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

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

Stem definition	Drug id	CAS RN
humanized origin	4970	189261-10-7

Description:

Molecule	Description
Synonyms: antegren natalizumab tysabri	A humanized monoclonal immunoglobulin G4 antibody to human INTEGRIN ALPHA4 that binds to the alpha4 subunit of INTEGRIN ALPHA4BETA1 and integrin alpha4beta7. It is used as an IMMUNOLOGIC FACTOR in the treatment of RELAPSING-REMITTING MULTIPLE SCLEROSIS and CROHN'S DISEASE. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Drug dosage:

Dose	Unit	Route
10	mg	P

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
June 27, 2006	EMA
Nov. 23, 2004	FDA	BIOGEN IDEC

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
Multiple sclerosis relapse	13035.57	13.26	4298	99392	44180	63341152
Progressive multifocal leukoencephalopathy	3818.38	13.26	1236	102454	11735	63373597
Immune reconstitution inflammatory syndrome	2592.38	13.26	770	102920	5314	63380018
General symptom	1795.36	13.26	488	103202	2320	63383012
Urinary tract infection	1752.05	13.26	2154	101536	262530	63122802
Opportunistic infection	1185.44	13.26	325	103365	1604	63383728
Malaise	1184.79	13.26	2290	101400	413664	62971668
Abortion spontaneous	1179.69	13.26	812	102878	46383	63338949
Drug specific antibody present	1139.85	13.26	378	103312	3881	63381451
Prescribed underdose	884.47	13.26	570	103120	29119	63356213
Poor venous access	750.57	13.26	401	103289	14384	63370948
Balance disorder	692.50	13.26	769	102921	83653	63301679
Gait disturbance	613.71	13.26	1084	102606	182094	63203238
Fall	595.13	13.26	1690	102000	390644	62994688
Off label use	547.35	13.26	210	103480	674252	62711080
Cognitive disorder	518.14	13.26	543	103147	55272	63330060
Central nervous system lesion	502.26	13.26	275	103415	10360	63374972
Magnetic resonance imaging abnormal	490.41	13.26	186	103504	2899	63382433
Memory impairment	478.33	13.26	712	102978	103546	63281786
Maternal exposure during pregnancy	472.43	13.26	1082	102608	218980	63166352
Neoplasm malignant	463.93	13.26	387	103303	29474	63355858
Seizure	462.14	13.26	799	102891	131835	63253497
Secondary progressive multiple sclerosis	419.47	13.26	136	103554	1291	63384041
Herpes zoster	409.87	13.26	585	103105	81877	63303455
Loss of control of legs	398.00	13.26	130	103560	1266	63384066
Breast cancer	390.02	13.26	437	103253	47946	63337386
Caesarean section	385.47	13.26	276	103414	16756	63368576
Muscular weakness	367.31	13.26	691	102999	121662	63263670
Diarrhoea	324.47	13.26	417	103273	714949	62670383
Joint swelling	315.77	13.26	74	103616	327592	63057740
Contraindicated product administered	310.33	13.26	10	103680	217638	63167694
Optic neuritis	306.85	13.26	184	103506	8251	63377081
Toxicity to various agents	296.49	13.26	30	103660	247220	63138112
Pemphigus	283.67	13.26	3	103687	183723	63201609
Rheumatoid arthritis	279.35	13.26	41	103649	253778	63131554
Product use issue	277.20	13.26	22	103668	220498	63164834
Decubitus ulcer	274.36	13.26	186	103504	10334	63374998
Muscle spasticity	269.24	13.26	248	103442	21546	63363786
Condition aggravated	266.50	13.26	164	103526	402053	62983279
Glossodynia	263.22	13.26	6	103684	178870	63206462
Invasive ductal breast carcinoma	256.26	13.26	153	103537	6805	63378527
Drug interaction	249.85	13.26	38	103652	229093	63156239
Hypoaesthesia	248.91	13.26	720	102970	167673	63217659
Abdominal discomfort	240.06	13.26	112	103578	320773	63064559
JC polyomavirus test positive	235.99	13.26	89	103601	1364	63383968
Asthenia	234.21	13.26	1239	102451	382365	63002967
Neutralising antibodies positive	221.64	13.26	57	103633	208	63385124
Drug hypersensitivity	219.49	13.26	117	103573	310570	63074762
Product use in unapproved indication	211.34	13.26	23	103667	179057	63206275
Musculoskeletal disorder	206.16	13.26	209	103481	20435	63364897
Systemic lupus erythematosus	205.47	13.26	45	103645	208873	63176459
Alopecia	200.36	13.26	155	103535	337381	63047951
Influenza	197.79	13.26	502	103188	108220	63277112
Drug delivery device placement	197.66	13.26	45	103645	81	63385251
Visual impairment	195.02	13.26	428	103262	84018	63301314
Peripheral swelling	190.98	13.26	98	103592	265844	63119488
Nasopharyngitis	183.07	13.26	861	102829	253396	63131936
Trigeminal neuralgia	180.09	13.26	96	103594	3423	63381909
Arthralgia	180.05	13.26	417	103273	569293	62816039
Injection site pain	174.75	13.26	9	103681	129791	63255541
Malignant melanoma	173.87	13.26	146	103544	11210	63374122
Acute kidney injury	173.44	13.26	108	103582	263307	63122025
Neurogenic bladder	172.02	13.26	91	103599	3194	63382138
Stress	168.38	13.26	352	103338	66815	63318517
Febrile neutropenia	166.78	13.26	6	103684	118443	63266889
Neutropenia	165.49	13.26	41	103649	174964	63210368
Cystitis	164.09	13.26	310	103380	54681	63330651
Surgery	164.08	13.26	245	103445	35667	63349665
Hypersensitivity	162.64	13.26	922	102768	291763	63093569
Peroneal nerve palsy	161.81	13.26	100	103590	4735	63380597
Hysterectomy	159.81	13.26	129	103561	9370	63375962
Hemiparesis	158.66	13.26	193	103497	23089	63362243
Drug intolerance	157.64	13.26	163	103527	308498	63076834
Swelling	156.42	13.26	132	103558	275246	63110086
Neuromyelitis optica spectrum disorder	155.93	13.26	60	103630	974	63384358
Decreased immune responsiveness	155.53	13.26	98	103592	4803	63380529
Progressive multiple sclerosis	155.25	13.26	62	103628	1116	63384216
Pericarditis	154.96	13.26	17	103673	131562	63253770
Arthropathy	153.53	13.26	97	103593	234695	63150637
Gait inability	148.76	13.26	291	103399	52668	63332664
Mobility decreased	147.18	13.26	484	103206	120675	63264657
Decreased appetite	146.71	13.26	117	103573	250935	63134397
Weight increased	144.47	13.26	128	103562	260664	63124668
Dyspnoea	144.45	13.26	574	103116	660739	62724593
Mental impairment	138.98	13.26	142	103548	14009	63371323
Multiple sclerosis	134.55	13.26	182	103508	24190	63361142
Vein disorder	134.29	13.26	91	103599	5050	63380282
Exposure during pregnancy	129.64	13.26	46	103644	155501	63229831
Epilepsy	127.02	13.26	187	103503	26878	63358454
Road traffic accident	126.43	13.26	220	103470	36412	63348920
Rash	124.15	13.26	484	103206	560387	62824945
Intentional product use issue	120.81	13.26	30	103660	127862	63257470
Ankle fracture	120.02	13.26	147	103543	17708	63367624
Stomatitis	119.12	13.26	39	103651	138686	63246646
Aphasia	118.89	13.26	202	103488	32798	63352534
Coordination abnormal	118.86	13.26	129	103561	13644	63371688
Helicobacter infection	117.22	13.26	9	103681	92776	63292556
Intraductal proliferative breast lesion	116.95	13.26	68	103622	2877	63382455
Therapeutic product effect incomplete	114.94	13.26	31	103659	125025	63260307
Intervertebral disc protrusion	112.97	13.26	165	103525	23544	63361788
Urosepsis	112.55	13.26	145	103545	18379	63366953
Nausea	112.45	13.26	877	102813	853594	62531738
Blister	110.57	13.26	37	103653	129777	63255555
C-reactive protein increased	107.14	13.26	14	103676	94693	63290639
Loss of personal independence in daily activities	106.26	13.26	16	103674	97274	63288058
Death	106.10	13.26	1004	102686	373377	63011955
Lower respiratory tract infection	103.81	13.26	43	103647	132264	63253068
Depression	103.76	13.26	611	103079	195881	63189451
Injection site erythema	102.49	13.26	9	103681	83165	63302167
Cervical dysplasia	101.32	13.26	64	103626	3150	63382182
Treatment failure	100.52	13.26	106	103584	198937	63186395
Hospitalisation	100.13	13.26	11	103679	85070	63300262
Bladder disorder	99.37	13.26	96	103594	8850	63376482
Speech disorder	96.10	13.26	208	103482	40421	63344911
Uterine leiomyoma	93.43	13.26	94	103596	9104	63376228
Muscle injury	93.06	13.26	3	103687	65342	63319990
Hip fracture	92.71	13.26	170	103520	29304	63356028
Relapsing-remitting multiple sclerosis	91.71	13.26	35	103655	555	63384777
Breech presentation	91.29	13.26	43	103647	1171	63384161
Disease progression	88.37	13.26	45	103645	122713	63262619
Central venous catheterisation	87.60	13.26	54	103636	2545	63382787
Pancytopenia	87.25	13.26	25	103665	96908	63288424
Discomfort	86.92	13.26	87	103603	167287	63218045
Ectopic pregnancy	85.67	13.26	53	103637	2514	63382818
Bronchitis	85.32	13.26	417	103273	124518	63260814
Breast cancer female	85.31	13.26	108	103582	13451	63371881
Diplopia	85.14	13.26	145	103545	23583	63361749
Thrombocytopenia	83.86	13.26	74	103616	151083	63234249
Adverse reaction	83.59	13.26	93	103597	10110	63375222
Anaphylactic shock	82.93	13.26	143	103547	23490	63361842
Upper respiratory tract infection	82.48	13.26	308	103382	81739	63303593
Completed suicide	82.41	13.26	70	103620	145603	63239729
Hyponatraemia	82.08	13.26	40	103650	111860	63273472
Prolonged labour	81.59	13.26	32	103658	548	63384784
Thyroid cancer	81.51	13.26	70	103620	5541	63379791
Nephrolithiasis	80.62	13.26	198	103492	41786	63343546
Urinary incontinence	80.45	13.26	168	103522	31846	63353486
Blood creatinine increased	80.29	13.26	22	103668	87822	63297510
Abdominal pain	78.52	13.26	233	103457	293223	63092109
White blood cell count increased	77.82	13.26	214	103476	48347	63336985
Atrial fibrillation	77.82	13.26	47	103643	116589	63268743
Electrocardiogram QT prolonged	77.43	13.26	5	103685	59525	63325807
No adverse event	77.11	13.26	193	103497	41212	63344120
Platelet count decreased	75.80	13.26	48	103642	116074	63269258
Folliculitis	75.79	13.26	12	103678	70305	63315027
Dyspepsia	75.77	13.26	36	103654	102160	63283172
Cervix carcinoma	75.16	13.26	52	103638	2985	63382347
Mental disorder	74.68	13.26	144	103546	25775	63359557
Muscle spasms	73.83	13.26	472	103218	155678	63229654
Wrong technique in product usage process	73.51	13.26	8	103682	62332	63323000
Haemoglobin decreased	72.84	13.26	78	103612	145407	63239925
Intentional overdose	72.77	13.26	16	103674	74136	63311196
Lymphocytosis	72.32	13.26	49	103641	2718	63382614
Gastric bypass	72.27	13.26	42	103648	1775	63383557
Renal impairment	72.11	13.26	27	103663	88328	63297004
Vomiting	70.74	13.26	580	103110	559037	62826295
Wound	70.69	13.26	98	103592	163165	63222167
JC virus granule cell neuronopathy	70.23	13.26	20	103670	116	63385216
Therapeutic response decreased	69.81	13.26	9	103681	61516	63323816
Staphylococcal infection	69.30	13.26	185	103505	41071	63344261
Vision blurred	67.96	13.26	314	103376	91610	63293722
Lower limb fracture	67.87	13.26	133	103557	24088	63361244
Pregnancy	67.86	13.26	171	103519	36665	63348667
Post lumbar puncture syndrome	66.14	13.26	28	103662	588	63384744
Leukopenia	65.85	13.26	22	103668	77268	63308064
Temperature intolerance	65.48	13.26	77	103613	8887	63376445
Herpes zoster necrotising retinopathy	65.03	13.26	12	103678	0	63385332
Drug abuse	64.72	13.26	19	103671	72499	63312833
Kidney infection	64.63	13.26	127	103563	23049	63362283
Pleural effusion	64.39	13.26	36	103654	93174	63292158
Dysgraphia	63.07	13.26	48	103642	3198	63382134
Neuropathy peripheral	62.61	13.26	56	103634	113611	63271721
Psoriasis	62.39	13.26	32	103658	86925	63298407
Intentional product misuse	62.15	13.26	12	103678	60905	63324427
Dyspnoea exertional	61.26	13.26	12	103678	60290	63325042
Injection site reaction	60.83	13.26	11	103679	58513	63326819
Incorrect dose administered	60.78	13.26	12	103678	59956	63325376
Cardiac failure	60.76	13.26	35	103655	89107	63296225
Therapy non-responder	60.60	13.26	24	103666	75877	63309455
Wheezing	60.37	13.26	41	103649	95554	63289778
Oxygen saturation decreased	60.06	13.26	35	103655	88550	63296782
Red blood cell sedimentation rate increased	59.33	13.26	3	103687	43979	63341353
White blood cell count decreased	58.72	13.26	85	103605	139019	63246313
Focal dyscognitive seizures	58.53	13.26	44	103646	2877	63382455
Blood cholesterol increased	58.49	13.26	41	103649	93991	63291341
Infusion site extravasation	57.75	13.26	78	103612	10348	63374984
Cough	57.54	13.26	264	103426	292479	63092853
Anaemia	56.86	13.26	266	103424	293164	63092168
Multiple organ dysfunction syndrome	56.19	13.26	12	103678	56740	63328592
Constipation	55.62	13.26	185	103505	224758	63160574
Gallbladder operation	55.38	13.26	39	103651	2304	63383028
Irritable bowel syndrome	55.26	13.26	33	103657	82379	63302953
Ataxia	54.70	13.26	93	103597	15102	63370230
Weight decreased	54.17	13.26	250	103440	276548	63108784
Therapeutic product effect decreased	54.11	13.26	150	103540	193037	63192295
Infection	53.94	13.26	592	103098	228581	63156751
Band sensation	53.84	13.26	27	103663	846	63384486
Neutrophil count decreased	53.70	13.26	13	103677	56393	63328939
Inflammation	53.69	13.26	34	103656	82239	63303093
Sensory disturbance	53.67	13.26	87	103603	13585	63371747
Amnesia	53.65	13.26	206	103484	55379	63329953
Viral infection	53.05	13.26	153	103537	35510	63349822
Hypoxia	52.74	13.26	16	103674	59776	63325556
Unevaluable event	52.68	13.26	10	103680	51376	63333956
Lung adenocarcinoma	52.32	13.26	50	103640	4547	63380785
Papillary thyroid cancer	52.04	13.26	37	103653	2219	63383113
Liver injury	51.95	13.26	17	103673	60503	63324829
Dysstasia	51.93	13.26	110	103580	21056	63364276
Pharyngitis streptococcal	51.90	13.26	75	103615	10597	63374735
Hypotension	51.71	13.26	249	103441	272355	63112977
Migraine	51.69	13.26	317	103373	103029	63282303
Invasive lobular breast carcinoma	50.31	13.26	26	103664	869	63384463
Head injury	50.27	13.26	127	103563	27269	63358063
Fibromyalgia	50.10	13.26	35	103655	80385	63304947
Medication error	49.87	13.26	12	103678	52272	63333060
Escherichia urinary tract infection	49.54	13.26	78	103612	11884	63373448
Appendicitis perforated	49.25	13.26	33	103657	1797	63383535
Partial seizures	49.15	13.26	54	103636	5788	63379544
Clostridial infection	48.53	13.26	47	103643	4345	63380987
Central nervous system lymphoma	47.57	13.26	30	103660	1472	63383860
Meningioma	47.56	13.26	44	103646	3841	63381491
Dry mouth	47.05	13.26	35	103655	77828	63307504
Upper limb fracture	47.02	13.26	99	103591	18869	63366463
Blood pressure systolic increased	46.97	13.26	10	103680	47387	63337945
Primary progressive multiple sclerosis	46.67	13.26	14	103676	100	63385232
Adenocarcinoma of colon	46.40	13.26	36	103654	2468	63382864
Neurological symptom	46.15	13.26	52	103638	5731	63379601
Frustration tolerance decreased	46.10	13.26	57	103633	6931	63378401
Oedema	45.95	13.26	55	103635	97567	63287765
Foetal exposure timing unspecified	45.53	13.26	17	103673	253	63385079
Hypertension	45.26	13.26	269	103421	279034	63106298
Meningitis herpes	44.96	13.26	16	103674	206	63385126
Lactic acidosis	44.92	13.26	5	103685	38282	63347050
Tremor	44.74	13.26	369	103321	131870	63253462
Gastroenteritis viral	44.67	13.26	111	103579	23589	63361743
Pain	44.58	13.26	898	102792	739730	62645602
Antibody test positive	43.92	13.26	36	103654	2671	63382661
Drug reaction with eosinophilia and systemic symptoms	43.53	13.26	3	103687	33833	63351499
Basal cell carcinoma	43.50	13.26	122	103568	27869	63357463
Chronic lymphocytic leukaemia	42.91	13.26	35	103655	2579	63382753
Hemianaesthesia	42.56	13.26	18	103672	377	63384955
Hypoglycaemia	41.76	13.26	23	103667	60042	63325290
International normalised ratio increased	41.72	13.26	12	103678	46413	63338919
Abortion missed	41.53	13.26	29	103661	1690	63383642
Ovarian cancer	41.45	13.26	50	103640	5926	63379406
Productive cough	41.41	13.26	26	103664	63182	63322150
Epistaxis	41.04	13.26	35	103655	72690	63312642
Endometriosis	41.04	13.26	47	103643	5273	63380059
Ophthalmic herpes zoster	41.04	13.26	31	103659	2042	63383290
Bladder dysfunction	40.93	13.26	23	103667	911	63384421
Agraphia	40.63	13.26	10	103680	29	63385303
Bipolar disorder	40.26	13.26	57	103633	7903	63377429
Urticaria	40.23	13.26	431	103259	165371	63219961
Rhabdomyolysis	40.17	13.26	11	103679	43940	63341392
Breast cancer in situ	40.12	13.26	27	103663	1481	63383851
Abdominal pain upper	40.04	13.26	187	103503	206257	63179075
Influenza like illness	39.97	13.26	215	103475	66609	63318723
Metabolic acidosis	39.86	13.26	12	103678	45057	63340275
Relapsing multiple sclerosis	39.50	13.26	14	103676	178	63385154
Sleep disorder	39.41	13.26	45	103645	81521	63303811
Dysarthria	39.35	13.26	156	103534	42555	63342777
Cardio-respiratory arrest	38.82	13.26	25	103665	59934	63325398
Paraparesis	38.81	13.26	31	103659	2217	63383115
Malignant melanoma in situ	38.29	13.26	22	103668	910	63384422
Hyperhidrosis	38.00	13.26	74	103616	107762	63277570
Uhthoff's phenomenon	37.93	13.26	7	103683	0	63385332
Dry skin	37.82	13.26	23	103667	56864	63328468
Meningoencephalitis herpetic	37.65	13.26	24	103666	1200	63384132
Motor dysfunction	37.60	13.26	65	103625	10696	63374636
Fibula fracture	37.45	13.26	37	103653	3505	63381827
Interstitial lung disease	37.18	13.26	28	103662	61880	63323452
Injury	36.95	13.26	39	103651	73208	63312124
Vaginal infection	36.80	13.26	53	103637	7465	63377867
Nasal congestion	36.57	13.26	32	103658	65628	63319704
Prescribed overdose	36.41	13.26	6	103684	34147	63351185
Blindness	36.13	13.26	97	103593	21602	63363730
Post procedural infection	36.06	13.26	59	103631	9283	63376049
Expanded disability status scale score increased	35.49	13.26	18	103672	578	63384754
Tachycardia	35.15	13.26	89	103601	118067	63267265
Blindness unilateral	35.04	13.26	47	103643	6194	63379138
Colon cancer	34.95	13.26	60	103630	9818	63375514
Female reproductive tract disorder	34.72	13.26	16	103674	414	63384918
Foetal malposition	34.69	13.26	10	103680	61	63385271
Urinary tract infection pseudomonal	34.68	13.26	20	103670	833	63384499
Myelitis	34.67	13.26	24	103666	1379	63383953
Cellulitis	34.63	13.26	241	103449	81717	63303615
Somnolence	34.56	13.26	162	103528	178523	63206809
Type 2 diabetes mellitus	34.52	13.26	32	103658	63836	63321496
Gastrooesophageal reflux disease	34.25	13.26	65	103625	95574	63289758
Foot fracture	34.04	13.26	101	103589	23813	63361519
Paraesthesia	33.97	13.26	399	103291	156567	63228765
Therapy interrupted	33.94	13.26	6	103684	32449	63352883
Gastrointestinal haemorrhage	33.85	13.26	50	103640	81126	63304206
Skin exfoliation	33.80	13.26	14	103676	43088	63342244
Hypokalaemia	33.41	13.26	75	103615	103729	63281603
Herpes zoster meningitis	33.39	13.26	10	103680	71	63385261
Autoimmune hepatitis	33.20	13.26	54	103636	8456	63376876
Herpes simplex meningitis	33.05	13.26	9	103681	43	63385289
Cholecystectomy	32.83	13.26	61	103629	10616	63374716
Tibia fracture	32.55	13.26	41	103649	5079	63380253
Female genital operation	32.55	13.26	8	103682	23	63385309
Urostomy	32.16	13.26	7	103683	9	63385323
Inappropriate schedule of product administration	31.95	13.26	77	103613	103888	63281444
Meningitis viral	31.93	13.26	23	103667	1408	63383924
Therapeutic procedure	31.73	13.26	19	103671	849	63384483
Arthropod bite	31.63	13.26	51	103639	7927	63377405
Oedema peripheral	31.48	13.26	181	103509	189330	63196002
Incorrect route of product administration	31.18	13.26	4	103686	27448	63357884
Steroid therapy	31.10	13.26	11	103679	139	63385193
Melaena	30.93	13.26	6	103684	30359	63354973
Lymphocyte count increased	30.91	13.26	33	103657	3425	63381907
Pneumonia aspiration	30.89	13.26	125	103565	34415	63350917
Ascites	30.71	13.26	14	103676	40714	63344618
Hepatic enzyme increased	30.61	13.26	199	103491	202129	63183203
Appendicitis	30.46	13.26	51	103639	8178	63377154
Back disorder	30.26	13.26	60	103630	10957	63374375
Post procedural complication	30.13	13.26	78	103612	16996	63368336
Vertigo	30.12	13.26	184	103506	59703	63325629
Major depression	30.09	13.26	50	103640	7968	63377364
Myalgia	30.04	13.26	130	103560	146399	63238933
Abdominal distension	30.03	13.26	60	103630	86555	63298777
Papilloma viral infection	30.03	13.26	23	103667	1547	63383785
Rectal haemorrhage	29.67	13.26	22	103668	49008	63336324
Headache	29.63	13.26	1290	102400	631951	62753381
Cholestasis	29.59	13.26	6	103684	29428	63355904
Pulmonary fibrosis	29.53	13.26	14	103676	39795	63345537
Flushing	29.52	13.26	217	103473	74870	63310462
Arrested labour	29.40	13.26	12	103678	229	63385103
Chronic kidney disease	29.29	13.26	19	103671	45379	63339953
Depressed level of consciousness	29.18	13.26	35	103655	62043	63323289
Blood creatine phosphokinase increased	28.99	13.26	7	103683	30423	63354909
Injection site haemorrhage	28.97	13.26	3	103687	24311	63361021
Delirium	28.91	13.26	24	103666	50517	63334815
Low birth weight baby	28.85	13.26	46	103644	7083	63378249
Red blood cell nucleated morphology present	28.78	13.26	7	103683	19	63385313
Neutralising antibodies	28.76	13.26	8	103682	42	63385290
Blindness transient	28.75	13.26	33	103657	3711	63381621
Serotonin syndrome	28.52	13.26	6	103684	28676	63356656
Drug ineffective for unapproved indication	28.48	13.26	10	103680	34053	63351279
Blood pressure increased	28.44	13.26	152	103538	161910	63223422
Impaired healing	28.41	13.26	80	103610	102462	63282870
Sedation	28.25	13.26	14	103676	38795	63346537
Hypervolaemia	28.14	13.26	6	103684	28407	63356925
Incontinence	28.01	13.26	60	103630	11572	63373760
Cardiac failure congestive	27.97	13.26	69	103621	92364	63292968
Herpes simplex encephalitis	27.87	13.26	13	103677	346	63384986
Mammoplasty	27.85	13.26	15	103675	546	63384786
Bursitis	27.52	13.26	13	103677	37028	63348304
Human papilloma virus test positive	27.50	13.26	15	103675	560	63384772
Sepsis	27.49	13.26	376	103314	152747	63232585
Stevens-Johnson syndrome	27.47	13.26	4	103686	24946	63360386
Endometrial cancer	27.46	13.26	30	103660	3195	63382137
Bone marrow failure	27.39	13.26	7	103683	29283	63356049
Blood urea increased	27.32	13.26	5	103685	26374	63358958
Frequent bowel movements	27.02	13.26	3	103687	23019	63362313
Fibroadenoma of breast	27.00	13.26	14	103676	471	63384861
Depression suicidal	27.00	13.26	23	103667	1800	63383532
Plasmablastic lymphoma	26.95	13.26	11	103679	210	63385122
Colon cancer metastatic	26.83	13.26	19	103671	1132	63384200
Accidental exposure to product	26.71	13.26	6	103684	27399	63357933
Progressive relapsing multiple sclerosis	26.52	13.26	7	103683	29	63385303
Tenderness	26.35	13.26	3	103687	22575	63362757
Pneumonia	26.34	13.26	952	102738	455815	62929517
Pineal gland cyst	26.28	13.26	6	103684	11	63385321
Oral pain	26.15	13.26	7	103683	28387	63356945
Anal incontinence	26.02	13.26	64	103626	13512	63371820
Fluid retention	25.64	13.26	36	103654	59650	63325682
Pruritus allergic	25.59	13.26	21	103669	1561	63383771
Fatigue	25.59	13.26	1729	101961	886299	62499033
Hypocalcaemia	25.36	13.26	10	103680	31703	63353629
Myelitis transverse	25.29	13.26	19	103671	1241	63384091
Osteoarthritis	25.23	13.26	76	103614	95267	63290065
JC polyomavirus test	25.13	13.26	7	103683	37	63385295
Dry eye	25.04	13.26	18	103672	40743	63344589
Night sweats	24.61	13.26	26	103664	48788	63336544
Plasma cell myeloma	24.60	13.26	14	103676	35891	63349441
Macular degeneration	24.44	13.26	5	103685	24371	63360961
Malignant melanoma stage I	24.38	13.26	7	103683	42	63385290
Generalised tonic-clonic seizure	24.37	13.26	103	103587	28913	63356419
Renal failure	24.34	13.26	104	103586	117548	63267784
Bradycardia	24.31	13.26	52	103638	73175	63312157
Hypercalcaemia	24.23	13.26	8	103682	28314	63357018
Drug level increased	24.23	13.26	4	103686	22732	63362600
Blood pressure diastolic decreased	24.18	13.26	4	103686	22702	63362630
Pulmonary arterial hypertension	23.99	13.26	4	103686	22573	63362759
Mouth ulceration	23.86	13.26	12	103678	32972	63352360
Infectious mononucleosis	23.81	13.26	22	103668	1917	63383415
Joint stiffness	23.81	13.26	20	103670	41849	63343483
Muscle tightness	23.77	13.26	57	103633	11843	63373489
Palpitations	23.75	13.26	99	103591	112671	63272661
Product administration error	23.73	13.26	4	103686	22393	63362939
Postoperative wound infection	23.65	13.26	54	103636	10871	63374461
Ejection fraction decreased	23.64	13.26	4	103686	22328	63363004
Grip strength decreased	23.57	13.26	4	103686	22283	63363049
Bladder catheterisation	23.41	13.26	11	103679	298	63385034
Pyelonephritis	23.35	13.26	73	103617	17705	63367627
Neuralgia	23.32	13.26	94	103596	25832	63359500
Knee operation	23.24	13.26	38	103652	5975	63379357
CD4 lymphocytes decreased	23.20	13.26	19	103671	1408	63383924
Flatulence	23.11	13.26	14	103676	34688	63350644
Hypomagnesaemia	23.08	13.26	9	103681	28728	63356604
Circulatory collapse	23.06	13.26	4	103686	21934	63363398
Dysphemia	22.98	13.26	25	103665	2650	63382682
Musculoskeletal stiffness	22.92	13.26	192	103498	184426	63200906
Precancerous cells present	22.74	13.26	19	103671	1448	63383884
Catheter placement	22.57	13.26	23	103667	2261	63383071
Ventricular tachycardia	22.47	13.26	3	103687	19976	63365356
Tubulointerstitial nephritis	22.36	13.26	3	103687	19900	63365432
Anembryonic gestation	22.31	13.26	13	103677	552	63384780
Rhinorrhoea	22.24	13.26	46	103644	65531	63319801
Lung cancer metastatic	21.97	13.26	24	103666	2556	63382776
Bile acid malabsorption	21.94	13.26	9	103681	174	63385158
Hyperemesis gravidarum	21.75	13.26	13	103677	579	63384753
Metastases to bone	21.73	13.26	4	103686	21015	63364317
Haemorrhagic adrenal infarction	21.65	13.26	6	103684	31	63385301
Conversion disorder	21.64	13.26	20	103670	1744	63383588
Perinatal stroke	21.62	13.26	5	103685	10	63385322
Paralysis	21.50	13.26	49	103641	9851	63375481
Concussion	21.48	13.26	47	103643	9197	63376135
Hyperglycaemia	21.44	13.26	22	103668	41845	63343487
Adenosquamous cell lung cancer stage IV	21.30	13.26	5	103685	11	63385321
Hepatocellular injury	21.30	13.26	9	103681	27372	63357960
Quadriplegia	21.29	13.26	20	103670	1780	63383552
Uterine cancer	21.19	13.26	32	103658	4701	63380631
Mammogram abnormal	21.15	13.26	14	103676	747	63384585
Panic attack	20.92	13.26	82	103608	22249	63363083
Foetal heart rate deceleration abnormality	20.87	13.26	12	103678	497	63384835
Rebound effect	20.84	13.26	31	103659	4495	63380837
Infusion site haematoma	20.81	13.26	10	103680	285	63385047
Drug ineffective	20.78	13.26	1449	102241	1043316	62342016
Gastroenteritis cryptosporidial	20.75	13.26	7	103683	76	63385256
Colour blindness acquired	20.66	13.26	7	103683	77	63385255
Impaired self-care	20.64	13.26	20	103670	1850	63383482
Immune system disorder	20.62	13.26	48	103642	9786	63375546
Disease recurrence	20.57	13.26	10	103680	28020	63357312
Diplegia	20.57	13.26	16	103674	1101	63384231
Asthma	20.55	13.26	123	103567	127438	63257894
Product administered to patient of inappropriate age	20.51	13.26	26	103664	3242	63382090
Drug resistance	20.47	13.26	6	103684	22927	63362405
Haematochezia	20.41	13.26	35	103655	53509	63331823
Neurogenic bowel	20.40	13.26	8	103682	137	63385195
Gastric banding	20.34	13.26	7	103683	81	63385251
Metastatic malignant melanoma	20.32	13.26	17	103673	1298	63384034
Micturition urgency	20.25	13.26	47	103643	9564	63375768
Paternal exposure before pregnancy	20.23	13.26	6	103684	41	63385291
Herpes virus infection	19.99	13.26	34	103656	5522	63379810
Medical device change	19.72	13.26	10	103680	321	63385011
Post-traumatic headache	19.71	13.26	5	103685	17	63385315
Sinusitis	19.68	13.26	497	103193	226156	63159176
Orthostatic hypotension	19.68	13.26	18	103672	36142	63349190
Cervical spinal stenosis	19.61	13.26	21	103669	2187	63383145
Overdose	19.59	13.26	109	103581	114969	63270363
Pulmonary hypertension	19.59	13.26	19	103671	37104	63348228
Status epilepticus	19.50	13.26	62	103628	15171	63370161
Tooth infection	19.45	13.26	69	103621	17851	63367481
Magnetic resonance imaging head abnormal	19.40	13.26	20	103670	1993	63383339
Demyelination	19.39	13.26	38	103652	6882	63378450
Device malfunction	19.34	13.26	3	103687	17854	63367478
Quadriparesis	19.27	13.26	20	103670	2009	63383323
Abortion	19.17	13.26	22	103668	2474	63382858
Animal bite	19.15	13.26	24	103666	2958	63382374
Wound sepsis	19.12	13.26	8	103682	163	63385169
Ligament sprain	19.12	13.26	55	103635	12745	63372587
Monoparesis	19.09	13.26	18	103672	1609	63383723
Corneal decompensation	19.09	13.26	6	103684	51	63385281
Autoimmune haemolytic anaemia	19.05	13.26	30	103660	4571	63380761
Joint range of motion decreased	19.05	13.26	15	103675	32413	63352919
Lung adenocarcinoma stage IV	19.03	13.26	8	103682	165	63385167
Pain in jaw	18.91	13.26	26	103664	43470	63341862
Insomnia	18.87	13.26	243	103447	215009	63170323
Ovarian cystectomy	18.72	13.26	8	103682	172	63385160
Erythema	18.69	13.26	190	103500	175561	63209771
Dysplastic naevus	18.60	13.26	8	103682	175	63385157
Face oedema	18.58	13.26	5	103685	20207	63365125
Haemoptysis	18.56	13.26	12	103678	28714	63356618
Calculus bladder	18.56	13.26	12	103678	615	63384717
Injection site mass	18.35	13.26	4	103686	18652	63366680
Lung neoplasm malignant	18.31	13.26	72	103618	19561	63365771
Breast cancer stage I	18.30	13.26	37	103653	6852	63378480
Hypercholesterolaemia	18.29	13.26	6	103684	21328	63364004
Cervix carcinoma stage III	18.22	13.26	6	103684	60	63385272
Foetal distress syndrome	18.04	13.26	16	103674	1322	63384010
Ligament rupture	18.00	13.26	25	103665	3405	63381927
Blood glucose increased	17.97	13.26	73	103617	83683	63301649
Incision site pain	17.95	13.26	15	103675	1143	63384189
Blood pressure fluctuation	17.91	13.26	30	103660	46287	63339045
Benign neoplasm	17.88	13.26	14	103676	973	63384359
Post procedural pneumonia	17.86	13.26	5	103685	27	63385305
Feeling abnormal	17.85	13.26	341	103349	148051	63237281
Appendicectomy	17.84	13.26	23	103667	2916	63382416
Necrotising retinitis	17.66	13.26	10	103680	402	63384930
Partial seizures with secondary generalisation	17.64	13.26	10	103680	403	63384929
Pneumonitis	17.48	13.26	19	103671	35203	63350129
Hepatic function abnormal	17.39	13.26	21	103669	37121	63348211
Dysgeusia	17.38	13.26	31	103659	46679	63338653
Blood lactate dehydrogenase increased	17.34	13.26	8	103682	23108	63362224
Cephalo-pelvic disproportion	17.32	13.26	8	103682	208	63385124
Cervicitis human papilloma virus	17.29	13.26	4	103686	8	63385324
Sputum discoloured	17.14	13.26	3	103687	16344	63368988
Endometrial adenocarcinoma	17.10	13.26	15	103675	1221	63384111
Infected skin ulcer	16.98	13.26	20	103670	2312	63383020
Adverse drug reaction	16.95	13.26	202	103488	79512	63305820
Status migrainosus	16.90	13.26	7	103683	139	63385193
Restlessness	16.83	13.26	14	103676	29439	63355893
Gastrointestinal viral infection	16.78	13.26	15	103675	1252	63384080
Squamous cell carcinoma of the cervix	16.78	13.26	9	103681	325	63385007
Feeling hot	16.74	13.26	140	103550	50214	63335118
Cardiac arrest	16.67	13.26	86	103604	92459	63292873
Latent tuberculosis	16.64	13.26	21	103669	2606	63382726
Product substitution issue	16.63	13.26	3	103687	15993	63369339
Incorrect drug administration rate	16.63	13.26	26	103664	3936	63381396
Cholecystitis infective	16.57	13.26	17	103673	1685	63383647
Haematuria	16.49	13.26	14	103676	29143	63356189
General physical health deterioration	16.33	13.26	231	103459	201171	63184161
Intracranial haemangioma	16.26	13.26	3	103687	0	63385332
Iron metabolism disorder	16.26	13.26	3	103687	0	63385332
Nutritional supplementation	16.26	13.26	3	103687	0	63385332
Gestational oedema	16.26	13.26	3	103687	0	63385332
Pruritus	16.17	13.26	458	103232	360995	63024337
Joint effusion	16.10	13.26	4	103686	17056	63368276
Inappropriate antidiuretic hormone secretion	15.86	13.26	3	103687	15459	63369873
Communication disorder	15.86	13.26	20	103670	2480	63382852
Emotional disorder	15.82	13.26	53	103637	13326	63372006
Goitre	15.82	13.26	32	103658	5929	63379403
Urinary retention	15.81	13.26	94	103596	30207	63355125
Pulmonary oedema	15.80	13.26	42	103648	54831	63330501
Respiratory tract infection	15.80	13.26	119	103571	41364	63343968
Visual acuity reduced	15.71	13.26	74	103616	21752	63363580
Metastatic squamous cell carcinoma	15.60	13.26	8	103682	263	63385069
Accident	15.55	13.26	32	103658	6000	63379332
Procedural complication	15.40	13.26	30	103660	5409	63379923
Proteinuria	15.37	13.26	6	103684	19139	63366193
Nervous system disorder	15.28	13.26	66	103624	18700	63366632
Imminent abortion	15.26	13.26	4	103686	16	63385316
Vulvar dysplasia	15.23	13.26	7	103683	180	63385152
Clumsiness	15.22	13.26	18	103672	2089	63383243
Adenomyosis	15.20	13.26	10	103680	528	63384804
Pertussis	15.18	13.26	11	103679	680	63384652
Rash erythematous	15.12	13.26	29	103661	42481	63342851
Transverse presentation	15.07	13.26	4	103686	17	63385315
Bladder repair	15.02	13.26	6	103684	108	63385224
Withdrawal syndrome	14.88	13.26	7	103683	19990	63365342
Tooth abscess	14.87	13.26	56	103634	14913	63370419
Multiple allergies	14.86	13.26	53	103637	13749	63371583
Bone pain	14.85	13.26	43	103647	54598	63330734
Drug tolerance decreased	14.83	13.26	5	103685	17468	63367864
Metabolic surgery	14.83	13.26	14	103676	1254	63384078
Paraplegia	14.81	13.26	20	103670	2652	63382680
Oral infection	14.80	13.26	28	103662	4940	63380392
Urinary tract disorder	14.78	13.26	21	103669	2920	63382412
Brain neoplasm	14.77	13.26	26	103664	4340	63380992
Synovial sarcoma	14.76	13.26	5	103685	55	63385277
Medical device removal	14.74	13.26	14	103676	1263	63384069
Uterine cyst	14.74	13.26	9	103681	417	63384915
Brain stem syndrome	14.66	13.26	9	103681	421	63384911
Postoperative abscess	14.56	13.26	9	103681	426	63384906
Astrocytoma malignant	14.54	13.26	4	103686	20	63385312
Cholelithiasis	14.53	13.26	122	103568	43803	63341529
Ovarian neoplasm	14.52	13.26	12	103678	901	63384431
Haemorrhage	14.51	13.26	51	103639	60971	63324361
H1N1 influenza	14.50	13.26	16	103674	1723	63383609
Eye irritation	14.44	13.26	9	103681	21962	63363370
Cellulitis staphylococcal	14.40	13.26	11	103679	737	63384595
Thermal burn	14.34	13.26	31	103659	6015	63379317
Premature delivery	14.31	13.26	17	103673	30264	63355068
Red blood cell count decreased	14.22	13.26	28	103662	40617	63344715
Vestibular neuronitis	14.19	13.26	10	103680	591	63384741
Nucleated red cells	14.18	13.26	3	103687	3	63385329
Post procedural sepsis	14.18	13.26	7	103683	212	63385120
Leukaemia	14.16	13.26	25	103665	4183	63381149
Gastrointestinal lymphoma	14.15	13.26	5	103685	63	63385269
Bladder spasm	14.14	13.26	16	103674	1772	63383560
Angina pectoris	14.09	13.26	17	103673	30061	63355271
Ovarian mass	14.08	13.26	11	103679	762	63384570
Cervical incompetence	13.96	13.26	10	103680	607	63384725
Breast cyst	13.90	13.26	16	103674	1805	63383527
Lip dry	13.90	13.26	4	103686	15466	63369866
Vulvovaginal mycotic infection	13.74	13.26	29	103661	5537	63379795
Lumbar puncture	13.71	13.26	6	103684	137	63385195
Disseminated intravascular coagulation	13.68	13.26	7	103683	19044	63366288
Foetal heart rate abnormal	13.67	13.26	10	103680	627	63384705
Spondylitic myelopathy	13.66	13.26	4	103686	26	63385306
Premature separation of placenta	13.62	13.26	16	103674	1845	63383487
Shock	13.60	13.26	11	103679	23452	63361880
Tumefactive multiple sclerosis	13.54	13.26	5	103685	72	63385260
Drowning	13.53	13.26	9	103681	484	63384848
Agitation	13.51	13.26	51	103639	59706	63325626
Cervix carcinoma stage 0	13.41	13.26	8	103682	355	63384977
Cardiomegaly	13.37	13.26	6	103684	17608	63367724
Underweight	13.36	13.26	12	103678	1008	63384324
Hip arthroplasty	13.32	13.26	37	103653	47609	63337723
Sinus tachycardia	13.30	13.26	12	103678	24256	63361076
Skin discolouration	13.28	13.26	26	103664	37802	63347530

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
Multiple sclerosis relapse	4680	16.19	1254	29033	11879	34914765
Progressive multifocal leukoencephalopathy	1902.97	16.19	584	29703	9180	34917464
Immune reconstitution inflammatory syndrome	962.19	16.19	340	29947	8419	34918225
Urinary tract infection	746.86	16.19	602	29685	83479	34843165
General symptom	679.87	16.19	157	30130	727	34925917
Opportunistic infection	443.91	16.19	127	30160	1531	34925113
Prescribed underdose	357.20	16.19	168	30119	8765	34917879
Drug specific antibody present	347.10	16.19	124	30163	3161	34923483
Malaise	329.86	16.19	582	29705	185243	34741401
Gait disturbance	329.86	16.19	387	29900	84753	34841891
Balance disorder	246.89	16.19	235	30052	40419	34886225
Cognitive disorder	242.38	16.19	200	30087	28493	34898151
Secondary progressive multiple sclerosis	240.39	16.19	58	30229	335	34926309
Magnetic resonance imaging abnormal	239.20	16.19	79	30208	1577	34925067
Fall	238.40	16.19	535	29752	202350	34724294
Memory impairment	232.43	16.19	234	30053	43084	34883560
Muscle spasticity	226.96	16.19	108	30179	5780	34920864
JC polyomavirus test positive	202.86	16.19	57	30230	640	34926004
Muscular weakness	202.40	16.19	281	30006	72616	34854028
Mobility decreased	197.94	16.19	182	30105	29946	34896698
Loss of control of legs	160.28	16.19	48	30239	685	34925959
Drug interaction	159.62	16.19	9	30278	225937	34700707
Gait inability	157.36	16.19	136	30151	20622	34906022
Off label use	154.80	16.19	86	30201	419438	34507206
Central nervous system lesion	154.63	16.19	86	30201	6377	34920267
Seizure	147.55	16.19	298	29989	104559	34822085
Poor venous access	143.56	16.19	76	30211	5107	34921537
Herpes zoster	138.97	16.19	160	30127	34239	34892405
Neoplasm malignant	134.11	16.19	122	30165	19783	34906861
Decubitus ulcer	131.45	16.19	87	30200	8834	34917810
Urosepsis	126.76	16.19	98	30189	12701	34913943
Hypersensitivity	126.03	16.19	205	30082	60830	34865814
Asthenia	116.70	16.19	470	29817	244781	34681863
Surgery	115.97	16.19	97	30190	14060	34912584
Acute kidney injury	113.04	16.19	62	30225	304926	34621718
Toxicity to various agents	112.96	16.19	19	30268	200343	34726301
Musculoskeletal disorder	112.55	16.19	69	30218	6135	34920509
Cystitis	108.28	16.19	80	30207	9685	34916959
Febrile neutropenia	104.76	16.19	3	30284	136846	34789798
Influenza	104.11	16.19	168	30119	49498	34877146
Neutropenia	102.67	16.19	9	30278	156769	34769875
Road traffic accident	102.27	16.19	99	30188	17351	34909293
Multiple sclerosis	95.95	16.19	64	30223	6581	34920063
Diarrhoea	94.41	16.19	120	30167	389792	34536852
Hypoaesthesia	92.78	16.19	180	30107	61264	34865380
Progressive multiple sclerosis	92.31	16.19	25	30262	242	34926402
Neurogenic bladder	91.09	16.19	40	30247	1773	34924871
Drug delivery device placement	88.43	16.19	21	30266	112	34926532
Anaemia	82.70	16.19	50	30237	233285	34693359
Primary progressive multiple sclerosis	79.62	16.19	16	30271	31	34926613
Nasopharyngitis	78.95	16.19	182	30105	69786	34856858
Product use in unapproved indication	71.11	16.19	9	30278	117490	34809154
Visual impairment	70.80	16.19	118	30169	35684	34890960
Coordination abnormal	70.21	16.19	56	30231	7588	34919056
Renal impairment	69.07	16.19	3	30284	94510	34832134
Lower limb fracture	67.51	16.19	43	30244	4088	34922556
Decreased appetite	67.29	16.19	30	30257	166362	34760282
Blood creatinine increased	66.29	16.19	4	30283	94972	34831672
Optic neuritis	65.46	16.19	40	30247	3534	34923110
Dyspnoea	64.32	16.19	145	30142	376637	34550007
Condition aggravated	64.21	16.19	44	30243	192152	34734492
Infection	63.51	16.19	198	30089	90717	34835927
Neuromyelitis optica spectrum disorder	62.70	16.19	16	30271	120	34926524
Drug ineffective	61.50	16.19	634	29653	456117	34470527
Depression	60.18	16.19	203	30084	96895	34829749
Thrombocytopenia	55.97	16.19	33	30254	156214	34770430
Cellulitis	54.57	16.19	133	30154	52818	34873826
Pancytopenia	53.60	16.19	9	30278	95148	34831496
Hyponatraemia	53.41	16.19	5	30282	82686	34843958
Haemoglobin decreased	51.66	16.19	20	30267	120752	34805892
Death	50.87	16.19	547	29740	397502	34529142
Urinary tract infection pseudomonal	50.01	16.19	22	30265	979	34925665
Disease progression	49.47	16.19	16	30271	108061	34818583
Hypotension	48.67	16.19	73	30214	221576	34705068
Drug abuse	48.41	16.19	13	30274	99083	34827561
Nausea	47.13	16.19	145	30142	339763	34586881
Agraphia	45.29	16.19	9	30278	16	34926628
Nephrolithiasis	44.69	16.19	88	30199	30245	34896399
Trigeminal neuralgia	42.69	16.19	21	30266	1208	34925436
Infusion site extravasation	42.42	16.19	33	30254	4311	34922333
Hip fracture	42.39	16.19	52	30235	11873	34914771
Nutritional supplementation	42.37	16.19	7	30280	0	34926644
Somnolence	41.89	16.19	22	30265	111094	34815550
Platelet count decreased	41.85	16.19	26	30261	119691	34806953
Rhabdomyolysis	41.76	16.19	5	30282	68158	34858486
Cardiac failure	40.89	16.19	14	30273	91234	34835410
Hyperkalaemia	40.34	16.19	6	30281	69383	34857261
JC virus granule cell neuronopathy	39.87	16.19	7	30280	3	34926641
Muscle spasms	39.75	16.19	149	30138	74852	34851792
Intervertebral disc protrusion	39.65	16.19	46	30241	9910	34916734
Gastrointestinal haemorrhage	38.92	16.19	14	30273	88463	34838181
Abdominal pain	38.76	16.19	51	30236	163567	34763077
Weight increased	37.21	16.19	17	30270	93016	34833628
Neutralising antibodies positive	37.19	16.19	10	30277	94	34926550
Influenza like illness	36.94	16.19	77	30210	27557	34899087
Foetal exposure timing unspecified	36.93	16.19	12	30275	227	34926417
Herpes zoster necrotising retinopathy	36.31	16.19	6	30281	0	34926644
Marburg's variant multiple sclerosis	36.31	16.19	6	30281	0	34926644
White blood cell count decreased	35.82	16.19	19	30268	95426	34831218
Epistaxis	33.94	16.19	5	30282	58246	34868398
Malignant melanoma	33.26	16.19	38	30249	8052	34918592
Mental disorder	32.59	16.19	52	30235	15157	34911487
Motor dysfunction	32.54	16.19	35	30252	6939	34919705
Staphylococcal infection	31.33	16.19	80	30207	32680	34893964
Epilepsy	31.22	16.19	62	30225	21433	34905211
Pleural effusion	30.94	16.19	16	30271	81530	34845114
No adverse event	30.77	16.19	64	30223	22863	34903781
Neutrophil count decreased	30.69	16.19	4	30283	51100	34875544
Renal failure	30.59	16.19	41	30246	130516	34796128
Chronic lymphocytic leukaemia	30.58	16.19	27	30260	4205	34922439
Escherichia urinary tract infection	30.49	16.19	25	30262	3521	34923123
Pneumonia aspiration	29.90	16.19	92	30195	41811	34884833
Tumefactive multiple sclerosis	29.69	16.19	7	30280	36	34926608
Peroneal nerve palsy	29.68	16.19	23	30264	2988	34923656
Product use issue	29.55	16.19	9	30278	63207	34863437
Adverse reaction	29.54	16.19	23	30264	3008	34923636
Leukopenia	29.29	16.19	9	30278	62847	34863797
Neuropathy peripheral	29.20	16.19	18	30269	83245	34843399
International normalised ratio increased	27.72	16.19	4	30283	47323	34879321
Bipolar disorder	27.70	16.19	24	30263	3645	34922999
Multiple organ dysfunction syndrome	27.63	16.19	16	30271	76550	34850094
Drug hypersensitivity	27.43	16.19	18	30269	80511	34846133
Metabolic acidosis	27.26	16.19	3	30284	43677	34882967
Hemiparesis	27.24	16.19	49	30238	15729	34910915
Ascites	27.13	16.19	4	30283	46567	34880077
Stem cell transplant	27.08	16.19	19	30268	2120	34924524
Speech disorder	26.95	16.19	65	30222	25621	34901023
Infected skin ulcer	26.88	16.19	17	30270	1596	34925048
C-reactive protein increased	26.59	16.19	7	30280	54091	34872553
Cardiac failure congestive	26.53	16.19	20	30267	83250	34843394
Decreased immune responsiveness	26.39	16.19	17	30270	1647	34924997
Testis cancer	26.19	16.19	16	30271	1413	34925231
Meningitis herpes	25.89	16.19	5	30282	7	34926637
Urinary incontinence	25.70	16.19	53	30234	18821	34907823
Relapsing-remitting multiple sclerosis	25.18	16.19	14	30273	1036	34925608
Antibody test positive	25.14	16.19	12	30275	646	34925998
Glioblastoma	25.07	16.19	14	30273	1045	34925599
Haematochezia	24.90	16.19	5	30282	46529	34880115
CD8 lymphocytes decreased	24.87	16.19	7	30280	79	34926565
HIV test positive	24.49	16.19	8	30279	154	34926490
Paraparesis	24.43	16.19	17	30270	1872	34924772
Appendicitis perforated	24.28	16.19	17	30270	1891	34924753
Intentional product misuse	24.20	16.19	5	30282	45606	34881038
Upper respiratory tract infection	23.97	16.19	73	30214	32986	34893658
Hemianaesthesia	23.63	16.19	7	30280	96	34926548
Tremor	23.61	16.19	137	30150	82450	34844194
Amnesia	23.48	16.19	63	30224	26500	34900144
Hypoglycaemia	23.42	16.19	9	30278	54631	34872013
Vision blurred	23.25	16.19	90	30197	45873	34880771
Chronic kidney disease	22.97	16.19	4	30283	41206	34885438
Prostate cancer	22.87	16.19	81	30206	39568	34887076
Central nervous system lymphoma	22.74	16.19	13	30274	1015	34925629
Intentional overdose	22.74	16.19	5	30282	43669	34882975
Peripheral swelling	22.38	16.19	20	30267	76521	34850123
Aphasia	22.20	16.19	54	30233	21400	34905244
Mental impairment	21.71	16.19	35	30252	10287	34916357
Dysgraphia	21.53	16.19	17	30270	2270	34924374
Plasma cell myeloma	21.51	16.19	5	30282	42032	34884612
Ophthalmic herpes zoster	21.49	16.19	12	30275	896	34925748
Gallbladder operation	21.34	16.19	10	30277	516	34926128
Intervertebral disc operation	20.91	16.19	8	30279	248	34926396
Sinusitis	20.88	16.19	81	30206	41321	34885323
Cardio-respiratory arrest	20.73	16.19	11	30276	55262	34871382
Agitation	20.69	16.19	12	30275	57387	34869257
Small for dates baby	20.63	16.19	21	30266	3906	34922738
Bladder catheterisation	20.56	16.19	10	30277	561	34926083
Uhthoff's phenomenon	20.55	16.19	4	30283	6	34926638
Tachycardia	20.48	16.19	26	30261	84746	34841898
Oedema peripheral	20.42	16.19	46	30241	119766	34806878
Headache	20.28	16.19	264	30023	200371	34726273
Lactic acidosis	20.22	16.19	3	30284	34769	34891875
Abdominal distension	20.01	16.19	13	30274	58479	34868165
Stomatitis	19.96	16.19	6	30281	42508	34884136
Dysstasia	19.95	16.19	37	30250	12158	34914486
Kidney infection	19.95	16.19	24	30263	5370	34921274
Constipation	19.94	16.19	57	30230	136925	34789719
Bladder disorder	19.83	16.19	19	30268	3285	34923359
Bradycardia	19.43	16.19	22	30265	75396	34851248
Osteomyelitis	19.31	16.19	43	30244	16093	34910551
Temperature intolerance	19.26	16.19	19	30268	3403	34923241
Hypoxia	19.19	16.19	12	30275	55083	34871561
Therapeutic product effect incomplete	19.04	16.19	10	30277	50531	34876113
Overdose	18.97	16.19	31	30256	91028	34835616
Ataxia	18.97	16.19	39	30248	13814	34912830
B-cell lymphoma	18.80	16.19	21	30266	4342	34922302
Herpes simplex encephalitis	18.71	16.19	8	30279	332	34926312
CD4 lymphocytes decreased	18.70	16.19	14	30273	1727	34924917
Vomiting	18.54	16.19	132	30155	247489	34679155
Arthropod bite	18.48	16.19	17	30270	2792	34923852
Joint swelling	18.30	16.19	15	30272	59875	34866769
Urticaria	18.16	16.19	104	30183	62273	34864371
Drug rehabilitation	18.16	16.19	3	30284	0	34926644
Wernicke-Korsakoff syndrome	18.16	16.19	3	30284	0	34926644
JC polyomavirus test	18.16	16.19	3	30284	0	34926644
Laryngeal cancer stage 0	18.16	16.19	3	30284	0	34926644
Spinal operation	17.80	16.19	17	30270	2927	34923717
Basal cell carcinoma	17.76	16.19	47	30240	19611	34907033
Urinary tract disorder	17.71	16.19	15	30272	2209	34924435
Ill-defined disorder	17.70	16.19	38	30249	13871	34912773
Dry skin	17.51	16.19	3	30284	31284	34895360
Lyme disease	17.47	16.19	11	30276	1024	34925620
Back disorder	17.46	16.19	25	30262	6626	34920018
Thrombocytopenia neonatal	17.44	16.19	8	30279	393	34926251
Pneumonitis	17.39	16.19	4	30283	33874	34892770
Migraine	17.03	16.19	43	30244	17435	34909209
Head injury	17.00	16.19	44	30243	18116	34908528
Rheumatoid arthritis	16.89	16.19	6	30281	38232	34888412
Lumbar radiculopathy	16.89	16.19	10	30277	834	34925810
Blindness	16.89	16.19	39	30248	14947	34911697
Focal dyscognitive seizures	16.86	16.19	12	30275	1369	34925275
Blood creatine phosphokinase increased	16.71	16.19	9	30278	44848	34881796
Rectal haemorrhage	16.64	16.19	7	30280	40242	34886402
Concussion	16.55	16.19	15	30272	2418	34924226
Foetal exposure during pregnancy	16.41	16.19	71	30216	38030	34888614
Brain malformation	16.39	16.19	6	30281	164	34926480

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
Multiple sclerosis relapse	13130.97	12.93	3995	93427	42538	79604428
Progressive multifocal leukoencephalopathy	5094.06	12.93	1603	95819	18997	79627969
Immune reconstitution inflammatory syndrome	3229.05	12.93	1031	96391	12810	79634156
Urinary tract infection	1973.58	12.93	2029	95393	272483	79374483
General symptom	1432.45	12.93	376	97046	2158	79644808
Abortion spontaneous	1055.01	12.93	575	96847	28932	79618034
Drug specific antibody present	994.57	12.93	355	97067	6297	79640669
Prescribed underdose	929.15	12.93	529	96893	28985	79617981
Malaise	773.64	12.93	1787	95635	488082	79158884
Fall	742.78	12.93	1754	95668	485875	79161091
Poor venous access	616.40	12.93	342	97080	17807	79629159
Balance disorder	602.01	12.93	671	96751	98186	79548780
Gait disturbance	561.03	12.93	950	96472	206556	79440410
Seizure	522.98	12.93	874	96548	187960	79459006
Off label use	520.64	12.93	230	97192	906985	78739981
Magnetic resonance imaging abnormal	495.95	12.93	179	97243	3280	79643686
Maternal exposure during pregnancy	455.07	12.93	688	96734	135850	79511116
Secondary progressive multiple sclerosis	443.76	12.93	132	97290	1265	79645701
Central nervous system lesion	443.25	12.93	248	97174	13120	79633846
Herpes zoster	405.00	12.93	533	96889	92550	79554416
Loss of control of legs	399.42	12.93	132	97290	1833	79645133
Memory impairment	375.02	12.93	565	96857	111169	79535797
Muscle spasticity	372.06	12.93	264	97158	21211	79625755
Drug interaction	371.88	12.93	38	97384	415145	79231821
Toxicity to various agents	371.39	12.93	41	97381	421499	79225467
Breast cancer	356.74	12.93	310	97112	33471	79613495
Muscular weakness	338.80	12.93	661	96761	160068	79486898
Cognitive disorder	315.91	12.93	408	97014	69518	79577448
Caesarean section	298.91	12.93	188	97234	12347	79634619
JC polyomavirus test positive	291.45	12.93	99	97323	1503	79645463
Optic neuritis	289.71	12.93	167	97255	9353	79637613
Invasive ductal breast carcinoma	288.74	12.93	142	97280	5750	79641216
Decubitus ulcer	288.38	12.93	200	97222	15487	79631479
Hypersensitivity	275.15	12.93	823	96599	261416	79385550
Acute kidney injury	270.87	12.93	149	97273	519255	79127711
Diarrhoea	261.97	12.93	421	97001	880068	78766898
Drug delivery device placement	256.14	12.93	58	97364	154	79646812
Febrile neutropenia	253.49	12.93	6	97416	230993	79415973
Condition aggravated	242.63	12.93	157	97265	500967	79145999
Influenza	240.84	12.93	506	96916	129100	79517866
Neutropenia	233.97	12.93	36	97386	287674	79359292
Nasopharyngitis	232.34	12.93	760	96662	253121	79393845
Cystitis	229.30	12.93	302	97120	52430	79594536
Hypoaesthesia	228.33	12.93	604	96818	178748	79468218
Product use in unapproved indication	208.93	12.93	29	97393	250330	79396636
Musculoskeletal disorder	208.81	12.93	188	97234	21260	79625706
Urosepsis	207.77	12.93	206	97216	26289	79620677
Trigeminal neuralgia	204.20	12.93	96	97326	3513	79643453
Asthenia	196.40	12.93	1180	96242	510509	79136457
Gait inability	196.20	12.93	297	97125	58620	79588346
Surgery	188.29	12.93	216	97206	32550	79614416
Opportunistic infection	187.29	12.93	85	97337	2865	79644101
Neurogenic bladder	187.18	12.93	95	97327	4117	79642849
Road traffic accident	180.51	12.93	244	97178	43420	79603546
Product use issue	175.77	12.93	24	97398	209798	79437168
Neutralising antibodies positive	173.21	12.93	45	97377	246	79646720
Hysterectomy	172.35	12.93	103	97319	6169	79640797
Visual impairment	170.27	12.93	359	97063	91772	79555194
Joint swelling	169.86	12.93	70	97352	288576	79358390
Mobility decreased	163.12	12.93	419	97003	121756	79525210
Rheumatoid arthritis	162.94	12.93	29	97393	208441	79438525
Neuromyelitis optica spectrum disorder	160.99	12.93	57	97365	985	79645981
Decreased appetite	160.54	12.93	111	97311	342307	79304659
Contraindicated product administered	153.06	12.93	10	97412	157528	79489438
Progressive multiple sclerosis	152.35	12.93	57	97365	1160	79645806
Drug hypersensitivity	148.12	12.93	91	97331	298825	79348141
Hip fracture	147.56	12.93	185	97237	30576	79616390
Malignant melanoma	145.04	12.93	130	97292	14611	79632355
Ankle fracture	144.40	12.93	138	97284	16831	79630135
Multiple sclerosis	143.66	12.93	156	97266	22126	79624840
Decreased immune responsiveness	140.36	12.93	86	97336	5389	79641577
Peripheral swelling	137.91	12.93	79	97343	269538	79377428
Epilepsy	134.63	12.93	205	97217	40655	79606311
Dyspnoea	132.83	12.93	568	96854	856457	78790509
Intervertebral disc protrusion	131.15	12.93	153	97269	23468	79623498
Hemiparesis	131.13	12.93	183	97239	33550	79613416
Drug abuse	130.72	12.93	21	97401	162670	79484296
Drug intolerance	130.01	12.93	81	97341	264038	79382928
Thrombocytopenia	129.68	12.93	82	97340	265177	79381789
Cervical dysplasia	126.95	12.93	59	97363	2102	79644864
Depression	126.88	12.93	563	96859	216227	79430739
Pancytopenia	125.35	12.93	25	97397	165720	79481246
Renal impairment	123.16	12.93	22	97400	157761	79489205
Hyponatraemia	122.25	12.93	33	97389	177815	79469151
Peroneal nerve palsy	120.44	12.93	81	97341	5961	79641005
Blood creatinine increased	120.21	12.93	22	97400	155035	79491931
Lower limb fracture	120.03	12.93	145	97277	23070	79623896
Hyperkalaemia	118.20	12.93	5	97417	114393	79532573
Disease progression	118.02	12.93	39	97383	184323	79462643
Injection site pain	115.75	12.93	12	97410	129826	79517140
Intraductal proliferative breast lesion	113.08	12.93	57	97365	2434	79644532
Stress	112.45	12.93	279	97143	79333	79567633
Weight increased	112.31	12.93	104	97318	277282	79369684
Glossodynia	108.51	12.93	4	97418	103333	79543633
Nephrolithiasis	108.27	12.93	216	97206	53075	79593891
Therapeutic product effect incomplete	107.87	12.93	21	97401	141624	79505342
Pemphigus	107.62	12.93	3	97419	99579	79547387
Bronchitis	103.47	12.93	373	97049	130271	79516695
Stomatitis	103.21	12.93	26	97396	146731	79500235
Coordination abnormal	102.62	12.93	116	97306	17196	79629770
Platelet count decreased	102.46	12.93	55	97367	194609	79452357
Vein disorder	102.17	12.93	69	97353	5113	79641853
Uterine leiomyoma	101.97	12.93	75	97347	6368	79640598
Anaemia	101.46	12.93	248	97174	444767	79202199
Pregnancy	100.41	12.93	143	97279	26708	79620258
Haemoglobin decreased	98.83	12.93	76	97346	222043	79424923
C-reactive protein increased	98.53	12.93	19	97403	129008	79517958
Abdominal pain	97.80	12.93	206	97216	389363	79257603
Herpes zoster necrotising retinopathy	97.05	12.93	17	97405	0	79646966
Arthralgia	95.26	12.93	368	97054	571435	79075531
Cardiac failure	95.23	12.93	35	97387	154807	79492159
Muscle spasms	94.90	12.93	444	96978	174286	79472680
Upper respiratory tract infection	92.43	12.93	283	97139	90885	79556081
Electrocardiogram QT prolonged	90.01	12.93	5	97417	90381	79556585
Breech presentation	88.32	12.93	33	97389	669	79646297
Abdominal discomfort	88.03	12.93	106	97316	250621	79396345
Mental impairment	87.35	12.93	112	97310	18924	79628042
Staphylococcal infection	87.32	12.93	209	97213	58086	79588880
Prolonged labour	85.44	12.93	29	97393	439	79646527
Aphasia	85.02	12.93	181	97241	46551	79600415
Intentional product use issue	84.50	12.93	40	97382	152072	79494894
Hypotension	84.28	12.93	267	97155	440050	79206916
JC virus granule cell neuronopathy	84.26	12.93	22	97400	123	79646843
Escherichia urinary tract infection	82.57	12.93	93	97329	13732	79633234
Intentional product misuse	81.79	12.93	10	97412	95155	79551811
Treatment failure	81.51	12.93	54	97368	170432	79476534
Multiple organ dysfunction syndrome	81.33	12.93	23	97399	120223	79526743
Hospitalisation	80.75	12.93	10	97412	94226	79552740
Intentional overdose	80.06	12.93	16	97406	105944	79541022
Urinary incontinence	79.74	12.93	163	97259	40746	79606220
Rhabdomyolysis	79.13	12.93	15	97407	103116	79543850
Kidney infection	78.23	12.93	114	97308	21737	79625229
Migraine	78.12	12.93	260	97162	87233	79559733
Anaphylactic shock	78.08	12.93	150	97272	35846	79611120
Gallbladder operation	76.98	12.93	41	97381	1964	79645002
Infusion site extravasation	76.30	12.93	77	97345	10031	79636935
Leukopenia	75.69	12.93	24	97398	116489	79530477
Relapsing-remitting multiple sclerosis	75.59	12.93	37	97385	1482	79645484
Loss of personal independence in daily activities	74.42	12.93	17	97405	102563	79544403
Nausea	73.91	12.93	781	96641	956415	78690551
Cellulitis	73.65	12.93	296	97126	108764	79538202
Urticaria	73.23	12.93	431	96991	184770	79462196
Injection site erythema	72.97	12.93	6	97416	78191	79568775
Head injury	72.96	12.93	149	97273	37220	79609746
Alopecia	72.84	12.93	106	97316	231249	79415717
Urinary tract infection pseudomonal	72.53	12.93	38	97384	1760	79645206
Pericarditis	72.26	12.93	19	97403	104217	79542749
Headache	71.90	12.93	1159	96263	652613	78994353
Speech disorder	71.86	12.93	186	97236	54259	79592707
Gastrointestinal haemorrhage	71.68	12.93	46	97376	147673	79499293
Neutrophil count decreased	71.38	12.93	14	97408	93945	79553021
Dyspnoea exertional	70.46	12.93	11	97411	87062	79559904
Central venous catheterisation	70.17	12.93	46	97376	3243	79643723
Interstitial lung disease	70.00	12.93	25	97397	112575	79534391
White blood cell count decreased	69.98	12.93	76	97346	188212	79458754
Focal dyscognitive seizures	69.81	12.93	47	97375	3465	79643501
Bladder disorder	69.52	12.93	70	97352	9095	79637871
Pleural effusion	69.45	12.93	46	97376	145216	79501750
Systemic lupus erythematosus	68.61	12.93	31	97391	121118	79525848
Post lumbar puncture syndrome	68.13	12.93	28	97394	737	79646229
Vision blurred	66.45	12.93	281	97141	105617	79541349
Diplopia	66.00	12.93	134	97288	33332	79613634
Gastric bypass	65.67	12.93	32	97390	1269	79645697
Wrong technique in product usage process	65.39	12.93	7	97415	73868	79573098
Meningitis herpes	65.33	12.93	20	97402	213	79646753
Neuropathy peripheral	64.56	12.93	47	97375	141258	79505708
Epistaxis	64.00	12.93	28	97394	111487	79535479
Central nervous system lymphoma	63.95	12.93	38	97384	2251	79644715
Atrial fibrillation	63.94	12.93	89	97333	197797	79449169
Mental disorder	63.72	12.93	127	97295	31175	79615791
Incorrect dose administered	63.58	12.93	9	97413	76621	79570345
Gastroenteritis viral	63.36	12.93	111	97311	24720	79622246
Drug reaction with eosinophilia and systemic symptoms	62.61	12.93	4	97418	64240	79582726
Chronic lymphocytic leukaemia	62.43	12.93	50	97372	4816	79642150
Ascites	62.40	12.93	9	97413	75553	79571413
Ectopic pregnancy	62.33	12.93	34	97388	1709	79645257
Papillary thyroid cancer	62.18	12.93	39	97383	2547	79644419
International normalised ratio increased	61.54	12.93	14	97408	84707	79562259
Appendicitis perforated	61.01	12.93	42	97380	3211	79643755
Cholecystectomy	60.73	12.93	66	97356	9366	79637600
Hypoxia	60.72	12.93	25	97397	103218	79543748
Helicobacter infection	60.70	12.93	7	97415	69697	79577269
Oxygen saturation decreased	60.17	12.93	42	97380	129005	79517961
Breast cancer in situ	59.24	12.93	27	97395	919	79646047
Metabolic acidosis	59.22	12.93	14	97408	82515	79564451
Lower respiratory tract infection	59.01	12.93	43	97379	129177	79517789
Lactic acidosis	58.99	12.93	8	97414	70351	79576615
Upper limb fracture	58.97	12.93	90	97332	17877	79629089
Sinusitis	58.94	12.93	425	96997	195076	79451890
Influenza like illness	58.68	12.93	207	97215	71500	79575466
Swelling	57.39	12.93	111	97311	216600	79430366
Pharyngitis streptococcal	57.15	12.93	68	97354	10646	79636320
Uhthoff's phenomenon	57.09	12.93	10	97412	0	79646966
Arthropathy	56.87	12.93	80	97342	177031	79469935
Cervix carcinoma	56.76	12.93	35	97387	2218	79644748
Thyroid cancer	56.40	12.93	50	97372	5538	79641428
Rash maculo-papular	56.15	12.93	3	97419	56075	79590891
Melaena	55.91	12.93	5	97417	60885	79586081
Renal failure	55.81	12.93	100	97322	200868	79446098
Blister	55.55	12.93	39	97383	119437	79527529
Primary progressive multiple sclerosis	55.46	12.93	15	97407	98	79646868
Bipolar disorder	55.07	12.93	57	97365	7650	79639316
Tremor	54.93	12.93	376	97046	169707	79477259
Therapy non-responder	54.86	12.93	22	97400	92283	79554683
Partial seizures	54.65	12.93	61	97361	8917	79638049
Somnolence	54.52	12.93	133	97289	238848	79408118
Hypoglycaemia	54.47	12.93	28	97394	101566	79545400
Foot fracture	54.46	12.93	97	97325	21884	79625082
Dyspepsia	53.89	12.93	33	97389	108654	79538312
Completed suicide	53.57	12.93	140	97282	245627	79401339
Breast cancer female	53.48	12.93	68	97354	11393	79635573
Dysgraphia	52.95	12.93	42	97380	3990	79642976
Therapeutic response decreased	52.85	12.93	9	97413	66844	79580122
Meningioma	52.68	12.93	43	97379	4255	79642711
Rash	52.08	12.93	454	96968	577904	79069062
Infection	51.62	12.93	486	96936	241226	79405740
Lymphocytosis	51.41	12.93	44	97378	4649	79642317
Cough	51.25	12.93	252	97170	366537	79280429
Adverse reaction	51.15	12.93	60	97362	9254	79637712
Cardio-respiratory arrest	51.00	12.93	35	97387	108475	79538491
Medication error	50.54	12.93	11	97411	68631	79578335
Invasive lobular breast carcinoma	49.97	12.93	22	97400	689	79646277
Endometriosis	49.87	12.93	39	97383	3629	79643337
White blood cell count increased	49.13	12.93	201	97221	74432	79572534
Adenocarcinoma of colon	48.92	12.93	46	97376	5495	79641471
Tachycardia	48.87	12.93	89	97333	177679	79469287
Lung adenocarcinoma	48.85	12.93	54	97368	7810	79639156
Foetal malposition	48.78	12.93	10	97412	13	79646953
Tibia fracture	48.29	12.93	45	97377	5316	79641650
Flushing	47.66	12.93	224	97198	88044	79558922
Fatigue	47.10	12.93	1476	95946	928251	78718715
Exposure during pregnancy	47.03	12.93	33	97389	101099	79545867
Blood pressure systolic increased	46.82	12.93	12	97410	66974	79579992
No adverse event	45.96	12.93	124	97298	37068	79609898
Temperature intolerance	45.95	12.93	58	97364	9647	79637319
Vomiting	45.84	12.93	557	96865	665271	78981695
Wheezing	45.70	12.93	45	97377	116619	79530347
Amnesia	45.68	12.93	175	97247	62882	79584084
Inappropriate schedule of product administration	45.29	12.93	58	97364	133570	79513396
Sensory disturbance	44.59	12.93	72	97350	15005	79631961
Rectal haemorrhage	44.02	12.93	19	97403	76281	79570685
Bradycardia	43.74	12.93	61	97361	135496	79511470
Abdominal distension	43.67	12.93	49	97373	119601	79527365
Cardiac failure congestive	43.10	12.93	67	97355	142335	79504631
Abortion missed	43.06	12.93	24	97398	1259	79645707
Blood creatine phosphokinase increased	42.23	12.93	14	97408	66076	79580890
Productive cough	42.17	12.93	28	97394	88303	79558663
Viral infection	42.16	12.93	132	97290	42884	79604082
Dysstasia	42.10	12.93	100	97322	27646	79619320
Injection site reaction	41.95	12.93	8	97414	54777	79592189
Ophthalmic herpes zoster	41.92	12.93	31	97391	2653	79644313
Basal cell carcinoma	41.64	12.93	120	97302	37255	79609711
Fibula fracture	41.38	12.93	35	97387	3639	79643327
Ovarian cancer	41.30	12.93	36	97386	3898	79643068
Agranulocytosis	40.54	12.93	4	97418	45026	79601940
Clostridial infection	40.36	12.93	42	97380	5672	79641294
Haematochezia	40.23	12.93	29	97393	87616	79559350
Marburg's variant multiple sclerosis	39.96	12.93	7	97415	0	79646966
Pneumonia aspiration	39.92	12.93	175	97247	66792	79580174
Herpes simplex encephalitis	39.87	12.93	19	97403	717	79646249
Pyelonephritis	39.45	12.93	81	97341	20307	79626659
Psoriasis	39.37	12.93	31	97391	89556	79557410
Inflammation	39.28	12.93	34	97388	93719	79553247
Concussion	39.10	12.93	53	97369	9450	79637516
Red blood cell sedimentation rate increased	39.05	12.93	5	97417	45937	79601029
Relapsing multiple sclerosis	39.01	12.93	12	97410	130	79646836
Generalised tonic-clonic seizure	38.75	12.93	130	97292	43780	79603186
Injection site bruising	38.66	12.93	3	97419	40999	79605967
Weight decreased	38.39	12.93	265	97157	354933	79292033
Oedema	38.39	12.93	54	97368	119526	79527440
Oedema peripheral	38.37	12.93	168	97254	252120	79394846
Bone marrow failure	38.01	12.93	8	97414	51099	79595867
Dry mouth	38.00	12.93	31	97391	87988	79558978
Haemoptysis	37.33	12.93	11	97411	55988	79590978
JC polyomavirus test	36.74	12.93	9	97413	37	79646929
Antibody test positive	36.48	12.93	29	97393	2763	79644203
Constipation	36.40	12.93	200	97222	282850	79364116
Dry skin	36.06	12.93	19	97403	67976	79578990
Post procedural infection	35.92	12.93	56	97366	11328	79635638
Serotonin syndrome	35.73	12.93	6	97416	45021	79601945
General physical health deterioration	35.66	12.93	194	97228	275044	79371922
Blood urea increased	35.55	12.93	8	97414	48782	79598184
Myalgia	35.14	12.93	113	97309	185528	79461438
Unevaluable event	35.12	12.93	12	97410	55573	79591393
Folliculitis	34.92	12.93	12	97410	55368	79591598
Agraphia	34.83	12.93	9	97413	48	79646918
Appendicectomy	34.75	12.93	28	97394	2720	79644246
Skin exfoliation	34.64	12.93	12	97410	55088	79591878
Drug level increased	34.48	12.93	4	97418	39647	79607319
Drug ineffective for unapproved indication	34.27	12.93	10	97412	51228	79595738
Hemianaesthesia	34.21	12.93	15	97407	465	79646501
Fibromyalgia	34.09	12.93	18	97404	64322	79582644
Delirium	33.89	12.93	32	97390	84595	79562371
Pneumonitis	33.79	12.93	16	97406	60844	79586122
Ataxia	33.50	12.93	86	97336	24953	79622013
Meningitis viral	33.41	12.93	24	97398	1964	79645002
Pruritus allergic	33.39	12.93	21	97401	1378	79645588
Urostomy	33.36	12.93	7	97415	11	79646955
Female genital operation	32.99	12.93	7	97415	12	79646954
Hypocalcaemia	32.92	12.93	10	97412	49914	79597052
Chronic kidney disease	32.91	12.93	20	97402	66134	79580832
Overdose	32.90	12.93	115	97307	184091	79462875
Tubulointerstitial nephritis	32.89	12.93	4	97418	38231	79608735
Hypertension	32.84	12.93	253	97169	330739	79316227
Band sensation	32.78	12.93	17	97405	771	79646195
Motor dysfunction	32.69	12.93	62	97360	14671	79632295
Paraparesis	32.49	12.93	31	97391	3772	79643194
Ventricular tachycardia	32.37	12.93	6	97416	41929	79605037
Agitation	32.04	12.93	45	97377	99670	79547296
Incorrect route of product administration	31.72	12.93	3	97419	34926	79612040
Osteonecrosis of jaw	31.67	12.93	7	97415	43219	79603747
Cholestasis	31.65	12.93	12	97410	52097	79594869
Hypokalaemia	31.40	12.93	82	97340	143958	79503008
Plasma cell myeloma	31.14	12.93	13	97409	53246	79593720
Meningoencephalitis herpetic	31.13	12.93	23	97399	1966	79645000
Hypervolaemia	31.11	12.93	7	97415	42683	79604283
Hyperhidrosis	30.96	12.93	89	97333	151403	79495563
Vaginal infection	30.84	12.93	37	97385	5843	79641123
B-cell lymphoma	30.79	12.93	38	97384	6177	79640789
Incontinence	30.68	12.93	59	97363	14105	79632861
Drug resistance	30.60	12.93	7	97415	42206	79604760
Adverse drug reaction	30.52	12.93	161	97261	66231	79580735
Immune system disorder	30.37	12.93	51	97371	10978	79635988
Cardiac arrest	30.36	12.93	108	97314	171988	79474978
Conversion disorder	30.21	12.93	22	97400	1839	79645127
Prescribed overdose	30.16	12.93	5	97417	37878	79609088
Arthropod bite	30.04	12.93	44	97378	8427	79638539
Haematuria	30.02	12.93	24	97398	68812	79578154
Hypomagnesaemia	29.86	12.93	10	97412	46901	79600065
Sedation	29.81	12.93	13	97409	51882	79595084
Liver injury	29.76	12.93	16	97406	56598	79590368
Sopor	29.54	12.93	3	97419	33007	79613959
Major depression	29.49	12.93	45	97377	8935	79638031
Vertigo	29.38	12.93	164	97258	68918	79578048
Arrested labour	29.36	12.93	10	97412	153	79646813
Tumefactive multiple sclerosis	29.14	12.93	9	97413	99	79646867
Malignant melanoma in situ	28.94	12.93	24	97398	2428	79644538
Hepatic function abnormal	28.85	12.93	28	97394	73079	79573887
Disease recurrence	28.79	12.93	9	97413	44100	79602866
Depressed level of consciousness	28.74	12.93	46	97376	96606	79550360
Blood cholesterol increased	28.71	12.93	36	97386	83684	79563282
Neutralising antibodies	28.53	12.93	7	97415	29	79646937
Bladder dysfunction	28.44	12.93	18	97404	1194	79645772
Nasal congestion	28.31	12.93	31	97391	76521	79570445
Sleep disorder	28.19	12.93	38	97384	85639	79561327
Glioblastoma	27.80	12.93	20	97402	1640	79645326
Obstructive airways disorder	27.79	12.93	3	97419	31456	79615510
Restlessness	27.75	12.93	11	97411	46481	79600485
Urinary tract infection staphylococcal	27.70	12.93	16	97406	899	79646067
Infected skin ulcer	27.69	12.93	27	97395	3374	79643592
Therapy interrupted	27.66	12.93	3	97419	31338	79615628
Bladder catheterisation	27.55	12.93	16	97406	908	79646058
Myelitis	27.39	12.93	23	97399	2368	79644598
Urinary tract disorder	27.32	12.93	28	97394	3714	79643252
Hepatocellular injury	27.22	12.93	12	97410	47581	79599385
Partial seizures with secondary generalisation	27.15	12.93	14	97408	627	79646339
Treatment noncompliance	27.14	12.93	15	97407	52253	79594713
Myelitis transverse	27.12	12.93	21	97401	1926	79645040
Animal bite	27.09	12.93	24	97398	2655	79644311
Anal incontinence	27.05	12.93	65	97357	18103	79628863
Depression suicidal	26.70	12.93	28	97394	3814	79643152
Mammoplasty	26.58	12.93	11	97411	295	79646671
Neurogenic bowel	26.57	12.93	10	97412	207	79646759
Hyperglycaemia	26.55	12.93	28	97394	70307	79576659
Proteinuria	26.53	12.93	4	97418	32498	79614468
Shock	26.50	12.93	10	97412	43538	79603428
Coagulopathy	26.04	12.93	6	97416	36000	79610966
Circulatory collapse	25.84	12.93	7	97415	37661	79609305
Muscle tightness	25.80	12.93	52	97370	12862	79634104
Status epilepticus	25.61	12.93	78	97344	24963	79622003
Irritable bowel syndrome	25.55	12.93	23	97399	62218	79584748
Discomfort	25.52	12.93	74	97348	125543	79521423
Umbilical cord around neck	25.25	12.93	6	97416	21	79646945
Orthostatic hypotension	25.23	12.93	19	97403	56145	79590821
Paraesthesia	24.97	12.93	327	97095	175996	79470970
Papilloma viral infection	24.80	12.93	19	97403	1715	79645251
Foetal heart rate deceleration abnormality	24.76	12.93	8	97414	103	79646863
Death	24.63	12.93	884	96538	565630	79081336
Intrathecal pump insertion	24.61	12.93	5	97417	6	79646960
Gastrooesophageal reflux disease	24.56	12.93	57	97365	104189	79542777
Postoperative wound infection	24.49	12.93	51	97371	12910	79634056
Pneumocystis jirovecii pneumonia	24.36	12.93	5	97417	32503	79614463
Feeling hot	24.21	12.93	140	97282	59594	79587372
Infectious mononucleosis	24.13	12.93	20	97402	2022	79644944
Medical device change	24.08	12.93	12	97410	500	79646466
Flatulence	24.08	12.93	11	97411	42713	79604253
Calculus bladder	24.06	12.93	17	97405	1355	79645611
Blood pressure diastolic decreased	24.03	12.93	4	97418	30212	79616754
Disseminated intravascular coagulation	23.96	12.93	7	97415	35835	79611131
Blood pressure fluctuation	23.95	12.93	28	97394	67117	79579849
Tachypnoea	23.88	12.93	5	97417	32058	79614908
Pulmonary fibrosis	23.88	12.93	12	97410	44100	79602866
Thermal burn	23.68	12.93	36	97386	7124	79639842
Steroid therapy	23.46	12.93	8	97414	123	79646843
Medical device removal	23.32	12.93	13	97409	682	79646284
Catheter placement	23.08	12.93	23	97399	2951	79644015
Colon cancer metastatic	22.98	12.93	20	97402	2161	79644805
Goitre	22.95	12.93	31	97391	5508	79641458
Bile acid malabsorption	22.91	12.93	9	97413	210	79646756
Colon cancer	22.75	12.93	53	97369	14470	79632496
Adenosquamous cell lung cancer stage IV	22.74	12.93	5	97417	11	79646955
Ejection fraction decreased	22.67	12.93	7	97415	34570	79612396
Blood pressure increased	22.66	12.93	158	97264	211202	79435764
Breast cancer stage I	22.61	12.93	34	97388	6666	79640300
H1N1 influenza	22.41	12.93	21	97401	2498	79644468
Progressive relapsing multiple sclerosis	22.35	12.93	6	97416	38	79646928
Post procedural complication	22.32	12.93	72	97350	23757	79623209
Ligament rupture	22.29	12.93	24	97398	3370	79643596
Cephalo-pelvic disproportion	22.19	12.93	8	97414	146	79646820
Pneumonia	22.16	12.93	1002	96420	659244	78987722
Haemorrhage	22.13	12.93	49	97373	91069	79555897
Osteomyelitis	22.01	12.93	89	97333	32776	79614190
Pelvic fracture	21.88	12.93	47	97375	12157	79634809
Autoimmune hepatitis	21.84	12.93	46	97376	11737	79635229
Haematemesis	21.83	12.93	19	97403	52245	79594721
Ovarian mass	21.79	12.93	11	97411	471	79646495
Ventricular fibrillation	21.78	12.93	6	97416	31920	79615046
Fibroadenoma of breast	21.73	12.93	10	97412	348	79646618
Cervix carcinoma stage III	21.71	12.93	6	97416	43	79646923
Cellulitis staphylococcal	21.66	12.93	15	97407	1158	79645808
Cervical spinal stenosis	21.63	12.93	20	97402	2339	79644627
Foetal distress syndrome	21.58	12.93	11	97411	481	79646485
Dysarthria	21.51	12.93	149	97273	67473	79579493
Hypercalcaemia	21.49	12.93	10	97412	38420	79608546
Pineal gland cyst	21.39	12.93	5	97417	16	79646950
Palpitations	21.31	12.93	81	97341	126529	79520437
Upper gastrointestinal haemorrhage	21.30	12.93	12	97410	41368	79605598
Respiratory depression	21.23	12.93	4	97418	27626	79619340
Frequent bowel movements	21.21	12.93	5	97417	29534	79617432
Therapeutic procedure	21.12	12.93	13	97409	821	79646145
Frustration tolerance decreased	21.07	12.93	35	97387	7467	79639499
Fluid retention	20.97	12.93	33	97389	69776	79577190
Blood potassium increased	20.93	12.93	5	97417	29270	79617696
Poisoning	20.88	12.93	3	97419	25269	79621697
Plasmablastic lymphoma	20.87	12.93	11	97411	516	79646450
Faeces discoloured	20.78	12.93	5	97417	29122	79617844
Rebound effect	20.68	12.93	34	97388	7192	79639774
Pulmonary hypertension	20.67	12.93	17	97405	48063	79598903
Lung adenocarcinoma stage IV	20.62	12.93	9	97413	276	79646690
Human papilloma virus test positive	20.61	12.93	11	97411	529	79646437
B-cell lymphoma stage I	20.60	12.93	4	97418	3	79646963
Infusion site haematoma	20.50	12.93	9	97413	280	79646686
Red blood cell count decreased	20.49	12.93	24	97398	57489	79589477
Endometrial adenocarcinoma	20.45	12.93	14	97408	1061	79645905
Cholelithiasis	20.42	12.93	122	97300	52542	79594424
Bladder repair	20.41	12.93	6	97416	55	79646911
Wound sepsis	20.35	12.93	8	97414	187	79646779
Herpes simplex meningitis	20.31	12.93	6	97416	56	79646910
Knee operation	20.12	12.93	30	97392	5836	79641130
Feeling abnormal	19.99	12.93	289	97133	158910	79488056
Quadriparesis	19.97	12.93	23	97399	3478	79643488
Red blood cell nucleated morphology present	19.96	12.93	5	97417	23	79646943
Osteonecrosis	19.87	12.93	83	97339	31012	79615954
Oral pain	19.86	12.93	7	97415	31791	79615175
Hyperemesis gravidarum	19.82	12.93	10	97412	428	79646538
CD4 lymphocytes decreased	19.76	12.93	20	97402	2614	79644352
Septic shock	19.75	12.93	80	97342	122721	79524245
JC virus infection	19.67	12.93	24	97398	3857	79643109
Appendicitis	19.63	12.93	63	97359	20731	79626235
Ependymoma	19.34	12.93	6	97416	67	79646899
Asthma	19.30	12.93	92	97330	135003	79511963
Spondylitic myelopathy	19.10	12.93	6	97416	70	79646896
Latent tuberculosis	19.08	12.93	22	97400	3331	79643635
Angina pectoris	19.07	12.93	21	97401	51711	79595255
Blindness unilateral	18.97	12.93	35	97387	8111	79638855
Therapeutic product effect decreased	18.81	12.93	120	97302	163743	79483223
Mammogram abnormal	18.78	12.93	10	97412	479	79646487
Glioblastoma multiforme	18.77	12.93	14	97408	1214	79645752
Hepatotoxicity	18.76	12.93	21	97401	51331	79595635
Tooth infection	18.64	12.93	58	97364	18774	79628192
Expanded disability status scale score increased	18.54	12.93	11	97411	650	79646316
Dysphemia	18.40	12.93	22	97400	3462	79643504
Leukocytosis	18.37	12.93	103	97319	43352	79603614
Blindness	18.32	12.93	76	97346	28307	79618659
Neurological symptom	18.31	12.93	36	97386	8747	79638219
Squamous cell carcinoma of the cervix	18.22	12.93	8	97414	249	79646717
Panic attack	18.19	12.93	68	97354	24148	79622818
Demyelination	18.09	12.93	34	97388	7989	79638977
Eczema	18.09	12.93	14	97408	40804	79606162
Foetal heart rate abnormal	18.06	12.93	9	97413	375	79646591
Drug dependence	18.05	12.93	14	97408	40755	79606211
Hip surgery	17.92	12.93	21	97401	3234	79643732
Blood lactate dehydrogenase increased	17.92	12.93	13	97409	39157	79607809
Pulmonary oedema	17.92	12.93	52	97370	88202	79558764
Abdominal pain upper	17.80	12.93	181	97241	223638	79423328
Cardiogenic shock	17.80	12.93	15	97407	41899	79605067
Endometrial cancer	17.76	12.93	17	97405	2077	79644889
Bladder operation	17.67	12.93	12	97410	897	79646069
Rash erythematous	17.64	12.93	27	97395	57742	79589224
Bronchopulmonary aspergillosis	17.62	12.93	3	97419	22291	79624675
Gastric banding	17.61	12.93	5	97417	40	79646926
Ear infection	17.58	12.93	86	97336	34346	79612620
Imminent abortion	17.56	12.93	4	97418	11	79646955
Magnetic resonance imaging head abnormal	17.42	12.93	19	97403	2707	79644259
Paralysis	17.36	12.93	45	97377	13132	79633834
Lung cancer metastatic	17.34	12.93	22	97400	3677	79643289
Mouth ulceration	17.23	12.93	13	97409	38381	79608585
Female reproductive tract disorder	17.16	12.93	8	97414	287	79646679
Urethral valves	17.13	12.93	3	97419	0	79646966
Gestational oedema	17.13	12.93	3	97419	0	79646966
Intracranial haemangioma	17.13	12.93	3	97419	0	79646966
Intervertebral disc operation	17.13	12.93	12	97410	944	79646022
Herpes zoster meningitis	17.11	12.93	7	97415	182	79646784
Lymphocyte count increased	17.09	12.93	28	97394	5904	79641062
Product administered to patient of inappropriate age	17.08	12.93	27	97395	5526	79641440
Abortion	17.06	12.93	14	97408	1396	79645570
Illness	17.02	12.93	19	97403	46492	79600474
Back disorder	16.78	12.93	41	97381	11537	79635429
Precancerous cells present	16.77	12.93	13	97409	1194	79645772
Gastrointestinal viral infection	16.73	12.93	14	97408	1434	79645532
Withdrawal syndrome	16.62	12.93	6	97416	26848	79620118
Transfusion	16.58	12.93	3	97419	21327	79625639
Hypoalbuminaemia	16.54	12.93	3	97419	21294	79625672
Fractured coccyx	16.40	12.93	12	97410	1010	79645956
Nodule	16.30	12.93	4	97418	22990	79623976
Dysgeusia	16.26	12.93	28	97394	57149	79589817
Night sweats	16.25	12.93	24	97398	52071	79594895
Cardiomegaly	16.12	12.93	6	97416	26346	79620620
Drowning	16.06	12.93	11	97411	834	79646132
Breast cyst	16.03	12.93	13	97409	1274	79645692
Diplegia	15.98	12.93	15	97407	1788	79645178
Dry eye	15.95	12.93	13	97409	36918	79610048
Melanocytic naevus	15.91	12.93	24	97398	4717	79642249
Heat exhaustion	15.88	12.93	8	97414	341	79646625
Blindness transient	15.78	12.93	24	97398	4752	79642214
HIV test positive	15.77	12.93	6	97416	128	79646838
Corneal decompensation	15.72	12.93	5	97417	61	79646905
Pertussis	15.71	12.93	11	97411	864	79646102
Neurofibroma	15.53	12.93	4	97418	21	79646945
Escherichia sepsis	15.52	12.93	33	97389	8475	79638491
Ovarian cyst	15.44	12.93	42	97380	12613	79634353
Product substitution issue	15.42	12.93	3	97419	20253	79626713
Type 2 diabetes mellitus	15.33	12.93	29	97393	57093	79589873
Jaundice	15.29	12.93	26	97396	53323	79593643
Breast cancer metastatic	15.27	12.93	33	97389	8569	79638397
Foetal heart rate decreased	15.23	12.93	4	97418	23	79646943
Oral infection	15.20	12.93	26	97396	5681	79641285
Patella fracture	15.17	12.93	15	97407	1906	79645060
Brain stem syndrome	15.13	12.93	11	97411	917	79646049
Grip strength decreased	15.12	12.93	4	97418	21865	79625101
Tenderness	15.12	12.93	5	97417	23637	79623329
Monoparesis	15.08	12.93	20	97402	3491	79643475
Renal cell carcinoma	14.99	12.93	28	97394	6550	79640416
Back injury	14.97	12.93	37	97385	10486	79636480
Wound	14.96	12.93	82	97340	116097	79530869
Drug eruption	14.95	12.93	19	97403	43916	79603050
Ligament sprain	14.77	12.93	43	97379	13421	79633545
Urinary retention	14.74	12.93	119	97303	56511	79590455
Face oedema	14.71	12.93	8	97414	28128	79618838
Pericardial effusion	14.71	12.93	21	97401	46216	79600750
Herpes zoster infection neurological	14.69	12.93	7	97415	264	79646702
Device malfunction	14.69	12.93	4	97418	21444	79625522
Astrocytoma malignant	14.68	12.93	4	97418	27	79646939
Lumbar radiculopathy	14.67	12.93	15	97407	1984	79644982
Anembryonic gestation	14.56	12.93	8	97414	408	79646558
Device extrusion	14.55	12.93	4	97418	28	79646938
Urinary tract infection enterococcal	14.51	12.93	19	97403	3276	79643690
Micturition urgency	14.48	12.93	41	97381	12600	79634366
Respiratory distress	14.47	12.93	31	97391	58308	79588658
Aggression	14.45	12.93	25	97397	50933	79596033
Abdominoplasty	14.36	12.93	5	97417	82	79646884
Gallbladder disorder	14.27	12.93	54	97368	19286	79627680
Skull fracture	14.25	12.93	14	97408	1766	79645200
Quadriplegia	14.22	12.93	19	97403	3341	79643625
Intervertebral disc disorder	14.21	12.93	23	97399	4802	79642164
Ovarian cystectomy	14.14	12.93	5	97417	86	79646880
Spinal fusion surgery	14.13	12.93	24	97398	5214	79641752
Pancreatic carcinoma metastatic	14.05	12.93	20	97402	3733	79643233
Arrhythmia	14.03	12.93	34	97388	61238	79585728
Neuralgia	14.02	12.93	79	97343	33305	79613661
Hepatic failure	13.99	12.93	34	97388	61178	79585788
Meningitis	13.96	12.93	34	97388	9548	79637418
Emotional disorder	13.96	12.93	44	97378	14343	79632623
Proteus infection	13.95	12.93	15	97407	2103	79644863
Rhinorrhoea	13.91	12.93	47	97375	76027	79570939
Poisoning deliberate	13.89	12.93	3	97419	18825	79628141
Platelet count increased	13.88	12.93	5	97417	22401	79624565
Alcoholic seizure	13.84	12.93	3	97419	6	79646960
Hepatic cytolysis	13.80	12.93	8	97414	27143	79619823
Staphylococcal osteomyelitis	13.75	12.93	6	97416	184	79646782
Clumsiness	13.72	12.93	18	97404	3109	79643857
Malignant melanoma stage III	13.67	12.93	4	97418	36	79646930
Automatic bladder	13.63	12.93	5	97417	96	79646870
Post-traumatic headache	13.63	12.93	5	97417	96	79646870
Vitamin D decreased	13.63	12.93	34	97388	9691	79637275
Benign neoplasm	13.62	12.93	11	97411	1072	79645894
Uterine cyst	13.59	12.93	7	97415	313	79646653
Lumbar puncture	13.57	12.93	6	97416	190	79646776
Vaccination complication	13.45	12.93	10	97412	863	79646103
Breast reconstruction	13.44	12.93	5	97417	100	79646866
Benign lung neoplasm	13.44	12.93	5	97417	100	79646866
Deep vein thrombosis	13.44	12.93	215	97207	120704	79526262
Dermatofibrosarcoma protuberans	13.38	12.93	4	97418	39	79646927
Vibratory sense increased	13.38	12.93	4	97418	39	79646927
Skull fractured base	13.36	12.93	7	97415	324	79646642
Abdominal adhesions	13.31	12.93	19	97403	3554	79643412
Thrombosis	13.19	12.93	159	97263	83941	79563025
Staphylococcal abscess	13.14	12.93	11	97411	1128	79645838
Vulvar dysplasia	13.09	12.93	5	97417	108	79646858
Respiratory tract infection	13.04	12.93	103	97319	48586	79598380
Device related infection	13.01	12.93	79	97343	34215	79612751
Gout	13.00	12.93	7	97415	24742	79622224
Protein S increased	12.98	12.93	3	97419	9	79646957

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L04AA23	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Selective immunosuppressants
MeSH PA	D007155	Immunologic Factors
FDA MoA	N0000175774	Integrin Receptor Antagonists
FDA EPC	N0000175775	Integrin Receptor Antagonist

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

Disease	Relation	SNOMED_ID	DOID
Multiple sclerosis	indication	24700007	DOID:2377
Crohn's disease	indication	34000006
Progressive multifocal leukoencephalopathy	contraindication	22255007	DOID:643

🐶 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
Integrin alpha-4/beta-1	Adhesion	P13612 P05556	ITA4_HUMAN ITB1_HUMAN	ANTIBODY BINDING				DRUG LABEL	DRUG LABEL
Integrin alpha-4/beta-7	Adhesion	P13612 P26010	ITA4_HUMAN ITB7_HUMAN	ANTIBODY BINDING				DRUG LABEL	DRUG LABEL

External reference:

ID	Source
D06886	KEGG_DRUG
4021508	VUID
N0000148870	NUI
4021508	VANDF
CHEMBL1201607	ChEMBL_ID
6591	IUPHAR_LIGAND_ID
DB00108	DRUGBANK_ID
354770	RXNORM
19083	MMSL
63826	MMSL
d05414	MMSL
008765	NDDF
414804006	SNOMEDCT_US
414805007	SNOMEDCT_US
D000069442	MESH_DESCRIPTOR_UI
C1172734	UMLSCUI
7716	INN_ID
3JB47N2Q2P	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
TYSABRI	HUMAN PRESCRIPTION DRUG LABEL	1	64406-008	INJECTION	300 mg	INTRAVENOUS	BLA	30 sections
TYSABRI	HUMAN PRESCRIPTION DRUG LABEL	1	64406-008	INJECTION	300 mg	INTRAVENOUS	BLA	30 sections
TYSABRI	HUMAN PRESCRIPTION DRUG LABEL	1	64406-008	INJECTION	300 mg	INTRAVENOUS	BLA	30 sections