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

Stem definition	Drug id	CAS RN
antineoplastics, taxane derivatives	2044	33069-62-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: paclitaxel (-)-Paclitaxel abraxane capxol cyclopax ebetaxel genaxol mitotax padexol plaxicel taxol Taxol A Tocosol Paclitaxel nabpaclitaxel ABI-007 nab-paclitaxel	A cyclodecane isolated from the bark of the Pacific yew tree, TAXUS BREVIFOLIA. It stabilizes MICROTUBULES in their polymerized form leading to cell death. Molecular weight: 853.92 Formula: C47H51NO14 CLOGP: 3.88 LIPINSKI: 2 HAC: 15 HDO: 4 TPSA: 221.29 ALOGS: -5.19 ROTB: 14 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

paclitaxel
(-)-Paclitaxel
abraxane
capxol
cyclopax
ebetaxel
genaxol
mitotax
padexol
plaxicel
taxol
Taxol A
Tocosol Paclitaxel
nabpaclitaxel
ABI-007
nab-paclitaxel

A cyclodecane isolated from the bark of the Pacific yew tree, TAXUS BREVIFOLIA. It stabilizes MICROTUBULES in their polymerized form leading to cell death.

Molecular weight: 853.92
Formula: C47H51NO14
CLOGP: 3.88
LIPINSKI: 2
HAC: 15
HDO: 4
TPSA: 221.29
ALOGS: -5.19
ROTB: 14

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)	2	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)	5.54 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	6.50 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	3 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	6.40 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.12 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	11 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company
May 10, 2019	EMA	TEVA BV
Sept. 20, 2019	PMDA	Taiho Pharmaceutical Co., Ltd.
Dec. 29, 1992	FDA	HQ SPCLT PHARMA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Malignant neoplasm progression	1910.19	12.84	1556	144032	72031	56074448
Neutropenia	1706.59	12.84	2071	143517	156096	55990383
Neuropathy peripheral	1648.03	12.84	1658	143930	101235	56045244
Disease progression	1223.19	12.84	1432	144156	103741	56042738
Metastases to liver	1107.20	12.84	692	144896	20894	56125585
Erythema	1039.61	12.84	1619	143969	154320	55992159
Metastases to bone	1034.97	12.84	639	144949	18869	56127610
Febrile neutropenia	1018.16	12.84	1308	144280	104237	56042242
Rheumatoid arthritis	894.74	12.84	20	145568	382584	55763895
Flushing	879.25	12.84	993	144595	69107	56077372
Breast cancer metastatic	857.05	12.84	521	145067	14948	56131531
Anaemia	826.17	12.84	2005	143583	265506	55880973
Myelosuppression	709.97	12.84	484	145104	16971	56129508
Drug ineffective	697.96	12.84	815	144773	918174	55228305
Metastases to lung	665.41	12.84	401	145187	11317	56135162
Neutrophil count decreased	662.71	12.84	728	144860	49094	56097385
Palmar-plantar erythrodysaesthesia syndrome	656.90	12.84	497	145091	20568	56125911
Dyspnoea	651.63	12.84	3137	142451	589440	55557039
Polyneuropathy	566.94	12.84	377	145211	12673	56133806
Neoplasm progression	557.96	12.84	541	145047	31475	56115004
Joint swelling	549.90	12.84	56	145532	289744	55856735
Peripheral sensory neuropathy	531.68	12.84	289	145299	6667	56139812
Acute myeloid leukaemia	495.30	12.84	385	145203	16587	56129892
Metastases to central nervous system	487.52	12.84	334	145254	11802	56134677
Thrombocytopenia	477.21	12.84	1074	144514	135150	56011329
Leukopenia	446.10	12.84	718	144870	70222	56076257
Metastases to lymph nodes	444.76	12.84	263	145325	7160	56139319
Neurotoxicity	442.98	12.84	350	145238	15445	56131034
Mucosal inflammation	441.38	12.84	549	145039	42261	56104218
Contraindicated product administered	412.06	12.84	16	145572	186270	55960209
Ejection fraction decreased	404.72	12.84	366	145222	19475	56127004
Arthropathy	403.33	12.84	30	145558	200245	55946234
Chest discomfort	395.91	12.84	823	144765	98034	56048445
Death	395.58	12.84	1838	143750	339588	55806891
Pneumonitis	393.43	12.84	446	145142	31118	56115361
Product dose omission issue	381.93	12.84	42	145546	204711	55941768
Systemic lupus erythematosus	380.34	12.84	21	145567	180057	55966422
Haematotoxicity	378.23	12.84	248	145340	8135	56138344
Synovitis	374.23	12.84	9	145579	161296	55985183
Ascites	364.04	12.84	467	145121	37077	56109402
Therapeutic product effect decreased	348.06	12.84	23	145565	169429	55977050
Glossodynia	344.44	12.84	11	145577	152447	55994032
Fall	338.84	12.84	258	145330	357252	55789227
Bone marrow failure	331.17	12.84	387	145201	27899	56118580
Abdominal discomfort	325.77	12.84	155	145433	277119	55869360
Sinusitis	325.34	12.84	59	145529	197522	55948957
Completed suicide	324.69	12.84	4	145584	133829	56012650
Anaphylactic shock	308.72	12.84	329	145259	21411	56125068
Pain	307.96	12.84	800	144788	662384	55484095
Swelling	302.25	12.84	121	145467	239650	55906829
Condition aggravated	299.48	12.84	271	145317	344627	55801852
Proteinuria	293.15	12.84	290	145298	17280	56129199
Breast cancer	288.94	12.84	481	145107	48352	56098127
Second primary malignancy	286.18	12.84	199	145389	7203	56139276
Weight increased	284.52	12.84	119	145469	229584	55916895
Pseudocirrhosis	283.21	12.84	93	145495	548	56145931
Metastases to peritoneum	281.34	12.84	143	145445	2861	56143618
Feeling hot	277.80	12.84	434	145154	41353	56105126
Epistaxis	276.45	12.84	565	145023	66458	56080021
Cystoid macular oedema	272.33	12.84	114	145474	1427	56145052
Myelodysplastic syndrome	272.26	12.84	270	145318	16136	56130343
Headache	267.26	12.84	664	144924	558380	55588099
Musculoskeletal stiffness	260.22	12.84	45	145543	155962	55990517
Bronchospasm	256.56	12.84	256	145332	15413	56131066
Pleural effusion	255.61	12.84	634	144954	84846	56061633
Product use issue	254.61	12.84	82	145506	185959	55960520
Interstitial lung disease	252.03	12.84	495	145093	56568	56089911
Drug intolerance	234.62	12.84	204	145384	264614	55881865
Onycholysis	233.28	12.84	99	145489	1285	56145194
Skin toxicity	230.26	12.84	140	145448	4013	56142466
Hypertension	226.52	12.84	1236	144352	243042	55903437
Gastrointestinal perforation	222.73	12.84	125	145463	3074	56143405
Wound	216.77	12.84	47	145541	138757	56007722
Ovarian cancer recurrent	215.03	12.84	88	145500	1036	56145443
Back pain	213.83	12.84	1191	144397	235979	55910500
General physical health deterioration	211.72	12.84	936	144652	169074	55977405
Peripheral swelling	211.32	12.84	178	145410	234548	55911931
Treatment failure	204.98	12.84	92	145496	170300	55976179
Vomiting	204.79	12.84	2076	143512	496152	55650327
Arthralgia	197.56	12.84	653	144935	501016	55645463
Diarrhoea	191.43	12.84	2502	143086	636005	55510474
Psoriasis	189.02	12.84	13	145575	92679	56053800
Injection site pain	188.35	12.84	37	145551	117081	56029398
Bone pain	184.78	12.84	404	145184	49781	56096698
Hypertransaminasaemia	183.02	12.84	127	145461	4580	56141899
Nausea	182.08	12.84	2876	142712	761302	55385177
Pericarditis	180.32	12.84	32	145556	108891	56037588
Nasopharyngitis	174.96	12.84	188	145400	220771	55925708
Cardiotoxicity	171.68	12.84	149	145439	7501	56138978
Helicobacter infection	170.18	12.84	4	145584	73264	56073215
Platelet count decreased	169.99	12.84	633	144955	105750	56040729
Embolism	166.41	12.84	144	145444	7220	56139259
Ovarian cancer	165.85	12.84	134	145454	6104	56140375
Cardiac dysfunction	164.99	12.84	87	145501	1883	56144596
Abdominal pain	162.13	12.84	1185	144403	257620	55888859
Sense of oppression	161.74	12.84	69	145519	908	56145571
Pyrexia	160.95	12.84	1722	143866	417051	55729428
Metastasis	160.52	12.84	118	145470	4666	56141813
Hepatic enzyme increased	160.37	12.84	125	145463	171259	55975220
Breast cancer recurrent	158.57	12.84	110	145478	3965	56142514
PIK3CA-activated mutation	156.42	12.84	67	145521	891	56145588
Drug abuse	155.85	12.84	4	145584	67606	56078873
Pancreatic carcinoma metastatic	154.70	12.84	87	145501	2148	56144331
Blood cholesterol increased	154.58	12.84	8	145580	72571	56073908
Irritable bowel syndrome	154.32	12.84	5	145583	68453	56078026
White blood cell count decreased	153.99	12.84	690	144898	125300	56021179
Therapy partial responder	151.67	12.84	140	145448	7645	56138834
Osteonecrosis of jaw	151.66	12.84	293	145295	33065	56113414
Mobility decreased	151.54	12.84	35	145553	98956	56047523
Duodenal ulcer perforation	150.56	12.84	6	145582	68336	56078143
Maternal exposure during pregnancy	150.34	12.84	161	145427	189392	55957087
Discomfort	147.70	12.84	92	145496	141669	56004810
Hospitalisation	145.95	12.84	13	145575	74987	56071492
Arthritis	143.81	12.84	40	145548	99812	56046667
Migraine	142.57	12.84	26	145562	86771	56059708
Lymphangiosis carcinomatosa	142.44	12.84	68	145520	1181	56145298
Hypokalaemia	141.85	12.84	551	145037	93886	56052593
Contusion	141.37	12.84	78	145510	128352	56018127
Hypoxia	140.68	12.84	380	145208	53517	56092962
Overdose	140.59	12.84	49	145539	105781	56040698
Drug hypersensitivity	139.71	12.84	316	145272	274889	55871590
Tachycardia	139.39	12.84	593	144995	105283	56041196
Loss of personal independence in daily activities	136.65	12.84	23	145565	81346	56065133
Somnolence	136.15	12.84	133	145455	163280	55983199
Suicide attempt	134.93	12.84	3	145585	57833	56088646
Injection site erythema	134.33	12.84	20	145568	77428	56069051
Paraesthesia	132.81	12.84	678	144910	129836	56016643
Fibromyalgia	132.09	12.84	5	145583	59598	56086881
Depression	130.94	12.84	164	145424	179953	55966526
Exposure during pregnancy	129.36	12.84	98	145490	136244	56010235
Asthma	129.26	12.84	65	145523	112705	56033774
Metastases to meninges	127.07	12.84	77	145511	2193	56144286
Pulmonary embolism	125.88	12.84	580	145008	106544	56039935
Oxygen saturation decreased	125.04	12.84	469	145119	78598	56067881
Nail disorder	123.02	12.84	150	145438	11301	56135178
Neutropenic sepsis	122.85	12.84	173	145415	15012	56131467
Hepatic failure	122.59	12.84	269	145319	33217	56113262
Left ventricular dysfunction	121.60	12.84	147	145441	10976	56135503
Disease recurrence	121.46	12.84	220	145368	23640	56122839
Dehydration	119.43	12.84	761	144827	158064	55988415
Influenza	116.77	12.84	50	145538	95211	56051268
Lower respiratory tract infection	116.14	12.84	77	145511	114717	56031762
Nail discolouration	115.41	12.84	75	145513	2421	56144058
Large intestine perforation	115.32	12.84	121	145467	7730	56138749
Throat tightness	112.02	12.84	205	145383	22202	56124277
Peripheral motor neuropathy	111.89	12.84	62	145526	1486	56144993
Asthenia	109.45	12.84	1361	144227	341612	55804867
Cyanosis	108.93	12.84	167	145421	15643	56130836
Biliary tract infection	108.89	12.84	45	145543	544	56145935
Decreased appetite	108.85	12.84	952	144636	218279	55928200
Pneumocystis jirovecii pneumonia	106.99	12.84	165	145423	15536	56130943
Nail toxicity	105.35	12.84	38	145550	308	56146171
Blister	104.91	12.84	77	145511	108810	56037669
Intestinal perforation	104.10	12.84	135	145453	10824	56135655
Ileus	101.85	12.84	151	145437	13731	56132748
Hepatic atrophy	101.58	12.84	35	145553	244	56146235
Confusional state	101.56	12.84	244	145344	207911	55938568
Injection site reaction	101.54	12.84	10	145578	53237	56093242
Gastrointestinal toxicity	101.54	12.84	101	145487	6055	56140424
Cholangitis	100.31	12.84	91	145497	4858	56141621
Inappropriate schedule of product administration	98.69	12.84	46	145542	83341	56063138
Toxicity to various agents	98.28	12.84	278	145310	224286	55922193
Memory impairment	97.53	12.84	51	145537	86506	56059973
Metastases to skin	96.18	12.84	55	145533	1403	56145076
Pancytopenia	95.95	12.84	469	145119	88246	56058233
Osteoarthritis	95.48	12.84	44	145544	80252	56066227
Urogenital fistula	95.07	12.84	31	145557	178	56146301
Injury	93.93	12.84	20	145568	59831	56086648
Feeling abnormal	93.60	12.84	125	145463	133477	56013002
Injection site swelling	92.17	12.84	5	145583	43573	56102906
Insomnia	91.93	12.84	227	145361	191633	55954846
Gait disturbance	91.65	12.84	177	145411	163144	55983335
Injection site pruritus	88.10	12.84	5	145583	41926	56104553
Cardiomyopathy	88.01	12.84	154	145434	16104	56130375
Pancreatic carcinoma	87.95	12.84	101	145487	7140	56139339
Intentional product misuse	87.71	12.84	14	145574	51490	56094989
Tumour necrosis	86.40	12.84	41	145547	702	56145777
Incorrect dose administered	85.72	12.84	16	145572	52531	56093948
Metastases to pleura	85.50	12.84	50	145538	1332	56145147
Laryngospasm	85.37	12.84	66	145522	2818	56143661
Dysaesthesia	84.05	12.84	76	145512	4040	56142439
Drug interaction	83.66	12.84	271	145317	209484	55936995
Plasma cell myeloma	83.34	12.84	11	145577	46635	56099844
Folliculitis	83.01	12.84	20	145568	54959	56091520
Small intestinal obstruction	82.93	12.84	153	145435	16672	56129807
Posterior reversible encephalopathy syndrome	82.30	12.84	148	145440	15812	56130667
Subileus	82.01	12.84	65	145523	2879	56143600
C-reactive protein abnormal	81.86	12.84	3	145585	36806	56109673
Non-small cell lung cancer	81.58	12.84	71	145517	3587	56142892
Muscle spasms	80.49	12.84	145	145443	137226	56009253
Recall phenomenon	79.91	12.84	36	145552	544	56145935
Metastatic neoplasm	79.41	12.84	72	145516	3841	56142638
Tumour marker increased	79.39	12.84	75	145513	4218	56142261
Metastases to spine	79.02	12.84	64	145524	2925	56143554
Hydronephrosis	78.81	12.84	108	145480	9134	56137345
Red blood cell sedimentation rate increased	78.09	12.84	4	145584	36619	56109860
Suicidal ideation	77.94	12.84	26	145562	57716	56088763
Tumour haemorrhage	77.70	12.84	48	145540	1416	56145063
Malignant pleural effusion	77.49	12.84	58	145530	2358	56144121
Triple negative breast cancer	76.73	12.84	27	145561	202	56146277
Acute promyelocytic leukaemia	74.70	12.84	40	145548	894	56145585
Osteoporosis	74.65	12.84	21	145567	52031	56094448
Cardiac failure	74.25	12.84	413	145175	81680	56064799
Anaphylactoid reaction	74.09	12.84	66	145522	3440	56143039
Hepatic function abnormal	72.17	12.84	225	145363	34333	56112146
Portal hypertension	71.55	12.84	65	145523	3476	56143003
Anaphylactic reaction	71.17	12.84	322	145266	58673	56087806
Computerised tomogram thorax abnormal	69.87	12.84	45	145543	1430	56145049
Radiation pneumonitis	69.48	12.84	45	145543	1444	56145035
Invasive ductal breast carcinoma	69.43	12.84	87	145501	6739	56139740
Hypoglycaemia	68.86	12.84	29	145559	55786	56090693
Fluid retention	68.50	12.84	27	145561	54051	56092428
Carbohydrate antigen 15-3 increased	68.29	12.84	42	145546	1229	56145250
Alveolitis	68.07	12.84	56	145532	2617	56143862
Illness	67.08	12.84	6	145582	34505	56111974
Bronchitis	65.38	12.84	119	145469	112192	56034287
Adverse event	64.82	12.84	31	145557	55345	56091134
Metastases to kidney	64.69	12.84	23	145565	178	56146301
Pain in extremity	64.59	12.84	477	145111	296954	55849525
Metastases to the mediastinum	63.80	12.84	29	145559	448	56146031
Pneumothorax	63.22	12.84	127	145461	14740	56131739
Bronchostenosis	63.13	12.84	28	145560	407	56146072
Abortion spontaneous	62.10	12.84	18	145570	43735	56102744
Therapeutic product effect incomplete	62.03	12.84	112	145476	105919	56040560
Secondary cerebellar degeneration	61.91	12.84	17	145571	47	56146432
Metastases to retroperitoneum	61.37	12.84	21	145567	143	56146336
Sleep disorder	61.17	12.84	51	145537	67612	56078867
Tumour lysis syndrome	60.75	12.84	88	145500	7835	56138644
Urticaria	60.41	12.84	183	145405	144493	56001986
Superior vena cava syndrome	60.32	12.84	31	145557	635	56145844
Hypertensive crisis	59.80	12.84	120	145468	13916	56132563
Performance status decreased	59.44	12.84	57	145531	3266	56143213
Anxiety	59.40	12.84	277	145311	192895	55953584
Palmar erythema	58.84	12.84	42	145546	1585	56144894
Paronychia	58.72	12.84	68	145520	4850	56141629
Lymphoedema	58.63	12.84	101	145487	10429	56136050
Blood pressure fluctuation	58.40	12.84	16	145572	40344	56106135
COVID-19	58.06	12.84	65	145523	74993	56071486
Colitis	57.95	12.84	238	145350	41573	56104906
Atelectasis	57.42	12.84	143	145445	19165	56127314
Thrombotic microangiopathy	57.37	12.84	94	145494	9317	56137162
Surgery	57.23	12.84	8	145580	32478	56114001
Carbohydrate antigen 125 increased	57.10	12.84	50	145538	2547	56143932
Ear infection	56.82	12.84	7	145581	31288	56115191
Small intestinal perforation	56.70	12.84	38	145550	1293	56145186
Macular oedema	56.66	12.84	59	145529	3735	56142744
Cataract	56.54	12.84	31	145557	51216	56095263
Multiple sclerosis	56.36	12.84	4	145584	27798	56118681
Pulmonary arterial hypertension	56.17	12.84	3	145585	26500	56119979
Urinary tract obstruction	55.70	12.84	43	145545	1832	56144647
Hyperaemia	55.18	12.84	45	145543	2077	56144402
Acute interstitial pneumonitis	54.65	12.84	29	145559	636	56145843
Recurrent cancer	54.47	12.84	42	145546	1786	56144693
Hot flush	54.10	12.84	252	145336	46474	56100005
Unevaluable event	53.85	12.84	28	145560	47659	56098820
Sepsis	53.42	12.84	575	145013	139265	56007214
Infusion related reaction	53.32	12.84	797	144791	208134	55938345
Neoplasm recurrence	53.29	12.84	47	145541	2417	56144062
Coronary artery disease	53.28	12.84	8	145580	30788	56115691
Hepatic lesion	52.77	12.84	60	145528	4195	56142284
Carcinoembryonic antigen increased	52.37	12.84	39	145549	1573	56144906
Gastric disorder	52.30	12.84	11	145577	33199	56113280
Pericardial effusion	52.25	12.84	172	145416	27003	56119476
Type 2 diabetes mellitus	52.20	12.84	28	145560	46834	56099645
Malignant ascites	52.11	12.84	31	145557	853	56145626
Hepatitis B reactivation	51.95	12.84	46	145542	2378	56144101
Adverse drug reaction	51.93	12.84	55	145533	65077	56081402
Pregnancy	51.90	12.84	11	145577	33022	56113457
Nephrolithiasis	51.82	12.84	16	145572	37319	56109160
Hypersensitivity	51.71	12.84	941	144647	255467	55891012
Bile duct stenosis	51.17	12.84	34	145554	1140	56145339
Dizziness	51.05	12.84	676	144912	375464	55771015
Device related infection	50.91	12.84	148	145440	21732	56124747
Drug reaction with eosinophilia and systemic symptoms	49.91	12.84	9	145579	30295	56116184
Wheezing	49.73	12.84	73	145515	74953	56071526
Metastases to chest wall	49.55	12.84	25	145563	492	56145987
Cholangitis sclerosing	49.49	12.84	36	145552	1400	56145079
Nasal congestion	49.11	12.84	44	145544	56326	56090153
Medication error	49.09	12.84	24	145564	42311	56104168
Bone lesion	48.65	12.84	65	145523	5365	56141114
Constipation	48.32	12.84	762	144826	201181	55945298
Hallucination	48.31	12.84	34	145554	49115	56097364
Coma	47.98	12.84	50	145538	59605	56086874
Basal cell carcinoma	47.40	12.84	5	145583	25216	56121263
Eczema asteatotic	47.30	12.84	20	145568	257	56146222
Tumour associated fever	47.30	12.84	20	145568	257	56146222
Hypomagnesaemia	46.91	12.84	157	145431	24858	56121621
Biliary sepsis	46.66	12.84	29	145559	865	56145614
Extravasation	46.53	12.84	41	145547	2106	56144373
Metastases to pelvis	46.50	12.84	22	145566	374	56146105
Drug dependence	46.39	12.84	3	145585	22530	56123949
Irritability	46.19	12.84	10	145578	29578	56116901
Hip arthroplasty	46.16	12.84	21	145567	38602	56107877
Enterocolitis infectious	46.16	12.84	36	145552	1557	56144922
Drug resistance	45.93	12.84	137	145451	20405	56126074
Subclavian vein thrombosis	45.86	12.84	38	145550	1794	56144685
Device related thrombosis	45.76	12.84	36	145552	1577	56144902
Serotonin syndrome	45.56	12.84	7	145581	26483	56119996
Capillary leak syndrome	45.55	12.84	39	145549	1927	56144552
Aortitis	45.42	12.84	30	145558	996	56145483
Toxic erythema of chemotherapy	44.65	12.84	16	145572	127	56146352
Respiratory distress	44.47	12.84	181	145407	31486	56114993
Intestinal obstruction	44.25	12.84	166	145422	27805	56118674
Suffocation feeling	44.23	12.84	32	145556	1234	56145245
Chronic obstructive pulmonary disease	44.10	12.84	50	145538	57365	56089114
Hormone receptor positive breast cancer	43.98	12.84	23	145565	489	56145990
Swollen tongue	43.92	12.84	12	145576	30312	56116167
Malignant peritoneal neoplasm	43.88	12.84	26	145562	710	56145769
Hyperpyrexia	43.82	12.84	48	145540	3220	56143259
Type I hypersensitivity	43.37	12.84	42	145546	2436	56144043
Wrong technique in product usage process	43.23	12.84	52	145536	58116	56088363
Nervousness	42.93	12.84	11	145577	29004	56117475
Dysgeusia	42.57	12.84	214	145374	40701	56105778
Oesophagobronchial fistula	42.50	12.84	12	145576	38	56146441
Road traffic accident	42.47	12.84	10	145578	27917	56118562
Transaminases increased	42.45	12.84	167	145421	28603	56117876
Gait inability	42.34	12.84	28	145560	41790	56104689
Febrile infection	41.80	12.84	32	145556	1346	56145133
Pleural neoplasm	41.65	12.84	20	145568	352	56146127
Periodontitis	41.62	12.84	46	145542	3117	56143362
Stress	41.35	12.84	55	145533	58855	56087624
Endocarditis noninfective	40.94	12.84	12	145576	45	56146434
Joint range of motion decreased	40.78	12.84	8	145580	25357	56121122
Administration site extravasation	40.55	12.84	25	145563	735	56145744
Prescribed overdose	40.45	12.84	5	145583	22291	56124188
Acute myelomonocytic leukaemia	40.39	12.84	16	145572	172	56146307
Rash pruritic	40.18	12.84	46	145542	52548	56093931
Muscle spasticity	40.10	12.84	3	145585	19957	56126522
Metastases to abdominal wall	39.75	12.84	14	145574	105	56146374
Hypoalbuminaemia	39.75	12.84	86	145502	10513	56135966
Disseminated intravascular coagulation	39.72	12.84	119	145469	17766	56128713
Cerebrovascular accident	39.71	12.84	128	145460	99142	56047337
Joint stiffness	39.70	12.84	21	145567	35404	56111075
Lactic acidosis	39.54	12.84	21	145567	35325	56111154
Dyskinesia	39.46	12.84	13	145575	29095	56117384
Inflammation	39.46	12.84	74	145514	68997	56077482
Lymphadenopathy mediastinal	39.42	12.84	41	145547	2592	56143887
Metastases to breast	39.37	12.84	18	145570	282	56146197
Lymphocele	39.28	12.84	25	145563	778	56145701
Adenocarcinoma	39.26	12.84	42	145546	2743	56143736
Immune-mediated enterocolitis	39.17	12.84	31	145557	1370	56145109
Deep vein thrombosis	39.01	12.84	336	145252	76641	56069838
Rhabdomyolysis	38.82	12.84	29	145559	40629	56105850
Psychotic disorder	38.79	12.84	7	145581	23551	56122928
Gastrooesophageal reflux disease	38.67	12.84	100	145488	83157	56063322
Blood uric acid decreased	38.31	12.84	24	145564	726	56145753
Limb injury	38.04	12.84	6	145582	22264	56124215
Product prescribing error	37.94	12.84	7	145581	23179	56123300
Pseudomembranous colitis	37.82	12.84	42	145546	2861	56143618
Ill-defined disorder	37.79	12.84	75	145513	68468	56078011
Hypocalcaemia	37.73	12.84	161	145427	28599	56117880
Myocardial infarction	37.67	12.84	119	145469	92751	56053728
Capillary permeability increased	37.43	12.84	10	145578	24	56146455
Hypervolaemia	37.33	12.84	11	145577	26447	56120032
Peritonitis	37.12	12.84	109	145479	16093	56130386
Amnesia	37.06	12.84	39	145549	46283	56100196
Impaired healing	36.84	12.84	109	145479	86732	56059747
Cachexia	36.60	12.84	54	145534	4888	56141591
Hypersensitivity pneumonitis	36.58	12.84	38	145550	2399	56144080
Metastases to stomach	36.54	12.84	15	145573	178	56146301
Stomatitis	36.50	12.84	475	145113	120335	56026144
Diabetes mellitus	36.24	12.84	50	145538	52685	56093794
Female genital tract fistula	36.07	12.84	51	145537	4441	56142038
Chills	36.02	12.84	415	145173	102189	56044290
Lymphadenopathy	35.82	12.84	183	145405	35025	56111454
Metastases to soft tissue	35.71	12.84	14	145574	146	56146333
Fistula	35.70	12.84	74	145514	8781	56137698
Onychalgia	35.59	12.84	24	145564	825	56145654
Hyperhidrosis	35.50	12.84	386	145202	93702	56052777
Nail dystrophy	35.41	12.84	25	145563	927	56145552
Foot deformity	35.31	12.84	9	145579	23816	56122663
Anastomotic leak	35.11	12.84	19	145569	434	56146045
Eye pain	34.99	12.84	18	145570	30829	56115650
Radiation necrosis	34.93	12.84	18	145570	371	56146108
Mental disorder	34.83	12.84	9	145579	23595	56122884
Herpes zoster	34.60	12.84	92	145496	75797	56070682
Oesophagitis	34.56	12.84	97	145491	13960	56132519
Hypotension	34.51	12.84	870	144718	249638	55896841
Cervix carcinoma	34.41	12.84	40	145548	2865	56143614
Tumour embolism	34.28	12.84	13	145575	123	56146356
International normalised ratio increased	34.21	12.84	38	145550	44003	56102476
Treatment noncompliance	34.18	12.84	21	145567	32602	56113877
Ovarian cancer metastatic	34.04	12.84	24	145564	888	56145591
Renal disorder	34.00	12.84	17	145571	29588	56116891
Crying	33.97	12.84	7	145581	21433	56125046
Therapy interrupted	33.78	12.84	12	145576	25613	56120866
Bradycardia	33.77	12.84	78	145510	67426	56079053
Computerised tomogram thorax	33.76	12.84	15	145573	219	56146260
Night sweats	33.76	12.84	34	145554	41179	56105300
Gallbladder disorder	33.72	12.84	3	145585	17331	56129148
Injection site haemorrhage	33.66	12.84	8	145580	22193	56124286
Acute erythroid leukaemia	33.61	12.84	11	145577	64	56146415
Pruritus	33.39	12.84	597	144991	316026	55830453
Acne	33.29	12.84	7	145581	21129	56125350
Bronchial fistula	33.28	12.84	9	145579	23	56146456
Scleroderma-like reaction	33.19	12.84	11	145577	67	56146412
Dyspnoea at rest	33.18	12.84	45	145543	3768	56142711
Bursitis	32.96	12.84	15	145573	27567	56118912
Dermatitis acneiform	32.94	12.84	48	145540	4296	56142183
Neutropenic colitis	32.87	12.84	38	145550	2705	56143774
Product administration error	32.82	12.84	7	145581	20922	56125557
Congestive cardiomyopathy	32.64	12.84	56	145532	5763	56140716
Radiation skin injury	32.50	12.84	23	145565	856	56145623
Kidney infection	32.36	12.84	7	145581	20718	56125761
Wound dehiscence	32.14	12.84	49	145539	4566	56141913
Blood glucose increased	32.11	12.84	94	145494	75057	56071422
Peritoneal disorder	32.02	12.84	18	145570	444	56146035
Eosinophil percentage increased	31.97	12.84	24	145564	980	56145499
Rectal perforation	31.91	12.84	17	145571	376	56146103
Infusion related hypersensitivity reaction	31.77	12.84	13	145575	153	56146326
Incorrect route of product administration	31.72	12.84	8	145580	21321	56125158
Stress cardiomyopathy	31.68	12.84	68	145520	8268	56138211
Invasive lobular breast carcinoma	31.37	12.84	22	145566	807	56145672
Primary cardiac lymphoma	31.08	12.84	9	145579	32	56146447
No adverse event	30.96	12.84	29	145559	36345	56110134
Vaginal fistula	30.96	12.84	17	145571	400	56146079
Head injury	30.95	12.84	13	145575	25053	56121426
Pulse absent	30.80	12.84	50	145538	4917	56141562
Immune-mediated hepatitis	30.79	12.84	24	145564	1037	56145442
Full blood count abnormal	30.68	12.84	15	145573	26447	56120032
Cardiac cirrhosis	30.46	12.84	12	145576	127	56146352
Neutrophil count abnormal	30.35	12.84	36	145552	2634	56143845
Blood bilirubin increased	30.27	12.84	168	145420	33186	56113293
Choking sensation	30.22	12.84	40	145548	3271	56143208
Tonsillar disorder	30.22	12.84	24	145564	1066	56145413
Loss of consciousness	30.18	12.84	423	145165	108926	56037553
Metastases to bladder	30.01	12.84	13	145575	178	56146301
Disability	29.99	12.84	3	145585	15777	56130702
Nightmare	29.98	12.84	4	145584	16822	56129657
Joint dislocation	29.97	12.84	3	145585	15770	56130709
Metastases to eye	29.96	12.84	12	145576	133	56146346
Pneumonitis chemical	29.81	12.84	13	145575	181	56146298
Panic attack	29.78	12.84	8	145580	20439	56126040
Neuromuscular toxicity	29.57	12.84	12	145576	138	56146341
Oropharyngeal pain	29.51	12.84	114	145474	83674	56062805
Alanine aminotransferase increased	29.45	12.84	371	145217	93291	56053188
Duodenitis haemorrhagic	29.41	12.84	7	145581	8	56146471
Gastrointestinal necrosis	29.18	12.84	35	145553	2591	56143888
Device dislocation	29.10	12.84	11	145577	22595	56123884
Flatulence	29.00	12.84	23	145565	31265	56115214
Eosinophilia	28.97	12.84	8	145580	20069	56126410
Glaucoma	28.86	12.84	5	145583	17324	56129155
Vena cava thrombosis	28.81	12.84	31	145557	2038	56144441
Neoplasm	28.81	12.84	56	145532	6345	56140134
HER2 positive breast cancer	28.74	12.84	16	145572	387	56146092
Tumour pain	28.67	12.84	25	145563	1266	56145213
Mastitis	28.60	12.84	34	145554	2494	56143985
Upper limb fracture	28.46	12.84	5	145583	17150	56129329
Pulmonary tumour thrombotic microangiopathy	28.31	12.84	9	145579	47	56146432
Venous thrombosis	28.26	12.84	46	145542	4534	56141945
Therapeutic response unexpected	28.20	12.84	5	145583	17039	56129440
Metabolic acidosis	28.16	12.84	38	145550	40416	56106063
Aggression	27.84	12.84	11	145577	21995	56124484
Tremor	27.78	12.84	191	145397	120898	56025581
Cough	27.75	12.84	874	144714	259087	55887392
Cytopenia	27.70	12.84	71	145517	9684	56136795
Gastrointestinal fistula	27.67	12.84	16	145572	417	56146062
Guillain-Barre syndrome	27.45	12.84	40	145548	3580	56142899
Skin laceration	27.33	12.84	9	145579	20147	56126332
Cytomegalovirus infection	27.27	12.84	8	145580	19288	56127191
Hypopituitarism	27.15	12.84	22	145566	1006	56145473
Nasal septum perforation	27.14	12.84	19	145569	695	56145784
Porokeratosis	26.99	12.84	11	145577	128	56146351
Musculoskeletal disorder	26.94	12.84	8	145580	19139	56127340
Bone marrow infiltration	26.88	12.84	17	145571	523	56145956
Sinus disorder	26.84	12.84	10	145578	20724	56125755
Prescribed underdose	26.59	12.84	10	145578	20607	56125872
Acute megakaryocytic leukaemia	26.50	12.84	8	145580	34	56146445
Protein urine	26.38	12.84	18	145570	631	56145848
Neck pain	26.29	12.84	77	145511	61478	56085001
Adrenocorticotropic hormone deficiency	26.22	12.84	14	145574	311	56146168
Thyroid dermatopathy	26.14	12.84	7	145581	17	56146462
Enterocolitis	25.91	12.84	57	145531	7047	56139432
Immune-mediated myocarditis	25.90	12.84	11	145577	143	56146336
Pelvic abscess	25.86	12.84	25	145563	1447	56145032
Foot fracture	25.84	12.84	12	145576	21797	56124682
Blood pressure systolic increased	25.83	12.84	41	145547	40795	56105684
Scintillating scotoma	25.77	12.84	11	145577	145	56146334
Laboratory test abnormal	25.73	12.84	16	145572	24679	56121800
Bone erosion	25.65	12.84	4	145584	14970	56131509
Double hit lymphoma	25.62	12.84	6	145582	6	56146473
Fear	25.50	12.84	4	145584	14904	56131575
Mood swings	25.46	12.84	6	145582	16741	56129738
Viral infection	25.44	12.84	27	145561	31919	56114560
Underdose	25.30	12.84	15	145573	23742	56122737
Duodenal perforation	25.22	12.84	19	145569	780	56145699
Vocal cord paralysis	25.20	12.84	28	145560	1909	56144570
Drug level increased	25.19	12.84	11	145577	20714	56125765
Upper respiratory tract infection	25.10	12.84	97	145491	71191	56075288
Cervix carcinoma recurrent	24.97	12.84	8	145580	43	56146436
Chest pain	24.90	12.84	655	144933	189142	55957337
Portal vein thrombosis	24.83	12.84	31	145557	2392	56144087
Carpal tunnel syndrome	24.78	12.84	8	145580	18136	56128343
Impaired work ability	24.72	12.84	4	145584	14568	56131911
Transfusion	24.60	12.84	3	145585	13517	56132962
Osteolysis	24.52	12.84	32	145556	2581	56143898
Tooth erosion	24.48	12.84	15	145573	436	56146043
Acute pulmonary oedema	24.44	12.84	58	145530	7539	56138940
Haemoglobin	24.43	12.84	11	145577	166	56146313
Procedural pain	24.40	12.84	6	145582	16265	56130214
Intestinal metastasis	24.34	12.84	10	145578	119	56146360
Laryngeal discomfort	24.30	12.84	13	145575	290	56146189
Gastroenteritis radiation	24.30	12.84	15	145573	442	56146037
Accidental exposure to product	24.28	12.84	17	145571	24630	56121849
Jugular vein thrombosis	24.27	12.84	33	145555	2770	56143709
Sciatica	24.26	12.84	19	145569	25991	56120488
Infection	24.20	12.84	368	145220	199838	55946641
Device malfunction	24.10	12.84	6	145582	16130	56130349
Oligoastrocytoma	23.93	12.84	7	145581	26	56146453
Embryonal rhabdomyosarcoma	23.90	12.84	6	145582	10	56146469
Hepatotoxicity	23.81	12.84	150	145438	31003	56115476
Colitis ulcerative	23.80	12.84	17	145571	24374	56122105
Adenocarcinoma pancreas	23.79	12.84	21	145567	1081	56145398
Intracranial tumour haemorrhage	23.68	12.84	11	145577	179	56146300
Blast cells present	23.57	12.84	14	145574	384	56146095
Cholangitis infective	23.56	12.84	12	145576	241	56146238
Spinal stenosis	23.43	12.84	4	145584	14010	56132469
Exostosis	23.43	12.84	5	145583	14938	56131541
Eastern Cooperative Oncology Group performance status worsened	23.35	12.84	19	145569	874	56145605
Acute lymphocytic leukaemia	23.29	12.84	32	145556	2712	56143767
Sinus congestion	23.19	12.84	6	145582	15718	56130761
Emphysematous cystitis	23.14	12.84	10	145578	136	56146343
Poisoning	22.94	12.84	3	145585	12810	56133669
Product quality issue	22.92	12.84	29	145559	31707	56114772
Blood potassium increased	22.89	12.84	8	145580	17253	56129226
Lymphopenia	22.86	12.84	95	145493	16679	56129800
Ankle fracture	22.82	12.84	7	145581	16396	56130083
Obesity	22.76	12.84	15	145573	22433	56124046
Right ventricular failure	22.76	12.84	7	145581	16372	56130107
Pelvic pain	22.71	12.84	75	145513	11792	56134687
Hypersomnia	22.68	12.84	7	145581	16334	56130145
Cancer pain	22.65	12.84	33	145555	2953	56143526
Laryngeal necrosis	22.57	12.84	6	145582	14	56146465
Peritoneal fibrosis	22.46	12.84	5	145583	3	56146476
Drug ineffective for unapproved indication	22.44	12.84	20	145568	25673	56120806
Vesical fistula	22.38	12.84	8	145580	63	56146416
Granulocyte count decreased	22.20	12.84	19	145569	938	56145541
Balance disorder	22.17	12.84	112	145476	76408	56070071
Infected lymphocele	22.15	12.84	11	145577	209	56146270
Respiratory failure	22.06	12.84	357	145231	94705	56051774
Angiosarcoma	22.02	12.84	12	145576	278	56146201
Dystonia	22.01	12.84	3	145585	12418	56134061
Organising pneumonia	22.00	12.84	45	145543	5290	56141189
Transient ischaemic attack	21.92	12.84	33	145555	33544	56112935
Cystitis noninfective	21.91	12.84	19	145569	955	56145524
Bladder perforation	21.85	12.84	10	145578	157	56146322
Haemolytic uraemic syndrome	21.84	12.84	29	145559	2379	56144100
Hypermetabolism	21.80	12.84	10	145578	158	56146321
Eye pruritus	21.77	12.84	5	145583	14201	56132278
Accidental overdose	21.67	12.84	13	145575	20448	56126031
Eye disorder	21.66	12.84	13	145575	20439	56126040
Scleroderma	21.60	12.84	43	145545	4958	56141521
Lymphatic disorder	21.59	12.84	13	145575	366	56146113
Macular degeneration	21.50	12.84	11	145577	18897	56127582
Arterioenteric fistula	21.49	12.84	6	145582	18	56146461
Electrocardiogram QT prolonged	21.40	12.84	71	145517	54517	56091962
Joint effusion	21.38	12.84	6	145582	14892	56131587
Retroperitoneal neoplasm metastatic	21.35	12.84	7	145581	41	56146438
Gelastic seizure	21.35	12.84	5	145583	5	56146474
Abnormal behaviour	21.31	12.84	13	145575	20259	56126220
Xerophthalmia	21.21	12.84	14	145574	464	56146015
Metastases to ovary	21.21	12.84	13	145575	378	56146101
Breast cellulitis	21.13	12.84	15	145573	561	56145918
Wrist fracture	21.09	12.84	3	145585	12023	56134456
Pancreatitis	21.04	12.84	54	145534	45026	56101453
Ovarian cancer stage IV	21.03	12.84	11	145577	234	56146245
Enteritis	20.95	12.84	54	145534	7389	56139090
Cerebral ischaemia	20.93	12.84	48	145540	6102	56140377
Seasonal allergy	20.92	12.84	9	145579	17099	56129380
Septic shock	20.87	12.84	245	145343	60590	56085889
Diverticulitis	20.84	12.84	38	145550	35814	56110665
Femur fracture	20.81	12.84	44	145544	39251	56107228
Pulmonary vein stenosis	20.71	12.84	8	145580	80	56146399
Full blood count decreased	20.61	12.84	18	145570	23331	56123148
Ocular hyperaemia	20.57	12.84	16	145572	21963	56124516
Seroma	20.47	12.84	25	145563	1886	56144593
BRAF gene mutation	20.42	12.84	7	145581	48	56146431
Transaminases	20.36	12.84	8	145580	84	56146395
Hepatic vein thrombosis	20.34	12.84	9	145579	130	56146349
Blood iron decreased	20.26	12.84	4	145584	12623	56133856
Lymphangitis	20.25	12.84	17	145571	817	56145662
Blood alkaline phosphatase increased	20.25	12.84	171	145417	38774	56107705
Vessel puncture site bruise	20.19	12.84	13	145575	413	56146066
Splenic artery thrombosis	20.17	12.84	7	145581	50	56146429
Hallucination, visual	20.10	12.84	10	145578	17458	56129021
Type 1 lepra reaction	20.04	12.84	5	145583	8	56146471
Abdominal infection	20.01	12.84	24	145564	1777	56144702
Pulmonary toxicity	19.97	12.84	55	145533	7828	56138651
Enterocutaneous fistula	19.88	12.84	20	145568	1215	56145264
Sopor	19.87	12.84	15	145573	20907	56125572
Bacterial parotitis	19.84	12.84	4	145584	0	56146479
Venous thrombosis limb	19.81	12.84	30	145558	2779	56143700
Brachiocephalic vein thrombosis	19.71	12.84	8	145580	92	56146387
Tumour ulceration	19.69	12.84	9	145579	141	56146338
Emotional disorder	19.51	12.84	4	145584	12291	56134188
Retroperitoneal lymphadenopathy	19.51	12.84	14	145574	533	56145946
Radiation oesophagitis	19.47	12.84	11	145577	274	56146205
TP53 gene mutation	19.43	12.84	6	145582	28	56146451
Pneumonia	19.40	12.84	858	144730	406240	55740239
Respiratory tract congestion	19.39	12.84	8	145580	15583	56130896
Immune-mediated hepatic disorder	19.33	12.84	11	145577	278	56146201
Respiratory depth decreased	19.25	12.84	6	145582	29	56146450
Duodenal obstruction	19.23	12.84	10	145578	210	56146269
Poor quality sleep	19.21	12.84	11	145577	17744	56128735
Intestinal ischaemia	19.11	12.84	50	145538	6905	56139574
Dermatomyositis	19.10	12.84	29	145559	2693	56143786
Neuroendocrine breast tumour	19.09	12.84	6	145582	30	56146449
Rash	19.06	12.84	1062	144526	491985	55654494
Delirium	19.03	12.84	52	145536	42465	56104014
Blood glucose decreased	19.02	12.84	13	145575	19074	56127405
Influenza like illness	18.99	12.84	87	145501	60901	56085578
Breast ulceration	18.96	12.84	7	145581	61	56146418
Device issue	18.96	12.84	16	145572	21090	56125389
Eye irritation	18.91	12.84	13	145575	19015	56127464
Pelvic infection	18.91	12.84	11	145577	290	56146189
Metastases to thorax	18.90	12.84	10	145578	218	56146261
Erythema multiforme	18.84	12.84	61	145527	9493	56136986
Emotional distress	18.72	12.84	30	145558	29733	56116746
Endometrial cancer recurrent	18.71	12.84	5	145583	12	56146467
Post procedural fistula	18.65	12.84	10	145578	224	56146255
Ear pain	18.62	12.84	32	145556	30858	56115621
Cholangitis acute	18.61	12.84	13	145575	474	56146005
Myoclonus	18.59	12.84	8	145580	15195	56131284
Electrolyte imbalance	18.53	12.84	94	145494	17939	56128540
Hydrothorax	18.52	12.84	16	145572	800	56145679
Clonal haematopoiesis	18.43	12.84	5	145583	13	56146466
Ovarian clear cell carcinoma	18.43	12.84	5	145583	13	56146466
Laryngeal cancer stage III	18.43	12.84	5	145583	13	56146466
Cardiovascular disorder	18.38	12.84	66	145522	10823	56135656
Metastases to pancreas	18.38	12.84	10	145578	231	56146248
Abdominal lymphadenopathy	18.34	12.84	15	145573	695	56145784
Fungal infection	18.27	12.84	36	145552	32957	56113522
Eye swelling	18.24	12.84	17	145571	21359	56125120
Aorto-oesophageal fistula	18.16	12.84	5	145583	14	56146465
Breast neoplasm	18.09	12.84	20	145568	1356	56145123
Metastases to adrenals	18.09	12.84	15	145573	709	56145770
Dementia	18.04	12.84	11	145577	17147	56129332
Aplasia	18.03	12.84	35	145553	3961	56142518
Ovarian epithelial cancer	18.00	12.84	11	145577	318	56146161
Blood pressure diastolic abnormal	17.94	12.84	4	145584	11594	56134885
Thrombophlebitis migrans	17.87	12.84	8	145580	119	56146360
Neutropenic infection	17.85	12.84	18	145570	1097	56145382
Cancer fatigue	17.77	12.84	7	145581	74	56146405
Angiodermatitis	17.77	12.84	7	145581	74	56146405
Glomerular vascular disorder	17.77	12.84	6	145582	39	56146440
Gastroenteritis viral	17.72	12.84	16	145572	20408	56126071
Cranial nerve disorder	17.70	12.84	13	145575	513	56145966
Vaginal perforation	17.67	12.84	5	145583	16	56146463
Liver scan abnormal	17.64	12.84	6	145582	40	56146439
Therapy cessation	17.60	12.84	27	145561	27237	56119242
Blood pressure immeasurable	17.58	12.84	18	145570	1117	56145362
Blood magnesium decreased	17.57	12.84	69	145519	11805	56134674
Hyponatraemia	17.54	12.84	366	145222	101773	56044706
Acute monocytic leukaemia	17.52	12.84	8	145580	125	56146354
Cardiac murmur	17.50	12.84	4	145584	11397	56135082
Gastric perforation	17.48	12.84	21	145567	1557	56144922
Live birth	17.44	12.84	15	145573	19590	56126889
Vulvovaginal inflammation	17.40	12.84	15	145573	748	56145731
Gout	17.39	12.84	5	145583	12216	56134263
Acquired gene mutation	17.37	12.84	16	145572	871	56145608
Endometrial cancer metastatic	17.29	12.84	8	145580	129	56146350
Photophobia	17.28	12.84	10	145578	16040	56130439
Intestinal prolapse	17.24	12.84	8	145580	130	56146349
Blood creatinine decreased	17.23	12.84	40	145548	5126	56141353
Mediastinitis	17.14	12.84	9	145579	193	56146286
Nail ridging	17.09	12.84	11	145577	349	56146130
Breast sarcoma	17.08	12.84	4	145584	4	56146475
Tumour cavitation	17.08	12.84	4	145584	4	56146475
Aortic dissection rupture	17.08	12.84	4	145584	4	56146475
Maternal death affecting foetus	17.08	12.84	4	145584	4	56146475
Sensory disturbance	17.06	12.84	71	145517	12472	56134007
Lymphatic obstruction	17.01	12.84	5	145583	19	56146460
Metastases to muscle	16.96	12.84	8	145580	135	56146344
Anaemia of malignant disease	16.90	12.84	12	145576	449	56146030
Mediastinal disorder	16.87	12.84	11	145577	357	56146122
Tumour invasion	16.86	12.84	8	145580	137	56146342
Uterine atrophy	16.81	12.84	6	145582	47	56146432
Pancreatic failure	16.80	12.84	16	145572	909	56145570
Exposed bone in jaw	16.76	12.84	28	145560	2820	56143659
Oesophageal varices haemorrhage	16.75	12.84	17	145571	1044	56145435
Carbohydrate antigen 19-9 increased	16.69	12.84	9	145579	204	56146275
Ovarian failure	16.68	12.84	18	145570	1187	56145292
Subdural haematoma	16.67	12.84	7	145581	13492	56132987
Gingival bleeding	16.63	12.84	67	145521	11599	56134880
Nail avulsion	16.60	12.84	8	145580	142	56146337
Myeloproliferative neoplasm	16.56	12.84	12	145576	464	56146015
Endometrial adenocarcinoma	16.52	12.84	18	145570	1200	56145279
Toxic neuropathy	16.50	12.84	11	145577	371	56146108
Laryngeal oedema	16.50	12.84	40	145548	5270	56141209
Tongue disorder	16.49	12.84	3	145585	10033	56136446
Median nerve injury	16.43	12.84	5	145583	22	56146457
Mood altered	16.37	12.84	7	145581	13348	56133131
Restless legs syndrome	16.29	12.84	12	145576	16935	56129544
Weight decreased	16.28	12.84	486	145102	240228	55906251
Tumour fistulisation	16.25	12.84	5	145583	23	56146456
Distal intestinal obstruction syndrome	16.24	12.84	11	145577	381	56146098
Bronchopleural fistula	16.23	12.84	9	145579	216	56146263
Angioedema	16.19	12.84	54	145534	41399	56105080
Product storage error	16.08	12.84	7	145581	13206	56133273
Lupus-like syndrome	16.07	12.84	6	145582	12421	56134058
Thyroiditis	16.04	12.84	23	145565	2029	56144450
Labelled drug-drug interaction medication error	16.01	12.84	5	145583	11581	56134898
Thyroid disorder	16.01	12.84	8	145580	13930	56132549
Immediate post-injection reaction	15.99	12.84	11	145577	391	56146088
Localised infection	15.98	12.84	29	145559	27383	56119096
Immune-mediated pancreatitis	15.95	12.84	7	145581	99	56146380
Keratitis	15.92	12.84	28	145560	2939	56143540
Aspartate aminotransferase increased	15.86	12.84	301	145287	82301	56064178
Vaginal cuff dehiscence	15.81	12.84	4	145584	7	56146472
Ileal perforation	15.77	12.84	11	145577	400	56146079
Pulmonary artery stenosis	15.74	12.84	8	145580	160	56146319
Urosepsis	15.70	12.84	85	145503	16631	56129848
Cholecystectomy	15.68	12.84	3	145585	9681	56136798
Gene mutation	15.59	12.84	19	145569	1430	56145049
Artificial menopause	15.59	12.84	5	145583	27	56146452
Cardiac pseudoaneurysm	15.59	12.84	5	145583	27	56146452
Lividity	15.55	12.84	9	145579	235	56146244
Application site recall reaction	15.47	12.84	4	145584	8	56146471
Blood lactate dehydrogenase increased	15.46	12.84	99	145489	20576	56125903
Embolism venous	15.44	12.84	27	145561	2821	56143658
Myeloid leukaemia	15.44	12.84	10	145578	321	56146158
Ototoxicity	15.42	12.84	17	145571	1149	56145330
Chemotherapy	15.32	12.84	19	145569	1456	56145023
Carcinoid tumour pulmonary	15.30	12.84	11	145577	420	56146059
Mucosal dryness	15.29	12.84	25	145563	2473	56144006
Biliary obstruction	15.27	12.84	25	145563	2476	56144003
Sputum discoloured	15.25	12.84	9	145579	14283	56132196
Speech disorder	15.22	12.84	48	145540	37445	56109034
Hiatus hernia	15.21	12.84	17	145571	19635	56126844
Orbital myositis	15.15	12.84	5	145583	30	56146449
Onychomadesis	15.14	12.84	36	145552	4685	56141794
Faeces discoloured	15.12	12.84	13	145575	16983	56129496
Glycosylated haemoglobin increased	15.11	12.84	5	145583	11160	56135319
BRCA2 gene mutation	15.10	12.84	6	145582	65	56146414
Pain in jaw	15.06	12.84	53	145535	39983	56106496
Cholelithiasis	15.01	12.84	52	145536	39412	56107067
Product supply issue	15.01	12.84	19	145569	1487	56144992
Gamma-glutamyltransferase increased	15.00	12.84	134	145454	30871	56115608
Ovarian cyst	14.98	12.84	10	145578	14856	56131623
Nail pigmentation	14.89	12.84	8	145580	180	56146299
Granulocyte count	14.88	12.84	3	145585	0	56146479
Porocarcinoma	14.88	12.84	3	145585	0	56146479
Ankyloglossia acquired	14.88	12.84	3	145585	0	56146479
Myiasis	14.88	12.84	3	145585	0	56146479
Therapeutic response decreased	14.84	12.84	78	145510	52680	56093799
Tuberculosis	14.82	12.84	5	145583	11024	56135455
Limb discomfort	14.78	12.84	29	145559	26593	56119886
Hyperbilirubinaemia	14.76	12.84	59	145529	10176	56136303
Pulmonary congestion	14.74	12.84	12	145576	16103	56130376
Nasal disorder	14.68	12.84	25	145563	2557	56143922
Affect lability	14.67	12.84	4	145584	10121	56136358
Obstructive shock	14.62	12.84	5	145583	34	56146445
Ovarian endometrioid carcinoma	14.62	12.84	5	145583	34	56146445
Anger	14.50	12.84	6	145582	11666	56134813
Scar	14.49	12.84	7	145581	12426	56134053
Hypothalamo-pituitary disorder	14.44	12.84	13	145575	687	56145792
Cardiac failure congestive	14.42	12.84	151	145437	87569	56058910
Ureteric stenosis	14.42	12.84	12	145576	570	56145909
Bone marrow disorder	14.41	12.84	22	145566	2052	56144427
Bacterial diarrhoea	14.41	12.84	6	145582	74	56146405
Lung infiltration	14.39	12.84	72	145516	13666	56132813
Hepatic cancer metastatic	14.38	12.84	10	145578	362	56146117
Polymicrogyria	14.34	12.84	6	145582	75	56146404
Extrapyramidal disorder	14.33	12.84	7	145581	12349	56134130
Toxic cardiomyopathy	14.29	12.84	7	145581	129	56146350
Thinking abnormal	14.27	12.84	4	145584	9937	56136542
Productive cough	14.26	12.84	86	145502	56146	56090333
Lichenoid keratosis	14.23	12.84	18	145570	1407	56145072
Transaminases abnormal	14.22	12.84	12	145576	581	56145898
Anhedonia	14.21	12.84	4	145584	9910	56136569
Clonal evolution	14.20	12.84	6	145582	77	56146402
Status epilepticus	14.20	12.84	11	145577	15130	56131349
Hernia	14.17	12.84	5	145583	10718	56135761
Hypercalcaemia of malignancy	14.10	12.84	8	145580	201	56146278
Oesophageal squamous cell carcinoma	14.10	12.84	7	145581	133	56146346
Seizure	14.09	12.84	233	145355	124886	56021593
Peritoneal lesion	14.09	12.84	4	145584	13	56146466
Mechanical ileus	14.07	12.84	10	145578	375	56146104
Panniculitis	14.05	12.84	4	145584	9838	56136641
Pulpitis dental	13.98	12.84	14	145574	846	56145633
Dysuria	13.95	12.84	131	145457	30598	56115881
Failure to thrive	13.92	12.84	43	145545	6527	56139952
Cannabinoid hyperemesis syndrome	13.92	12.84	5	145583	40	56146439
Rotator cuff syndrome	13.90	12.84	7	145581	12136	56134343
Meibomian gland dysfunction	13.86	12.84	7	145581	138	56146341
Cholecystitis chronic	13.85	12.84	4	145584	9744	56136735
Liver function test abnormal	13.71	12.84	66	145522	45605	56100874
Cystitis haemorrhagic	13.70	12.84	31	145557	3906	56142573
Nail infection	13.67	12.84	23	145565	2330	56144149
Delusion	13.55	12.84	6	145582	11209	56135270
Carbohydrate antigen 15-3	13.48	12.84	6	145582	88	56146391
Hypergeusia	13.44	12.84	4	145584	16	56146463
Uterine adhesions	13.40	12.84	5	145583	45	56146434
Movement disorder	13.39	12.84	18	145570	19180	56127299
Cardiac disorder	13.38	12.84	67	145521	45820	56100659
Morphoea	13.36	12.84	9	145579	309	56146170
Extremity necrosis	13.34	12.84	18	145570	1500	56144979
Hyperphosphataemia	13.32	12.84	21	145567	2014	56144465
Aortic dissection	13.32	12.84	20	145568	1839	56144640
Pharyngitis streptococcal	13.31	12.84	4	145584	9494	56136985
Metastatic gastric cancer	13.30	12.84	7	145581	151	56146328
Hyperferritinaemia	13.25	12.84	7	145581	152	56146327
Metastases to vagina	13.25	12.84	4	145584	17	56146462
Carcinoembryonic antigen	13.24	12.84	6	145582	92	56146387
Dandy-Walker syndrome	13.24	12.84	6	145582	92	56146387
Anal sphincter atony	13.23	12.84	8	145580	227	56146252
Systolic dysfunction	13.23	12.84	18	145570	1512	56144967
Deformity	13.18	12.84	5	145583	10250	56136229
Upper-airway cough syndrome	13.18	12.84	4	145584	9434	56137045
Blood pressure diastolic increased	13.15	12.84	3	145585	8558	56137921
Opsoclonus myoclonus	13.13	12.84	7	145581	155	56146324
Cognitive disorder	13.07	12.84	74	145514	49059	56097420
Foetal malnutrition	13.07	12.84	6	145582	95	56146384
Torsade de pointes	13.04	12.84	8	145580	12432	56134047
Respiratory depression	13.03	12.84	8	145580	12427	56134052
Impaired quality of life	12.95	12.84	3	145585	8471	56138008
Ulcer	12.92	12.84	24	145564	22461	56124018
Empyema	12.90	12.84	20	145568	1891	56144588
Peritoneal fluid analysis abnormal	12.89	12.84	4	145584	19	56146460
Transformation to acute myeloid leukaemia	12.89	12.84	8	145580	238	56146241
Walking aid user	12.88	12.84	3	145585	8440	56138039
Dermatitis	12.87	12.84	75	145513	15082	56131397
Lymphorrhoea	12.85	12.84	5	145583	51	56146428
Hereditary motor and sensory neuropathy	12.84	12.84	6	145582	99	56146380

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Malignant neoplasm progression	693.15	15.65	723	47912	78275	31570434
Febrile neutropenia	599.89	15.65	831	47804	121018	31527691
Neutropenia	585.74	15.65	885	47750	139479	31509230
Interstitial lung disease	394.03	15.65	478	48157	60925	31587784
Pancreatic carcinoma metastatic	369.66	15.65	147	48488	2797	31645912
Neuropathy peripheral	359.60	15.65	508	48127	75141	31573568
Pancreatic carcinoma	314.35	15.65	184	48451	8416	31640293
Disease progression	308.43	15.65	521	48114	89943	31558766
Neutrophil count decreased	265.15	15.65	341	48294	46053	31602656
Leukopenia	257.98	15.65	377	48258	57451	31591258
Anaemia	255.07	15.65	812	47823	212710	31435999
Thrombocytopenia	243.73	15.65	618	48017	142129	31506580
Pneumonitis	240.69	15.65	265	48370	30387	31618322
Non-small cell lung cancer	228.26	15.65	116	48519	3993	31644716
Alopecia	200.11	15.65	200	48435	20495	31628214
Death	177.31	15.65	1048	47587	359521	31289188
Myelosuppression	176.13	15.65	161	48474	14759	31633950
Cholangitis	168.46	15.65	121	48514	7865	31640844
Radiation pneumonitis	144.55	15.65	72	48563	2372	31646337
Mucosal inflammation	144.13	15.65	218	48417	34209	31614500
Cystoid macular oedema	135.15	15.65	48	48587	657	31648052
Product dose omission issue	130.19	15.65	8	48627	105578	31543131
Completed suicide	122.37	15.65	4	48631	91510	31557199
Metastases to central nervous system	119.82	15.65	97	48538	7539	31641170
Bone marrow failure	118.13	15.65	178	48457	27830	31620879
Haemoptysis	114.23	15.65	189	48446	32000	31616709
Neoplasm progression	114.11	15.65	148	48487	20124	31628585
Haematotoxicity	108.49	15.65	89	48546	7048	31641661
Flushing	107.04	15.65	177	48458	29951	31618758
Polyneuropathy	104.60	15.65	114	48521	12908	31635801
General physical health deterioration	104.10	15.65	396	48239	113039	31535670
Peripheral sensory neuropathy	102.87	15.65	82	48553	6233	31642476
Overdose	97.03	15.65	9	48626	84655	31564054
Immune-mediated hepatitis	96.01	15.65	49	48586	1701	31647008
Neurotoxicity	93.72	15.65	120	48515	16106	31632603
Pyrexia	89.20	15.65	781	47854	303059	31345650
Radiation oesophagitis	88.59	15.65	31	48604	405	31648304
Pneumothorax	88.29	15.65	119	48516	16791	31631918
Depression	84.66	15.65	18	48617	90797	31557912
Fall	84.17	15.65	97	48538	185992	31462717
White blood cell count decreased	82.52	15.65	308	48327	87090	31561619
Therapy partial responder	81.73	15.65	73	48562	6489	31642220
Immune-mediated lung disease	81.26	15.65	38	48597	1086	31647623
Dehydration	80.59	15.65	379	48256	118732	31529977
Biliary tract infection	78.70	15.65	31	48604	574	31648135
Decreased appetite	78.40	15.65	451	48184	152766	31495943
Plasma cell myeloma	73.72	15.65	3	48632	56528	31592181
Thrombotic microangiopathy	71.87	15.65	80	48555	9271	31639438
Drug ineffective	71.84	15.65	338	48297	395235	31253474
Drug interaction	71.46	15.65	132	48503	208411	31440298
Erythema	70.66	15.65	277	48358	80128	31568581
Anaphylactic shock	69.99	15.65	97	48538	14048	31634661
Pancytopenia	69.73	15.65	292	48343	87024	31561685
Sepsis	68.65	15.65	433	48202	151496	31497213
Headache	67.68	15.65	111	48524	183541	31465168
Metastases to liver	67.10	15.65	90	48545	12637	31636072
Anxiety	66.81	15.65	28	48607	91005	31557704
Metastases to lung	66.36	15.65	73	48562	8349	31640360
Liver abscess	64.10	15.65	49	48586	3502	31645207
Infusion related reaction	63.72	15.65	190	48445	47865	31600844
Gastrointestinal perforation	63.12	15.65	49	48586	3583	31645126
Dyspnoea	62.54	15.65	802	47833	342677	31306032
Platelet count decreased	61.02	15.65	332	48303	110103	31538606
Tumour haemorrhage	60.47	15.65	42	48593	2586	31646123
Nasopharyngitis	60.03	15.65	12	48623	63233	31585476
Pneumonia	58.96	15.65	778	47857	334534	31314175
Pulmonary toxicity	57.61	15.65	55	48580	5322	31643387
Colitis	56.83	15.65	146	48489	33741	31614968
Toxicity to various agents	56.04	15.65	122	48513	181365	31467344
Joint swelling	55.42	15.65	8	48627	53423	31595286
Adrenal insufficiency	54.13	15.65	81	48554	12578	31636131
Insomnia	53.97	15.65	40	48595	94796	31553913
Immune-mediated enterocolitis	52.93	15.65	36	48599	2142	31646567
Hypersensitivity	52.19	15.65	196	48439	55547	31593162
Kounis syndrome	51.96	15.65	35	48600	2049	31646660
Onycholysis	51.04	15.65	23	48612	602	31648107
Nausea	48.97	15.65	702	47933	307245	31341464
Weight increased	48.48	15.65	34	48601	82913	31565796
Rheumatoid arthritis	47.67	15.65	8	48627	47801	31600908
Coronary artery disease	47.57	15.65	7	48628	46080	31602629
Cardiac failure congestive	47.12	15.65	32	48603	79355	31569354
Diarrhoea	45.99	15.65	777	47858	351632	31297077
Somnolence	45.80	15.65	51	48584	99394	31549315
Vomiting	45.40	15.65	534	48101	223439	31425270
Metastases to meninges	45.37	15.65	27	48608	1272	31647437
Suicidal ideation	44.12	15.65	3	48632	36403	31612306
Psoriasis	44.05	15.65	9	48626	46710	31601999
Tremor	43.78	15.65	32	48603	76388	31572321
Pneumatosis intestinalis	43.69	15.65	40	48595	3671	31645038
Electrocardiogram QT prolonged	43.60	15.65	4	48631	37983	31610726
Intentional product misuse	43.55	15.65	4	48631	37947	31610762
Stomatitis	43.18	15.65	146	48489	39292	31609417
Aggression	42.61	15.65	4	48631	37287	31611422
Injection site pain	41.54	15.65	3	48632	34631	31614078
Bronchial fistula	41.32	15.65	14	48621	165	31648544
Bradycardia	41.06	15.65	28	48607	69299	31579410
Tracheal fistula	40.83	15.65	12	48623	85	31648624
Pulmonary radiation injury	40.67	15.65	11	48624	55	31648654
Pancreatic enzyme abnormality	40.67	15.65	11	48624	55	31648654
Hospitalisation	40.44	15.65	13	48622	49794	31598915
Cardiac disorder	40.37	15.65	6	48629	39208	31609501
Pleural effusion	39.84	15.65	223	48412	74697	31574012
Neutropenic sepsis	39.03	15.65	69	48566	12310	31636399
Metastases to bone	38.86	15.65	64	48571	10784	31637925
Scleroderma-like reaction	38.78	15.65	10	48625	40	31648669
Arthralgia	38.76	15.65	112	48523	151312	31497397
Hypoglycaemia	38.45	15.65	15	48620	50931	31597778
Performance status decreased	38.42	15.65	38	48597	3840	31644869
Tracheo-oesophageal fistula	38.41	15.65	17	48618	426	31648283
Prostate cancer	38.14	15.65	6	48629	37595	31611114
Embolism	37.78	15.65	51	48584	7202	31641507
Musculoskeletal stiffness	36.87	15.65	9	48626	41316	31607393
Immune-mediated hepatic disorder	36.70	15.65	18	48617	573	31648136
Oesophagitis	36.33	15.65	67	48568	12349	31636360
Immune-mediated dermatitis	36.27	15.65	13	48622	183	31648526
Skin toxicity	36.19	15.65	38	48597	4121	31644588
Hallucination	36.14	15.65	13	48622	46397	31602312
Enterocolitis infectious	35.46	15.65	24	48611	1416	31647293
Right ventricular ejection fraction decreased	34.90	15.65	9	48626	36	31648673
Agitation	34.67	15.65	20	48615	54149	31594560
Enterocolitis	34.67	15.65	49	48586	7225	31641484
Septic shock	34.56	15.65	196	48439	65962	31582747
Therapeutic product effect decreased	34.56	15.65	4	48631	31618	31617091
Recall phenomenon	34.49	15.65	17	48618	547	31648162
Hypertransaminasaemia	33.37	15.65	37	48598	4267	31644442
Pulmonary embolism	33.32	15.65	227	48408	81419	31567290
Blood glucose increased	33.17	15.65	27	48608	61056	31587653
Asthma	33.07	15.65	12	48623	42599	31606110
Gastritis bacterial	31.96	15.65	12	48623	194	31648515
Teratoma benign	31.86	15.65	8	48627	28	31648681
Gastrointestinal toxicity	31.74	15.65	27	48608	2247	31646462
Dysphagia	31.54	15.65	173	48462	57503	31591206
Tidal volume decreased	31.02	15.65	8	48627	32	31648677
Memory impairment	30.86	15.65	10	48625	38120	31610589
Oxygen saturation decreased	30.77	15.65	153	48482	48962	31599747
Intestinal perforation	30.74	15.65	50	48585	8339	31640370
Brain teratoma	30.70	15.65	7	48628	14	31648695
Bronchospasm	30.69	15.65	55	48580	9917	31638792
Angioedema	30.62	15.65	7	48628	33611	31615098
Adrenocorticotropic hormone deficiency	30.40	15.65	17	48618	711	31647998
Blood pressure increased	30.34	15.65	47	48588	79586	31569123
Confusional state	30.32	15.65	104	48531	133230	31515479
Condition aggravated	30.28	15.65	139	48496	163870	31484839
Metastases to peritoneum	30.16	15.65	23	48612	1637	31647072
Haemolytic uraemic syndrome	29.72	15.65	25	48610	2049	31646660
Coma	29.62	15.65	13	48622	41137	31607572
Ductal adenocarcinoma of pancreas	29.41	15.65	8	48627	41	31648668
Metastatic gastric cancer	29.34	15.65	11	48624	177	31648532
Nail dystrophy	29.17	15.65	11	48624	180	31648529
Disseminated intravascular coagulation	28.92	15.65	83	48552	20454	31628255
Dizziness	28.90	15.65	183	48452	198964	31449745
Unmasking of previously unidentified disease	28.64	15.65	17	48618	797	31647912
Pulmonary hypoplasia	28.59	15.65	14	48621	444	31648265
Anaphylactic reaction	28.55	15.65	105	48530	29448	31619261
International normalised ratio increased	28.51	15.65	17	48618	45206	31603503
Wrong technique in product usage process	28.34	15.65	8	48627	33335	31615374
Feeling abnormal	27.61	15.65	28	48607	56974	31591735
Myocardial infarction	27.52	15.65	86	48549	113368	31535341
Fluid retention	27.45	15.65	3	48632	24799	31623910
Periarticular thenar erythema with onycholysis	27.41	15.65	5	48630	0	31648709
Tumour necrosis	27.38	15.65	19	48616	1168	31647541
Lung adenocarcinoma	27.34	15.65	34	48601	4428	31644281
Oesophagopleural fistula	27.30	15.65	8	48627	56	31648653
Off label use	26.97	15.65	710	47925	346564	31302145
Muscle spasms	26.33	15.65	40	48595	68278	31580431
Hypoxia	26.23	15.65	149	48486	50164	31598545
Macular oedema	26.16	15.65	26	48609	2642	31646067
Influenza	26.11	15.65	18	48617	44307	31604402
Abnormal behaviour	26.07	15.65	3	48632	23825	31624884
Discontinued product administered	25.99	15.65	6	48629	13	31648696
Neutropenic colitis	25.97	15.65	26	48609	2666	31646043
Peripheral swelling	25.90	15.65	40	48595	67825	31580884
Heart rate decreased	25.52	15.65	6	48629	28260	31620449
Acute respiratory distress syndrome	25.24	15.65	89	48546	24451	31624258
Cytomegalovirus infection	24.93	15.65	4	48631	24703	31624006
Urticaria	24.85	15.65	31	48604	57486	31591223
Eastern Cooperative Oncology Group performance status worsened	24.81	15.65	16	48619	870	31647839
Dermatitis acneiform	24.79	15.65	37	48598	5730	31642979
Irritability	24.75	15.65	3	48632	22886	31625823
Inappropriate schedule of product administration	24.57	15.65	25	48610	50798	31597911
Lung abscess	24.25	15.65	24	48611	2427	31646282
Erythema multiforme	24.18	15.65	44	48591	8027	31640682
Pneumoperitoneum	23.95	15.65	20	48615	1623	31647086
Taeniasis	23.53	15.65	7	48628	52	31648657
Infectious pleural effusion	23.52	15.65	22	48613	2075	31646634
Oligohydramnios	23.12	15.65	11	48624	327	31648382
Pancreatic carcinoma recurrent	23.07	15.65	7	48628	56	31648653
Ileus	23.02	15.65	63	48572	15106	31633603
Chronic kidney disease	22.93	15.65	15	48620	37960	31610749
Lymphangiosis carcinomatosa	22.88	15.65	15	48620	839	31647870
Lung squamous cell carcinoma metastatic	22.86	15.65	7	48628	58	31648651
Stress cardiomyopathy	22.46	15.65	20	48615	1770	31646939
Feeling hot	22.27	15.65	65	48570	16168	31632541
Metastases to lymph nodes	22.21	15.65	30	48605	4238	31644471
Aortic injury	21.93	15.65	5	48630	10	31648699
Loss of personal independence in daily activities	21.89	15.65	8	48627	28280	31620429
Disturbance in attention	21.84	15.65	4	48631	22446	31626263
Sinusitis	21.48	15.65	15	48620	36681	31612028
Sense of oppression	21.33	15.65	12	48623	508	31648201
Non-small cell lung cancer stage IV	20.89	15.65	9	48626	211	31648498
Metabolic acidosis	20.86	15.65	18	48617	39559	31609150
Second primary malignancy	20.64	15.65	38	48597	6994	31641715
Radiation skin injury	20.56	15.65	13	48622	683	31648026
Metastases to skin	20.52	15.65	11	48624	423	31648286
Tumour pseudoprogression	20.52	15.65	11	48624	423	31648286
Lactic acidosis	20.13	15.65	12	48623	31925	31616784
Proteinuria	20.08	15.65	64	48571	16699	31632010
Seizure	19.94	15.65	82	48553	99686	31549023
Blood creatine phosphokinase increased	19.89	15.65	21	48614	41953	31606756
Pain	19.84	15.65	187	48448	186572	31462137
Cataract	19.70	15.65	6	48629	23801	31624908
Pulmonary artery occlusion	19.69	15.65	4	48631	3	31648706
Oesophagobronchial fistula	19.56	15.65	8	48627	164	31648545
Gastric perforation	19.54	15.65	21	48614	2338	31646371
Cachexia	19.49	15.65	36	48599	6643	31642066
Rhabdomyolysis	19.36	15.65	43	48592	63538	31585171
Subdural haematoma	19.30	15.65	3	48632	18968	31629741
Hyperkalaemia	19.20	15.65	44	48591	64307	31584402
Abdominal discomfort	19.10	15.65	31	48604	51536	31597173
Lung disorder	19.07	15.65	99	48536	32213	31616496
Adenocarcinoma pancreas	19.06	15.65	16	48619	1308	31647401
Nasal congestion	19.05	15.65	4	48631	20377	31628332
Eosinophilia	18.99	15.65	6	48629	23247	31625462
Paronychia	18.89	15.65	24	48611	3194	31645515
Herpes zoster	18.83	15.65	13	48622	31980	31616729
Hypopituitarism	18.70	15.65	19	48616	1982	31646727
Lymphopenia	18.36	15.65	56	48579	14273	31634436
Miller Fisher syndrome	18.33	15.65	6	48629	63	31648646
Transient ischaemic attack	18.28	15.65	7	48628	24049	31624660
Abdominal pain	18.26	15.65	320	48315	145632	31503077
Hepatic function abnormal	18.25	15.65	117	48518	41105	31607604
Pulmonary cavitation	18.13	15.65	13	48622	842	31647867
Metastases to kidney	18.08	15.65	9	48626	296	31648413
Pneumonia bacterial	17.91	15.65	45	48590	10251	31638458
Pericardial effusion	17.87	15.65	75	48560	22348	31626361
Pain in extremity	17.76	15.65	105	48530	116098	31532611
Arthritis	17.67	15.65	10	48625	27375	31621334
Hiccups	17.66	15.65	42	48593	9245	31639464
Immune-mediated pancreatitis	17.61	15.65	6	48629	72	31648637
Product use issue	17.60	15.65	38	48597	56721	31591988
Tumour marker increased	17.59	15.65	11	48624	567	31648142
Contusion	17.43	15.65	15	48620	33013	31615696
Balance disorder	17.42	15.65	19	48616	37403	31611306
Upper respiratory tract infection	17.26	15.65	12	48623	29410	31619299
Vascular pseudoaneurysm ruptured	17.17	15.65	6	48629	78	31648631
Treatment noncompliance	17.13	15.65	9	48626	25675	31623034
Hypophagia	17.00	15.65	73	48562	21969	31626740
Rhinorrhoea	16.99	15.65	7	48628	23005	31625704
Blood thyroid stimulating hormone abnormal	16.88	15.65	9	48626	342	31648367
Supraventricular tachycardia	16.85	15.65	44	48591	10263	31638446
Multiple-drug resistance	16.82	15.65	27	48608	4453	31644256
Metastases to the mediastinum	16.81	15.65	8	48627	238	31648471
Portal venous gas	16.79	15.65	9	48626	346	31648363
Immune-mediated nephritis	16.75	15.65	8	48627	240	31648469
Sleep apnoea syndrome	16.72	15.65	4	48631	18621	31630088
Hypothyroidism	16.69	15.65	63	48572	17884	31630825
Coronary artery aneurysm	16.64	15.65	6	48629	86	31648623
Upper gastrointestinal perforation	16.44	15.65	3	48632	0	31648709
Anaphylactoid shock	16.44	15.65	9	48626	361	31648348
Dysarthria	16.34	15.65	15	48620	32002	31616707
Respiratory failure	16.30	15.65	232	48403	101217	31547492
Hypophysitis	16.18	15.65	18	48617	2084	31646625
Thrombocytosis	16.17	15.65	24	48611	3699	31645010
Haemorrhage	16.12	15.65	30	48605	47304	31601405
Tumour lysis syndrome	15.99	15.65	56	48579	15329	31633380
Gastrooesophageal reflux disease	15.99	15.65	17	48618	33854	31614855
Palmar-plantar erythrodysaesthesia syndrome	15.79	15.65	56	48579	15427	31633282
Incorrect dose administered	15.72	15.65	19	48616	35733	31612976
Dry mouth	15.69	15.65	9	48626	24449	31624260
Colitis ischaemic	15.66	15.65	31	48604	6021	31642688

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	1829.65	12.14	1837	162556	125059	70638992
Malignant neoplasm progression	1701.23	12.14	1733	162660	120006	70644045
Neutropenia	1669.93	12.14	2485	161908	254671	70509380
Febrile neutropenia	1153.04	12.14	1852	162541	202466	70561585
Erythema	1032.89	12.14	1740	162653	197823	70566228
Flushing	1004.46	12.14	1090	163303	81082	70682969
Disease progression	924.37	12.14	1450	162943	155222	70608829
Anaemia	842.37	12.14	2440	161953	400983	70363068
Metastases to liver	833.42	12.14	596	163797	25282	70738769
Neutrophil count decreased	770.64	12.14	959	163434	82597	70681454
Metastases to bone	766.10	12.14	535	163858	21841	70742210
Myelosuppression	733.06	12.14	587	163806	29558	70734493
Dyspnoea	631.27	12.14	3471	160922	766589	69997462
Breast cancer metastatic	597.41	12.14	342	164051	9804	70754247
Rheumatoid arthritis	583.72	12.14	21	164372	291784	70472267
Metastases to lung	578.00	12.14	400	163993	16084	70747967
Leukopenia	531.65	12.14	915	163478	105645	70658406
Polyneuropathy	531.27	12.14	422	163971	20993	70743058
Interstitial lung disease	528.98	12.14	904	163489	103781	70660270
Thrombocytopenia	528.62	12.14	1478	162915	237632	70526419
Neoplasm progression	502.38	12.14	571	163822	44657	70719394
Completed suicide	498.98	12.14	5	164388	227130	70536921
Pneumonitis	492.56	12.14	620	163773	53977	70710074
Peripheral sensory neuropathy	479.82	12.14	317	164076	11793	70752258
Palmar-plantar erythrodysaesthesia syndrome	470.30	12.14	457	163936	29790	70734261
Pancreatic carcinoma metastatic	447.09	12.14	205	164188	3635	70760416
Drug ineffective	432.86	12.14	964	163429	938788	69825263
Joint swelling	417.09	12.14	49	164344	253162	70510889
Metastases to central nervous system	415.82	12.14	316	164077	14718	70749333
Cystoid macular oedema	411.55	12.14	159	164234	1793	70762258
Mucosal inflammation	402.27	12.14	630	163763	67220	70696831
Fall	376.16	12.14	288	164105	443808	70320243
Haematotoxicity	366.29	12.14	282	164111	13392	70750659
Neurotoxicity	362.90	12.14	395	163998	29431	70734620
Product dose omission issue	360.81	12.14	41	164352	217427	70546624
Anaphylactic shock	340.26	12.14	398	163995	32092	70731959
Acute myeloid leukaemia	339.10	12.14	388	164005	30552	70733499
Bone marrow failure	338.84	12.14	489	163904	48521	70715530
Metastases to lymph nodes	332.86	12.14	228	164165	9010	70755041
Chest discomfort	332.66	12.14	826	163567	123555	70640496
Drug abuse	319.86	12.14	4	164389	147252	70616799
Feeling hot	316.78	12.14	472	163921	48198	70715853
Bronchospasm	293.37	12.14	311	164082	22481	70741570
Pancreatic carcinoma	291.93	12.14	241	164152	12663	70751388
Onycholysis	263.82	12.14	113	164280	1690	70762361
Pseudocirrhosis	263.23	12.14	86	164307	565	70763486
General physical health deterioration	261.60	12.14	1162	163231	234869	70529182
Synovitis	259.23	12.14	9	164384	129219	70634832
Therapeutic product effect decreased	252.83	12.14	21	164372	142997	70621054
Contraindicated product administered	251.74	12.14	15	164378	134597	70629454
Weight increased	249.42	12.14	125	164268	242206	70521845
Nausea	248.79	12.14	3038	161355	849050	69915001
Condition aggravated	247.98	12.14	380	164013	427255	70336796
Headache	247.36	12.14	619	163774	579786	70184265
Arthropathy	242.15	12.14	31	164362	150026	70614025
Breast cancer	239.59	12.14	340	164053	33209	70730842
Metastases to peritoneum	236.30	12.14	133	164260	3686	70760365
Musculoskeletal stiffness	234.91	12.14	32	164361	147728	70616323
Overdose	234.53	12.14	53	164340	169692	70594359
Gastrointestinal perforation	230.60	12.14	151	164242	5530	70758521
Toxicity to various agents	224.02	12.14	337	164056	381835	70382216
Second primary malignancy	221.46	12.14	207	164186	12844	70751207
Cholangitis	221.08	12.14	196	164197	11353	70752698
Back pain	220.80	12.14	1223	163170	269929	70494122
Sinusitis	219.85	12.14	60	164333	169135	70594916
Vomiting	216.07	12.14	2210	162183	590901	70173150
White blood cell count decreased	214.24	12.14	871	163522	169270	70594781
Proteinuria	210.21	12.14	298	164095	29076	70734975
Diarrhoea	205.87	12.14	2740	161653	780601	69983450
Ejection fraction decreased	205.42	12.14	302	164091	30460	70733591
Therapy partial responder	204.30	12.14	194	164199	12280	70751771
Skin toxicity	202.80	12.14	153	164240	7045	70757006
Ascites	201.34	12.14	468	163925	67079	70696972
Platelet count decreased	198.53	12.14	879	163514	177343	70586708
Arthralgia	198.28	12.14	558	163835	502832	70261219
Pyrexia	196.10	12.14	2208	162185	604744	70159307
Myelodysplastic syndrome	189.70	12.14	286	164107	29499	70734552
Pleural effusion	189.03	12.14	707	163686	132157	70631894
Pain	185.62	12.14	789	163604	628027	70136024
Hypertransaminasaemia	183.70	12.14	158	164235	8785	70755266
Glossodynia	180.91	12.14	4	164389	86483	70677568
Depression	174.64	12.14	124	164269	198850	70565201
Infusion related reaction	174.27	12.14	911	163482	196623	70567428
Pemphigus	173.07	12.14	4	164389	83032	70681019
Biliary tract infection	172.82	12.14	75	164318	1160	70762891
Drug interaction	172.38	12.14	394	163999	381047	70383004
Injection site pain	172.23	12.14	32	164361	117587	70646464
Abdominal discomfort	171.67	12.14	147	164246	214511	70549540
Radiation pneumonitis	169.33	12.14	106	164287	3587	70760464
Product use issue	168.91	12.14	104	164289	179833	70584218
Hypertension	167.43	12.14	1217	163176	294816	70469235
Swelling	166.12	12.14	117	164276	188422	70575629
Peripheral swelling	165.99	12.14	182	164211	236381	70527670
Sense of oppression	165.51	12.14	77	164316	1413	70762638
Suicide attempt	165.06	12.14	4	164389	79506	70684545
Epistaxis	164.60	12.14	568	163825	102059	70661992
Nasopharyngitis	162.58	12.14	165	164228	222041	70542010
Systemic lupus erythematosus	159.75	12.14	23	164370	101879	70662172
Drug intolerance	159.04	12.14	173	164220	225514	70538537
Psoriasis	154.81	12.14	22	164371	98411	70665640
Somnolence	152.22	12.14	165	164228	215441	70548610
Embolism	149.29	12.14	167	164226	12821	70751230
Paraesthesia	148.03	12.14	699	163694	144838	70619213
Mobility decreased	146.63	12.14	30	164363	102969	70661082
Lymphangiosis carcinomatosa	144.85	12.14	76	164317	1825	70762226
Hypersensitivity	141.69	12.14	965	163428	228847	70535204
Cardiac dysfunction	141.09	12.14	93	164300	3444	70760607
Oxygen saturation decreased	137.79	12.14	585	163808	115844	70648207
Ovarian cancer recurrent	137.39	12.14	50	164343	471	70763580
Confusional state	137.31	12.14	283	164110	284115	70479936
Metastases to meninges	136.25	12.14	87	164306	3049	70761002
Non-small cell lung cancer	136.22	12.14	115	164278	6232	70757819
Intentional product misuse	134.47	12.14	14	164379	79581	70684470
Abdominal pain	133.43	12.14	1294	163099	340833	70423218
Hospitalisation	133.31	12.14	17	164376	82551	70681500
Neutropenic sepsis	129.97	12.14	218	164175	24612	70739439
Blood cholesterol increased	127.80	12.14	5	164388	64599	70699452
Throat tightness	124.78	12.14	215	164178	24807	70739244
Insomnia	124.63	12.14	195	164198	217611	70546440
Contusion	124.36	12.14	71	164322	127965	70636086
Dehydration	123.93	12.14	923	163470	225219	70538832
Ovarian cancer	123.62	12.14	91	164302	4034	70760017
Decreased appetite	122.88	12.14	1161	163232	303619	70460432
Hypoxia	122.28	12.14	484	163909	92860	70671191
Plasma cell myeloma	120.81	12.14	14	164379	73187	70690864
Asthma	120.19	12.14	65	164328	120728	70643323
Nail toxicity	119.52	12.14	41	164352	319	70763732
Arthritis	119.49	12.14	39	164354	97941	70666110
Pulmonary embolism	118.09	12.14	690	163703	155177	70608874
Pancytopenia	117.78	12.14	674	163719	150433	70613618
Influenza	116.35	12.14	59	164334	113641	70650410
Migraine	116.31	12.14	15	164378	72223	70691828
Loss of personal independence in daily activities	116.26	12.14	27	164366	84883	70679168
Cyanosis	115.20	12.14	199	164194	23007	70741044
Helicobacter infection	114.76	12.14	3	164390	55653	70708398
Pneumothorax	114.65	12.14	211	164182	25635	70738416
Hypoglycaemia	114.30	12.14	38	164355	94326	70669725
Hepatic enzyme increased	114.30	12.14	117	164276	156873	70607178
Gastrointestinal toxicity	113.33	12.14	104	164289	6301	70757750
Wound	112.39	12.14	44	164349	98688	70665363
Recall phenomenon	112.30	12.14	53	164340	1006	70763045
Tumour haemorrhage	111.30	12.14	82	164311	3640	70760411
Osteonecrosis of jaw	110.22	12.14	273	164120	40729	70723322
Metastases to skin	108.98	12.14	59	164334	1512	70762539
Thrombotic microangiopathy	108.87	12.14	168	164225	17680	70746371
Tachycardia	107.52	12.14	682	163711	157864	70606187
Bone pain	105.95	12.14	308	164085	50514	70713537
Breast cancer recurrent	105.53	12.14	71	164322	2722	70761329
Injection site erythema	104.29	12.14	21	164372	72903	70691148
Immune-mediated hepatitis	103.87	12.14	71	164322	2795	70761256
Blood pressure fluctuation	103.33	12.14	9	164384	59003	70705048
Nail disorder	103.00	12.14	124	164269	10300	70753751
Treatment failure	98.74	12.14	113	164280	144029	70620022
Coronary artery disease	98.69	12.14	14	164379	62722	70701329
Drug reaction with eosinophilia and systemic symptoms	98.52	12.14	10	164383	58003	70706048
Inappropriate schedule of product administration	98.37	12.14	64	164329	107491	70656560
Duodenal ulcer perforation	97.68	12.14	5	164388	51107	70712944
Pericarditis	97.65	12.14	37	164356	84668	70679383
Irritable bowel syndrome	97.10	12.14	5	164388	50845	70713206
Alopecia	96.45	12.14	788	163605	197702	70566349
Gait disturbance	94.63	12.14	178	164215	184928	70579123
Fibromyalgia	93.70	12.14	4	164389	47870	70716181
Anaphylactic reaction	92.80	12.14	382	164011	74592	70689459
Cardiotoxicity	92.35	12.14	121	164272	10949	70753102
Intestinal perforation	92.28	12.14	147	164246	15897	70748154
Memory impairment	91.94	12.14	50	164343	92591	70671460
Feeling abnormal	91.73	12.14	117	164276	142202	70621849
Colitis	91.03	12.14	340	164053	63474	70700577
Nail discolouration	90.94	12.14	64	164329	2642	70761409
Bradycardia	90.55	12.14	93	164300	124522	70639529
Ileus	90.53	12.14	184	164209	24053	70739998
Hallucination	90.13	12.14	32	164361	76228	70687823
Suicidal ideation	89.75	12.14	25	164368	69571	70694480
Peripheral motor neuropathy	89.17	12.14	67	164326	3065	70760986
Blister	89.00	12.14	62	164331	100464	70663587
Asthenia	88.19	12.14	1520	162873	456146	70307905
Injection site swelling	86.53	12.14	3	164390	43154	70720897
Triple negative breast cancer	86.31	12.14	27	164366	151	70763900
Drug hypersensitivity	86.27	12.14	315	164078	262144	70501907
Myocardial infarction	85.16	12.14	168	164225	171477	70592574
Performance status decreased	83.99	12.14	83	164310	5518	70758533
Injection site reaction	83.61	12.14	9	164384	49843	70714208
Hypokalaemia	82.62	12.14	554	163839	130634	70633417
Coma	82.17	12.14	56	164337	91788	70672263
Immune-mediated enterocolitis	82.06	12.14	67	164326	3464	70760587
Exposure during pregnancy	81.85	12.14	51	164342	87666	70676385
Dysaesthesia	81.33	12.14	80	164313	5288	70758763
Radiation oesophagitis	81.17	12.14	36	164357	588	70763463
Anxiety	80.18	12.14	253	164140	220077	70543974
Metastasis	79.68	12.14	84	164309	6030	70758021
Injury	79.49	12.14	26	164367	65219	70698832
Tumour necrosis	79.21	12.14	50	164343	1717	70762334
Incorrect dose administered	78.84	12.14	28	164365	66691	70697360
Electrocardiogram QT prolonged	78.70	12.14	48	164345	83469	70680582
Sepsis	78.25	12.14	889	163504	243656	70520395
Fluid retention	77.68	12.14	25	164368	63360	70700691
Injection site pruritus	77.67	12.14	3	164390	39207	70724844
Dizziness	77.58	12.14	695	163698	463446	70300605
PIK3CA-activated mutation	77.52	12.14	34	164359	540	70763511
Hepatic atrophy	76.42	12.14	31	164362	401	70763650
C-reactive protein abnormal	76.25	12.14	3	164390	38576	70725475
Rhabdomyolysis	75.98	12.14	66	164327	95694	70668357
Tumour marker increased	75.84	12.14	66	164327	3728	70760323
Metastatic neoplasm	75.56	12.14	72	164321	4576	70759475
Urogenital fistula	74.53	12.14	23	164370	122	70763929
Acute promyelocytic leukaemia	73.65	12.14	45	164348	1457	70762594
Invasive ductal breast carcinoma	72.50	12.14	78	164315	5731	70758320
Metastases to kidney	72.41	12.14	31	164362	463	70763588
Serotonin syndrome	72.19	12.14	7	164386	42107	70721944
Osteoarthritis	72.15	12.14	41	164352	74106	70689945
Discomfort	71.82	12.14	83	164310	105353	70658698
Lactic acidosis	70.73	12.14	31	164362	64993	70699058
Pneumocystis jirovecii pneumonia	70.24	12.14	190	164203	29892	70734159
International normalised ratio increased	69.87	12.14	51	164342	80675	70683376
Muscle spasms	69.54	12.14	159	164234	153887	70610164
Pain in extremity	69.47	12.14	460	163933	327622	70436429
Nasal congestion	68.80	12.14	33	164360	65639	70698412
Subileus	68.45	12.14	72	164321	5155	70758896
Posterior reversible encephalopathy syndrome	68.26	12.14	165	164228	24237	70739814
Large intestine perforation	67.92	12.14	115	164278	13080	70750971
Alveolitis	67.66	12.14	62	164331	3749	70760302
Aggression	67.12	12.14	15	164378	48431	70715620
Nephrolithiasis	66.89	12.14	14	164379	47309	70716742
Stomatitis	66.10	12.14	517	163876	127994	70636057
Lower respiratory tract infection	66.08	12.14	98	164295	111815	70652236
Macular oedema	65.64	12.14	70	164323	5092	70758959
Malignant pleural effusion	65.57	12.14	56	164337	3083	70760968
Metastases to spine	65.47	12.14	61	164332	3768	70760283
Cataract	64.65	12.14	24	164369	55621	70708430
Enterocolitis infectious	64.47	12.14	52	164341	2642	70761409
Scleroderma-like reaction	64.36	12.14	20	164373	109	70763942
Nail dystrophy	64.09	12.14	35	164358	913	70763138
Pulmonary arterial hypertension	63.46	12.14	3	164390	32852	70731199
Cardiac failure congestive	63.44	12.14	137	164256	135320	70628731
Metastases to the mediastinum	63.19	12.14	29	164364	515	70763536
Urticaria	63.05	12.14	182	164211	162867	70601184
Bronchial fistula	62.85	12.14	22	164371	183	70763868
Computerised tomogram thorax abnormal	62.23	12.14	46	164347	2052	70761999
Anaphylactoid reaction	62.08	12.14	67	164326	4940	70759111
Haemoptysis	61.19	12.14	259	164134	51193	70712858
Illness	61.10	12.14	3	164390	31788	70732263
COVID-19	61.09	12.14	94	164299	105663	70658388
Cholangitis sclerosing	60.95	12.14	47	164346	2236	70761815
Metabolic acidosis	60.50	12.14	50	164343	74296	70689755
Hyperaemia	59.84	12.14	51	164342	2800	70761251
Accidental overdose	59.77	12.14	6	164387	35115	70728936
Bronchitis	59.66	12.14	113	164280	117130	70646921
Basal cell carcinoma	59.38	12.14	5	164388	33693	70730358
Hypertensive crisis	59.05	12.14	135	164258	19127	70744924
Irritability	59.03	12.14	9	164384	38216	70725835
Cardiomyopathy	59.02	12.14	164	164229	26209	70737842
Oesophagitis	58.95	12.14	149	164244	22503	70741548
Acute interstitial pneumonitis	58.94	12.14	35	164358	1075	70762976
Osteoporosis	58.68	12.14	20	164373	48887	70715164
Metastases to pleura	58.34	12.14	37	164356	1281	70762770
Pulmonary toxicity	58.10	12.14	96	164297	10702	70753349
Immune-mediated lung disease	57.58	12.14	40	164353	1617	70762434
Sleep apnoea syndrome	57.24	12.14	5	164388	32708	70731343
Prostate cancer	56.67	12.14	4	164389	31159	70732892
Bronchostenosis	56.33	12.14	28	164365	598	70763453
Product prescribing error	56.14	12.14	11	164382	38941	70725110
Hepatic failure	55.79	12.14	273	164120	57352	70706699
Lymphoedema	55.72	12.14	96	164297	11073	70752978
Secondary cerebellar degeneration	55.35	12.14	15	164378	45	70764006
Stress	54.94	12.14	46	164347	67920	70696131
Eosinophilia	54.83	12.14	13	164380	40306	70723745
Maternal exposure during pregnancy	54.56	12.14	116	164277	115229	70648822
Suffocation feeling	54.05	12.14	38	164355	1566	70762485
Malignant ascites	54.03	12.14	33	164360	1068	70762983
Acute myelomonocytic leukaemia	54.00	12.14	22	164371	288	70763763
Disseminated intravascular coagulation	53.86	12.14	186	164207	33412	70730639
Cytomegalovirus infection	53.71	12.14	13	164380	39745	70724306
Paronychia	52.43	12.14	73	164320	7001	70757050
Palmar erythema	52.29	12.14	39	164354	1764	70762287
Medication error	51.84	12.14	34	164359	56878	70707173
Biliary sepsis	51.67	12.14	36	164357	1462	70762589
Drug level increased	51.11	12.14	11	164382	36458	70727593
Treatment noncompliance	50.98	12.14	22	164371	46552	70717499
Left ventricular dysfunction	50.84	12.14	122	164271	17835	70746216
Carbohydrate antigen 125 increased	50.67	12.14	40	164353	1970	70762081
Swollen tongue	50.27	12.14	12	164381	37034	70727017
Hot flush	50.24	12.14	238	164155	49346	70714705
Wrong technique in product usage process	50.20	12.14	51	164342	68647	70695404
Atelectasis	49.66	12.14	164	164229	28798	70735253
Road traffic accident	49.56	12.14	10	164383	34672	70729379
Oesophagobronchial fistula	48.96	12.14	19	164374	217	70763834
Unevaluable event	48.94	12.14	30	164363	52033	70712018
Dyskinesia	48.93	12.14	17	164376	41057	70722994
Hepatic function abnormal	48.86	12.14	297	164096	67699	70696352
Pericardial effusion	48.67	12.14	209	164184	41567	70722484
Carbohydrate antigen 15-3 increased	47.58	12.14	30	164363	1028	70763023
Laryngospasm	47.38	12.14	50	164343	3593	70760458
Device related infection	47.15	12.14	173	164220	32012	70732039
Tumour lysis syndrome	46.98	12.14	132	164261	21228	70742823
Wheezing	46.83	12.14	92	164301	94078	70669973
Gastric disorder	46.80	12.14	10	164383	33312	70730739
Febrile infection	46.48	12.14	46	164347	3063	70760988
Blood glucose increased	45.89	12.14	107	164286	102875	70661176
Small intestinal perforation	45.88	12.14	45	164348	2964	70761087
Haemolytic uraemic syndrome	45.58	12.14	52	164341	4078	70759973
Adrenocorticotropic hormone deficiency	45.35	12.14	29	164364	1019	70763032
Superior vena cava syndrome	45.34	12.14	30	164363	1118	70762933
Folliculitis	45.19	12.14	21	164372	42549	70721502
Immune-mediated hepatic disorder	44.92	12.14	28	164365	940	70763111
Limb injury	44.88	12.14	4	164389	25748	70738303
Liver abscess	44.85	12.14	60	164333	5539	70758512
Extravasation	44.85	12.14	47	164346	3350	70760701
Stress cardiomyopathy	44.35	12.14	81	164312	9781	70754270
Respiratory distress	44.00	12.14	246	164147	54404	70709647
Choking sensation	43.73	12.14	48	164345	3607	70760444
Immune-mediated dermatitis	43.25	12.14	19	164374	303	70763748
Ear infection	43.01	12.14	7	164386	28329	70735722
Type I hypersensitivity	42.91	12.14	48	164345	3684	70760367
Neutropenic colitis	42.82	12.14	56	164337	5058	70758993
Subdural haematoma	42.81	12.14	8	164385	29290	70734761
Tumour associated fever	42.75	12.14	25	164368	746	70763305
Psychotic disorder	42.57	12.14	17	164376	37684	70726367
Tremor	42.24	12.14	201	164192	155423	70608628
Full blood count abnormal	42.15	12.14	13	164380	33865	70730186
Surgery	42.12	12.14	9	164384	29980	70734071
Death	42.08	12.14	1510	162883	508551	70255500
Abnormal behaviour	41.98	12.14	14	164379	34695	70729356
Carcinoembryonic antigen increased	41.96	12.14	36	164357	1994	70762057
Cachexia	41.63	12.14	79	164314	9821	70754230
Angioedema	41.62	12.14	56	164337	66554	70697497
Gastrooesophageal reflux disease	41.59	12.14	93	164300	90746	70673305
Rash pruritic	41.38	12.14	51	164342	62940	70701111
Oropharyngeal pain	41.38	12.14	102	164291	96208	70667843
Hypersensitivity pneumonitis	41.05	12.14	45	164348	3377	70760674
Rectal perforation	41.01	12.14	25	164368	806	70763245
Head injury	40.89	12.14	14	164379	34127	70729924
Blood creatine phosphokinase increased	40.88	12.14	49	164344	61214	70702837
Poisoning	40.86	12.14	3	164390	22619	70741432
Mental disorder	40.65	12.14	8	164385	28232	70735819
Joint range of motion decreased	40.48	12.14	6	164387	26020	70738031
Adenocarcinoma pancreas	40.12	12.14	35	164358	1983	70762068
Hypomagnesaemia	40.09	12.14	194	164199	40570	70723481
Recurrent cancer	40.04	12.14	38	164355	2403	70761648
Drug withdrawal syndrome	39.91	12.14	13	164380	32702	70731349
Transient ischaemic attack	39.78	12.14	29	164364	45915	70718136
Adverse drug reaction	39.66	12.14	39	164354	53305	70710746
Portal hypertension	39.44	12.14	61	164332	6431	70757620
Hydronephrosis	39.39	12.14	100	164293	15142	70748909
Female genital tract fistula	39.31	12.14	42	164351	3061	70760990
Product administration error	39.21	12.14	10	164383	29513	70734538
Cardiac disorder	39.14	12.14	48	164345	59367	70704684
Labelled drug-drug interaction medication error	38.86	12.14	5	164388	24122	70739929
Adenocarcinoma	38.64	12.14	45	164348	3608	70760443
Nervousness	38.62	12.14	12	164381	31108	70732943
Agitation	38.49	12.14	101	164292	93274	70670777
Herpes zoster	38.43	12.14	88	164305	85147	70678904
Eastern Cooperative Oncology Group performance status worsened	38.40	12.14	31	164362	1577	70762474
Joint stiffness	37.89	12.14	17	164376	35159	70728892
Eye pain	37.49	12.14	16	164377	34086	70729965
Infusion related hypersensitivity reaction	37.31	12.14	16	164377	240	70763811
Metastases to retroperitoneum	37.24	12.14	18	164375	361	70763690
Capillary permeability increased	37.15	12.14	10	164383	29	70764022
Nightmare	37.15	12.14	4	164389	22152	70741899
Sleep disorder	36.73	12.14	66	164327	69806	70694245
Haemorrhage	36.61	12.14	88	164305	83727	70680324
Hypopituitarism	36.40	12.14	40	164353	3010	70761041
Cervix carcinoma	36.28	12.14	34	164359	2116	70761935
Acne	36.13	12.14	7	164386	24982	70739069
Skin laceration	35.87	12.14	8	164385	25870	70738181
Pulmonary radiation injury	35.86	12.14	11	164382	57	70763994
Bone lesion	35.79	12.14	53	164340	5377	70758674
Tracheal fistula	35.67	12.14	13	164380	123	70763928
Acute myocardial infarction	35.56	12.14	72	164321	72815	70691236
Capillary leak syndrome	35.55	12.14	42	164351	3420	70760631
Type 2 diabetes mellitus	35.42	12.14	30	164363	44050	70720001
Aortitis	35.40	12.14	28	164365	1383	70762668
Computerised tomogram thorax	35.28	12.14	15	164378	220	70763831
Injection site haemorrhage	35.17	12.14	8	164385	25519	70738532
Hyperhidrosis	34.93	12.14	462	163931	131124	70632927
Blood pressure systolic increased	34.91	12.14	49	164344	57210	70706841
Acute kidney injury	34.80	12.14	836	163557	473788	70290263
Dysgeusia	34.79	12.14	215	164178	49287	70714764
Chills	34.64	12.14	499	163894	144287	70619764
Prescribed overdose	34.60	12.14	10	164383	27171	70736880
Dystonia	34.51	12.14	3	164390	19703	70744348
Gait inability	34.49	12.14	35	164358	47140	70716911
Blood triglycerides increased	34.42	12.14	3	164390	19661	70744390
Toxic erythema of chemotherapy	34.27	12.14	15	164378	237	70763814
Hyperkalaemia	34.27	12.14	129	164264	106462	70657589
Gout	34.22	12.14	6	164387	23000	70741051
Emotional distress	34.16	12.14	22	164371	37166	70726885
Radiation skin injury	34.09	12.14	27	164366	1336	70762715
Enterocolitis	34.06	12.14	86	164307	12980	70751071
Heart rate decreased	34.04	12.14	57	164336	61958	70702093
Pneumatosis intestinalis	33.93	12.14	54	164339	5833	70758218
Metastases to stomach	33.93	12.14	15	164378	243	70763808
Pseudomembranous colitis	33.85	12.14	50	164343	5061	70758990
Drug ineffective for unapproved indication	33.79	12.14	24	164369	38514	70725537
Amnesia	33.46	12.14	43	164350	52112	70711939
Lymphadenopathy mediastinal	33.41	12.14	44	164349	4001	70760050
Constipation	33.34	12.14	793	163600	251645	70512406
Diabetes mellitus	33.32	12.14	73	164320	71751	70692300
Incorrect route of product administration	33.26	12.14	10	164383	26482	70737569
Device related thrombosis	33.23	12.14	34	164359	2356	70761695
Small intestinal obstruction	33.20	12.14	129	164264	24526	70739525
Eczema asteatotic	32.82	12.14	19	164374	556	70763495
Cancer pain	32.74	12.14	48	164345	4826	70759225
Crying	32.71	12.14	5	164388	21194	70742857
Tonsillar disorder	32.48	12.14	24	164369	1070	70762981
Upper respiratory tract infection	32.48	12.14	86	164307	79188	70684863
Primary cardiac lymphoma	32.05	12.14	9	164384	32	70764019
Obesity	32.03	12.14	11	164382	26760	70737291
Bile duct stenosis	31.94	12.14	30	164363	1872	70762179
Fear	31.91	12.14	5	164388	20806	70743245
Hypersomnia	31.81	12.14	5	164388	20759	70743292
Scleroderma	31.80	12.14	48	164345	4953	70759098
Metastases to chest wall	31.78	12.14	17	164376	425	70763626
Metastases to eye	31.77	12.14	14	164379	225	70763826
Pleural neoplasm	31.72	12.14	16	164377	353	70763698
Pregnancy	31.68	12.14	8	164385	23773	70740278
Immune-mediated pancreatitis	31.58	12.14	13	164380	175	70763876
Neck pain	31.54	12.14	67	164326	66590	70697461
Anastomotic leak	31.51	12.14	23	164370	1006	70763045
Retroperitoneal lymphadenopathy	31.49	12.14	23	164370	1007	70763044
Malignant peritoneal neoplasm	31.47	12.14	20	164373	695	70763356
Administration site extravasation	31.32	12.14	24	164369	1131	70762920
Erythema multiforme	31.31	12.14	97	164296	16467	70747584
Myoclonus	31.23	12.14	11	164382	26344	70737707
Dermatitis acneiform	31.16	12.14	66	164327	8879	70755172
Kounis syndrome	31.15	12.14	39	164354	3372	70760679
Inflammation	30.98	12.14	87	164306	78578	70685473
Adrenal insufficiency	30.86	12.14	128	164265	25067	70738984
Hypoalbuminaemia	30.76	12.14	106	164287	19016	70745035
Disease recurrence	30.76	12.14	170	164223	37433	70726618
Hypervolaemia	30.72	12.14	28	164365	39678	70724373
Flatulence	30.66	12.14	26	164367	38155	70725896
Right ventricular failure	30.64	12.14	7	164386	22267	70741784
Hyperpyrexia	30.57	12.14	49	164344	5325	70758726
Endocarditis noninfective	30.56	12.14	13	164380	191	70763860
Blood uric acid decreased	30.51	12.14	24	164369	1176	70762875
Balance disorder	30.34	12.14	107	164286	90021	70674030
Musculoskeletal disorder	30.17	12.14	5	164388	19966	70744085
Metastases to pelvis	30.16	12.14	18	164375	558	70763493
Duodenal perforation	30.16	12.14	30	164363	2010	70762041
Bursitis	30.16	12.14	12	164381	26661	70737390
Periarticular thenar erythema with onycholysis	30.03	12.14	8	164385	22	70764029
Transaminases increased	29.84	12.14	199	164194	46819	70717232
Right ventricular ejection fraction decreased	29.77	12.14	9	164384	44	70764007
Pancreatic enzyme abnormality	29.64	12.14	11	164382	110	70763941
Tumour pain	29.45	12.14	30	164363	2068	70761983
Mood swings	28.95	12.14	4	164389	18282	70745769
Deep vein thrombosis	28.70	12.14	388	164005	110654	70653397
Angiosarcoma	28.60	12.14	17	164376	523	70763528
Cerebrovascular accident	28.42	12.14	205	164188	143265	70620786
Panic attack	28.41	12.14	8	164385	22111	70741940
Urinary tract obstruction	28.41	12.14	42	164351	4255	70759796
Laryngeal necrosis	28.37	12.14	8	164385	29	70764022
Neoplasm recurrence	28.21	12.14	40	164353	3901	70760150
Pulse absent	28.17	12.14	65	164328	9265	70754786
Subclavian vein thrombosis	28.10	12.14	31	164362	2343	70761708
Accidental exposure to product	28.02	12.14	15	164378	28036	70736015
Metastases to bladder	27.97	12.14	13	164380	238	70763813
Oligohydramnios	27.94	12.14	36	164357	3204	70760847
Hepatotoxicity	27.81	12.14	186	164207	43800	70720251
Diabetes mellitus inadequate control	27.62	12.14	9	164384	22636	70741415
Respiratory tract congestion	27.62	12.14	4	164389	17649	70746402
Delirium	27.59	12.14	85	164308	74529	70689522
Peritonitis	27.55	12.14	127	164266	26032	70738019
Ovarian failure	27.53	12.14	17	164376	561	70763490
Foot deformity	27.42	12.14	7	164386	20648	70743403
Neuromuscular toxicity	27.39	12.14	12	164381	190	70763861
Ovarian cancer metastatic	27.32	12.14	17	164376	569	70763482
Tumour embolism	27.28	12.14	11	164382	140	70763911
Hepatic lesion	27.20	12.14	50	164343	6067	70757984
Venous thrombosis limb	27.18	12.14	40	164353	4035	70760016
Kidney infection	26.99	12.14	6	164387	19449	70744602
Drug resistance	26.92	12.14	166	164227	38024	70726027
Blood potassium increased	26.74	12.14	15	164378	27311	70736740
Sopor	26.73	12.14	20	164373	31247	70732804
Limb discomfort	26.71	12.14	18	164375	29687	70734364
Abortion spontaneous	26.69	12.14	14	164379	26465	70737586
Eosinophil percentage increased	26.54	12.14	24	164369	1426	70762625
Viral infection	26.37	12.14	30	164363	38361	70725690
Melaena	26.37	12.14	57	164336	56298	70707753
Gastric perforation	26.25	12.14	38	164355	3777	70760274
Cardiac cirrhosis	26.21	12.14	12	164381	212	70763839
Status epilepticus	26.19	12.14	12	164381	24514	70739537
Procedural pain	26.13	12.14	5	164388	18004	70746047
Bone marrow infiltration	26.13	12.14	16	164377	520	70763531
Seizure	26.04	12.14	275	164118	177687	70586364
Lymphopenia	26.04	12.14	129	164264	27230	70736821
Night sweats	26.02	12.14	38	164355	43646	70720405
Enteritis	26	12.14	77	164316	12754	70751297
Mastitis	25.90	12.14	28	164365	2068	70761983
Dysphagia	25.85	12.14	386	164007	112448	70651603
Septic shock	25.70	12.14	384	164009	111874	70652177
Gallbladder disorder	25.53	12.14	5	164388	17707	70746344
Blood pressure diastolic abnormal	25.49	12.14	3	164390	15501	70748550
Wound dehiscence	25.44	12.14	49	164344	6159	70757892
Thyroid dermatopathy	25.35	12.14	7	164386	23	70764028
Foot fracture	25.34	12.14	7	164386	19593	70744458
Metastatic gastric cancer	25.23	12.14	14	164379	377	70763674
Therapy interrupted	25.17	12.14	13	164380	24789	70739262
Tooth erosion	25.07	12.14	14	164379	382	70763669
Chest pain	25.06	12.14	761	163632	250499	70513552
Vocal cord paralysis	25.04	12.14	29	164364	2312	70761739
Duodenitis haemorrhagic	25.03	12.14	10	164383	124	70763927
Colitis ulcerative	24.99	12.14	25	164368	33898	70730153
Gastritis bacterial	24.97	12.14	13	164380	307	70763744
Acute megakaryocytic leukaemia	24.96	12.14	8	164385	49	70764002
Tumour pseudoprogression	24.87	12.14	16	164377	568	70763483
Therapeutic product effect incomplete	24.86	12.14	169	164224	119713	70644338
Adverse event	24.86	12.14	48	164345	49413	70714638
Sinus congestion	24.84	12.14	5	164388	17368	70746683
Oesophagopleural fistula	24.82	12.14	8	164385	50	70764001
Hepatic infection	24.78	12.14	19	164374	896	70763155
Aplasia	24.68	12.14	53	164340	7198	70756853
Paranoia	24.67	12.14	5	164388	17283	70746768
Liver function test abnormal	24.54	12.14	67	164326	61079	70702972
Sinus bradycardia	24.54	12.14	12	164381	23611	70740440
Haemoglobin	24.52	12.14	9	164384	87	70763964
Congestive cardiomyopathy	24.50	12.14	68	164325	10858	70753193
Oligoastrocytoma	24.49	12.14	7	164386	27	70764024
Pulmonary tumour thrombotic microangiopathy	24.43	12.14	9	164384	88	70763963
Glaucoma	24.27	12.14	6	164387	18086	70745965
Vena cava thrombosis	24.09	12.14	30	164363	2580	70761471
Sinus disorder	24.09	12.14	7	164386	18952	70745099
Eye disorder	24.08	12.14	9	164384	20776	70743275
Device dislocation	24.05	12.14	11	164382	22496	70741555
Movement disorder	23.96	12.14	13	164380	24116	70739935
Lung abscess	23.90	12.14	36	164357	3708	70760343
Weight decreased	23.80	12.14	543	163850	309945	70454106
Localised infection	23.79	12.14	25	164368	33133	70730918
Spinal stenosis	23.69	12.14	3	164390	14650	70749401
Orthostatic hypotension	23.66	12.14	53	164340	51690	70712361
Metastases to breast	23.66	12.14	12	164381	268	70763783
Anaemia of malignant disease	23.65	12.14	17	164376	726	70763325
Scintillating scotoma	23.64	12.14	11	164382	202	70763849
Joint dislocation	23.43	12.14	3	164390	14528	70749523
Intestinal metastasis	23.14	12.14	12	164381	281	70763770
Tracheo-oesophageal fistula	23.11	12.14	15	164378	541	70763510
Pruritus	23.05	12.14	617	163776	344943	70419108
Eye swelling	23.05	12.14	13	164380	23601	70740450
Exostosis	23.03	12.14	3	164390	14342	70749709
Mood altered	23.02	12.14	5	164388	16470	70747581
Uterine atrophy	22.94	12.14	6	164387	15	70764036
Chromaturia	22.90	12.14	13	164380	23515	70740536
Gastrointestinal haemorrhage	22.77	12.14	206	164187	137202	70626849
Anhedonia	22.76	12.14	3	164390	14210	70749841
Infected lymphocele	22.56	12.14	11	164382	225	70763826
Pyogenic granuloma	22.43	12.14	14	164379	471	70763580
Underdose	22.40	12.14	21	164372	29362	70734689
Ovarian epithelial cancer recurrent	22.39	12.14	6	164387	17	70764034
Extrapyramidal disorder	22.39	12.14	10	164383	20740	70743311
Hallucination, visual	22.33	12.14	21	164372	29316	70734735
Pulmonary cavitation	22.32	12.14	22	164371	1458	70762593
No adverse event	22.22	12.14	25	164368	32128	70731923
Teratoma benign	22.21	12.14	8	164385	73	70763978
Metastases to soft tissue	22.11	12.14	13	164380	392	70763659
Immune-mediated myocarditis	22.08	12.14	16	164377	692	70763359
Gelastic seizure	21.89	12.14	5	164388	5	70764046
Ductal adenocarcinoma of pancreas	21.87	12.14	10	164383	176	70763875
Xerophthalmia	21.84	12.14	15	164378	595	70763456
Faeces discoloured	21.84	12.14	18	164375	26791	70737260
Hormone receptor positive breast cancer	21.70	12.14	12	164381	321	70763730
Vaginal fistula	21.67	12.14	11	164382	246	70763805
Poor quality sleep	21.66	12.14	10	164383	20339	70743712
Dysarthria	21.63	12.14	73	164320	62240	70701811
Dermatomyositis	21.60	12.14	33	164360	3442	70760609
Intestinal obstruction	21.51	12.14	159	164234	38666	70725385
Urinary retention	21.49	12.14	57	164336	52463	70711588
Eye pruritus	21.40	12.14	4	164389	14643	70749408
Ventricular tachycardia	21.39	12.14	32	164361	36391	70727660
Speech disorder	21.38	12.14	54	164339	50526	70713525
Therapy cessation	21.36	12.14	28	164365	33648	70730403
Periodontitis	21.33	12.14	37	164356	4291	70759760
Bronchopulmonary aspergillosis	21.32	12.14	11	164382	20991	70743060
Nasal septum perforation	21.27	12.14	16	164377	733	70763318
Thrombophlebitis migrans	21.27	12.14	12	164381	334	70763717
Bronchopleural fistula	21.23	12.14	15	164378	623	70763428
Arterioenteric fistula	21.23	12.14	6	164387	22	70764029
Glycosylated haemoglobin increased	21.06	12.14	7	164386	17384	70746667
Metastases to abdominal cavity	21.03	12.14	14	164379	527	70763524
Device issue	21.01	12.14	15	164378	24010	70740041
Cystitis noninfective	20.99	12.14	20	164373	1271	70762780
Therapeutic response unexpected	20.94	12.14	8	164385	18223	70745828
Rash papular	20.90	12.14	8	164385	18202	70745849
Endometrial adenocarcinoma	20.87	12.14	18	164375	1004	70763047
Acquired gene mutation	20.80	12.14	25	164368	2073	70761978
Acute erythroid leukaemia	20.78	12.14	11	164382	269	70763782
Ocular hyperaemia	20.75	12.14	16	164377	24623	70739428
Muscle twitching	20.71	12.14	10	164383	19817	70744234
Tongue disorder	20.69	12.14	3	164390	13224	70750827
Taeniasis	20.69	12.14	7	164386	52	70763999
Gastrointestinal necrosis	20.49	12.14	40	164353	5078	70758973
Transfusion	20.45	12.14	9	164384	18827	70745224
Pulmonary congestion	20.36	12.14	17	164376	25137	70738914
Hip arthroplasty	20.27	12.14	21	164372	28019	70736032
Splenic artery thrombosis	20.24	12.14	7	164386	56	70763995
Hypocalcaemia	20.10	12.14	175	164218	44684	70719367
Chronic obstructive pulmonary disease	20.06	12.14	102	164291	77539	70686512
Fungal infection	20.04	12.14	35	164358	37432	70726619
Pancreatic failure	19.97	12.14	21	164372	1503	70762548
Immune-mediated nephritis	19.96	12.14	12	164381	377	70763674
Respiratory depth decreased	19.90	12.14	6	164387	29	70764022
Vessel puncture site bruise	19.90	12.14	13	164380	474	70763577
Aortic injury	19.88	12.14	5	164388	10	70764041
Blood urine present	19.85	12.14	10	164383	19343	70744708
Pancreatic carcinoma recurrent	19.81	12.14	9	164384	156	70763895
Neuroendocrine breast tumour	19.74	12.14	6	164387	30	70764021
Nail avulsion	19.69	12.14	8	164385	104	70763947
Impaired healing	19.62	12.14	97	164296	74277	70689774
Ovarian epithelial cancer	19.61	12.14	10	164383	226	70763825
Cough	19.59	12.14	932	163461	324445	70439606
Upper gastrointestinal perforation	19.56	12.14	5	164388	11	70764040
Radiation necrosis	19.55	12.14	12	164381	392	70763659
Post thrombotic syndrome	19.49	12.14	14	164379	597	70763454
Oesophageal stenosis	19.43	12.14	34	164359	3970	70760081
Pulmonary artery stenosis	19.41	12.14	8	164385	108	70763943
Lung adenocarcinoma	19.40	12.14	50	164343	7640	70756411
Device malfunction	19.37	12.14	10	164383	19074	70744977
Infectious pleural effusion	19.31	12.14	30	164363	3174	70760877
Gastroenteritis viral	19.29	12.14	13	164380	21442	70742609
Biliary obstruction	19.29	12.14	34	164359	3993	70760058
Renal failure	19.27	12.14	315	164078	188755	70575296
Cholangitis infective	19.24	12.14	13	164380	502	70763549
Carbohydrate antigen 19-9 increased	19.20	12.14	12	164381	405	70763646
Dysstasia	19.19	12.14	18	164375	25161	70738890
Joint effusion	19.15	12.14	6	164387	15471	70748580
Hypermetabolism	19.12	12.14	11	164382	318	70763733
Guillain-Barre syndrome	18.99	12.14	51	164342	7989	70756062
Immediate post-injection reaction	18.97	12.14	11	164382	323	70763728
Dyspnoea at rest	18.95	12.14	46	164347	6773	70757278
Lymphatic disorder	18.94	12.14	11	164382	324	70763727
Cholelithiasis	18.90	12.14	52	164341	47288	70716763
Musculoskeletal pain	18.90	12.14	127	164266	90200	70673851
Haematochezia	18.89	12.14	96	164297	72985	70691066
Disturbance in attention	18.76	12.14	45	164348	42849	70721202
Carpal tunnel syndrome	18.76	12.14	8	164385	17049	70747002
Emphysematous cystitis	18.69	12.14	10	164383	250	70763801
Angiodermatitis	18.69	12.14	7	164386	72	70763979
Swelling face	18.68	12.14	79	164314	63085	70700966
Photophobia	18.59	12.14	10	164383	18640	70745411
Muscle rigidity	18.59	12.14	10	164383	18640	70745411
Cardiac murmur	18.52	12.14	3	164390	12183	70751868
Pain in jaw	18.47	12.14	45	164348	42624	70721427
Epstein-Barr virus infection	18.45	12.14	4	164389	13194	70750857
Ill-defined disorder	18.41	12.14	65	164328	54676	70709375
Tumour ulceration	18.38	12.14	9	164384	186	70763865
Transaminases	18.35	12.14	7	164386	76	70763975
Depressed level of consciousness	18.25	12.14	123	164270	87308	70676743
Dementia	18.24	12.14	15	164378	22350	70741701
HER2 positive breast cancer	18.18	12.14	11	164382	350	70763701
Laryngeal discomfort	18.11	12.14	13	164380	554	70763497
Pneumonitis chemical	18.09	12.14	11	164382	353	70763698
Immune-mediated encephalitis	18.06	12.14	11	164382	354	70763697
Scar	18.06	12.14	5	164388	13976	70750075
Immune reconstitution inflammatory syndrome	18.04	12.14	4	164389	12986	70751065
Gastroenteritis radiation	18.03	12.14	14	164379	673	70763378
Thyroiditis	17.96	12.14	33	164360	4003	70760048
Hypothalamo-pituitary disorder	17.87	12.14	17	164376	1078	70762973
Loss of consciousness	17.83	12.14	480	163913	155236	70608815
Torsade de pointes	17.64	12.14	10	164383	18106	70745945
Lung adenocarcinoma stage IV	17.60	12.14	11	164382	371	70763680
Venous thrombosis	17.58	12.14	44	164349	6605	70757446
Blood glucose decreased	17.57	12.14	18	164375	24141	70739910
Empyema	17.57	12.14	32	164361	3855	70760196
Sputum discoloured	17.52	12.14	11	164382	18840	70745211
Breast sarcoma	17.52	12.14	4	164389	4	70764047
Maternal death affecting foetus	17.52	12.14	4	164389	4	70764047
Gene mutation	17.51	12.14	24	164369	2267	70761784
Product supply issue	17.46	12.14	20	164373	1575	70762476
Atrioventricular block first degree	17.46	12.14	3	164390	11670	70752381
Liver scan abnormal	17.46	12.14	6	164387	47	70764004
Vulvovaginal inflammation	17.38	12.14	12	164381	480	70763571
Taste disorder	17.36	12.14	62	164331	11323	70752728
Product storage error	17.35	12.14	6	164387	14535	70749516
Blood pressure immeasurable	17.32	12.14	22	164371	1930	70762121
Haematoma	17.30	12.14	56	164337	48362	70715689
Chemotherapy	17.25	12.14	20	164373	1596	70762455
Lymphadenopathy	17.23	12.14	181	164212	48610	70715441
Sciatica	17.18	12.14	19	164374	24608	70739443
Blast cells present	17.15	12.14	15	164378	853	70763198
Hypophysitis	17.07	12.14	31	164362	3727	70760324
Hypophagia	17.01	12.14	159	164234	41411	70722640
Non-small cell lung cancer stage IV	16.99	12.14	10	164383	302	70763749
Tumour cavitation	16.97	12.14	5	164388	22	70764029
Breast ulceration	16.93	12.14	6	164387	52	70763999
Portal vein thrombosis	16.90	12.14	38	164355	5324	70758727
Neutrophil count abnormal	16.87	12.14	28	164365	3133	70760918
Product quality issue	16.85	12.14	28	164365	30533	70733518
Glomerular vascular disorder	16.85	12.14	8	164385	154	70763897
Pulmonary hypoplasia	16.83	12.14	6	164387	53	70763998
Plethoric face	16.79	12.14	5	164388	23	70764028
Ulcer	16.76	12.14	21	164372	25733	70738318
Non-small cell lung cancer recurrent	16.76	12.14	7	164386	98	70763953
Choriocarcinoma	16.71	12.14	8	164385	157	70763894
Pulmonary vein stenosis	16.71	12.14	8	164385	157	70763894
Obstruction gastric	16.71	12.14	19	164374	1485	70762566
Schizophrenia	16.70	12.14	9	164384	16759	70747292
Hepatic vein thrombosis	16.61	12.14	9	164384	231	70763820
Respiratory failure	16.53	12.14	510	163883	168225	70595826
End stage renal disease	16.35	12.14	3	164390	11130	70752921
Double hit lymphoma	16.35	12.14	6	164387	58	70763993
Hernia	16.29	12.14	7	164386	14853	70749198
Obstructive airways disorder	16.26	12.14	22	164371	26091	70737960
Angiosarcoma metastatic	16.26	12.14	6	164387	59	70763992
Hypercholesterolaemia	16.26	12.14	11	164382	18106	70745945
Lung squamous cell carcinoma metastatic	16.26	12.14	6	164387	59	70763992
Vaginal cuff dehiscence	16.25	12.14	4	164389	7	70764044
Influenza like illness	16.22	12.14	87	164306	65244	70698807
Discontinued product administered	16.17	12.14	6	164387	60	70763991
Protein urine	16.13	12.14	18	164375	1378	70762673
Bladder cancer	16.11	12.14	10	164383	17232	70746819
Dermatitis	16.02	12.14	88	164305	19329	70744722
Mania	15.99	12.14	10	164383	17164	70746887
Acute respiratory distress syndrome	15.99	12.14	156	164237	41098	70722953
Apathy	15.88	12.14	4	164389	11904	70752147
Lymphoma	15.84	12.14	8	164385	15454	70748597
TP53 gene mutation	15.83	12.14	5	164388	29	70764022
Brachydactyly	15.83	12.14	5	164388	29	70764022
Keratitis	15.82	12.14	30	164363	3727	70760324
Pancreatitis	15.81	12.14	83	164310	62585	70701466
Cognitive disorder	15.79	12.14	80	164313	60876	70703175
Arteriosclerosis coronary artery	15.72	12.14	9	164384	16206	70747845
Renal cancer	15.65	12.14	4	164389	11792	70752259
Onychalgia	15.62	12.14	14	164379	822	70763229
Blood magnesium decreased	15.59	12.14	72	164321	14769	70749282
Campylobacter test positive	15.58	12.14	6	164387	67	70763984
Median nerve injury	15.55	12.14	5	164388	31	70764020
Progressive multifocal leukoencephalopathy	15.53	12.14	13	164380	19201	70744850
Arrhythmia	15.52	12.14	72	164321	56071	70707980
Immune-mediated hypothyroidism	15.52	12.14	10	164383	356	70763695
Prescribed underdose	15.48	12.14	16	164377	21369	70742682
Miller Fisher syndrome	15.44	12.14	8	164385	187	70763864
Depressed mood	15.44	12.14	51	164342	43769	70720282
Tidal volume decreased	15.42	12.14	6	164387	69	70763982
Laryngeal cancer stage III	15.41	12.14	5	164388	32	70764019
Dysentery	15.41	12.14	15	164378	979	70763072
Intestinal ischaemia	15.34	12.14	62	164331	12002	70752049
Bone erosion	15.32	12.14	8	164385	15165	70748886
Ecchymosis	15.32	12.14	7	164386	14325	70749726
Coagulopathy	15.25	12.14	34	164359	33215	70730836
Radiation pericarditis	15.21	12.14	3	164390	0	70764051
Ankyloglossia acquired	15.21	12.14	3	164390	0	70764051
Therapy non-responder	15.17	12.14	110	164283	76805	70687246
Adenocarcinoma of appendix	15.12	12.14	6	164387	73	70763978
Immune-mediated cholangitis	15.07	12.14	7	164386	128	70763923
Clonal haematopoiesis	15.03	12.14	5	164388	35	70764016
Blood pressure diastolic increased	14.98	12.14	5	164388	12386	70751665
Fatigue	14.95	12.14	2153	162240	822166	69941885
Pneumothorax spontaneous	14.87	12.14	17	164376	1336	70762715
Metastases to ovary	14.83	12.14	9	164384	288	70763763
Duodenal obstruction	14.82	12.14	10	164383	385	70763666
Blood creatinine decreased	14.79	12.14	44	164349	7305	70756746
Pneumoperitoneum	14.76	12.14	25	164368	2844	70761207
Pollakiuria	14.71	12.14	35	164358	33426	70730625
Fistula	14.70	12.14	57	164336	10824	70753227
Osteolysis	14.69	12.14	28	164365	3491	70760560
Uterine adhesions	14.68	12.14	5	164388	38	70764013
Hypotension	14.61	12.14	1107	163286	403274	70360777
Brachiocephalic vein thrombosis	14.60	12.14	8	164385	210	70763841
Hypercalcaemia of malignancy	14.53	12.14	10	164383	398	70763653
Invasive lobular breast carcinoma	14.51	12.14	12	164381	632	70763419
Glomerular filtration rate decreased	14.50	12.14	16	164377	20740	70743311
Metastases to abdominal wall	14.45	12.14	7	164386	141	70763910
Diverticulitis	14.41	12.14	49	164344	41685	70722366
Endometrial cancer metastatic	14.35	12.14	5	164388	41	70764010
Cannabinoid hyperemesis syndrome	14.35	12.14	5	164388	41	70764010
Thinking abnormal	14.33	12.14	5	164388	12046	70752005
Secretion discharge	14.33	12.14	6	164387	12927	70751124
Odynophagia	14.32	12.14	54	164339	10121	70753930
Metastatic malignant melanoma	14.24	12.14	26	164367	3138	70760913
Ankle fracture	14.20	12.14	9	164384	15335	70748716
Diverticulum	14.16	12.14	7	164386	13686	70750365
Carbohydrate antigen 15-3	14.11	12.14	6	164387	88	70763963
Superinfection bacterial	14.09	12.14	16	164377	1248	70762803
Frequent bowel movements	14.02	12.14	17	164376	21136	70742915
Intentional product use issue	14.01	12.14	195	164198	119947	70644104
Lung infiltration	14.00	12.14	92	164301	21532	70742519
Peritoneal disorder	14.00	12.14	12	164381	664	70763387
Meibomian gland dysfunction	13.98	12.14	7	164386	152	70763899
Needle issue	13.92	12.14	4	164389	10911	70753140
Ovarian cancer stage III	13.92	12.14	8	164385	231	70763820
Breast cellulitis	13.90	12.14	9	164384	323	70763728
Pseudocyst	13.90	12.14	9	164384	323	70763728
Steatorrhoea	13.90	12.14	13	164380	807	70763244
Pulmonary hypertension	13.88	12.14	58	164335	46478	70717573
Hypergeusia	13.88	12.14	4	164389	16	70764035
Skin cancer	13.87	12.14	7	164386	13529	70750522
Carcinoembryonic antigen	13.87	12.14	6	164387	92	70763959
Coronary artery occlusion	13.85	12.14	8	164385	14337	70749714
Post procedural fistula	13.85	12.14	8	164385	233	70763818
Vascular pseudoaneurysm ruptured	13.81	12.14	7	164386	156	70763895
Vision blurred	13.80	12.14	147	164246	94837	70669214
Haemodialysis	13.73	12.14	12	164381	17354	70746697
Lymphocele	13.72	12.14	18	164375	1631	70762420
Subclavian artery occlusion	13.69	12.14	7	164386	159	70763892
Metastases to vagina	13.68	12.14	4	164389	17	70764034
Ear pain	13.68	12.14	27	164366	27572	70736479
Electrocardiogram QRS complex prolonged	13.65	12.14	3	164390	9803	70754248
Dandy-Walker syndrome	13.65	12.14	5	164388	48	70764003
Pulmonary artery occlusion	13.65	12.14	5	164388	48	70764003
Xeroderma	13.58	12.14	8	164385	242	70763809
Renal disorder	13.56	12.14	44	164349	37965	70726086
Rhinorrhoea	13.54	12.14	94	164299	66277	70697774
Tumour hyperprogression	13.54	12.14	7	164386	163	70763888
Upper-airway cough syndrome	13.50	12.14	3	164390	9728	70754323
Vitamin D deficiency	13.50	12.14	6	164387	12481	70751570
Bladder necrosis	13.50	12.14	4	164389	18	70764033
Aortic dissection rupture	13.50	12.14	4	164389	18	70764033
Porokeratosis	13.43	12.14	8	164385	247	70763804
Mucosal infection	13.39	12.14	10	164383	453	70763598
Increased tendency to bruise	13.39	12.14	3	164390	9672	70754379
Laryngeal oedema	13.35	12.14	43	164350	7452	70756599
Uveitis	13.34	12.14	9	164384	14836	70749215
Lupus-like syndrome	13.32	12.14	5	164388	11510	70752541
Abnormal dreams	13.31	12.14	4	164389	10599	70753452
Systemic toxicity	13.31	12.14	6	164387	102	70763949
Acute pulmonary oedema	13.31	12.14	64	164329	13348	70750703
Cardiac failure	13.30	12.14	431	163962	143110	70620941
Eye irritation	13.23	12.14	13	164380	17775	70746276
Productive cough	13.16	12.14	117	164276	78220	70685831
Acquired amegakaryocytic thrombocytopenia	13.16	12.14	4	164389	20	70764031
Blood glucose abnormal	13.15	12.14	3	164390	9554	70754497
Toxic neuropathy	13.14	12.14	13	164380	865	70763186
Neoplasm	13.14	12.14	44	164349	7780	70756271
Vaginal perforation	13.14	12.14	3	164390	3	70764048
Ulcerated haemangioma	13.14	12.14	3	164390	3	70764048
Peritoneal lesion	13.14	12.14	3	164390	3	70764048
Breast prosthesis removal	13.14	12.14	3	164390	3	70764048
Type 1 lepra reaction	13.13	12.14	5	164388	54	70763997
Tumour perforation	13.10	12.14	9	164384	357	70763694
Restless legs syndrome	13.10	12.14	14	164379	18414	70745637
Diabetic ketoacidosis	13.05	12.14	34	164359	31478	70732573
Tumour invasion	13.04	12.14	9	164384	360	70763691
Ototoxicity	13.03	12.14	24	164369	2917	70761134
Generalised tonic-clonic seizure	13.01	12.14	51	164342	41610	70722441
Portal venous gas	12.97	12.14	9	164384	363	70763688
Obstructive shock	12.97	12.14	5	164388	56	70763995
Immune-mediated renal disorder	12.85	12.14	6	164387	111	70763940
Mediastinal fibrosis	12.84	12.14	4	164389	22	70764029
Pulpitis dental	12.83	12.14	14	164379	1045	70763006
Cholecystitis chronic	12.79	12.14	3	164390	9373	70754678
CSF white blood cell count decreased	12.69	12.14	4	164389	23	70764028
Blood loss anaemia	12.65	12.14	9	164384	14432	70749619
Metastases to adrenals	12.64	12.14	15	164378	1227	70762824
Infusion site hypersensitivity	12.55	12.14	4	164389	24	70764027
Haemolytic anaemia	12.47	12.14	74	164319	16720	70747331
Thrombotic thrombocytopenic purpura	12.45	12.14	37	164356	6140	70757911
Thrombocytosis	12.39	12.14	43	164350	7741	70756310
Injection site induration	12.38	12.14	3	164390	9165	70754886
Stent malfunction	12.30	12.14	5	164388	65	70763986
Larynx irritation	12.29	12.14	6	164387	123	70763928
Hereditary motor and sensory neuropathy	12.29	12.14	6	164387	123	70763928
Radiation dysphagia	12.28	12.14	3	164390	5	70764046
Organising pneumonia	12.26	12.14	51	164342	9999	70754052
Poor venous access	12.26	12.14	10	164383	14961	70749090
Nasal disorder	12.19	12.14	25	164368	3289	70760762
Blood alkaline phosphatase increased	12.17	12.14	197	164196	58324	70705727
Jugular vein thrombosis	12.17	12.14	28	164365	3982	70760069
Metastases to uterus	12.17	12.14	5	164388	67	70763984
Lung squamous cell carcinoma stage III	12.15	12.14	4	164389	27	70764024

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01CD01	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS PLANT ALKALOIDS AND OTHER NATURAL PRODUCTS Taxanes
FDA PE	N0000175085	Microtubule Inhibition
FDA EPC	N0000175592	Microtubule Inhibitor
MeSH PA	D000970	Antineoplastic Agents
CHEBI has role	CHEBI:25212	metabolites
CHEBI has role	CHEBI:35610	antineoplastic agents
CHEBI has role	CHEBI:61950	microtubule stabilizing role
CHEBI has role	CHEBI:77746	Homo sapiens metabolite
MeSH PA	D050256	Antimitotic Agents
MeSH PA	D000972	Antineoplastic Agents, Phytogenic
MeSH PA	D050257	Tubulin Modulators

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

Disease	Relation	SNOMED_ID	DOID
Ocular hypertension	indication	4210003	DOID:9282
Hypertensive disorder	indication	38341003	DOID:10763
Open-angle glaucoma	indication	84494001	DOID:1067
Secondary malignant neoplasm of pancreas	indication	94459006
Kaposi's sarcoma	indication	109385007
Non-small cell lung cancer	indication	254637007	DOID:3908
Carcinoma of breast	indication	254838004	DOID:3459
Carcinoma of fallopian tube	indication	276870001	DOID:1963
Malignant tumor of ovary	indication	363443007	DOID:2394
Malignant tumor of peritoneum	indication	363492001
Metastatic Breast Carcinoma	indication
Malignant glaucoma	off-label use	10100008
Aphakic glaucoma	off-label use	15374009
Secondary glaucoma	off-label use	95717004
Neoplasm of esophagus	off-label use	126817006	DOID:5041
Small cell carcinoma of lung	off-label use	254632001	DOID:5409
Endometrial carcinoma	off-label use	254878006	DOID:2871
Malignant tumor of head and/or neck	off-label use	255056009
Malignant tumor of cervix	off-label use	363354003	DOID:4362
Malignant tumor of testis	off-label use	363449006	DOID:2998
Malignant tumor of urinary bladder	off-label use	399326009	DOID:11054
Bronchospasm	contraindication	4386001
Psoriasis	contraindication	9014002	DOID:8893
Hyperbilirubinemia	contraindication	14783006	DOID:2741
Myocardial infarction	contraindication	22298006	DOID:5844
Complete atrioventricular block	contraindication	27885002
Acute cerebrovascular insufficiency	contraindication	29322000
Depressive disorder	contraindication	35489007
Anaphylaxis	contraindication	39579001
Conduction disorder of the heart	contraindication	44808001
Low blood pressure	contraindication	45007003
Chronic heart failure	contraindication	48447003
Bradycardia	contraindication	48867003
Sinus bradycardia	contraindication	49710005
Acute nephropathy	contraindication	58574008
Acute infectious disease	contraindication	63171007
Diabetes mellitus	contraindication	73211009	DOID:9351
Pulmonary emphysema	contraindication	87433001
Cardiogenic shock	contraindication	89138009
Kidney disease	contraindication	90708001	DOID:557
Myasthenia gravis	contraindication	91637004	DOID:437
Liver function tests abnormal	contraindication	166603001
Second degree atrioventricular block	contraindication	195042002
Decompensated cardiac failure	contraindication	195111005
Asthma	contraindication	195967001	DOID:2841
Heart block	contraindication	233916004
Disease of liver	contraindication	235856003	DOID:409
Hypoglycemic disorder	contraindication	237630007
Raynaud's phenomenon	contraindication	266261006
Anemia	contraindication	271737000	DOID:2355
Pregnancy, function	contraindication	289908002
Thrombocytopenic disorder	contraindication	302215000	DOID:1588
Peripheral nerve disease	contraindication	302226006
Pheochromocytoma	contraindication	302835009
Neutropenic disorder	contraindication	303011007	DOID:1227
Bone marrow depression	contraindication	307762000
Breastfeeding (mother)	contraindication	413712001
Acute exacerbation of asthma	contraindication	708038006

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	11.47	acidic
pKa2	12.08	acidic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
100MG/VIAL	ABRAXANE	ABRAXIS BIOSCIENCE	N021660	Jan. 7, 2005	RX	POWDER	INTRAVENOUS	7923536	Dec. 9, 2023	TREATMENT OF BREAST CANCER
100MG/VIAL	ABRAXANE	ABRAXIS BIOSCIENCE	N021660	Jan. 7, 2005	RX	POWDER	INTRAVENOUS	7923536	Dec. 9, 2023	TREATMENT OF LUNG CANCER
100MG/VIAL	ABRAXANE	ABRAXIS BIOSCIENCE	N021660	Jan. 7, 2005	RX	POWDER	INTRAVENOUS	7923536	Dec. 9, 2023	TREATMENT OF PANCREATIC CANCER
100MG/VIAL	ABRAXANE	ABRAXIS BIOSCIENCE	N021660	Jan. 7, 2005	RX	POWDER	INTRAVENOUS	8138229	Dec. 9, 2023	TREATMENT OF BREAST CANCER
100MG/VIAL	ABRAXANE	ABRAXIS BIOSCIENCE	N021660	Jan. 7, 2005	RX	POWDER	INTRAVENOUS	8138229	Dec. 9, 2023	TREATMENT OF LUNG CANCER
100MG/VIAL	ABRAXANE	ABRAXIS BIOSCIENCE	N021660	Jan. 7, 2005	RX	POWDER	INTRAVENOUS	8138229	Dec. 9, 2023	TREATMENT OF PANCREATIC CANCER
100MG/VIAL	ABRAXANE	ABRAXIS BIOSCIENCE	N021660	Jan. 7, 2005	RX	POWDER	INTRAVENOUS	8314156	Dec. 9, 2023	TREATMENT OF LUNG CANCER
100MG/VIAL	ABRAXANE	ABRAXIS BIOSCIENCE	N021660	Jan. 7, 2005	RX	POWDER	INTRAVENOUS	8314156	Dec. 9, 2023	TREATMENT OF PANCREATIC CANCER
100MG/VIAL	ABRAXANE	ABRAXIS BIOSCIENCE	N021660	Jan. 7, 2005	RX	POWDER	INTRAVENOUS	7820788	Oct. 27, 2024	TREATMENT OF BREAST CANCER
100MG/VIAL	ABRAXANE	ABRAXIS BIOSCIENCE	N021660	Jan. 7, 2005	RX	POWDER	INTRAVENOUS	7820788	Oct. 27, 2024	TREATMENT OF LUNG CANCER
100MG/VIAL	ABRAXANE	ABRAXIS BIOSCIENCE	N021660	Jan. 7, 2005	RX	POWDER	INTRAVENOUS	7820788	Oct. 27, 2024	TREATMENT OF PANCREATIC CANCER
100MG/VIAL	ABRAXANE	ABRAXIS BIOSCIENCE	N021660	Jan. 7, 2005	RX	POWDER	INTRAVENOUS	7758891	Feb. 21, 2026	TREATMENT OF PANCREATIC CANCER
100MG/VIAL	ABRAXANE	ABRAXIS BIOSCIENCE	N021660	Jan. 7, 2005	RX	POWDER	INTRAVENOUS	8268348	Feb. 21, 2026	TREATMENT OF LUNG CANCER
100MG/VIAL	ABRAXANE	ABRAXIS BIOSCIENCE	N021660	Jan. 7, 2005	RX	POWDER	INTRAVENOUS	9101543	Feb. 21, 2026	TREATMENT OF PANCREATIC CANCER
100MG/VIAL	ABRAXANE	ABRAXIS BIOSCIENCE	N021660	Jan. 7, 2005	RX	POWDER	INTRAVENOUS	8034375	Aug. 13, 2026	TREATMENT OF LUNG CANCER
100MG/VIAL	ABRAXANE	ABRAXIS BIOSCIENCE	N021660	Jan. 7, 2005	RX	POWDER	INTRAVENOUS	9393318	March 4, 2032	TREATMENT OF LUNG CANCER
100MG/VIAL	ABRAXANE	ABRAXIS BIOSCIENCE	N021660	Jan. 7, 2005	RX	POWDER	INTRAVENOUS	9597409	March 4, 2032	TREATMENT OF LUNG CANCER
100MG/VIAL	ABRAXANE	ABRAXIS BIOSCIENCE	N021660	Jan. 7, 2005	RX	POWDER	INTRAVENOUS	9511046	Jan. 12, 2034	TREATMENT OF PANCREATIC CANCER

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
100MG/VIAL	ABRAXANE	ABRAXIS BIOSCIENCE	N021660	Jan. 7, 2005	RX	POWDER	INTRAVENOUS	Dec. 6, 2022	ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
100MG/VIAL	ABRAXANE	ABRAXIS BIOSCIENCE	N021660	Jan. 7, 2005	RX	POWDER	INTRAVENOUS	June 6, 2023	PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Tubulin beta	Tumour-associated antigen	P07437 Q9H4B7 Q13885 Q9BVA1 Q13509 P04350 P68371 Q9BUF5 Q3ZCM7	TBB5_HUMAN TBB1_HUMAN TBB2A_HUMAN TBB2B_HUMAN TBB3_HUMAN TBB4A_HUMAN TBB4B_HUMAN TBB6_HUMAN TBB8_HUMAN	INHIBITOR	EC50	8.05	IUPHAR	SCIENTIFIC LITERATURE
Nuclear receptor subfamily 1 group I member 2	Nuclear hormone receptor	O75469	NR1I2_HUMAN	AGONIST	EC50	5.30	IUPHAR
Delta-type opioid receptor	GPCR	P41143	OPRD_HUMAN		Ki	5.83	DRUG MATRIX
Bile salt export pump	Transporter	O95342	ABCBB_HUMAN				WOMBAT-PK
Multidrug resistance-associated protein 7	Transporter	Q5T3U5	MRP7_HUMAN				WOMBAT-PK
Tubulin beta chain	Structural	P07437	TBB5_HUMAN	INHIBITOR	EC50	8.05	IUPHAR
Tyrosine-protein kinase Fyn	Kinase	P06241	FYN_HUMAN		IC50	4.62	DRUG MATRIX
Receptor tyrosine-protein kinase erbB-2	Kinase	P04626	ERBB2_HUMAN		IC50	4.95	DRUG MATRIX
Multidrug resistance protein 1	Transporter	P08183	MDR1_HUMAN		IC50	5.59	CHEMBL
Substance-K receptor	GPCR	P21452	NK2R_HUMAN		Ki	5.69	DRUG MATRIX
Melanocortin receptor 5	GPCR	P33032	MC5R_HUMAN		Ki	4.79	DRUG MATRIX
Tyrosine-protein kinase Mer	Kinase	Q12866	MERTK_HUMAN		IC50	5.31	CHEMBL
Tubulin beta-3 chain	Structural	Q13509	TBB3_HUMAN		IC50	8.11	CHEMBL
Nucleotide-binding oligomerization domain-containing protein 2	Cytosolic other	Q9HC29	NOD2_HUMAN		IC50	5.10	CHEMBL
Cholecystokinin receptor type A	GPCR	P32238	CCKAR_HUMAN		Ki	5.64	DRUG MATRIX
Botulinum neurotoxin type A	Enzyme		BXA1_CLOBO		IC50	5.28	CHEMBL

External reference:

ID	Source
4020736	VUID
N0000148314	NUI
D00491	KEGG_DRUG
4020736	VANDF
C0144576	UMLSCUI
CHEBI:45863	CHEBI
TA1	PDB_CHEM_ID
CHEMBL428647	ChEMBL_ID
D017239	MESH_DESCRIPTOR_UI
DB01229	DRUGBANK_ID
2770	IUPHAR_LIGAND_ID
7052	INN_ID
P88XT4IS4D	UNII
36314	PUBCHEM_CID
196466	RXNORM
2296	MMSL
42243	MMSL
5224	MMSL
64289	MMSL
d01376	MMSL
004116	NDDF
387374002	SNOMEDCT_US
67735003	SNOMEDCT_US
D000068196	MESH_DESCRIPTOR_UI

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0703-3213	INJECTION, SOLUTION, CONCENTRATE	6 mg	INTRAVENOUS	ANDA	16 sections
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0703-3213	INJECTION, SOLUTION, CONCENTRATE	6 mg	INTRAVENOUS	ANDA	16 sections
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0703-3216	INJECTION, SOLUTION, CONCENTRATE	6 mg	INTRAVENOUS	ANDA	16 sections
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0703-3216	INJECTION, SOLUTION, CONCENTRATE	6 mg	INTRAVENOUS	ANDA	16 sections
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0703-3217	INJECTION, SOLUTION, CONCENTRATE	6 mg	INTRAVENOUS	ANDA	16 sections
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0703-3218	INJECTION, SOLUTION, CONCENTRATE	6 mg	INTRAVENOUS	ANDA	16 sections
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0703-3218	INJECTION, SOLUTION, CONCENTRATE	6 mg	INTRAVENOUS	ANDA	16 sections
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0703-4764	INJECTION, SOLUTION, CONCENTRATE	6 mg	INTRAVENOUS	ANDA	16 sections
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0703-4768	INJECTION, SOLUTION, CONCENTRATE	6 mg	INTRAVENOUS	ANDA	16 sections
Paclitaxel	Human Prescription Drug Label	1	16714-137	INJECTION, SOLUTION	6 mg	INTRAVENOUS	ANDA	21 sections
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	16729-098	INJECTION, SOLUTION	6 mg	INTRAVENOUS	ANDA	16 sections
Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound)	HUMAN PRESCRIPTION DRUG LABEL	1	24979-710	INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION	100 mg	INTRAVENOUS	NDA authorized generic	32 sections
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	44567-504	INJECTION	6 mg	INTRAVENOUS	NDA	22 sections
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	44567-505	INJECTION	6 mg	INTRAVENOUS	NDA	22 sections
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	44567-506	INJECTION	6 mg	INTRAVENOUS	NDA	22 sections
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	45963-613	INJECTION, SOLUTION	6 mg	INTRAVENOUS	ANDA	16 sections
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	47781-593	INJECTION, SOLUTION	30 mg	INTRAVENOUS	ANDA	24 sections
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	47781-593	INJECTION, SOLUTION	30 mg	INTRAVENOUS	ANDA	24 sections
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	47781-594	INJECTION, SOLUTION	100 mg	INTRAVENOUS	ANDA	24 sections
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	47781-594	INJECTION, SOLUTION	100 mg	INTRAVENOUS	ANDA	24 sections
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	47781-595	INJECTION, SOLUTION	300 mg	INTRAVENOUS	ANDA	24 sections
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	47781-595	INJECTION, SOLUTION	300 mg	INTRAVENOUS	ANDA	24 sections
Paclitaxel protein-bound particles for injectable suspension (albumin-bound)	HUMAN PRESCRIPTION DRUG LABEL	1	60505-6230	INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION	100 mg	INTRAVENOUS	NDA authorized generic	32 sections
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	61703-342	INJECTION, SOLUTION	6 mg	INTRAVENOUS	ANDA	16 sections
Paclitaxel	Human Prescription Drug Label	1	62332-620	INJECTION	6 mg	INTRAVENOUS	ANDA	21 sections
Paclitaxel	Human Prescription Drug Label	1	62332-621	INJECTION	6 mg	INTRAVENOUS	ANDA	21 sections
Paclitaxel	Human Prescription Drug Label	1	62332-622	INJECTION	6 mg	INTRAVENOUS	ANDA	21 sections
Paclitaxel	Human Prescription Drug Label	1	63323-763	INJECTION, SOLUTION	6 mg	INTRAVENOUS	ANDA	21 sections
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	68001-516	INJECTION, SOLUTION	6 mg	INTRAVENOUS	ANDA	21 sections
PACLITAXELPACLITAXEL	Human Prescription Drug Label	1	68083-178	INJECTION, SOLUTION	6 mg	INTRAVENOUS	ANDA	19 sections