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

Stem definition	Drug id	CAS RN
humanized origin	4909	216503-57-0

Description:

Molecule	Description
Synonyms: campath alemtuzumab lemtrada	Alemtuzumab binds to CD52, an antigen present on the surface of B and T lymphocytes, a majority of monocytes, macrophages, NK cells, and a subpopulation of granulocytes. A proportion of bone marrow cells, including some CD34+ cells, express variable levels of CD52. The proposed mechanism of action is antibody-dependent cellular-mediated lysis following cell surface binding of alemtuzumab to the leukemic cells. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

campath
alemtuzumab
lemtrada

Alemtuzumab binds to CD52, an antigen present on the surface of B and T lymphocytes, a majority of monocytes, macrophages, NK cells, and a subpopulation of granulocytes. A proportion of bone marrow cells, including some CD34+ cells, express variable levels of CD52. The proposed mechanism of action is antibody-dependent cellular-mediated lysis following cell surface binding of alemtuzumab to the leukemic cells.

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

Drug dosage:

Dose	Unit	Route
0.13	mg	P

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
May 7, 2001	FDA	GENZYME
Sept. 26, 2014	PMDA	SANOFI K.K.

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
Lymphocyte count decreased	955.64	15.20	443	41115	29814	63417650
Immune thrombocytopenia	835.43	15.20	299	41259	10257	63437207
Urine abnormality	738.50	15.20	246	41312	6773	63440691
Urinary sediment present	484.00	15.20	136	41422	2067	63445397
Multiple sclerosis relapse	473.24	15.20	329	41229	48149	63399315
White blood cells urine positive	457.16	15.20	159	41399	4999	63442465
Urine leukocyte esterase positive	455.78	15.20	145	41413	3434	63444030
Red blood cells urine positive	441.21	15.20	137	41421	2989	63444475
Lymphocyte percentage decreased	388.64	15.20	123	41435	2862	63444602
Blood urine present	376.39	15.20	188	41370	14881	63432583
Cytomegalovirus infection	366.30	15.20	206	41352	20746	63426718
Crystal urine present	353.78	15.20	100	41458	1554	63445910
Neutrophil percentage increased	353.26	15.20	114	41444	2829	63444635
Urine analysis abnormal	348.03	15.20	129	41429	4887	63442577
Lymphopenia	344.48	15.20	189	41369	18138	63429326
Adenovirus infection	327.74	15.20	113	41445	3458	63444006
Bacterial test positive	259.93	15.20	106	41452	5201	63442263
Urine ketone body present	256.34	15.20	86	41472	2417	63445047
Bacterial test	246.66	15.20	70	41488	1104	63446360
Autoimmune thyroiditis	245.63	15.20	94	41464	3892	63443572
Blood thyroid stimulating hormone decreased	243.15	15.20	97	41461	4493	63442971
Flushing	241.41	15.20	271	41287	74816	63372648
Nitrite urine present	221.43	15.20	63	41495	1003	63446461
Hyperthyroidism	215.86	15.20	129	41429	14544	63432920
Red cell distribution width increased	212.95	15.20	114	41444	10410	63437054
Graft versus host disease in skin	206.26	15.20	76	41482	2829	63444635
Bradycardia	196.60	15.20	241	41317	72986	63374478
Drug ineffective	189.72	15.20	245	41313	1044520	62402944
Blood thyroid stimulating hormone increased	177.38	15.20	89	41469	7105	63440359
Haemoglobin urine present	172.58	15.20	49	41509	774	63446690
Culture urine positive	171.57	15.20	71	41487	3616	63443848
Chest discomfort	163.39	15.20	273	41285	109696	63337768
Drug intolerance	156.59	15.20	12	41546	308649	63138815
Haematocrit decreased	152.78	15.20	157	41401	39183	63408281
Leukocyturia	149.22	15.20	50	41508	1399	63446065
Protein urine present	148.79	15.20	75	41483	6045	63441419
Monocyte percentage increased	148.17	15.20	47	41511	1101	63446363
Headache	147.72	15.20	808	40750	632433	62815031
Platelet count decreased	147.43	15.20	269	41289	115853	63331611
Graft versus host disease	147.41	15.20	77	41481	6686	63440778
Post transplant lymphoproliferative disorder	144.26	15.20	69	41489	4962	63442502
Pyrexia	144.18	15.20	649	40909	469829	62977635
Specific gravity urine decreased	143.64	15.20	42	41516	740	63446724
Thyroxine free increased	138.56	15.20	42	41516	842	63446622
Rheumatoid arthritis	137.28	15.20	7	41551	253812	63193652
Product dose omission issue	135.06	15.20	4	41554	234309	63213155
Drug hypersensitivity	132.84	15.20	22	41536	310665	63136799
Neutrophil count increased	131.09	15.20	99	41459	16428	63431036
Magnetic resonance imaging abnormal	128.80	15.20	55	41503	3030	63444434
Mean cell haemoglobin decreased	127.47	15.20	64	41494	5115	63442349
Monocyte count decreased	122.79	15.20	48	41510	2105	63445359
Viraemia	122.13	15.20	42	41516	1274	63446190
White blood cell count decreased	121.54	15.20	276	41282	138828	63308636
Contraindicated product administered	117.69	15.20	6	41552	217642	63229822
Arthropathy	116.61	15.20	10	41548	234782	63212682
Epstein-Barr virus infection	116.38	15.20	70	41488	7980	63439484
Systemic lupus erythematosus	115.42	15.20	5	41553	208913	63238551
Anti-thyroid antibody positive	115.05	15.20	31	41527	399	63447065
Acute graft versus host disease in skin	113.37	15.20	52	41506	3400	63444064
Synovitis	108.40	15.20	3	41555	186915	63260549
Cytomegalovirus viraemia	108.16	15.20	59	41499	5590	63441874
Joint swelling	107.67	15.20	40	41518	327626	63119838
Feeling hot	107.40	15.20	148	41410	50206	63397258
Autoimmune haemolytic anaemia	102.04	15.20	53	41505	4548	63442916
Tachycardia	101.59	15.20	233	41325	117923	63329541
Death	99.64	15.20	61	41497	374320	63073144
Drug interaction	98.39	15.20	16	41542	229115	63218349
Treatment failure	97.41	15.20	9	41549	199034	63248430
Epstein-Barr viraemia	96.72	15.20	33	41525	977	63446487
Varicella zoster virus infection	96.20	15.20	43	41515	2646	63444818
Drug monitoring procedure not performed	95.31	15.20	29	41529	589	63446875
Graft versus host disease in gastrointestinal tract	94.60	15.20	45	41513	3196	63444268
Urinary casts	93.69	15.20	30	41528	725	63446739
Herpes zoster	92.17	15.20	181	41377	82281	63365183
Swelling	91.49	15.20	33	41525	275345	63172119
Maternal exposure during pregnancy	90.91	15.20	17	41541	220045	63227419
Hand deformity	90.85	15.20	3	41555	159454	63288010
Transplant failure	89.20	15.20	35	41523	1550	63445914
Endocrine ophthalmopathy	88.79	15.20	28	41530	643	63446821
Monocyte count increased	87.75	15.20	57	41501	7436	63440028
CD4 lymphocytes decreased	85.58	15.20	33	41525	1394	63446070
BK virus infection	85.07	15.20	42	41516	3237	63444227
Eosinophil count increased	83.44	15.20	64	41494	10864	63436600
Pain	82.59	15.20	232	41326	740396	62707068
Hypothyroidism	81.59	15.20	119	41439	42513	63404951
Red blood cells urine	80.72	15.20	25	41533	540	63446924
Body temperature increased	80.33	15.20	110	41448	37082	63410382
Listeriosis	80.05	15.20	32	41526	1489	63445975
Wound	78.25	15.20	8	41550	163255	63284209
Product use issue	77.46	15.20	24	41534	220496	63226968
Mean cell volume decreased	77.41	15.20	42	41516	3936	63443528
Urobilinogen urine increased	77.18	15.20	21	41537	281	63447183
Autoimmune thyroid disorder	76.73	15.20	13	41545	7	63447457
Muscular weakness	76.63	15.20	214	41344	122139	63325325
Heavy menstrual bleeding	76.45	15.20	75	41483	17698	63429766
Red blood cell count increased	75.24	15.20	38	41520	3074	63444390
Toxicity to various agents	74.99	15.20	34	41524	247216	63200248
Alopecia	74.28	15.20	67	41491	337469	63109995
Infusion site pain	74.08	15.20	72	41486	16797	63430667
Blood thyroid stimulating hormone abnormal	73.52	15.20	26	41532	858	63446606
CD4 lymphocytes abnormal	71.13	15.20	12	41546	6	63447458
Lymphocyte count abnormal	70.97	15.20	24	41534	691	63446773
Venoocclusive disease	70.73	15.20	32	41526	2026	63445438
Growth failure	70.25	15.20	20	41538	319	63447145
Cells in urine	69.38	15.20	18	41540	198	63447266
Diarrhoea	69.16	15.20	239	41319	715127	62732337
Leukopenia	68.15	15.20	154	41404	77136	63370328
Petechiae	66.12	15.20	62	41496	13835	63433629
Red blood cell count decreased	65.83	15.20	105	41453	40540	63406924
Urticaria	64.89	15.20	247	41311	165555	63281909
Red cell distribution width decreased	64.36	15.20	30	41528	2035	63445429
Overdose	62.72	15.20	3	41555	115075	63332389
Tri-iodothyronine free decreased	62.16	15.20	18	41540	306	63447158
Mean cell haemoglobin concentration decreased	61.70	15.20	35	41523	3577	63443887
Injection site pain	60.56	15.20	7	41551	129793	63317671
Autoimmune hypothyroidism	60.41	15.20	16	41542	192	63447272
Blood creatinine decreased	59.64	15.20	40	41518	5505	63441959
Urine leukocyte esterase	59.39	15.20	15	41543	147	63447317
Arthralgia	59.37	15.20	184	41374	569526	62877938
Tri-iodothyronine free increased	59.09	15.20	16	41542	210	63447254
Band sensation	58.89	15.20	22	41536	851	63446613
Eosinophil percentage increased	58.89	15.20	23	41535	1006	63446458
Chills	58.34	15.20	185	41373	113193	63334271
Poor quality sleep	57.34	15.20	68	41490	19867	63427597
Human herpesvirus 6 infection	56.93	15.20	31	41527	2926	63444538
Hepatic enzyme increased	56.55	15.20	31	41527	202297	63245167
Hypersensitivity	54.38	15.20	67	41491	292618	63154846
pH urine increased	54.13	15.20	17	41541	385	63447079
Haemophagocytic lymphohistiocytosis	53.64	15.20	49	41509	10578	63436886
Autoimmune disorder	53.43	15.20	61	41497	17116	63430348
Acute graft versus host disease in intestine	53.24	15.20	25	41533	1724	63445740
Transplant rejection	53.04	15.20	49	41509	10731	63436733
Multiple sclerosis	52.50	15.20	72	41486	24300	63423164
Thyroxine free decreased	52.29	15.20	19	41539	679	63446785
Haemoglobin decreased	52.26	15.20	211	41347	145274	63302190
Menstruation irregular	51.25	15.20	40	41518	6964	63440500
Therapeutic product effect incomplete	50.90	15.20	10	41548	125046	63322418
Encephalitis viral	50.40	15.20	24	41534	1708	63445756
Specific gravity urine increased	50.22	15.20	14	41544	206	63447258
Acute graft versus host disease	50.18	15.20	33	41525	4395	63443069
Abdominal discomfort	50.17	15.20	83	41475	320802	63126662
Eosinophil percentage decreased	49.85	15.20	14	41544	212	63447252
Meningitis listeria	49.60	15.20	18	41540	641	63446823
Thyroid stimulating immunoglobulin	49.50	15.20	11	41547	58	63447406
Mean cell haemoglobin concentration increased	49.48	15.20	17	41541	514	63446950
Impaired healing	49.18	15.20	5	41553	102537	63344927
Band neutrophil percentage increased	48.57	15.20	14	41544	234	63447230
Gastrointestinal disorder	48.42	15.20	13	41545	131226	63316238
White blood cells urine	47.53	15.20	16	41542	454	63447010
Fall	47.28	15.20	118	41440	392216	63055248
Pericarditis	46.76	15.20	14	41544	131565	63315899
Thyroid function test abnormal	45.81	15.20	29	41529	3618	63443846
Crystalluria	45.16	15.20	15	41543	408	63447056
Osteoarthritis	44.83	15.20	5	41553	95338	63352126
Anti-glomerular basement membrane disease	44.33	15.20	7	41551	0	63447464
Heart rate increased	44.18	15.20	149	41409	94089	63353375
Monocyte percentage decreased	44.09	15.20	13	41545	236	63447228
Discomfort	43.44	15.20	28	41530	167346	63280118
Herpes simplex	43.44	15.20	39	41519	8232	63439232
Thrombocytopenia	43.42	15.20	205	41353	150952	63296512
Feeling cold	43.28	15.20	65	41493	23823	63423641
Myelocyte count increased	43.04	15.20	14	41544	356	63447108
Creatinine urine decreased	42.35	15.20	12	41546	188	63447276
Peripheral swelling	42.29	15.20	68	41490	265874	63181590
Insomnia	42.22	15.20	263	41295	214989	63232475
Band neutrophil count increased	42.15	15.20	14	41544	381	63447083
Arthritis	41.80	15.20	12	41546	115909	63331555
Guillain-Barre syndrome	41.67	15.20	28	41530	3865	63443599
Acute disseminated encephalomyelitis	41.66	15.20	12	41546	200	63447264
Urinary tract infection	41.53	15.20	306	41252	264378	63183086
Fibromyalgia	41.08	15.20	3	41555	80417	63367047
T-lymphocyte count decreased	41.04	15.20	13	41545	303	63447161
Neutropenia	40.91	15.20	224	41334	174781	63272683
Platelet count abnormal	40.40	15.20	26	41532	3338	63444126
Menstrual disorder	40.30	15.20	31	41527	5282	63442182
Irritable bowel syndrome	39.57	15.20	4	41554	82408	63365056
Urine oxalate increased	39.15	15.20	12	41546	250	63447214
Cytomegalovirus infection reactivation	38.85	15.20	27	41531	3936	63443528
Neuropathy peripheral	38.77	15.20	13	41545	113654	63333810
Bacteriuria	38.18	15.20	17	41541	1036	63446428
Chronic graft versus host disease in liver	38.03	15.20	12	41546	276	63447188
Gingival bleeding	37.97	15.20	44	41514	12543	63434921
Stomatitis	37.67	15.20	22	41536	138703	63308761
Injection site erythema	37.53	15.20	5	41553	83169	63364295
Myelocyte percentage increased	37.14	15.20	11	41547	203	63447261
Atrial fibrillation	36.98	15.20	15	41543	116621	63330843
Urinary tract infection bacterial	36.93	15.20	29	41529	5093	63442371
Acute myeloid leukaemia recurrent	36.86	15.20	19	41539	1604	63445860
Drug abuse	36.21	15.20	3	41555	72515	63374949
Bilirubin urine present	36.12	15.20	9	41549	83	63447381
Pulmonary haemorrhage	36.02	15.20	33	41525	7148	63440316
Cystitis haemorrhagic	35.60	15.20	26	41532	4097	63443367
Quadriparesis	35.57	15.20	20	41538	2009	63445455
Multiple organ dysfunction syndrome	35.24	15.20	99	41459	56653	63390811
Pulmonary alveolar haemorrhage	34.89	15.20	27	41531	4641	63442823
Viral haemorrhagic cystitis	34.66	15.20	15	41543	854	63446610
Neutrophil count decreased	34.63	15.20	98	41460	56308	63391156
Sinus bradycardia	34.42	15.20	45	41513	14506	63432958
Injury	34.03	15.20	4	41554	73243	63374221
Heart rate decreased	33.89	15.20	85	41473	45475	63401989
Oropharyngeal pain	33.87	15.20	137	41421	94350	63353114
Drug exposure before pregnancy	33.62	15.20	15	41543	919	63446545
Optic neuritis	33.33	15.20	34	41524	8401	63439063
Adverse drug reaction	33.23	15.20	6	41552	79708	63367756
Autoimmune neutropenia	33.20	15.20	10	41548	196	63447268
Myocardial infarction	33.08	15.20	12	41546	99881	63347583
Thrombotic thrombocytopenic purpura	32.69	15.20	24	41534	3812	63443652
Haemorrhagic adrenal infarction	32.69	15.20	7	41551	30	63447434
Hypoaesthesia	31.91	15.20	204	41354	168189	63279275
Thyroid stimulating immunoglobulin increased	31.80	15.20	8	41550	77	63447387
Central nervous system lesion	31.78	15.20	37	41521	10598	63436866
Confusional state	31.74	15.20	67	41491	236313	63211151
Proteinuria	31.74	15.20	50	41508	19095	63428369
Idiopathic pneumonia syndrome	31.51	15.20	11	41547	349	63447115
Oedema peripheral	31.51	15.20	47	41511	189464	63258000
Psoriasis	31.35	15.20	9	41549	86948	63360516
Mean cell haemoglobin increased	31.10	15.20	21	41537	2922	63444542
Intentional product use issue	31.05	15.20	23	41535	127869	63319595
Infusion related reaction	30.99	15.20	72	41486	245449	63202015
Throat irritation	30.95	15.20	73	41485	37574	63409890
Adverse event	30.63	15.20	4	41554	67555	63379909
Limb discomfort	30.51	15.20	63	41495	29653	63417811
Mean platelet volume increased	30.36	15.20	12	41546	542	63446922
Thrombotic microangiopathy	30.33	15.20	36	41522	10525	63436939
Basophil count increased	30.12	15.20	14	41544	943	63446521
Cellulitis staphylococcal	30.12	15.20	13	41545	735	63446729
Chronic graft versus host disease in skin	30.04	15.20	13	41545	740	63446724
Folliculitis	29.95	15.20	5	41553	70312	63377152
Immature granulocyte count increased	29.91	15.20	11	41547	407	63447057
Depressed level of consciousness	29.83	15.20	3	41555	62075	63385389
Mean cell volume increased	29.78	15.20	22	41536	3529	63443935
Parvovirus infection	29.67	15.20	10	41548	285	63447179
Basophil percentage increased	29.61	15.20	8	41550	104	63447360
Acute kidney injury	29.58	15.20	82	41476	263333	63184131
Granulocyte percentage	29.09	15.20	7	41551	55	63447409
Infusion site extravasation	29.05	15.20	35	41523	10391	63437073
Eosinophil count decreased	28.98	15.20	18	41540	2172	63445292
B-lymphocyte count increased	28.94	15.20	8	41550	114	63447350
White blood cell count increased	28.48	15.20	83	41475	48478	63398986
Mycobacterium kansasii infection	28.25	15.20	8	41550	125	63447339
Chronic obstructive pulmonary disease	27.74	15.20	4	41554	62682	63384782
Listeria test positive	27.72	15.20	5	41553	6	63447458
Progressive multifocal leukoencephalopathy	27.45	15.20	38	41520	12933	63434531
Sinusitis	27.39	15.20	68	41490	226585	63220879
Polyomavirus viraemia	27.10	15.20	12	41546	722	63446742
Gastroenteritis adenovirus	26.92	15.20	9	41549	250	63447214
Lymphadenopathy	26.79	15.20	70	41488	38388	63409076
Exophthalmos	26.73	15.20	15	41543	1501	63445963
Lipaemic index score	26.66	15.20	7	41551	81	63447383
Temperature intolerance	26.48	15.20	31	41527	8933	63438531
Laboratory test abnormal	26.40	15.20	56	41502	26856	63420608
Type 2 diabetes mellitus	26.20	15.20	5	41553	63863	63383601
Hypoglycaemia	26.19	15.20	4	41554	60061	63387403
Creatinine urine increased	25.77	15.20	9	41549	286	63447178
Bronchopulmonary aspergillosis	25.73	15.20	30	41528	8605	63438859
Pathogen resistance	25.67	15.20	26	41532	6372	63441092
Haematuria	25.57	15.20	58	41500	29099	63418365
Haematocrit increased	25.54	15.20	17	41541	2309	63445155
Goodpasture's syndrome	25.33	15.20	4	41554	0	63447464
Injection site reaction	25.29	15.20	4	41554	58520	63388944
Vitiligo	25.19	15.20	14	41544	1375	63446089
Legionella infection	25.12	15.20	10	41548	460	63447004
Musculoskeletal stiffness	25.05	15.20	52	41506	184566	63262898
Fibrin D dimer increased	24.99	15.20	23	41535	5011	63442453
Vulvovaginal mycotic infection	24.89	15.20	24	41534	5542	63441922
Actinomycotic sepsis	24.80	15.20	7	41551	108	63447356
Serum amyloid A protein increased	24.63	15.20	9	41549	327	63447137
Anaemia	24.36	15.20	104	41454	293326	63154138
Incorrect dose administered	23.96	15.20	5	41553	59963	63387501
Blister	23.78	15.20	30	41528	129784	63317680
Epstein-Barr virus associated lymphoproliferative disorder	23.64	15.20	15	41543	1879	63445585
Haemolytic anaemia	23.46	15.20	31	41527	10094	63437370
Infertility	23.27	15.20	11	41547	770	63446694
Micturition urgency	23.16	15.20	30	41528	9581	63437883
Immune reconstitution inflammatory syndrome	23.10	15.20	24	41534	6060	63441404
Expanded disability status scale score increased	22.83	15.20	10	41548	586	63446878
Haemoglobin increased	22.81	15.20	19	41539	3627	63443837
Pollakiuria	22.77	15.20	54	41504	27883	63419581
Glomerulonephritis chronic	22.70	15.20	7	41551	149	63447315
Vaginal discharge	22.62	15.20	29	41529	9169	63438295
Glomerulonephritis membranous	22.61	15.20	10	41548	600	63446864
Nasal septum disorder	22.56	15.20	7	41551	152	63447312
Suicide attempt	22.53	15.20	6	41552	60912	63386552
Hyponatraemia	22.50	15.20	24	41534	111876	63335588
Erythema	22.50	15.20	194	41364	175557	63271907
Cystitis viral	22.48	15.20	7	41551	154	63447310
Neutrophil percentage decreased	22.29	15.20	9	41549	430	63447034
Fusarium infection	22.06	15.20	10	41548	636	63446828
Retinal depigmentation	22.04	15.20	8	41550	285	63447179
Ureaplasma infection	21.98	15.20	10	41548	641	63446823
Oral herpes	21.91	15.20	51	41507	26023	63421441
Anaphylactic reaction	21.78	15.20	8	41550	66092	63381372
Systemic mycosis	21.53	15.20	12	41546	1185	63446279
Decreased appetite	21.44	15.20	88	41470	250964	63196500
Interleukin-2 receptor increased	21.30	15.20	6	41552	92	63447372
Hemiparesis	21.19	15.20	47	41511	23235	63424229
Mean platelet volume decreased	21.18	15.20	16	41542	2653	63444811
Platelet count increased	21.14	15.20	40	41518	17671	63429793
Immature granulocyte percentage increased	21.04	15.20	5	41553	37	63447427
Cytokine storm	20.97	15.20	8	41550	328	63447136
Autoimmune pancytopenia	20.94	15.20	6	41552	98	63447366
Malignant neoplasm progression	20.94	15.20	14	41544	82107	63365357
Oesophageal candidiasis	20.89	15.20	22	41536	5641	63441823
Haemoptysis	20.74	15.20	53	41505	28673	63418791
Malignant melanoma	20.71	15.20	31	41527	11325	63436139
Feeling abnormal	20.69	15.20	167	41391	148225	63299239
Loss of personal independence in daily activities	20.54	15.20	20	41538	97270	63350194
Contusion	20.46	15.20	168	41390	149876	63297588
Growth retardation	20.26	15.20	12	41546	1329	63446135
Hepatitis infectious mononucleosis	20.24	15.20	6	41552	111	63447353
Blood cholesterol increased	20.24	15.20	19	41539	94013	63353451
Graft loss	20.16	15.20	8	41550	365	63447099
Gastroenteritis norovirus	20.06	15.20	14	41544	2054	63445410
Asthma	19.89	15.20	33	41525	127528	63319936
Chronic kidney disease	19.85	15.20	3	41555	45395	63402069
Cerebrovascular accident	19.74	15.20	25	41533	107999	63339465
Periportal oedema	19.55	15.20	4	41554	13	63447451
Cytomegalovirus chorioretinitis	19.44	15.20	13	41545	1780	63445684
Infusion site discomfort	19.43	15.20	12	41546	1434	63446030
JC polyomavirus test positive	19.37	15.20	12	41546	1441	63446023
Post herpetic neuralgia	19.29	15.20	14	41544	2185	63445279
Dysuria	19.15	15.20	57	41501	33681	63413783
White blood cell count abnormal	19.13	15.20	22	41536	6220	63441244
Loefgren syndrome	19.10	15.20	6	41552	136	63447328
Chronic graft versus host disease	19.06	15.20	16	41542	3086	63444378
Brain stem syndrome	19.06	15.20	8	41550	422	63447042
Chromaturia	19.03	15.20	37	41521	16680	63430784
Fumbling	18.78	15.20	6	41552	144	63447320
Urine odour abnormal	18.71	15.20	22	41536	6367	63441097
Thyroiditis subacute	18.66	15.20	7	41551	274	63447190
Palpitations	18.58	15.20	132	41426	112638	63334826
Bladder dysfunction	18.56	15.20	10	41548	924	63446540
Cardiac failure congestive	18.38	15.20	20	41538	92413	63355051
Bone marrow transplant rejection	18.37	15.20	5	41553	67	63447397
Cellulitis	18.31	15.20	16	41542	81942	63365522
Cough	18.29	15.20	281	41277	292462	63155002
Goitre	18.25	15.20	21	41537	5940	63441524
Bronchostenosis	18.24	15.20	8	41550	470	63446994
C-reactive protein abnormal	18.10	15.20	4	41554	46092	63401372
Lymphocyte percentage increased	18.09	15.20	8	41550	480	63446984
Meningism	17.98	15.20	8	41550	487	63446977
Thyroiditis	17.86	15.20	14	41544	2452	63445012
Joint stiffness	17.78	15.20	3	41555	41866	63405598
Engraftment syndrome	17.78	15.20	8	41550	500	63446964
Lymphodepletion	17.71	15.20	4	41554	23	63447441
Injection site pruritus	17.54	15.20	4	41554	45112	63402352
Infusion site scar	17.54	15.20	8	41550	516	63446948
Chronic hepatitis C	17.45	15.20	6	41552	182	63447282
Oedema	17.42	15.20	23	41535	97599	63349865
Microcytosis	17.41	15.20	6	41552	183	63447281
Acute motor axonal neuropathy	17.29	15.20	4	41554	26	63447438
Maternal exposure before pregnancy	17.19	15.20	23	41535	7580	63439884
Lymphocyte percentage abnormal	17.16	15.20	4	41554	27	63447437
Epstein-Barr virus infection reactivation	17.14	15.20	9	41549	789	63446675
Exposure during pregnancy	17.01	15.20	49	41509	155498	63291966
Injection site swelling	17.00	15.20	5	41553	47567	63399897
Monocyte count abnormal	16.99	15.20	6	41552	197	63447267
Pneumonia cytomegaloviral	16.97	15.20	13	41545	2201	63445263
Sleep disorder	16.95	15.20	17	41541	81549	63365915
Natural killer cell count increased	16.92	15.20	3	41555	3	63447461
CD4 lymphocyte percentage decreased	16.92	15.20	3	41555	3	63447461
Blood pressure systolic increased	16.91	15.20	5	41553	47392	63400072
Pseudomonas infection	16.83	15.20	28	41530	11185	63436279
Evans syndrome	16.74	15.20	6	41552	206	63447258
Hypogammaglobulinaemia	16.72	15.20	22	41536	7133	63440331
Anti-thyroid antibody	16.67	15.20	4	41554	31	63447433
Autoimmune hepatitis	16.63	15.20	24	41534	8486	63438978
Thyroid disorder	16.58	15.20	33	41525	15129	63432335
Cervical dysplasia	16.57	15.20	15	41543	3199	63444265
Nitrite urine	16.45	15.20	4	41554	33	63447431
Diverticulitis	16.43	15.20	3	41555	39554	63407910
Thyroid cyst	16.42	15.20	8	41550	599	63446865
Klebsiella test positive	16.33	15.20	10	41548	1177	63446287
Cardiac arrest	16.31	15.20	22	41536	92523	63354941
Diffuse large B-cell lymphoma	16.25	15.20	21	41537	6691	63440773
Blood luteinising hormone decreased	16.24	15.20	4	41554	35	63447429
Musculoskeletal pain	16.20	15.20	22	41536	92255	63355209
Disorder of globe	16.06	15.20	3	41555	5	63447459
Tri-iodothyronine free abnormal	16.04	15.20	4	41554	37	63447427
Sedation	16	15.20	3	41555	38806	63408658
Poor venous access	15.95	15.20	32	41526	14753	63432711
Dehydration	15.92	15.20	59	41499	173295	63274169
Chronic lymphocytic leukaemia recurrent	15.92	15.20	6	41552	238	63447226
Pneumonitis	15.89	15.20	55	41503	35167	63412297
Hallucination	15.89	15.20	8	41550	54809	63392655
Thyroxine decreased	15.86	15.20	8	41550	645	63446819
Lower respiratory tract infection	15.73	15.20	40	41518	132267	63315197
Lactic acidosis	15.70	15.20	3	41555	38284	63409180
Osteoporosis	15.69	15.20	9	41549	57329	63390135
Aspiration bone marrow abnormal	15.67	15.20	4	41554	41	63447423
Herpes zoster infection neurological	15.57	15.20	6	41552	253	63447211
Endometrial ablation	15.55	15.20	9	41549	955	63446509
Albumin urine present	15.48	15.20	6	41552	257	63447207
No adverse event	15.46	15.20	4	41554	41401	63406063
Extensor plantar response	15.42	15.20	10	41548	1301	63446163
Cytomegalovirus test positive	15.39	15.20	14	41544	3004	63444460
Fungal skin infection	15.37	15.20	17	41541	4605	63442859
Fungal infection	15.28	15.20	56	41502	36818	63410646

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
Cytomegalovirus infection	640.19	16.44	314	20988	25821	34909808
Post transplant lymphoproliferative disorder	377.26	16.44	144	21158	6384	34929245
Immune thrombocytopenia	376.47	16.44	158	21144	8994	34926635
Adenovirus infection	250.97	16.44	101	21201	5156	34930473
Autoimmune haemolytic anaemia	234.21	16.44	92	21210	4404	34931225
Lymphopenia	229.92	16.44	136	21166	16199	34919430
Epstein-Barr virus infection	224.10	16.44	104	21198	7524	34928105
Progressive multifocal leukoencephalopathy	168.81	16.44	93	21209	9671	34925958
Graft versus host disease	164.61	16.44	94	21208	10475	34925154
Lymphocyte count decreased	160.26	16.44	123	21179	22499	34913130
Transplant failure	151.60	16.44	63	21239	3490	34932139
End stage renal disease	146.61	16.44	82	21220	8779	34926850
Microsporidia infection	141.76	16.44	40	21262	666	34934963
Multiple sclerosis relapse	140.83	16.44	92	21210	13041	34922588
Pyrexia	138	16.44	480	20822	332533	34603096
Lymphocyte percentage decreased	137.53	16.44	51	21251	2081	34933548
JC virus infection	132.16	16.44	50	21252	2158	34933471
Graft versus host disease in gastrointestinal tract	120.06	16.44	54	21248	3629	34932000
Cytomegalovirus infection reactivation	117.66	16.44	59	21243	5059	34930570
Acute graft versus host disease in skin	110.94	16.44	57	21245	5144	34930485
BK virus infection	108.47	16.44	58	21244	5680	34929949
Transplant rejection	107.54	16.44	71	21231	10240	34925389
Herpes simplex	101.75	16.44	55	21247	5504	34930125
Neutrophil percentage increased	100.72	16.44	39	21263	1794	34933835
Cytomegalovirus viraemia	97.07	16.44	59	21243	7371	34928258
Crystal urine present	94.67	16.44	27	21275	468	34935161
Monocyte percentage increased	92.40	16.44	31	21271	938	34934691
Chronic graft versus host disease in skin	92.24	16.44	31	21271	943	34934686
Graft versus host disease in skin	77.93	16.44	41	21261	3884	34931745
Product use in unapproved indication	77.43	16.44	200	21102	117299	34818330
Epstein-Barr viraemia	75.96	16.44	29	21273	1283	34934346
Human herpesvirus 6 infection	75.84	16.44	33	21269	2048	34933581
Off label use	74.18	16.44	472	20830	419052	34516577
Blood thyroid stimulating hormone decreased	71.45	16.44	31	21271	1910	34933719
Meningitis viral	70.86	16.44	25	21277	882	34934747
Urine abnormality	70.58	16.44	31	21271	1968	34933661
Acute graft versus host disease in intestine	70.54	16.44	34	21268	2674	34932955
Drug interaction	70.33	16.44	25	21277	225921	34709708
Herpes zoster	69.65	16.44	95	21207	34304	34901325
Mucosal inflammation	66.89	16.44	99	21203	38523	34897106
Multiple organ dysfunction syndrome	65.17	16.44	144	21158	76422	34859207
Pneumonia cytomegaloviral	63.77	16.44	33	21269	3021	34932608
Haemolytic anaemia	61.40	16.44	51	21251	10428	34925201
Venoocclusive disease	59.92	16.44	31	21271	2836	34932793
Acute graft versus host disease	58.80	16.44	41	21261	6462	34929167
Thrombotic microangiopathy	58.71	16.44	50	21252	10580	34925049
Toxoplasmosis	58.39	16.44	24	21278	1292	34934337
Leukaemia recurrent	56.87	16.44	25	21277	1590	34934039
Aspergillus infection	56.43	16.44	52	21250	12202	34923427
Magnetic resonance imaging abnormal	56.27	16.44	25	21277	1631	34933998
Epstein-Barr virus associated lymphoproliferative disorder	55.25	16.44	26	21276	1938	34933691
Urine analysis abnormal	54.79	16.44	26	21276	1975	34933654
Autoimmune thyroiditis	54.10	16.44	22	21280	1152	34934477
Haemophagocytic lymphohistiocytosis	53.90	16.44	52	21250	12921	34922708
Chronic graft versus host disease in intestine	53.25	16.44	15	21287	248	34935381
Propionibacterium infection	53.08	16.44	15	21287	251	34935378
Graft loss	52.86	16.44	20	21282	863	34934766
Endocrine ophthalmopathy	52.77	16.44	11	21291	44	34935585
Chronic graft versus host disease	52.73	16.44	33	21269	4340	34931289
Pancytopenia	52.67	16.44	152	21150	95005	34840624
Epstein-Barr virus infection reactivation	51.94	16.44	21	21281	1083	34934546
Chronic graft versus host disease in liver	49.03	16.44	16	21286	443	34935186
Blood thyroid stimulating hormone increased	48.53	16.44	31	21271	4224	34931405
Polyomavirus viraemia	48.01	16.44	19	21283	926	34934703
Red blood cells urine positive	47.99	16.44	23	21279	1786	34933843
Diffuse large B-cell lymphoma	47.67	16.44	38	21264	7332	34928297
Bronchopulmonary aspergillosis	46.82	16.44	51	21251	14608	34921021
Meningitis tuberculous	46.44	16.44	17	21285	668	34934961
Polymyositis	46.39	16.44	21	21281	1432	34934197
White blood cells urine positive	45.49	16.44	20	21282	1272	34934357
Toxicity to various agents	44.81	16.44	34	21268	200328	34735301
Urine leukocyte esterase positive	44.64	16.44	15	21287	456	34935173
Bacterial test positive	44.13	16.44	26	21276	3067	34932562
Central nervous system lymphoma	43.08	16.44	18	21284	1010	34934619
Pyelonephritis fungal	43.04	16.44	10	21292	72	34935557
Completed suicide	42.48	16.44	5	21297	98163	34837466
Nitrite urine present	42.46	16.44	11	21291	130	34935499
Specific gravity urine increased	41.72	16.44	11	21291	140	34935489
Urine ketone body present	41.17	16.44	18	21284	1130	34934499
B-cell lymphoma	40.60	16.44	28	21274	4335	34931294
Enterococcal infection	39.98	16.44	38	21264	9268	34926361
CD4 lymphocytes decreased	39.80	16.44	20	21282	1721	34933908
Hyperthyroidism	39.53	16.44	40	21262	10526	34925103
Pseudomonas infection	39.41	16.44	43	21259	12339	34923290
Death	39.18	16.44	119	21183	397930	34537699
Chronic lymphocytic leukaemia transformation	38.55	16.44	11	21291	191	34935438
Cystitis viral	38.47	16.44	14	21288	541	34935088
Pulmonary nocardiosis	38.39	16.44	16	21286	892	34934737
Platelet count decreased	38.00	16.44	159	21143	119558	34816071
Varicella	37.56	16.44	19	21283	1658	34933971
Haematocrit decreased	37.42	16.44	69	21233	32147	34903482
Adenovirus reactivation	37.33	16.44	11	21291	215	34935414
Atypical mycobacterial pneumonia	37.18	16.44	10	21292	138	34935491
Venoocclusive liver disease	37.06	16.44	34	21268	7932	34927697
Arthralgia	36.56	16.44	30	21272	170011	34765618
Dyspnoea	36.10	16.44	114	21188	376668	34558961
Parainfluenzae virus infection	35.75	16.44	22	21280	2808	34932821
Chills	35.16	16.44	119	21183	80924	34854705
Anti-thyroid antibody positive	34.63	16.44	8	21294	56	34935573
Human polyomavirus infection	34.48	16.44	14	21288	730	34934899
Acanthamoeba infection	34.46	16.44	12	21290	407	34935222
Red cell distribution width increased	34.21	16.44	29	21273	6094	34929535
Mycobacterial infection	33.98	16.44	20	21282	2354	34933275
Mean cell haemoglobin concentration decreased	33.64	16.44	16	21286	1221	34934408
Viraemia	33.63	16.44	16	21286	1222	34934407
Varicella zoster virus infection	33.41	16.44	18	21284	1788	34933841
Dizziness	31.49	16.44	53	21249	218468	34717161
Diarrhoea	31.34	16.44	127	21175	389785	34545844
Nocardiosis	31.33	16.44	23	21279	3928	34931701
Eosinophil percentage increased	31.15	16.44	12	21290	544	34935085
Listeria sepsis	30.78	16.44	9	21293	171	34935458
Autoimmune disorder	30.75	16.44	17	21285	1777	34933852
Myocardial infarction	30.47	16.44	18	21284	121067	34814562
Fall	30.36	16.44	48	21254	202837	34732792
Lactobacillus infection	30.01	16.44	10	21292	296	34935333
Leukopenia	29.67	16.44	95	21207	62761	34872868
Bacterial sepsis	29.61	16.44	25	21277	5225	34930404
Bacteriuria	29.24	16.44	10	21292	321	34935308
Epstein-Barr virus associated lymphoma	29.01	16.44	12	21290	656	34934973
Meningeal neoplasm	28.85	16.44	7	21295	62	34935567
Petechiae	28.75	16.44	32	21270	9386	34926243
Neutropenia	28.46	16.44	178	21124	156600	34779029
Rhabdomyolysis	28.21	16.44	4	21298	68159	34867470
Stenotrophomonas infection	28.18	16.44	17	21285	2093	34933536
Lymphocyte count abnormal	28.09	16.44	14	21288	1184	34934445
Encephalitis	28.05	16.44	28	21274	7249	34928380
Aplastic anaemia	27.93	16.44	32	21270	9684	34925945
pH urine increased	27.48	16.44	7	21295	77	34935552
Bacterial test	27.16	16.44	8	21294	156	34935473
Myositis	26.97	16.44	35	21267	12035	34923594
Listeriosis	26.94	16.44	13	21289	1025	34934604
Anogenital warts	26.87	16.44	11	21291	586	34935043
White blood cell count decreased	26.63	16.44	122	21180	95323	34840306
Normocytic anaemia	26.54	16.44	17	21285	2327	34933302
Klebsiella sepsis	26.15	16.44	16	21286	2021	34933608
Band neutrophil percentage increased	25.55	16.44	7	21295	104	34935525
Stem cell transplant	25.43	16.44	16	21286	2123	34933506
Bone marrow transplant rejection	25.33	16.44	8	21294	199	34935430
Thrombocytopenia	25.07	16.44	172	21130	156075	34779554
Cytomegalovirus test positive	25.05	16.44	20	21282	3866	34931763
Drug hypersensitivity	24.85	16.44	9	21293	80520	34855109
Neutrophil percentage decreased	24.39	16.44	9	21293	362	34935267
Diarrhoea haemorrhagic	24.20	16.44	25	21277	6739	34928890
Graft versus host disease in lung	23.72	16.44	10	21292	574	34935055
Apoptosis	23.49	16.44	9	21293	402	34935227
Factor VIII deficiency	23.46	16.44	7	21295	143	34935486
Albuminuria	23.24	16.44	9	21293	414	34935215
Skin papilloma	23.19	16.44	15	21287	2088	34933541
Phaeohyphomycosis	22.96	16.44	11	21291	853	34934776
Bilirubin urine present	22.89	16.44	7	21295	156	34935473
Lymphadenopathy	22.47	16.44	52	21250	28411	34907218
Syncope	22.43	16.44	14	21288	91437	34844192
Norovirus infection	22.36	16.44	7	21295	169	34935460
Haemorrhagic cyst	22.23	16.44	6	21296	84	34935545
Enterococcal bacteraemia	22.08	16.44	14	21288	1883	34933746
Chronic lymphocytic leukaemia refractory	22.03	16.44	6	21296	87	34935542
Acute graft versus host disease in liver	21.91	16.44	13	21289	1553	34934076
Activated partial thromboplastin time shortened	21.90	16.44	9	21293	484	34935145
Specific gravity urine decreased	21.84	16.44	6	21296	90	34935539
Herpes zoster meningoencephalitis	21.84	16.44	8	21294	315	34935314
Meningitis listeria	21.74	16.44	9	21293	493	34935136
Confusional state	21.64	16.44	34	21268	144126	34791503
Mycobacterium kansasii infection	21.60	16.44	8	21294	325	34935304
Intracranial tumour haemorrhage	21.55	16.44	8	21294	327	34935302
Pneumonia fungal	21.45	16.44	24	21278	7076	34928553
Autoimmune pancytopenia	20.98	16.44	6	21296	105	34935524
Glucose urine present	20.78	16.44	11	21291	1054	34934575
Necrotising oesophagitis	20.70	16.44	9	21293	557	34935072
Haematocrit increased	20.70	16.44	14	21288	2099	34933530
Band sensation	20.57	16.44	6	21296	113	34935516
Blood urine present	20.53	16.44	29	21273	10805	34924824
Monocyte count abnormal	20.24	16.44	5	21297	48	34935581
Pneumocystis jirovecii pneumonia	20.15	16.44	40	21262	19670	34915959
Tuberculosis liver	20.15	16.44	5	21297	49	34935580
Complications of transplanted kidney	20.14	16.44	19	21283	4590	34931039
Retinitis	20.14	16.44	8	21294	394	34935235
Transplant dysfunction	20.06	16.44	15	21287	2634	34932995
Hypogammaglobulinaemia	19.77	16.44	24	21278	7716	34927913
Muscle spasticity	19.70	16.44	21	21281	5867	34929762
Leukaemic infiltration	19.65	16.44	6	21296	133	34935496
T-cell prolymphocytic leukaemia	19.55	16.44	5	21297	56	34935573
Thyroxine free increased	19.39	16.44	7	21295	264	34935365
Posterior reversible encephalopathy syndrome	19.39	16.44	27	21275	9927	34925702
Band neutrophil count increased	19.29	16.44	7	21295	268	34935361
Systemic mycosis	19.29	16.44	12	21290	1561	34934068
Granulocyte percentage	19.21	16.44	3	21299	0	34935629
Thyroid stimulating immunoglobulin	19.21	16.44	3	21299	0	34935629
Oral herpes	18.94	16.44	20	21282	5527	34930102
Urinary sediment present	18.91	16.44	7	21295	284	34935345
Respiratory failure	18.89	16.44	122	21180	108450	34827179
Papilloma viral infection	18.57	16.44	8	21294	484	34935145
Protein urine present	18.12	16.44	19	21283	5209	34930420
Acute myeloid leukaemia recurrent	18.04	16.44	13	21289	2157	34933472
Joint swelling	17.96	16.44	7	21295	59883	34875746
Fungal skin infection	17.93	16.44	14	21288	2620	34933009
Drug resistance	17.92	16.44	45	21257	25882	34909747
Device related infection	17.64	16.44	35	21267	17202	34918427
Chronic lymphocytic leukaemia	17.64	16.44	17	21285	4215	34931414
Coronary artery disease	17.47	16.44	4	21298	48301	34887328
Acute disseminated encephalomyelitis	17.40	16.44	5	21297	89	34935540
Cardiac failure	17.34	16.44	18	21284	91230	34844399
Oedema peripheral	17.28	16.44	29	21273	119783	34815846
Exophthalmos	17.27	16.44	8	21294	575	34935054
Constipation	17.25	16.44	36	21266	136946	34798683
Respiratory disorder	17.23	16.44	37	21265	19227	34916402
Pneumonia adenoviral	17.15	16.44	7	21295	370	34935259
Gastroenteritis norovirus	17.11	16.44	11	21291	1515	34934114
Polyomavirus-associated nephropathy	17.09	16.44	16	21286	3828	34931801
Herpes virus infection	16.99	16.44	14	21288	2828	34932801
International normalised ratio increased	16.95	16.44	4	21298	47323	34888306
Cerebrovascular accident	16.95	16.44	16	21286	84795	34850834
Monocyte count decreased	16.69	16.44	10	21292	1216	34934413
Platelet count abnormal	16.65	16.44	14	21288	2908	34932721
Chronic lymphocytic leukaemia recurrent	16.58	16.44	7	21295	403	34935226
B-lymphocyte count decreased	16.52	16.44	8	21294	635	34934994

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
Lymphocyte count decreased	1015.91	13.52	555	58489	46734	79638610
Immune thrombocytopenia	928.47	13.52	385	58659	17420	79667924
Cytomegalovirus infection	920.12	13.52	502	58542	42142	79643202
Urine abnormality	783.50	13.52	276	58768	7943	79677401
Multiple sclerosis relapse	543.75	13.52	370	58674	46163	79639181
Post transplant lymphoproliferative disorder	524.59	13.52	226	58818	11238	79674106
Adenovirus infection	513.50	13.52	204	58840	8243	79677101
Lymphocyte percentage decreased	504.56	13.52	175	58869	4801	79680543
Lymphopenia	501.29	13.52	301	58743	30256	79655088
White blood cells urine positive	496.23	13.52	182	58862	5893	79679451
Urine leukocyte esterase positive	493.87	13.52	164	58880	3927	79681417
Urinary sediment present	470.04	13.52	141	58903	2394	79682950
Red blood cells urine positive	455.24	13.52	162	58882	4801	79680543
Neutrophil percentage increased	437.47	13.52	155	58889	4534	79680810
Crystal urine present	430.31	13.52	127	58917	2033	79683311
Urine analysis abnormal	408.67	13.52	161	58883	6359	79678985
Blood urine present	375.96	13.52	220	58824	21077	79664267
Autoimmune haemolytic anaemia	318.33	13.52	145	58899	8235	79677109
Graft versus host disease	299.41	13.52	168	58876	14858	79670486
Blood thyroid stimulating hormone decreased	292.43	13.52	122	58922	5594	79679750
Bacterial test positive	289.61	13.52	131	58913	7318	79678026
Epstein-Barr virus infection	278.64	13.52	158	58886	14258	79671086
Urine ketone body present	277.13	13.52	103	58941	3462	79681882
Bacterial test	274.98	13.52	79	58965	1144	79684200
Autoimmune thyroiditis	266.94	13.52	105	58939	4128	79681216
Graft versus host disease in skin	252.70	13.52	112	58932	5961	79679383
Acute graft versus host disease in skin	252.06	13.52	120	58924	7538	79677806
Nitrite urine present	244.83	13.52	72	58972	1137	79684207
Monocyte percentage increased	243.21	13.52	82	58962	2059	79683285
Red cell distribution width increased	239.21	13.52	146	58898	15096	79670248
Transplant failure	220.54	13.52	94	58950	4547	79680797
Blood thyroid stimulating hormone increased	202.84	13.52	112	58932	9596	79675748
Pyrexia	200.48	13.52	1011	58033	677698	79007646
Flushing	200.47	13.52	285	58759	87983	79597361
Hyperthyroidism	193.79	13.52	148	58896	22061	79663283
Drug interaction	186.44	13.52	40	59004	415143	79270201
Haemoglobin urine present	176.53	13.52	53	58991	902	79684442
Headache	176.46	13.52	950	58094	652822	79032522
Product dose omission issue	168.22	13.52	3	59041	247534	79437810
Herpes simplex	166.72	13.52	107	58937	12080	79673264
Haematocrit decreased	166.57	13.52	216	58828	61096	79624248
Completed suicide	162.97	13.52	4	59040	245763	79439581
Magnetic resonance imaging abnormal	160.86	13.52	69	58975	3390	79681954
Graft versus host disease in gastrointestinal tract	159.97	13.52	83	58961	6273	79679071
Culture urine positive	159.84	13.52	74	58970	4361	79680983
Specific gravity urine decreased	154.87	13.52	47	58997	831	79684513
Cytomegalovirus viraemia	152.14	13.52	103	58941	12718	79672626
White blood cell count decreased	147.03	13.52	386	58658	187902	79497442
Transplant rejection	146.87	13.52	119	58925	19318	79666026
Protein urine present	146.34	13.52	92	58952	10020	79675324
Microsporidia infection	146.27	13.52	46	58998	920	79684424
Leukocyturia	145.77	13.52	55	58989	1928	79683416
Thyroxine free increased	143.16	13.52	48	58996	1184	79684160
Progressive multifocal leukoencephalopathy	138.76	13.52	118	58926	20482	79664862
Cytomegalovirus infection reactivation	135.50	13.52	83	58961	8633	79676711
BK virus infection	134.74	13.52	83	58961	8721	79676623
Drug hypersensitivity	133.70	13.52	29	59015	298887	79386457
Platelet count decreased	130.08	13.52	377	58667	194287	79491057
Toxicity to various agents	123.67	13.52	80	58964	421460	79263884
End stage renal disease	123.57	13.52	89	58955	12131	79673213
Chest discomfort	122.34	13.52	297	58747	137747	79547597
Drug intolerance	121.46	13.52	24	59020	264095	79421249
Monocyte count decreased	120.34	13.52	55	58989	3146	79682198
Anti-thyroid antibody positive	119.99	13.52	34	59010	467	79684877
Rheumatoid arthritis	119.96	13.52	9	59035	208461	79476883
JC virus infection	119.18	13.52	58	58986	3823	79681521
Overdose	118.42	13.52	4	59040	184202	79501142
Human herpesvirus 6 infection	115.07	13.52	63	58981	5307	79680037
Mean cell haemoglobin decreased	111.66	13.52	65	58979	6159	79679185
Endocrine ophthalmopathy	111.62	13.52	35	59009	693	79684651
CD4 lymphocytes decreased	110.94	13.52	49	58995	2585	79682759
Chronic graft versus host disease in skin	109.73	13.52	42	59002	1532	79683812
Epstein-Barr viraemia	109.22	13.52	46	58998	2159	79683185
Drug abuse	106.50	13.52	3	59041	162688	79522656
Specific gravity urine increased	104.31	13.52	30	59014	436	79684908
Death	102.95	13.52	163	58881	566351	79118993
Acute graft versus host disease	102.69	13.52	74	58970	10093	79675251
Arthropathy	100.89	13.52	8	59036	177103	79508241
Herpes zoster	98.71	13.52	215	58829	92868	79592476
Synovitis	97.86	13.52	3	59041	150731	79534613
Joint swelling	97.30	13.52	46	58998	288600	79396744
Neutrophil count increased	96.61	13.52	114	58930	29282	79656062
Epstein-Barr virus infection reactivation	95.49	13.52	40	59004	1852	79683492
Diarrhoea	95.42	13.52	334	58710	880155	78805189
Urinary casts	93.94	13.52	35	59009	1184	79684160
Drug monitoring procedure not performed	92.70	13.52	33	59011	978	79684366
Feeling hot	92.66	13.52	162	58882	59572	79625772
Varicella zoster virus infection	89.39	13.52	50	58994	4391	79680953
Eosinophil percentage increased	86.48	13.52	35	59009	1483	79683861
Acute graft versus host disease in intestine	85.46	13.52	47	58997	3994	79681350
Bradycardia	84.27	13.52	256	58788	135301	79550043
Lymphocyte count abnormal	83.38	13.52	34	59010	1469	79683875
Mean cell haemoglobin concentration decreased	82.62	13.52	48	58996	4531	79680813
Monocyte count increased	82.08	13.52	66	58978	10595	79674749
Chronic graft versus host disease	81.70	13.52	55	58989	6726	79678618
Chronic graft versus host disease in liver	81.54	13.52	27	59017	640	79684704
Infusion site pain	81.06	13.52	74	58970	14102	79671242
Autoimmune neutropenia	80.21	13.52	26	59018	575	79684769
Fall	79.67	13.52	150	58894	487479	79197865
Mucoepidermoid carcinoma of salivary gland	79.42	13.52	18	59026	91	79685253
Leukopenia	79.06	13.52	227	58817	116286	79569058
pH urine increased	78.88	13.52	24	59020	428	79684916
Red blood cell count increased	78.29	13.52	45	58999	4163	79681181
Urobilinogen urine increased	76.95	13.52	26	59018	657	79684687
Systemic lupus erythematosus	76.57	13.52	3	59041	121146	79564198
Body temperature increased	76.20	13.52	126	58918	44294	79641050
Red blood cells urine	75.85	13.52	26	59018	687	79684657
Red blood cell count decreased	74.11	13.52	144	58900	57369	79627975
Heavy menstrual bleeding	74.05	13.52	70	58974	13941	79671403
Viraemia	73.73	13.52	38	59006	2831	79682513
Band sensation	73.31	13.52	26	59018	762	79684582
Arthralgia	73.06	13.52	201	58843	571602	79113742
Tachycardia	72.51	13.52	292	58752	177476	79507868
Petechiae	71.33	13.52	82	58962	20483	79664861
Bilirubin urine present	71.15	13.52	21	59023	336	79685008
Myocardial infarction	70.75	13.52	24	59020	184105	79501239
Red cell distribution width decreased	70.33	13.52	33	59011	2005	79683339
Chills	70.04	13.52	269	58775	159965	79525379
Graft loss	69.74	13.52	27	59017	1016	79684328
Eosinophil count increased	69.32	13.52	74	58970	17031	79668313
Multiple organ dysfunction syndrome	69.11	13.52	221	58823	120025	79565319
Mean cell volume decreased	69.06	13.52	44	59000	4903	79680441
Pain	68.93	13.52	278	58766	703524	78981820
Blood thyroid stimulating hormone abnormal	68.30	13.52	26	59018	934	79684410
Autoimmune disorder	67.56	13.52	72	58972	16540	79668804
Band neutrophil percentage increased	67.34	13.52	21	59023	408	79684936
Drug ineffective	67.33	13.52	497	58547	1080416	78604928
CD4 lymphocytes abnormal	67.06	13.52	14	59030	44	79685300
Cells in urine	66.54	13.52	18	59026	206	79685138
Pneumonia cytomegaloviral	66.41	13.52	43	59001	4926	79680418
Muscular weakness	65.53	13.52	264	58780	160465	79524879
Confusional state	65.07	13.52	84	58960	317913	79367431
Bacteriuria	64.57	13.52	27	59017	1244	79684100
Thrombotic microangiopathy	64.26	13.52	77	58967	20092	79665252
Listeriosis	64.25	13.52	32	59012	2218	79683126
Thyroid stimulating immunoglobulin	63.85	13.52	14	59030	59	79685285
Polyomavirus viraemia	63.13	13.52	29	59015	1678	79683666
Poor quality sleep	61.60	13.52	80	58964	22642	79662702
Injection site pain	61.35	13.52	11	59033	129827	79555517
Urticaria	60.82	13.52	285	58759	184916	79500428
Glossodynia	60.75	13.52	4	59040	103333	79582011
Rhabdomyolysis	60.61	13.52	4	59040	103127	79582217
Atrial fibrillation	60.09	13.52	36	59008	197850	79487494
Haemolytic anaemia	60.03	13.52	70	58974	17750	79667594
Mucosal inflammation	59.98	13.52	156	58888	75424	79609920
Multiple sclerosis	59.70	13.52	78	58966	22204	79663140
Urine leukocyte esterase	58.99	13.52	16	59028	185	79685159
Menstruation irregular	58.65	13.52	40	59004	4996	79680348
Hypothyroidism	57.79	13.52	123	58921	52269	79633075
Venoocclusive disease	57.28	13.52	38	59006	4535	79680809
Diffuse large B-cell lymphoma	57.26	13.52	57	58987	12092	79673252
Swelling	57.10	13.52	46	58998	216665	79468679
Wound	56.76	13.52	9	59035	116170	79569174
Hypoglycaemia	56.71	13.52	5	59039	101589	79583755
Bronchopulmonary aspergillosis	56.59	13.52	76	58968	22218	79663126
Maternal exposure during pregnancy	55.66	13.52	16	59028	136522	79548822
Blood creatinine decreased	55.11	13.52	46	58998	7779	79677565
Acute kidney injury	54.76	13.52	199	58845	519205	79166139
Tri-iodothyronine free increased	54.56	13.52	16	59028	250	79685094
Band neutrophil count increased	53.86	13.52	20	59024	670	79684674
Chronic graft versus host disease in intestine	53.68	13.52	17	59027	348	79684996
Oedema peripheral	53.31	13.52	65	58979	252223	79433121
Hyponatraemia	53.10	13.52	33	59011	177815	79507529
Tri-iodothyronine free decreased	53.01	13.52	17	59027	363	79684981
Cystitis viral	52.82	13.52	20	59024	708	79684636
Acute myeloid leukaemia recurrent	52.03	13.52	32	59012	3351	79681993
Thyroxine free decreased	51.98	13.52	22	59022	1045	79684299
Meningitis listeria	51.94	13.52	22	59022	1047	79684297
Haemophagocytic lymphohistiocytosis	51.73	13.52	72	58972	21765	79663579
Autoimmune thyroid disorder	51.24	13.52	11	59033	41	79685303
Aspergillus infection	51.22	13.52	67	58977	19094	79666250
Epstein-Barr virus associated lymphoproliferative disorder	50.76	13.52	32	59012	3500	79681844
Meningitis viral	50.14	13.52	26	59018	1962	79683382
Autoimmune hypothyroidism	49.49	13.52	15	59029	264	79685080
Mean cell haemoglobin concentration increased	48.64	13.52	20	59024	883	79684461
Therapeutic product effect incomplete	48.58	13.52	22	59022	141623	79543721
Monocyte percentage decreased	48.07	13.52	15	59029	292	79685052
White blood cells urine	48.00	13.52	17	59027	496	79684848
Toxoplasmosis	47.94	13.52	28	59016	2669	79682675
Eosinophil percentage decreased	47.83	13.52	15	59029	297	79685047
Acute disseminated encephalomyelitis	47.79	13.52	15	59029	298	79685046
Arthritis	47.68	13.52	13	59031	114867	79570477
Pyelonephritis fungal	47.37	13.52	14	59030	225	79685119
Propionibacterium infection	47.14	13.52	15	59029	312	79685032
Cystitis haemorrhagic	46.90	13.52	45	58999	9127	79676217
Thyroid function test abnormal	46.57	13.52	29	59015	3105	79682239
Platelet count abnormal	45.95	13.52	34	59010	4828	79680516
Anaemia	45.90	13.52	172	58872	444843	79240501
Central nervous system lesion	45.85	13.52	53	58991	13315	79672029
Peripheral swelling	45.69	13.52	81	58963	269536	79415808
Mycobacterium kansasii infection	45.64	13.52	15	59029	347	79684997
Urinary tract infection bacterial	45.57	13.52	38	59006	6418	79678926
Hepatic enzyme increased	45.36	13.52	41	59003	182569	79502775
Neuropathy peripheral	45.34	13.52	24	59020	141281	79544063
Hypersensitivity	45.14	13.52	78	58966	262161	79423183
Haematocrit increased	44.53	13.52	31	59013	4003	79681341
Osteoarthritis	44.41	13.52	6	59038	87303	79598041
Menstrual disorder	44.30	13.52	31	59013	4036	79681308
Product use in unapproved indication	44.15	13.52	327	58717	250032	79435312
Optic neuritis	43.64	13.52	44	59000	9476	79675868
Alopecia	43.41	13.52	65	58979	231290	79454054
Urinary tract infection	43.11	13.52	349	58695	274163	79411181
Systemic mycosis	43.01	13.52	26	59018	2640	79682704
T-lymphocyte count decreased	42.67	13.52	16	59028	551	79684793
Urine oxalate increased	42.51	13.52	13	59031	236	79685108
Impaired healing	42.34	13.52	7	59037	87648	79597696
Product use issue	42.30	13.52	56	58988	209766	79475578
Oropharyngeal pain	41.70	13.52	176	58868	109177	79576167
Granulocyte percentage	41.47	13.52	10	59034	69	79685275
Myelocyte count increased	41.31	13.52	17	59027	752	79684592
Central nervous system lymphoma	41.31	13.52	24	59020	2265	79683079
Gastroenteritis adenovirus	40.95	13.52	14	59030	367	79684977
Venoocclusive liver disease	40.93	13.52	47	58997	11724	79673620
Chronic obstructive pulmonary disease	40.87	13.52	7	59037	85412	79599932
Adenovirus reactivation	40.66	13.52	14	59030	375	79684969
Mean cell haemoglobin increased	40.58	13.52	30	59014	4255	79681089
International normalised ratio increased	40.41	13.52	7	59037	84714	79600630
Insomnia	40.30	13.52	315	58729	244855	79440489
Lipaemic index score	40.26	13.52	11	59033	131	79685213
Neutrophil percentage decreased	39.69	13.52	17	59027	832	79684512
Pathogen resistance	39.66	13.52	51	58993	14291	79671053
Pseudomonas infection	39.54	13.52	62	58982	20841	79664503
Cardiac failure	39.38	13.52	34	59010	154808	79530536
Suicide attempt	39.23	13.52	7	59037	82925	79602419
Human polyomavirus infection	38.44	13.52	18	59026	1088	79684256
Cerebrovascular accident	38.41	13.52	35	59009	155257	79530087
Depressed level of consciousness	38.17	13.52	12	59032	96640	79588704
Myelocyte percentage increased	38.06	13.52	12	59032	242	79685102
Injury	37.85	13.52	6	59038	77490	79607854
Enterococcal infection	37.64	13.52	52	58992	15608	79669736
Creatinine urine decreased	37.60	13.52	12	59032	252	79685092
Lymphoproliferative disorder	37.47	13.52	32	59012	5583	79679761
Parainfluenzae virus infection	37.14	13.52	32	59012	5650	79679694
Pulmonary haemorrhage	37.09	13.52	50	58994	14667	79670677
Feeling cold	37.08	13.52	72	58972	28657	79656687
Treatment failure	36.98	13.52	43	59001	170443	79514901
Bone marrow transplant rejection	36.95	13.52	12	59032	267	79685077
Haemoglobin decreased	36.84	13.52	286	58758	221833	79463511
Fibromyalgia	36.36	13.52	3	59041	64337	79621007
Lymphadenopathy	36.34	13.52	104	58940	53143	79632201
Exophthalmos	36.25	13.52	20	59024	1710	79683634
Gingival bleeding	36.09	13.52	52	58992	16224	79669120
Psoriasis	35.59	13.52	11	59033	89576	79595768
Blood pressure systolic increased	35.55	13.52	4	59040	66982	79618362
Nocardiosis	35.14	13.52	31	59013	5648	79679696
Decreased appetite	34.85	13.52	133	58911	342285	79343059
Crystalluria	34.68	13.52	16	59028	935	79684409
Leukaemia recurrent	34.62	13.52	23	59021	2751	79682593
Urine bilirubin decreased	34.60	13.52	10	59034	148	79685196
Gastroenteritis norovirus	34.59	13.52	24	59020	3082	79682262
Listeria sepsis	34.58	13.52	15	59029	757	79684587
Infusion site extravasation	34.54	13.52	40	59004	10068	79675276
Coronary artery disease	34.52	13.52	4	59040	65470	79619874
Neutropenia	34.51	13.52	345	58699	287365	79397979
Mean platelet volume decreased	34.50	13.52	23	59021	2767	79682577
Hyperkalaemia	34.45	13.52	21	59023	114377	79570967
Immature granulocyte count increased	34.40	13.52	14	59030	602	79684742
Meningitis tuberculous	34.00	13.52	17	59027	1188	79684156
Thrombotic thrombocytopenic purpura	33.97	13.52	32	59012	6344	79679000
Chronic lymphocytic leukaemia transformation	33.45	13.52	11	59033	255	79685089
Acute myocardial infarction	33.35	13.52	8	59036	77028	79608316
Dehydration	33.31	13.52	85	58959	248102	79437242
Glucose urine present	33.26	13.52	19	59025	1737	79683607
Syncope	33.09	13.52	51	58993	179398	79505946
Incorrect dose administered	33.09	13.52	8	59036	76622	79608722
Pulmonary nocardiosis	32.64	13.52	17	59027	1294	79684050
Cardiac arrest	32.61	13.52	48	58996	172048	79513296
Basophil percentage increased	32.52	13.52	10	59034	185	79685159
Monocyte count abnormal	32.42	13.52	10	59034	187	79685157
Bacterial sepsis	32.40	13.52	35	59009	8163	79677181
Normocytic anaemia	32.29	13.52	26	59018	4181	79681163
Mean platelet volume increased	32.19	13.52	16	59028	1104	79684240
Oral herpes	32.07	13.52	66	58978	27388	79657956
Rotavirus infection	31.88	13.52	14	59030	728	79684616
Neutrophil count decreased	31.85	13.52	146	58898	93813	79591531
Anogenital warts	31.85	13.52	15	59029	919	79684425
Listeria test positive	31.76	13.52	6	59038	9	79685335
Vomiting	31.57	13.52	328	58716	665500	79019844
Acute graft versus host disease in liver	31.55	13.52	19	59025	1916	79683428
B-lymphocyte count decreased	31.43	13.52	17	59027	1397	79683947
Idiopathic pneumonia syndrome	31.42	13.52	13	59031	583	79684761
Autoimmune pancytopenia	31.34	13.52	10	59034	210	79685134
Drug reaction with eosinophilia and systemic symptoms	31.32	13.52	5	59039	64239	79621105
Pneumocystis jirovecii pneumonia	30.98	13.52	72	58972	32436	79652908
Hypoaesthesia	30.88	13.52	233	58811	179119	79506225
Orthostatic hypotension	30.71	13.52	3	59041	56161	79629183
Mean cell volume increased	30.70	13.52	30	59014	6223	79679121
Drug exposure before pregnancy	30.69	13.52	13	59031	619	79684725
Adverse drug reaction	30.55	13.52	6	59038	66386	79618958
Limb discomfort	30.48	13.52	72	58972	32778	79652566
Injection site erythema	30.36	13.52	10	59034	78187	79607157
Immature granulocyte percentage increased	30.28	13.52	8	59036	83	79685261
Factor VIII deficiency	30.15	13.52	9	59035	150	79685194
Cardiac disorder	30.14	13.52	6	59038	65751	79619593
Cytomegalovirus test positive	30.07	13.52	29	59015	5918	79679426
Pancytopenia	30.06	13.52	218	58826	165527	79519817
CD4 lymphocyte percentage decreased	30.04	13.52	6	59038	14	79685330
Acanthamoeba infection	30.00	13.52	12	59032	493	79684851
Irritable bowel syndrome	29.99	13.52	5	59039	62236	79623108
Thyroid stimulating immunoglobulin increased	29.94	13.52	8	59036	87	79685257
Fusarium infection	29.90	13.52	18	59026	1814	79683530
Cardio-respiratory arrest	29.88	13.52	22	59022	108488	79576856
Metabolic acidosis	29.59	13.52	12	59032	82517	79602827
Heart rate increased	29.37	13.52	171	58873	120553	79564791
Haemoglobin increased	29.32	13.52	29	59015	6103	79679241
Rectal haemorrhage	29.20	13.52	10	59034	76290	79609054
Gastrointestinal haemorrhage	29.18	13.52	40	59004	147679	79537665
Graft versus host disease in lung	29.12	13.52	14	59030	898	79684446
Varicella	28.83	13.52	21	59023	2911	79682433
Laboratory test abnormal	28.82	13.52	64	58980	27984	79657360
Stomatitis	28.73	13.52	40	59004	146717	79538627
Plasma cell myeloma	28.72	13.52	3	59041	53256	79632088
Anaphylactic reaction	28.72	13.52	13	59031	83730	79601614
Adverse event	28.66	13.52	5	59039	60209	79625135
Gastrointestinal disorder	28.52	13.52	29	59015	122176	79563168
Human herpesvirus 6 infection reactivation	28.49	13.52	12	59032	563	79684781
Aplastic anaemia	28.33	13.52	49	58995	17856	79667488
Thyroiditis	28.22	13.52	25	59019	4580	79680764
Polymyositis	28.18	13.52	21	59023	3015	79682329
Electrocardiogram QT prolonged	28.05	13.52	16	59028	90370	79594974
Discomfort	27.98	13.52	31	59013	125586	79559758
Enterococcal bacteraemia	27.98	13.52	21	59023	3047	79682297
Sedation	27.78	13.52	3	59041	51892	79633452
Herpes virus infection	27.69	13.52	30	59014	7019	79678325
Red blood cell elliptocytes present	27.60	13.52	9	59035	203	79685141
Vitiligo	27.57	13.52	18	59026	2091	79683253
B-cell lymphoma	27.17	13.52	28	59016	6187	79679157
Aggression	27.15	13.52	3	59041	50955	79634389
Staphylococcal bacteraemia	27.04	13.52	39	59005	12179	79673165
Chronic hepatitis C	27.02	13.52	12	59032	641	79684703
Expanded disability status scale score increased	26.88	13.52	12	59032	649	79684695
Encephalitis	26.84	13.52	43	59001	14717	79670627
Loss of personal independence in daily activities	26.72	13.52	22	59022	102558	79582786
Proteinuria	26.72	13.52	68	58976	32434	79652910
Malignant neoplasm progression	26.68	13.52	37	59007	135953	79549391
Type 2 diabetes mellitus	26.63	13.52	5	59039	57117	79628227
Intentional product misuse	26.58	13.52	19	59025	95146	79590198
Pericarditis	26.36	13.52	23	59021	104213	79581131
Pneumonia	26.32	13.52	338	58706	659908	79025436
B-lymphocyte count increased	26.28	13.52	8	59036	143	79685201
Constipation	26.24	13.52	114	58930	282936	79402408
Infertility	26.21	13.52	12	59032	689	79684655
Eosinophil count decreased	26.09	13.52	21	59023	3375	79681969
Temperature intolerance	26.04	13.52	34	59010	9671	79675673
Hepatitis infectious mononucleosis	25.92	13.52	8	59036	150	79685194
Angioedema	25.77	13.52	12	59032	76023	79609321
Lactobacillus infection	25.64	13.52	10	59034	384	79684960
Treatment noncompliance	25.63	13.52	4	59040	52264	79633080
Quadriparesis	25.53	13.52	21	59023	3480	79681864
Viral haemorrhagic cystitis	25.51	13.52	17	59027	2044	79683300
Intentional product use issue	25.47	13.52	46	58998	152066	79533278
White blood cell count abnormal	25.33	13.52	26	59018	5719	79679625
Creatinine urine increased	25.31	13.52	11	59033	558	79684786
Herpes zoster meningoencephalitis	25.27	13.52	12	59032	749	79684595
Basophil count increased	25.13	13.52	15	59029	1488	79683856
Delirium	24.84	13.52	16	59028	84611	79600733
Anti-glomerular basement membrane antibody positive	24.84	13.52	4	59040	0	79685344
Goodpasture's syndrome	24.84	13.52	4	59040	0	79685344
Anti-glomerular basement membrane antibody	24.84	13.52	4	59040	0	79685344
Embryonal rhabdomyosarcoma	24.81	13.52	6	59038	42	79685302
Drug-induced liver injury	24.73	13.52	9	59035	66108	79619236
Blood creatine phosphokinase increased	24.71	13.52	9	59035	66081	79619263
Mycobacterial infection	24.67	13.52	21	59023	3647	79681697
Hypokalaemia	24.63	13.52	43	59001	143997	79541347
Pollakiuria	24.61	13.52	72	58972	37245	79648099
Legionella infection	24.56	13.52	12	59032	798	79684546
Vulvovaginal mycotic infection	24.48	13.52	23	59021	4543	79680801
Thrombocytopenia	24.44	13.52	302	58742	264957	79420387
Hypomagnesaemia	24.40	13.52	3	59041	46908	79638436
Encephalitis viral	24.30	13.52	18	59026	2561	79682783
Fungal skin infection	24.26	13.52	26	59018	6010	79679334
Stenotrophomonas infection	24.16	13.52	21	59023	3752	79681592
Hypocalcaemia	24.08	13.52	4	59040	49920	79635424
Lactic acidosis	24.00	13.52	11	59033	70348	79614996
Epstein-Barr virus associated lymphoma	23.95	13.52	13	59031	1076	79684268
Rash	23.77	13.52	578	58466	577780	79107564
Transient ischaemic attack	23.75	13.52	5	59039	52690	79632654
Diplopia	23.45	13.52	66	58978	33400	79651944
Asthma	23.40	13.52	40	59004	135055	79550289
Immune reconstitution inflammatory syndrome	23.38	13.52	39	59005	13802	79671542
Activated partial thromboplastin time shortened	23.37	13.52	12	59032	887	79684457
Throat irritation	23.27	13.52	75	58969	40871	79644473
Parvovirus infection	23.23	13.52	11	59033	682	79684662
Abdominal discomfort	23.22	13.52	101	58943	250626	79434718
Anti-glomerular basement membrane disease	23.19	13.52	6	59038	57	79685287
Papilloma viral infection	23.16	13.52	15	59029	1719	79683625
Pneumonia adenoviral	23.11	13.52	10	59034	502	79684842
Oedema	23.00	13.52	33	59011	119547	79565797
Product prescribing error	22.98	13.52	3	59041	44810	79640534
Vaginal discharge	22.97	13.52	28	59016	7435	79677909
Apoptosis	22.96	13.52	10	59034	510	79684834
Pulmonary embolism	22.86	13.52	59	58985	171595	79513749
Contusion	22.70	13.52	188	58856	148588	79536756
Eosinophil count abnormal	22.39	13.52	11	59033	740	79684604
Altered state of consciousness	22.31	13.52	3	59041	43819	79641525
Tuberculosis liver	22.15	13.52	6	59038	69	79685275
Growth failure	22.13	13.52	8	59036	248	79685096
Urine bilirubin increased	22.07	13.52	7	59037	144	79685200
Muscle spasticity	22.06	13.52	49	58995	21426	79663918
Aplasia pure red cell	21.95	13.52	28	59016	7782	79677562
Granulocyte count increased	21.94	13.52	13	59031	1272	79684072
Drug resistance	21.92	13.52	75	58969	42138	79643206
Pregnancy of partner	21.86	13.52	8	59036	257	79685087
Acquired haemophilia	21.83	13.52	15	59029	1896	79683448
Pulmonary alveolar haemorrhage	21.69	13.52	34	59010	11423	79673921
Haemoglobin urine	21.54	13.52	7	59037	156	79685188
Weight increased	21.50	13.52	119	58925	277267	79408077
Atypical mycobacterial pneumonia	21.26	13.52	7	59037	163	79685181
Respiratory arrest	21.24	13.52	8	59036	57542	79627802
Infection in an immunocompromised host	21.19	13.52	13	59031	1355	79683989
Evans syndrome	21.18	13.52	9	59035	432	79684912
Infusion site discomfort	21.03	13.52	13	59031	1374	79683970
Musculoskeletal pain	20.94	13.52	27	59017	102327	79583017
Complications of bone marrow transplant	20.88	13.52	10	59034	636	79684708
Chronic lymphocytic leukaemia recurrent	20.85	13.52	10	59034	638	79684706
Goitre	20.76	13.52	23	59021	5516	79679828
Deep vein thrombosis	20.76	13.52	36	59008	120883	79564461
Lymphocyte percentage abnormal	20.67	13.52	5	59039	35	79685309
Klebsiella sepsis	20.62	13.52	18	59026	3234	79682110
Graft versus host disease in liver	20.59	13.52	14	59030	1740	79683604
Retinal depigmentation	20.27	13.52	8	59036	317	79685027
Pulmonary fibrosis	20.27	13.52	4	59040	44108	79641236
Blister	20.12	13.52	36	59008	119440	79565904
Actinomycotic sepsis	20.04	13.52	6	59038	101	79685243
Tri-iodothyronine free abnormal	19.98	13.52	5	59039	41	79685303
Hypotension	19.98	13.52	219	58825	440098	79245246
Engraft failure	19.94	13.52	10	59034	703	79684641
Folliculitis	19.94	13.52	8	59036	55372	79629972
Candida infection	19.93	13.52	68	58976	38146	79647198
Meningism	19.93	13.52	10	59034	704	79684640
Microangiopathy	19.81	13.52	14	59030	1851	79683493
Varicella virus test positive	19.81	13.52	7	59037	203	79685141
Bronchitis	19.72	13.52	42	59002	130602	79554742
Fibrin D dimer increased	19.70	13.52	28	59016	8626	79676718
Injection site reaction	19.59	13.52	8	59036	54777	79630567
Posterior reversible encephalopathy syndrome	19.57	13.52	53	58991	26228	79659116
Albuminuria	19.48	13.52	10	59034	739	79684605
Accidental overdose	19.48	13.52	3	59041	39578	79645766
T-cell prolymphocytic leukaemia	19.47	13.52	5	59039	46	79685298
Anti-thyroid antibody	19.47	13.52	5	59039	46	79685298
Infusion site scar	19.42	13.52	8	59036	355	79684989
Urine uric acid increased	19.37	13.52	5	59039	47	79685297
Hallucination	19.27	13.52	21	59023	85724	79599620
Chromaturia	19.25	13.52	52	58992	25694	79659650
C-reactive protein abnormal	19.10	13.52	6	59038	48361	79636983
Chronic lymphocytic leukaemia refractory	19.08	13.52	6	59038	120	79685224
Diabetes mellitus	18.98	13.52	18	59026	78372	79606972
Sinus bradycardia	18.89	13.52	51	58993	25196	79660148
Myositis	18.87	13.52	43	59001	19125	79666219
Chronic kidney disease	18.75	13.52	13	59031	66141	79619203
Interleukin-2 receptor increased	18.62	13.52	7	59037	243	79685101
Loefgren syndrome	18.37	13.52	6	59038	136	79685208
Viral test positive	18.37	13.52	8	59036	408	79684936
Erythema	18.36	13.52	249	58795	223041	79462303
Fumbling	18.33	13.52	6	59038	137	79685207
Dyspnoea	18.32	13.52	489	58555	856536	78828808
Coma	18.17	13.52	29	59015	100620	79584724
Pneumonia fungal	18.15	13.52	31	59013	11179	79674165
Fungal infection	18.14	13.52	70	58974	41678	79643666
Leukaemic infiltration	18.13	13.52	6	59038	142	79685202
Herpes zoster infection neurological	18.07	13.52	7	59037	264	79685080
Nitrite urine	18.03	13.52	4	59040	18	79685326
Condition aggravated	17.97	13.52	262	58782	500862	79184482
Suicidal ideation	17.94	13.52	18	59026	76322	79609022
Pneumonia pseudomonal	17.90	13.52	22	59022	5889	79679455
Cataract	17.88	13.52	12	59032	62108	79623236
Glomerulonephritis chronic	17.87	13.52	7	59037	272	79685072
Enterobacter bacteraemia	17.84	13.52	10	59034	882	79684462
Thyroid disorder	17.82	13.52	35	59009	14044	79671300
Neoplasm progression	17.75	13.52	8	59036	51674	79633670
Splenomegaly	17.66	13.52	44	59000	20710	79664634
Osteoporosis	17.63	13.52	9	59035	54103	79631241
Post herpetic neuralgia	17.62	13.52	15	59029	2606	79682738
Platelet morphology abnormal	17.56	13.52	6	59038	157	79685187
Paternal exposure timing unspecified	17.49	13.52	5	59039	71	79685273
Bladder dysfunction	17.47	13.52	11	59033	1201	79684143
Exposure during pregnancy	17.46	13.52	30	59014	101102	79584242
Thrombosis	17.39	13.52	22	59022	84078	79601266
Protein urine	17.37	13.52	12	59032	1530	79683814
Urobilinogen urine	17.37	13.52	4	59040	22	79685322
Gait disturbance	17.31	13.52	232	58812	207274	79478070
Injection site pruritus	17.14	13.52	5	59039	42278	79643066
Citrobacter infection	17.06	13.52	10	59034	960	79684384
Glomerulonephropathy	16.96	13.52	7	59037	312	79685032
Diarrhoea haemorrhagic	16.87	13.52	33	59011	13201	79672143
Lymphocyte percentage increased	16.87	13.52	9	59035	720	79684624
Urine odour abnormal	16.86	13.52	22	59022	6251	79679093
Nystagmus	16.85	13.52	28	59016	9876	79675468
Pancreas transplant rejection	16.83	13.52	7	59037	318	79685026
Neutrophil percentage abnormal	16.80	13.52	4	59040	26	79685318
General physical health deterioration	16.78	13.52	127	58917	275111	79410233
Weight decreased	16.77	13.52	175	58869	355023	79330321
Stem cell transplant	16.76	13.52	17	59027	3687	79681657
Femur fracture	16.75	13.52	4	59040	38648	79646696
Blood pressure fluctuation	16.75	13.52	15	59029	67130	79618214
Pneumonia aspiration	16.66	13.52	15	59029	66952	79618392
Injection site swelling	16.66	13.52	7	59037	47125	79638219
Thyroid hormones increased	16.60	13.52	8	59036	516	79684828
Loss of consciousness	16.57	13.52	66	58978	167877	79517467
Monocyte percentage abnormal	16.55	13.52	3	59041	3	79685341
Basophil count abnormal	16.54	13.52	4	59040	28	79685316
Thyroiditis subacute	16.53	13.52	7	59037	333	79685011
Blood stem cell transplant failure	16.44	13.52	8	59036	527	79684817
Skin papilloma	16.38	13.52	21	59023	5865	79679479
Ureaplasma infection	16.32	13.52	10	59034	1040	79684304
Chronic lymphocytic leukaemia	16.20	13.52	19	59025	4847	79680497
Shock	16.16	13.52	6	59038	43542	79641802
Infusion related reaction	16.12	13.52	102	58942	230135	79455209
Sleep disorder	16.12	13.52	24	59020	85653	79599691
Poikilocytosis	16.07	13.52	7	59037	357	79684987
Therapy cessation	16.06	13.52	4	59040	37558	79647786
Cytomegalovirus chorioretinitis	15.93	13.52	20	59024	5470	79679874
Melaena	15.93	13.52	13	59031	60877	79624467
Infusion site swelling	15.91	13.52	24	59020	7802	79677542
Disorder of globe	15.69	13.52	3	59041	5	79685339
Periportal oedema	15.67	13.52	5	59039	105	79685239
Dysgraphia	15.56	13.52	17	59027	4015	79681329
Malignant melanoma	15.55	13.52	34	59010	14707	79670637
Interstitial lung disease	15.53	13.52	38	59006	112562	79572782
Inappropriate schedule of product administration	15.53	13.52	49	58995	133579	79551765
Hot flush	15.53	13.52	81	58963	54796	79630548
Micturition urgency	15.49	13.52	31	59013	12610	79672734
Infection reactivation	15.44	13.52	14	59030	2643	79682701
Transfusion microchimerism	15.34	13.52	3	59041	6	79685338
Eosinophil percentage abnormal	15.34	13.52	3	59041	6	79685338
Thyroid cyst	15.32	13.52	7	59037	400	79684944
Dyskinesia	15.27	13.52	7	59037	44766	79640578
Hepatic function abnormal	15.25	13.52	19	59025	73088	79612256
Ventricular tachycardia	15.19	13.52	6	59038	41929	79643415
Endometrial ablation	15.16	13.52	9	59035	884	79684460
Phaeohyphomycosis	15.12	13.52	10	59034	1187	79684157
Semenuria	15.10	13.52	4	59040	42	79685302
Renal transplant failure	15.09	13.52	12	59032	1895	79683449
Surgery	14.99	13.52	3	59041	32763	79652581
Mycobacterium abscessus infection	14.93	13.52	10	59034	1212	79684132
Liver injury	14.92	13.52	12	59032	56602	79628742
Tri-iodothyronine increased	14.90	13.52	6	59038	251	79685093
Vaccination site inflammation	14.69	13.52	4	59040	47	79685297
JC polyomavirus test positive	14.69	13.52	11	59033	1591	79683753
CD8 lymphocytes decreased	14.63	13.52	6	59038	263	79685081
Paraparesis	14.62	13.52	16	59028	3787	79681557
Obesity	14.52	13.52	4	59040	35121	79650223
Allergy to arthropod bite	14.48	13.52	6	59038	270	79685074
Citric acid urine increased	14.46	13.52	4	59040	50	79685294
Malaise	14.30	13.52	266	58778	489603	79195741
Blood cholesterol increased	14.30	13.52	25	59019	83695	79601649
Colitis ulcerative	14.28	13.52	4	59040	34738	79650606
Intestinal obstruction	14.25	13.52	7	59037	43013	79642331
Increased appetite	14.23	13.52	29	59015	11949	79673395
Obstructive airways disorder	14.15	13.52	3	59041	31456	79653888
Musculoskeletal stiffness	14.15	13.52	74	58970	174934	79510410
Infusion site rash	14.09	13.52	11	59033	1691	79683653
Alopecia universalis	14.04	13.52	6	59038	292	79685052
White blood cell count increased	14.00	13.52	99	58945	74534	79610810
Klebsiella test positive	13.98	13.52	11	59033	1712	79683632
Haemorrhagic cyst	13.87	13.52	6	59038	301	79685043
Cytokine storm	13.85	13.52	9	59035	1037	79684307
Supportive care	13.81	13.52	3	59041	12	79685332
Bilirubin urine	13.81	13.52	3	59041	12	79685332
Pancreatitis acute	13.72	13.52	10	59034	49594	79635750
Raoultella ornithinolytica infection	13.67	13.52	4	59040	62	79685282
Skin ulcer	13.63	13.52	12	59032	54138	79631206
Cardiogenic shock	13.62	13.52	7	59037	41907	79643437
Platelet count increased	13.61	13.52	42	59002	22364	79662980
Hyperoxaluria	13.57	13.52	6	59038	317	79685027

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L04AA34	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Selective immunosuppressants
FDA MoA	N0000175079	CD52-directed Antibody Interactions
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D000074322	Antineoplastic Agents, Immunological
FDA EPC	N0000175659	CD52-directed Cytolytic Antibody

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

Disease	Relation	SNOMED_ID	DOID
Refractory chronic lymphocytic leukemia	indication	92814006
Conditioning treatment prior to allogeneic haematopoietic stem cell transplant	indication	234336002
Relapsing remitting multiple sclerosis	indication	426373005	DOID:2378
Recurrent chronic lymphocytic leukemia	indication	122961000119105

🐶 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
CAMPATH-1 antigen	Surface antigen	P31358	CD52_HUMAN	ANTIBODY BINDING				DRUG LABEL	DRUG LABEL

External reference:

ID	Source
D02802	KEGG_DRUG
4021265	VUID
N0000148705	NUI
4021265	VANDF
CHEMBL1201587	ChEMBL_ID
6770	IUPHAR_LIGAND_ID
DB00087	DRUGBANK_ID
117055	RXNORM
16025	MMSL
213286	MMSL
41389	MMSL
d04756	MMSL
009168	NDDF
009169	NDDF
129472003	SNOMEDCT_US
391632007	SNOMEDCT_US
C0383429	UMLSCUI
D000074323	MESH_DESCRIPTOR_UI
8005	INN_ID
3A189DH42V	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
LEMTRADA	HUMAN PRESCRIPTION DRUG LABEL	1	58468-0200	INJECTION, SOLUTION, CONCENTRATE	12 mg	INTRAVENOUS	BLA	29 sections
LEMTRADA	HUMAN PRESCRIPTION DRUG LABEL	1	58468-0200	INJECTION, SOLUTION, CONCENTRATE	12 mg	INTRAVENOUS	BLA	29 sections
LEMTRADA	HUMAN PRESCRIPTION DRUG LABEL	1	58468-0200	INJECTION, SOLUTION, CONCENTRATE	12 mg	INTRAVENOUS	BLA	29 sections
LEMTRADA	HUMAN PRESCRIPTION DRUG LABEL	1	58468-0200	INJECTION, SOLUTION, CONCENTRATE	12 mg	INTRAVENOUS	BLA	29 sections
Campath	HUMAN PRESCRIPTION DRUG LABEL	1	58468-0357	INJECTION	30 mg	INTRAVENOUS	BLA	28 sections
Campath	HUMAN PRESCRIPTION DRUG LABEL	1	58468-0357	INJECTION	30 mg	INTRAVENOUS	BLA	28 sections