic increased	10.20	9.14	102	207026	47295	63234599
Nocturia	10.18	9.14	53	207075	8088	63273806
Dyslalia	10.16	9.14	10	207118	467	63281427
Depressed mood	10.16	9.14	186	206942	40005	63241889
Macroglossia	10.12	9.14	12	207116	693	63281201
Surgery	10.11	9.14	72	207056	35840	63246054
Hyperlipidaemia	10.11	9.14	103	207025	19468	63262426
Cross sensitivity reaction	10.08	9.14	22	207106	2140	63279754
Intentional dose omission	10.07	9.14	7	207121	8068	63273826
Prescribed overdose	10.06	9.14	162	206966	33991	63247903
Central nervous system lesion	9.96	9.14	12	207116	10623	63271271
Skin haemorrhage	9.87	9.14	11	207117	10083	63271811
Fall	9.84	9.14	1125	206003	391209	62890685
Regurgitation	9.83	9.14	19	207109	1695	63280199
Caesarean section	9.82	9.14	26	207102	17006	63264888
Rash papular	9.79	9.14	86	207042	15616	63266278
Toxic epidermal necrolysis	9.78	9.14	126	207002	25208	63256686
Osteoporosis	9.76	9.14	130	206998	57208	63224686
Gastrointestinal tract irritation	9.75	9.14	10	207118	491	63281403
Disturbance in attention	9.75	9.14	177	206951	38012	63243882
Sinus disorder	9.74	9.14	44	207084	24509	63257385
Atypical femur fracture	9.72	9.14	39	207089	5333	63276561
Red cell distribution width increased	9.72	9.14	12	207116	10512	63271382
Femoral hernia	9.63	9.14	4	207124	38	63281856
Gestational diabetes	9.55	9.14	8	207120	8388	63273506
Disease recurrence	9.54	9.14	53	207075	27977	63253917
Bone erosion	9.51	9.14	28	207100	17689	63264205
Hyperphosphataemia	9.50	9.14	22	207106	2226	63279668
Adverse event	9.49	9.14	159	206969	67400	63214494
Flat affect	9.48	9.14	17	207111	1433	63280461
Gingival erosion	9.46	9.14	7	207121	220	63281674
Product preparation error	9.46	9.14	4	207124	6088	63275806
Neuroendocrine tumour	9.43	9.14	12	207116	746	63281148
Pulmonary venous thrombosis	9.40	9.14	3	207125	12	63281882
Injection site haemorrhage	9.40	9.14	44	207084	24270	63257624
Intentional product use issue	9.39	9.14	332	206796	127560	63154334
Glycosuria	9.38	9.14	15	207113	1151	63280743
Lip blister	9.36	9.14	23	207105	2417	63279477
Subendocardial ischaemia	9.31	9.14	5	207123	88	63281806
Spinal compression fracture	9.30	9.14	79	207049	14204	63267690
Abnormal faeces	9.30	9.14	39	207089	5441	63276453
Adenocarcinoma gastric	9.28	9.14	10	207118	520	63281374
Rash	9.22	9.14	1650	205478	559221	62722673
Renal hypertension	9.21	9.14	6	207122	153	63281741
Nail dystrophy	9.21	9.14	14	207114	1029	63280865
Pleurisy viral	9.21	9.14	3	207125	13	63281881
Ventricular dysfunction	9.15	9.14	25	207103	2803	63279091

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
Chronic kidney disease	560.35	10.11	748	136483	40462	34779238
Drug ineffective	415.78	10.11	725	136506	456026	34363674
Death	296.80	10.11	708	136523	397341	34422359
Completed suicide	264.48	10.11	36	137195	98132	34721568
End stage renal disease	254.63	10.11	238	136993	8623	34811077
Hyponatraemia	198.32	10.11	744	136487	81947	34737753
Colitis microscopic	184.99	10.11	115	137116	2222	34817478
Interstitial lung disease	182.74	10.11	618	136613	64664	34755036
Renal injury	175.18	10.11	218	137013	10977	34808723
Toxicity to various agents	172.45	10.11	328	136903	200034	34619666
Drug abuse	172.05	10.11	87	137144	99009	34720691
Product dose omission issue	140.08	10.11	158	137073	119553	34700147
Drug dispensed to wrong patient	134.41	10.11	57	137174	467	34819233
Off label use	123.80	10.11	1054	136177	418470	34401230
Appendicolith	106.01	10.11	149	137082	8452	34811248
Treatment failure	102.79	10.11	28	137203	46669	34773031
Acute kidney injury	101.75	10.11	1721	135510	303267	34516433
Cardiospasm	98.35	10.11	67	137164	1521	34818179
Palmoplantar keratoderma	88.10	10.11	68	137163	1885	34817815
Fatigue	87.36	10.11	983	136248	369670	34450030
Pruritus genital	87.11	10.11	71	137160	2133	34817567
Lip swelling	87.00	10.11	194	137037	15886	34803814
Cerebral infarction	86.75	10.11	271	136960	27184	34792516
Tension headache	86.03	10.11	81	137150	2961	34816739
Nephrogenic anaemia	84.82	10.11	70	137161	2141	34817559
Lower respiratory tract infection	80.22	10.11	290	136941	31347	34788353
Neutropenic sepsis	77.77	10.11	169	137062	13598	34806102
Appendicitis	77.16	10.11	176	137055	14631	34805069
Foetal exposure during pregnancy	74.71	10.11	28	137203	38073	34781627
Hepatic function abnormal	74.25	10.11	358	136873	44005	34775695
Hypertensive nephropathy	71.31	10.11	36	137195	455	34819245
Drug resistance	70.98	10.11	9	137222	25918	34793782
Product use in unapproved indication	70.02	10.11	232	136999	117267	34702433
Sleep terror	69.95	10.11	64	137167	2254	34817446
Immunisation	68.03	10.11	46	137185	1031	34818669
Atrial tachycardia	66.91	10.11	77	137154	3568	34816132
Venous pressure jugular increased	64.88	10.11	40	137191	761	34818939
Facial pain	64.24	10.11	76	137155	3628	34816072
Hypomagnesaemia	63.85	10.11	210	137021	21641	34798059
Intentional overdose	62.40	10.11	48	137183	43626	34776074
Antimicrobial susceptibility test resistant	61.99	10.11	30	137201	344	34819356
Wrong patient received product	60.80	10.11	63	137168	2591	34817109
Malaise	59.37	10.11	1042	136189	184783	34634917
Minimum inhibitory concentration	57.57	10.11	23	137208	159	34819541
Carotid artery occlusion	57.22	10.11	72	137159	3665	34816035
Suicide attempt	54.61	10.11	44	137187	39072	34780628
Anosmia	54.55	10.11	73	137158	3951	34815749
Toxic epidermal necrolysis	54.51	10.11	198	137033	21448	34798252
Disease progression	54.20	10.11	229	137002	107848	34711852
Pain of skin	51.71	10.11	89	137142	6020	34813680
Cholestasis	50.64	10.11	225	137006	26723	34792977
Hypoparathyroidism secondary	50.34	10.11	20	137211	136	34819564
Transient ischaemic attack	49.23	10.11	227	137004	27386	34792314
Liver function test abnormal	48.59	10.11	246	136985	30828	34788872
Adrenal suppression	46.61	10.11	30	137201	617	34819083
Renal impairment	46.34	10.11	571	136660	93942	34725758
Therapeutic response delayed	44.53	10.11	29	137202	609	34819091
Nephropathy	43.42	10.11	81	137150	5836	34813864
Full blood count abnormal	43.38	10.11	10	137221	18658	34801042
Hypergastrinaemia	43.31	10.11	15	137216	65	34819635
Diabetic nephropathy	42.55	10.11	47	137184	2081	34817619
Hospitalisation	41.48	10.11	102	137129	56800	34762900
Subarachnoid haemorrhage	41.09	10.11	126	137105	12509	34807191
Stress	40.48	10.11	230	137001	30117	34789583
Ventricular fibrillation	40.40	10.11	188	137043	22766	34796934
Pericarditis	39.63	10.11	118	137113	11527	34808173
Subacute cutaneous lupus erythematosus	39.01	10.11	32	137199	970	34818730
Muscle twitching	38.57	10.11	108	137123	10190	34809510
Weight increased	38.00	10.11	212	137019	92821	34726879
Abdominal distension	37.66	10.11	373	136858	58119	34761581
Therapeutic product effect incomplete	37.31	10.11	90	137141	50451	34769249
Gingival disorder	37.17	10.11	37	137194	1450	34818250
Nasopharyngitis	36.47	10.11	146	137085	69822	34749878
Occupational dermatitis	36.30	10.11	14	137217	87	34819613
Vomiting	35.68	10.11	1246	135985	246375	34573325
Haematemesis	35.64	10.11	208	137023	27503	34792197
Neutrophil count decreased	35.42	10.11	331	136900	50773	34768927
Blood phosphorus increased	35.06	10.11	87	137144	7634	34812066
Chronic kidney disease-mineral and bone disorder	34.98	10.11	21	137210	380	34819320
Overdose	34.79	10.11	212	137019	90847	34728853
Melaena	34.71	10.11	248	136983	35132	34784568
Tubulointerstitial nephritis	34.68	10.11	169	137062	20855	34798845
Tetanus	34.11	10.11	12	137219	55	34819645
Poisoning	34.06	10.11	4	137227	12222	34807478
Rash vesicular	34.06	10.11	48	137183	2729	34816971
Ascites	33.97	10.11	305	136926	46266	34773434
Rash papular	33.89	10.11	103	137128	10175	34809525
Hepatocellular injury	33.44	10.11	174	137057	22037	34797663
Device dependence	33.27	10.11	11	137220	40	34819660
Angioedema	33.27	10.11	256	136975	37118	34782582
Hypocalcaemia	33.00	10.11	185	137046	24104	34795596
Jaundice	32.75	10.11	226	137005	31656	34788044
Vasculitis	32.49	10.11	108	137123	11188	34808512
Agranulocytosis	32.07	10.11	181	137050	23640	34796060
Drug intolerance	31.87	10.11	123	137108	59447	34760253
Abdominal pain	31.74	10.11	854	136377	162764	34656936
Injection site pain	31.61	10.11	66	137165	38939	34780761
Tetany	31.37	10.11	26	137205	800	34818900
Inappropriate schedule of product administration	31.21	10.11	132	137099	62164	34757536
Drug eruption	30.74	10.11	157	137074	19741	34799959
Therapeutic product effect decreased	30.57	10.11	56	137175	34687	34785013
Tinnitus	30.56	10.11	158	137073	19960	34799740
Gastric cancer	30.55	10.11	74	137157	6395	34813305
Diplopia	29.68	10.11	138	137093	16705	34802995
Ventricular tachycardia	29.46	10.11	192	137039	26387	34793313
Hyperchlorhydria	29.00	10.11	23	137208	664	34819036
Weight decreased	28.39	10.11	504	136727	175797	34643903
Palpitations	28.21	10.11	260	136971	39726	34779974
Synovitis	28.14	10.11	10	137221	14056	34805644
Drug hypersensitivity	27.95	10.11	193	137038	80336	34739364
Gait disturbance	27.64	10.11	208	137023	84932	34734768
Eye pruritus	27.52	10.11	78	137153	7411	34812289
Pancreatitis acute	27.45	10.11	197	137034	27944	34791756
Unevaluable event	27.38	10.11	54	137177	32536	34787164
Haemorrhage subcutaneous	26.78	10.11	39	137192	2285	34817415
Blood pressure fluctuation	26.67	10.11	36	137195	25213	34794487
COVID-19	26.35	10.11	187	137044	77363	34742337
Gastric polyps	26.12	10.11	28	137203	1198	34818502
Cytokine release syndrome	25.85	10.11	31	137200	22846	34796854
Accidental exposure to product	25.78	10.11	9	137222	12793	34806907
Liver disorder	25.04	10.11	218	137013	32779	34786921
Pneumonia aspiration	24.95	10.11	263	136968	41640	34778060
Therapy partial responder	24.78	10.11	4	137227	9612	34810088
Intentional product use issue	24.58	10.11	136	137095	59680	34760020
Aplastic anaemia	24.56	10.11	89	137142	9627	34810073
Femoral neck fracture	23.92	10.11	45	137186	3262	34816438
Rheumatoid arthritis	23.79	10.11	74	137157	38164	34781536
Occupational exposure to air contaminants	23.75	10.11	12	137219	152	34819548
Melanoderma	23.68	10.11	12	137219	153	34819547
Pulmonary fibrosis	23.60	10.11	138	137093	18258	34801442
Blood uric acid increased	23.36	10.11	87	137144	9537	34810163
Orthostatic hypotension	23.32	10.11	178	137053	25741	34793959
Asthenia	23.19	10.11	760	136471	244491	34575209
Marasmus	23.08	10.11	19	137212	579	34819121
Hepatitis acute	23.06	10.11	74	137157	7527	34812173
Hepatic cytolysis	22.82	10.11	115	137116	14381	34805319
Therapy non-responder	22.80	10.11	78	137153	39068	34780632
Rectal haemorrhage	22.74	10.11	250	136981	39999	34779701
Amnesia	22.56	10.11	180	137051	26383	34793317
Enteritis infectious	22.52	10.11	27	137204	1307	34818393
Cardiogenic shock	22.40	10.11	180	137051	26438	34793262
Cystitis escherichia	22.26	10.11	12	137219	175	34819525
Protein-losing gastroenteropathy	22.08	10.11	15	137216	339	34819361
Haematotoxicity	22.05	10.11	3	137228	8191	34811509
Disseminated intravascular coagulation	22.02	10.11	154	137077	21662	34798038
Idiopathic pulmonary fibrosis	21.83	10.11	45	137186	3489	34816211
Chest pain	21.61	10.11	651	136580	126111	34693589
Pneumonia bacterial	21.45	10.11	98	137133	11774	34807926
Drug dependence	21.33	10.11	39	137192	24178	34795522
Renal failure	21.33	10.11	667	136564	129890	34689810
Prostatic specific antigen increased	21.13	10.11	16	137215	14664	34805036
Coma	20.94	10.11	100	137131	45578	34774122
Cardio-respiratory arrest	20.93	10.11	129	137102	55144	34764556
Hypoacusis	20.74	10.11	20	137211	16281	34803419
Pain	20.60	10.11	629	136602	204046	34615654
Pathogen resistance	20.28	10.11	6	137225	9476	34810224
Therapy cessation	20.26	10.11	22	137209	16951	34802749
Dehydration	19.93	10.11	659	136572	129310	34690390
Neurotoxicity	19.72	10.11	25	137206	17985	34801715
Neutrophil count increased	19.70	10.11	125	137106	17021	34802679
Gastric varices	19.66	10.11	17	137214	555	34819145
Laboratory test abnormal	19.65	10.11	31	137200	20360	34799340
Therapy interrupted	19.63	10.11	15	137216	13682	34806018
Infusion related reaction	19.49	10.11	125	137106	52932	34766768
Wrong technique in product usage process	19.44	10.11	74	137157	35912	34783788
Blood alkaline phosphatase increased	19.18	10.11	197	137034	30978	34788722
Hypotension	19.06	10.11	695	136536	220954	34598746
Gastrooesophageal reflux disease	18.94	10.11	230	137001	37694	34782006
Product use issue	18.86	10.11	158	137073	63058	34756642
Neuroendocrine tumour	18.85	10.11	19	137212	756	34818944
Hypozincaemia	18.80	10.11	5	137226	6	34819694
Sinobronchitis	18.80	10.11	5	137226	6	34819694
Enterochromaffin cell hyperplasia	18.78	10.11	6	137225	19	34819681
Drug reaction with eosinophilia and systemic symptoms	18.63	10.11	205	137026	32807	34786893
Platelet count decreased	18.60	10.11	608	136623	119109	34700591
Rebound acid hypersecretion	18.53	10.11	9	137222	104	34819596
Renal disorder	18.13	10.11	166	137065	25314	34794386
Failure to anastomose	18.09	10.11	11	137220	204	34819496
Loss of personal independence in daily activities	18.07	10.11	68	137163	33111	34786589
Dissociation	17.92	10.11	27	137204	1631	34818069
Immune reconstitution inflammatory syndrome	17.91	10.11	6	137225	8753	34810947
Hiatus hernia	17.64	10.11	68	137163	7577	34812123
Renal hypertension	17.36	10.11	10	137221	167	34819533
Duodenal polyp	17.32	10.11	11	137220	221	34819479
Bulbospinal muscular atrophy congenital	17.27	10.11	5	137226	10	34819690
Vasculitic rash	17.17	10.11	20	137211	939	34818761
Wrong product administered	17.16	10.11	53	137178	5281	34814419
Neuropathy peripheral	17.14	10.11	227	137004	83036	34736664
Nephrosclerosis	17.13	10.11	20	137211	941	34818759
Haemorrhagic cerebral infarction	17.01	10.11	19	137212	852	34818848
Dialysis	17.01	10.11	88	137143	11120	34808580
Constipation	16.95	10.11	678	136553	136304	34683396
Upper respiratory tract inflammation	16.90	10.11	27	137204	1717	34817983
Alcoholic liver disease	16.83	10.11	16	137215	592	34819108
Aspergillus infection	16.83	10.11	14	137217	12240	34807460
Biliary sepsis	16.79	10.11	17	137214	680	34819020
Poisoning deliberate	16.71	10.11	5	137226	7839	34811861
Localised infection	16.70	10.11	27	137204	17560	34802140
Paraesthesia oral	16.69	10.11	45	137186	4152	34815548
Respiratory muscle weakness	16.66	10.11	8	137223	90	34819610
Renal artery stenosis	16.65	10.11	31	137200	2230	34817470
Contraindication to medical treatment	16.49	10.11	17	137214	695	34819005
Renal cyst	16.39	10.11	75	137156	9018	34810682
Influenza	16.27	10.11	121	137110	49545	34770155
Sopor	16.19	10.11	92	137139	12044	34807656
Immune thrombocytopenia	16.13	10.11	75	137156	9077	34810623
Glomerulosclerosis	15.97	10.11	18	137213	815	34818885
Confusional state	15.91	10.11	705	136526	143455	34676245
Sedation	15.82	10.11	37	137194	20969	34798731
Psoriatic arthropathy	15.62	10.11	34	137197	19764	34799936
Gastrointestinal polyp haemorrhage	15.57	10.11	12	137219	332	34819368
Device malfunction	15.47	10.11	11	137220	10410	34809290
Myasthenia gravis	15.42	10.11	61	137170	6879	34812821
White blood cell count increased	15.40	10.11	237	136994	40914	34778786
Drug ineffective for unapproved indication	15.39	10.11	45	137186	23670	34796030
Terminal insomnia	15.38	10.11	15	137216	573	34819127
Oral disorder	15.36	10.11	44	137187	4205	34815495
Pulmonary thrombosis	15.28	10.11	5	137226	7402	34812298
Periprosthetic fracture	15.23	10.11	9	137222	158	34819542
Cholangitis	15.16	10.11	71	137160	8618	34811082
Incorrect dose administered	15.11	10.11	95	137136	40420	34779280
Mouth ulceration	15.05	10.11	89	137142	11821	34807879
Subdural haematoma	15.02	10.11	134	137097	20287	34799413
Toxic skin eruption	14.99	10.11	86	137145	11299	34808401
Hyperuricaemia	14.99	10.11	67	137164	7976	34811724
Mobility decreased	14.98	10.11	64	137167	30064	34789636
Follicular mucinosis	14.95	10.11	5	137226	19	34819681
Device issue	14.94	10.11	10	137221	9767	34809933
Faecal vomiting	14.92	10.11	13	137218	429	34819271
Renal haemangioma	14.75	10.11	5	137226	20	34819680
Central nervous system mass	14.65	10.11	9	137222	170	34819530
Gastric ulcer haemorrhage	14.61	10.11	51	137180	5415	34814285
Gastrointestinal ulcer	14.57	10.11	25	137206	1686	34818014
Wall motion score index abnormal	14.52	10.11	9	137222	173	34819527
Thrombotic cerebral infarction	14.51	10.11	12	137219	368	34819332
Respiratory depression	14.45	10.11	26	137205	16219	34803481
Joint swelling	14.33	10.11	158	137073	59732	34759968
Oesophagitis	14.21	10.11	95	137136	13166	34806534
Diffuse vasculitis	14.11	10.11	7	137224	85	34819615
Blindness	14.09	10.11	104	137127	14882	34804818
Migraine	14.06	10.11	117	137114	17361	34802339
Blood magnesium decreased	13.90	10.11	56	137175	6367	34813333
Ischaemic nephropathy	13.86	10.11	5	137226	25	34819675
Upper gastrointestinal haemorrhage	13.73	10.11	157	137074	25361	34794339
Macroglossia	13.69	10.11	12	137219	399	34819301
Premature baby	13.68	10.11	36	137195	19597	34800103
Multiple sclerosis relapse	13.59	10.11	19	137212	13114	34806586
Eosinophil count increased	13.49	10.11	68	137163	8504	34811196
Clostridium test positive	13.46	10.11	36	137195	3306	34816394
Dermatitis acneiform	13.43	10.11	54	137177	6135	34813565
Retinal vascular occlusion	13.42	10.11	9	137222	199	34819501
Electrocardiogram ST-T segment abnormal	13.28	10.11	10	137221	267	34819433
Blood albumin decreased	13.23	10.11	95	137136	13477	34806223
Crohn's disease	12.98	10.11	34	137197	3083	34816617
Burning feet syndrome	12.93	10.11	7	137224	103	34819597
Cardiac murmur	12.92	10.11	63	137168	7774	34811926
Pain in extremity	12.91	10.11	388	136843	126125	34693575
Lymphocyte stimulation test positive	12.86	10.11	15	137216	705	34818995
Septic embolus	12.83	10.11	20	137211	1245	34818455
Cardiac failure congestive	12.76	10.11	240	136991	83030	34736670
Oesophagogastric fundoplasty	12.68	10.11	4	137227	12	34819688
Gastrointestinal motility disorder	12.68	10.11	30	137201	2554	34817146
Hyponatraemic seizure	12.62	10.11	6	137225	66	34819634
Blood gastrin increased	12.58	10.11	5	137226	34	34819666
Procedural failure	12.54	10.11	6	137225	67	34819633
Pelvic cyst	12.46	10.11	5	137226	35	34819665
Abdominal pain upper	12.40	10.11	368	136863	71122	34748578
Therapeutic response decreased	12.39	10.11	66	137165	29247	34790453
Barrett's oesophagus	12.38	10.11	12	137219	455	34819245
Airway remodelling	12.29	10.11	9	137222	230	34819470
Inhibitory drug interaction	12.25	10.11	23	137208	1665	34818035
Product dispensing error	12.25	10.11	53	137178	6221	34813479
Bronchiectasis	12.23	10.11	73	137158	9728	34809972
Eosinophilia	12.22	10.11	157	137074	26065	34793635
Rash morbilliform	12.18	10.11	33	137198	3054	34816646
Hospice care	12.17	10.11	6	137225	6934	34812766
Enterocolitis	12.16	10.11	63	137168	7963	34811737
Haemoptysis	12.12	10.11	199	137032	34807	34784893
N-telopeptide urine increased	12.11	10.11	5	137226	38	34819662
Lymphocyte count decreased	12.09	10.11	139	137092	22483	34797217
Urinary retention	12.09	10.11	205	137026	36083	34783617
Gastrointestinal tract irritation	12.06	10.11	10	137221	308	34819392
Cardiac septal defect	12.03	10.11	10	137221	309	34819391
Oculocephalogyric reflex absent	12.00	10.11	4	137227	15	34819685
Full blood count decreased	11.97	10.11	34	137197	18054	34801646
Gastrostomy tube site complication	11.87	10.11	6	137225	76	34819624
Atopy	11.86	10.11	9	137222	243	34819457
Adrenocortical insufficiency acute	11.86	10.11	22	137209	1578	34818122
Erythema multiforme	11.83	10.11	66	137165	8583	34811117
Generalised onset non-motor seizure	11.80	10.11	4	137227	16	34819684
Hepatotoxicity	11.72	10.11	44	137187	21441	34798259
Carotid bruit	11.69	10.11	8	137223	183	34819517
Sterile pyuria	11.68	10.11	5	137226	42	34819658
Gastric varices haemorrhage	11.67	10.11	9	137222	249	34819451
Spinal cord haemorrhage	11.65	10.11	10	137221	323	34819377
Hip fracture	11.61	10.11	18	137213	11907	34807793
Skin irritation	11.58	10.11	48	137183	5529	34814171
Circulatory collapse	11.57	10.11	130	137101	20908	34798792
Gastric pH increased	11.57	10.11	3	137228	3	34819697
Metaplasia	11.55	10.11	9	137222	253	34819447
Hypersensitivity vasculitis	11.54	10.11	34	137197	3301	34816399
Hirsutism	11.54	10.11	8	137223	187	34819513
Putamen haemorrhage	11.40	10.11	9	137222	258	34819442
Aortic dissection	11.33	10.11	30	137201	2738	34816962
Blood cholesterol increased	11.33	10.11	127	137104	20416	34799284
Embolic cerebral infarction	11.32	10.11	14	137217	700	34819000
Rhinorrhoea	11.30	10.11	57	137174	25611	34794089
Adrenal insufficiency	11.28	10.11	94	137137	13953	34805747
Brain stem haemorrhage	11.27	10.11	16	137215	916	34818784
Radiation pneumonitis	11.21	10.11	29	137202	2611	34817089
Discoloured vomit	11.15	10.11	12	137219	516	34819184
Faeces discoloured	11.13	10.11	98	137133	14780	34804920
Renal atrophy	11.01	10.11	18	137213	1167	34818533
Mesothelioma	10.99	10.11	11	137220	434	34819266
Prostate cancer	10.98	10.11	101	137130	39548	34780152
Cerebral hyperperfusion syndrome	10.92	10.11	6	137225	91	34819609
Knee arthroplasty	10.86	10.11	8	137223	7436	34812264
Nocturia	10.85	10.11	73	137158	10137	34809563
Oral candidiasis	10.80	10.11	83	137148	12027	34807673
Cerebral haemorrhage	10.79	10.11	195	137036	34742	34784958
Exposed bone in jaw	10.76	10.11	21	137210	1565	34818135
Infective pulmonary exacerbation of cystic fibrosis	10.74	10.11	54	137177	6747	34812953
Adverse event	10.73	10.11	38	137193	18839	34800861
Electrocardiogram QRS complex prolonged	10.64	10.11	3	137228	4891	34814809
Intracranial haematoma	10.62	10.11	11	137220	452	34819248
Enterocolitis haemorrhagic	10.61	10.11	16	137215	967	34818733
Hepatic encephalopathy	10.61	10.11	96	137135	14589	34805111
Dyslalia	10.57	10.11	12	137219	548	34819152
Muscle strain	10.55	10.11	37	137194	3939	34815761
Osteonecrosis of jaw	10.51	10.11	112	137119	17777	34801923
Haematuria	10.46	10.11	264	136967	49802	34769898
Meniere's disease	10.43	10.11	5	137226	56	34819644
Treatment noncompliance	10.42	10.11	66	137165	28034	34791666
Ammonia decreased	10.36	10.11	3	137228	6	34819694
Dressler's syndrome	10.35	10.11	4	137227	25	34819675
Akathisia	10.26	10.11	10	137221	8099	34811601
Peptic ulcer	10.24	10.11	29	137202	2754	34816946
Cardiac disorder	10.23	10.11	114	137117	43012	34776688
Thrombosis	10.22	10.11	138	137093	50320	34769380
Therapeutic response unexpected	10.22	10.11	14	137217	9743	34809957
Cerebellar infarction	10.21	10.11	23	137208	1896	34817804
Mediastinal abscess	10.21	10.11	5	137226	59	34819641
Exposure during pregnancy	10.20	10.11	12	137219	8922	34810778
Amaurosis fugax	10.12	10.11	12	137219	574	34819126
Mental status changes	10.12	10.11	98	137133	37985	34781715

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
Drug ineffective	885.58	9.32	1677	294821	1079236	78368654
Completed suicide	647.49	9.32	77	296421	245690	79202200
Chronic kidney disease	564.34	9.32	938	295560	65216	79382674
Colitis microscopic	558.62	9.32	399	296099	10369	79437521
Hyponatraemia	534.56	9.32	1664	294834	176184	79271706
Death	364.22	9.32	999	295499	565515	78882375
Toxicity to various agents	314.18	9.32	688	295810	420852	79027038
Product dose omission issue	256.62	9.32	326	296172	247211	79200679
Interstitial lung disease	248.39	9.32	951	295547	111649	79336241
Acute kidney injury	245.30	9.32	2979	293519	516425	78931465
End stage renal disease	244.31	9.32	263	296235	11957	79435933
Hypomagnesaemia	240.39	9.32	536	295962	46375	79401515
Drug abuse	232.45	9.32	160	296338	162531	79285359
Off label use	219.58	9.32	2237	294261	904978	78542912
Therapeutic product effect incomplete	201.42	9.32	140	296358	141505	79306385
Neutropenic sepsis	194.55	9.32	356	296142	26708	79421182
Subacute cutaneous lupus erythematosus	189.42	9.32	134	296364	3427	79444463
Fatigue	182.64	9.32	2401	294097	927326	78520564
Cardiospasm	163.62	9.32	119	296379	3182	79444708
Treatment failure	161.05	9.32	240	296258	170246	79277644
Cerebral infarction	160.42	9.32	452	296046	45224	79402666
Pruritus genital	151.59	9.32	129	296369	4357	79443533
Drug intolerance	151.08	9.32	491	296007	263628	79184262
Palmoplantar keratoderma	151.07	9.32	119	296379	3597	79444293
Lip swelling	146.78	9.32	408	296090	40503	79407387
Synovitis	145.50	9.32	209	296289	150525	79297365
Hepatic function abnormal	145.49	9.32	598	295900	72509	79375381
Injection site pain	144.04	9.32	162	296336	129676	79318214
Renal injury	140.23	9.32	237	296261	16690	79431200
Pain	137.38	9.32	1819	294679	701983	78745907
Sleep terror	130.20	9.32	118	296380	4340	79443550
Subarachnoid haemorrhage	126.96	9.32	281	296217	24184	79423706
Tension headache	126.58	9.32	145	296353	7066	79440824
Atrial tachycardia	114.50	9.32	137	296361	6996	79440894
Nephrogenic anaemia	111.45	9.32	102	296396	3800	79444090
Appendicolith	111.43	9.32	148	296350	8403	79439487
Haematemesis	108.35	9.32	433	296065	51831	79396059
Joint swelling	105.83	9.32	634	295864	288012	79159878
Therapeutic product effect decreased	104.15	9.32	290	296208	163573	79284317
Immunisation	102.62	9.32	76	296422	2091	79445799
Melaena	102.01	9.32	473	296025	60417	79387473
Hypertensive nephropathy	101.58	9.32	57	296441	957	79446933
Lower respiratory tract infection	100.61	9.32	823	295675	128397	79319493
Angioedema	100.19	9.32	552	295946	75483	79372407
Loss of personal independence in daily activities	99.20	9.32	142	296356	102438	79345452
Cholestasis	94.95	9.32	415	296083	51694	79396196
Swollen tongue	94.18	9.32	360	296138	42210	79405680
Hypocalcaemia	92.03	9.32	399	296099	49525	79398365
Carotid artery occlusion	91.53	9.32	127	296371	7520	79440370
Weight increased	90.11	9.32	632	295866	276754	79171136
Arthropathy	90.01	9.32	346	296152	176765	79271125
Transient ischaemic attack	88.76	9.32	410	296088	52285	79395605
Confusional state	87.37	9.32	1664	294834	316333	79131557
Electric shock	87.26	9.32	58	296440	1336	79446554
Drug resistance	86.06	9.32	25	296473	42188	79405702
Drug dispensed to wrong patient	85.50	9.32	45	296453	661	79447229
Liver function test abnormal	84.89	9.32	468	296030	64007	79383883
Anosmia	84.36	9.32	132	296366	8712	79439178
Contraindicated product administered	83.82	9.32	302	296196	157236	79290654
Chest pain	83.73	9.32	1495	295003	280809	79167081
Appendicitis	83.27	9.32	216	296282	20578	79427312
Facial pain	83.18	9.32	158	296340	12192	79435698
Renal failure	81.15	9.32	1121	295377	199847	79248043
Abdominal pain	80.48	9.32	1956	294542	387613	79060277
Hepatocellular injury	79.93	9.32	370	296128	47223	79400667
Agranulocytosis	79.30	9.32	355	296143	44675	79403215
Jaundice	78.28	9.32	399	296099	52950	79394940
Tubulointerstitial nephritis	77.03	9.32	314	296184	37921	79409969
Suicide attempt	76.11	9.32	119	296379	82813	79365077
Sinusitis	73.95	9.32	425	296073	195076	79252814
Infusion related reaction	71.64	9.32	531	295967	229706	79218184
Device expulsion	70.83	9.32	7	296491	25854	79422036
Intentional overdose	70.72	9.32	183	296315	105777	79342113
Renal impairment	70.70	9.32	897	295601	156886	79291004
Drug hypersensitivity	66.64	9.32	750	295748	298166	79149724
Wrong patient received product	66.54	9.32	84	296414	4534	79443356
Hypergastrinaemia	66.41	9.32	26	296472	180	79447710
Product use issue	66.19	9.32	482	296016	209340	79238550
Nasopharyngitis	66.07	9.32	614	295884	253267	79194623
Vomiting	65.55	9.32	3064	293434	662764	78785126
Muscle twitching	65.48	9.32	222	296276	24542	79423348
Rectal haemorrhage	65.44	9.32	497	296001	75803	79372087
Electrocardiogram QT prolonged	64.68	9.32	565	295933	89821	79358069
Pain of skin	63.95	9.32	157	296341	14456	79433434
Product use in unapproved indication	63.64	9.32	609	295889	249750	79198140
Inappropriate schedule of product administration	63.50	9.32	268	296230	133360	79314530
Cholecystitis chronic	63.37	9.32	124	296374	9782	79438108
Sopor	63.29	9.32	267	296231	32743	79415147
Antimicrobial susceptibility test resistant	62.49	9.32	30	296468	358	79447532
Faeces discoloured	61.72	9.32	243	296255	28884	79419006
Diabetic nephropathy	61.69	9.32	65	296433	2882	79445008
Accidental exposure to product	61.24	9.32	20	296478	31302	79416588
Exposure during pregnancy	60.58	9.32	184	296314	100948	79346942
Neutrophil count decreased	60.46	9.32	574	295924	93385	79354505
Hypokalaemia	59.98	9.32	808	295690	143232	79304658
Minimum inhibitory concentration	59.02	9.32	23	296475	157	79447733
Hospitalisation	58.95	9.32	168	296330	94068	79353822
Wrong technique in product usage process	58.73	9.32	116	296382	73759	79374131
Malaise	58.16	9.32	2299	294199	487570	78960320
Therapy interrupted	56.22	9.32	23	296475	31318	79416572
Liver disorder	55.14	9.32	459	296039	71958	79375932
Injection site pruritus	54.70	9.32	46	296452	42237	79405653
Intervertebral discitis	53.08	9.32	77	296421	4751	79443139
Arthralgia	52.70	9.32	1672	294826	570131	78877759
Overdose	52.55	9.32	435	296063	183771	79264119
Venous pressure jugular increased	52.52	9.32	42	296456	1298	79446592
Injection site erythema	52.22	9.32	135	296363	78062	79369828
Influenza	52.14	9.32	276	296222	129330	79318560
Maternal exposure during pregnancy	52.06	9.32	296	296202	136242	79311648
Sedation	52.00	9.32	70	296428	51825	79396065
Hand deformity	51.51	9.32	205	296293	103714	79344176
Swelling face	51.39	9.32	446	296052	70766	79377124
Therapy cessation	50.93	9.32	39	296459	37523	79410367
Hepatic enzyme increased	50.84	9.32	434	296064	182176	79265714
Vasculitis	50.45	9.32	206	296292	24896	79422994
Abdominal pain upper	48.95	9.32	1133	295365	222686	79225204
Infective pulmonary exacerbation of cystic fibrosis	48.92	9.32	131	296367	12720	79435170
Drug reaction with eosinophilia and systemic symptoms	48.81	9.32	407	296091	63837	79384053
Dehydration	48.45	9.32	1237	295261	246950	79200940
Ventricular tachycardia	48.42	9.32	294	296204	41641	79406249
Injection site reaction	48.03	9.32	81	296417	54704	79393186
Dry mouth	47.66	9.32	519	295979	87500	79360390
Toxic epidermal necrolysis	47.39	9.32	306	296192	44275	79403615
Diplopia	46.81	9.32	247	296251	33219	79414671
Deep vein thrombosis postoperative	46.50	9.32	115	296383	10637	79437253
Poisoning	46.23	9.32	18	296480	25254	79422636
Haemorrhage subcutaneous	46.18	9.32	72	296426	4737	79443153
Gastrooesophageal reflux disease	45.98	9.32	591	295907	103655	79344235
Tinnitus	45.72	9.32	302	296196	44031	79403859
Rheumatoid arthritis	45.67	9.32	525	295973	207945	79239945
Injection site swelling	44.81	9.32	66	296432	47066	79400824
Therapy partial responder	44.42	9.32	6	296492	17391	79430499
Mobility decreased	44.37	9.32	269	296229	121906	79325984
Labile blood pressure	44.17	9.32	48	296450	2205	79445685
Nephropathy	44.08	9.32	106	296392	9632	79438258
Hypoparathyroidism secondary	44.07	9.32	20	296478	208	79447682
COVID-19	43.77	9.32	375	296123	157299	79290591
Palpitations	43.52	9.32	687	295811	125923	79321967
Device dependence	43.50	9.32	14	296484	49	79447841
Red blood cell sedimentation rate abnormal	43.50	9.32	12	296486	20951	79426939
Platelet count decreased	43.36	9.32	988	295510	193676	79254214
Pneumonia bacterial	43.18	9.32	164	296334	19167	79428723
Hepatic cytolysis	42.61	9.32	207	296291	26944	79420946
Brain stem glioma	42.60	9.32	19	296479	189	79447701
Lip dry	42.34	9.32	140	296358	15278	79432612
Disseminated intravascular coagulation	41.84	9.32	252	296246	35590	79412300
Rash papular	41.80	9.32	177	296321	21739	79426151
Facet joint syndrome	41.80	9.32	114	296384	11188	79436702
Blood alkaline phosphatase increased	41.48	9.32	390	296108	63274	79384616
Amnesia	41.45	9.32	387	296111	62670	79385220
Hepatotoxicity	41.36	9.32	80	296418	51272	79396618
Post-traumatic stress disorder	41.31	9.32	69	296429	4812	79443078
Upper respiratory tract inflammation	40.98	9.32	62	296436	3973	79443917
Pemphigus	40.65	9.32	211	296287	99371	79348519
Device dislocation	40.57	9.32	23	296475	25947	79421943
Gastritis	40.24	9.32	311	296187	47682	79400208
Chronic kidney disease-mineral and bone disorder	40.01	9.32	25	296473	516	79447374
Circulatory collapse	39.70	9.32	258	296240	37410	79410480
Hallucination	39.47	9.32	490	296008	85255	79362635
Toxic skin eruption	39.43	9.32	176	296322	22117	79425773
Diarrhoea	39.32	9.32	3791	292707	876698	78571192
Blood pressure increased	38.97	9.32	552	295946	210808	79237082
Pancreatitis acute	38.61	9.32	316	296182	49288	79398602
Reflux gastritis	38.33	9.32	34	296464	1215	79446675
Blood uric acid increased	38.21	9.32	123	296375	13237	79434653
Swelling	37.86	9.32	572	295926	216139	79231751
Pemphigoid	37.63	9.32	134	296364	15181	79432709
Oesophagitis	37.28	9.32	184	296314	24105	79423785
Mixed liver injury	37.04	9.32	85	296413	7493	79440397
Urine magnesium decreased	36.79	9.32	8	296490	0	79447890
Nasal congestion	36.68	9.32	153	296345	76399	79371491
Protein-losing gastroenteropathy	36.54	9.32	25	296473	605	79447285
Rhinorrhoea	36.48	9.32	152	296346	75922	79371968
Ventricular fibrillation	36.33	9.32	223	296275	31703	79416187
Pneumonia aspiration	36.31	9.32	395	296103	66572	79381318
Hyperkalaemia	36.07	9.32	612	295886	113786	79334104
Blood sodium decreased	35.80	9.32	229	296269	33026	79414864
Decreased appetite	35.57	9.32	1585	294913	340833	79107057
Coronary artery disease	34.95	9.32	385	296113	65089	79382801
Tetanus	34.75	9.32	12	296486	55	79447835
International normalised ratio increased	34.74	9.32	474	296024	84247	79363643
Biliary dyskinesia	34.63	9.32	45	296453	2500	79445390
Enterochromaffin cell hyperplasia	34.63	9.32	13	296485	79	79447811
Occupational dermatitis	34.46	9.32	15	296483	140	79447750
Gastric polyps	34.46	9.32	55	296443	3692	79444198
Rheumatoid nodule	34.33	9.32	11	296487	17427	79430463
Post cholecystectomy syndrome	33.84	9.32	20	296478	372	79447518
Hepatic ischaemia	33.52	9.32	30	296468	1085	79446805
Femoral neck fracture	33.30	9.32	97	296401	9887	79438003
Pain in extremity	33.26	9.32	1067	295431	363471	79084419
Aplastic anaemia	32.91	9.32	143	296355	17762	79430128
Alopecia	32.84	9.32	634	295864	230721	79217169
Cerebral haemorrhage	32.58	9.32	343	296155	57330	79390560
Peripheral venous disease	32.32	9.32	131	296367	15778	79432112
Drug ineffective for unapproved indication	32.29	9.32	91	296407	51147	79396743
Tetany	32.19	9.32	45	296453	2683	79445207
Orthostatic hypotension	32.19	9.32	335	296163	55829	79392061
Psoriasis	32.13	9.32	198	296300	89389	79358501
Enteritis infectious	32.09	9.32	50	296448	3288	79444602
Injection site bruising	32.05	9.32	65	296433	40937	79406953
Haematotoxicity	31.98	9.32	9	296489	15510	79432380
Sleep disorder due to a general medical condition	31.91	9.32	7	296491	14270	79433620
Respiratory arrest	31.47	9.32	109	296389	57441	79390449
Therapeutic response decreased	31.18	9.32	135	296363	66718	79381172
Blood pressure fluctuation	31.07	9.32	136	296362	67009	79380881
Therapeutic response delayed	30.97	9.32	29	296469	1113	79446777
Erythema multiforme	30.95	9.32	139	296359	17512	79430378
Biliary sepsis	30.92	9.32	34	296464	1583	79446307
Cardiac failure	30.85	9.32	774	295724	154068	79293822
Anti-cyclic citrullinated peptide antibody positive	30.74	9.32	182	296316	82961	79364929
Cholangitis	30.72	9.32	111	296387	12665	79435225
Neuroendocrine tumour	30.58	9.32	31	296467	1313	79446577
Disease progression	30.38	9.32	492	296006	183870	79264020
Eye pruritus	30.28	9.32	154	296344	20416	79427474
Hyperchlorhydria	30.25	9.32	38	296460	2041	79445849
Haemoptysis	30.22	9.32	330	296168	55669	79392221
Systemic lupus erythematosus	30.20	9.32	296	296202	120853	79327037
Abdominal distension	30.06	9.32	618	295880	119032	79328858
Autoimmune disorder	30.02	9.32	132	296366	16480	79431410
Hepatitis acute	30.01	9.32	126	296372	15416	79432474
Altered state of consciousness	29.83	9.32	271	296227	43551	79404339
Immune thrombocytopenia	29.58	9.32	138	296360	17667	79430223
Fluid retention	29.58	9.32	146	296352	69663	79378227
Neoplasm progression	29.55	9.32	96	296402	51586	79396304
Device malfunction	29.42	9.32	22	296476	21426	79426464
Full blood count decreased	29.14	9.32	34	296464	26785	79421105
Multiple sclerosis relapse	29.06	9.32	83	296415	46450	79401440
Poisoning deliberate	28.95	9.32	17	296481	18811	79429079
Device issue	28.78	9.32	35	296463	27073	79420817
Red blood cell sedimentation rate increased	28.65	9.32	82	296416	45860	79402030
Skin candida	28.55	9.32	37	296461	2050	79445840
Coma	28.54	9.32	238	296260	100411	79347479
Rectal ulcer	28.32	9.32	37	296461	2067	79445823
Musculoskeletal disorder	28.15	9.32	23	296475	21425	79426465
Carcinoid tumour of the stomach	27.90	9.32	14	296484	185	79447705
Demyelination	27.77	9.32	79	296419	7944	79439946
Coma scale abnormal	27.69	9.32	83	296415	8595	79439295
Eosinophilia	27.67	9.32	274	296224	45071	79402819
Gastric cancer	27.57	9.32	92	296406	10087	79437803
Lethargy	27.51	9.32	440	296058	80852	79367038
Hyperglycaemia	27.41	9.32	390	296108	69945	79377945
Basilar artery occlusion	27.38	9.32	14	296484	193	79447697
Upper gastrointestinal haemorrhage	27.21	9.32	254	296244	41126	79406764
Coordination abnormal	27.18	9.32	132	296366	17180	79430710
Device difficult to use	27.15	9.32	8	296490	13377	79434513
Idiopathic pulmonary fibrosis	27.14	9.32	53	296445	4175	79443715
Somatic delusion	27.07	9.32	22	296476	696	79447194
Gastrointestinal motility disorder	27.03	9.32	66	296432	6056	79441834
Weight decreased	26.85	9.32	1064	295434	354134	79093756
Glossodynia	26.81	9.32	250	296248	103087	79344803
Enterocolitis	26.75	9.32	116	296382	14396	79433494
Pathogen resistance	26.59	9.32	10	296488	14332	79433558
Urine potassium decreased	26.44	9.32	7	296491	9	79447881
Peripheral swelling	26.33	9.32	782	295716	268835	79179055
Joint stiffness	26.11	9.32	72	296426	40758	79407132
Gait disturbance	26.09	9.32	580	295918	206926	79240964
Drug dependence	25.99	9.32	72	296426	40697	79407193
Mouth ulceration	25.91	9.32	237	296261	38157	79409733
Gastric dysplasia	25.79	9.32	8	296490	24	79447866
Marasmus	25.77	9.32	25	296473	1003	79446887
Hip fracture	25.58	9.32	47	296451	30714	79417176
Blindness	25.53	9.32	187	296311	28196	79419694
Post viral fatigue syndrome	25.49	9.32	16	296482	333	79447557
Immune reconstitution inflammatory syndrome	25.08	9.32	10	296488	13831	79434059
Dysphagia	25.07	9.32	613	295885	121523	79326367
Blood pressure systolic increased	24.57	9.32	147	296351	66839	79381051
Syncope	24.56	9.32	856	295642	178593	79269297
Total lung capacity decreased	24.49	9.32	41	296457	2864	79445026
Constipation	24.49	9.32	1287	295211	281763	79166127
Gastric varices	24.41	9.32	21	296477	720	79447170
Occupational exposure to air contaminants	24.37	9.32	12	296486	152	79447738
Nephrocalcinosis	24.36	9.32	29	296469	1473	79446417
Subdural haematoma	24.33	9.32	200	296298	31234	79416656
Anaemia	24.25	9.32	1945	294553	443070	79004820
Haematuria	24.21	9.32	375	296123	68461	79379429
Blood phosphorus increased	24.12	9.32	89	296409	10258	79437632
Adrenal insufficiency	24.10	9.32	185	296313	28302	79419588
Limb discomfort	24.07	9.32	54	296444	32796	79415094
Abnormal loss of weight	23.85	9.32	77	296421	8299	79439591
Unevaluable event	23.69	9.32	116	296382	55469	79392421
Nightmare	23.61	9.32	171	296327	25690	79422200
Foot deformity	23.59	9.32	33	296465	24041	79423849
Cardio-respiratory arrest	23.46	9.32	274	296224	108236	79339654
Inappropriate antidiuretic hormone secretion	23.46	9.32	173	296325	26140	79421750
Erythema dyschromicum perstans	23.28	9.32	9	296489	60	79447830
Anaphylactic reaction	23.20	9.32	439	296059	83304	79364586
Discomfort	23.16	9.32	328	296170	125289	79322601
Respiratory tract congestion	23.11	9.32	24	296474	19930	79427960
Cystitis escherichia	22.98	9.32	19	296479	616	79447274
Rebound acid hypersecretion	22.91	9.32	10	296488	94	79447796
Musculoskeletal stiffness	22.91	9.32	486	296012	174522	79273368
Renal atrophy	22.88	9.32	31	296467	1794	79446096
Wound	22.63	9.32	300	296198	115879	79332011
Hypophosphataemic osteomalacia	22.59	9.32	15	296483	345	79447545
Hypoacusis	22.56	9.32	49	296449	30101	79417789
Hiatus hernia	22.36	9.32	156	296342	23156	79424734
Mouth swelling	22.34	9.32	61	296437	5990	79441900
Incorrect dose administered	22.27	9.32	180	296318	76450	79371440
Illness	22.26	9.32	93	296405	46418	79401472
Condition aggravated	22.19	9.32	1584	294914	499540	78948350
Hypersensitivity	22.15	9.32	775	295723	261464	79186426
Intentional product use issue	22.14	9.32	415	296083	151697	79296193
Urticaria	22.09	9.32	870	295628	184331	79263559
Cardioactive drug level increased	22.01	9.32	45	296453	3664	79444226
Urine output decreased	21.86	9.32	128	296370	17894	79429996
Hyperparathyroidism secondary	21.71	9.32	37	296461	2623	79445267
Gastrointestinal tract irritation	21.71	9.32	19	296479	667	79447223
Multiple allergies	21.68	9.32	6	296492	10454	79437436
Hyperuricaemia	21.51	9.32	94	296404	11705	79436185
Cholecystitis acute	21.43	9.32	103	296395	13348	79434542
Neuropathy, ataxia, retinitis pigmentosa syndrome	21.40	9.32	8	296490	48	79447842
Cardiac arrest	21.35	9.32	482	296016	171614	79276276
White blood cell count increased	21.29	9.32	393	296105	74240	79373650
Enterocolitis haemorrhagic	21.28	9.32	33	296465	2161	79445729
Rhabdomyolysis	21.28	9.32	518	295980	102613	79345277
Cytokine release syndrome	21.19	9.32	66	296432	35932	79411958
Myocardial ischaemia	21.19	9.32	165	296333	25354	79422536
Blood immunoglobulin A increased	21.15	9.32	22	296476	961	79446929
Tachypnoea	20.91	9.32	56	296442	32007	79415883
Barrett's oesophagus	20.90	9.32	20	296478	789	79447101
Medication error	20.83	9.32	365	296133	68277	79379613
Arthritis	20.82	9.32	301	296197	114579	79333311
Genital ulceration	20.81	9.32	23	296475	1077	79446813
Sinus congestion	20.79	9.32	26	296472	19870	79428020
Panniculitis	20.74	9.32	10	296488	12361	79435529
Transplant rejection	20.74	9.32	25	296473	19412	79428478
Hyperlipidaemia	20.73	9.32	167	296331	25926	79421964
Asthma	20.67	9.32	653	295845	134442	79313448
Muscle relaxant therapy	20.58	9.32	11	296487	167	79447723
Red cell distribution width increased	20.44	9.32	16	296482	15226	79432664
Gastric ulcer	20.27	9.32	204	296294	33701	79414189
Cardiac murmur	20.25	9.32	114	296384	15710	79432180
Immunodeficiency	20.19	9.32	31	296467	21737	79426153
Drug eruption	20.18	9.32	251	296247	43684	79404206
Foetal death	20.01	9.32	3	296495	8041	79439849
Pituitary tumour benign	19.94	9.32	35	296463	2541	79445349
Cystitis	19.72	9.32	115	296383	52617	79395273
Acne	19.68	9.32	45	296453	27145	79420745
Hypoglycaemic coma	19.63	9.32	50	296448	4710	79443180
Hyponatraemic syndrome	19.62	9.32	19	296479	761	79447129
Mental status changes	19.59	9.32	157	296341	66802	79381088
Purpura	19.52	9.32	132	296366	19395	79428495
Macroglossia	19.48	9.32	23	296475	1158	79446732
Hypersensitivity pneumonitis	19.46	9.32	43	296455	3696	79444194
Renal cyst	19.43	9.32	107	296391	14625	79433265
Angina pectoris	19.42	9.32	285	296213	51447	79396443
Electrocardiogram QRS complex prolonged	19.35	9.32	8	296490	10825	79437065
Food allergy	19.32	9.32	8	296490	10816	79437074
Cholecystitis	19.21	9.32	145	296353	22067	79425823
Ascites	19.21	9.32	391	296107	75171	79372719
Face oedema	19.15	9.32	174	296324	27962	79419928
Osteonecrosis of jaw	19.02	9.32	245	296253	42981	79404909
Basal cell carcinoma	18.98	9.32	73	296425	37302	79410588
Chromaturia	18.96	9.32	162	296336	25584	79422306
Lung opacity	18.95	9.32	52	296446	5122	79442768
Genital pain	18.93	9.32	19	296479	795	79447095
Unintentional medical device removal	18.90	9.32	3	296495	7709	79440181
Abortion spontaneous	18.89	9.32	52	296446	29455	79418435
Anal prolapse	18.73	9.32	8	296490	71	79447819
Bradycardia	18.63	9.32	647	295851	134910	79312980
Neutrophil count increased	18.61	9.32	179	296319	29217	79418673
Infection	18.47	9.32	723	295775	240989	79206901
Therapeutic response shortened	18.46	9.32	19	296479	15844	79432046
Psoriatic arthropathy	18.43	9.32	193	296305	77806	79370084
Myelosuppression	18.41	9.32	82	296416	40214	79407676
Bulbospinal muscular atrophy congenital	18.24	9.32	5	296493	8	79447882
Ventricular hypertrophy	18.17	9.32	62	296436	6876	79441014
Aspartate aminotransferase	18.15	9.32	16	296482	567	79447323
Extravasation blood	18.15	9.32	14	296484	410	79447480
Joint injury	18.06	9.32	58	296440	31277	79416613
Fall	18.05	9.32	1564	294934	486065	78961825
Vulvovaginal candidiasis	17.98	9.32	33	296465	2481	79445409
Drug use disorder	17.86	9.32	5	296493	8646	79439244
Urinary retention	17.86	9.32	303	296195	56327	79391563
Dermatitis bullous	17.81	9.32	102	296396	14143	79433747
Bone pain	17.58	9.32	128	296370	55614	79392276
Blood gastrin increased	17.58	9.32	7	296491	51	79447839
Cardiotoxicity	17.51	9.32	12	296486	12227	79435663
Temperature intolerance	17.45	9.32	77	296421	9628	79438262
Dialysis	17.39	9.32	123	296375	18339	79429551
Pancreatic carcinoma recurrent	17.36	9.32	10	296488	177	79447713
Pelvic cyst	17.35	9.32	7	296491	53	79447837
Pulmonary thrombosis	17.33	9.32	12	296486	12159	79435731
Dermatitis exfoliative	17.31	9.32	83	296415	10746	79437144
C-reactive protein	17.21	9.32	49	296449	4930	79442960
Disturbance in attention	17.20	9.32	275	296223	50526	79397364
Iron deficiency anaemia	17.09	9.32	158	296340	25514	79422376
Renal tubular acidosis	17.07	9.32	40	296458	3574	79444316
Nephrosclerosis	17.02	9.32	27	296471	1803	79446087
Pulmonary fibrosis	16.95	9.32	244	296254	43868	79404022
Lymphadenopathy	16.92	9.32	122	296376	53125	79394765
Product monitoring error	16.87	9.32	6	296492	8900	79438990
Haemorrhagic cerebral infarction	16.86	9.32	24	296474	1455	79446435
Neurotoxicity	16.84	9.32	63	296435	32455	79415435
Bronchopulmonary aspergillosis allergic	16.84	9.32	36	296462	3025	79444865
Cerebellar infarction	16.83	9.32	40	296458	3607	79444283
Drug interaction	16.76	9.32	1776	294722	413407	79034483
Alanine aminotransferase abnormal	16.75	9.32	6	296492	8861	79439029
Skin oedema	16.63	9.32	26	296472	1715	79446175
Hypervolaemia	16.56	9.32	92	296406	42598	79405292
Skin necrosis	16.54	9.32	26	296472	18061	79429829
Blood albumin decreased	16.54	9.32	150	296348	24093	79423797
Dilatation atrial	16.42	9.32	40	296458	3664	79444226
Melanoderma	16.39	9.32	13	296485	397	79447493
Oesophageal mucosal tear	16.37	9.32	5	296493	14	79447876
Aortic dissection	16.34	9.32	43	296455	4132	79443758
Hospice care	16.33	9.32	9	296489	10315	79437575
Disability	16.25	9.32	24	296474	17096	79430794
Staphylococcus test positive	16.17	9.32	57	296441	6424	79441466
Alcoholic liver disease	16.16	9.32	15	296483	569	79447321
Renal hypertension	16.15	9.32	10	296488	203	79447687
Hiccups	16.12	9.32	77	296421	9954	79437936
Penile curvature	16.12	9.32	5	296493	15	79447875
Acute coronary syndrome	16.11	9.32	134	296364	20999	79426891
Stoma site haemorrhage	16.10	9.32	27	296471	1889	79446001
Catarrh	16.09	9.32	29	296469	2149	79445741
Epstein-Barr virus infection	15.96	9.32	18	296480	14398	79433492
Rheumatoid factor positive	15.85	9.32	144	296354	59695	79388195
Heart rate decreased	15.81	9.32	176	296322	70140	79377750
Injection site haemorrhage	15.77	9.32	52	296446	27818	79420072
Hydronephrosis	15.70	9.32	115	296383	17339	79430551
Sinus disorder	15.60	9.32	38	296460	22426	79425464
Disease recurrence	15.55	9.32	98	296400	44011	79403879
Atypical fracture	15.55	9.32	16	296482	690	79447200
Blood pressure decreased	15.54	9.32	482	296016	98984	79348906
Single functional kidney	15.52	9.32	11	296487	282	79447608
Blood creatine phosphokinase increased	15.50	9.32	338	296160	65752	79382138
Gallbladder disorder	15.48	9.32	124	296374	19216	79428674
Infusion site streaking	15.47	9.32	14	296484	514	79447376
Oropharyngeal oedema	15.43	9.32	13	296485	433	79447457
Post transplant lymphoproliferative disorder	15.42	9.32	12	296486	11452	79436438
Alanine aminotransferase increased	15.24	9.32	745	295753	161825	79286065
Spleen congestion	15.23	9.32	13	296485	441	79447449
Nocturia	15.21	9.32	95	296403	13586	79434304
Failure to anastomose	15.21	9.32	10	296488	226	79447664
Flashback	15.16	9.32	11	296487	293	79447597
Bone erosion	15.08	9.32	27	296471	17820	79430070
Skin toxicity	15.08	9.32	6	296492	8308	79439582
No adverse event	15.06	9.32	79	296419	37113	79410777
Embolic cerebral infarction	15.05	9.32	21	296477	1250	79446640
Cold sweat	15.03	9.32	120	296378	18579	79429311
Chronic gastritis	15.01	9.32	41	296457	4027	79443863
Macular degeneration	14.97	9.32	12	296486	11284	79436606
Wall motion score index abnormal	14.97	9.32	9	296489	173	79447717
Central nervous system mass	14.92	9.32	9	296489	174	79447716
Bleeding time prolonged	14.92	9.32	21	296477	1260	79446630
Hypoaesthesia	14.92	9.32	531	295967	178821	79269069
Cerebral mass effect	14.88	9.32	26	296472	1880	79446010
Brain stem haemorrhage	14.87	9.32	24	296474	1626	79446264
Device use error	14.85	9.32	4	296494	7097	79440793
Chills	14.83	9.32	468	296030	159766	79288124
Vasculitic rash	14.78	9.32	28	296470	2156	79445734
Embolic stroke	14.77	9.32	63	296435	7763	79440127
Hypotension	14.74	9.32	1423	295075	438894	79008996
Follicular mucinosis	14.64	9.32	5	296493	22	79447868
Uveitis	14.64	9.32	25	296473	16805	79431085
Clostridium test positive	14.62	9.32	55	296443	6399	79441491
Contraindication to medical treatment	14.61	9.32	21	296477	1285	79446605
Laryngeal pain	14.60	9.32	53	296445	6061	79441829
Urine phosphorus decreased	14.59	9.32	6	296492	48	79447842
Microcytic anaemia	14.58	9.32	48	296450	5226	79442664
Hypozincaemia	14.48	9.32	6	296492	49	79447841
Central nervous system lesion	14.47	9.32	17	296481	13351	79434539
Gastrointestinal toxicity	14.47	9.32	6	296492	8103	79439787
Hypocalciuria	14.46	9.32	5	296493	23	79447867
Parosmia	14.44	9.32	58	296440	6956	79440934
Complication of device insertion	14.42	9.32	3	296495	6347	79441543
Polyneuropathy	14.41	9.32	44	296454	24107	79423783
Colon cancer	14.41	9.32	98	296400	14425	79433465
Hypophagia	14.40	9.32	243	296255	45124	79402766
Product quality issue	14.36	9.32	71	296427	33869	79414021
Multiple organ dysfunction syndrome	14.36	9.32	565	295933	119681	79328209
Infusion site pain	14.32	9.32	19	296479	14157	79433733
Hepatic encephalopathy	14.25	9.32	145	296353	24021	79423869
Finger deformity	14.21	9.32	5	296493	7469	79440421
Blood parathyroid hormone decreased	14.20	9.32	11	296487	10525	79437365
Gallbladder injury	14.20	9.32	20	296478	1201	79446689
Breast cancer female	14.18	9.32	13	296485	11448	79436442
Substance abuse	14.18	9.32	11	296487	10515	79437375
Dermatitis acneiform	14.14	9.32	74	296424	9919	79437971
Heart rate irregular	14.04	9.32	68	296430	32611	79415279
Myasthenia gravis	14.03	9.32	76	296422	10323	79437567
Poor venous access	13.99	9.32	29	296469	18120	79429770
Pharyngeal oedema	13.95	9.32	106	296392	16166	79431724
Hepatorenal syndrome	13.90	9.32	41	296457	4208	79443682
Sedation complication	13.89	9.32	23	296475	15646	79432244
Tongue disorder	13.85	9.32	19	296479	13956	79433934
Premature delivery	13.83	9.32	43	296455	23424	79424466
Bile duct stone	13.81	9.32	49	296449	5540	79442350
Oesophageal anastomosis	13.80	9.32	3	296495	0	79447890
Putamen haemorrhage	13.77	9.32	13	296485	504	79447386
Autonomic neuropathy	13.71	9.32	25	296473	1870	79446020
Malignant melanoma	13.67	9.32	21	296477	14720	79433170
Bursitis	13.66	9.32	198	296300	35646	79412244
Phyllodes tumour	13.66	9.32	5	296493	28	79447862
Eye haemorrhage	13.63	9.32	72	296426	9685	79438205
Blood cholinesterase decreased	13.63	9.32	10	296488	271	79447619
Product prescribing error	13.61	9.32	104	296394	44709	79403181
Surgery	13.61	9.32	69	296429	32697	79415193
Rash morbilliform	13.59	9.32	52	296446	6098	79441792
Injury	13.59	9.32	381	296117	77115	79370775
Activated partial thromboplastin time prolonged	13.52	9.32	95	296403	14133	79433757
Blood lactic acid decreased	13.48	9.32	10	296488	276	79447614
Laboratory test abnormal	13.47	9.32	56	296442	27992	79419898
Blood glucose increased	13.44	9.32	539	295959	114436	79333454
Blood cholesterol increased	13.42	9.32	407	296091	83313	79364577
Granulocyte count increased	13.41	9.32	20	296478	1265	79446625
Fasciitis	13.40	9.32	16	296482	815	79447075
Secretion discharge	13.36	9.32	22	296476	15000	79432890
Regurgitation	13.33	9.32	31	296467	2756	79445134
Knee arthroplasty	13.31	9.32	100	296398	43148	79404742
Blood magnesium decreased	13.29	9.32	106	296392	16406	79431484
Peptic ulcer	13.25	9.32	52	296446	6171	79441719
Hypochloraemia	13.17	9.32	29	296469	2486	79445404
Rheumatoid factor increased	13.14	9.32	24	296474	1797	79446093
Drug tolerance	13.10	9.32	8	296490	8667	79439223
Underdose	13.10	9.32	71	296427	33080	79414810
Cerebral ventricular rupture	13.09	9.32	12	296486	448	79447442
Joint destruction	13.05	9.32	3	296495	5922	79441968
Sinus node dysfunction	13.02	9.32	60	296438	7641	79440249
Radiation pneumonitis	12.91	9.32	38	296460	3895	79443995
Cognitive disorder	12.89	9.32	346	296152	69580	79378310
Gastric ulcer haemorrhage	12.88	9.32	67	296431	8960	79438930
Cutaneous lupus erythematosus	12.86	9.32	32	296466	2971	79444919
Glomerular filtration rate increased	12.86	9.32	19	296479	1192	79446698
Feeling hot	12.85	9.32	151	296347	59583	79388307
Intestinal ischaemia	12.84	9.32	89	296409	13181	79434709
Lymphocyte count decreased	12.79	9.32	247	296251	47042	79400848
Renal artery stenosis	12.76	9.32	35	296463	3447	79444443
Coagulation test abnormal	12.72	9.32	20	296478	1325	79446565
Ischaemic nephropathy	12.72	9.32	5	296493	35	79447855
Sepsis	12.68	9.32	1165	295333	268263	79179627
Thrombotic cerebral infarction	12.66	9.32	13	296485	559	79447331
Product substitution issue	12.65	9.32	123	296375	20133	79427757
Discoloured vomit	12.65	9.32	21	296477	1457	79446433
Adverse event	12.65	9.32	153	296345	60061	79387829
Human herpesvirus 6 infection reactivation	12.61	9.32	13	296485	562	79447328
Injection site mass	12.60	9.32	36	296462	20148	79427742
Prostatic specific antigen increased	12.59	9.32	12	296486	10374	79437516
Drug tolerance decreased	12.51	9.32	18	296480	12960	79434930
Liver injury	12.48	9.32	287	296211	56327	79391563
Diffuse vasculitis	12.45	9.32	7	296491	118	79447772
Respiratory muscle weakness	12.45	9.32	10	296488	311	79447579
Hyperprolactinaemia	12.43	9.32	42	296456	4634	79443256
Joint dislocation	12.29	9.32	28	296470	16911	79430979
Restlessness	12.26	9.32	112	296386	46380	79401510
Drug dose omission by device	12.20	9.32	4	296494	6246	79441644
Drug level below therapeutic	12.19	9.32	11	296487	9759	79438131
Hypoalbuminaemia	12.18	9.32	127	296371	21170	79426720
Intentional dose omission	12.15	9.32	9	296489	8808	79439082
Wheezing	12.08	9.32	540	295958	116124	79331766
Product dose omission in error	12.02	9.32	7	296491	7781	79440109
Vulval haemorrhage	12.02	9.32	4	296494	16	79447874
Vascular skin disorder	12.02	9.32	4	296494	16	79447874
Upper limb fracture	12.01	9.32	31	296467	17936	79429954
Oculomucocutaneous syndrome	11.97	9.32	10	296488	329	79447561
Rash maculo-papular	11.97	9.32	283	296215	55795	79392095
N-telopeptide urine increased	11.94	9.32	5	296493	42	79447848
Gastrointestinal polyp haemorrhage	11.94	9.32	12	296486	503	79447387
Generalised bullous fixed drug eruption	11.93	9.32	8	296490	187	79447703
Strangury	11.93	9.32	8	296490	187	79447703
Cardiac septal defect	11.90	9.32	10	296488	332	79447558
Flushing	11.87	9.32	244	296254	88024	79359866
Transplant dysfunction	11.86	9.32	6	296492	7215	79440675
Inflammatory bowel disease	11.85	9.32	47	296451	5604	79442286
Gastrointestinal haemorrhage	11.83	9.32	667	295831	147052	79300838
Metabolic disorder	11.83	9.32	10	296488	9160	79438730
General physical health deterioration	11.83	9.32	872	295626	274366	79173524
Paradoxical drug reaction	11.76	9.32	6	296492	7179	79440711
Sinobronchitis	11.74	9.32	5	296493	44	79447846
Herpes zoster	11.74	9.32	260	296238	92823	79355067
Anti A antibody	11.73	9.32	3	296495	3	79447887
Diabetic metabolic decompensation	11.72	9.32	33	296465	3299	79444591
Mouth haemorrhage	11.70	9.32	75	296423	10824	79437066
Violence-related symptom	11.67	9.32	14	296484	717	79447173
Dialysis hypotension	11.65	9.32	6	296492	84	79447806
Procedural failure	11.65	9.32	6	296492	84	79447806
Laryngotracheal oedema	11.65	9.32	5	296493	45	79447845
Dyslalia	11.64	9.32	17	296481	1055	79446835
Aphasia	11.61	9.32	241	296257	46491	79401399
Burning feet syndrome	11.61	9.32	8	296490	196	79447694
Mesenteric artery embolism	11.59	9.32	6	296492	85	79447805
Cardiac output increased	11.57	9.32	9	296489	267	79447623
Oral mucosal discolouration	11.55	9.32	10	296488	346	79447544
Muscle spasticity	11.52	9.32	41	296457	21434	79426456
Bronchitis	11.51	9.32	384	296114	130260	79317630
Sluggishness	11.50	9.32	5	296493	6567	79441323
Immobilisation syndrome	11.50	9.32	12	296486	526	79447364
Lymphangiosis carcinomatosa	11.47	9.32	25	296473	2129	79445761
Pharyngotonsillitis	11.43	9.32	9	296489	272	79447618
Vitamin B12 increased	11.42	9.32	18	296480	1195	79446695
Progressive multifocal leukoencephalopathy	11.39	9.32	122	296376	20478	79427412
Hyperleukocytosis	11.38	9.32	28	296470	2582	79445308
Urine calcium/creatinine ratio increased	11.35	9.32	7	296491	141	79447749
Lip blister	11.34	9.32	29	296469	2738	79445152
Pre-eclampsia	11.34	9.32	6	296492	7035	79440855
Middle insomnia	11.30	9.32	27	296471	16042	79431848
Congenital bowing of long bones	11.30	9.32	4	296494	20	79447870
Incision site complication	11.29	9.32	14	296484	742	79447148
Urinary straining	11.28	9.32	5	296493	49	79447841
Lacunar infarction	11.27	9.32	48	296450	5909	79441981
Muscle atrophy	11.27	9.32	76	296422	11156	79436734
Pressure of speech	11.26	9.32	18	296480	1210	79446680
Cough	11.22	9.32	1193	295305	365596	79082294
Rectal ulcer haemorrhage	11.20	9.32	9	296489	280	79447610
Blood pressure abnormal	11.18	9.32	30	296468	17139	79430751
Osteoporosis	11.17	9.32	138	296360	53974	79393916
Hypoperfusion	11.17	9.32	28	296470	2611	79445279
Injection site warmth	11.13	9.32	24	296474	14783	79433107
X-ray abnormal	11.13	9.32	47	296451	5766	79442124
Vaginal cellulitis	11.12	9.32	6	296492	93	79447797
Gastritis bacterial	11.07	9.32	10	296488	366	79447524
Airway remodelling	11.07	9.32	9	296489	285	79447605
Rapid eye movement sleep behaviour disorder	11.06	9.32	11	296487	455	79447435
Glomerulosclerosis	11.06	9.32	17	296481	1105	79446785
Hypophosphataemia	11.04	9.32	118	296380	19795	79428095
Pneumocystis jirovecii pneumonia	11.01	9.32	176	296322	32332	79415558
Lymphocyte stimulation test positive	10.93	9.32	17	296481	1116	79446774
Rash papulosquamous	10.89	9.32	7	296491	152	79447738
Haemodynamic instability	10.86	9.32	31	296467	17351	79430539
Autoimmune hepatitis	10.81	9.32	78	296420	11705	79436185
Heat illness	10.81	9.32	12	296486	565	79447325
Product preparation error	10.81	9.32	4	296494	5789	79442101
Therapeutic response unexpected	10.76	9.32	38	296460	19908	79427982
Stevens-Johnson syndrome	10.74	9.32	205	296293	38961	79408929
Gastroenteritis staphylococcal	10.70	9.32	9	296489	299	79447591
Post cardiac arrest syndrome	10.70	9.32	4	296494	24	79447866
Coeliac disease	10.69	9.32	16	296482	11335	79436555
Parakeratosis	10.67	9.32	10	296488	384	79447506
Oral candidiasis	10.64	9.32	162	296336	29466	79418424
Morbid thoughts	10.63	9.32	14	296484	788	79447102
Gastroenteritis	10.61	9.32	182	296316	33900	79413990
Localised infection	10.58	9.32	89	296409	37486	79410404
Blood phosphorus decreased	10.58	9.32	51	296447	6617	79441273
Aortic aneurysm rupture	10.55	9.32	18	296480	1277	79446613
Procedural pain	10.53	9.32	47	296451	23037	79424853
Device leakage	10.52	9.32	15	296483	10841	79437049
Injection site rash	10.51	9.32	33	296465	17921	79429969
Respiratory depression	10.47	9.32	60	296438	27570	79420320
Acanthosis	10.43	9.32	11	296487	488	79447402
Acute myocardial infarction	10.41	9.32	367	296131	76669	79371221
Akathisia	10.38	9.32	21	296477	13238	79434652
Glossitis	10.36	9.32	34	296464	3696	79444194
Blood urea increased	10.34	9.32	246	296252	48544	79399346
Gingival pain	10.33	9.32	63	296435	8935	79438955
Oesophageal carcinoma recurrent	10.32	9.32	5	296493	61	79447829
Gastrointestinal stoma output increased	10.31	9.32	10	296488	401	79447489
Tongue discolouration	10.29	9.32	34	296464	3709	79444181
Hallucination, visual	10.27	9.32	175	296323	32554	79415336
Oedema	10.18	9.32	543	295955	119037	79328853
Blood loss anaemia	10.16	9.32	27	296471	15471	79432419
Abortion induced	10.13	9.32	7	296491	7102	79440788
Helicobacter test positive	10.12	9.32	18	296480	1320	79446570
Plasma cell myeloma recurrent	10.12	9.32	3	296495	4998	79442892
Oropharyngeal swelling	10.10	9.32	18	296480	1322	79446568
Cystitis noninfective	10.10	9.32	18	296480	1322	79446568
Meniere's disease	10.10	9.32	7	296491	173	79447717
Aspiration	10.06	9.32	117	296381	20041	79427849
Periprosthetic fracture	10.04	9.32	12	296486	612	79447278
Cardiogenic shock	10.03	9.32	215	296283	41699	79406191
Narrow anterior chamber angle	10.03	9.32	7	296491	175	79447715
Blood iron decreased	10.03	9.32	27	296471	15407	79432483
Rectocele	10.02	9.32	12	296486	613	79447277
Adenocarcinoma gastric	10.02	9.32	21	296477	1740	79446150
Mucormycosis	10.02	9.32	10	296488	8459	79439431
Gastrointestinal infection	9.99	9.32	17	296481	11444	79436446
Abnormal faeces	9.99	9.32	55	296443	7516	79440374
Duodenal polyp	9.98	9.32	9	296489	329	79447561
Tumour haemorrhage	9.96	9.32	36	296462	4108	79443782
Joint effusion	9.93	9.32	34	296464	17980	79429910
Fat redistribution	9.90	9.32	6	296492	117	79447773
Frustration tolerance decreased	9.90	9.32	8	296490	7494	79440396
Acute graft versus host disease	9.90	9.32	14	296484	10153	79437737
Abdominal discomfort	9.89	9.32	800	295698	249927	79197963
Small intestinal haemorrhage	9.87	9.32	36	296462	4127	79443763
Cholelithiasis	9.82	9.32	261	296237	52403	79395487
Rash vesicular	9.82	9.32	46	296452	5899	79441991
Cytomegalovirus test positive	9.81	9.32	46	296452	5901	79441989
Nasal mucosal erosion	9.78	9.32	5	296493	69	79447821
Hepatic cancer metastatic	9.77	9.32	14	296484	854	79447036
Renal disorder	9.77	9.32	215	296283	41890	79406000
Thrombosis	9.74	9.32	238	296260	83862	79364028
Paramnesia	9.72	9.32	4	296494	32	79447858
Dissociation	9.72	9.32	35	296463	3986	79443904
Hepatic atrophy	9.72	9.32	10	296488	431	79447459
Respiratory tract oedema	9.70	9.32	14	296484	860	79447030
Drug-induced liver injury	9.70	9.32	318	296180	65799	79382091
Multiple sclerosis	9.68	9.32	126	296372	22156	79425734
Ulcer	9.68	9.32	161	296337	29811	79418079
Culture throat positive	9.67	9.32	3	296495	9	79447881
Erythema annulare	9.66	9.32	7	296491	186	79447704
Body temperature increased	9.66	9.32	112	296386	44308	79403582
Dysuria	9.64	9.32	253	296245	50698	79397192
Dermatitis atopic	9.64	9.32	14	296484	10042	79437848
Gamma-glutamyltransferase increased	9.63	9.32	269	296229	54411	79393479
Gynaecomastia	9.61	9.32	55	296443	7626	79440264
Gallbladder hypofunction	9.60	9.32	11	296487	536	79447354
Deformity	9.58	9.32	13	296485	9592	79438298
Atrioventricular block second degree	9.57	9.32	53	296445	7259	79440631
Analgesic therapy	9.54	9.32	15	296483	994	79446896
Tenosynovitis	9.52	9.32	28	296470	15526	79432364
Cerebral hyperperfusion syndrome	9.51	9.32	6	296492	126	79447764
Migraine	9.50	9.32	407	296091	87086	79360804
Feeling jittery	9.50	9.32	21	296477	12820	79435070
Bronchiectasis	9.48	9.32	126	296372	22260	79425630
Injection site urticaria	9.47	9.32	21	296477	12805	79435085
Sterile pyuria	9.47	9.32	5	296493	74	79447816
Posterior reversible encephalopathy syndrome	9.46	9.32	58	296440	26223	79421667
Cushingoid	9.45	9.32	13	296485	9539	79438351
Hyperammonaemic encephalopathy	9.44	9.32	3	296495	4779	79443111
Adjustment disorder with depressed mood	9.43	9.32	62	296436	9024	79438866
Periorbital discomfort	9.41	9.32	4	296494	35	79447855
Blood electrolytes increased	9.41	9.32	5	296493	75	79447815
Hypoglycaemia	9.40	9.32	465	296033	101129	79346761
Pancreatic carcinoma metastatic	9.36	9.32	33	296465	3720	79444170
Excessive eye blinking	9.35	9.32	20	296478	1681	79446209
Vitamin B1 decreased	9.34	9.32	11	296487	552	79447338

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	A02BC03	ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) Proton pump inhibitors
ATC	A02BC53	ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) Proton pump inhibitors
ATC	A02BD02	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	A02BD03	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	A02BD07	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	A02BD09	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	A02BD10	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 PE	N0000009724	Inhibition Gastric Acid Secretion
FDA EPC	N0000175525	Proton Pump Inhibitor
CHEBI has role	CHEBI:49200	proton pump inhibitors
CHEBI has role	CHEBI:49201	anti-ulcer drugs
MeSH PA	D000897	Anti-Ulcer Agents
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D005765	Gastrointestinal Agents
MeSH PA	D054328	Proton Pump Inhibitors

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

Disease	Relation	SNOMED_ID	DOID
Peptic ulcer	indication	13200003	DOID:750
Erosive esophagitis	indication	40719004
Duodenal ulcer disease	indication	51868009	DOID:1724
Zollinger-Ellison syndrome	indication	53132006	DOID:0050782
Gastroesophageal reflux disease	indication	235595009	DOID:8534
Gastric ulcer	indication	397825006	DOID:10808
NSAID-Induced Gastric Ulcer	indication
Gastric Hypersecretory Conditions	indication
Duodenal Ulcer due to H. Pylori	indication
Maintenance of Healing Duodenal Ulcer	indication
Upper gastrointestinal hemorrhage	off-label use	37372002
Pathological Gastric Hypersecretory Condition	off-label use
Prevention of Stress Ulcer	off-label use
Prevention of Acute Gastrointestinal Ulcer Re-Bleed	off-label use
Alcoholism	contraindication	7200002
Myocardial infarction	contraindication	22298006	DOID:5844
Ventricular tachycardia	contraindication	25569003
Obstruction of bile duct	contraindication	30144000
Torsades de pointes	contraindication	31722008
Hypertensive disorder	contraindication	38341003	DOID:10763
Gastrointestinal ulcer	contraindication	40845000
Body fluid retention	contraindication	43498006
Chronic heart failure	contraindication	48447003
Disorder of cardiovascular system	contraindication	49601007	DOID:1287
Acute nephropathy	contraindication	58574008
Hepatic failure	contraindication	59927004
Blood coagulation disorder	contraindication	64779008	DOID:1247
Osteoporosis	contraindication	64859006	DOID:11476
Gastrointestinal hemorrhage	contraindication	74474003
Kidney disease	contraindication	90708001	DOID:557
Myasthenia gravis	contraindication	91637004	DOID:437
Cholestatic hepatitis	contraindication	95556007
Prolonged QT interval	contraindication	111975006
Fracture of bone	contraindication	125605004
Liver function tests abnormal	contraindication	166603001
Hypomagnesemia	contraindication	190855004
Cerebrovascular accident	contraindication	230690007
Coronary artery bypass graft	contraindication	232717009
Disease of liver	contraindication	235856003	DOID:409
Esophageal dysmotility	contraindication	266434009	DOID:9192
Edema	contraindication	267038008
Infectious mononucleosis	contraindication	271558008	DOID:8568
Anemia	contraindication	271737000	DOID:2355
Pregnancy, function	contraindication	289908002
Thromboembolic disorder	contraindication	371039008
Cardiovascular event risk	contraindication	395112001
Pseudomembranous enterocolitis	contraindication	397683000
Porphyria	contraindication	418470004
Smokes tobacco daily	contraindication	449868002

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.23	acidic
pKa2	3.35	Basic
pKa3	2.72	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Potassium-transporting ATPase	Transporter	P20648 P51164	ATP4A_HUMAN ATP4B_HUMAN	INHIBITOR			CHEMBL	CHEMBL
ATP-binding cassette sub-family G member 2	Transporter	Q9UNQ0	ABCG2_HUMAN		IC50	4.84	CHEMBL
Cytochrome P450 2C19	Enzyme	P33261	CP2CJ_HUMAN		IC50	6.47	DRUG MATRIX
Fatty acid synthase	Enzyme	P49327	FAS_HUMAN		Ki	5.28	CHEMBL
Phosphoethanolamine/phosphocholine phosphatase	Enzyme	Q8TCT1	PHOP1_HUMAN		IC50	6.36	CHEMBL
Microtubule-associated protein tau	Structural	P10636	TAU_HUMAN		Ki	8.60	CHEMBL
N(G),N(G)-dimethylarginine dimethylaminohydrolase 1	Enzyme	O94760	DDAH1_HUMAN		IC50	4.29	CHEMBL
Cytochrome P450 2D6	Enzyme	P10635	CP2D6_HUMAN		IC50	5.28	DRUG MATRIX
Cytosolic endo-beta-N-acetylglucosaminidase	Enzyme	Q8NFI3	ENASE_HUMAN		IC50	4.61	CHEMBL
Indoleamine 2,3-dioxygenase 2	Enzyme		I23O2_MOUSE		IC50	5.09	CHEMBL
Indoleamine 2,3-dioxygenase 1	Enzyme		I23O1_MOUSE		IC50	4.03	CHEMBL

External reference:

ID	Source
D00355	KEGG_DRUG
4020922	VANDF
C0050940	UMLSCUI
CHEBI:6375	CHEBI
CHEMBL480	ChEMBL_ID
DB00448	DRUGBANK_ID
D064747	MESH_DESCRIPTOR_UI
3883	PUBCHEM_CID
7208	IUPHAR_LIGAND_ID
6397	INN_ID
0K5C5T2QPG	UNII
17128	RXNORM
169151	MMSL
330	MMSL
4958	MMSL
d03828	MMSL
004456	NDDF
108666007	SNOMEDCT_US
386888004	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Prevacid24 HR	HUMAN OTC DRUG LABEL	1	0067-6286	CAPSULE, DELAYED RELEASE	15 mg	ORAL	NDA	15 sections
Lansoprazole	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3008	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE	15 mg	ORAL	ANDA	29 sections
Lansoprazole	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3008	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE	15 mg	ORAL	ANDA	29 sections
Lansoprazole	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3008	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE	15 mg	ORAL	ANDA	29 sections
Lansoprazole	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3009	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE	30 mg	ORAL	ANDA	29 sections
Lansoprazole	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3009	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE	30 mg	ORAL	ANDA	29 sections
Lansoprazole	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3009	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE	30 mg	ORAL	ANDA	29 sections
Lansoprazole	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7350	CAPSULE, DELAYED RELEASE	15 mg	ORAL	ANDA	27 sections
Lansoprazole	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7350	CAPSULE, DELAYED RELEASE	15 mg	ORAL	ANDA	27 sections
Lansoprazole	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7350	CAPSULE, DELAYED RELEASE	15 mg	ORAL	ANDA	27 sections
Lansoprazole	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7351	CAPSULE, DELAYED RELEASE	30 mg	ORAL	ANDA	27 sections
Lansoprazole	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7351	CAPSULE, DELAYED RELEASE	30 mg	ORAL	ANDA	27 sections
Lansoprazole	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7351	CAPSULE, DELAYED RELEASE	30 mg	ORAL	ANDA	27 sections
Good Sense Lansoprazole	HUMAN OTC DRUG LABEL	1	0113-0116	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE	15 mg	ORAL	NDA	16 sections
Good Sense lansoprazole	HUMAN OTC DRUG LABEL	1	0113-0117	CAPSULE, DELAYED RELEASE	15 mg	ORAL	ANDA	16 sections
Good Sense Lansoprazole	HUMAN OTC DRUG LABEL	1	0113-1114	CAPSULE, DELAYED RELEASE	15 mg	ORAL	ANDA	16 sections
Good Sense Lansoprazole	HUMAN OTC DRUG LABEL	1	0113-1114	CAPSULE, DELAYED RELEASE	15 mg	ORAL	ANDA	16 sections
Prevacid 24 HR	HUMAN OTC DRUG LABEL	1	0113-6002	CAPSULE, DELAYED RELEASE	15 mg	ORAL	NDA	16 sections
Prevacid 24 HR	HUMAN OTC DRUG LABEL	1	0113-6002	CAPSULE, DELAYED RELEASE	15 mg	ORAL	NDA	16 sections
Prevacid 24 HR	HUMAN OTC DRUG LABEL	1	0113-6117	CAPSULE, DELAYED RELEASE	15 mg	ORAL	NDA	15 sections
Basic Care Lansoprazole	HUMAN OTC DRUG LABEL	1	0113-7003	CAPSULE, DELAYED RELEASE	15 mg	ORAL	ANDA	16 sections
basic care lansoprazole	HUMAN OTC DRUG LABEL	1	0113-7116	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE	15 mg	ORAL	NDA	16 sections
Lansoprazole	HUMAN OTC DRUG LABEL	1	0363-0037	CAPSULE, DELAYED RELEASE	15 mg	ORAL	ANDA	15 sections
Lansoprazole	HUMAN OTC DRUG LABEL	1	0363-0739	CAPSULE, DELAYED RELEASE	15 mg	ORAL	ANDA	15 sections
Lansoprazole	HUMAN OTC DRUG LABEL	1	0363-0739	CAPSULE, DELAYED RELEASE	15 mg	ORAL	ANDA	15 sections
lansoprazole	HUMAN OTC DRUG LABEL	1	0363-1212	CAPSULE, DELAYED RELEASE	15 mg	ORAL	ANDA	16 sections
lansoprazole	HUMAN OTC DRUG LABEL	1	0363-1212	CAPSULE, DELAYED RELEASE	15 mg	ORAL	ANDA	16 sections
Lansoprazole	HUMAN OTC DRUG LABEL	1	0363-1419	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE	15 mg	ORAL	NDA	16 sections
Lansoprazole	HUMAN OTC DRUG LABEL	1	0363-1419	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE	15 mg	ORAL	NDA	16 sections
Lansoprazole	HUMAN OTC DRUG LABEL	1	0363-4069	CAPSULE, DELAYED RELEASE	15 mg	ORAL	ANDA	16 sections