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

docusate sodium 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
	941	10041-19-7

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: docusate dioctyl sulfosuccinate dioctyl sulfosuccinic acid docusate sodium docusate calcium dioctyl disodium sulfosuccinate	All-purpose surfactant, wetting agent, and solubilizer used in the drug, cosmetics, and food industries. It has also been used in laxatives and as cerumenolytics. It is usually administered as either the calcium, potassium, or sodium salt. Molecular weight: 422.58 Formula: C20H38O7S CLOGP: 5.46 LIPINSKI: 1 HAC: 7 HDO: 1 TPSA: 106.97 ALOGS: -5.02 ROTB: 18

Drug dosage:

Dose	Unit	Route
0.15	g	O

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value	Unit	Confidence	Similarity
kinase-safety-class	ACVR2A,ACVR2B,ACVRL1,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GRK3,GSK3B,IKBKB,ITK,JAK2,JAK3,KDR,MAP2K6,MAP3K14,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPK9,MAPKAPK2,MTOR,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIK3CD,PIK3CG,PIM2,PLK1,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ZAP70	55
kinase-selectivity-class	AXL,EPHB4,GRK2,MAP2K6,STK33,TEK	6
pfas-class	PFAS structural alert (1 = True, 0 = False)	0

Approvals:

Date	Agency	Company	Orphan
None	FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Constipation	584.23	9.62	1226	122870	279169	90225182
Systemic lupus erythematosus	409.06	9.62	21	124075	361875	90142476
Pemphigus	404.19	9.62	9	124087	326855	90177496
Hand deformity	371.03	9.62	7	124089	296355	90207996
Glossodynia	312.61	9.62	37	124059	321742	90182609
Synovitis	303.42	9.62	45	124051	329707	90174644
Drug ineffective	286.67	9.62	959	123137	1383339	89121012
Duodenal ulcer perforation	282.06	9.62	4	124092	221284	90283067
Helicobacter infection	256.72	9.62	13	124083	226837	90277514
Folliculitis	243.68	9.62	8	124088	204345	90300006
Pericarditis	236.97	9.62	42	124054	270109	90234242
Pneumonia aspiration	236.34	9.62	286	123810	40654	90463697
Food allergy	235.05	9.62	228	123868	25250	90479101
Wound	231.74	9.62	64	124032	302916	90201435
Muscle injury	225.95	9.62	3	124093	176651	90327700
Back pain	211.91	9.62	928	123168	316247	90188104
Arthropathy	209.04	9.62	121	123975	366121	90138230
Temperature regulation disorder	207.78	9.62	167	123929	14412	90489939
Therapeutic product effect decreased	206.06	9.62	62	124034	277509	90226842
Discomfort	204.16	9.62	61	124035	274274	90230077
Maternal exposure during pregnancy	199.81	9.62	123	123973	359940	90144411
Swelling	172.20	9.62	192	123904	418866	90085485
Irritable bowel syndrome	171.89	9.62	37	124059	207411	90296940
Urinary tract infection	171.53	9.62	850	123246	304782	90199569
Immunodeficiency	166.61	9.62	248	123848	42986	90461365
Liver injury	162.15	9.62	21	124075	170546	90333805
C-reactive protein abnormal	159.42	9.62	3	124093	127426	90376925
Psoriatic arthropathy	155.53	9.62	59	124037	228276	90276075
Sleep disorder due to general medical condition, insomnia type	150.06	9.62	6	124090	128688	90375663
Impaired healing	145.93	9.62	69	124027	234130	90270221
Type 2 diabetes mellitus	144.40	9.62	49	124047	203195	90301156
Alopecia	142.26	9.62	290	123806	494781	90009570
Pulmonary embolism	141.18	9.62	447	123649	130373	90373978
Swollen joint count increased	137.58	9.62	3	124093	111203	90393148
Foetal death	131.55	9.62	152	123944	20571	90483780
Blister	125.64	9.62	99	123997	254899	90249452
Abdominal discomfort	122.06	9.62	298	123798	477030	90027321
Death	120.89	9.62	1051	123045	455500	90048851
Deep vein thrombosis	119.67	9.62	335	123761	91285	90413066
Plasma cell myeloma	118.67	9.62	206	123890	40622	90463729
Hyperhidrosis	118.28	9.62	433	123663	135872	90368479
Somnolence	114.71	9.62	578	123518	208506	90295845
General physical health deterioration	114.34	9.62	194	123902	354921	90149430
Mental status changes	113.99	9.62	213	123883	44466	90459885
Completed suicide	113.94	9.62	29	124067	145029	90359322
Lip dry	113.48	9.62	6	124090	100949	90403402
C-reactive protein increased	107.62	9.62	57	124039	181332	90323019
Facet joint syndrome	107.09	9.62	7	124089	98382	90405969
Fluid retention	105.28	9.62	312	123784	87779	90416572
Gastrooesophageal reflux disease	105.11	9.62	479	123617	165858	90338493
Upper respiratory tract infection	104.97	9.62	400	123696	127918	90376433
Condition aggravated	104.57	9.62	440	123656	595105	89909246
Dehydration	102.09	9.62	531	123565	193916	90310435
Ill-defined disorder	101.30	9.62	64	124032	184827	90319524
Fall	101.12	9.62	1056	123040	480754	90023597
Blood cholesterol increased	98.42	9.62	84	124012	207928	90296423
Grip strength decreased	96.72	9.62	8	124088	92568	90411783
Contraindicated product administered	93.16	9.62	186	123910	319953	90184398
Pulmonary malformation	91.39	9.62	30	124066	360	90503991
Pleural effusion	90.69	9.62	348	123748	111643	90392708
Gastrointestinal disorder	88.45	9.62	134	123962	256553	90247798
Total lung capacity decreased	87.13	9.62	58	124038	3737	90500614
Coma	84.65	9.62	255	123841	72377	90431974
Febrile neutropenia	84.19	9.62	434	123662	157915	90346436
Salpingo-oophorectomy unilateral	80.91	9.62	35	124061	933	90503418
Urticaria	79.26	9.62	196	123900	312538	90191813
Rash erythematous	79.13	9.62	232	123864	64872	90439479
Fibromyalgia	78.75	9.62	100	123996	206169	90298182
Live birth	76.97	9.62	9	124087	79098	90425253
Sinusitis fungal	76.13	9.62	42	124054	1922	90502429
Bronchopulmonary aspergillosis allergic	75.66	9.62	53	124043	3713	90500638
Hypoxia	74.99	9.62	244	123852	72155	90432196
Stomatitis	73.72	9.62	167	123929	274531	90229820
Joint range of motion decreased	72.86	9.62	48	124048	135595	90368756
Hypercholesterolaemia	72.20	9.62	24	124072	100868	90403483
Red blood cell sedimentation rate increased	72.01	9.62	13	124083	82582	90421769
Mobility decreased	71.79	9.62	147	123949	250587	90253764
Peripheral venous disease	71.48	9.62	14	124082	83907	90420444
Inflammation	70.89	9.62	84	124012	178508	90325843
Blood calcium increased	70.81	9.62	85	124011	11973	90492378
Lung opacity	70.63	9.62	62	124034	6040	90498311
Embolism venous	70.53	9.62	50	124046	3570	90500781
Cardiac failure congestive	68.98	9.62	293	123803	98401	90405950
Therapeutic product effect incomplete	68.95	9.62	99	123997	193797	90310554
Drug intolerance	68.78	9.62	347	123749	447244	90057107
Asthenia	67.30	9.62	1065	123031	532686	89971665
Haemoglobin decreased	66.98	9.62	415	123681	161541	90342810
Sputum increased	65.03	9.62	44	124052	2913	90501438
Anti-neutrophil cytoplasmic antibody positive vasculitis	63.93	9.62	49	124047	3944	90500407
Sleep disorder	63.85	9.62	108	123988	197922	90306429
Epilepsy	63.47	9.62	17	124079	82189	90422162
Intentional product misuse	63.39	9.62	267	123829	89337	90415014
Lung cyst	63.25	9.62	24	124072	451	90503900
Blepharospasm	63.25	9.62	3	124093	55442	90448909
Diverticulum	62.48	9.62	80	124016	12033	90492318
Hiatus hernia	62.32	9.62	119	123977	25242	90479109
Oedema peripheral	61.61	9.62	581	123515	257334	90247017
Dislocation of vertebra	60.85	9.62	4	124092	55964	90448387
Intentional product use issue	60.53	9.62	129	123967	216763	90287588
Nausea	59.25	9.62	1961	122135	1108355	89395996
Pneumonia	59.18	9.62	1213	122883	636846	89867505
Diastolic dysfunction	59.11	9.62	61	124035	7272	90497079
Adjustment disorder with depressed mood	59.01	9.62	5	124091	56748	90447603
Hospice care	57.96	9.62	69	124027	9635	90494716
Night sweats	56.15	9.62	56	124040	128710	90375641
Obesity	55.77	9.62	38	124058	105469	90398882
Abdominal pain	55.39	9.62	804	123292	394917	90109434
Wound infection	55.34	9.62	39	124057	106363	90397988
Hypotension	54.97	9.62	684	123412	324713	90179638
Full blood count decreased	54.97	9.62	124	123972	29565	90474786
Intentional overdose	54.89	9.62	30	124066	93804	90410547
Joint swelling	54.73	9.62	434	123662	502866	90001485
Obstructive airways disorder	54.70	9.62	114	123982	25755	90478596
Arthralgia	54.14	9.62	746	123350	777776	89726575
Treatment failure	52.94	9.62	225	123871	303703	90200648
Tricuspid valve incompetence	52.02	9.62	87	124009	16644	90487707
Autoimmune disorder	51.93	9.62	20	124076	76724	90427627
White blood cell count decreased	51.79	9.62	399	123697	166710	90337641
Off label use	51.67	9.62	1134	122962	1101118	89403233
Respiratory tract malformation	50.76	9.62	16	124080	167	90504184
Pleuritic pain	50.70	9.62	67	124029	10394	90493957
Aspiration	50.67	9.62	83	124013	15610	90488741
Therapy non-responder	50.39	9.62	68	124028	136636	90367715
Lethargy	50.11	9.62	195	123901	62944	90441407
Fungal infection	48.97	9.62	149	123947	42512	90461839
Respiratory symptom	48.81	9.62	43	124053	4209	90500142
Anaemia	48.65	9.62	715	123381	352087	90152264
Small intestinal obstruction	47.76	9.62	96	124000	21138	90483213
Hyponatraemia	47.19	9.62	329	123767	133209	90371142
Balance disorder	46.75	9.62	259	123837	96821	90407530
Product use in unapproved indication	46.46	9.62	270	123826	335966	90168385
Fatigue	45.85	9.62	1973	122123	1152050	89352301
Lung disorder	45.36	9.62	85	124011	149798	90354553
Bone erosion	44.83	9.62	9	124087	53012	90451339
Adverse event	44.71	9.62	57	124039	117361	90386990
Renal function test abnormal	44.39	9.62	52	124044	7139	90497212
Tremor	44.32	9.62	360	123736	152813	90351538
Nail disorder	44.13	9.62	13	124083	59054	90445297
Failure to thrive	44.09	9.62	56	124040	8355	90495996
Coeliac disease	44.09	9.62	148	123948	44462	90459889
Injection site reaction	43.75	9.62	37	124059	92043	90412308
Creatinine renal clearance increased	43.42	9.62	36	124060	3245	90501106
Carbuncle	43.10	9.62	26	124070	1410	90502941
Onychomadesis	42.89	9.62	6	124090	45992	90458359
Dyspnoea	42.87	9.62	1540	122556	879415	89624936
Intestinal pseudo-obstruction	42.70	9.62	24	124072	1139	90503212
Overdose	42.61	9.62	365	123731	157344	90347007
Lupus-like syndrome	41.91	9.62	8	124088	48838	90455513
Emphysema	41.58	9.62	66	124030	12089	90492262
Cellulitis	41.55	9.62	240	123856	91097	90413254
Myelosuppression	41.52	9.62	11	124085	53580	90450771
Atrial fibrillation	41.38	9.62	319	123777	133292	90371059
Blood potassium decreased	40.84	9.62	151	123945	47576	90456775
Monoclonal immunoglobulin present	40.60	9.62	29	124067	2095	90502256
Road traffic accident	40.21	9.62	53	124043	107573	90396778
Infection	39.90	9.62	311	123785	361783	90142568
Rales	39.79	9.62	75	124021	15752	90488599
Hip arthroplasty	39.54	9.62	28	124068	76180	90428171
Hip fracture	39.35	9.62	117	123979	32960	90471391
Gait inability	39.29	9.62	89	124007	146367	90357984
Cestode infection	38.71	9.62	15	124081	299	90504052
Musculoskeletal stiffness	38.39	9.62	243	123853	296289	90208062
International normalised ratio increased	38.25	9.62	147	123949	47169	90457182
Acute respiratory failure	37.75	9.62	137	123959	42781	90461570
Injury	37.57	9.62	141	123955	197208	90307143
Disease progression	37.46	9.62	353	123743	156262	90348089
Colitis ulcerative	37.13	9.62	18	124078	60248	90444103
Breast cancer stage II	37.05	9.62	3	124093	35331	90469020
Body height decreased	36.97	9.62	62	124034	11887	90492464
Sepsis	36.60	9.62	392	123704	179422	90324929
Platelet count decreased	35.95	9.62	315	123781	136654	90367697
Chronic obstructive pulmonary disease	35.56	9.62	197	123899	73632	90430719
Hypervolaemia	35.36	9.62	112	123984	32645	90471706
Knee arthroplasty	35.32	9.62	37	124059	83145	90421206
Cholelithiasis	35.23	9.62	154	123942	52352	90451999
Peritonitis bacterial	34.63	9.62	39	124057	5132	90499219
Hepatic cirrhosis	34.48	9.62	22	124074	63231	90441120
Thrombocytopenia	34.03	9.62	436	123660	208289	90296062
Exposure via breast milk	34.01	9.62	27	124069	2288	90502063
Frequent bowel movements	33.59	9.62	18	124078	56917	90447434
Rash	33.03	9.62	834	123262	795266	89709085
Drug tolerance decreased	32.95	9.62	3	124093	32127	90472224
Hypothalamo-pituitary disorder	32.52	9.62	26	124070	2226	90502125
Prescribed underdose	32.27	9.62	33	124063	74986	90429365
Magnesium deficiency	32.02	9.62	17	124079	720	90503631
Pulmonary mass	31.63	9.62	99	123997	28673	90475678
Lower limb fracture	31.61	9.62	42	124054	84971	90419380
Unresponsive to stimuli	31.28	9.62	119	123977	38002	90466349
Sputum discoloured	31.10	9.62	79	124017	20312	90484039
Gastrointestinal haemorrhage	31.08	9.62	221	123875	90027	90414324
Prescribed overdose	30.73	9.62	234	123862	97391	90406960
Liver disorder	30.69	9.62	76	124020	121193	90383158
Pregnancy	30.64	9.62	24	124072	62023	90442328
Lactation disorder	30.22	9.62	14	124082	440	90503911
Epistaxis	30.22	9.62	210	123886	84915	90419436
Myoclonus	30.00	9.62	75	124021	19093	90485258
Toxicity to various agents	29.96	9.62	251	123845	287595	90216756
Heart rate increased	29.81	9.62	260	123836	112642	90391709
Exostosis	29.63	9.62	18	124078	53116	90451235
Hypophagia	29.34	9.62	112	123984	35825	90468526
Hysterectomy	29.26	9.62	55	124041	11529	90492822
Abortion spontaneous	29.19	9.62	19	124077	54037	90450314
Blood creatinine increased	29.16	9.62	238	123858	101148	90403203
Drug ineffective for unapproved indication	29.03	9.62	29	124067	66615	90437736
Chest pain	28.98	9.62	606	123490	319039	90185312
Sleep apnoea syndrome	28.48	9.62	102	123994	31645	90472706
Drug-induced liver injury	28.41	9.62	50	124046	90268	90414083
Thrombosis	27.97	9.62	184	123912	73067	90431284
Respiratory failure	27.86	9.62	266	123830	118152	90386199
Carbohydrate antigen 125 increased	27.84	9.62	28	124068	3238	90501113
Premenstrual syndrome	27.81	9.62	16	124080	794	90503557
Dysphagia	27.81	9.62	255	123841	112023	90392328
Drug hypersensitivity	27.75	9.62	457	123639	463152	90041199
Blood test abnormal	27.72	9.62	77	124019	20875	90483476
Neuropathy peripheral	27.59	9.62	298	123798	136672	90367679
Poor sucking reflex	27.39	9.62	13	124083	432	90503919
Fibrosis	27.13	9.62	37	124059	5915	90498436
Rheumatoid arthritis	27.12	9.62	342	123754	362272	90142079
Retching	26.93	9.62	72	124024	19087	90485264
Neutrophil count decreased	26.90	9.62	179	123917	71353	90432998
Excessive eye blinking	26.84	9.62	19	124077	1353	90502998
Urinary incontinence	26.60	9.62	112	123984	37454	90466897
Onychomycosis	26.54	9.62	9	124087	37367	90466984
Decubitus ulcer	26.08	9.62	53	124043	11760	90492591
Haematocrit decreased	26.04	9.62	120	123976	41712	90462639
Autonomic dysreflexia	26	9.62	12	124084	374	90503977
Iron deficiency anaemia	25.63	9.62	81	124015	23581	90480770
Medication error	25.61	9.62	48	124048	84604	90419747
Suicide attempt	25.33	9.62	40	124056	75359	90428992
Hepatitis	25.25	9.62	36	124060	70703	90433648
Pneumonia viral	24.96	9.62	44	124052	8779	90495572
Product quality issue	24.88	9.62	44	124052	79281	90425070
Dental restoration failure	24.84	9.62	17	124079	1147	90503204
Sinusitis	24.76	9.62	326	123770	342762	90161589
Polymenorrhoea	24.04	9.62	18	124078	1399	90502952
Hyperaesthesia	23.61	9.62	48	124048	10654	90493697
Granulocytopenia	23.46	9.62	36	124060	6405	90497946
Haemorrhoids	23.28	9.62	85	124011	26617	90477734
Flatulence	23.10	9.62	115	123981	41252	90463099
Back injury	23.06	9.62	18	124078	46604	90457747
Sciatica	23.03	9.62	67	124029	101315	90403036
Overweight	22.80	9.62	34	124062	5900	90498451
Emotional distress	22.70	9.62	105	123991	36557	90467794
Wrist deformity	22.68	9.62	25	124071	3213	90501138
Presyncope	22.66	9.62	95	124001	31710	90472641
Pre-eclampsia	22.56	9.62	48	124048	11000	90493351
Ear infection	22.52	9.62	38	124058	69737	90434614
Lip pruritus	22.46	9.62	17	124079	1343	90503008
Joint dislocation	22.32	9.62	17	124079	44565	90459786
Transient ischaemic attack	22.00	9.62	117	123979	43059	90461292
Dyslipidaemia	21.91	9.62	45	124051	10062	90494289
Transfusion	21.89	9.62	63	124033	17425	90486926
Musculoskeletal pain	21.81	9.62	141	123955	171110	90333241
Interstitial lung disease	21.67	9.62	45	124051	76360	90427991
Maternal exposure during breast feeding	21.59	9.62	34	124062	6186	90498165
Blood glucose increased	21.44	9.62	212	123884	95034	90409317
Cerebrovascular accident	21.39	9.62	261	123835	123272	90381079
Menstruation delayed	21.30	9.62	20	124076	2125	90502226
Onychoclasis	21.06	9.62	37	124059	7362	90496989
Haemoptysis	21.05	9.62	96	124000	33224	90471127
Dyspnoea exertional	20.95	9.62	170	123926	72118	90432233
Oedema	20.67	9.62	175	123921	200120	90304231
Supraventricular tachycardia	20.60	9.62	59	124037	16277	90488074
Multiple sclerosis	20.49	9.62	84	124012	27756	90476595
Contusion	20.27	9.62	233	123863	250983	90253368
Lichen sclerosus	20.25	9.62	16	124080	1347	90503004
Acute kidney injury	20.17	9.62	578	123518	319809	90184542
Hepatic enzyme increased	20.14	9.62	360	123736	360376	90143975
Asthma	19.98	9.62	453	123643	241707	90262644
Red blood cell count decreased	19.92	9.62	120	123976	46231	90458120
Carotid artery occlusion	19.74	9.62	33	124063	6309	90498042
Premature baby	19.71	9.62	5	124091	25072	90479279
Nasal polyps	19.65	9.62	45	124051	10835	90493516
Infusion related reaction	19.63	9.62	428	123668	416352	90087999
Peripheral swelling	19.52	9.62	424	123672	412682	90091669
Drug interaction	19.46	9.62	264	123832	276189	90228162
Palmoplantar keratoderma	19.42	9.62	24	124072	3483	90500868
Bronchiectasis	19.40	9.62	71	124025	22259	90482092
Pneumococcal infection	19.33	9.62	15	124081	1230	90503121
Drug reaction with eosinophilia and systemic symptoms	19.32	9.62	18	124078	42740	90461611
Uterine perforation	19.24	9.62	36	124060	7518	90496833
Oesophageal ulcer	19.19	9.62	29	124067	5090	90499261
Blood calcium decreased	19.10	9.62	87	124009	30095	90474256
Decreased immune responsiveness	19.02	9.62	39	124057	8709	90495642
Abdominal distension	18.88	9.62	267	123829	130334	90374017
Drooling	18.84	9.62	27	124069	4519	90499832
Dyspepsia	18.76	9.62	177	123919	197983	90306368
Thyroid atrophy	18.75	9.62	9	124087	307	90504044
Device expulsion	18.73	9.62	17	124079	40869	90463482
Maternal exposure timing unspecified	18.63	9.62	4	124092	22479	90481872
Lower gastrointestinal haemorrhage	18.58	9.62	39	124057	8853	90495498
Taste disorder	18.53	9.62	35	124061	61511	90442840
Hallucination	18.51	9.62	154	123942	65805	90438546
Intestinal obstruction	18.50	9.62	100	123996	37031	90467320
Body temperature fluctuation	18.47	9.62	19	124077	2256	90502095
Chronic sinusitis	18.47	9.62	73	124023	23729	90480622
Vomiting	18.44	9.62	1284	122812	787009	89717342
Hyperlipidaemia	18.36	9.62	71	124025	22845	90481506
Proctalgia	18.36	9.62	37	124059	8161	90496190
Atelectasis	18.25	9.62	74	124022	24335	90480016
Cardiospasm	18.15	9.62	23	124073	3423	90500928
Oesophageal irritation	18.10	9.62	9	124087	332	90504019
Rheumatoid nodule	17.96	9.62	3	124093	20163	90484188
Cognitive disorder	17.88	9.62	159	123937	69248	90435103
Nasopharyngitis	17.77	9.62	423	123673	406681	90097670
Musculoskeletal chest pain	17.75	9.62	72	124024	23678	90480673
Hypoaesthesia	17.72	9.62	313	123783	313897	90190454
Cardiac murmur	17.66	9.62	60	124036	18134	90486217
Epiglottic erythema	17.64	9.62	6	124090	81	90504270
Noninfectious peritonitis	17.60	9.62	7	124089	150	90504201
Pulmonary hypertension	17.58	9.62	109	123987	42414	90461937
Nephropathy	17.57	9.62	39	124057	9196	90495155
Dysmetropsia	17.44	9.62	6	124090	84	90504267
Cough	17.36	9.62	643	123453	368319	90136032
Blood loss anaemia	17.28	9.62	41	124055	10099	90494252
Cholecystitis chronic	17.04	9.62	40	124056	9786	90494565
Epiglottic oedema	16.86	9.62	7	124089	168	90504183
Migraine	16.79	9.62	173	123923	190219	90314132
Accidental exposure to product	16.72	9.62	20	124076	42346	90462005
Lower respiratory tract infection	16.70	9.62	242	123854	250417	90253934
Renal failure	16.66	9.62	262	123834	130745	90373606
Adverse reaction	16.66	9.62	10	124086	29702	90474649
Nasal discharge discolouration	16.57	9.62	20	124076	2833	90501518
Candida infection	16.48	9.62	91	124005	33966	90470385
Loss of personal independence in daily activities	16.36	9.62	114	123982	135991	90368360
Sleep terror	16.33	9.62	25	124071	4439	90499912
Pruritus	16.29	9.62	592	123504	540933	89963418
Pruritus genital	15.94	9.62	25	124071	4533	90499818
Injection site erythema	15.88	9.62	75	124021	98427	90405924
Blood bilirubin decreased	15.80	9.62	12	124084	953	90503398
Diarrhoea	15.70	9.62	1491	122605	937699	89566652
Urinary tract infection enterococcal	15.68	9.62	20	124076	2996	90501355
Productive cough	15.67	9.62	168	123928	76895	90427456
Urinary retention postoperative	15.61	9.62	6	124090	117	90504234
Renal cyst	15.59	9.62	46	124050	12904	90491447
Duodenal stenosis	15.37	9.62	10	124086	620	90503731
Weight increased	15.15	9.62	446	123650	417481	90086870
Restless legs syndrome	15.14	9.62	66	124030	22404	90481947
Dry mouth	15.12	9.62	170	123926	183889	90320462
Seizure	15.02	9.62	293	123803	152336	90352015
Nasal congestion	14.77	9.62	177	123919	83237	90421114
Ear pain	14.72	9.62	36	124060	57666	90446685
Anaphylactic shock	14.66	9.62	13	124083	31604	90472747
Electrocardiogram PR prolongation	14.64	9.62	11	124085	859	90503492
Chills	14.60	9.62	258	123838	131723	90372628
Lymphocyte count decreased	14.59	9.62	90	124006	34960	90469391
Pneumonitis	14.53	9.62	107	123989	44063	90460288
Neuralgia	14.47	9.62	83	124013	31417	90472934
Pulmonary fibrosis	14.46	9.62	87	124009	107416	90396935
Mean platelet volume increased	14.34	9.62	11	124085	886	90503465
Breath sounds abnormal	14.29	9.62	50	124046	15336	90489015
Ascites	14.23	9.62	113	123983	47627	90456724
Wheezing	14.12	9.62	235	123861	237845	90266506
Mitochondrial myopathy	14.11	9.62	7	124089	257	90504094
Pustular psoriasis	14.02	9.62	4	124092	18552	90485799
Chronic kidney disease	13.99	9.62	117	123979	50074	90454277
Proteinuria	13.90	9.62	66	124030	23225	90481126
Cardiomegaly	13.85	9.62	57	124039	18868	90485483
Spinal compression fracture	13.81	9.62	49	124047	15129	90489222
Gastrointestinal arteriovenous malformation	13.72	9.62	9	124087	566	90503785
Bladder disorder	13.67	9.62	39	124057	10733	90493618
Catheter site bruise	13.59	9.62	9	124087	575	90503776
Blood sodium decreased	13.51	9.62	74	124022	27539	90476812
Rubber sensitivity	13.49	9.62	18	124078	2819	90501532
Injection site pruritus	13.41	9.62	34	124062	53800	90450551
Clostridium difficile infection	13.21	9.62	90	124006	36155	90468196
Ecchymosis	13.18	9.62	42	124054	12281	90492070
Sinus bradycardia	13.16	9.62	52	124044	16900	90487451
Foetal exposure timing unspecified	13.14	9.62	8	124088	441	90503910
Drug abuse	13.09	9.62	63	124033	82284	90422067
Escherichia bacteraemia	12.98	9.62	26	124070	5709	90498642
Intentional underdose	12.95	9.62	15	124081	2034	90502317
Adverse drug reaction	12.94	9.62	100	123996	116601	90387750
Upper gastrointestinal haemorrhage	12.91	9.62	64	124032	22912	90481439
Hypersomnia	12.84	9.62	61	124035	21470	90482881
Dysstasia	12.84	9.62	68	124028	24984	90479367
Injection site warmth	12.82	9.62	4	124092	17511	90486840
Localised oedema	12.75	9.62	27	124069	6167	90498184
Abdominal hernia	12.69	9.62	26	124070	5802	90498549
Arteriovenous graft site infection	12.64	9.62	3	124093	9	90504342
Premature delivery	12.61	9.62	21	124075	38741	90465610
Non-small cell lung cancer	12.59	9.62	22	124074	4359	90499992
Calculus bladder	12.58	9.62	9	124087	652	90503699
Multiple sclerosis relapse	12.55	9.62	118	123978	52187	90452164
Lip swelling	12.40	9.62	93	124003	38517	90465834
Malignant neoplasm of thorax	12.40	9.62	3	124093	10	90504341
Catheter site pain	12.28	9.62	25	124071	5554	90498797
Spleen atrophy	12.26	9.62	4	124092	47	90504304
Hot flush	12.24	9.62	130	123966	59358	90444993
Atrial tachycardia	12.20	9.62	26	124070	5964	90498387
Troponin increased	12.19	9.62	43	124053	13238	90491113
Immunisation	12.02	9.62	15	124081	2198	90502153
Gastrointestinal tract mucosal pigmentation	12.01	9.62	9	124087	700	90503651
Use of accessory respiratory muscles	12.01	9.62	7	124089	356	90503995
Orthostatic hypotension	11.92	9.62	98	123998	41729	90462622
Hypophosphataemia	11.88	9.62	46	124050	14808	90489543
End stage renal disease	11.84	9.62	32	124064	8539	90495812
Asterixis	11.78	9.62	13	124083	1672	90502679
Haemorrhage	11.76	9.62	146	123950	69223	90435128
Cytokine release syndrome	11.75	9.62	72	124024	27901	90476450
Burkholderia test positive	11.66	9.62	6	124090	238	90504113
Myocardial infarction	11.66	9.62	207	123889	105765	90398586
Multiple drug therapy	11.58	9.62	28	124068	6981	90497370
Impaired work ability	11.56	9.62	6	124090	19320	90485031
Enterocele	11.56	9.62	4	124092	57	90504294
Pulmonary oedema	11.55	9.62	133	123963	61947	90442404
Blood phosphorus increased	11.53	9.62	21	124075	4297	90500054
Heart rate decreased	11.51	9.62	118	123978	53387	90450964
Paraesthesia	11.50	9.62	258	123838	250068	90254283
Pericardial effusion	11.43	9.62	88	124008	36745	90467606
Intentional self-injury	11.41	9.62	14	124082	29320	90475031
Drug resistance	11.36	9.62	15	124081	30434	90473917
Gingival pain	11.35	9.62	34	124062	9618	90494733
Stoma site erythema	11.26	9.62	12	124084	1484	90502867
Infusion site reaction	11.26	9.62	6	124090	19033	90485318
Product use issue	11.23	9.62	355	123741	329564	90174787
Vasculitis	11.22	9.62	61	124035	22632	90481719
Aortic stenosis	11.21	9.62	26	124070	6310	90498041
Diabetes mellitus	11.19	9.62	137	123959	64738	90439613
Laryngitis	11.19	9.62	34	124062	50719	90453632
Anaphylactic reaction	11.17	9.62	72	124024	87452	90416899
Cardiomyopathy	11.16	9.62	56	124040	20150	90484201
Peritonitis	11.15	9.62	55	124041	19650	90484701
Mean cell haemoglobin concentration decreased	11.15	9.62	21	124075	4407	90499944
Embolic stroke	11.12	9.62	20	124076	4052	90500299
Posture abnormal	11.09	9.62	16	124080	2695	90501656
Macular degeneration	11.07	9.62	22	124074	37948	90466403
Dysuria	11.06	9.62	92	124004	39309	90465042
Lactic acidosis	10.99	9.62	34	124062	50429	90453922
Wrong product administered	10.97	9.62	29	124067	7636	90496715
Conjunctival pigmentation	10.97	9.62	4	124092	67	90504284
Brain neoplasm	10.95	9.62	22	124074	4842	90499509
Vision blurred	10.94	9.62	212	123884	110081	90394270
Blindness	10.92	9.62	68	124028	26500	90477851
Hypersensitivity	10.91	9.62	510	123586	454167	90050184
Moaning	10.89	9.62	10	124086	1033	90503318
Ventricular tachycardia	10.63	9.62	64	124032	24644	90479707
Injection site swelling	10.59	9.62	44	124052	59795	90444556
Sleep disorder due to a general medical condition	10.58	9.62	29	124067	44709	90459642
Abdominal mass	10.53	9.62	18	124078	3503	90500848
Transaminases increased	10.52	9.62	87	124009	37105	90467246
Anhedonia	10.49	9.62	37	124059	11394	90492957
Erythema	10.40	9.62	398	123698	228848	90275503
Blood pressure decreased	10.38	9.62	152	123944	74743	90429608
Hypovolaemia	10.36	9.62	39	124057	12392	90491959
Post procedural haemorrhage	10.35	9.62	31	124065	8767	90495584
Open angle glaucoma	10.32	9.62	6	124090	304	90504047
Hyperglycaemia	10.30	9.62	111	123985	50859	90453492
Urinary tract obstruction	10.28	9.62	14	124082	2235	90502116
Faeces hard	10.27	9.62	17	124079	3225	90501126
Postpartum anxiety	10.23	9.62	3	124093	24	90504327
Blood urea nitrogen/creatinine ratio increased	10.14	9.62	10	124086	1129	90503222
Implant site erosion	10.04	9.62	4	124092	86	90504265
Injection site rash	9.98	9.62	11	124085	24162	90480189
Weight decreased	9.96	9.62	625	123471	379285	90125066
Hepatotoxicity	9.90	9.62	31	124065	45811	90458540
Therapeutic response decreased	9.89	9.62	77	124019	89652	90414699
Facial pain	9.88	9.62	40	124056	13142	90491209
Cholestasis	9.78	9.62	22	124074	36277	90468074
Blood potassium increased	9.74	9.62	55	124041	20694	90483657
Right ventricular dysfunction	9.74	9.62	14	124082	2350	90502001
Paraphilia	9.72	9.62	3	124093	29	90504322
Faeces discoloured	9.68	9.62	56	124040	21264	90483087
Purpura	9.65	9.62	43	124053	14735	90489616
Large intestinal obstruction	9.65	9.62	15	124081	2699	90501652

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
Drug ineffective	278.44	10.51	486	80733	629711	41910405
Constipation	211.66	10.51	735	80484	161556	42378560
Drug abuse	127.14	10.51	23	81196	104748	42435368
Off label use	126.84	10.51	708	80511	637627	41902489
Neuritis	112.54	10.51	94	81125	6126	42533990
Pulmonary vasculitis	109.88	10.51	93	81126	6173	42533943
Respiratory symptom	102.57	10.51	116	81103	10990	42529126
Completed suicide	97.79	10.51	31	81188	96434	42443682
Febrile neutropenia	93.00	10.51	639	80580	185064	42355052
Plasma cell myeloma	92.37	10.51	248	80971	47330	42492786
Neurological symptom	81.65	10.51	98	81121	9893	42530223
Total lung capacity abnormal	78.02	10.51	66	81153	4377	42535739
Mental status changes	77.24	10.51	215	81004	41900	42498216
Urinary tract infection	75.83	10.51	382	80837	98902	42441214
Thrombosis	68.99	10.51	286	80933	68225	42471891
Eosinophilic granulomatosis with polyangiitis	67.77	10.51	83	81136	8555	42531561
Conjunctivitis allergic	65.54	10.51	68	81151	5843	42534273
Death	65.28	10.51	1259	79960	469926	42070190
Toxicity to various agents	63.41	10.51	224	80995	228912	42311204
IVth nerve paralysis	59.91	10.51	27	81192	564	42539552
Full blood count abnormal	59.25	10.51	157	81062	29719	42510397
Intentional overdose	56.85	10.51	14	81205	51442	42488674
Mite allergy	55.86	10.51	58	81161	4988	42535128
Hypoxia	55.74	10.51	272	80947	69514	42470602
Mycotic allergy	55.55	10.51	57	81162	4834	42535282
Dust allergy	54.96	10.51	59	81160	5273	42534843
Spirometry abnormal	54.91	10.51	58	81161	5088	42535028
Pneumonia	52.73	10.51	1111	80108	421038	42119078
Treatment failure	52.26	10.51	27	81192	62597	42477519
Pulmonary alveolar haemorrhage	52.22	10.51	98	81121	14718	42525398
Forced expiratory volume decreased	51.46	10.51	68	81151	7562	42532554
Antineutrophil cytoplasmic antibody positive	48.01	10.51	50	81169	4315	42535801
Anal inflammation	47.34	10.51	37	81182	2192	42537924
Fall	46.50	10.51	665	80554	233855	42306261
SARS-CoV-2 test negative	45.56	10.51	33	81186	1742	42538374
Drug resistance	44.96	10.51	6	81213	34242	42505874
Accident	42.39	10.51	57	81162	6446	42533670
Failure to thrive	41.86	10.51	69	81150	9353	42530763
Proctalgia	41.47	10.51	59	81160	7034	42533082
Myelosuppression	40.99	10.51	13	81206	40448	42499668
Myasthenia gravis	40.70	10.51	93	81126	16044	42524072
Drug interaction	40.16	10.51	321	80898	266678	42273438
Capillaritis	38.92	10.51	33	81186	2195	42537921
Pulmonary embolism	38.78	10.51	373	80846	119239	42420877
Haemoptysis	38.33	10.51	182	81037	45985	42494131
Fatigue	38.24	10.51	1093	80126	434548	42105568
Vasculitis	37.83	10.51	98	81121	18296	42521820
Burkholderia test positive	37.63	10.51	24	81195	1026	42539090
Failure to suspend medication	36.46	10.51	17	81202	385	42539731
Normochromic normocytic anaemia	35.98	10.51	63	81156	8968	42531148
Drug therapy	35.74	10.51	52	81167	6328	42533788
Interstitial lung disease	35.71	10.51	59	81160	78403	42461713
Dehydration	35.63	10.51	420	80799	141347	42398769
Hyperphosphataemia	35.10	10.51	77	81142	12927	42527189
Analgesic therapy	34.85	10.51	52	81167	6472	42533644
Sepsis	34.73	10.51	553	80666	198781	42341335
C-reactive protein increased	34.68	10.51	42	81177	63518	42476598
Blood test abnormal	34.36	10.51	76	81143	12830	42527286
Cholestasis	34.32	10.51	10	81209	32869	42507247
Coma	34.15	10.51	31	81188	53523	42486593
Hepatic function abnormal	33.90	10.51	29	81190	51538	42488578
Drug reaction with eosinophilia and systemic symptoms	33.85	10.51	19	81200	42056	42498060
IgA nephropathy	33.19	10.51	31	81188	2343	42537773
Confusional state	33.08	10.51	475	80744	167122	42372994
Vomiting	33.04	10.51	753	80466	288970	42251146
Obstructive airways disorder	32.90	10.51	113	81106	24646	42515470
Foetal exposure during pregnancy	31.85	10.51	26	81193	47285	42492831
Drug ineffective for unapproved indication	31.54	10.51	25	81194	46138	42493978
Nodule	31.35	10.51	72	81147	12462	42527654
Hypersomnia	31.22	10.51	79	81140	14539	42525577
Product use in unapproved indication	30.93	10.51	215	81004	184241	42355875
Hospice care	30.86	10.51	57	81162	8456	42531660
Hyponatraemia	30.25	10.51	311	80908	101151	42438965
Pulmonary fibrosis	29.73	10.51	115	81104	26566	42513550
Renal impairment	29.61	10.51	109	81110	110119	42429997
Appendicolith	29.03	10.51	73	81146	13383	42526733
Neuralgia	28.95	10.51	111	81108	25536	42514580
Back pain	28.84	10.51	404	80815	141372	42398744
Hallucination	28.76	10.51	198	81021	57309	42482807
Asthenia	28.72	10.51	719	80500	280074	42260042
Anticoagulant therapy	28.42	10.51	39	81180	4496	42535620
Haemorrhoids	28.15	10.51	84	81135	17013	42523103
Overdose	27.68	10.51	105	81114	105159	42434957
Painful respiration	27.52	10.51	22	81197	1347	42538769
Blood calcium increased	27.43	10.51	54	81165	8400	42531716
Sleep disorder therapy	27.34	10.51	48	81171	6846	42533270
Antacid therapy	27.23	10.51	39	81180	4678	42535438
Sleep disorder due to a general medical condition	27.10	10.51	84	81135	17369	42522747
Hepatocellular injury	27.03	10.51	6	81213	23672	42516444
Full blood count decreased	26.59	10.51	93	81126	20467	42519649
Hypophosphataemia	26.45	10.51	94	81125	20851	42519265
Abdominal distension	26.42	10.51	230	80989	71505	42468611
Hypothyroidism	26.28	10.51	126	81093	31958	42508158
Small intestinal obstruction	25.47	10.51	81	81138	16980	42523136
Walking aid user	25.16	10.51	28	81191	2605	42537511
Suicide attempt	24.58	10.51	31	81188	46069	42494047
Swelling	24.57	10.51	184	81035	54701	42485415
Lung disorder	24.56	10.51	166	81053	47757	42492359
Pleural effusion	24.45	10.51	288	80931	96878	42443238
Rheumatoid arthritis	24.27	10.51	27	81192	42413	42497703
Premature baby	24.24	10.51	7	81212	23146	42516970
Chest injury	23.96	10.51	23	81196	1799	42538317
Arteriosclerosis	23.81	10.51	82	81137	17907	42522209
Activated partial thromboplastin time prolonged	23.28	10.51	75	81144	15828	42524288
Accidental death	23.18	10.51	29	81190	3054	42537062
Anaphylactic shock	23.04	10.51	8	81211	23509	42516607
Therapy partial responder	23.00	10.51	5	81214	20016	42520100
Arteriosclerosis coronary artery	22.89	10.51	83	81136	18594	42521522
Granulocytopenia	22.55	10.51	45	81174	7069	42533047
Gangrene neonatal	22.36	10.51	10	81209	205	42539911
Blood phosphorus increased	22.03	10.51	63	81156	12462	42527654
Iron deficiency	21.80	10.51	58	81161	11003	42529113
Bacterial infection	21.77	10.51	108	81111	27771	42512345
Intestinal pseudo-obstruction	21.58	10.51	24	81195	2231	42537885
Gout	21.42	10.51	108	81111	27947	42512169
Unresponsive to stimuli	21.31	10.51	117	81102	31286	42508830
Peripheral artery thrombosis	21.29	10.51	26	81193	2671	42537445
Eosinophilia	21.02	10.51	19	81200	32880	42507236
Dry mouth	20.95	10.51	139	81080	39740	42500376
Appendicitis	20.69	10.51	86	81133	20527	42519589
Skin turgor decreased	20.25	10.51	13	81206	562	42539554
Metabolic acidosis	20.06	10.51	43	81176	51815	42488301
Haematocrit decreased	19.77	10.51	124	81095	34784	42505332
Colitis ulcerative	19.41	10.51	13	81206	26162	42513954
Gamma-glutamyltransferase increased	19.33	10.51	20	81199	32477	42507639
Dyspnoea	19.07	10.51	1028	80191	441593	42098523
Paraneoplastic rash	18.84	10.51	7	81212	87	42540029
Troponin increased	18.72	10.51	79	81140	18983	42521133
Spinal cord infarction	18.52	10.51	13	81206	653	42539463
Total lung capacity decreased	18.42	10.51	28	81191	3542	42536574
Poisoning	18.31	10.51	3	81216	14696	42525420
Blood uric acid increased	18.13	10.51	68	81151	15479	42524637
Epilepsy	18.09	10.51	14	81205	26157	42513959
Muscle spasticity	17.96	10.51	40	81179	6782	42533334
Toxic epidermal necrolysis	17.63	10.51	15	81204	26735	42513381
Peritonitis bacterial	17.60	10.51	40	81179	6875	42533241
Urticaria	17.48	10.51	77	81142	73959	42466157
Wheezing	17.32	10.51	170	81049	54611	42485505
Pleurothotonus	17.29	10.51	16	81203	1195	42538921
Cytomegalovirus infection	16.93	10.51	22	81197	32284	42507832
Spinal fracture	16.92	10.51	47	81172	9143	42530973
Decubitus ulcer	16.80	10.51	51	81168	10426	42529690
Therapeutic response decreased	16.67	10.51	28	81191	36984	42503132
Hypovitaminosis	16.59	10.51	13	81206	773	42539343
Rib fracture	16.52	10.51	69	81150	16502	42523614
Ascites	16.07	10.51	172	81047	56506	42483610
Injection site reaction	16.01	10.51	5	81214	15716	42524400
Stress	15.88	10.51	141	81078	44071	42496045
Incorrect dose administered	15.83	10.51	50	81169	52924	42487192
Chronic obstructive pulmonary disease	15.83	10.51	187	81032	62927	42477189
Cardiac failure congestive	15.83	10.51	240	80979	85362	42454754
Blood cholesterol increased	15.77	10.51	96	81123	26645	42513471
Synovitis	15.77	10.51	5	81214	15562	42524554
Hyporesponsive to stimuli	15.74	10.51	17	81202	1529	42538587
Product use issue	15.70	10.51	84	81135	76667	42463449
Metastatic renal cell carcinoma	15.63	10.51	20	81199	2154	42537962
Lumbar hernia	15.63	10.51	7	81212	144	42539972
Product prescribing error	15.61	10.51	16	81203	26096	42514020
Accidental exposure to product	15.29	10.51	10	81209	20383	42519733
Abdominal pain	15.29	10.51	473	80746	189998	42350118
Oral pustule	15.23	10.51	8	81211	236	42539880
Eczema	15.16	10.51	26	81193	34060	42506056
Accidental overdose	15.15	10.51	19	81200	28311	42511805
Metabolic encephalopathy	15.15	10.51	32	81187	5233	42534883
Neurogenic bladder	15.02	10.51	20	81199	2240	42537876
Hypoacusis	14.99	10.51	73	81146	18629	42521487
Injection site pain	14.96	10.51	58	81161	57740	42482376
White blood cell count decreased	14.82	10.51	294	80925	110102	42430014
Moaning	14.81	10.51	13	81206	906	42539210
Cellulitis	14.81	10.51	181	81038	61404	42478712
Acute hepatic failure	14.78	10.51	7	81212	17066	42523050
Sleep disorder	14.60	10.51	148	81071	47947	42492169
Ageusia	14.58	10.51	52	81167	11553	42528563
Arthritis	14.57	10.51	37	81182	42028	42498088
Bronchopulmonary aspergillosis allergic	14.47	10.51	29	81190	4569	42535547
Productive cough	14.39	10.51	156	81063	51411	42488705
Wrong technique in product usage process	14.38	10.51	38	81181	42597	42497519
Psoriatic arthropathy	14.15	10.51	16	81203	24951	42515165
Peripheral swelling	14.05	10.51	246	80973	90024	42450092
Paratracheal lymphadenopathy	14.03	10.51	6	81213	110	42540006
Erythema	14.01	10.51	136	81083	108657	42431459
Deep vein thrombosis	13.94	10.51	215	81004	76742	42463374
Pathological fracture	13.90	10.51	31	81188	5262	42534854
Pleuritic pain	13.83	10.51	37	81182	7040	42533076
Aspiration	13.76	10.51	69	81150	17817	42522299
Inappropriate schedule of product administration	13.60	10.51	117	81102	95785	42444331
Haemophagocytic lymphohistiocytosis	13.58	10.51	9	81210	18213	42521903
Intentional self-injury	13.53	10.51	6	81213	15196	42524920
Pain in extremity	13.44	10.51	379	80840	150225	42389891
Body temperature increased	13.24	10.51	75	81144	20283	42519833
Asthma	13.23	10.51	179	81040	62135	42477981
Hyperlipidaemia	13.17	10.51	78	81141	21438	42518678
Inflammation	13.14	10.51	28	81191	33819	42506297
Chills	13.13	10.51	252	80967	93814	42446302
Lung opacity	12.94	10.51	32	81187	5805	42534311
Pruritus	12.89	10.51	268	80951	188503	42351613
Polyneuropathy	12.88	10.51	10	81209	18651	42521465
Nausea	12.85	10.51	899	80320	395900	42144216
Drug eruption	12.84	10.51	15	81204	23060	42517056
Congenital hiatus hernia	12.80	10.51	33	81186	6141	42533975
Weight decrease neonatal	12.73	10.51	8	81211	333	42539783
Sitting disability	12.67	10.51	7	81212	229	42539887
Lactic acidosis	12.65	10.51	44	81175	45217	42494899
Oedema peripheral	12.58	10.51	344	80875	135732	42404384
Haemoglobin decreased	12.56	10.51	336	80883	132135	42407981
Dermatitis atopic	12.53	10.51	4	81215	12400	42527716
Contraindicated product administered	12.45	10.51	18	81201	25254	42514862
Psoriasis	12.43	10.51	49	81170	48555	42491561
Shock haemorrhagic	12.13	10.51	8	81211	16234	42523882
Impaired quality of life	11.99	10.51	6	81213	14171	42525945
Dysphagia	11.98	10.51	200	81019	72519	42467597
Cardiac failure	11.97	10.51	138	81081	106718	42433398
Haematochezia	11.92	10.51	64	81155	58372	42481744
Urinary retention	11.91	10.51	128	81091	42086	42498030
Postmortem blood drug level increased	11.83	10.51	9	81210	512	42539604
Aortic stenosis	11.69	10.51	40	81179	8705	42531411
Septic shock	11.63	10.51	115	81104	91557	42448559
Urosepsis	11.59	10.51	58	81161	14962	42525154
Essential thrombocythaemia	11.58	10.51	6	81213	172	42539944
Red blood cell count decreased	11.58	10.51	104	81115	32611	42507505
Aspergillus infection	11.56	10.51	8	81211	15829	42524287
Bone marrow failure	11.54	10.51	29	81190	33064	42507052
End stage renal disease	11.44	10.51	62	81157	16496	42523620
Muscular weakness	11.41	10.51	223	80996	83275	42456841
Intentional product use issue	11.40	10.51	85	81134	71748	42468368
Hepatotoxicity	11.37	10.51	19	81200	25148	42514968
Disturbance in attention	11.35	10.51	25	81194	29841	42510275
Anxiety	11.32	10.51	301	80918	118259	42421857
Myotonic dystrophy	11.27	10.51	6	81213	182	42539934
Band neutrophil percentage increased	11.20	10.51	5	81214	102	42540014
Hypervolaemia	11.19	10.51	79	81140	23046	42517070
Therapy non-responder	11.13	10.51	58	81161	53301	42486815
Hip fracture	11.10	10.51	53	81166	13419	42526697
Urinary incontinence	11.06	10.51	75	81144	21593	42518523
Drug use disorder	11.05	10.51	3	81216	10330	42529786
Respiratory rate decreased	11.03	10.51	20	81199	2925	42537191
Ecchymosis	10.84	10.51	36	81183	7716	42532400
Ventricular fibrillation	10.78	10.51	96	81123	30027	42510089
Angioedema	10.75	10.51	43	81176	42434	42497682
Hypophagia	10.75	10.51	88	81131	26868	42513248
Body height decreased	10.75	10.51	24	81195	4076	42536040
Post procedural complication	10.71	10.51	50	81169	12540	42527576
Maternal exposure during breast feeding	10.70	10.51	14	81205	1541	42538575
Micturition urgency	10.68	10.51	48	81171	11850	42528266
Tuberculosis	10.67	10.51	3	81216	10096	42530020
Blood lactate dehydrogenase increased	10.61	10.51	21	81198	26060	42514056
Eosinophil count decreased	10.60	10.51	22	81197	3554	42536562

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
Constipation	572.93	9.81	1512	167937	356274	110063576
Drug ineffective	375.62	9.81	1145	168304	1519395	108900455
Systemic lupus erythematosus	313.71	9.81	19	169430	254319	110165531
Hand deformity	301.05	9.81	7	169442	218499	110201351
Pemphigus	284.15	9.81	10	169439	214560	110205290
Synovitis	281.69	9.81	42	169407	274050	110145800
Duodenal ulcer perforation	243.60	9.81	6	169443	177694	110242156
Febrile neutropenia	224.47	9.81	1021	168428	315746	110104104
Helicobacter infection	223.01	9.81	14	169435	181863	110237987
Glossodynia	219.14	9.81	38	169411	221966	110197884
Folliculitis	214.60	9.81	10	169439	167643	110252207
Completed suicide	205.98	9.81	58	169391	242323	110177527
Pericarditis	204.62	9.81	43	169406	219071	110200779
Urinary tract infection	189.10	9.81	993	168456	325289	110094561
Death	187.75	9.81	1762	167687	697107	109722743
Therapeutic product effect decreased	183.93	9.81	72	169377	244244	110175606
Pulmonary embolism	182.54	9.81	731	168718	213743	110206107
Back pain	181.73	9.81	1079	168370	369917	110049933
Muscle injury	181.52	9.81	8	169441	140799	110279051
C-reactive protein abnormal	175.42	9.81	5	169444	129690	110290160
Mental status changes	172.81	9.81	369	169080	75753	110344097
Rheumatic fever	172.51	9.81	3	169446	122576	110297274
Respiratory symptom	168.20	9.81	157	169292	14788	110405062
Temperature regulation disorder	162.49	9.81	144	169305	12682	110407168
Plasma cell myeloma	160.41	9.81	320	169129	62616	110357234
Arthropathy	159.65	9.81	124	169325	287398	110132452
Maternal exposure during pregnancy	154.55	9.81	100	169349	254783	110165067
Irritable bowel syndrome	149.70	9.81	34	169415	164181	110255669
Discomfort	147.79	9.81	72	169377	214635	110205215
Pneumonia aspiration	144.85	9.81	358	169091	80875	110338975
Off label use	144.75	9.81	1537	167912	1498648	108921202
Hypoxia	140.88	9.81	478	168971	129037	110290813
Psoriatic arthropathy	140.02	9.81	63	169386	196698	110223152
Wound	139.40	9.81	94	169355	234343	110185507
Sleep disorder due to general medical condition, insomnia type	136.17	9.81	6	169443	105637	110314213
Lip dry	134.83	9.81	4	169445	100079	110319771
C-reactive protein increased	130.07	9.81	87	169362	217832	110202018
Facet joint syndrome	126.47	9.81	5	169444	96823	110323027
Food allergy	125.64	9.81	154	169295	19794	110400056
Impaired healing	125.06	9.81	73	169376	196644	110223206
Pulmonary vasculitis	123.99	9.81	93	169356	6467	110413383
Liver injury	120.53	9.81	40	169409	150373	110269477
Neuritis	120.44	9.81	96	169353	7303	110412547
Alopecia	117.16	9.81	239	169210	364514	110055336
Swollen joint count increased	113.97	9.81	3	169446	83658	110336192
Obstructive airways disorder	108.54	9.81	227	169222	45922	110373928
Foetal death	107.80	9.81	128	169321	15917	110403933
Upper respiratory tract infection	107.20	9.81	442	169007	130886	110288964
Type 2 diabetes mellitus	106.78	9.81	70	169379	177162	110242688
Fall	103.14	9.81	1393	168056	602089	109817761
Drug abuse	102.98	9.81	73	169376	177338	110242512
Total lung capacity decreased	102.56	9.81	86	169363	7028	110412822
Blood calcium increased	102.05	9.81	132	169317	17908	110401942
Deep vein thrombosis	102.01	9.81	455	168994	139432	110280418
Grip strength decreased	101.88	9.81	5	169444	80169	110339681
Toxicity to various agents	100.75	9.81	387	169062	480168	109939682
Ill-defined disorder	99.98	9.81	58	169391	156795	110263055
Urticaria	98.96	9.81	213	169236	318644	110101206
Intentional overdose	98.12	9.81	40	169409	132461	110287389
Blister	97.48	9.81	123	169326	227253	110192597
Myelosuppression	95.62	9.81	15	169434	94325	110325525
Pleural effusion	93.48	9.81	527	168922	177182	110242668
Inflammation	93.21	9.81	95	169354	193143	110226707
Pneumonia	92.06	9.81	1868	167581	874846	109545004
Sepsis	91.98	9.81	834	168615	326512	110093338
Dehydration	91.07	9.81	736	168713	278775	110141075
Fibromyalgia	90.72	9.81	77	169372	170832	110249018
Total lung capacity abnormal	88.91	9.81	66	169383	4517	110415333
Thrombosis	88.90	9.81	366	169083	108296	110311554
Peripheral venous disease	88.44	9.81	12	169437	84105	110335745
Failure to thrive	87.45	9.81	106	169343	13468	110406382
Bronchopulmonary aspergillosis allergic	86.24	9.81	84	169365	8342	110411508
Lung opacity	83.36	9.81	96	169353	11556	110408294
Fluid retention	83.02	9.81	325	169124	93982	110325868
Abdominal discomfort	81.99	9.81	318	169131	393540	110026310
Hyponatraemia	80.85	9.81	591	168858	217062	110202788
Neurological symptom	80.27	9.81	109	169340	15499	110404351
Joint swelling	79.66	9.81	378	169071	442467	109977383
Haemoptysis	79.02	9.81	265	169184	71089	110348761
Salpingo-oophorectomy unilateral	78.96	9.81	34	169415	797	110419053
Gastrooesophageal reflux disease	76.45	9.81	505	168944	179471	110240379
Epilepsy	76.26	9.81	29	169420	100180	110319670
Live birth	75.26	9.81	9	169440	69475	110350375
Intentional product use issue	74.11	9.81	169	169280	247737	110172113
Gastrointestinal disorder	72.28	9.81	165	169284	241787	110178063
Pulmonary malformation	72.03	9.81	23	169426	222	110419628
Dyspnoea	71.82	9.81	2210	167239	1104662	109315188
Immunodeficiency	70.10	9.81	172	169277	38666	110381184
Treatment failure	69.85	9.81	206	169243	277028	110142822
Eosinophilic granulomatosis with polyangiitis	69.74	9.81	84	169365	10602	110409248
Blood test abnormal	68.96	9.81	142	169307	28412	110391438
Conjunctivitis allergic	68.89	9.81	68	169381	6863	110412987
Fatigue	68.15	9.81	2386	167063	1213572	109206278
Blepharospasm	67.88	9.81	4	169445	54847	110365003
Contraindicated product administered	67.34	9.81	178	169271	248089	110171761
Small intestinal obstruction	67.23	9.81	151	169298	32062	110387788
Somnolence	67.06	9.81	724	168725	296725	110123125
Oedema peripheral	66.86	9.81	784	168665	327876	110091974
Mobility decreased	66.10	9.81	168	169281	237254	110182596
Pleuritic pain	65.86	9.81	101	169348	16039	110403811
General physical health deterioration	65.85	9.81	382	169067	424913	109994937
Condition aggravated	65.66	9.81	765	168684	734071	109685779
Aspiration	64.71	9.81	144	169305	30389	110389461
Proctalgia	64.48	9.81	90	169359	13132	110406718
Haemoglobin decreased	64.46	9.81	623	168826	248104	110171746
Intestinal pseudo-obstruction	64.37	9.81	48	169401	3308	110416542
IVth nerve paralysis	62.74	9.81	27	169422	632	110419218
Spirometry abnormal	62.34	9.81	58	169391	5439	110414411
Injection site reaction	61.06	9.81	30	169419	89040	110330810
Hospice care	60.98	9.81	85	169364	12388	110407462
Obesity	60.23	9.81	51	169398	113300	110306550
Mite allergy	59.67	9.81	58	169391	5745	110414105
Product use in unapproved indication	59.46	9.81	421	169028	446956	109972894
Red blood cell sedimentation rate increased	59.01	9.81	23	169426	78279	110341571
Drug ineffective for unapproved indication	58.77	9.81	43	169406	102795	110317055
Mycotic allergy	58.41	9.81	58	169391	5896	110413954
Dust allergy	58.03	9.81	58	169391	5943	110413907
Stomatitis	56.98	9.81	217	169232	270025	110149825
Sinusitis fungal	56.91	9.81	41	169408	2679	110417171
Colitis ulcerative	56.23	9.81	24	169425	77339	110342511
Hypotension	56.09	9.81	1120	168329	522729	109897121
Night sweats	55.84	9.81	74	169375	133909	110285941
Chronic obstructive pulmonary disease	55.59	9.81	321	169128	108837	110311013
Asthenia	55.57	9.81	1415	168034	687584	109732266
Joint range of motion decreased	55.29	9.81	63	169386	121769	110298081
Swelling	53.95	9.81	316	169133	350725	110069125
Granulocytopenia	53.91	9.81	81	169368	12634	110407216
Arthralgia	53.63	9.81	856	168593	778776	109641074
Nail disorder	52.77	9.81	12	169437	57923	110361927
Analgesic therapy	52.08	9.81	60	169389	7224	110412626
Dislocation of vertebra	51.73	9.81	4	169445	43717	110376133
Unresponsive to stimuli	51.48	9.81	214	169235	63576	110356274
Hepatocellular injury	51.43	9.81	8	169441	50634	110369216
Embolism venous	51.27	9.81	50	169399	4973	110414877
Antineutrophil cytoplasmic antibody positive	50.82	9.81	50	169399	5026	110414824
Pulmonary alveolar haemorrhage	50.78	9.81	102	169347	20048	110399802
Cellulitis	50.74	9.81	349	169100	125667	110294183
Therapy non-responder	50.52	9.81	103	169346	157204	110262646
Drug therapy	50.36	9.81	59	169390	7232	110412618
Peritonitis bacterial	50.33	9.81	71	169378	10462	110409388
Cardiac failure congestive	49.89	9.81	399	169050	150601	110269249
Autoimmune disorder	49.74	9.81	19	169430	65464	110354386
Vasculitis	49.68	9.81	144	169305	35729	110384121
Hiatus hernia	49.55	9.81	122	169327	27484	110392366
Onychomadesis	49.24	9.81	6	169443	45657	110374193
Lung cyst	48.86	9.81	21	169428	490	110419360
Suicide attempt	48.53	9.81	52	169397	103342	110316508
Myasthenia gravis	48.48	9.81	104	169345	21407	110398443
Abdominal pain	48.48	9.81	1077	168372	511912	109907938
Haemorrhoids	48.25	9.81	142	169307	35530	110384320
Lethargy	48.18	9.81	276	169173	93300	110326550
Bone erosion	47.84	9.81	7	169442	46364	110373486
Full blood count abnormal	47.58	9.81	191	169258	55861	110363989
Neuralgia	47.57	9.81	173	169276	48305	110371545
Hyperphosphataemia	47.51	9.81	88	169361	16293	110403557
Capillaritis	47.04	9.81	35	169414	2404	110417446
Appendicolith	47.01	9.81	81	169368	14174	110405676
X-ray abnormal	46.51	9.81	3	169446	38114	110381736
Anal inflammation	46.32	9.81	35	169414	2461	110417389
Full blood count decreased	45.56	9.81	130	169319	31969	110387881
Infection	44.68	9.81	348	169101	361852	110057998
Rash erythematous	44.54	9.81	245	169204	81587	110338263
Diverticulum	44.52	9.81	83	169366	15443	110404407
Adjustment disorder with depressed mood	44.41	9.81	7	169442	43876	110375974
Nausea	44.34	9.81	2315	167134	1233375	109186475
Hypersomnia	44.14	9.81	118	169331	27943	110391907
SARS-CoV-2 test negative	44.01	9.81	32	169417	2121	110417729
White blood cell count decreased	43.90	9.81	541	168908	228849	110191001
Drug reaction with eosinophilia and systemic symptoms	43.54	9.81	37	169412	82058	110337792
Interstitial lung disease	43.25	9.81	93	169356	139241	110280609
Anticoagulant therapy	43.20	9.81	47	169402	5314	110414536
Haematocrit decreased	42.97	9.81	208	169241	65909	110353941
Hypophosphataemia	42.91	9.81	130	169319	33052	110386798
Sleep disorder therapy	42.78	9.81	55	169394	7416	110412434
Blood phosphorus increased	42.73	9.81	84	169365	16256	110403594
Drug intolerance	42.40	9.81	408	169041	406104	110013746
Wound infection	41.51	9.81	52	169397	96413	110323437
Hypercholesterolaemia	41.18	9.81	47	169402	90790	110329060
Poor sucking reflex	40.85	9.81	13	169436	124	110419726
Antacid therapy	40.61	9.81	46	169403	5438	110414412
Hyperhidrosis	40.39	9.81	452	168997	186846	110233004
Diastolic dysfunction	40.28	9.81	70	169379	12334	110407516
Normochromic normocytic anaemia	40.22	9.81	72	169377	12985	110406865
Nasopharyngitis	40.20	9.81	398	169051	393963	110025887
Pregnancy	40.17	9.81	14	169435	51053	110368797
Hypervolaemia	39.97	9.81	166	169283	49294	110370556
Carbuncle	39.90	9.81	26	169423	1441	110418409
Blood cholesterol increased	39.18	9.81	148	169301	184637	110235213
Sputum increased	38.83	9.81	46	169403	5705	110414145
Respiratory tract malformation	38.83	9.81	12	169437	103	110419747
Hepatic enzyme increased	38.79	9.81	310	169139	320582	110099268
Blood potassium decreased	38.66	9.81	175	169274	53939	110365911
Drug resistance	38.62	9.81	19	169430	56355	110363495
Forced expiratory volume decreased	38.48	9.81	71	169378	13105	110406745
Blood creatinine increased	38.37	9.81	439	169010	182450	110237400
Retinitis	38.13	9.81	3	169446	32324	110387526
Ascites	37.93	9.81	258	169191	92550	110327300
Anti-neutrophil cytoplasmic antibody positive vasculitis	37.69	9.81	44	169405	5373	110414477
Cestode infection	37.36	9.81	15	169434	293	110419557
Monoclonal immunoglobulin present	37.22	9.81	31	169418	2509	110417341
Anaemia	36.83	9.81	1098	168351	545988	109873862
Acute respiratory failure	36.81	9.81	219	169230	75041	110344809
Iron deficiency	36.77	9.81	85	169364	18391	110401459
Hypophagia	36.71	9.81	169	169280	52457	110367393
Respiratory failure	36.63	9.81	497	168952	214835	110205015
Decubitus ulcer	36.41	9.81	84	169365	18152	110401698
Abdominal distension	35.70	9.81	418	169031	174685	110245165
Road traffic accident	35.61	9.81	69	169380	107329	110312521
Cholestasis	35.55	9.81	28	169421	64490	110355360
Dysphagia	35.10	9.81	375	169074	153225	110266625
Creatinine renal clearance increased	34.98	9.81	35	169414	3590	110416260
Drug interaction	34.73	9.81	548	168901	499635	109920215
Therapeutic response decreased	34.68	9.81	59	169390	96440	110323410
Tremor	34.50	9.81	467	168982	201765	110218085
Atrial fibrillation	34.27	9.81	518	168931	229124	110190726
Tricuspid valve incompetence	34.19	9.81	97	169352	23776	110396074
Lupus-like syndrome	34.19	9.81	10	169439	40782	110379068
Activated partial thromboplastin time prolonged	34.12	9.81	93	169356	22275	110397575
Hip fracture	34.12	9.81	125	169324	35026	110384824
Failure to suspend medication	33.82	9.81	16	169433	470	110419380
Migraine	33.53	9.81	142	169307	171510	110248340
Autonomic dysreflexia	33.42	9.81	16	169433	483	110419367
Coeliac disease	33.38	9.81	143	169306	43044	110376806
Hepatitis	33.35	9.81	54	169395	90000	110329850
Balance disorder	33.20	9.81	298	169151	116262	110303588
Asthma	32.99	9.81	553	168896	249738	110170112
Hallucination	32.94	9.81	267	169182	101165	110318685
Epistaxis	32.50	9.81	324	169125	130048	110289802
Troponin increased	32.46	9.81	110	169339	29656	110390194
Vomiting	32.15	9.81	1704	167745	908971	109510879
Adverse event	31.83	9.81	75	169374	108734	110311116
Hypothyroidism	31.81	9.81	206	169243	72693	110347157
Pulmonary mass	31.57	9.81	127	169322	37174	110382676
Onychomycosis	31.29	9.81	10	169439	38521	110381329
International normalised ratio increased	31.27	9.81	234	169215	86538	110333312
Arteriosclerosis coronary artery	31.16	9.81	97	169352	25021	110394829
Therapeutic product effect incomplete	30.98	9.81	208	169241	223597	110196253
Urinary incontinence	30.96	9.81	152	169297	48435	110371415
Pruritus	30.75	9.81	668	168781	580892	109838958
Premenstrual syndrome	30.48	9.81	16	169433	590	110419260
Rales	30.20	9.81	95	169354	24644	110395206
Frequent bowel movements	30.18	9.81	39	169410	71351	110348499
Anaphylactic shock	30.17	9.81	21	169428	51525	110368325
Chills	30.04	9.81	434	169015	190146	110229704
Lower limb fracture	30.00	9.81	43	169406	75305	110344545
Exposure via breast milk	29.89	9.81	19	169430	1009	110418841
Rheumatoid arthritis	29.84	9.81	304	169145	299309	110120541
Gout	29.76	9.81	123	169326	36443	110383407
End stage renal disease	29.54	9.81	86	169363	21387	110398463
IgA nephropathy	29.46	9.81	30	169419	3143	110416707
Platelet count decreased	29.22	9.81	506	168943	229937	110189913
Emphysema	29.00	9.81	81	169368	19675	110400175
Neutrophil count decreased	28.92	9.81	298	169151	120643	110299207
Hyperlipidaemia	28.72	9.81	120	169329	35728	110384122
Musculoskeletal pain	28.49	9.81	164	169285	182859	110236991
Renal function test abnormal	28.42	9.81	50	169399	8896	110410954
Appendicitis	28.28	9.81	102	169347	28362	110391488
Accident	28.27	9.81	56	169393	10896	110408954
Disease progression	28.18	9.81	528	168921	243506	110176344
Cholelithiasis	28.15	9.81	180	169269	63242	110356608
Red blood cell count decreased	27.98	9.81	185	169264	65738	110354112
Productive cough	27.97	9.81	283	169166	114022	110305828
Exostosis	27.87	9.81	18	169431	45938	110373912
Lactation disorder	27.76	9.81	12	169437	284	110419566
Gastrointestinal haemorrhage	27.72	9.81	381	169068	165137	110254713
Hypersensitivity	27.56	9.81	444	169005	403554	110016296
Burkholderia test positive	27.25	9.81	15	169434	609	110419241
Rash	26.84	9.81	1008	168441	819956	109599894
Magnesium deficiency	26.61	9.81	16	169433	769	110419081
Paraesthesia	26.54	9.81	283	169166	276238	110143612
Drug tolerance decreased	26.54	9.81	5	169444	27535	110392315
Hip arthroplasty	26.27	9.81	28	169421	55785	110364065
Sputum discoloured	25.97	9.81	98	169351	27847	110392003
Accidental exposure to product	25.95	9.81	23	169426	49985	110369865
Injection site erythema	25.92	9.81	67	169382	94109	110325741
Arteriosclerosis	25.68	9.81	90	169359	24677	110395173
Polymenorrhoea	25.68	9.81	18	169431	1126	110418724
Chest pain	25.46	9.81	756	168693	375619	110044231
Injury	25.42	9.81	163	169286	177102	110242748
Product quality issue	25.34	9.81	50	169399	77249	110342601
Sinusitis	25.22	9.81	312	169137	296376	110123474
Aortic stenosis	24.81	9.81	59	169390	13000	110406850
Hypothalamo-pituitary disorder	24.78	9.81	26	169423	2820	110417030
Product label confusion	24.40	9.81	3	169446	22674	110397176
Infusion related reaction	24.33	9.81	424	169025	380738	110039112
Fungal infection	24.31	9.81	147	169302	50659	110369191
Atelectasis	24.22	9.81	116	169333	36596	110383254
Retching	24.02	9.81	83	169366	22599	110397251
Product use issue	23.85	9.81	335	169114	311360	110108490
Hepatic cirrhosis	23.70	9.81	42	169407	67584	110352266
Eosinophil count decreased	23.63	9.81	37	169412	5981	110413869
Ecchymosis	23.43	9.81	69	169380	17269	110402581
Back injury	23.19	9.81	23	169426	47376	110372474
Bacterial infection	23.18	9.81	135	169314	45901	110373949
Weight increased	23.04	9.81	479	168970	419165	110000685
Drug-induced liver injury	23.03	9.81	100	169349	119967	110299883
Sciatica	23	9.81	69	169380	92330	110327520
Supraventricular tachycardia	22.99	9.81	86	169363	24336	110395514
Abortion spontaneous	22.82	9.81	12	169437	34270	110385580
Hysterectomy	22.79	9.81	43	169406	8071	110411779
Chest injury	22.58	9.81	27	169422	3382	110416468
Menstruation delayed	22.44	9.81	20	169429	1774	110418076
Maternal exposure during breast feeding	22.41	9.81	30	169419	4208	110415642
Blood uric acid increased	22.12	9.81	78	169371	21451	110398399
Injection site swelling	22.00	9.81	38	169411	61752	110358098
Drug eruption	21.98	9.81	30	169419	53629	110366221
Body height decreased	21.47	9.81	49	169400	10514	110409336
Foetal exposure timing unspecified	21.44	9.81	7	169442	73	110419777
Gait inability	21.33	9.81	122	169327	136254	110283596
Knee arthroplasty	21.29	9.81	42	169407	64906	110354944
Dental restoration failure	21.10	9.81	16	169433	1131	110418719
Injection site pain	20.97	9.81	173	169276	177749	110242101
Myoclonus	20.86	9.81	103	169346	32895	110386955
Lichen sclerosus	20.84	9.81	16	169433	1152	110418698
Sleep apnoea syndrome	20.62	9.81	119	169330	40328	110379522
Lactic acidosis	20.54	9.81	73	169376	92738	110327112
Pneumonitis	20.45	9.81	193	169256	76338	110343512
Post procedural complication	20.40	9.81	88	169361	26570	110393280
Drooling	20.26	9.81	38	169411	7101	110412749
Paraneoplastic rash	20.26	9.81	7	169442	88	110419762
Haemorrhage intracranial	20.18	9.81	93	169356	28876	110390974
Ventricular fibrillation	20.06	9.81	120	169329	41193	110378657
Feeling hot	19.94	9.81	72	169377	91034	110328816
Hepatic function abnormal	19.92	9.81	70	169379	89225	110330625
Maternal exposure timing unspecified	19.86	9.81	4	169445	21009	110398841
Cytomegalovirus infection	19.83	9.81	33	169416	54411	110365439
Heart rate increased	19.76	9.81	320	169129	143514	110276336
Product prescribing error	19.74	9.81	30	169419	51301	110368549
Ear infection	19.36	9.81	42	169407	62690	110357160
Liver disorder	19.28	9.81	133	169316	142110	110277740
Cerebrovascular accident	19.15	9.81	387	169062	180897	110238953
Lip pruritus	19.09	9.81	16	169433	1306	110418544
Medication error	18.87	9.81	90	169359	105276	110314574
Ileus	18.78	9.81	95	169354	30634	110389216
Acute generalised exanthematous pustulosis	18.73	9.81	5	169444	21659	110398191
Metastatic renal cell carcinoma	18.70	9.81	21	169428	2459	110417391
Congenital hiatus hernia	18.62	9.81	34	169415	6225	110413625
Bone marrow failure	18.46	9.81	38	169411	57810	110362040
Arthritis	18.39	9.81	166	169283	167420	110252430
Haemophagocytic lymphohistiocytosis	18.28	9.81	13	169436	31546	110388304
Hypoaesthesia	18.03	9.81	356	169093	313867	110105983
Thyroid atrophy	18.03	9.81	9	169440	298	110419552
Drug use disorder	18.03	9.81	3	169446	18071	110401779
Excessive eye blinking	17.95	9.81	18	169431	1852	110417998
Transfusion	17.91	9.81	82	169367	25390	110394460
Metabolic encephalopathy	17.89	9.81	47	169402	11013	110408837
Overweight	17.84	9.81	34	169415	6430	110413420
Urinary retention	17.76	9.81	174	169275	69509	110350341
Uterine perforation	17.69	9.81	35	169414	6805	110413045
Taste disorder	17.62	9.81	47	169402	65340	110354510
Diabetes mellitus	17.56	9.81	231	169218	99150	110320700
Wrist deformity	17.52	9.81	23	169426	3166	110416684
Musculoskeletal chest pain	17.50	9.81	89	169360	28758	110391092
Blood calcium decreased	17.33	9.81	104	169345	35741	110384109
Musculoskeletal stiffness	17.30	9.81	313	169136	279509	110140341
Adverse drug reaction	17.29	9.81	93	169356	105466	110314384
Neurogenic bladder	16.93	9.81	29	169420	5050	110414800
Dyspepsia	16.91	9.81	199	169250	190766	110229084
Epiglottic erythema	16.84	9.81	6	169443	83	110419767
Ageusia	16.71	9.81	67	169382	19578	110400272
Toxic epidermal necrolysis	16.67	9.81	39	169410	56688	110363162
Pneumonia viral	16.63	9.81	46	169403	11111	110408739
Carbohydrate antigen 125 increased	16.59	9.81	20	169429	2527	110417323
Micturition urgency	16.53	9.81	66	169383	19254	110400596
Neuropathy peripheral	16.45	9.81	375	169074	178902	110240948
Lumbar hernia	16.38	9.81	7	169442	161	110419689
Intentional self-injury	16.29	9.81	20	169429	37409	110382441
Fibrosis	16.14	9.81	36	169413	7606	110412244
Injection site pruritus	16.08	9.81	34	169415	51224	110368626
Painful respiration	16.07	9.81	24	169425	3723	110416127
Accidental death	15.92	9.81	28	169421	4981	110414869
Posture abnormal	15.67	9.81	26	169423	4412	110415438
Intestinal obstruction	15.63	9.81	137	169312	53090	110366760
Limb injury	15.60	9.81	105	169344	37531	110382319
Iron deficiency anaemia	15.54	9.81	92	169357	31467	110388383
Hot flush	15.44	9.81	162	169287	65874	110353976
Impaired quality of life	15.34	9.81	14	169435	30003	110389847
Spinal cord infarction	15.26	9.81	13	169436	1085	110418765
Orthostatic hypotension	15.25	9.81	162	169287	66087	110353763
Dyspnoea exertional	15.23	9.81	234	169215	103826	110316024
Oesophageal irritation	15.19	9.81	8	169441	297	110419553
Calculus bladder	15.16	9.81	16	169433	1748	110418102
Impaired work ability	15.15	9.81	11	169438	26408	110393442
Drug hypersensitivity	15.15	9.81	556	168893	453534	109966316
Polyneuropathy	15.13	9.81	16	169433	31996	110387854
Emotional distress	15.07	9.81	119	169330	44728	110375122
Presyncope	14.96	9.81	127	169322	48760	110371090
Abdominal mass	14.90	9.81	27	169422	4914	110414936
Epiglottic oedema	14.89	9.81	9	169440	437	110419413
Dysmetropsia	14.77	9.81	6	169443	121	110419729
Decreased immune responsiveness	14.71	9.81	40	169409	9566	110410284
Multiple sclerosis	14.70	9.81	78	169371	25620	110394230
Sleep disorder	14.66	9.81	215	169234	198429	110221421
Oral pain	14.65	9.81	103	169346	37341	110382509
Anxiety	14.48	9.81	657	168792	344421	110075429
Hypoacusis	14.48	9.81	98	169351	35093	110384757
Breath sounds abnormal	14.46	9.81	77	169372	25327	110394523
Stress	14.32	9.81	234	169215	105114	110314736
Spinal compression fracture	14.29	9.81	61	169388	18331	110401519
Aspergillus infection	14.26	9.81	11	169438	25605	110394245
Dysstasia	14.26	9.81	93	169356	32893	110386957
Anal incontinence	14.20	9.81	69	169380	21895	110397955
Rubber sensitivity	14.16	9.81	18	169431	2400	110417450
Joint dislocation	14.12	9.81	19	169430	34171	110385679
Transaminases increased	14.12	9.81	154	169295	63236	110356614
Agranulocytosis	14.06	9.81	48	169401	61712	110358138
Hyperaesthesia	13.98	9.81	52	169397	14675	110405175
Aortic aneurysm	13.95	9.81	40	169409	9864	110409986
Hepatotoxicity	13.94	9.81	50	169399	63350	110356500
Renal impairment	13.89	9.81	204	169245	188241	110231609
Rib fracture	13.87	9.81	94	169355	33676	110386174
Contusion	13.81	9.81	263	169186	233098	110186752
Adverse reaction	13.75	9.81	15	169434	29579	110390271
Therapeutic response shortened	13.74	9.81	15	169434	29568	110390282
Wrong technique in product usage process	13.73	9.81	78	169371	87270	110332580
Pleurothotonus	13.70	9.81	18	169431	2480	110417370
Infusion site reaction	13.65	9.81	5	169444	17677	110402173
Exposure during pregnancy	13.50	9.81	178	169271	167246	110252604
Blood glucose increased	13.38	9.81	281	169168	132215	110287635
Sinus tachycardia	13.31	9.81	115	169334	44378	110375472
Heparin-induced thrombocytopenia	13.15	9.81	43	169406	11381	110408469
Intentional product misuse	13.14	9.81	281	169168	132623	110287227
Ear pain	13.06	9.81	40	169409	53186	110366664
Gamma-glutamyltransferase increased	13.06	9.81	49	169400	61260	110358590
Blood sodium decreased	13.05	9.81	102	169347	38217	110381633
Pneumococcal infection	13.03	9.81	15	169434	1804	110418046
Urosepsis	12.97	9.81	86	169363	30589	110389261
Bacteroides infection	12.96	9.81	19	169430	2900	110416950
Oral pustule	12.95	9.81	7	169442	274	110419576
Device expulsion	12.93	9.81	17	169432	30874	110388976
Blood phosphorus decreased	12.84	9.81	33	169416	7632	110412218
Posterior reversible encephalopathy syndrome	12.82	9.81	20	169429	33841	110386009
Urinary tract obstruction	12.80	9.81	26	169423	5151	110414699
Drug effective for unapproved indication	12.77	9.81	3	169446	14164	110405686
Ankylosing spondylitis	12.77	9.81	4	169445	15608	110404242
Pulmonary hypertension	12.69	9.81	135	169314	55085	110364765
Blood loss anaemia	12.66	9.81	58	169391	17967	110401883
Lower gastrointestinal haemorrhage	12.62	9.81	59	169390	18427	110401423
Catheter site bruise	12.57	9.81	9	169440	582	110419268
Shock haemorrhagic	12.46	9.81	14	169435	27233	110392617
Duodenal stenosis	12.44	9.81	11	169438	966	110418884
Hyperglycaemia	12.32	9.81	191	169258	84899	110334951
Airway burns	12.30	9.81	3	169446	9	110419841
Non-cardiac chest pain	12.30	9.81	39	169410	10159	110409691
Noninfectious peritonitis	12.29	9.81	7	169442	304	110419546
Blood bilirubin decreased	12.29	9.81	13	169436	1424	110418426
Oesophageal injury	12.25	9.81	7	169442	306	110419544
Myotonic dystrophy	12.18	9.81	6	169443	193	110419657
Hypovitaminosis	12.12	9.81	13	169436	1447	110418403
Non-small cell lung cancer	12.11	9.81	33	169416	7902	110411948
Pneumonectomy	12.08	9.81	5	169444	106	110419744
Prescribed underdose	12.06	9.81	55	169394	65119	110354731
Rhabdomyolysis	12.04	9.81	122	169327	120279	110299571
Pustular psoriasis	12.03	9.81	3	169446	13602	110406248
Paratracheal lymphadenopathy	11.93	9.81	6	169443	202	110419648
Bronchopulmonary aspergillosis	11.93	9.81	17	169432	29846	110390004
Intentional underdose	11.89	9.81	17	169432	2535	110417315
Body temperature fluctuation	11.87	9.81	21	169428	3752	110416098
Pathological fracture	11.85	9.81	43	169406	11989	110407861
Osteonecrosis of jaw	11.85	9.81	36	169413	47981	110371869
Asterixis	11.83	9.81	19	169430	3139	110416711
Clostridium difficile infection	11.78	9.81	127	169322	52002	110367848
Injection site warmth	11.72	9.81	6	169443	17399	110402451
Inguinal hernia	11.66	9.81	32	169417	7693	110412157
Malignant neoplasm of thorax	11.64	9.81	3	169446	12	110419838
Nasal discharge discolouration	11.64	9.81	19	169430	3182	110416668
Multiple-drug resistance	11.55	9.81	3	169446	13232	110406618
Systemic inflammatory response syndrome	11.51	9.81	45	169404	12998	110406852
Pericardial effusion	11.39	9.81	136	169313	57081	110362769
Drug dose omission by device	11.38	9.81	4	169445	14512	110405338
Faeces discoloured	11.36	9.81	90	169359	33858	110385992
Multiple injuries	11.22	9.81	20	169429	3594	110416256
Nasal polyps	11.22	9.81	45	169404	13155	110406695
Mean platelet volume increased	11.11	9.81	13	169436	1591	110418259
Exposure to toxic agent	11.06	9.81	3	169446	12855	110406995
Catheter site pain	11.05	9.81	28	169421	6418	110413432
Oesophageal ulcer	11.05	9.81	32	169417	7932	110411918
Skin laceration	11.03	9.81	89	169360	33664	110386186
Cognitive disorder	11.03	9.81	192	169257	87319	110332531
Chronic sinusitis	11.01	9.81	71	169378	25013	110394837
Onychoclasis	10.95	9.81	30	169419	7207	110412643
Lymphocyte count decreased	10.93	9.81	135	169314	57108	110362742
Phlebosclerosis	10.93	9.81	5	169444	136	110419714
Circulatory collapse	10.77	9.81	32	169417	42961	110376889
Injection site rash	10.74	9.81	12	169437	23407	110396443
Nephropathy	10.72	9.81	45	169404	13422	110406428
Nodule	10.65	9.81	86	169363	32545	110387305
Coma	10.64	9.81	246	169203	117623	110302227
Gastrointestinal arteriovenous malformation	10.59	9.81	10	169439	955	110418895
Transient ischaemic attack	10.59	9.81	147	169302	63835	110356015
Perirectal abscess	10.59	9.81	15	169434	2219	110417631
Spleen atrophy	10.58	9.81	4	169445	66	110419784
Essential thrombocythaemia	10.54	9.81	7	169442	401	110419449
Epstein-Barr virus infection	10.49	9.81	8	169441	18730	110401120
Red cell distribution width increased	10.46	9.81	54	169395	17548	110402302
Pneumothorax	10.45	9.81	91	169358	35194	110384656
Cholecystitis chronic	10.26	9.81	35	169414	9465	110410385
Psychotic symptom	10.26	9.81	20	169429	3847	110416003
Blood chloride decreased	10.22	9.81	34	169415	9081	110410769
Diabetic wound	10.21	9.81	4	169445	73	110419777
Urinary retention postoperative	10.20	9.81	6	169443	277	110419573
Spinal cord compression	10.15	9.81	30	169419	7522	110412328
Osteoarthritis	10.14	9.81	208	169241	182415	110237435
Cervical vertebral fracture	10.07	9.81	22	169427	4583	110415267
Hypertonia	10.00	9.81	32	169417	8374	110411476
Light chain analysis increased	9.98	9.81	15	169434	2340	110417510
Conjunctival pigmentation	9.92	9.81	4	169445	79	110419771
Convulsive threshold lowered	9.91	9.81	10	169439	1036	110418814
Premature delivery	9.88	9.81	20	169429	30612	110389238
Inappropriate schedule of product administration	9.86	9.81	237	169212	203400	110216450
Mitochondrial myopathy	9.86	9.81	7	169442	447	110419403
Multiple sclerosis relapse	9.82	9.81	119	169330	50121	110369729

FDA Adverse Event Reporting System (Pediatric)

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
Hypovolaemic shock	29.29	28.84	17	342	372	113222

Pharmacologic Action:

Source	Code	Description
ATC	A06AA02	ALIMENTARY TRACT AND METABOLISM DRUGS FOR CONSTIPATION DRUGS FOR CONSTIPATION Softeners, emollients
ATC	A06AG10	ALIMENTARY TRACT AND METABOLISM DRUGS FOR CONSTIPATION DRUGS FOR CONSTIPATION Enemas
MeSH PA	D013501	Surface-Active Agents
CHEBI has role	CHEBI:50503	laxative
CHEBI has role	CHEBI:55324	gastrointestinal drug
CHEBI has role	CHEBI:75835	anti-anaemic agent

Related Drugs by ATC class:

A06AG Enemas 5 drugs

bisacodyldantronglycerolsodium phosphatesorbitol

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

Disease	Relation	SNOMED_ID	DOID
Constipation	indication	14760008	DOID:2089
Megaloblastic anemia due to folate deficiency	indication	85649008	DOID:14026
Iron deficiency anemia	indication	87522002
Pregnancy, function	indication	289908002
Breastfeeding (mother)	indication	413712001
Incomplete passage of stool	off-label use	249515001
Prevention of Fetal Neural Tube Defects during Pregnancy	off-label use
Peptic ulcer	contraindication	13200003	DOID:750
Primary hyperoxaluria	contraindication	17901006	DOID:2977
Gastroenteritis	contraindication	25374005	DOID:2326
Hemosiderosis	contraindication	39011001	DOID:12119
Hypokalemia	contraindication	43339004
Bleeding hemorrhoids	contraindication	51551000
Gastrectomy	contraindication	53442002
Leber's optic atrophy	contraindication	58610003	DOID:705
Hemolytic anemia	contraindication	61261009	DOID:583
Ulcerative colitis	contraindication	64766004	DOID:8577
Incontinence of feces	contraindication	72042002
Appendicitis	contraindication	74400008	DOID:8337
Atrophic gastritis	contraindication	84568007	DOID:8929
Disorder of mucous membrane	contraindication	95351003
Anemia due to enzyme deficiency	contraindication	111577008
Gastrointestinal obstruction	contraindication	126765001
Hb SS disease	contraindication	127040003	DOID:10923
Urinary incontinence	contraindication	165232002
Diverticular disease	contraindication	397881000
Hemochromatosis	contraindication	399187006	DOID:2352
Repeated Blood Transfusions	contraindication

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	12.0	acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

ID	Source
4019731	VUID
N0000179792	NUI
D03885	KEGG_DRUG
577-11-7	SECONDARY_CAS_RN
128-49-4	SECONDARY_CAS_RN
71722	RXNORM
4017673	VANDF
4019248	VANDF
4019731	VANDF
C0243237	UMLSCUI
CHEBI:4674	CHEBI
CHEMBL1905872	ChEMBL_ID
CHEMBL1477036	ChEMBL_ID
CHEMBL2106608	ChEMBL_ID
531	INN_ID
F05Q2T2JA0	UNII
23673837	PUBCHEM_CID
DB11089	DRUGBANK_ID
29340	MMSL
4627	MMSL
4629	MMSL
6142	MMSL
6143	MMSL
NOCODE	MMSL
d01021	MMSL
001180	NDDF
001181	NDDF
001183	NDDF
116528004	SNOMEDCT_US
387088007	SNOMEDCT_US
418528006	SNOMEDCT_US
418700002	SNOMEDCT_US
D004143	MESH_DESCRIPTOR_UI

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
good sense stool softener	HUMAN OTC DRUG LABEL	1	0113-0486	CAPSULE, LIQUID FILLED	100 mg	ORAL	OTC Monograph Drug	15 sections
Docusate Sodium	HUMAN OTC DRUG LABEL	1	0121-0935	LIQUID	50 mg	ORAL	OTC Monograph Drug	15 sections
Docusate Sodium	HUMAN OTC DRUG LABEL	1	0121-1870	LIQUID	100 mg	ORAL	OTC Monograph Drug	15 sections
Pedia-Lax	HUMAN OTC DRUG LABEL	1	0132-0113	LIQUID	50 mg	ORAL	OTC Monograph Drug	13 sections
Fleet	HUMAN OTC DRUG LABEL	1	0132-0402	CAPSULE, LIQUID FILLED	100 mg	ORAL	OTC Monograph Drug	14 sections
Ferralet 90	HUMAN PRESCRIPTION DRUG LABEL	5	0178-0089	TABLET, FILM COATED	50 mg	ORAL	unapproved drug other	17 sections
CitraNatal Harmony	HUMAN PRESCRIPTION DRUG LABEL	8	0178-0798	CAPSULE, GELATIN COATED	50 mg	ORAL	UNAPPROVED DRUG OTHER	11 sections
CitraNatal Harmony	HUMAN PRESCRIPTION DRUG LABEL	8	0178-0799	CAPSULE, GELATIN COATED	50 mg	ORAL	Unapproved drug other	11 sections
CitraNatal Harmony	HUMAN PRESCRIPTION DRUG LABEL	8	0178-0812	CAPSULE, GELATIN COATED	50 mg	ORAL	Unapproved drug other	11 sections
CitraNatal 90 DHA	HUMAN PRESCRIPTION DRUG LABEL	16	0178-0821	TABLET	50 mg	ORAL	unapproved drug other	11 sections
CitraNatal 90 DHA	HUMAN OTC DRUG LABEL	14	0178-0829	TABLET	50 mg	ORAL	Unapproved drug other	11 sections
CitraNatal Rx	HUMAN PRESCRIPTION DRUG LABEL	14	0178-0859	TABLET	50 mg	ORAL	Unapproved drug other	9 sections
CitraNatal DHA	HUMAN OTC DRUG LABEL	14	0178-0898	TABLET	50 mg	ORAL	Unapproved drug other	11 sections
Phillips Stool SoftenerBulk Docusate	HUMAN OTC DRUG LABEL	1	0280-1012	CAPSULE, LIQUID FILLED	100 mg	ORAL	OTC Monograph Drug	15 sections
Stool Softener LaxativePlus Stimulant	HUMAN OTC DRUG LABEL	2	0363-0827	TABLET	50 mg	ORAL	OTC Monograph Drug	14 sections
Stool Softener	HUMAN OTC DRUG LABEL	1	0363-0868	CAPSULE, LIQUID FILLED	240 mg	ORAL	OTC Monograph Drug	14 sections
Senna S	HUMAN OTC DRUG LABEL	2	0363-0883	TABLET	50 mg	ORAL	OTC Monograph Drug	14 sections
Gentle Stool Softener	HUMAN OTC DRUG LABEL	1	0363-1172	CAPSULE, LIQUID FILLED	100 mg	ORAL	OTC Monograph Drug	14 sections
Gentle Stool Softener	HUMAN OTC DRUG LABEL	1	0363-1172	CAPSULE, LIQUID FILLED	100 mg	ORAL	OTC Monograph Drug	14 sections
Senna S	HUMAN OTC DRUG LABEL	2	0363-1173	CAPSULE, LIQUID FILLED	50 mg	ORAL	OTC Monograph Drug	14 sections
Senna S	HUMAN OTC DRUG LABEL	2	0363-1173	CAPSULE, LIQUID FILLED	50 mg	ORAL	OTC Monograph Drug	14 sections
Gentle Stool Softener	HUMAN OTC DRUG LABEL	1	0363-1179	CAPSULE, LIQUID FILLED	100 mg	ORAL	OTC Monograph Drug	14 sections
Gentle Stool Softener	HUMAN OTC DRUG LABEL	1	0363-1179	CAPSULE, LIQUID FILLED	100 mg	ORAL	OTC Monograph Drug	14 sections
Stool Softener	HUMAN OTC DRUG LABEL	1	0363-2570	CAPSULE, LIQUID FILLED	240 mg	ORAL	OTC Monograph Drug	14 sections
Stool Softener Laxative	HUMAN OTC DRUG LABEL	1	0363-4100	CAPSULE, LIQUID FILLED	100 mg	ORAL	OTC Monograph Drug	14 sections
Stool Softener Laxative	HUMAN OTC DRUG LABEL	1	0363-4202	CAPSULE, LIQUID FILLED	100 mg	ORAL	OTC Monograph Drug	14 sections
Senna-S	HUMAN OTC DRUG LABEL	2	0363-6683	CAPSULE, LIQUID FILLED	50 mg	ORAL	OTC Monograph Drug	13 sections
Stool Softener Laxative	HUMAN OTC DRUG LABEL	1	0363-7111	CAPSULE, LIQUID FILLED	100 mg	ORAL	OTC Monograph Drug	14 sections
Walgreens Stool Softener Fruit Punch	HUMAN OTC DRUG LABEL	1	0363-7140	LIQUID	50 mg	ORAL	OTC Monograph Drug	11 sections
Stool Softener Laxative	HUMAN OTC DRUG LABEL	1	0363-8530	CAPSULE, LIQUID FILLED	100 mg	ORAL	OTC Monograph Drug	14 sections