All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

everolimus 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
immunosuppressants, rapamycin derivatives	1118	159351-69-6

Description:

Molecule

Description

Molfile Inchi Smiles Synonyms: votubia everolimus afinitor certican RAD001

A derivative of sirolimus and an inhibitor of TOR SERINE-THREONINE KINASES. It is used to prevent GRAFT REJECTION in heart and kidney transplant patients by blocking cell proliferation signals. It is also an ANTINEOPLASTIC AGENT. Molecular weight: 958.24 Formula: C53H83NO14 CLOGP: 7.10 LIPINSKI: 3 HAC: 15 HDO: 3 TPSA: 204.66 ALOGS: -5.77 ROTB: 9 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

Dose	Unit	Route
10	mg	O
1.50	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Bocci G, Oprea TI, Benet LZ
S (Water solubility)	0.01 mg/mL	Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine)	0 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.15 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value	Unit	Confidence	Similarity
azlogd74	LogD at pH 7.4	4.342		High	0.89
caco2-efflux	Caco-2 efflux ratio (BA/AB)	7.816		High	0.89
caco2-intrinsic-papp	Caco-2 intrinsic apparent permeability	22.029	10^-6 cm/s	High	0.89
dh-clint	Dog hepatocyte intrinsic clearance	100.231	uL/min/10^6 cells	High	0.89
dppb	Dog plasma protein binding (% unbound)	0.660	%	High	0.89
fcs-ppb	Fetal calf serum protein binding (% unbound)	2.200	%	High	0.89
herg	hERG pIC50	4.622	pIC50	High	0.89
hh-clint	Human hepatocyte intrinsic clearance	37.239	uL/min/10^6 cells	High	0.89
hlm-clint	Human liver microsomal intrinsic clearance	274.157	uL/min/mg protein	High	0.89
hppb	Human plasma protein binding (% unbound)	1.140	%	High	0.89
kinase-safety-class	ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,EIF2AK3,ERBB2,GRK2,ITK,NTRK2,PDK1,PDK2,PDK4,PRKDC,TEK	16
kinase-selectivity-class	GRK2	1
mdck-mdr1-bcrp-efflux	MDCK-MDR1-BCRP efflux ratio	40.926		High	1
mdck-mdr1-efflux	MDCK-MDR1 efflux ratio	7.379		High	0.89
mh-clint	Mouse hepatocyte intrinsic clearance	41.783		High	0.89
mppb	Mouse plasma protein binding (% unbound)	0.500		High	0.89
nih-mdck-mdr1-efflux	NIH MDCK-MDR1 efflux ratio	51.880		High	0.89
pfas-class	PFAS structural alert (1 = True, 0 = False)	0
pld-class	Phospholipidosis risk class (1 = positive, 0 = negative)	1		High	1
pppb	Pig plasma protein binding (% unbound)	1.020	%	High	0.89
rat-kpuu-brain	Rat brain Kpuu	0.023	%	High	1
rh-clint	Rat hepatocyte intrinsic clearance	79.433	uL/min/10^6 cells	High	0.89
rh-fuinc	Rat hepatocyte fraction unbound in incubation	3.690	%	High	0.89
rppb	Rat plasma protein binding (% unbound)	1.150	%	High	0.89
solubility-dd	Solubility at pH 7.4 in DMSO	13.459	uM	High	0.89

Approvals:

Date	Agency	Company	Orphan
Aug. 22, 2019	PMDA	Novartis Pharma K.K.
Sept. 2, 2011	EMA
March 30, 2009	FDA	NOVARTIS

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
Malignant neoplasm progression	4174.80	13.84	1928	71102	104942	90450475
Metastases to liver	1531.86	13.84	647	72383	28160	90527257
Metastases to bone	1343.21	13.84	569	72461	24936	90530481
Stomatitis	1092.29	13.84	1221	71809	273477	90281940
Pneumonitis	1087.55	13.84	584	72446	43586	90511831
Neoplasm progression	660.36	13.84	424	72606	44062	90511355
Metastases to lung	607.76	13.84	284	72746	15707	90539710
Death	537.40	13.84	1154	71876	455397	90100020
Disease progression	515.73	13.84	633	72397	155982	90399435
Mucosal inflammation	474.45	13.84	384	72646	57241	90498176
Pleural effusion	447.44	13.84	500	72530	111491	90443926
Metastases to lymph nodes	348.89	13.84	176	72854	11513	90543904
Tumour marker increased	337.20	13.84	139	72891	5668	90549749
Hyperglycaemia	328.15	13.84	295	72735	50675	90504742
Osteonecrosis of jaw	316.35	13.84	258	72772	38845	90516572
Interstitial lung disease	299.67	13.84	338	72692	76067	90479350
Infusion related reaction	281.29	13.84	13	73017	416767	90138650
Rheumatoid arthritis	271.61	13.84	4	73026	362610	90192807
Systemic lupus erythematosus	266.86	13.84	5	73025	361891	90193526
Ascites	258.55	13.84	251	72779	47489	90507928
Synovitis	249.74	13.84	3	73027	329749	90225668
Arthropathy	248.49	13.84	11	73019	366231	90189186
Contraindicated product administered	237.75	13.84	4	73026	320135	90235282
Breast cancer metastatic	236.27	13.84	149	72881	14983	90540434
Aphthous ulcer	225.31	13.84	152	72878	17135	90538282
Metastases to skin	217.28	13.84	77	72953	2063	90553354
Transplant rejection	215.32	13.84	132	72898	12626	90542791
Condition aggravated	208.80	13.84	110	72920	595435	89959982
Metastases to pleura	197.90	13.84	71	72959	1973	90553444
Musculoskeletal stiffness	191.41	13.84	12	73018	296520	90258897
Cough	190.98	13.84	692	72338	368270	90187147
Therapeutic product effect decreased	179.85	13.84	11	73019	277560	90277857
Maternal exposure during pregnancy	173.31	13.84	39	72991	360024	90195393
Wound	171.97	13.84	21	73009	302959	90252458
Hepatic lesion	170.99	13.84	86	72944	5587	90549830
Thrombotic microangiopathy	169.19	13.84	123	72907	15620	90539797
Pericarditis	168.34	13.84	13	73017	270138	90285279
Decreased appetite	168.29	13.84	674	72356	375866	90179551
PIK3CA-activated mutation	168.06	13.84	55	72975	1149	90554268
Helicobacter infection	167.69	13.84	3	73027	226847	90328570
Joint swelling	167.61	13.84	99	72931	503201	90052216
Anaemia	166.96	13.84	643	72387	352159	90203258
BK virus infection	165.04	13.84	78	72952	4420	90550997
Lung infiltration	163.33	13.84	119	72911	15163	90540254
Metastases to spine	162.66	13.84	73	72957	3670	90551747
Oral pain	160.58	13.84	163	72867	32520	90522897
Blood creatinine increased	151.83	13.84	284	72746	101102	90454315
Drug hypersensitivity	149.04	13.84	95	72935	463514	90091903
Neoplasm malignant	148.57	13.84	159	72871	33721	90521696
Irritable bowel syndrome	148.42	13.84	4	73026	207444	90347973
Discomfort	141.84	13.84	25	73005	274310	90281107
Glossodynia	141.17	13.84	42	72988	321737	90233680
Second primary malignancy	139.43	13.84	93	72937	10285	90545132
Mouth ulceration	138.52	13.84	166	72864	39808	90515609
Mobility decreased	136.02	13.84	20	73010	250714	90304703
Diarrhoea	135.22	13.84	1249	71781	937941	89617476
Epistaxis	134.43	13.84	244	72786	84881	90470536
Folliculitis	132.64	13.84	8	73022	204345	90351072
Hypersensitivity	131.89	13.84	104	72926	454573	90100844
Metastasis	131.19	13.84	74	72956	6063	90549354
Metastases to central nervous system	129.89	13.84	110	72920	17432	90537985
Metastases to peritoneum	125.26	13.84	63	72967	4092	90551325
Exposure during pregnancy	118.39	13.84	24	73006	238386	90317031
Polyomavirus viraemia	117.25	13.84	43	72987	1274	90554143
Pancreatic neuroendocrine tumour	114.12	13.84	35	72995	587	90554830
Injury	113.62	13.84	13	73017	197336	90358081
Lower respiratory tract infection	113.09	13.84	31	72999	250628	90304789
Polyomavirus-associated nephropathy	112.80	13.84	50	72980	2440	90552977
Weight increased	112.13	13.84	103	72927	417824	90137593
Sinusitis	111.99	13.84	69	72961	343019	90212398
Blood glucose increased	111.70	13.84	241	72789	95005	90460412
Viraemia	110.82	13.84	44	72986	1625	90553792
Blood triglycerides increased	109.58	13.84	90	72940	13671	90541746
Accidental exposure to product packaging	109.01	13.84	19	73011	9	90555408
Renal impairment	104.99	13.84	250	72780	105171	90450246
Dysgeusia	104.57	13.84	167	72863	52393	90503024
Oedema peripheral	103.55	13.84	447	72583	257468	90297949
Completed suicide	102.99	13.84	3	73027	145055	90410362
Gamma-glutamyltransferase increased	102.12	13.84	139	72891	37813	90517604
Bone lesion	102.03	13.84	64	72966	6373	90549044
Immunosuppressant drug level increased	101.58	13.84	57	72973	4623	90550794
Intentional product use issue	101.31	13.84	25	73005	216867	90338550
Hepatic enzyme increased	100.24	13.84	86	72944	360650	90194767
Diabetes mellitus	99.94	13.84	184	72846	64691	90490726
Carbohydrate antigen 15-3 increased	99.69	13.84	43	72987	1964	90553453
Liver injury	98.78	13.84	11	73019	170556	90384861
Ill-defined disorder	97.41	13.84	16	73014	184875	90370542
Lymphangiosis carcinomatosa	96.99	13.84	40	72990	1632	90553785
Acne	96.50	13.84	117	72913	28390	90527027
Joint range of motion decreased	95.59	13.84	3	73027	135640	90419777
Hypertriglyceridaemia	94.83	13.84	66	72964	7823	90547594
Thrombocytopenia	93.36	13.84	374	72656	208351	90347066
Arthralgia	93.26	13.84	319	72711	778203	89777214
Pyrexia	92.04	13.84	873	72157	659612	89895805
Blood lactate dehydrogenase increased	90.34	13.84	108	72922	25824	90529593
Treatment failure	88.72	13.84	69	72961	303859	90251558
Infusion site coldness	87.58	13.84	23	73007	212	90555205
Pericardial effusion	87.36	13.84	127	72903	36706	90518711
Lymphoedema	87.28	13.84	79	72951	13674	90541743
Bone pain	87.04	13.84	169	72861	61814	90493603
Post transplant lymphoproliferative disorder	85.56	13.84	59	72971	6890	90548527
Dehydration	85.03	13.84	346	72684	194101	90361316
Swelling	84.85	13.84	129	72901	418929	90136488
Pancreatic neuroendocrine tumour metastatic	83.90	13.84	18	73012	60	90555357
Therapy cessation	82.82	13.84	123	72907	36238	90519179
Gamma-glutamyltransferase decreased	82.20	13.84	24	73006	337	90555080
Fall	81.55	13.84	166	72864	481644	90073773
Type 2 diabetes mellitus	81.30	13.84	31	72999	203213	90352204
Weight decreased	80.56	13.84	553	72477	379357	90176060
Therapeutic product effect incomplete	80.22	13.84	28	73002	193868	90361549
Nephritic syndrome	79.36	13.84	24	73006	383	90555034
Product use issue	78.58	13.84	90	72940	329829	90225588
Wheezing	77.49	13.84	48	72982	238032	90317385
Concomitant disease progression	76.69	13.84	37	72993	2195	90553222
Kidney transplant rejection	76.25	13.84	48	72982	4809	90550608
Blood chromogranin A increased	76.17	13.84	23	73007	365	90555052
Palmar-plantar erythrodysaesthesia syndrome	75.94	13.84	103	72927	27920	90527497
Neutropenia	74.84	13.84	369	72661	224535	90330882
Osteoarthritis	74.79	13.84	32	72998	195698	90359719
Dyspnoea	74.09	13.84	1056	71974	879899	89675518
Alopecia	73.64	13.84	183	72847	494888	90060529
Abdominal discomfort	72.92	13.84	174	72856	477154	90078263
Bursitis	72.54	13.84	10	73020	131644	90423773
Arthritis	71.24	13.84	23	73007	167292	90388125
Loss of personal independence in daily activities	71.19	13.84	12	73018	136093	90419324
Breast cancer recurrent	70.77	13.84	48	72982	5455	90549962
Pain	70.60	13.84	492	72538	995849	89559568
Renal tubular necrosis	70.41	13.84	72	72958	14483	90540934
Device related thrombosis	69.82	13.84	34	72996	2059	90553358
Needle issue	69.36	13.84	70	72960	13864	90541553
Blister	69.33	13.84	62	72968	254936	90300481
Hypophosphataemia	69.18	13.84	72	72958	14782	90540635
Proteinuria	68.33	13.84	89	72941	23202	90532215
Cytomegalovirus infection	67.91	13.84	95	72935	26507	90528910
Confusional state	67.08	13.84	131	72899	386074	90169343
Drug ineffective	66.69	13.84	755	72275	1383543	89171874
Liver transplant rejection	66.59	13.84	31	72999	1697	90553720
Prescribed overdose	65.91	13.84	3	73027	97622	90457795
Metastases to the mediastinum	64.28	13.84	23	73007	634	90554783
Hormone receptor positive breast cancer	64.02	13.84	24	73006	757	90554660
Body temperature decreased	62.21	13.84	86	72944	23730	90531687
Asthma	62.17	13.84	62	72968	242098	90313319
General physical health deterioration	61.63	13.84	493	72537	354622	90200795
Urticaria	61.61	13.84	98	72932	312636	90242781
Parvovirus B19 infection	61.53	13.84	25	73005	981	90554436
Abdominal lymphadenopathy	61.32	13.84	25	73005	990	90554427
Cell marker increased	60.87	13.84	18	73012	265	90555152
Obesity	60.58	13.84	7	73023	105500	90449917
Depression	59.40	13.84	94	72936	300507	90254910
Drug intolerance	59.35	13.84	175	72855	447416	90108001
Haemoglobin decreased	58.39	13.84	272	72758	161684	90393733
Metastases to abdominal cavity	58.34	13.84	21	73009	589	90554828
Psoriasis	58.31	13.84	23	73007	147731	90407686
Leukopenia	58.07	13.84	196	72834	100514	90454903
Feeding disorder	57.85	13.84	71	72959	17441	90537976
Memory impairment	57.25	13.84	45	72985	197199	90358218
Polyneuropathy	56.88	13.84	74	72956	19267	90536150
Impaired healing	56.71	13.84	63	72967	234136	90321281
Intentional product misuse	56.66	13.84	4	73026	89600	90465817
Metastases to chest wall	56.39	13.84	21	73009	650	90554767
Nasopharyngitis	55.56	13.84	157	72873	406947	90148470
Spinal pain	55.47	13.84	66	72964	15701	90539716
Sleep disorder	55.21	13.84	47	72983	197983	90357434
Pneumocystis jirovecii pneumonia	54.89	13.84	77	72953	21539	90533878
Drug abuse	54.10	13.84	3	73027	82344	90473073
Gastrointestinal disorder	53.87	13.84	77	72953	256610	90298807
Malignant pleural effusion	53.44	13.84	32	72998	2932	90552485
Epstein-Barr virus infection	53.39	13.84	53	72977	10291	90545126
Product dose omission issue	53.22	13.84	96	72934	291591	90263826
Sciatica	52.88	13.84	9	73021	101373	90454044
Gait inability	52.74	13.84	26	73004	146430	90408987
Fatigue	51.89	13.84	1255	71775	1152768	89402649
Hypophagia	51.69	13.84	99	72931	35838	90519579
Lymphadenopathy mediastinal	51.48	13.84	32	72998	3135	90552282
Nephropathy toxic	51.18	13.84	57	72973	12631	90542786
Cholangitis	51.05	13.84	44	72986	7138	90548279
Renal failure	50.93	13.84	225	72805	130782	90424635
Platelet count decreased	50.82	13.84	232	72798	136737	90418680
Neoplasm	50.42	13.84	48	72982	8855	90546562
Autoimmune disorder	49.79	13.84	3	73027	76741	90478676
Breast cancer	49.77	13.84	124	72906	53637	90501780
Peripheral venous disease	49.63	13.84	5	73025	83916	90471501
Cytomegalovirus gastritis	49.17	13.84	16	73014	328	90555089
Complications of transplanted kidney	49.12	13.84	30	73000	2848	90552569
Blood alkaline phosphatase increased	48.90	13.84	115	72915	47964	90507453
Eating disorder	48.85	13.84	84	72946	27989	90527428
Concomitant disease aggravated	48.64	13.84	53	72977	11465	90543952
Injection site reaction	48.41	13.84	8	73022	92072	90463345
Joint stiffness	47.89	13.84	4	73026	78038	90477379
Drug level decreased	46.82	13.84	48	72982	9682	90545735
Metastases to spleen	46.26	13.84	14	73016	224	90555193
Odynophagia	46.05	13.84	46	72984	8997	90546420
West Nile viral infection	46.03	13.84	17	73013	514	90554903
Suicide attempt	45.90	13.84	4	73026	75395	90480022
Injection site hypersensitivity	45.84	13.84	28	73002	2659	90552758
Hepatic neoplasm	45.62	13.84	26	73004	2172	90553245
Metastases to adrenals	45.47	13.84	20	73010	958	90554459
Flatulence	45.44	13.84	102	72928	41265	90514152
Immunosuppressant drug level decreased	45.02	13.84	21	73009	1155	90554262
Aspartate aminotransferase increased	44.82	13.84	183	72847	102754	90452663
Night sweats	44.67	13.84	24	73006	128742	90426675
Onychoclasis	44.02	13.84	41	72989	7358	90548059
Off label use	43.68	13.84	626	72404	1101626	89453791
Hypoaesthesia	42.97	13.84	121	72909	314089	90241328
Pseudocirrhosis	42.90	13.84	19	73011	925	90554492
Lip dry	42.75	13.84	14	73016	100941	90454476
Karnofsky scale worsened	42.52	13.84	8	73022	10	90555407
Blood pressure systolic increased	42.35	13.84	123	72907	58222	90497195
Injection site mass	42.31	13.84	69	72961	22021	90533396
Oncologic complication	42.28	13.84	13	73017	220	90555197
Infusion site induration	42.24	13.84	22	73008	1537	90553880
Red blood cell sedimentation rate increased	41.63	13.84	8	73022	82587	90472830
Lower limb fracture	41.26	13.84	9	73021	85004	90470413
Muscle contractions involuntary	41.17	13.84	27	73003	2901	90552516
Lung disorder	40.97	13.84	233	72797	149650	90405767
Pelvic neoplasm	40.08	13.84	14	73016	359	90555058
Product use in unapproved indication	39.72	13.84	430	72600	335806	90219611
Wound infection	39.68	13.84	18	73012	106384	90449033
Glomerular filtration rate decreased	39.59	13.84	58	72972	16874	90538543
Amnesia	39.47	13.84	19	73011	108486	90446931
Drug level increased	39.34	13.84	76	72954	27686	90527731
Ingrowing nail	39.25	13.84	26	73004	2841	90552576
Adverse event	39.12	13.84	23	73007	117395	90438022
Cardiac failure	38.79	13.84	183	72847	109313	90446104
Mean cell haemoglobin decreased	38.69	13.84	34	72996	5661	90549756
Bradycardia	38.48	13.84	10	73020	83837	90471580
Heart transplant rejection	38.40	13.84	17	73013	827	90554590
Tumour pain	38.31	13.84	22	73008	1865	90553552
Kidney fibrosis	37.40	13.84	23	73007	2211	90553206
Skin toxicity	37.35	13.84	36	72994	6743	90548674
Migraine	37.15	13.84	60	72970	190332	90365085
Cachexia	36.91	13.84	36	72994	6842	90548575
Intestinal obstruction	36.88	13.84	88	72942	37043	90518374
Overdose	36.46	13.84	44	72986	157665	90397752
Escherichia sepsis	36.10	13.84	33	72997	5783	90549634
Asthenia	35.98	13.84	617	72413	533134	90022283
Adverse drug reaction	35.95	13.84	25	73005	116676	90438741
Headache	35.89	13.84	485	72545	862261	89693156
Metastases to thorax	35.83	13.84	12	73018	270	90555147
Ovarian cyst	35.78	13.84	56	72974	17262	90538155
Hepatic mass	35.40	13.84	22	73008	2155	90553262
Post-traumatic neck syndrome	34.91	13.84	23	73007	2491	90552926
Lymphocyte count decreased	34.74	13.84	83	72947	34967	90520450
Colitis ulcerative	34.59	13.84	4	73026	60262	90495155
Somnolence	34.49	13.84	73	72957	209011	90346406
Muscle spasms	34.43	13.84	97	72933	251786	90303631
Genitourinary tract neoplasm	34.21	13.84	8	73022	43	90555374
Metastases to pelvis	34.16	13.84	14	73016	562	90554855
Foot deformity	34.14	13.84	4	73026	59647	90495770
Hepatic function abnormal	33.99	13.84	98	72932	46190	90509227
Carcinoembryonic antigen increased	33.85	13.84	22	73008	2328	90553089
Eyelid oedema	33.71	13.84	44	72986	11490	90543927
Congenital coronary artery malformation	33.70	13.84	10	73020	149	90555268
Suicidal ideation	33.53	13.84	9	73021	73846	90481571
Porocarcinoma	33.44	13.84	7	73023	20	90555397
Multiple organ dysfunction syndrome	33.40	13.84	126	72904	68210	90487207
Recurrent cancer	32.94	13.84	22	73008	2437	90552980
Metastases to muscle	32.93	13.84	10	73020	162	90555255
Delirium	32.62	13.84	22	73008	104337	90451080
Dry skin	32.52	13.84	149	72881	87924	90467493
Vasodilatation	32.05	13.84	23	73007	2861	90552556
Contusion	31.98	13.84	100	72930	251116	90304301
Gastrooesophageal reflux disease	31.91	13.84	53	72977	166284	90389133
Product quality issue	31.87	13.84	12	73018	79313	90476104
Bone erosion	31.77	13.84	3	73027	53018	90502399
Nephrotic syndrome	31.39	13.84	34	72996	7305	90548112
Metastases to meninges	30.94	13.84	25	73005	3710	90551707
Intestinal metastasis	30.37	13.84	10	73020	213	90555204
Reflux gastritis	30.20	13.84	17	73013	1387	90554030
Muscular weakness	30.19	13.84	77	72953	206589	90348828
Nasal discharge discolouration	29.99	13.84	22	73008	2831	90552586
Metastases to pancreas	29.93	13.84	11	73019	328	90555089
Exposed bone in jaw	29.49	13.84	22	73008	2904	90552513
Anaphylactic reaction	29.36	13.84	17	73013	87507	90467910
Metastases to kidney	29.13	13.84	10	73020	243	90555174
Angiosarcoma	29.06	13.84	10	73020	245	90555172
Dyspepsia	28.82	13.84	74	72956	198086	90357331
Carcinoid tumour pulmonary	28.68	13.84	12	73018	508	90554909
Stomatitis haemorrhagic	28.48	13.84	8	73022	97	90555320
Soft tissue sarcoma	28.45	13.84	9	73021	168	90555249
Hepatic angiosarcoma	28.44	13.84	6	73024	18	90555399
Pulmonary mass	28.37	13.84	68	72962	28704	90526713
Drug-induced liver injury	28.28	13.84	19	73011	90299	90465118
Neuroendocrine tumour	28.16	13.84	14	73016	887	90554530
Lymphadenopathy	28.08	13.84	91	72939	45684	90509733
Pleural disorder	28.07	13.84	13	73017	703	90554714
Generalised oedema	28.03	13.84	53	72977	19000	90536417
Drug resistance	27.93	13.84	70	72960	30379	90525038
Cytomegalovirus gastrointestinal infection	27.68	13.84	11	73019	407	90555010
Bone cancer	27.54	13.84	17	73013	1645	90553772
Carcinoid tumour	27.46	13.84	11	73019	416	90555001
Renal amyloidosis	27.37	13.84	10	73020	293	90555124
Pleural neoplasm	27.36	13.84	11	73019	420	90554997
Nausea	27.28	13.84	1123	71907	1109193	89446224
Hepatic failure	27.16	13.84	82	72948	39646	90515771
Herpes simplex hepatitis	27.06	13.84	12	73018	586	90554831
Chronic obstructive pulmonary disease	26.74	13.84	13	73017	73816	90481601
Alanine aminotransferase increased	26.65	13.84	175	72855	118163	90437254
Hyperhidrosis	26.54	13.84	43	72987	136262	90419155
Lymphocele	26.53	13.84	13	73017	798	90554619
Urine output decreased	26.38	13.84	41	72989	12562	90542855
Therapeutic product effective for unapproved indication	26.32	13.84	8	73022	130	90555287
Pulmonary fibrosis	25.92	13.84	29	73001	107474	90447943
Japanese spotted fever	25.86	13.84	6	73024	31	90555386
Metastases to bladder	25.76	13.84	9	73021	231	90555186
Visual impairment	25.55	13.84	42	72988	132323	90423094
Injection site pruritus	25.52	13.84	6	73024	53828	90501589
Chapped lips	25.44	13.84	20	73010	2853	90552564
Organising pneumonia	25.41	13.84	31	72999	7566	90547851
Pathological fracture	25.40	13.84	35	72995	9625	90545792
Jejunal ulcer perforation	25.39	13.84	6	73024	34	90555383
Nasal cavity cancer	25.22	13.84	7	73023	81	90555336
Exostosis	25.04	13.84	6	73024	53128	90502289
Dizziness	24.91	13.84	330	72700	588954	89966463
Insomnia	24.81	13.84	162	72868	333312	90222105
Therapy change	24.72	13.84	32	72998	8290	90547127
Pulmonary tumour thrombotic microangiopathy	24.61	13.84	7	73023	89	90555328
Osteoporosis	24.43	13.84	25	73005	96506	90458911
Pulmonary oedema	24.40	13.84	107	72923	61973	90493444
Oral mucosal blistering	24.38	13.84	29	73001	6895	90548522
Tonic convulsion	24.37	13.84	16	73014	1722	90553695
Pneumothorax	24.19	13.84	50	72980	19117	90536300
Blood creatinine decreased	24.13	13.84	28	73002	6487	90548930
Lymphangitis	24.09	13.84	13	73017	976	90554441
Ageusia	24.00	13.84	45	72985	16031	90539386
Cognitive disorder	23.97	13.84	13	73017	69394	90486023
Renal disorder	23.89	13.84	76	72954	37783	90517634
Metastases to soft tissue	23.71	13.84	9	73021	294	90555123
Haemolytic uraemic syndrome	23.68	13.84	19	73011	2792	90552625
Abdominal distension	23.52	13.84	183	72847	130418	90424999
Toothache	23.51	13.84	54	72976	22176	90533241
Neutrophil count decreased	23.49	13.84	117	72913	71415	90484002
Gait disturbance	23.43	13.84	119	72911	260377	90295040
Cancer pain	23.36	13.84	22	73008	4003	90551414
Injection site erythema	23.28	13.84	27	73003	98475	90456942
Lactic acidosis	23.19	13.84	6	73024	50457	90504960
Hepatitis E	23.09	13.84	16	73014	1883	90553534
Road traffic accident	22.84	13.84	32	72998	107594	90447823
Tongue ulceration	22.71	13.84	22	73008	4146	90551271
Blood pressure fluctuation	22.66	13.84	7	73023	52406	90503011
Abdominal pain	22.63	13.84	446	72584	395275	90160142
Aortitis salmonella	22.59	13.84	5	73025	20	90555397
Selenium deficiency	22.59	13.84	6	73024	58	90555359
Peripheral coldness	22.14	13.84	40	72990	13852	90541565
Eosinophil cationic protein increased	21.97	13.84	6	73024	65	90555352
Insulinoma	21.86	13.84	7	73023	136	90555281
Vomiting	21.82	13.84	808	72222	787485	89767932
Oral herpes	21.80	13.84	68	72962	33456	90521961
Tumour marker abnormal	21.64	13.84	9	73021	375	90555042
Disseminated varicella zoster vaccine virus infection	21.57	13.84	6	73024	70	90555347
Hypotension	21.32	13.84	164	72866	325233	90230184
Mass	21.29	13.84	42	72988	15535	90539882
Oedematous kidney	21.26	13.84	7	73023	149	90555268
Tumour necrosis	21.21	13.84	12	73018	989	90554428
Cheilitis	21.07	13.84	23	73007	4984	90550433
Skin sensitisation	21.05	13.84	12	73018	1003	90554414
Invasive lobular breast carcinoma	20.90	13.84	12	73018	1017	90554400
Unevaluable event	20.88	13.84	9	73021	54839	90500578
Hydrothorax	20.85	13.84	12	73018	1021	90554396
Vein disorder	20.85	13.84	24	73006	5512	90549905
Lung transplant rejection	20.77	13.84	12	73018	1029	90554388
Macular degeneration	20.64	13.84	3	73027	37967	90517450
Hepatic atrophy	20.55	13.84	8	73022	280	90555137
Portal hypertension	20.49	13.84	22	73008	4679	90550738
Hallucination	20.48	13.84	14	73016	65945	90489472
Metastases to spinal cord	20.47	13.84	8	73022	283	90555134
Onychomalacia	20.46	13.84	4	73026	7	90555410
Enterocolitis	20.40	13.84	33	72997	10457	90544960
Jaundice	20.27	13.84	65	72965	32452	90522965
Crepitations	20.23	13.84	30	73000	8822	90546595
Therapeutic product ineffective for unapproved indication	20.21	13.84	8	73022	293	90555124
Onychomycosis	20.20	13.84	3	73027	37373	90518044
Upper respiratory tract infection	20.17	13.84	46	72984	128272	90427145
Kidney congestion	20.13	13.84	5	73025	36	90555381
Metastatic neoplasm	20.06	13.84	22	73008	4793	90550624
Hepatitis viral	20.02	13.84	10	73020	640	90554777
Cerebral ventricle collapse	20.01	13.84	5	73025	37	90555380
Dyslipidaemia	19.94	13.84	32	72998	10075	90545342
Renal transplant failure	19.84	13.84	12	73018	1120	90554297
Sedation	19.83	13.84	7	73023	48164	90507253
Respiratory failure	19.73	13.84	163	72867	118255	90437162
Transplantation associated food allergy	19.67	13.84	5	73025	40	90555377
Bile duct stenosis	19.60	13.84	14	73016	1728	90553689
5-hydroxyindolacetic acid increased	19.50	13.84	4	73026	10	90555407
Pruritus	19.47	13.84	313	72717	541212	90014205
Neck pain	19.45	13.84	39	72991	113924	90441493
Anxiety	19.42	13.84	158	72872	309614	90245803
Subileus	19.42	13.84	19	73011	3625	90551792
Mouth injury	19.34	13.84	12	73018	1172	90554245
Dermatitis	19.26	13.84	50	72980	22170	90533247
Skin lesion	19.18	13.84	70	72960	37295	90518122
Infection	19.08	13.84	193	72837	361901	90193516
Hormone refractory breast cancer	18.96	13.84	4	73026	12	90555405
5-hydroxyindolacetic acid	18.96	13.84	4	73026	12	90555405
Hydronephrosis	18.87	13.84	35	72995	12367	90543050
Walking aid user	18.85	13.84	3	73027	35503	90519914
Serum serotonin increased	18.85	13.84	7	73023	215	90555202
Agitation	18.60	13.84	16	73014	67082	90488335
5-hydroxyindolacetic acid in urine	18.49	13.84	4	73026	14	90555403
Plasma cell myeloma	18.49	13.84	5	73025	40823	90514594
Complications of transplanted heart	18.48	13.84	6	73024	122	90555295
Steatorrhoea	18.27	13.84	9	73021	559	90554858
Plasmodium falciparum infection	18.16	13.84	5	73025	56	90555361
Neutrophilic panniculitis	18.08	13.84	5	73025	57	90555360
Epstein-Barr virus infection reactivation	18.06	13.84	13	73017	1624	90553793
Oral disorder	18.06	13.84	31	72999	10314	90545103
Biliary dilatation	18.05	13.84	16	73014	2695	90552722
Metastases to breast	18.04	13.84	8	73022	391	90555026
Metastases to stomach	18.01	13.84	7	73023	244	90555173
Splenic lesion	17.98	13.84	7	73023	245	90555172
Infusion site haemorrhage	17.97	13.84	22	73008	5389	90550028
Acute kidney injury	17.94	13.84	360	72670	320027	90235390
Breast pain	17.90	13.84	31	72999	10387	90545030
Oesophagitis ulcerative	17.88	13.84	10	73020	806	90554611
Cytomegalovirus oesophagitis	17.72	13.84	8	73022	408	90555009
Injection site pain	17.59	13.84	76	72954	173623	90381794
Skin plaque	17.55	13.84	30	73000	9945	90545472
Terminal state	17.51	13.84	16	73014	2802	90552615
Joint dislocation	17.48	13.84	7	73023	44575	90510842
Renal lymphocele	17.48	13.84	5	73025	65	90555352
Delayed graft function	17.31	13.84	12	73018	1413	90554004
Lymphangioleiomyomatosis	17.17	13.84	7	73023	277	90555140
Vision blurred	16.96	13.84	40	72990	110253	90445164
Retinal detachment	16.87	13.84	24	73006	6798	90548619
Anorexia nervosa	16.83	13.84	7	73023	292	90555125
Varicella zoster virus infection	16.65	13.84	18	73012	3859	90551558
Bacterial infection	16.60	13.84	49	72981	23395	90532022
Radiation pneumonitis	16.60	13.84	13	73017	1845	90553572
Trichodysplasia spinulosa	16.45	13.84	9	73021	695	90554722
Mediastinal disorder	16.36	13.84	8	73022	489	90554928
Mucinous breast carcinoma	16.33	13.84	4	73026	27	90555390
Vasoactive intestinal polypeptide increased	16.30	13.84	3	73027	3	90555414
Primary pulmonary melanoma	16.30	13.84	3	73027	3	90555414
Bowel movement irregularity	16.23	13.84	23	73007	6491	90548926
Eastern Cooperative Oncology Group performance status worsened	16.11	13.84	13	73017	1926	90553491
Polyomavirus test positive	16.03	13.84	5	73025	89	90555328
Hepatic pain	15.98	13.84	17	73013	3578	90551839
Device dislocation	15.97	13.84	3	73027	31479	90523938
Ejection fraction decreased	15.93	13.84	52	72978	26201	90529216
Dysphagia	15.83	13.84	149	72881	112129	90443288
No adverse event	15.67	13.84	19	73011	67963	90487454
Emotional distress	15.67	13.84	5	73025	36657	90518760
Atypical pneumonia	15.56	13.84	20	73010	5144	90550273
Congestive cardiomyopathy	15.50	13.84	24	73006	7330	90548087
Post transplant distal limb syndrome	15.45	13.84	7	73023	360	90555057
Cardiac arrest	15.39	13.84	39	72991	104896	90450521
Febrile infection	15.37	13.84	13	73017	2056	90553361
Amenorrhoea	15.29	13.84	31	72999	11691	90543726
Cardio-respiratory arrest	15.25	13.84	17	73013	63123	90492294
Anal ulcer	15.18	13.84	9	73021	810	90554607
Ascariasis	15.08	13.84	3	73027	6	90555411
Oral administration complication	15.08	13.84	5	73025	109	90555308
Water intoxication	15.05	13.84	8	73022	583	90554834
Cardiomyopathy	15.05	13.84	43	72987	20163	90535254
Loss of consciousness	15.04	13.84	60	72970	140178	90415239
Transient ischaemic attack	15.04	13.84	8	73022	43168	90512249
Haematotoxicity	15.00	13.84	32	72998	12503	90542914
Acute respiratory distress syndrome	14.94	13.84	54	72976	28632	90526785
Amniotic fluid index decreased	14.94	13.84	4	73026	40	90555377
Burning sensation mucosal	14.94	13.84	4	73026	40	90555377
Impaired insulin secretion	14.94	13.84	4	73026	40	90555377
Noninfective gingivitis	14.92	13.84	13	73017	2140	90553277
Foetal exposure during pregnancy	14.91	13.84	8	73022	42967	90512450
Vena cava thrombosis	14.91	13.84	14	73016	2538	90552879
Carcinoid heart disease	14.85	13.84	4	73026	41	90555376
Sinus arrhythmia	14.84	13.84	11	73019	1438	90553979
Underdose	14.82	13.84	13	73017	54004	90501413
Mucosal haemorrhage	14.81	13.84	11	73019	1442	90553975
Dysuria	14.79	13.84	67	72963	39334	90516083
Blood urea increased	14.79	13.84	56	72974	30357	90525060
Treatment noncompliance	14.75	13.84	12	73018	51715	90503702
Alveolitis	14.71	13.84	15	73015	3006	90552411
Salpingectomy	14.69	13.84	7	73023	404	90555013
Fibrin D dimer increased	14.69	13.84	20	73010	5440	90549977
Hot flush	14.64	13.84	90	72940	59398	90496019
Septic shock	14.64	13.84	117	72913	84043	90471374
Uterine mass	14.62	13.84	7	73023	408	90555009
Throat tightness	14.55	13.84	3	73027	29481	90525936
Focal segmental glomerulosclerosis	14.51	13.84	12	73018	1839	90553578
Aortic intramural haematoma	14.47	13.84	5	73025	124	90555293
Rectal haemorrhage	14.39	13.84	28	73002	82716	90472701
Peritoneal disorder	14.39	13.84	8	73022	637	90554780
Pneumonia	14.39	13.84	640	72390	637419	89917998
Cornea verticillata	14.38	13.84	6	73024	252	90555165
Organ failure	14.37	13.84	15	73015	3090	90552327
Blood potassium increased	14.34	13.84	43	72987	20706	90534711
Pancreatitis viral	14.22	13.84	3	73027	9	90555408
Pleural mass	14.22	13.84	3	73027	9	90555408
Ovarian cyst torsion	14.22	13.84	3	73027	9	90555408
Bone disorder	14.21	13.84	46	72984	23074	90532343
Presyncope	14.20	13.84	4	73026	31801	90523616
Injection site induration	14.03	13.84	28	73002	10440	90544977
Escherichia infection	14.02	13.84	36	72994	15859	90539558
Renal salt-wasting syndrome	13.95	13.84	7	73023	452	90554965
Hypoxia	13.90	13.84	103	72927	72296	90483121
Arterial thrombosis	13.87	13.84	11	73019	1589	90553828

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
Malignant neoplasm progression	1096.73	13.11	965	50733	107435	42462202
Stomatitis	661.33	13.11	522	51176	49807	42519830
Polyomavirus-associated nephropathy	358.44	13.11	162	51536	5453	42564184
Polyomavirus viraemia	325.17	13.11	115	51583	1997	42567640
Neoplasm malignant	307.22	13.11	240	51458	22503	42547134
BK virus infection	260.19	13.11	151	51547	8633	42561004
Neoplasm progression	252.61	13.11	238	51460	28762	42540875
Metastases to liver	237.34	13.11	180	51518	16146	42553491
Post transplant lymphoproliferative disorder	224.02	13.11	139	51559	8981	42560656
Metastases to lung	211.83	13.11	146	51552	11278	42558359
Pneumonitis	210.03	13.11	256	51442	41462	42528175
Transplant rejection	191.31	13.11	147	51551	13441	42556196
Kidney transplant rejection	187.50	13.11	122	51576	8561	42561076
Viraemia	183.10	13.11	72	51626	1698	42567939
Interstitial lung disease	161.28	13.11	318	51380	78144	42491493
Diarrhoea	157.59	13.11	1025	50673	459824	42109813
Mouth ulceration	142.26	13.11	129	51569	14834	42554803
Proteinuria	140.67	13.11	156	51542	22827	42546810
Immunosuppressant drug level decreased	133.69	13.11	58	51640	1766	42567871
Renal impairment	130.78	13.11	360	51338	109868	42459769
Liver transplant rejection	124.86	13.11	61	51637	2452	42567185
Thrombotic microangiopathy	109.37	13.11	111	51587	14671	42554966
Drug abuse	106.05	13.11	5	51693	104766	42464871
Cytomegalovirus infection	105.84	13.11	161	51537	32145	42537492
Oral pain	105.11	13.11	101	51597	12495	42557142
Heart transplant rejection	103.43	13.11	46	51652	1488	42568149
Metastases to bone	101.98	13.11	107	51591	14702	42554935
Epstein-Barr virus infection	100.75	13.11	88	51610	9630	42560007
Death	100.57	13.11	940	50758	470245	42099392
Decreased appetite	92.06	13.11	470	51228	192667	42376970
Cough	86.67	13.11	436	51262	177667	42391970
Hepatitis E	85.24	13.11	51	51647	3083	42566554
Acne	79.01	13.11	90	51608	13554	42556083
Immunosuppressant drug level increased	78.12	13.11	69	51629	7662	42561975
Fall	75.13	13.11	105	51593	234415	42335222
Aphthous ulcer	74.75	13.11	60	51638	5841	42563796
Complications of transplanted kidney	69.06	13.11	55	51643	5295	42564342
Hyperglycaemia	67.98	13.11	163	51535	45696	42523941
Concomitant disease progression	66.18	13.11	40	51658	2463	42567174
Mucosal inflammation	64.26	13.11	167	51531	49207	42520430
Lymphocele	63.50	13.11	33	51665	1514	42568123
Blood creatinine increased	63.43	13.11	283	51415	109720	42459917
Pleural effusion	62.19	13.11	258	51440	96908	42472729
Metastases to lymph nodes	61.54	13.11	54	51644	5944	42563693
Infusion related reaction	61.20	13.11	3	51695	60803	42508834
C-reactive protein increased	60.41	13.11	192	51506	63368	42506269
Blood chromogranin A increased	58.75	13.11	20	51678	308	42569329
Gamma-glutamyltransferase increased	56.46	13.11	123	51575	32374	42537263
Hypotension	55.66	13.11	146	51552	257485	42312152
Stenotrophomonas infection	54.16	13.11	41	51657	3663	42565974
Atrial fibrillation	53.74	13.11	54	51644	139539	42430098
Lung infiltration	53.46	13.11	75	51623	13914	42555723
Renal transplant failure	53.03	13.11	29	51669	1476	42568161
Cholangitis	52.59	13.11	65	51633	10662	42558975
Condition aggravated	50.99	13.11	155	51543	260599	42309038
Fatigue	50.82	13.11	775	50923	434866	42134771
Human herpesvirus 8 infection	50.42	13.11	28	51670	1469	42568168
Oedema peripheral	50.02	13.11	309	51389	135767	42433870
Product dose omission issue	49.49	13.11	69	51629	154296	42415341
Somnolence	49.44	13.11	59	51639	141046	42428591
Hepatic lesion	49.22	13.11	42	51656	4452	42565185
Bradycardia	49.22	13.11	21	51677	85463	42484174
Product use in unapproved indication	49.05	13.11	387	51311	184069	42385568
Drug hypersensitivity	48.91	13.11	30	51668	99359	42470278
Osteonecrosis of jaw	48.86	13.11	85	51613	18964	42550673
Squamous cell carcinoma of skin	48.29	13.11	68	51630	12658	42556979
Metastasis	47.55	13.11	42	51656	4663	42564974
Asthma	47.48	13.11	9	51689	62305	42507332
Metastases to peritoneum	47.04	13.11	32	51666	2417	42567220
Chronic allograft nephropathy	46.06	13.11	27	51671	1571	42568066
Renal tubular atrophy	45.71	13.11	26	51672	1429	42568208
Second primary malignancy	45.31	13.11	57	51641	9518	42560119
Suicide attempt	44.17	13.11	3	51695	46097	42523540
Bile duct stenosis	44.14	13.11	25	51673	1363	42568274
Acanthoma	44.11	13.11	10	51688	27	42569610
Intentional product misuse	42.99	13.11	11	51687	61889	42507748
Palmar-plantar erythrodysaesthesia syndrome	42.92	13.11	84	51614	20498	42549139
Biphasic mesothelioma	41.84	13.11	11	51687	64	42569573
Blood pressure increased	41.64	13.11	238	51460	101690	42467947
Lung disorder	41.25	13.11	140	51558	47783	42521854
Febrile neutropenia	41.02	13.11	104	51594	185599	42384038
Superinfection viral	39	13.11	9	51689	27	42569610
Suicidal ideation	38.79	13.11	6	51692	48155	42521482
Mycobacterium haemophilum infection	38.53	13.11	16	51682	436	42569201
Loss of personal independence in daily activities	38.36	13.11	7	51691	49809	42519828
Foetal exposure during pregnancy	37.86	13.11	6	51692	47305	42522332
Pyrexia	37.40	13.11	678	51020	393364	42176273
Dizziness	36.99	13.11	166	51532	249088	42320549
Drug reaction with eosinophilia and systemic symptoms	36.87	13.11	4	51694	42071	42527566
Tachycardia	36.77	13.11	41	51657	101046	42468591
Insulinoma	36.02	13.11	8	51690	19	42569618
Epistaxis	35.57	13.11	168	51530	66658	42502979
Chronic obstructive pulmonary disease	35.54	13.11	16	51682	63098	42506539
Myocardial infarction	35.35	13.11	60	51638	123949	42445688
Needle issue	35.16	13.11	48	51650	8679	42560958
Psoriasis	35.00	13.11	8	51690	48596	42521041
Paraesthesia	35.00	13.11	23	51675	73436	42496201
Metastases to central nervous system	34.45	13.11	52	51646	10303	42559334
Enterocolitis viral	34.41	13.11	15	51683	462	42569175
Loss of consciousness	34.09	13.11	37	51661	92317	42477320
Lymphangiosis carcinomatosa	33.85	13.11	19	51679	1018	42568619
Disease progression	33.13	13.11	292	51406	143364	42426273
Metastases to pancreas	33.13	13.11	14	51684	399	42569238
Kidney fibrosis	33.05	13.11	27	51671	2695	42566942
Nephropathy toxic	33.04	13.11	67	51631	16771	42552866
Pancreatic neuroendocrine tumour	33.04	13.11	13	51685	307	42569330
Intentional product use issue	32.23	13.11	24	51674	71809	42497828
Musculoskeletal stiffness	31.98	13.11	15	51683	57750	42511887
Drug ineffective	31.84	13.11	556	51142	629641	41939996
Parvovirus B19 infection	31.75	13.11	22	51676	1712	42567925
Depression	31.63	13.11	54	51644	111309	42458328
Odynophagia	31.55	13.11	40	51658	6730	42562907
Carcinoid crisis	31.29	13.11	12	51686	264	42569373
Vascular hyalinosis	31.29	13.11	10	51688	125	42569512
Cardiac arrest	31.06	13.11	53	51645	109267	42460370
Gastric ulcer haemorrhage, obstructive	30.85	13.11	7	51691	19	42569618
Pancreatic neuroendocrine tumour metastatic	30.79	13.11	10	51688	132	42569505
JC virus infection	30.73	13.11	27	51671	2977	42566660
Anxiety	30.56	13.11	61	51637	118499	42451138
Metastases to gastrointestinal tract	30.25	13.11	9	51689	87	42569550
Metastases to adrenals	30.14	13.11	18	51680	1084	42568553
Weight decreased	29.79	13.11	384	51314	207564	42362073
Coma	29.50	13.11	14	51684	53540	42516097
Parasitic gastroenteritis	29.43	13.11	10	51688	153	42569484
Haemoglobin decreased	29.38	13.11	267	51431	132204	42437433
Elephantiasis nostras verrucosa	28.58	13.11	5	51693	0	42569637
Metastases to eye	28.57	13.11	9	51689	107	42569530
Anaemia	28.21	13.11	487	51211	279791	42289846
Isosporiasis	27.91	13.11	9	51689	116	42569521
Polyomavirus test positive	27.68	13.11	10	51688	185	42569452
Metastases to pleura	27.46	13.11	14	51684	617	42569020
International normalised ratio increased	27.45	13.11	12	51686	48156	42521481
Transitional cell carcinoma	27.41	13.11	24	51674	2634	42567003
Cardio-respiratory arrest	27.07	13.11	19	51679	58617	42511020
Blood alkaline phosphatase increased	27.04	13.11	96	51602	33501	42536136
Hypertriglyceridaemia	27.04	13.11	46	51652	10080	42559557
Dyslipidaemia	26.77	13.11	44	51654	9374	42560263
Overdose	26.41	13.11	55	51643	105209	42464428
Ascites	26.26	13.11	137	51561	56541	42513096
Hypercholesterolaemia	26.25	13.11	52	51646	12797	42556840
Lactic acidosis	26.24	13.11	11	51687	45250	42524387
Cytomegalovirus colitis	26.05	13.11	28	51670	3953	42565684
Hypoaesthesia	25.96	13.11	29	51669	71434	42498203
Pneumocystis jirovecii infection	25.89	13.11	24	51674	2836	42566801
Complications of transplanted heart	25.79	13.11	11	51687	321	42569316
Agitation	25.75	13.11	24	51674	64290	42505347
Electrocardiogram QT prolonged	25.70	13.11	13	51685	47932	42521705
Granulomatous rosacea	25.46	13.11	9	51689	156	42569481
Anogenital warts	25.45	13.11	14	51684	721	42568916
Biliary obstruction	25.26	13.11	25	51673	3204	42566433
Pneumonia cytomegaloviral	25.22	13.11	28	51670	4098	42565539
Pseudohypoaldosteronism	25.12	13.11	5	51693	5	42569632
Drug level decreased	24.91	13.11	44	51654	9933	42559704
Hallucination	24.79	13.11	20	51678	57487	42512150
Haemolytic uraemic syndrome	24.79	13.11	22	51676	2457	42567180
Hyperhidrosis	24.69	13.11	45	51653	90467	42479170
Pyelonephritis acute	24.63	13.11	22	51676	2478	42567159
Gastrointestinal ulcer perforation	24.48	13.11	7	51691	58	42569579
Mononeuropathy	24.06	13.11	10	51688	273	42569364
Cytokine release syndrome	23.98	13.11	12	51686	44515	42525122
Treatment noncompliance	23.77	13.11	8	51690	37664	42531973
Blood pressure systolic increased	23.44	13.11	81	51617	27887	42541750
Erythrophagocytosis	23.26	13.11	6	51692	32	42569605
Neoplasm	22.90	13.11	33	51665	6272	42563365
Accidental exposure to product packaging	22.86	13.11	4	51694	0	42569637
General physical health deterioration	22.79	13.11	282	51416	150964	42418673
Transplant dysfunction	22.73	13.11	24	51674	3319	42566318
Human polyomavirus infection	22.62	13.11	16	51682	1287	42568350
Drug dependence	22.59	13.11	4	51694	29090	42540547
Metastases to spine	22.56	13.11	23	51675	3054	42566583
Blood gastrin increased	22.39	13.11	6	51692	38	42569599
Toxic epidermal necrolysis	22.31	13.11	3	51695	26747	42542890
Cell marker increased	22.31	13.11	11	51687	451	42569186
Neuroendocrine tumour	22.31	13.11	14	51684	922	42568715
Anaphylactic reaction	22.30	13.11	12	51686	42731	42526906
Norovirus infection	22.22	13.11	13	51685	754	42568883
Abdominal pain	22.13	13.11	339	51359	190132	42379505
Drug level increased	22.06	13.11	76	51622	26124	42543513
Haematochezia	22.02	13.11	23	51675	58413	42511224
Cerebrovascular accident	21.75	13.11	54	51644	97106	42472531
Syncope	21.67	13.11	56	51642	99350	42470287
Therapeutic product effect incomplete	21.45	13.11	33	51665	70906	42498731
Biliary anastomosis complication	21.24	13.11	7	51691	97	42569540
Arthropathy	21.05	13.11	5	51693	29592	42540045
Hepatic artery stenosis	20.94	13.11	8	51690	174	42569463
Muscle spasms	20.71	13.11	46	51652	85998	42483639
Contraindicated product administered	20.69	13.11	3	51695	25269	42544368
Tumour compression	20.61	13.11	8	51690	182	42569455
Dysgeusia	20.46	13.11	89	51609	34100	42535537
Renal failure	20.38	13.11	265	51433	143461	42426176
COVID-19 pneumonia	20.25	13.11	65	51633	21548	42548089
Renal cancer metastatic	20.18	13.11	11	51687	556	42569081
Metastases to skin	20.17	13.11	11	51687	557	42569080
Cardiogenic shock	20.12	13.11	9	51689	35631	42534006
Lung consolidation	20.07	13.11	32	51666	6645	42562992
Anorectal varices	19.98	13.11	6	51692	60	42569577
Muscular weakness	19.81	13.11	45	51653	83453	42486184
Ileal ulcer	19.73	13.11	13	51685	931	42568706
Ventricular fibrillation	19.71	13.11	6	51692	30117	42539520
Blood lactate dehydrogenase increased	19.69	13.11	73	51625	26008	42543629
Neuropathy peripheral	19.53	13.11	61	51637	101792	42467845
Stress	19.53	13.11	15	51683	44197	42525440
Liver abscess	19.52	13.11	27	51671	4943	42564694
Hyponatraemia	19.29	13.11	61	51637	101401	42468236
Concomitant disease aggravated	19.03	13.11	31	51667	6555	42563082
Crepitations	18.95	13.11	22	51676	3379	42566258
Blood triglycerides increased	18.88	13.11	52	51646	15844	42553793
Carcinoid tumour pulmonary	18.83	13.11	4	51694	7	42569630
Hepatic vein stenosis	18.83	13.11	4	51694	7	42569630
Metastases to the mediastinum	18.79	13.11	9	51689	346	42569291
Renal cell carcinoma	18.77	13.11	28	51670	5489	42564148
Metastases to kidney	18.69	13.11	9	51689	350	42569287
Actinic keratosis	18.67	13.11	27	51671	5149	42564488
Oedema	18.39	13.11	117	51581	51884	42517753
Metastases to thorax	18.35	13.11	6	51692	81	42569556
Bone pain	18.31	13.11	67	51631	23725	42545912
Dehydration	18.30	13.11	257	51441	141510	42428127
Lymphoedema	18.12	13.11	26	51672	4922	42564715
Feeding disorder	18.12	13.11	35	51663	8456	42561181
Cardiac failure congestive	18.06	13.11	49	51649	85553	42484084
Palpitations	18.03	13.11	21	51677	50776	42518861
Transitional cell cancer of renal pelvis and ureter metastatic	17.87	13.11	4	51694	10	42569627
Arthralgia	17.85	13.11	161	51537	205077	42364560
Oxygen saturation decreased	17.78	13.11	32	51666	64655	42504982
Hepatic artery thrombosis	17.78	13.11	8	51690	266	42569371
Cytomegalovirus test positive	17.77	13.11	24	51674	4295	42565342
Acute respiratory distress syndrome	17.73	13.11	78	51620	30030	42539607
Inferior vena cava stenosis	17.71	13.11	6	51692	91	42569546
Donor specific antibody present	17.65	13.11	7	51691	169	42569468
Malacoplakia	17.57	13.11	12	51686	912	42568725
Biliary ischaemia	17.47	13.11	6	51692	95	42569542
Pyelonephritis	17.35	13.11	33	51665	7881	42561756
Lung squamous cell carcinoma stage II	17.33	13.11	4	51694	12	42569625
Tumour necrosis	17.26	13.11	15	51683	1629	42568008
Rhabdomyoma	17.15	13.11	3	51695	0	42569637
Confusional state	17.08	13.11	126	51572	167471	42402166
Incisional hernia	17.04	13.11	14	51684	1408	42568229
Transitional cell carcinoma metastatic	17.02	13.11	6	51692	103	42569534
Bacteriuria	17.01	13.11	8	51690	295	42569342
Gonococcal infection	16.93	13.11	5	51693	47	42569590
Cryptosporidiosis infection	16.84	13.11	11	51687	776	42568861
Mucosal toxicity	16.84	13.11	8	51690	302	42569335
Orthostatic hypotension	16.82	13.11	8	51690	30562	42539075
Anaphylactic shock	16.67	13.11	4	51694	23513	42546124
Necrosis of artery	16.65	13.11	4	51694	15	42569622
Carcinoid syndrome	16.51	13.11	6	51692	113	42569524
Brain neoplasm	16.50	13.11	21	51677	3547	42566090
Obstructive nephropathy	16.39	13.11	5	51693	53	42569584
Prostate cancer	16.34	13.11	18	51680	44625	42525012
Amnesia	16.34	13.11	7	51691	28430	42541207
Subdural haematoma	16.28	13.11	4	51694	23134	42546503
Coronary artery aneurysm	16.27	13.11	6	51692	118	42569519
Complex regional pain syndrome	16.26	13.11	10	51688	635	42569002
Cell death	16.26	13.11	19	51679	2940	42566697
Coronary artery disease	16.23	13.11	25	51673	53695	42515942
Lung transplant rejection	16.22	13.11	12	51686	1035	42568602
Encephalitis viral	16.16	13.11	14	51684	1514	42568123
Adverse drug reaction	16.16	13.11	13	51685	37421	42532216
Disturbance in attention	16.15	13.11	8	51690	29858	42539779
Therapy cessation	16.08	13.11	58	51640	20392	42549245
IgA nephropathy	16.07	13.11	17	51681	2357	42567280
Blood bilirubin abnormal	16.03	13.11	11	51687	843	42568794
Body temperature decreased	15.99	13.11	46	51652	14367	42555270
Diabetes mellitus	15.89	13.11	126	51572	59961	42509676
Cytomegalovirus gastrointestinal infection	15.81	13.11	8	51690	347	42569290
Procedural hypertension	15.75	13.11	5	51693	61	42569576
Alveolitis necrotising	15.72	13.11	4	51694	20	42569617
Impaired healing	15.72	13.11	51	51647	17002	42552635
Hypersensitivity	15.59	13.11	41	51657	72329	42497308
Eating disorder	15.58	13.11	36	51662	9849	42559788
Restlessness	15.57	13.11	8	51690	29241	42540396
Balance disorder	15.55	13.11	21	51677	47624	42522013
Psychotic disorder	15.53	13.11	8	51690	29200	42540437
Transient ischaemic attack	15.48	13.11	11	51687	33728	42535909
Sebaceous hyperplasia	15.48	13.11	6	51692	136	42569501
Hepatic neoplasm	15.38	13.11	16	51682	2175	42567462
Tumour invasion	15.33	13.11	8	51690	370	42569267
Injection site erythema	15.20	13.11	3	51695	20192	42549445
Pericardial effusion	15.13	13.11	73	51625	29202	42540435
Chimerism	15.07	13.11	7	51691	251	42569386
Hernial eventration	15.06	13.11	5	51693	71	42569566
Blood glucose increased	15.05	13.11	146	51552	73553	42496084
Trichodysplasia spinulosa	15.04	13.11	8	51690	385	42569252
Migraine	15.01	13.11	6	51692	25408	42544229
Eccrine carcinoma	14.97	13.11	4	51694	25	42569612
Depressed level of consciousness	14.80	13.11	22	51676	47948	42521689
Respiratory arrest	14.80	13.11	8	51690	28416	42541221
Renal mass	14.74	13.11	15	51683	1987	42567650
Unresponsive to stimuli	14.72	13.11	10	51688	31393	42538244
Performance status decreased	14.71	13.11	23	51675	4697	42564940
Drug withdrawal syndrome	14.63	13.11	4	51694	21545	42548092
Oral discomfort	14.53	13.11	18	51680	2959	42566678
Intestinal tuberculosis	14.50	13.11	6	51692	162	42569475
Urticaria	14.43	13.11	44	51654	73992	42495645
Delirium	14.42	13.11	26	51672	52493	42517144
Gastric antral vascular ectasia	14.38	13.11	8	51690	421	42569216
Neutrophil count decreased	14.38	13.11	35	51663	63380	42506257
Intra-abdominal fluid collection	14.36	13.11	13	51685	1490	42568147
Bile output abnormal	14.34	13.11	4	51694	30	42569607
Oesophageal obstruction	14.34	13.11	9	51689	593	42569044
Splenic artery aneurysm	14.23	13.11	4	51694	31	42569606
Contusion	14.22	13.11	18	51680	41967	42527670
Hepatocellular carcinoma	14.21	13.11	31	51667	8163	42561474
Asthenia	14.15	13.11	443	51255	280350	42289287
Bacterial infection	14.04	13.11	69	51629	27810	42541827
Metastases to salivary gland	14.02	13.11	5	51693	89	42569548
Incorrect route of product administration	13.93	13.11	6	51692	24299	42545338
Angiomyolipoma	13.92	13.11	5	51693	91	42569546
Tumour pain	13.88	13.11	12	51686	1295	42568342
Myocarditis	13.87	13.11	3	51695	18935	42550702
Renal hamartoma	13.86	13.11	3	51695	6	42569631
Infected seroma	13.86	13.11	3	51695	6	42569631
Lymphatic fistula	13.86	13.11	3	51695	6	42569631
Gastroduodenal haemorrhage	13.85	13.11	6	51692	182	42569455
Large intestinal ulcer	13.84	13.11	16	51682	2447	42567190
Human herpesvirus 6 infection reactivation	13.75	13.11	8	51690	459	42569178
Antiacetylcholine receptor antibody positive	13.62	13.11	5	51693	97	42569540
Thoracic cavity drainage	13.58	13.11	6	51692	191	42569446
Insomnia	13.48	13.11	86	51612	118167	42451470
Astrocytoma, low grade	13.34	13.11	5	51693	103	42569534
Drug resistance	13.33	13.11	79	51619	34169	42535468
Dysphonia	13.33	13.11	69	51629	28381	42541256
Cachexia	13.31	13.11	30	51668	8074	42561563
Vasculitis	13.30	13.11	3	51695	18391	42551246
Urinary tract infection staphylococcal	13.22	13.11	9	51689	681	42568956
Pneumocystis jirovecii pneumonia	13.17	13.11	63	51635	25118	42544519

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
Malignant neoplasm progression	3279.87	13.10	1967	92183	172600	110322549
Metastases to liver	1253.83	13.10	609	93541	34777	110460372
Metastases to bone	1031.03	13.10	513	93637	30859	110464290
Stomatitis	1010.49	13.10	1196	92954	269046	110226103
Polyomavirus-associated nephropathy	687.84	13.10	260	93890	7941	110487208
Pneumonitis	645.15	13.10	529	93621	76002	110419147
Metastases to lung	612.88	13.10	327	93823	22736	110472413
BK virus infection	579.58	13.10	263	93887	12843	110482306
Neoplasm progression	487.55	13.10	419	93731	64176	110430973
Polyomavirus viraemia	485.61	13.10	161	93989	3313	110491836
Transplant rejection	475.49	13.10	283	93867	24284	110470865
Post transplant lymphoproliferative disorder	419.39	13.10	223	93927	15390	110479759
Disease progression	395.32	13.10	729	93421	243305	110251844
Mucosal inflammation	384.25	13.10	441	93709	95700	110399449
Interstitial lung disease	373.93	13.10	524	93626	138810	110356339
Metastases to lymph nodes	332.85	13.10	189	93961	14843	110480306
Thrombotic microangiopathy	320.61	13.10	236	93914	28913	110466236
Viraemia	297.42	13.10	117	94033	3985	110491164
Kidney transplant rejection	282.46	13.10	157	93993	11830	110483319
Pleural effusion	277.74	13.10	523	93627	177186	110317963
Infusion related reaction	263.90	13.10	15	94135	381147	110114002
Hyperglycaemia	255.43	13.10	338	93812	84752	110410397
Osteonecrosis of jaw	252.94	13.10	255	93895	47762	110447387
Renal impairment	252.62	13.10	520	93630	187925	110307224
Death	246.64	13.10	1211	92939	697658	109797491
Aphthous ulcer	227.65	13.10	169	93981	20967	110474182
Mouth ulceration	223.63	13.10	239	93911	47899	110447250
Tumour marker increased	203.23	13.10	95	94055	4965	110490184
Arthropathy	203.10	13.10	10	94140	287512	110207637
Cytomegalovirus infection	199.56	13.10	239	93911	54205	110440944
Synovitis	198.63	13.10	8	94142	274084	110221065
Proteinuria	197.12	13.10	205	93945	39813	110455336
Immunosuppressant drug level decreased	193.78	13.10	77	94073	2694	110492455
Metastases to skin	193.17	13.10	73	94077	2226	110492923
Contraindicated product administered	191.72	13.10	4	94146	248263	110246886
Systemic lupus erythematosus	189.25	13.10	6	94144	254332	110240817
Cough	179.29	13.10	823	93327	460818	110034331
Immunosuppressant drug level increased	178.58	13.10	116	94034	11608	110483541
Therapeutic product effect decreased	167.86	13.10	10	94140	244306	110250843
Musculoskeletal stiffness	166.47	13.10	21	94129	279801	110215348
Hepatic lesion	164.73	13.10	98	94052	8395	110486754
Epstein-Barr virus infection	162.96	13.10	132	94018	18606	110476543
Condition aggravated	159.36	13.10	237	93913	734599	109760550
Liver transplant rejection	155.63	13.10	73	94077	3845	110491304
Diarrhoea	147.77	13.10	1549	92601	1137956	109357193
Pancreatic neuroendocrine tumour	142.00	13.10	46	94104	877	110494272
Joint swelling	138.19	13.10	105	94045	442740	110052409
Drug hypersensitivity	135	13.10	113	94037	453977	110041172
Decreased appetite	132.28	13.10	773	93377	475073	110020076
Pericarditis	131.40	13.10	16	94134	219098	110276051
Needle issue	131.03	13.10	114	94036	17726	110477423
Breast cancer metastatic	130.82	13.10	94	94056	11087	110484062
Lung infiltration	130.06	13.10	131	94019	24497	110470652
Drug abuse	125.80	13.10	6	94144	177405	110317744
Irritable bowel syndrome	125.38	13.10	3	94147	164212	110330937
Ascites	125.31	13.10	257	93893	92551	110402598
Complications of transplanted kidney	124.18	13.10	78	94072	7364	110487785
Metastasis	123.96	13.10	81	94069	8186	110486963
Maternal exposure during pregnancy	123.92	13.10	32	94118	254851	110240298
Fall	123.72	13.10	202	93948	603280	109891869
Hypersensitivity	120.73	13.10	100	94050	403898	110091251
Oral pain	120.51	13.10	154	93996	37290	110457859
Wound	118.74	13.10	27	94123	234410	110260739
Second primary malignancy	117.91	13.10	108	94042	17960	110477189
Blood creatinine increased	117.71	13.10	383	93767	182506	110312643
Neoplasm malignant	115.22	13.10	150	94000	36993	110458156
Oedema peripheral	115.12	13.10	569	93581	328091	110167058
Mobility decreased	115.06	13.10	30	94120	237392	110257757
Heart transplant rejection	113.50	13.10	48	94102	1973	110493176
Renal transplant failure	112.87	13.10	52	94098	2628	110492521
Helicobacter infection	112.26	13.10	12	94138	181865	110313284
Acne	109.68	13.10	139	94011	33381	110461768
Metastases to pleura	109.25	13.10	47	94103	2016	110493133
Metastases to peritoneum	106.89	13.10	64	94086	5546	110489603
Intentional product use issue	103.03	13.10	41	94109	247865	110247284
Anaemia	101.30	13.10	804	93346	546282	109948867
Accidental exposure to product packaging	100.07	13.10	18	94132	12	110495137
Metastases to spine	99.34	13.10	60	94090	5283	110489866
Intentional overdose	98.99	13.10	3	94147	132498	110362651
Lymphocele	97.03	13.10	42	94108	1829	110493320
Metastases to central nervous system	96.75	13.10	108	94042	22709	110472440
Pancreatic neuroendocrine tumour metastatic	96.54	13.10	25	94125	204	110494945
Lymphangiosis carcinomatosa	94.76	13.10	45	94105	2437	110492712
Pyrexia	92.28	13.10	1168	92982	897097	109598052
Product use in unapproved indication	92.03	13.10	674	93476	446703	110048446
Exposure during pregnancy	91.63	13.10	16	94134	167408	110327741
Parvovirus B19 infection	91.31	13.10	46	94104	2835	110492314
Diabetes mellitus	90.82	13.10	236	93914	99145	110396004
Bone pain	88.66	13.10	181	93969	64952	110430197
Arthralgia	87.73	13.10	354	93796	779278	109715871
Injury	86.64	13.10	22	94128	177243	110317906
Body temperature decreased	86.01	13.10	130	94020	36805	110458344
Ill-defined disorder	85.82	13.10	15	94135	156838	110338311
Folliculitis	85.50	13.10	19	94131	167634	110327515
Glossodynia	85.46	13.10	41	94109	221963	110273186
Discomfort	85.21	13.10	38	94112	214669	110280480
Loss of personal independence in daily activities	85.09	13.10	13	94137	150007	110345142
Epistaxis	84.74	13.10	274	93876	130098	110365051
Hepatic enzyme increased	84.56	13.10	89	94061	320803	110174346
Infusion site coldness	82.42	13.10	23	94127	256	110494893
Nephropathy toxic	82.17	13.10	109	94041	27369	110467780
Lower respiratory tract infection	81.89	13.10	53	94097	243053	110252096
Gamma-glutamyltransferase increased	81.83	13.10	169	93981	61140	110434009
Bone lesion	81.58	13.10	59	94091	7028	110488121
Therapy cessation	81.42	13.10	141	94009	44716	110450433
Blood triglycerides increased	81.11	13.10	101	94049	23825	110471324
Confusional state	80.87	13.10	174	93976	468506	110026643
Kidney fibrosis	80.83	13.10	49	94101	4343	110490806
Joint range of motion decreased	80.67	13.10	6	94144	121826	110373323
Hypertriglyceridaemia	79.98	13.10	83	94067	16071	110479078
Weight increased	79.96	13.10	147	94003	419497	110075652
Drug level increased	78.90	13.10	144	94006	47575	110447574
Gamma-glutamyltransferase decreased	78.41	13.10	24	94126	377	110494772
PIK3CA-activated mutation	77.60	13.10	27	94123	646	110494503
Cell marker increased	77.29	13.10	27	94123	654	110494495
Palmar-plantar erythrodysaesthesia syndrome	77.15	13.10	131	94019	40894	110454255
Liver injury	76.79	13.10	17	94133	150396	110344753
Sleep disorder due to general medical condition, insomnia type	76.78	13.10	3	94147	105640	110389509
Osteoarthritis	76.20	13.10	30	94120	182593	110312556
Blood glucose increased	75.98	13.10	267	93883	132229	110362920
Arthritis	75.97	13.10	24	94126	167562	110327587
Somnolence	75.59	13.10	85	94065	297364	110197785
Blood chromogranin A increased	75.35	13.10	27	94123	706	110494443
Sinusitis	75.16	13.10	85	94065	296603	110198546
Odynophagia	74.44	13.10	75	94075	14026	110481123
Asthma	73.44	13.10	63	94087	250228	110244921
Drug level decreased	72.21	13.10	84	94066	18464	110476685
Intentional product misuse	72.07	13.10	13	94137	132891	110362258
Obesity	71.18	13.10	7	94143	113344	110381805
Dysgeusia	71.06	13.10	173	93977	69812	110425337
Weight decreased	70.36	13.10	657	93493	467400	110027749
Product dose omission issue	70.35	13.10	103	94047	321679	110173470
Bursitis	69.82	13.10	13	94137	129905	110365244
Urticaria	69.77	13.10	102	94048	318755	110176394
Depression	68.96	13.10	102	94048	317233	110177916
Nephritic syndrome	68.83	13.10	23	94127	485	110494664
Suicide attempt	68.72	13.10	5	94145	103389	110391760
Therapeutic product effect incomplete	68.55	13.10	54	94096	223751	110271398
Hepatitis E	67.61	13.10	44	94106	4415	110490734
Bradycardia	67.48	13.10	24	94126	155493	110339656
Blood lactate dehydrogenase increased	67.33	13.10	129	94021	44205	110450944
Blood pressure systolic increased	66.71	13.10	188	93962	82803	110412346
Hypoaesthesia	66.35	13.10	103	94047	314120	110181029
Metastases to the mediastinum	65.97	13.10	25	94125	768	110494381
Wheezing	65.87	13.10	72	94078	255158	110239991
Hypotension	65.26	13.10	228	93922	523621	109971528
Memory impairment	63.56	13.10	45	94105	196899	110298250
Pneumocystis jirovecii pneumonia	63.25	13.10	123	94027	42612	110452537
Thrombocytopenia	62.43	13.10	509	93641	348376	110146773
Alopecia	62.41	13.10	136	94014	364617	110130532
Blister	62.23	13.10	61	94089	227315	110267834
Dyslipidaemia	61.65	13.10	72	94078	15893	110479256
Carbohydrate antigen 15-3 increased	61.28	13.10	29	94121	1558	110493591
Dizziness	60.96	13.10	347	93803	697846	109797303
Lymphoedema	60.46	13.10	69	94081	14860	110480289
Human herpesvirus 8 infection	59.67	13.10	30	94120	1841	110493308
Swelling	57.52	13.10	134	94016	350907	110144242
Cholangitis	57.05	13.10	70	94080	16265	110478884
Pericardial effusion	56.56	13.10	140	94010	57077	110438072
Prescribed overdose	56.08	13.10	5	94145	87576	110407573
Chronic allograft nephropathy	56.05	13.10	30	94120	2096	110493053
Hepatic neoplasm	55.82	13.10	37	94113	3830	110491319
Concomitant disease progression	55.67	13.10	36	94114	3574	110491575
Renal tubular necrosis	55.58	13.10	96	94054	30379	110464770
Stenotrophomonas infection	54.63	13.10	43	94107	5815	110489334
Device related thrombosis	54.56	13.10	35	94115	3427	110491722
Gait inability	54.31	13.10	24	94126	136352	110358797
Renal tubular atrophy	54.13	13.10	30	94120	2246	110492903
Haemolytic uraemic syndrome	53.99	13.10	40	94110	4945	110490204
Renal failure	53.36	13.10	353	93797	226221	110268928
Metastases to abdominal cavity	53.16	13.10	22	94128	856	110494293
Type 2 diabetes mellitus	52.72	13.10	44	94106	177188	110317961
Muscular weakness	51.91	13.10	82	94068	248386	110246763
Epstein-Barr viraemia	51.07	13.10	34	94116	3545	110491604
Injection site reaction	49.86	13.10	8	94142	89062	110406087
Lip dry	49.71	13.10	12	94138	100071	110395078
Metastases to pancreas	49.66	13.10	20	94130	725	110494424
Gastrointestinal disorder	49.47	13.10	81	94069	241871	110253278
Psoriasis	49.24	13.10	29	94121	139964	110355185
Suicidal ideation	49.21	13.10	10	94140	93927	110401222
Eating disorder	48.35	13.10	91	94059	30767	110464382
Polyomavirus test positive	47.32	13.10	15	94135	266	110494883
Hormone receptor positive breast cancer	47.32	13.10	18	94132	559	110494590
Chronic obstructive pulmonary disease	47.09	13.10	17	94133	109141	110386008
Feeding disorder	46.66	13.10	73	94077	21289	110473860
Abdominal discomfort	46.65	13.10	175	93975	393683	110101466
Drug resistance	46.58	13.10	129	94021	56245	110438904
Neuroendocrine tumour	46.41	13.10	24	94126	1563	110493586
Human polyomavirus infection	46.31	13.10	25	94125	1777	110493372
Haemoglobin decreased	46.16	13.10	366	93784	248361	110246788
Peripheral venous disease	46.10	13.10	8	94142	84109	110411040
Muscle spasms	45.70	13.10	106	94044	278051	110217098
Anal ulcer	45.37	13.10	25	94125	1851	110493298
Blood alkaline phosphatase increased	45.10	13.10	148	94002	70787	110424362
Atrial fibrillation	44.99	13.10	79	94071	229563	110265586
Lung transplant rejection	44.69	13.10	25	94125	1906	110493243
Metastases to chest wall	44.55	13.10	18	94132	658	110494491
Concomitant disease aggravated	44.51	13.10	62	94088	16302	110478847
Amnesia	44.48	13.10	17	94133	105391	110389758
Tumour pain	44.31	13.10	29	94121	2938	110492211
Autoimmune disorder	44.00	13.10	3	94147	65480	110429669
Metastases to pelvis	43.77	13.10	19	94131	833	110494316
Infusion site induration	43.70	13.10	22	94128	1354	110493795
Headache	43.62	13.10	511	93639	881866	109613283
Squamous cell carcinoma of skin	43.57	13.10	63	94087	17140	110478009
Mycobacterium haemophilum infection	43.48	13.10	18	94132	701	110494448
Complications of transplanted heart	43.35	13.10	16	94134	456	110494693
Insulinoma	43.28	13.10	13	94137	191	110494958
Acanthoma	43.16	13.10	10	94140	48	110495101
Sleep disorder	42.99	13.10	64	94086	198580	110296569
Metastases to thorax	42.78	13.10	14	94136	276	110494873
Migraine	42.56	13.10	50	94100	171602	110323547
Bile duct stenosis	42.04	13.10	27	94123	2649	110492500
Granulomatous rosacea	41.96	13.10	13	94137	213	110494936
Red blood cell sedimentation rate increased	41.72	13.10	8	94142	78294	110416855
Injection site mass	41.61	13.10	75	94075	24538	110470611
West Nile viral infection	41.52	13.10	21	94129	1305	110493844
Injection site hypersensitivity	41.48	13.10	26	94124	2445	110492704
Chronic kidney disease	41.38	13.10	151	93999	76140	110419009
Biphasic mesothelioma	41.29	13.10	10	94140	60	110495089
Vascular hyalinosis	40.95	13.10	12	94138	161	110494988
Bacterial infection	40.69	13.10	108	94042	45928	110449221
Joint stiffness	40.07	13.10	5	94145	67238	110427911
Treatment failure	39.87	13.10	113	94037	277121	110218028
Anaphylactic reaction	39.74	13.10	24	94126	114276	110380873
Breast cancer recurrent	39.73	13.10	30	94120	3816	110491333
Insomnia	39.65	13.10	165	93985	360425	110134724
Metastases to breast	39.25	13.10	14	94136	361	110494788
Pseudocirrhosis	39.15	13.10	18	94132	905	110494244
Serotonin syndrome	38.91	13.10	3	94147	59150	110435999
Nasopharyngitis	38.26	13.10	189	93961	394172	110100977
Pelvic neoplasm	38.22	13.10	13	94137	290	110494859
Cardio-respiratory arrest	37.98	13.10	26	94124	115810	110379339
Neoplasm	37.90	13.10	47	94103	11040	110484109
COVID-19 pneumonia	37.89	13.10	92	94058	37051	110458098
Overdose	37.67	13.10	90	94060	233704	110261445
Acute kidney injury	37.56	13.10	754	93396	634676	109860473
Cytomegalovirus gastritis	37.51	13.10	16	94134	672	110494477
Acute respiratory distress syndrome	37.48	13.10	115	94035	53083	110442066
Contusion	37.47	13.10	90	94060	233271	110261878
Pyelonephritis acute	37.41	13.10	38	94112	7175	110487974
Cardiac arrest	37.36	13.10	69	94081	196684	110298465
Ingrowing nail	37.19	13.10	27	94123	3235	110491914
Hydrothorax	37.11	13.10	21	94129	1637	110493512
Product quality issue	36.98	13.10	10	94140	77289	110417860
Toxic epidermal necrolysis	36.97	13.10	3	94147	56724	110438425
Enterocolitis viral	36.81	13.10	17	94133	864	110494285
Drug intolerance	36.53	13.10	200	93950	406312	110088837
Dehydration	36.40	13.10	381	93769	279130	110216019
Platelet count decreased	36.34	13.10	327	93823	230116	110265033
Cytomegalovirus colitis	36.26	13.10	37	94113	7024	110488125
Lactic acidosis	35.92	13.10	17	94133	92794	110402355
Superinfection viral	35.84	13.10	9	94141	64	110495085
Septic shock	35.61	13.10	243	93907	157285	110337864
Lower limb fracture	35.58	13.10	10	94140	75338	110419811
Congenital coronary artery malformation	35.38	13.10	10	94140	117	110495032
Hepatic mass	35.37	13.10	25	94125	2873	110492276
Pyelonephritis	35.34	13.10	71	94079	25179	110469970
Abdominal lymphadenopathy	35.21	13.10	21	94129	1807	110493342
Gastrooesophageal reflux disease	35.17	13.10	62	94088	179914	110315235
Pain	34.76	13.10	588	93562	954367	109540782
Hypophosphataemia	34.72	13.10	83	94067	33099	110462050
Spinal pain	34.65	13.10	59	94091	18456	110476693
Tachycardia	34.37	13.10	90	94060	226555	110268594
Tumour compression	34.04	13.10	11	94139	208	110494941
Prescribed underdose	34.01	13.10	7	94143	65167	110429982
Crepitations	33.97	13.10	44	94106	10791	110484358
Trichodysplasia spinulosa	33.97	13.10	17	94133	1033	110494116
Vasodilatation	33.88	13.10	27	94123	3717	110491432
Ovarian cyst	33.81	13.10	50	94100	13880	110481269
Hyperhidrosis	33.55	13.10	68	94082	187230	110307919
Cachexia	33.49	13.10	48	94102	12957	110482192
International normalised ratio increased	33.42	13.10	16	94134	86756	110408393
Gastric ulcer haemorrhage, obstructive	33.32	13.10	7	94143	19	110495130
Transitional cell carcinoma	33.32	13.10	25	94125	3150	110491999
Post-traumatic neck syndrome	33.10	13.10	23	94127	2572	110492577
Lung disorder	32.88	13.10	264	93886	179783	110315366
Anaphylactic shock	32.84	13.10	3	94147	51543	110443606
Cell death	32.79	13.10	32	94118	5759	110489390
Hypophagia	32.73	13.10	109	94041	52517	110442632
Mean cell haemoglobin decreased	32.22	13.10	35	94115	7139	110488010
Night sweats	32.18	13.10	40	94110	133943	110361206
Loss of consciousness	32.08	13.10	75	94075	196231	110298918
Tumour necrosis	32.03	13.10	22	94128	2414	110492735
Biliary anastomosis complication	31.83	13.10	10	94140	172	110494977
Drug reaction with eosinophilia and systemic symptoms	31.82	13.10	15	94135	82080	110413069
Delirium	31.71	13.10	41	94109	134984	110360165
Hepatic angiosarcoma	31.71	13.10	9	94141	107	110495042
Adverse drug reaction	31.64	13.10	26	94124	105533	110389616
Organising pneumonia	31.56	13.10	49	94101	14194	110480955
Metastases to muscle	31.53	13.10	12	94138	373	110494776
Gastrointestinal ulcer perforation	31.49	13.10	8	94142	60	110495089
Neck pain	31.46	13.10	35	94115	123095	110372054
Pulmonary mass	31.45	13.10	86	94064	37215	110457934
Fatigue	31.45	13.10	1299	92851	1214659	109280490
Pneumonia cytomegaloviral	31.36	13.10	34	94116	6920	110488229
Sciatica	31.29	13.10	20	94130	92379	110402770
Genitourinary tract neoplasm	31.03	13.10	8	94142	64	110495085
Renal cell carcinoma	30.82	13.10	35	94115	7495	110487654
Renal lymphocele	30.43	13.10	9	94141	125	110495024
Foot deformity	30.42	13.10	3	94147	48477	110446672
Elephantiasis nostras verrucosa	30.35	13.10	5	94145	0	110495149
Intestinal obstruction	30.27	13.10	107	94043	53120	110442029
Pneumocystis jirovecii infection	30.08	13.10	27	94123	4373	110490776
Liver abscess	30.04	13.10	35	94115	7704	110487445
Anogenital warts	29.86	13.10	16	94134	1120	110494029
Muscle contractions involuntary	29.85	13.10	27	94123	4417	110490732
Epstein-Barr virus infection reactivation	29.79	13.10	26	94124	4058	110491091
Transplant dysfunction	29.59	13.10	36	94114	8292	110486857
Metastases to kidney	29.53	13.10	13	94137	590	110494559
Recurrent cancer	29.52	13.10	24	94126	3399	110491750
Actinic keratosis	29.39	13.10	33	94117	6980	110488169
Exposed bone in jaw	29.30	13.10	25	94125	3786	110491363
Drug ineffective	29.23	13.10	1031	93119	1519509	108975640
Oxygen saturation decreased	28.97	13.10	56	94094	156926	110338223
Adverse event	28.83	13.10	30	94120	108779	110386370
Parasitic gastroenteritis	28.83	13.10	10	94140	237	110494912
Bone erosion	28.75	13.10	3	94147	46368	110448781
Leukopenia	28.72	13.10	221	93929	148570	110346579
Colitis ulcerative	28.68	13.10	15	94135	77348	110417801
Drug-induced liver injury	28.67	13.10	36	94114	120031	110375118
Depressed level of consciousness	28.59	13.10	32	94118	112246	110382903
Reflux gastritis	28.33	13.10	17	94133	1479	110493670
Lymphocyte count decreased	28.31	13.10	110	94040	57133	110438016
Anxiety	28.20	13.10	175	93975	344903	110150246
Syncope	28.06	13.10	84	94066	202452	110292697
Escherichia sepsis	28.06	13.10	39	94111	10233	110484916
Hallucination	27.98	13.10	27	94123	101405	110393744
Dry skin	27.96	13.10	172	93978	107481	110387668
Asthenia	27.93	13.10	776	93374	688223	109806926
Alveolar proteinosis	27.91	13.10	17	94133	1519	110493630
Injection site pruritus	27.81	13.10	5	94145	51253	110443896
Eyelid oedema	27.73	13.10	48	94102	15214	110479935
JC virus infection	27.67	13.10	28	94122	5262	110489887
Focal segmental glomerulosclerosis	27.48	13.10	25	94125	4120	110491029
Visual impairment	27.47	13.10	45	94105	134383	110360766
Dyspepsia	27.33	13.10	78	94072	190887	110304262
Carcinoid crisis	27.29	13.10	12	94138	543	110494606
Febrile neutropenia	27.27	13.10	158	93992	316609	110178540
Flatulence	27.26	13.10	102	94048	52047	110443102
Cytomegalovirus gastrointestinal infection	27.25	13.10	13	94137	711	110494438
Isosporiasis	27.15	13.10	9	94141	185	110494964
Agitation	26.89	13.10	34	94116	113017	110382132
Renal disorder	26.89	13.10	98	94052	49381	110445768
Drug dependence	26.88	13.10	5	94145	50015	110445134
Cheilitis	26.76	13.10	30	94120	6335	110488814
Cerebrovascular accident	26.72	13.10	73	94077	181211	110313938
Nasal discharge discolouration	26.67	13.10	22	94128	3179	110491970
Impaired insulin secretion	26.52	13.10	7	94143	62	110495087
Myocardial infarction	26.37	13.10	80	94070	192003	110303146
Gastric antral vascular ectasia	26.36	13.10	15	94135	1182	110493967
Oral herpes	26.36	13.10	79	94071	36001	110459148
Hepatocellular carcinoma	26.23	13.10	37	94113	9843	110485306
Oncologic complication	26.08	13.10	11	94139	449	110494700
Exostosis	26.01	13.10	4	94146	45952	110449197
Renal amyloidosis	25.92	13.10	10	94140	323	110494826
Therapy change	25.89	13.10	37	94113	9960	110485189
Metastases to eye	25.77	13.10	10	94140	328	110494821
Cognitive disorder	25.68	13.10	22	94128	87489	110407660
Glomerular filtration rate decreased	25.66	13.10	68	94082	28888	110466261
Japanese spotted fever	25.53	13.10	6	94144	31	110495118
Porocarcinoma	25.37	13.10	6	94144	32	110495117
Hydronephrosis	25.29	13.10	55	94095	20610	110474539
Steatorrhoea	25.28	13.10	14	94136	1047	110494102
Sedation	25.12	13.10	14	94136	69669	110425480
Erythrophagocytosis	25.06	13.10	6	94144	34	110495115
Lymphadenopathy mediastinal	25.06	13.10	27	94123	5457	110489692
Carcinoid heart disease	24.92	13.10	7	94143	80	110495069
Pruritus	24.88	13.10	347	93803	581213	109913936
Mononeuropathy	24.82	13.10	10	94140	363	110494786
Hepatic function abnormal	24.68	13.10	145	94005	89150	110405999
Skin sensitisation	24.58	13.10	14	94136	1105	110494044
Therapeutic product effective for unapproved indication	24.57	13.10	8	94142	155	110494994
Mucosal toxicity	24.53	13.10	12	94138	694	110494455
Nephrotic syndrome	24.48	13.10	43	94107	13788	110481361
Urine output decreased	24.44	13.10	53	94097	19823	110475326
Orthostatic hypotension	24.33	13.10	13	94137	66236	110428913
Impaired healing	24.19	13.10	86	94064	196631	110298518
Sleep apnoea syndrome	24.12	13.10	3	94147	40444	110454705
Cytokine release syndrome	24.11	13.10	15	94135	70291	110424858
Paraesthesia	23.76	13.10	138	94012	276383	110218766
Encephalitis viral	23.68	13.10	20	94130	2987	110492162
Toothache	23.63	13.10	58	94092	23517	110471632
Metastases to gastrointestinal tract	23.62	13.10	8	94142	176	110494973
Carcinoid tumour pulmonary	23.58	13.10	10	94140	414	110494735
Norovirus infection	23.49	13.10	18	94132	2341	110492808
Hallucination, visual	23.46	13.10	3	94147	39602	110455547
Carcinoid tumour	23.37	13.10	11	94139	584	110494565
Tumour marker abnormal	23.29	13.10	9	94141	292	110494857
Herpes simplex hepatitis	23.27	13.10	12	94138	777	110494372
Soft tissue sarcoma	23.26	13.10	9	94141	293	110494856
Renal cancer metastatic	23.20	13.10	12	94138	782	110494367
Malacoplakia	23.12	13.10	14	94136	1238	110493911
Biliary ischaemia	23.05	13.10	7	94143	107	110495042
Balance disorder	22.91	13.10	40	94110	116520	110378629
Respiratory failure	22.82	13.10	282	93868	215050	110280099
Unresponsive to stimuli	22.73	13.10	13	94137	63777	110431372
Dysplasia	22.69	13.10	16	94134	1832	110493317
Skin toxicity	22.65	13.10	38	94112	11745	110483404
Haematotoxicity	22.34	13.10	53	94097	21029	110474120
Metastases to adrenals	22.32	13.10	15	94135	1588	110493561
Renal mass	22.31	13.10	21	94129	3614	110491535
Escherichia infection	22.20	13.10	57	94093	23759	110471390
Cholestasis	22.04	13.10	111	94039	64407	110430742
Pulmonary fibrosis	21.95	13.10	33	94117	102009	110393140
Treatment noncompliance	21.85	13.10	18	94132	72972	110422177
Lung consolidation	21.77	13.10	35	94115	10441	110484708
Blood pressure fluctuation	21.73	13.10	19	94131	74805	110420344
Complications of transplanted lung	21.71	13.10	11	94139	686	110494463
Injection site erythema	21.70	13.10	29	94121	94147	110401002
Anorectal varices	21.65	13.10	6	94144	65	110495084
Eosinophil cationic protein increased	21.65	13.10	6	94144	65	110495084
Vasoactive intestinal polypeptide increased	21.51	13.10	4	94146	4	110495145
Transient ischaemic attack	21.46	13.10	14	94136	63968	110431181
Multiple organ dysfunction syndrome	21.27	13.10	210	93940	151500	110343649
Aortitis salmonella	21.25	13.10	5	94145	26	110495123
Metastases to spinal cord	21.07	13.10	8	94142	247	110494902
General physical health deterioration	21.03	13.10	492	93658	424803	110070346
Selenium deficiency	21.01	13.10	6	94144	73	110495076
Chapped lips	21.00	13.10	19	94131	3109	110492040
Stomatitis haemorrhagic	20.86	13.10	8	94142	254	110494895
IgA nephropathy	20.77	13.10	19	94131	3154	110491995
Angiosarcoma	20.76	13.10	10	94140	559	110494590
Donor specific antibody present	20.68	13.10	9	94141	397	110494752
Skin lesion	20.66	13.10	93	94057	51538	110443611
Nightmare	20.64	13.10	4	94146	38859	110456290
Pulmonary tumour thrombotic microangiopathy	20.63	13.10	7	94143	155	110494994
Muscle spasticity	20.62	13.10	3	94147	35912	110459237
Respiratory arrest	20.60	13.10	12	94138	58287	110436862
Pleural neoplasm	20.51	13.10	9	94141	405	110494744
Eccrine carcinoma	20.50	13.10	5	94145	31	110495118
Disseminated varicella zoster vaccine virus infection	20.46	13.10	7	94143	159	110494990
Cancer pain	20.46	13.10	27	94123	6745	110488404
Ventricular fibrillation	20.42	13.10	5	94145	41308	110453841
Onychomycosis	20.39	13.10	4	94146	38527	110456622
Pulmonary toxicity	20.33	13.10	46	94104	17700	110477449
Sebaceous hyperplasia	20.11	13.10	6	94144	86	110495063
Drug withdrawal syndrome	20.03	13.10	4	94146	38050	110457099
No adverse event	19.97	13.10	20	94130	73819	110421330
Infusion site haemorrhage	19.90	13.10	22	94128	4576	110490573
Graft loss	19.88	13.10	13	94137	1315	110493834
Metastases to spleen	19.73	13.10	11	94139	833	110494316
Abdominal distension	19.72	13.10	232	93918	174871	110320278
Biliary obstruction	19.70	13.10	24	94126	5534	110489615
Delayed graft function	19.52	13.10	21	94129	4236	110490913
Pathological fracture	19.50	13.10	36	94114	11996	110483153
Therapeutic product ineffective for unapproved indication	19.46	13.10	8	94142	306	110494843
Hepatic atrophy	19.36	13.10	9	94141	464	110494685
Laryngitis	19.34	13.10	6	94144	42405	110452744
Emotional distress	19.31	13.10	7	94143	44840	110450309
Drug interaction	19.31	13.10	560	93590	499623	109995526
Post transplant distal limb syndrome	19.26	13.10	11	94139	873	110494276
Road traffic accident	19.22	13.10	39	94111	107359	110387790
Cytomegalovirus viraemia	19.20	13.10	45	94105	17719	110477430
Tongue oedema	19.13	13.10	29	94121	8227	110486922
Blood urea increased	19.09	13.10	95	94055	54862	110440287
Onychoclasis	19.06	13.10	27	94123	7210	110487939
Wound infection	19.05	13.10	33	94117	96432	110398717
Transitional cell cancer of renal pelvis and ureter metastatic	19.00	13.10	4	94146	11	110495138
Pain in extremity	18.97	13.10	296	93854	486822	110008327
5-hydroxyindolacetic acid	18.74	13.10	4	94146	12	110495137
Carcinoembryonic antigen increased	18.66	13.10	17	94133	2807	110492342
Palpitations	18.66	13.10	71	94079	159141	110336008
Biliary dilatation	18.62	13.10	19	94131	3606	110491543
Rectal haemorrhage	18.61	13.10	47	94103	119786	110375363
Metastases to soft tissue	18.55	13.10	10	94140	709	110494440
Lymphadenopathy	18.51	13.10	105	94045	63730	110431419
Necrosis of artery	18.50	13.10	4	94146	13	110495136
Papilloma viral infection	18.46	13.10	15	94135	2123	110493026
Inferior vena cava stenosis	18.44	13.10	6	94144	116	110495033
Malignant pleural effusion	18.43	13.10	20	94130	4073	110491076
Dysarthria	18.29	13.10	27	94123	84094	110411055
Blood creatinine decreased	18.28	13.10	30	94120	9107	110486042
5-hydroxyindolacetic acid in urine	18.27	13.10	4	94146	14	110495135
Jejunal ulcer perforation	18.25	13.10	6	94144	120	110495029
Breast cancer	18.20	13.10	73	94077	38469	110456680
Haematochezia	18.18	13.10	45	94105	115479	110379670
Cytomegalovirus oesophagitis	18.14	13.10	11	94139	975	110494174
Abdominal pain	18.10	13.10	568	93582	512421	109982728
Abnormal faeces	18.04	13.10	30	94120	9206	110485943
Retinitis	17.88	13.10	3	94147	32324	110462825
Pneumonia bacterial	17.78	13.10	56	94094	26205	110468944
Cholangitis acute	17.75	13.10	14	94136	1899	110493250
Angioedema	17.74	13.10	144	94006	98356	110396793
Blood glucose abnormal	17.70	13.10	36	94114	12880	110482269
Metastatic carcinoid tumour	17.57	13.10	5	94145	60	110495089
Stevens-Johnson syndrome	17.53	13.10	9	94141	46892	110448257
Burning sensation mucosal	17.50	13.10	5	94145	61	110495088
Hyponatraemia	17.45	13.10	111	94039	217542	110277607
Tonic convulsion	17.43	13.10	17	94133	3057	110492092
Oral administration complication	17.43	13.10	6	94144	139	110495010
Pleural disorder	17.42	13.10	11	94139	1048	110494101
Vein disorder	17.42	13.10	24	94126	6246	110488903
Transitional cell carcinoma metastatic	17.15	13.10	6	94144	146	110495003
Oedematous kidney	17.14	13.10	7	94143	263	110494886
Gonococcal infection	17.14	13.10	5	94145	66	110495083
Alveolitis necrotising	17.13	13.10	4	94146	20	110495129
Incisional hernia	17.11	13.10	16	94134	2731	110492418
Osteoporosis	17.04	13.10	30	94120	87122	110408027
Skin plaque	17.03	13.10	35	94115	12610	110482539
Metastases to heart	17.01	13.10	8	94142	424	110494725
Febrile convulsion	16.95	13.10	11	94139	1099	110494050
Complex regional pain syndrome	16.92	13.10	15	94135	2390	110492759
Hernial eventration	16.87	13.10	5	94145	70	110495079
Liver function test increased	16.85	13.10	31	94119	88517	110406632
Malignant ascites	16.83	13.10	12	94138	1398	110493751
Lung squamous cell carcinoma stage II	16.81	13.10	4	94146	22	110495127
Pseudohypoaldosteronism	16.80	13.10	5	94145	71	110495078
Mental disorder	16.80	13.10	6	94144	38785	110456364
Pneumothorax	16.79	13.10	67	94083	35218	110459931
Smooth muscle cell neoplasm	16.78	13.10	12	94138	1405	110493744
Eye pain	16.75	13.10	11	94139	50088	110445061
Cytomegalovirus test positive	16.71	13.10	25	94125	7011	110488138
Restlessness	16.68	13.10	14	94136	56245	110438904
Cryptosporidiosis infection	16.65	13.10	11	94139	1132	110494017
Cardiac failure congestive	16.64	13.10	69	94081	150931	110344218
Eye irritation	16.63	13.10	4	94146	33448	110461701
Infection	16.60	13.10	213	93937	361987	110133162
Gait disturbance	16.59	13.10	154	93996	278054	110217095
Incorrect route of product administration	16.59	13.10	18	94132	64043	110431106
Bone cancer	16.58	13.10	15	94135	2455	110492694
Coronary artery aneurysm	16.39	13.10	6	94144	167	110494982
Metastases to meninges	16.35	13.10	21	94129	5107	110490042
Dyspnoea	16.31	13.10	1122	93028	1105750	109389399
Nasal cavity cancer	16.25	13.10	7	94143	301	110494848
Coma	16.24	13.10	49	94101	117820	110377329
Ileal ulcer	16.22	13.10	13	94137	1804	110493345
Hepatic pain	16.22	13.10	20	94130	4670	110490479
Gastroduodenal haemorrhage	16.21	13.10	7	94143	303	110494846
Anorexia nervosa	16.19	13.10	7	94143	304	110494845
Primary pulmonary melanoma	16.13	13.10	3	94147	3	110495146
Obstructive nephropathy	16.08	13.10	5	94145	83	110495066
Unevaluable event	16.06	13.10	16	94134	59211	110435938
Chimerism	15.98	13.10	7	94143	314	110494835
Bone neoplasm	15.91	13.10	10	94140	945	110494204
Intentional self-injury	15.85	13.10	6	94144	37423	110457726
Pseudomonas infection	15.84	13.10	56	94094	27797	110467352
Tongue ulceration	15.78	13.10	20	94130	4802	110490347
Metastases to salivary gland	15.75	13.10	5	94145	89	110495060
Mucinous breast carcinoma	15.74	13.10	4	94146	30	110495119
Cytomegalovirus gastroenteritis	15.72	13.10	9	94141	717	110494432
Varicella zoster virus infection	15.66	13.10	23	94127	6345	110488804
Neutrophilic panniculitis	15.65	13.10	5	94145	91	110495058
Salpingectomy	15.61	13.10	7	94143	332	110494817
Metastases to bladder	15.53	13.10	7	94143	336	110494813
Illness	15.43	13.10	29	94121	82142	110413007
Bile output abnormal	15.41	13.10	4	94146	33	110495116
Blood pressure diastolic decreased	15.40	13.10	66	94084	35819	110459330
Panic attack	15.32	13.10	3	94147	28937	110466212
Intestinal metastasis	15.19	13.10	8	94142	541	110494608
Withdrawal syndrome	15.12	13.10	4	94146	31376	110463773
Epstein-Barr virus associated lymphoma	15.02	13.10	12	94138	1658	110493491
Urinary fistula	14.98	13.10	5	94145	105	110495044
Cardiogenic shock	14.97	13.10	16	94134	57322	110437827
Paraesthesia oral	14.94	13.10	5	94145	33666	110461483
Myositis	14.93	13.10	4	94146	31112	110464037
Ascariasis	14.92	13.10	3	94147	6	110495143
Blood glucose decreased	14.85	13.10	57	94093	29431	110465718
Throat tightness	14.81	13.10	5	94145	33484	110461665
Tumour invasion	14.76	13.10	8	94142	573	110494576
Performance status decreased	14.73	13.10	24	94126	7242	110487907
Neutropenic sepsis	14.66	13.10	4	94146	30742	110464407
Fluid retention	14.63	13.10	37	94113	94270	110400879
Oophorectomy	14.62	13.10	7	94143	386	110494763
Tinnitus	14.61	13.10	18	94132	60522	110434627
Dry mouth	14.52	13.10	105	94045	199843	110295306
Renal vein thrombosis	14.42	13.10	10	94140	1115	110494034
Renal hamartoma	14.36	13.10	5	94145	120	110495029
Obstructive airways disorder	14.29	13.10	11	94139	46138	110449011
Sinus disorder	14.28	13.10	5	94145	32723	110462426
Vision blurred	14.19	13.10	59	94091	128963	110366186
Ventricular tachycardia	14.16	13.10	13	94137	49996	110445153
Pancytopenia	14.15	13.10	254	93896	209359	110285790
Nasopharyngeal cancer metastatic	14.06	13.10	3	94147	9	110495140
Shock haemorrhagic	13.99	13.10	53	94097	27194	110467955
Blood bilirubin abnormal	13.94	13.10	12	94138	1838	110493311
5-hydroxyindolacetic acid increased	13.94	13.10	5	94145	131	110495018
Angiofibroma	13.91	13.10	5	94145	132	110495017
Klebsiella infection	13.85	13.10	43	94107	19966	110475183
Depressed mood	13.73	13.10	19	94131	60790	110434359
Lymphopenia	13.64	13.10	69	94081	40101	110455048
Joint dislocation	13.64	13.10	6	94144	34184	110460965
Transplantation associated food allergy	13.63	13.10	5	94145	140	110495009
Injection site induration	13.59	13.10	30	94120	11353	110483796
Rash erythematous	13.57	13.10	31	94119	81801	110413348
Serositis	13.53	13.10	11	94139	1558	110493591
Oral cavity fistula	13.51	13.10	8	94142	679	110494470
Pneumonitis chemical	13.50	13.10	8	94142	680	110494469
Poisoning	13.49	13.10	4	94146	29101	110466048
Aplasia pure red cell	13.48	13.10	27	94123	9551	110485598
Impaired work ability	13.45	13.10	3	94147	26416	110468733
Intestinal tuberculosis	13.43	13.10	6	94144	282	110494867
Skin laceration	13.34	13.10	6	94144	33747	110461402
Pneumonia	13.30	13.10	891	93259	875823	109619326
Carcinoid syndrome	13.25	13.10	6	94144	291	110494858
Vascular stent thrombosis	13.21	13.10	17	94133	4144	110491005
Hyperlipidaemia	13.19	13.10	63	94087	35785	110459364
Hepatic vein stenosis	13.18	13.10	4	94146	61	110495088
Acute pulmonary oedema	13.16	13.10	38	94112	16958	110478191
Blood gastrin increased	13.12	13.10	4	94146	62	110495087

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01EG02	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS PROTEIN KINASE INHIBITORS Mammalian target of rapamycin (mTOR) kinase inhibitors
ATC	L04AH02	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Mammalian target of rapamycin (mTOR) kinase inhibitors
FDA MoA	N0000175076	Protein Kinase Inhibitors
FDA PE	N0000175550	Decreased Immunologic Activity
MeSH PA	D000091203	MTOR Inhibitors
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D007155	Immunologic Factors
MeSH PA	D007166	Immunosuppressive Agents
MeSH PA	D047428	Protein Kinase Inhibitors
FDA EPC	N0000175605	Kinase Inhibitor
FDA MoA	N0000175624	mTOR Inhibitors
FDA EPC	N0000175625	mTOR Inhibitor Immunosuppressant
FDA MoA	N0000182137	Cytochrome P450 2D6 Inhibitors
FDA MoA	N0000182141	Cytochrome P450 3A4 Inhibitors
CHEBI has role	CHEBI:35610	antineoplastic agent
CHEBI has role	CHEBI:35705	immunosuppressive agent
CHEBI has role	CHEBI:68481	mTOR inhibitor
CHEBI has role	CHEBI:149553	anticoronaviral agent
CHEBI has role	CHEBI:176497	geroprotector

Related Drugs by ATC class:

L01EG Mammalian target of rapamycin (mTOR) kinase inhibitors 3 drugs

ridaforolimussirolimustemsirolimus

L04AH Mammalian target of rapamycin (mTOR) kinase inhibitors 1 drug

sirolimus

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

Disease	Relation	SNOMED_ID	DOID
Tuberous sclerosis syndrome	indication	7199000	DOID:13515
Carcinoma of breast	indication	254838004	DOID:3459
Angiomyolipoma of kidney	indication	254921004	DOID:8411
Hormone receptor positive malignant neoplasm of breast	indication	417181009
Renal cell carcinoma	indication	702391001	DOID:4450
Pancreatic Neuroendocrine Tumor	indication	717919005
Prevention of Kidney Transplant Rejection	indication
Subependymal Giant Cell Astrocytoma associated with Tuberous Sclerosis	indication
Hypercholesterolemia	contraindication	13644009
Proteinuria	contraindication	29738008	DOID:576
Hyperlipidemia	contraindication	55822004	DOID:1168
Acute nephropathy	contraindication	58574008
Hepatic failure	contraindication	59927004
Stomatitis	contraindication	61170000	DOID:9637
Acute infectious disease	contraindication	63171007
Interstitial pneumonia	contraindication	64667001
Diabetes mellitus	contraindication	73211009	DOID:9351
Thrombotic thrombocytopenic purpura	contraindication	78129009	DOID:10772
Hyperglycemia	contraindication	80394007	DOID:4195
Leukopenia	contraindication	84828003	DOID:615
Kidney disease	contraindication	90708001	DOID:557
Thrombosis of renal artery	contraindication	95579008
Hemolytic uremic syndrome	contraindication	111407006	DOID:12554
Malignant lymphoma	contraindication	118600007	DOID:0060058
Disease of liver	contraindication	235856003	DOID:409
Edema	contraindication	267038008
Impaired wound healing	contraindication	271618001
Anemia	contraindication	271737000	DOID:2355
Pregnancy, function	contraindication	289908002
Thrombocytopenic disorder	contraindication	302215000	DOID:1588
Hypertriglyceridemia	contraindication	302870006
Neutropenic disorder	contraindication	303011007	DOID:1227
Primary malignant neoplasm	contraindication	372087000
Pericardial effusion	contraindication	373945007	DOID:118
Ascites	contraindication	389026000
Breastfeeding (mother)	contraindication	413712001
BK Polyomavirus Reactivation Nephropathy	contraindication
Pleural Effusions	contraindication

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	10.5	acidic
pKa2	13.7	acidic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
10MG	AFINITOR	NOVARTIS	N022334	March 30, 2009	RX	TABLET	ORAL	8410131	Nov. 1, 2025	TREATMENT OF SOLID EXCRETORY SYSTEM TUMORS; ADVANCED RENAL CELL CARCINOMA (RCC), AFTER FAILURE OF TREATMENT WITH SUNITINIB OR SORAFENIB
2.5MG	AFINITOR	NOVARTIS	N022334	July 9, 2010	RX	TABLET	ORAL	8410131	Nov. 1, 2025	TREATMENT OF SOLID EXCRETORY SYSTEM TUMORS; ADVANCED RENAL CELL CARCINOMA (RCC), AFTER FAILURE OF TREATMENT WITH SUNITINIB OR SORAFENIB
5MG	AFINITOR	NOVARTIS	N022334	March 30, 2009	RX	TABLET	ORAL	8410131	Nov. 1, 2025	TREATMENT OF SOLID EXCRETORY SYSTEM TUMORS; ADVANCED RENAL CELL CARCINOMA (RCC), AFTER FAILURE OF TREATMENT WITH SUNITINIB OR SORAFENIB
7.5MG	AFINITOR	NOVARTIS	N022334	March 30, 2012	RX	TABLET	ORAL	8410131	Nov. 1, 2025	TREATMENT OF SOLID EXCRETORY SYSTEM TUMORS; ADVANCED RENAL CELL CARCINOMA (RCC), AFTER FAILURE OF TREATMENT WITH SUNITINIB OR SORAFENIB
10MG	AFINITOR	NOVARTIS	N022334	March 30, 2009	RX	TABLET	ORAL	9006224	July 1, 2028	TREATMENT OF PATIENTS WITH PROGRESSIVE NEUROENDOCRINE TUMORS OF PANCREATIC ORIGIN (PNET) THAT ARE UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC
2.5MG	AFINITOR	NOVARTIS	N022334	July 9, 2010	RX	TABLET	ORAL	9006224	July 1, 2028	TREATMENT OF PATIENTS WITH PROGRESSIVE NEUROENDOCRINE TUMORS OF PANCREATIC ORIGIN (PNET) THAT ARE UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC
5MG	AFINITOR	NOVARTIS	N022334	March 30, 2009	RX	TABLET	ORAL	9006224	July 1, 2028	TREATMENT OF PATIENTS WITH PROGRESSIVE NEUROENDOCRINE TUMORS OF PANCREATIC ORIGIN (PNET) THAT ARE UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC
7.5MG	AFINITOR	NOVARTIS	N022334	March 30, 2012	RX	TABLET	ORAL	9006224	July 1, 2028	TREATMENT OF PATIENTS WITH PROGRESSIVE NEUROENDOCRINE TUMORS OF PANCREATIC ORIGIN (PNET) THAT ARE UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Peptidyl-prolyl cis-trans isomerase FKBP1A	Enzyme	P62942	FKB1A_HUMAN	INHIBITOR	IC50	8.26		WOMBAT-PK	CHEMBL
Multidrug resistance protein 1	Transporter	P08183	MDR1_HUMAN					WOMBAT-PK
Serine/threonine-protein kinase mTOR	Kinase	P42345	MTOR_HUMAN	INHIBITOR	IC50	8.70		IUPHAR

External reference:

ID	Source
4028636	VUID
N0000178379	NUI
D02714	KEGG_DRUG
4028636	VANDF
C0541315	UMLSCUI
CHEBI:68478	CHEBI
E53	PDB_CHEM_ID
CHEMBL1908360	ChEMBL_ID
D000068338	MESH_DESCRIPTOR_UI
DB01590	DRUGBANK_ID
5889	IUPHAR_LIGAND_ID
7863	INN_ID
9HW64Q8G6G	UNII
6442177	PUBCHEM_CID
141704	RXNORM
162489	MMSL
20447	MMSL
269938	MMSL
d05626	MMSL
010829	NDDF
428127005	SNOMEDCT_US
428698007	SNOMEDCT_US
9HW64Q8G6G	INXIGHT DRUGS

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Everolimus	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0470	TABLET	0.25 mg	ORAL	ANDA	27 sections
Everolimus	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0471	TABLET	0.50 mg	ORAL	ANDA	27 sections
Everolimus	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0472	TABLET	0.75 mg	ORAL	ANDA	27 sections
Everolimus	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0480	TABLET	2.50 mg	ORAL	ANDA	26 sections
Everolimus	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0481	TABLET	5 mg	ORAL	ANDA	26 sections
Everolimus	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0482	TABLET	10 mg	ORAL	ANDA	26 sections
Everolimus	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0497	TABLET	7.50 mg	ORAL	ANDA	26 sections
Everolimus	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0604	TABLET	1 mg	ORAL	ANDA	27 sections
Zortress	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0414	TABLET	0.50 mg	ORAL	NDA	32 sections
Zortress	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0415	TABLET	0.75 mg	ORAL	NDA	32 sections
Zortress	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0417	TABLET	0.25 mg	ORAL	NDA	32 sections
Zortress	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0422	TABLET	1 mg	ORAL	NDA	32 sections
Afinitor	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0566	TABLET	5 mg	ORAL	NDA	33 sections
Afinitor	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0567	TABLET	10 mg	ORAL	NDA	33 sections
Afinitor	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0594	TABLET	2.50 mg	ORAL	NDA	33 sections
Afinitor	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0620	TABLET	7.50 mg	ORAL	NDA	33 sections
AfinitorDisperz	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0626	TABLET, FOR SUSPENSION	2 mg	ORAL	NDA	33 sections
AfinitorDisperz	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0627	TABLET, FOR SUSPENSION	3 mg	ORAL	NDA	33 sections
AfinitorDisperz	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0628	TABLET, FOR SUSPENSION	5 mg	ORAL	NDA	33 sections
Everolimus	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7766	TABLET	2.50 mg	ORAL	ANDA	30 sections
Everolimus	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7767	TABLET	5 mg	ORAL	ANDA	30 sections
Everolimus	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7768	TABLET	7.50 mg	ORAL	ANDA	30 sections
Everolimus	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7769	TABLET	10 mg	ORAL	ANDA	30 sections
TORPENZ	HUMAN PRESCRIPTION DRUG LABEL	1	0245-0822	TABLET	2.50 mg	ORAL	ANDA	32 sections
TORPENZ	HUMAN PRESCRIPTION DRUG LABEL	1	0245-0822	TABLET	2.50 mg	ORAL	ANDA	32 sections
TORPENZ	HUMAN PRESCRIPTION DRUG LABEL	1	0245-0823	TABLET	5 mg	ORAL	ANDA	32 sections
TORPENZ	HUMAN PRESCRIPTION DRUG LABEL	1	0245-0823	TABLET	5 mg	ORAL	ANDA	32 sections
TORPENZ	HUMAN PRESCRIPTION DRUG LABEL	1	0245-0824	TABLET	7.50 mg	ORAL	ANDA	32 sections
TORPENZ	HUMAN PRESCRIPTION DRUG LABEL	1	0245-0824	TABLET	7.50 mg	ORAL	ANDA	32 sections
TORPENZ	HUMAN PRESCRIPTION DRUG LABEL	1	0245-0825	TABLET	10 mg	ORAL	ANDA	32 sections