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

Stem definition	Drug id	CAS RN
antineoplastic agents, platinum derivatives	4210	61825-94-3

Description:

Molecule	Description
Synonyms: oxaliplatin oxalatoplatin oxalatoplatinum	An organoplatinum complex in which the platinum atom is complexed with 1,2-diaminocyclohexane, and with an oxalate ligand which is displaced to yield active oxaliplatin derivatives. These derivatives form inter- and intra-strand DNA crosslinks that inhibit DNA replication and transcription. Oxaliplatin is an antineoplastic agent that is often administered with FLUOROURACIL and FOLINIC ACID in the treatment of metastatic COLORECTAL NEOPLASMS. Molecular weight: 397.29 Formula: C8H14N2O4Pt CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

oxaliplatin
oxalatoplatin
oxalatoplatinum

An organoplatinum complex in which the platinum atom is complexed with 1,2-diaminocyclohexane, and with an oxalate ligand which is displaced to yield active oxaliplatin derivatives. These derivatives form inter- and intra-strand DNA crosslinks that inhibit DNA replication and transcription. Oxaliplatin is an antineoplastic agent that is often administered with FLUOROURACIL and FOLINIC ACID in the treatment of metastatic COLORECTAL NEOPLASMS.

Molecular weight: 397.29
Formula: C8H14N2O4Pt
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

None

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	6 mg/mL	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	8.13 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution)	0.50 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	0.10 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.13 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	58.92 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Aug. 9, 2002	FDA
March 18, 2005	PMDA	Yakult Honsha

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
Neuropathy peripheral	992.43	17.06	835	55122	95922	50453245
Laryngospasm	906.12	17.06	260	55697	2428	50546739
Neutropenia	900.85	17.06	956	55001	147009	50402158
Neurotoxicity	664.79	17.06	325	55632	14415	50534752
Thrombocytopenia	640.35	17.06	746	55211	126927	50422240
Diarrhoea	565.12	17.06	1671	54286	586805	49962362
Disease progression	548.26	17.06	600	55357	95266	50453901
Mucosal inflammation	445.12	17.06	363	55594	39779	50509388
Palmar-plantar erythrodysaesthesia syndrome	414.58	17.06	265	55692	19833	50529334
Paraesthesia	400.23	17.06	574	55383	119669	50429498
Vomiting	378.16	17.06	1241	54716	459517	50089650
Drug ineffective	315.23	17.06	268	55689	819065	49730102
Bone marrow failure	312.87	17.06	253	55704	27371	50521796
Dysarthria	301.21	17.06	282	55675	37121	50512046
Stridor	300.60	17.06	118	55839	3051	50546116
Dermatitis acneiform	295.53	17.06	125	55832	3932	50545235
Peripheral sensory neuropathy	287.13	17.06	142	55815	6449	50542718
Bronchospasm	282.09	17.06	186	55771	14668	50534499
Throat tightness	277.33	17.06	210	55747	20637	50528530
Myelosuppression	258.49	17.06	170	55787	13347	50535820
Polyneuropathy	250.23	17.06	160	55797	11971	50537196
Arthralgia	244.89	17.06	90	55867	438612	50110555
Dysaesthesia pharynx	242.02	17.06	51	55906	97	50549070
Skin toxicity	240.68	17.06	107	55850	3806	50545361
Nausea	215.70	17.06	1422	54535	703976	49845191
Joint swelling	207.72	17.06	17	55940	245269	50303898
Arteriospasm coronary	202.75	17.06	91	55866	3311	50545856
Febrile neutropenia	201.70	17.06	376	55581	97291	50451876
Gastrointestinal toxicity	198.49	17.06	99	55858	4578	50544589
Metastases to liver	190.16	17.06	166	55791	19938	50529229
Haematotoxicity	187.75	17.06	114	55843	7781	50541386
Gastrointestinal perforation	186.01	17.06	83	55874	2978	50546189
Headache	181.69	17.06	176	55781	506359	50042808
Pain	172.13	17.06	234	55723	578669	49970498
Neutrophil count decreased	168.10	17.06	230	55727	45796	50503371
Product dose omission issue	166.56	17.06	9	55948	183829	50365338
Leukopenia	166.46	17.06	281	55676	67247	50481920
Posterior reversible encephalopathy syndrome	163.24	17.06	134	55823	14794	50534373
Malignant neoplasm progression	159.39	17.06	277	55680	67847	50481320
Arthropathy	155.76	17.06	4	55953	157902	50391265
Sinusitis	155.61	17.06	8	55949	170550	50378617
Swelling	154.33	17.06	20	55937	200852	50348315
Enteritis	153.59	17.06	96	55861	6899	50542268
Dyspnoea	148.39	17.06	1073	54884	546535	50002632
Erythema	147.70	17.06	425	55532	145989	50403178
Weight increased	143.86	17.06	25	55932	201866	50347301
Non-cirrhotic portal hypertension	142.53	17.06	34	55923	138	50549029
Dehydration	139.04	17.06	427	55530	152022	50397145
Nasopharyngitis	137.22	17.06	24	55933	192903	50356264
Contraindicated product administered	135.83	17.06	7	55950	148951	50400216
Systemic lupus erythematosus	133.51	17.06	5	55952	140617	50408550
Maternal exposure during pregnancy	127.42	17.06	14	55943	159764	50389403
Venoocclusive liver disease	123.64	17.06	70	55887	4191	50544976
Portal hypertension	121.35	17.06	64	55893	3328	50545839
Abdominal pain	119.24	17.06	547	55410	235681	50313486
Fall	119.11	17.06	117	55840	334815	50214352
Pemphigus	118.65	17.06	3	55954	120163	50429004
Laryngeal oedema	117.67	17.06	72	55885	4981	50544186
Ascites	115.81	17.06	169	55788	35692	50513475
Abdominal discomfort	113.84	17.06	57	55900	231584	50317583
Chills	113.69	17.06	297	55660	96390	50452777
Anaphylactic shock	111.20	17.06	124	55833	20031	50529136
Hyperammonaemia	109.21	17.06	67	55890	4657	50544510
Paronychia	108.76	17.06	66	55891	4498	50544669
Peripheral swelling	108.44	17.06	46	55911	205890	50343277
Glossodynia	106.72	17.06	5	55952	115564	50433603
Therapeutic product effect decreased	105.78	17.06	13	55944	136037	50413130
Dysphonia	105.44	17.06	169	55788	38723	50510444
Immune thrombocytopenia	105.04	17.06	84	55873	8933	50540234
Depression	104.48	17.06	27	55930	165396	50383771
Splenomegaly	104.11	17.06	86	55871	9574	50539593
Dysaesthesia	102.05	17.06	59	55898	3676	50545491
Insomnia	98.76	17.06	35	55922	174830	50374337
Paraesthesia oral	98.03	17.06	92	55865	12129	50537038
Wound	96.33	17.06	5	55952	105789	50443378
Speech disorder	94.35	17.06	153	55804	35395	50513772
Colorectal cancer metastatic	93.49	17.06	31	55926	484	50548683
Product use issue	91.37	17.06	26	55931	149449	50399718
Focal nodular hyperplasia	90.55	17.06	30	55927	467	50548700
Tongue oedema	90.16	17.06	55	55902	3784	50545383
Intestinal perforation	90.09	17.06	82	55875	10397	50538770
Intestinal obstruction	89.07	17.06	127	55830	26256	50522911
Bronchitis	88.68	17.06	7	55950	104152	50445015
Stomatitis	87.80	17.06	279	55678	101065	50448102
Large intestine perforation	87.69	17.06	70	55887	7424	50541743
Nodular regenerative hyperplasia	85.81	17.06	25	55932	247	50548920
Lower respiratory tract infection	85.12	17.06	5	55952	95196	50453971
Metastases to lung	84.66	17.06	81	55876	10939	50538228
Anaemia	83.78	17.06	521	55436	251935	50297232
Cardiotoxicity	83.00	17.06	66	55891	6961	50542206
Neuromyotonia	82.63	17.06	18	55939	43	50549124
Asthma	82.04	17.06	4	55953	89333	50459834
Decreased appetite	80.53	17.06	436	55521	200487	50348680
Dysphagia	79.00	17.06	226	55731	77292	50471875
Hypomagnesaemia	77.48	17.06	111	55846	23045	50526122
Drug intolerance	77.26	17.06	77	55880	219027	50330140
Asthenia	76.87	17.06	609	55348	318433	50230734
Stress cardiomyopathy	76.33	17.06	66	55891	7821	50541346
Influenza	76.26	17.06	6	55951	89532	50459635
Hypokalaemia	75.99	17.06	242	55715	87750	50461417
Flushing	75.83	17.06	203	55754	66812	50482355
Laryngeal discomfort	71.80	17.06	22	55935	262	50548905
Injection site pain	70.31	17.06	18	55939	111006	50438161
Metastases to peritoneum	70.17	17.06	42	55915	2791	50546376
Therapy partial responder	69.62	17.06	58	55899	6533	50542634
Pain in extremity	69.54	17.06	122	55835	272743	50276424
Exposure during pregnancy	68.68	17.06	24	55933	120991	50428176
Anastomotic leak	67.44	17.06	23	55934	393	50548774
Condition aggravated	66.86	17.06	143	55814	296915	50252252
Hyperammonaemic encephalopathy	66.67	17.06	36	55921	1963	50547204
Pyrexia	65.12	17.06	674	55283	379529	50169638
Hypertension	64.54	17.06	427	55530	210776	50338391
Musculoskeletal stiffness	63.99	17.06	31	55926	128450	50420717
Ileus	63.89	17.06	76	55881	13153	50536014
Haemolytic anaemia	63.37	17.06	64	55893	9228	50539939
Arthritis	63.35	17.06	10	55947	86711	50462456
Drug hypersensitivity	63.25	17.06	113	55844	250897	50298270
Hospitalisation	62.51	17.06	3	55954	67934	50481233
Pericarditis	62.43	17.06	7	55950	78682	50470485
Contusion	62.38	17.06	23	55934	112160	50437007
Platelet count decreased	62.07	17.06	248	55709	100478	50448689
Oxygen saturation decreased	61.91	17.06	200	55757	73048	50476119
Hepatic enzyme increased	61.37	17.06	38	55919	137342	50411825
Injection site erythema	61.16	17.06	6	55951	74930	50474237
General physical health deterioration	60.37	17.06	314	55643	142120	50407047
Hyperhidrosis	59.84	17.06	226	55731	89200	50459967
Peritonitis	58.95	17.06	79	55878	15407	50533760
Interstitial lung disease	58.06	17.06	159	55798	53017	50496150
Tumour perforation	57.21	17.06	15	55942	96	50549071
Cardiac failure congestive	56.75	17.06	12	55945	84370	50464797
Anaphylactic reaction	56.42	17.06	159	55798	53896	50495271
Hyperthermia	56.17	17.06	55	55902	7641	50541526
Hypertensive crisis	56.14	17.06	71	55886	13083	50536084
Enterocutaneous fistula	56.03	17.06	27	55930	1157	50548010
Chemical peritonitis	53.75	17.06	14	55943	87	50549080
Treatment failure	53.70	17.06	44	55913	137593	50411574
Alopecia	53.43	17.06	120	55837	244927	50304240
Enterocolitis	51.83	17.06	49	55908	6518	50542649
Neoplasm progression	51.27	17.06	105	55852	29052	50520115
Drug abuse	50.99	17.06	4	55953	59842	50489325
Metastases to meninges	50.42	17.06	30	55927	1972	50547195
Feeling hot	49.73	17.06	124	55833	39078	50510089
Hydronephrosis	49.62	17.06	54	55903	8487	50540680
Suicidal ideation	49.22	17.06	3	55954	55382	50493785
Gait disturbance	49.17	17.06	56	55901	149949	50399218
Diffuse large B-cell lymphoma recurrent	48.44	17.06	27	55930	1568	50547599
Colitis	47.96	17.06	121	55836	38408	50510759
Neutropenic colitis	47.66	17.06	31	55926	2386	50546781
Drug interaction	47.49	17.06	93	55864	199528	50349639
Somnolence	47.47	17.06	61	55896	154924	50394243
Blood lactate dehydrogenase abnormal	47.14	17.06	15	55942	204	50548963
Rectal perforation	46.11	17.06	17	55940	368	50548799
Band sensation	46.09	17.06	20	55937	670	50548497
Varices oesophageal	45.96	17.06	32	55925	2757	50546410
Disseminated intravascular coagulation	45.79	17.06	74	55883	17061	50532106
Suicide attempt	45.39	17.06	3	55954	51729	50497438
Pneumonia	45.30	17.06	240	55717	378161	50171006
Extravasation	45.27	17.06	28	55929	1974	50547193
Upper respiratory tract infection	45.08	17.06	9	55948	65889	50483278
Evans syndrome	44.93	17.06	14	55943	177	50548990
Off label use	44.23	17.06	753	55204	473673	50075494
Diffuse large B-cell lymphoma refractory	43.96	17.06	22	55935	1024	50548143
Cough	43.49	17.06	130	55827	241134	50308033
Proteinuria	43.44	17.06	71	55886	16526	50532641
Suffocation feeling	43.30	17.06	23	55934	1213	50547954
Helicobacter infection	43.26	17.06	3	55954	49699	50499468
Hypertransaminasaemia	42.82	17.06	34	55923	3577	50545590
Cholinergic syndrome	42.58	17.06	16	55941	366	50548801
Injury	42.45	17.06	3	55954	48922	50500245
Steatohepatitis	42.43	17.06	17	55940	464	50548703
Neutrophil count abnormal	42.37	17.06	29	55928	2430	50546737
Choking sensation	42.19	17.06	32	55925	3148	50546019
Carcinoembryonic antigen increased	42.18	17.06	24	55933	1450	50547717
Stress	42.13	17.06	5	55952	53788	50495379
Dihydropyrimidine dehydrogenase deficiency	42.01	17.06	11	55946	70	50549097
Mucosal toxicity	41.47	17.06	15	55942	307	50548860
Overdose	41.28	17.06	30	55927	99697	50449470
Cold dysaesthesia	40.93	17.06	8	55949	8	50549159
Injection site reaction	40.84	17.06	4	55953	50028	50499139
Hepatic failure	40.83	17.06	102	55855	32181	50516986
Cataract	40.75	17.06	3	55954	47297	50501870
Splenic artery thrombosis	40.73	17.06	10	55947	47	50549120
Factor VII deficiency	40.34	17.06	9	55948	25	50549142
Sensation of foreign body	40.25	17.06	34	55923	3902	50545265
Intentional product misuse	40.16	17.06	3	55954	46731	50502436
Anxiety	39.48	17.06	86	55871	177520	50371647
Chronic obstructive pulmonary disease	39.39	17.06	6	55951	53429	50495738
Acute coronary syndrome	39.06	17.06	50	55907	9324	50539843
Duodenal ulcer perforation	38.99	17.06	3	55954	45608	50503559
Tachycardia	38.88	17.06	215	55742	99548	50449619
Hypertrichosis	38.84	17.06	20	55937	989	50548178
Cardiac ventricular thrombosis	38.84	17.06	16	55941	470	50548697
Acute polyneuropathy	38.79	17.06	13	55944	210	50548957
White blood cell count decreased	38.68	17.06	241	55716	116481	50432686
Leukoencephalopathy	38.60	17.06	33	55924	3850	50545317
Tremor	38.55	17.06	238	55719	114665	50434502
Cystitis radiation	38.41	17.06	10	55947	62	50549105
Discomfort	38.26	17.06	38	55919	108342	50440825
Short-bowel syndrome	38.09	17.06	15	55942	391	50548776
Infusion related hypersensitivity reaction	38.01	17.06	10	55947	65	50549102
Bladder tamponade	37.24	17.06	10	55947	71	50549096
Atypical haemolytic uraemic syndrome	36.73	17.06	16	55941	541	50548626
Formication	36.27	17.06	31	55926	3615	50545552
Female genital tract fistula	36.13	17.06	31	55926	3635	50545532
Fatigue	35.92	17.06	559	55398	707042	49842125
Cytokine release syndrome	35.89	17.06	46	55911	8588	50540579
Osteoporosis	35.57	17.06	4	55953	44875	50504292
Pancytopenia	35.39	17.06	185	55772	83845	50465322
Ileal perforation	35.19	17.06	14	55943	375	50548792
Multiple organ dysfunction syndrome	35.14	17.06	129	55828	50208	50498959
Laryngeal dyspnoea	35.02	17.06	11	55946	143	50549024
Thrombocytopenic purpura	34.89	17.06	20	55937	1226	50547941
Large intestinal obstruction	34.72	17.06	23	55934	1826	50547341
Pharyngeal paraesthesia	34.38	17.06	21	55936	1448	50547719
Hypoalbuminaemia	34.06	17.06	48	55909	9812	50539355
Blister	33.68	17.06	27	55930	85391	50463776
Injection site pruritus	33.60	17.06	3	55954	40408	50508759
ECG signs of myocardial ischaemia	33.39	17.06	9	55948	65	50549102
Migraine	33.35	17.06	21	55936	75259	50473908
Mobility decreased	33.15	17.06	24	55933	79924	50469243
Muscle spasms	33.09	17.06	245	55712	125308	50423859
Metastases to spleen	32.72	17.06	10	55947	118	50549049
Memory impairment	32.67	17.06	24	55933	79336	50469831
Abortion spontaneous	32.42	17.06	4	55953	41768	50507399
Incorrect dose administered	32.31	17.06	7	55950	48407	50500760
Anastomotic fistula	32.05	17.06	7	55950	17	50549150
Muscle rigidity	31.25	17.06	46	55911	9783	50539384
Nicotinic acid deficiency	31.24	17.06	8	55949	46	50549121
Myalgia	31.24	17.06	56	55901	124263	50424904
Tumour ulceration	31.16	17.06	10	55947	140	50549027
Motion sickness	31.13	17.06	16	55941	788	50548379
Ocular toxicity	30.64	17.06	14	55943	531	50548636
Vascular pain	30.59	17.06	15	55942	668	50548499
Infection	30.57	17.06	94	55863	172860	50376307
Catheter site bruise	30.42	17.06	12	55945	314	50548853
Metastases to ovary	29.60	17.06	12	55945	338	50548829
Metastasis	29.59	17.06	30	55927	4345	50544822
Gastric perforation	29.34	17.06	19	55938	1451	50547716
Paraphilia	29.04	17.06	5	55952	0	50549167
Oropharyngeal discomfort	28.95	17.06	28	55929	3830	50545337
Subileus	28.56	17.06	24	55933	2735	50546432
Hemiparaesthesia	28.53	17.06	8	55949	68	50549099
Perforation	28.41	17.06	16	55941	948	50548219
Herpes zoster	28.38	17.06	22	55935	70764	50478403
Pulmonary embolism	28.25	17.06	201	55756	101503	50447664
Dysgeusia	28.23	17.06	101	55856	38815	50510352
Wrong technique in product usage process	28.22	17.06	13	55944	55497	50493670
Skin fissures	28.18	17.06	41	55916	8627	50540540
Haemolysis	28.13	17.06	34	55923	5982	50543185
Inappropriate schedule of product administration	27.95	17.06	23	55934	71808	50477359
Lip oedema	27.47	17.06	25	55932	3168	50545999
Type 2 diabetes mellitus	27.40	17.06	3	55954	34372	50514795
Tonic clonic movements	27.21	17.06	17	55940	1220	50547947
Hemiparesis	27.11	17.06	65	55892	19983	50529184
K-ras gene mutation	27.07	17.06	6	55951	16	50549151
Left ventricular failure	27.07	17.06	30	55927	4811	50544356
Metastases to lymph nodes	26.99	17.06	36	55921	6988	50542179
Inferior vena cava stenosis	26.81	17.06	6	55951	17	50549150
Sleep disorder	26.76	17.06	15	55942	57268	50491899
Medical device site extravasation	26.70	17.06	5	55952	3	50549164
Cholangitis	26.68	17.06	29	55928	4550	50544617
Tumour necrosis	26.68	17.06	14	55943	720	50548447
Trismus	26.46	17.06	25	55932	3323	50545844
Hypophagia	26.45	17.06	79	55878	27649	50521518
Blood pressure fluctuation	26.45	17.06	4	55953	35819	50513348
Cardiospasm	26.31	17.06	6	55951	19	50549148
Feeling abnormal	26.07	17.06	63	55894	125429	50423738
Palmar erythema	25.91	17.06	18	55939	1545	50547622
White blood cell count abnormal	25.85	17.06	31	55926	5409	50543758
Gastric varices haemorrhage	25.61	17.06	8	55949	102	50549065
Schistosomiasis	25.58	17.06	5	55952	5	50549162
Haematemesis	25.52	17.06	78	55879	27647	50521520
Gastrointestinal anastomotic leak	25.36	17.06	9	55948	174	50548993
Rhabdomyolysis	25.33	17.06	6	55951	39021	50510146
Catabolic state	25.23	17.06	7	55950	57	50549110
Type I hypersensitivity	25.21	17.06	21	55936	2364	50546803
Urinary tract infection	25.15	17.06	145	55812	223875	50325292
Peripheral motor neuropathy	24.95	17.06	17	55940	1414	50547753
Metastases to bone marrow	24.92	17.06	10	55947	274	50548893
Aortic intramural haematoma	24.81	17.06	7	55950	61	50549106
Soft tissue necrosis	24.72	17.06	11	55946	392	50548775
Monoparesis	24.60	17.06	17	55940	1447	50547720
Myopathy toxic	24.56	17.06	11	55946	398	50548769
Hyperpyrexia	24.54	17.06	23	55934	3026	50546141
Influenza like illness	24.14	17.06	17	55940	57442	50491725
Administration site extravasation	24.09	17.06	13	55944	708	50548459
Dizziness	24.01	17.06	256	55701	346113	50203054
Metastases to diaphragm	23.97	17.06	6	55951	31	50549136
Hepatocellular injury	23.88	17.06	73	55884	25874	50523293
Hepatic function abnormal	23.86	17.06	85	55872	32596	50516571
Inflammation	23.70	17.06	17	55940	56895	50492272
Folliculitis	23.62	17.06	7	55950	39218	50509949
Type II hypersensitivity	23.56	17.06	5	55952	10	50549157
Skin reaction	23.16	17.06	44	55913	11524	50537643
Treatment noncompliance	23.12	17.06	3	55954	30147	50519020
Hypocapnia	22.93	17.06	10	55947	339	50548828
Productive cough	22.93	17.06	15	55942	52679	50496488
Cyanosis	22.46	17.06	51	55906	15133	50534034
Portal shunt	22.38	17.06	5	55952	14	50549153
Implant site dehiscence	22.38	17.06	5	55952	14	50549153
Subacute cutaneous lupus erythematosus	22.38	17.06	19	55938	2196	50546971
Oesophageal varices haemorrhage	22.27	17.06	14	55943	1016	50548151
Chest discomfort	22.22	17.06	177	55780	92545	50456622
Colon cancer metastatic	22.14	17.06	14	55943	1026	50548141
COVID-19	22.11	17.06	12	55945	46650	50502517
Loss of personal independence in daily activities	22.03	17.06	27	55930	70023	50479144
Gastrointestinal stoma complication	21.83	17.06	16	55941	1494	50547673
Rectal cancer recurrent	21.65	17.06	5	55952	17	50549150
Small intestinal obstruction	21.62	17.06	52	55905	16016	50533151
Haemolytic uraemic syndrome	21.62	17.06	19	55938	2300	50546867
Unevaluable event	21.60	17.06	12	55945	46054	50503113
Hypotension	21.57	17.06	373	55584	235096	50314071
Sedation	21.31	17.06	4	55953	30606	50518561
Hyperventilation	21.21	17.06	28	55929	5381	50543786
Eyelid ptosis	21.19	17.06	30	55927	6157	50543010
Respiratory distress	21.16	17.06	78	55879	30411	50518756
Adverse drug reaction	21.09	17.06	18	55939	55204	50493963
Infusion related reaction	21.09	17.06	283	55674	169274	50379893
Respiratory fatigue	21.01	17.06	7	55950	111	50549056
Lacrimation disorder	21.00	17.06	4	55953	3	50549164
Hepatic encephalopathy	20.98	17.06	38	55919	9598	50539569
Blood glucose increased	20.88	17.06	29	55928	71295	50477872
Renal tubular disorder	20.81	17.06	19	55938	2418	50546749
Impaired healing	20.80	17.06	28	55929	69758	50479409
Toxic encephalopathy	20.78	17.06	28	55929	5487	50543680
Ileus paralytic	20.77	17.06	24	55933	4026	50545141
Biliary tract infection	20.72	17.06	10	55947	430	50548737
Dyslalia	20.63	17.06	10	55947	434	50548733
Coronary artery disease	20.45	17.06	4	55953	29722	50519445
Pelvic fluid collection	20.42	17.06	12	55945	771	50548396
Balance disorder	20.36	17.06	29	55928	70561	50478606
Nasal congestion	20.35	17.06	16	55941	51104	50498063
Colitis ischaemic	20.15	17.06	37	55920	9446	50539721
Granulocyte count decreased	20.09	17.06	12	55945	794	50548373
Encapsulating peritoneal sclerosis	20.01	17.06	9	55948	329	50548838
Confusional state	19.99	17.06	122	55835	185806	50363361
Diabetes mellitus	19.96	17.06	15	55942	49018	50500149
Portal vein dilatation	19.95	17.06	5	55952	26	50549141
Paralysis	19.93	17.06	35	55922	8629	50540538
Sputum abnormal	19.85	17.06	10	55947	472	50548695
Colorectal cancer recurrent	19.58	17.06	4	55953	6	50549161
Rhinorrhoea	19.47	17.06	17	55940	51566	50497601
Heart rate decreased	19.42	17.06	8	55949	36489	50512678
Oral dysaesthesia	19.39	17.06	6	55951	74	50549093
Subclavian vein thrombosis	19.35	17.06	16	55941	1783	50547384
Drug reaction with eosinophilia and systemic symptoms	19.19	17.06	4	55953	28420	50520747
Hyperlipasaemia	19.10	17.06	10	55947	512	50548655
Disease recurrence	18.95	17.06	57	55900	20024	50529143
Hepatic vein stenosis	18.94	17.06	5	55952	33	50549134
Dry eye	18.83	17.06	6	55951	32089	50517078
Tongue discomfort	18.82	17.06	16	55941	1852	50547315
Aortic dissection	18.81	17.06	15	55942	1588	50547579
Hereditary motor and sensory neuropathy	18.76	17.06	6	55951	83	50549084
Viral infection	18.71	17.06	5	55952	29981	50519186
Gastrooesophageal reflux disease	18.68	17.06	35	55922	76393	50472774
Hyperbilirubinaemia	18.67	17.06	36	55921	9534	50539633
Red cell fragmentation syndrome	18.56	17.06	5	55952	36	50549131
Peripheral nerve injury	18.52	17.06	9	55948	393	50548774
Hypervolaemia	18.48	17.06	3	55954	25496	50523671
Encephalopathy	18.39	17.06	80	55877	33631	50515536
Stoma site haemorrhage	18.38	17.06	12	55945	929	50548238
Diaphragmatic paralysis	18.36	17.06	10	55947	555	50548612
Hypersensitivity	18.34	17.06	337	55620	214824	50334343
Gastrointestinal inflammation	18.33	17.06	24	55933	4576	50544591
Adverse event	18.32	17.06	13	55944	43750	50505417
Trichomegaly	17.99	17.06	5	55952	41	50549126
Jaw operation	17.87	17.06	11	55946	769	50548398
Aortic thrombosis	17.84	17.06	12	55945	977	50548190
Congestive cardiomyopathy	17.79	17.06	26	55931	5492	50543675
Duodenal ulcer	17.75	17.06	29	55928	6746	50542421
Retching	17.71	17.06	42	55915	12820	50536347
Endometrial dysplasia	17.70	17.06	4	55953	12	50549155
Weight decreased	17.63	17.06	158	55799	221087	50328080
Respiratory failure	17.63	17.06	166	55791	91015	50458152
Appendicitis noninfective	17.43	17.06	3	55954	0	50549167
Road traffic accident	17.35	17.06	3	55954	24349	50524818
Hypothyroidism	17.33	17.06	8	55949	34117	50515050
Femoral artery embolism	17.29	17.06	5	55952	48	50549119
Acute respiratory distress syndrome	17.26	17.06	57	55900	21042	50528125
Femur fracture	17.22	17.06	10	55947	37454	50511713
Gastrointestinal stoma output increased	17.21	17.06	7	55950	199	50548968
Pneumatosis intestinalis	17.19	17.06	16	55941	2087	50547080
Pigmentation disorder	17.15	17.06	21	55936	3743	50545424
Embolism	17.15	17.06	29	55928	6939	50542228
Surgery	17.11	17.06	6	55951	30199	50518968
Pulmonary artery thrombosis	17.09	17.06	10	55947	637	50548530

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
Neuropathy peripheral	1212.37	15.09	1190	76164	69837	29427336
Disease progression	661.72	15.09	936	76418	80980	29416193
Neurotoxicity	635.48	15.09	424	76930	14189	29482984
Diarrhoea	628.39	15.09	2098	75256	330600	29166573
Neutropenia	602.08	15.09	1164	76190	130547	29366626
Palmar-plantar erythrodysaesthesia syndrome	558.36	15.09	393	76961	14366	29482807
Dermatitis acneiform	536.92	15.09	270	77084	5221	29491952
Skin toxicity	485.67	15.09	224	77130	3547	29493626
Thrombocytopenia	453.67	15.09	1052	76302	133771	29363402
Arteriospasm coronary	448.86	15.09	189	77165	2376	29494797
Paronychia	329.78	15.09	159	77195	2794	29494379
Vomiting	327.78	15.09	1256	76098	211004	29286169
Erythema	317.78	15.09	646	76708	74960	29422213
Metastases to liver	315.72	15.09	256	77098	11600	29485573
Interstitial lung disease	311.78	15.09	549	76805	57169	29440004
Peripheral sensory neuropathy	284.08	15.09	183	77171	5756	29491417
Paraesthesia	279.01	15.09	503	76851	53342	29443831
Nausea	277.18	15.09	1486	75868	287769	29209404
Venoocclusive liver disease	258.73	15.09	183	77171	6734	29490439
Mucosal inflammation	255.88	15.09	362	76992	31233	29465940
Gastrointestinal perforation	238.16	15.09	135	77219	3348	29493825
Polyneuropathy	237.64	15.09	220	77134	11932	29485241
Drug ineffective	235.14	15.09	368	76986	362802	29134371
Portal hypertension	232.67	15.09	133	77221	3353	29493820
Bone marrow failure	231.94	15.09	321	77033	27128	29470045
Myelosuppression	221.18	15.09	212	77142	12015	29485158
Chills	220.36	15.09	539	76815	70761	29426412
Completed suicide	220.30	15.09	3	77351	90243	29406930
Product dose omission issue	213.49	15.09	9	77345	96374	29400799
Hypersensitivity	196.48	15.09	430	76924	52473	29444700
Arthralgia	193.83	15.09	62	77292	139555	29357618
Stomatitis	193.79	15.09	348	77006	36765	29460408
Haematotoxicity	191.87	15.09	151	77203	6548	29490625
Enteritis	183.65	15.09	148	77206	6643	29490530
Fall	170.18	15.09	129	77225	177049	29320124
Metastases to lung	166.87	15.09	149	77205	7706	29489467
Gastrointestinal toxicity	165.98	15.09	90	77264	2041	29495132
Drug interaction	165.01	15.09	164	77190	197221	29299952
Laryngospasm	157.91	15.09	74	77280	1216	29495957
Bronchospasm	152.23	15.09	155	77199	9454	29487719
Abdominal pain	148.15	15.09	723	76631	134634	29362539
Headache	144.89	15.09	145	77209	173862	29323311
Hyperammonaemic encephalopathy	141.11	15.09	79	77275	1911	29495262
Flushing	140.14	15.09	263	77091	28729	29468444
Overdose	139.77	15.09	21	77333	79798	29417375
Focal nodular hyperplasia	139.51	15.09	39	77315	116	29497057
Pneumonia	136.53	15.09	409	76945	319763	29177410
Decreased appetite	133.89	15.09	740	76614	144602	29352571
Cardiotoxicity	131.70	15.09	105	77249	4639	29492534
Carcinoembryonic antigen increased	129.64	15.09	52	77302	572	29496601
Dysaesthesia pharynx	122.52	15.09	29	77325	31	29497142
Feeling hot	121.69	15.09	175	77179	15313	29481860
Proteinuria	117.54	15.09	174	77180	15630	29481543
Hyperammonaemia	117.47	15.09	106	77248	5557	29491616
Hypomagnesaemia	116.75	15.09	183	77171	17285	29479888
Neutrophil count decreased	107.50	15.09	303	77051	43264	29453909
Cardiac failure congestive	106.18	15.09	34	77320	76547	29420626
Leukopenia	104.56	15.09	350	77004	54853	29442320
Skin reaction	104.30	15.09	89	77265	4328	29492845
Infusion related reaction	104.19	15.09	301	77053	43585	29453588
Dehydration	104.08	15.09	582	76772	114166	29383007
Intravascular haemolysis	102.05	15.09	39	77315	373	29496800
Pyrexia	100.59	15.09	1171	76183	286451	29210722
Ascites	98.62	15.09	263	77091	36356	29460817
Intestinal obstruction	98.32	15.09	179	77175	19098	29478075
Depression	96.72	15.09	51	77303	85096	29412077
Insomnia	93.91	15.09	58	77296	88703	29408470
Oxygen saturation decreased	92.37	15.09	293	77061	44644	29452529
Therapy partial responder	91.84	15.09	89	77265	5110	29492063
Anastomotic leak	88.13	15.09	39	77315	557	29496616
Varices oesophageal	88.12	15.09	70	77284	3076	29494097
Hospitalisation	88.03	15.09	9	77345	45979	29451194
Anastomotic complication	86.31	15.09	33	77321	316	29496857
Anxiety	85.93	15.09	59	77295	85306	29411867
Myalgia	84.56	15.09	44	77310	73975	29423198
Metastases to peritoneum	83.12	15.09	51	77303	1469	29495704
Somnolence	83.12	15.09	74	77280	93881	29403292
Ileus	82.85	15.09	141	77213	14261	29482912
Anaphylactic shock	82.65	15.09	135	77219	13201	29483972
Tumour perforation	80.41	15.09	29	77325	232	29496941
Joint swelling	80.40	15.09	16	77338	49614	29447559
Peripheral swelling	78.77	15.09	34	77320	63705	29433468
Aggression	76.43	15.09	4	77350	35537	29461636
Rhabdomyolysis	75.84	15.09	32	77322	60776	29436397
Weight increased	74.52	15.09	55	77299	76612	29420561
Confusional state	73.67	15.09	139	77215	127738	29369435
Malignant neoplasm progression	73.23	15.09	384	76970	73475	29423698
Enterocolitis	71.93	15.09	88	77266	6578	29490595
Large intestine perforation	69.68	15.09	91	77263	7265	29489908
Type I hypersensitivity	69.13	15.09	40	77314	1032	29496141
Diffuse large B-cell lymphoma recurrent	68.94	15.09	56	77298	2541	29494632
Influenza	68.90	15.09	13	77341	41868	29455305
Inappropriate schedule of product administration	68.64	15.09	16	77338	44456	29452717
Peritonitis	68.54	15.09	132	77222	14692	29482481
Portal shunt	68.04	15.09	17	77337	27	29497146
Toxic leukoencephalopathy	67.46	15.09	26	77328	255	29496918
Dihydropyrimidine dehydrogenase deficiency	67.11	15.09	19	77335	60	29497113
Incorrect dose administered	67.07	15.09	5	77349	32979	29464194
Pneumatosis intestinalis	67.07	15.09	60	77294	3109	29494064
Tumour necrosis	66.94	15.09	40	77314	1097	29496076
Extravasation	66.63	15.09	46	77308	1626	29495547
Disseminated intravascular coagulation	65.85	15.09	155	77199	19825	29477348
Injection site pain	65.75	15.09	5	77349	32441	29464732
Vascular pain	65.15	15.09	21	77333	114	29497059
Stomal varices	64.58	15.09	17	77337	37	29497136
Hallucination	63.48	15.09	19	77335	44693	29452480
Myocardial infarction	63.41	15.09	120	77234	110176	29386997
Neoplasm progression	63.10	15.09	146	77208	18466	29478707
Non-cirrhotic portal hypertension	62.57	15.09	24	77330	232	29496941
Contusion	62.42	15.09	5	77349	31090	29466083
Blood glucose increased	61.73	15.09	39	77315	58945	29438228
Rectal perforation	61.62	15.09	27	77327	376	29496797
Suicidal ideation	61.04	15.09	9	77345	34707	29462466
Hepatic atrophy	59.92	15.09	21	77333	153	29497020
Electrocardiogram QT prolonged	59.90	15.09	11	77343	36126	29461047
Electrocardiogram ST segment elevation	59.68	15.09	66	77288	4426	29492747
Product use issue	59.60	15.09	30	77324	51414	29445759
Paraesthesia oral	59.58	15.09	59	77295	3478	29493695
Pain in extremity	59.32	15.09	125	77229	110308	29386865
Nodular regenerative hyperplasia	59.26	15.09	31	77323	652	29496521
Hypertransaminasaemia	58.62	15.09	59	77295	3547	29493626
Metastases to lymph nodes	58.58	15.09	62	77292	3955	29493218
Memory impairment	58.56	15.09	12	77342	36458	29460715
Death	57.17	15.09	596	76758	341488	29155685
General physical health deterioration	57.10	15.09	462	76892	102395	29394778
Foetal exposure during pregnancy	56.81	15.09	10	77344	33857	29463316
Cholinergic syndrome	56.79	15.09	27	77327	459	29496714
Intestinal perforation	55.81	15.09	86	77268	8000	29489173
Colon cancer metastatic	54.71	15.09	39	77315	1452	29495721
Necrotising fasciitis	54.60	15.09	55	77299	3310	29493863
Laryngeal discomfort	54.39	15.09	19	77335	137	29497036
Tumour lysis syndrome	53.92	15.09	115	77239	13769	29483404
Coronary artery disease	53.91	15.09	24	77330	44166	29453007
Dysphonia	53.83	15.09	140	77214	19056	29478117
Hyperhidrosis	53.62	15.09	320	77034	64220	29432953
Colorectal cancer metastatic	53.11	15.09	27	77327	534	29496639
Administration site extravasation	52.95	15.09	26	77328	476	29496697
Palmar erythema	52.76	15.09	21	77333	226	29496947
Asthma	52.59	15.09	12	77342	33837	29463336
Toxicity to various agents	51.68	15.09	256	77098	173405	29323768
Pulmonary embolism	51.63	15.09	360	76994	76174	29420999
Hiccups	51.34	15.09	87	77267	8766	29488407
Agitation	50.89	15.09	36	77318	51268	29445905
Rash pustular	50.73	15.09	62	77292	4629	29492544
Feeling abnormal	50.42	15.09	41	77313	54404	29442769
Splenomegaly	49.29	15.09	108	77246	13171	29484002
Gastrointestinal anastomotic leak	48.21	15.09	22	77332	339	29496834
Cholangitis	47.65	15.09	77	77277	7460	29489713
Arthritis	47.60	15.09	5	77349	25014	29472159
Stoma site haemorrhage	46.89	15.09	27	77327	690	29496483
Therapeutic product effect decreased	46.64	15.09	10	77344	29441	29467732
Unevaluable event	45.55	15.09	11	77343	29840	29467333
Transdifferentiation of neoplasm	45.41	15.09	14	77340	64	29497109
Drug reaction with eosinophilia and systemic symptoms	45.38	15.09	9	77345	27983	29469190
Prinzmetal angina	44.89	15.09	28	77326	831	29496342
Malignant ascites	44.22	15.09	21	77333	356	29496817
Nasopharyngitis	43.77	15.09	55	77299	59610	29437563
Treatment noncompliance	43.25	15.09	6	77348	24221	29472952
Drug dependence	43.18	15.09	3	77351	20978	29476195
Anastomotic fistula	43.16	15.09	13	77341	54	29497119
Perforation	43.12	15.09	17	77337	178	29496995
Cellulitis	43.10	15.09	34	77320	45806	29451367
Asthenia	42.68	15.09	795	76559	214455	29282718
Febrile neutropenia	42.62	15.09	465	76889	111775	29385398
Enterovesical fistula	42.48	15.09	24	77330	591	29496582
Temperature intolerance	42.45	15.09	45	77309	2876	29494297
Evans syndrome	42.19	15.09	18	77336	234	29496939
Periportal sinus dilatation	42.09	15.09	11	77343	23	29497150
Intestinal ischaemia	41.80	15.09	68	77286	6624	29490549
Throat tightness	41.54	15.09	70	77284	7021	29490152
Nicotinic acid deficiency	40.57	15.09	13	77341	69	29497104
Dizziness	40.57	15.09	310	77044	189374	29307799
Septic shock	40.27	15.09	291	77063	62269	29434904
Chronic obstructive pulmonary disease	40.27	15.09	29	77325	40926	29456247
Subileus	39.82	15.09	43	77311	2807	29494366
Large intestinal obstruction	39.80	15.09	31	77323	1323	29495850
Oxygen saturation normal	39.59	15.09	8	77346	0	29497173
Noninfective epididymitis	39.59	15.09	8	77346	0	29497173
Hyperthermia	38.82	15.09	80	77274	9350	29487823
Immune thrombocytopenia	38.71	15.09	72	77282	7805	29489368
Pain	38.65	15.09	276	77078	171156	29326017
Small intestinal obstruction	38.42	15.09	97	77257	12964	29484209
Abnormal behaviour	38.41	15.09	7	77347	23120	29474053
Blood pressure immeasurable	38.19	15.09	25	77329	808	29496365
Dysaesthesia	37.92	15.09	36	77318	2014	29495159
Drug level increased	37.76	15.09	3	77351	18784	29478389
Off label use	37.68	15.09	1041	76313	299759	29197414
Neutropenic sepsis	37.58	15.09	90	77264	11637	29485536
Musculoskeletal stiffness	37.52	15.09	26	77328	37432	29459741
Influenza like illness	37.37	15.09	9	77345	24461	29472712
Sinusitis	36.92	15.09	22	77332	34328	29462845
Chronic kidney disease	36.84	15.09	25	77329	36391	29460782
Hypokalaemia	36.73	15.09	241	77113	49962	29447211
Liver function test abnormal	36.39	15.09	15	77339	28903	29468270
Hypoglycaemia	36.05	15.09	44	77310	48302	29448871
Acute coronary syndrome	35.69	15.09	91	77263	12234	29484939
International normalised ratio increased	35.67	15.09	38	77316	44334	29452839
Diabetes mellitus	35.64	15.09	31	77323	39800	29457373
Hepatic infarction	35.44	15.09	15	77339	191	29496982
Fluid retention	35.33	15.09	9	77345	23551	29473622
Stridor	34.92	15.09	36	77318	2227	29494946
Acute abdomen	34.86	15.09	32	77322	1715	29495458
Cardiac disorder	34.57	15.09	28	77326	37235	29459938
Cytomegalovirus infection	34.56	15.09	9	77345	23206	29473967
Tumour marker increased	34.29	15.09	20	77334	524	29496649
Psychotic disorder	34.15	15.09	6	77348	20348	29476825
Premature baby	34.07	15.09	3	77351	17277	29479896
Splenorenal shunt	34.07	15.09	8	77346	8	29497165
Wrong technique in product usage process	33.96	15.09	20	77334	31408	29465765
Cyanosis	33.48	15.09	84	77270	11183	29485990
Abdominal discomfort	33.24	15.09	46	77308	47857	29449316
Blood pressure fluctuation	33.09	15.09	6	77348	19888	29477285
Condition aggravated	32.73	15.09	236	77118	146059	29351114
Bronchitis	32.62	15.09	29	77325	36839	29460334
Blood creatine phosphokinase increased	32.46	15.09	35	77319	40609	29456564
Performance status decreased	32.07	15.09	44	77310	3683	29493490
Pelvic abscess	31.92	15.09	23	77331	871	29496302
Hypoalbuminaemia	31.85	15.09	78	77276	10227	29486946
Leukoencephalopathy	31.70	15.09	44	77310	3723	29493450
Type II hypersensitivity	31.65	15.09	9	77345	29	29497144
Contraindicated product administered	31.50	15.09	5	77349	18261	29478912
Mobility decreased	31.44	15.09	14	77340	25766	29471407
Seizure	31.41	15.09	131	77223	92992	29404181
Herpes zoster	31.25	15.09	20	77334	30032	29467141
Portal venous gas	30.95	15.09	16	77338	328	29496845
Haematoma	30.94	15.09	11	77343	23201	29473972
Oesophageal haemorrhage	30.90	15.09	25	77329	1128	29496045
Pulmonary fibrosis	30.54	15.09	100	77254	15482	29481691
Metastasis	30.29	15.09	41	77313	3388	29493785
Right ventricular ejection fraction decreased	30.15	15.09	9	77345	36	29497137
Alopecia	30.09	15.09	114	77240	18970	29478203
Hyperaemia	29.95	15.09	23	77331	961	29496212
Haemolytic anaemia	29.87	15.09	72	77282	9347	29487826
Hypervolaemia	29.82	15.09	5	77349	17540	29479633
Biliary fistula	29.76	15.09	9	77345	38	29497135
Sciatic nerve palsy	29.76	15.09	9	77345	38	29497135
Carbohydrate antigen 19-9 increased	29.74	15.09	13	77341	180	29496993
Oesophageal varices haemorrhage	29.68	15.09	36	77318	2666	29494507
Hepatectomy	29.51	15.09	10	77344	65	29497108
Recall phenomenon	29.38	15.09	18	77336	517	29496656
Hypertensive crisis	29.32	15.09	64	77290	7784	29489389
Cerebrovascular accident	29.28	15.09	103	77251	76808	29420365
Lymphangiosis carcinomatosa	29.24	15.09	21	77333	791	29496382
Perforation bile duct	29.08	15.09	8	77346	22	29497151
Blood alkaline phosphatase abnormal	28.99	15.09	16	77338	376	29496797
Failure to anastomose	28.39	15.09	13	77341	202	29496971
Acute respiratory distress syndrome	28.27	15.09	127	77227	22808	29474365
Encapsulating peritoneal sclerosis	28.02	15.09	18	77336	563	29496610
Hypovolaemic shock	27.98	15.09	54	77300	6018	29491155
Accidental overdose	27.80	15.09	6	77348	17587	29479586
Haemoglobinuria	27.79	15.09	18	77336	571	29496602
Device related infection	27.69	15.09	97	77257	15539	29481634
Hyperbilirubinaemia	27.63	15.09	94	77260	14840	29482333
Haemorrhage intracranial	27.42	15.09	3	77351	14539	29482634
Sedation	27.38	15.09	6	77348	17399	29479774
Anal sphincter atony	27.30	15.09	10	77344	84	29497089
Necrotising oesophagitis	27.24	15.09	17	77337	505	29496668
Subdural haematoma	27.18	15.09	7	77347	18186	29478987
Delirium	27.17	15.09	38	77316	39359	29457814
Gastric perforation	27.13	15.09	31	77323	2155	29495018
Brain teratoma	26.99	15.09	7	77347	14	29497159
Pulmonary toxicity	26.97	15.09	47	77307	4843	29492330
Portal vein thrombosis	26.88	15.09	38	77316	3271	29493902
Ocular toxicity	26.77	15.09	12	77342	177	29496996
ECG signs of myocardial ischaemia	26.53	15.09	12	77342	181	29496992
Muscular weakness	26.47	15.09	79	77275	61973	29435200
Head injury	26.42	15.09	5	77349	16076	29481097
Anaphylactic reaction	26.36	15.09	142	77212	27431	29469742
Cachexia	26.29	15.09	54	77300	6295	29490878
Pseudocirrhosis	26.06	15.09	7	77347	17	29497156
Emotional distress	25.87	15.09	3	77351	13892	29483281
Pruritus	25.72	15.09	439	76915	116410	29380763
Localised infection	25.68	15.09	3	77351	13813	29483360
Oesophagitis	25.63	15.09	79	77275	11844	29485329
Vocal cord paralysis	25.59	15.09	20	77334	858	29496315
Hyperkalaemia	25.58	15.09	79	77275	61313	29435860
Osteomyelitis	25.42	15.09	3	77351	13706	29483467
Blood cholesterol increased	25.30	15.09	5	77349	15590	29481583
Medication error	25.12	15.09	12	77342	21199	29475974
Nasal congestion	25.07	15.09	9	77345	18870	29478303
Wound dehiscence	25.03	15.09	35	77319	2982	29494191
Ileal perforation	24.70	15.09	18	77336	694	29496479
Pulmonary artery thrombosis	24.69	15.09	17	77337	598	29496575
Throat irritation	24.55	15.09	64	77290	8721	29488452
Dyspnoea	24.52	15.09	1066	76288	325666	29171507
Swelling	24.36	15.09	34	77320	35249	29461924
Basal cell carcinoma	24.33	15.09	7	77347	16903	29480270
Nephrotic syndrome	24.09	15.09	52	77302	6276	29490897
Papilloedema	24.02	15.09	30	77324	2290	29494883
Full blood count abnormal	23.97	15.09	5	77349	15008	29482165
Koebner phenomenon	23.87	15.09	8	77346	50	29497123
Blood creatinine increased	23.83	15.09	128	77226	84974	29412199
Perihepatic abscess	23.65	15.09	9	77345	85	29497088
Adverse drug reaction	23.62	15.09	17	77337	24003	29473170
Cardiac ventricular disorder	23.62	15.09	12	77342	237	29496936
Upper respiratory tract infection	23.61	15.09	22	77332	27327	29469846
Renal disorder	23.54	15.09	15	77339	22580	29474593
Fistula of small intestine	23.53	15.09	14	77340	381	29496792
Pachymeningitis	23.37	15.09	9	77345	88	29497085
Road traffic accident	23.22	15.09	6	77348	15555	29481618
Erectile dysfunction	23.22	15.09	9	77345	18000	29479173
Anaphylactoid reaction	23.16	15.09	27	77327	1918	29495255
Product prescribing error	23.15	15.09	9	77345	17967	29479206
Biliary tract infection	23.13	15.09	15	77339	477	29496696
Gait disturbance	23.01	15.09	106	77248	73243	29423930
Rectal cancer metastatic	22.92	15.09	11	77343	191	29496982
Productive cough	22.72	15.09	29	77325	31230	29465943
COVID-19	22.64	15.09	37	77317	35977	29461196
Hyperpyrexia	22.53	15.09	29	77325	2281	29494892
Blood pressure systolic increased	22.42	15.09	8	77346	16837	29480336
Pelvic fluid collection	22.36	15.09	9	77345	100	29497073
Nephrolithiasis	22.32	15.09	20	77334	25314	29471859
Muscle contractions involuntary	22.30	15.09	25	77329	1702	29495471
Intestinal dilatation	22.29	15.09	20	77334	1040	29496133
Oesophagobronchial fistula	22.28	15.09	10	77344	148	29497025
Hepatic failure	22.27	15.09	150	77204	31362	29465811
Cerebral vasoconstriction	22.22	15.09	11	77343	205	29496968
Interventricular septum rupture	22.22	15.09	6	77348	15	29497158
Embolism	22.17	15.09	53	77301	6843	29490330
Skin fissures	22.05	15.09	38	77316	3881	29493292
Metastases to muscle	21.99	15.09	11	77343	210	29496963
Toxic epidermal necrolysis	21.91	15.09	10	77344	18143	29479030
Fingerprint loss	21.87	15.09	7	77347	37	29497136
Cholestasis	21.86	15.09	120	77234	23342	29473831
Laryngeal oedema	21.85	15.09	33	77321	3015	29494158
Metastases to retroperitoneum	21.71	15.09	11	77343	216	29496957
Jaundice	21.64	15.09	141	77213	29155	29468018
Pulmonary oedema	21.58	15.09	50	77304	42685	29454488
Obstruction gastric	21.50	15.09	18	77336	852	29496321
Oropharyngeal pain	21.46	15.09	27	77327	29258	29467915
Induration	21.40	15.09	18	77336	858	29496315
Eosinophilia	21.38	15.09	16	77338	22145	29475028
Gastric dilatation	21.29	15.09	15	77339	548	29496625
Hyperfibrinolysis	21.18	15.09	6	77348	19	29497154
Drug intolerance	21.06	15.09	61	77293	48318	29448855
Underdose	21.04	15.09	3	77351	11866	29485307
Chronic myeloid leukaemia	20.99	15.09	26	77328	1968	29495205
Shock	20.98	15.09	111	77243	21293	29475880
Sarcoidosis	20.98	15.09	30	77324	2610	29494563
Liver abscess	20.96	15.09	34	77320	3304	29493869
Aortic thrombosis	20.91	15.09	16	77338	665	29496508
Monocytopenia	20.89	15.09	8	77346	77	29497096
Folliculitis	20.88	15.09	37	77317	3863	29493310
Portal vein dilatation	20.82	15.09	5	77349	6	29497167
Hypersplenism	20.65	15.09	12	77342	312	29496861
Full blood count decreased	20.60	15.09	8	77346	15984	29481189
Laboratory test abnormal	20.47	15.09	11	77343	18174	29478999
Trismus	20.39	15.09	28	77326	2345	29494828
Cold sweat	20.34	15.09	60	77294	8782	29488391
Catheter site extravasation	20.27	15.09	8	77346	84	29497089
Acral peeling skin syndrome	20.22	15.09	7	77347	49	29497124
Allodynia	20.14	15.09	15	77339	598	29496575
Mucosal toxicity	20.08	15.09	10	77344	189	29496984
Small intestinal perforation	20.01	15.09	23	77331	1609	29495564
Hypercreatinaemia	19.94	15.09	9	77345	135	29497038
Band sensation	19.86	15.09	8	77346	89	29497084
Feeling cold	19.85	15.09	61	77293	9130	29488043
Respiratory arrest	19.80	15.09	23	77331	25810	29471363
Pneumonitis chemical	19.70	15.09	9	77345	139	29497034
Injection site erythema	19.68	15.09	6	77348	13950	29483223
Hand-foot-genital syndrome	19.62	15.09	5	77349	9	29497164
Hot flush	19.59	15.09	84	77270	14786	29482387
Pneumonitis	19.52	15.09	133	77221	27911	29469262
Labelled drug-drug interaction medication error	19.52	15.09	4	77350	12155	29485018
Peripheral ischaemia	19.41	15.09	42	77312	5077	29492096
Gout	19.37	15.09	10	77344	16901	29480272
Cataract	19.32	15.09	18	77336	22360	29474813
Fistula	19.30	15.09	42	77312	5097	29492076
Ischiorectal hernia	19.28	15.09	5	77349	10	29497163
Rectosigmoid cancer	19.20	15.09	9	77345	148	29497025
Peritoneal haematoma	19.09	15.09	7	77347	59	29497114
Choking sensation	18.97	15.09	18	77336	1006	29496167
Oropharyngeal spasm	18.93	15.09	9	77345	153	29497020
Metastases to spleen	18.89	15.09	12	77342	368	29496805
Perineal disorder	18.89	15.09	7	77347	61	29497112
Neck pain	18.81	15.09	17	77337	21430	29475743
Gastrointestinal stoma complication	18.73	15.09	19	77335	1153	29496020
Malaise	18.68	15.09	548	76806	159054	29338119
Metastases to bone marrow	18.59	15.09	13	77341	469	29496704
Sleep disorder	18.38	15.09	22	77332	24364	29472809
Appendicitis noninfective	18.37	15.09	5	77349	13	29497160
Fixed eruption	18.33	15.09	19	77335	1183	29495990
Haemoglobin abnormal	18.24	15.09	31	77323	3130	29494043
Conjunctivitis	18.14	15.09	54	77300	7944	29489229
Nephritis allergic	18.08	15.09	12	77342	397	29496776
Chemical peritonitis	18.03	15.09	8	77346	115	29497058
B-cell small lymphocytic lymphoma	17.91	15.09	8	77346	117	29497056
Microangiopathic haemolytic anaemia	17.72	15.09	16	77338	839	29496334
Balance disorder	17.72	15.09	43	77311	36127	29461046
Amaurosis fugax	17.55	15.09	13	77341	514	29496659
Wheezing	17.51	15.09	38	77316	33202	29463971
Proteus infection	17.40	15.09	16	77338	859	29496314
Vascular injury	17.39	15.09	10	77344	255	29496918
Perineal ulceration	17.38	15.09	5	77349	17	29497156
Oedema peripheral	17.36	15.09	180	77174	103377	29393796
Acute motor-sensory axonal neuropathy	17.32	15.09	8	77346	127	29497046
Oral dysaesthesia	17.29	15.09	7	77347	79	29497094
Peritoneal disorder	17.28	15.09	10	77344	258	29496915
Haematemesis	17.27	15.09	117	77237	24509	29472664
Blood triglycerides increased	17.24	15.09	6	77348	12828	29484345
Pulmonary hypertension	17.23	15.09	14	77340	18594	29478579
Duodenal stenosis	17.22	15.09	9	77345	189	29496984
Angioedema	17.21	15.09	36	77318	31879	29465294
Tunnel vision	17.16	15.09	12	77342	433	29496740
Metastases to pelvis	17.04	15.09	10	77344	265	29496908
Intrahepatic portal hepatic venous fistula	17.03	15.09	4	77350	4	29497169
Blindness transient	17.02	15.09	23	77331	1897	29495276
Abdominal sepsis	16.99	15.09	16	77338	886	29496287
Obstructive airways disorder	16.92	15.09	4	77350	11012	29486161
Lower respiratory tract infection	16.87	15.09	27	77327	26475	29470698
VIth nerve disorder	16.75	15.09	5	77349	20	29497153
Diffuse large B-cell lymphoma refractory	16.69	15.09	16	77338	906	29496267
Thrombotic thrombocytopenic purpura	16.63	15.09	30	77324	3176	29493997
Phrenic nerve paralysis	16.48	15.09	7	77347	90	29497083
Bacterial colitis	16.42	15.09	6	77348	50	29497123
Nail disorder	16.40	15.09	22	77332	1802	29495371
Peripheral motor neuropathy	16.39	15.09	21	77333	1644	29495529
Hypersomnia	16.33	15.09	4	77350	10750	29486423
Hypotension	16.32	15.09	642	76712	193712	29303461
Infusion site urticaria	16.27	15.09	7	77347	93	29497080
Prostate cancer	16.26	15.09	26	77328	25501	29471672
Pancreatitis	16.15	15.09	42	77312	34472	29462701
Xerosis	16.12	15.09	12	77342	478	29496695
Abdominal mass	16.09	15.09	18	77336	1222	29495951
Blood pressure increased	16.02	15.09	120	77234	73683	29423490
Ichthyosis	16.01	15.09	7	77347	97	29497076
Prostatic calcification	16.01	15.09	7	77347	97	29497076
Colon cancer recurrent	15.94	15.09	7	77347	98	29497075
Electromyogram abnormal	15.92	15.09	6	77348	55	29497118
Retroperitoneal abscess	15.88	15.09	8	77346	155	29497018
Radiation interaction	15.85	15.09	5	77349	25	29497148
Stevens-Johnson syndrome	15.80	15.09	12	77342	16485	29480688
Rectal obstruction	15.77	15.09	4	77350	7	29497166
Pneumoperitoneum	15.74	15.09	20	77334	1553	29495620
Trichomegaly	15.69	15.09	5	77349	26	29497147
Gastrointestinal mucosal necrosis	15.65	15.09	8	77346	160	29497013
Blood glucose decreased	15.61	15.09	6	77348	12063	29485110
Product administration error	15.61	15.09	9	77345	14301	29482872
Bradycardia	15.57	15.09	104	77250	65525	29431648
Neurosarcoidosis	15.56	15.09	8	77346	162	29497011
Therapeutic product effect prolonged	15.56	15.09	9	77345	232	29496941
Respiratory depression	15.48	15.09	8	77346	13515	29483658
Vestibular neuronitis	15.39	15.09	8	77346	166	29497007
Proctitis	15.28	15.09	23	77331	2096	29495077
Limb injury	15.18	15.09	3	77351	9352	29487821
Skin laceration	15.16	15.09	5	77349	11057	29486116
Soft tissue swelling	15.14	15.09	10	77344	328	29496845
Faeces discoloured	15.14	15.09	8	77346	13343	29483830
Hypophagia	15.13	15.09	100	77254	20772	29476401
Type III immune complex mediated reaction	15.12	15.09	9	77345	245	29496928
Hyperlipidaemia	15.10	15.09	7	77347	12583	29484590

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
Neuropathy peripheral	2383.96	15.31	1865	116609	115660	64264598
Neutropenia	1406.86	15.31	1953	116521	237671	64142587
Neurotoxicity	1250.47	15.31	721	117753	26683	64353575
Disease progression	1214.65	15.31	1396	117078	140284	64239974
Thrombocytopenia	1049.48	15.31	1642	116832	222159	64158099
Diarrhoea	976.97	15.31	3221	115253	719483	63660775
Palmar-plantar erythrodysaesthesia syndrome	881.84	15.31	588	117886	28231	64352027
Laryngospasm	848.92	15.31	296	118178	3149	64377109
Dermatitis acneiform	794.41	15.31	362	118112	8081	64372177
Paraesthesia	662.99	15.31	1011	117463	133511	64246747
Skin toxicity	655.78	15.31	294	118180	6308	64373950
Arteriospasm coronary	625.87	15.31	269	118205	5196	64375062
Mucosal inflammation	573.23	15.31	639	117835	61945	64318313
Peripheral sensory neuropathy	520.45	15.31	300	118174	11078	64369180
Bone marrow failure	508.26	15.31	529	117945	47423	64332835
Vomiting	500.32	15.31	2167	116307	548950	63831308
Myelosuppression	466.13	15.31	371	118103	23459	64356799
Venoocclusive liver disease	457.90	15.31	264	118210	9751	64370507
Arthralgia	453.54	15.31	126	118348	442134	63938124
Erythema	423.37	15.31	1009	117465	186061	64194197
Polyneuropathy	422.14	15.31	325	118149	19569	64360689
Metastases to liver	414.16	15.31	347	118127	23594	64356664
Bronchospasm	407.99	15.31	330	118144	21352	64358906
Drug ineffective	394.79	15.31	585	117889	839662	63540596
Paronychia	387.34	15.31	204	118270	6288	64373970
Interstitial lung disease	357.81	15.31	643	117831	97089	64283169
Headache	357.35	15.31	271	118203	529196	63851062
Portal hypertension	352.91	15.31	189	118285	6030	64374228
Nausea	346.95	15.31	2545	115929	783255	63597003
Chills	339.57	15.31	767	117707	136497	64243761
Gastrointestinal perforation	325.19	15.31	171	118303	5253	64375005
Enteritis	311.69	15.31	222	118252	11855	64368403
Gastrointestinal toxicity	308.35	15.31	164	118310	5158	64375100
Haematotoxicity	303.11	15.31	224	118250	12672	64367586
Product dose omission issue	298.85	15.31	14	118460	194733	64185525
Dysaesthesia pharynx	290.61	15.31	69	118405	137	64380121
Joint swelling	286.24	15.31	31	118443	215351	64164907
Fall	280.14	15.31	214	118260	416612	63963646
Throat tightness	260.67	15.31	264	118210	22896	64357362
Neutrophil count decreased	248.81	15.31	481	117993	76715	64303543
Stridor	248.49	15.31	138	118336	4736	64375522
Neoplasm progression	243.81	15.31	337	118137	40627	64339631
Metastases to lung	235.00	15.31	207	118267	15057	64365201
Cardiotoxicity	231.50	15.31	174	118300	10100	64370158
Stomatitis	226.15	15.31	571	117903	109034	64271224
Type I hypersensitivity	223.75	15.31	116	118358	3458	64376800
Pain	223.38	15.31	424	118050	553087	63827171
Drug abuse	222.96	15.31	4	118470	132370	64247888
Leukopenia	217.88	15.31	536	117938	100706	64279552
Malignant neoplasm progression	213.34	15.31	569	117905	112302	64267956
Focal nodular hyperplasia	207.37	15.31	68	118406	589	64379669
Dysarthria	204.82	15.31	381	118093	59025	64321233
Arthropathy	202.33	15.31	4	118470	120963	64259295
Weight increased	201.75	15.31	70	118404	213278	64166980
Hyperammonaemia	199.65	15.31	157	118317	9747	64370511
Peripheral swelling	198.86	15.31	68	118406	209085	64171173
Decreased appetite	197.00	15.31	1028	117446	280261	64099997
Hyperammonaemic encephalopathy	196.29	15.31	111	118363	3947	64376311
Flushing	194.88	15.31	440	118034	78208	64302050
Non-cirrhotic portal hypertension	192.48	15.31	57	118417	338	64379920
Drug interaction	188.49	15.31	233	118241	361850	64018408
Depression	182.36	15.31	55	118419	183236	64197022
Sinusitis	181.64	15.31	26	118448	145902	64234356
Abdominal pain	181.13	15.31	1085	117389	311290	64068968
Ascites	178.96	15.31	369	118105	61632	64318626
Febrile neutropenia	178.45	15.31	750	117724	186907	64193351
Nasopharyngitis	172.60	15.31	72	118402	196001	64184257
Anaphylactic shock	172.26	15.31	244	118230	30084	64350174
Insomnia	170.40	15.31	75	118399	197761	64182497
Splenomegaly	168.78	15.31	186	118288	17775	64362483
Therapy partial responder	167.88	15.31	144	118330	10104	64370154
Swelling	165.05	15.31	45	118429	160173	64220085
Dysphonia	161.78	15.31	299	118175	46083	64334175
Overdose	158.51	15.31	48	118426	159518	64220740
Contraindicated product administered	158.35	15.31	10	118464	107819	64272439
Proteinuria	157.39	15.31	223	118251	27500	64352758
Nodular regenerative hyperplasia	155.53	15.31	59	118415	811	64379447
Intestinal obstruction	155.30	15.31	256	118218	36030	64344228
Feeling hot	152.57	15.31	289	118185	45374	64334884
Hypersensitivity	152.20	15.31	739	117735	195713	64184545
Product use issue	151.86	15.31	45	118429	151670	64228588
Hypomagnesaemia	149.72	15.31	256	118218	37120	64343138
Pyrexia	145.07	15.31	1615	116859	557029	63823229
Contusion	142.52	15.31	20	118454	113945	64266313
Therapeutic product effect decreased	142.49	15.31	21	118453	115330	64264928
Pain in extremity	138.62	15.31	214	118260	302871	64077387
Maternal exposure during pregnancy	137.55	15.31	10	118464	95874	64284384
Influenza	137.28	15.31	17	118457	106514	64273744
Injection site pain	135.97	15.31	21	118453	111387	64268871
Paraesthesia oral	133.92	15.31	142	118332	12989	64367269
Pneumonia	133.65	15.31	552	117922	559024	63821234
Hyperhidrosis	133.59	15.31	518	117956	124402	64255856
Cytokine release syndrome	132.46	15.31	177	118297	20652	64359606
Abdominal discomfort	132.24	15.31	86	118388	182236	64198022
Cardiac failure congestive	132.01	15.31	38	118436	130542	64249716
Dyspnoea	129.78	15.31	1943	116531	716731	63663527
Carcinoembryonic antigen increased	129.48	15.31	65	118409	1808	64378450
Dysaesthesia	129.29	15.31	92	118382	4903	64375355
Asthma	128.23	15.31	13	118461	95212	64285046
Systemic lupus erythematosus	128.06	15.31	3	118471	77609	64302649
Varices oesophageal	124.81	15.31	91	118383	5039	64375219
Oxygen saturation decreased	124.18	15.31	456	118018	106720	64273538
Large intestine perforation	122.73	15.31	133	118341	12471	64367787
Tumour perforation	122.53	15.31	39	118435	304	64379954
Anastomotic leak	122.06	15.31	51	118423	915	64379343
Somnolence	121.36	15.31	117	118357	203528	64176730
Dehydration	120.44	15.31	745	117729	216018	64164240
Anxiety	120.10	15.31	117	118357	202532	64177726
Bronchitis	118.84	15.31	27	118447	108716	64271542
Intentional product misuse	118.50	15.31	3	118471	72292	64307966
Enterocolitis	117.34	15.31	127	118347	11891	64368367
Suicide attempt	116.18	15.31	3	118471	71004	64309254
Laryngeal discomfort	115.75	15.31	41	118433	458	64379800
Arthritis	114.01	15.31	11	118463	83803	64296455
Immune thrombocytopenia	113.07	15.31	139	118335	14927	64365331
Skin reaction	112.75	15.31	126	118348	12226	64368032
Colorectal cancer metastatic	112.36	15.31	48	118426	912	64379346
Asthenia	112.06	15.31	1240	117234	426804	63953454
Intravascular haemolysis	111.54	15.31	44	118430	676	64379582
Metastases to peritoneum	107.52	15.31	72	118402	3475	64376783
Hospitalisation	107.42	15.31	8	118466	75199	64305059
Myalgia	106.85	15.31	81	118393	158536	64221722
Laryngeal oedema	106.57	15.31	95	118379	7018	64373240
Posterior reversible encephalopathy syndrome	105.14	15.31	167	118307	22779	64357479
Hypertransaminasaemia	103.70	15.31	94	118380	7097	64373161
Ileus	103.66	15.31	166	118308	22800	64357458
Osteoarthritis	102.42	15.31	3	118471	63333	64316925
Peritonitis	101.01	15.31	172	118302	24851	64355407
Musculoskeletal stiffness	99.45	15.31	51	118423	123155	64257103
Administration site extravasation	98.31	15.31	45	118429	1014	64379244
Extravasation	97.47	15.31	65	118409	3115	64377143
Condition aggravated	96.02	15.31	356	118118	372070	64008188
Disseminated intravascular coagulation	95.05	15.31	194	118280	32154	64348104
Injection site erythema	94.46	15.31	10	118464	70790	64309468
Pemphigus	94.24	15.31	4	118470	60697	64319561
Hyperthermia	94.10	15.31	129	118345	15421	64364837
Stress	93.94	15.31	4	118470	60530	64319728
Drug intolerance	93.50	15.31	125	118349	187867	64192391
Lower respiratory tract infection	92.95	15.31	29	118445	94585	64285673
Intestinal perforation	92.61	15.31	127	118347	15186	64365072
Portal shunt	89.75	15.31	22	118452	53	64380205
Haemolytic anaemia	89.44	15.31	128	118346	15925	64364333
General physical health deterioration	87.51	15.31	659	117815	203766	64176492
Exposure during pregnancy	87.48	15.31	18	118456	77657	64302601
Suicidal ideation	87.25	15.31	10	118464	66532	64313726
Confusional state	86.92	15.31	222	118252	260922	64119336
Pneumatosis intestinalis	86.72	15.31	74	118400	5155	64375103
Glossodynia	86.66	15.31	9	118465	64687	64315571
Wound	85.56	15.31	18	118456	76459	64303799
Hypertensive crisis	85.25	15.31	134	118340	18114	64362144
Cholinergic syndrome	85.17	15.31	38	118436	805	64379453
Rhabdomyolysis	85.09	15.31	31	118443	91695	64288563
Tumour necrosis	83.34	15.31	47	118427	1662	64378596
Dihydropyrimidine dehydrogenase deficiency	82.30	15.31	23	118451	107	64380151
Diffuse large B-cell lymphoma recurrent	81.55	15.31	58	118416	3088	64377170
Memory impairment	81.11	15.31	28	118446	85654	64294604
Tongue oedema	79.97	15.31	75	118399	5915	64374343
Anastomotic complication	78.26	15.31	29	118445	372	64379886
Fluid retention	78.04	15.31	9	118465	59597	64320661
Drug hypersensitivity	77.73	15.31	204	118270	237611	64142647
Incorrect dose administered	77.54	15.31	10	118464	60755	64319503
Electrocardiogram QT prolonged	76.89	15.31	25	118449	79423	64300835
Infusion related reaction	76.56	15.31	541	117933	163926	64216332
Inappropriate schedule of product administration	76.27	15.31	37	118437	92249	64288009
Acute coronary syndrome	75.66	15.31	131	118343	19179	64361079
Blood cholesterol increased	75.46	15.31	4	118470	50062	64330196
Off label use	74.13	15.31	1599	116875	631207	63749051
Anastomotic fistula	73.60	15.31	20	118454	82	64380176
Toxic leukoencephalopathy	72.95	15.31	35	118439	880	64379378
Aggression	71.92	15.31	3	118471	46229	64334029
Pulmonary embolism	71.40	15.31	487	117987	145869	64234389
Chronic obstructive pulmonary disease	71.19	15.31	21	118453	71027	64309231
Nicotinic acid deficiency	71.13	15.31	21	118453	123	64380135
Hepatic enzyme increased	70.25	15.31	81	118393	129862	64250396
Stomal varices	70.24	15.31	17	118457	38	64380220
Rectal perforation	69.63	15.31	32	118442	728	64379530
Electrocardiogram ST segment elevation	69.62	15.31	76	118398	7183	64373075
Stress cardiomyopathy	68.81	15.31	85	118389	9172	64371086
Leukoencephalopathy	68.67	15.31	74	118400	6893	64373365
Tumour lysis syndrome	68.62	15.31	126	118348	19314	64360944
Mobility decreased	68.57	15.31	36	118438	85804	64294454
Myocardial infarction	68.39	15.31	125	118349	165696	64214562
Hypokalaemia	67.62	15.31	419	118055	121484	64258774
Vascular pain	67.08	15.31	32	118442	794	64379464
Hypertension	66.73	15.31	749	117725	258512	64121746
Injection site reaction	66.53	15.31	5	118469	46659	64333599
Anaphylactic reaction	66.36	15.31	276	118198	68388	64311870
Neuromyotonia	66.01	15.31	18	118456	75	64380183
Platelet count decreased	65.30	15.31	529	117945	167182	64213076
Upper respiratory tract infection	65.17	15.31	26	118448	72759	64307499
Osteoporosis	64.57	15.31	3	118471	42077	64338181
Cholangitis	64.44	15.31	89	118385	10713	64369545
Coronary artery disease	64.05	15.31	16	118458	60417	64319841
Hiccups	64.02	15.31	78	118396	8298	64371960
Evans syndrome	63.38	15.31	25	118449	384	64379874
Feeling abnormal	63.24	15.31	92	118382	133510	64246748
Hypoalbuminaemia	62.94	15.31	115	118359	17559	64362699
Blood pressure fluctuation	62.77	15.31	10	118464	51861	64328397
Subileus	62.04	15.31	60	118414	4917	64375341
Migraine	61.94	15.31	19	118455	62658	64317600
Blood glucose increased	61.15	15.31	54	118420	98019	64282239
Band sensation	60.76	15.31	28	118446	641	64379617
Colon cancer metastatic	60.62	15.31	40	118434	1883	64378375
Hallucination	60.43	15.31	29	118445	72759	64307499
Drug reaction with eosinophilia and systemic symptoms	60.15	15.31	13	118461	54204	64326054
Metastases to lymph nodes	59.96	15.31	77	118397	8640	64371618
Rash pustular	59.80	15.31	82	118392	9803	64370455
Gastrointestinal anastomotic leak	59.72	15.31	24	118450	388	64379870
Dizziness	59.42	15.31	505	117969	429658	63950600
Gait disturbance	59.07	15.31	144	118330	172011	64208247
Periportal sinus dilatation	58.57	15.31	14	118460	29	64380229
Herpes zoster	57.85	15.31	37	118437	79150	64301108
Sedation	57.56	15.31	5	118469	41457	64338801
Chemical peritonitis	57.12	15.31	21	118453	263	64379995
Injection site pruritus	57.07	15.31	3	118471	37823	64342435
Stoma site haemorrhage	56.87	15.31	36	118438	1577	64378681
Choking sensation	56.53	15.31	49	118425	3486	64376772
Speech disorder	55.97	15.31	206	118268	48235	64332023
Mucosal toxicity	55.61	15.31	24	118450	468	64379790
Cellulitis	55.52	15.31	54	118420	93603	64286655
Oesophageal varices haemorrhage	55.42	15.31	49	118425	3580	64376678
Influenza like illness	55.31	15.31	22	118452	61680	64318578
International normalised ratio increased	55.14	15.31	39	118435	79128	64301130
Hyperbilirubinaemia	55.13	15.31	121	118353	21084	64359174
Large intestinal obstruction	54.81	15.31	43	118431	2659	64377599
Emotional distress	53.93	15.31	3	118471	36035	64344223
Cyanosis	53.77	15.31	123	118351	22032	64358226
Treatment failure	53.77	15.31	82	118392	116734	64263524
Anaemia	53.62	15.31	985	117489	377695	64002563
Treatment noncompliance	53.48	15.31	8	118466	43474	64336784
Palmar erythema	52.52	15.31	35	118439	1675	64378583
Ocular toxicity	52.38	15.31	25	118449	621	64379637
Hepatic atrophy	52.38	15.31	22	118452	400	64379858
Diffuse large B-cell lymphoma refractory	52.36	15.31	30	118444	1094	64379164
ECG signs of myocardial ischaemia	52.34	15.31	21	118453	338	64379920
Encapsulating peritoneal sclerosis	52.28	15.31	27	118447	798	64379460
Wrong technique in product usage process	52.26	15.31	27	118447	64947	64315311
Metastasis	51.81	15.31	58	118416	5637	64374621
Prinzmetal angina	51.64	15.31	33	118441	1470	64378788
Necrotising fasciitis	51.50	15.31	56	118418	5270	64374988
Drug level increased	50.70	15.31	3	118471	34193	64346065
Hepatic failure	50.68	15.31	219	118255	55175	64325083
Enterocutaneous fistula	50.57	15.31	33	118441	1524	64378734
Helicobacter infection	49.70	15.31	6	118468	38356	64341902
Cough	49.58	15.31	338	118136	301810	64078448
Hypervolaemia	49.57	15.31	6	118468	38279	64341979
Urinary tract infection	49.33	15.31	238	118236	231358	64148900
Nasal congestion	49.17	15.31	24	118450	59634	64320624
Drug dependence	49.16	15.31	3	118471	33309	64346949
Enterovesical fistula	48.78	15.31	27	118447	920	64379338
Gastric perforation	48.75	15.31	45	118429	3478	64376780
Psychotic disorder	48.47	15.31	4	118470	34574	64345684
Dysphagia	48.30	15.31	349	118125	106463	64273795
Blister	47.63	15.31	47	118427	80920	64299338
Ileal perforation	47.41	15.31	26	118448	870	64379388
Pericarditis	47.35	15.31	28	118446	62488	64317770
Pulmonary toxicity	47.31	15.31	68	118406	8493	64371765
Acute abdomen	46.90	15.31	40	118434	2784	64377474
Transdifferentiation of neoplasm	46.31	15.31	14	118460	90	64380168
Septic shock	46.24	15.31	342	118132	105095	64275163
Diabetes mellitus	45.96	15.31	33	118441	66441	64313817
Liver function test abnormal	45.85	15.31	26	118448	59375	64320883
Metastases to bone marrow	45.64	15.31	23	118451	645	64379613
Metastases to spleen	45.40	15.31	21	118453	485	64379773
Sleep disorder	44.86	15.31	27	118447	59682	64320576
Productive cough	44.80	15.31	41	118433	73162	64307096
Formication	44.21	15.31	47	118427	4310	64375948
Steatohepatitis	44.20	15.31	24	118450	787	64379471
Malignant ascites	43.84	15.31	26	118448	1012	64379246
Viral infection	43.65	15.31	7	118467	36133	64344125
Hypoglycaemia	43.42	15.31	61	118413	89831	64290427
Biliary tract infection	43.28	15.31	25	118449	926	64379332
Head injury	42.89	15.31	5	118469	32837	64347421
Performance status decreased	42.71	15.31	51	118423	5313	64374945
Oxygen saturation normal	42.41	15.31	8	118466	0	64380258
White blood cell count decreased	41.93	15.31	459	118015	157378	64222880
Cataract	41.67	15.31	21	118453	51241	64329017
Hyperpyrexia	41.63	15.31	49	118425	5028	64375230
Colitis	41.30	15.31	215	118259	58459	64321799
Haemoglobinuria	40.81	15.31	22	118452	711	64379547
Splenorenal shunt	40.55	15.31	9	118465	11	64380247
Skin fissures	40.48	15.31	70	118404	10236	64370022
Hyperkalaemia	40.12	15.31	78	118396	101051	64279207
Nervousness	39.87	15.31	4	118470	29552	64350706
Cold sweat	39.54	15.31	91	118383	16364	64363894
Unevaluable event	39.11	15.31	22	118452	50467	64329791
Tachycardia	38.82	15.31	433	118041	149146	64231112
Type II hypersensitivity	38.49	15.31	10	118464	33	64380225
Medication error	38.38	15.31	22	118452	49944	64330314
Trismus	38.04	15.31	46	118428	4855	64375403
Lip oedema	37.53	15.31	47	118427	5142	64375116
Oropharyngeal pain	37.51	15.31	66	118408	88801	64291457
Acute respiratory distress syndrome	37.21	15.31	156	118318	38779	64341479
Basal cell carcinoma	37.19	15.31	6	118468	30832	64349426
Cardiac disorder	36.93	15.31	29	118445	55787	64324471
Cold dysaesthesia	36.88	15.31	8	118466	8	64380250
Recall phenomenon	36.84	15.31	23	118451	983	64379275
K-ras gene mutation	36.80	15.31	10	118464	41	64380217
Irritability	36.55	15.31	11	118463	36735	64343523
Underdose	36.17	15.31	3	118471	25826	64354432
Portal vein dilatation	36.05	15.31	10	118464	45	64380213
Discomfort	36.04	15.31	58	118416	80820	64299438
Portal venous gas	35.99	15.31	16	118458	336	64379922
Heart rate decreased	35.94	15.31	29	118445	55038	64325220
Factor VII deficiency	35.80	15.31	9	118465	25	64380233
Small intestinal perforation	35.79	15.31	33	118441	2547	64377711
Peripheral motor neuropathy	35.52	15.31	35	118439	2935	64377323
Abnormal behaviour	35.44	15.31	9	118465	33613	64346645
Duodenal ulcer perforation	35.11	15.31	10	118464	34615	64345643
Infusion related hypersensitivity reaction	35.06	15.31	13	118461	167	64380091
Hepatocellular injury	34.82	15.31	170	118304	45065	64335193
Neck pain	34.73	15.31	37	118437	61496	64318762
Splenic artery thrombosis	34.71	15.31	10	118464	53	64380205
Haematoma	34.62	15.31	21	118453	46229	64334029
Hallucination, visual	34.51	15.31	5	118469	27829	64352429
Product prescribing error	34.29	15.31	11	118463	35258	64345000
Guillain-Barre syndrome	34.19	15.31	55	118419	7580	64372678
Hypertrichosis	34.07	15.31	23	118451	1125	64379133
Perforation	34.07	15.31	23	118451	1125	64379133
Balance disorder	33.93	15.31	64	118410	83862	64296396
COVID-19	33.71	15.31	42	118432	65098	64315160
Blood pressure immeasurable	33.69	15.31	28	118446	1880	64378378
Laryngeal dyspnoea	33.62	15.31	14	118460	249	64380009
Pharyngeal paraesthesia	33.58	15.31	28	118446	1889	64378369
Metastases to meninges	33.34	15.31	33	118441	2782	64377476
Small intestinal obstruction	33.12	15.31	107	118367	23466	64356792
Hypovolaemic shock	33.07	15.31	64	118410	10202	64370056
Short-bowel syndrome	33.00	15.31	16	118458	412	64379846
Road traffic accident	32.85	15.31	8	118466	30737	64349521
Rhinorrhoea	32.81	15.31	37	118437	59932	64320326
Aortic thrombosis	32.69	15.31	25	118449	1489	64378769
Abortion spontaneous	32.41	15.31	4	118470	25139	64355119
Blood pressure systolic increased	32.33	15.31	26	118448	49427	64330831
Dysgeusia	32.15	15.31	171	118303	46876	64333382
Embolism	32.01	15.31	70	118404	12165	64368093
Cystitis radiation	31.97	15.31	11	118463	112	64380146
Right ventricular ejection fraction decreased	31.84	15.31	9	118465	44	64380214
Noninfective epididymitis	31.81	15.31	6	118468	0	64380258
Accidental overdose	31.69	15.31	11	118463	33546	64346712
Oesophageal haemorrhage	31.68	15.31	25	118449	1559	64378699
Hydronephrosis	31.64	15.31	76	118398	14049	64366209
Jaundice	31.58	15.31	174	118300	48338	64331920
Trichomegaly	31.52	15.31	10	118464	77	64380181
Biliary fistula	31.52	15.31	10	118464	77	64380181
Toxicity to various agents	31.46	15.31	474	118000	363039	64017219
Muscle contractions involuntary	31.41	15.31	34	118440	3183	64377075
Intestinal ischaemia	31.28	15.31	67	118407	11482	64368776
Neutropenic sepsis	31.23	15.31	104	118370	23168	64357090
Pulmonary fibrosis	31.16	15.31	123	118351	29755	64350503
Portal vein thrombosis	31.10	15.31	42	118432	4949	64375309
Liver abscess	30.74	15.31	43	118431	5237	64375021
Pulmonary artery thrombosis	30.72	15.31	22	118452	1184	64379074
Type 2 diabetes mellitus	30.70	15.31	12	118462	34008	64346250
Toxic epidermal necrolysis	30.55	15.31	15	118459	37151	64343107
Oropharyngeal discomfort	30.40	15.31	43	118431	5292	64374966
Tooth disorder	30.30	15.31	3	118471	22399	64357859
Haematemesis	30.21	15.31	168	118306	46831	64333427
Temperature intolerance	29.76	15.31	54	118420	8201	64372057
Gastrooesophageal reflux disease	29.73	15.31	68	118406	83075	64297183
Hypersplenism	29.72	15.31	15	118459	422	64379836
Anaphylactoid reaction	29.72	15.31	40	118434	4698	64375560
Suffocation feeling	29.69	15.31	24	118450	1550	64378708
Full blood count abnormal	29.43	15.31	9	118465	29748	64350510
Hypothyroidism	29.41	15.31	19	118455	40438	64339820
Pelvic fluid collection	29.40	15.31	17	118457	631	64379627
Femur fracture	29.26	15.31	13	118461	34122	64346136
Neutropenic colitis	29.23	15.31	39	118435	4542	64375716
Perforation bile duct	29.21	15.31	8	118466	34	64380224
Hypophagia	29.21	15.31	147	118327	39440	64340818
Appendicitis noninfective	29.12	15.31	7	118467	15	64380243
Cytomegalovirus infection	29.11	15.31	16	118458	37183	64343075
Oral dysaesthesia	28.94	15.31	11	118463	152	64380106
Oedema peripheral	28.92	15.31	247	118227	210070	64170188
Eosinophilia	28.91	15.31	17	118457	38059	64342199
Hypotension	28.74	15.31	909	117565	380065	64000193
Thrombocytopenic purpura	28.73	15.31	27	118447	2135	64378123
Loss of personal independence in daily activities	28.64	15.31	56	118418	72398	64307860
Pelvic abscess	28.35	15.31	25	118449	1820	64378438
Failure to anastomose	28.28	15.31	12	118462	224	64380034
Perineal disorder	28.23	15.31	7	118467	18	64380240
Osteomyelitis	27.91	15.31	8	118466	27579	64352679
Sciatic nerve palsy	27.86	15.31	9	118465	74	64380184
Death	27.74	15.31	675	117799	482030	63898228
Medical device site extravasation	27.66	15.31	6	118468	6	64380252
Oesophagitis	27.56	15.31	95	118379	21535	64358723
Hepatectomy	27.53	15.31	11	118463	175	64380083
Granulocyte count decreased	27.39	15.31	21	118453	1255	64379003
Nephrolithiasis	27.29	15.31	24	118450	43659	64336599
Wound dehiscence	27.25	15.31	43	118431	5831	64374427
Hypercreatinaemia	27.21	15.31	12	118462	247	64380011
Obesity	27.18	15.31	3	118471	20559	64359699
Oropharyngeal spasm	27.08	15.31	12	118462	250	64380008
Tumour ulceration	27.03	15.31	11	118463	184	64380074
Haemolytic uraemic syndrome	26.84	15.31	35	118439	3986	64376272
Sensation of foreign body	26.84	15.31	37	118437	4445	64375813
Impaired quality of life	26.80	15.31	45	118429	6426	64373832
Koebner phenomenon	26.79	15.31	8	118466	49	64380209
Blood glucose decreased	26.78	15.31	5	118469	23118	64357140
Fistula of small intestine	26.61	15.31	16	118458	639	64379619
Respiratory arrest	26.55	15.31	35	118439	52950	64327308
Nephrotic syndrome	26.48	15.31	56	118418	9511	64370747
Hyperfibrinolysis	26.31	15.31	7	118467	26	64380232
Device issue	26.01	15.31	5	118469	22643	64357615
Ear pain	25.97	15.31	7	118467	25129	64355129
Full blood count decreased	25.91	15.31	5	118469	22577	64357681
Retching	25.89	15.31	74	118400	15182	64365076
Heart rate irregular	25.86	15.31	9	118465	27404	64352854
Necrotising oesophagitis	25.84	15.31	16	118458	674	64379584
Atypical haemolytic uraemic syndrome	25.80	15.31	16	118458	676	64379582
Acute polyneuropathy	25.56	15.31	13	118461	372	64379886
Respiratory distress	25.40	15.31	174	118300	52157	64328101
Hyperaemia	25.35	15.31	28	118446	2681	64377577
Hypoacusis	25.27	15.31	8	118466	25859	64354399
Blood creatine phosphokinase increased	25.15	15.31	43	118431	58515	64321743
Localised infection	25.05	15.31	12	118462	30149	64350109
Drug ineffective for unapproved indication	24.94	15.31	13	118461	31120	64349138
Skin laceration	24.85	15.31	7	118467	24410	64355848
Tonic clonic movements	24.83	15.31	24	118450	1965	64378293
Cholestasis	24.71	15.31	154	118320	44718	64335540
Hepatic encephalopathy	24.68	15.31	90	118384	20976	64359282
Subacute cutaneous lupus erythematosus	24.48	15.31	29	118445	2996	64377262
Sinus bradycardia	24.37	15.31	6	118468	22887	64357371
Tendonitis	24.33	15.31	4	118470	20278	64359980
Fear	24.15	15.31	4	118470	20167	64360091
Female genital tract fistula	24.06	15.31	27	118447	2631	64377627
Haemorrhage intracranial	24.03	15.31	7	118467	23877	64356381
Gastric varices haemorrhage	23.99	15.31	12	118462	331	64379927
Retroperitoneal abscess	23.96	15.31	12	118462	332	64379926
Adverse drug reaction	23.85	15.31	29	118445	45435	64334823
Vasospasm	23.64	15.31	17	118457	921	64379337
Hypoaesthesia oral	23.50	15.31	60	118414	11520	64368738
Proctitis	23.47	15.31	29	118445	3130	64377128
Limb injury	23.45	15.31	7	118467	23498	64356760
Haemolysis	23.24	15.31	58	118416	10981	64369277
Fatigue	23.17	15.31	1132	117342	747598	63632660
Perihepatic abscess	23.13	15.31	9	118465	133	64380125
Obstruction gastric	23.04	15.31	20	118454	1426	64378832
Allodynia	23.01	15.31	19	118455	1264	64378994
Catheter site extravasation	23.01	15.31	12	118462	362	64379896
Livedo reticularis	22.86	15.31	31	118443	3666	64376592
Carbohydrate antigen 19-9 increased	22.86	15.31	12	118462	367	64379891
Organising pneumonia	22.78	15.31	51	118423	9004	64371254
Chest discomfort	22.76	15.31	319	118155	115787	64264471
Epistaxis	22.74	15.31	278	118196	97853	64282405
Acral peeling skin syndrome	22.65	15.31	7	118467	49	64380209
Product substitution issue	22.64	15.31	3	118471	17858	64362400
Bradycardia	22.60	15.31	126	118348	118093	64262165
Gastrointestinal stoma complication	22.57	15.31	24	118450	2202	64378056
Hyperlipasaemia	22.52	15.31	17	118457	993	64379265
Cytopenia	22.44	15.31	71	118403	15400	64364858
Interventricular septum rupture	22.40	15.31	6	118468	23	64380235
Surgery	22.27	15.31	12	118462	28201	64352057
Hepatic lesion	22.15	15.31	39	118435	5785	64374473
Multiple sclerosis	22.14	15.31	4	118470	18937	64361321
Pulmonary hypertension	22.12	15.31	28	118446	43111	64337147
Intervertebral disc protrusion	22.07	15.31	5	118469	20186	64360072
Renal hydrocele	22.00	15.31	6	118468	25	64380233
Venous thrombosis limb	21.97	15.31	31	118443	3806	64376452
Dry eye	21.97	15.31	13	118461	29006	64351252
Cardiomegaly	21.96	15.31	8	118466	23676	64356582
Hepatic function abnormal	21.90	15.31	197	118277	64116	64316142
Blood alkaline phosphatase abnormal	21.80	15.31	15	118459	757	64379501
Platelet count increased	21.75	15.31	4	118470	18692	64361566
Pigmentation disorder	21.72	15.31	34	118440	4578	64375680
Fingerprint loss	21.62	15.31	7	118467	58	64380200
Metastases to muscle	21.62	15.31	11	118463	315	64379943
Blood pressure diastolic decreased	21.60	15.31	7	118467	22294	64357964
Premature delivery	21.57	15.31	4	118470	18585	64361673
Eczema	21.55	15.31	14	118460	29706	64350552
Cardiospasm	21.45	15.31	6	118468	28	64380230
Hand-foot-genital syndrome	21.38	15.31	5	118469	9	64380249
Pain in jaw	21.38	15.31	26	118448	40729	64339529
Musculoskeletal pain	21.35	15.31	77	118397	81217	64299041
Hypersomnia	21.32	15.31	5	118469	19712	64360546
Limbic encephalitis	21.25	15.31	14	118460	657	64379601
Gallbladder disorder	21.25	15.31	3	118471	17027	64363231
Aortitis	21.22	15.31	17	118457	1084	64379174
Gait inability	21.21	15.31	28	118446	42340	64337918
Hepatic vein stenosis	21.21	15.31	7	118467	62	64380196
Prostatic calcification	21.21	15.31	7	118467	62	64380196
Abdominal wall oedema	21.21	15.31	4	118470	0	64380258
Hallucination, auditory	21.10	15.31	3	118471	16936	64363322
Cardiac ventricular disorder	21.09	15.31	11	118463	332	64379926
Hepatic infarction	21.08	15.31	15	118459	799	64379459
Cachexia	21.08	15.31	50	118424	9167	64371091
Ischiorectal hernia	21.03	15.31	5	118469	10	64380248
Cerebrovascular accident	21.02	15.31	157	118317	137426	64242832
Colitis ulcerative	20.98	15.31	8	118466	23020	64357238
Rectal cancer metastatic	20.96	15.31	12	118462	437	64379821
Loss of consciousness	20.95	15.31	386	118088	147979	64232279
Adverse event	20.92	15.31	25	118449	39464	64340794
Protein urine	20.82	15.31	18	118456	1276	64378982
Ventricular fibrillation	20.81	15.31	93	118381	23767	64356491
Implant site dehiscence	20.79	15.31	6	118468	32	64380226
Tremor	20.71	15.31	385	118089	147845	64232413
Swelling face	20.66	15.31	49	118425	59117	64321141
Blood potassium increased	20.59	15.31	11	118463	25969	64354289
Hemiparaesthesia	20.51	15.31	8	118466	119	64380139
Chronic myeloid leukaemia	20.43	15.31	28	118446	3346	64376912
Hypocapnia	20.38	15.31	13	118461	577	64379681
Congestive cardiomyopathy	20.38	15.31	53	118421	10291	64369967
Gout	20.25	15.31	7	118467	21406	64358852
Fistula	20.25	15.31	51	118423	9710	64370548
Drug eruption	20.09	15.31	22	118452	36114	64344144
Musculoskeletal discomfort	20.00	15.31	3	118471	16274	64363984
Diaphragmatic paralysis	20.00	15.31	16	118458	1018	64379240
Cholelithiasis	19.93	15.31	33	118441	45473	64334785
Seizure	19.93	15.31	203	118271	166689	64213569
Skin disorder	19.87	15.31	102	118372	27578	64352680
Hiatus hernia	19.80	15.31	6	118468	19951	64360307
Vocal cord paralysis	19.77	15.31	22	118452	2124	64378134
Peripheral ischaemia	19.76	15.31	46	118428	8332	64371926
Toothache	19.75	15.31	4	118470	17455	64362803
Catheter site bruise	19.73	15.31	10	118464	284	64379974
Tumour haemorrhage	19.67	15.31	28	118446	3465	64376793
Pneumonitis	19.64	15.31	159	118315	50206	64330052
Peripheral sensorimotor neuropathy	19.64	15.31	24	118450	2561	64377697
Palpitations	19.63	15.31	112	118362	104376	64275882
Labelled drug-drug interaction medication error	19.55	15.31	8	118466	22054	64358204
Gastric disorder	19.53	15.31	15	118459	29182	64351076
Macroglossia	19.49	15.31	16	118458	1056	64379202
Mucosal disorder	19.43	15.31	26	118448	3036	64377222
Pseudocirrhosis	19.33	15.31	13	118461	632	64379626
Oesophagobronchial fistula	19.26	15.31	9	118465	213	64380045
Delirium	19.21	15.31	64	118410	69130	64311128
Dry skin	19.14	15.31	160	118314	51001	64329257
Infusion site hypoaesthesia	19.13	15.31	5	118469	17	64380241
Anger	19.12	15.31	3	118471	15738	64364520
Pulmonary congestion	19.08	15.31	10	118464	23870	64356388
Metastases to diaphragm	19.05	15.31	6	118468	45	64380213
Skin discolouration	19.01	15.31	22	118452	35233	64345025
Therapeutic response unexpected	19.01	15.31	4	118470	16997	64363261
Chemotherapy cardiotoxicity attenuation	18.91	15.31	5	118469	18	64380240
Hyperthyroidism	18.90	15.31	5	118469	18174	64362084
Malaise	18.83	15.31	899	117575	395348	63984910
Monocytopenia	18.82	15.31	8	118466	150	64380108
Anal sphincter atony	18.78	15.31	10	118464	315	64379943
Induration	18.77	15.31	19	118455	1645	64378613
Pneumoperitoneum	18.73	15.31	24	118450	2687	64377571
Device related infection	18.71	15.31	108	118366	30518	64349740
No adverse event	18.69	15.31	15	118459	28546	64351712
Catabolic state	18.67	15.31	7	118467	93	64380165
Depressed mood	18.66	15.31	29	118445	40983	64339275
Soft tissue necrosis	18.57	15.31	13	118461	675	64379583
Musculoskeletal disorder	18.48	15.31	5	118469	17901	64362357
Neonatal asphyxia	18.44	15.31	4	118470	4	64380254
Intrahepatic portal hepatic venous fistula	18.44	15.31	4	118470	4	64380254
Inferior vena cava stenosis	18.40	15.31	6	118468	51	64380207
Pachymeningitis	18.34	15.31	9	118465	238	64380020
Rectal cancer recurrent	18.30	15.31	5	118469	21	64380237
Impaired work ability	18.26	15.31	3	118471	15216	64365042
Venoocclusive disease	18.25	15.31	29	118445	3956	64376302
Pancreatic neuroendocrine tumour metastatic	18.21	15.31	7	118467	100	64380158
Colorectal cancer recurrent	18.19	15.31	6	118468	53	64380205
Therapy interrupted	18.19	15.31	7	118467	20029	64360229
Liver function test increased	18.18	15.31	18	118456	30952	64349306
Impaired healing	18.15	15.31	54	118420	60419	64319839
Cerebral haemorrhage	18.09	15.31	42	118432	51048	64329210
Microangiopathic haemolytic anaemia	18.08	15.31	17	118457	1345	64378913
Mental impairment	17.96	15.31	4	118470	16339	64363919
Heart rate increased	17.88	15.31	107	118367	98568	64281690
Tetany	17.87	15.31	21	118453	2151	64378107
Metastases to ovary	17.84	15.31	9	118465	253	64380005
Pruritus	17.76	15.31	722	117752	311678	64068580
Venous injury	17.72	15.31	12	118462	590	64379668
Cerebral vasoconstriction	17.67	15.31	16	118458	1206	64379052
Amnesia	17.64	15.31	39	118435	48230	64332028
Immunodeficiency	17.61	15.31	4	118470	16120	64364138
Endometrial dysplasia	17.60	15.31	5	118469	25	64380233
Abdominal abscess	17.57	15.31	37	118437	6267	64373991
Splenic abscess	17.56	15.31	11	118463	473	64379785
Blood creatinine increased	17.54	15.31	162	118312	135620	64244638
Radiation interaction	17.53	15.31	6	118468	60	64380198
Tunnel vision	17.51	15.31	15	118459	1050	64379208
Metastases to retroperitoneum	17.49	15.31	10	118464	363	64379895
Product administration error	17.49	15.31	15	118459	27628	64352630
Extrapyramidal disorder	17.47	15.31	7	118467	19545	64360713
Gastrointestinal obstruction	17.43	15.31	17	118457	1408	64378850
VIth nerve disorder	17.28	15.31	5	118469	27	64380231
Disease recurrence	17.26	15.31	108	118366	31402	64348856
Restless legs syndrome	17.25	15.31	5	118469	17111	64363147
Chronic kidney disease	17.18	15.31	52	118422	57867	64322391
Gastrointestinal necrosis	17.17	15.31	32	118442	4960	64375298
Aortic intramural haematoma	17.15	15.31	7	118467	118	64380140
Motion sickness	17.13	15.31	13	118461	765	64379493
Peripheral nerve injury	17.12	15.31	12	118462	624	64379634
Renal disorder	17.07	15.31	24	118450	35341	64344917
Gastrointestinal mucosal necrosis	16.98	15.31	8	118466	193	64380065
Atrioventricular block complete	16.95	15.31	3	118471	14415	64365843
Sciatica	16.93	15.31	8	118466	20256	64360002
Nephritis allergic	16.92	15.31	12	118462	636	64379622
Night sweats	16.87	15.31	25	118449	36021	64344237
Autoimmune haemolytic anaemia	16.85	15.31	39	118435	7037	64373221
Mixed adenoneuroendocrine carcinoma	16.83	15.31	4	118470	8	64380250
Eye pain	16.77	15.31	20	118454	31605	64348653
Therapy cessation	16.75	15.31	21	118453	32468	64347790
Ichthyosis	16.73	15.31	7	118467	126	64380132
Amaurosis fugax	16.71	15.31	13	118461	794	64379464
Post embolisation syndrome	16.70	15.31	6	118468	70	64380188
Gastric varices	16.65	15.31	11	118463	519	64379739
Laboratory test abnormal	16.56	15.31	12	118462	24051	64356207
Lacrimation disorder	16.51	15.31	4	118470	9	64380249
Blood triglycerides increased	16.46	15.31	7	118467	18859	64361399
Oesophageal fistula	16.39	15.31	9	118465	302	64379956
Fixed eruption	16.33	15.31	20	118454	2139	64378119
Adenocarcinoma of colon	16.31	15.31	31	118443	4877	64375381
Aplasia	16.21	15.31	38	118436	6915	64373343
Aplastic anaemia	16.14	15.31	3	118471	13917	64366341
Feeling cold	16.13	15.31	86	118388	23592	64356666
Lymphadenopathy mediastinal	16.11	15.31	27	118447	3849	64376409
Infection	15.98	15.31	241	118233	184639	64195619
Eyelid ptosis	15.97	15.31	46	118428	9479	64370779
Mental disorder	15.95	15.31	15	118459	26430	64353828
Dyskinesia	15.95	15.31	30	118444	39358	64340900
Neuronal neuropathy	15.91	15.31	3	118471	0	64380258
Gastrointestinal stoma output increased	15.82	15.31	8	118466	226	64380032
Coombs positive haemolytic anaemia	15.74	15.31	13	118461	865	64379393
Subdural haematoma	15.68	15.31	17	118457	28037	64352221
Tumour marker increased	15.65	15.31	25	118449	3425	64376833
Lymphangiosis carcinomatosa	15.64	15.31	18	118456	1803	64378455
Oedema	15.47	15.31	102	118372	91833	64288425
Myoclonus	15.45	15.31	14	118460	25104	64355154
Liver injury	15.41	15.31	101	118373	29831	64350427
Abdominal sepsis	15.41	15.31	18	118456	1832	64378426
Ankle fracture	15.38	15.31	4	118470	14706	64365552
Sense of oppression	15.38	15.31	16	118458	1431	64378827

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01XA03	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Platinum compounds
FDA EXT	N0000175073	Platinum-containing Compounds
FDA EPC	N0000175413	Platinum-based Drug
MeSH PA	D000970	Antineoplastic Agents
CHEBI has role	CHEBI:25435	mutagens
CHEBI has role	CHEBI:35610	antineoplastic agents

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

Disease	Relation	SNOMED_ID	DOID
Metastasis from malignant tumor of colon	indication	314998002
Small intestine cancer	indication	363509000	DOID:10154
Lymph Node Positive Colorectal Carcinoma	indication
Malignant tumor of colon	off-label use	363406005	DOID:219
Malignant tumor of testis	off-label use	363449006	DOID:2998
Adenocarcinoma of pancreas	off-label use	700423003	DOID:4074
Fibrosis of lung	contraindication	51615001	DOID:3770
Interstitial pneumonia	contraindication	64667001
Kidney disease	contraindication	90708001	DOID:557
Liver function tests abnormal	contraindication	166603001
Disease of liver	contraindication	235856003	DOID:409
Pregnancy, function	contraindication	289908002
Peripheral nerve disease	contraindication	302226006
Breastfeeding (mother)	contraindication	413712001

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

ID	Source
4021355	VUID
N0000148774	NUI
D01790	KEGG_DRUG
4021355	VANDF
C0069717	UMLSCUI
CHEBI:31941	CHEBI
1PT	PDB_CHEM_ID
CHEMBL414804	ChEMBL_ID
D000077150	MESH_DESCRIPTOR_UI
DB00526	DRUGBANK_ID
7433	IUPHAR_LIGAND_ID
6012	INN_ID
04ZR38536J	UNII
9887053	PUBCHEM_CID
32592	RXNORM
165344	MMSL
16916	MMSL
d04811	MMSL
007166	NDDF
327032007	SNOMEDCT_US
395814003	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	0703-3985	INJECTION, SOLUTION, CONCENTRATE	50 mg	INTRAVENOUS	NDA	28 sections
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	0703-3986	INJECTION, SOLUTION, CONCENTRATE	100 mg	INTRAVENOUS	NDA	28 sections
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3315	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	29 sections
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3317	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	29 sections
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	0781-9315	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	28 sections
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	0781-9317	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	28 sections
OXALIPLATIN	HUMAN PRESCRIPTION DRUG LABEL	1	0955-1725	INJECTION, SOLUTION, CONCENTRATE	5 mg	INTRAVENOUS	NDA AUTHORIZED GENERIC	33 sections
OXALIPLATIN	HUMAN PRESCRIPTION DRUG LABEL	1	0955-1727	INJECTION, SOLUTION, CONCENTRATE	5 mg	INTRAVENOUS	NDA AUTHORIZED GENERIC	33 sections
OXALIPLATIN	HUMAN PRESCRIPTION DRUG LABEL	1	0955-1731	INJECTION, SOLUTION, CONCENTRATE	5 mg	INTRAVENOUS	NDA AUTHORIZED GENERIC	33 sections
OXALIPLATIN	HUMAN PRESCRIPTION DRUG LABEL	1	0955-1733	INJECTION, SOLUTION, CONCENTRATE	5 mg	INTRAVENOUS	NDA AUTHORIZED GENERIC	33 sections
oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	16714-727	INJECTION	5 mg	INTRAVENOUS	ANDA	27 sections
oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	16714-728	INJECTION	5 mg	INTRAVENOUS	ANDA	27 sections
oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	16729-332	INJECTION, SOLUTION, CONCENTRATE	5 mg	INTRAVENOUS	ANDA	30 sections
oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	25021-233	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	28 sections
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	43066-014	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	28 sections
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	43066-018	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	28 sections
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	45963-611	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	5 mg	INTRAVENOUS	ANDA	20 sections
Oxaliplatin	Human Prescription Drug Label	1	47335-046	INJECTION, SOLUTION, CONCENTRATE	50 mg	INTRAVENOUS	ANDA	27 sections
Oxaliplatin	Human Prescription Drug Label	1	47335-047	INJECTION, SOLUTION, CONCENTRATE	100 mg	INTRAVENOUS	ANDA	27 sections
Oxaliplatin	Human Prescription Drug Label	1	47335-176	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 mg	INTRAVENOUS	ANDA	28 sections
Oxaliplatin	Human Prescription Drug Label	1	47335-178	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	ANDA	28 sections
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	50742-405	INJECTION, SOLUTION	50 mg	INTRAVENOUS	ANDA	26 sections
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	50742-406	INJECTION, SOLUTION	100 mg	INTRAVENOUS	ANDA	26 sections
Oxaliplatin	Human Prescription Drug Label	1	55150-331	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	29 sections
Oxaliplatin	Human Prescription Drug Label	1	55150-332	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	29 sections
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	57277-001	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	26 sections
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	57277-002	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	26 sections
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	60505-6132	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	25 sections
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	60505-6132	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	25 sections
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	61703-363	INJECTION, SOLUTION, CONCENTRATE	5 mg	INTRAVENOUS	ANDA	33 sections