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

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

Stem definition	Drug id	CAS RN
	3152	9006-65-9

Description:

Molecule	Description
Synonyms: simethicone dimethicone Silicone Fluid 350 polydimethylsiloxane dimeticone dimethicone 410	A poly(dimethylsiloxane) which is a polymer of 200-350 units of dimethylsiloxane, along with added silica gel. It is used as an antiflatulent, surfactant, and ointment base. Molecular weight: Formula: C6H18Si2(C2H6O2Si)n CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
June 26, 1997	FDA	MCNEIL

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
Completed suicide	1937.57	9.32	1967	120706	129922	50352529
Toxicity to various agents	904.19	9.32	1744	120929	210755	50271696
Drug abuse	549.60	9.32	701	121972	59145	50423306
Cardio-respiratory arrest	374.85	9.32	552	122121	53340	50429111
Milk-alkali syndrome	311.50	9.32	100	122573	585	50481866
Intentional overdose	311.24	9.32	550	122123	61954	50420497
Drug ineffective	290.29	9.32	1020	121653	818313	49664138
Alcohol interaction	265.12	9.32	121	122552	2023	50480428
Overdose	206.26	9.32	620	122053	99107	50383344
Suicide attempt	190.84	9.32	401	122272	51331	50431120
Suspected suicide	175.64	9.32	127	122546	5230	50477221
Coma	162.06	9.32	398	122275	56481	50425970
Hypocalcaemia	137.31	9.32	239	122434	26577	50455874
Pneumonia aspiration	131.82	9.32	255	122418	30749	50451702
Alcohol poisoning	125.88	9.32	69	122604	1731	50480720
Diarrhoea	110.64	9.32	2020	120653	586456	49895995
Macular degeneration	109.64	9.32	154	122519	14234	50468217
Alcohol abuse	106.39	9.32	63	122610	1838	50480613
Recalled product	104.06	9.32	55	122618	1280	50481171
Alcohol use	101.01	9.32	62	122611	1933	50480518
Somnolence	99.52	9.32	680	121993	154305	50328146
Contraindicated product administered	97.48	9.32	131	122542	148827	50333624
Therapeutic product effect decreased	92.78	9.32	116	122557	135934	50346517
Pemphigus	91.14	9.32	94	122579	120072	50362379
Infusion related reaction	87.69	9.32	174	122499	169383	50313068
Gastrooesophageal reflux disease	87.23	9.32	392	122281	76036	50406415
Drug hypersensitivity	85.78	9.32	316	122357	250694	50231757
Liver injury	83.10	9.32	185	122488	24621	50457830
Hypomania	82.38	9.32	76	122597	4429	50478022
Treatment failure	82.23	9.32	129	122544	137508	50344943
Respiratory arrest	81.25	9.32	206	122467	29803	50452648
Systemic lupus erythematosus	80.09	9.32	136	122537	140486	50341965
Off label use	78.81	9.32	753	121920	473673	50008778
Hand deformity	76.40	9.32	78	122595	100121	50382330
Jaundice cholestatic	74.26	9.32	76	122597	5035	50477416
Asphyxia	74.00	9.32	78	122595	5349	50477102
Schizophrenia	73.15	9.32	90	122583	7307	50475144
Synovitis	72.19	9.32	118	122555	123747	50358704
Drug intolerance	71.49	9.32	281	122392	218823	50263628
Hypercalcaemia	71.41	9.32	168	122505	23184	50459267
Hepatotoxicity	70.71	9.32	184	122489	27042	50455409
Pain	70.04	9.32	986	121687	577917	49904534
Dehydration	69.58	9.32	618	122055	151831	50330620
Maternal exposure during pregnancy	69.56	9.32	180	122493	159598	50322853
Glossodynia	68.38	9.32	109	122564	115460	50366991
Swelling	64.64	9.32	259	122414	200613	50281838
Nephrocalcinosis	64.44	9.32	36	122637	938	50481513
Rheumatoid arthritis	64.03	9.32	263	122410	202287	50280164
Rash	63.73	9.32	716	121957	436755	50045696
Joint swelling	60.43	9.32	348	122325	244938	50237513
Methaemoglobinaemia	59.28	9.32	45	122628	1997	50480454
Anti-cyclic citrullinated peptide antibody positive	58.44	9.32	51	122622	70536	50411915
Sleep disorder due to general medical condition, insomnia type	57.63	9.32	5	122668	31442	50451009
Intentional product misuse	56.56	9.32	244	122429	46490	50435961
Discomfort	54.48	9.32	113	122560	108267	50374184
Alopecia	53.95	9.32	360	122313	244687	50237764
Abdominal pain	53.62	9.32	837	121836	235391	50247060
Lower respiratory tract infection	53.33	9.32	93	122580	95108	50387343
Hypersensitivity	52.59	9.32	306	122367	214855	50267596
Product dose omission issue	51.87	9.32	249	122424	183589	50298862
Infection	49.53	9.32	233	122440	172721	50309730
Device expulsion	49.16	9.32	6	122667	28816	50453635
Exposure to toxic agent	47.10	9.32	51	122622	3607	50478844
Calcium ionised decreased	45.72	9.32	19	122654	250	50482201
Flatulence	45.48	9.32	166	122507	29292	50453159
Tetany	45.47	9.32	35	122638	1586	50480865
Arthropathy	44.46	9.32	214	122459	157692	50324759
Postmortem blood drug level abnormal	43.62	9.32	20	122653	338	50482113
Cardiac arrest	43.36	9.32	349	122324	83302	50399149
Hypophosphataemic osteomalacia	42.87	9.32	16	122657	155	50482296
Nicotine dependence	42.77	9.32	24	122649	631	50481820
Headache	42.41	9.32	921	121752	505614	49976837
Blood alcohol increased	42.25	9.32	23	122650	569	50481882
Small intestinal obstruction	41.11	9.32	108	122565	15960	50466491
Ill-defined disorder	38.93	9.32	45	122628	54609	50427842
Segmental diverticular colitis	38.51	9.32	14	122659	125	50482326
Sinusitis	38.30	9.32	249	122424	170309	50312142
Wound	38.20	9.32	130	122543	105664	50376787
Injection site reaction	38.06	9.32	39	122634	49993	50432458
Pedal pulse abnormal	37.75	9.32	14	122659	133	50482318
Alcoholism	36.98	9.32	31	122642	1589	50480862
Injection site erythema	36.92	9.32	79	122594	74857	50407594
Pericarditis	35.50	9.32	87	122586	78602	50403849
Arteriosclerosis coronary artery	35.16	9.32	65	122608	7571	50474880
Constipation	34.79	9.32	638	122035	185070	50297381
Salivary gland calculus	32.97	9.32	13	122660	148	50482303
Full blood count abnormal	32.95	9.32	128	122545	23260	50459191
Vomiting	32.82	9.32	1397	121276	459361	50023090
Large intestine polyp	32.00	9.32	61	122612	7271	50475180
Folliculitis	31.67	9.32	29	122644	39196	50443255
Blood calcium decreased	31.38	9.32	116	122557	20590	50461861
Feeding intolerance	31.15	9.32	18	122655	501	50481950
Hypokalaemia	30.96	9.32	338	122335	87654	50394797
Abdominal distension	30.41	9.32	290	122383	72613	50409838
Sputum purulent	29.69	9.32	22	122651	941	50481510
Weight increased	29.46	9.32	330	122343	201561	50280890
Muscle injury	29.30	9.32	28	122645	37083	50445368
Head banging	29.27	9.32	16	122657	399	50482052
Pruritus	29.03	9.32	498	122175	283070	50199381
Arthralgia	28.72	9.32	827	121846	437875	50044576
Urticaria	28.64	9.32	190	122483	129371	50353080
Victim of sexual abuse	28.46	9.32	17	122656	504	50481947
Peripheral swelling	28.34	9.32	341	122332	205595	50276856
Loss of personal independence in daily activities	28.15	9.32	82	122591	69968	50412483
Injection site swelling	28.05	9.32	36	122637	41737	50440714
Injection site pruritus	28.00	9.32	34	122639	40377	50442074
Crohn's disease	27.98	9.32	45	122628	4688	50477763
Arteriovenous fistula occlusion	27.81	9.32	15	122658	364	50482087
Calciphylaxis	27.55	9.32	33	122640	2605	50479846
Stress fracture	27.34	9.32	55	122618	6820	50475631
Product quality issue	27.14	9.32	21	122652	30837	50451614
Rheumatoid factor positive	26.75	9.32	50	122623	49809	50432642
Red blood cell sedimentation rate abnormal	26.45	9.32	4	122669	16339	50466112
Blood bilirubin increased	26.42	9.32	150	122523	31888	50450563
Cholelithiasis	26.36	9.32	170	122503	37803	50444648
Nasal obstruction	26.11	9.32	21	122652	1015	50481436
No adverse event	25.74	9.32	26	122647	33552	50448899
Product use issue	25.65	9.32	235	122438	149240	50333211
Neurologic neglect syndrome	25.51	9.32	24	122649	1434	50481017
Exposure during pregnancy	25.49	9.32	180	122493	120835	50361616
Injection site pain	25.46	9.32	161	122512	110863	50371588
Gastrointestinal disorder	25.42	9.32	130	122543	94326	50388125
Injection site bruising	25.40	9.32	31	122642	36737	50445714
Hypercalciuria	25.19	9.32	12	122661	222	50482229
Herpes zoster	24.86	9.32	88	122585	70698	50411753
Intestinal obstruction	24.78	9.32	128	122545	26255	50456196
Blue toe syndrome	24.16	9.32	14	122659	392	50482059
Condition aggravated	23.67	9.32	544	122129	296514	50185937
Secondary immunodeficiency	23.60	9.32	21	122652	1167	50481284
Colitis	23.47	9.32	167	122506	38362	50444089
Product use in unapproved indication	23.08	9.32	175	122498	115644	50366807
Substance abuse	22.74	9.32	38	122635	4086	50478365
Psychotic disorder	22.74	9.32	109	122564	21703	50460748
Post procedural diarrhoea	22.71	9.32	10	122663	153	50482298
Haemorrhoids	22.68	9.32	99	122574	18954	50463497
Duodenal ulcer perforation	22.53	9.32	48	122625	45563	50436888
Wrong technique in product usage process	22.29	9.32	65	122608	55445	50427006
Gastrointestinal toxicity	21.77	9.32	40	122633	4637	50477814
Hypoparathyroidism	21.59	9.32	15	122658	579	50481872
Throat clearing	21.50	9.32	20	122653	1178	50481273
Therapy interrupted	21.46	9.32	11	122662	20141	50462310
Multiple sclerosis relapse	21.40	9.32	45	122628	42919	50439532
Carotid artery thrombosis	21.25	9.32	22	122651	1477	50480974
Chemical submission	21.24	9.32	10	122663	180	50482271
Poisoning deliberate	21.08	9.32	54	122619	7858	50474593
Abdominal discomfort	20.82	9.32	416	122257	231225	50251226
Drug use disorder	20.66	9.32	31	122642	3041	50479410
Abdominal rigidity	20.62	9.32	23	122650	1681	50480770
Fanconi syndrome	20.45	9.32	19	122654	1117	50481334
Therapy cessation	20.10	9.32	20	122653	25991	50456460
Acquired haemophilia	20.04	9.32	17	122656	886	50481565
Myocarditis	19.91	9.32	53	122620	7894	50474557
Renal tubular necrosis	19.84	9.32	62	122611	10106	50472345
Lymph node palpable	19.84	9.32	8	122665	97	50482354
Hospitalisation	19.73	9.32	91	122582	67846	50414605
Impaired healing	19.38	9.32	95	122578	69691	50412760
Gonorrhoea	19.27	9.32	8	122665	105	50482346
Skin haemorrhage	19.25	9.32	48	122625	6870	50475581
Hypophosphataemia	18.98	9.32	54	122619	8360	50474091
Protein C increased	18.87	9.32	8	122665	111	50482340
Urine calcium/creatinine ratio increased	18.81	9.32	8	122665	112	50482339
Peripheral pulse decreased	18.70	9.32	6	122667	35	50482416
Hip fracture	18.56	9.32	117	122556	25814	50456637
Multiple drug therapy	18.24	9.32	23	122650	1914	50480537
Red blood cell sedimentation rate increased	18.09	9.32	27	122646	29389	50453062
Dyspnoea	18.00	9.32	1116	121557	546492	49935959
Hepatic enzyme increased	17.94	9.32	230	122443	137150	50345301
Adjustment disorder	17.49	9.32	23	122650	1996	50480455
Pregnancy	17.38	9.32	28	122645	29549	50452902
Heavy menstrual bleeding	17.27	9.32	8	122665	15529	50466922
Depressed level of consciousness	17.10	9.32	197	122476	51756	50430695
Injection site rash	16.97	9.32	9	122664	16168	50466283
Calcification metastatic	16.87	9.32	4	122669	5	50482446
Gastrointestinal sounds abnormal	16.82	9.32	31	122642	3603	50478848
Gluten sensitivity	16.72	9.32	12	122661	488	50481963
Drug resistance	16.60	9.32	13	122660	18976	50463475
Metamyelocyte count increased	16.55	9.32	9	122664	222	50482229
Eating disorder	16.06	9.32	77	122596	15332	50467119
Rib deformity	16.01	9.32	8	122665	165	50482286
Pulmonary toxicity	15.91	9.32	39	122634	5523	50476928
Vaginal flatulence	15.82	9.32	9	122664	243	50482208
Intentional self-injury	15.75	9.32	103	122570	23009	50459442
Gastric dilatation	15.72	9.32	14	122659	779	50481672
Mydriasis	15.66	9.32	59	122614	10568	50471883
Osteomalacia	15.63	9.32	13	122660	659	50481792
Acute respiratory failure	15.40	9.32	121	122552	28661	50453790
Migraine	15.35	9.32	113	122560	75167	50407284
Anaphylactic reaction	15.34	9.32	73	122600	53982	50428469
Pathological fracture	15.14	9.32	47	122626	7635	50474816
Musculoskeletal disorder	15.01	9.32	12	122661	17337	50465114
Fracture pain	15.01	9.32	10	122663	360	50482091
Rhinorrhoea	14.97	9.32	191	122482	51392	50431059
Myelosuppression	14.97	9.32	7	122666	13510	50468941
Homicide	14.96	9.32	10	122663	362	50482089
Blood potassium decreased	14.92	9.32	146	122527	36799	50445652
Substance dependence	14.76	9.32	8	122665	196	50482255
Low turnover osteopathy	14.76	9.32	31	122642	3963	50478488
Loss of consciousness	14.74	9.32	344	122329	104009	50378442
Amnesia	14.70	9.32	162	122511	42098	50440353
Nephroangiosclerosis	14.62	9.32	7	122666	131	50482320
Noninfectious peritonitis	14.43	9.32	7	122666	135	50482316
Intestinal fibrosis	14.38	9.32	7	122666	136	50482315
Hypermagnesaemia	14.29	9.32	14	122659	880	50481571
Hyperparathyroidism secondary	14.28	9.32	17	122656	1333	50481118
Therapeutic reaction time decreased	14.26	9.32	17	122656	1335	50481116
Alcoholic	14.23	9.32	5	122668	40	50482411
Drug eruption	14.20	9.32	22	122651	23584	50458867
Tenosynovitis	14.19	9.32	4	122669	10561	50471890
Femur fracture	14.14	9.32	146	122527	37318	50445133
Blood calcium increased	14.09	9.32	46	122627	7673	50474778
Myocardial infarction	13.98	9.32	143	122530	88884	50393567
Decreased appetite	13.97	9.32	608	122065	200315	50282136
Hepatocellular injury	13.94	9.32	26	122647	25921	50456530
Unresponsive to stimuli	13.89	9.32	124	122549	30485	50451966
Induced abortion failed	13.71	9.32	8	122665	227	50482224
Poliomyelitis	13.53	9.32	5	122668	47	50482404
Frequent bowel movements	13.40	9.32	68	122605	13850	50468601
Spinal cord injury lumbar	13.35	9.32	5	122668	49	50482402
Abortion spontaneous	13.32	9.32	54	122619	41718	50440733
Hypomagnesaemia	13.31	9.32	99	122574	23057	50459394
Personality disorder	13.10	9.32	31	122642	4293	50478158
Sneezing	13.09	9.32	68	122605	13976	50468475
Skin necrosis	13.04	9.32	5	122668	10862	50471589
Myelocyte count increased	13.03	9.32	9	122664	344	50482107
Bone erosion	13.02	9.32	6	122667	11681	50470770
Periarticular disorder	13.00	9.32	5	122668	53	50482398
Device difficult to use	12.81	9.32	4	122669	9882	50472569
Postmortem blood drug level	12.69	9.32	6	122667	109	50482342
Oncocytoma	12.67	9.32	4	122669	22	50482429
Device issue	12.61	9.32	18	122655	19954	50462497
Sinus congestion	12.58	9.32	67	122606	13904	50468547
Coronary artery disease	12.53	9.32	34	122639	29692	50452759
Weight decreased	12.52	9.32	656	122017	220589	50261862
Blood ethanol increased	12.50	9.32	6	122667	113	50482338
Spinal compression fracture	12.30	9.32	62	122611	12594	50469857
Metabolic alkalosis	12.27	9.32	23	122650	2708	50479743
Mental status changes	12.14	9.32	138	122535	36134	50446317
Breath sounds abnormal	12.10	9.32	44	122629	7748	50474703
Anti-erythropoietin antibody positive	12.08	9.32	9	122664	388	50482063
Screaming	12.05	9.32	24	122649	2954	50479497
Psoriasis	12.04	9.32	108	122565	68892	50413559
Blood urea increased	11.99	9.32	98	122575	23487	50458964
Angioedema	11.83	9.32	49	122624	37627	50444824
Arthritis	11.76	9.32	144	122529	86577	50395874
Failure to thrive	11.71	9.32	38	122635	6320	50476131
Malabsorption	11.70	9.32	27	122646	3679	50478772
Congenital knee deformity	11.69	9.32	5	122668	71	50482380
Duodenitis	11.65	9.32	25	122648	3243	50479208
Pancreatitis chronic	11.64	9.32	20	122653	2200	50480251
Premature delivery	11.60	9.32	25	122648	23638	50458813
Congenital umbilical hernia	11.60	9.32	8	122665	305	50482146
Oesophagogastric fundoplasty	11.50	9.32	5	122668	74	50482377
Inappropriate antidiuretic hormone secretion	11.49	9.32	9	122664	13134	50469317
Ear infection	11.48	9.32	29	122644	25941	50456510
Amputation	11.45	9.32	6	122667	137	50482314
Aggression	11.42	9.32	89	122584	21027	50461424
Blood creatinine increased	11.36	9.32	253	122420	75907	50406544
Type 2 diabetes mellitus	11.24	9.32	44	122629	34331	50448120
Bradycardia	11.17	9.32	101	122572	64325	50418126
Product storage error	11.16	9.32	8	122665	12216	50470235
Parathyroid gland enlargement	11.08	9.32	4	122669	35	50482416
Leukocytosis	11.04	9.32	93	122580	22486	50459965
Periorbital cellulitis	11.01	9.32	10	122663	571	50481880
Nephrogenic systemic fibrosis	11.00	9.32	29	122644	4293	50478158
Coordination abnormal	10.86	9.32	56	122617	11478	50470973
Skin exfoliation	10.86	9.32	127	122546	33485	50448966
Nasopharyngitis	10.80	9.32	371	122302	192556	50289895
Amphetamines positive	10.75	9.32	6	122667	156	50482295
Sialoadenitis	10.69	9.32	15	122658	1385	50481066
Arteriosclerosis	10.68	9.32	47	122626	9030	50473421
Hyperglycaemia	10.65	9.32	135	122538	36270	50446181
Cytomegalovirus infection	10.56	9.32	17	122656	17945	50464506
Drug dependence	10.53	9.32	83	122590	19676	50462775
Somnambulism	10.52	9.32	31	122642	4893	50477558
Jaundice acholuric	10.52	9.32	5	122668	92	50482359
Conjunctival discolouration	10.52	9.32	4	122669	41	50482410
Product communication issue	10.48	9.32	8	122665	358	50482093
Pharyngo-oesophageal diverticulum	10.48	9.32	3	122670	11	50482440
Knee arthroplasty	10.41	9.32	48	122625	35798	50446653
Renal tubular dysfunction	10.35	9.32	8	122665	365	50482086
Self-injurious ideation	10.30	9.32	19	122654	2210	50480241
Liver function test increased	10.26	9.32	30	122643	25576	50456875
Obstructive airways disorder	10.21	9.32	69	122604	15583	50466868
Device malfunction	10.18	9.32	13	122660	15108	50467343
Sciatica	10.15	9.32	23	122650	21359	50461092
Respiratory tract congestion	10.12	9.32	64	122609	14135	50468316
Pneumothorax spontaneous	9.98	9.32	10	122663	646	50481805
Congestive hepatopathy	9.97	9.32	20	122653	2474	50479977
Bronchopulmonary aspergillosis	9.96	9.32	3	122670	7589	50474862
Blood ethanol	9.96	9.32	4	122669	48	50482403
White blood cell count decreased	9.92	9.32	361	122312	116361	50366090
Injection site urticaria	9.90	9.32	9	122664	12208	50470243
Orthostatic intolerance	9.83	9.32	12	122661	966	50481485
Gastrointestinal stoma complication	9.82	9.32	15	122658	1495	50480956
Obstruction	9.76	9.32	18	122655	2093	50480358
Adverse event	9.75	9.32	64	122609	43699	50438752
Lip discolouration	9.73	9.32	9	122664	526	50481925
Clostridium difficile colitis	9.72	9.32	75	122598	17667	50464784
Leiomyoma	9.71	9.32	8	122665	400	50482051
Surgery	9.66	9.32	39	122634	30166	50452285
Neurogenic bowel	9.36	9.32	5	122668	119	50482332

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 abuse	2125.60	10.17	1701	73822	78182	29420822
Completed suicide	1673.30	10.17	1564	73959	88682	29410322
Toxicity to various agents	1294.23	10.17	1881	73642	171780	29327224
Cardio-respiratory arrest	359.71	10.17	538	74985	50063	29448941
Intentional overdose	337.95	10.17	453	75070	38075	29460929
Alcohol abuse	324.96	10.17	177	75346	4156	29494848
Alcohol interaction	315.77	10.17	149	75374	2554	29496450
Overdose	215.74	10.17	565	74958	79254	29419750
Suspected suicide	205.33	10.17	128	75395	3892	29495112
Drug ineffective	184.54	10.17	410	75113	362760	29136244
Intentional product misuse	181.42	10.17	321	75202	34340	29464664
Milk-alkali syndrome	177.42	10.17	62	75461	460	29498544
Suicide attempt	176.08	10.17	314	75209	33796	29465208
Alcohol poisoning	154.35	10.17	97	75426	2992	29496012
Substance abuse	137.41	10.17	124	75399	6663	29492341
Drug dependence	114.53	10.17	198	75325	20783	29478221
Alcohol use	92.05	10.17	71	75452	3061	29495943
Exposure to toxic agent	68.41	10.17	55	75468	2520	29496484
Off label use	66.86	10.17	472	75051	300328	29198676
Blood alcohol increased	63.70	10.17	33	75490	697	29498307
Respiratory arrest	56.97	10.17	170	75353	25663	29473341
Myocardial infarction	56.92	10.17	123	75400	110173	29388831
Respiratory depression	55.53	10.17	113	75410	13410	29485594
Product use in unapproved indication	55.43	10.17	85	75438	86790	29412214
Asphyxia	55.17	10.17	68	75455	5247	29493757
Hypercalcaemia	52.85	10.17	107	75416	12652	29486352
Poisoning deliberate	52.65	10.17	69	75454	5662	29493342
Blood mercury abnormal	49.59	10.17	19	75504	188	29498816
5-hydroxyindolacetic acid in urine increased	47.49	10.17	19	75504	213	29498791
Coma	46.56	10.17	212	75311	39238	29459766
Calciphylaxis	41.31	10.17	28	75495	984	29498020
Intentional product use issue	41.27	10.17	216	75307	42282	29456722
Aggression	41.20	10.17	190	75333	35351	29463653
Cardiac arrest	40.37	10.17	364	75159	85227	29413777
Treatment failure	40.34	10.17	22	75501	36917	29462087
Diarrhoea	39.01	10.17	1118	74405	331580	29167424
Incorrect route of product administration	37.15	10.17	84	75439	10717	29488287
Drug hypersensitivity	36.34	10.17	75	75448	68331	29430673
Alcohol withdrawal syndrome	35.78	10.17	29	75494	1344	29497660
Product dose omission issue	33.88	10.17	129	75394	96254	29402750
Drug resistance	33.59	10.17	7	75516	21533	29477471
Granulomatous pneumonitis	32.10	10.17	9	75514	28	29498976
Alcohol intolerance	32.03	10.17	17	75506	378	29498626
Small intestinal obstruction	31.73	10.17	89	75434	12972	29486032
Dehydration	29.63	10.17	434	75089	114314	29384690
Ex-drug abuser	29.41	10.17	12	75511	142	29498862
Pouchitis	27.53	10.17	18	75505	595	29498409
Hyperparathyroidism secondary	27.20	10.17	24	75499	1251	29497753
Therapeutic product effect decreased	26.18	10.17	22	75501	29429	29469575
Interstitial lung disease	26.06	10.17	69	75454	57649	29441355
Hypocalcaemia	25.84	10.17	113	75410	20552	29478452
Hungry bone syndrome	25.73	10.17	9	75514	67	29498937
Intentional self-injury	25.59	10.17	80	75443	12381	29486623
Ileus	25.57	10.17	88	75435	14314	29484690
Low density lipoprotein decreased	25.44	10.17	21	75502	999	29498005
Drug withdrawal syndrome	25.34	10.17	102	75421	17882	29481122
Nephrogenic systemic fibrosis	23.89	10.17	39	75484	3903	29495101
Metabolic alkalosis	23.88	10.17	22	75501	1214	29497790
Poisoning	22.25	10.17	66	75457	9927	29489077
Blood parathyroid hormone increased	22.16	10.17	22	75501	1333	29497671
Growth hormone deficiency	21.82	10.17	11	75512	219	29498785
Drug intolerance	21.72	10.17	58	75465	48321	29450683
Calcinosis	21.42	10.17	16	75507	657	29498347
Methaemoglobinaemia	21.26	10.17	30	75493	2641	29496363
Atypical fracture	21.23	10.17	9	75514	118	29498886
Rheumatoid arthritis	20.93	10.17	31	75492	32121	29466883
Drug screen positive	20.90	10.17	36	75487	3765	29495239
Rash	20.55	10.17	351	75172	189468	29309536
Accidental death	20.23	10.17	26	75497	2092	29496912
Open reduction of fracture	20.13	10.17	8	75515	88	29498916
Enterocolitis bacterial	20.12	10.17	11	75512	260	29498744
Foetal alcohol syndrome	20.09	10.17	9	75514	136	29498868
Alcoholism	19.88	10.17	29	75494	2632	29496372
Joint swelling	19.73	10.17	63	75460	49567	29449437
Hypophosphatasia	19.68	10.17	6	75517	27	29498977
Enterocolonic fistula	19.51	10.17	8	75515	96	29498908
Condition aggravated	19.43	10.17	260	75263	146035	29352969
Nasal polyps	18.95	10.17	23	75500	1746	29497258
Angioedema	18.68	10.17	33	75490	31882	29467122
Gastrointestinal obstruction	18.62	10.17	15	75508	689	29498315
Haematopoietic stem cell mobilisation	18.57	10.17	9	75514	164	29498840
Abdominal distension	18.53	10.17	189	75334	45722	29453282
Mydriasis	18.39	10.17	45	75478	6040	29492964
Drug use disorder	18.28	10.17	32	75491	3390	29495614
Hepatic fibrosis	18.14	10.17	31	75492	3221	29495783
N-telopeptide urine increased	18.12	10.17	6	75517	37	29498967
Product prescribing error	17.81	10.17	12	75511	17964	29481040
Anaphylactic reaction	17.54	10.17	27	75496	27546	29471458
Intestinal obstruction	17.36	10.17	96	75427	19181	29479823
Renal impairment	17.30	10.17	129	75394	81204	29417800
Foetal exposure during pregnancy	17.25	10.17	38	75485	33829	29465175
Red blood cell count decreased	17.08	10.17	118	75405	25484	29473520
Impaired driving ability	16.83	10.17	25	75498	2306	29496698
Chest pain	16.74	10.17	194	75329	111779	29387225
Drug reaction with eosinophilia and systemic symptoms	16.33	10.17	29	75494	27963	29471041
Antineutrophil cytoplasmic antibody positive	16.12	10.17	13	75510	598	29498406
Miosis	16.06	10.17	51	75472	7958	29491046
Renal tubular dysfunction	15.85	10.17	11	75512	402	29498602
Cardiac failure	15.81	10.17	128	75395	79159	29419845
Contraindicated product administered	15.80	10.17	14	75509	18252	29480752
Colitis	15.80	10.17	135	75388	31113	29467891
Electrocardiogram QT prolonged	15.66	10.17	151	75372	35986	29463018
Accident at work	15.56	10.17	13	75510	629	29498375
Hepatic neoplasm	15.18	10.17	21	75502	1815	29497189
Dextrocardia	15.15	10.17	7	75516	114	29498890
Bone density decreased	15.08	10.17	20	75503	1660	29497344
Homicide	15.05	10.17	15	75508	913	29498091
Coronary artery disease	14.96	10.17	60	75463	44130	29454874
Nerve degeneration	14.95	10.17	8	75515	181	29498823
Urogenital fistula	14.92	10.17	3	75520	0	29499004
Drug ineffective for unapproved indication	14.75	10.17	9	75514	14205	29484799
Weight increased	14.73	10.17	125	75398	76542	29422462
Crohn's disease	14.62	10.17	27	75496	2982	29496022
Blood 25-hydroxycholecalciferol decreased	14.48	10.17	6	75517	74	29498930
Abscess intestinal	14.33	10.17	18	75505	1416	29497588
Fatty liver alcoholic	14.27	10.17	6	75517	77	29498927
Myelosuppression	13.76	10.17	7	75516	12220	29486784
Arrhythmia	13.70	10.17	38	75485	31275	29467729
Substance-induced mood disorder	13.68	10.17	6	75517	86	29498918
Sensorimotor disorder	13.64	10.17	10	75513	399	29498605
Opiates positive	13.55	10.17	11	75512	511	29498493
Gastrointestinal sounds abnormal	13.54	10.17	20	75503	1836	29497168
SARS-CoV-2 antibody test positive	13.38	10.17	8	75515	225	29498779
Myocardial fibrosis	13.30	10.17	15	75508	1053	29497951
Mean cell haemoglobin	13.12	10.17	4	75519	18	29498986
Physical assault	13.12	10.17	15	75508	1069	29497935
Bilirubin conjugated abnormal	13.08	10.17	6	75517	96	29498908
Injection site erythema	12.94	10.17	10	75513	13946	29485058
Eosinophilia	12.89	10.17	23	75500	22138	29476866
Macrognathia	12.85	10.17	3	75520	3	29499001
Systemic inflammatory response syndrome	12.84	10.17	39	75484	5942	29493062
Blood immunoglobulin E increased	12.81	10.17	20	75503	1927	29497077
Femur fracture	12.66	10.17	43	75480	6948	29492056
Synovitis	12.61	10.17	6	75517	10884	29488120
Erythema	12.49	10.17	128	75395	75478	29423526
Blood albumin decreased	12.44	10.17	61	75462	11634	29487370
Metabolic acidosis	12.42	10.17	149	75374	37513	29461491
Injection site pain	12.33	10.17	42	75481	32404	29466600
Therapeutic product effect incomplete	12.30	10.17	55	75468	39250	29459754
Rectal prolapse	12.27	10.17	8	75515	263	29498741
Type 2 diabetes mellitus	12.25	10.17	10	75513	13571	29485433
Disorientation	12.14	10.17	122	75401	29393	29469611
Headache	12.11	10.17	345	75178	173662	29325342
Arthralgia	12.09	10.17	268	75255	139349	29359655
Blood ethanol increased	12.02	10.17	10	75513	481	29498523
Musculoskeletal stiffness	11.97	10.17	52	75471	37406	29461598
Chronic sinusitis	11.85	10.17	18	75505	1693	29497311
Lower respiratory tract infection	11.72	10.17	32	75491	26470	29472534
Acute myocardial infarction	11.69	10.17	74	75449	48364	29450640
Calcification metastatic	11.64	10.17	3	75520	6	29498998
Sopor	11.61	10.17	57	75466	10877	29488127
Amnesia	11.54	10.17	98	75425	22545	29476459
Renal cyst haemorrhage	11.51	10.17	9	75514	396	29498608
Necrotising ulcerative gingivostomatitis	11.50	10.17	5	75518	70	29498934
Abdominal pain	11.42	10.17	438	75085	134919	29364085
Psoriasis	11.39	10.17	43	75480	32184	29466820
Acrochordon	11.34	10.17	8	75515	300	29498704
Respiratory symptom	11.30	10.17	13	75510	933	29498071
Blood ethanol	11.25	10.17	5	75518	74	29498930
Drug abuser	11.25	10.17	28	75495	3799	29495205
Frequent bowel movements	11.15	10.17	50	75473	9189	29489815
Road traffic accident	11.14	10.17	73	75450	15488	29483516
Neuroleptic malignant syndrome	11.07	10.17	15	75508	16133	29482871
Haematocrit decreased	11.01	10.17	118	75405	28904	29470100
Rash maculo-papular	10.99	10.17	29	75494	24260	29474744
Premature baby	10.92	10.17	17	75506	17263	29481741
Medication error	10.91	10.17	92	75431	21119	29477885
Alcoholic liver disease	10.88	10.17	10	75513	550	29498454
Blood potassium decreased	10.78	10.17	73	75450	15661	29483343
Thrombocytopenia	10.77	10.17	262	75261	134561	29364443
Withdrawal syndrome	10.75	10.17	56	75467	10936	29488068
Pain in extremity	10.73	10.17	208	75315	110225	29388779
Therapy interrupted	10.71	10.17	4	75519	8382	29490622
Intraductal papillary mucinous neoplasm	10.63	10.17	8	75515	332	29498672
Dyspnoea	10.53	10.17	706	74817	326026	29172978
Central nervous system mass	10.47	10.17	5	75518	88	29498916
Colitis ulcerative	10.45	10.17	62	75461	12707	29486297
Psychiatric disorder prophylaxis	10.40	10.17	4	75519	40	29498964
Muscle swelling	10.39	10.17	8	75515	344	29498660
Proctalgia	10.38	10.17	29	75494	4216	29494788
Tachycardia	10.34	10.17	250	75273	72160	29426844
Abdominal wall haemorrhage	10.25	10.17	7	75516	249	29498755

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
Completed suicide	3503.49	9.46	3486	155939	220928	64118379
Drug abuse	2507.08	9.46	2291	157134	130083	64209224
Toxicity to various agents	2165.44	9.46	3490	155935	360023	63979284
Cardio-respiratory arrest	744.28	9.46	1059	158366	97334	64241973
Intentional overdose	510.82	9.46	848	158577	89096	64250211
Alcohol interaction	482.83	9.46	230	159195	4171	64335136
Milk-alkali syndrome	478.04	9.46	159	159266	1034	64338273
Drug ineffective	410.38	9.46	922	158503	839325	63499982
Suspected suicide	352.14	9.46	236	159189	8418	64330889
Overdose	343.86	9.46	1019	158406	158547	64180760
Alcohol abuse	322.35	9.46	181	159244	4671	64334636
Alcohol poisoning	227.81	9.46	138	159287	4117	64335190
Suicide attempt	214.17	9.46	514	158911	70493	64268814
Intentional product misuse	213.43	9.46	519	158906	71776	64267531
Coma	177.67	9.46	548	158877	87067	64252240
Alcohol use	162.46	9.46	115	159310	4487	64334820
Respiratory arrest	136.17	9.46	361	159064	52624	64286683
Substance abuse	120.09	9.46	131	159294	9161	64330146
Off label use	116.02	9.46	1004	158421	631802	63707505
Hypercalcaemia	114.25	9.46	245	159180	31171	64308136
Exposure to toxic agent	113.02	9.46	105	159320	6054	64333253
Hypocalcaemia	110.87	9.46	288	159137	41465	64297842
Asphyxia	110.17	9.46	127	159298	9439	64329868
Drug hypersensitivity	108.08	9.46	270	159155	237545	64101762
Drug dependence	102.40	9.46	243	159182	33069	64306238
Blood alcohol increased	92.09	9.46	49	159376	1133	64338174
Pneumonia aspiration	86.22	9.46	332	159093	58939	64280368
Therapeutic product effect decreased	85.83	9.46	95	159330	115256	64224051
Contraindicated product administered	83.35	9.46	86	159339	107743	64231564
Treatment failure	80.71	9.46	102	159323	116714	64222593
Infusion related reaction	80.04	9.46	180	159245	164287	64175020
Cardiac arrest	79.65	9.46	652	158773	153412	64185895
Product dose omission issue	77.34	9.46	236	159189	194511	64144796
Methaemoglobinaemia	75.71	9.46	72	159353	4276	64335031
Rheumatoid arthritis	72.69	9.46	189	159236	164105	64175202
Hypomania	68.39	9.46	77	159348	5577	64333730
Small intestinal obstruction	66.10	9.46	166	159259	23407	64315900
Arthropathy	65.08	9.46	125	159300	120842	64218465
Drug intolerance	64.95	9.46	242	159183	187750	64151557
Poisoning deliberate	64.70	9.46	118	159307	13340	64325967
Diarrhoea	64.69	9.46	2285	157140	720419	63618888
Myocardial infarction	64.37	9.46	203	159222	165618	64173689
Somnolence	64.36	9.46	778	158647	202867	64136440
Schizophrenia	61.57	9.46	104	159321	11064	64328243
Dehydration	60.80	9.46	810	158615	215953	64123354
Nephrocalcinosis	60.65	9.46	39	159386	1295	64338012
Product use in unapproved indication	57.39	9.46	233	159192	176385	64162922
Calciphylaxis	56.06	9.46	54	159371	3258	64336049
Gastrooesophageal reflux disease	55.54	9.46	374	159051	82769	64256538
Joint swelling	53.28	9.46	313	159112	215069	64124238
Sleep disorder due to general medical condition, insomnia type	52.72	9.46	3	159422	26267	64313040
Recalled product	52.29	9.46	31	159394	888	64338419
Blood mercury abnormal	50.19	9.46	19	159406	188	64339119
Rash	49.95	9.46	815	158610	457734	63881573
Hand deformity	49.71	9.46	49	159376	62722	64276585
Synovitis	49.38	9.46	107	159318	98983	64240324
Drug resistance	49.10	9.46	13	159412	35089	64304218
Pain	49.00	9.46	1020	158405	552491	63786816
Headache	48.86	9.46	969	158456	528498	63810809
Postmortem blood drug level abnormal	48.10	9.46	26	159399	621	64338686
5-hydroxyindolacetic acid in urine increased	47.93	9.46	19	159406	215	64339092
Pemphigus	47.37	9.46	48	159377	60653	64278654
Infection	47.15	9.46	266	159159	184614	64154693
Jaundice cholestatic	46.82	9.46	80	159345	8590	64330717
Systemic lupus erythematosus	42.79	9.46	79	159346	77533	64261774
Injection site erythema	42.76	9.46	68	159357	70732	64268575
Lower respiratory tract infection	41.70	9.46	109	159316	94505	64244802
Anti-cyclic citrullinated peptide antibody positive	41.23	9.46	37	159388	49525	64289782
Calcium ionised decreased	41.06	9.46	22	159403	516	64338791
Abdominal pain	40.03	9.46	1033	158392	311342	64027965
Maternal exposure during pregnancy	38.89	9.46	115	159310	95769	64243538
Hypersensitivity	38.38	9.46	306	159119	196146	64143161
Injection site bruising	38.38	9.46	21	159404	36352	64302955
Segmental diverticular colitis	38.25	9.46	14	159411	125	64339182
Anaphylactic reaction	37.76	9.46	70	159355	68594	64270713
Incorrect route of product administration	37.62	9.46	135	159290	23163	64316144
Feeding intolerance	37.08	9.46	21	159404	551	64338756
Hypophosphataemic osteomalacia	36.83	9.46	17	159408	286	64339021
Arthralgia	36.76	9.46	823	158602	441437	63897870
Liver injury	36.65	9.46	159	159266	29773	64309534
Pedal pulse abnormal	36.42	9.46	14	159411	145	64339162
Weight increased	36.06	9.46	345	159080	213003	64126304
Drug use disorder	35.55	9.46	58	159367	5996	64333311
Vomiting	35.44	9.46	1683	157742	549434	63789873
Alcoholism	35.43	9.46	43	159382	3374	64335933
Injection site pain	34.91	9.46	149	159276	111259	64228048
Gastrointestinal disorder	34.67	9.46	110	159315	89599	64249708
Intentional self-injury	34.59	9.46	153	159272	28891	64310416
Aggression	34.56	9.46	214	159211	46018	64293289
Condition aggravated	34.17	9.46	682	158743	371744	63967563
Tetany	34.13	9.46	34	159391	2138	64337169
Injection site reaction	34.07	9.46	39	159386	46625	64292682
Swelling	33.92	9.46	244	159181	159974	64179333
Peripheral swelling	33.35	9.46	343	159082	208810	64130497
Device expulsion	33.27	9.46	6	159419	21130	64318177
Blood calcium decreased	33.03	9.46	138	159287	25416	64313891
Myelosuppression	33.00	9.46	9	159416	23821	64315486
Sinusitis	32.99	9.46	218	159207	145710	64193597
Abdominal distension	32.61	9.46	372	159053	95622	64243685
Metabolic alkalosis	32.20	9.46	44	159381	3884	64335423
Stress fracture	31.84	9.46	53	159372	5571	64333736
Angioedema	31.42	9.46	66	159359	61755	64277552
Nephrogenic systemic fibrosis	31.33	9.46	54	159371	5838	64333469
Arteriosclerosis coronary artery	31.32	9.46	97	159328	15432	64323875
Coronary artery disease	31.15	9.46	64	159361	60369	64278938
Granulomatous pneumonitis	30.60	9.46	10	159415	61	64339246
Hyperparathyroidism secondary	30.37	9.46	33	159392	2297	64337010
Alcohol withdrawal syndrome	29.77	9.46	29	159396	1774	64337533
Injection site swelling	29.72	9.46	35	159390	41318	64297989
Red blood cell sedimentation rate abnormal	29.52	9.46	3	159422	16303	64323004
Hepatotoxicity	29.26	9.46	184	159241	39778	64299529
Respiratory depression	29.06	9.46	125	159300	23318	64315989
Hungry bone syndrome	28.78	9.46	12	159413	156	64339151
Nicotine dependence	27.95	9.46	20	159405	794	64338513
Flatulence	27.87	9.46	167	159258	35499	64303808
Ill-defined disorder	27.85	9.46	41	159384	44011	64295296
Intentional product use issue	27.79	9.46	359	159066	95005	64244302
Glossodynia	27.40	9.46	76	159349	64620	64274687
Arteriovenous fistula occlusion	27.33	9.46	17	159408	532	64338775
Injection site pruritus	27.20	9.46	32	159393	37794	64301513
Abdominal rigidity	27.15	9.46	33	159392	2594	64336713
Low turnover osteopathy	27.02	9.46	28	159397	1845	64337462
Hepatocellular injury	26.79	9.46	44	159381	45191	64294116
Discomfort	26.69	9.46	106	159319	80772	64258535
Drug ineffective for unapproved indication	26.19	9.46	23	159402	31110	64308197
Cytomegalovirus infection	26.18	9.46	32	159393	37167	64302140
Urticaria	25.83	9.46	236	159189	147081	64192226
Drug reaction with eosinophilia and systemic symptoms	25.81	9.46	60	159365	54157	64285150
Dyspnoea	25.78	9.46	1484	157941	717190	63622117
Pouchitis	25.47	9.46	19	159406	805	64338502
Pruritus	25.45	9.46	583	158842	311817	64027490
Colitis	25.45	9.46	239	159186	58435	64280872
Gonorrhoea	25.34	9.46	11	159414	159	64339148
Product quality issue	25.08	9.46	22	159403	29777	64309530
Accidental death	25.08	9.46	38	159387	3687	64335620
Neurologic neglect syndrome	24.82	9.46	25	159400	1593	64337714
Low density lipoprotein decreased	24.82	9.46	21	159404	1069	64338238
Herpes zoster	24.75	9.46	106	159319	79081	64260226
Wrong technique in product usage process	24.18	9.46	81	159344	64893	64274414
Calcification metastatic	24.17	9.46	6	159419	10	64339297
Salivary gland calculus	24.12	9.46	12	159413	240	64339067
Mydriasis	24.11	9.46	88	159337	15224	64324083
Blood parathyroid hormone increased	24.04	9.46	34	159391	3100	64336207
Therapy cessation	23.88	9.46	27	159398	32462	64306845
Homicide	23.82	9.46	21	159404	1130	64338177
Renal impairment	23.80	9.46	216	159209	134801	64204506
Intestinal obstruction	23.49	9.46	162	159263	36124	64303183
Full blood count abnormal	23.04	9.46	139	159286	29618	64309689
Ileus	22.97	9.46	115	159310	22851	64316456
Gastrointestinal sounds abnormal	22.69	9.46	42	159383	4801	64334506
Blood ethanol increased	22.21	9.46	16	159409	642	64338665
Opiates positive	21.90	9.46	18	159407	880	64338427
Depressed level of consciousness	21.84	9.46	302	159123	81134	64258173
Product prescribing error	21.17	9.46	34	159391	35235	64304072
Throat clearing	21.13	9.46	21	159404	1317	64337990
Failure to thrive	20.99	9.46	65	159360	10339	64328968
Blood ethanol	20.99	9.46	9	159416	126	64339181
Head banging	20.92	9.46	14	159411	498	64338809
Alopecia	20.90	9.46	286	159139	165404	64173903
Nasal obstruction	20.85	9.46	21	159404	1338	64337969
Red blood cell sedimentation rate increased	20.81	9.46	28	159397	31207	64308100
Sputum purulent	20.77	9.46	20	159405	1206	64338101
Drug eruption	20.62	9.46	36	159389	36100	64303207
Therapy interrupted	20.52	9.46	12	159413	20024	64319283
Hypokalaemia	20.51	9.46	419	159006	121484	64217823
Death	20.13	9.46	1418	158007	481287	63858020
Femur fracture	20.12	9.46	149	159276	33986	64305321
Cholelithiasis	19.55	9.46	185	159240	45321	64293986
Therapeutic reaction time decreased	19.53	9.46	24	159401	1908	64337399
Hypophosphataemia	19.42	9.46	80	159345	14640	64324667
Muscle injury	19.40	9.46	22	159403	26415	64312892
Blue toe syndrome	19.38	9.46	14	159411	564	64338743
Chemical submission	19.33	9.46	10	159415	218	64339089
Psychotic disorder	19.30	9.46	149	159276	34429	64304878
Open reduction of fracture	19.24	9.46	10	159415	220	64339087
Substance dependence	19.07	9.46	13	159412	477	64338830
Alcohol intolerance	19	9.46	12	159413	386	64338921
Obstruction	18.91	9.46	31	159394	3217	64336090
Nephroangiosclerosis	18.91	9.46	11	159414	304	64339003
Amphetamines positive	18.80	9.46	10	159415	231	64339076
Poisoning	18.76	9.46	105	159320	21774	64317533
Victim of sexual abuse	18.75	9.46	12	159413	395	64338912
Pericarditis	18.74	9.46	85	159340	62431	64276876
Multiple sclerosis relapse	18.42	9.46	47	159378	41088	64298219
Impaired healing	18.26	9.46	82	159343	60391	64278916
Blood potassium decreased	18.24	9.46	166	159259	40233	64299074
Neuroleptic malignant syndrome	18.13	9.46	21	159404	24975	64314332
Hypophosphatasia	18.04	9.46	6	159419	39	64339268
Postmortem blood drug level	17.88	9.46	10	159415	256	64339051
Frequent bowel movements	17.84	9.46	91	159334	18214	64321093
Growth hormone deficiency	17.81	9.46	11	159414	340	64338967
N-telopeptide urine increased	17.78	9.46	6	159419	41	64339266
Cardiac failure congestive	17.71	9.46	222	159203	130358	64208949
Carotid artery thrombosis	17.66	9.46	22	159403	1773	64337534
Haematotoxicity	17.62	9.46	5	159420	12891	64326416
Cardiac failure	17.60	9.46	226	159199	132147	64207160
Erythema	17.59	9.46	341	159084	186729	64152578
Enterocolonic fistula	17.31	9.46	8	159417	135	64339172
Rheumatoid factor positive	17.17	9.46	38	159387	34900	64304407
Urine calcium/creatinine ratio increased	17.05	9.46	8	159417	140	64339167
Inappropriate antidiuretic hormone secretion	16.96	9.46	18	159407	22271	64317036
Haematopoietic stem cell mobilisation	16.96	9.46	9	159416	207	64339100
Bone erosion	16.79	9.46	4	159421	11591	64327716
Product storage error	16.71	9.46	6	159419	13312	64325995
Arthritis	16.61	9.46	130	159295	83684	64255623
Lymph node palpable	16.60	9.46	8	159417	149	64339158
Exposure during pregnancy	16.57	9.46	118	159307	77557	64261750
Nasal polyps	16.42	9.46	31	159394	3598	64335709
Bone marrow failure	16.36	9.46	62	159363	47890	64291417
Abortion spontaneous	16.29	9.46	23	159402	25120	64314187
Hepatic neoplasm	16.10	9.46	28	159397	3049	64336258
Interstitial lung disease	16.09	9.46	159	159266	97573	64241734
Hypoparathyroidism	16.04	9.46	15	159410	872	64338435
Loss of personal independence in daily activities	15.98	9.46	109	159316	72345	64266962
Protein C increased	15.95	9.46	7	159418	104	64339203
Adjustment disorder	15.71	9.46	26	159399	2719	64336588
Pregnancy	15.71	9.46	17	159408	20848	64318459
Hyperphosphataemia	15.58	9.46	32	159393	3949	64335358
Hepatic fibrosis	15.46	9.46	39	159386	5513	64333794
Venoocclusive liver disease	15.43	9.46	3	159422	10012	64329295
Folliculitis	15.37	9.46	32	159393	30045	64309262
Toxicologic test abnormal	15.36	9.46	17	159408	1208	64338099
Musculoskeletal disorder	15.34	9.46	13	159412	17893	64321414
Injection site rash	15.33	9.46	10	159415	15732	64323575
Gluten sensitivity	15.31	9.46	10	159415	341	64338966
Pathological fracture	15.24	9.46	53	159372	8952	64330355
Autoimmune colitis	15.24	9.46	18	159407	1373	64337934
Multiple drug therapy	15.18	9.46	23	159402	2231	64337076
Large intestine polyp	15.18	9.46	60	159365	10777	64328530
Hypermagnesaemia	15.11	9.46	16	159409	1081	64338226
Hepatic function abnormal	15.07	9.46	95	159330	64218	64275089
Rib deformity	14.99	9.46	7	159418	121	64339186
Fracture pain	14.98	9.46	10	159415	354	64338953
Haemorrhoids	14.86	9.46	106	159319	23895	64315412
Blood bilirubin increased	14.85	9.46	212	159213	57341	64281966
Hospitalisation	14.74	9.46	117	159308	75090	64264217
Acquired haemophilia	14.59	9.46	19	159406	1601	64337706
Wound	14.52	9.46	120	159305	76357	64262950
Labelled drug-drug interaction medication error	14.48	9.46	20	159405	22042	64317265
Red blood cell count decreased	14.45	9.46	183	159242	48203	64291104
Post transplant lymphoproliferative disorder	14.41	9.46	3	159422	9541	64329766
Enterocolitis bacterial	14.40	9.46	11	159414	483	64338824
Peripheral pulse decreased	14.36	9.46	5	159420	38	64339269
Chest pain	14.35	9.46	459	158966	235521	64103786
Rhinorrhoea	14.34	9.46	218	159207	59751	64279556
Neuralgia	14.12	9.46	27	159398	26157	64313150
Liver disorder	14.00	9.46	76	159349	53275	64286032
C-reactive protein abnormal	13.94	9.46	32	159393	29015	64310292
Amnesia	13.76	9.46	181	159244	48088	64291219
Musculoskeletal stiffness	13.68	9.46	218	159207	122988	64216319
Miosis	13.67	9.46	67	159358	13199	64326108
Electrocardiogram QT prolonged	13.66	9.46	274	159151	79174	64260133
Atypical fracture	13.64	9.46	12	159413	644	64338663
Hip fracture	13.61	9.46	114	159311	26985	64312322
Device issue	13.44	9.46	22	159403	22626	64316681
Acute graft versus host disease	13.42	9.46	3	159422	9081	64330226
Drug abuser	13.35	9.46	38	159387	5770	64333537
Poliomyelitis	13.34	9.46	5	159420	48	64339259
Skin haemorrhage	13.23	9.46	49	159376	8536	64330771
Bilirubin conjugated abnormal	13.16	9.46	6	159419	98	64339209
Compartment syndrome	13.14	9.46	31	159394	4201	64335106
SARS-CoV-2 antibody test positive	13.13	9.46	8	159417	241	64339066
Personality disorder	13.02	9.46	33	159392	4678	64334629
Device difficult to use	13.02	9.46	4	159421	9794	64329513
Duodenal ulcer perforation	12.99	9.46	43	159382	34582	64304725
Malaise	12.95	9.46	825	158600	395422	63943885
Sinus tachycardia	12.91	9.46	129	159296	32059	64307248
Therapeutic product effect incomplete	12.91	9.46	179	159246	103303	64236004
Fracture nonunion	12.90	9.46	17	159408	1449	64337858
Device related infection	12.90	9.46	124	159301	30502	64308805
Tibia fracture	12.87	9.46	33	159392	4712	64334595
Electrocardiogram QRS complex prolonged	12.80	9.46	51	159374	9193	64330114
Hepatic enzyme increased	12.79	9.46	235	159190	129708	64209599
Cerebral infarction	12.78	9.46	55	159370	40989	64298318
Congenital knee deformity	12.74	9.46	4	159421	21	64339286
Cerebral haemorrhage	12.74	9.46	74	159351	51016	64288291
Heavy menstrual bleeding	12.70	9.46	7	159418	12070	64327237
Tendonitis	12.70	9.46	19	159406	20263	64319044
Drug screen positive	12.70	9.46	37	159388	5692	64333615
Sleep disorder due to a general medical condition	12.69	9.46	47	159378	8187	64331120
Substance use disorder	12.56	9.46	9	159416	358	64338949
Blood calcium increased	12.54	9.46	48	159377	8494	64330813
Migraine	12.52	9.46	97	159328	62580	64276727
Nerve degeneration	12.51	9.46	8	159417	263	64339044
Angina pectoris	12.51	9.46	63	159362	45018	64294289
Spinal cord injury lumbar	12.50	9.46	5	159420	58	64339249
Pulmonary oedema	12.44	9.46	268	159157	78406	64260901
Hypovolaemia	12.41	9.46	73	159352	15413	64323894
Substance-induced mood disorder	12.39	9.46	6	159419	113	64339194
Blood 25-hydroxycholecalciferol decreased	12.38	9.46	7	159418	183	64339124
Chest discomfort	12.38	9.46	207	159218	115899	64223408
Induced abortion failed	12.35	9.46	7	159418	184	64339123
Pulmonary calcification	12.28	9.46	9	159416	371	64338936
Injection site haemorrhage	12.27	9.46	26	159399	24252	64315055
Visual acuity reduced	12.16	9.46	31	159394	27110	64312197
Protein total decreased	11.98	9.46	45	159380	7891	64331416
Myocardial fibrosis	11.91	9.46	17	159408	1563	64337744
Drug withdrawal syndrome	11.88	9.46	124	159301	31167	64308140
No adverse event	11.76	9.46	34	159391	28527	64310780
Metabolic acidosis	11.63	9.46	243	159182	70715	64268592
Type 2 diabetes mellitus	11.60	9.46	44	159381	33976	64305331
Skin necrosis	11.56	9.46	11	159414	14318	64324989
Device malfunction	11.55	9.46	16	159409	17617	64321690
Oncocytoma	11.54	9.46	4	159421	30	64339277
Delayed graft function	11.41	9.46	24	159401	3012	64336295
Acute respiratory failure	11.35	9.46	180	159245	49754	64289553
Post procedural diarrhoea	11.34	9.46	7	159418	216	64339091
Sleep apnoea syndrome	11.23	9.46	37	159388	29795	64309512
Polyarthritis	11.17	9.46	5	159420	9710	64329597
Lip dry	11.13	9.46	32	159393	4886	64334421
Penile erythema	11.11	9.46	6	159419	143	64339164
Rhinovirus infection	11.09	9.46	37	159388	6119	64333188
Necrotising ulcerative gingivostomatitis	11.00	9.46	4	159421	35	64339272
Gastritis alcoholic	11.00	9.46	4	159421	35	64339272
Diplopia	10.92	9.46	32	159393	26733	64312574
Unresponsive to stimuli	10.84	9.46	180	159245	50213	64289094
Alcoholic	10.80	9.46	4	159421	37	64339270
Blood albumin decreased	10.77	9.46	89	159336	20984	64318323
Abdominal infection	10.77	9.46	23	159402	2917	64336390
Renal cyst haemorrhage	10.72	9.46	9	159416	453	64338854
Fluid retention	10.65	9.46	95	159330	59511	64279796
Agitation	10.64	9.46	290	159135	88077	64251230
Noninfectious peritonitis	10.64	9.46	7	159418	242	64339065
Intraductal papillary mucinous neoplasm	10.61	9.46	10	159415	587	64338720
Osteomalacia	10.54	9.46	15	159410	1376	64337931
Psychiatric disorder prophylaxis	10.53	9.46	4	159421	40	64339267
Therapy non-responder	10.52	9.46	108	159317	65791	64273516
Ulcer	10.50	9.46	26	159399	22964	64316343
Abscess intestinal	10.48	9.46	20	159405	2340	64336967
Shunt occlusion	10.45	9.46	14	159411	1213	64338094
Central nervous system mass	10.43	9.46	5	159420	92	64339215
Bradycardia	10.36	9.46	218	159207	118001	64221306
Loss of consciousness	10.32	9.46	457	158968	147908	64191399
Hot flush	10.26	9.46	166	159259	46069	64293238
Impaired driving ability	10.26	9.46	30	159395	4624	64334683
Tachycardia	10.25	9.46	460	158965	149119	64190188
Intramedullary rod insertion	10.24	9.46	6	159419	168	64339139
Disability	10.23	9.46	9	159416	12163	64327144
Achlorhydria	10.22	9.46	3	159422	12	64339295
Angina unstable	10.17	9.46	14	159411	15453	64323854
Nasopharyngitis	10.16	9.46	389	159036	195684	64143623
Wall motion score index abnormal	10.14	9.46	5	159420	98	64339209
Hyperparathyroidism	10.09	9.46	22	159403	2830	64336477
Lip discolouration	10.05	9.46	10	159415	628	64338679
Sinus congestion	10.03	9.46	69	159356	15370	64323937
Leukopenia	9.99	9.46	183	159242	101059	64238248
Blindness	9.98	9.46	25	159400	21994	64317313
Chronic kidney disease-mineral and bone disorder	9.94	9.46	9	159416	502	64338805
Sensorimotor disorder	9.93	9.46	11	159414	782	64338525
Constipation	9.93	9.46	676	158749	228661	64110646
Sunburn	9.91	9.46	24	159401	3308	64335999
Benzodiazepine drug level therapeutic	9.88	9.46	4	159421	48	64339259
Myelodysplastic syndrome	9.84	9.46	35	159390	27544	64311763
Mucormycosis	9.75	9.46	3	159422	7338	64331969
Cirrhosis alcoholic	9.72	9.46	12	159413	958	64338349
Injection site urticaria	9.72	9.46	8	159417	11173	64328134
Unevaluable event	9.68	9.46	79	159346	50410	64288897
Mixed dementia	9.67	9.46	7	159418	283	64339024
Fanconi syndrome	9.67	9.46	20	159405	2481	64336826
Accident at work	9.64	9.46	12	159413	967	64338340
Vision blurred	9.63	9.46	161	159264	90155	64249152
Neutropenia	9.62	9.46	489	158936	239135	64100172
Epstein-Barr virus infection	9.60	9.46	10	159415	12478	64326829
Erythema multiforme	9.55	9.46	15	159410	15686	64323621
Ear infection	9.53	9.46	28	159397	23376	64315931
Loss of proprioception	9.49	9.46	10	159415	672	64338635

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	P03AX05	ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS ECTOPARASITICIDES, INCL. SCABICIDES, INSECTICIDES AND REPELLENTS ECTOPARASITICIDES, INCL. SCABICIDES Other ectoparasiticides, incl. scabicides
FDA PE	N0000010282	Skin Barrier Activity
MeSH PA	D000934	Antifoaming Agents
MeSH PA	D003879	Dermatologic Agents
MeSH PA	D004643	Emollients
MeSH PA	D013501	Surface-Active Agents
CHEBI has role	CHEBI:63047	food emulsifiers
CHEBI has role	CHEBI:77965	food anti-caking agent
CHEBI has role	CHEBI:78058	food antifoaming agents

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

Disease	Relation	SNOMED_ID	DOID
Diaper rash	indication	91487003

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

ID	Source
4018922	VUID
N0000147215	NUI
D01540	KEGG_DRUG
4018922	VANDF
4019331	VANDF
C1113707	UMLSCUI
CHEBI:31498	CHEBI
CHEMBL2108200	ChEMBL_ID
DB11074	DRUGBANK_ID
CHEMBL4297192	ChEMBL_ID
CHEMBL1200838	ChEMBL_ID
24764	PUBCHEM_CID
C501844	MESH_SUPPLEMENTAL_RECORD_UI
C013830	MESH_SUPPLEMENTAL_RECORD_UI
2898	INN_ID
92RU3N3Y1O	UNII
DB09512	DRUGBANK_ID
DB14005	DRUGBANK_ID
1299921	RXNORM
4607	MMSL
5175	MMSL
5464	MMSL
d01027	MMSL
001144	NDDF
001915	NDDF
387442005	SNOMEDCT_US
396031000	SNOMEDCT_US
420874002	SNOMEDCT_US
77898008	SNOMEDCT_US
D012841	MESH_DESCRIPTOR_UI

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Gas-XExtra Strength	HUMAN OTC DRUG LABEL	1	0067-0117	TABLET, CHEWABLE	125 mg	ORAL	OTC monograph final	10 sections
Gas-XTotal Relief Maximum Strength	HUMAN OTC DRUG LABEL	2	0067-0118	TABLET, CHEWABLE	250 mg	ORAL	OTC monograph final	14 sections
Gas-XTotal Relief Maximum Strength	HUMAN OTC DRUG LABEL	2	0067-0119	TABLET, CHEWABLE	250 mg	ORAL	OTC monograph final	14 sections
Gas-XExtra Strength	HUMAN OTC DRUG LABEL	1	0067-0129	TABLET, CHEWABLE	125 mg	ORAL	OTC monograph final	10 sections
Gas-XUltra Strength AntiGas Softgels	HUMAN OTC DRUG LABEL	1	0067-6274	CAPSULE, LIQUID FILLED	180 mg	ORAL	OTC monograph final	10 sections
Gas-XExtra Strength Softgels	HUMAN OTC DRUG LABEL	1	0067-6275	CAPSULE, LIQUID FILLED	125 mg	ORAL	OTC monograph final	10 sections
Gas-XMaximum Strength Softgels	HUMAN OTC DRUG LABEL	1	0067-6283	CAPSULE, LIQUID FILLED	250 mg	ORAL	OTC monograph final	10 sections
Moisturel	HUMAN OTC DRUG LABEL	1	0093-3204	LOTION	30 g	TOPICAL	OTC monograph final	13 sections
good sense anti diarrheal anti gas	HUMAN OTC DRUG LABEL	2	0113-0087	TABLET	125 mg	ORAL	ANDA	16 sections
Good Sense antacid	HUMAN OTC DRUG LABEL	3	0113-0340	SUSPENSION	80 mg	ORAL	OTC monograph final	13 sections
Good Sense AntacidRegular Strength	HUMAN OTC DRUG LABEL	3	0113-0357	SUSPENSION	40 mg	ORAL	OTC monograph final	13 sections
Good Sense Gas ReliefExtra Strength	HUMAN OTC DRUG LABEL	1	0113-0428	CAPSULE, LIQUID FILLED	125 mg	ORAL	OTC monograph final	10 sections
Good Sense AntacidMaximum Strength	HUMAN OTC DRUG LABEL	3	0113-0588	SUSPENSION	80 mg	ORAL	OTC monograph final	13 sections
good sense gas relief	HUMAN OTC DRUG LABEL	1	0113-0657	CAPSULE, LIQUID FILLED	180 mg	ORAL	OTC monograph final	11 sections
good sense antacid	HUMAN OTC DRUG LABEL	3	0113-0851	SUSPENSION	40 mg	ORAL	OTC monograph final	13 sections
good sense simethiconeinfants	HUMAN OTC DRUG LABEL	1	0113-0882	EMULSION	20 mg	ORAL	OTC monograph final	11 sections
Good Sense Anti Diarrheal Anti Gas	HUMAN OTC DRUG LABEL	2	0113-1087	TABLET	125 mg	ORAL	ANDA	16 sections
basic care loperamide hydrochloride and simethicone	HUMAN OTC DRUG LABEL	2	0113-7119	TABLET	125 mg	ORAL	ANDA	16 sections
Mag-AL Plus	HUMAN OTC DRUG LABEL	3	0121-1761	SUSPENSION	20 mg	ORAL	OTC monograph final	14 sections
Mag-AL PlusXS	HUMAN OTC DRUG LABEL	3	0121-1762	SUSPENSION	40 mg	ORAL	OTC monograph final	15 sections
PHAZYME	HUMAN OTC DRUG LABEL	1	0132-0208	CAPSULE, GELATIN COATED	180 mg	ORAL	OTC MONOGRAPH FINAL	12 sections
PHAZYME	HUMAN OTC DRUG LABEL	1	0132-0210	CAPSULE, GELATIN COATED	180 mg	ORAL	export only	10 sections
PHAZYME	HUMAN OTC DRUG LABEL	1	0132-0211	CAPSULE, GELATIN COATED	250 mg	ORAL	OTC MONOGRAPH FINAL	12 sections
PHAZYME	HUMAN OTC DRUG LABEL	1	0132-0214	CAPSULE, GELATIN COATED	250 mg	ORAL	OTC MONOGRAPH FINAL	11 sections
PHAZYME	HUMAN OTC DRUG LABEL	1	0132-0215	CAPSULE, GELATIN COATED	250 mg	ORAL	OTC MONOGRAPH FINAL	11 sections
PHAZYME ULTIMATE	HUMAN OTC DRUG LABEL	1	0132-0217	CAPSULE, LIQUID FILLED	500 mg	ORAL	OTC MONOGRAPH FINAL	12 sections
Boudreauxs Butt Barrier	HUMAN OTC DRUG LABEL	1	0132-0326	OINTMENT	1 g	TOPICAL	OTC monograph final	13 sections
PHAZYME	HUMAN OTC DRUG LABEL	2	0132-0507	TABLET, CHEWABLE	250 mg	ORAL	OTC monograph final	11 sections
Summers Eve Active Chafe	HUMAN OTC DRUG LABEL	1	0132-8744	GEL	12 mg	TOPICAL	OTC MONOGRAPH FINAL	14 sections
Tums Chewy Bites with Gas Relief	HUMAN OTC DRUG LABEL	2	0135-0624	TABLET, CHEWABLE	80 mg	ORAL	OTC monograph final	12 sections