docetaxel Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
antineoplastics, taxane derivatives	939	114977-28-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: docetaxel hydrate docetaxel docetaxol docetere taxotel taxotere docetaxel anhydrous RP 56976 RP-56976	A semisynthetic analog of PACLITAXEL used in the treatment of locally advanced or metastatic BREAST NEOPLASMS and NON-SMALL CELL LUNG CANCER. Molecular weight: 807.89 Formula: C43H53NO14 CLOGP: 4.08 LIPINSKI: 2 HAC: 15 HDO: 5 TPSA: 224.45 ALOGS: -4.80 ROTB: 13 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
S (Water solubility)	0.01 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	5 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.15 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	0 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	2.10 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	14 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.04 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	11 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
May 14, 1996	FDA	SANOFI AVENTIS US

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
Febrile neutropenia	1742.87	12.48	1429	85811	93198	46505624
Neutropenia	1351.56	12.48	1494	85746	141710	46457112
Palmar-plantar erythrodysaesthesia syndrome	1095.00	12.48	601	86639	19850	46578972
Mucosal inflammation	769.46	12.48	614	86626	38362	46560460
Malignant neoplasm progression	769.24	12.48	766	86474	64160	46534662
Diarrhoea	701.83	12.48	2460	84780	557142	46041680
Disease progression	662.59	12.48	834	86406	90466	46508356
Ejection fraction decreased	653.51	12.48	411	86829	17526	46581296
Metastases to bone	566.34	12.48	372	86868	17104	46581718
Bone marrow failure	561.23	12.48	456	86784	29213	46569609
Metastases to liver	548.89	12.48	381	86859	19204	46579618
Drug ineffective	436.13	12.48	378	86862	677460	45921362
Rheumatoid arthritis	427.14	12.48	4	87236	240211	46358611
Neuropathy peripheral	407.07	12.48	660	86580	90233	46508589
Metastases to central nervous system	349.30	12.48	233	87007	10988	46587834
Metastases to lung	320.71	12.48	217	87023	10479	46588343
Neutropenic sepsis	306.56	12.48	223	87017	12101	46586721
Stomatitis	301.64	12.48	493	86747	67804	46531018
Skin toxicity	265.87	12.48	132	87108	3522	46595300
Fall	258.85	12.48	147	87093	328950	46269872
Cardiotoxicity	257.27	12.48	159	87081	6563	46592259
Pleural effusion	254.30	12.48	511	86729	82441	46516381
Breast cancer metastatic	249.64	12.48	206	87034	13472	46585350
Completed suicide	248.09	12.48	5	87235	145915	46452907
Polyneuropathy	243.65	12.48	190	87050	11454	46587368
Metastases to lymph nodes	234.06	12.48	149	87091	6482	46592340
Leukopenia	228.85	12.48	437	86803	67906	46530916
Bone pain	217.21	12.48	346	86894	46544	46552278
Drug hypersensitivity	206.23	12.48	99	87141	243726	46355096
Onycholysis	201.87	12.48	78	87162	1110	46597712
Product dose omission issue	196.99	12.48	38	87202	168482	46430340
Pyrexia	196.56	12.48	1217	86023	347585	46251237
Agranulocytosis	195.54	12.48	224	87016	21961	46576861
Breast cancer	194.71	12.48	324	86916	45194	46553628
Colitis	187.47	12.48	286	86954	37061	46561761
Acute myeloid leukaemia	186.22	12.48	186	87054	15592	46583230
Peripheral sensory neuropathy	186.19	12.48	129	87111	6474	46592348
Myelosuppression	183.91	12.48	136	87104	7567	46591255
Neutropenic colitis	181.50	12.48	87	87153	2145	46596677
Joint swelling	176.92	12.48	46	87194	166027	46432795
Breast cancer recurrent	176.87	12.48	103	87137	3808	46595014
Neoplasm progression	170.15	12.48	229	87011	26454	46572368
Condition aggravated	152.59	12.48	140	87100	244912	46353910
Haematotoxicity	151.30	12.48	116	87124	6817	46592005
Somnolence	151.00	12.48	52	87188	156469	46442353
Erythema	150.35	12.48	596	86644	142224	46456598
Injection site pain	146.56	12.48	15	87225	107137	46491685
Metastasis	145.03	12.48	94	87146	4218	46594604
Metastases to skin	144.14	12.48	64	87176	1316	46597506
Interstitial lung disease	139.29	12.48	310	86930	53639	46545183
Nail disorder	138.01	12.48	116	87124	7780	46591042
Skin exfoliation	136.23	12.48	231	87009	32707	46566115
Neutrophil count decreased	135.93	12.48	270	86970	43156	46555666
Neutropenic infection	135.89	12.48	58	87182	1080	46597742
Vomiting	135.49	12.48	1365	85875	451429	46147393
Flushing	135.10	12.48	342	86898	64272	46534550
Left ventricular dysfunction	132.41	12.48	127	87113	10128	46588694
Gastrointestinal toxicity	130.13	12.48	88	87152	4243	46594579
Dehydration	126.86	12.48	612	86628	158928	46439894
Headache	126.71	12.48	464	86776	477888	46120934
Osteonecrosis	124.75	12.48	194	87046	25550	46573272
Therapeutic product effect decreased	122.80	12.48	8	87232	82593	46516229
Second primary malignancy	121.88	12.48	100	87140	6484	46592338
Overdose	121.23	12.48	22	87218	101957	46496865
Contraindicated product administered	118.09	12.48	8	87232	79939	46518883
Aortitis	117.64	12.48	46	87194	677	46598145
Lymphoedema	117.58	12.48	110	87130	8502	46590320
Nail toxicity	116.60	12.48	38	87202	316	46598506
Decreased appetite	113.65	12.48	684	86556	193152	46405670
Sinusitis	110.63	12.48	52	87188	129716	46469106
Capillary leak syndrome	110.47	12.48	59	87181	1838	46596984
Alopecia	106.17	12.48	590	86650	161824	46436998
Drug abuse	104.54	12.48	3	87237	63405	46535417
Recall phenomenon	101.96	12.48	39	87201	539	46598283
Neurotoxicity	101.93	12.48	127	87113	13590	46585232
Lacrimation increased	99.39	12.48	135	87105	15726	46583096
Pneumonitis	96.61	12.48	183	87057	28237	46570585
Injection site erythema	95.36	12.48	13	87227	74414	46524408
Lymphangiosis carcinomatosa	93.52	12.48	45	87195	1119	46597703
Systemic lupus erythematosus	92.09	12.48	8	87232	65172	46533650
Maternal exposure during pregnancy	90.67	12.48	39	87201	102510	46496312
Dysgeusia	89.53	12.48	219	87021	40272	46558550
Arthropathy	89.11	12.48	24	87216	84676	46514146
Weight increased	88.74	12.48	106	87134	164367	46434455
Drug interaction	88.73	12.48	152	87088	202942	46395880
Biopsy lung abnormal	88.05	12.48	25	87215	122	46598700
White blood cell count decreased	88.02	12.48	429	86811	111802	46487020
Febrile bone marrow aplasia	84.86	12.48	83	87157	6779	46592043
Nausea	84.62	12.48	1774	85466	685680	45913142
Radiation skin injury	83.94	12.48	38	87202	819	46598003
Metastases to pleura	83.92	12.48	41	87199	1055	46597767
Gastrointestinal necrosis	81.67	12.48	56	87184	2762	46596060
Metastases to spine	81.56	12.48	55	87185	2639	46596183
Treatment failure	81.35	12.48	36	87204	93051	46505771
Confusional state	81.09	12.48	108	87132	159784	46439038
Epistaxis	80.59	12.48	284	86956	64021	46534801
Exposure during pregnancy	79.72	12.48	52	87188	108160	46490662
Hospitalisation	76.79	12.48	13	87227	63372	46535450
Abdominal discomfort	76.76	12.48	102	87138	151063	46447759
Musculoskeletal stiffness	76.49	12.48	44	87196	97949	46500873
Psoriasis	75.95	12.48	26	87214	78578	46520244
Myocardial infarction	74.41	12.48	45	87195	97483	46501339
Paronychia	73.51	12.48	64	87176	4502	46594320
Myalgia	71.17	12.48	433	86807	122655	46476167
Tooth extraction	70.40	12.48	91	87149	10102	46588720
Product use issue	70.37	12.48	45	87195	94599	46504223
Cerebrovascular accident	69.86	12.48	52	87188	100987	46497835
Disease recurrence	67.87	12.48	123	87117	18348	46580474
Suicide attempt	67.30	12.48	11	87229	55025	46543797
Myositis	66.59	12.48	78	87162	7826	46590996
Migraine	66.22	12.48	24	87216	70002	46528820
Arthritis	65.84	12.48	31	87209	77285	46521537
Influenza	65.61	12.48	43	87197	89227	46509595
Cardiomyopathy	65.48	12.48	112	87128	15961	46582861
Hypokalaemia	65.11	12.48	331	86909	87693	46511129
Dermatitis	64.58	12.48	104	87136	14104	46584718
Contusion	64.49	12.48	42	87198	87445	46511377
Depression	64.08	12.48	139	87101	169965	46428857
Inappropriate schedule of product administration	63.68	12.48	21	87219	64992	46533830
Ascites	63.67	12.48	181	87059	36403	46562419
Intentional product misuse	63.38	12.48	7	87233	47121	46551701
Injection site swelling	62.72	12.48	3	87237	40324	46558498
Asthma	62.15	12.48	48	87192	91494	46507328
Plasma cell myeloma	61.38	12.48	6	87234	44472	46554350
Onychomadesis	60.49	12.48	47	87193	2816	46596006
Blood cholesterol increased	59.09	12.48	4	87236	40009	46558813
Multifocal micronodular pneumocyte hyperplasia	58.72	12.48	16	87224	65	46598757
Bronchial polyp	58.72	12.48	16	87224	65	46598757
Pericardial effusion	58.43	12.48	140	87100	25403	46573419
Large intestine perforation	57.63	12.48	71	87169	7509	46591313
Injection site reaction	57.54	12.48	10	87230	47839	46550983
Invasive ductal breast carcinoma	57.26	12.48	64	87176	6104	46592718
Intestinal perforation	57.12	12.48	85	87155	10766	46588056
Toxicity to various agents	56.76	12.48	204	87036	211562	46387260
Anaemia	56.22	12.48	727	86513	255052	46343770
Metastatic neoplasm	55.12	12.48	49	87191	3544	46595278
Feeling abnormal	55.12	12.48	93	87147	124967	46473855
Thrombocytopenia	55.02	12.48	415	86825	126166	46472656
Dyspnoea	54.83	12.48	1304	85936	514244	46084578
Osteonecrosis of jaw	53.00	12.48	163	87077	34239	46564583
Incorrect dose administered	51.64	12.48	11	87229	45539	46553283
Lung infiltration	50.94	12.48	93	87147	13950	46584872
Injection site pruritus	50.76	12.48	7	87233	39736	46559086
Pseudocirrhosis	50.48	12.48	25	87215	663	46598159
Bone disorder	50.42	12.48	114	87126	19919	46578903
Fibromyalgia	50.10	12.48	5	87235	36458	46562364
Vascular device infection	50.09	12.48	46	87194	3471	46595351
Pain	50.04	12.48	611	86629	476337	46122485
Device related thrombosis	49.44	12.48	30	87210	1197	46597625
Periarticular thenar erythema with onycholysis	49.13	12.48	11	87229	14	46598808
Metastases to peritoneum	48.55	12.48	40	87200	2608	46596214
Electrocardiogram QT prolonged	47.83	12.48	18	87222	51307	46547515
Nail discolouration	47.47	12.48	37	87203	2227	46596595
Enterocolitis	47.26	12.48	58	87182	6110	46592712
Osteolysis	46.94	12.48	39	87201	2573	46596249
Nail dystrophy	46.76	12.48	21	87219	444	46598378
Intestinal ischaemia	46.54	12.48	61	87179	6864	46591958
Mastectomy	46.48	12.48	31	87209	1460	46597362
Acute leukaemia	46.31	12.48	28	87212	1110	46597712
Enterocolitis infectious	46.07	12.48	31	87209	1482	46597340
Agitation	45.98	12.48	23	87217	55392	46543430
Therapeutic product effect incomplete	45.81	12.48	47	87193	78106	46520716
Abortion spontaneous	44.71	12.48	13	87227	43633	46555189
Hand deformity	44.37	12.48	6	87234	34568	46564254
Loss of personal independence in daily activities	44.15	12.48	26	87214	57157	46541665
Organising pneumonia	44.03	12.48	50	87190	4852	46593970
Dacryostenosis acquired	43.80	12.48	20	87220	440	46598382
Performance status decreased	43.52	12.48	41	87199	3196	46595626
Bradycardia	43.44	12.48	36	87204	66262	46532560
Suicidal ideation	43.01	12.48	26	87214	56356	46542466
Coronary artery disease	42.97	12.48	6	87234	33746	46565076
Insomnia	42.77	12.48	161	87079	164763	46434059
Tremor	42.28	12.48	96	87144	115543	46483279
Ejection fraction	41.92	12.48	21	87219	571	46598251
Metastases to adrenals	41.73	12.48	22	87218	667	46598155
Bronchitis	41.22	12.48	85	87155	105894	46492928
Cystoid macular oedema	40.95	12.48	29	87211	1507	46597315
Ventricular hypokinesia	40.78	12.48	44	87196	4034	46594788
General physical health deterioration	39.80	12.48	360	86880	115409	46483413
Hallucination	39.58	12.48	22	87218	49929	46548893
Anxiety	39.57	12.48	190	87050	181767	46417055
Nephrolithiasis	39.54	12.48	7	87233	33044	46565778
Blood glucose increased	39.24	12.48	46	87194	71967	46526855
Cataract	38.98	12.48	18	87222	45397	46553425
Gas gangrene	38.74	12.48	12	87228	83	46598739
Acute promyelocytic leukaemia	38.35	12.48	23	87217	898	46597924
Therapy cessation	38.35	12.48	3	87237	26626	46572196
Dermatomyositis	38.04	12.48	31	87209	1990	46596832
Osteoarthritis	37.85	12.48	36	87204	61989	46536833
Hepatic enzyme increased	37.73	12.48	59	87181	81728	46517094
Metastases to meninges	37.21	12.48	30	87210	1897	46596925
Nasal congestion	36.96	12.48	22	87218	48091	46550731
Injury	36.94	12.48	18	87222	44009	46554813
Hypoglycaemia	36.24	12.48	29	87211	54320	46544502
Blood lactate dehydrogenase increased	36.22	12.48	102	87138	20398	46578424
Erysipelas	36.02	12.48	54	87186	6884	46591938
Mobility decreased	36.01	12.48	36	87204	60558	46538264
Foetal exposure during pregnancy	35.73	12.48	7	87233	30740	46568082
Obstructive shock	35.39	12.48	9	87231	26	46598796
Congestive cardiomyopathy	34.84	12.48	48	87192	5665	46593157
Blood pressure systolic increased	34.65	12.48	6	87234	28781	46570041
Asthenia	34.52	12.48	792	86448	310283	46288539
Adverse drug reaction	34.48	12.48	20	87220	44342	46554480
Bone sequestrum	34.34	12.48	27	87213	1646	46597176
Metastases to chest wall	34.11	12.48	17	87223	457	46598365
Cardiac failure	34.09	12.48	261	86979	79687	46519135
Hypertension	33.49	12.48	222	87018	196134	46402688
Carotidynia	33.21	12.48	12	87228	140	46598682
Sepsis	33.00	12.48	394	86846	135620	46463202
Unevaluable event	32.90	12.48	23	87217	46152	46552670
Chest discomfort	32.71	12.48	284	86956	89985	46508837
Mastitis	32.62	12.48	30	87210	2268	46596554
Multiple sclerosis	32.54	12.48	4	87236	24787	46574035
Muscle spasms	32.03	12.48	120	87120	122993	46475829
Nephritis bacterial	32.01	12.48	8	87232	21	46598801
Pregnancy	31.92	12.48	6	87234	27131	46571691
Sedation	31.85	12.48	3	87237	22907	46575915
Lactic acidosis	31.41	12.48	12	87228	33897	46564925
Gastric disorder	31.20	12.48	6	87234	26699	46572123
Dizziness	30.91	12.48	449	86791	339965	46258857
Cellulitis	30.82	12.48	231	87009	70057	46528765
Irritability	30.81	12.48	8	87232	28938	46569884
Extravasation	30.78	12.48	28	87212	2087	46596735
Triple negative breast cancer	30.62	12.48	11	87229	126	46598696
Diabetes mellitus	30.61	12.48	29	87211	50036	46548786
Myelodysplastic syndrome	30.58	12.48	81	87159	15630	46583192
Sequestrectomy	30.51	12.48	21	87219	1042	46597780
Tumour embolism	30.31	12.48	11	87229	130	46598692
Tonsillar disorder	30.10	12.48	20	87220	936	46597886
Vision blurred	30.09	12.48	65	87175	79643	46519179
Hypocalcaemia	29.91	12.48	114	87126	26671	46572151
Hot flush	29.64	12.48	160	87080	43357	46555465
Chronic kidney disease	29.59	12.48	20	87220	40851	46557971
Ear infection	29.51	12.48	4	87236	23009	46575813
Drug intolerance	29.43	12.48	158	87082	146891	46451931
Bone lesion	29.43	12.48	41	87199	4890	46593932
Product quality issue	29.27	12.48	15	87225	35633	46563189
Odynophagia	29.24	12.48	48	87192	6614	46592208
Dermatitis acneiform	29.15	12.48	37	87203	4033	46594789
Chronic obstructive pulmonary disease	29.11	12.48	39	87201	57594	46541228
Malaise	28.99	12.48	440	86800	330792	46268030
Mucosal infection	28.96	12.48	10	87230	101	46598721
Blood pressure increased	28.86	12.48	130	87110	126536	46472286
Muscle necrosis	28.58	12.48	16	87224	548	46598274
Hepatic failure	28.53	12.48	131	87109	33285	46565537
Medication error	28.53	12.48	11	87229	30900	46567922
Bone debridement	28.42	12.48	14	87226	367	46598455
Road traffic accident	28.38	12.48	5	87235	23686	46575136
Nasopharyngitis	28.37	12.48	170	87070	153828	46444994
Full blood count decreased	28.16	12.48	4	87236	22207	46576615
Gait disturbance	28.02	12.48	158	87082	145105	46453717
Stress	28.00	12.48	33	87207	51518	46547304
Coma	27.96	12.48	41	87199	58308	46540514
International normalised ratio increased	27.69	12.48	28	87212	46855	46551967
Purtscher retinopathy	27.56	12.48	6	87234	6	46598816
Tongue coated	27.49	12.48	21	87219	1227	46597595
Hepatic lesion	27.23	12.48	35	87205	3862	46594960
Dyskinesia	27.19	12.48	10	87230	28915	46569907
Wheezing	27.09	12.48	36	87204	53350	46545472
Barotrauma	27.07	12.48	11	87229	180	46598642
Cystitis noninfective	27.04	12.48	18	87222	845	46597977
Back pain	26.87	12.48	546	86694	209493	46389329
Vessel puncture site bruise	26.84	12.48	13	87227	328	46598494
Embolism	26.81	12.48	48	87192	7090	46591732
Acute respiratory distress syndrome	26.74	12.48	96	87144	21826	46576996
Hepatic function abnormal	26.53	12.48	131	87109	34290	46564532
Nervousness	26.50	12.48	10	87230	28465	46570357
Vascular fragility	26.36	12.48	10	87230	135	46598687
Infusion related reaction	26.24	12.48	297	86943	100911	46497911
Pneumothorax	26.05	12.48	73	87167	14556	46584266
Memory impairment	26.05	12.48	67	87173	77270	46521552
Onychalgia	26.04	12.48	16	87224	653	46598169
Debridement	26.03	12.48	21	87219	1329	46597493
Swollen tongue	26.01	12.48	11	87229	29221	46569601
Computerised tomogram thorax abnormal	25.88	12.48	21	87219	1340	46597482
Metastases to the mediastinum	25.73	12.48	14	87226	453	46598369
Sensory disturbance	25.68	12.48	65	87175	12202	46586620
Urticaria	25.67	12.48	123	87117	117769	46481053
Injection site haemorrhage	25.63	12.48	4	87236	20705	46578117
Amnesia	25.59	12.48	24	87216	41607	46557215
Portal hypertension	25.48	12.48	32	87208	3451	46595371
Joint injury	25.46	12.48	3	87237	19206	46579616
Osteoporosis	25.44	12.48	23	87217	40585	46558237
Desmoplastic small round cell tumour	25.40	12.48	10	87230	150	46598672
Morphoea	25.14	12.48	12	87228	293	46598529
Herpes zoster	25.08	12.48	56	87184	67816	46531006
Recurrent cancer	25.04	12.48	23	87217	1736	46597086
Vein discolouration	24.93	12.48	10	87230	158	46598664
Perforation	24.85	12.48	18	87222	969	46597853
Generalised oedema	24.81	12.48	71	87169	14328	46584494
Colitis ischaemic	24.76	12.48	57	87183	10075	46588747
Aggression	24.76	12.48	6	87234	22738	46576084
Device related infection	24.70	12.48	91	87149	20950	46577872
Gait inability	24.47	12.48	18	87222	35185	46563637
Blood creatine increased	24.22	12.48	36	87204	4554	46594268
Ovarian necrosis	24.22	12.48	6	87234	15	46598807
Pulmonary mass	24.22	12.48	81	87159	17776	46581046
Cardiac dysfunction	24.21	12.48	21	87219	1470	46597352
Lymphangitis	24.18	12.48	17	87223	873	46597949
Paraesthesia	24.15	12.48	330	86910	117107	46481715
Clostridial infection	24.14	12.48	35	87205	4330	46594492
Subclavian vein thrombosis	24.09	12.48	23	87217	1823	46596999
Sclerema	24.08	12.48	5	87235	3	46598819
Pruritus	23.99	12.48	314	86926	242038	46356784
Chromosomal mutation	23.94	12.48	6	87234	16	46598806
Hyperkalaemia	23.94	12.48	36	87204	50673	46548149
Panophthalmitis	23.89	12.48	7	87233	39	46598783
Malignant pleural effusion	23.67	12.48	26	87214	2432	46596390
Blood creatinine decreased	23.55	12.48	36	87204	4668	46594154
Retinal toxicity	23.51	12.48	18	87222	1055	46597767
Delirium	23.43	12.48	21	87219	37207	46561615
Seroma	23.32	12.48	24	87216	2083	46596739
Metastases to thorax	23.15	12.48	10	87230	192	46598630
Eosinophilia	23.14	12.48	4	87236	19213	46579609
Basal cell carcinoma	23.11	12.48	5	87235	20482	46578340
Dysaesthesia	22.98	12.48	29	87211	3142	46595680
Neoplasm recurrence	22.67	12.48	25	87215	2348	46596474
Neck pain	22.66	12.48	43	87197	55263	46543559
Fatigue	22.62	12.48	1370	85870	607327	45991495
Excessive eye blinking	22.58	12.48	14	87226	581	46598241
White blood cell count abnormal	22.55	12.48	37	87203	5095	46593727
Gallbladder disorder	22.54	12.48	3	87237	17495	46581327
Glossodynia	22.43	12.48	30	87210	44343	46554479
Arthralgia	22.35	12.48	515	86725	364088	46234734
Abdominal pain	22.26	12.48	575	86665	229456	46369366
Vulvovaginal dryness	22.23	12.48	24	87216	2201	46596621
Metastases to soft tissue	22.11	12.48	9	87231	148	46598674
Septic shock	21.94	12.48	184	87056	57709	46541113
No adverse event	21.91	12.48	19	87221	34212	46564610
Drug level increased	21.85	12.48	4	87236	18437	46580385
Balance disorder	21.65	12.48	56	87184	64465	46534357
Underdose	21.61	12.48	5	87235	19553	46579269
Oral candidiasis	21.57	12.48	77	87163	17455	46581367
Hypoalbuminaemia	21.55	12.48	54	87186	10073	46588749
Pancreatitis	21.55	12.48	30	87210	43597	46555225
Blood uric acid decreased	21.42	12.48	13	87227	519	46598303
Constipation	21.40	12.48	450	86790	173647	46425175
Radiation necrosis	21.34	12.48	11	87229	318	46598504
Bone marrow infiltration	21.30	12.48	12	87228	416	46598406
Menopausal disorder	21.29	12.48	7	87233	60	46598762
Choroidal effusion	21.15	12.48	12	87228	422	46598400
Breast pain	21.13	12.48	45	87195	7549	46591273
Asthenopia	21.05	12.48	22	87218	1944	46596878
Epidermolysis	20.92	12.48	10	87230	245	46598577
Pneumonia aspiration	20.90	12.48	17	87223	31588	46567234
Gingival swelling	20.87	12.48	31	87209	3919	46594903
Skin reaction	20.86	12.48	56	87184	10890	46587932
Osteitis condensans	20.85	12.48	6	87234	31	46598791
Femur fracture	20.83	12.48	23	87217	36974	46561848
Blood glucose decreased	20.54	12.48	5	87235	18887	46579935
Accidental overdose	20.51	12.48	6	87234	20060	46578762
Hepatitis	20.48	12.48	18	87222	32197	46566625
Lymphadenopathy mediastinal	20.47	12.48	24	87216	2410	46596412
Acral peeling skin syndrome	20.33	12.48	5	87235	12	46598810
Superior vena cava syndrome	20.28	12.48	13	87227	572	46598250
Acoustic stimulation tests abnormal	20.26	12.48	8	87232	121	46598701
Vasculitis	20.22	12.48	64	87176	13647	46585175
Post-traumatic pain	20.07	12.48	11	87229	361	46598461
Malignant neoplasm of pleura	19.99	12.48	7	87233	74	46598748
Mucosal disorder	19.84	12.48	21	87219	1883	46596939
Nail bed bleeding	19.83	12.48	10	87230	276	46598546
Wound	19.61	12.48	31	87209	42771	46556051
Therapy partial responder	19.56	12.48	33	87207	4649	46594173
Paraparesis	19.53	12.48	21	87219	1918	46596904
Transaminases	19.50	12.48	7	87233	80	46598742
Monocyte count decreased	19.42	12.48	20	87220	1737	46597085
Merycism	19.35	12.48	8	87232	137	46598685
Transient ischaemic attack	19.32	12.48	22	87218	34881	46563941
Invasive lobular breast carcinoma	19.18	12.48	13	87227	629	46598193
Madarosis	19.15	12.48	20	87220	1766	46597056
Faeces discoloured	19.14	12.48	4	87236	16783	46582039
Intentional product use issue	19.13	12.48	44	87196	52736	46546086
Viral infection	19.09	12.48	17	87223	30218	46568604
Tumour marker increased	19.01	12.48	28	87212	3513	46595309
Radiation pneumonitis	19.00	12.48	17	87223	1240	46597582
Nasal disorder	18.90	12.48	22	87218	2192	46596630
Neuromuscular toxicity	18.84	12.48	8	87232	147	46598675
Caesarean section	18.84	12.48	4	87236	16599	46582223
Dysuria	18.73	12.48	102	87138	27731	46571091
HER2 positive breast cancer	18.69	12.48	7	87233	91	46598731
Drug resistance	18.64	12.48	73	87167	17295	46581527
Device issue	18.62	12.48	7	87233	19973	46578849
Cardio-respiratory arrest	18.56	12.48	54	87186	59815	46539007
Non-small cell lung cancer	18.55	12.48	26	87214	3118	46595704
Eye pain	18.51	12.48	15	87225	27925	46570897
Upper respiratory tract infection	18.51	12.48	59	87181	63497	46535325
Hypothalamo-pituitary disorder	18.50	12.48	13	87227	667	46598155
Tympanic membrane disorder	18.50	12.48	8	87232	154	46598668
Granulocyte count decreased	18.35	12.48	14	87226	816	46598006
Nail bed tenderness	18.28	12.48	7	87233	97	46598725
Necrotising colitis	18.24	12.48	12	87228	552	46598270
Leukaemia cutis	18.22	12.48	7	87233	98	46598724
Chemical peritonitis	18.22	12.48	7	87233	98	46598724
Product administration error	18.17	12.48	7	87233	19674	46579148
Device dislocation	18.16	12.48	9	87231	21793	46577029
Exposed bone in jaw	18.15	12.48	26	87214	3182	46595640
Oral pain	18.14	12.48	93	87147	24704	46574118
Cardiac tamponade	18.09	12.48	31	87209	4423	46594399
Skin laceration	18.07	12.48	6	87234	18496	46580326
Uterine leiomyosarcoma	18.03	12.48	5	87235	22	46598800
Miller Fisher syndrome	18.03	12.48	7	87233	101	46598721
Leukocytosis	17.99	12.48	89	87151	23309	46575513
Metastases to ovary	17.95	12.48	10	87230	339	46598483
Chemotherapy	17.94	12.48	17	87223	1335	46597487
Hip fracture	17.92	12.48	14	87226	26542	46572280
Systemic scleroderma	17.83	12.48	14	87226	852	46597970
Depressed level of consciousness	17.78	12.48	39	87201	47530	46551292
Osteosclerosis	17.73	12.48	27	87213	3489	46595333
Inflammatory carcinoma of the breast	17.71	12.48	6	87234	57	46598765
Fluid overload	17.51	12.48	15	87225	27170	46571652
Vulvitis	17.44	12.48	9	87231	261	46598561
Emotional distress	17.39	12.48	19	87221	30688	46568134
Retinitis pigmentosa	17.37	12.48	7	87233	112	46598710
Fistula	17.35	12.48	43	87197	7967	46590855
Nail infection	17.30	12.48	19	87221	1777	46597045
Myoclonus	17.25	12.48	3	87237	14349	46584473
Alopecia areata	17.25	12.48	12	87228	606	46598216
Seizure	17.22	12.48	147	87093	122907	46475915
Axillary vein thrombosis	17.21	12.48	10	87230	368	46598454
Metastases to uterus	17.17	12.48	6	87234	63	46598759
Neutrophil count abnormal	17.11	12.48	22	87218	2428	46596394
Blood pressure fluctuation	17.07	12.48	19	87221	30429	46568393
Appendiceal abscess	17.04	12.48	8	87232	188	46598634
Clostridium bacteraemia	17.00	12.48	8	87232	189	46598633
Oral surgery	16.96	12.48	15	87225	1077	46597745
Metastases to nervous system	16.89	12.48	5	87235	29	46598793
Cytotoxic oedema	16.87	12.48	7	87233	121	46598701
Metastases to muscle	16.82	12.48	7	87233	122	46598700
Staphylococcal impetigo	16.76	12.48	4	87236	8	46598814
Peripheral motor neuropathy	16.68	12.48	17	87223	1459	46597363
Peripheral swelling	16.67	12.48	202	87038	157869	46440953
Renal failure	16.66	12.48	134	87106	113460	46485362
Chills	16.64	12.48	262	86978	95770	46503052
Drug ineffective for unapproved indication	16.61	12.48	5	87235	16408	46582414
Hyperpyrexia	16.51	12.48	23	87217	2743	46596079
Pain in extremity	16.50	12.48	363	86877	258317	46340505
Foot fracture	16.43	12.48	8	87232	19574	46579248
Troponin I increased	16.42	12.48	19	87221	1881	46596941
Vascular pain	16.41	12.48	12	87228	656	46598166
Skin fissures	16.39	12.48	41	87199	7639	46591183
Adverse event	16.39	12.48	24	87216	34160	46564662
Fear	16.23	12.48	5	87235	16167	46582655
Gastrointestinal haemorrhage	16.10	12.48	82	87158	77291	46521531
Hypersensitivity pneumonitis	16.09	12.48	21	87219	2352	46596470
Acne pustular	16.09	12.48	6	87234	77	46598745
Acute interstitial pneumonitis	16.06	12.48	12	87228	678	46598144
Calcium ionised increased	16.03	12.48	7	87233	138	46598684
Swelling	15.99	12.48	152	87088	124359	46474463
Vena cava thrombosis	15.91	12.48	20	87220	2159	46596663
Astringent therapy	15.85	12.48	3	87237	0	46598822
Limb injury	15.84	12.48	8	87232	19166	46579656
Eosinophil percentage increased	15.75	12.48	13	87227	850	46597972
Muscle twitching	15.72	12.48	4	87236	14668	46584154
Hyperaemia	15.70	12.48	19	87221	1973	46596849
Autonomic neuropathy	15.68	12.48	12	87228	703	46598119
Breast inflammation	15.67	12.48	7	87233	146	46598676
Injection site rash	15.67	12.48	5	87235	15808	46583014
Vaginal prolapse	15.64	12.48	10	87230	438	46598384
Necrotising myositis	15.59	12.48	9	87231	327	46598495
Oral cavity fistula	15.58	12.48	12	87228	710	46598112
Seasonal allergy	15.57	12.48	3	87237	13331	46585491
Pleural disorder	15.54	12.48	11	87229	571	46598251
Upper limb fracture	15.51	12.48	5	87235	15708	46583114
Kidney infection	15.45	12.48	6	87234	16783	46582039
Left ventricular enlargement	15.40	12.48	5	87235	41	46598781
Palmar erythema	15.40	12.48	16	87224	1404	46597418
Bursitis	15.34	12.48	9	87231	19833	46578989
Procedural pain	15.31	12.48	3	87237	13176	46585646
Red cell distribution width increased	15.28	12.48	40	87200	7664	46591158
Chemical burn	15.28	12.48	9	87231	340	46598482
PIK3CA-activated mutation	15.22	12.48	11	87229	590	46598232
Coating in mouth	15.21	12.48	7	87233	157	46598665
Oesophagitis	15.16	12.48	58	87182	13593	46585229
Pituitary tumour	15.08	12.48	13	87227	902	46597920
Skin hypopigmentation	15.02	12.48	9	87231	351	46598471
Subdural haematoma	15.02	12.48	3	87237	12994	46585828
Dandy-Walker syndrome	15.00	12.48	6	87234	94	46598728
Carbohydrate antigen 15-3 increased	14.97	12.48	13	87227	911	46597911
Brachial plexopathy	14.94	12.48	6	87234	95	46598727
Ejection fraction abnormal	14.89	12.48	11	87229	611	46598211
Incorrect route of product administration	14.84	12.48	6	87234	16377	46582445
Renal impairment	14.81	12.48	80	87160	74292	46524530
Adenocarcinoma	14.66	12.48	20	87220	2339	46596483
Lymphadenopathy	14.64	12.48	110	87130	33378	46565444
Dysarthria	14.63	12.48	30	87210	37468	46561354
Nodular regenerative hyperplasia	14.56	12.48	8	87232	264	46598558
Iron deficiency anaemia	14.48	12.48	7	87233	17199	46581623
Ear pain	14.46	12.48	12	87228	22080	46576742
Necrotising fasciitis	14.46	12.48	21	87219	2602	46596220
Osteotomy	14.37	12.48	8	87232	271	46598551
Rhabdomyolysis	14.34	12.48	36	87204	41873	46556949
Red blood cell sedimentation rate increased	14.30	12.48	13	87227	22876	46575946
Paralysis recurrent laryngeal nerve	14.27	12.48	5	87235	53	46598769
Salmonella bacteraemia	14.19	12.48	6	87234	109	46598713
Facial discomfort	14.18	12.48	4	87236	19	46598803
Metastases to breast	14.16	12.48	8	87232	279	46598543
Glaucoma	14.15	12.48	6	87234	15915	46582907
Vagus nerve disorder	14.14	12.48	6	87234	110	46598712
Pancreatic atrophy	14.09	12.48	6	87234	111	46598711
Cancer pain	14.07	12.48	20	87220	2430	46596392
Neutrophil count	14.05	12.48	8	87232	283	46598539
Disorientation	14.01	12.48	30	87210	36888	46561934
Cachexia	14.01	12.48	29	87211	4770	46594052
Blood count abnormal	13.98	12.48	8	87232	17870	46580952
Sopor	13.96	12.48	10	87230	19818	46579004
Pneumocystis jirovecii pneumonia	13.93	12.48	61	87179	15187	46583635
Eastern Cooperative Oncology Group performance status worsened	13.92	12.48	9	87231	402	46598420
Anal erythema	13.92	12.48	7	87233	192	46598630
Acute kidney injury	13.90	12.48	335	86905	235520	46363302
Purulent discharge	13.88	12.48	29	87211	4801	46594021
Urogenital prolapse	13.85	12.48	4	87236	21	46598801
Acute myocardial infarction	13.81	12.48	24	87216	31900	46566922
Osteomyelitis chronic	13.80	12.48	9	87231	408	46598414
Metastases to heart	13.79	12.48	5	87235	59	46598763
Subretinal hyperreflective exudation	13.78	12.48	3	87237	3	46598819
Meningeal neoplasm	13.78	12.48	3	87237	3	46598819
Gastrointestinal perforation	13.77	12.48	23	87217	3214	46595608
Phlebitis	13.75	12.48	33	87207	5993	46592829
Sense of oppression	13.66	12.48	13	87227	1026	46597796
Left ventricular dilatation	13.66	12.48	8	87232	299	46598523
Liver function test abnormal	13.64	12.48	43	87197	46444	46552378
Obstruction gastric	13.54	12.48	12	87228	864	46597958
Hypersomnia	13.43	12.48	6	87234	15433	46583389
Foot deformity	13.41	12.48	6	87234	15419	46583403
Hormone receptor positive breast cancer	13.36	12.48	9	87231	431	46598391
Streptococcal sepsis	13.31	12.48	16	87224	1649	46597173
Skin disorder	13.27	12.48	79	87161	22184	46576638
Sinus congestion	13.25	12.48	4	87236	13105	46585717
Immunodeficiency	13.25	12.48	4	87236	13102	46585720
Skin hyperpigmentation	13.22	12.48	30	87210	5252	46593570
Gastrooesophageal reflux disease	13.19	12.48	83	87157	74261	46524561
Treatment noncompliance	13.18	12.48	22	87218	29709	46569113
Borrelia infection	13.14	12.48	6	87234	132	46598690
Abnormal behaviour	13.10	12.48	12	87228	21046	46577776
Eye swelling	13.06	12.48	11	87229	20092	46578730
Generalised tonic-clonic seizure	13.05	12.48	19	87221	27103	46571719
Feeling hot	13.04	12.48	118	87122	37810	46561012
Arachnoid cyst	12.99	12.48	7	87233	222	46598600
Monocytopenia	12.95	12.48	5	87235	71	46598751
Sciatica	12.86	12.48	10	87230	19010	46579812
Axillary pain	12.84	12.48	14	87226	1299	46597523
Type 2 diabetes mellitus	12.76	12.48	11	87229	19864	46578958
Rash pustular	12.76	12.48	35	87205	6894	46591928
Rotator cuff syndrome	12.72	12.48	3	87237	11580	46587242
Osteitis	12.72	12.48	22	87218	3163	46595659
Dermatitis exfoliative	12.71	12.48	31	87209	5685	46593137
Loss of consciousness	12.71	12.48	135	87105	108103	46490719
Pseudomembranous colitis	12.67	12.48	22	87218	3173	46595649
Soft tissue infection	12.62	12.48	17	87223	1963	46596859
Wrist fracture	12.59	12.48	3	87237	11500	46587322
Therapy responder	12.58	12.48	8	87232	347	46598475
Periodontitis	12.58	12.48	23	87217	3453	46595369
Muscle oedema	12.57	12.48	3	87237	6	46598816
Sinus bradycardia	12.56	12.48	5	87235	13777	46585045
Thermal burn	12.54	12.48	28	87212	4849	46593973
Tooth development disorder	12.52	12.48	4	87236	31	46598791
Frequent bowel movements	12.51	12.48	4	87236	12628	46586194
Muscle spasticity	12.49	12.48	3	87237	11437	46587385

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	734.18	13.79	699	42880	71588	29837311
Febrile neutropenia	640.59	13.79	781	42798	105912	29802987
Osteonecrosis of jaw	566.20	13.79	347	43232	18271	29890628
Neutropenia	390.24	13.79	682	42897	127858	29781041
Interstitial lung disease	328.85	13.79	421	43158	59776	29849123
Diarrhoea	289.64	13.79	1101	42478	333002	29575897
Disease progression	248.63	13.79	429	43150	79445	29829454
Mucosal inflammation	237.57	13.79	256	43323	30238	29878661
Metastases to bone	203.02	13.79	143	43436	9515	29899384
Osteonecrosis	202.30	13.79	176	43403	15959	29892940
Neutropenic sepsis	181.73	13.79	143	43436	11266	29897633
Stomatitis	173.07	13.79	241	43338	37038	29871861
Dehydration	171.28	13.79	479	43100	123060	29785839
Prostatic specific antigen increased	150.58	13.79	131	43448	11873	29897026
Neutrophil count decreased	146.52	13.79	239	43340	42215	29866684
Pneumonitis	122.21	13.79	174	43405	27280	29881619
Leukopenia	119.56	13.79	257	43322	55902	29852997
Tooth extraction	117.10	13.79	78	43501	4733	29904166
Bone disorder	110.60	13.79	86	43493	6655	29902244
Neoplasm progression	107.69	13.79	132	43447	17891	29891008
Metastases to lung	106.83	13.79	90	43489	7805	29901094
Hypocalcaemia	106.41	13.79	143	43436	21233	29887666
Onycholysis	105.83	13.79	34	43545	355	29908544
Drug abuse	105.51	13.79	3	43576	82069	29826830
Drug interaction	100.20	13.79	86	43493	199482	29709417
Prostate cancer metastatic	97.23	13.79	71	43508	4996	29903903
Prostate cancer	95.27	13.79	144	43435	23813	29885086
Product dose omission issue	92.59	13.79	12	43567	91619	29817280
Alopecia	91.47	13.79	126	43453	19149	29889750
Palmar-plantar erythrodysaesthesia syndrome	90.60	13.79	110	43469	14760	29894139
Bone marrow failure	87.30	13.79	156	43423	29629	29879270
White blood cell count decreased	85.86	13.79	293	43286	83654	29825245
Drug ineffective	83.61	13.79	238	43341	340149	29568750
Headache	81.63	13.79	87	43492	182219	29726680
Septic shock	79.60	13.79	238	43341	63369	29845530
Portal venous gas	79.06	13.79	26	43553	294	29908605
Fall	78.99	13.79	89	43490	181783	29727116
Anaemia	78.93	13.79	545	43034	207447	29701452
Metastases to liver	76.98	13.79	91	43488	11874	29897025
Metastases to lymph nodes	76.93	13.79	56	43523	3921	29904978
Decreased appetite	74.45	13.79	421	43158	149489	29759410
Overdose	72.23	13.79	17	43562	84320	29824579
Nausea	68.72	13.79	696	42883	296261	29612638
Non-small cell lung cancer	68.71	13.79	51	43528	3679	29905220
Pleural effusion	68.38	13.79	250	43329	73816	29835083
Skin toxicity	68.01	13.79	48	43531	3201	29905698
Recall phenomenon	66.58	13.79	27	43552	572	29908327
Bacterial translocation	63.50	13.79	21	43558	242	29908657
Haematotoxicity	61.10	13.79	59	43520	6111	29902788
Pyrexia	60.96	13.79	675	42904	293814	29615085
Metastases to central nervous system	59.93	13.79	63	43516	7221	29901678
Peripheral sensory neuropathy	59.51	13.79	57	43522	5844	29903055
Plasma cell myeloma	59.12	13.79	5	43574	53457	29855442
Nasopharyngitis	58.73	13.79	8	43571	58841	29850058
General physical health deterioration	58.65	13.79	294	43285	99650	29809249
Bone pain	57.47	13.79	101	43478	18925	29889974
Vomiting	54.03	13.79	522	43057	219296	29689603
Metastasis	53.93	13.79	42	43537	3256	29905643
Nail disorder	53.84	13.79	33	43546	1732	29907167
Oesophagobronchial fistula	53.04	13.79	16	43563	133	29908766
Disseminated intravascular coagulation	52.43	13.79	106	43473	22065	29886834
Tremor	52.40	13.79	22	43557	75341	29833558
Oesophageal fistula	52.11	13.79	17	43562	187	29908712
Onychomadesis	49.48	13.79	21	43558	501	29908398
Hormone-refractory prostate cancer	47.70	13.79	22	43557	643	29908256
Pneumothorax	46.39	13.79	84	43495	16109	29892790
Agitation	46.08	13.79	11	43568	54062	29854837
Radiation pneumonitis	45.32	13.79	31	43548	1965	29906934
Exposed bone in jaw	45.18	13.79	30	43549	1810	29907089
Depression	44.05	13.79	40	43539	90397	29818502
Radiation skin injury	43.86	13.79	21	43558	669	29908230
Reproductive toxicity	43.58	13.79	9	43570	9	29908890
Urinary tract toxicity	43.58	13.79	9	43570	9	29908890
Gastrointestinal toxicity	42.80	13.79	30	43549	1978	29906921
Bone sequestrum	42.66	13.79	21	43558	712	29908187
Pulmonary toxicity	42.50	13.79	42	43537	4474	29904425
Aggression	42.07	13.79	3	43576	36904	29871995
Somnolence	41.23	13.79	48	43531	96715	29812184
Insomnia	41.19	13.79	45	43534	93291	29815608
Hyponatraemia	41.03	13.79	200	43379	67002	29841897
Weight increased	40.36	13.79	30	43549	74883	29834016
Rheumatoid arthritis	40.16	13.79	6	43573	41191	29867708
Hypokalaemia	39.40	13.79	161	43418	50031	29858868
Pneumatosis intestinalis	39.16	13.79	32	43547	2658	29906241
Prostate cancer recurrent	39.14	13.79	20	43559	735	29908164
Intentional product misuse	39.00	13.79	3	43576	34664	29874235
Blood pressure increased	38.50	13.79	29	43550	71899	29837000
Hallucination	38.02	13.79	12	43567	49047	29859852
Musculoskeletal stiffness	37.96	13.79	4	43575	35877	29873022
Acute respiratory distress syndrome	37.42	13.79	96	43483	23376	29885523
Neuropathy peripheral	36.94	13.79	201	43378	70274	29838625
Nail toxicity	36.66	13.79	9	43570	30	29908869
Respiratory failure	36.43	13.79	261	43318	100381	29808518
Rhabdomyolysis	36.18	13.79	24	43555	63556	29845343
Polyneuropathy	36.01	13.79	63	43516	11760	29897139
Mediastinitis	35.99	13.79	17	43562	525	29908374
Myocardial infarction	35.98	13.79	81	43498	125544	29783355
Erythema	35.42	13.79	213	43366	77238	29831661
Gastric perforation	35.11	13.79	27	43552	2054	29906845
Metastases to skin	35.07	13.79	15	43564	365	29908534
Drug hypersensitivity	34.94	13.79	29	43550	68490	29840409
Cardiac failure congestive	34.76	13.79	43	43536	84364	29824535
Seizure	34.76	13.79	56	43523	98419	29810480
Hypophagia	34.47	13.79	90	43489	22146	29886753
Angioedema	33.53	13.79	5	43574	34379	29874520
Urticaria	33.31	13.79	19	43560	54587	29854312
Acute motor-sensory axonal neuropathy	33.01	13.79	11	43568	130	29908769
Influenza	32.95	13.79	11	43568	43387	29865512
Dermatitis	32.43	13.79	49	43530	8093	29900806
Joint swelling	32.15	13.79	14	43565	46932	29861967
Osteomyelitis	32.13	13.79	68	43511	14613	29894286
Rash	31.98	13.79	157	43422	191732	29717167
Cerebrovascular accident	31.84	13.79	45	43534	83432	29825467
Gingivitis	31.61	13.79	30	43549	3040	29905859
Atypical haemolytic uraemic syndrome	31.60	13.79	10	43569	99	29908800
Dyspnoea	31.60	13.79	669	42910	332626	29576273
Necrotising retinitis	31.32	13.79	17	43562	708	29908191
Muscle spasms	31.18	13.79	29	43550	64809	29844090
Neoplasm recurrence	31.01	13.79	24	43555	1843	29907056
Pruritus	30.85	13.79	80	43499	118124	29790775
Carbohydrate antigen 15-3 increased	30.82	13.79	9	43570	66	29908833
Nail ridging	30.69	13.79	8	43571	36	29908863
Drug reaction with eosinophilia and systemic symptoms	30.59	13.79	3	43576	28485	29880414
Dysphagia	30.58	13.79	163	43416	56535	29852364
Nicotinic acid deficiency	29.92	13.79	9	43570	74	29908825
Intestinal ischaemia	29.62	13.79	43	43536	6854	29902045
Suicidal ideation	29.51	13.79	8	43571	36106	29872793
Contusion	29.49	13.79	5	43574	31275	29877624
Anxiety	29.07	13.79	54	43525	89817	29819082
Metastases to pleura	29.00	13.79	13	43566	355	29908544
Capillary leak syndrome	28.88	13.79	22	43557	1650	29907249
Toxicity to various agents	28.36	13.79	147	43432	177036	29731863
Neutropenic infection	28.25	13.79	18	43561	1012	29907887
Oral pain	28.24	13.79	50	43529	9419	29899480
Hypoxia	28.18	13.79	141	43438	47713	29861186
Incorrect dose administered	27.89	13.79	6	43573	31680	29877219
Haemoptysis	27.88	13.79	104	43475	30974	29877925
Eubacterium infection	27.67	13.79	5	43574	0	29908899
Karnofsky scale worsened	27.67	13.79	5	43574	0	29908899
Bone lesion	27.43	13.79	26	43553	2631	29906268
Bronchial fistula	27.07	13.79	10	43569	163	29908736
Psoriasis	27.07	13.79	14	43565	42492	29866407
Metastases to spine	27.02	13.79	24	43555	2234	29906665
Inappropriate schedule of product administration	26.96	13.79	12	43567	39716	29869183
Pain in jaw	26.25	13.79	56	43523	12100	29896799
Hospitalisation	26.21	13.79	16	43563	44303	29864596
Oesophageal perforation	25.89	13.79	13	43566	460	29908439
Tracheal fistula	25.57	13.79	8	43571	76	29908823
Bradycardia	25.31	13.79	35	43544	65491	29843408
Neutropenic colitis	25.30	13.79	23	43556	2207	29906692
Dizziness	25.22	13.79	173	43406	194736	29714163
Cholangitis sclerosing	25.04	13.79	16	43563	904	29907995
Gastrointestinal ischaemia	24.92	13.79	10	43569	206	29908693
Therapeutic product effect decreased	24.60	13.79	6	43573	29070	29879829
PCO2 decreased	24.57	13.79	19	43560	1457	29907442
Lung adenocarcinoma	24.44	13.79	30	43549	4069	29904830
Abnormal behaviour	24.36	13.79	4	43575	25619	29883280
Memory impairment	24.04	13.79	12	43567	37162	29871737
Splenic vein thrombosis	23.87	13.79	11	43568	321	29908578
Dental care	23.70	13.79	10	43569	235	29908664
Irritability	23.31	13.79	3	43576	23047	29885852
Feeling abnormal	23.26	13.79	29	43550	56727	29852172
Pharyngeal abscess	23.21	13.79	12	43567	452	29908447
Toothache	23.19	13.79	35	43544	5776	29903123
Sequestrectomy	22.99	13.79	11	43568	350	29908549
Sinusitis	22.74	13.79	10	43569	33335	29875564
Hypophosphataemia	22.64	13.79	42	43537	8203	29900696
Fatigue	22.55	13.79	618	42961	320055	29588844
Injection site pain	22.46	13.79	8	43571	30302	29878597
Diabetes mellitus	22.24	13.79	17	43562	41848	29867051
Pancreatitis viral	22.19	13.79	5	43574	10	29908889
Lacrimation increased	22.17	13.79	38	43541	6978	29901921
Eosinophilia	22.13	13.79	3	43576	22157	29886742
Osteitis	22.05	13.79	18	43561	1493	29907406
Lactic acidosis	21.86	13.79	9	43570	31204	29877695
Superior mesenteric artery syndrome	21.79	13.79	7	43572	73	29908826
Chemotherapy	21.50	13.79	12	43567	528	29908371
Tumour pain	21.45	13.79	15	43564	985	29907914
Pharyngeal fistula	21.29	13.79	5	43574	13	29908886
Metastases to meninges	21.21	13.79	16	43563	1183	29907716
Gastrointestinal necrosis	21.12	13.79	25	43554	3264	29905635
Bone debridement	21.02	13.79	10	43569	314	29908585
Hypertension	20.94	13.79	98	43481	121256	29787643
Aorto-oesophageal fistula	20.79	13.79	6	43573	42	29908857
Macroenzyme creatine kinase	20.76	13.79	5	43574	15	29908884
Dacryostenosis acquired	20.48	13.79	8	43571	153	29908746
Colitis	20.45	13.79	94	43485	30726	29878173
Peripheral swelling	20.36	13.79	36	43543	61038	29847861
Flushing	20.35	13.79	91	43488	29401	29879498
Hypovolaemic shock	20.27	13.79	35	43544	6465	29902434
Tumour necrosis	20.26	13.79	15	43564	1078	29907821
Disturbance in attention	19.86	13.79	4	43575	22125	29886774
Biopsy site unspecified abnormal	19.77	13.79	6	43573	51	29908848
Tracheal stenosis	19.75	13.79	8	43571	169	29908730
Pain in extremity	19.62	13.79	88	43491	110133	29798766
Metastases to peritoneum	19.53	13.79	17	43562	1540	29907359
Trigeminal nerve paresis	19.37	13.79	4	43575	4	29908895
Infusion site plaque	19.37	13.79	4	43575	4	29908895
Jaw disorder	19.35	13.79	20	43559	2247	29906652
Soft tissue infection	19.09	13.79	17	43562	1588	29907311
Cranial nerve disorder	18.88	13.79	10	43569	396	29908503
Purulent discharge	18.68	13.79	22	43557	2857	29906042
Enteritis	18.43	13.79	34	43545	6611	29902288
Blood creatine phosphokinase increased	18.39	13.79	22	43557	43826	29865073
Gingival swelling	18.32	13.79	15	43564	1249	29907650
Tracheo-oesophageal fistula	18.32	13.79	10	43569	421	29908478
Foetal exposure during pregnancy	18.30	13.79	16	43563	36855	29872044
Transdifferentiation of neoplasm	18.00	13.79	6	43573	71	29908828
Metastases to adrenals	17.92	13.79	13	43566	905	29907994
Hydronephrosis	17.82	13.79	40	43539	8943	29899956
Arthralgia	17.81	13.79	120	43459	135671	29773228
Scleroderma	17.69	13.79	15	43564	1312	29907587
Tumour haemorrhage	17.55	13.79	20	43559	2508	29906391
Periorbital disorder	17.45	13.79	5	43574	34	29908865
Portosplenomesenteric venous thrombosis	17.14	13.79	4	43575	10	29908889
Cytomegalovirus oesophagitis	17.12	13.79	8	43571	241	29908658
Enterovesical fistula	17.11	13.79	11	43568	628	29908271
Oesophagitis	17.09	13.79	45	43534	11126	29897773
Osteoradionecrosis	17.08	13.79	6	43573	84	29908815
Pulmonary embolism	16.92	13.79	181	43398	77954	29830945
Debridement	16.87	13.79	13	43566	992	29907907
Sarcoma	16.64	13.79	9	43570	372	29908527
Carotidynia	16.60	13.79	3	43576	0	29908899
Oral candidiasis	16.33	13.79	44	43535	11027	29897872
Retroperitoneal lymphadenopathy	16.21	13.79	11	43568	688	29908211
Blood pressure fluctuation	16.06	13.79	3	43576	17500	29891399
Coronary artery disease	15.95	13.79	30	43549	49682	29859217
Metastases to the mediastinum	15.93	13.79	7	43572	182	29908717
Intestinal perforation	15.87	13.79	37	43542	8482	29900417
Gout	15.81	13.79	3	43576	17312	29891587
Radiation mucositis	15.80	13.79	6	43573	106	29908793
Cardiac disorder	15.71	13.79	21	43558	39872	29869027
Dermatitis acneiform	15.64	13.79	29	43550	5660	29903239
Product quality issue	15.64	13.79	4	43575	18770	29890129
Road traffic accident	15.50	13.79	3	43576	17068	29891831
PO2 increased	15.49	13.79	10	43569	575	29908324
Polyneuropathy in malignant disease	15.40	13.79	6	43573	114	29908785
Breakthrough pain	15.37	13.79	10	43569	583	29908316
Fistula	15.21	13.79	27	43552	5095	29903804
Chest X-ray abnormal	15.16	13.79	22	43557	3505	29905394
Blood calcium decreased	15.12	13.79	39	43540	9523	29899376
Haematoma	15.09	13.79	8	43571	23945	29884954
Traumatic lung injury	15.03	13.79	13	43566	1168	29907731
Electrocardiogram QT prolonged	15.01	13.79	18	43561	35817	29873082
Prostate cancer stage IV	14.98	13.79	7	43572	211	29908688
Human chorionic gonadotropin increased	14.84	13.79	4	43575	21	29908878
Cytomegalovirus infection	14.77	13.79	8	43571	23666	29885233
Metastases to soft tissue	14.71	13.79	7	43572	220	29908679
Nodular rash	14.64	13.79	5	43574	64	29908835
Performance status decreased	14.62	13.79	23	43556	3934	29904965
Product use issue	14.56	13.79	28	43551	45988	29862911
Bone trimming	14.53	13.79	4	43575	23	29908876
Hyperchromasia	14.53	13.79	3	43576	3	29908896
Idiosyncratic drug reaction	14.37	13.79	9	43570	491	29908408
Abdominal discomfort	14.32	13.79	31	43548	48760	29860139
Hypoalbuminaemia	14.32	13.79	42	43537	11050	29897849
Pneumonia	14.24	13.79	608	42971	333698	29575201
Adverse drug reaction	14.18	13.79	8	43571	23137	29885762
Vascular pseudoaneurysm	14.18	13.79	16	43563	1984	29906915
Arthritis	14.16	13.79	9	43570	24392	29884507
Cardiotoxicity	14.07	13.79	24	43555	4390	29904509
Laboratory test abnormal	13.99	13.79	4	43575	17438	29891461
Adenocarcinoma	13.99	13.79	15	43564	1758	29907141
No adverse event	13.96	13.79	4	43575	17415	29891484
Clostridium difficile infection	13.86	13.79	3	43576	15780	29893119
Chondritis	13.84	13.79	6	43573	151	29908748
Malignant pleural effusion	13.83	13.79	13	43566	1301	29907598
Psychotic disorder	13.83	13.79	7	43572	21508	29887391
Paraneoplastic pemphigus	13.80	13.79	5	43574	77	29908822

Pharmacologic Action:

Source	Code	Description
ATC	L01CD02	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS PLANT ALKALOIDS AND OTHER NATURAL PRODUCTS Taxanes
FDA PE	N0000175085	Microtubule Inhibition
FDA EPC	N0000175592	Microtubule Inhibitor
CHEBI has role	CHEBI:35610	cytostatic
CHEBI has role	CHEBI:38068	antimalarials
CHEBI has role	CHEBI:47868	photosensitising agent
MeSH PA	D050256	Antimitotic Agents
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D050257	Tubulin Modulators

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Non-small cell lung cancer	indication	254637007	DOID:3908
Carcinoma of breast	indication	254838004	DOID:3459
Malignant tumor of head and/or neck	indication	255056009
Malignant tumor of stomach	indication	363349007	DOID:10534
Malignant tumor of prostate	indication	399068003	DOID:10283
Metastatic Breast Carcinoma	indication
Ewing's sarcoma	off-label use	76909002	DOID:3369
Small cell carcinoma of lung	off-label use	254632001	DOID:5409
Malignant tumor of esophagus	off-label use	363402007
Malignant tumor of ovary	off-label use	363443007	DOID:2394
Invasive Bladder Malignancy	off-label use
Refractory Osteosarcoma	off-label use
Asthenia	contraindication	13791008
Hyperbilirubinemia	contraindication	14783006	DOID:2741
Pulmonary edema	contraindication	19242006	DOID:11396
Cardiac tamponade	contraindication	35304003	DOID:115
Body fluid retention	contraindication	43498006
Stomatitis	contraindication	61170000	DOID:9637
Diarrhea	contraindication	62315008
Acute infectious disease	contraindication	63171007
Peripheral motor neuropathy	contraindication	95663000	DOID:683
Liver function tests abnormal	contraindication	166603001
Disease of liver	contraindication	235856003	DOID:409
Anemia	contraindication	271737000	DOID:2355
Peripheral edema	contraindication	271809000
Pregnancy, function	contraindication	289908002
Thrombocytopenic disorder	contraindication	302215000	DOID:1588
Peripheral nerve disease	contraindication	302226006
Neutropenic disorder	contraindication	303011007	DOID:1227
Bone marrow depression	contraindication	307762000
Ascites	contraindication	389026000
Breastfeeding (mother)	contraindication	413712001
Pleural Effusions	contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.9	acidic
pKa2	11.64	acidic
pKa3	12.4	acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Tubulin beta	Tumour-associated antigen	P04350 P07437 P68371 Q13509 Q13885 Q3ZCM7 Q9BUF5 Q9BVA1 Q9H4B7	TBB1_HUMAN TBB2A_HUMAN TBB2B_HUMAN TBB3_HUMAN TBB4A_HUMAN TBB4B_HUMAN TBB5_HUMAN TBB6_HUMAN TBB8_HUMAN	INHIBITOR	ID50	6.70		WOMBAT-PK	CHEMBL
Epidermal growth factor receptor	Kinase	P00533	EGFR_HUMAN	INHIBITOR	Kd	9.09		WOMBAT-PK
Cytochrome P450 3A4	Enzyme	P08684	CP3A4_HUMAN		IC50	5.70		DRUG MATRIX
Substance-K receptor	GPCR	P21452	NK2R_HUMAN		Ki	6.28		DRUG MATRIX
Multidrug resistance-associated protein 7	Transporter	Q5T3U5	MRP7_HUMAN					WOMBAT-PK
Multidrug resistance protein 1	Transporter	P08183	MDR1_HUMAN					WOMBAT-PK
Growth hormone-releasing hormone receptor	GPCR	Q02643	GHRHR_HUMAN		IC50	9.85		CHEMBL

External reference:

ID	Source
4020968	VUID
N0000148441	NUI
D02165	KEGG_DRUG
148408-66-6	SECONDARY_CAS_RN
4020968	VANDF
C0246415	UMLSCUI
CHEBI:59809	CHEBI
TXL	PDB_CHEM_ID
CHEMBL3545252	ChEMBL_ID
CHEMBL92	ChEMBL_ID
DB01248	DRUGBANK_ID
D000077143	MESH_DESCRIPTOR_UI
148124	PUBCHEM_CID
6809	IUPHAR_LIGAND_ID
6621	INN_ID
15H5577CQD	UNII
1299922	RXNORM
178776	MMSL
180476	MMSL
4626	MMSL
5984	MMSL
d04009	MMSL
005187	NDDF
005188	NDDF
108806006	SNOMEDCT_US
386918005	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Docetaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9204	INJECTION, SOLUTION, CONCENTRATE	20 mg	INTRAVENOUS	ANDA	31 sections
Docetaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9205	INJECTION, SOLUTION, CONCENTRATE	20 mg	INTRAVENOUS	ANDA	31 sections
Docetaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0409-0201	INJECTION, SOLUTION	10 mg	INTRAVENOUS	NDA	31 sections
Docetaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0409-0365	INJECTION, SOLUTION	20 mg	INTRAVENOUS	NDA	33 sections
Docetaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0409-0366	INJECTION, SOLUTION	20 mg	INTRAVENOUS	NDA	31 sections
Docetaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0409-0367	INJECTION, SOLUTION	20 mg	INTRAVENOUS	NDA	31 sections
Docetaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0409-0368	INJECTION, SOLUTION	20 mg	INTRAVENOUS	NDA	31 sections
Docetaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0409-1732	INJECTION, SOLUTION	10 mg	INTRAVENOUS	NDA	33 sections
Docetaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0409-2956	INJECTION, SOLUTION	10 mg	INTRAVENOUS	NDA	33 sections
Docetaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0409-4235	INJECTION, SOLUTION	20 mg	INTRAVENOUS	NDA	33 sections
Docetaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0409-5068	INJECTION, SOLUTION	20 mg	INTRAVENOUS	NDA	33 sections
Docetaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0409-7870	INJECTION, SOLUTION	10 mg	INTRAVENOUS	NDA	33 sections
Docetaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0955-1020	INJECTION, SOLUTION, CONCENTRATE	20 mg	INTRAVENOUS	NDA authorized generic	30 sections
Docetaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0955-1021	INJECTION, SOLUTION, CONCENTRATE	80 mg	INTRAVENOUS	NDA authorized generic	30 sections
Docetaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0955-1022	INJECTION, SOLUTION, CONCENTRATE	160 mg	INTRAVENOUS	NDA authorized generic	30 sections
DOCETAXEL	HUMAN PRESCRIPTION DRUG LABEL	1	16729-231	INJECTION, SOLUTION, CONCENTRATE	20 mg	INTRAVENOUS	NDA	30 sections
DOCETAXEL	HUMAN PRESCRIPTION DRUG LABEL	1	16729-267	INJECTION, SOLUTION, CONCENTRATE	20 mg	INTRAVENOUS	NDA	30 sections
Docetaxel	HUMAN PRESCRIPTION DRUG LABEL	1	25021-245	INJECTION, SOLUTION	20 mg	INTRAVENOUS	ANDA	29 sections
Docetaxel	HUMAN PRESCRIPTION DRUG LABEL	1	43066-001	INJECTION, SOLUTION	10 mg	INTRAVENOUS	NDA	28 sections
Docetaxel	HUMAN PRESCRIPTION DRUG LABEL	1	43066-006	INJECTION, SOLUTION	10 mg	INTRAVENOUS	NDA	28 sections
Docetaxel	HUMAN PRESCRIPTION DRUG LABEL	1	43066-010	INJECTION, SOLUTION	10 mg	INTRAVENOUS	NDA	28 sections
Docetaxel	HUMAN PRESCRIPTION DRUG LABEL	1	43598-258	INJECTION, SOLUTION	20 mg	INTRAVENOUS	ANDA	26 sections
Docetaxel	HUMAN PRESCRIPTION DRUG LABEL	1	43598-259	INJECTION, SOLUTION	80 mg	INTRAVENOUS	ANDA	26 sections
Docetaxel	HUMAN PRESCRIPTION DRUG LABEL	1	43598-389	INJECTION, SOLUTION	160 mg	INTRAVENOUS	ANDA	26 sections
Docetaxel	HUMAN PRESCRIPTION DRUG LABEL	1	43598-610	INJECTION, SOLUTION	80 mg	INTRAVENOUS	ANDA	26 sections
Docetaxel	HUMAN PRESCRIPTION DRUG LABEL	1	43598-611	INJECTION, SOLUTION	20 mg	INTRAVENOUS	ANDA	26 sections
Docetaxel	HUMAN PRESCRIPTION DRUG LABEL	1	45963-734	INJECTION, SOLUTION, CONCENTRATE	20 mg	INTRAVENOUS	NDA	22 sections
Docetaxel	HUMAN PRESCRIPTION DRUG LABEL	1	45963-765	INJECTION, SOLUTION, CONCENTRATE	20 mg	INTRAVENOUS	NDA	22 sections
Docetaxel	HUMAN PRESCRIPTION DRUG LABEL	1	45963-790	INJECTION, SOLUTION, CONCENTRATE	20 mg	INTRAVENOUS	NDA	22 sections
Docetaxel	Human Prescription Drug Label	1	47335-323	INJECTION, SOLUTION	20 mg	INTRAVENOUS	NDA	30 sections