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

Stem definition	Drug id	CAS RN
antibiotics, cefalosporanic acid derivatives	564	73384-59-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: ceftriaxone sodium hydrate ceftriaxone biotrakson rocefin rocephalin rophex ceftriaxone sodium	A broad-spectrum cephalosporin antibiotic and cefotaxime derivative with a very long half-life and high penetrability to meninges, eyes and inner ears. Molecular weight: 554.57 Formula: C18H18N8O7S3 CLOGP: -1.24 LIPINSKI: 2 HAC: 15 HDO: 4 TPSA: 208.98 ALOGS: -3.72 ROTB: 8 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

ceftriaxone sodium hydrate
ceftriaxone
biotrakson
rocefin
rocephalin
rophex
ceftriaxone sodium

A broad-spectrum cephalosporin antibiotic and cefotaxime derivative with a very long half-life and high penetrability to meninges, eyes and inner ears.

Molecular weight: 554.57
Formula: C18H18N8O7S3
CLOGP: -1.24
LIPINSKI: 2
HAC: 15
HDO: 4
TPSA: 208.98
ALOGS: -3.72
ROTB: 8

Status: OFP

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

Drug dosage:

Dose	Unit	Route
2	g	P
2	g	P

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	400 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	46 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	120.27 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	0 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.12 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	0.22 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.10 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	7.60 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Dec. 21, 1984	FDA

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
Drug reaction with eosinophilia and systemic symptoms	736.10	12.38	403	47480	33433	63407706
Acute generalised exanthematous pustulosis	405.71	12.38	188	47695	10911	63430228
Toxic epidermal necrolysis	389.50	12.38	241	47642	25093	63416046
Acute kidney injury	356.58	12.38	679	47204	262736	63178403
Eosinophilia	338.50	12.38	212	47671	22544	63418595
Pseudocholelithiasis	328.64	12.38	54	47829	6	63441133
Rash maculo-papular	291.37	12.38	220	47663	31676	63409463
Fatigue	244.07	12.38	189	47694	887839	62553300
Multiple organ dysfunction syndrome	238.02	12.38	252	47631	56500	63384639
Pain	214.45	12.38	149	47734	740479	62700660
Jarisch-Herxheimer reaction	208.79	12.38	50	47833	327	63440812
Off label use	206.08	12.38	1027	46856	673435	62767704
Joint swelling	205.64	12.38	10	47873	327656	63113483
Premature delivery	184.34	12.38	165	47718	30116	63411023
Septic shock	182.77	12.38	238	47645	66391	63374748
Agranulocytosis	181.49	12.38	151	47732	24983	63416156
Clostridium difficile colitis	179.28	12.38	138	47745	20431	63420708
Stevens-Johnson syndrome	176.23	12.38	148	47735	24802	63416337
Alopecia	167.53	12.38	27	47856	337509	63103630
Cholestasis	166.66	12.38	154	47729	29280	63411859
Cholelithiasis	163.13	12.38	183	47700	43742	63397397
Drug interaction	159.14	12.38	455	47428	228676	63212463
Rheumatoid arthritis	158.38	12.38	8	47875	253811	63187328
Arthropathy	158.23	12.38	4	47879	234788	63206351
Arthralgia	157.62	12.38	120	47763	569590	62871549
Drug intolerance	154.72	12.38	24	47859	308637	63132502
Electrocardiogram QT prolonged	153.01	12.38	206	47677	59324	63381815
Pyrexia	152.21	12.38	729	47154	469749	62971390
Recalled product administered	145.03	12.38	40	47843	485	63440654
Haemolytic anaemia	144.69	12.38	92	47791	10033	63431106
Hepatitis	139.66	12.38	161	47722	39627	63401512
Clostridium test positive	138.45	12.38	61	47822	3140	63437999
Abdominal discomfort	135.96	12.38	37	47846	320848	63120291
Status epilepticus	134.49	12.38	103	47780	15130	63426009
Factor V inhibition	127.36	12.38	29	47854	147	63440992
Anaphylactic shock	126.77	12.38	120	47763	23513	63417626
Tubulointerstitial nephritis	126.19	12.38	111	47772	19792	63421347
Therapeutic product effect decreased	120.77	12.38	6	47877	193181	63247958
Glossodynia	120.67	12.38	3	47880	178873	63262266
Pemphigus	120.57	12.38	4	47879	183722	63257417
Swelling	119.97	12.38	30	47853	275348	63165791
Headache	118.99	12.38	184	47699	633057	62808082
Contraindicated product administered	113.49	12.38	15	47868	217633	63223506
Hepatocellular injury	110.17	12.38	119	47764	27262	63413877
Systemic lupus erythematosus	109.89	12.38	14	47869	208904	63232235
Leukocytosis	106.60	12.38	114	47769	25821	63415318
Pulmonary function test abnormal	106.28	12.38	43	47840	1787	63439352
Blood lactic acid increased	105.28	12.38	66	47817	7020	63434119
Weight increased	103.29	12.38	34	47849	260758	63180381
Encephalopathy	102.82	12.38	136	47747	38484	63402655
Exposure during pregnancy	100.29	12.38	301	47582	155246	63285893
Drug ineffective for unapproved indication	96.99	12.38	124	47759	33939	63407200
Clostridium difficile infection	96.56	12.38	116	47767	29806	63411333
Wound	96.20	12.38	7	47876	163256	63277883
Chest X-ray abnormal	95.54	12.38	53	47830	4496	63436643
Peripheral swelling	94.75	12.38	41	47842	265901	63175238
Nasopharyngitis	94.13	12.38	37	47846	254220	63186919
Postrenal failure	93.71	12.38	23	47860	169	63440970
Respiratory failure	92.77	12.38	224	47659	101634	63339505
Product dose omission issue	91.98	12.38	31	47852	234282	63206857
Acute respiratory distress syndrome	90.70	12.38	100	47783	23434	63417705
Fall	90.01	12.38	98	47785	392236	63048903
Hepatitis cholestatic	87.24	12.38	58	47825	6820	63434319
Thrombocytopenia	86.80	12.38	281	47602	150876	63290263
Pericarditis	85.84	12.38	3	47880	131576	63309563
Ear pruritus	85.48	12.38	47	47836	3918	63437221
Cardiac arrest	84.78	12.38	204	47679	92341	63348798
Drug-induced liver injury	83.85	12.38	126	47757	40096	63401043
Sepsis	82.86	12.38	279	47604	152844	63288295
Altered state of consciousness	81.72	12.38	98	47785	25132	63416007
Pseudomembranous colitis	81.51	12.38	42	47841	3070	63438069
Transaminases increased	79.73	12.38	108	47775	31259	63409880
Enterococcal infection	75.79	12.38	56	47827	7792	63433347
Pain in extremity	73.59	12.38	85	47798	331401	63109738
Musculoskeletal stiffness	73.18	12.38	24	47859	184594	63256545
Discomfort	71.37	12.38	19	47864	167355	63273784
Neutropenia	71.32	12.38	291	47592	174714	63266425
Anaphylactic reaction	69.66	12.38	154	47729	65946	63375193
Haemophagocytic lymphohistiocytosis	68.83	12.38	60	47823	10567	63430572
Toxic encephalopathy	68.19	12.38	49	47834	6530	63434609
Pleocytosis	67.38	12.38	25	47858	820	63440319
Linear IgA disease	67.14	12.38	29	47854	1422	63439717
Dizziness	67.02	12.38	140	47743	429785	63011354
Contusion	65.96	12.38	16	47867	150028	63291111
Long QT syndrome	65.59	12.38	37	47846	3242	63437897
Injection site pain	65.16	12.38	10	47873	129790	63311349
Insomnia	65.07	12.38	41	47842	215211	63225928
Bronchopulmonary aspergillosis	64.65	12.38	53	47830	8582	63432557
Tachypnoea	62.36	12.38	71	47812	17231	63423908
Dermatitis exfoliative	62.01	12.38	43	47840	5416	63435723
Pneumococcal infection	61.65	12.38	20	47863	435	63440704
Acinetobacter infection	61.54	12.38	28	47855	1555	63439584
Alveolitis	61.32	12.38	34	47849	2881	63438258
Erythema	60.68	12.38	278	47605	175473	63265666
Metabolic acidosis	60.45	12.38	116	47767	44953	63396186
Hypoxia	60.42	12.38	137	47746	59655	63381484
Low birth weight baby	60.30	12.38	47	47836	7082	63434057
Choreoathetosis	58.70	12.38	20	47863	509	63440630
Cholecystitis	58.66	12.38	65	47818	15312	63425827
Nasal polyps	58.11	12.38	43	47840	5996	63435143
Urticaria	57.78	12.38	263	47620	165539	63275600
Helicobacter infection	57.58	12.38	3	47880	92782	63348357
Tachycardia	56.72	12.38	207	47676	117949	63323190
Psoriatic arthropathy	56.66	12.38	3	47880	91517	63349622
Torsade de pointes	53.65	12.38	58	47825	13293	63427846
No adverse event	52.41	12.38	104	47779	41301	63399838
Myasthenia gravis crisis	51.54	12.38	18	47865	494	63440645
Weight decreased	51.25	12.38	81	47802	276717	63164422
Platelet count increased	51.24	12.38	65	47818	17646	63423493
Infusion related reaction	51.23	12.38	66	47817	245455	63195684
Muscle spasms	51.09	12.38	27	47856	156123	63285016
Gait disturbance	49.93	12.38	39	47844	183139	63258000
Vasculitis	49.81	12.38	65	47818	18144	63422995
Influenza B virus test positive	49.54	12.38	15	47868	258	63440881
Pathogen resistance	49.44	12.38	40	47843	6358	63434781
Encephalitis	49.35	12.38	46	47837	8834	63432305
Mobility decreased	49.33	12.38	15	47868	121144	63319995
Dermatitis bullous	49.08	12.38	45	47838	8463	63432676
Renal failure	48.98	12.38	197	47686	117455	63323684
Sinusitis	48.25	12.38	60	47823	226593	63214546
Breath sounds abnormal	48.23	12.38	50	47833	10923	63430216
Symmetrical drug-related intertriginous and flexural exanthema	47.99	12.38	17	47866	487	63440652
Psoriasis	47.75	12.38	5	47878	86952	63354187
Hydronephrosis	47.61	12.38	49	47834	10613	63430526
Product use issue	47.34	12.38	58	47825	220462	63220677
Rash morbilliform	46.97	12.38	30	47853	3295	63437844
Shock	46.77	12.38	72	47811	23391	63417748
Acute respiratory failure	46.54	12.38	89	47794	34396	63406743
Nausea	46.03	12.38	418	47465	854053	62587086
Cholangitis	45.60	12.38	36	47847	5525	63435614
Gastrointestinal disorder	45.49	12.38	21	47862	131218	63309921
Rhinitis allergic	45.47	12.38	50	47833	11677	63429462
Depression	45.07	12.38	49	47834	196443	63244696
Premature baby	44.70	12.38	66	47817	20669	63420470
Lower respiratory tract infection	44.59	12.38	22	47861	132285	63308854
SJS-TEN overlap	44.16	12.38	15	47868	378	63440761
CSF oligoclonal band present	43.90	12.38	15	47868	385	63440754
Stenotrophomonas infection	43.62	12.38	24	47859	2003	63439136
Malaise	43.57	12.38	164	47719	415790	63025349
Pancytopenia	43.33	12.38	166	47717	96767	63344372
Cross sensitivity reaction	42.18	12.38	24	47859	2138	63439001
Ill-defined disorder	41.71	12.38	6	47877	81749	63359390
Migraine	41.70	12.38	13	47870	103333	63337806
Neutrophilia	41.56	12.38	31	47852	4375	63436764
Folliculitis	41.44	12.38	3	47880	70314	63370825
Stress cardiomyopathy	41.42	12.38	43	47840	9407	63431732
Stomatitis	41.12	12.38	27	47856	138698	63302441
Leukopenia	41.03	12.38	140	47743	77150	63363989
Hepatic cytolysis	40.60	12.38	54	47829	15353	63425786
Osteoarthritis	40.29	12.38	11	47872	95332	63345807
Treatment failure	39.99	12.38	55	47828	198988	63242151
Pyuria	39.38	12.38	22	47861	1892	63439247
Pyelonephritis	38.92	12.38	57	47826	17721	63423418
Nosocomial infection	38.76	12.38	21	47862	1700	63439439
Drug resistance	38.37	12.38	65	47818	22868	63418271
Injection site erythema	38.29	12.38	8	47875	83166	63357973
Rash erythematous	38.14	12.38	93	47790	42417	63398722
Guillain-Barre syndrome	38.09	12.38	28	47855	3865	63437274
Maternal exposure during pregnancy	37.97	12.38	290	47593	219772	63221367
Arthritis	37.97	12.38	20	47863	115901	63325238
Hypokalaemia	37.89	12.38	167	47716	103637	63337502
Abdominal pain upper	37.63	12.38	61	47822	206383	63234756
Haemolysis	37.50	12.38	35	47848	6733	63434406
Haemodynamic instability	37.06	12.38	40	47843	9150	63431989
Propofol infusion syndrome	37.00	12.38	17	47866	966	63440173
International normalised ratio increased	36.90	12.38	97	47786	46328	63394811
Fibromyalgia	36.48	12.38	8	47875	80412	63360727
Upper-airway cough syndrome	36.39	12.38	44	47839	11374	63429765
Myopathy toxic	36.19	12.38	14	47869	516	63440623
Hypertension	35.53	12.38	101	47782	279202	63161937
Hepatic enzyme increased	34.84	12.38	62	47821	202266	63238873
Immune reconstitution inflammatory syndrome	34.75	12.38	32	47851	6052	63435087
Impaired healing	34.62	12.38	17	47866	102525	63338614
Respiratory distress	34.52	12.38	78	47805	33873	63407266
Klebsiella infection	34.04	12.38	37	47846	8529	63432610
Angioedema	33.91	12.38	96	47787	47869	63393270
Partial seizures	33.90	12.38	31	47852	5811	63435328
Blood creatinine increased	33.34	12.38	143	47740	87701	63353438
Normal newborn	33.10	12.38	36	47847	8305	63432834
Leukaemoid reaction	32.97	12.38	10	47873	173	63440966
CSF measles antibody positive	32.81	12.38	8	47875	57	63441082
Hepatitis infectious mononucleosis	32.71	12.38	9	47874	108	63441031
Weber tuning fork test abnormal	32.56	12.38	9	47874	110	63441029
Hypertransaminasaemia	32.49	12.38	32	47851	6577	63434562
Cyanosis	32.40	12.38	51	47832	16884	63424255
Hypoaesthesia	32.36	12.38	48	47835	168345	63272794
Oliguria	32.21	12.38	37	47846	9064	63432075
Rubella antibody positive	32.00	12.38	8	47875	64	63441075
Mitochondrial DNA mutation	31.88	12.38	12	47871	410	63440729
Unresponsive to stimuli	31.43	12.38	75	47808	33741	63407398
Lip oedema	31.31	12.38	25	47858	3899	63437240
Enterobacter infection	31.23	12.38	20	47863	2207	63438932
Aspartate aminotransferase increased	30.52	12.38	142	47741	90135	63351004
Intentional overdose	30.51	12.38	9	47874	74143	63366996
Death	30.51	12.38	162	47721	374219	63066920
Hepatic function abnormal	29.92	12.38	78	47805	37064	63404075
Sneezing	29.64	12.38	51	47832	18167	63422972
Neurotoxicity	29.55	12.38	49	47834	16941	63424198
Blood brain barrier defect	29.47	12.38	8	47875	91	63441048
Systemic inflammatory response syndrome	29.10	12.38	28	47855	5593	63435546
Back pain	29.04	12.38	102	47781	264043	63177096
Agitation	28.91	12.38	105	47778	59652	63381487
Dyspepsia	28.80	12.38	21	47862	102175	63338964
Hypotension	28.65	12.38	323	47560	272281	63168858
Sleep disorder	28.34	12.38	13	47870	81553	63359586
Adverse event	28.16	12.38	8	47875	67551	63373588
Gastroenteritis clostridial	27.94	12.38	12	47871	580	63440559
Fibrin D dimer increased	27.83	12.38	26	47857	5008	63436131
Dermatitis exfoliative generalised	27.73	12.38	23	47860	3784	63437355
Blood gases abnormal	27.56	12.38	13	47870	784	63440355
Haemoperitoneum	27.46	12.38	20	47863	2721	63438418
Memory impairment	27.39	12.38	23	47860	104235	63336904
Multiple-drug resistance	27.24	12.38	26	47857	5144	63435995
Alanine aminotransferase increased	27.22	12.38	152	47731	103618	63337521
Feeling abnormal	26.89	12.38	44	47839	148348	63292791
Laryngeal stenosis	26.66	12.38	14	47869	1064	63440075
Bile duct stone	26.45	12.38	22	47861	3634	63437505
Factor V deficiency	26.17	12.38	7	47876	75	63441064
Dry mouth	26.14	12.38	13	47870	77850	63363289
COVID-19 pneumonia	26.09	12.38	42	47841	14167	63426972
Electrolyte imbalance	26.09	12.38	51	47832	20025	63421114
Drug abuse	26.07	12.38	11	47872	72507	63368632
Cholestatic liver injury	26.05	12.38	19	47864	2591	63438548
CSF protein increased	26.05	12.38	11	47872	510	63440629
Pelvic inflammatory disease	26.00	12.38	16	47867	1646	63439493
Gene mutation	25.98	12.38	16	47867	1649	63439490
Autoimmune haemolytic anaemia	25.89	12.38	24	47859	4577	63436562
Face oedema	25.85	12.38	51	47832	20161	63420978
Erythema multiforme	25.81	12.38	35	47848	10134	63431005
Hepatitis acute	25.63	12.38	33	47850	9087	63432052
Balance disorder	25.60	12.38	16	47867	84406	63356733
Escherichia infection	25.22	12.38	39	47844	12715	63428424
Cardiogenic shock	25.08	12.38	47	47836	17885	63423254
Toxic skin eruption	24.92	12.38	39	47844	12846	63428293
Bronchial obstruction	24.84	12.38	15	47868	1492	63439647
Nephropathy toxic	24.63	12.38	33	47850	9446	63431693
Intervertebral discitis	24.56	12.38	20	47863	3208	63437931
Anuria	24.29	12.38	38	47845	12513	63428626
Disseminated intravascular coagulation	24.28	12.38	48	47835	19003	63422136
Blood pressure increased	24.16	12.38	54	47829	162008	63279131
Eosinophilic pneumonia	24.14	12.38	17	47866	2194	63438945
Clostridium colitis	23.93	12.38	16	47867	1898	63439241
Palpitations	23.82	12.38	30	47853	112740	63328399
Therapeutic product effect incomplete	23.68	12.38	36	47847	125020	63316119
Hyporesponsive to stimuli	23.56	12.38	13	47870	1091	63440048
Organic brain syndrome	23.50	12.38	8	47875	203	63440936
Musculoskeletal pain	23.46	12.38	21	47862	92256	63348883
Abdominal wall haematoma	23.39	12.38	19	47864	3036	63438103
Muscle tension dysphonia	23.39	12.38	8	47875	206	63440933
Coombs negative haemolytic anaemia	23.32	12.38	8	47875	208	63440931
Suicidal ideation	23.20	12.38	9	47874	62412	63378727
Renal tubular necrosis	23.04	12.38	36	47847	11842	63429297
Vascular device infection	23.01	12.38	28	47855	7284	63433855
Full blood count abnormal	22.92	12.38	64	47819	31653	63409486
Thunderclap headache	22.79	12.38	8	47875	223	63440916
Lacrimation increased	22.78	12.38	49	47834	20582	63420557
Cholangitis acute	22.63	12.38	10	47873	518	63440621
Anxiety	22.58	12.38	86	47797	217455	63223684
Eye pruritus	22.55	12.38	46	47837	18625	63422514
Encephalitis brain stem	22.47	12.38	7	47876	133	63441006
Blood pressure fluctuation	22.27	12.38	4	47879	46313	63394826
Haemostasis	22.17	12.38	8	47875	242	63440897
Type IV hypersensitivity reaction	22.14	12.38	18	47865	2880	63438259
Jaundice	22.11	12.38	60	47823	29191	63411948
Product use in unapproved indication	21.99	12.38	219	47664	178861	63262278
Pyelonephritis acute	21.95	12.38	22	47861	4619	63436520
Otitis media acute	21.85	12.38	12	47871	998	63440141
Myocardial infarction	21.70	12.38	26	47857	99867	63341272
Multiple sclerosis relapse	21.62	12.38	5	47878	48473	63392666
Hyperbilirubinaemia	21.54	12.38	34	47849	11280	63429859
Haemodialysis	21.51	12.38	30	47853	8917	63432222
Endocarditis	21.40	12.38	24	47859	5726	63435413
Renal papillary necrosis	21.40	12.38	8	47875	268	63440871
Bacteriuria	21.38	12.38	12	47871	1041	63440098
Paraesthesia	21.26	12.38	55	47828	156911	63284228
Hospitalisation	20.87	12.38	20	47863	85061	63356078
Veillonella infection	20.84	12.38	5	47878	33	63441106
Drug eruption	20.84	12.38	58	47825	28636	63412503
Coagulation factor deficiency	20.72	12.38	4	47879	7	63441132
Pneumonia necrotising	20.71	12.38	9	47874	448	63440691
Pancreatitis necrotising	20.66	12.38	14	47869	1698	63439441
Hyperglycaemia	20.62	12.38	74	47809	41793	63399346
Laryngeal mass	20.58	12.38	5	47878	35	63441104
Rhinocerebral mucormycosis	20.56	12.38	9	47874	456	63440683
Morganella infection	20.34	12.38	10	47873	661	63440478
Confabulation	20.25	12.38	8	47875	312	63440827
Meningitis	20.22	12.38	26	47857	7151	63433988
Iris transillumination defect	20.10	12.38	6	47877	98	63441041
Meningism	20.02	12.38	9	47874	486	63440653
Encephalitis autoimmune	19.99	12.38	13	47870	1473	63439666
Cataract	19.96	12.38	9	47874	57044	63384095
Infection	19.87	12.38	97	47786	229076	63212063
Type I hypersensitivity	19.84	12.38	17	47866	2925	63438214
Influenza like illness	19.80	12.38	13	47870	66811	63374328
Myocarditis	19.62	12.38	31	47852	10294	63430845
Foetal death	19.54	12.38	32	47851	10948	63430191
Intravascular haemolysis	19.53	12.38	8	47875	343	63440796
Postpartum sepsis	19.48	12.38	4	47879	11	63441128
Hepatosplenomegaly	19.48	12.38	16	47867	2598	63438541
Eyelid oedema	19.28	12.38	31	47852	10448	63430691
Erythema nodosum	19.27	12.38	21	47862	4854	63436285
Aspergillus infection	19.26	12.38	27	47856	8066	63433073
Bronchopleural fistula	19.21	12.38	7	47876	218	63440921
Transverse sinus thrombosis	18.99	12.38	9	47874	549	63440590
Acquired haemophilia	18.92	12.38	11	47872	1020	63440119
Blood potassium decreased	18.79	12.38	72	47811	41954	63399185
Stress	18.67	12.38	14	47869	67153	63373986
Conjunctival hyperaemia	18.65	12.38	15	47868	2364	63438775
Anti factor V antibody	18.57	12.38	3	47880	0	63441139
Red blood cell agglutination	18.57	12.38	3	47880	0	63441139
Acute hepatic failure	18.51	12.38	42	47841	18285	63422854
Meningitis bacterial	18.49	12.38	12	47871	1355	63439784
Gastric disorder	18.47	12.38	3	47880	37366	63403773
Respiratory acidosis	18.41	12.38	24	47859	6691	63434448
Dry skin	18.35	12.38	10	47873	56877	63384262
Visual impairment	18.32	12.38	22	47861	84424	63356715
Inflammatory marker increased	18.06	12.38	24	47859	6815	63434324
Eosinophilic pneumonia acute	18.04	12.38	8	47875	418	63440721
Mixed liver injury	18.03	12.38	20	47863	4715	63436424
Bronchospasm	17.90	12.38	40	47843	17240	63423899
Bacteraemia	17.79	12.38	40	47843	17308	63423831
Gastrooesophageal reflux disease	17.66	12.38	28	47855	95611	63345528
Hypofibrinogenaemia	17.64	12.38	11	47872	1159	63439980
Injection site pruritus	17.62	12.38	6	47877	45110	63396029
Hyperthyroidism	17.54	12.38	36	47847	14637	63426502
Clostridial infection	17.50	12.38	19	47864	4373	63436766
Lactic acidosis	17.45	12.38	66	47817	38221	63402918
Purpura	17.39	12.38	31	47852	11354	63429785
Cholecystitis acute	17.38	12.38	26	47857	8234	63432905
Herpes zoster	17.35	12.38	22	47861	82440	63358699
Asymptomatic bacteriuria	17.34	12.38	7	47876	289	63440850
Normochromic anaemia	17.30	12.38	7	47876	291	63440848
Cerebral artery stenosis	17.13	12.38	8	47875	472	63440667
Foetal exposure during pregnancy	17.04	12.38	58	47825	31904	63409235
Pseudophaeochromocytoma	17.03	12.38	5	47878	77	63441062
Vision blurred	16.89	12.38	27	47856	91897	63349242
Therapeutic response decreased	16.87	12.38	13	47870	61512	63379627
Unmasking of previously unidentified disease	16.83	12.38	10	47873	966	63440173
Hyperpyrexia	16.78	12.38	17	47866	3615	63437524
Haematoma	16.68	12.38	61	47822	34759	63406380
Septic pulmonary embolism	16.68	12.38	5	47878	83	63441056
Skin test positive	16.68	12.38	9	47874	723	63440416
Nocardiosis	16.65	12.38	13	47870	1963	63439176
Hypoalbuminaemia	16.58	12.38	31	47852	11774	63429365
Antibiotic associated colitis	16.50	12.38	3	47880	3	63441136
Ventricular fibrillation	16.47	12.38	31	47852	11836	63429303
Sciatica	16.43	12.38	3	47880	34321	63406818
Infantile apnoea	16.30	12.38	10	47873	1023	63440116
Hyperlactacidaemia	16.30	12.38	15	47868	2834	63438305
Foetal growth restriction	16.22	12.38	24	47859	7529	63433610
Anaemia	16.21	12.38	311	47572	293119	63148020
Bursitis	16.17	12.38	4	47879	37037	63404102
Relapsing fever	16.11	12.38	6	47877	199	63440940
Device related bacteraemia	16.05	12.38	6	47877	201	63440938
Coagulation factor decreased	16.05	12.38	5	47878	95	63441044
Blood creatine phosphokinase increased	16.03	12.38	55	47828	30375	63410764
Inappropriate schedule of product administration	16.02	12.38	34	47849	103931	63337208
Hyperkalaemia	15.98	12.38	82	47801	54121	63387018
Wound haemorrhage	15.88	12.38	14	47869	2502	63438637
Hypercreatininaemia	15.81	12.38	8	47875	563	63440576
Idiosyncratic drug reaction	15.64	12.38	9	47874	819	63440320
Hyperthermia malignant	15.58	12.38	9	47874	825	63440314
Ear pain	15.57	12.38	4	47879	36114	63405025
Generalised bullous fixed drug eruption	15.53	12.38	5	47878	106	63441033
Toxicity to various agents	15.46	12.38	116	47767	247134	63194005
Anoxia	15.29	12.38	6	47877	230	63440909
Post treatment Lyme disease syndrome	15.28	12.38	3	47880	6	63441133
Fixed eruption	15.21	12.38	10	47873	1154	63439985
Night sweats	15.15	12.38	9	47874	48805	63392334
Pancreatitis acute	15.11	12.38	50	47833	27116	63414023
Adverse drug reaction	15.04	12.38	23	47860	79691	63361448
Arthritis reactive	15.02	12.38	7	47876	411	63440728
Thrombosis	14.99	12.38	16	47867	64739	63376400
Candida test positive	14.98	12.38	9	47874	887	63440252
Septic embolus	14.97	12.38	9	47874	888	63440251
Gamma-glutamyltransferase increased	14.96	12.38	58	47825	33973	63407166
Anticonvulsant drug level below therapeutic	14.96	12.38	8	47875	631	63440508
Cerebral aspergillosis	14.95	12.38	7	47876	415	63440724
Stomatococcal infection	14.95	12.38	5	47878	120	63441019
Brain herniation	14.82	12.38	16	47867	3661	63437478
Pneumonia mycoplasmal	14.71	12.38	9	47874	916	63440223
Vitamin K deficiency	14.68	12.38	7	47876	433	63440706
Ureterolithiasis	14.65	12.38	12	47871	1940	63439199
Generalised oedema	14.61	12.38	35	47848	15783	63425356
Ventricular dysfunction	14.48	12.38	14	47869	2814	63438325
Amniotic cavity infection	14.47	12.38	10	47873	1253	63439886
Central nervous system vasculitis	14.46	12.38	9	47874	945	63440194
Chemotherapeutic drug level increased	14.36	12.38	5	47878	136	63441003
Constipation	14.32	12.38	105	47778	224838	63216301
Petechiae	14.20	12.38	32	47851	13865	63427274
Hypertensive heart disease	14.20	12.38	13	47870	2439	63438700
Anti-platelet antibody positive	14.18	12.38	4	47879	53	63441086
Hyperthermia	14.07	12.38	25	47858	9131	63432008
Nephritis	13.92	12.38	13	47870	2503	63438636
Drug hypersensitivity	13.81	12.38	319	47564	310368	63130771
Condition aggravated	13.80	12.38	399	47484	401818	63039321
Eye inflammation	13.80	12.38	19	47864	5580	63435559
Orthostatic hypotension	13.80	12.38	5	47878	36155	63404984
Granulomatous dermatitis	13.71	12.38	5	47878	156	63440983
Localised infection	13.71	12.38	3	47880	30207	63410932
Stridor	13.67	12.38	15	47868	3495	63437644
Fluid retention	13.54	12.38	15	47868	59671	63381468
Alpha 1 microglobulin increased	13.48	12.38	4	47879	64	63441075
Apgar score low	13.43	12.38	8	47875	776	63440363
Superior sagittal sinus thrombosis	13.37	12.38	8	47875	783	63440356
Prescribed underdose	13.37	12.38	3	47880	29686	63411453
Dysmetria	13.35	12.38	7	47876	530	63440609
Decreased appetite	13.33	12.38	123	47760	250929	63190210
Joint injury	13.29	12.38	3	47880	29569	63411570
Deafness bilateral	13.28	12.38	10	47873	1432	63439707
Dysphemia	13.24	12.38	13	47870	2662	63438477
Loss of personal independence in daily activities	13.24	12.38	34	47849	97256	63343883
Hemianopia	13.24	12.38	9	47874	1098	63440041
Oropharyngeal discomfort	13.19	12.38	18	47865	5242	63435897
Muscle haemorrhage	13.10	12.38	14	47869	3165	63437974
Sleep apnoea syndrome	13.00	12.38	3	47880	29130	63412009
Cardiac tamponade	12.99	12.38	17	47866	4758	63436381
Splenomegaly	12.90	12.38	27	47856	11130	63430009
Systemic candida	12.87	12.38	14	47869	3231	63437908
Procalcitonin increased	12.86	12.38	9	47874	1150	63439989
Muscle strength abnormal	12.84	12.38	4	47879	76	63441063
Hypoxic-ischaemic encephalopathy	12.82	12.38	16	47867	4271	63436868
Foaming at mouth	12.80	12.38	9	47874	1159	63439980
Peri-implantitis	12.79	12.38	4	47879	77	63441062
Chest discomfort	12.77	12.38	133	47750	109836	63331303
Base excess	12.74	12.38	4	47879	78	63441061
Vaccination complication	12.74	12.38	9	47874	1168	63439971
Normocytic anaemia	12.66	12.38	11	47872	1929	63439210
Dysgeusia	12.64	12.38	10	47873	46700	63394439
Febrile infection	12.59	12.38	10	47873	1547	63439592
Chorioretinitis	12.57	12.38	7	47876	598	63440541
Blood urea increased	12.46	12.38	46	47837	26333	63414806
Leukoencephalopathy	12.45	12.38	16	47867	4397	63436742
Overlap syndrome	12.45	12.38	8	47875	888	63440251
Staphylococcus test positive	12.39	12.38	15	47868	3881	63437258
Microangiopathic haemolytic anaemia	12.38	12.38	7	47876	616	63440523

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
Off label use	512.53	12.17	1586	51158	417938	34486249
Drug reaction with eosinophilia and systemic symptoms	445.03	12.17	381	52363	32631	34871556
Postrenal failure	291.90	12.17	78	52666	377	34903810
Jarisch-Herxheimer reaction	262.79	12.17	76	52668	515	34903672
Appendicolith	235.18	12.17	152	52592	8449	34895738
Pseudocholelithiasis	225.43	12.17	41	52703	0	34904187
Rash maculo-papular	197.65	12.17	229	52515	28222	34875965
Appendicitis	197.54	12.17	170	52574	14637	34889550
Multiple organ dysfunction syndrome	185.08	12.17	377	52367	76189	34827998
Fatigue	173.17	12.17	183	52561	370470	34533717
Acute generalised exanthematous pustulosis	171.24	12.17	114	52630	6662	34897525
Cardiogenic shock	169.59	12.17	205	52539	26413	34877774
Acute kidney injury	163.03	12.17	896	51848	304092	34600095
Hepatocellular injury	159.68	12.17	182	52562	22029	34882158
Toxic epidermal necrolysis	135.09	12.17	165	52579	21481	34882706
Cholelithiasis	133.27	12.17	162	52582	20986	34883201
Cholestasis	133.13	12.17	183	52561	26765	34877422
Eosinophilia	132.46	12.17	180	52564	26042	34878145
Agranulocytosis	131.83	12.17	171	52573	23650	34880537
Death	129.15	12.17	254	52490	397795	34506392
Hypertransaminasaemia	119.65	12.17	85	52659	5521	34898666
Toxic encephalopathy	117.63	12.17	82	52662	5167	34899020
Drug ineffective for unapproved indication	115.57	12.17	160	52584	23555	34880632
Drug abuse	115.42	12.17	9	52735	99087	34805100
Product dose omission issue	112.54	12.17	22	52722	119689	34784498
Ventricular fibrillation	110.56	12.17	154	52590	22800	34881387
Kounis syndrome	103.91	12.17	58	52686	2460	34901727
Anaphylactic shock	103.51	12.17	124	52620	15817	34888370
Pathogen resistance	101.12	12.17	96	52648	9386	34894801
Pyrexia	100.48	12.17	850	51894	332163	34572024
Dizziness	99.42	12.17	110	52634	218411	34685776
Anaphylactic reaction	93.78	12.17	172	52572	32129	34872058
Hepatitis	92.93	12.17	145	52599	23759	34880428
Clostridium test positive	91.19	12.17	59	52685	3283	34900904
Fall	90.23	12.17	104	52640	202781	34701406
Ascites	89.27	12.17	209	52535	46362	34857825
Blood phosphorus increased	87.77	12.17	81	52663	7640	34896547
Stress	87.35	12.17	161	52583	30186	34874001
Clostridium difficile colitis	87.14	12.17	113	52631	15617	34888570
Drug-induced liver injury	86.84	12.17	156	52588	28676	34875511
Depression	86.83	12.17	20	52724	97078	34807109
Ureterolithiasis	85.45	12.17	49	52695	2190	34901997
Bronchopulmonary aspergillosis	83.87	12.17	107	52637	14552	34889635
Factor V inhibition	81.69	12.17	24	52720	173	34904014
Haemolytic anaemia	80.65	12.17	89	52655	10390	34893797
Recalled product administered	78.95	12.17	30	52714	511	34903676
Long QT syndrome	77.75	12.17	50	52694	2753	34901434
Respiratory failure	76.83	12.17	346	52398	108226	34795961
Weight increased	75.90	12.17	23	52721	93010	34811177
Immune reconstitution inflammatory syndrome	73.73	12.17	78	52666	8681	34895506
Hyponatraemia	71.33	12.17	280	52464	82411	34821776
Condition aggravated	68.95	12.17	511	52233	191685	34712502
Pain	68.40	12.17	128	52616	204547	34699640
Septic shock	67.52	12.17	250	52494	71584	34832603
Haemolysis	62.73	12.17	69	52675	8025	34896162
Alanine aminotransferase increased	58.99	12.17	260	52484	80555	34823632
Tubulointerstitial nephritis	58.56	12.17	110	52634	20914	34883273
Myocardial infarction	58.30	12.17	58	52686	121027	34783160
Insomnia	55.73	12.17	45	52699	103862	34800325
Hydronephrosis	55.25	12.17	73	52671	10273	34893914
Joint swelling	54.20	12.17	12	52732	59878	34844309
Electrocardiogram QT prolonged	53.16	12.17	159	52585	40793	34863394
Stevens-Johnson syndrome	52.51	12.17	98	52646	18541	34885646
Acute respiratory distress syndrome	52.44	12.17	119	52625	25850	34878337
Abdominal discomfort	52.14	12.17	13	52731	59822	34844365
Liver injury	52.00	12.17	86	52658	14792	34889395
Nocardiosis	51.94	12.17	45	52699	3906	34900281
Toxicity to various agents	51.75	12.17	144	52600	200218	34703969
Cerebrovascular accident	51.70	12.17	32	52712	84779	34819408
Arthralgia	50.28	12.17	114	52630	169927	34734260
Blood glucose increased	50.05	12.17	19	52725	66699	34837488
Sepsis	49.37	12.17	424	52320	166137	34738050
Klebsiella infection	48.37	12.17	62	52682	8469	34895718
Hospitalisation	48.37	12.17	13	52731	56889	34847298
Brain abscess	48.13	12.17	39	52705	3086	34901101
Trichosporon infection	47.88	12.17	23	52721	711	34903476
Drug ineffective	47.73	12.17	959	51785	455792	34448395
Anuria	47.51	12.17	68	52676	10317	34893870
Rash morbilliform	46.43	12.17	38	52706	3049	34901138
Inappropriate schedule of product administration	46.30	12.17	18	52726	62278	34841909
Anxiety	46.29	12.17	49	52695	99379	34804808
Mucormycosis	44.91	12.17	50	52694	5892	34898295
Abdominal distension	44.82	12.17	191	52553	58301	34845886
Pain in extremity	44.10	12.17	77	52667	126436	34777751
Disseminated intravascular coagulation	44.08	12.17	100	52644	21716	34882471
Cross sensitivity reaction	43.97	12.17	27	52717	1370	34902817
Asthenia	43.05	12.17	207	52537	245044	34659143
Candida infection	42.44	12.17	87	52657	17628	34886559
Nasopharyngitis	41.81	12.17	27	52717	69941	34834246
Disseminated cryptococcosis	41.63	12.17	26	52718	1360	34902827
Transaminases increased	41.51	12.17	111	52633	26712	34877475
Product use in unapproved indication	41.25	12.17	311	52433	117188	34786999
Ureteral disorder	40.73	12.17	14	52730	176	34904011
Toxic skin eruption	40.04	12.17	66	52678	11319	34892868
Cardiac failure congestive	39.93	12.17	40	52704	83230	34820957
Clostridium difficile infection	39.72	12.17	88	52656	18810	34885377
Muscle spasms	39.56	12.17	33	52711	74968	34829219
Inflammatory marker increased	39.20	12.17	43	52701	4985	34899202
Diarrhoea	38.36	12.17	390	52354	389522	34514665
Feeling abnormal	36.98	12.17	25	52719	63210	34840977
COVID-19 pneumonia	36.78	12.17	80	52664	16887	34887300
Cryptococcal meningoencephalitis	36.77	12.17	12	52732	127	34904060
Portal fibrosis	36.45	12.17	15	52729	318	34903869
Headache	35.38	12.17	169	52575	200466	34703721
Dehydration	35.34	12.17	91	52653	129878	34774309
Bacterial pericarditis	35.33	12.17	10	52734	62	34904125
Thrombocytopenia	34.99	12.17	375	52369	155872	34748315
Cardiac disorder	34.54	12.17	11	52733	43115	34861072
Coronary artery disease	34.20	12.17	15	52729	48290	34855897
Myasthenia gravis	34.06	12.17	47	52697	6893	34897294
Encephalitis	33.80	12.17	48	52696	7229	34896958
Intentional overdose	33.49	12.17	12	52732	43662	34860525
Therapeutic product effect decreased	33.44	12.17	6	52738	34737	34869450
Gait disturbance	33.27	12.17	48	52696	85092	34819095
Liver function test increased	33.10	12.17	70	52674	14495	34889692
Hepatitis fulminant	32.95	12.17	36	52708	4154	34900033
Hepatitis toxic	32.00	12.17	27	52717	2260	34901927
Weight decreased	31.96	12.17	147	52597	176154	34728033
Leukocytosis	31.76	12.17	94	52650	23971	34880216
Drug hypersensitivity	31.61	12.17	219	52525	80310	34823877
Torsade de pointes	31.22	12.17	46	52698	7163	34897024
Hepatitis acute	30.78	12.17	47	52697	7554	34896633
Hepatitis cholestatic	30.58	12.17	48	52696	7899	34896288
Malignant neoplasm progression	30.29	12.17	54	52690	87992	34816195
Myasthenia gravis crisis	30.20	12.17	16	52728	611	34903576
Blood uric acid increased	30.15	12.17	53	52691	9571	34894616
Arthropathy	29.80	12.17	3	52741	26904	34877283
Contusion	29.62	12.17	9	52735	36355	34867832
Flank pain	29.62	12.17	43	52701	6608	34897579
Urticaria	29.61	12.17	178	52566	62199	34841988
Pruritus	29.60	12.17	336	52408	141645	34762542
Choreoathetosis	29.56	12.17	19	52725	1045	34903142
Drug resistance	29.33	12.17	96	52648	25831	34878356
Hypoxia	29.28	12.17	162	52582	54933	34849254
Pseudomembranous colitis	29.26	12.17	28	52716	2763	34901424
Crying	29.22	12.17	40	52704	5822	34898365
Chest pain	29.18	12.17	96	52648	126666	34777521
Alcohol intolerance	29.17	12.17	14	52730	432	34903755
Hyperferritinaemia	29.11	12.17	14	52730	434	34903753
Malignant mesenteric neoplasm	29.08	12.17	8	52736	44	34904143
Sphincter of Oddi dysfunction	29.07	12.17	10	52734	126	34904061
Prostate cancer	28.57	12.17	12	52732	39637	34864550
Crystalluria	28.16	12.17	14	52730	467	34903720
Peripheral swelling	28.12	12.17	45	52699	76496	34827691
Malaise	28.02	12.17	165	52579	185660	34718527
Hepatic enzyme increased	27.93	12.17	125	52619	38955	34865232
Escherichia infection	27.92	12.17	47	52697	8198	34895989
Suicidal ideation	27.88	12.17	13	52731	40375	34863812
Mycotic endophthalmitis	27.86	12.17	9	52735	92	34904095
Acute hepatic failure	27.86	12.17	64	52680	14010	34890177
Fixed eruption	27.85	12.17	22	52722	1678	34902509
Respiratory distress	27.72	12.17	117	52627	35548	34868639
Hypertension	27.65	12.17	109	52635	136334	34767853
Hyper IgE syndrome	27.56	12.17	8	52736	55	34904132
Blood pressure fluctuation	27.48	12.17	3	52741	25246	34878941
Corynebacterium infection	27.45	12.17	15	52729	610	34903577
Tachypnoea	27.44	12.17	75	52669	18277	34885910
Wrong technique in product usage process	27.40	12.17	10	52734	35976	34868211
Procalcitonin increased	27.28	12.17	22	52722	1729	34902458
Hepatomegaly	27.23	12.17	53	52691	10343	34893844
Cerebral cyst	27.04	12.17	12	52732	308	34903879
Cheilitis	27.01	12.17	25	52719	2366	34901821
Neuropathy peripheral	26.94	12.17	53	52691	83210	34820977
Memory impairment	26.87	12.17	16	52728	43302	34860885
Intervertebral discitis	26.85	12.17	24	52720	2171	34902016
Device related sepsis	26.84	12.17	28	52716	3065	34901122
Jaundice	26.68	12.17	107	52637	31775	34872412
Enterobacter infection	26.66	12.17	25	52719	2405	34901782
Dry gangrene	26.36	12.17	13	52731	426	34903761
Back pain	26.16	12.17	95	52649	121694	34782493
Syncope	25.65	12.17	63	52681	91388	34812799
Janeway lesion	25.49	12.17	6	52738	15	34904172
Blood pressure increased	25.25	12.17	60	52684	88042	34816145
Balance disorder	25.24	12.17	15	52729	40639	34863548
Cyanosis	25.22	12.17	58	52686	12706	34891481
Drug effective for unapproved indication	25.21	12.17	25	52719	2577	34901610
Drug interaction	24.99	12.17	479	52265	225467	34678720
Vascular purpura	24.90	12.17	21	52723	1757	34902430
Hyperphosphataemia	24.76	12.17	32	52712	4405	34899782
Abdominal pain	24.73	12.17	365	52379	163253	34740934
Aspartate aminotransferase increased	24.66	12.17	181	52563	67602	34836585
Hepatic function abnormal	24.61	12.17	132	52612	44231	34859956
Vision blurred	24.51	12.17	20	52724	45943	34858244
Type IV hypersensitivity reaction	24.45	12.17	19	52725	1415	34902772
Jejunal ulcer perforation	24.40	12.17	8	52736	86	34904101
Metastases to stomach	24.40	12.17	8	52736	86	34904101
Haemodynamic instability	24.28	12.17	48	52696	9475	34894712
General physical health deterioration	24.27	12.17	298	52446	127971	34776216
Shock	24.25	12.17	86	52658	24093	34880094
Serum sickness-like reaction	24.09	12.17	9	52735	146	34904041
Transient ischaemic attack	24.05	12.17	6	52738	27607	34876580
Allergy test positive	24.00	12.17	8	52736	91	34904096
Loss of personal independence in daily activities	23.97	12.17	10	52734	33169	34871018
Incorrect dose administered	23.70	12.17	16	52728	40499	34863688
Drug dependence	23.70	12.17	4	52740	24213	34879974
Pleocytosis	23.56	12.17	13	52731	539	34903648
Aspergillus infection	23.46	12.17	55	52689	12199	34891988
Analgesic therapy	23.32	12.17	16	52728	982	34903205
Endocarditis	23.24	12.17	38	52706	6473	34897714
Drug eruption	22.80	12.17	74	52670	19824	34884363
Dermatitis exfoliative generalised	22.70	12.17	28	52716	3679	34900508
Systemic candida	22.58	12.17	28	52716	3698	34900489
No adverse event	22.53	12.17	81	52663	22846	34881341
Oliguria	22.29	12.17	43	52701	8337	34895850
Omental necrosis	22.28	12.17	6	52738	30	34904157
Cataract	22.21	12.17	6	52738	26180	34878007
Acute respiratory failure	22.15	12.17	99	52645	30829	34873358
Coagulopathy	22.14	12.17	73	52671	19716	34884471
Injection site pain	22.03	12.17	16	52728	38989	34865198
Procalcitonin abnormal	22.02	12.17	11	52733	371	34903816
Infective chondritis	22.01	12.17	5	52739	10	34904177
Blood alkaline phosphatase increased	21.74	12.17	99	52645	31076	34873111
Dry skin	21.70	12.17	10	52734	31277	34872910
Overdose	21.61	12.17	68	52676	90991	34813196
Encephalopathy	21.61	12.17	108	52636	35211	34868976
Hepatic cytolysis	21.43	12.17	59	52685	14437	34889750
Drug therapy	21.39	12.17	16	52728	1125	34903062
Bacterial parotitis	21.37	12.17	6	52738	36	34904151
Intracranial pressure increased	21.26	12.17	28	52716	3927	34900260
Cryptococcosis	21.17	12.17	22	52722	2397	34901790
Erectile dysfunction	21.13	12.17	3	52741	20634	34883553
Malabsorption from administration site	20.97	12.17	7	52737	80	34904107
Eastern Cooperative Oncology Group performance status	20.96	12.17	6	52738	39	34904148
Tissue infiltration	20.89	12.17	7	52737	81	34904106
Coagulation factor decreased	20.66	12.17	7	52737	84	34904103
Dyspnoea	20.65	12.17	423	52321	376359	34527828
Psoriasis	20.55	12.17	17	52727	38795	34865392
Red blood cell schistocytes present	20.10	12.17	9	52735	236	34903951
Liver transplant failure	20.08	12.17	7	52737	92	34904095
Orthostatic hypotension	20.07	12.17	7	52737	25912	34878275
Stenotrophomonas infection	19.94	12.17	20	52724	2090	34902097
Splenomegaly	19.89	12.17	59	52685	15058	34889129
Neurotoxicity	19.76	12.17	66	52678	17944	34886243
Muscle abscess	19.56	12.17	12	52732	608	34903579
Antinuclear antibody negative	19.47	12.17	5	52739	20	34904167
Antimicrobial susceptibility test resistant	19.31	12.17	10	52734	364	34903823
Amnesia	19.20	12.17	8	52736	26555	34877632
Hypoaesthesia	19.11	12.17	40	52704	61404	34842783
Neutropenia	18.92	12.17	337	52407	156441	34747746
Pulmonary physical examination abnormal	18.91	12.17	5	52739	23	34904164
Shock haemorrhagic	18.60	12.17	48	52696	11306	34892881
Neoplasm progression	18.56	12.17	6	52738	23294	34880893
Sleep apnoea syndrome	18.52	12.17	4	52740	20317	34883870
Faeces pale	18.48	12.17	16	52728	1387	34902800
Vanishing bile duct syndrome	18.48	12.17	14	52730	1004	34903183
Erythema	18.43	12.17	210	52534	88570	34815617
Gastrooesophageal reflux disease	18.42	12.17	18	52726	37906	34866281
Sleep disorder therapy	18.42	12.17	14	52730	1009	34903178
Bile duct stone	18.31	12.17	21	52723	2556	34901631
Arteriospasm coronary	18.26	12.17	24	52720	3358	34900829
Contraindicated product administered	18.07	12.17	5	52739	21476	34882711
Antibiotic level below therapeutic	18.02	12.17	6	52738	68	34904119
Low birth weight baby	17.97	12.17	38	52706	7867	34896320
Vitamin A deficiency	17.95	12.17	5	52739	29	34904158
Basal cell carcinoma	17.65	12.17	4	52740	19654	34884533
Unevaluable event	17.60	12.17	14	52730	32576	34871611
Interleukin-2 receptor increased	17.57	12.17	7	52737	136	34904051
Influenza	17.49	12.17	30	52714	49636	34854551
Haemophagocytic lymphohistiocytosis	17.42	12.17	51	52693	12922	34891265
Suicide attempt	17.39	12.17	20	52724	39096	34865091
Peritoneal dialysis	17.34	12.17	11	52733	591	34903596
Decreased appetite	17.30	12.17	164	52580	166228	34737959
Abdominal compartment syndrome	17.06	12.17	13	52731	940	34903247
White blood cell count decreased	17.02	12.17	80	52664	95365	34808822
Irritability	16.96	12.17	8	52736	24682	34879505
Altered state of consciousness	16.94	12.17	74	52670	22819	34881368
Musculoskeletal pain	16.92	12.17	14	52730	31949	34872238
Gamma-glutamyltransferase increased	16.91	12.17	88	52656	29143	34875044
Hyperamylasaemia	16.89	12.17	11	52733	619	34903568
Cardiac ventricular thrombosis	16.86	12.17	14	52730	1146	34903041
Osteomyelitis fungal	16.72	12.17	8	52736	245	34903942
Erythema nodosum	16.57	12.17	15	52729	1379	34902808
ADAMTS13 activity decreased	16.55	12.17	6	52738	89	34904098
Infective spondylitis	16.54	12.17	8	52736	251	34903936
Bronchopleural fistula	16.54	12.17	10	52734	493	34903694
Calculus urinary	16.45	12.17	15	52729	1392	34902795
Renal papillary necrosis	16.32	12.17	7	52737	165	34904022
Morganella infection	16.20	12.17	10	52734	512	34903675
Cerebellar syndrome	16.20	12.17	19	52725	2369	34901818
Mobility decreased	16.19	12.17	13	52731	30115	34874072
Face oedema	16.17	12.17	46	52698	11470	34892717
Prothrombin time ratio decreased	16.16	12.17	9	52735	380	34903807
Dysgeusia	16.13	12.17	10	52734	26487	34877700
Encephalomalacia	16.02	12.17	12	52732	846	34903341
Hypofibrinogenaemia	15.97	12.17	16	52728	1670	34902517
Palmar-plantar erythrodysaesthesia syndrome	15.94	12.17	3	52741	16792	34887395
Cholecystitis acute	15.87	12.17	32	52712	6407	34897780
Erythema multiforme	15.67	12.17	38	52706	8611	34895576
Carotid artery insufficiency	15.58	12.17	4	52740	16	34904171
Arterial angioplasty	15.58	12.17	5	52739	50	34904137
Chondrocalcinosis	15.56	12.17	9	52735	409	34903778
Disturbance in attention	15.51	12.17	10	52734	25935	34878252
Type IIa hyperlipidaemia	15.38	12.17	7	52737	191	34903996
Herpes zoster reactivation	15.36	12.17	8	52736	295	34903892
Human T-cell lymphotropic virus type I infection	15.20	12.17	4	52740	18	34904169
Palpitations	15.17	12.17	23	52721	39963	34864224
Alopecia	15.09	12.17	9	52735	24346	34879841
Fungaemia	15.09	12.17	19	52725	2549	34901638
Epileptic encephalopathy	15.05	12.17	7	52737	201	34903986
Vomiting	15.02	12.17	484	52260	247137	34657050
Discomfort	14.86	12.17	5	52739	18933	34885254
Tuberculosis of genitourinary system	14.86	12.17	4	52740	20	34904167
Asthma	14.81	12.17	26	52718	42630	34861557
Iron deficiency	14.79	12.17	28	52716	5353	34898834
Influenza like illness	14.76	12.17	12	52732	27622	34876565
Rash	14.73	12.17	440	52304	222312	34681875
Red blood cell sedimentation rate decreased	14.68	12.17	5	52739	61	34904126
Pancytopenia	14.64	12.17	213	52531	94944	34809243
Glucose-6-phosphate dehydrogenase deficiency	14.55	12.17	6	52738	128	34904059
Full blood count abnormal	14.53	12.17	5	52739	18663	34885524
Cholangitis	14.50	12.17	37	52707	8652	34895535
Dyspnoea exertional	14.47	12.17	27	52717	43252	34860935
Delusion of parasitosis	14.42	12.17	3	52741	3	34904184
Pneumonia bacterial	14.37	12.17	45	52699	11827	34892360
Heart rate decreased	14.36	12.17	16	52728	31729	34872458
Henoch-Schonlein purpura	14.34	12.17	15	52729	1647	34902540
Drug withdrawal syndrome	14.29	12.17	6	52738	19828	34884359
Strongyloidiasis	14.27	12.17	19	52725	2692	34901495
Incorrect route of product administration	14.20	12.17	52	52692	14793	34889394
Premature baby	14.17	12.17	63	52681	19570	34884617
Coagulation factor V level decreased	14.09	12.17	7	52737	233	34903954
Delirium	14.06	12.17	114	52630	43877	34860310
Hypercreatininaemia	14.05	12.17	9	52735	492	34903695
Therapeutic product effect incomplete	14.02	12.17	35	52709	50506	34853681
Listeriosis	14.00	12.17	12	52732	1026	34903161
Fluid retention	13.96	12.17	12	52732	26875	34877312
Psychotic disorder	13.85	12.17	10	52734	24442	34879745
Gait inability	13.84	12.17	7	52737	20751	34883436
Metastases to heart	13.70	12.17	6	52738	149	34904038
Meningitis candida	13.68	12.17	5	52739	76	34904111
Status epilepticus	13.63	12.17	46	52698	12568	34891619
Colitis ulcerative	13.61	12.17	4	52740	16516	34887671
Ocular icterus	13.50	12.17	19	52725	2838	34901349
Meningitis bacterial	13.49	12.17	13	52731	1294	34902893
Osteonecrosis	13.43	12.17	3	52741	14887	34889300
Bronchial haemorrhage	13.42	12.17	10	52734	699	34903488
Purpura	13.34	12.17	40	52704	10271	34893916
PO2 decreased	13.16	12.17	14	52730	1567	34902620
Cell death	13.15	12.17	17	52727	2340	34901847
Tremor	13.14	12.17	72	52672	82515	34821672
Adverse event	13.14	12.17	6	52738	18871	34885316
COVID-19 treatment	13.12	12.17	7	52737	271	34903916
Administration site reaction	13.11	12.17	5	52739	86	34904101
Dyspepsia	13.11	12.17	22	52722	36710	34867477
Empyema	13.09	12.17	20	52724	3216	34900971
Migraine	13.06	12.17	5	52739	17473	34886714
Rash erythematous	12.96	12.17	73	52671	24904	34879283
Neuroborreliosis	12.94	12.17	4	52740	35	34904152
Flatulence	12.90	12.17	8	52736	21190	34882997
Enterococcal infection	12.90	12.17	37	52707	9269	34894918
Hypocoagulable state	12.89	12.17	11	52733	935	34903252
Injection site erythema	12.83	12.17	4	52740	15895	34888292
Cardiac arrest	12.78	12.17	210	52534	95949	34808238
Hyperthermia	12.72	12.17	40	52704	10537	34893650
Pollakiuria	12.58	12.17	7	52737	19667	34884520
Surgery	12.48	12.17	3	52741	14154	34890033
Urticarial vasculitis	12.46	12.17	4	52740	40	34904147
Chorioretinitis	12.40	12.17	8	52736	443	34903744
Fibrous dysplasia of bone	12.35	12.17	3	52741	9	34904178
Head injury	12.29	12.17	6	52738	18154	34886033
Ischaemic limb pain	12.29	12.17	4	52740	42	34904145
Ureteric obstruction	12.27	12.17	12	52732	1216	34902971
Haematuria traumatic	12.27	12.17	6	52738	193	34903994
Visual impairment	12.27	12.17	22	52722	35780	34868407
Urinary tract infection fungal	12.24	12.17	8	52736	453	34903734
SJS-TEN overlap	12.20	12.17	7	52737	313	34903874
Lower respiratory tract infection	12.19	12.17	18	52726	31619	34872568

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 reaction with eosinophilia and systemic symptoms	1098.89	11.22	774	93837	63470	79586307
Off label use	719.09	11.22	2529	92082	904686	78745091
Pseudocholelithiasis	532.68	11.22	94	94517	7	79649770
Acute generalised exanthematous pustulosis	486.39	11.22	285	94326	16969	79632808
Acute kidney injury	471.99	11.22	1519	93092	517885	79131892
Rash maculo-papular	441.52	11.22	431	94180	55647	79594130
Eosinophilia	427.06	11.22	385	94226	44960	79604817
Multiple organ dysfunction syndrome	423.05	11.22	612	93999	119634	79530143
Toxic epidermal necrolysis	405.12	11.22	371	94240	44210	79605567
Fatigue	391.57	11.22	319	94292	929408	78720369
Postrenal failure	388.12	11.22	101	94510	576	79649201
Jarisch-Herxheimer reaction	376.06	11.22	106	94505	851	79648926
Pain	297.66	11.22	240	94371	703562	78946215
Agranulocytosis	295.92	11.22	314	94297	44716	79605061
Cholelithiasis	285.39	11.22	332	94279	52332	79597445
Cholestasis	278.21	11.22	326	94285	51783	79597994
Completed suicide	270.87	11.22	4	94607	245763	79404014
Appendicolith	266.99	11.22	151	94460	8400	79641377
Joint swelling	266.20	11.22	20	94591	288626	79361151
Clostridium test positive	265.90	11.22	137	94474	6317	79643460
Clostridium difficile colitis	246.34	11.22	244	94367	32039	79617738
Hepatocellular injury	238.00	11.22	288	94323	47305	79602472
Hepatitis	233.88	11.22	309	94302	55418	79594359
Septic shock	226.73	11.22	470	94141	122331	79527446
Arthralgia	215.19	11.22	217	94394	571586	79078191
Haemolytic anaemia	214.02	11.22	174	94437	17646	79632131
Pyrexia	210.92	11.22	1451	93160	677258	78972519
Anaphylactic shock	210.34	11.22	236	94375	35760	79614017
Rheumatoid arthritis	202.39	11.22	11	94600	208459	79441318
Drug ineffective for unapproved indication	195.09	11.22	271	94340	50967	79598810
Cardiogenic shock	194.03	11.22	244	94367	41670	79608107
Appendicitis	192.65	11.22	175	94436	20619	79629158
Factor V inhibition	190.48	11.22	51	94560	330	79649447
Electrocardiogram QT prolonged	188.44	11.22	364	94247	90022	79559755
Arthropathy	186.66	11.22	5	94606	177106	79472671
Respiratory failure	182.77	11.22	550	94061	180361	79469416
Fall	181.15	11.22	187	94424	487442	79162335
Toxic encephalopathy	179.64	11.22	131	94480	11309	79638468
Weight increased	177.90	11.22	54	94557	277332	79372445
Abdominal discomfort	177.56	11.22	40	94571	250687	79399090
Headache	175.22	11.22	318	94293	653454	78996323
Dizziness	174.85	11.22	221	94390	526220	79123557
Alopecia	171.89	11.22	33	94578	231322	79418455
Synovitis	163.74	11.22	3	94608	150731	79499046
Product dose omission issue	159.06	11.22	48	94563	247489	79402288
Stevens-Johnson syndrome	157.91	11.22	213	94398	38953	79610824
Drug-induced liver injury	156.21	11.22	281	94330	65836	79583941
Therapeutic product effect decreased	154.92	11.22	10	94601	163853	79485924
Bronchopulmonary aspergillosis	152.73	11.22	159	94452	22135	79627642
Nasopharyngitis	151.31	11.22	56	94555	253825	79395952
Tubulointerstitial nephritis	149.70	11.22	205	94406	38030	79611747
Drug interaction	145.78	11.22	916	93695	414267	79235510
Pain in extremity	141.96	11.22	134	94477	364404	79285373
Drug intolerance	140.26	11.22	69	94542	264050	79385727
Pathogen resistance	139.36	11.22	124	94487	14218	79635559
Peripheral swelling	139.35	11.22	73	94538	269544	79380233
Sepsis	138.77	11.22	660	93951	268768	79381009
Ventricular fibrillation	138.53	11.22	180	94431	31746	79618031
Long QT syndrome	136.03	11.22	86	94525	5869	79643908
Hypertransaminasaemia	136	11.22	113	94498	11811	79637966
Premature delivery	130.54	11.22	150	94461	23317	79626460
Drug abuse	127.84	11.22	20	94591	162671	79487106
Contraindicated product administered	126.93	11.22	18	94593	157520	79492257
Acute respiratory distress syndrome	120.73	11.22	200	94411	43867	79605910
Leukocytosis	118.75	11.22	197	94414	43258	79606519
Insomnia	117.21	11.22	73	94538	245097	79404680
Contusion	115.29	11.22	19	94592	148757	79501020
Anaphylactic reaction	114.87	11.22	285	94326	83458	79566319
Status epilepticus	114.64	11.22	145	94466	24896	79624881
Clostridium difficile infection	111.97	11.22	190	94421	42495	79607282
Depression	111.55	11.22	59	94552	216731	79433046
Immune reconstitution inflammatory syndrome	110.01	11.22	107	94504	13734	79636043
Hydronephrosis	108.10	11.22	118	94493	17336	79632441
Thrombocytopenia	107.55	11.22	608	94003	264651	79385126
Transaminases increased	106.11	11.22	207	94404	51536	79598241
Ureterolithiasis	101.72	11.22	61	94550	3787	79645990
Glossodynia	101.68	11.22	5	94606	103332	79546445
Kounis syndrome	100.72	11.22	63	94548	4219	79645558
Hepatitis cholestatic	100.68	11.22	102	94509	13750	79636027
Pseudomembranous colitis	99.35	11.22	68	94543	5306	79644471
Wound	99.11	11.22	11	94600	116168	79533609
Haemolysis	98.01	11.22	97	94514	12715	79637062
Malaise	97.19	11.22	280	94331	489589	79160188
Encephalopathy	96.28	11.22	233	94378	67164	79582613
Pemphigus	94.33	11.22	6	94605	99576	79550201
Injection site pain	93.31	11.22	20	94591	129818	79519959
Systemic lupus erythematosus	92.70	11.22	16	94595	121133	79528644
Sinusitis	92.34	11.22	59	94552	195442	79454335
Death	89.78	11.22	357	94254	566157	79083620
Muscle spasms	87.76	11.22	49	94562	174681	79475096
Ascites	87.09	11.22	241	94370	75321	79574456
Discomfort	86.97	11.22	21	94590	125596	79524181
Blood phosphorus increased	86.03	11.22	82	94529	10265	79639512
Tachypnoea	84.46	11.22	143	94468	31920	79617857
Rash morbilliform	82.29	11.22	64	94547	6086	79643691
Gait disturbance	82.20	11.22	75	94536	207431	79442346
Pleocytosis	81.62	11.22	38	94573	1401	79648376
Klebsiella infection	79.98	11.22	96	94515	15624	79634153
Encephalitis	79.83	11.22	93	94518	14667	79635110
Musculoskeletal stiffness	79.69	11.22	55	94556	174953	79474824
Toxicity to various agents	78.51	11.22	248	94363	421292	79228485
Choreoathetosis	78.46	11.22	38	94573	1532	79648245
Cross sensitivity reaction	78.33	11.22	51	94560	3661	79646116
Neutropenia	76.75	11.22	594	94017	287116	79362661
Exposure during pregnancy	76.55	11.22	279	94332	100853	79548924
Mobility decreased	76.09	11.22	25	94586	122150	79527627
Alanine aminotransferase increased	75.57	11.22	387	94224	162183	79487594
Hypoxia	74.94	11.22	281	94330	102962	79546815
Swelling	74.91	11.22	88	94523	216623	79433154
Drug ineffective	74.79	11.22	1741	92870	1079172	78570605
Nocardiosis	73.61	11.22	58	94553	5621	79644156
Cardiac arrest	73.37	11.22	400	94211	171696	79478081
Drug resistance	72.53	11.22	157	94454	42056	79607721
Disseminated intravascular coagulation	71.79	11.22	142	94469	35700	79614077
Anxiety	70.80	11.22	116	94495	248396	79401381
Altered state of consciousness	70.79	11.22	159	94452	43663	79606114
Weight decreased	70.40	11.22	203	94408	354995	79294782
Hypertension	69.44	11.22	184	94427	330808	79318969
Enterococcal infection	69.03	11.22	89	94522	15571	79634206
Infusion related reaction	68.88	11.22	104	94507	230133	79419644
Anuria	68.27	11.22	103	94508	20860	79628917
Toxic skin eruption	67.63	11.22	106	94505	22187	79627590
Intentional overdose	67.19	11.22	21	94590	105939	79543838
Respiratory distress	67.15	11.22	186	94425	58153	79591624
Urticaria	66.92	11.22	412	94199	184789	79464988
Lower respiratory tract infection	66.69	11.22	35	94576	129185	79520592
Product use in unapproved indication	66.26	11.22	516	94095	249843	79399934
Hypoaesthesia	66.19	11.22	69	94542	179283	79470494
Pneumococcal infection	66.08	11.22	29	94582	929	79648848
Brain abscess	65.25	11.22	51	94560	4885	79644892
Haemophagocytic lymphohistiocytosis	65.10	11.22	103	94508	21734	79628043
Ear pruritus	64.33	11.22	47	94564	4068	79645709
Migraine	63.84	11.22	13	94598	87480	79562297
Torsade de pointes	63.05	11.22	95	94516	19217	79630560
Myasthenia gravis crisis	61.96	11.22	29	94582	1082	79648695
Musculoskeletal pain	61.90	11.22	22	94589	102332	79547445
Trichosporon infection	61.49	11.22	28	94583	980	79648797
Myocardial infarction	61.27	11.22	77	94534	184052	79465725
Helicobacter infection	60.99	11.22	6	94605	69698	79580079
Mucormycosis	60.89	11.22	62	94549	8407	79641370
Erythema	60.62	11.22	463	94148	222827	79426950
Injection site erythema	60.54	11.22	10	94601	78187	79571590
COVID-19 pneumonia	59.85	11.22	116	94495	28733	79621044
Condition aggravated	59.65	11.22	879	93732	500245	79149532
Abdominal pain upper	59.62	11.22	109	94502	223710	79426067
Inappropriate schedule of product administration	59.50	11.22	43	94568	133585	79516192
Shock	59.47	11.22	148	94463	43400	79606377
Feeling abnormal	59.02	11.22	61	94550	159138	79490639
Hyponatraemia	58.90	11.22	387	94224	177461	79472316
Pericarditis	58.75	11.22	25	94586	104211	79545566
Blood pressure fluctuation	58.18	11.22	6	94605	67139	79582638
Stomatitis	58.15	11.22	53	94558	146704	79503073
Osteoarthritis	57.74	11.22	16	94595	87293	79562484
Pulmonary function test abnormal	57.35	11.22	44	94567	4100	79645677
Hepatic cytolysis	57.34	11.22	110	94501	27041	79622736
Back pain	57.26	11.22	178	94433	304002	79345775
Chest X-ray abnormal	57.20	11.22	58	94553	7825	79641952
Blood pressure increased	57.13	11.22	102	94509	211258	79438519
Ill-defined disorder	56.78	11.22	6	94605	65869	79583908
Stenotrophomonas infection	56.52	11.22	42	94569	3731	79646046
Linear IgA disease	56.41	11.22	39	94572	3093	79646684
Haemodynamic instability	56.03	11.22	85	94526	17297	79632480
Blood lactic acid increased	55.50	11.22	72	94539	12672	79637105
Cholangitis	55.36	11.22	72	94539	12704	79637073
Balance disorder	55.26	11.22	24	94587	98833	79550944
Fibromyalgia	55.10	11.22	6	94605	64334	79585443
Psoriatic arthropathy	54.06	11.22	13	94598	77986	79571791
Enterobacter infection	53.62	11.22	44	94567	4518	79645259
Nausea	52.50	11.22	810	93801	956386	78693391
Inflammatory marker increased	52.05	11.22	64	94547	10676	79639101
Cyanosis	51.93	11.22	101	94510	25081	79624696
Psoriasis	51.27	11.22	21	94590	89566	79560211
Folliculitis	50.53	11.22	4	94607	55376	79594401
Dermatitis exfoliative generalised	50.23	11.22	52	94559	7189	79642588
Hepatitis acute	50.09	11.22	76	94535	15466	79634311
Injection site reaction	49.87	11.22	4	94607	54781	79594996
Memory impairment	49.69	11.22	36	94575	111698	79538079
Escherichia infection	49.64	11.22	82	94529	17935	79631842
Hospitalisation	49.40	11.22	25	94586	94211	79555566
Dermatitis bullous	49.27	11.22	72	94539	14173	79635604
Hepatic function abnormal	48.97	11.22	194	94417	72913	79576864
Arthritis	48.55	11.22	39	94572	114841	79534936
Jaundice	48.06	11.22	156	94455	53193	79596584
Endocarditis	47.93	11.22	61	94550	10536	79639241
Intervertebral discitis	47.41	11.22	42	94569	4786	79644991
Pancytopenia	47.41	11.22	348	94263	165397	79484380
Oliguria	47.34	11.22	76	94535	16233	79633544
Dyspepsia	47.06	11.22	36	94575	108651	79541126
Neurotoxicity	47.05	11.22	113	94498	32405	79617372
Dermatitis exfoliative	46.88	11.22	61	94550	10768	79639009
Palpitations	46.38	11.22	49	94562	126561	79523216
Symmetrical drug-related intertriginous and flexural exanthema	45.96	11.22	22	94589	864	79648913
Bile duct stone	45.91	11.22	44	94567	5545	79644232
Cataract	45.80	11.22	9	94602	62111	79587666
Leukopenia	45.78	11.22	265	94346	116248	79533529
C-reactive protein abnormal	45.55	11.22	3	94608	48364	79601413
Aspartate aminotransferase increased	45.47	11.22	301	94310	138340	79511437
Candida infection	45.13	11.22	123	94488	38091	79611686
Renal failure	45.00	11.22	399	94212	200569	79449208
Type 2 diabetes mellitus	44.90	11.22	7	94604	57115	79592662
Acute respiratory failure	44.82	11.22	164	94447	59377	79590400
Myasthenia gravis	44.12	11.22	58	94553	10341	79639436
Acinetobacter infection	44.05	11.22	32	94579	2745	79647032
Aspergillus infection	43.41	11.22	80	94531	19081	79630696
Type IV hypersensitivity reaction	43.09	11.22	37	94574	4044	79645733
Fixed eruption	42.28	11.22	32	94579	2922	79646855
Metabolic acidosis	42.26	11.22	202	94409	82327	79567450
Cholecystitis	42.09	11.22	86	94525	22126	79627651
Drug eruption	41.88	11.22	131	94480	43804	79605973
Acute hepatic failure	41.81	11.22	103	94508	30010	79619767
Platelet count increased	41.57	11.22	86	94525	22320	79627457
Nosocomial infection	41.25	11.22	31	94580	2801	79646976
Gastrooesophageal reflux disease	40.88	11.22	38	94573	104208	79545569
Asthenia	40.85	11.22	399	94212	511290	79138487
Disseminated cryptococcosis	40.68	11.22	26	94585	1808	79647969
Blood glucose increased	40.45	11.22	46	94565	114929	79534848
Road traffic accident	40.27	11.22	3	94608	43661	79606116
SJS-TEN overlap	39.84	11.22	19	94592	740	79649037
Gastrointestinal disorder	39.71	11.22	52	94559	122153	79527624
Hepatitis fulminant	39.68	11.22	46	94565	7216	79642561
International normalised ratio increased	39.56	11.22	202	94409	84519	79565258
Therapeutic product effect incomplete	39.49	11.22	67	94544	141578	79508199
Suicidal ideation	38.90	11.22	21	94590	76319	79573458
Vision blurred	38.76	11.22	41	94570	105857	79543920
Hypofibrinogenaemia	38.60	11.22	26	94585	1976	79647801
Liver function test increased	38.29	11.22	119	94492	39654	79610123
Influenza B virus test positive	37.95	11.22	15	94596	367	79649410
Procalcitonin increased	37.46	11.22	30	94581	2976	79646801
Cardiac failure congestive	37.32	11.22	70	94541	142332	79507445
Diarrhoea	37.15	11.22	780	93831	879709	78770068
Bacterial pericarditis	37.05	11.22	10	94601	67	79649710
Hepatomegaly	36.86	11.22	74	94537	18800	79630977
CSF oligoclonal band present	36.53	11.22	15	94596	406	79649371
Unresponsive to stimuli	36.52	11.22	147	94464	55641	79594136
No adverse event	36.47	11.22	112	94499	37080	79612697
Alveolitis	36.42	11.22	34	94577	4146	79645631
Adverse event	36.31	11.22	13	94598	60201	79589576
Renal papillary necrosis	36.23	11.22	15	94596	415	79649362
Systemic candida	35.84	11.22	42	94569	6664	79643113
Tachycardia	35.79	11.22	345	94266	177423	79472354
Hepatitis toxic	35.77	11.22	37	94574	5110	79644667
Bronchopleural fistula	35.65	11.22	17	94594	662	79649115
Morganella infection	35.44	11.22	20	94591	1107	79648670
Erythema multiforme	35.43	11.22	70	94541	17581	79632196
Splenomegaly	35.43	11.22	77	94534	20677	79629100
Loss of personal independence in daily activities	35.05	11.22	42	94569	102538	79547239
Chest pain	34.56	11.22	195	94416	282109	79367668
Alcohol intolerance	34.49	11.22	15	94596	470	79649307
Nasal polyps	34.44	11.22	43	94568	7284	79642493
Injection site swelling	34.39	11.22	7	94604	47125	79602652
Cerebrovascular accident	34.32	11.22	84	94527	155208	79494569
Impaired healing	34.31	11.22	32	94579	87623	79562154
Dry skin	34.22	11.22	19	94592	67976	79581801
Orthostatic hypotension	34.08	11.22	12	94599	56152	79593625
Wrong technique in product usage process	33.90	11.22	23	94588	73852	79575925
Coagulation factor decreased	33.78	11.22	12	94599	216	79649561
Partial seizures	33.43	11.22	47	94564	8931	79640846
Erythema nodosum	33.01	11.22	36	94575	5281	79644496
Crystalluria	32.98	11.22	18	94593	933	79648844
Cryptococcal meningoencephalitis	32.24	11.22	12	94599	248	79649529
Rash erythematous	32.22	11.22	145	94466	57624	79592153
Ureteral disorder	32.09	11.22	15	94596	558	79649219
Influenza like illness	32.01	11.22	23	94588	71684	79578093
Renal tubular necrosis	32.00	11.22	83	94528	24956	79624821
Blood uric acid increased	31.81	11.22	57	94554	13303	79636474
Multiple sclerosis relapse	31.77	11.22	8	94603	46525	79603252
Fluid retention	31.68	11.22	22	94589	69787	79579990
Neutrophilia	31.67	11.22	43	94568	7908	79641869
Hip arthroplasty	31.48	11.22	3	94608	35753	79614024
Drug effective for unapproved indication	31.10	11.22	37	94574	5964	79643813
Product use issue	30.79	11.22	136	94475	209686	79440091
Decreased appetite	30.78	11.22	259	94352	342159	79307618
Coronary artery disease	30.56	11.22	20	94591	65454	79584323
Gamma-glutamyltransferase increased	30.31	11.22	137	94474	54543	79595234
Cholecystitis acute	30.27	11.22	56	94555	13395	79636382
Oropharyngeal pain	30.23	11.22	52	94559	109301	79540476
Intracranial pressure increased	30.15	11.22	43	94568	8279	79641498
Muscle injury	30.11	11.22	10	94601	48551	79601226
Rhinitis allergic	30.05	11.22	53	94558	12216	79637561
Autoimmune haemolytic anaemia	29.92	11.22	43	94568	8337	79641440
Malignant mesenteric neoplasm	29.72	11.22	8	94603	53	79649724
Purpura	29.48	11.22	69	94542	19458	79630319
Hyperphosphataemia	29.30	11.22	37	94574	6339	79643438
Blood pressure systolic increased	29.24	11.22	22	94589	66964	79582813
CSF measles antibody positive	29.21	11.22	8	94603	57	79649720
Visual impairment	29.12	11.22	40	94571	92091	79557686
Vasculitis	28.85	11.22	80	94531	25022	79624755
Herpes zoster	28.84	11.22	41	94570	93042	79556735
Rubella antibody positive	28.74	11.22	8	94603	61	79649716
Sciatica	28.70	11.22	3	94608	33219	79616558
Anti factor V antibody	28.69	11.22	5	94606	0	79649777
Hypercreatininaemia	28.63	11.22	17	94594	1036	79648741
Weber tuning fork test abnormal	28.54	11.22	9	94602	110	79649667
Gastric disorder	28.50	11.22	5	94606	37428	79612349
Pyuria	28.31	11.22	23	94588	2329	79647448
Cholestatic liver injury	28.18	11.22	32	94579	4909	79644868
Neoplasm progression	28.17	11.22	13	94598	51669	79598108
Organic brain syndrome	28.13	11.22	13	94598	471	79649306
Angioedema	27.97	11.22	170	94441	75865	79573912
Portal fibrosis	27.96	11.22	14	94597	607	79649170
Transient ischaemic attack	27.58	11.22	14	94597	52681	79597096
Procalcitonin abnormal	27.53	11.22	12	94599	378	79649399
Sleep apnoea syndrome	27.50	11.22	5	94606	36473	79613304
Nephropathy toxic	27.46	11.22	69	94542	20350	79629427
Systemic inflammatory response syndrome	27.41	11.22	49	94562	11416	79638361
Propofol infusion syndrome	27.32	11.22	21	94590	1962	79647815
Liver injury	27.14	11.22	136	94475	56478	79593299
Coagulopathy	26.94	11.22	99	94512	35907	79613870
Janeway lesion	26.93	11.22	6	94605	15	79649762
Face oedema	26.91	11.22	84	94527	28052	79621725
Device related sepsis	26.78	11.22	35	94576	6205	79643572
Neck pain	26.71	11.22	30	94581	75387	79574390
Analgesic therapy	26.68	11.22	16	94595	993	79648784
Empyema	26.63	11.22	29	94582	4247	79645530
Flank pain	26.63	11.22	67	94544	19777	79630000
Vascular purpura	26.61	11.22	25	94586	3073	79646704
Maternal exposure during pregnancy	26.50	11.22	263	94348	136275	79513502
Nervousness	26.48	11.22	4	94607	33411	79616366
Hyperthermia	26.43	11.22	63	94548	17974	79631803
Cerebral cyst	26.43	11.22	12	94599	417	79649360
Peritoneal dialysis	26.41	11.22	15	94596	841	79648936
Mitochondrial DNA mutation	26.33	11.22	12	94599	421	79649356
Sphincter of Oddi dysfunction	26.33	11.22	12	94599	421	79649356
Hepatitis infectious mononucleosis	26.03	11.22	9	94602	149	79649628
Hip fracture	26.01	11.22	3	94608	30758	79619019
Hepatosplenomegaly	25.98	11.22	34	94577	6035	79643742
Injection site pruritus	25.71	11.22	9	94602	42274	79607503
Pneumonia mycoplasmal	25.67	11.22	18	94593	1460	79648317
Stress	25.58	11.22	172	94439	79440	79570337
Muscle abscess	25.57	11.22	16	94595	1072	79648705
Blood creatinine increased	25.56	11.22	289	94322	154768	79495009
Multiple-drug resistance	25.50	11.22	41	94570	8767	79641010
Pyelonephritis	25.46	11.22	67	94544	20321	79629456
Encephalitis brain stem	25.44	11.22	10	94601	241	79649536
COVID-19 treatment	25.39	11.22	12	94599	458	79649319
Meningitis bacterial	25.31	11.22	23	94588	2709	79647068
Leukaemoid reaction	25.28	11.22	11	94600	345	79649432
Neuropathy peripheral	24.95	11.22	85	94526	141220	79508557
Corynebacterium infection	24.90	11.22	17	94594	1321	79648456
Gait inability	24.89	11.22	20	94591	58897	79590880
Normal newborn	24.83	11.22	36	94575	7036	79642741
Serum sickness-like reaction	24.78	11.22	13	94598	622	79649155
Amnesia	24.70	11.22	23	94588	63034	79586743
Dysgeusia	24.67	11.22	19	94592	57158	79592619
Vascular device infection	24.67	11.22	44	94567	10232	79639545
Localised infection	24.63	11.22	7	94604	37568	79612209
Cheilitis	24.56	11.22	31	94580	5310	79644467
Blood alkaline phosphatase increased	24.47	11.22	144	94467	63520	79586257
Hypokalaemia	24.44	11.22	270	94341	143770	79506007
Basal cell carcinoma	24.43	11.22	7	94604	37368	79612409
Joint stiffness	24.30	11.22	9	94602	40821	79608956
Joint injury	24.27	11.22	4	94607	31331	79618446
Type I hypersensitivity	24.26	11.22	28	94583	4370	79645407
Suicide attempt	24.26	11.22	38	94573	82894	79566883
Drug therapy	24.12	11.22	16	94595	1185	79648592
Sedation	24.02	11.22	16	94595	51879	79597898
Haemostasis	24.00	11.22	11	94600	391	79649386
Mycotic endophthalmitis	23.87	11.22	9	94602	193	79649584
Chorioretinitis	23.70	11.22	15	94596	1025	79648752
Jejunal ulcer perforation	23.68	11.22	8	94603	123	79649654
Breath sounds abnormal	23.61	11.22	56	94555	15928	79633849
Pneumonia bacterial	23.60	11.22	63	94548	19268	79630509
Granulomatous dermatitis	23.51	11.22	11	94600	410	79649367
Ureteric obstruction	23.49	11.22	22	94589	2694	79647083
Lip oedema	23.42	11.22	33	94578	6283	79643494
Brain herniation	23.35	11.22	36	94575	7427	79642350
Hyperbilirubinaemia	23.27	11.22	73	94538	24445	79625332
Intentional self-injury	23.27	11.22	5	94606	32414	79617363
Staphylococcal infection	23.15	11.22	133	94478	58162	79591615
Pruritus	22.99	11.22	622	93989	394026	79255751
Myopathy toxic	22.96	11.22	15	94596	1083	79648694
Hyperferritinaemia	22.93	11.22	13	94598	726	79649051
Bursitis	22.90	11.22	7	94604	35837	79613940
Influenza	22.86	11.22	78	94533	129528	79520249
Cholangitis acute	22.83	11.22	17	94594	1515	79648262
Lymphadenopathy	22.82	11.22	124	94487	53123	79596654
Heart rate decreased	22.76	11.22	30	94581	70286	79579491
Dyspnoea exertional	22.64	11.22	43	94568	87030	79562747
Drug dependence	22.61	11.22	10	94601	40759	79609018
Otitis media acute	22.57	11.22	16	94595	1321	79648456
Infection	22.54	11.22	181	94430	241531	79408246
Blood brain barrier defect	22.52	11.22	8	94603	144	79649633
Pancreatitis acute	22.27	11.22	117	94494	49487	79600290
Bacterial parotitis	22.13	11.22	6	94605	41	79649736
Interleukin-2 receptor increased	22.01	11.22	9	94602	241	79649536
Pelvic inflammatory disease	21.99	11.22	16	94595	1376	79648401
Factor V deficiency	21.94	11.22	7	94604	89	79649688
Rash	21.68	11.22	865	93746	577493	79072284
Pain in jaw	21.67	11.22	14	94597	46137	79603640
Surgery	21.67	11.22	6	94605	32760	79617017
Omental necrosis	21.64	11.22	6	94605	45	79649732
Mixed liver injury	21.57	11.22	35	94576	7543	79642234
Acquired haemophilia	21.56	11.22	18	94593	1893	79647884
Paraesthesia	21.45	11.22	122	94489	176201	79473576
Sleep disorder therapy	21.44	11.22	14	94597	1010	79648767
Calculus urinary	21.41	11.22	20	94591	2440	79647337
Hyperpyrexia	21.37	11.22	31	94580	6061	79643716
Muscular weakness	21.33	11.22	108	94503	160621	79489156
Tooth disorder	21.11	11.22	3	94608	26230	79623547
Abdominal distension	21.09	11.22	226	94385	119424	79530353
Eastern Cooperative Oncology Group performance status	21.09	11.22	6	94605	50	79649727
Bronchospasm	20.88	11.22	71	94540	24788	79624989
Fibrin D dimer increased	20.70	11.22	37	94574	8617	79641160
Antinuclear antibody negative	20.67	11.22	5	94606	20	79649757
Laryngeal stenosis	20.66	11.22	14	94597	1074	79648703
Encephalitis autoimmune	20.64	11.22	19	94592	2275	79647502
Cardiac ventricular thrombosis	20.63	11.22	17	94594	1756	79648021
Generalised bullous fixed drug eruption	20.58	11.22	8	94603	187	79649590
Cryptococcosis	20.56	11.22	23	94588	3470	79646307
Vitamin K deficiency	20.44	11.22	12	94599	716	79649061
Gastroenteritis clostridial	20.20	11.22	13	94598	915	79648862
Strongyloidiasis	20.15	11.22	24	94587	3874	79645903
Pulmonary physical examination abnormal	20.10	11.22	5	94606	23	79649754
Liver transplant failure	20.02	11.22	7	94604	120	79649657
Hyperamylasaemia	20.00	11.22	14	94597	1133	79648644
Ear pain	19.98	11.22	7	94604	32862	79616915
Hypoalbuminaemia	19.83	11.22	63	94548	21234	79628543
Stress cardiomyopathy	19.71	11.22	42	94569	11124	79638653
Blood gases abnormal	19.64	11.22	14	94597	1166	79648611
Upper-airway cough syndrome	19.52	11.22	43	94568	11650	79638127
Cerebellar syndrome	19.39	11.22	28	94583	5452	79644325
CSF protein increased	19.01	11.22	14	94597	1226	79648551
Encephalomalacia	19.00	11.22	14	94597	1227	79648550
Infective chondritis	19.00	11.22	5	94606	30	79649747
Hyperlactacidaemia	18.94	11.22	28	94583	5567	79644210
Pneumothorax	18.83	11.22	75	94536	28248	79621529
Lymphopenia	18.80	11.22	79	94532	30478	79619299
Dehydration	18.73	11.22	196	94415	247991	79401786
Urinary tract infection fungal	18.70	11.22	13	94598	1040	79648737
Flatulence	18.68	11.22	14	94597	42710	79607067
Normocytic anaemia	18.68	11.22	24	94587	4183	79645594
Injury	18.67	11.22	40	94571	77456	79572321
Hypernatraemia	18.57	11.22	48	94563	14403	79635374
Vanishing bile duct syndrome	18.53	11.22	16	94595	1762	79648015
Endocarditis bacterial	18.50	11.22	15	94596	1514	79648263
Iris transillumination defect	18.49	11.22	7	94604	152	79649625
Antibiotic level below therapeutic	18.48	11.22	6	94605	81	79649696
Petechiae	18.39	11.22	60	94551	20505	79629272
Macule	18.32	11.22	20	94591	2937	79646840
Coombs negative haemolytic anaemia	18.26	11.22	9	94602	377	79649400
Antibiotic associated colitis	18.25	11.22	4	94607	9	79649768
Hypertriglyceridaemia	18.13	11.22	44	94567	12696	79637081
Sneezing	18.12	11.22	58	94553	19625	79630152
Hypovolaemic shock	18.12	11.22	43	94568	12233	79637544
Type IIa hyperlipidaemia	18.09	11.22	8	94603	261	79649516
Cell death	18.09	11.22	25	94586	4674	79645103
Head injury	18.01	11.22	11	94600	37358	79612419
Bone marrow failure	17.99	11.22	113	94498	50994	79598783
Postpartum sepsis	17.95	11.22	4	94607	10	79649767
Pneumonia pneumococcal	17.88	11.22	23	94588	4014	79645763
Syncope	17.84	11.22	132	94479	179317	79470460
Malabsorption from administration site	17.83	11.22	7	94604	168	79649609
Prothrombin time ratio decreased	17.80	11.22	12	94599	913	79648864
Hypocoagulable state	17.74	11.22	17	94594	2142	79647635
Relapsing fever	17.65	11.22	9	94602	406	79649371
Overdose	17.60	11.22	137	94474	184069	79465708
Depressed mood	17.48	11.22	19	94592	48461	79601316
Metastases to stomach	17.46	11.22	8	94603	284	79649493
Skin test positive	17.43	11.22	13	94598	1161	79648616
Blood pressure diastolic decreased	17.42	11.22	7	94604	30209	79619568
Pneumococcal sepsis	17.41	11.22	15	94596	1647	79648130
Pyelonephritis acute	17.39	11.22	28	94583	5995	79643782
Osteomyelitis fungal	17.31	11.22	8	94603	290	79649487
Bacteraemia	17.27	11.22	81	94530	32743	79617034
Renal impairment	17.24	11.22	273	94338	157510	79492267
Megacolon	17.22	11.22	21	94590	3474	79646303
Red blood cell agglutination	17.21	11.22	3	94608	0	79649777
Joint range of motion decreased	17.18	11.22	9	94602	33273	79616504
Veillonella infection	17.13	11.22	5	94606	46	79649731
Prescribed overdose	17.11	11.22	12	94599	37871	79611906
Sinus disorder	17.10	11.22	3	94608	22461	79627316
Hypersensitivity vasculitis	17.02	11.22	30	94581	6913	79642864
Pneumonia necrotising	16.92	11.22	13	94598	1214	79648563
Accidental exposure to product	16.88	11.22	8	94603	31314	79618463
Injection site haemorrhage	16.83	11.22	6	94605	27864	79621913
Arterial angioplasty	16.76	11.22	5	94606	50	79649727
Dysstasia	16.71	11.22	6	94605	27740	79622037
Osteonecrosis of jaw	16.65	11.22	16	94595	43210	79606567
Cardiac disorder	16.63	11.22	33	94578	65724	79584053
Pollakiuria	16.61	11.22	12	94599	37305	79612472
Tracheobronchitis	16.60	11.22	16	94595	2030	79647747
Foot fracture	16.59	11.22	3	94608	21978	79627799
Carotid artery insufficiency	16.53	11.22	4	94607	16	79649761
Bacteriuria	16.51	11.22	13	94598	1258	79648519
Incorrect dose administered	16.49	11.22	42	94569	76588	79573189
Haemorrhoids	16.39	11.22	7	94604	29121	79620656
Dry eye	16.28	11.22	12	94599	36919	79612858
Foetal death	16.26	11.22	32	94579	8012	79641765
Henoch-Schonlein purpura	16.22	11.22	18	94593	2692	79647085
Guillain-Barre syndrome	16.15	11.22	34	94577	8931	79640846
Septic pulmonary embolism	16.12	11.22	6	94605	124	79649653
Obesity	16.03	11.22	11	94600	35114	79614663
Eosinophilic pneumonia acute	15.95	11.22	12	94599	1086	79648691
Abdominal wall haematoma	15.95	11.22	24	94587	4849	79644928
Delirium	15.92	11.22	162	94449	84465	79565312
Abdominal compartment syndrome	15.90	11.22	14	94597	1583	79648194
Bone pain	15.87	11.22	26	94585	55716	79594061
Lower limb fracture	15.83	11.22	4	94607	23211	79626566
Meningitis aseptic	15.78	11.22	29	94582	6899	79642878
Eosinophilic pneumonia	15.76	11.22	25	94586	5285	79644492
Shock haemorrhagic	15.72	11.22	56	94555	20004	79629773
Blood cholesterol increased	15.72	11.22	49	94562	83671	79566106
Procedural pain	15.70	11.22	4	94607	23080	79626697
Therapeutic response decreased	15.69	11.22	35	94576	66818	79582959
Device related bacteraemia	15.69	11.22	10	94601	692	79649085
Palmar-plantar erythrodysaesthesia syndrome	15.63	11.22	10	94601	33124	79616653
Pulmonary necrosis	15.58	11.22	9	94602	521	79649256
Neuroborreliosis	15.56	11.22	6	94605	137	79649640
Meningism	15.53	11.22	10	94601	704	79649073
Hepatic failure	15.52	11.22	125	94486	61087	79588690
Red blood cell sedimentation rate increased	15.49	11.22	19	94592	45923	79603854
Allergy test positive	15.36	11.22	10	94601	718	79649059
Central nervous system vasculitis	15.35	11.22	13	94598	1395	79648382
Antimicrobial susceptibility test resistant	15.30	11.22	8	94603	380	79649397
Heart rate irregular	15.23	11.22	10	94601	32669	79617108
Limb injury	15.22	11.22	8	94603	29520	79620257
Metastases to bone	15.20	11.22	5	94606	24422	79625355
Endotracheal intubation	15.18	11.22	23	94588	4674	79645103
Ocular icterus	15.11	11.22	25	94586	5475	79644302
Feeling hot	15.09	11.22	30	94581	59704	79590073
Lung consolidation	15.05	11.22	33	94578	8914	79640863
Laryngeal mass	15.04	11.22	5	94606	73	79649704
Malignant neoplasm progression	15.01	11.22	97	94514	135893	79513884
Thunderclap headache	14.98	11.22	8	94603	397	79649380
Multiple sclerosis	14.89	11.22	4	94607	22278	79627499
Drug hypersensitivity	14.88	11.22	462	94149	298454	79351323
Sleep disorder	14.81	11.22	52	94559	85625	79564152
Septic embolus	14.72	11.22	15	94596	2036	79647741
Red blood cell schistocytes present	14.70	11.22	9	94602	580	79649197
Blood fibrinogen increased	14.66	11.22	14	94597	1756	79648021
Gene mutation	14.65	11.22	17	94594	2669	79647108
Diabetes insipidus	14.65	11.22	24	94587	5213	79644564
Meningitis	14.62	11.22	34	94577	9548	79640229
Pneumonia staphylococcal	14.54	11.22	23	94588	4851	79644926
Haemodialysis	14.48	11.22	51	94560	18117	79631660
Grip strength decreased	14.47	11.22	4	94607	21865	79627912
Oral pain	14.45	11.22	10	94601	31788	79617989
Muscle tension dysphonia	14.42	11.22	6	94605	168	79649609
Hypothyroidism	14.40	11.22	25	94586	52367	79597410
Eye pain	14.37	11.22	14	94597	37564	79612213
Hot flush	14.35	11.22	27	94584	54850	79594927
Amniotic cavity infection	14.20	11.22	10	94601	817	79648960
Epistaxis	14.19	11.22	76	94535	111439	79538338
Fungaemia	14.16	11.22	22	94589	4569	79645208
Localised oedema	14.14	11.22	30	94581	7922	79641855
Nephritis	14.14	11.22	21	94590	4193	79645584
Rhinocerebral mucormycosis	14.13	11.22	11	94600	1047	79648730
Vitamin A deficiency	14.13	11.22	5	94606	89	79649688
Psychotic disorder	14.09	11.22	17	94594	41385	79608392
Embolia cutis medicamentosa	14.06	11.22	9	94602	627	79649150
Dysmetria	14.01	11.22	11	94600	1060	79648717
Lymphocyte transformation test positive	13.99	11.22	4	94607	34	79649743
Unevaluable event	13.97	11.22	28	94583	55557	79594220
Rash pustular	13.95	11.22	37	94574	11274	79638503
Post treatment Lyme disease syndrome	13.93	11.22	3	94608	6	79649771
Illness	13.90	11.22	21	94590	46490	79603287
Pancreatitis necrotising	13.87	11.22	20	94591	3888	79645889
ADAMTS13 activity decreased	13.85	11.22	6	94605	186	79649591
Myalgia	13.84	11.22	147	94464	185494	79464283
Prescribed underdose	13.79	11.22	9	94602	29505	79620272
Cardiac valve abscess	13.78	11.22	4	94607	36	79649741
Glycosylated haemoglobin increased	13.76	11.22	3	94608	19257	79630520
Fungal peritonitis	13.75	11.22	11	94600	1089	79648688
Necrosis	13.74	11.22	33	94578	9460	79640317
Idiosyncratic drug reaction	13.72	11.22	12	94599	1345	79648432
Haematuria traumatic	13.71	11.22	6	94605	191	79649586
Transverse sinus thrombosis	13.70	11.22	9	94602	656	79649121
Hypotension	13.67	11.22	646	93965	439671	79210106
Pseudomonas infection	13.61	11.22	55	94556	20848	79628929
Listeriosis	13.56	11.22	15	94596	2235	79647542
Pseudophaeochromocytoma	13.54	11.22	5	94606	101	79649676
Tubulointerstitial nephritis and uveitis syndrome	13.48	11.22	7	94604	328	79649449
Agitation	13.45	11.22	179	94432	99536	79550241
Confabulation	13.44	11.22	8	94603	490	79649287
POEMS syndrome	13.41	11.22	4	94607	40	79649737
Staphylococcus test positive	13.37	11.22	26	94585	6455	79643322
Panic attack	13.34	11.22	6	94605	24210	79625567
Tooth infection	13.32	11.22	3	94608	18829	79630948
PO2 decreased	13.31	11.22	17	94594	2946	79646831
Infective spondylitis	13.20	11.22	8	94603	506	79649271
Prostate cancer	13.19	11.22	12	94599	33256	79616521
Respiratory acidosis	13.17	11.22	36	94575	11164	79638613
Intentional product misuse	13.16	11.22	63	94548	95102	79554675
Clostridial infection	13.12	11.22	24	94587	5690	79644087
Lung abscess	13.10	11.22	20	94591	4092	79645685
Hemianopia	13.06	11.22	13	94598	1715	79648062
Histoplasmosis disseminated	13.01	11.22	15	94596	2338	79647439
Anoxia	12.99	11.22	7	94604	354	79649423
Ischaemic limb pain	12.98	11.22	4	94607	45	79649732
Osteoporosis	12.97	11.22	28	94583	54084	79595693
Multisystem inflammatory syndrome in children	12.90	11.22	4	94607	46	79649731
White blood cell count decreased	12.89	11.22	152	94459	188136	79461641
Acidosis	12.87	11.22	52	94559	19710	79630067
Blood lactate dehydrogenase increased	12.80	11.22	85	94526	39085	79610692
Pneumonia streptococcal	12.73	11.22	16	94595	2729	79647048
Bronchial obstruction	12.62	11.22	16	94595	2752	79647025
Dry gangrene	12.60	11.22	10	94601	979	79648798
Toxic shock syndrome	12.53	11.22	11	94600	1238	79648539
Pleural effusion	12.52	11.22	242	94369	145020	79504757
Hepatic necrosis	12.50	11.22	31	94580	9069	79640708
Hyper IgE syndrome	12.43	11.22	8	94603	563	79649214
Injection site rash	12.42	11.22	3	94608	17951	79631826
Glaucoma	12.37	11.22	4	94607	19757	79630020
Blood potassium decreased	12.35	11.22	96	94515	46416	79603361
Haemoglobinuria	12.29	11.22	9	94602	782	79648995
Haemoperitoneum	12.28	11.22	20	94591	4323	79645454
Heparin-induced thrombocytopenia	12.27	11.22	32	94579	9650	79640127
Haemorrhoids thrombosed	12.27	11.22	6	94605	247	79649530
Body temperature decreased	12.27	11.22	12	94599	32133	79617644
Tuberculosis of genitourinary system	12.25	11.22	4	94607	55	79649722
Pulmonary function test	12.21	11.22	3	94608	13	79649764
Abdominal pain	12.18	11.22	572	94039	388997	79260780
Meningitis candida	12.05	11.22	5	94606	139	79649638
Conjunctival hyperaemia	12.04	11.22	20	94591	4393	79645384
Chondrocalcinosis	12.03	11.22	10	94601	1046	79648731
Neoplasm malignant	11.99	11.22	12	94599	31798	79617979
Femur fracture	11.99	11.22	17	94594	38635	79611142
Arthritis reactive	11.90	11.22	8	94603	606	79649171
Intravascular haemolysis	11.90	11.22	9	94602	821	79648956
Expired product administered	11.85	11.22	26	94585	7025	79642752
Anticonvulsant drug level below therapeutic	11.82	11.22	10	94601	1071	79648706
Osteomyelitis	11.78	11.22	73	94538	32792	79616985
Acne	11.77	11.22	9	94602	27181	79622596
Hyperkalaemia	11.77	11.22	196	94415	114202	79535575
Throat irritation	11.75	11.22	19	94592	40927	79608850
Mechanical urticaria	11.71	11.22	7	94604	432	79649345
Coagulation factor V level decreased	11.70	11.22	8	94603	623	79649154
Urine potassium increased	11.70	11.22	3	94608	16	79649761
Periostosis	11.70	11.22	3	94608	16	79649761
Upper respiratory tract infection	11.67	11.22	62	94549	91106	79558671
Gastrointestinal mucormycosis	11.66	11.22	7	94604	435	79649342
Wound infection	11.65	11.22	7	94604	23984	79625793
Haematochezia	11.56	11.22	59	94552	87586	79562191
Neuralgic amyotrophy	11.50	11.22	6	94605	284	79649493
Normochromic anaemia	11.42	11.22	7	94604	452	79649325
Metastases to heart	11.40	11.22	6	94605	289	79649488
Alpha 1 microglobulin increased	11.36	11.22	4	94607	70	79649707
CD4 lymphocytes increased	11.34	11.22	6	94605	292	79649485
Tenderness	11.34	11.22	7	94604	23635	79626142
Tetany	11.24	11.22	15	94596	2713	79647064

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	J01DD04	ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE OTHER BETA-LACTAM ANTIBACTERIALS Third-generation cephalosporins
ATC	J01DD54	ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE OTHER BETA-LACTAM ANTIBACTERIALS Third-generation cephalosporins
ATC	J01DD63	ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE OTHER BETA-LACTAM ANTIBACTERIALS Third-generation cephalosporins
FDA CS	M0003827	Cephalosporins
FDA EPC	N0000175488	Cephalosporin Antibacterial
MeSH PA	D000900	Anti-Bacterial Agents
MeSH PA	D000890	Anti-Infective Agents
CHEBI has role	CHEBI:35625	beta-lactamase inhibitors
CHEBI has role	CHEBI:36047	antibacterial drugs
CHEBI has role	CHEBI:88188	allergenic drug

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

Disease	Relation	SNOMED_ID	DOID
Gonococcal meningitis	indication	151004
Streptococcal meningitis	indication	4510004	DOID:11574
Septicemia due to Escherichia coli	indication	9323009
Bacterial septicemia	indication	10001005	DOID:0040085
Staphylococcal meningitis	indication	12166008
Gonorrhea	indication	15628003	DOID:7551
Infection of skin AND/OR subcutaneous tissue	indication	19824006
Acute gonococcal cervicitis	indication	20943002	DOID:10615
Staphylococcal pneumonia	indication	22754005
Streptococcal septicemia	indication	29577008
Acute gonococcal urethritis	indication	29864006
Pneumonia due to Streptococcus	indication	34020007
Gonorrhea of rectum	indication	42746002
Gonococcal infection of joint	indication	44743006
Bacterial arthritis	indication	48245008
Salmonella septicemia	indication	49786009
Lower respiratory tract infection	indication	50417007
Pneumococcal meningitis	indication	51169003
Pneumonia due to Escherichia coli	indication	51530003
Bacterial pneumonia	indication	53084003	DOID:874
Klebsiella cystitis	indication	60867007
Gonococcal endocarditis	indication	61048000
Acute gonococcal endometritis	indication	65295003	DOID:7527
Haemophilus influenzae pneumonia	indication	70036007
Infection due to Escherichia coli	indication	71057007
Bacterial infection due to Serratia	indication	71120004
Rhinoscleroma	indication	72409005	DOID:11336
Gonorrhea of pharynx	indication	74372003
Endometritis	indication	78623009	DOID:1002
Bacterial meningitis	indication	95883001	DOID:9470
Infection of bone	indication	111253001
Staphylococcal septicemia	indication	111821004
Female genital tract infection	indication	125585007
Infectious disease of abdomen	indication	128070006
Infection due to Enterobacteriaceae	indication	128945009
Bacterial infection due to Klebsiella pneumoniae	indication	186435004
Meningococcal meningitis	indication	192644005
Escherichia coli meningitis	indication	192655005
Proteus pneumonia	indication	195888009
Chancroid	indication	266143009	DOID:13778
Escherichia coli urinary tract infection	indication	301011002
Proteus urinary tract infection	indication	301012009
Streptococcus pyogenes infection	indication	302809008
Bacterial urinary infection	indication	312124009
Infective otitis media	indication	312218008
Infectious disorder of joint	indication	363162000
Meningitis due to Klebsiella mobilis	indication	420585007
Peptostreptococcus infection	indication	135341000119101
Klebsiella Pneumoniae Osteomyelitis	indication
Inflammatory Disease of Female Pelvic Organs	indication
Proteus Mirabilis Osteomyelitis	indication
Peptostreptococcus Peritonitis	indication
Enterobacter Pneumonia	indication
Proteus Joint Infection	indication
Haemophilus Septic Arthritis	indication
Skin and Skin Structure Serratia Infection	indication
E. Coli Peritonitis	indication
Prevention of Perioperative Infection	indication
Haemophilus Influenzae Type B Infections	indication
Adult Gonococcal Conjunctivitis	indication
E. Coli Septic Arthritis	indication
Haemophilus Septicemia	indication
Disseminated Gonococcal Infection	indication
Klebsiella Pneumoniae Peritonitis	indication
H. Influenzae Meningitis	indication
Prevention of Meningococcal Meningitis	indication
Gram-Negative Aerobic Bacillary Pneumonia	indication
Skin and Skin Structure Proteus Infection	indication
Haemophilus Osteomyelitis	indication
Haemophilus Parainfluenzae Pneumonia	indication
Enterobacter Osteomyelitis	indication
Streptococcal Joint Infection	indication
Pelvic Inflammatory Disease with Neisseria Gonorrhea	indication
Klebsiella Joint Infection	indication
EnterobacterJoint Infection	indication
Skin and Skin Structure Morganella Morganii Infection	indication
Streptococcus Osteomyelitis	indication
E. Coli Joint Infection	indication
E. Coli Osteomyelitis	indication
Pyrexia of unknown origin	off-label use	7520000
Lyme disease	off-label use	23502006	DOID:11729
Lyme arthritis	off-label use	33937009
Pseudotuberculosis	off-label use	36753006
Lyme carditis	off-label use	77863005
Infection by Yersinia enterocolitica	off-label use	80960004
Ventilator-acquired pneumonia	off-label use	429271009
Lyme Disease of the Central Nervous System	off-label use
Sexual Transmitted Disease Exposure from Sexual Assault	off-label use
Disorder of gallbladder	contraindication	39621005	DOID:0060262
Acute nephropathy	contraindication	58574008
Hemolytic anemia	contraindication	61261009	DOID:583
Disease of liver	contraindication	235856003	DOID:409
Neonatal hyperbilirubinemia	contraindication	281610001
Pseudomembranous enterocolitis	contraindication	397683000

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	2.65	acidic
pKa2	4.17	acidic
pKa3	13.31	acidic
pKa4	3.29	Basic
pKa5	0.93	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
D-amino-acid oxidase	Enzyme	P14920	OXDA_HUMAN		IC50	5	CHEMBL
Alpha-synuclein	Transporter	P37840	SYUA_HUMAN		Kd	6.28	CHEMBL
Peptidoglycan synthase FtsI	Enzyme		FTSI_ECOLI	INHIBITOR	IC50	6.14	WOMBAT-PK	CHEMBL
Penicillin-binding protein 1A	Enzyme		PBPA_ECOLI	INHIBITOR	IC50	6.51	WOMBAT-PK	CHEMBL
Penicillin-binding protein 1B	Enzyme		PBPB_ECOLI	INHIBITOR	IC50	5.74	WOMBAT-PK	CHEMBL
Penicillin-binding protein 2	Enzyme		PBP2_ECOLI	INHIBITOR	IC50	6.21	WOMBAT-PK	CHEMBL

External reference:

ID	Source
4019667	VUID
N0000147759	NUI
D00924	KEGG_DRUG
104376-79-6	SECONDARY_CAS_RN
203172	RXNORM
C0007561	UMLSCUI
CHEBI:29007	CHEBI
9F2	PDB_CHEM_ID
CHEMBL1200995	ChEMBL_ID
CHEMBL161	ChEMBL_ID
CHEMBL3183968	ChEMBL_ID
D002443	MESH_DESCRIPTOR_UI
DB01212	DRUGBANK_ID
5326	IUPHAR_LIGAND_ID
4923	INN_ID
75J73V1629	UNII
5479530	PUBCHEM_CID
1314	MMSL
4387	MMSL
69782	MMSL
d00052	MMSL
002734	NDDF
004849	NDDF
19841008	SNOMEDCT_US
33440000	SNOMEDCT_US
372670001	SNOMEDCT_US
4017814	VANDF
4019667	VANDF

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Ceftriaxone	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9678	INJECTION, POWDER, FOR SOLUTION	10 g	INTRAVENOUS	ANDA	26 sections
Ceftriaxone	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9678	INJECTION, POWDER, FOR SOLUTION	10 g	INTRAVENOUS	ANDA	26 sections
Ceftriaxone	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9768	INJECTION, POWDER, FOR SOLUTION	10 g	INTRAVENOUS	ANDA	23 sections
Ceftriaxone	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9856	INJECTION, POWDER, FOR SOLUTION	2 g	INTRAMUSCULAR	ANDA	24 sections
Ceftriaxone	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9856	INJECTION, POWDER, FOR SOLUTION	2 g	INTRAMUSCULAR	ANDA	24 sections
Ceftriaxone	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9856	INJECTION, POWDER, FOR SOLUTION	2 g	INTRAMUSCULAR	ANDA	24 sections
Ceftriaxone	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9857	INJECTION, POWDER, FOR SOLUTION	1 g	INTRAMUSCULAR	ANDA	24 sections
Ceftriaxone	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9857	INJECTION, POWDER, FOR SOLUTION	1 g	INTRAMUSCULAR	ANDA	24 sections
Ceftriaxone	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9857	INJECTION, POWDER, FOR SOLUTION	1 g	INTRAMUSCULAR	ANDA	24 sections
Ceftriaxone	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9858	INJECTION, POWDER, FOR SOLUTION	500 mg	INTRAMUSCULAR	ANDA	24 sections
Ceftriaxone	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9858	INJECTION, POWDER, FOR SOLUTION	500 mg	INTRAMUSCULAR	ANDA	24 sections
Ceftriaxone	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9858	INJECTION, POWDER, FOR SOLUTION	500 mg	INTRAMUSCULAR	ANDA	24 sections
Ceftriaxone	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9859	INJECTION, POWDER, FOR SOLUTION	250 mg	INTRAMUSCULAR	ANDA	24 sections
Ceftriaxone	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9859	INJECTION, POWDER, FOR SOLUTION	250 mg	INTRAMUSCULAR	ANDA	24 sections
Ceftriaxone	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9859	INJECTION, POWDER, FOR SOLUTION	250 mg	INTRAMUSCULAR	ANDA	24 sections
CEFTRIAXONE AND DEXTROSE	HUMAN PRESCRIPTION DRUG LABEL	1	0264-3153	INJECTION, SOLUTION	1 g	INTRAVENOUS	NDA	27 sections
CEFTRIAXONE AND DEXTROSE	HUMAN PRESCRIPTION DRUG LABEL	1	0264-3155	INJECTION, SOLUTION	2 g	INTRAVENOUS	NDA	27 sections
Ceftriaxone	HUMAN PRESCRIPTION DRUG LABEL	1	0338-5002	INJECTION, SOLUTION	1 g	INTRAVENOUS	ANDA	23 sections
Ceftriaxone	HUMAN PRESCRIPTION DRUG LABEL	1	0338-5002	INJECTION, SOLUTION	1 g	INTRAVENOUS	ANDA	23 sections
Ceftriaxone	HUMAN PRESCRIPTION DRUG LABEL	1	0338-5003	INJECTION, SOLUTION	2 g	INTRAVENOUS	ANDA	23 sections
Ceftriaxone	HUMAN PRESCRIPTION DRUG LABEL	1	0338-5003	INJECTION, SOLUTION	2 g	INTRAVENOUS	ANDA	23 sections
Ceftriaxone Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0409-7332	INJECTION, POWDER, FOR SOLUTION	1 g	INTRAVENOUS	ANDA	24 sections
Ceftriaxone Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0409-7332	INJECTION, POWDER, FOR SOLUTION	1 g	INTRAVENOUS	ANDA	24 sections
Ceftriaxone Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0409-7332	INJECTION, POWDER, FOR SOLUTION	1 g	INTRAVENOUS	ANDA	24 sections
Ceftriaxone Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0409-7332	INJECTION, POWDER, FOR SOLUTION	1 g	INTRAVENOUS	ANDA	24 sections
Ceftriaxone Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0409-7333	INJECTION, POWDER, FOR SOLUTION	1 g	INTRAVENOUS	ANDA	21 sections
Ceftriaxone Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0409-7333	INJECTION, POWDER, FOR SOLUTION	1 g	INTRAVENOUS	ANDA	21 sections
Ceftriaxone Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0409-7333	INJECTION, POWDER, FOR SOLUTION	1 g	INTRAVENOUS	ANDA	21 sections
Ceftriaxone Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0409-7333	INJECTION, POWDER, FOR SOLUTION	1 g	INTRAVENOUS	ANDA	21 sections
Ceftriaxone Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0409-7334	INJECTION, POWDER, FOR SOLUTION	10 g	INTRAVENOUS	ANDA	25 sections