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

Stem definition	Drug id	CAS RN
	2561	10540-29-1

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: tamoxifen tamoxifen citrate tamoxifene tamoxifene citrate	One of the SELECTIVE ESTROGEN RECEPTOR MODULATORS with tissue-specific activities. Tamoxifen acts as an anti-estrogen (inhibiting agent) in the mammary tissue, but as an estrogen (stimulating agent) in cholesterol metabolism, bone density, and cell proliferation in the ENDOMETRIUM. Molecular weight: 371.52 Formula: C26H29NO CLOGP: 6.82 LIPINSKI: 1 HAC: 2 HDO: 0 TPSA: 12.47 ALOGS: -5.56 ROTB: 8 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

tamoxifen
tamoxifen citrate
tamoxifene
tamoxifene citrate

One of the SELECTIVE ESTROGEN RECEPTOR MODULATORS with tissue-specific activities. Tamoxifen acts as an anti-estrogen (inhibiting agent) in the mammary tissue, but as an estrogen (stimulating agent) in cholesterol metabolism, bone density, and cell proliferation in the ENDOMETRIUM.

Molecular weight: 371.52
Formula: C26H29NO
CLOGP: 6.82
LIPINSKI: 1
HAC: 2
HDO: 0
TPSA: 12.47
ALOGS: -5.56
ROTB: 8

Status: OFP

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

Drug dosage:

Dose	Unit	Route
20	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.50 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0.50 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	1.18 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

Date	Agency	Company	Orphan
Dec. 30, 1977	FDA

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
Metastases to bone	1569.05	11.35	559	36376	18949	56236183
Malignant neoplasm progression	1448.52	11.35	781	36154	72806	56182326
Metastases to liver	899.22	11.35	384	36551	21202	56233930
Breast cancer metastatic	886.71	11.35	346	36589	15123	56240009
Breast cancer	586.05	11.35	377	36558	48456	56206676
Metastases to lung	496.11	11.35	211	36724	11507	56243625
Metastases to lymph nodes	457.04	11.35	175	36760	7248	56247884
Breast cancer recurrent	425.01	11.35	142	36793	3933	56251199
Disease progression	382.26	11.35	405	36530	104768	56150364
Neoplasm progression	378.51	11.35	245	36690	31771	56223361
Osteonecrosis of jaw	234.26	11.35	186	36749	33172	56221960
Metastasis	201.93	11.35	86	36849	4698	56250434
Metastases to central nervous system	181.69	11.35	108	36827	12028	56243104
Rheumatoid arthritis	178.66	11.35	21	36914	382583	55872549
Metastases to spine	175.15	11.35	68	36867	2921	56252211
Uterine polyp	159.85	11.35	56	36879	1793	56253339
Hot flush	143.61	11.35	165	36770	46561	56208571
Endometrial hyperplasia	138.94	11.35	41	36894	745	56254387
Osteonecrosis	136.91	11.35	117	36818	23098	56232034
Bone disorder	132.96	11.35	107	36828	19436	56235696
PIK3CA-activated mutation	130.94	11.35	41	36894	917	56254215
Bone lesion	127.36	11.35	65	36870	5365	56249767
Second primary malignancy	127.05	11.35	72	36863	7330	56247802
Hormone receptor positive breast cancer	118.73	11.35	33	36902	479	56254653
Drug ineffective	115.14	11.35	273	36662	918716	55336416
Metastases to pleura	112.40	11.35	40	36895	1342	56253790
Tumour marker increased	108.34	11.35	54	36881	4239	56250893
Acute myeloid leukaemia	103.06	11.35	87	36848	16885	56238247
Contraindicated product administered	101.43	11.35	5	36930	186281	56068851
Sarcoma uterus	100.04	11.35	18	36917	21	56255111
Neuropathy peripheral	98.38	11.35	212	36723	102681	56152451
Endometrial hypertrophy	97.85	11.35	25	36910	257	56254875
Systemic lupus erythematosus	97.52	11.35	5	36930	180073	56075059
Hepatic lesion	97.09	11.35	50	36885	4205	56250927
Glossodynia	86.64	11.35	3	36932	152455	56102677
Joint swelling	86.55	11.35	41	36894	289759	55965373
Metastases to peritoneum	85.43	11.35	41	36894	2963	56252169
Metastases to the mediastinum	84.83	11.35	25	36910	452	56254680
Therapeutic product effect decreased	82.27	11.35	8	36927	169444	56085688
Neutropenia	81.98	11.35	259	36676	157908	56097224
Palmar-plantar erythrodysaesthesia syndrome	81.47	11.35	84	36851	20981	56234151
Metastases to skin	81.29	11.35	32	36903	1426	56253706
Hysteroscopy	81.02	11.35	15	36920	23	56255109
Bone pain	80.20	11.35	129	36806	50056	56205076
Invasive ductal breast carcinoma	80.01	11.35	52	36883	6774	56248358
Synovitis	79.96	11.35	7	36928	161298	56093834
Death	79.64	11.35	437	36498	340989	55914143
Osteolysis	78.39	11.35	37	36898	2576	56252556
Device related thrombosis	78.16	11.35	32	36903	1581	56253551
Pseudocirrhosis	77.55	11.35	25	36910	616	56254516
Endometrial cancer	76.12	11.35	38	36897	2992	56252140
Tonsillar disorder	68.15	11.35	26	36909	1064	56254068
Lymphoedema	68.12	11.35	56	36879	10474	56244658
Recurrent cancer	67.79	11.35	30	36905	1798	56253334
Carbohydrate antigen 15-3 increased	67.73	11.35	27	36908	1244	56253888
Uterine cancer	67.39	11.35	40	36895	4439	56250693
Endometrial atrophy	66.13	11.35	14	36921	56	56255076
Nasal disorder	63.74	11.35	32	36903	2550	56252582
Wound	63.71	11.35	8	36927	138796	56116336
Pleural effusion	62.91	11.35	159	36776	85321	56169811
Pulmonary mass	62.37	11.35	72	36863	20398	56234734
Blood uric acid decreased	62.10	11.35	22	36913	728	56254404
Nail disorder	60.05	11.35	54	36881	11397	56243735
Abdominal discomfort	58.99	11.35	57	36878	277217	55977915
Metastases to pelvis	58.55	11.35	18	36917	378	56254754
Excessive eye blinking	58.40	11.35	23	36912	1026	56254106
Lymphadenopathy	58.30	11.35	92	36843	35116	56220016
Acute promyelocytic leukaemia	57.40	11.35	22	36913	912	56254220
Endocervical curettage	56.97	11.35	9	36926	0	56255132
Eosinophil percentage increased	55.85	11.35	22	36913	982	56254150
Eastern Cooperative Oncology Group performance status worsened	54.75	11.35	21	36914	872	56254260
Maternal exposure during pregnancy	54.75	11.35	28	36907	189525	56065607
Hepatic enzyme increased	54.67	11.35	22	36913	171362	56083770
Ascites	53.92	11.35	92	36843	37452	56217680
Metastases to chest wall	53.83	11.35	18	36917	499	56254633
Breast mass	53.26	11.35	41	36894	6978	56248154
Ovarian hyperstimulation syndrome	53.25	11.35	32	36903	3632	56251500
Left ventricular dilatation	51.09	11.35	17	36918	464	56254668
Ovarian cancer	50.79	11.35	38	36897	6200	56248932
Metastases to thorax	49.70	11.35	14	36921	214	56254918
Swelling	49.03	11.35	51	36884	239720	56015412
Recall phenomenon	47.97	11.35	17	36918	563	56254569
Ejection fraction decreased	47.82	11.35	62	36873	19779	56235353
Disease recurrence	47.56	11.35	68	36867	23792	56231340
Hypersensitivity	46.54	11.35	60	36875	256348	55998784
Hypertriglyceridaemia	46.39	11.35	35	36900	5781	56249351
Tooth extraction	46.33	11.35	43	36892	9450	56245682
Vitreous detachment	45.36	11.35	23	36912	1872	56253260
Lymphangiosis carcinomatosa	44.72	11.35	20	36915	1229	56253903
Completed suicide	44.64	11.35	16	36919	133817	56121315
Peritoneal disorder	43.83	11.35	15	36920	447	56254685
Endometriosis	43.63	11.35	31	36904	4671	56250461
Infusion related reaction	43.20	11.35	44	36891	208887	56046245
Uterine leiomyoma	43.07	11.35	39	36896	8303	56246829
Treatment failure	42.43	11.35	30	36905	170362	56084770
Vulvovaginal dryness	42.36	11.35	24	36911	2441	56252691
Metastases to ovary	42.25	11.35	14	36921	377	56254755
Product use issue	42.21	11.35	36	36899	186005	56069127
Invasive lobular breast carcinoma	42.06	11.35	17	36918	812	56254320
Retinopathy	42.06	11.35	25	36910	2781	56252351
Pericarditis	41.85	11.35	10	36925	108913	56146219
Dural arteriovenous fistula	41.54	11.35	8	36927	17	56255115
Metastatic neoplasm	41.48	11.35	28	36907	3885	56251247
Rash	41.28	11.35	175	36760	492872	55762260
Sinusitis	40.41	11.35	42	36893	197539	56057593
Exposure during pregnancy	39.56	11.35	20	36915	136322	56118810
Cerebral venous thrombosis	39.42	11.35	21	36914	1892	56253240
Arthropathy	39.37	11.35	44	36891	200231	56054901
Haematotoxicity	39.04	11.35	37	36898	8346	56246786
Lymphadenopathy mediastinal	38.28	11.35	23	36912	2610	56252522
Polyneuropathy	38.25	11.35	45	36890	13005	56242127
Pulmonary embolism	37.17	11.35	154	36781	106970	56148162
Breast cancer female	36.92	11.35	43	36892	12295	56242837
Pneumonia	36.89	11.35	140	36795	406958	55848174
Metastases to muscle	36.78	11.35	10	36925	133	56254999
Bronchomalacia	36.72	11.35	11	36924	211	56254921
Onycholysis	36.67	11.35	18	36917	1366	56253766
Endometrial thickening	35.84	11.35	12	36923	334	56254798
Maculopathy	35.39	11.35	20	36915	2024	56253108
BRAF gene mutation	35.25	11.35	8	36927	47	56255085
Spinal cord compression	35.23	11.35	25	36910	3759	56251373
Endometrial disorder	35.04	11.35	14	36921	649	56254483
Drug hypersensitivity	34.77	11.35	81	36854	275124	55980008
Radiation necrosis	34.46	11.35	12	36923	377	56254755
Portal hypertension	34.37	11.35	24	36911	3517	56251615
Exposed bone in jaw	34.12	11.35	22	36913	2826	56252306
Condition aggravated	33.62	11.35	115	36820	344783	55910349
Blood creatinine decreased	32.43	11.35	27	36908	5139	56249993
Ovarian endometrioid carcinoma	32.31	11.35	7	36928	32	56255100
Malignant pleural effusion	32.29	11.35	20	36915	2396	56252736
Menopause	31.99	11.35	20	36915	2436	56252696
Bone cancer metastatic	31.62	11.35	9	36926	143	56254989
Metastases to uterus	31.33	11.35	8	36927	82	56255050
Nasopharyngitis	31.27	11.35	61	36874	220898	56034234
Radiation skin injury	31.23	11.35	14	36921	865	56254267
Pain	30.70	11.35	283	36652	662901	55592231
Left ventricular dysfunction	30.37	11.35	37	36898	11086	56244046
Pleural disorder	30.16	11.35	12	36923	550	56254582
Menopausal disorder	29.79	11.35	7	36928	49	56255083
Discomfort	29.12	11.35	30	36905	141731	56113401
Osteosclerosis	29.12	11.35	22	36913	3641	56251491
Hydrothorax	29.00	11.35	13	36922	803	56254329
Oestrogen receptor assay positive	28.54	11.35	11	36924	463	56254669
Drug abuse	28.47	11.35	5	36930	67605	56187527
Hypertransaminasaemia	28.30	11.35	24	36911	4683	56250449
Cervical polyp	28.18	11.35	9	36926	215	56254917
Atrophic vulvovaginitis	28.08	11.35	16	36919	1645	56253487
Acquired gene mutation	27.97	11.35	13	36922	874	56254258
Uterine dilation and curettage	27.90	11.35	13	36922	879	56254253
Cardiac cirrhosis	27.89	11.35	8	36927	131	56255001
Adnexa uteri mass	27.67	11.35	11	36924	503	56254629
Tumour invasion	27.55	11.35	8	36927	137	56254995
Adenocarcinoma	27.32	11.35	19	36916	2766	56252366
Osteitis condensans	27.09	11.35	6	36929	31	56255101
Central nervous system lesion	27.04	11.35	33	36902	9905	56245227
Neoplasm recurrence	27	11.35	18	36917	2446	56252686
Mucosal inflammation	26.78	11.35	75	36860	42735	56212397
Hepatic cirrhosis	26.52	11.35	49	36886	21214	56233918
Oestradiol abnormal	26.47	11.35	6	36929	35	56255097
RET gene mutation	26.16	11.35	5	36930	10	56255122
Pain in jaw	25.89	11.35	71	36864	39965	56215167
Porphyria non-acute	25.63	11.35	9	36926	290	56254842
Tympanic membrane disorder	25.50	11.35	8	36927	180	56254952
Jaw operation	25.45	11.35	12	36923	833	56254299
Metastases to stomach	25.30	11.35	8	36927	185	56254947
Infection	25.21	11.35	59	36876	200147	56054985
Bone sequestrum	25.09	11.35	14	36921	1383	56253749
Vaginal haemorrhage	24.61	11.35	53	36882	25620	56229512
Psoriatic arthropathy	24.41	11.35	9	36926	73999	56181133
Gingival bleeding	24.36	11.35	34	36901	11632	56243500
Radiation pneumonitis	24.25	11.35	14	36921	1475	56253657
Muscle injury	24.14	11.35	3	36932	52497	56202635
Mucosal toxicity	23.88	11.35	9	36926	356	56254776
Ovarian cancer stage IV	23.42	11.35	8	36927	237	56254895
Actinomycosis	23.39	11.35	12	36923	1001	56254131
Tumour marker decreased	23.37	11.35	6	36929	63	56255069
Deprescribing error	23.23	11.35	5	36930	22	56255110
Metastases to eye	23.18	11.35	7	36928	138	56254994
HER2 positive breast cancer	23.01	11.35	9	36926	394	56254738
Breast disorder	22.92	11.35	16	36919	2343	56252789
Jaw disorder	22.84	11.35	22	36913	5061	56250071
Gastrointestinal toxicity	22.81	11.35	24	36911	6132	56249000
Sequestrectomy	22.75	11.35	11	36924	808	56254324
Injection site pain	22.70	11.35	26	36909	117092	56138040
Leiomyoma	22.65	11.35	9	36926	411	56254721
Blister	22.41	11.35	23	36912	108864	56146268
Peripheral swelling	22.35	11.35	79	36856	234647	56020485
Malignant neoplasm of pleura	22.34	11.35	6	36929	76	56255056
Pathological fracture	22.24	11.35	27	36908	8062	56247070
Ovarian granulosa cell tumour	22.23	11.35	5	36930	28	56255104
Invasive breast carcinoma	21.86	11.35	10	36925	648	56254484
Metastases to breast	21.84	11.35	8	36927	292	56254840
Malignant neoplasm of choroid	21.66	11.35	4	36931	6	56255126
Hepatic steatosis	21.65	11.35	51	36884	26163	56228969
Dental operation	21.37	11.35	12	36923	1200	56253932
Contusion	21.32	11.35	32	36903	128398	56126734
Metastases to bone marrow	21.26	11.35	8	36927	315	56254817
Fibrous histiocytoma	21.17	11.35	9	36926	489	56254643
Abdominal lymphadenopathy	21.13	11.35	10	36925	700	56254432
Skin hypopigmentation	21.03	11.35	10	36925	708	56254424
Hysterectomy	20.94	11.35	27	36908	8564	56246568
Central nervous system infection	20.83	11.35	10	36925	723	56254409
Toothache	20.81	11.35	40	36895	17840	56237292
Arteriovenous malformation	20.48	11.35	12	36923	1300	56253832
Ventricular hypokinesia	20.44	11.35	19	36916	4182	56250950
Jaundice	20.30	11.35	51	36884	27243	56227889
Performance status decreased	20.10	11.35	17	36918	3306	56251826
Alopecia	19.95	11.35	112	36823	293346	55961786
Therapy partial responder	19.82	11.35	25	36910	7760	56247372
Neutrophilia	19.55	11.35	18	36917	3915	56251217
Intentional product use issue	19.48	11.35	22	36913	99711	56155421
Loss of personal independence in daily activities	19.37	11.35	15	36920	81354	56173778
Pruritus	19.34	11.35	125	36810	316498	55938634
Folliculitis	19.32	11.35	6	36929	54973	56200159
Meningeal disorder	19.28	11.35	7	36928	249	56254883
Therapeutic product effect incomplete	19.01	11.35	25	36910	106006	56149126
Uterine polypectomy	18.99	11.35	3	36932	0	56255132
Pulmonary radiation injury	18.99	11.35	3	36932	0	56255132
Weight increased	18.87	11.35	82	36853	229621	56025511
Injection site extravasation	18.83	11.35	25	36910	8159	56246973
Product dose omission issue	18.77	11.35	70	36865	204683	56050449
Osteomyelitis	18.64	11.35	46	36889	24300	56230832
Neoplasm	18.64	11.35	22	36913	6379	56248753
Congestive cardiomyopathy	18.62	11.35	21	36914	5798	56249334
Cardiotoxicity	18.58	11.35	24	36911	7626	56247506
Polypectomy	18.56	11.35	9	36926	665	56254467
Amenorrhoea	18.48	11.35	26	36909	8960	56246172
Intentional overdose	18.29	11.35	11	36924	68106	56187026
Oxygen saturation decreased	18.28	11.35	15	36920	79052	56176080
Breath odour	18.28	11.35	11	36924	1251	56253881
Myelodysplastic syndrome	18.24	11.35	36	36899	16370	56238762
Ovarian cyst	18.22	11.35	34	36901	14832	56240300
Respiratory tract oedema	18.21	11.35	8	36927	471	56254661
Carcinoembryonic antigen increased	18.21	11.35	12	36923	1600	56253532
Activated PI3 kinase delta syndrome	18.17	11.35	4	36931	20	56255112
Gastrointestinal haemorrhage	18.08	11.35	14	36921	75937	56179195
Portal vein thrombosis	18.05	11.35	14	36921	2409	56252723
Adenomyosis	17.94	11.35	8	36927	488	56254644
Lymphangioleiomyomatosis	17.92	11.35	6	36929	167	56254965
Hydronephrosis	17.92	11.35	26	36909	9216	56245916
Skin exfoliation	17.78	11.35	59	36876	36841	56218291
Somnolence	17.63	11.35	52	36883	163361	56091771
Oophorectomy	17.51	11.35	8	36927	517	56254615
Aeromonas infection	17.48	11.35	5	36930	81	56255051
Disturbance in attention	17.47	11.35	54	36881	32486	56222646
Breast neoplasm	17.41	11.35	11	36924	1365	56253767
Macular hole	17.40	11.35	9	36926	763	56254369
Corneal graft rejection	17.28	11.35	4	36931	26	56255106
Corneal degeneration	17.25	11.35	5	36930	85	56255047
Paraneoplastic syndrome	17.22	11.35	8	36927	537	56254595
Knee arthroplasty	17.12	11.35	4	36931	44255	56210877
Menopausal symptoms	17.10	11.35	13	36922	2172	56252960
Myalgia	16.89	11.35	146	36789	131879	56123253
Cerebral haemorrhage	16.80	11.35	49	36886	28557	56226575
Diabetic hyperosmolar coma	16.79	11.35	7	36928	362	56254770
Blood alkaline phosphatase increased	16.78	11.35	60	36875	38885	56216247
Respiratory tract inflammation	16.73	11.35	8	36927	573	56254559
Non-alcoholic steatohepatitis	16.67	11.35	11	36924	1470	56253662
Cortisol increased	16.35	11.35	7	36928	387	56254745
Debridement	16.31	11.35	10	36925	1177	56253955
Nasal dryness	16.22	11.35	16	36919	3790	56251342
Atrial thrombosis	16.18	11.35	11	36924	1544	56253588
Septic shock	16.09	11.35	10	36925	60825	56194307
Libido decreased	15.98	11.35	13	36922	2395	56252737
Headache	15.80	11.35	265	36670	558779	55696353
Blood bilirubin increased	15.78	11.35	53	36882	33301	56221831
Sensory loss	15.69	11.35	24	36911	8911	56246221
Liver scan abnormal	15.58	11.35	4	36931	42	56255090
Fibromyalgia	15.48	11.35	10	36925	59593	56195539
Intermenstrual bleeding	15.45	11.35	21	36914	7006	56248126
Gingivitis	15.40	11.35	22	36913	7687	56247445
Rapidly progressive osteoarthritis	15.38	11.35	3	36932	7	56255125
Uterine haemorrhage	15.31	11.35	15	36920	3525	56251607
Acarodermatitis	15.30	11.35	9	36926	982	56254150
Mobility decreased	15.17	11.35	26	36909	98965	56156167
Salpingitis	15.14	11.35	6	36929	272	56254860
Rhabdomyolysis	15.09	11.35	4	36931	40654	56214478
Oral pustule	15.09	11.35	4	36931	48	56255084
Desmoid tumour	15.08	11.35	5	36930	135	56254997
Vertebral lesion	15.00	11.35	7	36928	475	56254657
Paraesthesia	14.99	11.35	141	36794	130373	56124759
Cardiomyopathy	14.94	11.35	33	36902	16225	56238907
Drug resistance	14.87	11.35	38	36897	20504	56234628
Blood follicle stimulating hormone decreased	14.84	11.35	3	36932	9	56255123
Haemangioma of liver	14.83	11.35	9	36926	1040	56254092
Periodontitis	14.80	11.35	14	36921	3149	56251983
Breast pain	14.79	11.35	22	36913	7972	56247160
Salpingo-oophorectomy bilateral	14.74	11.35	5	36930	145	56254987
Oesophageal varices haemorrhage	14.73	11.35	9	36926	1052	56254080
Acute kidney injury	14.72	11.35	95	36840	240668	56014464
Coagulation factor V level decreased	14.70	11.35	6	36929	294	56254838
Visual acuity reduced	14.66	11.35	38	36897	20688	56234444
Deafness	14.62	11.35	33	36902	16461	56238671
Blood copper increased	14.60	11.35	3	36932	10	56255122
Toxicity to various agents	14.56	11.35	87	36848	224477	56030655
Intraductal proliferative breast lesion	14.55	11.35	13	36922	2720	56252412
Acute lymphocytic leukaemia	14.50	11.35	13	36922	2731	56252401
Blood follicle stimulating hormone increased	14.48	11.35	5	36930	153	56254979
Neurotoxicity	14.45	11.35	32	36903	15763	56239369
Breast cancer stage IV	14.40	11.35	11	36924	1851	56253281
Adenoid cystic carcinoma	14.38	11.35	3	36932	11	56255121
Breast cancer in situ	14.37	11.35	10	36925	1458	56253674
Diverticulitis	14.35	11.35	3	36932	35849	56219283
Hydrocephalus	14.28	11.35	17	36918	4972	56250160
Chronic hepatic failure	14.24	11.35	7	36928	533	56254599
Injection site erythema	14.15	11.35	18	36917	77430	56177702
Atypical femur fracture	14.12	11.35	17	36918	5030	56250102
Hair texture abnormal	14.11	11.35	15	36920	3877	56251255
Encephalopathy	14.05	11.35	3	36932	35322	56219810
Retinal artery occlusion	13.95	11.35	10	36925	1528	56253604
Trigger finger	13.92	11.35	15	36920	3938	56251194
Encapsulating peritoneal sclerosis	13.91	11.35	6	36929	338	56254794
Musculoskeletal chest pain	13.88	11.35	36	36899	19605	56235527
Varices oesophageal	13.83	11.35	13	36922	2903	56252229
Pelvic mass	13.80	11.35	9	36926	1179	56253953
Anorectal disorder	13.73	11.35	10	36925	1565	56253567
Blood lactate dehydrogenase increased	13.70	11.35	37	36898	20638	56234494
Heart rate irregular	13.69	11.35	37	36898	20642	56234490
Oral mucosal hypertrophy	13.62	11.35	3	36932	15	56255117
Urticaria	13.55	11.35	49	36886	144627	56110505
Postmenopausal haemorrhage	13.53	11.35	11	36924	2025	56253107
Hepatic cancer metastatic	13.46	11.35	6	36929	366	56254766
Metastases to neck	13.44	11.35	4	36931	75	56255057
Ovarian cancer metastatic	13.34	11.35	8	36927	904	56254228
Sepsis	13.34	11.35	47	36888	139793	56115339
Blood cholesterol increased	13.12	11.35	17	36918	72562	56182570
Papillary thyroid cancer	13.12	11.35	11	36924	2113	56253019
Migraine	13.11	11.35	23	36912	86774	56168358
Ocular toxicity	12.82	11.35	7	36928	662	56254470
Myocardial infarction	12.81	11.35	26	36909	92844	56162288
Internal fixation of fracture	12.78	11.35	7	36928	667	56254465
Oestradiol increased	12.75	11.35	4	36931	90	56255042
Corneal disorder	12.73	11.35	10	36925	1752	56253380
Breast reconstruction	12.55	11.35	5	36930	230	56254902
Purulent discharge	12.54	11.35	15	36920	4409	56250723
Madarosis	12.53	11.35	12	36923	2741	56252391
Blood phosphorus increased	12.45	11.35	12	36923	2764	56252368
Injection site reaction	12.44	11.35	10	36925	53237	56201895
Multiple sclerosis relapse	12.41	11.35	7	36928	44896	56210236
Pneumonia aspiration	12.40	11.35	3	36932	32408	56222724
Hypotension	12.36	11.35	105	36830	250403	56004729
Metastases to adrenals	12.31	11.35	7	36928	717	56254415
Superior sagittal sinus thrombosis	12.28	11.35	7	36928	720	56254412
Adverse event	12.20	11.35	11	36924	55365	56199767
Blood potassium abnormal	12.18	11.35	11	36924	2334	56252798
Dental caries	12.14	11.35	23	36912	10145	56244987
Incorrect dose administered	12.11	11.35	10	36925	52537	56202595
Alopecia areata	12.08	11.35	9	36926	1458	56253674
Blood phosphorus decreased	12.07	11.35	14	36921	3983	56251149
Reversible cerebral vasoconstriction syndrome	12.05	11.35	11	36924	2366	56252766
Hair colour changes	12.02	11.35	12	36923	2883	56252249
Vein disorder	11.98	11.35	15	36920	4622	56250510
Neoplasm malignant	11.93	11.35	42	36893	27013	56228119
Psoriasis	11.91	11.35	27	36908	92665	56162467
Overdose	11.91	11.35	33	36902	105797	56149335
Brain abscess	11.85	11.35	10	36925	1939	56253193
Serous cystadenocarcinoma ovary	11.82	11.35	3	36932	30	56255102
Ear infection	11.77	11.35	3	36932	31292	56223840
Drug intolerance	11.76	11.35	114	36821	264704	55990428
Eosinophil count increased	11.76	11.35	22	36913	9615	56245517
Mastectomy	11.75	11.35	9	36926	1521	56253611
Fungal disease carrier	11.73	11.35	3	36932	31	56255101
Ovarian granulosa-theca cell tumour	11.73	11.35	3	36932	31	56255101
HER2 gene amplification	11.73	11.35	3	36932	31	56255101
Blood pressure fluctuation	11.58	11.35	6	36929	40354	56214778
Human epidermal growth factor receptor negative	11.56	11.35	3	36932	33	56255099
Glutamate dehydrogenase increased	11.56	11.35	3	36932	33	56255099
Tooth disorder	11.55	11.35	40	36895	25513	56229619
Pulmonary hypoplasia	11.53	11.35	5	36930	285	56254847
Intestinal metastasis	11.51	11.35	4	36931	125	56255007
Back pain	11.50	11.35	219	36716	236951	56018181
Bile duct stenosis	11.49	11.35	8	36927	1166	56253966
Ill-defined disorder	11.45	11.35	17	36918	68526	56186606
Musculoskeletal stiffness	11.44	11.35	58	36877	155949	56099183

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
Metastases to bone	78.76	27.39	25	1157	10823	31685339
Carbohydrate antigen 15-3 increased	63.26	27.39	9	1173	70	31696092
Encapsulating peritoneal sclerosis	45.18	27.39	9	1173	581	31695581
Desmoid tumour	43.43	27.39	7	1175	133	31696029
Metastases to lung	43.40	27.39	15	1167	8407	31687755
Metastases to central nervous system	33.24	27.39	12	1170	7624	31688538
Metastases to the mediastinum	32.92	27.39	6	1176	240	31695922
Malignant neoplasm progression	31.62	27.39	25	1157	78973	31617189
PIK3CA-activated mutation	31.02	27.39	5	1177	95	31696067
Hepatic lesion	29.78	27.39	9	1173	3294	31692868

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
Metastases to bone	1228.22	12.60	428	28699	21948	70877369
Malignant neoplasm progression	765.81	12.60	526	28601	121213	70778104
Breast cancer metastatic	693.56	12.60	229	28898	9917	70889400
Metastases to liver	535.35	12.60	245	28882	25633	70873684
Breast cancer	518.62	12.60	260	28867	33289	70866028
Metastases to lung	471.07	12.60	196	28931	16288	70883029
Metastases to lymph nodes	354.88	12.60	136	28991	9102	70890215
Breast cancer recurrent	343.65	12.60	99	29028	2694	70896623
Neoplasm progression	236.53	12.60	175	28952	45053	70854264
Disease progression	191.04	12.60	276	28851	156396	70742921
Osteonecrosis of jaw	188.65	12.60	147	28980	40855	70858462
Metastases to central nervous system	162.84	12.60	92	29035	14942	70884375
Metastases to spine	149.28	12.60	57	29070	3772	70895545
Bone lesion	126.79	12.60	56	29071	5374	70893943
Hot flush	118.76	12.60	123	29004	49461	70849856
Sarcoma uterus	113.79	12.60	18	29109	11	70899306
Tumour marker increased	107.94	12.60	45	29082	3749	70895568
Osteonecrosis	101.60	12.60	89	29038	29071	70870246
Second primary malignancy	95.21	12.60	62	29065	12989	70886328
Hepatic lesion	90.29	12.60	46	29081	6071	70893246
Metastases to skin	89.70	12.60	31	29096	1540	70897777
Metastases to the mediastinum	88.48	12.60	24	29103	520	70898797
Acute myeloid leukaemia	87.45	12.60	84	29043	30856	70868461
Metastasis	87.42	12.60	45	29082	6069	70893248
PIK3CA-activated mutation	87.20	12.60	24	29103	550	70898767
Pseudocirrhosis	84.21	12.60	24	29103	627	70898690
Invasive ductal breast carcinoma	83.76	12.60	43	29084	5766	70893551
Neuropathy peripheral	83.36	12.60	170	28957	126726	70772591
Endometrial cancer	82.29	12.60	31	29096	1976	70897341
Endometrial hyperplasia	79.01	12.60	22	29105	527	70898790
Breast mass	78.18	12.60	41	29086	5744	70893573
Uterine polyp	77.43	12.60	27	29100	1378	70897939
Carbohydrate antigen 15-3 increased	76.76	12.60	25	29102	1033	70898284
Bone disorder	76.73	12.60	61	29066	17429	70881888
Tonsillar disorder	75.94	12.60	25	29102	1069	70898248
Device related thrombosis	73.59	12.60	30	29097	2360	70896957
Rheumatoid arthritis	71.80	12.60	16	29111	291789	70607528
Endometrial atrophy	71.69	12.60	13	29114	34	70899283
Metastases to pleura	71.37	12.60	25	29102	1293	70898024
Lymphadenopathy	65.33	12.60	90	29037	48701	70850616
Hormone receptor positive breast cancer	65.13	12.60	17	29110	316	70899001
Lymphoedema	64.67	12.60	46	29081	11123	70888194
Bone pain	62.49	12.60	90	29037	50732	70848585
Nasal disorder	61.09	12.60	29	29098	3285	70896032
Metastases to chest wall	60.36	12.60	17	29110	425	70898892
Blood uric acid decreased	58.30	12.60	21	29106	1179	70898138
Nail disorder	58.22	12.60	42	29085	10382	70888935
Pulmonary mass	57.72	12.60	62	29065	25971	70873346
Acute promyelocytic leukaemia	57.26	12.60	22	29105	1480	70897837
Osteolysis	56.45	12.60	28	29099	3491	70895826
Eosinophil percentage increased	54.43	12.60	21	29106	1429	70897888
Completed suicide	52.83	12.60	14	29113	227121	70672196
Eastern Cooperative Oncology Group performance status worsened	52.32	12.60	21	29106	1587	70897730
Metastases to pelvis	51.67	12.60	16	29111	560	70898757
Mucosal toxicity	51.13	12.60	16	29111	580	70898737
Excessive eye blinking	50.93	12.60	20	29107	1427	70897890
Uterine cancer	50.73	12.60	26	29101	3473	70895844
Recurrent cancer	50.07	12.60	23	29104	2418	70896899
Maculopathy	48.47	12.60	23	29104	2603	70896714
Disease recurrence	48.29	12.60	68	29059	37535	70861782
Retinopathy	47.81	12.60	25	29102	3481	70895836
Vitreous detachment	47.17	12.60	21	29106	2052	70897265
Left ventricular dilatation	46.25	12.60	17	29110	1011	70898306
Metastases to peritoneum	45.80	12.60	25	29102	3794	70895523
Recall phenomenon	45.76	12.60	17	29110	1042	70898275
Lymphangiosis carcinomatosa	45.65	12.60	20	29107	1881	70897436
Joint swelling	44.90	12.60	24	29103	253187	70646130
Endometrial hypertrophy	44.54	12.60	11	29116	162	70899155
Ovarian cancer	44.00	12.60	25	29102	4100	70895217
Cerebral venous thrombosis	43.30	12.60	21	29106	2494	70896823
Bronchomalacia	41.82	12.60	11	29116	211	70899106
Lymphadenopathy mediastinal	41.76	12.60	24	29103	4021	70895296
Peritoneal disorder	41.17	12.60	14	29113	662	70898655
Metastases to eye	41.01	12.60	11	29116	228	70899089
Neutropenia	40.15	12.60	210	28917	256946	70642371
Endometrial thickening	39.56	12.60	11	29116	262	70899055
Drug ineffective	39.43	12.60	226	28901	939526	69959791
Pulmonary embolism	39.35	12.60	147	28980	155720	70743597
Uterine leiomyoma	38.92	12.60	26	29101	5681	70893636
Metastases to ovary	38.65	12.60	11	29116	286	70899031
Contraindicated product administered	38.31	12.60	5	29122	134607	70764710
Pneumonia	38.12	12.60	122	29005	596110	70303207
Desmoid tumour	37.81	12.60	10	29117	196	70899121
Adnexa uteri mass	37.73	12.60	11	29116	312	70899005
Ejection fraction decreased	37.11	12.60	54	29073	30708	70868609
Hypertriglyceridaemia	37.07	12.60	34	29093	11777	70887540
Therapeutic product effect decreased	36.89	12.60	7	29120	143011	70756306
Breast cancer female	36.50	12.60	32	29095	10454	70888863
Synovitis	36.30	12.60	5	29122	129223	70770094
Endometriosis	35.56	12.60	20	29107	3216	70896101
Radiation necrosis	35.31	12.60	11	29116	393	70898924
Palmar-plantar erythrodysaesthesia syndrome	34.90	12.60	52	29075	30195	70869122
Haematotoxicity	34.68	12.60	35	29092	13639	70885678
Menopausal disorder	34.28	12.60	7	29120	40	70899277
Acute kidney injury	34.02	12.60	92	29035	474532	70424785
Menopause	33.92	12.60	16	29111	1787	70897530
Vulvovaginal dryness	33.89	12.60	16	29111	1790	70897527
Pathological fracture	32.87	12.60	29	29098	9554	70889763
Left ventricular dysfunction	31.70	12.60	38	29089	17919	70881398
Tooth extraction	31.54	12.60	29	29098	10078	70889239
Pleural disorder	31.26	12.60	12	29115	805	70898512
Systemic lupus erythematosus	30.97	12.60	3	29124	101899	70797418
Blood creatinine decreased	30.88	12.60	25	29102	7324	70891993
Invasive lobular breast carcinoma	30.27	12.60	11	29116	633	70898684
Pleural effusion	30.01	12.60	121	29006	132743	70766574
Osteitis condensans	29.89	12.60	6	29121	31	70899286
Metastases to thorax	29.51	12.60	8	29119	173	70899144
Tympanic membrane disorder	29.20	12.60	8	29119	180	70899137
Invasive breast carcinoma	28.28	12.60	10	29117	532	70898785
Malignant pleural effusion	28.14	12.60	17	29110	3122	70896195
Radiation pneumonitis	28.05	12.60	18	29109	3675	70895642
Cardiac cirrhosis	27.82	12.60	8	29119	216	70899101
Ascites	27.38	12.60	75	29052	67472	70831845
Tumour marker decreased	27.20	12.60	6	29121	52	70899265
Portal hypertension	27.10	12.60	22	29105	6470	70892847
Atrophic vulvovaginitis	26.66	12.60	12	29115	1203	70898114
Metastatic neoplasm	26.58	12.60	19	29108	4629	70894688
Exposed bone in jaw	26.22	12.60	17	29110	3532	70895785
Hepatic enzyme increased	26.21	12.60	16	29111	156974	70742343
Arteriovenous malformation	25.94	12.60	13	29114	1657	70897660
Metastases to uterus	25.91	12.60	6	29121	66	70899251
Menopausal symptoms	25.62	12.60	13	29114	1701	70897616
Sepsis	25.56	12.60	38	29089	244507	70654810
Osteosclerosis	25.56	12.60	17	29110	3688	70895629
Deprescribing error	25.39	12.60	5	29122	23	70899294
Radiation skin injury	25.35	12.60	12	29115	1351	70897966
Glossodynia	25.12	12.60	3	29124	86484	70812833
Vaginal haemorrhage	24.94	12.60	36	29091	20316	70879001
Hypertransaminasaemia	24.73	12.60	24	29103	8919	70890398
Gastrointestinal haemorrhage	24.38	12.60	13	29114	137395	70761922
Hepatic steatosis	24.21	12.60	47	29080	33766	70865551
Septic shock	24.11	12.60	8	29119	112250	70787067
Sequestrectomy	23.87	12.60	10	29117	843	70898474
Toxicity to various agents	23.82	12.60	79	29048	382093	70517224
Paraesthesia	23.48	12.60	120	29007	145417	70753900
Breast cancer in situ	23.23	12.60	10	29117	901	70898416
Fibrous histiocytoma	23.22	12.60	9	29118	620	70898697
Gastrointestinal toxicity	23.21	12.60	20	29107	6385	70892932
Wound	23.10	12.60	6	29121	98726	70800591
Disturbance in attention	23.02	12.60	53	29074	42841	70856476
Myocardial infarction	22.91	12.60	22	29105	171623	70727694
RET gene mutation	22.80	12.60	4	29123	8	70899309
Cardiotoxicity	22.17	12.60	25	29102	11045	70888272
Drug abuse	21.93	12.60	17	29110	147239	70752078
Hypersensitivity	21.86	12.60	38	29089	229774	70669543
Adenomyosis	21.85	12.60	7	29120	274	70899043
Porphyria non-acute	21.75	12.60	9	29118	735	70898582
Gingival bleeding	21.75	12.60	29	29098	15203	70884114
Cervical polyp	21.66	12.60	6	29121	141	70899176
Injection site extravasation	21.47	12.60	22	29105	8724	70890593
Therapy partial responder	21.37	12.60	26	29101	12448	70886869
Lymphangioleiomyomatosis	21.34	12.60	6	29121	149	70899168
Hepatic cirrhosis	21.14	12.60	42	29085	30689	70868628
Non-alcoholic steatohepatitis	20.86	12.60	12	29115	2015	70897302
Leiomyoma	20.69	12.60	7	29120	326	70898991
Nasal dryness	20.57	12.60	15	29112	3768	70895549
Toothache	20.29	12.60	31	29096	18399	70880918
Central nervous system infection	20.28	12.60	10	29117	1231	70898086
Oestradiol abnormal	20.20	12.60	4	29123	19	70899298
Abdominal lymphadenopathy	20.18	12.60	10	29117	1244	70898073
Tumour invasion	19.98	12.60	7	29120	362	70898955
Amenorrhoea	19.92	12.60	19	29108	6911	70892406
Sensory loss	19.88	12.60	24	29103	11395	70887922
Treatment failure	19.79	12.60	18	29109	144124	70755193
Multiple organ dysfunction syndrome	19.64	12.60	10	29117	108505	70790812
Lower limb fracture	19.59	12.60	29	29098	16743	70882574
Onycholysis	19.43	12.60	11	29116	1792	70897525
Atypical femur fracture	19.35	12.60	16	29111	4827	70894490
Oxygen saturation decreased	19.25	12.60	12	29115	116417	70782900
Superior sagittal sinus thrombosis	19.16	12.60	9	29118	995	70898322
Meningeal disorder	19.02	12.60	7	29120	418	70898899
Pain in jaw	18.93	12.60	49	29078	42620	70856697
Postmenopausal haemorrhage	18.75	12.60	10	29117	1449	70897868
Breast disorder	18.63	12.60	11	29116	1938	70897379
Madarosis	18.43	12.60	12	29115	2511	70896806
Vertebral lesion	18.37	12.60	7	29120	460	70898857
Metastases to meninges	18.35	12.60	13	29114	3123	70896194
Metastases to stomach	18.33	12.60	6	29121	252	70899065
Cortisol increased	18.17	12.60	7	29120	474	70898843
Hypotension	18.09	12.60	95	29032	404286	70495031
Cardiomyopathy	18.08	12.60	36	29091	26337	70872980
Respiratory tract oedema	18.03	12.60	8	29119	776	70898541
Ovarian hyperstimulation syndrome	17.97	12.60	13	29114	3227	70896090
Back pain	17.88	12.60	180	28947	270972	70628345
Deafness	17.86	12.60	30	29097	19273	70880044
Product use issue	17.80	12.60	29	29098	179908	70719409
Bone sequestrum	17.74	12.60	9	29118	1177	70898140
Ovarian cyst	17.72	12.60	23	29104	11749	70887568
Corneal degeneration	17.60	12.60	5	29122	129	70899188
Respiratory tract inflammation	17.54	12.60	8	29119	827	70898490
Encapsulating peritoneal sclerosis	17.52	12.60	8	29119	829	70898488
Skin toxicity	17.48	12.60	18	29109	7180	70892137
Neutrophilia	17.43	12.60	18	29109	7203	70892114
Performance status decreased	17.34	12.60	16	29111	5585	70893732
Breast pain	17.12	12.60	18	29109	7353	70891964
Hepatotoxicity	16.99	12.60	48	29079	43938	70855379
Breast neoplasm	16.95	12.60	8	29119	894	70898423
Acarodermatitis	16.88	12.60	9	29118	1303	70898014
Liver scan abnormal	16.88	12.60	4	29123	49	70899268
Polyneuropathy	16.86	12.60	31	29096	21384	70877933
Central nervous system lesion	16.70	12.60	23	29104	12430	70886887
Hydrothorax	16.60	12.60	9	29118	1347	70897970
Paraneoplastic syndrome	16.60	12.60	8	29119	937	70898380
Spinal cord compression	16.56	12.60	16	29111	5912	70893405
Metabolic acidosis	16.50	12.60	5	29122	74341	70824976
Trigger finger	16.34	12.60	13	29114	3714	70895603
Actinomycosis	16.30	12.60	8	29119	975	70898342
Intermenstrual bleeding	16.26	12.60	15	29112	5235	70894082
Corneal graft rejection	16.07	12.60	4	29123	61	70899256
Sinusitis	16.06	12.60	28	29099	169167	70730150
Hair texture abnormal	15.92	12.60	12	29115	3168	70896149
Congestive cardiomyopathy	15.90	12.60	21	29106	10905	70888412
Rapidly progressive osteoarthritis	15.78	12.60	3	29124	11	70899306
Hair colour changes	15.76	12.60	13	29114	3910	70895407
Ventricular hypokinesia	15.52	12.60	18	29109	8194	70891123
Reversible cerebral vasoconstriction syndrome	15.41	12.60	11	29116	2674	70896643
Anorectal disorder	15.32	12.60	10	29117	2101	70897216
Haemangioma of liver	15.31	12.60	8	29119	1112	70898205
Breath odour	15.30	12.60	9	29118	1575	70897742
BRCA2 gene mutation	15.29	12.60	4	29123	75	70899242
Intentional overdose	15.12	12.60	11	29116	98424	70800893
Blood potassium abnormal	15.11	12.60	11	29116	2757	70896560
Diabetic hyperosmolar coma	15.09	12.60	7	29120	752	70898565
Respiratory failure	15.06	12.60	29	29098	168706	70730611
Abdominal discomfort	15.05	12.60	42	29085	214616	70684701
Corneal disorder	15.03	12.60	10	29117	2169	70897148
Alopecia areata	15.03	12.60	9	29118	1627	70897690
Hysteroscopy	14.86	12.60	3	29124	16	70899301
Oral mucosal hypertrophy	14.86	12.60	3	29124	16	70899301
Debridement	14.82	12.60	9	29118	1668	70897649
Discomfort	14.67	12.60	13	29114	105423	70793894
Jaw operation	14.59	12.60	7	29120	812	70898505
Exposure during pregnancy	14.55	12.60	9	29118	87708	70811609
Cardio-respiratory arrest	14.51	12.60	12	29115	100665	70798652
Breast reconstruction	14.48	12.60	4	29123	93	70899224
Adenocarcinoma	14.45	12.60	12	29115	3641	70895676
Coma	14.45	12.60	10	29117	91834	70807483
Oestradiol increased	14.32	12.60	4	29123	97	70899220
Retinal artery occlusion	14.30	12.60	11	29116	2995	70896322
Dyspareunia	14.25	12.60	9	29118	1788	70897529
Pneumonia aspiration	14.17	12.60	4	29123	62285	70837032
Portal vein thrombosis	14.10	12.60	14	29113	5348	70893969
Skin exfoliation	14.08	12.60	48	29079	48578	70850739
Metastases to breast	13.98	12.60	5	29122	275	70899042
Encephalopathy	13.95	12.60	4	29123	61657	70837660
Serous cystadenocarcinoma ovary	13.81	12.60	3	29124	24	70899293
Adenoid cystic carcinoma	13.81	12.60	3	29124	24	70899293
Chronic hepatic failure	13.70	12.60	7	29120	929	70898388
Neoplasm recurrence	13.66	12.60	12	29115	3929	70895388
Atrial thrombosis	13.61	12.60	11	29116	3214	70896103
Cystoid macular oedema	13.57	12.60	9	29118	1943	70897374
Ovarian granulosa-theca cell tumour	13.40	12.60	3	29124	28	70899289
Coagulation factor V level decreased	13.38	12.60	6	29121	596	70898721
Carcinoembryonic antigen increased	13.25	12.60	9	29118	2021	70897296
Metastases to muscle	13.19	12.60	5	29122	324	70898993
Mucosal inflammation	13.14	12.60	59	29068	67791	70831526
Endometrial adenocarcinoma	13.12	12.60	7	29120	1015	70898302
Rhabdomyolysis	13.09	12.60	12	29115	95748	70803569
Gastric infection	13.07	12.60	11	29116	3400	70895917
Blood pressure fluctuation	13.04	12.60	4	29123	59008	70840309
Dental operation	12.95	12.60	7	29120	1041	70898276
Condition aggravated	12.86	12.60	113	29014	427522	70471795
Atypical fracture	12.85	12.60	6	29121	655	70898662
Infection	12.82	12.60	44	29083	210741	70688576
HER2 positive breast cancer	12.74	12.60	5	29122	356	70898961
Aeromonas infection	12.62	12.60	5	29122	365	70898952

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L02BA01	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ENDOCRINE THERAPY HORMONE ANTAGONISTS AND RELATED AGENTS Anti-estrogens
FDA MoA	N0000000168	Selective Estrogen Receptor Modulators
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D018931	Antineoplastic Agents, Hormonal
MeSH PA	D050071	Bone Density Conservation Agents
MeSH PA	D004965	Estrogen Antagonists
MeSH PA	D020847	Estrogen Receptor Modulators
MeSH PA	D006727	Hormone Antagonists
MeSH PA	D020845	Selective Estrogen Receptor Modulators
FDA EPC	N0000175826	Estrogen Agonist/Antagonist
CHEBI has role	CHEBI:35610	antineoplastic agents
CHEBI has role	CHEBI:37700	protein kinase C inhibitors
CHEBI has role	CHEBI:48422	angiogenesis antagonist
CHEBI has role	CHEBI:50646	antiosteoporotic
CHEBI has role	CHEBI:50792	estrogen receptor antagonists
CHEBI has role	CHEBI:50837	oestrogen antagonist
CHEBI has role	CHEBI:62872	quinoline oxidase inhibitors

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

Disease	Relation	SNOMED_ID	DOID
Infiltrating duct carcinoma of breast	indication	408643008	DOID:3008
Carcinoma of female breast	indication	447782002
Prevention of Breast Carcinoma	indication
Pain of breast	off-label use	53430007
Endometrial carcinoma	off-label use	254878006	DOID:2871
Malignant tumor of ovary	off-label use	363443007	DOID:2394
Hypercalcemia	contraindication	66931009	DOID:12678
Leukopenia	contraindication	84828003	DOID:615
Bilateral cataracts	contraindication	95722004
Deep venous thrombosis	contraindication	128053003
Cerebrovascular accident	contraindication	230690007
Pulmonary thromboembolism	contraindication	233935004
Pregnancy, function	contraindication	289908002
Thrombocytopenic disorder	contraindication	302215000	DOID:1588
Thromboembolic disorder	contraindication	371039008
Visual impairment	contraindication	397540003
Breastfeeding (mother)	contraindication	413712001

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.61	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Estrogen receptor	Nuclear hormone receptor	P03372	ESR1_HUMAN	MODULATOR	Ki	7.51	CHEMBL	CHEMBL
Beta-1 adrenergic receptor	GPCR	P08588	ADRB1_HUMAN		Ki	5.00	DRUG MATRIX
Prostaglandin G/H synthase 2	Enzyme	P35354	PGH2_HUMAN		IC50	4.46	WOMBAT-PK
Prostaglandin G/H synthase 1	Enzyme	P23219	PGH1_HUMAN		IC50	5.36	DRUG MATRIX
Mu-type opioid receptor	GPCR	P35372	OPRM_HUMAN		Ki	5.15	DRUG MATRIX
D(1A) dopamine receptor	GPCR	P21728	DRD1_HUMAN		Ki	5.37	DRUG MATRIX
D(2) dopamine receptor	GPCR	P14416	DRD2_HUMAN		Ki	5.34	DRUG MATRIX
Adenosine receptor A2a	GPCR	P29274	AA2AR_HUMAN		Ki	5.40	DRUG MATRIX
Alpha-2A adrenergic receptor	GPCR	P08913	ADA2A_HUMAN		Ki	6.14	DRUG MATRIX
Sigma non-opioid intracellular receptor 1	Membrane receptor	Q99720	SGMR1_HUMAN		Ki	7.50	WOMBAT-PK
Potassium voltage-gated channel subfamily H member 2	Ion channel	Q12809	KCNH2_HUMAN		IC50	5.80	CHEMBL
3-beta-hydroxysteroid-Delta(8),Delta(7)-isomerase	Enzyme	Q15125	EBP_HUMAN		Ki	8.30	WOMBAT-PK
Multidrug resistance protein 1	Transporter	P08183	MDR1_HUMAN		Ki	7	WOMBAT-PK
Sodium-dependent serotonin transporter	Transporter	P31645	SC6A4_HUMAN		Ki	5.91	DRUG MATRIX
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN		Ki	5.84	DRUG MATRIX
5-hydroxytryptamine receptor 1A	GPCR	P08908	5HT1A_HUMAN		Ki	5.16	DRUG MATRIX
5-hydroxytryptamine receptor 2A	GPCR	P28223	5HT2A_HUMAN		Ki	5.86	DRUG MATRIX
5-hydroxytryptamine receptor 2B	GPCR	P41595	5HT2B_HUMAN		Ki	5.88	DRUG MATRIX
5-hydroxytryptamine receptor 2C	GPCR	P28335	5HT2C_HUMAN		Ki	6.62	DRUG MATRIX
5-hydroxytryptamine receptor 6	GPCR	P50406	5HT6R_HUMAN		Ki	5.98	CHEMBL
Alpha-2B adrenergic receptor	GPCR	P18089	ADA2B_HUMAN		Ki	5.79	DRUG MATRIX
D(3) dopamine receptor	GPCR	P35462	DRD3_HUMAN		Ki	6.44	DRUG MATRIX
Histamine H2 receptor	GPCR	P25021	HRH2_HUMAN		Ki	5.03	DRUG MATRIX
Muscarinic acetylcholine receptor M1	GPCR	P11229	ACM1_HUMAN		Ki	6.17	DRUG MATRIX
Muscarinic acetylcholine receptor M2	GPCR	P08172	ACM2_HUMAN		Ki	5.56	DRUG MATRIX
Muscarinic acetylcholine receptor M3	GPCR	P20309	ACM3_HUMAN		Ki	6.20	DRUG MATRIX
Muscarinic acetylcholine receptor M4	GPCR	P08173	ACM4_HUMAN		Ki	6.17	DRUG MATRIX
Muscarinic acetylcholine receptor M5	GPCR	P08912	ACM5_HUMAN		Ki	5.73	DRUG MATRIX
Aldehyde oxidase	Enzyme	Q06278	AOXA_HUMAN		IC50	5.66	WOMBAT-PK
Beta-3 adrenergic receptor	GPCR	P13945	ADRB3_HUMAN		Ki	5.24	DRUG MATRIX
Sodium-dependent dopamine transporter	Transporter	Q01959	SC6A3_HUMAN		Ki	5.84	DRUG MATRIX
Adenosine receptor A1	GPCR	P30542	AA1R_HUMAN		Ki	4.86	DRUG MATRIX
Adenosine receptor A3	GPCR	P0DMS8	AA3R_HUMAN		Ki	5.68	DRUG MATRIX
Nuclear receptor subfamily 1 group I member 2	Nuclear hormone receptor	O75469	NR1I2_HUMAN		Ki	7.46	WOMBAT-PK
D(4) dopamine receptor	GPCR	P21917	DRD4_HUMAN		Ki	5.41	DRUG MATRIX
Alpha-1D adrenergic receptor	GPCR	P25100	ADA1D_HUMAN		Ki	5.61	DRUG MATRIX
Kappa-type opioid receptor	GPCR	P41145	OPRK_HUMAN		Ki	5.20	DRUG MATRIX
Progesterone receptor	Nuclear hormone receptor	P06401	PRGR_HUMAN		IC50	6.89	CHEMBL
Delta-type opioid receptor	GPCR	P41143	OPRD_HUMAN		Ki	5.33	DRUG MATRIX
Estrogen receptor beta	Nuclear hormone receptor	Q92731	ESR2_HUMAN		IC50	5.91	WOMBAT-PK
G-protein coupled estrogen receptor 1	GPCR	Q99527	GPER1_HUMAN		IC50	7.50	WOMBAT-PK
Estrogen-related receptor gamma	Nuclear hormone receptor	P62508	ERR3_HUMAN		Ki	7.10	WOMBAT-PK
Epidermal growth factor receptor	Kinase	P00533	EGFR_HUMAN		IC50	5.45	DRUG MATRIX
Substance-P receptor	GPCR	P25103	NK1R_HUMAN		Ki	5.07	DRUG MATRIX
Tyrosine-protein kinase Lck	Kinase	P06239	LCK_HUMAN		IC50	5.10	DRUG MATRIX
Tyrosine-protein kinase Fyn	Kinase	P06241	FYN_HUMAN		IC50	5.92	DRUG MATRIX
Receptor tyrosine-protein kinase erbB-2	Kinase	P04626	ERBB2_HUMAN		IC50	5.53	DRUG MATRIX
Glucosylceramidase	Enzyme	P04062	GLCM_HUMAN		EC50	5.60	CHEMBL
Thromboxane-A synthase	Enzyme	P24557	THAS_HUMAN		IC50	6.04	DRUG MATRIX
Steroid hormone receptor ERR1	Nuclear hormone receptor	P11474	ERR1_HUMAN		IC50	6.70	CHEMBL
Substance-K receptor	GPCR	P21452	NK2R_HUMAN		Ki	5.91	DRUG MATRIX
B2 bradykinin receptor	GPCR	P30411	BKRB2_HUMAN		Ki	4.92	DRUG MATRIX
Melanocortin receptor 4	GPCR	P32245	MC4R_HUMAN		Ki	4.53	DRUG MATRIX
Melanocortin receptor 5	GPCR	P33032	MC5R_HUMAN		Ki	4.60	DRUG MATRIX
Melanocortin receptor 3	GPCR	P41968	MC3R_HUMAN		Ki	4.76	DRUG MATRIX
Serine/threonine-protein phosphatase 2B catalytic subunit alpha isoform	Enzyme	Q08209	PP2BA_HUMAN		IC50	4.52	DRUG MATRIX
Solute carrier family 22 member 2	Transporter	O15244	S22A2_HUMAN		IC50	4.06	WOMBAT-PK
Emopamil-binding protein-like	Enzyme	Q9BY08	EBPL_HUMAN		Ki	8.55	CHEMBL
Anti-estrogen binding site (AEBS)	Enzyme	Q15125 Q9UBM7	EBP_HUMAN DHCR7_HUMAN		Kd	9	CHEMBL
Androgen receptor	Transcription factor		ANDR_RAT		Ki	4.82	DRUG MATRIX
Membrane-associated progesterone receptor component 1	Membrane receptor		PGRC1_RAT		Ki	6.42	DRUG MATRIX
Progesterone receptor	Transcription factor		Q690N0_BOVIN		Ki	5.59	DRUG MATRIX
Alpha-1A adrenergic receptor	GPCR		ADA1A_RAT		IC50	4.66	CHEMBL
5-hydroxytryptamine receptor 1A	GPCR		5HT1A_RAT		IC50	4.92	CHEMBL
C-8 sterol isomerase	Enzyme		ERG2_YEAST		Ki	5.82	CHEMBL
Sodium/potassium-transporting ATPase subunit alpha-2	Ion channel		AT1A2_PIG		IC50	4.81	DRUG MATRIX
Transcriptional activator protein luxR	Unclassified		LUXR_ALIFS		IC50	4.40	CHEMBL

External reference:

ID	Source
4019939	VUID
N0000148024	NUI
D00966	KEGG_DRUG
54965-24-1	SECONDARY_CAS_RN
4018462	VANDF
4019939	VANDF
C0039286	UMLSCUI
CHEBI:41774	CHEBI
CTX	PDB_CHEM_ID
CHEMBL83	ChEMBL_ID
DB00675	DRUGBANK_ID
CHEMBL786	ChEMBL_ID
D013629	MESH_DESCRIPTOR_UI
2733526	PUBCHEM_CID
1016	IUPHAR_LIGAND_ID
3299	INN_ID
094ZI81Y45	UNII
10324	RXNORM
2281	MMSL
4270	MMSL
5540	MMSL
d00381	MMSL
002670	NDDF
004826	NDDF
373345002	SNOMEDCT_US
41395001	SNOMEDCT_US
75959001	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Tamoxifen Citrate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-0144	TABLET	10 mg	ORAL	ANDA	26 sections
Tamoxifen Citrate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-0144	TABLET	10 mg	ORAL	ANDA	26 sections
Tamoxifen Citrate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-0274	TABLET	20 mg	ORAL	ANDA	26 sections
Tamoxifen Citrate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-0274	TABLET	20 mg	ORAL	ANDA	26 sections
Tamoxifen Citrate	HUMAN PRESCRIPTION DRUG LABEL	1	0591-2472	TABLET	10 mg	ORAL	ANDA	25 sections
Tamoxifen Citrate	HUMAN PRESCRIPTION DRUG LABEL	1	0591-2472	TABLET	10 mg	ORAL	ANDA	25 sections
Tamoxifen Citrate	HUMAN PRESCRIPTION DRUG LABEL	1	0591-2473	TABLET	20 mg	ORAL	ANDA	25 sections
Tamoxifen Citrate	HUMAN PRESCRIPTION DRUG LABEL	1	0591-2473	TABLET	20 mg	ORAL	ANDA	25 sections
Tamoxifen Citrate	HUMAN PRESCRIPTION DRUG LABEL	1	50090-0485	TABLET	10 mg	ORAL	ANDA	25 sections
Tamoxifen Citrate	HUMAN PRESCRIPTION DRUG LABEL	1	50090-0942	TABLET	20 mg	ORAL	ANDA	25 sections
Tamoxifen Citrate	HUMAN PRESCRIPTION DRUG LABEL	1	51407-439	TABLET, FILM COATED	10 mg	ORAL	ANDA	28 sections
Tamoxifen Citrate	HUMAN PRESCRIPTION DRUG LABEL	1	51407-439	TABLET, FILM COATED	10 mg	ORAL	ANDA	28 sections
Tamoxifen Citrate	HUMAN PRESCRIPTION DRUG LABEL	1	51407-440	TABLET, FILM COATED	20 mg	ORAL	ANDA	28 sections
Tamoxifen Citrate	HUMAN PRESCRIPTION DRUG LABEL	1	51407-440	TABLET, FILM COATED	20 mg	ORAL	ANDA	28 sections
Tamoxifen Citrate	HUMAN PRESCRIPTION DRUG LABEL	1	51862-446	TABLET, FILM COATED	20 mg	ORAL	ANDA	26 sections
Tamoxifen Citrate	HUMAN PRESCRIPTION DRUG LABEL	1	51862-446	TABLET, FILM COATED	20 mg	ORAL	ANDA	26 sections
Tamoxifen Citrate	HUMAN PRESCRIPTION DRUG LABEL	1	51862-447	TABLET, FILM COATED	10 mg	ORAL	ANDA	26 sections
Tamoxifen Citrate	HUMAN PRESCRIPTION DRUG LABEL	1	51862-447	TABLET, FILM COATED	10 mg	ORAL	ANDA	26 sections
Tamoxifen Citrate	HUMAN PRESCRIPTION DRUG LABEL	1	51862-642	TABLET, FILM COATED	10 mg	ORAL	ANDA	28 sections
Tamoxifen Citrate	HUMAN PRESCRIPTION DRUG LABEL	1	51862-642	TABLET, FILM COATED	10 mg	ORAL	ANDA	28 sections
Tamoxifen Citrate	HUMAN PRESCRIPTION DRUG LABEL	1	51862-643	TABLET, FILM COATED	20 mg	ORAL	ANDA	28 sections
Tamoxifen Citrate	HUMAN PRESCRIPTION DRUG LABEL	1	51862-643	TABLET, FILM COATED	20 mg	ORAL	ANDA	28 sections
SOLTAMOX	HUMAN PRESCRIPTION DRUG LABEL	1	51862-682	LIQUID	20 mg	ORAL	NDA	33 sections
Tamoxifen Citrate	HUMAN PRESCRIPTION DRUG LABEL	1	54868-3004	TABLET, FILM COATED	10 mg	ORAL	ANDA	26 sections
Tamoxifen Citrate	HUMAN PRESCRIPTION DRUG LABEL	1	54868-4287	TABLET, FILM COATED	20 mg	ORAL	ANDA	26 sections
Tamoxifen Citrate	Human Prescription Drug Label	1	59651-299	TABLET, FILM COATED	10 mg	ORAL	ANDA	24 sections
Tamoxifen Citrate	Human Prescription Drug Label	1	59651-300	TABLET, FILM COATED	20 mg	ORAL	ANDA	24 sections
Tamoxifen Citrate	HUMAN PRESCRIPTION DRUG LABEL	1	60429-909	TABLET, FILM COATED	10 mg	ORAL	ANDA	26 sections
Tamoxifen Citrate	HUMAN PRESCRIPTION DRUG LABEL	1	60429-909	TABLET, FILM COATED	10 mg	ORAL	ANDA	26 sections
Tamoxifen Citrate	HUMAN PRESCRIPTION DRUG LABEL	1	60429-909	TABLET, FILM COATED	10 mg	ORAL	ANDA	26 sections