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

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

Stem definition	Drug id	CAS RN
hypnotic tranquillizers	2873	43200-80-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: zopiclone zimovane imovane	S(+)-enantiomer of racemic zopiclone; azabicyclo(4.3.0)nonane; a nonbenzodiazepine; one of the so-called of Z drugs (zopiclone, eszopiclone, zolpidem, and zaleplon) for which there is some correlation with tumors; was term of zopiclone 2004-2007 Molecular weight: 388.81 Formula: C17H17ClN6O3 CLOGP: 1.25 LIPINSKI: 0 HAC: 9 HDO: 0 TPSA: 91.76 ALOGS: -2.64 ROTB: 3

Drug dosage:

Dose	Unit	Route
7.50	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.12 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	4.50 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.28 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution)	1.30 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	3.30 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.20 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	5.20 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Dec. 15, 2004	FDA	SUNOVION PHARMS INC

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
Lower respiratory tract infection	722.44	11.49	1035	113842	131272	63242873
Intentional overdose	697.36	11.49	762	114115	73390	63300755
Coma	595.70	11.49	656	114221	63708	63310437
Intentional self-injury	593.93	11.49	439	114438	25248	63348897
Folliculitis	457.21	11.49	599	114278	69718	63304427
Muscle injury	450.45	11.49	573	114304	64772	63309373
Muscle spasticity	445.29	11.49	346	114531	21448	63352697
Ill-defined disorder	431.81	11.49	630	114247	81125	63293020
Poisoning deliberate	410.88	11.49	255	114622	10963	63363182
Ear pain	403.28	11.49	407	114470	35711	63338434
Body temperature increased	378.94	11.49	399	114478	36793	63337352
Irritable bowel syndrome	378.37	11.49	595	114282	81817	63292328
Respiratory disorder	347.08	11.49	390	114487	38692	63335453
Gastrointestinal disorder	302.78	11.49	707	114170	130532	63243613
Sinusitis	302.07	11.49	999	113878	225654	63148491
Night sweats	288.40	11.49	397	114480	48417	63325728
Impaired healing	286.96	11.49	597	114280	101945	63272200
Blister	269.05	11.49	671	114206	129143	63245002
Confusional state	268.28	11.49	988	113889	235392	63138753
Pneumonia aspiration	244.42	11.49	307	114570	34233	63339912
Schizoaffective disorder	243.27	11.49	122	114755	3440	63370705
Peripheral swelling	225.76	11.49	1016	113861	264926	63109219
Stomatitis	223.04	11.49	653	114224	138072	63236073
Sleep disorder due to general medical condition, insomnia type	219.05	11.49	362	114515	51855	63322290
Product dose omission issue	204.49	11.49	84	114793	234229	63139916
Somnolence	201.83	11.49	746	114131	177939	63196206
Sleep disorder	172.44	11.49	425	114452	81141	63293004
Insomnia	166.78	11.49	801	114076	214451	63159694
Pruritus	165.10	11.49	1169	113708	360284	63013861
Nasopharyngitis	161.49	11.49	895	113982	253362	63120783
Death	156.11	11.49	274	114603	374107	63000038
Electrocardiogram QT prolonged	139.63	11.49	323	114554	59207	63314938
Electric shock	135.83	11.49	60	114817	1260	63372885
Toxicity to various agents	134.73	11.49	836	114041	246414	63127731
Weight increased	131.75	11.49	865	114012	259927	63114218
Urticaria	131.26	11.49	621	114256	165181	63208964
Joint swelling	126.01	11.49	1018	113859	326648	63047497
Cardiac failure congestive	111.48	11.49	17	114860	92416	63281729
Drug level increased	104.00	11.49	164	114713	22572	63351573
Infection	99.68	11.49	733	114144	228440	63145705
Akathisia	96.47	11.49	100	114777	9046	63365099
Therapeutic product effect decreased	89.83	11.49	628	114249	192559	63181586
Miosis	87.83	11.49	86	114791	7267	63366878
Intervertebral discitis	85.62	11.49	60	114817	3168	63370977
Post-traumatic stress disorder	83.34	11.49	72	114805	5179	63368966
Depressed level of consciousness	81.88	11.49	273	114604	61805	63312340
Suicide attempt	80.44	11.49	268	114609	60650	63313495
Prescription form tampering	75.11	11.49	31	114846	547	63373598
Injection site pain	74.36	11.49	75	114802	129725	63244420
Contusion	73.42	11.49	494	114383	149550	63224595
Drug ineffective	71.94	11.49	1397	113480	1043368	62330777
Neovascularisation	71.73	11.49	37	114840	1108	63373037
Sepsis	65.57	11.49	110	114767	153013	63221132
White blood cell count decreased	64.24	11.49	95	114782	139009	63235136
Obstructive airways disorder	61.94	11.49	124	114753	20575	63353570
Abdominal pain upper	60.99	11.49	606	114271	205838	63168307
Antipsychotic drug level increased	60.47	11.49	50	114827	3385	63370760
Medication error	59.50	11.49	219	114658	52065	63322080
Granulocyte count increased	59.42	11.49	30	114847	858	63373287
Respiratory failure	59.32	11.49	58	114819	101800	63272345
Lupus vasculitis	58.99	11.49	26	114851	543	63373602
Vaginal flatulence	58.11	11.49	48	114829	3245	63370900
Drug dependence	57.55	11.49	133	114744	24350	63349795
Proctitis	56.50	11.49	59	114818	5382	63368763
Sputum discoloured	56.37	11.49	104	114773	16243	63357902
Vocal cord dysfunction	56.29	11.49	25	114852	532	63373613
Duodenal ulcer perforation	55.88	11.49	308	114569	86901	63287244
Pneumonia	55.73	11.49	543	114334	456224	62917921
Back pain	54.89	11.49	724	114153	263421	63110724
Skin candida	54.05	11.49	35	114842	1620	63372525
Pain in extremity	53.74	11.49	365	114512	331121	63043024
Cerebrovascular accident	53.65	11.49	70	114807	107954	63266191
Platelet count decreased	52.94	11.49	80	114797	116042	63258103
Pyrexia	52.85	11.49	1167	113710	469311	62904834
Broncholithiasis	52.25	11.49	19	114858	234	63373911
Demyelination	51.32	11.49	63	114814	6857	63367288
Hepatocellular injury	49.90	11.49	135	114742	27246	63346899
Newborn persistent pulmonary hypertension	49.85	11.49	18	114859	217	63373928
COVID-19	49.58	11.49	80	114797	113023	63261122
Urine leukocyte esterase positive	48.72	11.49	45	114832	3534	63370611
Wrong technique in product usage process	48.68	11.49	26	114851	62314	63311831
Myocardial infarction	48.31	11.49	66	114811	99827	63274318
Abortion spontaneous	47.95	11.49	13	114864	47182	63326963
Bronchial wall thickening	47.24	11.49	31	114846	1468	63372677
Lymph node calcification	47.23	11.49	19	114858	313	63373832
Foetal death	47.20	11.49	77	114800	10903	63363242
Unevaluable event	47.12	11.49	17	114860	51369	63322776
Helicobacter infection	46.87	11.49	308	114569	92477	63281668
Therapy interrupted	46.82	11.49	3	114874	32452	63341693
Incorrect route of product administration	46.71	11.49	132	114745	27320	63346825
Altered state of consciousness	46.59	11.49	125	114752	25105	63349040
Disease progression	46.50	11.49	95	114782	122663	63251482
Nausea	46.20	11.49	1186	113691	853285	62520860
Injection site reaction	44.83	11.49	25	114852	58499	63315646
Sinus rhythm	43.32	11.49	24	114853	832	63373313
Injection site erythema	43.28	11.49	52	114825	83122	63291023
Premature delivery	43.09	11.49	3	114874	30278	63343867
Temperature intolerance	42.86	11.49	66	114811	8898	63365247
Neutropenia	42.26	11.49	168	114709	174837	63199308
Post cholecystectomy syndrome	42.12	11.49	19	114858	420	63373725
Colitis ulcerative	42.02	11.49	123	114754	25968	63348177
Somnambulism	41.98	11.49	51	114826	5492	63368653
Osmolar gap increased	41.19	11.49	13	114864	100	63374045
No adverse event	40.96	11.49	12	114865	41393	63332752
Female genital tract fistula	40.93	11.49	59	114818	7500	63366645
Blood glucose increased	40.84	11.49	55	114822	83701	63290444
Laryngeal stenosis	40.72	11.49	25	114852	1053	63373092
Frequent bowel movements	40.45	11.49	112	114765	22910	63351235
Urinary tract infection	40.16	11.49	297	114580	264387	63109758
Pulmonary hypertension	40.10	11.49	9	114868	37114	63337031
Mydriasis	39.89	11.49	75	114802	11881	63362264
Decompression sickness	39.76	11.49	12	114865	78	63374067
Drug hypersensitivity	39.69	11.49	365	114512	310322	63063823
Hospitalisation	39.37	11.49	58	114819	85023	63289122
Cryopyrin associated periodic syndrome	39.10	11.49	17	114860	343	63373802
Thrombosis	38.71	11.49	36	114841	64719	63309426
Hypersensitivity	38.71	11.49	744	114133	291941	63082204
Gastrooesophageal reflux disease	38.18	11.49	300	114577	95339	63278806
Product quality issue	38.13	11.49	9	114868	35856	63338289
Therapy cessation	38.12	11.49	5	114872	30452	63343693
Injection site pruritus	37.98	11.49	17	114860	45099	63329046
Completed suicide	37.66	11.49	136	114741	145537	63228608
Excessive eye blinking	36.79	11.49	25	114852	1255	63372890
Renal impairment	36.41	11.49	65	114812	88290	63285855
Condition aggravated	35.92	11.49	512	114365	401705	62972440
Chronic kidney disease	35.34	11.49	19	114858	45379	63328766
Contraindicated product administered	35.09	11.49	571	114306	217077	63157068
Atrial fibrillation	34.93	11.49	102	114775	116534	63257611
Total lung capacity decreased	34.78	11.49	30	114847	2153	63371992
Blood immunoglobulin A increased	34.49	11.49	20	114857	758	63373387
Progressive multifocal leukoencephalopathy	34.46	11.49	74	114803	12897	63361248
Bronchopulmonary aspergillosis allergic	33.90	11.49	30	114847	2228	63371917
Vaginal discharge	33.59	11.49	60	114817	9138	63365007
Overdose	33.55	11.49	337	114540	114741	63259404
Liver function test abnormal	33.55	11.49	23	114854	48158	63325987
Extrapyramidal disorder	33.26	11.49	74	114803	13210	63360935
Swelling	33.06	11.49	690	114187	274688	63099457
Aspartate aminotransferase	32.91	11.49	16	114861	421	63373724
Paradoxical drug reaction	32.75	11.49	39	114838	4113	63370032
Coronary artery disease	32.74	11.49	9	114868	32368	63341777
Hypervolaemia	32.53	11.49	6	114871	28407	63345738
Renal failure	32.32	11.49	107	114770	117545	63256600
Diabetes mellitus	32.23	11.49	32	114845	55778	63318367
Glomerular filtration rate increased	31.83	11.49	20	114857	878	63373267
Deep vein thrombosis postoperative	30.36	11.49	65	114812	11304	63362841
Asphyxia	30.24	11.49	46	114831	6135	63368010
Calcium deficiency	30.23	11.49	21	114856	1093	63373052
Middle insomnia	30.06	11.49	69	114808	12574	63361571
Post-traumatic neck syndrome	30.04	11.49	27	114850	2047	63372098
Dyspnoea exertional	30.01	11.49	39	114838	60263	63313882
Alopecia	30.00	11.49	430	114447	337106	63037039
Postmortem blood drug level abnormal	29.68	11.49	14	114863	344	63373801
Hyponatraemia	29.46	11.49	321	114556	111579	63262566
Depressed mood	29.20	11.49	147	114730	40044	63334101
Injection site bruising	29.19	11.49	20	114857	41890	63332255
Red blood cells urine	29.03	11.49	16	114861	549	63373596
Eye irritation	29.01	11.49	3	114874	21968	63352177
Libido increased	28.87	11.49	22	114855	1323	63372822
Maternal exposure during pregnancy	28.75	11.49	257	114620	219805	63154340
Full blood count decreased	28.73	11.49	6	114871	26018	63348127
Carcinoid tumour pulmonary	28.66	11.49	15	114862	463	63373682
Gallbladder adenocarcinoma	28.60	11.49	10	114867	109	63374036
Adrenal insufficiency	28.41	11.49	84	114793	17831	63356314
Concussion	28.40	11.49	56	114821	9188	63364957
Mobility decreased	28.18	11.49	118	114759	121041	63253104
Cellulitis	28.09	11.49	67	114810	81891	63292254
Postmortem blood drug level increased	28.03	11.49	16	114861	588	63373557
Exposure during pregnancy	27.34	11.49	167	114710	155380	63218765
Feeling abnormal	27.31	11.49	157	114720	148235	63225910
Coordination abnormal	27.23	11.49	70	114807	13703	63360442
Neoplasm malignant	27.17	11.49	10	114867	29851	63344294
Soft tissue injury	26.92	11.49	23	114854	1629	63372516
Sopor	26.89	11.49	4	114873	22160	63351985
Behaviour disorder	26.81	11.49	31	114846	3168	63370977
Injection site swelling	26.65	11.49	28	114849	47544	63326601
Hostility	26.38	11.49	24	114853	1848	63372297
Vasoplegia syndrome	26.36	11.49	23	114854	1676	63372469
Haemoglobin urine	26.34	11.49	10	114867	140	63374005
Lupus nephritis	26.33	11.49	29	114848	2810	63371335
Deep vein thrombosis	26.03	11.49	72	114805	83728	63290417
Seizure	25.67	11.49	138	114739	132496	63241649
Aspartate aminotransferase increased	25.56	11.49	81	114796	90196	63283949
Lung opacity	25.39	11.49	30	114847	3138	63371007
Surgery	25.20	11.49	17	114860	35895	63338250
Radiculopathy	25.06	11.49	51	114826	8560	63365585
Electrocardiogram repolarisation abnormality	24.93	11.49	20	114857	1297	63372848
Cytomegalovirus infection	24.92	11.49	4	114873	20948	63353197
Neutrophil count increased	24.80	11.49	76	114801	16451	63357694
Throat clearing	24.70	11.49	26	114851	2393	63371752
Staphylococcal infection	24.58	11.49	23	114854	41233	63332912
Arthritis	24.49	11.49	117	114760	115804	63258341
Antipsychotic drug level above therapeutic	24.48	11.49	18	114859	1025	63373120
Agitation neonatal	24.32	11.49	14	114863	523	63373622
Diaphragmatic rupture	24.06	11.49	11	114866	251	63373894
Multiple organ dysfunction syndrome	24.06	11.49	41	114836	56711	63317434
Psychotic symptom	23.96	11.49	21	114856	1540	63372605
Hypotonia neonatal	23.75	11.49	19	114858	1227	63372918
Accidental exposure to product	23.58	11.49	10	114867	27395	63346750
X-ray abnormal	23.56	11.49	48	114829	8062	63366083
Cardiac arrest	23.51	11.49	87	114790	92458	63281687
White blood cells urine positive	23.30	11.49	37	114840	5121	63369024
Vitamin B12 increased	23.23	11.49	18	114859	1110	63373035
Rash	23.13	11.49	1238	113639	559633	62814512
Neonatal respiratory failure	22.89	11.49	11	114866	282	63373863
Presyncope	22.57	11.49	11	114866	27774	63346371
Cholestasis	22.34	11.49	109	114768	29325	63344820
Neutropenic sepsis	22.30	11.49	73	114804	16365	63357780
Pulmonary embolism	22.25	11.49	122	114755	116562	63257583
Neonatal asphyxia	22.07	11.49	11	114866	306	63373839
Distal intestinal obstruction syndrome	21.93	11.49	12	114865	406	63373739
Hypothermia	21.84	11.49	64	114813	13517	63360628
Atelectasis	21.67	11.49	6	114871	21477	63352668
Abdominal discomfort	21.58	11.49	430	114447	320455	63053690
Antidepressant drug level above therapeutic	21.43	11.49	12	114865	425	63373720
Suicidal ideation	21.28	11.49	189	114688	62232	63311913
Device dislocation	21.15	11.49	10	114867	25695	63348450
Drug abuse	20.95	11.49	212	114665	72306	63301839
Septic shock	20.88	11.49	57	114820	66572	63307573
Malignant polyp	20.68	11.49	9	114868	182	63373963
Rales	20.58	11.49	60	114817	12637	63361508
Bursitis	20.58	11.49	126	114751	36915	63337230
Blood pressure systolic decreased	20.58	11.49	43	114834	7354	63366791
Bronchiolitis	20.36	11.49	25	114852	2722	63371423
Drug resistance	20.33	11.49	8	114869	22925	63351220
Balance disorder	20.33	11.49	238	114639	84184	63289961
Adjustment disorder with depressed mood	20.31	11.49	52	114825	10152	63363993
Myocarditis septic	20.29	11.49	6	114871	36	63374109
Fluid retention	20.29	11.49	49	114828	59637	63314508
Plasma cell myeloma	20.26	11.49	21	114856	35884	63338261
Therapeutic product effect incomplete	20.07	11.49	138	114739	124918	63249227
Oral candidiasis	19.94	11.49	88	114789	22710	63351435
Therapeutic reaction time decreased	19.92	11.49	23	114854	2347	63371798
Lactic acidosis	19.87	11.49	128	114749	38159	63335986
Nightmare	19.85	11.49	78	114799	19116	63355029
Urine abnormality	19.75	11.49	41	114836	6978	63367167
Drug level above therapeutic	19.71	11.49	33	114844	4772	63369373
Burnout syndrome	19.70	11.49	9	114868	205	63373940
Negative thoughts	19.54	11.49	15	114862	912	63373233
Hypertension	19.47	11.49	372	114505	278931	63095214
Fungal infection	19.23	11.49	23	114854	36851	63337294
Nodule	19.20	11.49	7	114870	21019	63353126
Sternal fracture	19.16	11.49	22	114855	2232	63371913
Rheumatoid factor increased	19.11	11.49	20	114857	1829	63372316
Dyspnoea	19.03	11.49	1415	113462	659898	62714247
Loss of personal independence in daily activities	18.95	11.49	101	114776	97189	63276956
Right ventricular failure	18.90	11.49	4	114873	17184	63356961
Disturbance in attention	18.81	11.49	126	114751	38063	63336082
Monocyte percentage increased	18.74	11.49	16	114861	1132	63373013
Post procedural complication	18.72	11.49	4	114873	17070	63357075
Osteomyelitis	18.68	11.49	12	114865	26008	63348137
Fear of disease	18.60	11.49	17	114860	1317	63372828
Blindness	18.54	11.49	8	114869	21691	63352454
Rheumatoid factor positive	18.53	11.49	84	114793	84322	63289823
Blood creatine increased	18.52	11.49	35	114842	5566	63368579
Hepatotoxicity	18.38	11.49	24	114853	37017	63337128
Cholelithiasis	18.38	11.49	32	114845	43893	63330252
Skin ulcer	18.34	11.49	31	114846	43014	63331131
Blood test abnormal	18.22	11.49	66	114811	15563	63358582
Joint injury	18.20	11.49	16	114861	29556	63344589
Toxicologic test abnormal	18.19	11.49	13	114864	708	63373437
Transient ischaemic attack	18.19	11.49	25	114852	37728	63336417
Infusion related reaction	18.19	11.49	577	114300	244944	63129201
Wrong rate	18.08	11.49	6	114871	55	63374090
Hypocoagulable state	18.05	11.49	16	114861	1191	63372954
Hallucination, synaesthetic	17.99	11.49	6	114871	56	63374089
Visual impairment	17.97	11.49	85	114792	84361	63289784
Bulimia nervosa	17.92	11.49	11	114866	463	63373682
Hypersensitivity vasculitis	17.89	11.49	29	114848	4083	63370062
Bone pain	17.68	11.49	46	114831	54595	63319550
Neoplasm progression	17.67	11.49	24	114853	36404	63337741
Gallbladder disorder	17.67	11.49	6	114871	18836	63355309
Gait deviation	17.36	11.49	6	114871	63	63374082
Tooth hypoplasia	17.19	11.49	6	114871	65	63374080
Intentional product use issue	17.17	11.49	326	114551	127566	63246579
Drug eruption	17.09	11.49	16	114861	28678	63345467
Lymphadenopathy	17.03	11.49	27	114850	38431	63335714
Haematocrit increased	16.97	11.49	21	114856	2305	63371840
Neonatal seizure	16.95	11.49	11	114866	511	63373634
Rheumatoid nodule	16.91	11.49	5	114872	17150	63356995
Coagulopathy	16.89	11.49	8	114869	20536	63353609
Dry skin	16.84	11.49	50	114827	56837	63317308
Ascites	16.74	11.49	30	114847	40698	63333447
Myalgia	16.64	11.49	177	114700	146352	63227793
Anaemia	16.62	11.49	404	114473	293026	63081119
Myelocyte percentage increased	16.61	11.49	8	114869	206	63373939
Angina pectoris	16.51	11.49	18	114859	30060	63344085
Ligament pain	16.44	11.49	8	114869	211	63373934
Antibody test abnormal	16.32	11.49	11	114866	545	63373600
Hypocalcaemia	16.31	11.49	20	114857	31693	63342452
Temperature regulation disorder	16.31	11.49	35	114842	6097	63368048
Asthenia	16.23	11.49	849	114028	382755	62991390
Housebound	15.94	11.49	8	114869	226	63373919
Creatinine renal clearance decreased	15.63	11.49	5	114872	16303	63357842
Tenosynovitis	15.61	11.49	3	114874	13792	63360353
Cardiac failure	15.50	11.49	96	114781	89046	63285099
Band neutrophil percentage increased	15.50	11.49	8	114869	240	63373905
Acute respiratory failure	15.47	11.49	24	114853	34461	63339684
Posterior reversible encephalopathy syndrome	15.46	11.49	6	114871	17339	63356806
Tenderness	15.42	11.49	11	114866	22567	63351578
Choking	15.36	11.49	46	114831	9833	63364312
Gait disturbance	15.33	11.49	236	114641	182942	63191203
Blood immunoglobulin E increased	15.22	11.49	26	114851	3823	63370322
Psoriatic arthropathy	15.18	11.49	100	114777	91420	63282725
Procedural anxiety	15.15	11.49	12	114865	764	63373381
Granulomatous liver disease	15.12	11.49	12	114865	766	63373379
Urine oxalate increased	15.08	11.49	8	114869	254	63373891
Diabetic hyperosmolar coma	15.06	11.49	9	114868	361	63373784
Poor feeding infant	15.06	11.49	9	114868	361	63373784
Malignant neoplasm progression	15.04	11.49	87	114790	82034	63292111
Postnatal growth restriction	14.86	11.49	4	114873	16	63374129
Accommodation disorder	14.81	11.49	9	114868	372	63373773
Breast cancer	14.71	11.49	42	114835	48341	63325804
Diverticulitis	14.64	11.49	31	114846	39526	63334619
Urinary tract obstruction	14.62	11.49	19	114858	2189	63371956
Ankle fracture	14.60	11.49	7	114870	17848	63356297
Pharyngeal paraesthesia	14.43	11.49	18	114859	1991	63372154
Dry mouth	14.33	11.49	209	114668	77654	63296491
Complement factor C4 decreased	14.32	11.49	8	114869	282	63373863
Cardiomegaly	14.26	11.49	7	114870	17607	63356538
Eye pruritus	14.26	11.49	8	114869	18663	63355482
Retinal depigmentation	14.24	11.49	8	114869	285	63373860
Multiple sclerosis	14.23	11.49	84	114793	24288	63349857
Respiratory tract infection	14.14	11.49	34	114843	41449	63332696
Alanine aminotransferase increased	14.06	11.49	120	114757	103650	63270495
Hepatitis	14.05	11.49	32	114845	39756	63334389
Autoimmune disorder	14.04	11.49	65	114812	17112	63357033
Basal cell carcinoma	14.03	11.49	18	114859	27973	63346172
Treatment noncompliance	14.03	11.49	29	114848	37296	63336849
Chronic obstructive pulmonary disease	13.99	11.49	62	114815	62624	63311521
Pulmonary congestion	13.99	11.49	7	114870	17411	63356734
Mass	13.95	11.49	4	114873	13996	63360149
Drug use disorder	13.89	11.49	29	114848	4955	63369190
Ocular hyperaemia	13.86	11.49	15	114862	25129	63349016
Hepatic function abnormal	13.84	11.49	29	114848	37113	63337032
Crystal urine present	13.82	11.49	16	114861	1638	63372507
Acute hepatic failure	13.79	11.49	8	114869	18319	63355826
Hypoaesthesia	13.74	11.49	218	114659	168175	63205970
Leukocytosis	13.72	11.49	16	114861	25919	63348226
Hypoventilation	13.65	11.49	28	114849	4726	63369419
Pericarditis	13.64	11.49	323	114554	131256	63242889
Treatment failure	13.58	11.49	266	114611	198777	63175368
Glucocorticoids increased	13.58	11.49	6	114871	126	63374019
Spinal stenosis	13.57	11.49	5	114872	14920	63359225
Leukopenia	13.56	11.49	83	114794	77207	63296938
Abdominal pain	13.54	11.49	655	114222	292801	63081344
Dizziness	13.50	11.49	638	114239	429287	62944858
Tri-iodothyronine free decreased	13.49	11.49	8	114869	316	63373829
Eosinophil count abnormal	13.47	11.49	10	114867	578	63373567
Caesarean section	13.45	11.49	7	114870	17025	63357120
Chest pain	13.44	11.49	293	114584	215666	63158479
Pericardial effusion	13.41	11.49	21	114856	30037	63344108
Disseminated intravascular coagulation	13.39	11.49	9	114868	19042	63355103
Rhinorrhoea	13.37	11.49	67	114810	65510	63308635
Occult blood	13.32	11.49	14	114863	1287	63372858
Device issue	13.31	11.49	14	114863	23767	63350378
Ear infection	13.28	11.49	31	114846	38182	63335963
Anti-cyclic citrullinated peptide antibody positive	13.21	11.49	289	114588	115923	63258222
Hyperhidrosis	13.17	11.49	271	114606	107565	63266580
Drug diversion	13.06	11.49	12	114865	936	63373209
Premature baby	13.03	11.49	11	114866	20724	63353421
Gastrointestinal haemorrhage	12.81	11.49	90	114787	81086	63293059
Chest wall mass	12.80	11.49	5	114872	76	63374069
Cardiac disorder	12.76	11.49	48	114829	50768	63323377
Failed induction of labour	12.72	11.49	8	114869	352	63373793
Sensory level abnormal	12.70	11.49	6	114871	148	63373997
Hypoacusis	12.66	11.49	15	114862	24136	63350009
Swollen joint count	12.56	11.49	13	114864	1173	63372972
Myocardial depression	12.52	11.49	9	114868	495	63373650
Myelocyte count increased	12.52	11.49	8	114869	362	63373783
Pain	12.49	11.49	1526	113351	739102	62635043
Eye paraesthesia	12.48	11.49	6	114871	154	63373991
Hypoalbuminaemia	12.47	11.49	3	114874	11802	63362343
Hypercalcaemia	12.43	11.49	20	114857	28302	63345843
Blood pressure abnormal	12.37	11.49	6	114871	15192	63358953
Injection site warmth	12.36	11.49	6	114871	15189	63358956
Cerebral infarction	12.36	11.49	15	114862	23878	63350267
Oedema	12.30	11.49	115	114762	97507	63276638
Inappropriate antidiuretic hormone secretion	12.27	11.49	58	114819	15404	63358741
Liver injury	12.25	11.49	62	114815	60458	63313687
Anuria	12.17	11.49	50	114827	12501	63361644
Blood creatinine increased	12.16	11.49	101	114776	87743	63286402
Dactylitis	12.16	11.49	19	114858	2593	63371552
Adverse event	12.14	11.49	72	114805	67487	63306658
Seasonal allergy	12.11	11.49	12	114865	20938	63353207
Anticonvulsant drug level above therapeutic	12.08	11.49	9	114868	523	63373622
Osteonecrosis	12.06	11.49	16	114861	24514	63349631
Band neutrophil count increased	12.04	11.49	8	114869	387	63373758
Decreased appetite	12.02	11.49	354	114523	250698	63123447
Eye disorder	11.99	11.49	14	114863	22671	63351474
Complication associated with device	11.96	11.49	8	114869	16970	63357175
Pancreatic carcinoma recurrent	11.92	11.49	5	114872	92	63374053
Throat irritation	11.82	11.49	112	114765	37535	63336610
Incorrect dose administered	11.82	11.49	62	114815	59906	63314239
Epistaxis	11.79	11.49	80	114797	72645	63301500
Eosinophilia	11.76	11.49	76	114801	22680	63351465
Rectal haemorrhage	11.70	11.49	138	114739	48892	63325253
Labelled drug-food interaction medication error	11.68	11.49	6	114871	178	63373967
Blood triglycerides increased	11.67	11.49	4	114873	12484	63361661
Pleural effusion	11.66	11.49	110	114767	93100	63281045
Urinary sediment present	11.64	11.49	17	114860	2186	63371959
Tobacco interaction	11.57	11.49	4	114873	42	63374103
Viral infection	11.56	11.49	30	114847	35633	63338512
Chronic sinusitis	11.55	11.49	50	114827	12793	63361352

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
Depression	944.72	11.96	852	42323	96246	34817510
Drug interaction	661.28	11.96	1075	42100	224871	34688885
Poisoning deliberate	427.76	11.96	204	42971	7640	34906116
Coma	412.06	11.96	385	42790	45293	34868463
Loss of personal independence in daily activities	208.15	11.96	230	42945	32949	34880807
Intentional overdose	189.32	11.96	251	42924	43423	34870333
Psychiatric decompensation	186.80	11.96	85	43090	2852	34910904
Depression suicidal	154.61	11.96	71	43104	2434	34911322
Psychomotor skills impaired	149.56	11.96	80	43095	3826	34909930
Suicidal ideation	149.31	11.96	215	42960	40173	34873583
Somnolence	146.99	11.96	382	42793	110734	34803022
Depressive symptom	142.66	11.96	70	43105	2789	34910967
Toxicity to various agents	142.66	11.96	556	42619	199806	34713950
Tearfulness	141.21	11.96	68	43107	2599	34911157
Suicide attempt	137.00	11.96	203	42972	38913	34874843
Miosis	136.60	11.96	105	43070	9430	34904326
Hypothermia	107.29	11.96	96	43079	10652	34903104
Intentional self-injury	106.89	11.96	107	43068	13664	34900092
Psychotic disorder	88.62	11.96	129	43046	24323	34889433
Paranoia	88.61	11.96	91	43084	11977	34901779
Prescription form tampering	85.26	11.96	29	43146	437	34913319
Drug dependence	83.78	11.96	125	43050	24092	34889664
Electrocardiogram QT prolonged	80.83	11.96	165	43010	40787	34872969
Neuroleptic malignant syndrome	75.99	11.96	102	43073	17832	34895924
Hepatocellular injury	75.91	11.96	114	43061	22097	34891659
Disease progression	73.79	11.96	21	43154	108056	34805700
Blood mercury abnormal	69.30	11.96	21	43154	213	34913543
Product dose omission issue	68.58	11.96	31	43144	119680	34794076
5-hydroxyindolacetic acid in urine increased	67.36	11.96	21	43154	236	34913520
Drug abuse	65.47	11.96	269	42906	98827	34814929
Overdose	62.39	11.96	250	42925	90809	34822947
Low density lipoprotein decreased	60.07	11.96	29	43146	1114	34912642
Device dislocation	54.94	11.96	52	43123	6197	34907559
Confusional state	52.56	11.96	331	42844	143829	34769927
Housebound	52.28	11.96	17	43158	221	34913535
Cardiac failure congestive	51.84	11.96	19	43156	83251	34830505
Asphyxia	51.00	11.96	52	43123	6783	34906973
Cerebral artery thrombosis	50.94	11.96	23	43152	757	34912999
Dystonic tremor	49.56	11.96	16	43159	203	34913553
Altered state of consciousness	46.05	11.96	93	43082	22800	34890956
Myocardial infarction	45.99	11.96	49	43126	121036	34792720
Brain scan abnormal	45.26	11.96	22	43153	858	34912898
Agitation	43.70	11.96	163	43012	57236	34856520
Fall	43.25	11.96	411	42764	202474	34711282
Thrombosis	42.31	11.96	6	43169	50452	34863304
Cholestasis	40.09	11.96	97	43078	26851	34886905
Restless legs syndrome	39.24	11.96	50	43125	8304	34905452
Arteriovenous fistula	37.67	11.96	21	43154	1090	34912666
Withdrawal syndrome	37.07	11.96	60	43115	12395	34901361
Hepatic cytolysis	36.74	11.96	65	43110	14431	34899325
Serum ferritin abnormal	36.35	11.96	13	43162	229	34913527
Death	36.32	11.96	316	42859	397733	34516023
Macrophages increased	36.09	11.96	12	43163	168	34913588
Anxiety	36.01	11.96	228	42947	99200	34814556
Mental status changes	35.80	11.96	3	43172	38080	34875676
Bladder dilatation	34.40	11.96	22	43153	1470	34912286
Pneumonia aspiration	33.57	11.96	121	43054	41782	34871974
Logorrhoea	33.18	11.96	26	43149	2400	34911356
Alcohol poisoning	31.78	11.96	30	43145	3563	34910193
Bradypnoea	31.71	11.96	27	43148	2802	34910954
Hyperthermia	31.54	11.96	51	43124	10526	34903230
Agranulocytosis	31.50	11.96	82	43093	23739	34890017
Hepatic neoplasm	31.03	11.96	23	43152	1954	34911802
Tardive dyskinesia	30.98	11.96	37	43138	5753	34908003
Dysarthria	30.95	11.96	104	43071	34678	34879078
Toxic skin eruption	30.08	11.96	52	43123	11333	34902423
Respiratory tract haemorrhage	29.96	11.96	19	43156	1251	34912505
Implant site extravasation	29.79	11.96	13	43162	394	34913362
Puncture site haematoma	29.63	11.96	10	43165	147	34913609
Psychomotor retardation	29.50	11.96	29	43146	3621	34910135
Respiratory failure	29.27	11.96	56	43119	108516	34805240
Gastrointestinal haemorrhage	29.13	11.96	40	43135	88437	34825319
Prescribed overdose	28.62	11.96	49	43126	10598	34903158
Tooth injury	28.36	11.96	18	43157	1187	34912569
Overlap syndrome	28.33	11.96	9	43166	108	34913648
Hypoglycaemia	28.26	11.96	138	43037	54502	34859254
Sedation	27.46	11.96	72	43103	20934	34892822
Behaviour disorder	27.30	11.96	32	43143	4878	34908878
Coronary artery disease	26.88	11.96	13	43162	48292	34865464
Post concussion syndrome	26.68	11.96	9	43166	132	34913624
Muscle rigidity	26.44	11.96	47	43128	10471	34903285
Feelings of worthlessness	26.02	11.96	11	43164	308	34913448
Renal failure	25.96	11.96	79	43096	130478	34783278
Accessory spleen	25.96	11.96	9	43166	144	34913612
Burnout syndrome	25.73	11.96	9	43166	148	34913608
Diarrhoea	25.61	11.96	334	42841	389578	34524178
Dystonia	25.41	11.96	47	43128	10798	34902958
Drug monitoring procedure incorrectly performed	25.20	11.96	10	43165	237	34913519
Depressed mood	25.04	11.96	66	43109	19251	34894505
Rheumatoid arthritis	24.58	11.96	103	43072	38135	34875621
Obesity	24.34	11.96	51	43124	12827	34900929
Blood ethanol increased	24.15	11.96	12	43163	491	34913265
Injection site pain	24.09	11.96	9	43166	38996	34874760
Dyspnoea	23.92	11.96	325	42850	376457	34537299
Tremor	23.74	11.96	179	42996	82408	34831348
Contraindicated product administered	23.50	11.96	69	43106	21412	34892344
Behavioural addiction	23.46	11.96	7	43168	67	34913689
Pneumonia	22.94	11.96	313	42862	362314	34551442
Antiphospholipid antibodies positive	22.71	11.96	10	43165	310	34913446
Areflexia	22.50	11.96	23	43152	3008	34910748
Red blood cell elliptocytes present	22.36	11.96	8	43167	141	34913615
Coma scale abnormal	22.08	11.96	26	43149	3982	34909774
Faecaloma	21.89	11.96	30	43145	5347	34908409
Paraneoplastic rash	21.81	11.96	7	43168	87	34913669
Rash maculo-papular	21.81	11.96	81	43094	28370	34885386
Optic nerve operation	21.51	11.96	11	43164	479	34913277
Perineal infection	21.45	11.96	12	43163	627	34913129
Hyperreflexia	21.43	11.96	23	43152	3183	34910573
Scrotal infection	21.21	11.96	12	43163	641	34913115
Femoral artery aneurysm	21.20	11.96	8	43167	165	34913591
Therapy non-responder	21.08	11.96	11	43164	39135	34874621
Deep vein thrombosis	20.97	11.96	30	43145	65218	34848538
VACTERL syndrome	20.85	11.96	6	43169	50	34913706
Drug ineffective	20.76	11.96	419	42756	456332	34457424
Substance abuse	20.32	11.96	35	43140	7606	34906150
Bradycardia	20.30	11.96	161	43014	75257	34838499
Eosinophil percentage increased	20.20	11.96	11	43164	545	34913211
Drug intolerance	19.96	11.96	134	43041	59436	34854320
Restlessness	19.91	11.96	73	43102	25409	34888347
General physical health deterioration	19.89	11.96	244	42931	128025	34785731
Opiates positive	19.75	11.96	11	43164	570	34913186
Neutrophil percentage increased	19.54	11.96	17	43158	1816	34911940
Antipsychotic drug level increased	19.54	11.96	24	43151	3841	34909915
Disorientation	19.49	11.96	87	43088	33101	34880655
Abulia	19.42	11.96	11	43164	589	34913167
Lymphocyte percentage decreased	19.24	11.96	18	43157	2114	34911642
Spinal cord haemorrhage	19.18	11.96	9	43166	324	34913432
Expired product administered	18.95	11.96	22	43153	3319	34910437
Toxic epidermal necrolysis	18.62	11.96	64	43111	21582	34892174
Delirium febrile	18.52	11.96	5	43170	32	34913724
Sepsis	18.52	11.96	125	43050	166436	34747320
Pemphigoid	18.38	11.96	36	43139	8630	34905126
Disturbance in attention	18.35	11.96	72	43103	25873	34887883
Blood pressure diastolic abnormal	18.30	11.96	26	43149	4792	34908964
Hypersexuality	18.29	11.96	15	43160	1478	34912278
Device malfunction	18.24	11.96	40	43135	10381	34903375
Acute kidney injury	18.18	11.96	499	42676	304489	34609267
Depressed level of consciousness	17.89	11.96	102	43073	42739	34871017
Reduced facial expression	17.82	11.96	13	43162	1078	34912678
Drug resistance	17.75	11.96	5	43170	25922	34887834
Infected dermal cyst	17.74	11.96	12	43163	882	34912874
Acute respiratory failure	17.70	11.96	8	43167	30920	34882836
Respiratory depression	17.60	11.96	52	43123	16193	34897563
Normochromic normocytic anaemia	17.57	11.96	24	43151	4263	34909493
Ischaemic stroke	17.52	11.96	56	43119	18194	34895562
Phlebotomy	17.48	11.96	6	43169	93	34913663
Hemiplegia	17.33	11.96	31	43144	6941	34906815
Blepharospasm	17.33	11.96	13	43162	1125	34912631
Blood pressure systolic increased	17.30	11.96	65	43110	22887	34890869
Cardiac arrest	17.16	11.96	61	43114	96098	34817658
Pyrexia	17.10	11.96	299	42876	332714	34581042
Phonophobia	17.08	11.96	7	43168	181	34913575
Band neutrophil percentage increased	16.81	11.96	6	43169	105	34913651
Capillary fragility	16.75	11.96	5	43170	48	34913708
Intentional device misuse	16.52	11.96	7	43168	197	34913559
Chronic kidney disease	16.40	11.96	16	43159	41194	34872562
Anal haemorrhage	16.37	11.96	18	43157	2560	34911196
Loss of consciousness	16.34	11.96	165	43010	82502	34831254
Urine leukocyte esterase positive	16.23	11.96	9	43166	462	34913294
Therapeutic response decreased	16.14	11.96	8	43167	29305	34884451
COVID-19	16.07	11.96	46	43129	77504	34836252
Blood pressure diastolic decreased	16.02	11.96	35	43140	9059	34904697
Hypersensitivity	15.99	11.96	32	43143	61003	34852753
Blood cholesterol decreased	15.86	11.96	12	43163	1052	34912704
Pain	15.82	11.96	169	43006	204506	34709250
Conjunctival hyperaemia	15.65	11.96	17	43158	2385	34911371
Implant site infection	15.60	11.96	12	43163	1078	34912678
General symptom	15.50	11.96	11	43164	873	34912883
Bacillus bacteraemia	15.31	11.96	5	43170	66	34913690
Double inlet left ventricle	15.04	11.96	4	43171	24	34913732
Blood glucose increased	15.01	11.96	38	43137	66680	34847076
Respiratory arrest	14.92	11.96	8	43167	28035	34885721
Disease prodromal stage	14.90	11.96	4	43171	25	34913731
Urogenital haemorrhage	14.78	11.96	10	43165	735	34913021
Hallucination, auditory	14.72	11.96	40	43135	11877	34901879
Hemivertebra	14.71	11.96	6	43169	153	34913603
Mean cell haemoglobin concentration increased	14.68	11.96	8	43167	397	34913359
Obsessive thoughts	14.66	11.96	10	43165	745	34913011
Bone marrow failure	14.63	11.96	9	43166	29244	34884512
Cough	14.61	11.96	117	43058	150023	34763733
pH urine increased	14.48	11.96	5	43170	79	34913677
Pancreatitis	14.46	11.96	16	43159	38875	34874881
Clumsiness	14.44	11.96	14	43161	1718	34912038
Wrong technique in product usage process	14.28	11.96	14	43161	35972	34877784
Congenital hand malformation	14.28	11.96	9	43166	586	34913170
Dermatitis psoriasiform	14.21	11.96	13	43162	1483	34912273
Obsessive-compulsive disorder	14.16	11.96	25	43150	5539	34908217
Product prescribing error	14.14	11.96	61	43114	22866	34890890
Sensorimotor disorder	14.02	11.96	8	43167	434	34913322
Gamma-glutamyltransferase increased	13.82	11.96	72	43103	29159	34884597
Intra-abdominal fluid collection	13.82	11.96	12	43163	1279	34912477
Perineal pain	13.77	11.96	10	43165	823	34912933
Univentricular heart	13.63	11.96	4	43171	36	34913720
Spleen congestion	13.62	11.96	7	43168	308	34913448
Dermal cyst	13.56	11.96	14	43161	1853	34911903
Heart rate decreased	13.53	11.96	76	43099	31669	34882087
Electrocardiogram abnormal	13.44	11.96	33	43142	9214	34904542
Body temperature decreased	13.44	11.96	41	43134	12993	34900763
Psychiatric symptom	13.40	11.96	19	43156	3494	34910262
Blood creatinine increased	13.38	11.96	66	43109	94910	34818846
Speech disorder	13.36	11.96	65	43110	25621	34888135
Peripheral swelling	13.36	11.96	49	43126	76492	34837264
Neutrophil count increased	13.29	11.96	49	43126	17097	34896659
Oxygen saturation decreased	12.93	11.96	112	43063	53706	34860050
Candida infection	12.92	11.96	3	43172	17712	34896044
Dysuria	12.92	11.96	67	43108	27085	34886671
Diabetic coma	12.91	11.96	10	43165	907	34912849
Exhibitionism	12.91	11.96	4	43171	44	34913712
Mania	12.84	11.96	33	43142	9478	34904278
Joint swelling	12.80	11.96	35	43140	59855	34853901
Bradyphrenia	12.79	11.96	22	43153	4776	34908980
Incoherent	12.64	11.96	21	43154	4431	34909325
Tendon pain	12.63	11.96	17	43158	2978	34910778
Snoring	12.62	11.96	18	43157	3328	34910428
Erythrosis	12.58	11.96	5	43170	119	34913637
Abdominal compartment syndrome	12.57	11.96	10	43165	943	34912813
Differential white blood cell count abnormal	12.56	11.96	12	43163	1447	34912309
Red blood cell burr cells present	12.52	11.96	4	43171	49	34913707
Rash pruritic	12.51	11.96	9	43166	26932	34886824
Reading disorder	12.46	11.96	8	43167	538	34913218
Microvascular coronary artery disease	12.30	11.96	4	43171	52	34913704
Onychomycosis	12.29	11.96	15	43160	2385	34911371
Mean cell haemoglobin concentration decreased	12.24	11.96	11	43164	1226	34912530
Neuropathy peripheral	12.23	11.96	57	43118	83206	34830550
Brain stem syndrome	12.21	11.96	8	43167	557	34913199
Tachycardia	12.17	11.96	159	43016	84613	34829143
Hypercapnia	11.99	11.96	20	43155	4235	34909521

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
Coma	934.82	10.45	1007	137295	99642	79506444
Poisoning deliberate	798.09	10.45	463	137839	18365	79587721
Intentional overdose	575.22	10.45	809	137493	105151	79500935
Intentional self-injury	363.13	10.45	359	137943	32060	79574026
Somnolence	361.79	10.45	1071	137231	237910	79368176
Lower respiratory tract infection	339.49	10.45	715	137587	128505	79477581
Depression	339.05	10.45	983	137319	215807	79390279
Ear pain	235.71	10.45	288	138014	32581	79573505
Muscle spasticity	226.11	10.45	230	138072	21245	79584841
Suicide attempt	208.59	10.45	451	137851	82481	79523605
Pneumonia aspiration	204.93	10.45	395	137907	66572	79539514
Miosis	195.90	10.45	185	138117	15604	79590482
Toxicity to various agents	182.86	10.45	1304	136998	420236	79185850
Product dose omission issue	175.42	10.45	106	138196	247431	79358655
Muscle injury	169.32	10.45	303	137999	48258	79557828
Folliculitis	167.41	10.45	325	137977	55055	79551031
Body temperature increased	166.34	10.45	286	138016	44134	79561952
Respiratory disorder	160.41	10.45	283	138019	44573	79561513
Ill-defined disorder	159.67	10.45	353	137949	65522	79540564
Confusional state	157.66	10.45	1017	137285	316980	79289106
Cardiac failure congestive	151.81	10.45	31	138271	142371	79463715
Psychiatric decompensation	148.40	10.45	90	138212	3873	79602213
Suicidal ideation	144.91	10.45	372	137930	75968	79530118
Drug interaction	144.24	10.45	1220	137082	413963	79192123
Night sweats	137.53	10.45	289	138013	51806	79554280
Irritable bowel syndrome	131.52	10.45	316	137986	61925	79544161
Electric shock	128.73	10.45	58	138244	1336	79604750
Sleep disorder due to general medical condition, insomnia type	128.46	10.45	253	138049	43303	79562783
Death	126.12	10.45	530	137772	565984	79040102
Sinusitis	114.39	10.45	653	137649	194848	79411238
Psychomotor skills impaired	109.74	10.45	83	138219	5154	79600932
Depression suicidal	108.43	10.45	73	138229	3769	79602317
Hypothermia	103.53	10.45	160	138142	22586	79583500
Hepatocellular injury	103.10	10.45	244	138058	47349	79558737
Depressive symptom	98.89	10.45	85	138217	6338	79599748
Mental status changes	95.45	10.45	5	138297	66954	79539132
Insomnia	93.92	10.45	737	137565	244433	79361653
Electrocardiogram QT prolonged	92.90	10.45	356	137946	90030	79516056
Disease progression	90.41	10.45	112	138190	184250	79421836
Respiratory failure	89.67	10.45	109	138193	180802	79425284
Myocardial infarction	89.10	10.45	113	138189	184016	79422070
Gastrointestinal disorder	87.75	10.45	432	137870	121773	79484313
Akathisia	86.76	10.45	111	138191	13148	79592938
Duodenal ulcer perforation	84.50	10.45	280	138022	65931	79540155
Impaired healing	84.22	10.45	338	137964	87317	79518769
Altered state of consciousness	82.58	10.45	213	138089	43609	79562477
Sepsis	81.77	10.45	220	138082	269208	79336878
Drug dependence	80.82	10.45	202	138100	40567	79565519
Post-traumatic stress disorder	80.08	10.45	67	138235	4814	79601272
Tearfulness	79.16	10.45	73	138229	5972	79600114
Overdose	77.98	10.45	567	137735	183639	79422447
Blister	76.47	10.45	409	137893	119067	79487019
Helicobacter infection	74.48	10.45	278	138024	69426	79536660
Asphyxia	73.38	10.45	96	138206	11624	79594462
Antipsychotic drug level increased	72.37	10.45	69	138233	5888	79600198
Neovascularisation	70.29	10.45	37	138265	1208	79604878
Sleep disorder	69.62	10.45	314	137988	85363	79520723
Contusion	69.44	10.45	469	137833	148307	79457779
Depressed level of consciousness	68.90	10.45	341	137961	96311	79509775
Urine leukocyte esterase positive	68.87	10.45	57	138245	4034	79602052
Intervertebral discitis	66.54	10.45	60	138242	4768	79601318
Drug ineffective	65.28	10.45	1405	136897	1079508	78526578
Injection site pain	64.56	10.45	78	138224	129760	79476326
Blood mercury abnormal	62.28	10.45	21	138281	213	79605873
Pneumonia	61.55	10.45	792	137510	659454	78946632
Housebound	61.09	10.45	25	138277	451	79605635
5-hydroxyindolacetic acid in urine increased	60.19	10.45	21	138281	238	79605848
Urticaria	59.84	10.45	536	137766	184665	79421421
Lupus vasculitis	59.83	10.45	26	138276	548	79605538
Paranoia	58.65	10.45	114	138188	19318	79586768
Neuroleptic malignant syndrome	58.29	10.45	140	138162	27419	79578667
Nasopharyngitis	58.26	10.45	685	137617	253196	79352890
COVID-19	57.22	10.45	117	138185	157557	79448529
Coronary artery disease	57.14	10.45	21	138281	65453	79540633
Somnambulism	56.12	10.45	59	138243	5662	79600424
Depressed mood	55.71	10.45	198	138104	48282	79557804
Renal failure	55.18	10.45	172	138130	200796	79405290
Vocal cord dysfunction	54.93	10.45	25	138277	590	79605496
Drug resistance	54.81	10.45	5	138297	42208	79563878
Behaviour disorder	54.73	10.45	61	138241	6252	79599834
Incorrect route of product administration	54.08	10.45	158	138144	34771	79571315
Thrombosis	51.61	10.45	42	138260	84058	79522028
Cardiac arrest	51.07	10.45	142	138160	171954	79434132
Wrong technique in product usage process	50.39	10.45	33	138269	73842	79532244
Skin candida	50.32	10.45	36	138266	2051	79604035
Broncholithiasis	50.08	10.45	18	138284	224	79605862
Renal impairment	50.01	10.45	126	138176	157657	79448429
Completed suicide	49.68	10.45	238	138064	245529	79360557
Cholestasis	49.29	10.45	200	138102	51909	79554177
Psychotic disorder	49.22	10.45	171	138131	41231	79564855
Low density lipoprotein decreased	49.01	10.45	29	138273	1192	79604894
Prescription form tampering	48.31	10.45	20	138282	372	79605714
Rheumatoid arthritis	48.04	10.45	563	137739	207907	79398179
Myelosuppression	46.79	10.45	7	138295	40289	79565797
Peripheral swelling	45.47	10.45	688	137614	268929	79337157
Contraindicated product administered	44.91	10.45	444	137858	157094	79448992
Dystonic tremor	44.23	10.45	16	138286	203	79605883
Temperature intolerance	43.79	10.45	68	138234	9637	79596449
Demyelination	43.08	10.45	61	138241	7962	79598124
Foetal death	42.95	10.45	61	138241	7983	79598103
Obstructive airways disorder	42.80	10.45	136	138166	31323	79574763
Granulocyte count increased	42.58	10.45	27	138275	1258	79604828
Deep vein thrombosis	41.96	10.45	92	138210	120827	79485259
White blood cell count decreased	41.85	10.45	176	138126	188112	79417974
Laryngeal stenosis	41.49	10.45	25	138277	1063	79605023
Extrapyramidal disorder	41.45	10.45	109	138193	22570	79583516
Infusion related reaction	40.96	10.45	593	137709	229644	79376442
Lymph node calcification	40.67	10.45	18	138284	397	79605689
Osmolar gap increased	40.64	10.45	13	138289	110	79605976
Chronic kidney disease	40.64	10.45	33	138269	66121	79539965
Blood glucose increased	40.29	10.45	87	138215	114888	79491198
Sputum discoloured	40.25	10.45	105	138197	21638	79584448
Gastrointestinal haemorrhage	40.13	10.45	127	138175	147592	79458494
Decompression sickness	39.75	10.45	12	138290	82	79606004
Multiple organ dysfunction syndrome	39.69	10.45	94	138208	120152	79485934
Bladder dilatation	38.78	10.45	31	138271	2088	79603998
Post cholecystectomy syndrome	38.41	10.45	17	138285	375	79605711
White blood cells urine positive	38.40	10.45	50	138252	6025	79600061
Cytomegalovirus infection	38.37	10.45	13	138289	42631	79563455
Cryopyrin associated periodic syndrome	38.12	10.45	17	138285	382	79605704
Platelet count decreased	37.89	10.45	191	138111	194473	79411613
Burnout syndrome	37.59	10.45	16	138286	320	79605766
Atrial fibrillation	37.48	10.45	196	138106	197690	79408396
Stomatitis	37.26	10.45	404	137898	146353	79459733
Bronchial wall thickening	36.75	10.45	33	138269	2608	79603478
Injection site reaction	36.65	10.45	25	138277	54760	79551326
Monocyte percentage increased	36.40	10.45	30	138272	2111	79603975
Acute respiratory failure	36.20	10.45	30	138272	59511	79546575
Disturbance in attention	36.02	10.45	179	138123	50622	79555464
Loss of personal independence in daily activities	35.77	10.45	302	138000	102278	79503808
Hypervolaemia	35.10	10.45	15	138287	42675	79563411
Product quality issue	34.91	10.45	8	138294	33932	79572154
Pulmonary hypertension	34.85	10.45	20	138282	48060	79558026
Pain in extremity	34.35	10.45	436	137866	364102	79241984
Drug abuse	34.25	10.45	432	137870	162259	79443827
Pruritus	34.12	10.45	911	137391	393737	79212349
Hepatic cytolysis	33.90	10.45	114	138188	27037	79579049
Injection site erythema	33.80	10.45	52	138250	78145	79527941
Neutrophil count increased	33.72	10.45	120	138182	29276	79576810
Cerebral artery thrombosis	33.50	10.45	22	138280	1089	79604997
Neutropenia	33.47	10.45	328	137974	287382	79318704
Balance disorder	33.40	10.45	289	138013	98568	79507518
Postmortem blood drug level abnormal	32.90	10.45	18	138284	636	79605450
Pericarditis	32.78	10.45	300	138002	103936	79502150
Calcium deficiency	32.59	10.45	20	138282	879	79605207
Carcinoid tumour pulmonary	32.39	10.45	15	138287	369	79605717
Anti-cyclic citrullinated peptide antibody positive	32.36	10.45	251	138051	82892	79523194
Coagulopathy	32.36	10.45	11	138291	35995	79570091
Ascites	31.94	10.45	51	138251	75511	79530575
Neutrophil percentage increased	31.86	10.45	40	138262	4649	79601437
Psychomotor retardation	31.71	10.45	46	138256	6138	79599948
Weight increased	31.50	10.45	665	137637	276721	79329365
Red blood cells urine	31.44	10.45	18	138284	695	79605391
Alcohol poisoning	30.98	10.45	40	138262	4781	79601305
X-ray abnormal	30.92	10.45	44	138258	5769	79600317
Post-traumatic neck syndrome	30.80	10.45	27	138275	2067	79604019
Choking	30.61	10.45	66	138236	12035	79594051
Injection site pruritus	30.06	10.45	18	138284	42265	79563821
Lymphocyte percentage decreased	29.98	10.45	40	138262	4936	79601150
Deep vein thrombosis postoperative	29.95	10.45	61	138241	10691	79595395
Gastrooesophageal reflux disease	29.79	10.45	294	138008	103952	79502134
Therapy cessation	29.63	10.45	14	138288	37548	79568538
Mydriasis	29.44	10.45	82	138220	17561	79588525
Medication error	29.42	10.45	212	138090	68430	79537656
Brain scan abnormal	29.27	10.45	21	138281	1202	79604884
Hyponatraemia	29.25	10.45	452	137850	177396	79428690
Respiratory arrest	29.21	10.45	34	138268	57516	79548570
Therapy interrupted	29.18	10.45	9	138293	31332	79574754
Neurotoxicity	29.11	10.45	10	138292	32508	79573578
Total lung capacity decreased	28.57	10.45	30	138272	2875	79603211
Blood immunoglobulin A increased	28.51	10.45	19	138283	964	79605122
Bradypnoea	28.14	10.45	43	138259	6009	79600077
Blood calcium decreased	28.11	10.45	10	138292	31809	79574277
Gallbladder adenocarcinoma	27.93	10.45	10	138292	123	79605963
Band neutrophil percentage increased	27.83	10.45	14	138288	415	79605671
Joint swelling	27.77	10.45	676	137626	287970	79318116
Arteriovenous fistula	27.36	10.45	21	138281	1333	79604753
Bronchopulmonary aspergillosis allergic	27.27	10.45	30	138272	3031	79603055
Colitis ulcerative	27.22	10.45	126	138176	34616	79571470
Excessive eye blinking	27.19	10.45	23	138279	1678	79604408
Injection site swelling	27.14	10.45	25	138277	47107	79558979
Macrophages increased	26.93	10.45	12	138290	269	79605817
Postmortem blood drug level increased	26.81	10.45	17	138285	792	79605294
Sopor	26.51	10.45	12	138290	32998	79573088
Aspartate aminotransferase	26.47	10.45	15	138287	568	79605518
Dyspnoea exertional	26.45	10.45	71	138231	87002	79519084
Blood test abnormal	26.36	10.45	79	138223	17631	79588455
Soft tissue injury	26.27	10.45	23	138279	1758	79604328
Agitation	26.00	10.45	276	138026	99439	79506647
Lupus nephritis	25.97	10.45	29	138273	2979	79603107
Unevaluable event	25.95	10.45	35	138267	55550	79550536
Haemoglobin urine	25.94	10.45	10	138292	153	79605933
Diaphragmatic rupture	25.84	10.45	11	138291	220	79605866
Angina pectoris	25.79	10.45	31	138271	51701	79554385
General physical health deterioration	25.70	10.45	642	137660	274596	79331490
Anxiety	25.42	10.45	587	137715	247925	79358161
Glomerular filtration rate increased	24.95	10.45	19	138283	1192	79604894
Blood creatinine increased	24.86	10.45	162	138140	154895	79451191
No adverse event	24.84	10.45	17	138285	37175	79568911
Anaemia	24.82	10.45	585	137717	444430	79161656
Cellulitis	24.81	10.45	101	138201	108959	79497127
Multiple sclerosis	24.74	10.45	90	138212	22192	79583894
Puncture site haematoma	24.72	10.45	10	138292	175	79605911
Feelings of worthlessness	24.52	10.45	14	138288	538	79605548
Injection site bruising	24.51	10.45	21	138281	40981	79565105
Hepatotoxicity	24.32	10.45	32	138270	51320	79554766
Cerebral infarction	24.26	10.45	26	138276	45650	79560436
Abdominal pain upper	24.25	10.45	533	137769	223286	79382800
Aspartate aminotransferase increased	24.23	10.45	141	138161	138500	79467586
Hospitalisation	24.22	10.45	83	138219	94153	79511933
Liver function test abnormal	24.10	10.45	47	138255	64428	79541658
Libido increased	23.97	10.45	23	138279	1978	79604108
Prescribed overdose	23.75	10.45	129	138173	37754	79568332
Drug hypersensitivity	23.70	10.45	370	137932	298546	79307540
Posterior reversible encephalopathy syndrome	23.67	10.45	8	138294	26273	79579813
Pemphigus	23.38	10.45	270	138032	99312	79506774
Middle insomnia	23.27	10.45	71	138231	15998	79590088
Abortion spontaneous	23.27	10.45	11	138291	29496	79576590
Staphylococcal infection	23.11	10.45	41	138261	58254	79547832
Concussion	23.10	10.45	51	138251	9452	79596634
Toxic skin eruption	23.05	10.45	88	138214	22205	79583881
Frequent bowel movements	23.05	10.45	107	138195	29432	79576654
Aspergillus infection	23.02	10.45	3	138299	19158	79586928
Hostility	22.97	10.45	24	138278	2286	79603800
Drug detoxification	22.82	10.45	12	138290	391	79605695
Accidental exposure to product	22.74	10.45	13	138289	31309	79574777
Coma scale abnormal	22.73	10.45	48	138254	8630	79597456
Atelectasis	22.56	10.45	14	138288	32243	79573843
Pemphigoid	22.49	10.45	68	138234	15247	79590839
Serum ferritin abnormal	22.27	10.45	12	138290	411	79605675
Glossodynia	22.00	10.45	275	138027	103062	79503024
Osteomyelitis	21.98	10.45	15	138287	32850	79573236
Obsessive-compulsive disorder	21.97	10.45	38	138264	5889	79600197
Throat clearing	21.91	10.45	25	138277	2629	79603457
Disseminated intravascular coagulation	21.86	10.45	18	138284	35824	79570262
Surgery	21.85	10.45	15	138287	32751	79573335
Band neutrophil count increased	21.63	10.45	14	138288	676	79605410
Ligament pain	21.52	10.45	10	138292	248	79605838
Haemodialysis	21.46	10.45	3	138299	18165	79587921
Hepatic neoplasm	21.35	10.45	28	138274	3398	79602688
Dry mouth	21.27	10.45	240	138062	87779	79518307
Specific gravity urine increased	21.18	10.45	12	138290	454	79605632
Blood pressure systolic increased	21.16	10.45	193	138109	66793	79539293
Infection	21.15	10.45	559	137743	241153	79364933
Full blood count decreased	21.15	10.45	10	138292	26809	79579277
Presyncope	21.11	10.45	24	138278	41030	79565056
Bursitis	21.10	10.45	120	138182	35724	79570362
Urine abnormality	20.99	10.45	45	138257	8174	79597912
Proctitis	20.97	10.45	39	138263	6393	79599693
Heart rate decreased	20.91	10.45	200	138102	70116	79535970
Psychiatric symptom	20.90	10.45	41	138261	6994	79599092
Septic shock	20.87	10.45	126	138176	122675	79483411
Malignant neoplasm progression	20.83	10.45	144	138158	135846	79470240
Vaginal flatulence	20.83	10.45	24	138278	2551	79603535
Alanine aminotransferase increased	20.76	10.45	181	138121	162389	79443697
Myocarditis septic	20.54	10.45	6	138296	36	79606050
Cardiac failure	20.40	10.45	171	138131	154671	79451415
Rheumatoid nodule	20.31	10.45	3	138299	17435	79588651
Haematuria	20.26	10.45	57	138245	68779	79537307
Therapy partial responder	20.25	10.45	3	138299	17394	79588692
Cerebrovascular accident	20.23	10.45	172	138130	155120	79450966
Condition aggravated	20.22	10.45	689	137613	500435	79105651
Bone marrow failure	20.21	10.45	36	138266	51071	79555015
Chills	20.20	10.45	179	138123	160055	79446031
Post procedural complication	20.19	10.45	8	138294	23821	79582265
Plasma cell myeloma	19.75	10.45	39	138263	53220	79552866
Hepatic function abnormal	19.74	10.45	63	138239	73044	79533042
Fear of disease	19.69	10.45	17	138285	1275	79604811
Nightmare	19.68	10.45	93	138209	25768	79580318
Accessory spleen	19.67	10.45	9	138293	215	79605871
International normalised ratio increased	19.56	10.45	78	138224	84643	79521443
Paraneoplastic rash	19.48	10.45	7	138295	87	79605999
Implant site extravasation	19.46	10.45	14	138288	805	79605281
Hyperthermia	19.31	10.45	72	138230	17965	79588121
Coordination abnormal	19.28	10.45	70	138232	17242	79588844
Nausea	19.27	10.45	1415	136887	955781	78650305
Transient ischaemic attack	19.19	10.45	39	138263	52656	79553430
Adjustment disorder with depressed mood	19.04	10.45	46	138256	9040	79597046
Toxicologic test abnormal	18.94	10.45	17	138285	1343	79604743
Lactic acidosis	18.93	10.45	196	138106	70163	79535923
Fungal infection	18.78	10.45	27	138275	41721	79564365
Epistaxis	18.64	10.45	115	138187	111400	79494686
Myelocyte percentage increased	18.59	10.45	9	138293	245	79605841
Creatinine renal clearance decreased	18.53	10.45	5	138297	18997	79587089
Bilirubin urine present	18.44	10.45	10	138292	347	79605739
Product storage error	18.43	10.45	3	138299	16223	79589863
Blood immunoglobulin E increased	18.35	10.45	35	138267	5847	79600239
Malignant polyp	18.35	10.45	8	138294	170	79605916
Discomfort	18.31	10.45	313	137989	125304	79480782
Respiratory tract haemorrhage	18.24	10.45	19	138283	1804	79604282
Hallucination	18.17	10.45	228	138074	85517	79520569
Scrotal infection	18.15	10.45	12	138290	601	79605485
Inappropriate antidiuretic hormone secretion	18.15	10.45	92	138210	26221	79579865
Oedema	18.13	10.45	127	138175	119453	79486633
Agranulocytosis	18.11	10.45	137	138165	44893	79561193
Optic nerve operation	18.02	10.45	11	138291	479	79605607
Paradoxical drug reaction	17.96	10.45	39	138263	7146	79598940
Respiratory depression	17.94	10.45	95	138207	27535	79578551
Sternal fracture	17.86	10.45	22	138280	2508	79603578
Mean cell haemoglobin concentration decreased	17.82	10.45	30	138272	4549	79601537
Gait deviation	17.69	10.45	6	138296	62	79606024
Distal intestinal obstruction syndrome	17.67	10.45	13	138289	774	79605312
Fluid retention	17.59	10.45	62	138240	69747	79536339
Ataxia	17.59	10.45	88	138214	24951	79581135
Cardio-respiratory arrest	17.57	10.45	113	138189	108397	79497689
Dysarthria	17.54	10.45	187	138115	67435	79538651
Myalgia	17.47	10.45	222	138080	185419	79420667
Pulmonary embolism	17.40	10.45	202	138100	171452	79434634
Tenosynovitis	17.39	10.45	3	138299	15551	79590535
Haemorrhage	17.38	10.45	90	138212	91028	79515058
Hallucination, synaesthetic	17.36	10.45	6	138296	66	79606020
Transplant rejection	17.36	10.45	6	138296	19431	79586655
Metastases to lung	17.30	10.45	5	138297	18158	79587928
Wrong rate	17.20	10.45	6	138296	68	79606018
Vasoplegia syndrome	17.17	10.45	26	138276	3604	79602482
Femoral artery aneurysm	17.15	10.45	8	138294	200	79605886
Acute myocardial infarction	17.11	10.45	72	138230	76964	79529122
Antidepressant drug level above therapeutic	17.08	10.45	12	138290	664	79605422
Ventricular tachycardia	17.07	10.45	29	138273	41906	79564180
Back pain	17.07	10.45	667	137635	303513	79302573
Red blood cell elliptocytes present	17.01	10.45	8	138294	204	79605882
Opiates positive	16.92	10.45	14	138288	990	79605096
Neutropenic sepsis	16.86	10.45	92	138210	26972	79579114
Tuberculosis	16.84	10.45	3	138299	15195	79590891
Blood pressure diastolic abnormal	16.82	10.45	72	138230	19130	79586956
Blood ethanol increased	16.82	10.45	12	138290	681	79605405
Diverticulitis	16.72	10.45	34	138268	45902	79560184
Hypoventilation	16.69	10.45	38	138264	7186	79598900
Vitamin B12 increased	16.57	10.45	15	138287	1198	79604888
Skin ulcer	16.56	10.45	44	138258	54106	79551980
Rheumatoid factor increased	16.49	10.45	18	138284	1803	79604283
Toxic epidermal necrolysis	16.47	10.45	133	138169	44448	79561638
Electrocardiogram repolarisation abnormality	16.47	10.45	20	138282	2247	79603839
Rash maculo-papular	16.43	10.45	159	138143	55919	79550167
Mania	16.41	10.45	69	138233	18191	79587895
Lung opacity	16.41	10.45	31	138271	5143	79600943
Diabetes mellitus	16.36	10.45	75	138227	78315	79527771
Urinary retention	16.31	10.45	160	138142	56470	79549616
Seizure	16.25	10.45	230	138072	188604	79417482
Antipsychotic drug level above therapeutic	16.18	10.45	19	138283	2061	79604025
Acute hepatic failure	16.15	10.45	17	138285	30096	79575990
Scratch	16.11	10.45	41	138261	8322	79597764
Respiratory tract infection	16.11	10.45	38	138264	48651	79557435
Ventricular fibrillation	16.05	10.45	19	138283	31907	79574179
Nodule	16.05	10.45	10	138292	22984	79583102
Pleural effusion	15.88	10.45	168	138134	145094	79460992
Mean cell haemoglobin decreased	15.81	10.45	34	138268	6190	79599896
Urine oxalate increased	15.79	10.45	8	138294	241	79605845
Blood pressure diastolic decreased	15.76	10.45	98	138204	30118	79575968
Procedural anxiety	15.74	10.45	12	138290	754	79605332
Bronchiolitis	15.72	10.45	27	138275	4161	79601925
Erythrosis	15.71	10.45	7	138295	157	79605929
Epstein-Barr virus infection	15.64	10.45	3	138299	14413	79591673
Drug monitoring procedure incorrectly performed	15.64	10.45	10	138292	473	79605613
Red cell distribution width increased	15.62	10.45	60	138242	15182	79590904
Drug eruption	15.59	10.45	33	138269	43902	79562184
Oxygen saturation decreased	15.49	10.45	312	137990	128735	79477351
Prostate cancer	15.48	10.45	21	138281	33247	79572839
Hypersensitivity vasculitis	15.47	10.45	36	138266	6907	79599179
Haematotoxicity	15.29	10.45	4	138298	15515	79590571
Perineal infection	15.19	10.45	12	138290	795	79605291
Bronchopulmonary aspergillosis	15.14	10.45	10	138292	22284	79583802
Product prescribing error	15.12	10.45	131	138171	44682	79561404
Restless legs syndrome	15.10	10.45	72	138230	20020	79586066
Phlebotomy	15.10	10.45	6	138296	100	79605986
Therapeutic reaction time decreased	15.06	10.45	24	138278	3477	79602609
Persecutory delusion	15.06	10.45	29	138273	4880	79601206
Drug level above therapeutic	15.01	10.45	41	138261	8682	79597404
Urinary tract infection	14.96	10.45	362	137940	274150	79331936
Tooth injury	14.91	10.45	18	138284	2010	79604076
Logorrhoea	14.91	10.45	27	138275	4338	79601748
Progressive multifocal leukoencephalopathy	14.89	10.45	73	138229	20527	79585559
Communication disorder	14.87	10.45	26	138276	4064	79602022
Urine analysis abnormal	14.74	10.45	34	138268	6486	79599600
Oliguria	14.62	10.45	5	138297	16304	79589782
Adrenal insufficiency	14.61	10.45	92	138210	28395	79577691
Systemic lupus erythematosus	14.57	10.45	293	138009	120856	79485230
Ventricular extrasystoles	14.56	10.45	8	138294	19696	79586390
Abdominal distension	14.49	10.45	135	138167	119515	79486571
Eye irritation	14.43	10.45	9	138293	20672	79585414
Menopause	14.39	10.45	18	138284	2084	79604002
Anhedonia	14.38	10.45	4	138298	14894	79591192
Neoplasm progression	14.33	10.45	44	138258	51638	79554448
Lymphadenopathy	14.30	10.45	46	138256	53201	79552885
Serotonin syndrome	14.22	10.45	36	138266	44991	79561095
Mucosal inflammation	14.22	10.45	75	138227	75505	79530581
Nephropathy toxic	14.09	10.45	9	138293	20410	79585676
Right ventricular failure	14.08	10.45	12	138290	23485	79582601
Hypertension	14.06	10.45	452	137850	330540	79275546
Electrocardiogram QRS complex shortened	14.05	10.45	11	138291	719	79605367
Therapeutic product effect decreased	14.05	10.45	378	137924	163485	79442601
Hallucination, auditory	14.02	10.45	72	138230	20621	79585465
Polymicrogyria	14.00	10.45	3	138299	3	79606083
Crystal urine present	14.00	10.45	18	138284	2142	79603944
Analgesic drug level increased	13.97	10.45	22	138280	3156	79602930
Substance abuse	13.86	10.45	45	138257	10481	79595605
Distributive shock	13.80	10.45	20	138282	2667	79603419
Prothrombin time prolonged	13.79	10.45	6	138296	16893	79589193
Bezoar	13.79	10.45	20	138282	2668	79603418
Retinal depigmentation	13.79	10.45	8	138294	317	79605769
Eosinophil count abnormal	13.77	10.45	11	138291	740	79605346
Glucocorticoids increased	13.74	10.45	6	138296	128	79605958
Post concussion syndrome	13.70	10.45	10	138292	588	79605498
Accommodation disorder	13.70	10.45	10	138292	588	79605498
Uveitis	13.70	10.45	6	138296	16824	79589262
Hepatic enzyme increased	13.65	10.45	414	137888	182196	79423890
Leukocytosis	13.53	10.45	35	138267	43420	79562666
Rash pruritic	13.52	10.45	71	138231	71558	79534528
Bradycardia	13.48	10.45	319	137983	135238	79470848
Headache	13.43	10.45	1312	136990	652460	78953626
Visual impairment	13.41	10.45	99	138203	92032	79514054
Activated partial thromboplastin time prolonged	13.40	10.45	4	138298	14224	79591862
Amyotrophy	13.38	10.45	10	138292	610	79605476
Tubulointerstitial nephritis	13.33	10.45	29	138273	38206	79567880
Poor quality sleep	13.33	10.45	76	138226	22646	79583440
Bacterial infection	13.32	10.45	21	138281	31259	79574827
Paternal exposure timing unspecified	13.31	10.45	5	138297	71	79606015
Appendicitis	13.24	10.45	10	138292	20784	79585302
Complement factor C4 decreased	13.24	10.45	8	138294	342	79605744
Coronary artery occlusion	13.21	10.45	5	138297	15310	79590776
Splenomegaly	13.19	10.45	10	138292	20744	79585342
Cardiac disorder	13.08	10.45	64	138238	65693	79540393
Hand deformity	13.06	10.45	253	138049	103666	79502420
Tongue disorder	13.03	10.45	4	138298	13971	79592115
Delirium febrile	13.00	10.45	5	138297	76	79606010
Infusion site scar	12.97	10.45	8	138294	355	79605731
Feeling abnormal	12.97	10.45	196	138106	159003	79447083
Dialysis	12.93	10.45	8	138294	18454	79587632
Pancreatitis	12.93	10.45	68	138234	68507	79537579
Reading disorder	12.93	10.45	12	138290	990	79605096
Arthritis	12.91	10.45	132	138170	114748	79491338
Poor venous access	12.90	10.45	64	138238	18085	79588001
Maternal exposure timing unspecified	12.87	10.45	30	138272	5762	79600324
Autoimmune disorder	12.83	10.45	60	138242	16552	79589534
Urine bilirubin decreased	12.79	10.45	6	138296	152	79605934
Swollen joint count	12.76	10.45	13	138289	1202	79604884
Ileus	12.75	10.45	16	138286	26195	79579891
Nystagmus	12.73	10.45	42	138260	9862	79596224
Disorganised speech	12.73	10.45	17	138285	2100	79603986
Device issue	12.72	10.45	17	138285	27091	79578995
Phonophobia	12.67	10.45	9	138293	507	79605579
Temperature regulation disorder	12.66	10.45	30	138272	5823	79600263
Tri-iodothyronine free decreased	12.63	10.45	8	138294	372	79605714
Antibody test abnormal	12.61	10.45	10	138292	666	79605420
Eye paraesthesia	12.58	10.45	6	138296	158	79605928
Panniculitis	12.55	10.45	3	138299	12368	79593718
Injection site warmth	12.50	10.45	5	138297	14802	79591284
Hypersexuality	12.49	10.45	15	138287	1665	79604421
Injection site mass	12.48	10.45	10	138292	20174	79585912
Myocardial depression	12.47	10.45	9	138293	520	79605566
Thrombotic microangiopathy	12.46	10.45	10	138292	20159	79585927
Diabetic coma	12.45	10.45	13	138289	1238	79604848
Encephalitis	12.44	10.45	5	138297	14755	79591331
Infected dermal cyst	12.39	10.45	13	138289	1245	79604841
Viral infection	12.38	10.45	36	138266	42980	79563106
Staphylococcal bacteraemia	12.33	10.45	3	138299	12215	79593871
Drug use disorder	12.32	10.45	38	138264	8613	79597473
Psychotic symptom	12.31	10.45	19	138283	2678	79603408
Labelled drug-food interaction medication error	12.31	10.45	6	138296	166	79605920
Female genital tract fistula	12.25	10.45	30	138272	5945	79600141
Therapeutic response decreased	12.21	10.45	67	138235	66786	79539300
Pharyngeal paraesthesia	12.18	10.45	19	138283	2702	79603384
Red blood cell sedimentation rate increased	12.12	10.45	40	138262	45902	79560184
Urine ketone body present	12.11	10.45	22	138280	3543	79602543
Enterococcal infection	12.10	10.45	6	138296	15654	79590432
Flank pain	12.06	10.45	10	138292	19834	79586252
Failed induction of labour	12.05	10.45	7	138295	278	79605808
Eosinophil percentage increased	12.03	10.45	14	138288	1504	79604582
Drug reaction with eosinophilia and systemic symptoms	12.01	10.45	167	138135	64077	79542009
Tenderness	11.96	10.45	14	138288	23628	79582458
Cardiac valve disease	11.96	10.45	29	138273	5712	79600374
Hyperbilirubinaemia	11.90	10.45	15	138287	24503	79581583
Social anxiety disorder	11.85	10.45	9	138293	562	79605524
Cholelithiasis	11.83	10.45	49	138253	52615	79553471
Spinal cord haemorrhage	11.81	10.45	9	138293	565	79605521
Angina unstable	11.80	10.45	7	138295	16520	79589566
Ischaemic stroke	11.79	10.45	98	138204	33033	79573053
Failure to thrive	11.77	10.45	3	138299	11841	79594245
Eye pruritus	11.74	10.45	11	138291	20559	79585527
Venoocclusive liver disease	11.66	10.45	3	138299	11768	79594318
Hyperlipidaemia	11.61	10.45	17	138285	26076	79580010
Fall	11.58	10.45	989	137313	486640	79119446
Chronic sinusitis	11.53	10.45	49	138253	12977	79593109
Hepatic encephalopathy	11.50	10.45	15	138287	24151	79581935
Tachycardia	11.46	10.45	396	137906	177372	79428714
Thirst decreased	11.44	10.45	7	138295	306	79605780
Myelodysplastic syndrome	11.40	10.45	22	138280	30279	79575807
Wound infection	11.40	10.45	76	138226	23915	79582171
pH urine increased	11.37	10.45	8	138294	444	79605642
Red blood cells urine positive	11.35	10.45	26	138276	4937	79601149
Hypercholesterolaemia	11.34	10.45	14	138288	23081	79583005
Exhibitionism	11.34	10.45	4	138298	47	79606039
Negative thoughts	11.25	10.45	13	138289	1386	79604700
Hallucination, visual	11.21	10.45	96	138206	32633	79573453
Hyperhidrosis	11.20	10.45	343	137959	151149	79454937
Diabetic hyperosmolar coma	11.17	10.45	10	138292	787	79605299
Incoherent	11.15	10.45	34	138268	7658	79598428
Rales	11.15	10.45	66	138236	19935	79586151
Platelet disorder	11.15	10.45	19	138283	2910	79603176
Spinal fracture	11.09	10.45	9	138293	18045	79588041
Alcohol abuse	11.08	10.45	27	138275	5336	79600750
Glycosylated haemoglobin increased	11.02	10.45	64	138238	19196	79586890
Myocardial ischaemia	11.00	10.45	17	138285	25502	79580584
Tooth hypoplasia	10.99	10.45	6	138296	211	79605875
Sinus tachycardia	10.98	10.45	105	138197	36803	79569283
Hypocoagulable state	10.98	10.45	16	138286	2143	79603943
Bacterial test	10.92	10.45	12	138290	1211	79604875
Treatment noncompliance	10.91	10.45	50	138252	52218	79553868
Coronary artery stenosis	10.90	10.45	4	138298	12480	79593606
Abulia	10.87	10.45	11	138291	1009	79605077
Disorientation	10.87	10.45	161	138141	62615	79543471
Spinal stenosis	10.84	10.45	7	138295	15784	79590302
Pneumonia fungal	10.84	10.45	3	138299	11207	79594879
Subarachnoid haemorrhage	10.83	10.45	16	138286	24449	79581637
Cutaneous lupus erythematosus	10.80	10.45	19	138283	2984	79603102
Malaise	10.78	10.45	988	137314	488881	79117205
Joint injury	10.73	10.45	24	138278	31311	79574775
Viral disease carrier	10.73	10.45	3	138299	15	79606071
Drug diversion	10.70	10.45	12	138290	1238	79604848
Red blood cell burr cells present	10.70	10.45	4	138298	56	79606030
Behavioural addiction	10.70	10.45	4	138298	56	79606030
Oesophageal carcinoma	10.65	10.45	3	138299	11081	79595005
Menopausal symptoms	10.65	10.45	15	138287	1948	79604138
Lacrimation increased	10.65	10.45	14	138288	22463	79583623
Occult blood	10.61	10.45	14	138288	1709	79604377
Intentional product use issue	10.61	10.45	342	137960	151770	79454316
Meningitis herpes	10.59	10.45	6	138296	227	79605859
Sinus rhythm	10.54	10.45	10	138292	848	79605238
Peripheral venous disease	10.54	10.45	55	138247	15854	79590232
End stage renal disease	10.53	10.45	4	138298	12216	79593870
Mixed liver injury	10.53	10.45	33	138269	7545	79598541
Optic nerve cupping	10.51	10.45	4	138298	59	79606027
Throat irritation	10.51	10.45	113	138189	40833	79565253
Osteonecrosis	10.50	10.45	24	138278	31071	79575015
Regurgitation	10.50	10.45	18	138284	2769	79603317
Bladder cancer	10.50	10.45	11	138291	19515	79586571
Dermatitis psoriasiform	10.47	10.45	18	138284	2776	79603310
Hypercalcaemia	10.46	10.45	33	138269	38397	79567689
Pulmonary thrombosis	10.46	10.45	4	138298	12167	79593919

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	N05CF01	NERVOUS SYSTEM PSYCHOLEPTICS HYPNOTICS AND SEDATIVES Benzodiazepine related drugs
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D002492	Central Nervous System Depressants
MeSH PA	D006993	Hypnotics and Sedatives
CHEBI has role	CHEBI:35488	central nervous system depressants
CHEBI has role	CHEBI:35717	hypnotics

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

Disease	Relation	SNOMED_ID	DOID
Insomnia	indication	193462001
Suicidal thoughts	contraindication	6471006
Asthenia	contraindication	13791008
Alcohol intoxication	contraindication	25702006
Depressive disorder	contraindication	35489007
Hepatic failure	contraindication	59927004
Sleep automatism	contraindication	247962006
Severe chronic obstructive pulmonary disease	contraindication	313299006

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	7.95	Basic
pKa2	2.26	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
GABA A receptor alpha-5/beta-2/gamma-3	Ion channel	P31644 P47870 Q99928	GBRA5_HUMAN GBRB2_HUMAN GBRG3_HUMAN	POSITIVE MODULATOR	Ki	6.75		WOMBAT-PK	DRUG LABEL
GABA-A receptor alpha-1/beta-2/gamma-2	Ion channel	P14867 P18507 P47870	GBRA1_HUMAN GBRG2_HUMAN GBRB2_HUMAN	POSITIVE MODULATOR	Ki	7.18		WOMBAT-PK	DRUG LABEL
GABA-A receptor alpha-5/beta-3/gamma-2	Ion channel	P18507 P28472 P31644	GBRG2_HUMAN GBRB3_HUMAN GBRA5_HUMAN	POSITIVE MODULATOR	Ki	7.28		WOMBAT-PK	DRUG LABEL
GABA-A receptor alpha-1/beta-2/gamma-3	Ion channel	P14867 P47870 Q99928	GBRA1_HUMAN GBRB2_HUMAN GBRG3_HUMAN	POSITIVE MODULATOR	Ki	7.16		WOMBAT-PK	DRUG LABEL
GABA A receptor alpha-3/beta-2/gamma-2	Ion channel	P18507 P34903 P47870	GBRG2_HUMAN GBRA3_HUMAN GBRB2_HUMAN	POSITIVE MODULATOR	Ki	6.58		WOMBAT-PK	DRUG LABEL
GABA A receptor alpha-3/beta-2/gamma-3	Ion channel	P34903 P47870 Q99928	GBRA3_HUMAN GBRB2_HUMAN GBRG3_HUMAN	POSITIVE MODULATOR	Ki	6.49		WOMBAT-PK	DRUG LABEL
GABA A receptor alpha-5/beta-3/gamma-3	Ion channel	P28472 P31644 Q99928	GBRB3_HUMAN GBRA5_HUMAN GBRG3_HUMAN	POSITIVE MODULATOR	Ki	6.75		WOMBAT-PK	DRUG LABEL
GABA A receptor alpha-5/beta-2/gamma-2	Ion channel	P18507 P31644 P47870	GBRG2_HUMAN GBRA5_HUMAN GBRB2_HUMAN	POSITIVE MODULATOR	Ki	7.28		WOMBAT-PK	DRUG LABEL
GABA-A receptor; anion channel	Ion channel		GBRP_RAT GBRB1_RAT GBRD_RAT GBRG2_RAT GBRA5_RAT GBRA3_RAT GBRG1_RAT GBRA2_RAT GBRA4_RAT GBRG3_RAT GBRA6_RAT GBRA1_RAT GBRB3_RAT GBRB2_RAT Q91ZM7_RAT GBRE_RAT		IC50	7.54		CHEMBL

External reference:

ID	Source
D01372	KEGG_DRUG
C1436328	UMLSCUI
CHEBI:53762	CHEBI
ZPC	PDB_CHEM_ID
CHEMBL135400	ChEMBL_ID
DB01198	DRUGBANK_ID
C515050	MESH_SUPPLEMENTAL_RECORD_UI
5735	PUBCHEM_CID
7430	IUPHAR_LIGAND_ID
4462	INN_ID
03A5ORL08Q	UNII
152527	RXNORM
003775	NDDF
321174005	SNOMEDCT_US
395929002	SNOMEDCT_US

Pharmaceutical products:

None