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

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

Stem definition	Drug id	CAS RN
	3017	139-07-1

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: benzalkonium chloride benzalkonium benzyldodecyldimethylammonium chloride benzododecinium	A mixture of alkylbenzyldimethylammonium compounds. It is a bactericidal quaternary ammonium detergent used topically in medicaments, deodorants, mouthwashes, as a surgical antiseptic, and as a as preservative and emulsifier in drugs and cosmetics. Molecular weight: 304.54 Formula: C21H38N CLOGP: 3.18 LIPINSKI: 0 HAC: 1 HDO: 0 TPSA: ALOGS: -7.85 ROTB: 13

Drug dosage:

None

ADMET properties:

None

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
Completed suicide	2983.14	10.07	1998	74955	131835	56083279
Toxicity to various agents	1820.97	10.07	1864	75089	222700	55992414
Drug abuse	934.48	10.07	759	76194	66851	56148263
Cardio-respiratory arrest	662.59	10.07	572	76381	54749	56160365
Intentional overdose	557.31	10.07	570	76383	67547	56147567
Overdose	426.94	10.07	619	76334	105211	56109903
Local anaesthetic systemic toxicity	412.46	10.07	111	76842	623	56214491
Cardiac arrest	361.41	10.07	514	76439	85800	56129314
Alcohol interaction	329.53	10.07	123	76830	2210	56212904
Suicide attempt	271.38	10.07	364	76589	57472	56157642
Suspected suicide	254.63	10.07	132	76821	5334	56209780
Toxic anterior segment syndrome	220.59	10.07	84	76869	1598	56213516
Rheumatoid arthritis	195.53	10.07	143	76810	382461	55832653
Pemphigus	191.40	10.07	5	76948	157207	56057907
Methaemoglobinaemia	186.86	10.07	80	76873	2082	56213032
Alcohol poisoning	175.61	10.07	73	76880	1762	56213352
Respiratory arrest	172.32	10.07	211	76742	30414	56184700
Glossodynia	162.41	10.07	12	76941	152446	56062668
Sinusitis	152.92	10.07	604	76349	196977	56018137
Systemic lupus erythematosus	151.24	10.07	31	76922	180047	56035067
Synovitis	148.06	10.07	22	76931	161283	56053831
Death	145.27	10.07	879	76074	340547	55874567
Intentional product misuse	142.52	10.07	254	76699	51250	56163864
Alcohol use	139.80	10.07	64	76889	1961	56213153
Alopecia	138.07	10.07	119	76834	293339	55921775
Abdominal discomfort	133.43	10.07	110	76843	277164	55937950
Contraindicated product administered	112.59	10.07	57	76896	186229	56028885
Infusion site swelling	111.46	10.07	90	76863	7831	56207283
Wound	110.28	10.07	27	76926	138777	56076337
Hepatic enzyme increased	108.84	10.07	49	76904	171335	56043779
Infusion site extravasation	108.63	10.07	90	76863	8120	56206994
Therapy interrupted	107.68	10.07	153	76800	25472	56189642
Alcohol abuse	107.27	10.07	53	76900	1931	56213183
Infusion site pain	106.67	10.07	112	76841	13650	56201464
Gastrointestinal toxicity	104.13	10.07	78	76875	6078	56209036
Drug intolerance	103.40	10.07	126	76827	264692	55950422
Pericarditis	101.92	10.07	14	76939	108909	56106205
Drug ineffective	96.16	10.07	801	76152	918188	55296926
Anaesthetic complication	95.32	10.07	47	76906	1705	56213409
Joint swelling	95.15	10.07	156	76797	289644	55925470
Maternal exposure during delivery	91.72	10.07	40	76913	1090	56214024
General physical health deterioration	88.67	10.07	62	76891	169948	56045166
Infusion site pruritus	88.27	10.07	64	76889	4743	56210371
Infusion site erythema	86.91	10.07	85	76868	9521	56205593
Pulmonary toxicity	85.22	10.07	77	76876	7806	56207308
Ventricular tachycardia	81.70	10.07	108	76845	16793	56198321
Pulseless electrical activity	80.68	10.07	71	76882	6953	56208161
Helicobacter infection	80.23	10.07	5	76948	73263	56141851
Swelling	76.88	10.07	131	76822	239640	55975474
COVID-19	75.39	10.07	250	76703	74808	56140306
Somnolence	74.60	10.07	429	76524	162984	56052130
Exposure to toxic agent	74.53	10.07	52	76901	3626	56211488
Anaphylactic shock	74.48	10.07	118	76835	21622	56193492
Diarrhoea	73.79	10.07	541	76412	637966	55577148
Generalised tonic-clonic seizure	73.74	10.07	134	76819	27432	56187682
Seizure	72.58	10.07	351	76602	124768	56090346
Infusion site haemorrhage	71.99	10.07	51	76902	3644	56211470
Coma	68.41	10.07	208	76745	59447	56155667
Therapeutic product effect decreased	67.81	10.07	79	76874	169373	56045741
Mydriasis	65.06	10.07	78	76875	10993	56204121
Arthralgia	64.86	10.07	411	76542	501258	55713856
Rash	64.23	10.07	403	76550	492644	55722470
Anaphylactic reaction	59.68	10.07	197	76756	58798	56156316
Body tinea	59.63	10.07	32	76921	1388	56213726
Incorrect drug administration rate	57.74	10.07	42	76911	3128	56211986
Agitation	57.47	10.07	188	76765	55848	56159266
Incorrect route of product administration	57.45	10.07	104	76849	21225	56193889
Loss of consciousness	57.22	10.07	298	76655	109051	56106063
Corneal oedema	56.80	10.07	31	76922	1391	56213723
Folliculitis	56.64	10.07	5	76948	54974	56160140
Extradural abscess	56.42	10.07	26	76927	809	56214305
Bradycardia	55.88	10.07	211	76742	67293	56147821
Hypotension	55.72	10.07	555	76398	249953	55965161
Infusion site bruising	55.25	10.07	39	76914	2770	56212344
Arthropathy	54.96	10.07	120	76833	200155	56014959
Blood alcohol increased	54.65	10.07	23	76930	573	56214541
Postmortem blood drug level abnormal	54.64	10.07	20	76933	339	56214775
Substance abuse	54.51	10.07	47	76906	4478	56210636
Unresponsive to stimuli	52.87	10.07	127	76826	31598	56183516
Tachycardia	50.95	10.07	282	76671	105594	56109520
Hypersensitivity	50.75	10.07	180	76773	256228	55958886
Poisoning deliberate	50.28	10.07	65	76888	9888	56205226
Product use issue	49.79	10.07	113	76840	185928	56029186
Mobility decreased	49.12	10.07	38	76915	98953	56116161
Alcoholism	48.94	10.07	33	76920	2176	56212938
Muscle injury	48.50	10.07	7	76946	52493	56162621
Procedural hypotension	48.44	10.07	26	76927	1128	56213986
Blister	47.74	10.07	47	76906	108840	56106274
Discomfort	47.69	10.07	75	76878	141686	56073428
Impaired healing	47.50	10.07	30	76923	86811	56128303
Neoplasm malignant	45.83	10.07	109	76844	26946	56188168
Extradural haematoma	45.58	10.07	28	76925	1572	56213542
Seasonal allergy	45.54	10.07	83	76870	17025	56198089
Psoriatic arthropathy	44.14	10.07	23	76930	73985	56141129
Infusion site urticaria	43.77	10.07	25	76928	1226	56213888
Pulse absent	43.17	10.07	43	76910	4924	56210190
Off label use	42.76	10.07	521	76432	555659	55659455
Ventricular fibrillation	42.52	10.07	63	76890	10889	56204225
Respiratory depression	41.91	10.07	67	76886	12368	56202746
Ear infection	41.53	10.07	115	76838	31180	56183934
Anaesthetic complication neurological	40.58	10.07	14	76939	198	56214916
Inhibitory drug interaction	40.31	10.07	30	76923	2314	56212800
Lagophthalmos	40.29	10.07	16	76937	342	56214772
Infection susceptibility increased	39.96	10.07	32	76921	2751	56212363
Hepatotoxicity	39.89	10.07	113	76840	31040	56184074
Asthenia	39.74	10.07	290	76663	342683	55872431
Victim of sexual abuse	38.10	10.07	18	76935	593	56214521
Electrocardiogram ST segment elevation	38.02	10.07	35	76918	3634	56211480
Nystagmus	37.49	10.07	43	76910	5782	56209332
Mental status changes	36.83	10.07	124	76829	37377	56177737
Joint injury	36.78	10.07	97	76856	25557	56189557
Poisoning	36.46	10.07	64	76889	12749	56202365
Neutropenia	36.18	10.07	104	76849	158063	56057051
Drug interaction	36.17	10.07	442	76511	209313	56005801
C-reactive protein increased	35.61	10.07	33	76920	78651	56136463
Administration site pain	34.51	10.07	18	76935	736	56214378
Fear	34.33	10.07	68	76885	14840	56200274
Type 2 diabetes mellitus	33.70	10.07	11	76942	46851	56168263
Embolia cutis medicamentosa	33.56	10.07	14	76939	341	56214773
Hypopyon	32.67	10.07	17	76936	692	56214422
Stress cardiomyopathy	32.43	10.07	48	76905	8288	56206826
Infusion site mass	32.36	10.07	22	76931	1470	56213644
Bursitis infective	32.17	10.07	21	76932	1311	56213803
Acute kidney injury	31.65	10.07	196	76757	240567	55974547
Anterior chamber cell	31.43	10.07	15	76938	506	56214608
Aggression	31.34	10.07	83	76870	21923	56193191
Upper respiratory tract infection	31.09	10.07	185	76768	71103	56144011
Infusion site rash	31.07	10.07	22	76931	1570	56213544
Corneal epithelium defect	30.84	10.07	13	76940	325	56214789
Infusion site nodule	30.74	10.07	20	76933	1242	56213872
Lower respiratory tract infection	30.47	10.07	70	76883	114724	56100390
Type I hypersensitivity	30.38	10.07	26	76927	2452	56212662
Fear of eating	30.30	10.07	13	76940	340	56214774
Sinus tachycardia	30.30	10.07	83	76870	22361	56192753
Platelet aggregation inhibition	30.04	10.07	10	76943	126	56214988
Illness	29.48	10.07	109	76844	34402	56180712
Drug use disorder	29.26	10.07	34	76919	4635	56210479
Pneumocephalus	29.21	10.07	10	76943	138	56214976
Staphylococcal infection	29.00	10.07	115	76838	37503	56177611
Peripheral swelling	28.86	10.07	195	76758	234531	55980583
Disease progression	28.84	10.07	63	76890	105110	56110004
Retinal vasculitis	28.79	10.07	17	76936	888	56214226
Psoriasis	28.43	10.07	52	76901	92640	56122474
Respiratory tract infection	28.40	10.07	111	76842	35960	56179154
Cauda equina syndrome	28.34	10.07	17	76936	914	56214200
Parophthalmia	28.22	10.07	12	76941	307	56214807
Vitritis	28.21	10.07	17	76936	922	56214192
Dyspnoea	28.17	10.07	607	76346	591970	55623144
Administration site swelling	28.11	10.07	18	76935	1087	56214027
Electrocardiogram QRS complex prolonged	28.08	10.07	36	76917	5431	56209683
Abdominal pain upper	27.89	10.07	137	76816	178176	56036938
Glucose tolerance impaired	27.88	10.07	36	76917	5469	56209645
Renal injury	27.40	10.07	46	76907	8841	56206273
Product adhesion issue	27.02	10.07	32	76921	4451	56210663
Aqueous fibrin	26.75	10.07	8	76945	69	56215045
Blood cholesterol increased	26.75	10.07	36	76917	72543	56142571
Stomatitis	26.49	10.07	81	76872	120729	56094385
Loss of personal independence in daily activities	26.46	10.07	44	76909	81325	56133789
Myocarditis	26.19	10.07	45	76908	8813	56206301
Pulmonary oedema	25.78	10.07	138	76815	51005	56164109
Surgery	25.60	10.07	100	76853	32386	56182728
Chemical submission	25.57	10.07	10	76943	205	56214909
Kounis syndrome	25.48	10.07	18	76935	1280	56213834
Peripheral nerve injury	25.33	10.07	12	76941	398	56214716
Drug dependence	25.29	10.07	78	76875	22455	56192659
Pancytopenia	25.27	10.07	52	76901	88663	56126451
Septic arthritis staphylococcal	24.89	10.07	12	76941	414	56214700
Unevaluable event	24.26	10.07	129	76824	47558	56167556
Thrombocytopenia	24.09	10.07	100	76853	136124	56078990
Fatigue	24.01	10.07	860	76093	787692	55427422
Spinal epidural haemorrhage	23.94	10.07	8	76945	102	56215012
Cyanosis	23.92	10.07	61	76892	15749	56199365
Bundle branch block left	23.84	10.07	36	76917	6326	56208788
Anhedonia	23.77	10.07	46	76907	9868	56205246
COVID-19 immunisation	23.73	10.07	18	76935	1429	56213685
Anal skin tags	23.58	10.07	12	76941	466	56214648
Upper airway obstruction	23.52	10.07	13	76940	598	56214516
Drug level increased	23.50	10.07	72	76881	20653	56194461
Leukopenia	23.40	10.07	38	76915	70902	56144212
Protein C increased	23.33	10.07	8	76945	111	56215003
Ill-defined disorder	23.29	10.07	36	76917	68507	56146607
Shock	23.26	10.07	74	76879	21654	56193460
Drug withdrawal syndrome	23.21	10.07	83	76870	25774	56189340
Depressed level of consciousness	22.43	10.07	143	76810	56290	56158824
Meningitis chemical	22.34	10.07	8	76945	127	56214987
Hypoxia	22.31	10.07	138	76815	53759	56161355
Decreased appetite	22.28	10.07	192	76761	219039	55996075
Ophthalmoplegia	22.12	10.07	17	76936	1376	56213738
Hyponatraemia	22.02	10.07	69	76884	102070	56113044
Orthostatic hypotension	21.83	10.07	9	76944	33190	56181924
Treatment failure	21.71	10.07	140	76813	170252	56044862
Apnoea	21.69	10.07	37	76916	7205	56207909
Nerve root injury	21.68	10.07	6	76947	38	56215076
Kidney infection	21.66	10.07	70	76883	20655	56194459
Punctate keratitis	21.65	10.07	12	76941	555	56214559
Atonic urinary bladder	21.41	10.07	7	76946	83	56215031
Cardiac failure congestive	21.30	10.07	56	76897	87664	56127450
Removal of foreign body	21.07	10.07	5	76948	15	56215099
Spinal anaesthesia	20.92	10.07	6	76947	44	56215070
Bronchitis	20.80	10.07	240	76713	112071	56103043
Somnambulism	20.79	10.07	30	76923	5062	56210052
Respiratory acidosis	20.48	10.07	33	76920	6130	56208984
Poor quality sleep	20.43	10.07	62	76891	17693	56197421
Trigemino-cardiac reflex	20.35	10.07	6	76947	49	56215065
Abortion spontaneous	20.21	10.07	18	76935	43735	56171379
Dermatitis contact	20.21	10.07	42	76911	9485	56205629
Miosis	20.16	10.07	34	76919	6558	56208556
Homicide	20.00	10.07	10	76943	374	56214740
Neurotoxicity	19.93	10.07	57	76896	15738	56199376
Neuromuscular block prolonged	19.90	10.07	11	76942	506	56214608
Nerve block	19.69	10.07	12	76941	664	56214450
Infusion site reaction	19.68	10.07	22	76931	2876	56212238
Insurance issue	19.52	10.07	25	76928	3767	56211347
Accidental overdose	19.51	10.07	67	76886	20394	56194720
Status epilepticus	19.46	10.07	55	76898	15086	56200028
Substance dependence	19.13	10.07	8	76945	196	56214918
Spinal epidural haematoma	19.12	10.07	14	76939	1053	56214061
Arthritis	19.12	10.07	71	76882	99781	56115333
Infusion related reaction	19.06	10.07	188	76765	208743	56006371
Ventricular hypokinesia	19.01	10.07	26	76927	4175	56210939
Glossoptosis	18.93	10.07	6	76947	64	56215050
Anaemia	18.84	10.07	255	76698	267256	55947858
Septic shock	18.77	10.07	34	76919	60801	56154313
Ventricular extrasystoles	18.63	10.07	44	76909	10826	56204288
Malignant neoplasm progression	18.62	10.07	46	76907	73541	56141573
Electrocardiogram QT prolonged	18.51	10.07	133	76820	54455	56160659
Sensory loss	18.50	10.07	39	76914	8896	56206218
Prescribed underdose	18.47	10.07	3	76950	20614	56194500
Postmortem blood drug level	18.24	10.07	7	76946	136	56214978
Red blood cell sedimentation rate increased	18.23	10.07	14	76939	36609	56178505
Pain	18.21	10.07	732	76221	662452	55552662
Serotonin syndrome	18.07	10.07	78	76875	26412	56188702
Accidental death	18.06	10.07	17	76936	1815	56213299
Circulatory collapse	18.01	10.07	66	76887	20737	56194377
Irritable bowel syndrome	17.95	10.07	42	76911	68416	56146698
Induced abortion failed	17.85	10.07	8	76945	233	56214881
Hip arthroplasty	17.71	10.07	16	76937	38607	56176507
Substance use disorder	17.52	10.07	7	76946	152	56214962
Multiple allergies	17.46	10.07	42	76911	10454	56204660
Stridor	17.40	10.07	22	76931	3273	56211841
Urinary tract infection	17.36	10.07	441	76512	240072	55975042
Drug reaction with eosinophilia and systemic symptoms	17.22	10.07	10	76943	30294	56184820
Nail bed tenderness	17.21	10.07	9	76944	370	56214744
Femur fracture	17.17	10.07	17	76936	39278	56175836
Delirium	17.05	10.07	108	76845	42409	56172705
Eye infarction	17.05	10.07	5	76948	40	56215074
Alcoholic	17.05	10.07	5	76948	40	56215074
Adverse event	17.04	10.07	31	76922	55345	56159769
Emotional distress	16.87	10.07	83	76870	29680	56185434
Procedural complication	16.81	10.07	27	76926	5004	56210110
Interstitial lung disease	16.63	10.07	33	76920	57030	56158084
Cholestasis	16.59	10.07	8	76945	26905	56188209
Hospitalisation	16.54	10.07	166	76787	74834	56140280
Infusion site discomfort	16.53	10.07	13	76940	1089	56214025
Areflexia	16.47	10.07	20	76933	2855	56212259
Anorgasmia	16.38	10.07	10	76943	555	56214559
Blood ethanol	16.34	10.07	5	76948	47	56215067
Phrenic nerve paralysis	16.28	10.07	7	76946	184	56214930
Axillary nerve injury	16.17	10.07	4	76949	15	56215099
Therapy cessation	16.15	10.07	77	76876	27187	56187927
Osteoarthritis	16.10	10.07	56	76897	80240	56134874
Cardiogenic shock	16.04	10.07	54	76899	16271	56198843
Arthritis bacterial	15.97	10.07	29	76924	5932	56209182
Brain death	15.88	10.07	20	76933	2963	56212151
Congenital umbilical hernia	15.86	10.07	8	76945	305	56214809
Blood ethanol increased	15.81	10.07	6	76947	113	56215001
Vascular stenosis	15.81	10.07	8	76945	307	56214807
Device infusion issue	15.51	10.07	15	76938	1657	56213457
Intentional dose omission	15.45	10.07	29	76924	6081	56209033
Anaphylactoid shock	15.39	10.07	8	76945	325	56214789
Abdominal pain	15.36	10.07	255	76698	258550	55956564
Impaired quality of life	15.29	10.07	35	76918	8439	56206675
Incision site rash	15.25	10.07	4	76949	20	56215094
Trigeminal palsy	15.25	10.07	4	76949	20	56215094
Vitamin D increased	15.24	10.07	10	76943	630	56214484
Haemoglobin decreased	15.22	10.07	114	76839	134023	56081091
Endophthalmitis	15.06	10.07	20	76933	3123	56211991
Tryptase increased	15.03	10.07	8	76945	341	56214773
Obesity	14.90	10.07	6	76947	22442	56192672
Anal sphincter atony	14.89	10.07	7	76946	228	56214886
Anaphylactoid reaction	14.82	10.07	21	76932	3485	56211629
Condition aggravated	14.72	10.07	359	76594	344539	55870575
Diplopia	14.69	10.07	61	76892	20308	56194806
Post procedural complication	14.67	10.07	51	76902	15615	56199499
Pruritus	14.50	10.07	326	76627	316297	55898817
Opiates positive	14.38	10.07	8	76945	373	56214741
Suicidal ideation	14.31	10.07	131	76822	57611	56157503
Hypocalcaemia	14.31	10.07	11	76942	28749	56186365
Dissociative amnesia	14.23	10.07	4	76949	27	56215087
Tracheal deviation	14.16	10.07	6	76947	152	56214962
Eyelid ptosis	14.13	10.07	29	76924	6490	56208624
Spinal operation	13.96	10.07	31	76922	7325	56207789
Gastroenteritis	13.95	10.07	8	76945	24404	56190710
Intercepted medication error	13.95	10.07	9	76944	551	56214563
Paralysis	13.82	10.07	35	76918	8997	56206117
Spinal stroke	13.75	10.07	4	76949	31	56215083
Migraine	13.69	10.07	180	76773	86617	56128497
Administration site extravasation	13.68	10.07	10	76943	750	56214364
Intentional self-injury	13.67	10.07	69	76884	24923	56190191
Amnesia	13.53	10.07	109	76844	46213	56168901
Device expulsion	13.50	10.07	13	76940	30436	56184678
Blood creatinine increased	13.48	10.07	60	76893	80131	56134983
Airway peak pressure increased	13.38	10.07	7	76946	288	56214826
Administration site erythema	13.31	10.07	9	76944	596	56214518
Pupillary reflex impaired	13.27	10.07	15	76938	1985	56213129
Amphetamines positive	13.22	10.07	6	76947	180	56214934
Propionibacterium infection	13.13	10.07	4	76949	37	56215077
Multiple sclerosis relapse	13.06	10.07	26	76927	44877	56170237
Gastric mucosa erythema	13.06	10.07	7	76946	303	56214811
Vascular resistance systemic decreased	13.04	10.07	5	76948	97	56215017
Disinhibition	13.00	10.07	10	76943	811	56214303
Osteonecrosis of jaw	12.85	10.07	16	76937	33342	56181772
Asphyxia	12.84	10.07	26	76927	5763	56209351
Drug resistance	12.83	10.07	6	76947	20536	56194578
Inadequate analgesia	12.80	10.07	17	76936	2654	56212460
Retinal artery occlusion	12.79	10.07	13	76940	1525	56213589
Systemic toxicity	12.76	10.07	4	76949	41	56215073
Drug hypersensitivity	12.70	10.07	283	76670	274922	55940192
Blood pressure decreased	12.69	10.07	130	76823	58920	56156194
Body dysmorphic disorder	12.69	10.07	7	76946	321	56214793
Orbital infection	12.67	10.07	4	76949	42	56215072
Application site alopecia	12.64	10.07	3	76950	9	56215105
Transferrin decreased	12.58	10.07	6	76947	202	56214912
Pneumocystis jirovecii pneumonia	12.56	10.07	3	76950	15698	56199416
Conjunctival oedema	12.54	10.07	9	76944	656	56214458
Autonomic neuropathy	12.52	10.07	11	76942	1074	56214040
Harlequin syndrome	12.51	10.07	4	76949	44	56215070
Road traffic accident	12.51	10.07	73	76880	27854	56187260
Product contamination microbial	12.50	10.07	6	76947	205	56214909
White blood cell count decreased	12.49	10.07	111	76842	125879	56089235
Implant site swelling	12.39	10.07	8	76945	490	56214624
Genital ulceration	12.36	10.07	8	76945	492	56214622
Withdrawal syndrome	12.32	10.07	54	76899	18408	56196706
Brain injury	12.31	10.07	27	76926	6328	56208786
Infusion site discolouration	12.19	10.07	9	76944	686	56214428
Agranulocytosis	12.15	10.07	8	76945	22651	56192463
Haematochezia	12.13	10.07	26	76927	43692	56171422
Toxicologic test abnormal	12.08	10.07	9	76944	695	56214419
Infusion site irritation	12.08	10.07	9	76944	695	56214419
Spinal cord oedema	11.94	10.07	5	76948	123	56214991
Foetal heart rate abnormal	11.87	10.07	8	76945	527	56214587
Paranasal cyst	11.86	10.07	7	76946	365	56214749
Epidural analgesia	11.83	10.07	4	76949	53	56215061
Weight increased	11.83	10.07	232	76721	229471	55985643
Cardiac death	11.80	10.07	8	76945	532	56214582
Sleep disorder	11.75	10.07	50	76903	67613	56147501
Hyperlipasaemia	11.74	10.07	8	76945	537	56214577
Cholestasis of pregnancy	11.72	10.07	11	76942	1170	56213944
Fear-related avoidance of activities	11.61	10.07	5	76948	132	56214982
Birth mark	11.58	10.07	5	76948	133	56214981
Blood pressure systolic increased	11.57	10.07	24	76929	40812	56174302
Dysarthria	11.52	10.07	93	76860	39457	56175657
Left ventricle outflow tract obstruction	11.49	10.07	6	76947	246	56214868
Normal newborn	11.48	10.07	29	76924	7441	56207673
Spinal cord infarction	11.45	10.07	6	76947	248	56214866
Coccygectomy	11.44	10.07	3	76950	15	56215099
Arthritis fungal	11.44	10.07	3	76950	15	56215099
Nasopharyngitis	11.43	10.07	223	76730	220736	55994378
Malaise	11.39	10.07	400	76553	367460	55847654
Gastrointestinal disorder	11.30	10.07	99	76854	112603	56102511
Vaginal abscess	11.27	10.07	7	76946	401	56214713
Immunodeficiency	11.25	10.07	4	76949	16153	56198961
Tooth infection	11.22	10.07	47	76906	15705	56199409
Visual acuity reduced	11.18	10.07	57	76896	20669	56194445
Hallucination, tactile	11.10	10.07	6	76947	264	56214850
Quadriparesis	11.08	10.07	13	76940	1791	56213323
Liver disorder	11.02	10.07	28	76925	44342	56170772
Apnoeic attack	10.94	10.07	6	76947	272	56214842
Product administration error	10.90	10.07	57	76896	20872	56194242
Spinal cord compression	10.89	10.07	19	76934	3765	56211349
Blood lactic acid increased	10.89	10.07	25	76928	6039	56209075
Repetitive strain injury	10.87	10.07	5	76948	155	56214959
Therapy non-responder	10.86	10.07	130	76823	61225	56153889
Cerebral congestion	10.84	10.07	3	76950	19	56215095
Heliotrope rash	10.84	10.07	5	76948	156	56214958
Purpura	10.83	10.07	35	76918	10327	56204787
Haemorrhagic vasculitis	10.81	10.07	4	76949	70	56215044
Retinal cyst	10.81	10.07	4	76949	70	56215044
Disease recurrence	10.80	10.07	10	76943	23850	56191264
Skin infection	10.71	10.07	41	76912	13154	56201960
Underdose	10.70	10.07	10	76943	23747	56191367
Neoplasm progression	10.70	10.07	17	76936	31999	56183115
Gait disturbance	10.66	10.07	158	76795	163163	56051951
Metabolic acidosis	10.65	10.07	93	76860	40361	56174753
Paraplegia	10.53	10.07	15	76938	2502	56212612
Haemorrhoids	10.51	10.07	55	76898	20151	56194963
Liver function test abnormal	10.45	10.07	30	76923	45641	56169473
Gastrointestinal haemorrhage	10.40	10.07	61	76892	75890	56139224
Infusion site streaking	10.31	10.07	7	76946	467	56214647
Drug eruption	10.30	10.07	12	76941	25751	56189363
Ataxia	10.28	10.07	43	76910	14360	56200754
Congestive hepatopathy	10.26	10.07	15	76938	2561	56212553
Neurogenic shock	10.24	10.07	6	76947	309	56214805
Femoral nerve injury	10.23	10.07	3	76950	24	56215090
Cranial nerve palsies multiple	10.23	10.07	3	76950	24	56215090
Environmental exposure	10.23	10.07	4	76949	82	56215032
Pneumonia mycoplasmal	10.21	10.07	9	76944	883	56214231
Skin exfoliation	10.19	10.07	22	76931	36878	56178236
Knee arthroplasty	10.18	10.07	29	76924	44230	56170884
Myocardial depression	10.11	10.07	7	76946	482	56214632
Incontinence	10.10	10.07	35	76918	10700	56204414
Pupil fixed	10.08	10.07	12	76941	1678	56213436

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	3137.62	10.97	1883	49944	85875	31559642
Toxicity to various agents	2377.96	10.97	2120	49707	179367	31466150
Completed suicide	2342.36	10.97	1592	50235	89922	31555595
Cardio-respiratory arrest	531.02	10.97	531	51296	51195	31594322
Intentional overdose	523.79	10.97	477	51350	40912	31604605
Overdose	451.79	10.97	621	51206	84043	31561474
Alcohol abuse	423.14	10.97	187	51640	4377	31641140
Alcohol interaction	382.26	10.97	151	51676	2638	31642879
Intentional product misuse	335.84	10.97	360	51467	37591	31607926
Suicide attempt	280.81	10.97	325	51502	36923	31608594
Suspected suicide	259.11	10.97	129	51698	3978	31641539
Methaemoglobinaemia	224.56	10.97	106	51721	2900	31642617
Substance abuse	214.35	10.97	138	51689	7020	31638497
Cardiac arrest	199.71	10.97	446	51381	88616	31556901
Alcohol poisoning	198.26	10.97	99	51728	3072	31642445
Respiratory depression	175.05	10.97	163	51664	14347	31631170
Respiratory arrest	172.98	10.97	214	51613	26043	31619474
Drug dependence	166.70	10.97	195	51632	22384	31623133
Coma	153.71	10.97	256	51571	40894	31604623
Alcohol use	122.74	10.97	72	51755	3095	31642422
Anaphylactic reaction	118.66	10.97	190	51637	29363	31616154
Anaesthetic complication	117.68	10.97	49	51778	985	31644532
Diarrhoea	117.65	10.97	251	51576	352158	31293359
Local anaesthetic systemic toxicity	108.33	10.97	32	51795	215	31645302
Aggression	102.33	10.97	203	51624	37088	31608429
Poisoning deliberate	99.34	10.97	88	51739	7256	31638261
Asphyxia	98.59	10.97	79	51748	5672	31639845
Toxic anterior segment syndrome	97.55	10.97	44	51783	1081	31644436
Exposure to toxic agent	92.75	10.97	56	51771	2539	31642978
Incorrect route of product administration	91.48	10.97	104	51723	11569	31633948
Tachycardia	89.38	10.97	301	51526	75906	31569611
Mydriasis	83.66	10.97	76	51751	6476	31639041
Blood alcohol increased	82.69	10.97	35	51792	734	31644783
Hypotension	81.63	10.97	593	51234	204025	31441492
Injury	80.86	10.97	128	51699	19581	31625936
Ventricular tachycardia	78.67	10.97	140	51687	23561	31621956
Unresponsive to stimuli	76.32	10.97	145	51682	25655	31619862
Death	76.01	10.97	911	50916	359658	31285859
Miosis	73.42	10.97	80	51747	8490	31637027
Anaemia	72.79	10.97	150	51677	213372	31432145
Poisoning	72.13	10.97	87	51740	10304	31635213
Fear	70.04	10.97	84	51743	9890	31635627
Anaphylactic shock	66.69	10.97	98	51729	14047	31631470
General physical health deterioration	63.78	10.97	55	51772	113380	31532137
Intentional product use issue	62.38	10.97	200	51627	49147	31596370
Drug use disorder	58.45	10.97	50	51777	3933	31641584
Renal injury	57.83	10.97	79	51748	10586	31634931
Decreased appetite	54.42	10.97	105	51722	153112	31492405
Disease progression	53.15	10.97	42	51785	90422	31555095
Weight decreased	52.25	10.97	115	51712	159837	31485680
Anhedonia	51.15	10.97	62	51765	7380	31638137
Dyspnoea	50.95	10.97	341	51486	343138	31302379
Generalised tonic-clonic seizure	50.49	10.97	105	51722	19826	31625691
Emotional distress	50.49	10.97	87	51740	14269	31631248
Fatigue	49.10	10.97	334	51493	334872	31310645
Accidental overdose	48.05	10.97	98	51729	18252	31627265
Interstitial lung disease	46.60	10.97	21	51806	61382	31584135
Drug withdrawal syndrome	46.59	10.97	98	51729	18652	31626865
Depressed level of consciousness	44.79	10.97	152	51675	38449	31607068
Alcohol withdrawal syndrome	44.54	10.97	28	51799	1365	31644152
Substance use disorder	44.05	10.97	20	51807	499	31645018
Rheumatoid arthritis	43.73	10.97	12	51815	47797	31597720
Agitation	43.68	10.97	190	51637	53979	31591538
Loss of consciousness	43.60	10.97	245	51582	77110	31568407
Electrocardiogram QRS complex prolonged	42.51	10.97	43	51784	4186	31641331
Rash	41.47	10.97	179	51648	201307	31444210
Pulmonary oedema	41.31	10.97	163	51664	44339	31601178
Drug screen positive	40.25	10.97	40	51787	3812	31641705
Suicidal ideation	40.18	10.97	141	51686	36265	31609252
Off label use	40.16	10.97	369	51458	346905	31298612
Medication error	39.08	10.97	103	51724	22669	31622848
Brain oedema	39.03	10.97	73	51754	12759	31632758
Sinusitis	38.68	10.97	140	51687	36556	31608961
Cardiac failure congestive	38.27	10.97	44	51783	79343	31566174
Asthenia	37.46	10.97	215	51612	224540	31420977
Electrocardiogram ST segment elevation	37.39	10.97	42	51785	4609	31640908
Bradycardia	37.37	10.97	217	51610	69110	31576407
Neutropenia	37.29	10.97	112	51715	140252	31505265
Accidental death	37.03	10.97	30	51797	2187	31643330
Haemoglobin decreased	35.96	10.97	82	51745	112593	31532924
Pyrexia	35.90	10.97	321	51506	303519	31341998
Therapy interrupted	35.68	10.97	63	51764	10533	31634984
Anaesthetic complication neurological	35.64	10.97	15	51812	310	31645207
Road traffic accident	35.45	10.97	81	51746	16300	31629217
Psoriasis	35.41	10.97	16	51811	46703	31598814
Alcohol intolerance	35.40	10.97	16	51811	395	31645122
Arthralgia	35.28	10.97	128	51699	151296	31494221
Ventricular fibrillation	35.18	10.97	88	51739	18760	31626757
Metabolic acidosis	35.16	10.97	143	51684	39434	31606083
Sinus tachycardia	35	10.97	79	51748	15770	31629747
Drug intolerance	34.74	10.97	21	51806	52012	31593505
Ex-drug abuser	34.62	10.97	12	51815	142	31645375
White blood cell count decreased	34.51	10.97	56	51771	87342	31558175
Myocardial infarction	34.27	10.97	85	51742	113369	31532148
Condition aggravated	34.16	10.97	145	51682	163864	31481653
Acute kidney injury	33.70	10.97	294	51533	279420	31366097
Abdominal pain	32.94	10.97	125	51702	145827	31499690
Oedema peripheral	32.62	10.97	83	51744	109756	31535761
Malaise	32.08	10.97	154	51673	168357	31477160
Behaviour disorder	31.16	10.97	37	51790	4310	31641207
Oculocardiac reflex	30.27	10.97	9	51818	62	31645455
Alcoholism	29.58	10.97	32	51795	3367	31642150
Dehydration	29.54	10.97	98	51729	119013	31526504
Cardiac failure	29.53	10.97	60	51767	85893	31559624
Drug abuser	29.43	10.97	34	51793	3846	31641671
Infusion site pain	29.34	10.97	31	51796	3175	31642342
Amnesia	28.78	10.97	94	51733	23308	31622209
Platelet count decreased	28.68	10.97	89	51738	110346	31535171
Malignant neoplasm progression	28.13	10.97	54	51773	78944	31566573
Homicide	27.97	10.97	18	51809	914	31644603
Intentional self-injury	27.89	10.97	65	51762	13250	31632267
Pain in extremity	27.87	10.97	97	51730	116106	31529411
Pneumonia	27.78	10.97	384	51443	334928	31310589
Cough	27.56	10.97	120	51707	134694	31510823
Shock	26.11	10.97	89	51738	22556	31622961
Haematochezia	26.08	10.97	17	51810	40447	31605070
Conjunctival scar	26.00	10.97	9	51818	106	31645411
Respiratory acidosis	25.98	10.97	35	51792	4627	31640890
Dysarthria	25.57	10.97	112	51715	31905	31613612
Prostate cancer	25.34	10.97	15	51812	37586	31607931
Removal of foreign body	25.31	10.97	6	51821	14	31645503
Impaired driving ability	25.04	10.97	25	51802	2396	31643121
Cytomegalovirus infection	24.96	10.97	5	51822	24702	31620815
Myalgia	24.81	10.97	56	51771	77202	31568315
Myocardial fibrosis	24.74	10.97	18	51809	1118	31644399
Diabetes mellitus	24.67	10.97	20	51807	42536	31602981
Angina pectoris	24.33	10.97	9	51818	29632	31615885
Loss of personal independence in daily activities	24.23	10.97	8	51819	28280	31617237
Foetal alcohol syndrome	23.97	10.97	9	51818	136	31645381
Spinal cord infarction	23.74	10.97	11	51816	288	31645229
Unevaluable event	23.69	10.97	106	51721	30469	31615048
Asthma	23.51	10.97	21	51806	42590	31602927
Corneal oedema	23.32	10.97	18	51809	1223	31644294
Drug reaction with eosinophilia and systemic symptoms	23.19	10.97	10	51817	30008	31615509
Embolia cutis medicamentosa	22.98	10.97	10	51817	225	31645292
Leukopenia	22.87	10.97	37	51790	57791	31587726
Sensorimotor disorder	22.75	10.97	12	51815	418	31645099
Hypoxia	22.41	10.97	150	51677	50163	31595354
Pancytopenia	22.22	10.97	71	51756	87245	31558272
Infusion site swelling	22.12	10.97	22	51805	2099	31643418
Agranulocytosis	22.10	10.97	4	51823	21243	31624274
Thrombocytopenia	21.93	10.97	140	51687	142607	31502910
Plasma cell myeloma	21.59	10.97	37	51790	56494	31589023
Somnolence	21.53	10.97	253	51574	99192	31546325
Hepatic fibrosis	21.46	10.97	29	51798	3845	31641672
Infusion site extravasation	21.33	10.97	28	51799	3609	31641908
Therapeutic product effect incomplete	21.29	10.97	24	51803	43672	31601845
Bezoar	21.18	10.97	15	51812	893	31644624
Neuropathy peripheral	21.06	10.97	59	51768	75590	31569927
Eosinophilia	20.95	10.97	6	51821	23247	31622270
Blood creatinine increased	20.92	10.97	75	51752	89003	31556514
Tryptase increased	20.58	10.97	9	51818	205	31645312
Opiates positive	20.55	10.97	12	51815	511	31645006
Dyspnoea exertional	20.41	10.97	20	51807	38817	31606700
Pupil fixed	20.24	10.97	19	51808	1688	31643829
Weight increased	20.04	10.97	69	51758	82878	31562639
Intracranial hypotension	20.03	10.97	9	51818	219	31645298
Aqueous fibrin	19.98	10.97	6	51821	43	31645474
Circulatory collapse	19.69	10.97	74	51753	19670	31625847
Coronary artery disease	19.66	10.97	28	51799	46059	31599458
Deep vein thrombosis	19.52	10.97	44	51783	60692	31584825
Lagophthalmos	19.46	10.97	7	51820	93	31645424
Melaena	19.36	10.97	15	51812	32639	31612878
Nausea	19.07	10.97	372	51455	307575	31337942
Restlessness	18.86	10.97	82	51745	23279	31622238
Acute pulmonary oedema	18.77	10.97	38	51789	7038	31638479
Blood pressure fluctuation	18.50	10.97	7	51820	22729	31622788
Accident	18.29	10.97	27	51800	3884	31641633
Apnoea	18.19	10.97	35	51792	6247	31639270
Dextrocardia	18.16	10.97	7	51820	114	31645403
Tubulointerstitial nephritis	18.16	10.97	4	51823	18492	31627025
Pruritus	18.09	10.97	125	51702	125042	31520475
Reperfusion arrhythmia	17.96	10.97	6	51821	63	31645454
Anxiety	17.71	10.97	227	51600	90806	31554711
Abdominal discomfort	17.70	10.97	36	51791	51531	31593986
Pulmonary fibrosis	17.63	10.97	3	51824	16657	31628860
Infusion site bruising	17.54	10.97	11	51816	534	31644983
Ear infection	17.14	10.97	42	51785	8839	31636678
Haematuria	17.06	10.97	31	51796	46283	31599234
Accidental poisoning	16.88	10.97	12	51815	719	31644798
Catecholamine crisis	16.87	10.97	5	51822	34	31645483
Musculoskeletal stiffness	16.75	10.97	26	51801	41299	31604218
Sopor	16.61	10.97	49	51778	11503	31634014
Physical assault	16.51	10.97	14	51813	1088	31644429
Disease recurrence	16.48	10.97	5	51822	18656	31626861
Drug resistance	16.31	10.97	9	51818	23444	31622073
Substance-induced mood disorder	16.27	10.97	6	51821	86	31645431
Product adhesion issue	16.24	10.97	16	51811	1509	31644008
Anal sphincter atony	16.14	10.97	6	51821	88	31645429
Neuromuscular blockade	16.14	10.97	8	51819	244	31645273
Sepsis	15.97	10.97	165	51662	151764	31493753
Injection site ulcer	15.96	10.97	8	51819	250	31645267
Pneumocystis jirovecii pneumonia	15.92	10.97	5	51822	18246	31627271
Vitreous disorder	15.90	10.97	6	51821	92	31645425
Blood pressure systolic increased	15.83	10.97	6	51821	19464	31626053
Trigemino-cardiac reflex	15.37	10.97	7	51820	176	31645341
Electrocardiogram T wave amplitude increased	15.36	10.97	5	51822	48	31645469
Myoclonus	15.27	10.97	54	51773	13936	31631581
Bone marrow failure	15.21	10.97	14	51813	27994	31617523
Suicidal behaviour	15.20	10.97	15	51812	1417	31644100
Myelosuppression	15.11	10.97	3	51824	14917	31630600
Toxicologic test abnormal	15.00	10.97	10	51817	539	31644978
Respiratory tract infection bacterial	14.91	10.97	15	51812	1451	31644066
Drug level increased	14.90	10.97	69	51758	20117	31625400
Hypoxic-ischaemic encephalopathy	14.86	10.97	26	51801	4315	31641202
Hepatic function abnormal	14.82	10.97	28	51799	41194	31604323
Wrong product administered	14.78	10.97	28	51799	4940	31640577
Gastrointestinal disorder	14.76	10.97	17	51810	30643	31614874
Dyspepsia	14.67	10.97	19	51808	32534	31612983
Ascites	14.62	10.97	28	51799	40985	31604532
Mobility decreased	14.60	10.97	14	51813	27455	31618062
Phaeochromocytoma crisis	14.59	10.97	5	51822	57	31645460
Gun shot wound	14.58	10.97	13	51814	1081	31644436
Cardiotoxicity	14.54	10.97	28	51799	4999	31640518
Delayed recovery from anaesthesia	14.53	10.97	11	51816	726	31644791
Pulse absent	14.41	10.97	29	51798	5348	31640169
Hyperthermia malignant	14.41	10.97	17	51810	1967	31643550
Feeling drunk	14.40	10.97	16	51811	1735	31643782
Withdrawal syndrome	14.35	10.97	47	51780	11670	31633847
Transient ischaemic attack	14.33	10.97	11	51816	24045	31621472
Diabetic ketoacidosis	14.10	10.97	5	51822	16900	31628617
Septic shock	14.05	10.97	58	51769	66100	31579417
Drug hypersensitivity	13.99	10.97	66	51761	72533	31572984
Accidental exposure to product	13.97	10.97	46	51781	11449	31634068
Administration site pain	13.96	10.97	7	51820	219	31645298
Delirium tremens	13.92	10.97	10	51817	609	31644908
Proteinuria	13.91	10.97	5	51822	16758	31628759
Product preparation error	13.81	10.97	16	51811	1816	31643701
Somnambulism	13.79	10.97	20	51807	2832	31642685
Constipation	13.72	10.97	133	51694	123858	31521659
Injection site extravasation	13.64	10.97	19	51808	2591	31642926
Seizure	13.60	10.97	234	51593	99534	31545983
Postmortem blood drug level	13.55	10.97	6	51821	141	31645376
Muscular weakness	13.51	10.97	58	51769	65390	31580127
Product administration error	13.46	10.97	55	51772	15192	31630325
Infusion site erythema	13.45	10.97	16	51811	1867	31643650
Prescription drug used without a prescription	13.41	10.97	14	51813	1414	31644103
Blood ethanol	13.41	10.97	5	51822	74	31645443
Jaundice	13.31	10.97	18	51809	30269	31615248
Brachial plexus injury	13.29	10.97	5	51822	76	31645441
Tracheitis	13.25	10.97	10	51817	657	31644860
Drug diversion	13.23	10.97	11	51816	832	31644685
Surgery	13.21	10.97	48	51779	12551	31632966
Administration related reaction	12.94	10.97	5	51822	82	31645435
Vitreous floaters	12.90	10.97	21	51806	3286	31642231
Retinal vasculitis	12.87	10.97	8	51819	382	31645135
Endophthalmitis	12.82	10.97	22	51805	3594	31641923
Red blood cell count decreased	12.76	10.97	15	51812	26792	31618725
Liver disorder	12.71	10.97	18	51809	29689	31615828
Anticholinergic syndrome	12.69	10.97	12	51815	1076	31644441
Myokymia	12.67	10.97	5	51822	87	31645430
Corneal opacity	12.62	10.97	9	51818	542	31644975
Hypertonia	12.60	10.97	23	51804	3945	31641572
Procedural hypotension	12.58	10.97	11	51816	891	31644626
Pulmonary embolism	12.56	10.97	80	51747	81566	31563951
Alcoholic liver disease	12.46	10.97	9	51818	553	31644964
Haemoptysis	12.35	10.97	21	51806	32168	31613349
Postmortem blood drug level abnormal	12.21	10.97	7	51820	288	31645229
Bronchospasm	12.21	10.97	40	51787	9932	31635585
Psychiatric disorder prophylaxis	12.15	10.97	4	51823	40	31645477
Gastrointestinal haemorrhage	12.14	10.97	82	51745	82467	31563050
Pulseless electrical activity	12.12	10.97	31	51796	6696	31638821
Renal impairment	12.09	10.97	87	51740	86262	31559255
Hyponatraemia	12.04	10.97	71	51756	73728	31571789
Chemical poisoning	12.03	10.97	5	51822	100	31645417
Chronic obstructive pulmonary disease	12.00	10.97	36	51791	45130	31600387
Hypercalcaemia	11.92	10.97	4	51823	13996	31631521
Joint swelling	11.87	10.97	46	51781	53385	31592132
Acute myocardial infarction	11.79	10.97	43	51784	50780	31594737
Brain stem syndrome	11.76	10.97	8	51819	446	31645071
Drug interaction	11.75	10.97	434	51393	208109	31437408
Febrile neutropenia	11.73	10.97	135	51692	121714	31523803
Phlebitis superficial	11.70	10.97	7	51820	312	31645205
Product prescribing error	11.67	10.97	9	51818	19633	31625884
Hyperkalaemia	11.54	10.97	60	51767	64291	31581226
Respiratory tract infection	11.50	10.97	58	51769	17503	31628014
Benzodiazepine drug level therapeutic	11.49	10.97	4	51823	48	31645469
Stress	11.49	10.97	75	51752	24866	31620651
Colitis	11.34	10.97	24	51803	33863	31611654
Diaphragmatic paralysis	11.31	10.97	8	51819	475	31645042
Ventricular extrasystoles	11.31	10.97	42	51785	11100	31634417
Oesophageal obstruction	11.26	10.97	8	51819	479	31645038
Retinal artery occlusion	11.25	10.97	14	51813	1712	31643805
Blood ethanol increased	11.20	10.97	8	51819	483	31645034
Neoplasm progression	11.17	10.97	10	51817	20262	31625255
Seizure like phenomena	11.15	10.97	9	51818	653	31644864
Multiple sclerosis relapse	11.06	10.97	3	51824	12044	31633473
Spinal operation	11.04	10.97	17	51810	2537	31642980
Respiratory tract infection viral	11.04	10.97	15	51812	1999	31643518
Infusion site haemorrhage	10.99	10.97	10	51817	853	31644664
Ophthalmoplegia	10.98	10.97	14	51813	1754	31643763

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	5171.55	9.83	3529	100871	223606	70600438
Toxicity to various agents	4156.53	9.83	3843	100557	378329	70445715
Drug abuse	3897.25	9.83	2517	101883	144739	70679305
Cardio-respiratory arrest	1223.49	9.83	1083	103317	99594	70724450
Intentional overdose	920.91	9.83	916	103484	97519	70726525
Overdose	767.42	9.83	1089	103311	168656	70655388
Alcohol interaction	599.41	9.83	234	104166	4419	70819625
Cardiac arrest	577.59	9.83	924	103476	158910	70665134
Suspected suicide	478.81	9.83	242	104158	8592	70815452
Local anaesthetic systemic toxicity	472.73	9.83	130	104270	735	70823309
Intentional product misuse	457.91	9.83	575	103825	79020	70745024
Alcohol abuse	399.30	9.83	180	104220	4927	70819117
Respiratory arrest	348.02	9.83	413	103987	53520	70770524
Methaemoglobinaemia	346.82	9.83	160	104240	4626	70819418
Suicide attempt	345.28	9.83	501	103899	79009	70745035
Death	322.37	9.83	1543	102857	508518	70315526
Toxic anterior segment syndrome	313.29	9.83	125	104275	2505	70821539
Alcohol poisoning	310.30	9.83	144	104256	4221	70819823
Alcohol use	216.91	9.83	115	104285	4512	70819532
Substance abuse	215.26	9.83	150	104250	9687	70814357
Anaesthetic complication	206.36	9.83	93	104307	2543	70821501
Coma	192.83	9.83	421	103979	91423	70732621
Anaphylactic reaction	189.52	9.83	371	104029	74603	70749441
Rheumatoid arthritis	184.28	9.83	100	104300	291705	70532339
Diarrhoea	175.38	9.83	581	103819	782760	70041284
Respiratory depression	171.53	9.83	197	104203	24634	70799410
Drug dependence	167.51	9.83	239	104161	37082	70786962
Exposure to toxic agent	163.21	9.83	106	104294	6088	70817956
Incorrect route of product administration	154.77	9.83	193	104207	26299	70797745
Anaphylactic shock	145.72	9.83	208	104192	32282	70791762
Synovitis	145.21	9.83	12	104388	129216	70694828
Hypotension	142.22	9.83	1050	103350	403331	70420713
Ventricular tachycardia	141.54	9.83	218	104182	36205	70787839
General physical health deterioration	134.82	9.83	91	104309	235940	70588104
Arthralgia	133.76	9.83	344	104056	503046	70320998
Therapy interrupted	132.75	9.83	173	104227	24629	70799415
Poisoning deliberate	130.93	9.83	143	104257	16917	70807127
Unresponsive to stimuli	127.61	9.83	254	104146	51677	70772367
Mydriasis	126.77	9.83	137	104263	16016	70808028
Drug intolerance	126.26	9.83	89	104311	225598	70598446
Blood alcohol increased	121.60	9.83	51	104349	1166	70822878
Tachycardia	119.33	9.83	506	103894	158040	70666004
Joint swelling	119.30	9.83	118	104282	253093	70570951
Generalised tonic-clonic seizure	118.68	9.83	217	104183	41444	70782600
Hand deformity	113.12	9.83	3	104397	86479	70737565
Aggression	102.68	9.83	223	104177	48223	70775821
Pemphigus	101.31	9.83	5	104395	83031	70741013
Fear	98.90	9.83	137	104263	20674	70803370
Abdominal discomfort	98.85	9.83	102	104298	214556	70609488
Agitation	94.92	9.83	328	104072	93047	70730997
Miosis	94.24	9.83	110	104290	13991	70810053
Pericarditis	92.09	9.83	9	104391	84696	70739348
Loss of consciousness	92.01	9.83	463	103937	155253	70668791
Renal injury	90.42	9.83	115	104285	15979	70808065
Systemic lupus erythematosus	89.77	9.83	20	104380	101882	70722162
Poisoning	88.72	9.83	136	104264	22486	70801558
Rash	87.08	9.83	421	103979	510141	70313903
Asphyxia	86.97	9.83	91	104309	10251	70813793
Electrocardiogram QRS complex prolonged	85.54	9.83	88	104312	9718	70814326
Glossodynia	84.70	9.83	13	104387	86474	70737570
Maternal exposure during delivery	83.57	9.83	37	104363	969	70823075
Fatigue	83.06	9.83	795	103605	823524	70000520
Bradycardia	82.60	9.83	383	104017	124232	70699812
Drug use disorder	81.91	9.83	79	104321	8072	70815972
Pulseless electrical activity	81.58	9.83	99	104301	13116	70810928
Pulmonary oedema	80.15	9.83	285	104115	81993	70742051
Hepatic enzyme increased	80.02	9.83	68	104332	156922	70667122
Alopecia	78.86	9.83	106	104294	198384	70625660
Off label use	78.53	9.83	708	103692	742352	70081692
Seizure	74.72	9.83	483	103917	177479	70646565
Asthenia	73.65	9.83	385	104015	457281	70366763
Sinus tachycardia	72.88	9.83	157	104243	33756	70790288
Therapeutic product effect decreased	72.83	9.83	62	104338	142956	70681088
Anhedonia	72.75	9.83	97	104303	14116	70809928
Corneal oedema	72.03	9.83	45	104355	2415	70821629
Anaesthetic complication neurological	70.82	9.83	28	104372	547	70823497
Contraindicated product administered	70.22	9.83	57	104343	134555	70689489
Helicobacter infection	69.03	9.83	3	104397	55653	70768391
Ventricular fibrillation	68.27	9.83	134	104266	26977	70797067
Dyspnoea	67.56	9.83	767	103633	769293	70054751
Anaemia	67.37	9.83	335	104065	403088	70420956
Postmortem blood drug level abnormal	64.18	9.83	27	104373	622	70823422
Disease progression	63.93	9.83	82	104318	156590	70667454
Mobility decreased	63.91	9.83	36	104364	102963	70721081
Arthropathy	63.89	9.83	76	104324	149981	70674063
Substance use disorder	63.51	9.83	27	104373	639	70823405
Accidental overdose	62.60	9.83	151	104249	34970	70789074
Neutropenia	59.83	9.83	187	104213	256969	70567075
Decreased appetite	58.69	9.83	240	104160	304540	70519504
Unevaluable event	58.31	9.83	189	104211	51874	70772170
Extradural abscess	58.28	9.83	31	104369	1224	70822820
Depressed level of consciousness	58.12	9.83	269	104131	87162	70736882
Procedural hypotension	57.65	9.83	36	104364	1930	70822114
Lagophthalmos	57.15	9.83	22	104378	399	70823645
Nasopharyngitis	56.46	9.83	155	104245	222051	70601993
Body tinea	55.46	9.83	31	104369	1352	70822692
Somnolence	55.33	9.83	522	103878	215084	70608960
Emotional distress	54.99	9.83	149	104251	37039	70787005
Acute kidney injury	54.13	9.83	443	103957	474181	70349863
Shock	53.91	9.83	156	104244	40269	70783775
Electrocardiogram ST segment elevation	53.64	9.83	61	104339	7543	70816501
Accidental death	53.33	9.83	45	104355	3863	70820181
Pulse absent	52.94	9.83	67	104333	9263	70814781
Wound	52.50	9.83	41	104359	98691	70725353
Alcoholism	52.23	9.83	47	104353	4398	70819646
Embolia cutis medicamentosa	51.23	9.83	22	104378	534	70823510
Injury	51.19	9.83	211	104189	65034	70759010
Swelling	50.57	9.83	128	104272	188411	70635633
Cough	50.46	9.83	277	104123	325100	70498944
Interstitial lung disease	50.16	9.83	48	104352	104637	70719407
Metabolic acidosis	49.60	9.83	229	104171	74117	70749927
Product adhesion issue	49.48	9.83	36	104364	2488	70821556
Malaise	49.39	9.83	404	103996	432528	70391516
Weight decreased	48.87	9.83	263	104137	310225	70513819
Hypoxia	48.54	9.83	268	104132	93076	70730968
Extradural haematoma	47.25	9.83	36	104364	2669	70821375
Infusion related reaction	47.10	9.83	142	104258	197392	70626652
Respiratory acidosis	46.35	9.83	66	104334	10215	70813829
Condition aggravated	46.10	9.83	405	103995	427230	70396814
Folliculitis	45.03	9.83	5	104395	42565	70781479
Cardiac failure congestive	44.59	9.83	82	104318	135375	70688669
Lower respiratory tract infection	44.18	9.83	60	104340	111853	70712191
Psoriatic arthropathy	44.13	9.83	20	104380	64751	70759293
Abdominal pain	42.87	9.83	311	104089	341816	70482228
Psoriasis	42.81	9.83	49	104351	98384	70725660
Drug reaction with eosinophilia and systemic symptoms	42.62	9.83	16	104384	57997	70766047
Drug hypersensitivity	42.58	9.83	220	104180	262239	70561805
Hypopyon	42.43	9.83	24	104376	1071	70822973
Retinal vasculitis	42.04	9.83	25	104375	1227	70822817
Removal of foreign body	41.92	9.83	10	104390	28	70824016
Peripheral swelling	41.43	9.83	193	104207	236370	70587674
Abdominal pain upper	41.42	9.83	146	104254	193456	70630588
Aqueous fibrin	41.36	9.83	13	104387	124	70823920
Apnoea	41.01	9.83	64	104336	10745	70813299
Homicide	40.95	9.83	24	104376	1146	70822898
Nystagmus	40.63	9.83	59	104341	9296	70814748
Pyrexia	40.56	9.83	639	103761	606313	70217731
Drug level increased	40.48	9.83	132	104268	36337	70787707
Alcohol withdrawal syndrome	40.10	9.83	28	104372	1813	70822231
Intentional product use issue	39.82	9.83	308	104092	119834	70704210
Pain in extremity	39.78	9.83	301	104099	327781	70496263
Drug screen positive	39.76	9.83	46	104354	5794	70818250
Muscle injury	39.53	9.83	5	104395	38489	70785555
Drug interaction	39.46	9.83	784	103616	380657	70443387
Pancytopenia	39.43	9.83	104	104296	151003	70673041
Behaviour disorder	38.83	9.83	44	104356	5420	70818624
Anterior chamber cell	38.25	9.83	21	104379	884	70823160
Mental status changes	38.20	9.83	189	104211	62912	70761132
Nausea	37.72	9.83	961	103439	851127	69972917
Musculoskeletal stiffness	37.57	9.83	103	104297	147657	70676387
Impaired healing	36.93	9.83	33	104367	74341	70749703
Leukopenia	36.42	9.83	63	104337	106497	70717547
Fear of eating	36.39	9.83	16	104384	412	70823632
Malignant neoplasm progression	36.36	9.83	78	104322	121661	70702383
Drug abuser	36.30	9.83	44	104356	5820	70818224
Infusion site swelling	35.94	9.83	45	104355	6153	70817891
Brain oedema	35.80	9.83	95	104305	23323	70800721
Vitritis	35.77	9.83	25	104375	1621	70822423
Infusion site pruritus	35.63	9.83	33	104367	3204	70820840
Haematochezia	35.60	9.83	33	104367	73048	70750996
Surgery	35.52	9.83	111	104289	29878	70794166
Opiates positive	34.81	9.83	20	104380	920	70823124
Circulatory collapse	34.63	9.83	123	104277	35351	70788693
Spinal cord infarction	34.30	9.83	17	104383	578	70823466
Infection susceptibility increased	34.22	9.83	31	104369	2926	70821118
Pruritus	33.47	9.83	336	104064	345224	70478820
Trigemino-cardiac reflex	33.41	9.83	13	104387	243	70823801
Agranulocytosis	33.36	9.83	9	104391	40289	70783755
White blood cell count decreased	33.33	9.83	133	104267	170008	70654036
Thrombocytopenia	33.09	9.83	211	104189	238899	70585145
Therapy cessation	33.07	9.83	117	104283	33559	70790485
Loss of personal independence in daily activities	33.03	9.83	46	104354	84864	70739180
Intentional self-injury	32.85	9.83	112	104288	31538	70792506
Arthritis	32.52	9.83	59	104341	97921	70726123
Weight increased	32.44	9.83	216	104184	242115	70581929
Haemoglobin decreased	32.13	9.83	174	104226	204985	70619059
Hyponatraemia	32.09	9.83	124	104276	159963	70664081
Oedema peripheral	31.70	9.83	201	104199	227890	70596154
Postmortem blood drug level	31.67	9.83	13	104387	281	70823763
Ophthalmoplegia	31.57	9.83	29	104371	2786	70821258
Tryptase increased	31.46	9.83	16	104384	575	70823469
Cyanosis	31.37	9.83	90	104310	23116	70800928
Oculocardiac reflex	31.21	9.83	9	104391	62	70823982
Infusion site extravasation	31.20	9.83	48	104352	7960	70816084
Hypersensitivity	30.68	9.83	205	104195	229607	70594437
Drug ineffective	30.68	9.83	1104	103296	938648	69885396
Incorrect drug administration rate	30.64	9.83	30	104370	3122	70820922
Anal sphincter atony	30.41	9.83	13	104387	312	70823732
Gastrointestinal disorder	30.29	9.83	69	104331	105358	70718686
Stress cardiomyopathy	30.16	9.83	53	104347	9809	70814235
Conjunctival scar	29.96	9.83	11	104389	174	70823870
Drug withdrawal syndrome	29.87	9.83	111	104289	32604	70791440
Suicidal ideation	29.85	9.83	190	104210	69406	70754638
Cauda equina syndrome	29.68	9.83	20	104380	1222	70822822
Road traffic accident	29.47	9.83	115	104285	34567	70789477
Endophthalmitis	29.45	9.83	41	104359	6214	70817830
Blood ethanol	29.38	9.83	10	104390	125	70823919
Dysarthria	29.17	9.83	174	104226	62139	70761905
Myocardial fibrosis	29.09	9.83	22	104378	1613	70822431
Corneal epithelium defect	29	9.83	16	104384	680	70823364
C-reactive protein increased	28.87	9.83	76	104324	110441	70713603
Diabetes mellitus	28.86	9.83	38	104362	71786	70752258
Medication error	28.64	9.83	162	104238	56750	70767294
Blood pressure fluctuation	28.33	9.83	27	104373	58985	70765059
Amnesia	27.95	9.83	151	104249	52004	70772040
Product administration error	27.65	9.83	101	104299	29422	70794622
Blood cholesterol increased	27.19	9.83	33	104367	64571	70759473
Blister	27.13	9.83	68	104332	100458	70723586
Orthostatic hypotension	26.86	9.83	22	104378	51721	70772323
Serotonin syndrome	26.82	9.83	128	104272	41986	70782058
Infusion site pain	26.54	9.83	55	104345	11509	70812535
Type 2 diabetes mellitus	26.49	9.83	16	104384	44064	70779980
Infusion site erythema	26.36	9.83	43	104357	7492	70816552
Retinal artery occlusion	26.26	9.83	27	104373	2979	70821065
Neurotoxicity	26.24	9.83	100	104300	29726	70794318
Inhibitory drug interaction	25.94	9.83	30	104370	3777	70820267
Asthma	25.88	9.83	91	104309	120702	70703342
Septic shock	25.81	9.83	82	104318	112176	70711868
Cardiotoxicity	25.81	9.83	53	104347	11017	70813027
Victim of sexual abuse	25.75	9.83	13	104387	460	70823584
Drug resistance	25.69	9.83	12	104388	38178	70785866
Myocardial infarction	25.55	9.83	148	104252	171497	70652547
Liver disorder	25.33	9.83	32	104368	61536	70762508
Blood creatinine increased	24.82	9.83	117	104283	142884	70681160
Melaena	24.56	9.83	28	104372	56327	70767717
Meningitis chemical	24.54	9.83	10	104390	212	70823832
Platelet aggregation inhibition	24.53	9.83	9	104391	142	70823902
Myelosuppression	24.45	9.83	7	104393	30138	70793906
Blood ethanol increased	24.36	9.83	14	104386	644	70823400
Electrocardiogram QT prolonged	24.36	9.83	208	104192	83309	70740735
COVID-19	24.15	9.83	250	104150	105507	70718537
Sensorimotor disorder	24.07	9.83	15	104385	801	70823243
Toxicologic test abnormal	23.93	9.83	18	104382	1309	70822735
Pupil fixed	23.68	9.83	27	104373	3347	70820697
Disease recurrence	23.52	9.83	13	104387	37590	70786454
Underdose	23.51	9.83	7	104393	29376	70794668
Delayed recovery from anaesthesia	23.48	9.83	19	104381	1538	70822506
Infusion site bruising	23.47	9.83	21	104379	1950	70822094
Cardiac failure	23.44	9.83	120	104280	143421	70680623
Blood pressure systolic increased	23.31	9.83	30	104370	57229	70766815
Infusion site mass	23.30	9.83	17	104383	1180	70822864
Platelet count decreased	23.27	9.83	160	104240	178062	70645982
Withdrawal syndrome	23.16	9.83	85	104315	24819	70799225
Wrong product administered	23.14	9.83	43	104357	8308	70815736
Chemical submission	23.13	9.83	10	104390	247	70823797
Cytomegalovirus infection	23.11	9.83	15	104385	39743	70784301
Type I hypersensitivity	23.10	9.83	28	104372	3704	70820340
Bronchospasm	23.08	9.83	80	104320	22712	70801332
Status epilepticus	23.05	9.83	84	104316	24442	70799602
Hyperkalaemia	23.04	9.83	80	104320	106511	70717533
Gastrointestinal toxicity	23.02	9.83	37	104363	6368	70817676
Amphetamines positive	22.90	9.83	10	104390	253	70823791
Bone marrow failure	22.86	9.83	23	104377	48987	70775057
Parophthalmia	22.81	9.83	11	104389	352	70823692
Pulmonary fibrosis	22.74	9.83	11	104389	34299	70789745
Pneumocystis jirovecii pneumonia	22.60	9.83	8	104392	30074	70793970
Nerve root injury	22.43	9.83	6	104394	30	70824014
Punctate keratitis	22.43	9.83	15	104385	905	70823139
Bursitis infective	22.42	9.83	17	104383	1251	70822793
Sensory loss	22.42	9.83	51	104349	11368	70812676
Pneumocephalus	22.23	9.83	10	104390	272	70823772
Spinal anaesthesia	22.16	9.83	7	104393	68	70823976
Upper airway obstruction	22.09	9.83	17	104383	1279	70822765
Ventricular extrasystoles	22.08	9.83	68	104332	18158	70805886
Product preparation error	21.93	9.83	30	104370	4472	70819572
Restlessness	21.92	9.83	121	104279	42007	70782037
Kounis syndrome	21.78	9.83	26	104374	3385	70820659
Plasma cell myeloma	21.77	9.83	47	104353	73154	70750890
Cholestasis	21.72	9.83	23	104377	47849	70776195
Hepatic function abnormal	21.63	9.83	42	104358	67954	70756090
Pneumonia	21.58	9.83	691	103709	595541	70228503
Discomfort	21.55	9.83	81	104319	105355	70718689
Neuromuscular block prolonged	21.53	9.83	15	104385	968	70823076
Peripheral nerve injury	21.46	9.83	13	104387	660	70823384
Anxiety	21.46	9.83	449	103951	219881	70604163
Alcohol intolerance	21.41	9.83	11	104389	404	70823640
Gastrointestinal haemorrhage	21.25	9.83	117	104283	137291	70686753
Anticholinergic syndrome	21.18	9.83	24	104376	2956	70821088
Atonic urinary bladder	21.14	9.83	7	104393	80	70823964
Gastroenteritis	20.70	9.83	10	104390	31203	70792841
Bezoar	20.67	9.83	21	104379	2285	70821759
Dehydration	20.60	9.83	223	104177	225919	70598125
Red blood cell sedimentation rate increased	20.59	9.83	16	104384	38626	70785418
Treatment failure	20.54	9.83	126	104274	144016	70680028
COVID-19 immunisation	20.28	9.83	15	104385	1063	70822981
Product contamination microbial	20.28	9.83	14	104386	890	70823154
Multiple sclerosis relapse	20.28	9.83	20	104380	42997	70781047
Osteoarthritis	20.13	9.83	50	104350	74097	70749947
Stomatitis	20.10	9.83	109	104291	128402	70695642
Glucose tolerance impaired	20.07	9.83	36	104364	6770	70817274
Angina pectoris	20.06	9.83	25	104375	48358	70775686
Adverse event	20.04	9.83	26	104374	49435	70774609
Eosinophilia	19.88	9.83	18	104382	40301	70783743
Product use issue	19.52	9.83	170	104230	179767	70644277
Pupillary reflex impaired	19.47	9.83	24	104376	3230	70820814
Protein C increased	19.47	9.83	7	104393	104	70823940
Substance dependence	19.40	9.83	11	104389	493	70823551
Prostate cancer	19.17	9.83	11	104389	31152	70792892
Ill-defined disorder	19.04	9.83	32	104368	54709	70769335
Hepatocellular injury	18.91	9.83	24	104376	46067	70777977
Infusion site haemorrhage	18.87	9.83	22	104378	2793	70821251
Accidental poisoning	18.87	9.83	17	104383	1593	70822451
Nasal congestion	18.85	9.83	43	104357	65629	70758415
Glossoptosis	18.83	9.83	8	104392	189	70823855
Blood lactic acid increased	18.80	9.83	47	104353	11126	70812918
Arthritis bacterial	18.71	9.83	39	104361	8194	70815850
Harlequin syndrome	18.58	9.83	6	104394	63	70823981
Product prescribing error	18.49	9.83	18	104382	38934	70785110
Accidental exposure to product	18.40	9.83	86	104314	27965	70796079
Neuromuscular blockade	18.15	9.83	11	104389	559	70823485
Fall	17.95	9.83	507	103893	443589	70380455
Phrenic nerve paralysis	17.89	9.83	9	104391	316	70823728
Post procedural complication	17.78	9.83	72	104328	22009	70802035
Respiratory tract infection bacterial	17.76	9.83	17	104383	1720	70822324
Therapeutic product effect incomplete	17.50	9.83	104	104296	119778	70704266
Paralysis	17.47	9.83	48	104352	12024	70812020
Myoclonus	17.44	9.83	81	104319	26274	70797770
Irritable bowel syndrome	17.43	9.83	30	104370	50820	70773224
Catecholamine crisis	17.39	9.83	5	104395	34	70824010
Brain death	17.38	9.83	29	104371	5149	70818895
Hypercalcaemia	17.38	9.83	15	104385	34370	70789674
Balance disorder	17.30	9.83	71	104329	90057	70733987
Prescribed underdose	17.28	9.83	5	104395	21380	70802664
Spinal epidural haemorrhage	17.24	9.83	7	104393	147	70823897
Osteonecrosis of jaw	17.19	9.83	21	104379	40981	70783063
Obesity	17.12	9.83	9	104391	26762	70797282
Neoplasm progression	17.10	9.83	25	104375	45203	70778841
Foreign body in respiratory tract	17.09	9.83	9	104391	348	70823696
Headache	17.05	9.83	690	103710	579715	70244329
Somnambulism	17.04	9.83	29	104371	5231	70818813
Sinusitis	16.86	9.83	346	104054	168849	70655195
Diabetic ketoacidosis	16.85	9.83	13	104387	31499	70792545
Constipation	16.71	9.83	266	104134	252172	70571872
Impaired quality of life	16.60	9.83	39	104361	8877	70815167
Tracheal deviation	16.53	9.83	7	104393	164	70823880
Coronary artery disease	16.49	9.83	43	104357	62693	70761351
Nail bed tenderness	16.48	9.83	9	104391	375	70823669
Infusion site urticaria	16.47	9.83	12	104388	831	70823213
Stridor	16.47	9.83	28	104372	5048	70818996
Peritonitis	16.43	9.83	9	104391	26150	70797894
Neutropenic sepsis	16.40	9.83	8	104392	24822	70799222
Intracranial hypotension	16.35	9.83	9	104391	381	70823663
Application site alopecia	16.32	9.83	4	104396	13	70824031
Lung neoplasm malignant	16.30	9.83	8	104392	24734	70799310
Inappropriate antidiuretic hormone secretion	16.15	9.83	7	104393	23269	70800775
Impaired driving ability	16.03	9.83	27	104373	4830	70819214
Delirium tremens	15.94	9.83	11	104389	699	70823345
Intentional dose omission	15.91	9.83	33	104367	6908	70817136
Hypoxic-ischaemic encephalopathy	15.89	9.83	34	104366	7274	70816770
Axillary nerve injury	15.88	9.83	4	104396	15	70824029
Hepatic fibrosis	15.80	9.83	31	104369	6236	70817808
Ascites	15.77	9.83	49	104351	67498	70756546
Colitis ulcerative	15.73	9.83	16	104384	33907	70790137
Induced abortion failed	15.58	9.83	7	104393	190	70823854
Injection site bruising	15.40	9.83	20	104380	38012	70786032
Dizziness	15.34	9.83	544	103856	463597	70360447
Spinal epidural haematoma	15.30	9.83	14	104386	1339	70822705
Brachial plexus injury	15.28	9.83	6	104394	115	70823929
Procedural complication	15.25	9.83	34	104366	7480	70816564
Anaphylactoid shock	15.21	9.83	11	104389	753	70823291
Abdominal distension	15.17	9.83	91	104309	104578	70719466
Substance-induced mood disorder	15.09	9.83	6	104394	119	70823925
Incision site rash	14.95	9.83	4	104396	20	70824024
Trigeminal palsy	14.95	9.83	4	104396	20	70824024
Euphoric mood	14.92	9.83	32	104368	6857	70817187
Dyspnoea exertional	14.91	9.83	62	104338	78368	70745676
Chemical burn	14.91	9.83	9	104391	454	70823590
Hypocalcaemia	14.89	9.83	27	104373	44832	70779212
Foreign body	14.88	9.83	19	104381	2649	70821395
Cardiogenic shock	14.88	9.83	98	104302	36209	70787835
Pulmonary embolism	14.88	9.83	152	104248	155715	70668329
Gait disturbance	14.74	9.83	188	104212	184918	70639126
Metastases to liver	14.72	9.83	10	104390	25868	70798176
Delirium	14.56	9.83	171	104229	74443	70749601
Spinal operation	14.48	9.83	32	104368	6996	70817048
Chest pain	14.31	9.83	272	104128	250988	70573056
Ventricular hypokinesia	14.30	9.83	35	104365	8177	70815867
Red blood cell count decreased	14.29	9.83	35	104365	52126	70771918
Angina unstable	14.23	9.83	3	104397	15890	70808154
Jaundice	14.22	9.83	33	104367	50075	70773969
Irregular breathing	14.22	9.83	9	104391	494	70823550
Haemodynamic instability	14.19	9.83	53	104347	15605	70808439
Anaphylactoid reaction	14.15	9.83	26	104374	4981	70819063
Spinal cord oedema	14.10	9.83	8	104392	359	70823685
Transient ischaemic attack	14.08	9.83	29	104371	45915	70778129
Sexual abuse	14.07	9.83	7	104393	240	70823804
Abortion spontaneous	14.06	9.83	11	104389	26468	70797576
Injection site ulcer	14.01	9.83	10	104390	671	70823373
Mean arterial pressure decreased	14.00	9.83	8	104392	364	70823680
Opisthotonus	13.99	9.83	10	104390	672	70823372
Bladder cancer	13.99	9.83	4	104396	17238	70806806
Lymphadenopathy	13.96	9.83	32	104368	48759	70775285
Paraplegia	13.92	9.83	25	104375	4705	70819339
Congestive hepatopathy	13.92	9.83	23	104377	4051	70819993
Vitreous disorder	13.91	9.83	7	104393	246	70823798
Myelodysplastic syndrome	13.86	9.83	14	104386	29771	70794273
Skin exfoliation	13.82	9.83	32	104368	48594	70775450
Bradypnoea	13.76	9.83	27	104373	5432	70818612
Oxidative stress	13.69	9.83	4	104396	29	70824015
Physical assault	13.58	9.83	14	104386	1550	70822494
Injection site joint infection	13.58	9.83	4	104396	30	70824014
Full blood count abnormal	13.53	9.83	18	104382	33860	70790184
Foetal heart rate abnormal	13.53	9.83	7	104393	261	70823783
Acute pulmonary oedema	13.51	9.83	47	104353	13365	70810679
Spinal stroke	13.46	9.83	4	104396	31	70824013
Stevens-Johnson syndrome	13.42	9.83	20	104380	35887	70788157
Deep vein thrombosis	13.37	9.83	102	104298	110940	70713104
Hypercholesterolaemia	13.30	9.83	5	104395	18112	70805932
Familial periodic paralysis	13.28	9.83	6	104394	165	70823879
Neuropathy peripheral	13.27	9.83	121	104279	126775	70697269
Osteoporosis	13.26	9.83	33	104367	48874	70775170
Brain injury	13.23	9.83	40	104360	10577	70813467
Non-cardiogenic pulmonary oedema	13.19	9.83	13	104387	1364	70822680
Paranasal cyst	13.14	9.83	8	104392	410	70823634
Graft versus host disease	13.12	9.83	3	104397	15020	70809024
Anal ulcer	13.09	9.83	12	104388	1150	70822894
Infusion site nodule	13.08	9.83	7	104393	280	70823764
Visual acuity reduced	13.07	9.83	78	104322	27852	70796192
Renal impairment	13.07	9.83	142	104258	143795	70680249
Poor quality product administered	13.02	9.83	20	104380	3311	70820733
Progressive multifocal leukoencephalopathy	12.98	9.83	6	104394	19208	70804836
Reperfusion arrhythmia	12.96	9.83	7	104393	285	70823759
Blindness	12.95	9.83	68	104332	23159	70800885
Skin lesion	12.90	9.83	23	104377	38437	70785607
Cholestasis of pregnancy	12.90	9.83	11	104389	958	70823086
Uveitis	12.90	9.83	3	104397	14842	70809202
Suicidal behaviour	12.87	9.83	19	104381	3037	70821007
Alcoholic	12.84	9.83	4	104396	37	70824007
Nerve block	12.79	9.83	9	104391	590	70823454
Inflammation	12.70	9.83	66	104334	78599	70745445
Gait inability	12.65	9.83	32	104368	47143	70776901
Gastrooesophageal reflux disease	12.63	9.83	80	104320	90759	70733285
Immunodeficiency	12.63	9.83	5	104395	17550	70806494
Accident	12.62	9.83	31	104369	7260	70816784
Symblepharon	12.62	9.83	6	104394	186	70823858
Apnoeic attack	12.59	9.83	9	104391	605	70823439
Femoral nerve injury	12.56	9.83	4	104396	40	70824004
Psychiatric disorder prophylaxis	12.56	9.83	4	104396	40	70824004
Lung disorder	12.56	9.83	56	104344	69428	70754616
Diabetes mellitus inadequate control	12.55	9.83	9	104391	22636	70801408
Ear infection	12.54	9.83	78	104322	28258	70795786
Intentional product misuse to child	12.49	9.83	5	104395	101	70823943
Injection site reaction	12.48	9.83	35	104365	49817	70774227
Body dysmorphic disorder	12.45	9.83	7	104393	309	70823735
Glycosylated haemoglobin increased	12.44	9.83	5	104395	17386	70806658
Gastritis alcoholic	12.30	9.83	4	104396	43	70824001
Pulmonary congestion	12.26	9.83	71	104329	25083	70798961
Hospitalisation	12.25	9.83	180	104220	82388	70741656
Creatinine renal clearance decreased	12.21	9.83	5	104395	17195	70806849
Sinus arrest	12.14	9.83	19	104381	3196	70820848
Dyspepsia	12.10	9.83	79	104321	88998	70735046
Drug eruption	12.04	9.83	25	104375	39471	70784573
Chest discomfort	11.99	9.83	121	104279	124260	70699784
Left ventricle outflow tract obstruction	11.93	9.83	7	104393	335	70823709
Benzodiazepine drug level therapeutic	11.90	9.83	4	104396	48	70823996
Hyperthermia malignant	11.87	9.83	17	104383	2644	70821400
Airway peak pressure increased	11.85	9.83	7	104393	339	70823705
Abnormal sleep-related event	11.85	9.83	10	104390	858	70823186
Myokymia	11.85	9.83	5	104395	116	70823928
International normalised ratio increased	11.79	9.83	70	104330	80656	70743388
Vascular resistance systemic decreased	11.71	9.83	6	104394	219	70823825
Poor quality sleep	11.64	9.83	60	104340	20289	70803755
Eczema	11.51	9.83	20	104380	33761	70790283
Vaginal abscess	11.51	9.83	7	104393	358	70823686
Stab wound	11.49	9.83	6	104394	228	70823816
Administration related reaction	11.47	9.83	5	104395	126	70823918
Haematotoxicity	11.42	9.83	3	104397	13671	70810373
Palpitations	11.41	9.83	106	104294	110647	70713397
Epidural analgesia	11.41	9.83	4	104396	55	70823989
Vascular stenosis	11.38	9.83	8	104392	524	70823520
Metastases to lung	11.37	9.83	5	104395	16479	70807565
Gun shot wound	11.34	9.83	11	104389	1132	70822912
Areflexia	11.33	9.83	24	104376	5098	70818946
Vitamin D increased	11.29	9.83	8	104392	530	70823514
Coccygectomy	11.22	9.83	3	104397	15	70824029
Influenza	11.21	9.83	110	104290	113590	70710454
Inadequate analgesia	11.14	9.83	21	104379	4101	70819943
Pancreatitis acute	11.13	9.83	32	104368	45192	70778852
Normal newborn	11.13	9.83	27	104373	6273	70817771
Blood pressure decreased	11.13	9.83	193	104207	91322	70732722
Hip arthroplasty	11.09	9.83	15	104385	28025	70796019
Pulmonary toxicity	11.02	9.83	38	104362	10760	70813284
Fatty liver alcoholic	10.97	9.83	4	104396	62	70823982
Bundle branch block left	10.97	9.83	37	104363	10362	70813682
Diffuse large B-cell lymphoma	10.95	9.83	3	104397	13299	70810745
Diplopia	10.95	9.83	75	104325	28072	70795972
Tubulointerstitial nephritis	10.90	9.83	20	104380	33056	70790988
Drug diversion	10.84	9.83	11	104389	1195	70822849
Repetitive strain injury	10.79	9.83	5	104395	146	70823898
Cardiac death	10.77	9.83	12	104388	1451	70822593
Corneal opacity	10.75	9.83	10	104390	976	70823068
Disinhibition	10.71	9.83	15	104385	2286	70821758
Rash pruritic	10.65	9.83	52	104348	62939	70761105
Postmortem blood drug level increased	10.65	9.83	9	104391	774	70823270
Immune reconstitution inflammatory syndrome	10.57	9.83	3	104397	12987	70811057
Respiratory tract infection	10.53	9.83	102	104298	42296	70781748
Coma scale abnormal	10.51	9.83	31	104369	8085	70815959
Anal skin tags	10.49	9.83	7	104393	421	70823623
Air embolism	10.47	9.83	7	104393	422	70823622
Pancreatic carcinoma	10.46	9.83	3	104397	12901	70811143
Foot deformity	10.45	9.83	9	104391	20646	70803398
Sinus bradycardia	10.44	9.83	65	104335	23558	70800486
Breast cancer	10.43	9.83	21	104379	33528	70790516
Myalgia	10.42	9.83	179	104221	167713	70656331
Upper gastrointestinal haemorrhage	10.38	9.83	25	104375	37452	70786592
Heliotrope rash	10.37	9.83	5	104395	160	70823884
Full blood count decreased	10.29	9.83	12	104388	23906	70800138
Gastric disorder	10.24	9.83	21	104379	33301	70790743
Acute myocardial infarction	10.23	9.83	64	104336	72823	70751221
Palmar-plantar erythrodysaesthesia syndrome	10.22	9.83	18	104382	30229	70793815
Neuroleptic malignant syndrome	10.20	9.83	14	104386	25993	70798051
Orbital infection	10.17	9.83	4	104396	77	70823967
Tracheitis	10.15	9.83	11	104389	1290	70822754
Chemical poisoning	10.11	9.83	5	104395	169	70823875
Seasonal allergy	10.10	9.83	43	104357	13441	70810603
Alcoholic pancreatitis	10.09	9.83	5	104395	170	70823874
Amaurosis	10.06	9.83	10	104390	1060	70822984
Thrombotic microangiopathy	10.02	9.83	7	104393	17841	70806203
Sleep disorder	9.99	9.83	61	104339	69811	70754233
Cerebral haemorrhage	9.98	9.83	43	104357	53821	70770223
Procedural haemorrhage	9.96	9.83	21	104379	4446	70819598
Acute myeloid leukaemia	9.94	9.83	19	104381	30921	70793123
Exophthalmos	9.93	9.83	12	104388	1582	70822462
Pain in jaw	9.92	9.83	31	104369	42638	70781406
Cholelithiasis	9.91	9.83	36	104364	47304	70776740

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
Methaemoglobinaemia	53.98	21.16	9	5	72	89706

Pharmacologic Action:

Source	Code	Description
ATC	D08AJ01	DERMATOLOGICALS ANTISEPTICS AND DISINFECTANTS ANTISEPTICS AND DISINFECTANTS Quaternary ammonium compounds
ATC	D09AA05	DERMATOLOGICALS MEDICATED DRESSINGS MEDICATED DRESSINGS Medicated dressings with antiinfectives
ATC	D09AA11	DERMATOLOGICALS MEDICATED DRESSINGS MEDICATED DRESSINGS Medicated dressings with antiinfectives
ATC	R02AA16	RESPIRATORY SYSTEM THROAT PREPARATIONS THROAT PREPARATIONS Antiseptics
CHEBI has role	CHEBI:27780	Detergents
CHEBI has role	CHEBI:33282	bactericides
CHEBI has role	CHEBI:35195	surfactant
CHEBI has role	CHEBI:48218	antiseptics
CHEBI has role	CHEBI:48219	disinfectants
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D000891	Anti-Infective Agents, Local
MeSH PA	D003902	Detergents
MeSH PA	D010592	Pharmaceutic Aids
MeSH PA	D011310	Preservatives, Pharmaceutical
MeSH PA	D013501	Surface-Active Agents
CHEBI has role	CHEBI:51076	Marine pesticide

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

Disease	Relation	SNOMED_ID	DOID
Otitis externa	indication	3135009
Uveitis	indication	128473001	DOID:13141
Skin irritation	indication	367466007
Local anesthesia	indication	386761002
Allergic otitis externa	indication	405821001
Itching of skin	indication	418363000
Itching of ear	indication	699392007
Post-Op Ocular Inflammation	indication
Suppression of the Gag Reflex	indication
Mouth Irritation	indication
Prevent Minor Bacterial Skin Infection	indication
Minor Skin Wound Pain	indication
Bacterial septicemia	contraindication	10001005	DOID:0040085
Hypocupremia	contraindication	19577007
Infection of skin AND/OR subcutaneous tissue	contraindication	19824006
Shock	contraindication	27942005
Methemoglobinemia	contraindication	38959009	DOID:10783
Conduction disorder of the heart	contraindication	44808001
Perforation of tympanic membrane	contraindication	60442001
Diabetes mellitus	contraindication	73211009	DOID:9351
Decreased respiratory function	contraindication	80954004
Anemia due to enzyme deficiency	contraindication	111577008
Deficiency of glucose-6-phosphate dehydrogenase	contraindication	124134002	DOID:2862
Deficiency of cytochrome-b>5< reductase	contraindication	124184009
Open wound	contraindication	125643001
Seizure disorder	contraindication	128613002
Heart block	contraindication	233916004
Disease of liver	contraindication	235856003	DOID:409
Condyloma acuminatum	contraindication	240542006	DOID:11168
Peripheral vascular disease	contraindication	400047006
Blister	contraindication	417237009
Denuded skin	contraindication	418242004
Inflammatory dermatosis	contraindication	703938007

🐶 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
4018249	VUID
N0000178890	NUI
D00857	KEGG_DRUG
8001-54-5	SECONDARY_CAS_RN
4018249	VANDF
4023321	VANDF
C0005025	UMLSCUI
CHEBI:3020	CHEBI
CHEMBL1187417	ChEMBL_ID
CHEMBL502109	ChEMBL_ID
CHEMBL1907001	ChEMBL_ID
D001548	MESH_DESCRIPTOR_UI
DB11105	DRUGBANK_ID
7N6JUD5X6Y	UNII
2330	PUBCHEM_CID
DB13282	DRUGBANK_ID
1311593	RXNORM
4255	MMSL
5003	MMSL
003141	NDDF
005466	NDDF
006369	NDDF
373549009	SNOMEDCT_US
64686009	SNOMEDCT_US
735078001	SNOMEDCT_US
90370005	SNOMEDCT_US
1168	INN_ID

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Stay Safe Hand Sanitizer Alcohol Free	HUMAN OTC DRUG LABEL	1	0295-9049	GEL	0.13 mg	TOPICAL	OTC monograph not final	10 sections
Hand wash	HUMAN OTC DRUG LABEL	1	0363-0082	SOAP	1.30 mg	TOPICAL	OTC monograph not final	11 sections
Hand wash	HUMAN OTC DRUG LABEL	1	0363-0082	SOAP	1.30 mg	TOPICAL	OTC monograph not final	11 sections
Walgreen	HUMAN OTC DRUG LABEL	1	0363-0242	SOAP	130 mg	TOPICAL	OTC monograph not final	12 sections
Walgreen	HUMAN OTC DRUG LABEL	1	0363-0242	SOAP	130 mg	TOPICAL	OTC monograph not final	12 sections
Walgreen	HUMAN OTC DRUG LABEL	1	0363-0242	SOAP	130 mg	TOPICAL	OTC monograph not final	12 sections
Walgreens Cold Sore Treatment	HUMAN OTC DRUG LABEL	2	0363-0407	CREAM	1.30 mg	TOPICAL	OTC monograph not final	10 sections
Walgreens Cold Sore Treatment	HUMAN OTC DRUG LABEL	2	0363-0407	CREAM	1.30 mg	TOPICAL	OTC monograph not final	10 sections
Nicefresh scent	HUMAN OTC DRUG LABEL	1	0363-0554	CLOTH	0.12 g	TOPICAL	OTC monograph not final	11 sections
First Aid Antiseptic Wipes	HUMAN OTC DRUG LABEL	1	0363-0589	CLOTH	0.00 mg	TOPICAL	OTC monograph not final	11 sections
First Aid Antiseptic Wipes	HUMAN OTC DRUG LABEL	1	0363-0589	CLOTH	0.00 mg	TOPICAL	OTC monograph not final	11 sections
4x Medicated Toothache and Gum Cream	HUMAN OTC DRUG LABEL	4	0363-0607	CREAM	0.13 g	ORAL	OTC monograph not final	9 sections
Hand wipes	HUMAN OTC DRUG LABEL	1	0363-0644	CLOTH	1.30 g	TOPICAL	OTC monograph not final	12 sections
Hand wipes	HUMAN OTC DRUG LABEL	1	0363-0644	CLOTH	1.30 g	TOPICAL	OTC monograph not final	12 sections
Hand Wash	HUMAN OTC DRUG LABEL	1	0363-0651	LIQUID	1.30 mg	TOPICAL	OTC monograph not final	12 sections
Hand Wash	HUMAN OTC DRUG LABEL	1	0363-0651	LIQUID	1.30 mg	TOPICAL	OTC monograph not final	12 sections
Hand Wash	HUMAN OTC DRUG LABEL	1	0363-0683	LIQUID	1.30 mg	TOPICAL	OTC monograph not final	11 sections
Hand Wash	HUMAN OTC DRUG LABEL	1	0363-0683	LIQUID	1.30 mg	TOPICAL	OTC monograph not final	11 sections
First Aid AntisepticWell at Walgreens	HUMAN OTC DRUG LABEL	2	0363-3286	SPRAY	0.13 g	TOPICAL	OTC monograph not final	11 sections
4x Medicated Toothache and Gum Gel	HUMAN OTC DRUG LABEL	4	0363-6008	GEL	0.13 g	ORAL	OTC monograph not final	9 sections
Walgreen Maximum strengthpain relieving cleansing	HUMAN OTC DRUG LABEL	2	0363-7020	LIQUID	0.13 g	TOPICAL	OTC monograph not final	14 sections
Walgreen Maximum strengthpain relieving cleansing	HUMAN OTC DRUG LABEL	2	0363-7020	LIQUID	0.13 g	TOPICAL	OTC monograph not final	14 sections
Antiseptic	HUMAN OTC DRUG LABEL	1	0363-7110	LIQUID	1.25 g	TOPICAL	OTC monograph not final	11 sections
STUDIO 35 BEAUTYAMBER ANTIBACTERIAL REFILL	HUMAN OTC DRUG LABEL	1	0363-7210	LIQUID	1.30 mg	TOPICAL	OTC monograph not final	12 sections
WalgreensANTIBACTERIAL HAND REFILL	HUMAN OTC DRUG LABEL	1	0363-7211	LIQUID	1.30 mg	TOPICAL	OTC monograph not final	12 sections
WalgreensANTIBACTERIAL HAND REFILL	HUMAN OTC DRUG LABEL	1	0363-7211	LIQUID	1.30 mg	TOPICAL	OTC monograph not final	12 sections
STUDIO 35AMBER	HUMAN OTC DRUG LABEL	1	0363-7215	LIQUID	1.30 mg	TOPICAL	OTC monograph not final	12 sections
Antiseptic Pain Relieving	HUMAN OTC DRUG LABEL	2	0363-7779	SPRAY	0.10 g	TOPICAL	OTC monograph not final	7 sections
Walgreens	HUMAN OTC DRUG LABEL	2	0363-7950	SPRAY	0.13 g	TOPICAL	OTC monograph not final	12 sections
Walgreens	HUMAN OTC DRUG LABEL	2	0363-7950	SPRAY	0.13 g	TOPICAL	OTC monograph not final	12 sections