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

Stem definition	Drug id	CAS RN
uracil type antineoplastics	26	51-21-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: 5-fluorouracil adrucil fluoroblastin fluorouracil 5-FU	A pyrimidine analog that is an antineoplastic antimetabolite. It interferes with DNA synthesis by blocking the THYMIDYLATE SYNTHETASE conversion of deoxyuridylic acid to thymidylic acid. Molecular weight: 130.08 Formula: C4H3FN2O2 CLOGP: -0.58 LIPINSKI: 0 HAC: 4 HDO: 2 TPSA: 58.20 ALOGS: -1.35 ROTB: 0 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

5-fluorouracil
adrucil
fluoroblastin
fluorouracil
5-FU

A pyrimidine analog that is an antineoplastic antimetabolite. It interferes with DNA synthesis by blocking the THYMIDYLATE SYNTHETASE conversion of deoxyuridylic acid to thymidylic acid.

Molecular weight: 130.08
Formula: C4H3FN2O2
CLOGP: -0.58
LIPINSKI: 0
HAC: 4
HDO: 2
TPSA: 58.20
ALOGS: -1.35
ROTB: 0

Status: OFP

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

Drug dosage:

None

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	12.20 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	5 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	92.25 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	28 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.23 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	26 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.64 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	0.12 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
April 25, 1962	FDA	SPECTRUM PHARMS
Sept. 21, 2018	PMDA	Kyowa Hakko Kirin Co., Ltd.

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
Neutropenia	1805.39	13.43	1584	72045	146381	50385114
Febrile neutropenia	974.83	13.43	936	72693	96731	50434764
Mucosal inflammation	914.68	13.43	624	73005	39518	50491977
Neuropathy peripheral	775.96	13.43	824	72805	95933	50435562
Diarrhoea	701.99	13.43	2155	71474	586321	49945174
Thrombocytopenia	566.77	13.43	807	72822	126866	50404629
Disease progression	562.74	13.43	695	72934	95171	50436324
Palmar-plantar erythrodysaesthesia syndrome	551.24	13.43	351	73278	19747	50511748
Leukopenia	509.10	13.43	557	73072	66971	50464524
Neurotoxicity	461.29	13.43	280	73349	14460	50517035
Dermatitis acneiform	451.55	13.43	183	73446	3874	50527621
Malignant neoplasm progression	424.05	13.43	509	73120	67615	50463880
Skin toxicity	416.69	13.43	171	73458	3742	50527753
Metastases to liver	375.40	13.43	277	73352	19827	50511668
Drug ineffective	367.40	13.43	393	73236	818940	49712555
Vomiting	344.75	13.43	1452	72177	459306	50072189
Bone marrow failure	335.66	13.43	296	73333	27328	50504167
Stomatitis	292.67	13.43	527	73102	100817	50430678
Metastases to lung	273.93	13.43	181	73448	10839	50520656
Acute myeloid leukaemia	259.80	13.43	198	73431	14876	50516619
Joint swelling	234.46	13.43	38	73591	245248	50286247
Neutrophil count decreased	233.94	13.43	311	73318	45715	50485780
Metastases to bone	218.91	13.43	193	73436	17802	50513693
Polyneuropathy	214.92	13.43	162	73467	11969	50519526
Nausea	214.34	13.43	1751	71878	703647	49827848
Neoplasm progression	213.41	13.43	237	73392	28920	50502575
Arthralgia	208.68	13.43	199	73430	438503	50092992
Gastrointestinal toxicity	208.58	13.43	112	73517	4565	50526930
Product dose omission issue	204.06	13.43	17	73612	183821	50347674
Metastasis	201.38	13.43	107	73522	4268	50527227
Posterior reversible encephalopathy syndrome	199.60	13.43	169	73460	14759	50516736
Haematotoxicity	199.44	13.43	131	73498	7764	50523731
Gastrointestinal perforation	197.17	13.43	94	73535	2967	50528528
Peripheral sensory neuropathy	195.42	13.43	121	73508	6470	50525025
Ejection fraction decreased	187.05	13.43	179	73450	18341	50513154
Second primary malignancy	185.14	13.43	119	73510	6795	50524700
Abdominal discomfort	184.69	13.43	54	73575	231587	50299908
Systemic lupus erythematosus	177.69	13.43	6	73623	140616	50390879
Cardiomyopathy	177.38	13.43	161	73468	15425	50516070
Paronychia	175.19	13.43	99	73530	4465	50527030
Arteriospasm coronary	173.14	13.43	89	73540	3313	50528182
Interstitial lung disease	169.53	13.43	289	73340	52887	50478608
Acute promyelocytic leukaemia	168.03	13.43	59	73570	825	50530670
Contraindicated product administered	164.66	13.43	14	73615	148944	50382551
Laryngospasm	162.40	13.43	79	73550	2609	50528886
Cardiotoxicity	161.62	13.43	110	73519	6917	50524578
Pain	158.90	13.43	383	73246	578520	49952975
Pulmonary embolism	158.33	13.43	412	73217	101292	50430203
Swelling	157.96	13.43	48	73581	200824	50330671
Weight increased	157.40	13.43	49	73580	201842	50329653
Disease recurrence	156.97	13.43	169	73460	19912	50511583
Sinusitis	155.10	13.43	30	73599	170528	50360967
Pyrexia	155.09	13.43	1014	72615	379189	50152306
Hyperammonaemia	150.99	13.43	91	73538	4633	50526862
Fall	150.97	13.43	159	73470	334773	50196722
Dehydration	150.63	13.43	526	73103	151923	50379572
Headache	145.42	13.43	327	73302	506208	50025287
Decreased appetite	144.53	13.43	627	73002	200296	50331199
Therapeutic product effect decreased	144.48	13.43	15	73614	136035	50395460
Anaemia	143.07	13.43	735	72894	251721	50279774
Arthropathy	141.00	13.43	29	73600	157877	50373618
Pemphigus	139.33	13.43	9	73620	120157	50411338
Myelosuppression	135.27	13.43	130	73499	13387	50518108
Nasopharyngitis	134.78	13.43	56	73573	192871	50338624
Abdominal pain	134.69	13.43	689	72940	235539	50295956
Metastases to lymph nodes	131.56	13.43	97	73532	6927	50524568
Wound	128.61	13.43	6	73623	105788	50425707
Neutropenic sepsis	124.76	13.43	127	73502	14020	50517475
Hypomagnesaemia	124.63	13.43	161	73468	22995	50508500
General physical health deterioration	122.58	13.43	470	73159	141964	50389531
Glossodynia	119.51	13.43	14	73615	115555	50415940
Drug hypersensitivity	118.92	13.43	114	73515	250896	50280599
Product use issue	116.96	13.43	36	73593	149439	50382056
Hypokalaemia	116.52	13.43	336	73293	87656	50443839
Injection site pain	115.93	13.43	13	73616	111011	50420484
Large intestine perforation	115.16	13.43	92	73537	7402	50524093
Enteritis	114.21	13.43	89	73540	6906	50524589
Paraesthesia	112.80	13.43	408	73221	119835	50411660
Proteinuria	111.38	13.43	129	73500	16468	50515027
Peripheral swelling	109.12	13.43	84	73545	205852	50325643
Pain in extremity	100.45	13.43	151	73478	272714	50258781
Musculoskeletal stiffness	98.62	13.43	32	73597	128449	50403046
Asthenia	98.23	13.43	796	72833	318246	50213249
Stress cardiomyopathy	94.72	13.43	84	73545	7803	50523692
Colorectal cancer metastatic	92.67	13.43	33	73596	482	50531013
Neutropenic colitis	91.61	13.43	52	73577	2365	50529130
Non-cirrhotic portal hypertension	90.36	13.43	25	73604	147	50531348
Contusion	87.77	13.43	27	73602	112156	50419339
Death	87.60	13.43	788	72841	324591	50206904
Portal hypertension	87.41	13.43	57	73572	3335	50528160
Hypertransaminasaemia	86.56	13.43	58	73571	3553	50527942
Ileus	85.72	13.43	101	73528	13128	50518367
Depression	85.68	13.43	69	73560	165354	50366141
Ascites	85.45	13.43	172	73457	35689	50495806
Maternal exposure during pregnancy	84.83	13.43	65	73564	159713	50371782
Focal nodular hyperplasia	82.49	13.43	30	73599	467	50531028
Intestinal perforation	81.55	13.43	88	73541	10391	50521104
Psoriasis	80.46	13.43	5	73624	68995	50462500
Discomfort	79.70	13.43	29	73600	108351	50423144
Extravasation	78.39	13.43	44	73585	1958	50529537
Cardiac failure	75.53	13.43	263	73366	75777	50455718
Hospitalisation	73.37	13.43	7	73622	67930	50463565
Hyperammonaemic encephalopathy	73.06	13.43	42	73587	1957	50529538
Injection site erythema	72.86	13.43	11	73618	74925	50456570
Left ventricular dysfunction	72.75	13.43	83	73546	10423	50521072
Condition aggravated	71.70	13.43	209	73420	296849	50234646
Influenza	71.03	13.43	21	73608	89517	50441978
Drug abuse	70.80	13.43	4	73625	59842	50471653
Drug intolerance	70.64	13.43	132	73497	218972	50312523
Pruritus	70.27	13.43	197	73432	283371	50248124
Arthritis	69.41	13.43	20	73609	86701	50444794
Insomnia	68.01	13.43	93	73536	174772	50356723
Dysarthria	67.05	13.43	160	73469	37243	50494252
Intestinal obstruction	67.02	13.43	130	73499	26253	50505242
Migraine	66.79	13.43	14	73615	75266	50456229
Hepatic enzyme increased	66.62	13.43	61	73568	137319	50394176
Enterocutaneous fistula	66.17	13.43	33	73596	1151	50530344
Haemolytic anaemia	65.34	13.43	74	73555	9218	50522277
Bronchitis	63.89	13.43	36	73593	104123	50427372
Loss of personal independence in daily activities	62.20	13.43	13	73616	70037	50461458
Peritonitis	61.41	13.43	93	73536	15393	50516102
Mobility decreased	61.17	13.43	20	73609	79928	50451567
Osteoarthritis	60.37	13.43	13	73616	68593	50462902
Pancytopenia	60.09	13.43	262	73367	83768	50447727
Helicobacter infection	59.80	13.43	3	73626	49699	50481796
Therapy partial responder	59.63	13.43	60	73569	6531	50524964
Suicidal ideation	59.04	13.43	6	73623	55379	50476116
Anxiety	58.11	13.43	106	73523	177500	50353995
Dihydropyrimidine dehydrogenase deficiency	57.82	13.43	15	73614	66	50531429
Drug interaction	57.74	13.43	128	73501	199493	50332002
Device related thrombosis	57.44	13.43	31	73598	1276	50530219
Rectal perforation	55.67	13.43	21	73608	364	50531131
Oesophageal fistula	55.20	13.43	16	73613	114	50531381
Leukoencephalopathy	54.04	13.43	45	73584	3838	50527657
Treatment failure	53.70	13.43	73	73556	137564	50393931
Deep vein thrombosis	53.51	13.43	230	73399	73074	50458421
Cholangitis	53.46	13.43	48	73581	4531	50526964
Disseminated intravascular coagulation	53.08	13.43	92	73537	17043	50514452
Pericarditis	53.05	13.43	24	73605	78665	50452830
Pneumonia	53.02	13.43	328	73301	378073	50153422
Dizziness	52.91	13.43	292	73337	346077	50185418
Lower respiratory tract infection	52.74	13.43	37	73592	95164	50436331
White blood cell count decreased	52.71	13.43	320	73309	116402	50415093
Intentional product misuse	52.69	13.43	4	73625	46730	50484765
Chronic obstructive pulmonary disease	51.59	13.43	8	73621	53427	50478068
Congestive cardiomyopathy	51.33	13.43	51	73578	5467	50526028
Gastrointestinal necrosis	51.19	13.43	37	73592	2561	50528934
Immune thrombocytopenia	50.56	13.43	64	73565	8953	50522542
Splenomegaly	50.15	13.43	66	73563	9594	50521901
Feeling abnormal	49.52	13.43	66	73563	125426	50406069
Suicide attempt	49.37	13.43	8	73621	51724	50479771
Subacute cutaneous lupus erythematosus	49.34	13.43	34	73595	2181	50529314
Chills	48.80	13.43	273	73356	96414	50435081
Carcinoembryonic antigen increased	48.68	13.43	29	73600	1445	50530050
Tumour perforation	48.64	13.43	14	73615	97	50531398
Breast cancer recurrent	48.62	13.43	42	73587	3766	50527729
Colony stimulating factor therapy	48.36	13.43	18	73611	300	50531195
Metastases to peritoneum	48.33	13.43	37	73592	2796	50528699
Breast cancer metastatic	48.02	13.43	67	73562	10297	50521198
Injury	47.98	13.43	7	73622	48918	50482577
Fluid retention	47.96	13.43	8	73621	50641	50480854
Agranulocytosis	47.78	13.43	100	73529	21321	50510174
Stress	47.72	13.43	10	73619	53783	50477712
Febrile bone marrow aplasia	47.36	13.43	52	73577	6259	50525236
Colitis	47.02	13.43	143	73486	38386	50493109
Gait disturbance	46.89	13.43	92	73537	149913	50381582
Metastases to pleura	46.56	13.43	27	73602	1279	50530216
Troponin I increased	46.32	13.43	31	73598	1895	50529600
Duodenal ulcer perforation	45.97	13.43	6	73623	45605	50485890
Female genital tract fistula	45.93	13.43	40	73589	3626	50527869
Haemolytic uraemic syndrome	45.63	13.43	33	73596	2286	50529209
Adverse drug reaction	45.56	13.43	12	73617	55210	50476285
Myocarditis	45.51	13.43	57	73572	7890	50523605
Myelodysplastic syndrome	45.26	13.43	80	73549	15052	50516443
Cholinergic syndrome	45.16	13.43	18	73611	364	50531131
Metastases to skin	45.13	13.43	27	73602	1356	50530139
Injection site reaction	45.01	13.43	9	73620	50023	50481472
Mucosal toxicity	44.53	13.43	17	73612	305	50531190
Sleep disorder	44.40	13.43	14	73615	57269	50474226
Malignant respiratory tract neoplasm	43.04	13.43	11	73618	45	50531450
Administration site extravasation	42.98	13.43	21	73608	700	50530795
Balance disorder	42.42	13.43	25	73604	70565	50460930
Epistaxis	42.39	13.43	195	73434	63759	50467736
Urticaria	41.76	13.43	78	73551	129483	50402012
Steatohepatitis	41.15	13.43	18	73611	463	50531032
Somnolence	41.11	13.43	104	73525	154881	50376614
Injection site swelling	40.91	13.43	6	73623	41767	50489728
Metastases to central nervous system	40.88	13.43	65	73564	11217	50520278
COVID-19	40.73	13.43	9	73620	46653	50484842
Short-bowel syndrome	40.71	13.43	17	73612	389	50531106
Asthma	40.59	13.43	42	73587	89295	50442200
Trichomegaly	40.14	13.43	10	73619	36	50531459
Embolism	39.93	13.43	50	73579	6918	50524577
Nodular regenerative hyperplasia	39.92	13.43	15	73614	257	50531238
Aortic thrombosis	39.44	13.43	22	73607	967	50530528
Memory impairment	38.73	13.43	35	73594	79325	50452170
Splenic artery thrombosis	38.01	13.43	10	73619	47	50531448
Factor VII deficiency	37.88	13.43	9	73620	25	50531470
Hypertensive crisis	37.37	13.43	68	73561	13086	50518409
Proctalgia	37.16	13.43	41	73588	4962	50526533
Septic shock	36.91	13.43	173	73456	57002	50474493
Aplasia	36.88	13.43	36	73593	3777	50527718
Hypophagia	36.77	13.43	106	73523	27622	50503873
Blister	36.76	13.43	42	73587	85376	50446119
Aortitis	36.43	13.43	20	73609	852	50530643
Subileus	36.39	13.43	31	73598	2728	50528767
Tumour ulceration	36.30	13.43	12	73617	138	50531357
Rash	36.20	13.43	435	73194	437036	50094459
Type 2 diabetes mellitus	35.93	13.43	4	73625	34371	50497124
Dermatitis	35.92	13.43	70	73559	14181	50517314
Cataract	35.88	13.43	12	73617	47288	50484207
Hyperbilirubinaemia	35.87	13.43	56	73573	9514	50521981
Wheezing	35.86	13.43	23	73606	62024	50469471
Cystitis radiation	35.69	13.43	10	73619	62	50531433
Dysaesthesia	35.63	13.43	35	73594	3700	50527795
Venous pressure jugular decreased	35.58	13.43	9	73620	35	50531460
Incorrect dose administered	35.50	13.43	13	73616	48401	50483094
Infusion related hypersensitivity reaction	35.29	13.43	10	73619	65	50531430
Overdose	34.89	13.43	57	73572	99670	50431825
Hormone receptor positive breast cancer	34.62	13.43	16	73613	470	50531025
Abortion spontaneous	34.61	13.43	9	73620	41763	50489732
Bladder tamponade	34.53	13.43	10	73619	71	50531424
Unevaluable event	34.40	13.43	12	73617	46054	50485441
White blood cell count abnormal	34.36	13.43	41	73588	5399	50526096
Nasal congestion	33.82	13.43	16	73613	51104	50480391
Large intestinal obstruction	33.43	13.43	25	73604	1824	50529671
Confusional state	33.36	13.43	148	73481	185780	50345715
Miller Fisher syndrome	32.95	13.43	10	73619	85	50531410
Jugular vein thrombosis	32.94	13.43	29	73600	2667	50528828
Ocular toxicity	32.87	13.43	16	73613	529	50530966
Neuromyotonia	32.66	13.43	9	73620	52	50531443
Atypical haemolytic uraemic syndrome	32.54	13.43	16	73613	541	50530954
Nephritis bacterial	32.51	13.43	8	73621	27	50531468
Heart rate decreased	31.93	13.43	7	73622	36490	50495005
Liver abscess	31.90	13.43	28	73601	2565	50528930
Organising pneumonia	31.84	13.43	37	73592	4737	50526758
Venoocclusive liver disease	31.79	13.43	35	73594	4226	50527269
Sepsis	31.67	13.43	314	73315	132611	50398884
Metastases to meninges	31.66	13.43	25	73604	1977	50529518
Hepatic failure	31.46	13.43	111	73518	32172	50499323
Acute lymphocytic leukaemia	31.25	13.43	26	73603	2215	50529280
Rhabdomyolysis	31.22	13.43	9	73620	39018	50492477
Hydrothorax	31.18	13.43	17	73612	714	50530781
Sedation	30.91	13.43	4	73625	30606	50500889
Stridor	30.80	13.43	30	73599	3139	50528356
Cough	30.76	13.43	215	73414	241049	50290446
Hypertension	30.63	13.43	454	73175	210749	50320746
Anastomotic leak	30.58	13.43	14	73615	402	50531093
Venous thrombosis	30.44	13.43	35	73594	4431	50527064
Toxic leukoencephalopathy	30.36	13.43	16	73613	627	50530868
Wrong technique in product usage process	30.18	13.43	22	73607	55488	50476007
Osteonecrosis of jaw	30.13	13.43	110	73519	32416	50499079
Skin fissures	30.12	13.43	49	73580	8619	50522876
Thrombocytopenic purpura	29.83	13.43	20	73609	1226	50530269
Renal salt-wasting syndrome	29.82	13.43	12	73617	249	50531246
Vena cava thrombosis	29.33	13.43	24	73605	1997	50529498
Red blood cell sedimentation rate increased	29.33	13.43	4	73625	29412	50502083
Device related infection	29.19	13.43	81	73548	20654	50510841
Dysgeusia	29.07	13.43	123	73506	38793	50492702
Small intestinal obstruction	29.07	13.43	69	73560	15999	50515496
Nicotinic acid deficiency	29.07	13.43	8	73621	46	50531449
Metastases to reproductive organ	29.06	13.43	6	73623	6	50531489
Rash pustular	28.70	13.43	41	73588	6440	50525055
Cachexia	28.36	13.43	34	73595	4499	50526996
Malignant pleural effusion	28.34	13.43	25	73604	2305	50529190
Ileal perforation	28.31	13.43	13	73616	376	50531119
Upper respiratory tract infection	27.71	13.43	33	73596	65865	50465630
Dry skin	27.37	13.43	130	73499	43061	50488434
Encephalopathy	27.11	13.43	109	73520	33602	50497893
Acute abdomen	27.02	13.43	20	73609	1436	50530059
Conjunctival filtering bleb leak	26.97	13.43	6	73623	11	50531484
Intentional product use issue	26.87	13.43	44	73585	76874	50454621
ECG signs of myocardial ischaemia	26.57	13.43	8	73621	66	50531429
Gastrooesophageal reflux disease	26.44	13.43	44	73585	76384	50455111
Metastases to ovary	26.43	13.43	12	73617	338	50531157
Bradycardia	26.31	13.43	33	73596	64393	50467102
Emotional distress	26.11	13.43	5	73624	28658	50502837
Metastases to spine	26.03	13.43	26	73603	2805	50528690
Throat tightness	26.02	13.43	78	73551	20769	50510726
Metastases to the mediastinum	25.97	13.43	13	73616	457	50531038
Tumour necrosis	25.70	13.43	15	73614	719	50530776
Cardiac ventricular thrombosis	25.56	13.43	13	73616	473	50531022
Subclavian vein thrombosis	25.35	13.43	21	73608	1778	50529717
Aortic dissection	25.31	13.43	20	73609	1583	50529912
Acute interstitial pneumonitis	25.23	13.43	14	73615	609	50530886
Inferior vena cava stenosis	25.17	13.43	6	73623	17	50531478
Urinary tract infection	25.06	13.43	207	73422	223813	50307682
Therapy cessation	24.86	13.43	4	73625	26007	50505488
Soft tissue necrosis	24.81	13.43	12	73617	391	50531104
Blood creatine increased	24.77	13.43	33	73596	4854	50526641
Tumour lysis syndrome	24.51	13.43	41	73588	7380	50524115
Respiratory failure	24.50	13.43	221	73408	90960	50440535
Myocardial ischaemia	24.49	13.43	53	73576	11560	50519935
Osteonecrosis	24.20	13.43	80	73549	22437	50509058
Gastrointestinal stoma complication	24.19	13.43	19	73610	1491	50530004
Enterocolitis	24.02	13.43	38	73591	6529	50524966
Vision blurred	23.90	13.43	49	73580	78598	50452897
Pleural effusion	23.74	13.43	201	73428	81253	50450242
Nasal septum perforation	23.73	13.43	14	73615	685	50530810
Diaphragmatic paralysis	23.72	13.43	13	73616	552	50530943
Encapsulating peritoneal sclerosis	23.68	13.43	11	73618	327	50531168
Hepatic lesion	23.35	13.43	29	73600	3979	50527516
Hypocapnia	23.34	13.43	11	73618	338	50531157
Catabolic state	23.33	13.43	7	73622	57	50531438
Pregnancy	23.33	13.43	7	73622	29570	50501925
Electrocardiogram ST segment elevation	23.30	13.43	27	73602	3446	50528049
Gastric disorder	23.30	13.43	7	73622	29541	50501954
Product quality issue	23.11	13.43	8	73621	30850	50500645
Tonic clonic movements	22.98	13.43	17	73612	1220	50530275
Adverse event	22.95	13.43	18	73611	43745	50487750
Aortic intramural haematoma	22.91	13.43	7	73622	61	50531434
Stomatitis haemorrhagic	22.84	13.43	6	73623	28	50531467
Pelvic abscess	22.83	13.43	18	73611	1420	50530075
Tympanic membrane disorder	22.76	13.43	9	73620	178	50531317
Acute leukaemia	22.70	13.43	16	73613	1064	50530431
Ear infection	22.68	13.43	5	73624	25965	50505530
Oesophagitis	22.64	13.43	56	73573	13327	50518168
Platelet count decreased	22.57	13.43	235	73394	100491	50431004
Xerosis	22.26	13.43	13	73616	624	50530871
Type II hypersensitivity	22.19	13.43	5	73624	10	50531485
Cardiomyopathy acute	22.13	13.43	9	73620	192	50531303
Hypervolaemia	22.09	13.43	5	73624	25494	50506001
Adenocarcinoma of colon	22.02	13.43	21	73608	2141	50529354
Irritability	21.93	13.43	7	73622	28419	50503076
Gastrointestinal stoma output increased	21.92	13.43	9	73620	197	50531298
Recurrent cancer	21.67	13.43	19	73610	1738	50529757
Pulmonary alveolar haemorrhage	21.66	13.43	28	73601	3999	50527496
Portal vein thrombosis	21.61	13.43	21	73608	2191	50529304
Tumour haemorrhage	21.60	13.43	17	73612	1338	50530157
Amnesia	21.39	13.43	18	73611	42242	50489253
Depilation	21.29	13.43	5	73624	13	50531482
Nephrolithiasis	21.25	13.43	12	73617	34681	50496814
Left ventricular dilatation	21.21	13.43	11	73618	417	50531078
Recall phenomenon	21.17	13.43	12	73617	544	50530951
Blood pressure fluctuation	21.08	13.43	13	73616	35810	50495685
Radiation skin injury	21.02	13.43	14	73615	849	50530646
Aorto-oesophageal fistula	21.02	13.43	5	73624	14	50531481
Duodenal perforation	20.77	13.43	13	73616	708	50530787
Gait apraxia	20.76	13.43	5	73624	15	50531480
Myeloproliferative neoplasm	20.33	13.43	11	73618	455	50531040
Hyperkalaemia	20.30	13.43	24	73605	48065	50483430
K-ras gene mutation	20.29	13.43	5	73624	17	50531478
Rectal cancer recurrent	20.29	13.43	5	73624	17	50531478
Hypocalcaemia	20.22	13.43	85	73544	26731	50504764
Carbohydrate antigen 19-9 increased	20.20	13.43	8	73621	159	50531336
Chronic myeloid leukaemia	20.19	13.43	20	73609	2136	50529359
Oral pain	20.18	13.43	81	73548	24952	50506543
Coronary artery disease	20.13	13.43	9	73620	29717	50501778
Protein urine	20.10	13.43	12	73617	600	50530895
Acute coronary syndrome	20.02	13.43	43	73586	9331	50522164
Xerophthalmia	20.02	13.43	10	73619	350	50531145
Hallucination	20.01	13.43	23	73606	46634	50484861
Pigmentation disorder	19.98	13.43	26	73603	3738	50527757
Renal tubular disorder	19.90	13.43	21	73608	2416	50529079
Blood phosphorus decreased	19.84	13.43	26	73603	3763	50527732
Pelvic fluid collection	19.79	13.43	13	73616	770	50530725
Gait inability	19.71	13.43	15	73614	37012	50494483
Gastric varices haemorrhage	19.61	13.43	7	73622	103	50531392
Adenocarcinoma	19.59	13.43	21	73608	2460	50529035
Heart rate increased	19.58	13.43	53	73576	77197	50454298
Tumour marker increased	19.57	13.43	26	73603	3814	50527681
Dyskinesia	19.56	13.43	8	73621	27853	50503642
Visual impairment	19.53	13.43	44	73585	68231	50463264
Folliculitis	19.49	13.43	17	73612	39208	50492287
Gastrointestinal anastomotic leak	19.49	13.43	8	73621	175	50531320
Psychotic disorder	19.46	13.43	4	73625	21808	50509687
Foot fracture	19.41	13.43	3	73626	20088	50511407
Varices oesophageal	19.25	13.43	22	73607	2767	50528728
Wernicke's encephalopathy	19.09	13.43	5	73624	23	50531472
Fistula	19.07	13.43	39	73590	8179	50523316
Fistula of small intestine	18.91	13.43	9	73620	283	50531212
Vaginal fistula	18.91	13.43	10	73619	395	50531100
Oesophageal varices haemorrhage	18.78	13.43	14	73615	1016	50530479
Road traffic accident	18.78	13.43	6	73623	24346	50507149
Vesical fistula	18.73	13.43	6	73623	62	50531433
Colon cancer metastatic	18.66	13.43	14	73615	1026	50530469
No adverse event	18.65	13.43	13	73616	33565	50497930
Night sweats	18.65	13.43	13	73616	33561	50497934
Portal vein dilatation	18.59	13.43	5	73624	26	50531469
Aggression	18.57	13.43	4	73625	21112	50510383
Productive cough	18.53	13.43	30	73599	52664	50478831
Anastomotic complication	18.52	13.43	7	73622	122	50531373
Head injury	18.38	13.43	6	73623	24014	50507481
Osteoporosis	18.31	13.43	23	73606	44856	50486639
Erythema	18.27	13.43	307	73322	146107	50385388
Rib fracture	18.27	13.43	3	73626	19218	50512277
Retroperitoneal abscess	18.21	13.43	7	73622	128	50531367
Toxic cardiomyopathy	18.16	13.43	7	73622	129	50531366
Necrosis	18.15	13.43	28	73601	4708	50526787
Biliary tract infection	18.13	13.43	10	73619	430	50531065
Cardiac myxoma	18.07	13.43	8	73621	212	50531283
Blood pressure systolic increased	18.06	13.43	15	73614	35434	50496061
Neutrophil count abnormal	18.00	13.43	20	73609	2439	50529056
Multiple organ dysfunction syndrome	17.86	13.43	130	73499	50207	50481288
Chemical burns of eye	17.85	13.43	6	73623	73	50531422
Liver function test abnormal	17.80	13.43	23	73606	44316	50487179
Multiple sclerosis	17.79	13.43	4	73625	20489	50511006
Hyperpyrexia	17.67	13.43	22	73607	3027	50528468
Treatment noncompliance	17.66	13.43	11	73618	30139	50501356
Hepatic vein stenosis	17.58	13.43	5	73624	33	50531462
Ill-defined disorder	17.51	13.43	33	73596	54621	50476874
Splenic marginal zone lymphoma recurrent	17.44	13.43	4	73625	9	50531486
Marchiafava-Bignami disease	17.44	13.43	4	73625	9	50531486
Respiratory disorder	17.42	13.43	12	73617	31175	50500320
Anal inflammation	17.41	13.43	7	73622	145	50531350
Joint range of motion decreased	17.35	13.43	3	73626	18509	50512986
Illness	17.31	13.43	7	73622	24533	50506962
Blood glucose increased	17.28	13.43	50	73579	71274	50460221
Cutaneous tuberculosis	17.19	13.43	7	73622	150	50531345
Vasospasm	17.17	13.43	11	73618	624	50530871
Diabetes mellitus	17.17	13.43	28	73601	49005	50482490
Menopause	17.16	13.43	19	73610	2308	50529187
Dysphonia	17.14	13.43	106	73523	38786	50492709
Device issue	17.13	13.43	4	73625	19968	50511527
SAPHO syndrome	17.08	13.43	6	73623	84	50531411
Palpitations	17.07	13.43	75	73554	94431	50437064
Pulmonary artery thrombosis	16.98	13.43	11	73618	636	50530859
Pneumatosis intestinalis	16.96	13.43	18	73611	2085	50529410
Venous thrombosis limb	16.95	13.43	20	73609	2602	50528893
Intercepted product administration error	16.89	13.43	6	73623	87	50531408
Endocardial fibrosis	16.87	13.43	4	73625	11	50531484
Localised infection	16.82	13.43	8	73621	25477	50506018
Malignant peritoneal neoplasm	16.77	13.43	11	73618	650	50530845
International normalised ratio increased	16.70	13.43	23	73606	43129	50488366
Ocular vasculitis	16.64	13.43	5	73624	41	50531454
Endometrial dysplasia	16.61	13.43	4	73625	12	50531483
Vascular access site swelling	16.60	13.43	3	73626	0	50531495
Percussion test abnormal	16.60	13.43	3	73626	0	50531495
Dandy-Walker syndrome	16.58	13.43	6	73623	92	50531403
Tongue oedema	16.58	13.43	24	73605	3815	50527680
Proctitis	16.44	13.43	17	73612	1911	50529584
Monoparesis	16.41	13.43	15	73614	1449	50530046
Gastric perforation	16.36	13.43	15	73614	1455	50530040
Skin exfoliation	16.34	13.43	94	73535	33518	50497977
Blood creatine phosphokinase increased	16.32	13.43	9	73620	26358	50505137
Multiple-drug resistance	16.22	13.43	22	73607	3292	50528203
Withdrawal syndrome	16.17	13.43	3	73626	17587	50513908
Intravascular haemolysis	16.15	13.43	8	73621	275	50531220
Bursitis	16.13	13.43	6	73623	22129	50509366
Colon cancer recurrent	16.03	13.43	5	73624	47	50531448
Full blood count abnormal	15.97	13.43	7	73622	23381	50508114
Malignant neoplasm of pleura	15.94	13.43	5	73624	48	50531447
Portal shunt	15.93	13.43	4	73625	15	50531480
Cerebral infarction	15.91	13.43	68	73561	21536	50509959
Vitamin B1 deficiency	15.78	13.43	8	73621	289	50531206
T-cell type acute leukaemia	15.76	13.43	5	73624	50	50531445
Duodenal ulcer	15.54	13.43	32	73597	6743	50524752
Cardiogenic shock	15.51	13.43	54	73575	15545	50515950
Carbohydrate antigen 15-3 increased	15.51	13.43	13	73616	1119	50530376
Hypertensive encephalopathy	15.51	13.43	10	73619	574	50530921
Herpes zoster	15.47	13.43	52	73577	70734	50460761
Depressed mood	15.44	13.43	16	73613	34007	50497488
Herpes simplex encephalitis	15.41	13.43	8	73621	304	50531191
Anaemia of malignant disease	15.39	13.43	9	73620	433	50531062
Performance status decreased	15.32	13.43	21	73608	3174	50528321
Chemotherapy	15.29	13.43	14	73615	1355	50530140
Joint stiffness	15.23	13.43	13	73616	30295	50501200
Acute pulmonary oedema	15.14	13.43	33	73596	7234	50524261
Obesity	15.12	13.43	3	73626	16772	50514723
Surgery	15.12	13.43	13	73616	30192	50501303
Superior vena cava syndrome	15.11	13.43	10	73619	600	50530895
Thrombotic microangiopathy	15.10	13.43	37	73592	8754	50522741
Hypophosphataemia	15.08	13.43	36	73593	8378	50523117
Tendonitis	15.03	13.43	3	73626	16702	50514793
Gastrointestinal motility disorder	15.01	13.43	25	73604	4484	50527011
Hyperthermia	14.96	13.43	34	73595	7662	50523833
Bone marrow infiltration	14.92	13.43	9	73620	459	50531036
Pulmonary toxicity	14.85	13.43	28	73601	5534	50525961
Acute polyneuropathy	14.83	13.43	7	73622	216	50531279
Metastases to chest wall	14.74	13.43	9	73620	469	50531026
Nail disorder	14.74	13.43	39	73590	9669	50521826
Hydronephrosis	14.72	13.43	36	73593	8505	50522990
Red blood cell nucleated morphology present	14.68	13.43	4	73625	22	50531473
Anal fistula	14.65	13.43	19	73610	2723	50528772
Tumour obstruction	14.53	13.43	3	73626	3	50531492
Pulmonary fistula	14.53	13.43	3	73626	3	50531492
Haemolysis	14.50	13.43	29	73600	5987	50525508
Musculoskeletal pain	14.46	13.43	55	73574	72122	50459373
Intestinal ischaemia	14.44	13.43	31	73598	6726	50524769
Systolic dysfunction	14.43	13.43	14	73615	1458	50530037
Extrasystoles	14.42	13.43	25	73604	4630	50526865
Abdominal abscess	14.39	13.43	23	73606	3985	50527510
Enterocolitis infectious	14.38	13.43	14	73615	1464	50530031
Mental disorder	14.36	13.43	7	73622	21984	50509511
Spinal cord compression	14.32	13.43	22	73607	3687	50527808
Skin disorder	14.27	13.43	71	73558	23959	50507536
Dysphagia	14.25	13.43	174	73455	77344	50454151
Metastases to pelvis	14.23	13.43	8	73621	357	50531138
Dysaesthesia pharynx	14.18	13.43	6	73623	142	50531353
Metastases to neck	14.17	13.43	5	73624	71	50531424
Arterial thrombosis	14.15	13.43	13	73616	1264	50530231
Periodontal disease	14.13	13.43	14	73615	1496	50529999
Nasal crusting	14.12	13.43	7	73622	241	50531254
Anal erosion	14.12	13.43	4	73625	26	50531469
Accidental exposure to product	14.08	13.43	8	73621	23049	50508446
Scintillating scotoma	14.06	13.43	6	73623	145	50531350
Oesophageal stenosis	14.03	13.43	19	73610	2839	50528656
Restless legs syndrome	14.01	13.43	3	73626	15894	50515601
Small intestinal perforation	13.97	13.43	13	73616	1285	50530210
Gingival atrophy	13.86	13.43	4	73625	28	50531467
Neck pain	13.83	13.43	40	73589	57027	50474468
Therapy interrupted	13.81	13.43	6	73623	20146	50511349
Hepatic cytolysis	13.80	13.43	34	73595	8069	50523426
Ankle fracture	13.78	13.43	3	73626	15719	50515776
Onycholysis	13.72	13.43	13	73616	1315	50530180
Hypermetabolism	13.69	13.43	6	73623	155	50531340
Eosinophilia	13.68	13.43	5	73624	18647	50512848
Transaminases increased	13.65	13.43	78	73551	27746	50503749
HER2 gene amplification	13.62	13.43	4	73625	30	50531465
Product intolerance	13.62	13.43	4	73625	30	50531465
Enterobacter sepsis	13.58	13.43	7	73622	262	50531233
Dry eye	13.57	13.43	16	73613	32079	50499416
Drug ineffective for unapproved indication	13.56	13.43	7	73622	21274	50510221
Bronchospasm	13.56	13.43	50	73579	14804	50516691
Peripheral nerve injury	13.51	13.43	8	73621	394	50531101
Back pain	13.48	13.43	232	73397	219798	50311697
Thrombotic thrombocytopenic purpura	13.47	13.43	21	73608	3564	50527931

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
Neutropenia	1206.12	13.44	1661	81884	130050	29360932
Diarrhoea	947.84	13.44	2547	80998	330151	29160831
Dermatitis acneiform	861.39	13.44	383	83162	5108	29485874
Neuropathy peripheral	737.47	13.44	954	82591	70073	29420909
Mucosal inflammation	727.74	13.44	648	82897	30947	29460035
Stomatitis	583.01	13.44	617	82928	36496	29454486
Skin toxicity	549.91	13.44	250	83295	3521	29487461
Arteriospasm coronary	501.13	13.44	209	83336	2356	29488626
Disease progression	496.17	13.44	855	82690	81061	29409921
Palmar-plantar erythrodysaesthesia syndrome	445.47	13.44	354	83191	14405	29476577
Paronychia	437.62	13.44	198	83347	2755	29488227
Thrombocytopenia	424.23	13.44	1075	82470	133748	29357234
Interstitial lung disease	359.09	13.44	610	82935	57108	29433874
Neurotoxicity	344.67	13.44	304	83241	14309	29476673
Leukopenia	336.24	13.44	578	82967	54625	29436357
Metastases to liver	335.74	13.44	274	83271	11582	29479400
Decreased appetite	289.52	13.44	985	82560	144357	29346625
Nausea	268.60	13.44	1559	81986	287696	29203286
Febrile neutropenia	255.16	13.44	796	82749	111444	29379538
Peripheral sensory neuropathy	254.61	13.44	176	83369	5763	29485219
Vomiting	242.11	13.44	1211	82334	211049	29279933
Drug ineffective	229.46	13.44	424	83121	362746	29128236
Hyperammonaemia	229.18	13.44	162	83383	5501	29485481
Completed suicide	226.81	13.44	6	83539	90240	29400742
Cardiotoxicity	211.43	13.44	144	83401	4600	29486382
Proteinuria	210.22	13.44	241	83304	15563	29475419
Gastrointestinal toxicity	209.89	13.44	108	83437	2023	29488959
Gastrointestinal perforation	205.21	13.44	126	83419	3357	29487625
Bone marrow failure	194.68	13.44	308	83237	27141	29463841
Metastases to lung	194.41	13.44	168	83377	7687	29483295
Drug interaction	193.83	13.44	164	83381	197221	29293761
Arthralgia	184.20	13.44	82	83463	139535	29351447
Polyneuropathy	183.44	13.44	198	83347	11954	29479028
Hyperammonaemic encephalopathy	182.09	13.44	96	83449	1894	29489088
Hypomagnesaemia	178.21	13.44	233	83312	17235	29473747
General physical health deterioration	175.35	13.44	663	82882	102194	29388788
Product dose omission issue	174.26	13.44	31	83514	96352	29394630
Dehydration	171.73	13.44	710	82835	114038	29376944
Alopecia	163.62	13.44	234	83311	18850	29472132
Intestinal obstruction	153.12	13.44	228	83317	19049	29471933
Neutrophil count decreased	153.05	13.44	363	83182	43204	29447778
Skin reaction	150.74	13.44	114	83431	4303	29486679
Portal hypertension	137.07	13.44	98	83447	3388	29487594
Pneumatosis intestinalis	133.68	13.44	93	83452	3076	29487906
Fall	129.01	13.44	188	83357	176990	29313992
Headache	127.32	13.44	184	83361	173823	29317159
Carcinoembryonic antigen increased	125.77	13.44	52	83493	572	29490410
Abdominal pain	119.36	13.44	721	82824	134636	29356346
Enteritis	119.26	13.44	120	83425	6671	29484311
Pyrexia	118.82	13.44	1287	82258	286335	29204647
Myelosuppression	116.87	13.44	158	83387	12069	29478913
Portal venous gas	113.41	13.44	41	83504	303	29490679
Pulmonary embolism	108.45	13.44	466	83079	76068	29414914
Neoplasm progression	108.08	13.44	191	83354	18421	29472561
Paraesthesia	107.75	13.44	366	83179	53479	29437503
Rhabdomyolysis	106.78	13.44	21	83524	60787	29430195
Cardiac failure congestive	105.67	13.44	42	83503	76539	29414443
Myalgia	104.78	13.44	39	83506	73980	29417002
Anxiety	103.59	13.44	56	83489	85309	29405673
Malignant neoplasm progression	101.04	13.44	445	83100	73414	29417568
Haematotoxicity	100.82	13.44	109	83436	6590	29484392
Weight increased	99.48	13.44	46	83499	76621	29414361
Chills	98.61	13.44	431	83114	70869	29420113
Somnolence	97.12	13.44	74	83471	93881	29397101
Ileus	94.43	13.44	156	83389	14246	29476736
Peritonitis	93.76	13.44	158	83387	14666	29476316
Depression	91.98	13.44	64	83481	85083	29405899
Hospitalisation	91.84	13.44	11	83534	45977	29445005
Hiccups	87.04	13.44	116	83429	8737	29482245
Tumour necrosis	85.03	13.44	48	83497	1089	29489893
Rash pustular	84.40	13.44	84	83461	4607	29486375
Death	82.66	13.44	597	82948	341487	29149495
Extravasation	82.31	13.44	54	83491	1618	29489364
Oesophageal fistula	82.27	13.44	28	83517	169	29490813
Insomnia	80.68	13.44	79	83466	88682	29402300
Aggression	80.46	13.44	5	83540	35536	29455446
Anastomotic complication	76.89	13.44	31	83514	318	29490664
Toxicity to various agents	76.53	13.44	244	83301	173417	29317565
Pelvic abscess	75.81	13.44	41	83504	853	29490129
Ileal perforation	75.69	13.44	38	83507	674	29490308
Pain in extremity	75.64	13.44	122	83423	110311	29380671
Electrocardiogram ST segment elevation	74.55	13.44	77	83468	4415	29486567
Small intestinal obstruction	74.49	13.44	133	83412	12928	29478054
Overdose	73.74	13.44	70	83475	79749	29411233
Hypokalaemia	73.63	13.44	309	83236	49894	29441088
Large intestine perforation	73.27	13.44	97	83448	7259	29483723
Anastomotic leak	72.89	13.44	35	83510	561	29490421
Peripheral swelling	72.77	13.44	45	83500	63694	29427288
Suicidal ideation	72.64	13.44	7	83538	34709	29456273
Subileus	72.63	13.44	62	83483	2788	29488194
Intentional product misuse	72.50	13.44	7	83538	34654	29456328
Injection site pain	72.16	13.44	5	83540	32441	29458541
Septic shock	71.65	13.44	358	83187	62202	29428780
Hallucination	71.39	13.44	19	83526	44693	29446289
Metastases to lymph nodes	70.56	13.44	71	83474	3946	29487036
Asthma	70.37	13.44	7	83538	33842	29457140
Therapy partial responder	70.32	13.44	80	83465	5119	29485863
Pneumonia	70.11	13.44	574	82971	319598	29171384
Joint swelling	68.80	13.44	27	83518	49603	29441379
Focal nodular hyperplasia	68.55	13.44	23	83522	132	29490850
Aorto-oesophageal fistula	68.36	13.44	18	83527	35	29490947
Chronic obstructive pulmonary disease	68.10	13.44	16	83529	40939	29450043
Colorectal cancer metastatic	65.76	13.44	32	83513	529	29490453
Device related infection	65.73	13.44	140	83405	15496	29475486
Necrotising fasciitis	65.67	13.44	63	83482	3302	29487680
Intravascular haemolysis	65.42	13.44	29	83516	383	29490599
Disseminated intravascular coagulation	65.32	13.44	162	83383	19818	29471164
Leukoencephalopathy	65.10	13.44	66	83479	3701	29487281
Ascites	64.70	13.44	239	83306	36380	29454602
Dermatitis	64.45	13.44	94	83451	7704	29483278
Cholangitis	63.96	13.44	92	83453	7445	29483537
Psoriasis	63.63	13.44	8	83537	32219	29458763
Dizziness	62.74	13.44	299	83246	189385	29301597
Confusional state	62.57	13.44	171	83374	127706	29363276
Blood glucose increased	61.50	13.44	46	83499	58938	29432044
Influenza	61.06	13.44	21	83524	41860	29449122
Rheumatoid arthritis	61.06	13.44	9	83536	32143	29458839
Incorrect dose administered	60.90	13.44	10	83535	32974	29458008
Cholinergic syndrome	60.84	13.44	29	83516	457	29490525
Metastases to peritoneum	60.38	13.44	43	83502	1477	29489505
Feeling abnormal	60.01	13.44	40	83505	54405	29436577
Administration site extravasation	59.94	13.44	29	83516	473	29490509
Asthenia	59.13	13.44	894	82651	214356	29276626
Dry skin	59.07	13.44	172	83373	23135	29467847
Bradycardia	58.94	13.44	59	83486	65570	29425412
Therapeutic product effect decreased	58.90	13.44	7	83538	29444	29461538
Acute coronary syndrome	58.46	13.44	116	83429	12209	29478773
Muscle spasms	56.76	13.44	60	83485	65022	29425960
Folliculitis	56.15	13.44	62	83483	3838	29487144
Agitation	56.13	13.44	38	83507	51266	29439716
Sinusitis	55.97	13.44	14	83531	34336	29456646
Conjunctivitis	55.64	13.44	89	83456	7909	29483073
Venous thrombosis	55.10	13.44	55	83490	3027	29487955
Coronary artery disease	55.04	13.44	28	83517	44162	29446820
Wheezing	53.29	13.44	14	83531	33226	29457756
Small intestinal perforation	53.22	13.44	41	83504	1591	29489391
Product use issue	52.51	13.44	41	83504	51403	29439579
Contusion	51.99	13.44	12	83533	31083	29459899
Tremor	51.50	13.44	80	83465	73458	29417524
Electrocardiogram QT prolonged	51.18	13.44	19	83526	36118	29454864
Intestinal perforation	50.88	13.44	86	83459	8000	29482982
Rectal perforation	50.30	13.44	24	83521	379	29490603
Memory impairment	50.28	13.44	20	83525	36450	29454532
Tumour perforation	50.08	13.44	21	83524	240	29490742
Oesophagitis	49.24	13.44	106	83439	11817	29479165
Epistaxis	49.04	13.44	281	83264	51423	29439559
Nasopharyngitis	48.75	13.44	58	83487	59607	29431375
Stress	48.71	13.44	3	83542	21487	29469495
Large intestinal obstruction	48.54	13.44	36	83509	1318	29489664
Disturbance in attention	48.53	13.44	3	83542	21421	29469561
Mucosal toxicity	48.45	13.44	19	83526	180	29490802
Hypertransaminasaemia	47.94	13.44	55	83490	3551	29487431
Fistula	46.97	13.44	65	83480	5074	29485908
Anastomotic fistula	46.44	13.44	14	83531	53	29490929
Hypoglycaemia	46.29	13.44	41	83504	48305	29442677
Incorrect drug administration rate	46.09	13.44	33	83512	1143	29489839
Pulmonary artery thrombosis	46.09	13.44	26	83519	589	29490393
Foetal exposure during pregnancy	45.99	13.44	19	83526	33848	29457134
Hyperbilirubinaemia	45.59	13.44	118	83427	14816	29476166
Unevaluable event	45.22	13.44	14	83531	29837	29461145
Musculoskeletal stiffness	44.78	13.44	25	83520	37433	29453549
Myocardial infarction	43.75	13.44	162	83383	110134	29380848
Subclavian vein thrombosis	43.64	13.44	28	83517	807	29490175
Aortic thrombosis	43.63	13.44	26	83519	655	29490327
Bacterial translocation	43.53	13.44	18	83527	198	29490784
Dysphonia	43.32	13.44	136	83409	19060	29471922
Vena cava thrombosis	43.23	13.44	30	83515	988	29489994
Neutropenic colitis	43.05	13.44	43	83502	2368	29488614
Malignant ascites	42.68	13.44	21	83524	356	29490626
Irritability	42.53	13.44	6	83539	22146	29468836
Injury	42.16	13.44	3	83542	19043	29471939
Carbohydrate antigen 19-9 increased	42.02	13.44	17	83528	176	29490806
Duodenal perforation	41.42	13.44	31	83514	1151	29489831
Treatment noncompliance	41.20	13.44	9	83536	24218	29466764
Cytomegalovirus infection	40.77	13.44	8	83537	23207	29467775
Colon cancer recurrent	40.26	13.44	14	83531	91	29490891
Transdifferentiation of neoplasm	40.23	13.44	13	83532	65	29490917
Acral peeling skin syndrome	40.11	13.44	12	83533	44	29490938
Nicotinic acid deficiency	39.59	13.44	13	83532	69	29490913
Arthritis	39.24	13.44	11	83534	25008	29465974
Cellulitis	39.13	13.44	43	83502	45797	29445185
Venoocclusive liver disease	38.88	13.44	70	83475	6847	29484135
Skin disorder	38.81	13.44	95	83450	11523	29479459
Anal haemorrhage	38.79	13.44	37	83508	1925	29489057
Anal erythema	38.55	13.44	13	83532	76	29490906
Abnormal behaviour	38.51	13.44	9	83536	23118	29467864
Skin fissures	37.98	13.44	51	83494	3868	29487114
Intestinal ischaemia	37.97	13.44	68	83477	6624	29484358
Fluid retention	37.62	13.44	10	83535	23550	29467432
Anaemia	37.08	13.44	784	82761	200167	29290815
Drug hypersensitivity	36.88	13.44	87	83458	68319	29422663
Tumour haemorrhage	36.63	13.44	40	83505	2445	29488537
Pelvic fluid collection	35.97	13.44	13	83532	96	29490886
Nodular regenerative hyperplasia	35.93	13.44	23	83522	660	29490322
Hyperkalaemia	35.61	13.44	75	83470	61317	29429665
Abdominal discomfort	35.58	13.44	50	83495	47853	29443129
Balance disorder	35.44	13.44	30	83515	36140	29454842
Proteus infection	35.32	13.44	25	83520	850	29490132
Cardiac disorder	35.19	13.44	32	83513	37231	29453751
Perforation	35.12	13.44	15	83530	180	29490802
Laryngospasm	34.80	13.44	29	83516	1261	29489721
Liver abscess	34.76	13.44	45	83500	3293	29487689
Biliary tract infection	34.72	13.44	20	83525	472	29490510
Chronic kidney disease	34.72	13.44	31	83514	36385	29454597
Acute abdomen	34.64	13.44	33	83512	1714	29489268
Diabetes mellitus	34.40	13.44	37	83508	39794	29451188
Respiratory arrest	34.27	13.44	15	83530	25818	29465164
Hypersensitivity	34.05	13.44	261	83284	52642	29438340
Psychotic disorder	33.73	13.44	8	83537	20346	29470636
Dysphagia	33.71	13.44	268	83277	54658	29436324
White blood cell count decreased	33.69	13.44	372	83173	82990	29407992
Vasospasm	33.59	13.44	17	83528	307	29490675
Aphthous ulcer	33.56	13.44	49	83496	4019	29486963
Portal vein thrombosis	33.51	13.44	44	83501	3265	29487717
Prinzmetal angina	33.43	13.44	24	83521	835	29490147
Hypophagia	33.38	13.44	132	83413	20740	29470242
Hypoalbuminaemia	33.09	13.44	83	83462	10222	29480760
Enterovesical fistula	33.08	13.44	21	83524	594	29490388
Induration	33.01	13.44	24	83521	852	29490130
Gait disturbance	32.98	13.44	102	83443	73247	29417735
Tumour lysis syndrome	32.84	13.44	100	83445	13784	29477198
Odynophagia	32.53	13.44	52	83493	4618	29486364
Stoma site haemorrhage	32.50	13.44	22	83523	695	29490287
Oesophageal stenosis	32.37	13.44	30	83515	1505	29489477
Cytomegalovirus oesophagitis	32.30	13.44	18	83527	398	29490584
Hypovolaemic shock	32.30	13.44	60	83485	6012	29484970
International normalised ratio increased	32.28	13.44	47	83498	44325	29446657
Xerosis	32.15	13.44	19	83526	471	29490511
Oral pain	32.05	13.44	77	83468	9230	29481752
Gastric perforation	31.90	13.44	35	83510	2151	29488831
Pain	31.85	13.44	320	83225	171112	29319870
Oesophagobronchial fistula	31.28	13.44	13	83532	145	29490837
Type II hypersensitivity	30.97	13.44	9	83536	29	29490953
Stress cardiomyopathy	30.93	13.44	30	83515	1594	29489388
Jugular vein thrombosis	30.76	13.44	28	83517	1372	29489610
Blood pressure fluctuation	30.73	13.44	9	83536	19885	29471097
Enterocolitis	30.72	13.44	62	83483	6604	29484378
Recall phenomenon	30.61	13.44	19	83526	516	29490466
Hepatic lesion	30.54	13.44	41	83504	3109	29487873
Embolism	30.44	13.44	63	83482	6833	29484149
Cachexia	30.40	13.44	60	83485	6289	29484693
Adverse drug reaction	30.23	13.44	15	83530	24005	29466977
Catheter site thrombosis	30.08	13.44	9	83536	33	29490949
Bronchitis	29.93	13.44	36	83509	36832	29454150
Influenza like illness	29.73	13.44	16	83529	24454	29466528
Blood creatine phosphokinase increased	29.62	13.44	43	83502	40601	29450381
Peritoneal neoplasm	29.47	13.44	9	83536	36	29490946
Right ventricular ejection fraction decreased	29.47	13.44	9	83536	36	29490946
Pulmonary fibrosis	29.46	13.44	104	83441	15478	29475504
Condition aggravated	29.32	13.44	268	83277	146027	29344955
Prostate cancer	29.15	13.44	18	83527	25509	29465473
Sciatic nerve palsy	29.08	13.44	9	83536	38	29490944
Colitis microscopic	28.86	13.44	30	83515	1733	29489249
Pneumonitis chemical	28.70	13.44	12	83533	136	29490846
Palmar erythema	28.68	13.44	14	83531	233	29490749
Renal disorder	28.60	13.44	14	83531	22581	29468401
Sedation	28.53	13.44	7	83538	17398	29473584
Subdural haematoma	28.52	13.44	8	83537	18185	29472797
Vocal cord paralysis	28.50	13.44	22	83523	856	29490126
Perforation bile duct	28.47	13.44	8	83537	22	29490960
Colitis	28.43	13.44	168	83377	31080	29459902
Hypertension	28.39	13.44	475	83070	116139	29374843
Liver function test abnormal	28.31	13.44	24	83521	28894	29462088
Acne	28.29	13.44	73	83472	9147	29481835
Pneumonitis	28.29	13.44	155	83390	27889	29463093
Dihydropyrimidine dehydrogenase deficiency	28.25	13.44	10	83535	69	29490913
Neutropenic sepsis	28.24	13.44	85	83460	11642	29479340
Blood pressure increased	28.21	13.44	110	83435	73693	29417289
Nephrotic syndrome	28.15	13.44	58	83487	6270	29484712
Drug level increased	28.11	13.44	9	83536	18778	29472204
Venous thrombosis limb	28.01	13.44	29	83516	1667	29489315
Tumour marker increased	27.83	13.44	18	83527	526	29490456
Mouth ulceration	27.77	13.44	78	83467	10277	29480705
Device related thrombosis	27.42	13.44	22	83523	906	29490076
Colon cancer metastatic	27.38	13.44	27	83518	1464	29489518
Head injury	27.29	13.44	6	83539	16075	29474907
Gastrointestinal necrosis	27.28	13.44	38	83507	2984	29487998
Erythema	27.24	13.44	330	83215	75276	29415706
Gastrointestinal ischaemia	27.10	13.44	12	83533	158	29490824
Haematoma	27.02	13.44	16	83529	23196	29467786
Cough	26.78	13.44	229	83316	126498	29364484
Subacute cutaneous lupus erythematosus	26.75	13.44	21	83524	838	29490144
Nail toxicity	26.60	13.44	8	83537	30	29490952
Gastrointestinal anastomotic leak	26.35	13.44	15	83530	346	29490636
Dyspnoea	26.20	13.44	713	82832	326019	29164963
Eosinophilia	26.19	13.44	15	83530	22146	29468836
Enterocutaneous fistula	26.18	13.44	20	83525	766	29490216
Emotional distress	26.13	13.44	4	83541	13891	29477091
Abdominal pain lower	26.10	13.44	68	83477	8570	29482412
Cerebrovascular accident	26.09	13.44	120	83425	76791	29414191
Nephrolithiasis	26.08	13.44	20	83525	25314	29465668
Urticaria	26.02	13.44	74	83471	54586	29436396
PIK3CA-activated mutation	25.95	13.44	10	83535	90	29490892
Left ventricular dysfunction	25.80	13.44	69	83476	8833	29482149
Sepsis	25.73	13.44	555	82990	142127	29348855
Evans syndrome	25.48	13.44	13	83532	239	29490743
Sleep apnoea syndrome	25.34	13.44	9	83536	17590	29473392
Proctalgia	25.20	13.44	44	83501	4201	29486781
Cell-mediated cytotoxicity	25.09	13.44	8	83537	38	29490944
Anaemia of malignant disease	25.06	13.44	15	83530	381	29490601
Deep vein thrombosis	24.97	13.44	260	83285	57139	29433843
Pulmonary oedema	24.95	13.44	52	83493	42683	29448299
Toxic epidermal necrolysis	24.94	13.44	10	83535	18143	29472839
Prothrombin level decreased	24.91	13.44	22	83523	1036	29489946
Drug ineffective for unapproved indication	24.74	13.44	5	83540	14209	29476773
Carbohydrate antigen 15-3 increased	24.61	13.44	9	83536	69	29490913
Nail disorder	24.55	13.44	28	83517	1796	29489186
COVID-19	24.42	13.44	40	83505	35974	29455008
Proctitis	24.34	13.44	30	83515	2089	29488893
Loss of personal independence in daily activities	23.84	13.44	22	83523	25418	29465564
Trichomegaly	23.76	13.44	7	83538	24	29490958
Stoma site pain	23.71	13.44	16	83529	503	29490479
Renal salt-wasting syndrome	23.44	13.44	11	83534	167	29490815
Conjunctival filtering bleb leak	23.38	13.44	6	83539	10	29490972
Colitis ulcerative	23.28	13.44	4	83541	12765	29478217
Koebner phenomenon	23.27	13.44	8	83537	50	29490932
Off label use	23.26	13.44	1055	82490	299745	29191237
Varices oesophageal	23.25	13.44	36	83509	3110	29487872
Dysaesthesia pharynx	23.01	13.44	8	83537	52	29490930
Hypercreatininaemia	22.73	13.44	15	83530	454	29490528
Pachymeningitis	22.70	13.44	9	83536	88	29490894
Herpes zoster	22.68	13.44	31	83514	30021	29460961
Fistula of small intestine	22.53	13.44	14	83531	381	29490601
Myoclonus	22.52	13.44	5	83540	13304	29477678
Rectal tenesmus	22.49	13.44	17	83528	641	29490341
Mobility decreased	22.20	13.44	24	83521	25756	29465226
Gout	22.14	13.44	10	83535	16901	29474081
Rectal cancer metastatic	22.12	13.44	11	83534	191	29490791
Contraindicated product administered	22.11	13.44	12	83533	18254	29472728
Perineal disorder	22.03	13.44	8	83537	60	29490922
Hypervolaemia	22.01	13.44	11	83534	17534	29473448
Balanoposthitis	21.94	13.44	20	83525	982	29490000
Haemoglobinuria	21.88	13.44	16	83529	573	29490409
Abdominal abscess	21.88	13.44	39	83506	3785	29487197
Interventricular septum rupture	21.76	13.44	6	83539	15	29490967
Adverse event	21.71	13.44	8	83537	15283	29475699
Hepatitis B	21.70	13.44	48	83497	5449	29485533
Heart rate decreased	21.67	13.44	23	83522	24889	29466093
Blood glucose decreased	21.53	13.44	4	83541	12065	29478917
Cerebral vasoconstriction	21.42	13.44	11	83534	205	29490777
Lower respiratory tract infection	21.38	13.44	26	83519	26476	29464506
Febrile bone marrow aplasia	21.33	13.44	57	83488	7294	29483688
Delirium	21.31	13.44	50	83495	39347	29451635
Hepatectomy	21.26	13.44	8	83537	67	29490915
Ectropion	21.26	13.44	8	83537	67	29490915
Splenomegaly	21.24	13.44	84	83461	13195	29477787
Drug intolerance	21.23	13.44	68	83477	48311	29442671
Wrong technique in product usage process	21.22	13.44	35	83510	31393	29459589
Respiratory depression	21.10	13.44	6	83539	13517	29477465
Underdose	21.03	13.44	4	83541	11865	29479117
Unresponsive to stimuli	20.97	13.44	24	83521	25102	29465880
Pseudocirrhosis	20.97	13.44	6	83539	18	29490964
Toxic erythema of chemotherapy	20.96	13.44	8	83537	70	29490912
Pneumoperitoneum	20.92	13.44	24	83521	1549	29489433
Anger	20.79	13.44	3	83542	10887	29480095
Blood cholesterol increased	20.77	13.44	9	83536	15586	29475396
Perioral dermatitis	20.71	13.44	9	83536	113	29490869
Hepatic atrophy	20.62	13.44	10	83535	164	29490818
Swelling	20.54	13.44	43	83502	35240	29455742
Clostridial infection	20.51	13.44	35	83510	3280	29487702
Diffuse alveolar damage	20.43	13.44	27	83518	2016	29488966
NPM1 gene mutation	20.43	13.44	9	83536	117	29490865
Oesophageal perforation	20.42	13.44	17	83528	738	29490244
Anorectal discomfort	20.36	13.44	24	83521	1595	29489387
Vision blurred	20.16	13.44	53	83492	40123	29450859
Pulmonary infarction	20.15	13.44	20	83525	1093	29489889
Product prescribing error	20.08	13.44	13	83532	17963	29473019
Thrombotic thrombocytopenic purpura	20.04	13.44	34	83511	3172	29487810
Soft tissue disorder	20.01	13.44	16	83529	656	29490326
Premature baby	19.99	13.44	12	83533	17268	29473714
Seizure	19.78	13.44	168	83377	92955	29398027
Protein urine	19.53	13.44	17	83528	785	29490197
Perihepatic abscess	19.51	13.44	8	83537	86	29490896
Tubulointerstitial nephritis	19.38	13.44	13	83532	17630	29473352
Accidental overdose	19.27	13.44	13	83532	17580	29473402
Refeeding syndrome	19.26	13.44	6	83539	26	29490956
Microgenia	19.24	13.44	5	83540	9	29490973
Dyskinesia	19.21	13.44	17	83528	20044	29470938
Anal fissure	19.19	13.44	31	83514	2777	29488205
Device related sepsis	19.07	13.44	29	83516	2466	29488516
Pelvic venous thrombosis	19.06	13.44	14	83531	505	29490477
Osteoarthritis	19.01	13.44	14	83531	18089	29472893
Necrotising oesophagitis	18.99	13.44	14	83531	508	29490474
Ischiorectal hernia	18.90	13.44	5	83540	10	29490972
Paraesthesia oral	18.87	13.44	35	83510	3502	29487480
Prostatic specific antigen increased	18.83	13.44	6	83539	12558	29478424
Erectile dysfunction	18.82	13.44	14	83531	17995	29472987
Dysgeusia	18.78	13.44	119	83426	22555	29468427
Enterocolitis haemorrhagic	18.68	13.44	17	83528	833	29490149
Guillain-Barre syndrome	18.67	13.44	43	83502	5015	29485967
Arthropathy	18.63	13.44	20	83525	21534	29469448
Lymph node abscess	18.58	13.44	5	83540	11	29490971
Intestinal strangulation	18.57	13.44	6	83539	30	29490952
Peritoneal haematoma	18.57	13.44	7	83538	59	29490923
Cerebral haemorrhage	18.55	13.44	38	83507	31388	29459594
Jaundice	18.54	13.44	144	83401	29152	29461830
Superior vena cava syndrome	18.54	13.44	14	83531	527	29490455
Duodenal ulcer perforation	18.41	13.44	22	83523	1484	29489498
Heart rate irregular	18.39	13.44	7	83538	13110	29477872
Metastasis	18.38	13.44	34	83511	3395	29487587
Portal vein embolisation	18.28	13.44	5	83540	12	29490970
Accidental exposure to product	18.27	13.44	4	83541	10749	29480233
Retroperitoneal abscess	18.22	13.44	9	83536	154	29490828
Acute respiratory distress syndrome	18.16	13.44	119	83426	22816	29468166
Tetany	18.10	13.44	15	83530	647	29490335
Muscular weakness	18.09	13.44	102	83443	61950	29429032
Lymphoma	18.09	13.44	3	83542	9825	29481157
Primitive neuroectodermal tumour	18.07	13.44	7	83538	64	29490918
Eyelash changes	17.99	13.44	5	83540	13	29490969
Colony stimulating factor therapy	17.96	13.44	9	83536	159	29490823
Mental disorder	17.91	13.44	7	83538	12898	29478084
Bronchiolitis obliterans syndrome	17.86	13.44	9	83536	161	29490821
Diabetes mellitus inadequate control	17.83	13.44	6	83539	12128	29478854
Inappropriate schedule of product administration	17.82	13.44	65	83480	44407	29446575
Intentional product use issue	17.77	13.44	61	83484	42437	29448545
Oesophageal haemorrhage	17.77	13.44	19	83526	1134	29489848
Myopathy	17.73	13.44	4	83541	10529	29480453
Pancreatitis	17.72	13.44	45	83500	34469	29456513
Performance status decreased	17.58	13.44	35	83510	3692	29487290
Wound dehiscence	17.56	13.44	31	83514	2986	29487996
Gastrointestinal stoma complication	17.51	13.44	19	83526	1153	29489829
Visceral venous thrombosis	17.47	13.44	5	83540	15	29490967
Injection site reaction	17.39	13.44	5	83540	11183	29479799
Lymphangiosis carcinomatosa	17.37	13.44	16	83529	796	29490186
Neck pain	17.35	13.44	21	83524	21426	29469556
B-cell small lymphocytic lymphoma	17.32	13.44	8	83537	117	29490865
Hypersplenism	17.27	13.44	11	83534	313	29490669
Haemorrhagic tumour necrosis	17.26	13.44	4	83541	3	29490979
K-ras gene mutation	17.23	13.44	5	83540	16	29490966
Injection site erythema	17.14	13.44	9	83536	13947	29477035
Nail ridging	17.13	13.44	6	83539	40	29490942
Fixed eruption	17.12	13.44	19	83526	1183	29489799
Stevens-Johnson syndrome	17.01	13.44	13	83532	16484	29474498
Angioedema	16.86	13.44	41	83504	31874	29459108
Monocytopenia	16.85	13.44	7	83538	78	29490904
Acute cutaneous lupus erythematosus	16.77	13.44	7	83538	79	29490903
Acute motor-sensory axonal neuropathy	16.73	13.44	8	83537	127	29490855
Intrahepatic portal hepatic venous fistula	16.73	13.44	4	83541	4	29490978
Hepatic enzyme increased	16.64	13.44	45	83500	33754	29457228
Rectal ulcer	16.64	13.44	16	83529	841	29490141
Osteomyelitis	16.60	13.44	9	83536	13700	29477282
Product use in unapproved indication	16.59	13.44	161	83384	86714	29404268
Neoplasm recurrence	16.58	13.44	24	83521	1953	29489029
Product administration error	16.46	13.44	10	83535	14300	29476682
Swollen tongue	16.46	13.44	7	83538	12259	29478723
Hepatitis B surface antigen positive	16.40	13.44	8	83537	133	29490849
VIth nerve disorder	16.37	13.44	5	83540	20	29490962
Pulmonary toxicity	16.35	13.44	40	83505	4850	29486132
Metastases to pelvis	16.33	13.44	10	83535	265	29490717
Catheter site extravasation	16.31	13.44	7	83538	85	29490897
Bacteraemia	16.31	13.44	90	83455	16233	29474749
Radiation mucositis	16.29	13.44	8	83537	135	29490847
Blood triglycerides increased	16.17	13.44	8	83537	12826	29478156
Pancreatic neuroendocrine tumour metastatic	16.17	13.44	7	83538	87	29490895
Treatment failure	16.15	13.44	52	83493	36887	29454095
Toxic leukoencephalopathy	16.13	13.44	10	83535	271	29490711
Laryngeal oedema	16.06	13.44	30	83515	3018	29487964
Bacterial colitis	15.97	13.44	6	83539	50	29490932
Bile duct stenosis	15.94	13.44	18	83527	1142	29489840
Fatigue	15.92	13.44	1068	82477	315753	29175229
Rib fracture	15.92	13.44	8	83537	12710	29478272
Visual impairment	15.83	13.44	38	83507	29670	29461312
Colorectal cancer recurrent	15.81	13.44	5	83540	23	29490959
Product quality issue	15.79	13.44	13	83532	15882	29475100
Hepatic failure	15.77	13.44	147	83398	31365	29459617
Radiation skin injury	15.73	13.44	14	83531	666	29490316
Anaphylactic shock	15.73	13.44	77	83468	13259	29477723
Hyperlipidaemia	15.64	13.44	8	83537	12582	29478400
Laboratory test abnormal	15.58	13.44	17	83528	18168	29472814
Heart rate increased	15.54	13.44	57	83488	38881	29452101
Aplasia	15.50	13.44	35	83510	4028	29486954
Electromyogram abnormal	15.47	13.44	6	83539	55	29490927
Radiation interaction	15.47	13.44	5	83540	25	29490957
Respiratory alkalosis	15.46	13.44	20	83525	1463	29489519
Therapy cessation	15.43	13.44	11	83534	14451	29476531
Localised infection	15.42	13.44	10	83535	13806	29477176
Hyperthermia	15.36	13.44	60	83485	9370	29481612
Swelling face	15.35	13.44	21	83524	20329	29470653
Gastrointestinal obstruction	15.31	13.44	14	83531	690	29490292
Tracheal stenosis	15.30	13.44	8	83537	155	29490827
Tooth disorder	15.30	13.44	4	83541	9525	29481457
Pulmonary hypertension	15.28	13.44	18	83527	18590	29472392
Chimerism	15.27	13.44	9	83536	222	29490760
Sarcoidosis	15.20	13.44	27	83518	2613	29488369
Rectal abscess	15.20	13.44	16	83529	938	29490044
Road traffic accident	15.13	13.44	13	83532	15548	29475434
Therapeutic response unexpected	15.12	13.44	3	83542	8635	29482347
Pneumoretroperitoneum	15.10	13.44	6	83539	59	29490923
Cardiomyopathy	15.09	13.44	82	83463	14705	29476277
Neurosarcoidosis	14.98	13.44	8	83537	162	29490820
Eye pain	14.96	13.44	7	83538	11588	29479394
Limb injury	14.88	13.44	4	83541	9351	29481631
Periportal sinus dilatation	14.86	13.44	5	83540	29	29490953
Intestinal mucosal hypertrophy	14.84	13.44	6	83539	62	29490920
Vestibular neuronitis	14.81	13.44	8	83537	166	29490816
Nasal congestion	14.73	13.44	19	83526	18860	29472122
Rectal stenosis	14.72	13.44	8	83537	168	29490814
Klebsiella infection	14.72	13.44	50	83495	7299	29483683
Colorectal cancer	14.70	13.44	22	83523	1845	29489137
Oedema peripheral	14.69	13.44	205	83340	103352	29387630
Hypersomnia	14.65	13.44	6	83539	10748	29480234
Herpes simplex meningomyelitis	14.62	13.44	3	83542	0	29490982
Tumour fistulisation	14.51	13.44	4	83541	10	29490972
Faeces discoloured	14.45	13.44	10	83535	13341	29477641
Soft tissue swelling	14.44	13.44	10	83535	328	29490654
Product substitution issue	14.44	13.44	4	83541	9168	29481814
Hernia	14.42	13.44	3	83542	8355	29482627
Non-cirrhotic portal hypertension	14.42	13.44	9	83536	247	29490735
Productive cough	14.37	13.44	43	83502	31216	29459766
Rectal haemorrhage	14.32	13.44	155	83390	34394	29456588
Pneumomediastinum	14.27	13.44	21	83524	1735	29489247
Aspergillus infection	14.26	13.44	6	83539	10575	29480407
Astringent therapy	14.23	13.44	4	83541	11	29490971
Stress ulcer	14.12	13.44	6	83539	71	29490911
Suture rupture	14.10	13.44	10	83535	341	29490641
Rectal adenocarcinoma	14.09	13.44	14	83531	766	29490216
Peritoneal disorder	14.04	13.44	9	83536	259	29490723
Adenocarcinoma	14.03	13.44	20	83525	1605	29489377
Chemotherapy	14.01	13.44	12	83533	542	29490440
Peritoneal adhesions	14.00	13.44	7	83538	123	29490859
Axillary vein thrombosis	14.00	13.44	8	83537	186	29490796
Metapneumovirus bronchiolitis	13.98	13.44	4	83541	12	29490970
Temperature difference of extremities	13.98	13.44	4	83541	12	29490970
Cytokine release syndrome	13.97	13.44	10	83535	13109	29477873
Gastrointestinal inflammation	13.89	13.44	28	83517	2980	29488002
Night sweats	13.89	13.44	13	83532	14919	29476063
Duodenal stenosis	13.84	13.44	8	83537	190	29490792
Osteoradionecrosis	13.83	13.44	6	83539	75	29490907
Amnesia	13.69	13.44	27	83518	22616	29468366
Viral infection	13.65	13.44	13	83532	14797	29476185
Full blood count decreased	13.64	13.44	15	83530	15977	29475005
Portal shunt	13.60	13.44	5	83540	39	29490943
Blister	13.59	13.44	22	83523	19884	29471098
Hepatic pain	13.52	13.44	17	83528	1208	29489774
Encapsulating peritoneal sclerosis	13.52	13.44	12	83533	569	29490413
Oesophageal varices haemorrhage	13.50	13.44	26	83519	2676	29488306
Movement disorder	13.49	13.44	6	83539	10231	29480751
Oral dysaesthesia	13.48	13.44	6	83539	80	29490902
Bacteriuria	13.47	13.44	9	83536	278	29490704

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
Neutropenia	2707.94	12.49	2908	133101	236716	64126007
Neuropathy peripheral	1733.17	12.49	1650	134359	115875	64246848
Diarrhoea	1506.44	12.49	4100	131909	718604	63644119
Mucosal inflammation	1432.19	12.49	1130	134879	61454	64301269
Dermatitis acneiform	1263.57	12.49	523	135486	7920	64354803
Disease progression	1125.18	12.49	1438	134571	140242	64222481
Thrombocytopenia	952.28	12.49	1697	134312	222104	64140619
Palmar-plantar erythrodysaesthesia syndrome	912.32	12.49	633	135376	28186	64334537
Febrile neutropenia	836.76	12.49	1453	134556	186204	64176519
Skin toxicity	831.84	12.49	362	135647	6240	64356483
Leukopenia	753.75	12.49	996	135013	100246	64262477
Neurotoxicity	723.20	12.49	539	135470	26865	64335858
Stomatitis	715.82	12.49	1012	134997	108593	64254130
Arteriospasm coronary	628.28	12.49	281	135728	5184	64357539
Metastases to liver	563.69	12.49	440	135569	23501	64339222
Paronychia	534.14	12.49	265	135744	6227	64356496
Interstitial lung disease	497.89	12.49	804	135205	96928	64265795
Neoplasm progression	495.12	12.49	517	135492	40447	64322276
Bone marrow failure	485.06	12.49	551	135458	47401	64315322
Completed suicide	437.53	12.49	7	136002	224407	64138316
Vomiting	428.77	12.49	2288	133721	548829	63813894
Decreased appetite	419.69	12.49	1425	134584	279864	64082859
Drug ineffective	415.80	12.49	711	135298	839536	63523187
Metastases to lung	406.59	12.49	302	135707	14962	64347761
Gastrointestinal toxicity	399.00	12.49	204	135805	5118	64357605
Peripheral sensory neuropathy	398.14	12.49	266	135743	11112	64351611
Malignant neoplasm progression	398.11	12.49	791	135218	112080	64250643
Arthralgia	389.53	12.49	225	135784	442035	63920688
Nausea	385.32	12.49	2899	133110	782901	63579822
Polyneuropathy	358.26	12.49	313	135696	19581	64343142
Hyperammonaemia	354.89	12.49	235	135774	9669	64353054
Cardiotoxicity	351.83	12.49	237	135772	10037	64352686
Proteinuria	336.92	12.49	351	135658	27372	64335351
Neutrophil count decreased	335.78	12.49	592	135417	76604	64286119
Rheumatoid arthritis	305.01	12.49	9	136000	164285	64198438
Product dose omission issue	294.99	12.49	33	135976	194714	64168009
Joint swelling	285.78	12.49	54	135955	215328	64147395
General physical health deterioration	275.44	12.49	1002	135007	203423	64159300
Headache	266.60	12.49	442	135567	529025	63833698
Gastrointestinal perforation	260.52	12.49	155	135854	5269	64357454
Fall	259.88	12.49	298	135711	416528	63946195
Haematotoxicity	256.87	12.49	215	135794	12681	64350042
Hypomagnesaemia	255.37	12.49	353	135656	37023	64325700
Myelosuppression	254.87	12.49	282	135727	23548	64339175
Drug abuse	250.37	12.49	6	136003	132368	64230355
Hyperammonaemic encephalopathy	243.26	12.49	134	135875	3924	64358799
Weight increased	237.48	12.49	77	135932	213271	64149452
Pyrexia	233.83	12.49	1990	134019	556654	63806069
Dehydration	227.05	12.49	982	135027	215781	64146942
Enteritis	223.46	12.49	193	135816	11884	64350839
Portal hypertension	221.44	12.49	147	135862	6072	64356651
Drug interaction	221.15	12.49	263	135746	361820	64000903
Paraesthesia	213.89	12.49	697	135312	133825	64228898
Acute myeloid leukaemia	209.94	12.49	274	135735	27189	64335534
Sinusitis	205.85	12.49	31	135978	145897	64216826
Intestinal obstruction	203.24	12.49	312	135697	35974	64326749
Pulmonary embolism	201.74	12.49	723	135286	145633	64217090
Pain	180.76	12.49	583	135426	552928	63809795
Injection site pain	178.84	12.49	15	135994	111393	64251330
Therapeutic product effect decreased	178.56	12.49	18	135991	115333	64247390
Abdominal discomfort	174.56	12.49	83	135926	182239	64180484
Abdominal pain	172.36	12.49	1188	134821	311187	64051536
Peripheral swelling	171.85	12.49	115	135894	209038	64153685
Nasopharyngitis	169.06	12.49	102	135907	195971	64166752
Pain in extremity	168.60	12.49	236	135773	302849	64059874
Swelling	167.65	12.49	64	135945	160154	64202569
Metastases to lymph nodes	164.71	12.49	141	135868	8576	64354147
Extravasation	158.29	12.49	93	135916	3087	64359636
Depression	155.72	12.49	97	135912	183194	64179529
Asthenia	155.21	12.49	1479	134530	426565	63936158
Product use issue	153.18	12.49	64	135945	151651	64211072
Contusion	152.29	12.49	28	135981	113937	64248786
Anxiety	150.25	12.49	124	135885	202525	64160198
Ileus	148.07	12.49	211	135798	22755	64339968
Oesophageal fistula	145.95	12.49	45	135964	266	64362457
Contraindicated product administered	145.15	12.49	26	135983	107803	64254920
Arthropathy	144.91	12.49	38	135971	120929	64241794
Anaemia	144.51	12.49	1323	134686	377357	63985366
Drug hypersensitivity	140.54	12.49	177	135832	237638	64125085
Systemic lupus erythematosus	137.92	12.49	6	136003	77606	64285117
Therapy partial responder	137.67	12.49	137	135872	10111	64352612
Hypokalaemia	137.36	12.49	565	135444	121338	64241385
Posterior reversible encephalopathy syndrome	135.14	12.49	202	135807	22744	64339979
Chills	134.57	12.49	610	135399	136654	64226069
Focal nodular hyperplasia	134.29	12.49	51	135958	606	64362117
Musculoskeletal stiffness	130.91	12.49	48	135961	123158	64239565
Second primary malignancy	130.19	12.49	145	135864	12192	64350531
Carcinoembryonic antigen increased	129.49	12.49	68	135941	1805	64360918
Metastases to bone	127.72	12.49	185	135824	20250	64342473
Large intestine perforation	127.64	12.49	145	135864	12459	64350264
Hypertransaminasaemia	127.15	12.49	112	135897	7079	64355644
Insomnia	126.80	12.49	138	135871	197698	64165025
Administration site extravasation	126.67	12.49	56	135953	1003	64361720
Colorectal cancer metastatic	125.36	12.49	54	135955	906	64361817
Pneumatosis intestinalis	124.97	12.49	97	135912	5132	64357591
Laryngospasm	124.03	12.49	82	135927	3363	64359360
Ascites	121.64	12.49	346	135663	61655	64301068
Acute promyelocytic leukaemia	121.15	12.49	59	135950	1329	64361394
Intentional product misuse	120.95	12.49	8	136001	72287	64290436
Peritonitis	120.67	12.49	201	135808	24822	64337901
Influenza	119.25	12.49	38	135971	106493	64256230
Suicide attempt	118.37	12.49	8	136001	70999	64291724
Somnolence	117.78	12.49	154	135855	203491	64159232
Portal venous gas	116.25	12.49	39	135970	313	64362410
Leukoencephalopathy	116.23	12.49	105	135904	6862	64355861
Hospitalisation	115.69	12.49	12	135997	75195	64287528
Rhabdomyolysis	113.36	12.49	27	135982	91699	64271024
Arthritis	113.25	12.49	20	135989	83794	64278929
Venoocclusive liver disease	113.13	12.49	122	135887	9893	64352830
Psoriasis	111.45	12.49	11	135998	71692	64291031
Intestinal perforation	111.19	12.49	149	135860	15164	64347559
Ejection fraction decreased	110.59	12.49	209	135800	28498	64334225
Cardiomyopathy	108.28	12.49	193	135816	25163	64337560
Cholangitis	107.24	12.49	123	135886	10679	64352044
Hiccups	107.06	12.49	109	135900	8267	64354456
Dizziness	106.92	12.49	505	135504	429658	63933065
Electrocardiogram ST segment elevation	106.79	12.49	102	135907	7157	64355566
Subileus	105.41	12.49	86	135923	4891	64357832
Stress cardiomyopathy	104.97	12.49	113	135896	9144	64353579
Septic shock	104.38	12.49	470	135539	104967	64257756
Suicidal ideation	103.97	12.49	10	135999	66532	64296191
Neutropenic sepsis	103.07	12.49	180	135829	23092	64339631
Neutropenic colitis	103.06	12.49	82	135927	4499	64358224
Chronic obstructive pulmonary disease	102.70	12.49	14	135995	71034	64291689
Anastomotic leak	102.56	12.49	47	135962	919	64361804
Overdose	100.36	12.49	113	135896	159453	64203270
Skin reaction	100.29	12.49	127	135882	12225	64350498
Rash pustular	98.88	12.49	113	135896	9772	64352951
Tumour necrosis	98.51	12.49	55	135954	1654	64361069
Epistaxis	94.57	12.49	434	135575	97697	64265026
Maternal exposure during pregnancy	94.28	12.49	42	135967	95842	64266881
Injury	94.24	12.49	6	136003	55986	64306737
Wound	93.54	12.49	23	135986	76454	64286269
Injection site erythema	93.28	12.49	18	135991	70782	64291941
Asthma	93.18	12.49	42	135967	95183	64267540
Bronchitis	93.07	12.49	57	135952	108686	64254037
Cholinergic syndrome	92.60	12.49	42	135967	801	64361922
Pemphigus	92.56	12.49	10	135999	60691	64302032
Small intestinal obstruction	92.52	12.49	173	135836	23400	64339323
Pelvic abscess	91.94	12.49	54	135955	1791	64360932
Feeling abnormal	91.47	12.49	88	135921	133514	64229209
Aorto-oesophageal fistula	90.80	12.49	23	135986	55	64362668
Myalgia	90.62	12.49	121	135888	158496	64204227
Stress	89.73	12.49	11	135998	60523	64302200
Wheezing	89.72	12.49	29	135980	80550	64282173
Electrocardiogram QT prolonged	89.51	12.49	28	135981	79420	64283303
Non-cirrhotic portal hypertension	89.25	12.49	33	135976	362	64362361
Dermatitis	88.51	12.49	146	135863	17883	64344840
Migraine	86.79	12.49	14	135995	62663	64300060
White blood cell count decreased	86.08	12.49	599	135410	157238	64205485
Condition aggravated	85.72	12.49	449	135560	371977	63990746
Mucosal toxicity	85.69	12.49	34	135975	458	64362265
Nodular regenerative hyperplasia	85.12	12.49	40	135969	830	64361893
Hepatic enzyme increased	85.05	12.49	89	135920	129854	64232869
Pneumonia	84.09	12.49	765	135244	558811	63803912
Rectal perforation	83.91	12.49	38	135971	722	64362001
Osteoarthritis	83.66	12.49	16	135993	63320	64299403
Fluid retention	83.24	12.49	13	135996	59593	64303130
Device related infection	82.93	12.49	193	135816	30433	64332290
Glossodynia	82.02	12.49	18	135991	64678	64298045
Drug intolerance	81.83	12.49	171	135838	187821	64174902
Acute coronary syndrome	81.19	12.49	146	135863	19164	64343559
Dry skin	81.12	12.49	265	135744	50896	64311827
Ileal perforation	80.96	12.49	39	135970	857	64361866
Splenomegaly	80.94	12.49	140	135869	17821	64344902
Aggression	80.75	12.49	4	136005	46228	64316495
Mobility decreased	80.70	12.49	40	135969	85800	64276923
Aortic thrombosis	79.92	12.49	46	135963	1468	64361255
Confusional state	79.55	12.49	283	135726	260861	64101862
Tumour perforation	78.77	12.49	29	135980	314	64362409
Hyperbilirubinaemia	78.74	12.49	152	135857	21053	64341670
Intravascular haemolysis	76.35	12.49	35	135974	685	64362038
Device related thrombosis	75.96	12.49	50	135959	2035	64360688
Treatment failure	75.34	12.49	81	135928	116735	64245988
Bradycardia	75.11	12.49	83	135926	118136	64244587
Incorrect dose administered	74.85	12.49	18	135991	60747	64301976
Dihydropyrimidine dehydrogenase deficiency	74.75	12.49	22	135987	108	64362615
Blood cholesterol increased	74.45	12.49	9	136000	50057	64312666
Venous thrombosis	74.31	12.49	79	135930	6302	64356421
Disseminated intravascular coagulation	73.93	12.49	191	135818	32157	64330566
Metastases to peritoneum	72.42	12.49	60	135949	3487	64359236
Gait disturbance	72.09	12.49	160	135849	171995	64190728
Vena cava thrombosis	72.08	12.49	52	135957	2460	64360263
Lower respiratory tract infection	71.18	12.49	57	135952	94557	64268166
Enterocutaneous fistula	70.90	12.49	43	135966	1514	64361209
Colitis	70.06	12.49	277	135732	58397	64304326
Subacute cutaneous lupus erythematosus	69.88	12.49	55	135954	2970	64359753
Discomfort	69.75	12.49	42	135967	80836	64281887
Loss of personal independence in daily activities	69.26	12.49	33	135976	72421	64290302
Memory impairment	69.12	12.49	48	135961	85634	64277089
Large intestinal obstruction	68.69	12.49	52	135957	2650	64360073
Nicotinic acid deficiency	68.27	12.49	21	135988	123	64362600
Injection site swelling	67.93	12.49	5	136004	41348	64321375
Gastrointestinal necrosis	67.54	12.49	67	135942	4925	64357798
Necrotising fasciitis	67.51	12.49	69	135940	5257	64357466
Anastomotic complication	67.36	12.49	27	135982	374	64362349
Irritable bowel syndrome	66.02	12.49	3	136006	37366	64325357
Injection site reaction	65.57	12.49	10	135999	46654	64316069
Balance disorder	65.11	12.49	49	135960	83877	64278846
Left ventricular dysfunction	64.76	12.49	123	135886	16831	64345892
Cough	64.69	12.49	373	135636	301775	64060948
Hallucination	63.90	12.49	37	135972	72751	64289972
Pruritus	63.54	12.49	392	135617	312008	64050715
Liver abscess	62.60	12.49	66	135943	5214	64357509
Acute abdomen	62.35	12.49	50	135959	2774	64359949
Exposure during pregnancy	62.01	12.49	44	135965	77631	64285092
Urticaria	61.60	12.49	137	135872	147180	64215543
Deep vein thrombosis	60.78	12.49	405	135604	104777	64257946
Febrile bone marrow aplasia	60.52	12.49	95	135914	11160	64351563
Tumour lysis syndrome	59.91	12.49	129	135880	19311	64343412
Hypertension	59.40	12.49	820	135189	258441	64104282
Helicobacter infection	59.31	12.49	6	136003	38356	64324367
Tremor	58.64	12.49	142	135867	148088	64214635
Cardiac failure congestive	58.31	12.49	117	135892	130463	64232260
Hypophagia	58.28	12.49	200	135809	39387	64323336
Blister	58.17	12.49	51	135958	80916	64281807
Sedation	57.99	12.49	9	136000	41453	64321270
Colony stimulating factor therapy	57.65	12.49	26	135983	489	64362234
Emotional distress	57.41	12.49	5	136004	36033	64326690
Respiratory arrest	57.35	12.49	20	135989	52965	64309758
Embolism	57.28	12.49	97	135912	12138	64350585
Dysphonia	56.20	12.49	220	135789	46162	64316561
Sepsis	55.83	12.49	736	135273	229605	64133118
Blood pressure fluctuation	55.43	12.49	20	135989	51851	64310872
Treatment noncompliance	55.31	12.49	12	135997	43470	64319253
Dysgeusia	54.47	12.49	220	135789	46827	64315896
Heart rate decreased	54.31	12.49	24	135985	55043	64307680
Nasal congestion	54.28	12.49	29	135980	59629	64303094
Recall phenomenon	54.26	12.49	31	135978	975	64361748
Plasma cell myeloma	54.16	12.49	15	135994	46060	64316663
Coronary artery disease	54.08	12.49	30	135979	60403	64302320
Small intestinal perforation	53.42	12.49	44	135965	2536	64360187
Biliary tract infection	53.17	12.49	30	135979	921	64361802
Anastomotic fistula	53.17	12.49	16	135993	86	64362637
Haemolytic anaemia	52.33	12.49	109	135900	15944	64346779
Hepatic lesion	52.30	12.49	63	135946	5761	64356962
Intentional product use issue	52.18	12.49	75	135934	95289	64267434
Carbohydrate antigen 19-9 increased	51.74	12.49	22	135987	357	64362366
Pulmonary artery thrombosis	51.58	12.49	32	135977	1174	64361549
Duodenal perforation	51.50	12.49	38	135971	1862	64360861
Unevaluable event	51.40	12.49	21	135988	50468	64312255
Trichomegaly	51.24	12.49	15	135994	72	64362651
International normalised ratio increased	50.92	12.49	55	135954	79112	64283611
Intestinal ischaemia	50.71	12.49	89	135920	11460	64351263
Renal salt-wasting syndrome	50.60	12.49	23	135986	441	64362282
Skin fissures	49.97	12.49	83	135926	10223	64352500
Conjunctival filtering bleb leak	49.87	12.49	12	135997	21	64362702
Portal vein thrombosis	49.83	12.49	57	135952	4934	64357789
Toxicity to various agents	49.79	12.49	508	135501	363005	63999718
Oesophagitis	49.72	12.49	128	135881	21502	64341221
Muscle spasms	49.04	12.49	144	135865	140879	64221844
Blood glucose increased	49.01	12.49	82	135927	97991	64264732
Metastasis	48.54	12.49	60	135949	5635	64357088
Vasospasm	48.18	12.49	28	135981	910	64361813
Proctalgia	48.06	12.49	69	135940	7490	64355233
Red blood cell sedimentation rate increased	47.99	12.49	5	136004	31230	64331493
Hypoglycaemia	47.91	12.49	72	135937	89820	64272903
Fistula	47.85	12.49	79	135930	9682	64353041
Hyperkalaemia	47.42	12.49	88	135921	101041	64261682
Jugular vein thrombosis	47.41	12.49	49	135960	3782	64358941
Agitation	46.88	12.49	71	135938	88296	64274427
Steatohepatitis	46.47	12.49	26	135983	785	64361938
Skin disorder	46.25	12.49	146	135863	27534	64335189
Blood pressure increased	46.09	12.49	197	135812	172355	64190368
Enterocolitis	45.67	12.49	87	135922	11931	64350792
Oesophageal stenosis	45.59	12.49	48	135961	3786	64358937
Immune thrombocytopenia	45.31	12.49	99	135910	14967	64347756
Hypoalbuminaemia	45.27	12.49	109	135900	17565	64345158
Irritability	45.03	12.49	11	135998	36735	64325988
Dysarthria	44.67	12.49	245	135764	59161	64303562
Drug level increased	44.40	12.49	9	136000	34187	64328536
Dysphagia	44.07	12.49	380	135629	106432	64256291
Acral peeling skin syndrome	43.57	12.49	12	135997	44	64362679
Toxic leukoencephalopathy	43.55	12.49	26	135983	889	64361834
Pelvic fluid collection	43.30	12.49	23	135986	625	64362098
COVID-19	43.30	12.49	44	135965	65096	64297627
Congestive cardiomyopathy	43.21	12.49	78	135931	10266	64352457
Stoma site haemorrhage	43.13	12.49	32	135977	1581	64361142
Psychotic disorder	43.06	12.49	10	135999	34568	64328155
Adverse drug reaction	43.00	12.49	21	135988	45443	64317280
Subclavian vein thrombosis	42.84	12.49	37	135972	2277	64360446
Sleep apnoea syndrome	42.82	12.49	6	136003	29826	64332897
Underdose	42.78	12.49	3	136006	25826	64336897
Herpes zoster	42.61	12.49	63	135946	79124	64283599
Metastases to meninges	42.25	12.49	40	135969	2775	64359948
Hypervolaemia	42.22	12.49	14	135995	38271	64324452
Gastrooesophageal reflux disease	42.02	12.49	69	135940	83074	64279649
Odynophagia	41.95	12.49	74	135935	9567	64353156
Cellulitis	41.73	12.49	84	135925	93573	64269150
Gastric perforation	41.70	12.49	44	135965	3479	64359244
Metastases to skin	41.53	12.49	30	135979	1422	64361301
Myocardial infarction	41.47	12.49	194	135815	165627	64197096
Metastases to central nervous system	41.37	12.49	91	135918	13821	64348902
Drug ineffective for unapproved indication	40.82	12.49	8	136001	31125	64331598
Blood pressure systolic increased	40.82	12.49	27	135982	49426	64313297
Liver function test abnormal	40.78	12.49	39	135970	59362	64303361
Aplasia	40.63	12.49	61	135948	6892	64355831
Prinzmetal angina	40.60	12.49	30	135979	1473	64361250
Gastrointestinal anastomotic leak	40.49	12.49	19	135990	393	64362330
Venous thrombosis limb	40.31	12.49	45	135964	3792	64358931
Transdifferentiation of neoplasm	40.29	12.49	13	135996	91	64362632
Gastrointestinal stoma complication	40.02	12.49	35	135974	2191	64360532
Palpitations	39.83	12.49	102	135907	104386	64258337
Pulmonary fibrosis	39.73	12.49	146	135863	29732	64332991
Injection site haemorrhage	39.69	12.49	3	136006	24275	64338448
Bacterial translocation	39.59	12.49	19	135990	414	64362309
Tumour ulceration	39.36	12.49	15	135994	180	64362543
Conjunctivitis	39.33	12.49	113	135896	20241	64342482
Cachexia	39.14	12.49	70	135939	9147	64353576
Aortitis	39.14	12.49	26	135983	1075	64361648
Varices oesophageal	38.91	12.49	51	135958	5079	64357644
Nephrolithiasis	38.63	12.49	22	135987	43661	64319062
Proctitis	38.37	12.49	40	135969	3119	64359604
Full blood count abnormal	38.28	12.49	8	136001	29749	64332974
Anal haemorrhage	38.27	12.49	41	135968	3299	64359424
Withdrawal syndrome	38.13	12.49	3	136006	23489	64339234
Encapsulating peritoneal sclerosis	38.12	12.49	23	135986	802	64361921
Head injury	38.03	12.49	11	135998	32831	64329892
Enterovesical fistula	37.67	12.49	24	135985	923	64361800
Wrong technique in product usage process	37.66	12.49	49	135960	64925	64297798
Dyskinesia	37.55	12.49	18	135991	39370	64323353
Fistula of small intestine	37.54	12.49	21	135988	634	64362089
Type II hypersensitivity	37.12	12.49	10	135999	33	64362690
Troponin I increased	37.07	12.49	43	135966	3778	64358945
Short-bowel syndrome	36.78	12.49	18	135991	410	64362313
Agranulocytosis	36.74	12.49	169	135840	38060	64324663
Colon cancer recurrent	36.48	12.49	12	135997	90	64362633
Accidental exposure to product	36.25	12.49	6	136003	26358	64336365
Upper respiratory tract infection	36.23	12.49	61	135948	72724	64289999
Colon cancer metastatic	36.11	12.49	31	135978	1892	64360831
Nephrotic syndrome	36.03	12.49	69	135940	9498	64353225
Abnormal behaviour	35.86	12.49	13	135996	33609	64329114
Malignant ascites	35.66	12.49	24	135985	1014	64361709
Hepatic failure	35.50	12.49	219	135790	55175	64307548
Cytomegalovirus infection	35.46	12.49	17	135992	37182	64325541
K-ras gene mutation	35.43	12.49	10	135999	41	64362682
Product prescribing error	35.37	12.49	15	135994	35254	64327469
Dysaesthesia	35.34	12.49	48	135961	4947	64357776
Ocular toxicity	35.10	12.49	20	135989	626	64362097
Illness	35.06	12.49	3	136006	21935	64340788
Right ventricular ejection fraction decreased	35.05	12.49	10	135999	43	64362680
Hypovolaemic shock	34.99	12.49	71	135938	10195	64352528
Poisoning	34.94	12.49	3	136006	21876	64340847
Superior vena cava syndrome	34.90	12.49	24	135985	1051	64361672
Heart rate increased	34.85	12.49	100	135909	98575	64264148
Sleep disorder	34.63	12.49	45	135964	59664	64303059
Factor VII deficiency	34.57	12.49	9	136000	25	64362698
Xerosis	34.55	12.49	23	135986	954	64361769
Vision blurred	34.55	12.49	88	135921	90228	64272495
Miller Fisher syndrome	34.49	12.49	13	135996	151	64362572
Rib fracture	34.12	12.49	5	136004	24033	64338690
Eosinophilia	33.92	12.49	19	135990	38057	64324666
Atypical haemolytic uraemic syndrome	33.82	12.49	20	135989	672	64362051
Joint stiffness	33.73	12.49	11	135998	30393	64332330
Viral infection	33.72	12.49	17	135992	36123	64326600
Haemolytic uraemic syndrome	33.69	12.49	42	135967	3979	64358744
Off label use	33.36	12.49	1642	134367	631164	63731559
Splenic artery thrombosis	33.35	12.49	10	135999	53	64362670
Type 2 diabetes mellitus	33.28	12.49	15	135994	34005	64328718
Productive cough	33.17	12.49	65	135944	73138	64289585
C-reactive protein abnormal	33.14	12.49	10	135999	29037	64333686
Hepatitis B	33.12	12.49	59	135950	7686	64355037
Hypertensive crisis	33.05	12.49	99	135910	18149	64344574
Female genital tract fistula	32.90	12.49	34	135975	2624	64360099
Anal erythema	32.77	12.49	13	135996	175	64362548
Performance status decreased	32.70	12.49	48	135961	5316	64357407
Radiation skin injury	32.50	12.49	25	135984	1305	64361418
Sopor	32.44	12.49	11	135998	29650	64333073
Therapy cessation	32.29	12.49	14	135995	32475	64330248
Incorrect drug administration rate	32.26	12.49	34	135975	2685	64360038
Perineal disorder	32.23	12.49	8	136001	17	64362706
Oesophageal varices haemorrhage	32.17	12.49	39	135970	3590	64359133
Oral pain	32.17	12.49	129	135880	27364	64335359
Refeeding syndrome	32.17	12.49	10	135999	61	64362662
Rectal haemorrhage	32.14	12.49	232	135777	61585	64301138
Joint injury	32.05	12.49	5	136004	22942	64339781
Adverse event	32.00	12.49	22	135987	39467	64323256
Diabetes mellitus	31.91	12.49	57	135952	66417	64296306
Lung neoplasm malignant	31.53	12.49	4	136005	21444	64341279
Adenocarcinoma of colon	31.49	12.49	45	135964	4863	64357860
Cardiac disorder	31.42	12.49	43	135966	55773	64306950
Pulmonary toxicity	31.33	12.49	61	135948	8500	64354223
Neck pain	31.15	12.49	51	135958	61482	64301241
Thrombocytopenic purpura	31.08	12.49	30	135979	2132	64360591
Oesophageal perforation	30.90	12.49	22	135987	1019	64361704
Visual impairment	30.86	12.49	69	135940	74008	64288715
Cytomegalovirus oesophagitis	30.78	12.49	18	135991	592	64362131
Cataract	30.39	12.49	38	135971	51224	64311499
Blood creatine phosphokinase increased	30.15	12.49	48	135961	58510	64304213
Tumour haemorrhage	30.09	12.49	37	135972	3456	64359267
Cardiac arrest	29.89	12.49	196	135813	153868	64208855
Myoclonus	29.85	12.49	8	136001	25110	64337613
Road traffic accident	29.38	12.49	14	135995	30731	64331992
Crying	28.93	12.49	4	136005	20086	64342637
Tumour marker increased	28.85	12.49	36	135973	3414	64359309
Diaphragmatic paralysis	28.75	12.49	21	135988	1013	64361710
Mental disorder	28.59	12.49	10	135999	26435	64336288
Pneumonitis	28.52	12.49	193	135816	50172	64312551
Duodenal ulcer perforation	28.45	12.49	19	135990	34606	64328117
Toxic epidermal necrolysis	28.44	12.49	22	135987	37144	64325579
Hepatic atrophy	28.26	12.49	15	135994	407	64362316
Aphthous ulcer	28.25	12.49	75	135934	12831	64349892
Accidental overdose	28.13	12.49	18	135991	33539	64329184
Pregnancy	28.13	12.49	5	136004	20860	64341863
Nephritis bacterial	27.93	12.49	8	136001	35	64362688
Periportal sinus dilatation	27.93	12.49	8	136001	35	64362688
Pericarditis	27.91	12.49	56	135953	62460	64300263
Chronic myeloid leukaemia	27.88	12.49	35	135974	3339	64359384
Product quality issue	27.83	12.49	14	135995	29785	64332938
Hyperthermia	27.82	12.49	84	135925	15466	64347257
Induration	27.60	12.49	25	135984	1639	64361084
Metastases to the mediastinum	27.59	12.49	16	135993	518	64362205
Pancytopenia	27.57	12.49	440	135569	142869	64219854
White blood cell count abnormal	27.54	12.49	42	135967	4812	64357911
Portal shunt	27.53	12.49	9	136000	66	64362657
Chronic kidney disease	27.50	12.49	50	135959	57869	64304854
Nail disorder	27.46	12.49	58	135951	8566	64354157
Diffuse alveolar damage	27.44	12.49	34	135975	3201	64359522
Oesophagobronchial fistula	27.40	12.49	12	135997	210	64362513
Prescribed underdose	27.38	12.49	3	136006	18012	64344711
Osteoporosis	27.32	12.49	29	135980	42051	64320672
Kidney infection	27.03	12.49	3	136006	17835	64344888
Abdominal abscess	26.93	12.49	48	135961	6256	64356467
Ear infection	26.80	12.49	8	136001	23396	64339327
Cystitis radiation	26.78	12.49	10	135999	113	64362610
Night sweats	26.75	12.49	22	135987	36024	64326699
Multiple sclerosis	26.74	12.49	4	136005	18937	64343786
Cell-mediated cytotoxicity	26.74	12.49	8	136001	42	64362681
Haematoma	26.68	12.49	35	135974	46215	64316508
Organising pneumonia	26.66	12.49	59	135950	8996	64353727
Protein urine	26.65	12.49	22	135987	1272	64361451
Sciatic nerve palsy	26.64	12.49	9	136000	74	64362649
Metastases to chest wall	26.47	12.49	14	135995	377	64362346
Pigmentation disorder	26.29	12.49	40	135969	4572	64358151
Guillain-Barre syndrome	26.25	12.49	53	135956	7582	64355141
Balanoposthitis	26.22	12.49	18	135991	786	64361937
Hallucination, visual	26.11	12.49	13	135996	27821	64334902
Urinary tract infection	26.06	12.49	338	135671	231258	64131465
Erythema	26.04	12.49	546	135463	186524	64176199
Cystitis	25.97	12.49	31	135978	42644	64320079
Injection site mass	25.93	12.49	3	136006	17267	64345456
Proteus infection	25.92	12.49	24	135985	1619	64361104
Venous pressure jugular decreased	25.83	12.49	9	136000	82	64362641
Koebner phenomenon	25.71	12.49	8	136001	49	64362674
Chemotherapy	25.70	12.49	23	135986	1484	64361239
Extrapyramidal disorder	25.69	12.49	5	136004	19547	64343176
Back pain	25.68	12.49	372	135637	249799	64112924
Neuromyotonia	25.63	12.49	9	136000	84	64362639
VIth nerve disorder	25.56	12.49	7	136002	25	64362698
NPM1 gene mutation	25.52	12.49	10	135999	130	64362593
Pain in jaw	25.45	12.49	29	135980	40726	64321997
Gastric disorder	25.40	12.49	15	135994	29182	64333541
Amnesia	25.39	12.49	39	135970	48230	64314493
Joint range of motion decreased	25.30	12.49	5	136004	19338	64343385
Retroperitoneal abscess	25.24	12.49	13	135996	331	64362392
Limb injury	25.22	12.49	9	136000	23496	64339227
PIK3CA-activated mutation	25.20	12.49	15	135994	510	64362213
Metastases to pleura	25.01	12.49	21	135988	1243	64361480
Myocarditis	24.99	12.49	86	135923	16957	64345766
Adenocarcinoma	24.93	12.49	33	135976	3318	64359405
Musculoskeletal disorder	24.78	12.49	4	136005	17902	64344821
Muscle spasticity	24.77	12.49	3	136006	16666	64346057
Muscular weakness	24.70	12.49	162	135847	127176	64235547
Stridor	24.64	12.49	40	135969	4834	64357889
Ectropion	24.62	12.49	13	135996	349	64362374
Nervousness	24.58	12.49	16	135993	29540	64333183
Eye disorder	24.42	12.49	5	136004	18864	64343859
Hiatus hernia	24.40	12.49	6	136003	19951	64342772
Myopathy	24.36	12.49	4	136005	17676	64345047
Cerebral haemorrhage	24.35	12.49	44	135965	51046	64311677
Alopecia	24.18	12.49	487	135522	165203	64197520
Localised infection	24.18	12.49	17	135992	30144	64332579
Death	24.17	12.49	805	135204	481900	63880823
Musculoskeletal discomfort	24.02	12.49	3	136006	16274	64346449
Disturbance in attention	23.77	12.49	31	135978	41043	64321680
Toxic erythema of chemotherapy	23.73	12.49	11	135998	221	64362502
Gastrointestinal inflammation	23.73	12.49	45	135964	6150	64356573
Rectal tenesmus	23.69	12.49	19	135990	1054	64361669
Perforation bile duct	23.68	12.49	7	136002	35	64362688
Myelodysplastic syndrome	23.66	12.49	118	135891	27461	64335262
Gastrointestinal stoma output increased	23.64	12.49	11	135998	223	64362500
Platelet count decreased	23.51	12.49	490	135519	167221	64195502
Portal vein embolisation	23.50	12.49	6	136003	15	64362708
Mood altered	23.44	12.49	3	136006	15976	64346747
Radiation mucositis	23.36	12.49	10	135999	165	64362558
Anal erosion	23.20	12.49	7	136002	38	64362685
Evans syndrome	23.13	12.49	13	135996	396	64362327
Infusion related hypersensitivity reaction	23.09	12.49	10	135999	170	64362553
Nasal septum perforation	23.04	12.49	16	135993	712	64362011
Inappropriate schedule of product administration	23.04	12.49	108	135901	92178	64270545
Bacteraemia	22.99	12.49	115	135894	26796	64335927
Anger	22.99	12.49	3	136006	15738	64346985
Medication error	22.96	12.49	44	135965	49922	64312801
Cardio-respiratory arrest	22.92	12.49	118	135891	98275	64264448
Jaundice	22.91	12.49	178	135831	48334	64314389
Laryngeal oedema	22.84	12.49	48	135961	7065	64355658
Musculoskeletal pain	22.82	12.49	91	135918	81203	64281520
Oesophageal haemorrhage	22.81	12.49	22	135987	1562	64361161
Colitis ulcerative	22.76	12.49	10	135999	23018	64339705
Faeces discoloured	22.69	12.49	13	135996	25716	64337007
Movement disorder	22.64	12.49	9	136000	21991	64340732
Encephalopathy	22.57	12.49	206	135803	58613	64304110
Anal fistula	22.44	12.49	40	135969	5213	64357510
Biliary fistula	22.39	12.49	8	136001	79	64362644
Metastases to pelvis	22.32	12.49	14	135995	524	64362199
Astringent therapy	22.23	12.49	6	136003	20	64362703
Neoplasm recurrence	22.13	12.49	33	135976	3706	64359017
Device issue	22.13	12.49	10	135999	22638	64340085
Prothrombin level decreased	22.08	12.49	21	135988	1465	64361258
Full blood count decreased	22.02	12.49	10	135999	22572	64340151
Rectal cancer metastatic	22.00	12.49	13	135996	436	64362287
Oxygen saturation decreased	21.99	12.49	134	135875	107042	64255681
Pneumonitis chemical	21.98	12.49	12	135997	345	64362378
Dysaesthesia pharynx	21.80	12.49	10	135999	196	64362527
Wound dehiscence	21.67	12.49	42	135967	5832	64356891
Gout	21.64	12.49	9	136000	21404	64341319
Anaemia of malignant disease	21.61	12.49	15	135994	667	64362056
Interventricular septum rupture	21.58	12.49	6	136003	23	64362700
Gait inability	21.55	12.49	35	135974	42333	64320390
Necrotising colitis	21.45	12.49	17	135992	927	64361796
Eye pain	21.43	12.49	21	135988	31604	64331119
Blood glucose decreased	21.39	12.49	11	135998	23112	64339611
Subdural haematoma	20.97	12.49	17	135992	28037	64334686
Delusion	20.92	12.49	6	136003	18008	64344715
Angioedema	20.85	12.49	64	135945	61757	64300966
Anorectal discomfort	20.83	12.49	28	135981	2857	64359866
Anorectal disorder	20.82	12.49	23	135986	1916	64360807
Pancreatic neuroendocrine tumour metastatic	20.77	12.49	8	136001	99	64362624
Depressed mood	20.75	12.49	34	135975	40978	64321745
Gastrointestinal ischaemia	20.73	12.49	12	135997	387	64362336
Pulmonary arterial hypertension	20.73	12.49	14	135995	25353	64337370
Fungal infection	20.71	12.49	25	135984	34226	64328497
Microgenia	20.69	12.49	5	136004	9	64362714
Haemoglobinuria	20.64	12.49	15	135994	718	64362005
Pneumoperitoneum	20.63	12.49	27	135982	2684	64360039
Radiation interaction	20.57	12.49	7	136002	59	64362664
Ischiorectal hernia	20.35	12.49	5	136004	10	64362713
Sarcoidosis	20.35	12.49	42	135967	6104	64356619
Anal fissure	20.34	12.49	37	135972	4899	64357824
Breast cancer metastatic	20.31	12.49	46	135963	7123	64355600
Incorrect route of product administration	20.22	12.49	12	135997	23286	64339437
Acute respiratory distress syndrome	20.16	12.49	146	135863	38789	64323934
Respiratory disorder	20.14	12.49	28	135981	36083	64326640
Breast cancer recurrent	20.09	12.49	26	135983	2557	64360166
Pachymeningitis	20.07	12.49	10	135999	237	64362486
Pseudocirrhosis	20.00	12.49	14	135995	631	64362092
Thrombotic thrombocytopenic purpura	19.94	12.49	41	135968	5943	64356780
Acute interstitial pneumonitis	19.91	12.49	17	135992	1030	64361693
Pulmonary infarction	19.88	12.49	29	135980	3193	64359530
Tendonitis	19.75	12.49	9	136000	20273	64342450
Tympanic membrane disorder	19.73	12.49	9	136000	174	64362549
Rash pruritic	19.66	12.49	59	135950	57345	64305378
Intervertebral disc protrusion	19.59	12.49	9	136000	20182	64342541
Hepatectomy	19.59	12.49	9	136000	177	64362546
Spinal stenosis	19.53	12.49	3	136006	13928	64348795
Depilation	19.44	12.49	5	136004	13	64362710
Bronchiolitis obliterans syndrome	19.44	12.49	10	135999	254	64362469
Clostridial infection	19.38	12.49	37	135972	5082	64357641
Restless legs syndrome	19.33	12.49	6	136003	17110	64345613
No adverse event	19.31	12.49	19	135990	28542	64334181
Nail toxicity	19.28	12.49	11	135998	345	64362378
Soft tissue necrosis	19.19	12.49	14	135995	674	64362049
Renal disorder	19.15	12.49	28	135981	35337	64327386
Intracardiac thrombus	19.07	12.49	31	135978	3750	64358973
Vascular pain	19.04	12.49	15	135994	811	64361912
Nodule	19.04	12.49	7	136002	17940	64344783
Chimerism	19.02	12.49	10	135999	266	64362457
Vocal cord paralysis	18.92	12.49	23	135986	2123	64360600
Bile duct stenosis	18.87	12.49	21	135988	1763	64360960
Hydronephrosis	18.76	12.49	69	135940	14056	64348667
Hernia	18.75	12.49	3	136006	13515	64349208
Bursitis	18.74	12.49	11	135998	21474	64341249
Influenza like illness	18.66	12.49	67	135942	61635	64301088
Perihepatic abscess	18.58	12.49	8	136001	134	64362589
Metastases to spine	18.55	12.49	30	135979	3613	64359110
Scintillating scotoma	18.55	12.49	9	136000	201	64362522
Lip swelling	18.55	12.49	24	135985	31883	64330840
Dyspnoea	18.52	12.49	1286	134723	717388	63645335
Lymphadenopathy mediastinal	18.50	12.49	31	135978	3845	64358878
Visceral venous thrombosis	18.45	12.49	5	136004	17	64362706
Haemorrhage intracranial	18.45	12.49	14	135995	23870	64338853
Ventricular fibrillation	18.33	12.49	99	135910	23761	64338962
Creatinine renal clearance decreased	18.30	12.49	4	136005	14417	64348306
Foot deformity	18.26	12.49	6	136003	16498	64346225
Gait apraxia	18.23	12.49	5	136004	18	64362705
Chemotherapy cardiotoxicity attenuation	18.23	12.49	5	136004	18	64362705
Sinus congestion	18.19	12.49	5	136004	15434	64347289
Paraesthesia oral	18.16	12.49	65	135944	13066	64349657
Basal cell carcinoma	18.13	12.49	23	135986	30815	64331908
Swelling face	18.06	12.49	64	135945	59102	64303621
Peritoneal neoplasm	18.01	12.49	7	136002	89	64362634
Neonatal asphyxia	17.89	12.49	4	136005	4	64362719
Intrahepatic portal hepatic venous fistula	17.89	12.49	4	136005	4	64362719
Therapy interrupted	17.84	12.49	10	135999	20026	64342697
Thrombocytopenia neonatal	17.81	12.49	5	136004	20	64362703
Neutrophil count abnormal	17.77	12.49	26	135983	2870	64359853
Drug-induced liver injury	17.77	12.49	47	135962	47596	64315127
Catabolic state	17.73	12.49	7	136002	93	64362630
Cytokine release syndrome	17.70	12.49	11	135998	20818	64341905
Hormone receptor positive breast cancer	17.69	12.49	10	135999	308	64362415
Adrenal insufficiency	17.60	12.49	13	135996	22474	64340249
Inferior vena cava stenosis	17.58	12.49	6	136003	51	64362672
T-cell type acute leukaemia	17.48	12.49	8	136001	156	64362567
Hypocalcaemia	17.45	12.49	149	135860	41604	64321119
Tumour fistulisation	17.43	12.49	5	136004	22	64362701
Skin hyperpigmentation	17.42	12.49	41	135968	6510	64356213
Blood triglycerides increased	17.41	12.49	9	136000	18857	64343866
Necrosis	17.40	12.49	47	135962	8124	64354599
Cardiomyopathy acute	17.34	12.49	9	136000	233	64362490
Gastroenteritis radiation	17.33	12.49	13	135996	653	64362070
Hypersomnia	17.33	12.49	10	135999	19707	64343016
Intestinal strangulation	17.28	12.49	6	136003	54	64362669
Product substitution issue	17.27	12.49	8	136001	17853	64344870
Limbic encephalitis	17.25	12.49	13	135996	658	64362065
Hydrothorax	17.24	12.49	17	135992	1240	64361483
Gastrointestinal haemorrhage	17.21	12.49	187	135822	132125	64230598
Vaginal fistula	17.20	12.49	9	136000	237	64362486
Hypersplenism	17.20	12.49	11	135998	426	64362297
Colonic fistula	17.10	12.49	12	135997	543	64362180
Recurrent cancer	17.09	12.49	23	135986	2350	64360373
Hypercreatininaemia	17.09	12.49	14	135995	801	64361922
Carpal tunnel syndrome	17.08	12.49	6	136003	15822	64346901
Aortic dissection	17.00	12.49	28	135981	3424	64359299
Labelled drug-drug interaction medication error	16.95	12.49	13	135996	22049	64340674
Necrotising oesophagitis	16.93	12.49	13	135996	677	64362046
Endometrial dysplasia	16.91	12.49	5	136004	25	64362698
Rash macular	16.91	12.49	15	135994	23670	64339053
Ankle fracture	16.90	12.49	5	136004	14705	64348018
Hepatitis B surface antigen positive	16.89	12.49	8	136001	169	64362554
Lymphangiosis carcinomatosa	16.85	12.49	20	135989	1801	64360922
Dyspnoea exertional	16.84	12.49	89	135920	73641	64289082
Haemorrhagic infarction	16.68	12.49	13	135996	692	64362031
Metastases to ovary	16.67	12.49	9	136000	253	64362470
Mood swings	16.62	12.49	8	136001	17460	64345263
Oedema peripheral	16.60	12.49	328	135681	209989	64152734
Wernicke's encephalopathy	16.59	12.49	5	136004	27	64362696
Hypothyroidism	16.59	12.49	38	135971	40419	64322304
Osteopenia	16.59	12.49	6	136003	15534	64347189
Perineal abscess	16.47	12.49	11	135998	459	64362264
Prostatic calcification	16.46	12.49	6	136003	63	64362660
Hypocapnia	16.44	12.49	12	135997	578	64362145
Toxic cardiomyopathy	16.44	12.49	10	135999	354	64362369
Enterocolitis infectious	16.41	12.49	23	135986	2441	64360282
Perioral dermatitis	16.32	12.49	9	136000	264	64362459
Febrile infection	16.31	12.49	25	135984	2876	64359847
Mixed adenoneuroendocrine carcinoma	16.28	12.49	4	136005	8	64362715
Disability	16.23	12.49	3	136006	12169	64350554
Aortic intramural haematoma	16.22	12.49	7	136002	118	64362605
Miosis	16.20	12.49	4	136005	13262	64349461
Mydriasis	16.19	12.49	6	136003	15306	64347417
Splenic abscess	16.17	12.49	11	135998	473	64362250
Obstructive airways disorder	16.17	12.49	15	135994	23170	64339553
Viral hepatitis carrier	16.15	12.49	5	136004	30	64362693
Sneezing	16.09	12.49	6	136003	15245	64347478
Klebsiella infection	16.09	12.49	63	135946	13218	64349505
Mucosal ulceration	16.03	12.49	19	135990	1708	64361015
Hyperpyrexia	16.00	12.49	34	135975	5043	64357680
Cyst	15.96	12.49	3	136006	12024	64350699
Gallbladder disorder	15.90	12.49	8	136001	17022	64345701
Hyperlipidaemia	15.87	12.49	15	135994	22961	64339762
Glycosylated haemoglobin increased	15.76	12.49	7	136002	16012	64346711
Electrocardiogram ST segment depression	15.73	12.49	31	135978	4358	64358365
Peripheral sensorimotor neuropathy	15.57	12.49	23	135986	2562	64360161
Delirium	15.54	12.49	84	135925	69110	64293613
Cardiac ventricular thrombosis	15.52	12.49	17	135992	1403	64361320
Herpes simplex meningomyelitis	15.49	12.49	3	136006	0	64362723
Cholecystocholangitis	15.49	12.49	3	136006	0	64362723
Gastrointestinal obstruction	15.47	12.49	17	135992	1408	64361315
Peritoneal disorder	15.42	12.49	12	135997	637	64362086
Cholelithiasis	15.42	12.49	47	135962	45459	64317264
Soft tissue disorder	15.37	12.49	26	135983	3250	64359473
Liver function test increased	15.37	12.49	26	135983	30944	64331779
Therapy non-responder	15.36	12.49	79	135930	65820	64296903
Growth of eyelashes	15.32	12.49	7	136002	136	64362587
Ill-defined disorder	15.29	12.49	45	135964	44007	64318716
Lactic acidosis	15.25	12.49	72	135937	61338	64301385
Limb discomfort	15.23	12.49	21	135988	27154	64335569
Arterial thrombosis	15.18	12.49	22	135987	2408	64360315
Infectious pleural effusion	15.17	12.49	24	135985	2838	64359885
Metapneumovirus bronchiolitis	15.14	12.49	4	136005	12	64362711
Marchiafava-Bignami disease	15.14	12.49	4	136005	12	64362711
Throat tightness	15.11	12.49	92	135917	23068	64339655
COVID-19 pneumonia	15.04	12.49	8	136001	16496	64346227
Hyperleukocytosis	15.04	12.49	20	135989	2020	64360703
Tooth disorder	15.04	12.49	15	135994	22387	64340336
Pneumomediastinum	14.93	12.49	24	135985	2876	64359847
Ventricular hypokinesia	14.88	12.49	43	135966	7726	64354997
Nasal crusting	14.85	12.49	11	135998	542	64362181
Aspergillus infection	14.84	12.49	8	136001	16371	64346352
Drug eruption	14.77	12.49	34	135975	36102	64326621
Periodontal disease	14.71	12.49	18	135991	1673	64361050
Monocytopenia	14.65	12.49	7	136002	151	64362572
Thrombophlebitis	14.62	12.49	35	135974	5619	64357104
Pneumoretroperitoneum	14.60	12.49	6	136003	89	64362634
Respiratory alkalosis	14.55	12.49	28	135981	3869	64358854
Temperature difference of extremities	14.45	12.49	4	136005	15	64362708
Glomerular filtration rate decreased	14.45	12.49	12	135997	19560	64343163
Oral dysaesthesia	14.44	12.49	7	136002	156	64362567
Gastric varices haemorrhage	14.41	12.49	9	136000	334	64362389
Vitamin B1 deficiency	14.39	12.49	11	135998	569	64362154
Renal tubular disorder	14.35	12.49	36	135973	5951	64356772
Tissue injury	14.30	12.49	5	136004	46	64362677
Metastatic neoplasm	14.29	12.49	30	135979	4412	64358311
Sciatica	14.26	12.49	13	135996	20251	64342472
Duodenal varices	14.25	12.49	4	136005	16	64362707
Stevens-Johnson syndrome	14.18	12.49	32	135977	34217	64328506
Pulmonary alveolar haemorrhage	14.15	12.49	49	135960	9689	64353034
Tumour invasion	14.13	12.49	9	136000	346	64362377
Stomatitis haemorrhagic	14.13	12.49	6	136003	97	64362626
Lymph node abscess	14.12	12.49	5	136004	48	64362675
Dandy-Walker syndrome	14.12	12.49	5	136004	48	64362675
Colitis microscopic	14.10	12.49	41	135968	7391	64355332
Tetany	14.06	12.49	20	135989	2152	64360571
ECG signs of myocardial ischaemia	14.04	12.49	9	136000	350	64362373
Facial discomfort	14.03	12.49	5	136004	49	64362674
Hypercreatinaemia	14.02	12.49	8	136001	251	64362472
Cerebral vasoconstriction	14	12.49	15	135994	1207	64361516
Xerophthalmia	13.99	12.49	10	135999	466	64362257
Acute cutaneous lupus erythematosus	13.97	12.49	9	136000	353	64362370
Cerebrovascular accident	13.95	12.49	205	135804	137378	64225345
Capillary leak syndrome	13.95	12.49	25	135984	3272	64359451
Portal vein dilatation	13.94	12.49	5	136004	50	64362673
Peritoneal haematoma	13.93	12.49	7	136002	169	64362554
Hypertensive encephalopathy	13.91	12.49	13	135996	887	64361836
Intercepted product administration error	13.86	12.49	7	136002	171	64362552
Electrolyte imbalance	13.85	12.49	96	135913	25147	64337576
Dementia	13.83	12.49	14	135995	20752	64341971
Muscle rigidity	13.81	12.49	10	135999	17463	64345260
Eye swelling	13.75	12.49	16	135993	22265	64340458
Eastern Cooperative Oncology Group performance status worsened	13.74	12.49	15	135994	1233	64361490
Catheter site extravasation	13.70	12.49	9	136000	365	64362358
Tendon rupture	13.63	12.49	3	136006	10764	64351959
Head discomfort	13.63	12.49	4	136005	11830	64350893
Colorectal cancer recurrent	13.59	12.49	5	136004	54	64362669
Hepatitis B DNA increased	13.58	12.49	11	135998	619	64362104
Prostate cancer	13.58	12.49	13	135996	19782	64342941
Obstruction gastric	13.57	12.49	16	135993	1430	64361293
Hip arthroplasty	13.54	12.49	15	135994	21336	64341387
Left ventricular dilatation	13.53	12.49	13	135996	919	64361804
Diabetes mellitus inadequate control	13.50	12.49	15	135994	21306	64341417
Gastrointestinal fistula	13.47	12.49	11	135998	626	64362097
Bronchial fistula	13.46	12.49	7	136002	182	64362541
Procedural pain	13.44	12.49	8	136001	15500	64347223
Tooth infection	13.42	12.49	7	136002	14594	64348129
Lhermitte's sign	13.42	12.49	3	136006	3	64362720
Thrombotic microangiopathy	13.41	12.49	70	135939	16585	64346138
Dystonia	13.40	12.49	12	135997	18853	64343870
Pseudomembranous colitis	13.33	12.49	31	135978	4885	64357838
Mania	13.29	12.49	9	136000	16277	64346446
Purulent pericarditis	13.27	12.49	5	136004	58	64362665
Iatrogenic infection	13.27	12.49	5	136004	58	64362665
Respiratory depression	13.25	12.49	18	135991	23425	64339298
Sudden death	13.22	12.49	80	135929	20016	64342707
Rectal cancer recurrent	13.21	12.49	4	136005	22	64362701
Malignant pleural effusion	13.20	12.49	23	135986	2944	64359779
Catheter site thrombosis	13.19	12.49	7	136002	190	64362533
Systemic scleroderma	13.17	12.49	13	135996	950	64361773
Wrong rate	13.12	12.49	5	136004	60	64362663
Bladder tamponade	13.08	12.49	10	135999	517	64362206
Red blood cell nucleated morphology present	13.07	12.49	4	136005	23	64362700
Diverticulitis	13.00	12.49	40	135969	38578	64324145
Product administration error	13.00	12.49	24	135985	27619	64335104
Hypertrichosis	12.99	12.49	14	135995	1134	64361589
Oesophageal squamous cell carcinoma metastatic	12.96	12.49	3	136006	4	64362719
Pulmonary hypertension	12.94	12.49	47	135962	43092	64319631
Tracheal stenosis	12.93	12.49	8	136001	292	64362431
Procedural vomiting	12.93	12.49	11	135998	663	64362060
Pleural fistula	12.92	12.49	4	136005	24	64362699
Carbohydrate antigen 15-3 increased	12.90	12.49	13	135996	974	64361749
Pulmonary congestion	12.84	12.49	19	135990	23861	64338862
Rectal adenocarcinoma	12.84	12.49	15	135994	1328	64361395
Hepatic vein stenosis	12.83	12.49	5	136004	64	64362659
Blood pressure decreased	12.80	12.49	118	135891	86081	64276642
Ovarian failure	12.78	12.49	10	135999	535	64362188
Neutrophilia	12.77	12.49	37	135972	6657	64356066
Duodenal stenosis	12.74	12.49	11	135998	677	64362046
Blood pressure diastolic decreased	12.73	12.49	17	135992	22284	64340439
Blood potassium increased	12.72	12.49	22	135987	25958	64336765
Fixed eruption	12.70	12.49	19	135990	2140	64360583
Cardiogenic shock	12.66	12.49	114	135895	32313	64330410
Diverticulum	12.63	12.49	6	136003	13192	64349531
Rectal abscess	12.62	12.49	16	135993	1541	64361182
Pollakiuria	12.62	12.49	30	135979	31500	64331223
Angina pectoris	12.59	12.49	148	135861	44933	64317790
Stress ulcer	12.57	12.49	6	136003	129	64362594
Cutaneous tuberculosis	12.55	12.49	7	136002	210	64362513
Renal hydrocele	12.52	12.49	4	136005	27	64362696

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01BC02	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS ANTIMETABOLITES Pyrimidine analogues
ATC	L01BC52	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS ANTIMETABOLITES Pyrimidine analogues
FDA MoA	N0000000233	Nucleic Acid Synthesis Inhibitors
FDA EPC	N0000175595	Nucleoside Metabolic Inhibitor
MeSH PA	D000963	Antimetabolites
MeSH PA	D000964	Antimetabolites, Antineoplastic
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D007155	Immunologic Factors
MeSH PA	D007166	Immunosuppressive Agents
MeSH PA	D009676	Noxae
CHEBI has role	CHEBI:35221	antimetabolite
CHEBI has role	CHEBI:35610	antineoplastic agents
CHEBI has role	CHEBI:35703	Xenobiotic
CHEBI has role	CHEBI:35705	immunosuppressive agents
CHEBI has role	CHEBI:78298	environmental contaminants
CHEBI has role	CHEBI:132992	radiosensitizing agents
CHEBI has role	CHEBI:25435	mutagens
CHEBI has role	CHEBI:77746	Homo sapiens metabolite

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

Disease	Relation	SNOMED_ID	DOID
Actinic keratosis	indication	201101007	DOID:8866
Metastasis from malignant tumor of colon	indication	314998002
Malignant tumor of stomach	indication	363349007	DOID:10534
Malignant tumor of colon	indication	363406005	DOID:219
Small intestine cancer	indication	363509000	DOID:10154
Superficial basal cell carcinoma	indication	403914000
Adenocarcinoma of pancreas	indication	700423003	DOID:4074
Metastatic Breast Carcinoma	indication
Carcinoid syndrome	off-label use	35868009
Actinic cheilitis	off-label use	46795000
Radiation dermatitis	off-label use	49084001
Neoplasm of glans penis	off-label use	126898002
Carcinoma of breast	off-label use	254838004	DOID:3459
Malignant tumor of head and/or neck	off-label use	255056009
Malignant tumor of cervix	off-label use	363354003	DOID:4362
Malignant tumor of esophagus	off-label use	363402007
Malignant tumor of anus	off-label use	363490009	DOID:14110
Malignant tumor of urinary bladder	off-label use	399326009	DOID:11054
Leukoplakia of oral mucosa	off-label use	414603003
Pancreatic Neuroendocrine Tumor	off-label use	717919005
Biliary Tract Malignancy	off-label use
Metastatic Malignant Tumor of Anus	off-label use
Nutritional disorder	contraindication	2492009	DOID:374
Acute vomiting	contraindication	23971007
Stomatitis	contraindication	61170000	DOID:9637
Diarrhea	contraindication	62315008
Acute infectious disease	contraindication	63171007
Gastrointestinal hemorrhage	contraindication	74474003
Dihydrouracil dehydrogenase (NADP^+^) deficiency	contraindication	77365006	DOID:14218
Leukopenia	contraindication	84828003	DOID:615
Kidney disease	contraindication	90708001	DOID:557
Superficial ulcer of skin	contraindication	93448009
Secondary malignant neoplasm of bone marrow	contraindication	94217008
Bleeding	contraindication	131148009
Angina pectoris	contraindication	194828000
Disease of liver	contraindication	235856003	DOID:409
Pregnancy, function	contraindication	289908002
Thrombocytopenic disorder	contraindication	302215000	DOID:1588
Neutropenic disorder	contraindication	303011007	DOID:1227
Bone marrow depression	contraindication	307762000
Pharyngitis	contraindication	405737000	DOID:2275
Breastfeeding (mother)	contraindication	413712001
Palmar-Plantar Erythrodysesthesia	contraindication

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.02	acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Thymidylate synthase	Enzyme	P04818	TYSY_HUMAN	INHIBITOR			WOMBAT-PK	CHEMBL
Multidrug resistance-associated protein 5	Transporter	O15440	MRP5_HUMAN				WOMBAT-PK
ATP-binding cassette sub-family C member 11	Transporter	Q96J66	ABCCB_HUMAN				WOMBAT-PK
Thymidylate synthase	Enzyme		TYSY_MOUSE		IC50	7.70	CHEMBL
Uracil phosphoribosyltransferase	Enzyme		UPP_ECOLI		Ki	4.89	CHEMBL

External reference:

ID	Source
4017806	VUID
N0000146166	NUI
D00584	KEGG_DRUG
202632	RXNORM
C0016360	UMLSCUI
CHEBI:46345	CHEBI
URF	PDB_CHEM_ID
CHEMBL185	ChEMBL_ID
D005472	MESH_DESCRIPTOR_UI
DB00544	DRUGBANK_ID
4789	IUPHAR_LIGAND_ID
1421	INN_ID
U3P01618RT	UNII
3385	PUBCHEM_CID
4694	MMSL
4745	MMSL
6969	MMSL
d00235	MMSL
002646	NDDF
4017806	VANDF
3127006	SNOMEDCT_US
387172005	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Efudex	HUMAN PRESCRIPTION DRUG LABEL	1	0187-3202	SOLUTION	0.50 g	TOPICAL	NDA	2 sections
Efudex	HUMAN PRESCRIPTION DRUG LABEL	1	0187-3203	SOLUTION	1.25 g	TOPICAL	NDA	2 sections
Efudex	HUMAN PRESCRIPTION DRUG LABEL	1	0187-3204	CREAM	2 g	TOPICAL	NDA	2 sections
Carac	HUMAN PRESCRIPTION DRUG LABEL	1	0187-5200	CREAM	5 mg	TOPICAL	NDA	24 sections
Fluorouracil	HUMAN PRESCRIPTION DRUG LABEL	1	0378-4791	CREAM	5 mg	TOPICAL	NDA authorized generic	19 sections
Fluorouracil Cream	HUMAN PRESCRIPTION DRUG LABEL	1	0378-8078	CREAM	5 mg	TOPICAL	NDA authorized generic	22 sections
Fluoroplex	HUMAN PRESCRIPTION DRUG LABEL	1	16110-812	CREAM	10 mg	TOPICAL	NDA	23 sections
Fluoroplex	HUMAN PRESCRIPTION DRUG LABEL	1	16110-812	CREAM	10 mg	TOPICAL	NDA	23 sections
Fluorouracil	HUMAN PRESCRIPTION DRUG LABEL	1	16714-178	CREAM	50 mg	TOPICAL	ANDA	20 sections
Fluorouracil	HUMAN PRESCRIPTION DRUG LABEL	1	16729-276	INJECTION, SOLUTION	50 mg	INTRAVENOUS	ANDA	24 sections
Fluorouracil	HUMAN PRESCRIPTION DRUG LABEL	1	16729-276	INJECTION, SOLUTION	50 mg	INTRAVENOUS	ANDA	24 sections
Fluorouracil	HUMAN PRESCRIPTION DRUG LABEL	1	16729-542	CREAM	50 mg	TOPICAL	ANDA	19 sections
Fluorouracil	HUMAN PRESCRIPTION DRUG LABEL	1	16729-542	CREAM	50 mg	TOPICAL	ANDA	19 sections
FLUOROURACIL	HUMAN PRESCRIPTION DRUG LABEL	1	21695-829	CREAM	50 mg	TOPICAL	ANDA	18 sections
fluorouracil	HUMAN PRESCRIPTION DRUG LABEL	1	25021-215	INJECTION, SOLUTION	50 mg	INTRAVENOUS	ANDA	26 sections
TOLAK	HUMAN PRESCRIPTION DRUG LABEL	1	28105-421	CREAM	0.04 g	TOPICAL	NDA	26 sections
Fluorouracil	HUMAN PRESCRIPTION DRUG LABEL	1	50090-4264	CREAM	50 mg	TOPICAL	ANDA	20 sections
Fluorouracil	HUMAN PRESCRIPTION DRUG LABEL	1	51672-4062	SOLUTION	20 mg	TOPICAL	ANDA	21 sections
Fluorouracil	HUMAN PRESCRIPTION DRUG LABEL	1	51672-4063	SOLUTION	50 mg	TOPICAL	ANDA	21 sections
Fluorouracil	HUMAN PRESCRIPTION DRUG LABEL	1	51672-4118	CREAM	50 mg	TOPICAL	ANDA	20 sections
FLUOROURACIL	HUMAN PRESCRIPTION DRUG LABEL	1	51862-362	CREAM	50 mg	TOPICAL	ANDA	20 sections
Fluorouracil	HUMAN PRESCRIPTION DRUG LABEL	1	52549-4118	CREAM	50 mg	TOPICAL	ANDA	21 sections
FLUOROURACIL	Human Prescription Drug Label	1	54868-6293	CREAM	50 mg	TOPICAL	ANDA	18 sections
Fluorouracil	Human Prescription Drug Label	1	63323-117	INJECTION, SOLUTION	50 mg	INTRAVENOUS	ANDA	25 sections
Fluorouracil	Human Prescription Drug Label	1	63323-117	INJECTION, SOLUTION	50 mg	INTRAVENOUS	ANDA	25 sections
Fluorouracil	Human Prescription Drug Label	1	63323-117	INJECTION, SOLUTION	50 mg	INTRAVENOUS	ANDA	25 sections
Fluorouracil	Human Prescription Drug Label	1	63323-117	INJECTION, SOLUTION	50 mg	INTRAVENOUS	ANDA	25 sections
Fluorouracil	Human Prescription Drug Label	1	63323-117	INJECTION, SOLUTION	50 mg	INTRAVENOUS	ANDA	25 sections
Fluorouracil	Human Prescription Drug Label	1	63323-117	INJECTION, SOLUTION	50 mg	INTRAVENOUS	ANDA	25 sections
FLUOROURACIL	Human Prescription Drug Label	1	66530-249	CREAM	50 mg	TOPICAL	ANDA	18 sections