All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

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

Stem definition	Drug id	CAS RN
humanized origin	4979	180288-69-1

Description:

Molecule

Description

Synonyms: trastuzumab-dkst ogivri trastuzumab herceptin trastuzumab (genetical recombination)

The HER2 (or c-erbB2) proto-oncogene encodes a transmembrane receptor protein of 185 kDa, which is structurally related to the epidermal growth factor receptor. Trastuzumab products have been shown, in both in vitro assays and in animals, to inhibit the proliferation of human tumor cells that overexpress HER2. Trastuzumab products are mediators of antibody-dependent cellular cytotoxicity (ADCC). In vitro, trastuzumab product-mediated ADCC has been shown to be preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Aug. 28, 2000	EMA	ROCHE REGISTRATION GMBH
Sept. 25, 1998	FDA	GENENTECH
April 4, 2001	PMDA	ROCHE JAPAN

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
Ejection fraction decreased	2737.29	13.24	1134	108980	18707	56163246
Disease progression	1559.05	13.24	1432	108682	103741	56078212
Myelosuppression	1471.73	13.24	707	109407	16748	56165205
Metastases to central nervous system	1353.43	13.24	597	109517	11539	56170414
Diarrhoea	1145.08	13.24	3270	106844	635237	55546716
Palmar-plantar erythrodysaesthesia syndrome	1130.88	13.24	630	109484	20435	56161518
Cardiotoxicity	1043.20	13.24	434	109680	7216	56174737
Neuropathy peripheral	852.77	13.24	1028	109086	101865	56080088
Febrile neutropenia	747.68	13.24	975	109139	104570	56077383
Drug ineffective	685.18	13.24	485	109629	918504	55263449
Rheumatoid arthritis	654.79	13.24	21	110093	382583	55799370
Neutropenia	634.53	13.24	1121	108993	157046	56024907
Bone marrow failure	547.10	13.24	449	109665	27837	56154116
Metastases to bone	509.20	13.24	370	109744	19138	56162815
Mucosal inflammation	465.48	13.24	493	109621	42317	56139636
Metastases to liver	464.96	13.24	365	109749	21221	56160732
Chills	430.21	13.24	742	109372	101862	56080091
Breast cancer metastatic	425.69	13.24	303	109811	15166	56166787
Cardiac dysfunction	414.22	13.24	153	109961	1817	56180136
Metastases to lung	406.81	13.24	265	109849	11453	56170500
Polyneuropathy	395.00	13.24	271	109843	12779	56169174
Left ventricular dysfunction	365.36	13.24	243	109871	10880	56171073
Breast cancer recurrent	337.00	13.24	163	109951	3912	56178041
Interstitial lung disease	325.12	13.24	475	109639	56588	56125365
Joint swelling	323.56	13.24	84	110030	289716	55892237
Malignant neoplasm progression	318.61	13.24	540	109574	73047	56108906
Metastases to lymph nodes	313.24	13.24	190	109924	7233	56174720
Drug hypersensitivity	312.56	13.24	77	110037	275128	55906825
Cardiac failure	303.33	13.24	562	109552	81531	56100422
Synovitis	294.50	13.24	4	110110	161301	56020652
Systemic lupus erythematosus	287.30	13.24	16	110098	180062	56001891
Condition aggravated	261.96	13.24	177	109937	344721	55837232
Cardiomyopathy	261.01	13.24	232	109882	16026	56165927
Therapeutic product effect decreased	258.59	13.24	19	110095	169433	56012520
Arthropathy	249.93	13.24	45	110069	200230	55981723
Completed suicide	245.69	13.24	3	110111	133830	56048123
Peripheral sensory neuropathy	243.12	13.24	158	109956	6798	56175155
Fall	241.44	13.24	207	109907	357303	55824650
Death	231.52	13.24	1294	108820	340132	55841821
Abdominal discomfort	223.20	13.24	133	109981	277141	55904812
Metastasis	218.86	13.24	129	109985	4655	56177298
Pleural effusion	213.20	13.24	498	109616	84982	56096971
Skin toxicity	205.93	13.24	118	109996	4035	56177918
Sinusitis	195.64	13.24	71	110043	197510	55984443
Lymphoedema	190.74	13.24	161	109953	10369	56171584
Neoplasm progression	182.98	13.24	267	109847	31749	56150204
Metastases to skin	182.96	13.24	78	110036	1380	56180573
Pneumonitis	181.51	13.24	264	109850	31300	56150653
Treatment failure	181.38	13.24	54	110060	170338	56011615
Neutropenic sepsis	181.37	13.24	184	109930	15001	56166952
Neurotoxicity	178.89	13.24	186	109928	15609	56166344
Epistaxis	178.74	13.24	401	109713	66622	56115331
Breast cancer	177.37	13.24	332	109782	48501	56133452
Nail disorder	167.31	13.24	155	109959	11296	56170657
Drug interaction	165.37	13.24	103	110011	209652	55972301
Glossodynia	164.67	13.24	47	110067	152411	56029542
Onycholysis	160.41	13.24	70	110044	1314	56180639
Product dose omission issue	159.41	13.24	102	110012	204651	55977302
Pyrexia	150.99	13.24	1362	108752	417411	55764542
Swelling	141.74	13.24	156	109958	239615	55942338
Weight increased	140.75	13.24	145	109969	229558	55952395
Psoriasis	139.62	13.24	11	110103	92681	56089272
Pain	139.35	13.24	747	109367	662437	55519516
Osteonecrosis of jaw	139.27	13.24	241	109873	33117	56148836
Drug intolerance	137.94	13.24	190	109924	264628	55917325
Computerised tomogram thorax abnormal	137.26	13.24	64	110050	1411	56180542
Product use issue	129.96	13.24	104	110010	185937	55996016
Onychoclasis	127.96	13.24	98	110016	5487	56176466
Bone pain	127.93	13.24	295	109819	49890	56132063
Hypokalaemia	127.77	13.24	441	109673	93996	56087957
Decreased appetite	127.66	13.24	799	109315	218432	55963521
Wound	125.75	13.24	57	110057	138747	56043206
Maternal exposure during pregnancy	125.01	13.24	112	110002	189441	55992512
Nausea	124.94	13.24	2141	107973	762037	55419916
Ventricular hypokinesia	124.18	13.24	86	110028	4115	56177838
Confusional state	122.38	13.24	136	109978	208019	55973934
Stomatitis	119.74	13.24	511	109603	120299	56061654
Haematotoxicity	119.63	13.24	112	110002	8271	56173682
Drug abuse	117.97	13.24	3	110111	67607	56114346
Vomiting	117.48	13.24	1488	108626	496740	55685213
Nail discolouration	116.00	13.24	68	110046	2428	56179525
Nail toxicity	115.75	13.24	38	110076	308	56181645
Pericardial effusion	113.00	13.24	196	109918	26979	56154974
Therapeutic product effect incomplete	112.06	13.24	34	110080	105997	56075956
Loss of personal independence in daily activities	106.50	13.24	16	110098	81353	56100600
Lacrimation increased	106.25	13.24	154	109960	18194	56163759
Somnolence	106.02	13.24	98	110016	163315	56018638
Toxicity to various agents	105.39	13.24	173	109941	224391	55957562
Gastrointestinal toxicity	105.12	13.24	91	110023	6065	56175888
Acute myeloid leukaemia	104.98	13.24	147	109967	16825	56165128
Mitral valve incompetence	104.59	13.24	152	109962	18001	56163952
Alveolitis	104.06	13.24	65	110049	2608	56179345
Metastatic neoplasm	103.84	13.24	75	110039	3838	56178115
Hospitalisation	102.29	13.24	13	110101	74987	56106966
Musculoskeletal stiffness	101.87	13.24	93	110021	155914	56026039
Injection site pain	101.62	13.24	51	110063	117067	56064886
Overdose	101.39	13.24	40	110074	105790	56076163
Neutrophil count decreased	98.67	13.24	266	109848	49556	56132397
Biopsy lung abnormal	97.80	13.24	28	110086	134	56181819
Thrombocytopenia	97.80	13.24	525	109589	135699	56046254
Dyspnoea	97.19	13.24	1662	108452	590915	55591038
Fibromyalgia	95.90	13.24	5	110109	59598	56122355
Exposure during pregnancy	95.46	13.24	76	110038	136266	56045687
Duodenal ulcer perforation	95.28	13.24	11	110103	68331	56113622
Neutropenic infection	93.40	13.24	45	110069	1070	56180883
Cellulitis	92.78	13.24	340	109774	74609	56107344
Hepatic enzyme increased	92.17	13.24	120	109994	171264	56010689
Hyperpyrexia	92.16	13.24	65	110049	3203	56178750
Asthenia	90.08	13.24	1046	109068	341927	55840026
Dysgeusia	89.78	13.24	227	109887	40688	56141265
Colitis	89.70	13.24	230	109884	41581	56140372
Leukopenia	89.66	13.24	324	109790	70616	56111337
Onychomadesis	89.25	13.24	74	110040	4647	56177306
Radiation necrosis	88.41	13.24	32	110082	357	56181596
Dry skin	87.81	13.24	246	109868	46863	56135090
Discomfort	87.32	13.24	89	110025	141672	56040281
Erysipelas	87.22	13.24	88	110026	7125	56174828
Inappropriate schedule of product administration	85.86	13.24	28	110086	83359	56098594
Lymphangiosis carcinomatosa	85.65	13.24	44	110070	1205	56180748
Paronychia	84.58	13.24	73	110041	4845	56177108
HER2 positive breast cancer	83.62	13.24	31	110083	372	56181581
Metastases to spine	83.25	13.24	59	110055	2930	56179023
Breast pain	83.18	13.24	90	110024	7904	56174049
Recall phenomenon	82.74	13.24	34	110080	546	56181407
Vascular device infection	82.30	13.24	76	110038	5514	56176439
Contusion	82.13	13.24	78	110036	128352	56053601
Anaemia	81.77	13.24	841	109273	266670	55915283
Mobility decreased	81.62	13.24	46	110068	98945	56083008
Nail dystrophy	81.50	13.24	39	110075	913	56181040
Disease recurrence	81.40	13.24	158	109956	23702	56158251
Dermatitis acneiform	79.86	13.24	67	110047	4277	56177676
Organising pneumonia	79.45	13.24	73	110041	5262	56176691
Hypertransaminasaemia	79.20	13.24	69	110045	4638	56177315
Suicide attempt	78.92	13.24	10	110104	57826	56124127
Invasive ductal breast carcinoma	78.40	13.24	81	110033	6745	56175208
Injection site erythema	78	13.24	27	110087	77421	56104532
Asthma	77.51	13.24	64	110050	112706	56069247
Arthritis	77.29	13.24	50	110064	99802	56082151
Blood cholesterol increased	77.17	13.24	23	110091	72556	56109397
Lung infiltration	76.20	13.24	113	110001	13625	56168328
Osteonecrosis	75.89	13.24	151	109963	23064	56158889
Radiation skin injury	75.22	13.24	36	110078	843	56181110
Irritable bowel syndrome	72.23	13.24	22	110092	68436	56113517
Hot flush	70.98	13.24	227	109887	46499	56135454
Hepatic function abnormal	70.94	13.24	187	109927	34371	56147582
Aortitis	69.94	13.24	36	110078	990	56180963
Constipation	68.54	13.24	649	109465	201294	55980659
Osteoarthritis	68.10	13.24	36	110078	80260	56101693
Product use in unapproved indication	67.41	13.24	107	110007	140715	56041238
Plasma cell myeloma	66.30	13.24	7	110107	46639	56135314
Multifocal micronodular pneumocyte hyperplasia	65.27	13.24	18	110096	73	56181880
Bronchial polyp	65.27	13.24	18	110096	73	56181880
Pericarditis	65.24	13.24	70	110044	108853	56073100
Onychalgia	64.34	13.24	32	110082	817	56181136
Injury	63.57	13.24	19	110095	59832	56122121
Granulocyte count decreased	63.57	13.24	33	110081	924	56181029
Dehydration	63.44	13.24	529	109585	158296	56023657
Injection site swelling	63.35	13.24	6	110108	43572	56138381
Myalgia	62.83	13.24	458	109656	131567	56050386
Injection site bruising	62.71	13.24	3	110111	38518	56143435
Recurrent cancer	62.60	13.24	41	110073	1787	56180166
Cough	62.54	13.24	780	109334	259181	55922772
Alanine aminotransferase increased	62.51	13.24	354	109760	93308	56088645
Fatigue	62.42	13.24	1998	108116	786554	55395399
Madarosis	62.40	13.24	48	110066	2705	56179248
Migraine	61.21	13.24	48	110066	86749	56095204
Injection site pruritus	60.36	13.24	6	110108	41925	56140028
Breast neoplasm	60.06	13.24	36	110078	1340	56180613
Oligohydramnios	59.78	13.24	66	110048	5928	56176025
Acute interstitial pneumonitis	59.24	13.24	28	110086	637	56181316
Systolic dysfunction	59.04	13.24	37	110077	1493	56180460
Blood lactate dehydrogenase increased	58.80	13.24	127	109987	20548	56161405
Device related infection	57.26	13.24	130	109984	21750	56160203
Chest discomfort	56.61	13.24	359	109755	98498	56083455
Ejection fraction abnormal	56.54	13.24	32	110082	1068	56180885
White blood cell count decreased	55.95	13.24	430	109684	125560	56056393
Erythema	55.31	13.24	506	109608	155433	56026520
Mastitis	54.95	13.24	43	110071	2485	56179468
Mastectomy	54.07	13.24	35	110079	1495	56180458
Second primary malignancy	53.23	13.24	69	110045	7333	56174620
Adverse event	52.90	13.24	21	110093	55355	56126598
Injection site reaction	52.86	13.24	19	110095	53228	56128725
Radiation pneumonitis	52.47	13.24	34	110080	1455	56180498
Atelectasis	51.96	13.24	116	109998	19192	56162761
Blister	51.85	13.24	83	110031	108804	56073149
Arthralgia	51.21	13.24	683	109431	500986	55680967
Congestive cardiomyopathy	51.13	13.24	60	110054	5759	56176194
Pulmonary embolism	50.60	13.24	371	109743	106753	56075200
Alopecia areata	50.47	13.24	33	110081	1434	56180519
Feeling abnormal	50.41	13.24	117	109997	133485	56048468
Axillary pain	50.25	13.24	35	110079	1690	56180263
Metastases to meninges	50.19	13.24	39	110075	2231	56179722
Paraesthesia	50.14	13.24	431	109683	130083	56051870
Sedation	50.13	13.24	5	110109	34849	56147104
Blood bilirubin increased	49.71	13.24	161	109953	33193	56148760
Hyperkalaemia	49.07	13.24	19	110095	50846	56131107
Nail infection	48.95	13.24	39	110075	2314	56179639
Urticaria	48.92	13.24	134	109980	144542	56037411
Platelet count decreased	48.86	13.24	366	109748	106017	56075936
Incorrect dose administered	48.47	13.24	21	110093	52526	56129427
Tumour marker increased	47.61	13.24	50	110064	4243	56177710
Blood uric acid decreased	47.36	13.24	25	110089	725	56181228
Drug reaction with eosinophilia and systemic symptoms	47.34	13.24	3	110111	30301	56151652
Impaired healing	46.45	13.24	61	110053	86780	56095173
Lactic acidosis	46.13	13.24	7	110107	35339	56146614
Peripheral swelling	45.96	13.24	270	109844	234456	55947497
Dermatitis	45.29	13.24	95	110019	15062	56166891
Aspartate aminotransferase increased	44.85	13.24	296	109818	82306	56099647
Hyperbilirubinaemia	44.09	13.24	75	110039	10160	56171793
Transaminases increased	43.90	13.24	140	109974	28630	56153323
Agranulocytosis	43.87	13.24	120	109994	22539	56159414
Wheezing	42.96	13.24	50	110064	74976	56106977
Nasal congestion	42.56	13.24	29	110085	56341	56125612
Suicidal ideation	41.90	13.24	31	110083	57711	56124242
Hallucination	41.72	13.24	22	110092	49127	56132826
Dyspnoea exertional	41.41	13.24	214	109900	54475	56127478
Ear infection	41.30	13.24	6	110108	31289	56150664
Intentional product misuse	40.93	13.24	25	110089	51479	56130474
Ascites	40.43	13.24	163	109951	37381	56144572
Osteoporosis	40.35	13.24	26	110088	52026	56129927
Depression	40.33	13.24	198	109916	179919	56002034
Gait disturbance	39.85	13.24	174	109940	163147	56018806
Peripheral motor neuropathy	39.55	13.24	29	110085	1519	56180434
Bronchitis	39.50	13.24	102	110012	112209	56069744
Acute respiratory distress syndrome	39.38	13.24	113	110001	21813	56160140
Therapy cessation	38.98	13.24	4	110110	27260	56154693
Tachycardia	38.76	13.24	346	109768	105530	56076423
Tonsillar disorder	38.68	13.24	25	110089	1065	56180888
Chronic kidney disease	38.48	13.24	17	110097	42039	56139914
Skin fissures	38.43	13.24	68	110046	9505	56172448
Hepatotoxicity	38.25	13.24	141	109973	31012	56150941
Hair colour changes	38.12	13.24	37	110077	2858	56179095
Computerised tomogram thorax	37.80	13.24	15	110099	219	56181734
Metastases to chest wall	37.74	13.24	19	110095	498	56181455
Neoplasm	37.45	13.24	54	110060	6347	56175606
Neoplasm recurrence	37.25	13.24	34	110080	2430	56179523
Meibomian gland dysfunction	37.01	13.24	13	110101	132	56181821
Ejection fraction	36.91	13.24	29	110085	1686	56180267
Pseudocirrhosis	36.65	13.24	20	110094	621	56181332
Enterocolitis infectious	36.60	13.24	28	110086	1565	56180388
Ventricular dysfunction	36.49	13.24	35	110079	2664	56179289
Anxiety	36.32	13.24	225	109889	192947	55989006
Influenza	36.27	13.24	83	110031	95178	56086775
Dermatomyositis	36.23	13.24	35	110079	2687	56179266
Cystitis noninfective	36.20	13.24	23	110091	951	56181002
Hyperfibrinogenaemia	36.06	13.24	9	110105	22	56181931
Troponin I increased	36.01	13.24	31	110083	2050	56179903
Skin exfoliation	35.67	13.24	155	109959	36745	56145208
Performance status decreased	35.60	13.24	38	110076	3285	56178668
International normalised ratio increased	35.53	13.24	21	110093	44020	56137933
Foot deformity	35.38	13.24	3	110111	23822	56158131
Wrong technique in product usage process	35.25	13.24	37	110077	58131	56123822
Breast mass	35.06	13.24	55	110059	6964	56174989
Tumour pain	34.84	13.24	25	110089	1266	56180687
Enterocolitis	34.57	13.24	55	110059	7049	56174904
Sleep apnoea syndrome	34.38	13.24	5	110109	26056	56155897
Pulmonary mass	34.38	13.24	103	110011	20367	56161586
Carcinoembryonic antigen increased	34.14	13.24	27	110087	1585	56180368
Cataract	34.08	13.24	30	110084	51217	56130736
Jaw operation	34.04	13.24	21	110093	824	56181129
Toxic cardiomyopathy	33.98	13.24	12	110102	124	56181829
Coma	33.89	13.24	40	110074	59615	56122338
Breast inflammation	33.89	13.24	12	110102	125	56181828
Blood creatinine decreased	33.83	13.24	46	110068	5120	56176833
Foetal exposure during pregnancy	33.69	13.24	12	110102	33811	56148142
Adverse drug reaction	33.57	13.24	47	110067	65085	56116868
Cardiac failure congestive	33.31	13.24	289	109825	87431	56094522
Folliculitis	33.28	13.24	35	110079	54944	56127009
Dyskinesia	33.25	13.24	8	110106	29100	56152853
Left ventricular dilatation	33.14	13.24	17	110097	464	56181489
Eosinophil percentage increased	33.12	13.24	22	110092	982	56180971
Electrocardiogram QT prolonged	32.76	13.24	35	110079	54553	56127400
Blood alkaline phosphatase increased	32.74	13.24	157	109957	38788	56143165
Lymphadenopathy	32.60	13.24	146	109968	35062	56146891
Blood glucose increased	32.38	13.24	61	110053	75090	56106863
Cardiac disorder	32.30	13.24	176	109938	45711	56136242
Gait inability	32.26	13.24	21	110093	41797	56140156
Excessive eye blinking	32.24	13.24	22	110092	1027	56180926
Chronic obstructive pulmonary disease	32.08	13.24	39	110075	57376	56124577
Aggression	32.06	13.24	3	110111	22003	56159950
Unresponsive to stimuli	32.04	13.24	11	110103	31714	56150239
Acute pulmonary oedema	31.84	13.24	55	110059	7542	56174411
Product prescribing error	31.65	13.24	4	110110	23182	56158771
Therapy interrupted	31.40	13.24	6	110108	25619	56156334
Sense of oppression	31.25	13.24	21	110093	956	56180997
Metastases to breast	31.00	13.24	14	110100	286	56181667
Therapy partial responder	30.87	13.24	55	110059	7730	56174223
Basal cell carcinoma	30.70	13.24	6	110108	25215	56156738
Delirium	30.62	13.24	23	110091	42494	56139459
Central nervous system lesion	30.52	13.24	63	110051	9875	56172078
Device issue	30.43	13.24	3	110111	21103	56160850
Hypoxia	30.38	13.24	195	109919	53702	56128251
Perforation	29.95	13.24	21	110093	1025	56180928
Myocarditis	29.41	13.24	58	110056	8800	56173153
Diabetes mellitus	29.28	13.24	36	110078	52699	56129254
Rhabdomyolysis	29.27	13.24	22	110092	40636	56141317
Accidental overdose	29.26	13.24	3	110111	20458	56161495
Hair texture abnormal	29.12	13.24	37	110077	3855	56178098
Pulmonary toxicity	29.11	13.24	54	110060	7829	56174124
Hypoglycaemia	29.04	13.24	40	110074	55775	56126178
Metastases to pleura	28.95	13.24	23	110091	1359	56180594
Breast disorder	28.92	13.24	29	110085	2330	56179623
Depressed level of consciousness	28.80	13.24	41	110073	56392	56125561
Irritability	28.62	13.24	11	110103	29577	56152376
Bladder irritation	28.47	13.24	12	110102	206	56181747
Tumour marker abnormal	28.38	13.24	14	110100	351	56181602
Malignant pleural effusion	28.34	13.24	29	110085	2387	56179566
Vulvovaginal inflammation	28.31	13.24	18	110096	745	56181208
Mouth ulceration	28.26	13.24	124	109990	29516	56152437
Seroma	28.17	13.24	26	110088	1885	56180068
Biliary sepsis	28.08	13.24	19	110095	875	56181078
Hepatic lesion	28.03	13.24	38	110076	4217	56177736
Vocal cord paralysis	27.87	13.24	26	110088	1911	56180042
Hip arthroplasty	27.68	13.24	21	110093	38602	56143351
Joint injury	27.50	13.24	8	110106	25646	56156307
Multiple sclerosis	27.46	13.24	10	110104	27792	56154161
Eye pain	27.40	13.24	13	110101	30834	56151119
Red cell distribution width increased	27.28	13.24	58	110056	9282	56172671
Nephrolithiasis	27.14	13.24	20	110094	37315	56144638
Treatment noncompliance	27.11	13.24	15	110099	32608	56149345
Keratitis	26.75	13.24	31	110083	2936	56179017
Gastric disorder	26.55	13.24	16	110098	33194	56148759
Orthostatic hypotension	26.54	13.24	16	110098	33183	56148770
Diastolic dysfunction	26.50	13.24	43	110071	5602	56176351
Cardio-respiratory arrest	26.48	13.24	42	110072	55279	56126674
Blood pressure fluctuation	26.39	13.24	24	110090	40336	56141617
Bone lesion	26.37	13.24	42	110072	5388	56176565
Rash pustular	26.32	13.24	47	110067	6616	56175337
Axillary vein thrombosis	26.31	13.24	13	110101	327	56181626
Retinal detachment	26.30	13.24	42	110072	5399	56176554
Breast oedema	26.30	13.24	8	110106	49	56181904
Eosinophilia	26.14	13.24	4	110110	20073	56161880
Sensory disturbance	25.86	13.24	68	110046	12475	56169478
Bile duct stenosis	25.59	13.24	20	110094	1154	56180799
Bursitis	25.47	13.24	11	110103	27571	56154382
Hiccups	25.41	13.24	25	110089	1963	56179990
Nodular regenerative hyperplasia	25.27	13.24	14	110100	448	56181505
Dysuria	25.20	13.24	123	109991	30606	56151347
Blood creatine increased	25.10	13.24	40	110074	5133	56176820
Calcium ionised increased	24.98	13.24	9	110105	99	56181854
Type 2 diabetes mellitus	24.97	13.24	33	110081	46829	56135124
Nail bed bleeding	24.88	13.24	12	110102	286	56181667
Hydrothorax	24.81	13.24	17	110097	799	56181154
Hepatitis B reactivation	24.71	13.24	27	110087	2397	56179556
Gastrointestinal haemorrhage	24.44	13.24	72	110042	75879	56106074
Respiratory arrest	24.14	13.24	15	110099	30610	56151343
Brachial plexopathy	24.13	13.24	9	110105	110	56181843
Asthenopia	24.09	13.24	25	110089	2092	56179861
Tumour lysis syndrome	24.07	13.24	50	110064	7873	56174080
Hypervolaemia	23.73	13.24	11	110103	26447	56155506
Mental status changes	23.69	13.24	23	110091	37478	56144475
Injection site haemorrhage	23.66	13.24	7	110107	22194	56159759
Vessel puncture site bruise	23.55	13.24	13	110101	413	56181540
Eastern Cooperative Oncology Group performance status worsened	23.43	13.24	17	110097	876	56181077
Hypoaesthesia	23.42	13.24	398	109716	141093	56040860
Mean platelet volume decreased	23.35	13.24	25	110089	2169	56179784
Nasal disorder	23.31	13.24	27	110087	2555	56179398
Product quality issue	23.07	13.24	17	110097	31719	56150234
Odynophagia	23.07	13.24	45	110069	6773	56175180
Osteolysis	23.05	13.24	27	110087	2586	56179367
Dysaesthesia	23.03	13.24	34	110080	4082	56177871
Nail ridging	22.73	13.24	12	110102	348	56181605
Distichiasis	22.67	13.24	6	110108	20	56181933
Vulvovaginal dryness	22.63	13.24	26	110088	2439	56179514
Flushing	22.60	13.24	223	109891	69877	56112076
Breast cellulitis	22.40	13.24	14	110100	562	56181391
Vascular fragility	22.40	13.24	9	110105	136	56181817
Swollen tongue	22.36	13.24	16	110098	30308	56151645
Acute leukaemia	22.36	13.24	18	110096	1084	56180869
Abnormal behaviour	22.33	13.24	6	110108	20266	56161687
Multicentric reticulohistiocytosis	22.26	13.24	5	110109	6	56181947
Acoustic stimulation tests abnormal	22.20	13.24	8	110106	88	56181865
Lymphangitis	22.16	13.24	16	110098	818	56181135
Illness	22.00	13.24	21	110093	34490	56147463
Embolism	21.82	13.24	46	110068	7318	56174635
Palmar erythema	21.81	13.24	21	110093	1606	56180347
Plantar erythema	21.76	13.24	10	110104	213	56181740
Coronary artery disease	21.74	13.24	17	110097	30779	56151174
Rhinorrhoea	21.69	13.24	188	109926	56849	56125104
Tricuspid valve incompetence	21.61	13.24	66	110048	13187	56168766
Osteosclerosis	21.58	13.24	31	110083	3632	56178321
Sopor	21.57	13.24	7	110107	20915	56161038
Sarcoid-like reaction	21.43	13.24	5	110109	8	56181945
Disorientation	21.39	13.24	24	110090	36589	56145364
Intercepted product preparation error	21.35	13.24	13	110101	498	56181455
Secondary cerebellar degeneration	21.29	13.24	7	110107	57	56181896
Kidney infection	21.25	13.24	7	110107	20718	56161235
Cardiac tamponade	21.17	13.24	34	110080	4392	56177561
Prescribed underdose	21.08	13.24	7	110107	20610	56161343
Dyschezia	21.07	13.24	23	110091	2040	56179913
Pustule	20.91	13.24	19	110095	1350	56180603
Full blood count abnormal	20.81	13.24	13	110101	26449	56155504
Cytomegalovirus infection	20.72	13.24	6	110108	19290	56162663
Atrial thrombosis	20.71	13.24	20	110094	1535	56180418
Left ventricular enlargement	20.58	13.24	7	110107	64	56181889
Osteitis condensans	20.58	13.24	6	110108	31	56181922
Bone sequestrum	20.58	13.24	19	110095	1378	56180575
Superior vena cava syndrome	20.55	13.24	14	110100	652	56181301
Gamma-glutamyltransferase increased	20.54	13.24	117	109997	30888	56151065
Medication error	20.40	13.24	32	110082	42303	56139650
Emotional distress	20.30	13.24	17	110097	29746	56152207
Headache	20.23	13.24	891	109223	558153	55623800
Infection	20.18	13.24	273	109841	199933	55982020
Sequestrectomy	20.15	13.24	15	110099	804	56181149
Tooth extraction	20.12	13.24	52	110062	9441	56172512
Toxic optic neuropathy	19.92	13.24	9	110105	184	56181769
Hypothalamo-pituitary disorder	19.92	13.24	14	110100	686	56181267
Pneumonitis chemical	19.88	13.24	9	110105	185	56181768
Viral infection	19.71	13.24	20	110094	31926	56150027
Myeloproliferative neoplasm	19.61	13.24	12	110102	464	56181489
Metastases to the mediastinum	19.58	13.24	12	110102	465	56181488
Xerophthalmia	19.56	13.24	12	110102	466	56181487
Bone erosion	19.46	13.24	3	110111	14971	56166982
Hepatic failure	19.39	13.24	122	109992	33364	56148589
Post-traumatic pain	19.38	13.24	11	110103	369	56181584
Gallbladder disorder	19.34	13.24	5	110109	17329	56164624
Gait apraxia	19.29	13.24	5	110109	15	56181938
Pneumocystis jirovecii pneumonia	19.22	13.24	71	110043	15630	56166323
Cardiac failure chronic	19.12	13.24	31	110083	4036	56177917
Fluid retention	19.09	13.24	49	110065	54029	56127924
Chromosomal mutation	19.05	13.24	5	110109	16	56181937
Cystoid macular oedema	19.00	13.24	19	110095	1522	56180431
Neutropenic colitis	18.84	13.24	25	110089	2718	56179235
Brain oedema	18.82	13.24	63	110051	13208	56168745
Transaminases	18.81	13.24	7	110107	85	56181868
Creatinine renal clearance decreased	18.73	13.24	3	110111	14556	56167397
Injection site rash	18.71	13.24	5	110109	16953	56165000
Rectal haemorrhage	18.65	13.24	142	109972	41325	56140628
Corneal disorder	18.61	13.24	20	110094	1742	56180211
Sinus congestion	18.60	13.24	4	110110	15720	56166233
Nasopharyngitis	18.60	13.24	312	109802	220647	55961306
Leukaemia cutis	18.59	13.24	7	110107	88	56181865
Entropion	18.57	13.24	6	110108	46	56181907
Autonomic neuropathy	18.44	13.24	16	110098	1069	56180884
Therapy non-responder	18.44	13.24	60	110054	61295	56120658
Pruritus	18.40	13.24	475	109639	316148	55865805
Spinal pain	18.28	13.24	58	110056	11826	56170127
Hydrocephalus	18.20	13.24	34	110080	4955	56176998
Breast sarcoma	18.19	13.24	4	110110	4	56181949
Dysarthria	18.02	13.24	31	110083	39519	56142434
Gingival bleeding	18.00	13.24	57	110057	11609	56170344
Congenital syphilitic osteochondritis	17.99	13.24	5	110109	21	56181932
Skin disorder	17.90	13.24	100	110014	26209	56155744
Vasogenic cerebral oedema	17.86	13.24	12	110102	546	56181407
Paralysis recurrent laryngeal nerve	17.82	13.24	6	110108	53	56181900
Inflammation	17.81	13.24	72	110042	68999	56112954
Pleural disorder	17.78	13.24	12	110102	550	56181403
Pericardial effusion malignant	17.78	13.24	7	110107	100	56181853
Telangiectasia	17.65	13.24	14	110100	825	56181128
Bradycardia	17.64	13.24	70	110044	67434	56114519
Status epilepticus	17.61	13.24	4	110110	15137	56166816
Gastritis	17.42	13.24	122	109992	34580	56147373
Overflow diarrhoea	17.41	13.24	7	110107	106	56181847
Chest wall abscess	17.34	13.24	6	110108	58	56181895
Renal impairment	17.32	13.24	90	110024	80623	56101330
Noninfective conjunctivitis	17.30	13.24	4	110110	6	56181947
Surgery	17.18	13.24	23	110091	32463	56149490
Skin laceration	17.14	13.24	9	110105	20147	56161806
Dilatation ventricular	17.13	13.24	22	110092	2316	56179637
Botryomycosis	17.12	13.24	5	110109	26	56181927
Pituitary tumour	17.08	13.24	14	110100	865	56181088
Barotrauma	17.05	13.24	8	110106	179	56181774
Neuromyopathy	17.02	13.24	12	110102	591	56181362
Hypersensitivity	17.01	13.24	377	109737	256031	55925922
Spider naevus	17.00	13.24	7	110107	113	56181840
Breast ulceration	16.99	13.24	6	110108	62	56181891
Inflammatory carcinoma of the breast	16.99	13.24	6	110108	62	56181891
Breast haemorrhage	16.97	13.24	8	110106	181	56181772
Hepatic cancer metastatic	16.93	13.24	10	110104	362	56181591
Retracted nipple	16.92	13.24	4	110110	7	56181946
Hyperaesthesia	16.91	13.24	46	110068	8611	56173342
Nasal ulcer	16.86	13.24	20	110094	1942	56180011
Capillary leak syndrome	16.82	13.24	20	110094	1946	56180007
Breast induration	16.81	13.24	5	110109	28	56181925
Herpangina	16.81	13.24	5	110109	28	56181925
Disability	16.77	13.24	5	110109	15775	56166178
Oral candidiasis	16.76	13.24	77	110037	18686	56163267
Joint dislocation	16.76	13.24	5	110109	15768	56166185
Toxic neuropathy	16.69	13.24	10	110104	372	56181581
Cholangiectasis acquired	16.58	13.24	4	110110	8	56181945
Device dislocation	16.57	13.24	12	110102	22594	56159359
Nasal crusting	16.56	13.24	9	110105	277	56181676
Aortic valve incompetence	16.56	13.24	35	110079	5577	56176376
Hepatic neoplasm	16.54	13.24	19	110095	1782	56180171
Hyperchlorhydria	16.48	13.24	18	110096	1597	56180356
Respiratory tract congestion	16.46	13.24	5	110109	15586	56166367
Arachnoid cyst	16.42	13.24	8	110106	195	56181758
Metabolic acidosis	16.42	13.24	34	110080	40420	56141533
Full blood count decreased	16.34	13.24	13	110101	23336	56158617
Subclavian vein thrombosis	16.28	13.24	19	110095	1813	56180140
Jaundice	16.15	13.24	100	110014	27194	56154759
Upper respiratory tract infection	16.15	13.24	78	110036	71210	56110743
Adenocarcinoma gastric	16.13	13.24	11	110103	513	56181440
Frequent bowel movements	16.06	13.24	6	110108	16418	56165535
Blood pressure systolic increased	16.01	13.24	35	110079	40801	56141152
Mucosal dryness	15.99	13.24	22	110092	2476	56179477
Merycism	15.95	13.24	8	110106	208	56181745
Metastases to nervous system	15.74	13.24	5	110109	36	56181917
Inflammatory carcinoma of breast stage IV	15.72	13.24	3	110111	0	56181953
Left atrial volume increased	15.72	13.24	3	110111	0	56181953
Multiple gated acquisition scan abnormal	15.72	13.24	3	110111	0	56181953
Globulinuria	15.72	13.24	3	110111	0	56181953
Poisoning	15.70	13.24	3	110111	12810	56169143
Gingival pain	15.66	13.24	37	110077	6351	56175602
Transient ischaemic attack	15.59	13.24	26	110088	33551	56148402
Thyroid disorder	15.59	13.24	4	110110	13934	56168019
Blood phosphorus decreased	15.54	13.24	28	110086	3969	56177984
Apical granuloma	15.51	13.24	5	110109	38	56181915
Product administration error	15.49	13.24	11	110103	20918	56161035
Therapeutic response unexpected	15.42	13.24	7	110107	17037	56164916
Extravasation	15.42	13.24	20	110094	2127	56179826
Bone cancer metastatic	15.41	13.24	7	110107	145	56181808
Intracranial pressure increased	15.38	13.24	30	110084	4515	56177438
Agitation	15.35	13.24	57	110057	55979	56125974
Back pain	15.35	13.24	588	109526	236582	55945371
Fear	15.35	13.24	5	110109	14903	56167050
Catheter site pain	15.34	13.24	29	110085	4264	56177689
Sepsis	15.34	13.24	370	109744	139470	56042483
Joint effusion	15.33	13.24	5	110109	14893	56167060
Vaginal prolapse	15.30	13.24	10	110104	434	56181519
Infusion site pain	15.30	13.24	4	110110	13758	56168195
Bronchospasm	15.28	13.24	66	110048	15603	56166350
Scintillating scotoma	15.24	13.24	7	110107	149	56181804
Dyspnoea at rest	15.20	13.24	27	110087	3786	56178167
Acral peeling skin syndrome	15.19	13.24	4	110110	13	56181940
Bone disorder	15.15	13.24	77	110037	19466	56162487
Pneumonia aspiration	15.14	13.24	25	110089	32386	56149567
Superinfection	15.12	13.24	20	110094	2168	56179785
Respiratory depression	15.05	13.24	3	110111	12432	56169521
Abdominal rigidity	15.01	13.24	18	110096	1767	56180186
Hiatus hernia	14.98	13.24	10	110104	19642	56162311
Oropharyngeal candidiasis	14.97	13.24	14	110100	1032	56180921
Rash follicular	14.97	13.24	5	110109	43	56181910
Gram stain positive	14.97	13.24	5	110109	43	56181910
Dizziness	14.94	13.24	593	109521	375547	55806406
Nervousness	14.88	13.24	21	110093	28994	56152959
HER2 negative breast cancer	14.87	13.24	5	110109	44	56181909
Blood bilirubin decreased	14.86	13.24	12	110102	726	56181227
Dandy-Walker syndrome	14.85	13.24	6	110108	92	56181861
Impaired work ability	14.80	13.24	5	110109	14567	56167386
Ocular vasculitis	14.77	13.24	5	110109	45	56181908
Hypoalbuminaemia	14.75	13.24	50	110064	10549	56171404
Laboratory test abnormal	14.63	13.24	16	110098	24679	56157274
Essential thrombocythaemia	14.62	13.24	7	110107	164	56181789
Myositis	14.59	13.24	43	110071	8425	56173528
Central nervous system neoplasm	14.55	13.24	4	110110	16	56181937
Rotator cuff syndrome	14.55	13.24	3	110111	12140	56169813
Underdose	14.51	13.24	15	110099	23742	56158211
SAPHO syndrome	14.45	13.24	6	110108	99	56181854
Vena cava thrombosis	14.43	13.24	19	110095	2050	56179903
Feeling jittery	14.38	13.24	3	110111	12043	56169910
Hypocalcaemia	14.37	13.24	101	110013	28659	56153294
Vulvovaginal candidiasis	14.37	13.24	23	110091	2963	56178990
Glaucoma	14.35	13.24	8	110106	17321	56164632
Cardiac failure acute	14.29	13.24	44	110070	8829	56173124
Foot fracture	14.22	13.24	13	110101	21796	56160157
Nail bed tenderness	14.21	13.24	9	110105	370	56181583
Stress	14.21	13.24	63	110051	58847	56123106
Corneal bleeding	14.17	13.24	4	110110	18	56181935
Intervertebral disc protrusion	14.06	13.24	13	110101	21681	56160272
Device malfunction	14.02	13.24	7	110107	16129	56165824
Peripheral sensorimotor neuropathy	14.02	13.24	15	110099	1300	56180653
Pneumothorax	14.02	13.24	62	110052	14805	56167148
Skin infection	13.97	13.24	57	110057	13138	56168815
Catheter site erythema	13.94	13.24	27	110087	4043	56177910
Dacryostenosis acquired	13.87	13.24	10	110104	510	56181443
Vagus nerve disorder	13.78	13.24	6	110108	112	56181841
Pulmonary arterial hypertension	13.78	13.24	19	110095	26484	56155469
Crying	13.72	13.24	13	110101	21427	56160526
Cerebrovascular accident	13.71	13.24	126	109988	99144	56082809
Anal erythema	13.68	13.24	7	110107	190	56181763
Limb injury	13.68	13.24	14	110100	22256	56159697
Folate deficiency	13.68	13.24	19	110095	2158	56179795
Urogenital prolapse	13.67	13.24	4	110110	21	56181932
Gastrointestinal ulcer perforation	13.64	13.24	3	110111	3	56181950
Metastases to pituitary gland	13.64	13.24	3	110111	3	56181950
Eye swelling	13.63	13.24	13	110101	21363	56160590
Road traffic accident	13.56	13.24	21	110093	27906	56154047
Bone marrow infiltration	13.54	13.24	10	110104	530	56181423
Arrhythmia	13.53	13.24	116	109998	34967	56146986
Bacterial rhinitis	13.51	13.24	4	110110	22	56181931
Soft tissue infection	13.48	13.24	18	110096	1969	56179984
Premature delivery	13.47	13.24	20	110094	27040	56154913
Appendiceal abscess	13.45	13.24	7	110107	197	56181756
Amnesia	13.44	13.24	46	110068	46276	56135677
Joint range of motion decreased	13.37	13.24	18	110096	25347	56156606
Ulcerative keratitis	13.34	13.24	20	110094	2435	56179518
Naevus haemorrhage	13.27	13.24	6	110108	123	56181830

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
Disease progression	199.18	25.30	149	5536	90315	31601344
Off label use	119.57	25.30	218	5467	347056	31344603
Palmar-plantar erythrodysaesthesia syndrome	115.25	25.30	56	5629	15427	31676232
Myelosuppression	108.16	25.30	53	5632	14867	31676792
Death	89.82	25.30	198	5487	360371	31331288
Oligohydramnios	73.29	25.30	16	5669	322	31691337
Bone marrow failure	63.27	25.30	47	5638	27961	31663698
Pulmonary hypoplasia	63.21	25.30	15	5670	443	31691216
Intentional product use issue	60.10	25.30	58	5627	49289	31642370
Anastomotic complication	55.52	25.30	13	5672	362	31691297
Therapy partial responder	52.63	25.30	25	5660	6537	31685122
Carbohydrate antigen 15-3 increased	49.11	25.30	9	5676	70	31691589
Tidal volume decreased	48.15	25.30	8	5677	32	31691627
Ejection fraction decreased	47.97	25.30	33	5652	17401	31674258
Delusion of grandeur	47.15	25.30	13	5672	704	31690955
Metastases to central nervous system	43.29	25.30	23	5662	7613	31684046
Diarrhoea	40.05	25.30	146	5539	352263	31339396
Gastric perforation	38.97	25.30	15	5670	2344	31689315
Breast cancer	35.99	25.30	9	5676	332	31691327
Onycholysis	35.03	25.30	10	5675	615	31691044
Nasal discomfort	33.55	25.30	12	5673	1528	31690131
Paranasal sinus discomfort	33.39	25.30	10	5675	728	31690931
Neuropathy peripheral	31.56	25.30	52	5633	75597	31616062
Obstruction gastric	31.52	25.30	10	5675	882	31690777
Anastomotic leak	30.69	25.30	9	5676	609	31691050
Rectal polyp	30.45	25.30	9	5676	626	31691033
Alopecia	30.34	25.30	27	5658	20668	31670991
Metastases to liver	30.16	25.30	22	5663	12705	31678954
Metastases to lung	28.14	25.30	18	5667	8404	31683255
Drug interaction	26.94	25.30	3	5682	208540	31483119
Lymphoedema	26.90	25.30	13	5672	3527	31688132
Malignant sweat gland neoplasm	26.46	25.30	4	5681	7	31691652
Affective disorder	26.23	25.30	13	5672	3723	31687936
Foetal growth restriction	25.98	25.30	13	5672	3802	31687857

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
Ejection fraction decreased	1754.40	13.67	822	85918	29940	70811764
Myelosuppression	1320.92	13.67	673	86067	29472	70812232
Diarrhoea	900.49	13.67	2531	84209	780810	70060894
Palmar-plantar erythrodysaesthesia syndrome	796.15	13.67	483	86257	29764	70811940
Disease progression	777.24	13.67	957	85783	155715	70685989
Metastases to central nervous system	774.88	13.67	375	86365	14659	70827045
Neuropathy peripheral	630.42	13.67	776	85964	126120	70715584
Cardiotoxicity	576.10	13.67	278	86462	10792	70830912
Bone marrow failure	505.92	13.67	444	86296	48566	70793138
Drug ineffective	434.52	13.67	312	86428	939440	69902264
Breast cancer metastatic	408.04	13.67	214	86526	9932	70831772
Febrile neutropenia	395.52	13.67	811	85929	203507	70638197
Metastases to bone	382.68	13.67	273	86467	22103	70819601
Metastases to liver	353.74	13.67	276	86464	25602	70816102
Polyneuropathy	338.25	13.67	249	86491	21166	70820538
Chills	332.68	13.67	618	86122	144168	70697536
Cardiac dysfunction	330.49	13.67	134	86606	3403	70838301
Rheumatoid arthritis	319.18	13.67	8	86732	291797	70549907
Neutropenia	316.33	13.67	855	85885	256301	70585403
Mucosal inflammation	301.75	13.67	393	86347	67457	70774247
Metastases to lung	290.83	13.67	205	86535	16279	70825425
Breast cancer recurrent	271.95	13.67	109	86631	2684	70839020
Left ventricular dysfunction	250.79	13.67	194	86546	17763	70823941
Metastases to lymph nodes	244.16	13.67	148	86592	9090	70832614
Drug interaction	211.71	13.67	101	86639	381340	70460364
Lymphoedema	190.31	13.67	136	86604	11033	70830671
Fall	187.18	13.67	161	86579	443935	70397769
Cardiomyopathy	186.49	13.67	194	86546	26179	70815525
Breast cancer	185.65	13.67	217	86523	33332	70808372
Interstitial lung disease	183.01	13.67	399	86341	104286	70737418
Malignant neoplasm progression	174.36	13.67	429	86311	121310	70720394
Nausea	174.16	13.67	1695	85045	850393	69991311
Neutropenic sepsis	170.83	13.67	180	86560	24650	70817054
Condition aggravated	168.37	13.67	165	86575	427470	70414234
Peripheral sensory neuropathy	167.28	13.67	130	86610	11980	70829724
Stomatitis	165.47	13.67	435	86305	128076	70713628
Drug abuse	164.98	13.67	3	86737	147253	70694451
Drug hypersensitivity	157.41	13.67	62	86678	262397	70579307
Onycholysis	157.17	13.67	65	86675	1738	70839966
Toxicity to various agents	155.63	13.67	143	86597	382029	70459675
Joint swelling	148.30	13.67	62	86678	253149	70588555
Computerised tomogram thorax abnormal	144.45	13.67	64	86676	2034	70839670
Synovitis	143.28	13.67	3	86737	129225	70712479
Contraindicated product administered	142.30	13.67	5	86735	134607	70707097
Neoplasm progression	139.21	13.67	220	86520	45008	70796696
Cardiac failure	133.87	13.67	433	86307	143108	70698596
Osteonecrosis of jaw	132.54	13.67	204	86536	40798	70800906
Product dose omission issue	127.72	13.67	53	86687	217415	70624289
Epistaxis	127.63	13.67	343	86397	102284	70739420
Metastases to skin	124.76	13.67	53	86687	1518	70840186
Confusional state	123.51	13.67	100	86640	284298	70557406
Therapeutic product effect decreased	118.42	13.67	17	86723	143001	70698703
Pleural effusion	117.79	13.67	394	86346	132470	70709234
Nail disorder	116.72	13.67	99	86641	10325	70831379
Metastasis	114.76	13.67	79	86661	6035	70835669
Skin toxicity	114.32	13.67	84	86656	7114	70834590
Nail toxicity	114.24	13.67	34	86706	326	70841378
Vomiting	111.58	13.67	1161	85579	591950	70249754
Biopsy lung abnormal	109.82	13.67	28	86712	140	70841564
Hypokalaemia	109.25	13.67	381	86359	130807	70710897
Bone pain	106.74	13.67	209	86531	50613	70791091
Overdose	105.23	13.67	38	86702	169707	70671997
Gastrointestinal toxicity	104.56	13.67	76	86664	6329	70835375
Invasive ductal breast carcinoma	101.88	13.67	72	86668	5737	70835967
Pneumonitis	100.99	13.67	213	86527	54384	70787320
Alveolitis	100.56	13.67	61	86679	3750	70837954
Hyperpyrexia	99.83	13.67	69	86671	5305	70836399
Arthropathy	97.52	13.67	31	86709	150026	70691678
Decreased appetite	96.74	13.67	671	86069	304109	70537595
Psoriasis	96.46	13.67	6	86734	98427	70743277
Nail discolouration	94.56	13.67	52	86688	2654	70839050
Nail dystrophy	92.30	13.67	37	86703	911	70840793
Systemic lupus erythematosus	92.04	13.67	9	86731	101893	70739811
Cellulitis	91.80	13.67	298	86442	98630	70743074
Neurotoxicity	90.28	13.67	144	86596	29682	70812022
Alopecia	89.65	13.67	479	86261	198011	70643693
Dysgeusia	89.10	13.67	191	86549	49311	70792393
Dyspnoea	89.02	13.67	1377	85363	768683	70073021
Lacrimation increased	87.98	13.67	115	86625	19784	70821920
Fatigue	84.85	13.67	1446	85294	822873	70018831
Pyrexia	83.43	13.67	1119	85621	605833	70235871
Sinusitis	83.24	13.67	52	86688	169143	70672561
Abdominal discomfort	80.72	13.67	86	86654	214572	70627132
HER2 positive breast cancer	80.41	13.67	26	86714	335	70841369
Ventricular hypokinesia	79.89	13.67	72	86668	8140	70833564
Erysipelas	79.28	13.67	78	86662	9846	70831858
Madarosis	78.69	13.67	45	86695	2478	70839226
Treatment failure	78.55	13.67	39	86701	144103	70697601
Pericardial effusion	77.27	13.67	163	86577	41613	70800091
Somnolence	77.10	13.67	90	86650	215516	70626188
Paronychia	76.78	13.67	66	86674	7008	70834696
Multifocal micronodular pneumocyte hyperplasia	73.66	13.67	18	86722	73	70841631
Bronchial polyp	73.27	13.67	18	86722	75	70841629
Hyperkalaemia	72.93	13.67	20	86720	106571	70735133
Hypertransaminasaemia	72.77	13.67	71	86669	8872	70832832
Metastases to meninges	72.13	13.67	46	86694	3090	70838614
Aortitis	72.08	13.67	35	86705	1376	70840328
Vascular device infection	71.50	13.67	67	86673	7963	70833741
Rhabdomyolysis	71.34	13.67	15	86725	95745	70745959
Lymphangiosis carcinomatosa	70.50	13.67	38	86702	1863	70839841
Plasma cell myeloma	70.14	13.67	5	86735	73196	70768508
Mitral valve incompetence	70.10	13.67	121	86619	26607	70815097
Weight increased	69.87	13.67	118	86622	242213	70599491
Metastatic neoplasm	68.80	13.67	52	86688	4596	70837108
Recall phenomenon	68.74	13.67	31	86709	1028	70840676
Inappropriate schedule of product administration	68.49	13.67	23	86717	107532	70734172
Oligohydramnios	68.32	13.67	45	86695	3195	70838509
Loss of personal independence in daily activities	68.19	13.67	11	86729	84899	70756805
Paraesthesia	66.89	13.67	353	86387	145184	70696520
Suicide attempt	66.86	13.67	9	86731	79501	70762203
Haematotoxicity	66.72	13.67	83	86657	13591	70828113
Acute myeloid leukaemia	64.67	13.67	127	86613	30813	70810891
Colitis	64.47	13.67	198	86542	63616	70778088
Mastitis	64.35	13.67	37	86703	2059	70839645
Hot flush	63.91	13.67	168	86572	49416	70792288
Injection site pain	63.82	13.67	32	86708	117587	70724117
Metastases to spine	63.79	13.67	46	86694	3783	70837921
Hospitalisation	63.46	13.67	12	86728	82556	70759148
Product use issue	63.37	13.67	76	86664	179861	70661843
Therapy partial responder	62.93	13.67	77	86663	12397	70829307
Disease recurrence	61.90	13.67	140	86600	37463	70804241
Alopecia areata	61.51	13.67	33	86707	1603	70840101
Neutropenic infection	60.44	13.67	35	86705	1974	70839730
Granulocyte count decreased	59.74	13.67	31	86709	1406	70840298
Infusion related reaction	59.73	13.67	430	86310	197104	70644600
Breast pain	59.00	13.67	58	86682	7313	70834391
Drug reaction with eosinophilia and systemic symptoms	58.48	13.67	3	86737	58010	70783694
Acute interstitial pneumonitis	58.11	13.67	28	86712	1082	70840622
Product use in unapproved indication	58.00	13.67	103	86637	207375	70634329
Tumour marker increased	57.39	13.67	43	86697	3751	70837953
Cough	57.24	13.67	629	86111	324748	70516956
Therapeutic product effect incomplete	56.03	13.67	39	86701	119843	70721861
Onychalgia	55.95	13.67	25	86715	811	70840893
Organising pneumonia	55.57	13.67	65	86675	9985	70831719
Lactic acidosis	55.54	13.67	7	86733	65017	70776687
Radiation skin injury	55.51	13.67	29	86711	1334	70840370
Pain	55.49	13.67	497	86243	628319	70213385
Myocardial infarction	54.79	13.67	78	86662	171567	70670137
Onychoclasis	53.08	13.67	46	86694	4938	70836766
Neutrophil count decreased	52.52	13.67	222	86518	83334	70758370
White blood cell count decreased	52.37	13.67	372	86368	169769	70671935
Device related infection	50.95	13.67	118	86622	32067	70809637
Chest discomfort	50.65	13.67	292	86448	124089	70717615
Hair texture abnormal	50.25	13.67	37	86703	3143	70838561
Mastectomy	49.93	13.67	25	86715	1051	70840653
Osteonecrosis	49.60	13.67	110	86630	29050	70812654
Tonsillar disorder	49.54	13.67	25	86715	1069	70840635
Gastrointestinal haemorrhage	49.49	13.67	57	86683	137351	70704353
Axillary pain	48.85	13.67	30	86710	1885	70839819
International normalised ratio increased	48.45	13.67	19	86721	80707	70760997
Atelectasis	47.86	13.67	108	86632	28854	70812850
Mobility decreased	47.48	13.67	34	86706	102965	70738739
Acute kidney injury	47.32	13.67	363	86377	474261	70367443
Cardio-respiratory arrest	46.72	13.67	33	86707	100644	70741060
Fibromyalgia	46.65	13.67	3	86737	47871	70793833
Dermatitis acneiform	46.40	13.67	56	86684	8889	70832815
Leukopenia	45.92	13.67	254	86486	106306	70735398
Metastases to chest wall	45.64	13.67	18	86722	424	70841280
Erythema	45.36	13.67	407	86333	199156	70642548
Computerised tomogram thorax	44.61	13.67	15	86725	220	70841484
Drug intolerance	44.57	13.67	135	86605	225552	70616152
Blood uric acid decreased	44.54	13.67	24	86716	1176	70840528
Carbohydrate antigen 15-3 increased	44.49	13.67	23	86717	1035	70840669
Constipation	44.36	13.67	488	86252	251950	70589754
Arthritis	44.31	13.67	33	86707	97947	70743757
Myalgia	44.28	13.67	354	86386	167538	70674166
Injection site erythema	44.03	13.67	17	86723	72907	70768797
Breast mass	43.50	13.67	44	86696	5741	70835963
Hair colour changes	43.39	13.67	37	86703	3886	70837818
Hepatic enzyme increased	42.91	13.67	79	86661	156911	70684793
Intentional product misuse	42.65	13.67	22	86718	79573	70762131
Musculoskeletal stiffness	42.52	13.67	72	86668	147688	70694016
Pseudocirrhosis	42.07	13.67	19	86721	632	70841072
Dry skin	41.89	13.67	157	86583	55774	70785930
Meibomian gland dysfunction	41.83	13.67	13	86727	146	70841558
Asthma	41.48	13.67	52	86688	120741	70720963
Bradycardia	41.40	13.67	55	86685	124560	70717144
Hallucination	40.98	13.67	21	86719	76239	70765465
Delirium	40.92	13.67	20	86720	74594	70767110
Ejection fraction	40.91	13.67	26	86714	1736	70839968
Second primary malignancy	40.86	13.67	64	86676	12987	70828717
Contusion	40.05	13.67	59	86681	127977	70713727
Sedation	39.98	13.67	5	86735	46726	70794978
Injury	39.74	13.67	15	86725	65230	70776474
Anaemia	39.21	13.67	702	86038	402721	70438983
Breast neoplasm	39.06	13.67	20	86720	882	70840822
Unresponsive to stimuli	38.95	13.67	8	86732	51923	70789781
Coronary artery disease	38.93	13.67	14	86726	62722	70778982
Injection site reaction	38.83	13.67	7	86733	49845	70791859
Orthostatic hypotension	38.75	13.67	8	86732	51735	70789969
Hypoglycaemia	38.68	13.67	35	86705	94329	70747375
Blood lactate dehydrogenase increased	38.31	13.67	112	86628	35015	70806689
Nail infection	38.06	13.67	27	86713	2164	70839540
Dermatitis	37.35	13.67	77	86663	19340	70822364
Cytomegalovirus infection	37.28	13.67	3	86737	39755	70801949
Radiation necrosis	36.69	13.67	15	86725	389	70841315
Bladder irritation	36.68	13.67	13	86727	225	70841479
Blood creatinine decreased	36.48	13.67	45	86695	7304	70834400
Product prescribing error	36.35	13.67	3	86737	38949	70802755
Swelling	36.35	13.67	114	86626	188425	70653279
Adverse event	36.32	13.67	8	86732	49453	70792251
Central nervous system lesion	36.15	13.67	59	86681	12394	70829310
Dyskinesia	36.12	13.67	4	86736	41070	70800634
Duodenal ulcer perforation	36.08	13.67	9	86731	51103	70790601
Asthenia	35.91	13.67	771	85969	456895	70384809
Drug ineffective for unapproved indication	35.88	13.67	3	86737	38535	70803169
Wound	35.50	13.67	41	86699	98691	70743013
Vulvovaginal dryness	35.47	13.67	24	86716	1782	70839922
Electrocardiogram QT prolonged	35.41	13.67	30	86710	83487	70758217
Eosinophilia	35.27	13.67	4	86736	40315	70801389
Wheezing	35.06	13.67	38	86702	94132	70747572
Dehydration	34.73	13.67	426	86314	225716	70615988
Acoustic stimulation tests abnormal	34.60	13.67	8	86732	24	70841680
Pulmonary mass	34.35	13.67	89	86651	25944	70815760
Feeling abnormal	34.31	13.67	77	86663	142242	70699462
Coma	34.27	13.67	37	86703	91807	70749897
Enterocolitis	34.06	13.67	59	86681	13007	70828697
Chronic kidney disease	34.04	13.67	16	86724	61041	70780663
Injection site pruritus	34.03	13.67	4	86736	39206	70802498
Congestive cardiomyopathy	33.40	13.67	53	86687	10873	70830831
Recurrent cancer	33.26	13.67	26	86714	2415	70839289
Mental status changes	32.99	13.67	18	86722	63083	70778621
Chronic obstructive pulmonary disease	32.78	13.67	28	86712	77613	70764091
Perforation	32.74	13.67	20	86720	1245	70840459
Eosinophil percentage increased	32.68	13.67	21	86719	1429	70840275
Agranulocytosis	32.61	13.67	116	86624	40182	70801522
Nasal congestion	32.53	13.67	20	86720	65652	70776052
Cystitis noninfective	32.36	13.67	20	86720	1271	70840433
Flushing	32.20	13.67	191	86549	81981	70759723
Jaw operation	32.14	13.67	17	86723	802	70840902
Accidental overdose	31.98	13.67	3	86737	35118	70806586
Respiratory arrest	31.86	13.67	13	86727	53920	70787784
Blood glucose increased	31.67	13.67	48	86692	102934	70738770
Asthenopia	31.25	13.67	24	86716	2172	70839532
Arthralgia	31.15	13.67	431	86309	502959	70338745
Hypoaesthesia	31.14	13.67	306	86434	153433	70688271
Platelet count decreased	31.03	13.67	344	86396	177878	70663826
Vascular fragility	30.99	13.67	10	86730	128	70841576
Discomfort	30.67	13.67	51	86689	105385	70736319
Depression	30.67	13.67	132	86608	198842	70642862
Blood pressure fluctuation	30.61	13.67	17	86723	58995	70782709
Cardiac arrest	30.56	13.67	97	86643	159737	70681967
Mean platelet volume decreased	30.46	13.67	24	86716	2255	70839449
Hyperfibrinogenaemia	30.45	13.67	9	86731	84	70841620
Troponin I increased	30.44	13.67	31	86709	4077	70837627
Blood cholesterol increased	30.20	13.67	21	86719	64583	70777121
Tumour pain	30.01	13.67	23	86717	2075	70839629
Sense of oppression	29.74	13.67	20	86720	1470	70840234
Red cell distribution width increased	29.68	13.67	57	86683	13600	70828104
Depressed level of consciousness	29.64	13.67	38	86702	87393	70754311
Hepatic lesion	29.63	13.67	37	86703	6080	70835624
Systolic dysfunction	29.14	13.67	28	86712	3433	70838271
Diabetes mellitus	29.01	13.67	27	86713	71797	70769907
Tachycardia	28.98	13.67	309	86431	158237	70683467
Enterocolitis infectious	28.96	13.67	25	86715	2669	70839035
Glossodynia	28.90	13.67	38	86702	86449	70755255
Anxiety	28.82	13.67	155	86585	220175	70621529
Renal failure	28.79	13.67	126	86614	188944	70652760
Onychomadesis	28.68	13.67	30	86710	4071	70837633
Medication error	28.65	13.67	17	86723	56895	70784809
Anastomotic complication	28.63	13.67	13	86727	438	70841266
Lung infiltration	28.61	13.67	74	86666	21550	70820154
Pulmonary embolism	28.59	13.67	304	86436	155563	70686141
Hepatic function abnormal	28.56	13.67	161	86579	67835	70773869
Irritability	28.44	13.67	6	86734	38219	70803485
Suicidal ideation	28.30	13.67	26	86714	69570	70772134
Nasal discomfort	28.14	13.67	32	86708	4769	70836935
Odynophagia	27.91	13.67	47	86693	10128	70831576
Breast inflammation	27.90	13.67	9	86731	115	70841589
Excessive eye blinking	27.87	13.67	19	86721	1428	70840276
Vessel puncture site bruise	27.68	13.67	13	86727	474	70841230
Osteoarthritis	27.51	13.67	30	86710	74117	70767587
Tumour marker abnormal	27.47	13.67	11	86729	270	70841434
Biliary sepsis	27.28	13.67	19	86721	1479	70840225
Keratitis	27.20	13.67	28	86712	3729	70837975
Blister	27.09	13.67	51	86689	100475	70741229
Metastases to pleura	27.05	13.67	18	86722	1300	70840404
Dysarthria	26.89	13.67	22	86718	62291	70779413
Disorientation	26.85	13.67	19	86721	57904	70783800
Abnormal behaviour	26.76	13.67	5	86735	34704	70807000
Hydrothorax	26.58	13.67	18	86722	1338	70840366
Wrong technique in product usage process	26.38	13.67	27	86713	68671	70773033
Nasal disorder	26.38	13.67	26	86714	3288	70838416
Carcinoembryonic antigen increased	26.33	13.67	21	86719	2009	70839695
Death	26.12	13.67	812	85928	509249	70332455
Neoplasm recurrence	26.09	13.67	28	86712	3913	70837791
Papilloedema	26.03	13.67	34	86706	5844	70835860
Blood creatine phosphokinase increased	25.98	13.67	22	86718	61241	70780463
Performance status decreased	25.74	13.67	33	86707	5568	70836136
Osteosclerosis	25.73	13.67	27	86713	3678	70838026
Breast cellulitis	25.70	13.67	11	86729	321	70841383
Therapy cessation	25.65	13.67	5	86735	33671	70808033
Vulvovaginal candidiasis	25.53	13.67	22	86718	2344	70839360
Metabolic acidosis	25.52	13.67	32	86708	74314	70767390
Gait disturbance	25.45	13.67	128	86612	184978	70656726
Bone lesion	24.97	13.67	32	86708	5398	70836306
Treatment noncompliance	24.76	13.67	13	86727	46561	70795143
Hepatotoxicity	24.69	13.67	113	86627	43873	70797831
Calcium ionised increased	24.62	13.67	9	86731	171	70841533
Multicentric reticulohistiocytosis	24.60	13.67	5	86735	6	70841698
Vulvovaginal inflammation	24.52	13.67	12	86728	480	70841224
Skin fissures	24.45	13.67	47	86693	11223	70830481
Nail bed bleeding	24.40	13.67	12	86728	485	70841219
Ear infection	24.32	13.67	3	86737	28333	70813371
Nephrolithiasis	24.02	13.67	14	86726	47309	70794395
Pustule	23.91	13.67	18	86722	1581	70840123
Peripheral motor neuropathy	23.88	13.67	24	86716	3108	70838596
Off label use	23.76	13.67	1123	85617	741937	70099767
Basal cell carcinoma	23.66	13.67	6	86734	33692	70808012
Back pain	23.59	13.67	464	86276	270688	70571016
Emotional distress	23.58	13.67	8	86732	37180	70804524
Post-traumatic pain	23.45	13.67	11	86729	400	70841304
Osteitis condensans	23.37	13.67	6	86734	31	70841673
Sensory disturbance	23.32	13.67	52	86688	13780	70827924
Acute pulmonary oedema	23.27	13.67	51	86689	13361	70828343
Exposure during pregnancy	23.20	13.67	45	86695	87672	70754032
Irritable bowel syndrome	23.15	13.67	17	86723	50833	70790871
Renal impairment	23.09	13.67	94	86646	143843	70697861
Sopor	23.07	13.67	5	86735	31262	70810442
Subdural haematoma	23.07	13.67	4	86736	29294	70812410
HER2 positive gastric cancer	22.83	13.67	4	86736	0	70841704
Cerebrovascular accident	22.83	13.67	94	86646	143376	70698328
Cystoid macular oedema	22.80	13.67	19	86721	1933	70839771
Hyperbilirubinaemia	22.76	13.67	70	86670	22498	70819206
Osteoporosis	22.72	13.67	16	86724	48891	70792813
Gait inability	22.50	13.67	15	86725	47160	70794544
Dyspepsia	22.48	13.67	186	86554	88891	70752813
Temperature intolerance	22.23	13.67	39	86701	8684	70833020
Dysaesthesia	22.15	13.67	30	86710	5338	70836366
Xerophthalmia	22.08	13.67	12	86728	598	70841106
Lymphangitis	22.00	13.67	16	86724	1333	70840371
Palmar erythema	22.00	13.67	18	86722	1785	70839919
Migraine	21.89	13.67	34	86706	72204	70769500
Influenza	21.73	13.67	69	86671	113631	70728073
Urticaria	21.70	13.67	114	86626	162935	70678769
Osteolysis	21.55	13.67	24	86716	3495	70838209
Pneumonia aspiration	21.18	13.67	27	86713	62262	70779442
Rash pustular	21.16	13.67	42	86698	10266	70831438
Blood alkaline phosphatase increased	21.01	13.67	133	86607	58388	70783316
Left ventricular dilatation	21.00	13.67	14	86726	1014	70840690
Corneal disorder	20.99	13.67	19	86721	2160	70839544
Gait apraxia	20.93	13.67	5	86735	18	70841686
Distichiasis	20.93	13.67	5	86735	18	70841686
Lymphadenopathy	20.80	13.67	116	86624	48675	70793029
Breast disorder	20.78	13.67	18	86722	1931	70839773
Radiation pneumonitis	20.61	13.67	24	86716	3669	70838035
Pulmonary hypoplasia	20.60	13.67	6	86734	53	70841651
Overflow diarrhoea	20.55	13.67	7	86733	107	70841597
Respiratory depression	20.43	13.67	3	86737	24828	70816876
Acute respiratory distress syndrome	20.27	13.67	102	86638	41152	70800552
Pericarditis	20.27	13.67	46	86694	84659	70757045
Barotrauma	20.22	13.67	8	86732	190	70841514
Swollen tongue	20.20	13.67	10	86730	37036	70804668
Hypothalamo-pituitary disorder	20.20	13.67	14	86726	1081	70840623
Spinal pain	20.18	13.67	49	86691	13721	70827983
Infection	20.12	13.67	163	86577	210622	70631082
Delusion of grandeur	20.11	13.67	13	86727	894	70840810
Dermatomyositis	20.09	13.67	23	86717	3452	70838252
Breast sarcoma	20.06	13.67	4	86736	4	70841700
Vaginal prolapse	20.05	13.67	9	86731	295	70841409
Dizziness	20.05	13.67	424	86316	463717	70377987
Ovarian failure	19.90	13.67	11	86729	567	70841137
Mouth ulceration	19.84	13.67	89	86651	34260	70807444
Hypervolaemia	19.79	13.67	12	86728	39694	70802010
Acute myocardial infarction	19.62	13.67	37	86703	72850	70768854
Dysuria	19.61	13.67	109	86631	45685	70796019
Subclavian vein thrombosis	19.60	13.67	19	86721	2355	70839349
Hyperchlorhydria	19.58	13.67	17	86723	1829	70839875
Haemorrhoids	19.30	13.67	72	86668	25516	70816188
Tidal volume decreased	19.18	13.67	6	86734	69	70841635
Skin infection	19.15	13.67	53	86687	16059	70825645
Hypotension	19.08	13.67	364	86376	404017	70437687
Agitation	19.03	13.67	55	86685	93320	70748384
Gastritis	19.00	13.67	106	86634	44485	70797219
Herpangina	18.99	13.67	5	86735	29	70841675
Inflammatory carcinoma of the breast	18.99	13.67	5	86735	29	70841675
Impaired healing	18.94	13.67	39	86701	74335	70767369
Eye pain	18.91	13.67	9	86731	34093	70807611
Merycism	18.67	13.67	8	86732	234	70841470
Transaminases	18.58	13.67	6	86734	77	70841627
Gastrointestinal disorder	18.57	13.67	204	86536	105223	70736481
Thrombocytopenia	18.43	13.67	402	86338	238708	70602996
Blood creatine increased	18.34	13.67	36	86704	8728	70832976
Therapy interrupted	18.23	13.67	4	86736	24798	70816906
Entropion	18.06	13.67	5	86735	36	70841668
Nail bed tenderness	18.05	13.67	9	86731	375	70841329
Toxic neuropathy	18.04	13.67	12	86728	866	70840838
Cataract	18.03	13.67	25	86715	55620	70786084
Retinal detachment	17.99	13.67	35	86705	8432	70833272
Vocal cord paralysis	17.96	13.67	18	86722	2323	70839381
Sarcoid-like reaction	17.83	13.67	4	86736	10	70841694
Encephalopathy	17.77	13.67	30	86710	61631	70780073
Metastases to the mediastinum	17.77	13.67	10	86730	534	70841170
Urinary retention	17.62	13.67	23	86717	52497	70789207
Metastases to breast	17.55	13.67	8	86732	272	70841432
Maternal exposure during pregnancy	17.47	13.67	77	86663	115268	70726436
Eastern Cooperative Oncology Group performance status worsened	17.45	13.67	15	86725	1593	70840111
Device issue	17.41	13.67	4	86736	24021	70817683
Pituitary tumour	17.31	13.67	13	86727	1138	70840566
Limb injury	17.30	13.67	5	86735	25747	70815957
Colitis ulcerative	17.26	13.67	10	86730	33913	70807791
Lower respiratory tract infection	17.23	13.67	211	86529	111702	70730002
Leukaemia cutis	17.18	13.67	7	86733	180	70841524
Globulinuria	17.12	13.67	3	86737	0	70841704
Left atrial volume increased	17.12	13.67	3	86737	0	70841704
Tooth extraction	17.04	13.67	38	86702	10069	70831635
Malignant pleural effusion	16.85	13.67	20	86720	3119	70838585
Dandy-Walker syndrome	16.79	13.67	5	86735	48	70841656
Illness	16.71	13.67	9	86731	31782	70809922
Aphasia	16.60	13.67	17	86723	43232	70798472
Transient ischaemic attack	16.59	13.67	19	86721	45925	70795779
Road traffic accident	16.57	13.67	11	86729	34671	70807033
Tongue coated	16.56	13.67	13	86727	1215	70840489
Axillary vein thrombosis	16.52	13.67	10	86730	612	70841092
Clostridial infection	16.50	13.67	26	86714	5303	70836401
Adenocarcinoma gastric	16.45	13.67	15	86725	1721	70839983
Catheter site pain	16.44	13.67	25	86715	4943	70836761
Generalised tonic-clonic seizure	16.42	13.67	16	86724	41645	70800059
Pleural disorder	16.39	13.67	11	86729	806	70840898
Metastases to nervous system	16.35	13.67	5	86735	53	70841651
Breast ulceration	16.35	13.67	5	86735	53	70841651
Gout	16.34	13.67	4	86736	23002	70818702
Adverse drug reaction	16.27	13.67	25	86715	53319	70788385
Oral candidiasis	16.22	13.67	67	86673	24885	70816819
Spider naevus	16.17	13.67	6	86734	119	70841585
Alopecia totalis	16.12	13.67	8	86732	330	70841374
Angioedema	16.07	13.67	36	86704	66574	70775130
Viral infection	16.02	13.67	14	86726	38377	70803327
Naevus haemorrhage	15.99	13.67	6	86734	123	70841581
Paralysis recurrent laryngeal nerve	15.99	13.67	6	86734	123	70841581
Nasal ulcer	15.90	13.67	15	86725	1798	70839906
Urinary tract disorder	15.87	13.67	20	86720	3317	70838387
Foot deformity	15.87	13.67	3	86737	20652	70821052
Botryomycosis	15.86	13.67	5	86735	59	70841645
Full blood count abnormal	15.85	13.67	11	86729	33867	70807837
Pancreatitis	15.84	13.67	33	86707	62635	70779069
Hypoxia	15.70	13.67	179	86561	93165	70748539
Gingival pain	15.67	13.67	29	86711	6728	70834976
Movement disorder	15.64	13.67	5	86735	24124	70817580
Pneumonitis chemical	15.56	13.67	8	86732	356	70841348
Dental fistula	15.53	13.67	9	86731	508	70841196
Urogenital prolapse	15.53	13.67	4	86736	21	70841683
Pleural neoplasm	15.45	13.67	8	86732	361	70841343
Gastric disorder	15.35	13.67	11	86729	33311	70808393
Injection site haemorrhage	15.33	13.67	6	86734	25521	70816183
Gastric perforation	15.26	13.67	21	86719	3794	70837910
Amenorrhoea	15.15	13.67	29	86711	6901	70834803
Joint injury	15.10	13.67	7	86733	26925	70814779
Myeloproliferative neoplasm	15.08	13.67	11	86729	921	70840783
Diabetic ketoacidosis	15.05	13.67	10	86730	31502	70810202
Atrial thrombosis	14.82	13.67	19	86721	3206	70838498
Fluid retention	14.70	13.67	35	86705	63350	70778354
Hepatitis	14.69	13.67	24	86716	49956	70791748
Flatulence	14.67	13.67	15	86725	38166	70803538
Product administration error	14.61	13.67	9	86731	29514	70812190
Incorrect dose administered	14.57	13.67	38	86702	66681	70775023
Myoclonus	14.55	13.67	7	86733	26348	70815356
Carbohydrate antigen 19-9 increased	14.53	13.67	8	86732	409	70841295
Postural orthostatic tachycardia syndrome	14.45	13.67	9	86731	580	70841124
Corneal bleeding	14.43	13.67	4	86736	29	70841675
Frequent bowel movements	14.40	13.67	4	86736	21149	70820555
Rhinorrhoea	14.36	13.67	134	86606	66237	70775467
Hypertensive crisis	14.36	13.67	54	86686	19208	70822496
Pulmonary toxicity	14.33	13.67	37	86703	10761	70830943
Chromosomal mutation	14.31	13.67	4	86736	30	70841674
Appendiceal abscess	14.23	13.67	7	86733	283	70841421
Product quality issue	14.19	13.67	10	86730	30551	70811153
Tumour haemorrhage	14.16	13.67	20	86720	3702	70838002
Folate deficiency	14.16	13.67	18	86722	3012	70838692
Fear	14.05	13.67	4	86736	20807	70820897
Toothache	14.02	13.67	52	86688	18378	70823326
Bronchitis	13.96	13.67	85	86655	117158	70724546
Labelled drug-drug interaction medication error	13.95	13.67	6	86734	24121	70817583
Nodular regenerative hyperplasia	13.90	13.67	12	86728	1281	70840423
Lymphocyte count decreased	13.84	13.67	96	86644	43443	70798261
HER2 positive salivary gland cancer	13.84	13.67	3	86737	6	70841698
Catheter site bruise	13.83	13.67	7	86733	301	70841403
Mouth swelling	13.74	13.67	24	86716	5325	70836379
Plantar erythema	13.73	13.67	7	86733	306	70841398

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01FD01	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES HER2 (Human Epidermal Growth Factor Receptor 2) inhibitors
ATC	L01XY02	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Combinations of antineoplastic agents
FDA MoA	N0000020008	HER2/Neu/cerbB2 Antagonists
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D000074322	Antineoplastic Agents, Immunological
FDA EPC	N0000175661	HER2/neu Receptor Antagonist

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

Disease	Relation	SNOMED_ID	DOID
Secondary malignant neoplasm of female breast	indication	94297009
Secondary malignant neoplasm of stomach	indication	94606003
Human epidermal growth factor 2 positive gastric cancer	indication	102453009
HER2-positive salivary gland tumors	indication	255072001
HER2-positive rectal cancer	indication	363351006	DOID:1993
HER2-positive colon cancer	indication	363406005	DOID:219
HER2-positive carcinoma of breast	indication	427685000

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Receptor tyrosine-protein kinase erbB-2	Kinase	P04626	ERBB2_HUMAN	ANTIBODY BINDING				DRUG LABEL	DRUG LABEL

External reference:

ID	Source
P188ANX8CK	UNII
D03257	KEGG_DRUG
4021140	VUID
N0000148593	NUI
C0728747	UMLSCUI
CHEMBL1201585	ChEMBL_ID
DB00072	DRUGBANK_ID
D000068878	MESH_DESCRIPTOR_UI
7637	INN_ID
C000630669	MESH_SUPPLEMENTAL_RECORD_UI
5082	IUPHAR_LIGAND_ID
101306	RXNORM
11893	MMSL
266775	MMSL
33398	MMSL
7554	MMSL
d04357	MMSL
007663	NDDF
017423	NDDF
327397006	SNOMEDCT_US
387003001	SNOMEDCT_US
4021140	VANDF
4038908	VANDF

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Ontruzant	HUMAN PRESCRIPTION DRUG LABEL	1	0006-5033	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	150 mg	INTRAVENOUS	BLA	28 sections
Trazimera	HUMAN PRESCRIPTION DRUG LABEL	1	0069-0308	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	150 mg	INTRAVENOUS	BLA	29 sections
Herceptin Hylecta	HUMAN PRESCRIPTION DRUG LABEL	2	50242-077	INJECTION, SOLUTION	600 mg	SUBCUTANEOUS	BLA	28 sections
Herceptin	HUMAN PRESCRIPTION DRUG LABEL	1	50242-132	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	150 mg	INTRAVENOUS	BLA	25 sections
Phesgo	HUMAN PRESCRIPTION DRUG LABEL	3	50242-245	INJECTION, SOLUTION	600 mg	SUBCUTANEOUS	BLA	30 sections
Phesgo	HUMAN PRESCRIPTION DRUG LABEL	3	50242-245	INJECTION, SOLUTION	600 mg	SUBCUTANEOUS	BLA	30 sections
Phesgo	HUMAN PRESCRIPTION DRUG LABEL	3	50242-260	INJECTION, SOLUTION	600 mg	SUBCUTANEOUS	BLA	30 sections
Phesgo	HUMAN PRESCRIPTION DRUG LABEL	3	50242-260	INJECTION, SOLUTION	600 mg	SUBCUTANEOUS	BLA	30 sections
Kanjinti	HUMAN PRESCRIPTION DRUG LABEL	1	55513-132	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	420 mg	INTRAVENOUS	BLA	28 sections
Kanjinti	HUMAN PRESCRIPTION DRUG LABEL	1	55513-132	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	420 mg	INTRAVENOUS	BLA	28 sections
Kanjinti	HUMAN PRESCRIPTION DRUG LABEL	1	55513-141	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	150 mg	INTRAVENOUS	BLA	28 sections
Kanjinti	HUMAN PRESCRIPTION DRUG LABEL	1	55513-141	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	150 mg	INTRAVENOUS	BLA	28 sections
HERZUMA	HUMAN PRESCRIPTION DRUG LABEL	1	63459-303	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	150 mg	INTRAVENOUS	BLA	29 sections
HERZUMA	HUMAN PRESCRIPTION DRUG LABEL	1	63459-303	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	150 mg	INTRAVENOUS	BLA	29 sections
OGIVRI	HUMAN PRESCRIPTION DRUG LABEL	1	67457-845	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	420 mg	INTRAVENOUS	BLA	29 sections
OGIVRI	HUMAN PRESCRIPTION DRUG LABEL	1	67457-991	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	150 mg	INTRAVENOUS	BLA	29 sections
Ontruzant	HUMAN PRESCRIPTION DRUG LABEL	1	78206-147	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	150 mg	INTRAVENOUS	BLA	28 sections