folic acid Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	1231	59-30-3

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: folic acid acifolic aspol cytofol folacid pteroylglutamic acid folate sodium	A member of the vitamin B family that stimulates the hematopoietic system. It is present in the liver and kidney and is found in mushrooms, spinach, yeast, green leaves, and grasses (POACEAE). Folic acid is used in the treatment and prevention of folate deficiencies and megaloblastic anemia. Molecular weight: 441.40 Formula: C19H19N7O6 CLOGP: -2.04 LIPINSKI: 2 HAC: 13 HDO: 6 TPSA: 207.93 ALOGS: -3.74 ROTB: 9

Molecule

Description

Molfile Inchi Smiles

Synonyms:

folic acid
acifolic
aspol
cytofol
folacid
pteroylglutamic acid
folate sodium

A member of the vitamin B family that stimulates the hematopoietic system. It is present in the liver and kidney and is found in mushrooms, spinach, yeast, green leaves, and grasses (POACEAE). Folic acid is used in the treatment and prevention of folate deficiencies and megaloblastic anemia.

Molecular weight: 441.40
Formula: C19H19N7O6
CLOGP: -2.04
LIPINSKI: 2
HAC: 13
HDO: 6
TPSA: 207.93
ALOGS: -3.74
ROTB: 9

Drug dosage:

Dose	Unit	Route
0.40	mg	O
10	mg	P

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.00 mg/mL	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	11.43 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	75 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	9.70 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	52 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.50 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	2.60 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Aug. 13, 1946	FDA	LEDERLE

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
Rheumatoid arthritis	1020.67	9.73	3750	311697	236465	46134150
Pemphigus	871.03	9.73	1288	314159	43986	46326629
Systemic lupus erythematosus	745.12	9.73	1471	313976	63709	46306906
Completed suicide	729.48	9.73	71	315376	145849	46224766
Maternal exposure during pregnancy	621.88	9.73	1809	313638	100740	46269875
Glossodynia	562.99	9.73	1047	314400	43326	46327289
Exposure during pregnancy	455.23	9.73	1686	313761	106526	46264089
Hand deformity	420.12	9.73	801	314646	33773	46336842
Toxicity to various agents	381.79	9.73	524	314923	211242	46159373
Death	346.16	9.73	1139	314308	334409	46036206
Arthropathy	329.11	9.73	1287	314160	83413	46287202
Alopecia	324.26	9.73	2041	313406	160373	46210242
Gestational diabetes	315.88	9.73	312	315135	6907	46363708
Infusion related reaction	308.17	9.73	1428	314019	99780	46270835
Abdominal discomfort	292.02	9.73	1884	313563	149281	46221334
Joint swelling	285.62	9.73	2011	313436	164062	46206553
Foetal exposure during pregnancy	281.40	9.73	634	314813	30113	46340502
Drug abuse	280.02	9.73	46	315401	63362	46307253
Wound	267.74	9.73	764	314683	42038	46328577
Pain	260.11	9.73	4593	310854	472355	45898260
Arthralgia	250.71	9.73	3650	311797	360953	46009662
Intentional overdose	238.71	9.73	71	315376	64873	46305742
Synovitis	225.07	9.73	913	314534	60162	46310453
Drug hypersensitivity	203.01	9.73	902	314545	242923	46127692
Anti-cyclic citrullinated peptide antibody positive	200.59	9.73	417	315030	18728	46351887
Small for dates baby	197.09	9.73	177	315270	3460	46367155
Contraindicated product administered	194.50	9.73	1059	314388	78888	46291727
Pericarditis	192.33	9.73	469	314978	23458	46347157
Overdose	171.11	9.73	265	315182	101714	46268901
Rheumatoid factor positive	169.74	9.73	406	315041	20055	46350560
Swelling	167.26	9.73	1424	314023	123087	46247528
Suicide attempt	160.08	9.73	86	315361	54950	46315665
Hip arthroplasty	159.63	9.73	368	315079	17744	46352871
Nasopharyngitis	157.45	9.73	1662	313785	152336	46218279
Abortion spontaneous	155.66	9.73	646	314801	43000	46327615
Product use issue	154.33	9.73	1132	314315	93512	46277103
Cardiac arrest	152.52	9.73	234	315213	90165	46280450
Pregnancy	146.58	9.73	460	314987	26677	46343938
Knee arthroplasty	142.72	9.73	417	315030	23248	46347367
Red blood cell sedimentation rate abnormal	142.64	9.73	297	315150	13352	46357263
Febrile neutropenia	138.57	9.73	268	315179	94359	46276256
Sickle cell anaemia with crisis	134.37	9.73	150	315297	3842	46366773
Musculoskeletal stiffness	133.82	9.73	1125	314322	96868	46273747
C-reactive protein abnormal	133.29	9.73	380	315067	20890	46349725
Drug interaction	131.04	9.73	819	314628	202275	46168340
Discomfort	117.37	9.73	624	314823	46046	46324569
Injection site erythema	117.21	9.73	883	314564	73544	46297071
Device expulsion	117.16	9.73	22	315425	27520	46343095
Malignant neoplasm progression	115.43	9.73	162	315285	64764	46305851
Depressed level of consciousness	105.91	9.73	99	315348	47470	46323145
Respiratory arrest	101.06	9.73	51	315396	33765	46336850
Disease progression	100.78	9.73	300	315147	91000	46279615
Atrial septal defect	97.83	9.73	163	315284	6169	46364446
Injection site pruritus	97.63	9.73	528	314919	39215	46331400
Injection site pain	97.32	9.73	1130	314317	106022	46264593
Caesarean section	95.77	9.73	288	315159	16315	46354300
Bradycardia	91.71	9.73	194	315253	66104	46304511
Anxiety	89.90	9.73	791	314656	181166	46189449
Arthritis	89.30	9.73	856	314591	76460	46294155
Blood pressure fluctuation	87.71	9.73	423	315024	30025	46340590
Basal cell carcinoma	85.80	9.73	319	315128	20168	46350447
Psoriatic arthropathy	85.80	9.73	478	314969	35901	46334714
Acute kidney injury	84.76	9.73	1104	314343	234751	46135864
Dyspnoea	84.39	9.73	2749	312698	512799	45857816
Respiratory disorder neonatal	81.79	9.73	60	315387	868	46369747
Agitation	81.05	9.73	157	315290	55258	46315357
Ventricular septal defect	80.72	9.73	117	315330	3917	46366698
Injection site swelling	80.39	9.73	507	314940	39820	46330795
Therapeutic product effect decreased	79.91	9.73	882	314565	81719	46288896
Pancytopenia	78.10	9.73	899	314548	84159	46286456
Cardio-respiratory arrest	78.04	9.73	181	315266	59688	46310927
Duodenal ulcer perforation	76.30	9.73	174	315273	8328	46362287
Pre-eclampsia	75.54	9.73	167	315280	7827	46362788
Premature delivery	75.05	9.73	322	315125	21747	46348868
Dizziness	74.74	9.73	1741	313706	338673	46031942
Injection site reaction	74.36	9.73	566	314881	47283	46323332
Nausea	74.06	9.73	3846	311601	683608	45687007
Osteoarthritis	73.75	9.73	691	314756	61334	46309281
Electrocardiogram QT prolonged	72.83	9.73	148	315299	51177	46319438
Live birth	72.11	9.73	192	315255	10138	46360477
Tremor	71.59	9.73	472	314975	115167	46255448
Asthma	70.50	9.73	348	315099	91194	46279421
Product quality issue	69.48	9.73	83	315364	35565	46335050
Helicobacter infection	69.03	9.73	205	315242	11531	46359084
Premature labour	68.98	9.73	200	315247	11099	46359516
Cardiac failure	67.43	9.73	294	315153	79654	46290961
Drug withdrawal syndrome	67.05	9.73	52	315395	27332	46343283
Disability assessment scale score increased	66.91	9.73	79	315368	2153	46368462
Joint effusion	66.31	9.73	205	315242	11790	46358825
Lactic acidosis	66.03	9.73	79	315368	33830	46336785
Drug dependence	64.14	9.73	27	315420	19874	46350741
Multiple sclerosis relapse	63.66	9.73	117	315330	42008	46328607
Insomnia	63.31	9.73	761	314686	164163	46206452
Intentional self-injury	62.93	9.73	43	315404	24123	46346492
Rhabdomyolysis	62.80	9.73	117	315330	41792	46328823
Sedation	59.35	9.73	41	315406	22869	46347746
Joint laxity	57.63	9.73	71	315376	2025	46368590
Impaired healing	57.29	9.73	435	315012	36308	46334307
Constipation	56.73	9.73	831	314616	173266	46197349
Renal failure	55.97	9.73	494	314953	113100	46257515
Somnolence	54.21	9.73	738	314709	155783	46214832
Maternal drugs affecting foetus	52.96	9.73	116	315331	5402	46365213
Red blood cell sedimentation rate increased	52.80	9.73	299	315148	22590	46348025
Intentional product misuse	51.88	9.73	155	315292	46973	46323642
Localised infection	51.71	9.73	306	315141	23495	46347120
Neck deformity	51.29	9.73	63	315384	1791	46368824
Premature rupture of membranes	50.67	9.73	100	315347	4323	46366292
Drug reaction with eosinophilia and systemic symptoms	50.27	9.73	76	315371	29472	46341143
Blood pressure diastolic abnormal	50.17	9.73	123	315324	6171	46364444
Confusional state	50.08	9.73	769	314678	159123	46211492
Diarrhoea	50.07	9.73	3186	312261	556416	45814199
Tachycardia	50.07	9.73	431	315016	99191	46271424
Palmar-plantar erythrodysaesthesia syndrome	49.86	9.73	39	315408	20412	46350203
Psoriasis	49.83	9.73	777	314670	77827	46292788
Lower respiratory tract infection	48.66	9.73	578	314869	54511	46316104
Dysmorphism	48.30	9.73	62	315385	1845	46368770
Foetal death	47.93	9.73	149	315298	8594	46362021
Hypotension	47.81	9.73	1201	314246	231388	46139227
Neuropathy peripheral	47.59	9.73	389	315058	90504	46280111
Talipes	47.58	9.73	53	315394	1354	46369261
Myalgia	47.58	9.73	567	314880	122521	46248094
Drug ineffective	47.50	9.73	5250	310197	672588	45698027
Treatment failure	47.34	9.73	888	314559	92199	46278416
Herpes zoster	47.33	9.73	682	314765	67190	46303425
Hepatic enzyme increased	47.20	9.73	796	314651	80991	46289624
Congenital umbilical hernia	46.93	9.73	33	315414	445	46370170
Sopor	46.86	9.73	39	315408	19789	46350826
Hyperhidrosis	46.86	9.73	382	315065	88926	46281689
Juvenile idiopathic arthritis	46.83	9.73	93	315354	4039	46366576
Tuberculosis	46.51	9.73	164	315283	10101	46360514
Developmental hip dysplasia	46.29	9.73	50	315397	1233	46369382
Hepatic failure	46.02	9.73	98	315349	33318	46337297
Neutropenia	45.78	9.73	686	314761	142518	46228097
Hyponatraemia	45.48	9.73	451	314996	100881	46269734
Neoplasm progression	45.04	9.73	69	315378	26614	46344001
Injection site bruising	44.36	9.73	401	315046	35235	46335380
Cardiac failure congestive	44.31	9.73	401	315046	91349	46279266
Rheumatoid nodule	44.27	9.73	148	315299	8872	46361743
Malignant melanoma	44.23	9.73	161	315286	10073	46360542
Osteoporosis	44.13	9.73	444	315003	40164	46330451
Injection site rash	43.61	9.73	217	315230	15596	46355019
Pulmonary arterial hypertension	42.86	9.73	68	315379	25860	46344755
Premature baby	42.71	9.73	238	315209	17874	46352741
Drug resistance	42.50	9.73	33	315414	17335	46353280
Foot deformity	42.07	9.73	211	315236	15214	46355401
Coma	41.98	9.73	227	315220	58122	46312493
Poisoning	41.97	9.73	21	315426	13973	46356642
Urticaria	41.84	9.73	553	314894	117339	46253276
Therapeutic response decreased	41.84	9.73	461	314986	42684	46327931
Loss of personal independence in daily activities	41.64	9.73	579	314868	56604	46314011
Vomiting	41.63	9.73	2571	312876	450223	45920392
Sinusitis	41.32	9.73	1159	314288	128609	46242006
Infective pulmonary exacerbation of cystic fibrosis	41.21	9.73	11	315436	10796	46359819
Hypoglycaemia	40.46	9.73	209	315238	54140	46316475
Asthenia	39.70	9.73	1708	313739	309367	46061248
Depression	39.49	9.73	862	314585	169242	46201373
Skin ulcer	39.26	9.73	363	315084	32095	46338520
Blood pressure systolic abnormal	38.97	9.73	103	315344	5414	46365201
Cytomegalovirus infection	38.94	9.73	39	315408	18105	46352510
Hyperglycaemia	38.85	9.73	115	315332	34956	46335659
Oropharyngeal pain	38.56	9.73	710	314737	73458	46297157
Blood glucose increased	38.24	9.73	307	315140	71706	46298909
Hypoxia	38.22	9.73	200	315247	51638	46318977
Diabetic ketoacidosis	38.11	9.73	40	315407	18170	46352445
Plasma cell myeloma	37.84	9.73	163	315284	44315	46326300
Emotional distress	37.51	9.73	96	315351	30611	46340004
Pulmonary tuberculosis	37.23	9.73	92	315355	4639	46365976
Condition aggravated	37.03	9.73	2017	313430	243035	46127580
No adverse event	36.66	9.73	114	315333	34117	46336498
Serotonin syndrome	35.95	9.73	68	315379	24152	46346463
Decreased appetite	35.60	9.73	1017	314430	192819	46177796
Bone erosion	35.42	9.73	142	315305	9301	46361314
Fluid retention	35.41	9.73	201	315246	50845	46319770
Oral herpes	35.11	9.73	238	315209	19152	46351463
Anaphylactic reaction	34.79	9.73	213	315234	52899	46317716
Fracture	34.65	9.73	210	315237	16261	46354354
Mental status changes	34.64	9.73	136	315311	37952	46332663
Syncope	34.54	9.73	499	314948	104304	46266311
Mydriasis	34.52	9.73	14	315433	10539	46360076
Respiratory failure	34.28	9.73	443	315004	94373	46276242
Renal impairment	34.21	9.73	329	315118	74043	46296572
Limb deformity	34.12	9.73	75	315372	3501	46367114
Neutrophil count decreased	33.46	9.73	165	315282	43261	46327354
Myocardial infarction	32.97	9.73	462	314985	97066	46273549
Hallucination	32.88	9.73	200	315247	49751	46320864
Blood creatine phosphokinase increased	32.86	9.73	88	315359	27636	46342979
Feeling abnormal	32.81	9.73	621	314826	124439	46246176
Inflammation	32.76	9.73	487	314960	48294	46322321
Metastases to bone	32.68	9.73	42	315405	17434	46353181
Arthritis infective	32.66	9.73	92	315355	5021	46365594
Polyhydramnios	31.61	9.73	52	315395	1947	46368668
Nodule	31.59	9.73	197	315250	15408	46355207
Placental disorder	31.36	9.73	43	315404	1366	46369249
Neck mass	31.35	9.73	69	315378	3224	46367391
Metabolic acidosis	31.25	9.73	145	315302	38635	46331980
Joint destruction	31.23	9.73	66	315381	2998	46367617
Latent tuberculosis	31.01	9.73	51	315396	1909	46368706
Musculoskeletal pain	30.96	9.73	655	314792	69473	46301142
Congenital hydronephrosis	30.96	9.73	24	315423	379	46370236
Muscle spasms	30.87	9.73	616	314831	122497	46248118
Femur fracture	30.85	9.73	384	315063	36613	46334002
Injection site warmth	30.52	9.73	178	315269	13594	46357021
Polyarthritis	30.05	9.73	105	315342	6437	46364178
Blood pressure diastolic decreased	29.77	9.73	181	315266	14030	46356585
Ejection fraction decreased	29.68	9.73	47	315400	17890	46352725
Grip strength decreased	29.59	9.73	126	315321	8480	46362135
Hypotonia neonatal	29.50	9.73	33	315414	847	46369768
Blood pressure systolic increased	29.49	9.73	311	315136	28476	46342139
Influenza	29.44	9.73	801	314646	88469	46282146
Shock	29.30	9.73	65	315382	21780	46348835
Smear cervix abnormal	28.96	9.73	57	315390	2459	46368156
Abnormal behaviour	28.79	9.73	62	315385	20996	46349619
Hepatic function abnormal	28.75	9.73	127	315320	34294	46336321
Ventricular tachycardia	28.52	9.73	44	315403	16923	46353692
Respiratory depression	28.43	9.73	22	315425	11578	46359037
Cellulitis	28.33	9.73	648	314799	69640	46300975
Patent ductus arteriosus	28.20	9.73	73	315374	3789	46366826
Wheezing	28.15	9.73	228	315219	53158	46317457
Synovial cyst	27.98	9.73	111	315336	7235	46363380
Bronchitis	27.95	9.73	925	314522	105054	46265561
Amniotic fluid volume increased	27.74	9.73	16	315431	149	46370466
Neonatal hypoxia	27.19	9.73	24	315423	458	46370157
Serum ferritin increased	27.10	9.73	88	315359	5195	46365420
Multiple fractures	27.01	9.73	91	315356	5476	46365139
Schizophrenia	27.01	9.73	12	315435	8556	46362059
Acute hepatic failure	26.89	9.73	36	315411	14685	46355930
Dyspnoea exertional	26.87	9.73	214	315233	50075	46320540
Exomphalos	26.80	9.73	25	315422	514	46370101
Enthesopathy	26.71	9.73	81	315366	4609	46366006
Low birth weight baby	26.52	9.73	89	315358	5345	46365270
Foetal growth restriction	26.45	9.73	101	315346	6466	46364149
Seizure	26.44	9.73	631	314816	122423	46248192
Heart rate decreased	26.33	9.73	329	315118	31394	46339221
Foetal anticonvulsant syndrome	26.32	9.73	23	315424	433	46370182
Drug level increased	26.30	9.73	53	315394	18388	46352227
Encephalopathy	26.24	9.73	127	315320	33462	46337153
Agitation neonatal	26.23	9.73	24	315423	481	46370134
Dysgeusia	26.19	9.73	163	315284	40328	46330287
Delirium	26.14	9.73	146	315301	37082	46333533
Neuroleptic malignant syndrome	26.13	9.73	22	315425	11100	46359515
Pain in jaw	26.12	9.73	152	315295	38220	46332395
Joint stiffness	25.98	9.73	289	315158	26819	46343796
Immunosuppression	25.94	9.73	110	315337	7390	46363225
Speech disorder	25.85	9.73	141	315306	36026	46334589
Peripheral swelling	25.84	9.73	1311	314136	156760	46213855
Blood pressure diastolic increased	25.83	9.73	94	315353	5880	46364735
Angioedema	25.65	9.73	158	315289	39184	46331431
Skin papilloma	25.57	9.73	74	315373	4102	46366513
Restlessness	25.26	9.73	88	315359	25436	46345179
Suicidal ideation	25.26	9.73	251	315196	56131	46314484
Abortion late	25.15	9.73	14	315433	121	46370494
Vision blurred	25.05	9.73	383	315064	79325	46291290
Skin cancer	24.99	9.73	122	315325	8701	46361914
Swollen joint count increased	24.81	9.73	52	315395	2348	46368267
Mouth ulceration	24.78	9.73	284	315163	26548	46344067
Tenosynovitis stenosans	24.71	9.73	46	315401	1903	46368712
Joint range of motion decreased	24.67	9.73	181	315266	14943	46355672
Osteonecrosis of jaw	24.65	9.73	134	315313	34268	46336347
Fibromyalgia	24.47	9.73	364	315083	36099	46334516
Brain oedema	24.37	9.73	29	315418	12449	46358166
Ventricular fibrillation	24.34	9.73	25	315422	11471	46359144
Rheumatic fever	24.21	9.73	57	315390	2786	46367829
C-reactive protein increased	24.19	9.73	542	314905	58048	46312567
Breast feeding	24.15	9.73	30	315417	863	46369752
Hypothermia	24.13	9.73	28	315419	12155	46358460
Squamous cell carcinoma	24.12	9.73	111	315336	7725	46362890
Multiple organ dysfunction syndrome	24.09	9.73	228	315219	51482	46319133
Muscle spasticity	24.08	9.73	25	315422	11415	46359200
Postoperative wound infection	24.05	9.73	120	315327	8633	46361982
Chest discomfort	24.05	9.73	447	315000	89822	46280793
Large for dates baby	24.04	9.73	22	315425	441	46370174
Akathisia	24.01	9.73	11	315436	7703	46362912
Loss of consciousness	23.82	9.73	553	314894	107685	46262930
Aspartate aminotransferase increased	23.77	9.73	381	315066	78319	46292296
Pain in extremity	23.77	9.73	2043	313404	256637	46113978
Palpitations	23.47	9.73	478	314969	94781	46275834
Altered state of consciousness	23.44	9.73	80	315367	23268	46347347
Blood creatinine increased	23.37	9.73	369	315078	76034	46294581
Blood pressure decreased	23.35	9.73	260	315187	56899	46313716
Metastases to liver	23.33	9.73	62	315385	19523	46351092
Maternal exposure before pregnancy	23.31	9.73	75	315372	4406	46366209
Drug intolerance	23.30	9.73	1216	314231	145833	46224782
Extrapyramidal disorder	23.30	9.73	25	315422	11243	46359372
Unresponsive to stimuli	23.23	9.73	125	315322	32049	46338566
Complication of device insertion	23.18	9.73	3	315444	4941	46365674
Product use in unapproved indication	23.13	9.73	450	314997	89823	46280792
Normal newborn	23.12	9.73	91	315356	5910	46364705
Balance disorder	23.12	9.73	302	315145	64219	46306396
Induced labour	23.08	9.73	30	315417	904	46369711
Stillbirth	23.07	9.73	96	315351	6395	46364220
Pulmonary embolism	23.00	9.73	558	314889	108027	46262588
Posterior reversible encephalopathy syndrome	22.92	9.73	42	315405	15099	46355516
Dysarthria	22.71	9.73	154	315293	37344	46333271
Abortion missed	22.35	9.73	39	315408	1533	46369082
Arthritis bacterial	22.11	9.73	87	315360	5649	46364966
Tenderness	22.06	9.73	192	315255	16689	46353926
Oligohydramnios	21.97	9.73	84	315363	5381	46365234
Acute chest syndrome	21.96	9.73	23	315424	547	46370068
Torsade de pointes	21.92	9.73	30	315417	12124	46358491
Memory impairment	21.85	9.73	379	315068	76958	46293657
Psychotic disorder	21.72	9.73	79	315368	22542	46348073
Neurotoxicity	21.71	9.73	37	315410	13680	46356935
Device dislocation	21.69	9.73	75	315372	21727	46348888
Cholestasis of pregnancy	21.62	9.73	32	315415	1092	46369523
Gastroenteritis viral	21.59	9.73	202	315245	17917	46352698
Weight increased	21.59	9.73	1337	314110	163136	46207479
Placental insufficiency	21.56	9.73	35	315412	1296	46369319
Haemorrhage in pregnancy	21.36	9.73	39	315408	1589	46369026
Cerebral haemorrhage neonatal	21.18	9.73	13	315434	137	46370478
Product adhesion issue	20.98	9.73	4	315443	4951	46365664
Blood bilirubin increased	20.89	9.73	140	315307	34044	46336571
Maternal exposure during breast feeding	20.65	9.73	53	315394	2736	46367879
Synovial fluid analysis	20.64	9.73	35	315412	1344	46369271
Alanine aminotransferase increased	20.57	9.73	448	314999	88003	46282612
Oedema	20.49	9.73	324	315123	66747	46303868
Twin pregnancy	20.42	9.73	32	315415	1149	46369466
Respiratory disorder	20.31	9.73	105	315342	27195	46343420
Scleritis	20.20	9.73	54	315393	2858	46367757
Fear	20.19	9.73	50	315397	16122	46354493
Transplant rejection	20.17	9.73	21	315426	9575	46361040
White blood cell count decreased	20.03	9.73	591	314856	111640	46258975
Birth mark	19.94	9.73	15	315432	226	46370389
Disturbance in attention	19.92	9.73	128	315319	31432	46339183
Clear cell renal cell carcinoma	19.59	9.73	29	315418	990	46369625
Graft versus host disease	19.58	9.73	10	315437	6578	46364037
Cerebrovascular accident	19.58	9.73	526	314921	100513	46270102
Surgery	19.57	9.73	288	315159	28497	46342118
Contusion	19.46	9.73	749	314698	86738	46283877
Ascites	19.40	9.73	156	315291	36428	46334187
Anaphylactic shock	19.33	9.73	71	315376	20203	46350412
Mania	19.33	9.73	27	315420	10819	46359796
Injury	19.30	9.73	197	315250	43830	46326785
Abortion threatened	19.26	9.73	22	315425	578	46370037
Immunodeficiency	19.23	9.73	153	315294	12953	46357662
Gestational hypertension	19.22	9.73	44	315403	2111	46368504
Bradyphrenia	19.21	9.73	9	315438	6221	46364394
Body height below normal	19.19	9.73	40	315407	1799	46368816
Injection site haematoma	19.13	9.73	87	315360	6025	46364590
Hospitalisation	19.09	9.73	307	315140	63078	46307537
Disorientation	18.86	9.73	159	315288	36759	46333856
Loose body in joint	18.80	9.73	29	315418	1027	46369588
Blood alkaline phosphatase increased	18.73	9.73	174	315273	39435	46331180
Bronchioloalveolar carcinoma	18.71	9.73	10	315437	79	46370536
Antinuclear antibody positive	18.63	9.73	88	315359	6192	46364423
Neonatal respiratory distress syndrome	18.62	9.73	48	315399	2485	46368130
Haemorrhage	18.51	9.73	260	315187	54609	46316006
Bronchospasm	18.50	9.73	50	315397	15657	46354958
Diverticulitis	18.48	9.73	320	315127	32719	46337896
Substance abuse	18.44	9.73	3	315444	4164	46366451
Fluid overload	18.34	9.73	108	315339	27077	46343538
Platelet count decreased	18.28	9.73	525	314922	99499	46271116
Arrhythmia	18.27	9.73	149	315298	34692	46335923
Congenital arterial malformation	18.21	9.73	17	315430	350	46370265
Breast cancer metastatic	18.10	9.73	41	315406	13637	46356978
Atrioventricular block complete	18.02	9.73	15	315432	7612	46363003
Metastases to central nervous system	18.01	9.73	30	315417	11191	46359424
Cushingoid	18.00	9.73	87	315360	6179	46364436
Nightmare	17.97	9.73	55	315392	16543	46354072
Disability	17.93	9.73	124	315323	10043	46360572
Foetal distress syndrome	17.70	9.73	31	315416	1222	46369393
Hypomania	17.64	9.73	4	315443	4384	46366231
Acute graft versus host disease	17.61	9.73	3	315444	4027	46366588
Multiple sclerosis	17.52	9.73	97	315350	24694	46345921
Foot fracture	17.52	9.73	206	315241	19376	46351239
Device difficult to use	17.41	9.73	17	315430	7987	46362628
Inappropriate antidiuretic hormone secretion	17.29	9.73	44	315403	14058	46356557
Anaemia macrocytic	17.21	9.73	48	315399	2605	46368010
Joint noise	17.18	9.73	54	315393	3133	46367482
Failed induction of labour	17.15	9.73	16	315431	329	46370286
B-cell lymphoma	17.02	9.73	55	315392	3239	46367376
Irritability	16.97	9.73	120	315327	28826	46341789
Fatigue	16.93	9.73	4489	310958	604208	45766407
Antibody test positive	16.93	9.73	42	315405	2123	46368492
Cholecystitis chronic	16.91	9.73	28	315419	10471	46360144
Lymphoma	16.91	9.73	119	315328	9694	46360921
Hypokalaemia	16.86	9.73	459	314988	87565	46283050
Coagulopathy	16.85	9.73	66	315381	18433	46352182
Venoocclusive liver disease	16.84	9.73	4	315443	4247	46366368
Febrile bone marrow aplasia	16.84	9.73	13	315434	6849	46363766
Complication associated with device	16.83	9.73	51	315396	15390	46355225
Product administration error	16.81	9.73	72	315375	19609	46351006
Autoimmune haemolytic anaemia	16.75	9.73	65	315382	4193	46366422
Fracture delayed union	16.71	9.73	42	315405	2140	46368475
Aggression	16.62	9.73	88	315359	22656	46347959
Post transplant lymphoproliferative disorder	16.57	9.73	3	315444	3853	46366762
Erythema multiforme	16.47	9.73	25	315422	9679	46360936
Wheelchair user	16.44	9.73	62	315385	3946	46366669
Injection site haemorrhage	16.43	9.73	213	315234	20496	46350119
Blood iron increased	16.36	9.73	31	315416	1300	46369315
Chest pain	16.33	9.73	1000	314447	175324	46195291
Poor venous access	16.27	9.73	104	315343	8204	46362411
Anhedonia	16.25	9.73	28	315419	10307	46360308
Synovial disorder	16.24	9.73	24	315423	818	46369797
International normalised ratio increased	16.22	9.73	221	315226	46662	46323953
Breech presentation	16.20	9.73	28	315419	1092	46369523
Tumour lysis syndrome	16.17	9.73	15	315432	7221	46363394
Disseminated tuberculosis	16.12	9.73	48	315399	2704	46367911
Injection site urticaria	16.10	9.73	137	315310	11830	46358785
Laryngitis	16.07	9.73	113	315334	9203	46361412
Respiratory distress	16.06	9.73	138	315309	31778	46338837
Congenital hypertrichosis	16.02	9.73	4	315443	0	46370615
Cystitis	15.96	9.73	386	315061	41855	46328760
Disseminated intravascular coagulation	15.95	9.73	70	315377	18935	46351680
Crying	15.90	9.73	81	315366	21060	46349555
Tonsillitis	15.79	9.73	71	315376	4893	46365722
Injection site irritation	15.70	9.73	64	315383	4223	46366392
Hiatus hernia	15.70	9.73	191	315256	18111	46352504
Withdrawal syndrome	15.70	9.73	66	315381	18068	46352547
Pulmonary fibrosis	15.67	9.73	206	315241	19886	46350729
Hypoglycaemia neonatal	15.65	9.73	25	315422	913	46369702
Haemoglobin decreased	15.60	9.73	1041	314406	127908	46242707
Obstructive airways disorder	15.57	9.73	43	315404	13369	46357246
Congenital musculoskeletal anomaly	15.39	9.73	17	315430	430	46370185
Pulmonary hypertension	15.39	9.73	162	315285	35831	46334784
Cervical incompetence	15.38	9.73	20	315427	603	46370012
Status epilepticus	15.36	9.73	46	315401	13933	46356682
Hypoplastic left heart syndrome	15.35	9.73	12	315435	192	46370423
Preterm premature rupture of membranes	15.32	9.73	26	315421	999	46369616
Human antichimeric antibody positive	15.32	9.73	31	315416	1365	46369250
Drug ineffective for unapproved indication	15.31	9.73	58	315389	16355	46354260
Tardive dyskinesia	15.30	9.73	17	315430	7526	46363089
Lung neoplasm malignant	15.24	9.73	166	315281	15323	46355292
Folate deficiency	15.24	9.73	35	315412	1683	46368932
Pulmonary oedema	15.23	9.73	248	315199	50857	46319758
Gamma-glutamyltransferase increased	15.19	9.73	139	315308	31601	46339014
Bone pain	15.18	9.73	224	315223	46666	46323949
Ketoacidosis	15.13	9.73	4	315443	3951	46366664
Hyperlipidaemia	15.12	9.73	69	315378	18470	46352145
Hyperbilirubinaemia neonatal	15.00	9.73	15	315432	337	46370278
Dactylitis	14.93	9.73	28	315419	1165	46369450
Glycosylated haemoglobin increased	14.89	9.73	32	315415	10844	46359771
Mood altered	14.88	9.73	42	315405	12965	46357650
Autism spectrum disorder	14.86	9.73	19	315428	563	46370052
Flushing	14.81	9.73	328	315119	64286	46306329
Haematotoxicity	14.76	9.73	15	315432	6918	46363697
Chronic kidney disease	14.75	9.73	191	315256	40680	46329935
Dehydration	14.73	9.73	905	314542	158635	46211980
Post procedural infection	14.68	9.73	94	315353	7419	46363196
Device use error	14.68	9.73	8	315439	5073	46365542
Face oedema	14.62	9.73	73	315374	19080	46351535
Sickle cell anaemia	14.61	9.73	19	315428	573	46370042
Dyskinesia	14.58	9.73	125	315322	28800	46341815
Aspergillus infection	14.57	9.73	15	315432	6875	46363740
Congenital tricuspid valve atresia	14.56	9.73	7	315440	43	46370572
Spinal stenosis	14.53	9.73	139	315308	12404	46358211
Asphyxia	14.51	9.73	9	315438	5317	46365298
Bursitis	14.47	9.73	201	315246	19641	46350974
Complication of device removal	14.40	9.73	3	315444	3487	46367128
Second primary malignancy	14.30	9.73	14	315433	6570	46364045
Catheter site pain	14.27	9.73	4	315443	3802	46366813
Pathogen resistance	14.22	9.73	12	315435	6048	46364567
Atrioventricular block	14.21	9.73	15	315432	6796	46363819
Pharyngitis streptococcal	14.19	9.73	102	315345	8366	46362249
Fine motor skill dysfunction	14.16	9.73	56	315391	3644	46366971
Muscular weakness	14.14	9.73	493	314954	91351	46279264
Chondropathy	14.14	9.73	37	315410	1933	46368682
Cerebral haemorrhage	14.13	9.73	123	315324	28248	46342367
Neonatal asphyxia	14.08	9.73	12	315435	218	46370397
Transplant dysfunction	14.08	9.73	7	315440	4675	46365940
Tremor neonatal	14.04	9.73	9	315438	103	46370512
Catatonia	14.02	9.73	4	315443	3758	46366857
Impaired quality of life	14.01	9.73	51	315396	3191	46367424
Hygroma colli	13.98	9.73	5	315442	12	46370603
Rotator cuff repair	13.98	9.73	31	315416	1456	46369159
Renal injury	13.97	9.73	27	315420	9514	46361101
Joint lock	13.96	9.73	38	315409	2033	46368582
Right aortic arch	13.95	9.73	13	315434	267	46370348
Pancreatitis	13.92	9.73	209	315238	43418	46327197
Haemorrhage intracranial	13.89	9.73	42	315405	12682	46357933
Morning sickness	13.88	9.73	20	315427	666	46369949
Cognitive disorder	13.82	9.73	171	315276	36712	46333903
Lymphadenectomy	13.75	9.73	23	315424	873	46369742
Lethargy	13.75	9.73	253	315194	50918	46319697
Joint warmth	13.74	9.73	28	315419	1239	46369376
Bone density abnormal	13.74	9.73	49	315398	3035	46367580
Corneal degeneration	13.73	9.73	8	315439	76	46370539
Tooth infection	13.66	9.73	135	315312	12151	46358464
Aorta hypoplasia	13.61	9.73	9	315438	109	46370506
Orthostatic hypotension	13.60	9.73	104	315343	24554	46346061
Knee operation	13.57	9.73	66	315381	4700	46365915
Cardiac failure acute	13.52	9.73	21	315426	8057	46362558
Thrombotic microangiopathy	13.52	9.73	22	315425	8284	46362331
Choanal atresia	13.48	9.73	6	315441	30	46370585
Joint dislocation	13.47	9.73	125	315322	11061	46359554
Tenosynovitis	13.46	9.73	92	315355	7423	46363192
Acute generalised exanthematous pustulosis	13.44	9.73	27	315420	9378	46361237
Joint injury	13.37	9.73	193	315254	19016	46351599
Cardiogenic shock	13.35	9.73	61	315386	16323	46354292
Complication of pregnancy	13.34	9.73	17	315430	502	46370113
Skin laceration	13.32	9.73	187	315260	18315	46352300
Benign congenital hypotonia	13.27	9.73	4	315443	4	46370611
Rash	13.26	9.73	2665	312782	353847	46016768
Wrong technique in product usage process	13.12	9.73	274	315173	54148	46316467
Myopathy	13.12	9.73	25	315422	8856	46361759
Ingrown hair	13.10	9.73	16	315431	452	46370163
Pancreatic steatosis	13.09	9.73	24	315423	981	46369634
Colitis microscopic	13.06	9.73	15	315432	6541	46364074
Bone disorder	13.06	9.73	199	315248	19834	46350781
Speech disorder developmental	12.90	9.73	15	315432	402	46370213
Drug abuser	12.89	9.73	3	315444	3230	46367385
Lupus-like syndrome	12.87	9.73	94	315353	7750	46362865
Naevus flammeus	12.82	9.73	9	315438	121	46370494
Unevaluable event	12.81	9.73	227	315220	45948	46324667
Cleft lip and palate	12.81	9.73	14	315433	350	46370265
Limb reduction defect	12.78	9.73	14	315433	351	46370264
Cholestasis	12.77	9.73	118	315329	26775	46343840
Hypoplastic right heart syndrome	12.72	9.73	7	315440	59	46370556
Tendon disorder	12.69	9.73	67	315380	4928	46365687
Infusion site erythema	12.67	9.73	20	315427	7622	46362993
Oliguria	12.64	9.73	25	315422	8734	46361881
Immune reconstitution inflammatory syndrome	12.64	9.73	12	315435	5713	46364902
Eye infection	12.57	9.73	105	315342	9018	46361597
Cyst	12.52	9.73	131	315316	11969	46358646
Threatened labour	12.50	9.73	21	315426	800	46369815
Papilloma viral infection	12.44	9.73	28	315419	1328	46369287
Dysphagia	12.37	9.73	413	315034	76899	46293716
Small cell carcinoma	12.33	9.73	10	315437	169	46370446
Panic attack	12.32	9.73	83	315364	20159	46350456
Polyneuropathy	12.31	9.73	39	315408	11605	46359010
Jaundice	12.26	9.73	130	315317	28715	46341900
Hypersensitivity	12.22	9.73	1177	314270	149144	46221471
Wound infection pseudomonas	12.20	9.73	29	315418	1426	46369189
Incorrect route of product administration	12.19	9.73	63	315384	16320	46354295
Postpartum haemorrhage	12.14	9.73	33	315414	1764	46368851
Injection site extravasation	12.11	9.73	83	315364	6702	46363913
Anterior chamber cleavage syndrome	12.09	9.73	10	315437	174	46370441
Parkinsonism	12.07	9.73	22	315425	7926	46362689
Genital haemorrhage	12.05	9.73	16	315431	6550	46364065
Infusion site pain	12.04	9.73	32	315415	10075	46360540
Blood pressure increased	12.02	9.73	1003	314444	125663	46244952
Congenital pulmonary artery anomaly	12.01	9.73	3	315444	0	46370615
Double ureter	12.01	9.73	3	315444	0	46370615
Lung neoplasm	11.96	9.73	73	315374	5667	46364948
Gastroenteritis	11.94	9.73	230	315217	23989	46346626
Hyperemesis gravidarum	11.94	9.73	16	315431	497	46370118
Catheter site erythema	11.91	9.73	6	315441	3977	46366638
Congenital cerebral cyst	11.86	9.73	10	315437	179	46370436
Vanishing twin syndrome	11.82	9.73	8	315439	101	46370514
Lung adenocarcinoma	11.81	9.73	58	315389	4146	46366469
Lordosis	11.74	9.73	12	315435	277	46370338
Pregnancy with contraceptive device	11.74	9.73	8	315439	4495	46366120
Coronary artery disease	11.71	9.73	159	315288	33593	46337022
Mycobacterium tuberculosis complex test positive	11.70	9.73	30	315417	1548	46369067
Dystonia	11.69	9.73	38	315409	11219	46359396
Injection site induration	11.68	9.73	94	315353	7985	46362630
Forceps delivery	11.68	9.73	10	315437	183	46370432
Paralysis	11.66	9.73	26	315421	8695	46361920
Hypomagnesaemia	11.64	9.73	95	315352	22115	46348500
Wound infection	11.61	9.73	114	315333	10245	46360370
Chest X-ray abnormal	11.56	9.73	53	315394	3682	46366933
Swollen tongue	11.53	9.73	134	315313	29098	46341517
Body temperature decreased	11.53	9.73	140	315307	13269	46357346
Thrombocytopenia	11.51	9.73	719	314728	125862	46244753
Ear infection	11.50	9.73	219	315228	22794	46347821
Angiocentric lymphoma	11.49	9.73	15	315432	454	46370161
Abdominal distension	11.46	9.73	393	315054	72958	46297657
Human anti-human antibody test	11.46	9.73	13	315434	339	46370276
Nervousness	11.44	9.73	130	315317	28345	46342270
Dry eye	11.43	9.73	277	315170	30045	46340570
Stress cardiomyopathy	11.42	9.73	22	315425	7762	46362853
Red blood cell sedimentation rate	11.42	9.73	32	315415	1741	46368874
Vertigo	11.42	9.73	266	315181	51782	46318833
Congenital oral malformation	11.41	9.73	10	315437	189	46370426
Hallucination, auditory	11.39	9.73	36	315411	10720	46359895
Ventricular hypoplasia	11.36	9.73	9	315438	147	46370468
Frequent bowel movements	11.35	9.73	133	315314	12499	46358116
Uterine contractions during pregnancy	11.35	9.73	16	315431	522	46370093
Viral infection	11.34	9.73	276	315171	29959	46340656
Device breakage	11.31	9.73	31	315416	9661	46360954
Vacuum extractor delivery	11.31	9.73	9	315438	148	46370467
Erysipelas	11.30	9.73	83	315364	6855	46363760
Delivery	11.23	9.73	18	315429	659	46369956
Loss of proprioception	11.16	9.73	13	315434	349	46370266
Sinus tachycardia	11.16	9.73	93	315354	21556	46349059
Hyperprolactinaemia	11.15	9.73	3	315444	2929	46367686
Renal mass	11.14	9.73	32	315415	1766	46368849
Lymphatic fistula	11.14	9.73	21	315426	877	46369738
Polychondritis	11.13	9.73	14	315433	408	46370207
Crystal nephropathy	11.13	9.73	20	315427	805	46369810
Pelvi-ureteric obstruction	11.12	9.73	8	315439	112	46370503
Abortion	11.11	9.73	37	315410	2213	46368402
Pulmonary valve stenosis congenital	11.06	9.73	9	315438	153	46370462
Pleural effusion	11.06	9.73	453	314994	82499	46288116
Inflammatory marker increased	11.01	9.73	69	315378	5406	46365209
Anger	10.98	9.73	42	315405	11810	46358805
Vascular device infection	10.97	9.73	5	315442	3512	46367103
Femoral hernia incarcerated	10.96	9.73	21	315426	888	46369727
Nail injury	10.95	9.73	14	315433	415	46370200
Congenital skin dimples	10.91	9.73	9	315438	156	46370459
Carpal tunnel syndrome	10.91	9.73	159	315288	15700	46354915
Congenital megaureter	10.86	9.73	7	315440	81	46370534
Cleft palate	10.83	9.73	21	315426	896	46369719
Limb injury	10.83	9.73	186	315261	18988	46351627
Laryngospasm	10.81	9.73	3	315444	2870	46367745
Muscle rigidity	10.79	9.73	33	315414	9928	46360687
Prothrombin consumption time prolonged	10.76	9.73	6	315441	52	46370563
Conjunctivitis	10.75	9.73	155	315292	15269	46355346
Stevens-Johnson syndrome	10.73	9.73	103	315344	23194	46347421
Headache	10.70	9.73	2974	312473	475378	45895237
Axonal neuropathy	10.70	9.73	22	315425	980	46369635
Coronary arterial stent insertion	10.70	9.73	3	315444	2850	46367765
Amniotic fluid volume decreased	10.67	9.73	14	315433	426	46370189
Endodontic procedure	10.66	9.73	39	315408	2446	46368169
Creatinine renal clearance decreased	10.65	9.73	19	315428	6901	46363714
Somnambulism	10.61	9.73	11	315436	5026	46365589
Pelvic fracture	10.59	9.73	122	315325	11417	46359198
Abortion induced	10.58	9.73	111	315336	10149	46360466
Acute respiratory failure	10.57	9.73	136	315311	29002	46341613
Respiration abnormal	10.55	9.73	9	315438	4512	46366103
Pleurisy	10.52	9.73	89	315358	7673	46362942
Renal aplasia	10.51	9.73	10	315437	211	46370404
Miosis	10.50	9.73	18	315429	6639	46363976
Syndactyly	10.49	9.73	12	315435	316	46370299
Acute myeloid leukaemia	10.47	9.73	63	315384	15715	46354900
Pyrexia	10.46	9.73	2139	313308	346663	46023952
Cartilage injury	10.46	9.73	29	315418	1568	46369047
Mucosal toxicity	10.46	9.73	12	315435	317	46370298
Gastrointestinal haemorrhage	10.43	9.73	422	315025	76951	46293664
Inflammatory pain	10.38	9.73	17	315430	634	46369981
Catheter management	10.37	9.73	3	315444	2792	46367823
Hyperkalaemia	10.34	9.73	262	315185	50447	46320168
Intestinal stenosis	10.34	9.73	39	315408	2482	46368133
Carcinoma in situ of skin	10.32	9.73	10	315437	216	46370399
Pustular psoriasis	10.29	9.73	54	315393	3963	46366652
Ulcer	10.29	9.73	170	315277	17222	46353393
Rheumatoid lung	10.29	9.73	30	315417	1670	46368945
Vascular rupture	10.26	9.73	25	315422	1249	46369366
Foetal hypokinesia	10.23	9.73	14	315433	444	46370171
Tachypnoea	10.22	9.73	56	315391	14295	46356320
Atrial fibrillation	10.20	9.73	584	314863	103006	46267609
Potentiating drug interaction	10.19	9.73	7	315440	3916	46366699
Anal prolapse	10.18	9.73	8	315439	129	46370486
Foetal heart rate deceleration abnormality	10.18	9.73	14	315433	446	46370169
Mass	10.17	9.73	122	315325	11531	46359084
Limb malformation	10.16	9.73	14	315433	447	46370168
Delusion	10.14	9.73	40	315407	11148	46359467
General physical health deterioration	10.11	9.73	660	314787	115109	46255506
Product physical issue	10.11	9.73	11	315436	4916	46365699
Decreased insulin requirement	10.08	9.73	8	315439	131	46370484
Drug screen positive	10.03	9.73	7	315440	3884	46366731
Haematocrit decreased	10.02	9.73	309	315138	34748	46335867
Off label use	10.02	9.73	2344	313103	377497	45993118
Rheumatoid factor increased	9.96	9.73	26	315421	1356	46369259
Cervix haematoma uterine	9.95	9.73	3	315444	3	46370612
Congenital oesophageal anomaly	9.95	9.73	3	315444	3	46370612
Congenital neurological disorder	9.95	9.73	3	315444	3	46370612
Gross motor delay	9.92	9.73	7	315440	95	46370520
Crohn's disease	9.91	9.73	79	315368	6692	46363923
Myofascial pain syndrome	9.86	9.73	32	315415	1889	46368726
Selective eating disorder	9.81	9.73	30	315417	1715	46368900
Teratoma benign	9.80	9.73	6	315441	63	46370552
Lip swelling	9.79	9.73	117	315330	25278	46345337

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
Foetal exposure during pregnancy	780.87	9.71	926	143699	35945	29771908
Rheumatoid arthritis	415.10	9.71	727	143898	40470	29767383
Drug abuse	314.08	9.71	21	144604	82051	29725802
Completed suicide	252.21	9.71	83	144542	99409	29708444
Toxicity to various agents	250.74	9.71	292	144333	176891	29630962
Atrial septal defect	232.27	9.71	219	144406	6482	29801371
Small for dates baby	222.18	9.71	157	144468	3051	29804802
Arthralgia	170.60	9.71	1181	143444	134610	29673243
Hypospadias	167.00	9.71	123	144502	2556	29805297
Premature baby	164.65	9.71	292	144333	16399	29791454
Ventricular septal defect	139.19	9.71	124	144501	3405	29804448
Psoriatic arthropathy	113.00	9.71	241	144384	15520	29792333
Maternal exposure during pregnancy	110.85	9.71	114	144511	3757	29804096
Dysmorphism	108.91	9.71	85	144540	1932	29805921
Sickle cell anaemia with crisis	103.98	9.71	89	144536	2313	29805540
Neonatal respiratory distress syndrome	98.70	9.71	109	144516	3903	29803950
Death	95.36	9.71	1187	143438	356096	29451757
Cryptorchism	89.10	9.71	70	144555	1607	29806246
Respiratory disorder neonatal	88.96	9.71	61	144564	1127	29806726
Pancytopenia	88.04	9.71	707	143918	84345	29723508
Agitation neonatal	87.26	9.71	57	144568	968	29806885
Joint swelling	81.34	9.71	444	144181	46502	29761351
Congenital umbilical hernia	80.61	9.71	39	144586	356	29807497
Drug interaction	77.46	9.71	605	144020	198963	29608890
Maternal drugs affecting foetus	76.91	9.71	99	144526	4174	29803679
Exposure during pregnancy	76.30	9.71	150	144475	9111	29798742
Intentional overdose	73.00	9.71	56	144569	41425	29766428
Low birth weight baby	71.46	9.71	115	144510	5961	29801892
Hypoglycaemia neonatal	71.28	9.71	60	144565	1523	29806330
Tenosynovitis	70.55	9.71	86	144539	3429	29804424
Haemangioma congenital	67.35	9.71	38	144587	488	29807365
Enthesopathy	64.76	9.71	75	144550	2831	29805022
Overdose	61.66	9.71	205	144420	84132	29723721
Suicide attempt	61.49	9.71	52	144573	36645	29771208
Foetal anticonvulsant syndrome	60.95	9.71	41	144584	733	29807120
Hypotonia neonatal	59.13	9.71	45	144580	984	29806869
Syndactyly	57.89	9.71	39	144586	699	29807154
Nasopharyngitis	56.47	9.71	481	144144	58368	29749485
Talipes	54.73	9.71	53	144572	1622	29806231
Bradycardia neonatal	54.73	9.71	41	144584	875	29806978
Speech disorder developmental	53.73	9.71	45	144580	1134	29806719
Renal aplasia	53.59	9.71	36	144589	642	29807211
Musculoskeletal stiffness	53.42	9.71	326	144299	35555	29772298
Hypertonia neonatal	51.27	9.71	28	144597	336	29807517
Intentional product misuse	51.22	9.71	55	144570	34612	29773241
Hyperbilirubinaemia neonatal	50.65	9.71	35	144590	655	29807198
Patent ductus arteriosus	50.24	9.71	69	144556	3100	29804753
Blood pressure fluctuation	50.11	9.71	192	144433	17311	29790542
Drug withdrawal syndrome neonatal	48.64	9.71	68	144557	3107	29804746
Synovitis	47.86	9.71	129	144496	9654	29798199
Selective eating disorder	47.15	9.71	49	144576	1635	29806218
Hepatic function abnormal	46.44	9.71	82	144543	41863	29765990
Large for dates baby	45.54	9.71	36	144589	834	29807019
Psoriasis	44.84	9.71	355	144270	42151	29765702
Maternal exposure during breast feeding	44.82	9.71	47	144578	1585	29806268
Drug resistance	44.05	9.71	21	144604	20112	29787741
Drug reaction with eosinophilia and systemic symptoms	43.43	9.71	44	144581	28444	29779409
Developmental delay	42.35	9.71	52	144573	2089	29805764
Tongue disorder	41.82	9.71	75	144550	4247	29803606
Basal cell carcinoma	40.97	9.71	170	144455	15898	29791955
Exposure via breast milk	40.92	9.71	44	144581	1528	29806325
Drug withdrawal syndrome	39.89	9.71	23	144602	19786	29788067
Cardiac arrest	39.02	9.71	275	144350	92575	29715278
Pulmonary fibrosis	38.87	9.71	166	144459	15724	29792129
Drug dependence	38.42	9.71	28	144597	21267	29786586
Rhabdomyolysis	38.39	9.71	167	144458	63413	29744440
Coma	37.99	9.71	87	144538	40362	29767491
Caesarean section	37.66	9.71	49	144576	2088	29805765
Serotonin syndrome	37.14	9.71	20	144605	17871	29789982
Foetal growth restriction	37.00	9.71	64	144561	3521	29804332
Rheumatoid nodule	36.63	9.71	43	144582	1647	29806206
Palmar-plantar erythrodysaesthesia syndrome	36.60	9.71	13	144612	14857	29792996
Spina bifida	36.56	9.71	22	144603	321	29807532
Febrile neutropenia	36.11	9.71	335	144290	106358	29701495
Autism spectrum disorder	36.10	9.71	38	144587	1287	29806566
Foot deformity	35.01	9.71	61	144564	3376	29804477
C-reactive protein abnormal	34.99	9.71	81	144544	5512	29802341
Respiratory arrest	34.41	9.71	55	144570	29203	29778650
Agitation	33.27	9.71	141	144484	53932	29753921
Infusion related reaction	33.01	9.71	320	144305	40244	29767609
Plagiocephaly	31.97	9.71	20	144605	314	29807539
Suicidal ideation	31.30	9.71	81	144544	36033	29771820
Haemoglobin decreased	31.19	9.71	746	143879	113352	29694501
Congenital hydronephrosis	31.19	9.71	26	144599	651	29807202
Birth mark	30.29	9.71	17	144608	216	29807637
Drug intolerance	30.12	9.71	343	144282	44948	29762905
General physical health deterioration	29.96	9.71	662	143963	99282	29708571
Poisoning	29.68	9.71	9	144616	11373	29796480
Arthritis	29.22	9.71	210	144415	24191	29783662
Osteoarthritis	28.76	9.71	169	144456	18180	29789673
Renal failure	28.64	9.71	444	144181	128522	29679331
Kidney duplex	28.37	9.71	19	144606	337	29807516
Congenital tricuspid valve incompetence	28.37	9.71	14	144611	134	29807719
Intellectual disability	28.30	9.71	27	144598	811	29807042
Bradycardia	28.05	9.71	193	144432	65333	29742520
Medical device implantation	27.71	9.71	22	144603	513	29807340
Angioedema	27.64	9.71	80	144545	34304	29773549
Pain	27.51	9.71	1056	143569	171585	29636268
Blood creatine phosphokinase increased	27.18	9.71	114	144511	43734	29764119
Constipation	27.04	9.71	383	144242	112523	29695330
Delirium	26.85	9.71	103	144522	40528	29767325
Altered state of consciousness	26.84	9.71	34	144591	19885	29787968
Folate deficiency	25.84	9.71	28	144597	981	29806872
Arthropathy	25.76	9.71	180	144445	20547	29787306
Abnormal palmar/plantar creases	25.65	9.71	15	144610	207	29807646
Neonatal seizure	25.42	9.71	20	144605	460	29807393
Lower respiratory tract infection	25.42	9.71	218	144407	26496	29781357
Hyperglycaemia	25.40	9.71	86	144539	35114	29772739
Low set ears	25.34	9.71	19	144606	406	29807447
Foetal heart rate deceleration abnormality	25.22	9.71	19	144606	409	29807444
Pathogen resistance	25.14	9.71	5	144620	8405	29799448
Electrocardiogram QT prolonged	24.88	9.71	89	144536	35746	29772107
Alanine aminotransferase abnormal	24.77	9.71	45	144580	2574	29805279
Hypermobility syndrome	24.23	9.71	15	144610	231	29807622
Product use in unapproved indication	24.23	9.71	233	144392	73460	29734393
Blood pressure systolic abnormal	24.17	9.71	33	144592	1474	29806379
Skin cancer	24.17	9.71	89	144536	7872	29799981
Motor developmental delay	24.16	9.71	17	144608	328	29807525
Dermatitis psoriasiform	24.07	9.71	29	144596	1142	29806711
Pyelocaliectasis	23.93	9.71	27	144598	990	29806863
Congenital hand malformation	23.79	9.71	19	144606	447	29807406
Single umbilical artery	23.68	9.71	15	144610	241	29807612
Blood pressure systolic increased	23.57	9.71	139	144486	14971	29792882
Juvenile idiopathic arthritis	23.38	9.71	27	144598	1016	29806837
Infantile apnoea	23.34	9.71	25	144600	864	29806989
Loss of personal independence in daily activities	23.33	9.71	181	144444	21354	29786499
Disease progression	23.21	9.71	260	144365	79614	29728239
Serum ferritin increased	22.98	9.71	68	144557	5369	29802484
Knee arthroplasty	22.46	9.71	69	144556	5561	29802292
Temperature regulation disorder	22.22	9.71	19	144606	493	29807360
Weight decrease neonatal	22.20	9.71	16	144609	321	29807532
Congenital myopia	22.12	9.71	7	144618	16	29807837
Anal fistula	22.00	9.71	55	144570	3931	29803922
Infective pulmonary exacerbation of cystic fibrosis	21.95	9.71	7	144618	8565	29799288
Congenital knee deformity	21.79	9.71	9	144616	54	29807799
Congenital skin dimples	21.76	9.71	12	144613	147	29807706
Shock	21.60	9.71	49	144576	22810	29785043
Prostate cancer	21.49	9.71	193	144432	23764	29784089
Floppy infant	21.48	9.71	10	144615	83	29807770
Substance abuse	21.44	9.71	4	144621	7036	29800817
Developmental coordination disorder	21.42	9.71	8	144617	35	29807818
Product quality issue	21.42	9.71	36	144589	18738	29789115
Musculoskeletal pain	21.33	9.71	236	144389	30704	29777149
Knee deformity	21.29	9.71	16	144609	343	29807510
Polydactyly	21.27	9.71	28	144597	1207	29806646
Psychotic disorder	21.25	9.71	45	144580	21470	29786383
Cleft lip and palate	21.24	9.71	15	144610	291	29807562
Vitamin D deficiency	21.22	9.71	64	144561	5106	29802747
Congenital astigmatism	21.01	9.71	7	144618	20	29807833
Sedation	20.98	9.71	29	144596	16344	29791509
Arthritis bacterial	20.97	9.71	58	144567	4406	29803447
Urticaria	20.89	9.71	166	144459	54440	29753413
Neuroleptic malignant syndrome	20.74	9.71	29	144596	16266	29791587
Joint effusion	20.70	9.71	51	144574	3612	29804241
Somnolence	20.50	9.71	336	144289	96427	29711426
Otitis media	20.40	9.71	41	144584	2530	29805323
Immunosuppression	20.25	9.71	63	144562	5112	29802741
Pulmonary artery stenosis congenital	20.18	9.71	18	144607	495	29807358
Microcephaly	20.13	9.71	20	144605	632	29807221
Hand deformity	20.07	9.71	34	144591	1839	29806014
Joint range of motion decreased	20.03	9.71	68	144557	5777	29802076
Foetal disorder	19.97	9.71	20	144605	638	29807215
Joint laxity	19.30	9.71	9	144616	75	29807778
Post procedural infection	19.15	9.71	57	144568	4515	29803338
Sopor	19.12	9.71	15	144610	10976	29796877
Congenital bladder anomaly	18.96	9.71	14	144611	292	29807561
Cardio-respiratory arrest	18.91	9.71	181	144444	57125	29750728
Pectus excavatum	18.90	9.71	9	144616	79	29807774
Ectopic kidney	18.71	9.71	8	144617	53	29807800
Blood pressure increased	18.65	9.71	467	144158	71461	29736392
Maternal exposure before pregnancy	18.63	9.71	15	144610	357	29807496
Multiple congenital abnormalities	18.28	9.71	17	144608	494	29807359
Tendonitis	18.17	9.71	82	144543	7954	29799899
Limb malformation	17.98	9.71	14	144611	317	29807536
Tuberculosis	17.95	9.71	82	144543	7995	29799858
Lacrimal disorder	17.94	9.71	14	144611	318	29807535
Hydrocele	17.93	9.71	34	144591	2010	29805843
Cleft palate	17.58	9.71	18	144607	590	29807263
Jaundice neonatal	17.56	9.71	24	144601	1073	29806780
Tonsil cancer	17.41	9.71	20	144605	748	29807105
Language disorder	17.41	9.71	26	144599	1262	29806591
Respiratory failure	17.41	9.71	362	144263	100280	29707573
Ankyloglossia congenital	17.37	9.71	13	144612	277	29807576
Acute hepatic failure	17.20	9.71	19	144606	11808	29796045
Body temperature decreased	17.17	9.71	92	144533	9563	29798290
Hypoxia	17.16	9.71	148	144477	47706	29760147
Haematocrit decreased	17.15	9.71	225	144400	30474	29777379
Depressed level of consciousness	17.14	9.71	111	144514	38111	29769742
Pain in extremity	17.00	9.71	672	143953	109549	29698304
Pulmonary valve stenosis congenital	16.98	9.71	10	144615	140	29807713
Transposition of the great vessels	16.89	9.71	16	144609	476	29807377
Hypoglycaemia	16.83	9.71	161	144464	50820	29757033
Poor venous access	16.72	9.71	37	144588	2443	29805410
Kinematic imbalances due to suboccipital strain	16.49	9.71	6	144619	24	29807829
Microphthalmos	16.48	9.71	11	144614	194	29807659
Dyspraxia	16.43	9.71	12	144613	246	29807607
Nasal disorder	16.35	9.71	24	144601	1147	29806706
Hepatic failure	16.23	9.71	97	144528	33946	29773907
Post transplant lymphoproliferative disorder	16.19	9.71	3	144622	5303	29802550
Wound	16.18	9.71	109	144516	12293	29795560
Hallucination	16.16	9.71	155	144470	48904	29758949
Off label use	16.10	9.71	1013	143612	248277	29559576
Mean cell volume increased	15.97	9.71	33	144592	2077	29805776
Acute kidney injury	15.97	9.71	1123	143502	272719	29535134
Congenital cerebral cyst	15.93	9.71	5	144620	11	29807842
Neck mass	15.85	9.71	26	144599	1369	29806484
Hepatic cyst	15.82	9.71	36	144589	2422	29805431
Cleft lip	15.78	9.71	13	144612	320	29807533
Renal impairment	15.70	9.71	299	144326	83885	29723968
Malignant neoplasm progression	15.64	9.71	250	144375	72037	29735816
Accessory spleen	15.50	9.71	10	144615	166	29807687
Learning disorder	15.44	9.71	15	144610	461	29807392
Coarctation of the aorta	15.41	9.71	15	144610	462	29807391
Intentional self-injury	15.39	9.71	26	144599	13506	29794347
Base excess decreased	15.38	9.71	11	144614	218	29807635
Peripheral swelling	15.38	9.71	395	144230	60679	29747174
Lung neoplasm malignant	15.20	9.71	125	144500	15007	29792846
Epispadias	15.10	9.71	10	144615	174	29807679
Poikiloderma	15.05	9.71	10	144615	175	29807678
Arthrodesis	14.99	9.71	14	144611	409	29807444
Injection site pain	14.84	9.71	217	144408	30093	29777760
Maternal exposure timing unspecified	14.77	9.71	13	144612	351	29807502
Wrong technique in product usage process	14.73	9.71	89	144536	31066	29776787
Umbilical hernia	14.73	9.71	45	144580	3616	29804237
Diverticular perforation	14.65	9.71	41	144584	3136	29804717
Pulmonary valve stenosis	14.62	9.71	13	144612	356	29807497
Kyphosis congenital	14.60	9.71	4	144621	4	29807849
Incorrect route of product administration	14.54	9.71	20	144605	11295	29796558
Joint stiffness	14.53	9.71	86	144539	9275	29798578
Bronchial carcinoma	14.50	9.71	20	144605	902	29806951
Pseudolymphoma	14.44	9.71	15	144610	500	29807353
Cytomegalovirus infection	14.39	9.71	62	144563	23612	29784241
Congenital melanocytic naevus	14.36	9.71	5	144620	17	29807836
Anal atresia	14.28	9.71	12	144613	304	29807549
Grip strength decreased	14.23	9.71	32	144593	2136	29805717
Therapeutic product effect decreased	14.17	9.71	208	144417	28868	29778985
Congenital anomaly	14.17	9.71	24	144601	1298	29806555
Malignant melanoma	14.13	9.71	72	144553	7339	29800514
Blood pressure diastolic increased	14.13	9.71	37	144588	2721	29805132
Dysgraphia	14.09	9.71	26	144599	1505	29806348
Prominent epicanthal folds	14.08	9.71	9	144616	147	29807706
Septic arthritis staphylococcal	14.07	9.71	14	144611	443	29807410
Drug-induced liver injury	14.01	9.71	54	144571	21220	29786633
Plasma cell myeloma	14.00	9.71	178	144447	53284	29754569
Red blood cell sedimentation rate increased	14.00	9.71	71	144554	7224	29800629
Infection	13.97	9.71	484	144141	77590	29730263
Intraventricular haemorrhage neonatal	13.90	9.71	10	144615	200	29807653
Unresponsive to stimuli	13.83	9.71	73	144552	26346	29781507
Congenital megaureter	13.77	9.71	8	144617	109	29807744
Hydrops foetalis	13.76	9.71	11	144614	259	29807594
Emphysema	13.72	9.71	85	144540	9317	29798536
Fine motor skill dysfunction	13.69	9.71	22	144603	1139	29806714
Anxiety	13.62	9.71	330	144295	89541	29718312
Peripheral artery thrombosis	13.61	9.71	32	144593	2200	29805653
Oesophageal adenocarcinoma	13.59	9.71	19	144606	868	29806985
Toxic epidermal necrolysis	13.51	9.71	43	144582	17897	29789956
Congenital central nervous system anomaly	13.50	9.71	13	144612	395	29807458
Cerebral haemorrhage neonatal	13.41	9.71	11	144614	269	29807584
Vitamin B12 deficiency	13.40	9.71	35	144590	2570	29805283
Foetal distress syndrome	13.39	9.71	20	144605	971	29806882
Finger deformity	13.38	9.71	20	144605	972	29806881
Asthma	13.36	9.71	111	144514	36063	29771790
Pulmonary artery stenosis	13.33	9.71	9	144616	162	29807691
Joint contracture	13.29	9.71	28	144597	1787	29806066
Neutrophil count decreased	13.20	9.71	136	144489	42318	29765535
Congenital mitral valve incompetence	13.11	9.71	7	144618	80	29807773
Hypotension	13.11	9.71	814	143811	199751	29608102
Haptoglobin decreased	13.10	9.71	15	144610	559	29807294
Mouth ulceration	13.10	9.71	92	144533	10517	29797336
Injection site bruising	13.10	9.71	70	144555	7268	29800585
Ventricular fibrillation	13.08	9.71	34	144591	15104	29792749
Immunodeficiency	13.03	9.71	48	144577	4246	29803607
Ultrasound antenatal screen	13.01	9.71	3	144622	0	29807853
Umbilical granuloma	13.01	9.71	3	144622	0	29807853
Ophthalmia neonatorum	13.01	9.71	3	144622	0	29807853
Diabetic ketoacidosis	12.99	9.71	37	144588	15949	29791904
Oxygen consumption decreased	12.95	9.71	9	144616	170	29807683
Ear infection	12.93	9.71	70	144555	7304	29800549
Vascular insufficiency	12.89	9.71	12	144613	349	29807504
Venoocclusive liver disease	12.86	9.71	8	144617	6605	29801248
Aggression	12.85	9.71	115	144510	36792	29771061
Latent tuberculosis	12.82	9.71	19	144606	916	29806937
Hernia pain	12.79	9.71	10	144615	228	29807625
Skull malformation	12.73	9.71	12	144613	355	29807498
Pyrexia	12.70	9.71	1237	143388	293252	29514601
Bronchiolitis	12.70	9.71	33	144592	2415	29805438
Weight decreased	12.60	9.71	868	143757	150053	29657800
Arthritis infective	12.59	9.71	35	144590	2667	29805186
Erectile dysfunction	12.54	9.71	45	144580	18057	29789796
Strabismus	12.46	9.71	21	144604	1131	29806722
Foetal hypokinesia	12.45	9.71	12	144613	365	29807488
Blood insulin increased	12.37	9.71	12	144613	368	29807485
Reticulocytosis	12.35	9.71	11	144614	302	29807551
C-reactive protein decreased	12.33	9.71	25	144600	1553	29806300
Astigmatism	12.30	9.71	17	144608	768	29807085
Hypothermia neonatal	12.27	9.71	7	144618	92	29807761
Haemolysis	12.25	9.71	68	144557	7163	29800690
Clinodactyly	12.24	9.71	8	144617	136	29807717
Nightmare	12.14	9.71	25	144600	12051	29795802
Placental insufficiency	12.14	9.71	7	144618	94	29807759
Cystitis haemorrhagic	12.10	9.71	4	144621	4783	29803070
Cholelithiasis	12.04	9.71	150	144475	20075	29787778
Oropharyngeal pain	12.04	9.71	199	144426	28297	29779556
Sexual dysfunction	12.03	9.71	7	144618	5994	29801859
Lung cancer metastatic	12.03	9.71	33	144592	2495	29805358
Blood pressure diastolic abnormal	12.03	9.71	22	144603	1265	29806588
Neonatal respiratory distress	12.01	9.71	13	144612	455	29807398
Arnold-Chiari malformation	11.94	9.71	10	144615	252	29807601
Stevens-Johnson syndrome	11.92	9.71	44	144581	17512	29790341
JC virus CSF test positive	11.88	9.71	7	144618	98	29807755
Scleroderma renal crisis	11.88	9.71	7	144618	98	29807755
Oesophageal atresia	11.87	9.71	13	144612	461	29807392
Skin indentation	11.87	9.71	4	144621	12	29807841
Palindromic rheumatism	11.86	9.71	9	144616	196	29807657
Crohn's disease	11.85	9.71	47	144578	4305	29803548
Peritoneal tuberculosis	11.75	9.71	12	144613	392	29807461
Hypertrophy	11.71	9.71	11	144614	324	29807529
Abnormal behaviour	11.70	9.71	74	144551	25549	29782304
Lower respiratory tract congestion	11.68	9.71	19	144606	994	29806859
Sinusitis	11.66	9.71	226	144399	33119	29774734
Premature delivery	11.64	9.71	7	144618	102	29807751
Excessive cerumen production	11.61	9.71	10	144615	262	29807591
Laryngomalacia	11.61	9.71	10	144615	262	29807591
Cellulitis	11.60	9.71	302	144323	46482	29761371
Gangrene neonatal	11.51	9.71	9	144616	205	29807648
Developmental hip dysplasia	11.49	9.71	10	144615	266	29807587
Congenital musculoskeletal anomaly	11.44	9.71	9	144616	207	29807646
Pleural fibrosis	11.43	9.71	23	144602	1421	29806432
Poor sucking reflex	11.42	9.71	10	144615	268	29807585
Abnormal labour affecting foetus	11.40	9.71	4	144621	14	29807839
Injection site swelling	11.35	9.71	77	144548	8703	29799150
Scleroedema	11.34	9.71	5	144620	36	29807817
Congenital aortic valve incompetence	11.34	9.71	8	144617	155	29807698
Kidney infection	11.33	9.71	48	144577	4530	29803323
Moaning	11.31	9.71	16	144609	739	29807114
Neuroendocrine tumour of the lung metastatic	11.30	9.71	7	144618	108	29807745
Bursitis	11.28	9.71	48	144577	4538	29803315
Inguinal hernia	11.27	9.71	66	144559	7089	29800764
Intestinal stenosis	11.27	9.71	27	144598	1878	29805975
Pneumonia	11.21	9.71	1807	142818	332499	29475354
Nose deformity	11.21	9.71	8	144617	158	29807695
Duodenal atresia	11.19	9.71	4	144621	15	29807838
Prognathism	11.19	9.71	4	144621	15	29807838
Micropenis	11.12	9.71	5	144620	38	29807815
Neurotoxicity	11.09	9.71	30	144595	13152	29794701
Alcohol abuse	11.09	9.71	6	144619	5347	29802506
Delusion	11.08	9.71	26	144599	11963	29795890
Congenital diaphragmatic hernia	11.08	9.71	9	144616	217	29807636
Radiation inflammation	11.02	9.71	7	144618	113	29807740
Glycosylated haemoglobin increased	11.01	9.71	18	144607	9473	29798380
No adverse event	10.97	9.71	45	144580	17374	29790479
Urinary tract malformation	10.95	9.71	3	144622	3	29807850
Encephalocele	10.95	9.71	3	144622	3	29807850
Hernia congenital	10.95	9.71	3	144622	3	29807850
Myalgia	10.94	9.71	284	144341	76383	29731470
Thinking abnormal	10.93	9.71	6	144619	5305	29802548
Dermatitis acneiform	10.90	9.71	7	144618	5682	29802171
Tachycardia	10.83	9.71	272	144353	73467	29734386
Red blood cell count decreased	10.82	9.71	183	144442	26138	29781715
Major depression	10.82	9.71	3	144622	4019	29803834
Strabismus congenital	10.79	9.71	5	144620	41	29807812
Gastrooesophageal sphincter insufficiency	10.77	9.71	6	144619	75	29807778
Ear disorder	10.75	9.71	17	144608	868	29806985
Adenomatous polyposis coli	10.75	9.71	8	144617	169	29807684
Steatorrhoea	10.63	9.71	15	144610	691	29807162
Anti-erythropoietin antibody positive	10.63	9.71	17	144608	876	29806977
Foetal heart rate abnormal	10.63	9.71	8	144617	172	29807681
Meconium in amniotic fluid	10.62	9.71	4	144621	18	29807835
Aorticopulmonary septal defect	10.62	9.71	4	144621	18	29807835
Squamous cell carcinoma of lung	10.60	9.71	25	144600	1722	29806131
Brain oedema	10.59	9.71	28	144597	12370	29795483
Skin infection	10.55	9.71	58	144567	6086	29801767
Lipase increased	10.49	9.71	16	144609	8660	29799193
Multiple organ dysfunction syndrome	10.49	9.71	230	144395	63257	29744596
Anaemia vitamin B12 deficiency	10.49	9.71	10	144615	300	29807553
Oral herpes	10.48	9.71	46	144579	4409	29803444
Neutropenia neonatal	10.47	9.71	13	144612	528	29807325
BK virus infection	10.43	9.71	4	144621	4360	29803493
Scoliosis	10.41	9.71	24	144601	1628	29806225
Hepatitis C	10.41	9.71	31	144594	13174	29794679
Myocardial infarction	10.40	9.71	498	144127	125127	29682726
Cardiac failure	10.38	9.71	315	144310	83103	29724750
Transverse presentation	10.38	9.71	6	144619	81	29807772
Abscess limb	10.37	9.71	36	144589	3093	29804760
Hyperammonaemia	10.30	9.71	7	144618	5513	29802340
Psychomotor retardation	10.29	9.71	30	144595	2349	29805504
Gross motor delay	10.29	9.71	9	144616	241	29807612
Umbilical cord around neck	10.28	9.71	8	144617	181	29807672
Aplasia pure red cell	10.27	9.71	54	144571	5572	29802281
Body dysmorphic disorder	10.25	9.71	6	144619	83	29807770
Hepatic siderosis	10.24	9.71	8	144617	182	29807671
Vomiting	10.23	9.71	918	143707	218900	29588953
Mesothelioma	10.21	9.71	12	144613	460	29807393
Macrosomia	10.19	9.71	6	144619	84	29807769
Joint instability	10.18	9.71	11	144614	384	29807469
Subdural haematoma	10.17	9.71	52	144573	18920	29788933
Blood pressure diastolic decreased	10.16	9.71	58	144567	6173	29801680
Disseminated intravascular coagulation	10.14	9.71	64	144561	22107	29785746
Autosomal chromosome anomaly	10.12	9.71	4	144621	21	29807832
Ligament laxity	10.12	9.71	4	144621	21	29807832
Pancreatic duct stenosis	10.06	9.71	8	144617	187	29807666
Congenital pulmonary hypertension	10.03	9.71	5	144620	49	29807804
Large intestinal stenosis	10.00	9.71	20	144605	1230	29806623
Ear malformation	9.98	9.71	9	144616	251	29807602
Renal hypertrophy	9.97	9.71	4	144621	22	29807831
Tachycardia foetal	9.94	9.71	10	144615	321	29807532
Contraindicated product administered	9.92	9.71	127	144498	17104	29790749
Neonatal hyponatraemia	9.89	9.71	6	144619	89	29807764
Potentiating drug interaction	9.87	9.71	5	144620	4626	29803227
Fracture	9.85	9.71	56	144569	5950	29801903
Pulmonary tuberculosis	9.83	9.71	48	144577	4809	29803044
Aplasia cutis congenita	9.77	9.71	7	144618	139	29807714
C-reactive protein increased	9.75	9.71	277	144348	43196	29764657
Congenital spinal cord anomaly	9.75	9.71	3	144622	6	29807847
Pyloric stenosis	9.72	9.71	13	144612	569	29807284

Pharmacologic Action:

Source	Code	Description
ATC	B03BB01	BLOOD AND BLOOD FORMING ORGANS ANTIANEMIC PREPARATIONS VITAMIN B12 AND FOLIC ACID Folic acid and derivatives
ATC	V04CX02	VARIOUS DIAGNOSTIC AGENTS OTHER DIAGNOSTIC AGENTS Other diagnostic agents
ATC	B03AE01	BLOOD AND BLOOD FORMING ORGANS ANTIANEMIC PREPARATIONS IRON PREPARATIONS Iron in other combinations
ATC	B03AE02	BLOOD AND BLOOD FORMING ORGANS ANTIANEMIC PREPARATIONS IRON PREPARATIONS Iron in other combinations
ATC	B03BB51	BLOOD AND BLOOD FORMING ORGANS ANTIANEMIC PREPARATIONS VITAMIN B12 AND FOLIC ACID Folic acid and derivatives
MeSH PA	D006397	Hematinics
MeSH PA	D006401	Hematologic Agents
MeSH PA	D018977	Micronutrients
MeSH PA	D014803	Vitamin B Complex
MeSH PA	D014815	Vitamins
CHEBI has role	CHEBI:33284	nutrients
CHEBI has role	CHEBI:75769	vitamin b
CHEBI has role	CHEBI:75771	mus musculus metabolite
CHEBI has role	CHEBI:77746	h. sapiens metabolites

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Megaloblastic anemia due to folate deficiency	indication	85649008	DOID:14026
Vitamin deficiency	indication	85670002
Iron deficiency anemia	indication	87522002
Mineral deficiency	indication	111379007
Folic acid deficiency	indication	190633005
Pregnancy, function	indication	289908002
Breastfeeding (mother)	indication	413712001
Vitamin Deficiency Prevention	indication
Mineral Deficiency Prevention	indication
Prevention of Vitamin B12 Deficiency	indication
Homocystinuria	off-label use	11282001	DOID:9263
Homocystinemia	off-label use	52311001
Prevention of Fetal Neural Tube Defects during Pregnancy	off-label use
Peptic ulcer	contraindication	13200003	DOID:750
Bipolar disorder	contraindication	13746004	DOID:3312
Constipation	contraindication	14760008	DOID:2089
Operation on stomach	contraindication	16453004
Primary hyperoxaluria	contraindication	17901006	DOID:2977
Gastroenteritis	contraindication	25374005	DOID:2326
Sarcoidosis	contraindication	31541009	DOID:11335
Dehydration	contraindication	34095006
Hemosiderosis	contraindication	39011001	DOID:12119
Hypokalemia	contraindication	43339004
Gastrectomy	contraindication	53442002
Leber's optic atrophy	contraindication	58610003	DOID:705
Hemolytic anemia	contraindication	61261009	DOID:583
Diarrhea	contraindication	62315008
Ulcerative colitis	contraindication	64766004	DOID:8577
Hypercalcemia	contraindication	66931009	DOID:12678
Hyperparathyroidism	contraindication	66999008	DOID:13543
Diabetes mellitus	contraindication	73211009	DOID:9351
Phototoxicity	contraindication	84326006
Atrophic gastritis	contraindication	84568007	DOID:8929
Kidney disease	contraindication	90708001	DOID:557
Kidney stone	contraindication	95570007
Anemia due to enzyme deficiency	contraindication	111577008
Hb SS disease	contraindication	127040003	DOID:10923
Osteolysis	contraindication	203522001
Hypomania	contraindication	231496004
Esophageal dysmotility	contraindication	266434009	DOID:9192
Diverticular disease	contraindication	397881000
Hemochromatosis	contraindication	399187006	DOID:2352
Repeated Blood Transfusions	contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	3.46	acidic
pKa2	5.15	acidic
pKa3	12.96	acidic
pKa4	4.55	Basic
pKa5	4.15	Basic
pKa6	2.28	Basic
pKa7	1.73	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Thymidylate synthase	Enzyme	P04818	TYSY_HUMAN		Ki	4.40		CHEMBL
Dihydrofolate reductase	Unclassified		B0BL08_ECOLX		Kd	6.09		CHEMBL

External reference:

ID	Source
4017507	VUID
N0000145892	NUI
D00070	KEGG_DRUG
6484-89-5	SECONDARY_CAS_RN
4017507	VANDF
C0304894	UMLSCUI
CHEBI:27470	CHEBI
FOL	PDB_CHEM_ID
135398658	PUBCHEM_CID
CHEMBL2107429	ChEMBL_ID
CHEMBL1622	ChEMBL_ID
DB00158	DRUGBANK_ID
D005492	MESH_DESCRIPTOR_UI
4563	IUPHAR_LIGAND_ID
68	INN_ID
9P9W8GGU78	UNII
1300473	RXNORM
264	MMSL
4759	MMSL
d00241	MMSL
001049	NDDF
126224002	SNOMEDCT_US
6247001	SNOMEDCT_US
63718003	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Ferralet 90	HUMAN PRESCRIPTION DRUG LABEL	5	0178-0089	TABLET, FILM COATED	1 mg	ORAL	unapproved drug other	17 sections
NataFort	HUMAN PRESCRIPTION DRUG LABEL	10	0178-0716	TABLET	1 mg	ORAL	Unapproved drug other	12 sections
CitraNatal Harmony 3.0	HUMAN PRESCRIPTION DRUG LABEL	8	0178-0796	CAPSULE, GELATIN COATED	1 mg	ORAL	unapproved drug other	10 sections
CitraNatal Harmony	HUMAN PRESCRIPTION DRUG LABEL	8	0178-0798	CAPSULE, GELATIN COATED	1 mg	ORAL	UNULLPPROVED DRUG OTHER	11 sections
CitraNatal Harmony	HUMAN PRESCRIPTION DRUG LABEL	8	0178-0799	CAPSULE, GELATIN COATED	1 mg	ORAL	Unapproved drug other	11 sections
CitraNatal Harmony	HUMAN PRESCRIPTION DRUG LABEL	8	0178-0812	CAPSULE, GELATIN COATED	1 mg	ORAL	Unapproved drug other	11 sections
CitraNatal Bloom	HUMAN PRESCRIPTION DRUG LABEL	6	0178-0813	TABLET, FILM COATED	1.40 mg	ORAL	unapproved drug other	15 sections
CitraNatal 90 DHA	HUMAN PRESCRIPTION DRUG LABEL	16	0178-0821	TABLET	1 mg	ORAL	unapproved drug other	11 sections
CitraNatal 90 DHA	HUMAN OTC DRUG LABEL	14	0178-0829	TABLET	1 mg	ORAL	Unapproved drug other	11 sections
CitraNatal Rx	HUMAN PRESCRIPTION DRUG LABEL	13	0178-0858	TABLET	1 mg	ORAL	Unapproved drug other	12 sections
CitraNatal Rx	HUMAN PRESCRIPTION DRUG LABEL	14	0178-0859	TABLET	1 mg	ORAL	Unapproved drug other	9 sections
CitraNatal Medley	HUMAN PRESCRIPTION DRUG LABEL	8	0178-0896	CAPSULE, GELATIN COATED	1 mg	ORAL	unapproved drug other	10 sections
CitraNatal DHA	HUMAN OTC DRUG LABEL	14	0178-0898	TABLET	1 mg	ORAL	Unapproved drug other	11 sections
Folic Acid	HUMAN PRESCRIPTION DRUG LABEL	1	0603-3162	TABLET	1 mg	ORAL	ANDA	19 sections
Folic Acid	HUMAN PRESCRIPTION DRUG LABEL	1	0615-7814	TABLET	1 mg	ORAL	ANDA	12 sections
VitafolOne	HUMAN PRESCRIPTION DRUG LABEL	16	0642-0070	CAPSULE, GELATIN COATED	1 mg	ORAL	unapproved drug other	7 sections
Vitafol Caplet	HUMAN PRESCRIPTION DRUG LABEL	12	0642-0072	CAPSULE	1 mg	ORAL	UNULLPPROVED DRUG OTHER	13 sections
Select OB	HUMAN PRESCRIPTION DRUG LABEL	15	0642-0077	TABLET, CHEWABLE	0.40 mg	ORAL	UNULLPPROVED DRUG OTHER	14 sections
Vitafol OB Caplet	HUMAN PRESCRIPTION DRUG LABEL	15	0642-0079	TABLET	1 mg	ORAL	Unapproved drug other	14 sections
Vitafol Plus	HUMAN PRESCRIPTION DRUG LABEL	17	0642-0092	CAPSULE, LIQUID FILLED	1 mg	ORAL	UNULLPPROVED DRUG OTHER	13 sections
Vitafol Ultra	HUMAN PRESCRIPTION DRUG LABEL	17	0642-0093	CAPSULE, LIQUID FILLED	680 ug	ORAL	UNULLPPROVED DRUG OTHER	13 sections
Vitafol Nano	HUMAN PRESCRIPTION DRUG LABEL	7	0642-0094	TABLET, COATED	680 ug	ORAL	UNULLPPROVED DRUG OTHER	14 sections
Select OB	HUMAN PRESCRIPTION DRUG LABEL	15	0642-0120	TABLET, CHEWABLE	0.40 mg	ORAL	UNULLPPROVED DRUG OTHER	13 sections
Strovite Forte Caplet	HUMAN PRESCRIPTION DRUG LABEL	19	0642-0204	TABLET, COATED	1 mg	ORAL	UNULLPPROVED DRUG OTHER	15 sections
Strovite One Caplets	HUMAN PRESCRIPTION DRUG LABEL	20	0642-0207	TABLET	1 mg	ORAL	UNULLPPROVED DRUG OTHER	14 sections
Reaphirm Plant Source DHA	HUMAN PRESCRIPTION DRUG LABEL	16	0642-3010	CAPSULE, GELATIN COATED	1 mg	ORAL	unapproved drug other	7 sections
Vitafol	HUMAN PRESCRIPTION DRUG LABEL	4	0642-7468	STRIP	1 mg	ORAL	Unapproved drug other	13 sections
Vitafol Fe Plus	HUMAN PRESCRIPTION DRUG LABEL	17	0642-7473	CAPSULE, LIQUID FILLED	680 mg	ORAL	UNULLPPROVED DRUG OTHER	14 sections
Marnatal F	HUMAN PRESCRIPTION DRUG LABEL	13	0682-1570	CAPSULE	1000 ug	ORAL	UNULLPPROVED DRUG OTHER	4 sections
BACMIN	HUMAN PRESCRIPTION DRUG LABEL	19	0682-3001	TABLET, COATED	1 mg	ORAL	UNULLPPROVED DRUG OTHER	10 sections