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

Stem definition	Drug id	CAS RN
diazepam derivatives	1802	59467-70-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: buccolam midazolam mezolam midazolam hydrochloride midazolam HCl	A short-acting hypnotic-sedative drug with anxiolytic and amnestic properties. It is used in dentistry, cardiac surgery, endoscopic procedures, as preanesthetic medication, and as an adjunct to local anesthesia. The short duration and cardiorespiratory stability makes it useful in poor-risk, elderly, and cardiac patients. It is water-soluble at pH less than 4 and lipid-soluble at physiological pH. Molecular weight: 325.77 Formula: C18H13ClFN3 CLOGP: 3.42 LIPINSKI: 0 HAC: 3 HDO: 0 TPSA: 30.18 ALOGS: -4.52 ROTB: 1 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

buccolam
midazolam
mezolam
midazolam hydrochloride
midazolam HCl

A short-acting hypnotic-sedative drug with anxiolytic and amnestic properties. It is used in dentistry, cardiac surgery, endoscopic procedures, as preanesthetic medication, and as an adjunct to local anesthesia. The short duration and cardiorespiratory stability makes it useful in poor-risk, elderly, and cardiac patients. It is water-soluble at pH less than 4 and lipid-soluble at physiological pH.

Molecular weight: 325.77
Formula: C18H13ClFN3
CLOGP: 3.42
LIPINSKI: 0
HAC: 3
HDO: 0
TPSA: 30.18
ALOGS: -4.52
ROTB: 1

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
5	mg	N
15	mg	O
15	mg	P
10	mg	SL

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	10.30 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	5.60 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.26 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	44 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	1.10 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	5.30 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.02 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	3.10 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company
Sept. 25, 2020	PMDA	TAKEDA PHARMACEUTICAL COMPANY LIMITED
Dec. 20, 1985	FDA
Sept. 4, 2011	EMA	Laboratorios Lesvi S.L.

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
Status epilepticus	344.76	16.00	159	29053	15074	63444736
Multiple-drug resistance	322.00	16.00	112	29100	5058	63454752
Serotonin syndrome	309.26	16.00	182	29030	28500	63431310
Hypotension	299.95	16.00	486	28726	272118	63187692
Cardiac arrest	255.62	16.00	261	28951	92284	63367526
Myoglobin urine present	207.69	16.00	52	29160	720	63459090
Anaphylactic reaction	198.21	16.00	195	29017	65905	63393905
Propofol infusion syndrome	195.22	16.00	52	29160	931	63458879
Toxic encephalopathy	175.31	16.00	77	29135	6502	63453308
Drug interaction	164.49	16.00	340	28872	228791	63231019
Fatigue	149.29	16.00	115	29097	887913	62571897
Drug ineffective	142.47	16.00	891	28321	1043874	62415936
Drug ineffective for unapproved indication	142.17	16.00	121	29091	33942	63425868
Joint swelling	132.62	16.00	4	29208	327662	63132148
Respiratory acidosis	130.10	16.00	63	29149	6652	63453158
Diabetes insipidus	130.00	16.00	48	29164	2577	63457233
Tachycardia	129.93	16.00	211	29001	117945	63341865
Metabolic acidosis	129.57	16.00	130	29082	44939	63414871
Seizure	126.16	16.00	222	28990	132412	63327398
Female genital tract fistula	125.94	16.00	64	29148	7495	63452315
Vaginal flatulence	122.89	16.00	49	29163	3244	63456566
Alopecia	121.04	16.00	9	29203	337527	63122283
Proctitis	120.58	16.00	56	29156	5385	63454425
Multiple organ dysfunction syndrome	119.75	16.00	139	29073	56613	63403197
Anaphylactic shock	115.45	16.00	92	29120	23541	63436269
Amylase increased	115.36	16.00	57	29155	6288	63453522
Labile blood pressure	112.32	16.00	39	29173	1750	63458060
Partial seizures	110.74	16.00	54	29158	5788	63454022
Blood creatine phosphokinase increased	110.73	16.00	100	29112	30330	63429480
Unwanted awareness during anaesthesia	107.26	16.00	26	29186	312	63459498
Generalised tonic-clonic seizure	106.86	16.00	96	29116	28920	63430890
Mitochondrial DNA mutation	106.45	16.00	27	29185	395	63459415
Encephalopathy	104.81	16.00	108	29104	38512	63421298
Circulatory collapse	104.17	16.00	84	29128	21854	63437956
Abdominal discomfort	103.37	16.00	13	29199	320872	63138938
Radiculopathy	98.99	16.00	57	29155	8554	63451256
Agitation	98.08	16.00	129	29083	59628	63400182
Swelling	96.85	16.00	8	29204	275370	63184440
Shock	95.14	16.00	82	29130	23381	63436429
Arthropathy	94.47	16.00	3	29209	234789	63225021
Frequent bowel movements	94.46	16.00	81	29131	22941	63436869
Intra-abdominal pressure increased	93.79	16.00	22	29190	227	63459583
Troponin increased	92.99	16.00	58	29154	10063	63449747
Bradycardia	89.05	16.00	137	29075	73090	63386720
Arthralgia	86.57	16.00	81	29131	569629	62890181
Oral candidiasis	85.07	16.00	76	29136	22722	63437088
Colitis	84.69	16.00	108	29104	48420	63411390
Anticholinergic syndrome	83.90	16.00	34	29178	2348	63457462
Unresponsive to stimuli	83.62	16.00	90	29122	33726	63426084
Systemic lupus erythematosus	82.87	16.00	3	29209	208915	63250895
Renal ischaemia	82.18	16.00	24	29188	609	63459201
Myoclonus	80.13	16.00	63	29149	15805	63444005
Drug intolerance	79.24	16.00	22	29190	308639	63151171
Respiratory failure	77.47	16.00	155	29057	101703	63358107
Respiratory depression	77.01	16.00	58	29154	13657	63446153
Peripheral swelling	76.08	16.00	15	29197	265927	63193883
Vaginal discharge	75.27	16.00	49	29163	9149	63450661
Pain	75.15	16.00	142	29070	740486	62719324
Systemic inflammatory response syndrome	74.91	16.00	41	29171	5580	63454230
Off label use	74.35	16.00	547	28665	673915	62785895
PCO2 increased	73.90	16.00	26	29186	1213	63458597
Apnoea	73.77	16.00	46	29166	7976	63451834
Fall	71.94	16.00	46	29166	392288	63067522
Oxygen saturation abnormal	71.06	16.00	34	29178	3495	63456315
Delirium	70.69	16.00	101	29111	50440	63409370
Ventricular hypokinesia	70.67	16.00	37	29175	4607	63455203
Pain in extremity	69.25	16.00	33	29179	331453	63128357
Pulseless electrical activity	68.84	16.00	43	29169	7478	63452332
Hepatic ischaemia	68.15	16.00	21	29191	643	63459167
Pneumatosis	67.72	16.00	19	29193	416	63459394
Colitis ulcerative	67.26	16.00	71	29141	26020	63433790
Necrosis ischaemic	66.80	16.00	22	29190	838	63458972
PO2 increased	66.33	16.00	22	29190	857	63458953
Delayed recovery from anaesthesia	65.06	16.00	21	29191	750	63459060
Blood pH decreased	64.80	16.00	29	29183	2558	63457252
CSF oligoclonal band present	64.68	16.00	18	29194	382	63459428
Blood gases abnormal	64.38	16.00	21	29191	776	63459034
Intestinal ischaemia	64.11	16.00	41	29171	7427	63452383
Blood lactate dehydrogenase increased	63.35	16.00	65	29147	23051	63436759
Blood potassium increased	62.37	16.00	58	29154	18251	63441559
Hepatic failure	61.65	16.00	79	29133	35577	63424233
Oxygen saturation decreased	60.52	16.00	129	29083	88456	63371354
Nasopharyngitis	60.08	16.00	21	29191	254236	63205574
Electrocardiogram QRS complex prolonged	59.58	16.00	36	29176	5902	63453908
Gene mutation	59.44	16.00	24	29188	1641	63458169
Contraindicated product administered	58.72	16.00	14	29198	217634	63242176
Weight increased	57.53	16.00	24	29188	260768	63199042
Diarrhoea	56.44	16.00	157	29055	715209	62744601
Blood lactic acid increased	56.16	16.00	37	29175	7049	63452761
Toxicity to various agents	55.47	16.00	243	28969	247007	63212803
Cardiogenic shock	53.87	16.00	53	29159	17879	63441931
Acute respiratory distress syndrome	53.60	16.00	60	29152	23474	63436336
Discomfort	53.31	16.00	7	29205	167367	63292443
Epilepsy	53.26	16.00	64	29148	27001	63432809
Renal impairment	52.84	16.00	122	29090	88233	63371577
Perforation	52.63	16.00	20	29192	1163	63458647
Anaesthetic complication neurological	52.59	16.00	14	29198	250	63459560
Anaesthetic complication	52.40	16.00	23	29189	1937	63457873
Foetal death	52.03	16.00	42	29170	10938	63448872
Haemodynamic instability	51.90	16.00	39	29173	9151	63450659
Pleocytosis	51.43	16.00	18	29194	827	63458983
Product dose omission issue	50.97	16.00	22	29190	234291	63225519
Neuromuscular block prolonged	50.84	16.00	16	29196	526	63459284
Sinusitis	49.75	16.00	21	29191	226632	63233178
Disseminated intravascular coagulation	49.38	16.00	52	29160	18999	63440811
Blood bicarbonate decreased	49.27	16.00	25	29187	2916	63456894
Altered state of consciousness	48.57	16.00	59	29153	25171	63434639
Brain oedema	48.41	16.00	45	29167	14150	63445660
Muscle relaxant therapy	47.86	16.00	12	29200	167	63459643
Ventricular extrasystoles	47.69	16.00	41	29171	11646	63448164
Dizziness	47.47	16.00	78	29134	429847	63029963
Epileptic aura	47.00	16.00	10	29202	63	63459747
Electroencephalogram abnormal	46.77	16.00	26	29186	3646	63456164
Nausea	45.95	16.00	220	28992	854251	62605559
Electrocardiogram ST segment elevation	45.15	16.00	26	29186	3901	63455909
Mydriasis	44.88	16.00	40	29172	11916	63447894
Bronchospasm	44.49	16.00	47	29165	17233	63442577
Posterior reversible encephalopathy syndrome	44.34	16.00	47	29165	17298	63442512
Oropharyngeal oedema	44.28	16.00	13	29199	336	63459474
Electrocardiogram ST segment depression	44.00	16.00	23	29189	2854	63456956
Anorectal ulcer	43.26	16.00	9	29203	50	63459760
Hepatorenal syndrome	43.16	16.00	20	29192	1912	63457898
Left ventricular dysfunction	42.82	16.00	39	29173	11949	63447861
Non-consummation	42.82	16.00	9	29203	53	63459757
Anaesthetic complication pulmonary	42.82	16.00	9	29203	53	63459757
Change in seizure presentation	41.82	16.00	13	29199	410	63459400
Arthritis	41.75	16.00	3	29209	115918	63343892
Cardiotoxicity	41.52	16.00	33	29179	8405	63451405
Diabetic macroangiopathy	41.03	16.00	10	29202	123	63459687
Malaise	40.95	16.00	81	29131	415873	63043937
Headache	40.79	16.00	152	29060	633089	62826721
Musculoskeletal stiffness	40.68	16.00	17	29195	184601	63275209
Patent ductus arteriosus	40.67	16.00	25	29187	4225	63455585
Intestinal infarction	40.49	16.00	16	29196	1034	63458776
Depressed level of consciousness	39.64	16.00	88	29124	61990	63397820
Hypoxia	39.59	16.00	86	29126	59706	63400104
Hepatic enzyme increased	39.44	16.00	22	29190	202306	63257504
Asthma	39.06	16.00	6	29206	127555	63332255
Ultrasound ovary abnormal	38.81	16.00	9	29203	88	63459722
Lower respiratory tract infection	38.79	16.00	7	29205	132300	63327510
Carcinoid crisis	38.61	16.00	11	29201	255	63459555
Unmasking of previously unidentified disease	38.08	16.00	15	29197	961	63458849
Hypernatraemia	37.96	16.00	30	29182	7579	63452231
Pseudopolyp	37.74	16.00	11	29201	277	63459533
Airway peak pressure increased	37.48	16.00	11	29201	284	63459526
Toxic epidermal necrolysis	37.44	16.00	52	29160	25282	63434528
Systolic dysfunction	37.12	16.00	17	29195	1582	63458228
Rectal haemorrhage	36.51	16.00	74	29138	48956	63410854
Sinus bradycardia	36.44	16.00	39	29173	14512	63445298
Arrhythmia	36.40	16.00	64	29148	38076	63421734
Stress cardiomyopathy	36.23	16.00	32	29180	9418	63450392
Contusion	36.10	16.00	12	29200	150032	63309778
Acute hepatic failure	35.51	16.00	43	29169	18284	63441526
Upper airway obstruction	35.34	16.00	13	29199	690	63459120
Macroglossia	35.31	16.00	13	29199	692	63459118
Sinus tachycardia	34.66	16.00	49	29163	24219	63435591
Hepatocellular injury	34.34	16.00	52	29160	27329	63432481
Hypertrophic cardiomyopathy	34.13	16.00	16	29196	1571	63458239
Acid base balance abnormal	34.05	16.00	10	29202	259	63459551
Device related sepsis	33.96	16.00	22	29190	4072	63455738
Alanine aminotransferase increased	33.91	16.00	115	29097	103655	63356155
Mixed liver injury	33.39	16.00	23	29189	4712	63455098
Intensive care unit acquired weakness	33.38	16.00	13	29199	808	63459002
Impaired healing	33.34	16.00	4	29208	102538	63357272
Back pain	32.93	16.00	44	29168	264101	63195709
Brain death	32.48	16.00	20	29192	3390	63456420
Acute coronary syndrome	32.42	16.00	31	29181	10095	63449715
Bulimia nervosa	32.35	16.00	11	29201	463	63459347
Epilepsy with myoclonic-atonic seizures	32.34	16.00	8	29204	105	63459705
Stevens-Johnson syndrome	32.17	16.00	48	29164	24902	63434908
Overdose	32.03	16.00	121	29091	114957	63344853
Encephalitis autoimmune	32.01	16.00	15	29197	1471	63458339
Asthenia	31.79	16.00	82	29130	383522	63076288
Abdominal pain upper	31.66	16.00	29	29183	206415	63253395
Infusion related reaction	31.53	16.00	40	29172	245481	63214329
Paradoxical drug reaction	31.26	16.00	21	29191	4131	63455679
Vulvovaginal candidiasis	31.21	16.00	19	29193	3156	63456654
Drug resistance	30.84	16.00	45	29167	22888	63436922
Hypersensitivity	30.53	16.00	55	29157	292630	63167180
Hypoaesthesia	30.45	16.00	20	29192	168373	63291437
Nail dystrophy	30.37	16.00	13	29199	1030	63458780
Stomatitis	30.19	16.00	13	29199	138712	63321098
Respiratory arrest	30.14	16.00	54	29158	32591	63427219
Electrocardiogram QT prolonged	30.02	16.00	77	29135	59453	63400357
Laryngeal stenosis	29.96	16.00	13	29199	1065	63458745
Neurotoxicity	29.92	16.00	38	29174	16952	63442858
Pseudomonas infection	29.76	16.00	31	29181	11182	63448628
Cardio-respiratory arrest	29.67	16.00	77	29135	59882	63399928
Intentional overdose	29.55	16.00	88	29124	74064	63385746
Tachyphylaxis	29.48	16.00	9	29203	267	63459543
Acidosis hyperchloraemic	29.43	16.00	10	29202	420	63459390
Tonic clonic movements	29.42	16.00	14	29198	1421	63458389
Clonus	29.17	16.00	21	29191	4615	63455195
Premature delivery	29.13	16.00	51	29161	30230	63429580
Muscle rigidity	29.11	16.00	31	29181	11469	63448341
Local anaesthetic systemic toxicity	28.83	16.00	12	29200	887	63458923
Dyschezia	28.56	16.00	16	29196	2278	63457532
Product administered to patient of inappropriate age	28.19	16.00	18	29194	3250	63456560
Hyperammonaemic encephalopathy	27.67	16.00	16	29196	2418	63457392
Gastrointestinal mucosa hyperaemia	27.58	16.00	8	29204	198	63459612
Drug reaction with eosinophilia and systemic symptoms	27.52	16.00	53	29159	33783	63426027
Oliguria	27.52	16.00	27	29185	9074	63450736
Blood cholesterol increased	27.50	16.00	5	29207	94027	63365783
Gastrointestinal scarring	27.27	16.00	9	29203	345	63459465
Palpitations	27.15	16.00	9	29203	112761	63347049
Procedural vomiting	27.15	16.00	10	29202	533	63459277
Anuria	26.88	16.00	31	29181	12520	63447290
Psoriasis	26.82	16.00	4	29208	86953	63372857
Intensive care unit delirium	26.73	16.00	6	29206	50	63459760
Bronchitis	26.72	16.00	12	29200	124923	63334887
Myoglobin blood increased	26.67	16.00	13	29199	1392	63458418
Pituitary apoplexy	26.24	16.00	7	29205	126	63459684
Adverse drug reaction	26.19	16.00	3	29209	79711	63380099
Gastrointestinal disorder	25.96	16.00	14	29198	131225	63328585
Procedural hypotension	25.60	16.00	12	29200	1178	63458632
Therapeutic product effect decreased	25.29	16.00	31	29181	193156	63266654
Hyperaesthesia	25.07	16.00	26	29186	9332	63450478
Restlessness	25.02	16.00	47	29165	29406	63430404
Tachypnoea	24.80	16.00	35	29177	17267	63442543
Loss of personal independence in daily activities	24.80	16.00	7	29205	97283	63362527
Musculoskeletal pain	24.74	16.00	6	29206	92271	63367539
Left ventricular hypertrophy	24.48	16.00	20	29192	5295	63454515
Electrocardiogram repolarisation abnormality	24.44	16.00	12	29200	1305	63458505
Acute respiratory failure	24.44	16.00	51	29161	34434	63425376
Pruritus	24.37	16.00	85	29127	361368	63098442
Euthyroid sick syndrome	24.24	16.00	6	29206	79	63459731
Lactic acidosis	24.13	16.00	54	29158	38233	63421577
Neurodevelopmental disorder	24.10	16.00	7	29205	174	63459636
Paralysis	23.85	16.00	26	29186	9874	63449936
Ventricular tachycardia	23.73	16.00	37	29175	19942	63439868
Rash	23.72	16.00	156	29056	560715	62899095
Pulmonary hypertensive crisis	23.54	16.00	8	29204	336	63459474
Delayed graft function	23.44	16.00	11	29201	1082	63458728
Drug-induced liver injury	23.44	16.00	55	29157	40167	63419643
Infection parasitic	23.38	16.00	8	29204	343	63459467
Myalgia	23.15	16.00	20	29192	146509	63313301
Myocardial ischaemia	23.02	16.00	29	29183	12830	63446980
Procedural pain	22.96	16.00	38	29174	21531	63438279
Acidosis	22.82	16.00	27	29185	11206	63448604
Irritable bowel syndrome	22.81	16.00	5	29207	82407	63377403
Sinus arrest	22.66	16.00	13	29199	1936	63457874
Atrioventricular dissociation	22.57	16.00	7	29205	219	63459591
Ill-defined disorder	22.55	16.00	5	29207	81750	63378060
Sleep disorder	22.47	16.00	5	29207	81561	63378249
Axillary pain	22.45	16.00	13	29199	1970	63457840
Hepatitis acute	22.06	16.00	24	29188	9096	63450714
Wrong product administered	21.97	16.00	20	29192	6121	63453689
Seizure cluster	21.93	16.00	7	29205	241	63459569
Coagulopathy	21.61	16.00	36	29176	20508	63439302
Haematemesis	21.57	16.00	45	29167	30367	63429443
Catheter site haemorrhage	21.40	16.00	15	29197	3160	63456650
Product use in unapproved indication	21.15	16.00	148	29064	178932	63280878
Mobility decreased	21.08	16.00	15	29197	121144	63338666
Dry mouth	21.00	16.00	5	29207	77858	63381952
Post procedural stroke	20.94	16.00	5	29207	56	63459754
Blood magnesium decreased	20.88	16.00	28	29184	13170	63446640
Encephalitis	20.84	16.00	23	29189	8857	63450953
Gaze palsy	20.71	16.00	11	29201	1409	63458401
Apnoeic attack	20.69	16.00	7	29205	290	63459520
Hypovolaemia	20.60	16.00	25	29187	10648	63449162
Symptom masked	20.59	16.00	9	29203	750	63459060
Nephrocalcinosis	20.54	16.00	10	29202	1068	63458742
Exposure during pregnancy	20.43	16.00	132	29080	155415	63304395
Gait disturbance	20.38	16.00	33	29179	183145	63276665
Granulomatous liver disease	20.38	16.00	9	29203	769	63459041
White matter lesion	20.34	16.00	12	29200	1883	63457927
Methaemoglobinaemia	20.15	16.00	13	29199	2390	63457420
Weight decreased	20.09	16.00	63	29149	276735	63183075
Hypoventilation	20.05	16.00	17	29195	4737	63455073
Procedural complication	20.02	16.00	18	29194	5421	63454389
Resuscitation	19.97	16.00	10	29202	1134	63458676
Chronic sinusitis	19.94	16.00	27	29185	12816	63446994
Haematochezia	19.88	16.00	62	29150	53482	63406328
Coma	19.86	16.00	70	29142	64294	63395516
Laryngospasm	19.70	16.00	14	29198	3014	63456796
Hyperdynamic left ventricle	19.59	16.00	6	29206	180	63459630
Hypokalaemia	19.53	16.00	97	29115	103707	63356103
Coronary artery embolism	19.40	16.00	6	29206	186	63459624
Therapeutic product effect prolonged	19.39	16.00	7	29205	352	63459458
Dyspnoea	19.29	16.00	203	29009	661110	62798700
Infection	18.95	16.00	49	29163	229124	63230686
Premature baby	18.76	16.00	34	29178	20701	63439109
Airway complication of anaesthesia	18.70	16.00	6	29206	210	63459600
Respiratory rate increased	18.67	16.00	27	29185	13621	63446189
White blood cell count decreased	18.54	16.00	22	29190	139082	63320728
C-reactive protein decreased	18.51	16.00	9	29203	958	63458852
Muscle spasms	18.46	16.00	27	29185	156123	63303687
Sepsis	18.34	16.00	127	29085	152996	63306814
Hypotonia	18.33	16.00	22	29190	9263	63450547
Ventricular dysfunction	18.23	16.00	13	29199	2815	63456995
Tonsillar hypertrophy	18.21	16.00	9	29203	992	63458818
Bronchopulmonary dysplasia	18.12	16.00	7	29205	426	63459384
Large intestinal ulcer	18.09	16.00	14	29198	3430	63456380
Pulmonary oedema	18.08	16.00	61	29151	54812	63404998
Intermittent claudication	18.06	16.00	11	29201	1828	63457982
Burkholderia test positive	17.96	16.00	6	29206	239	63459571
Inappropriate schedule of product administration	17.92	16.00	13	29199	103952	63355858
Coronary artery bypass	17.88	16.00	12	29200	2357	63457453
Foetal exposure during pregnancy	17.86	16.00	43	29169	31919	63427891
Stridor	17.85	16.00	14	29198	3496	63456314
Renal infarct	17.76	16.00	10	29202	1437	63458373
Drug level below therapeutic	17.71	16.00	16	29196	4850	63454960
Septic shock	17.66	16.00	69	29143	66560	63393250
Post procedural haemorrhage	17.61	16.00	20	29192	7944	63451866
Maternal exposure during delivery	17.43	16.00	10	29202	1490	63458320
Immunosuppressant drug level increased	17.41	16.00	14	29198	3624	63456186
Hypochloraemia	17.17	16.00	11	29201	1998	63457812
Abdominal rigidity	17.09	16.00	11	29201	2013	63457797
Gastrointestinal vascular malformation	17.08	16.00	4	29208	41	63459769
Ventricular fibrillation	17	16.00	24	29188	11843	63447967
Influenza	16.98	16.00	15	29197	108707	63351103
Cholestasis	16.88	16.00	40	29172	29394	63430416
Selective eating disorder	16.86	16.00	11	29201	2061	63457749
Oedema peripheral	16.86	16.00	39	29173	189472	63270338
Neonatal seizure	16.85	16.00	7	29205	515	63459295
Epileptic encephalopathy	16.83	16.00	6	29206	291	63459519
Neuromuscular blockade	16.81	16.00	6	29206	292	63459518
Injection site pain	16.80	16.00	21	29191	129779	63330031
Extremity necrosis	16.75	16.00	10	29202	1603	63458207
Hyperammonaemia	16.72	16.00	16	29196	5216	63454594
Hyperthermia malignant	16.68	16.00	8	29204	826	63458984
Influenza like illness	16.68	16.00	5	29207	66819	63392991
Therapeutic product effect variable	16.51	16.00	9	29203	1214	63458596
Migraine	16.45	16.00	14	29198	103332	63356478
Gastrooesophageal reflux disease	16.43	16.00	12	29200	95627	63364183
Rash morbilliform	16.35	16.00	13	29199	3312	63456498
Cytokine release syndrome	16.29	16.00	26	29186	14288	63445522
Teratoma	16.29	16.00	5	29207	151	63459659
Rapid eye movement sleep behaviour disorder	16.28	16.00	6	29206	320	63459490
Vasoplegia syndrome	16.27	16.00	10	29202	1689	63458121
Pneumonia fungal	16.15	16.00	16	29196	5439	63454371
Tracheal injury	16.14	16.00	4	29208	53	63459757
Anaphylactoid shock	16.09	16.00	6	29206	331	63459479
Procedural intestinal perforation	16.04	16.00	5	29207	159	63459651

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
Status epilepticus	265.26	14.33	149	27285	12465	34917032
Drug ineffective	229.47	14.33	830	26604	455921	34473576
Hyperthermia malignant	184.29	14.33	68	27366	2109	34927388
Hypotension	183.91	14.33	481	26953	221168	34708329
Drug reaction with eosinophilia and systemic symptoms	170.47	14.33	167	27267	32845	34896652
Multiple-drug resistance	161.68	14.33	80	27354	5159	34924338
Cardiac arrest	158.10	14.33	276	27158	95883	34833614
Anaphylactic reaction	142.31	14.33	150	27284	32151	34897346
Drug ineffective for unapproved indication	137.65	14.33	128	27306	23587	34905910
Bradycardia	133.81	14.33	224	27210	75194	34854303
Serotonin syndrome	130.24	14.33	115	27319	19818	34909679
Propofol infusion syndrome	119.42	14.33	40	27394	926	34928571
Diabetes insipidus	109.43	14.33	51	27383	2877	34926620
Myoclonus	104.35	14.33	89	27345	14636	34914861
Respiratory failure	103.72	14.33	249	27185	108323	34821174
Intensive care unit acquired weakness	101.60	14.33	36	27398	991	34928506
Hypoxia	100.83	14.33	166	27268	54929	34874568
Sedation complication	99.04	14.33	41	27393	1736	34927761
Fatigue	97.23	14.33	89	27345	370564	34558933
Metabolic acidosis	95.74	14.33	143	27291	43537	34885960
Anaphylactic shock	94.34	14.33	87	27347	15854	34913643
Respiratory depression	91.01	14.33	86	27348	16159	34913338
Delirium	89.33	14.33	139	27295	43852	34885645
Rhabdomyolysis	83.81	14.33	173	27261	67990	34861507
Off label use	81.14	14.33	584	26850	418940	34510557
Coma	78.71	14.33	134	27300	45544	34883953
Generalised tonic-clonic seizure	75.40	14.33	88	27346	21086	34908411
Diarrhoea	75.25	14.33	119	27315	389793	34539704
Dizziness	73.58	14.33	40	27394	218481	34711016
Tachycardia	73.05	14.33	187	27247	84585	34844912
Multiple organ dysfunction syndrome	71.33	14.33	174	27260	76392	34853105
Autonomic nervous system imbalance	70.04	14.33	36	27398	2515	34926982
Agitation	69.74	14.33	145	27289	57254	34872243
Nausea	69.15	14.33	100	27334	339808	34589689
Product dose omission issue	68.91	14.33	7	27427	119704	34809793
Brain oedema	64.09	14.33	66	27368	13755	34915742
Respiratory acidosis	63.51	14.33	43	27391	5007	34924490
Headache	61.54	14.33	41	27393	200594	34728903
Acute respiratory distress syndrome	61.19	14.33	88	27346	25881	34903616
Electroencephalogram abnormal	59.58	14.33	32	27402	2446	34927051
Unresponsive to stimuli	57.18	14.33	88	27346	27481	34902016
Delayed recovery from anaesthesia	56.85	14.33	22	27412	779	34928718
Toxic epidermal necrolysis	56.43	14.33	77	27357	21569	34907928
Haemodynamic instability	56.38	14.33	52	27382	9471	34920026
Stress cardiomyopathy	56.36	14.33	29	27405	2030	34927467
Hypercapnia	55.35	14.33	37	27397	4218	34925279
Arthralgia	54.52	14.33	33	27401	170008	34759489
Seizure like phenomena	54.28	14.33	21	27413	743	34928754
Acidosis hyperchloraemic	53.40	14.33	18	27416	425	34929072
Drug interaction	53.35	14.33	331	27103	225615	34703882
Depressed level of consciousness	52.93	14.33	109	27325	42732	34886765
Electrocardiogram ST segment elevation	52.88	14.33	39	27395	5199	34924298
Necrosis ischaemic	52.17	14.33	16	27418	276	34929221
Partial seizures	51.60	14.33	37	27397	4723	34924774
Septic shock	50.41	14.33	147	27287	71687	34857810
Toxicity to various agents	50.12	14.33	298	27136	200064	34729433
Hyperthermia	49.92	14.33	51	27383	10526	34918971
Anaesthetic complication neurological	49.82	14.33	16	27418	323	34929174
Hypoventilation	47.60	14.33	31	27403	3383	34926114
Seizure	47.35	14.33	185	27249	104672	34824825
Sedation	46.32	14.33	69	27365	20937	34908560
Product administered to patient of inappropriate age	46.17	14.33	30	27404	3261	34926236
Behaviour disorder	46.10	14.33	35	27399	4875	34924622
Shock	45.74	14.33	74	27360	24105	34905392
Pain in extremity	44.24	14.33	22	27412	126491	34803006
Catatonia	43.21	14.33	34	27400	4991	34924506
Peripheral swelling	42.69	14.33	5	27429	76536	34852961
COVID-19 pneumonia	42.18	14.33	59	27375	16908	34912589
Hyperammonaemia	42.09	14.33	37	27397	6330	34923167
Hypertransaminasaemia	42.00	14.33	35	27399	5571	34923926
Myalgia	41.19	14.33	8	27426	84102	34845395
Laryngospasm	40.42	14.33	21	27413	1500	34927997
Anaesthetic complication	40.28	14.33	19	27415	1101	34928396
Dyskinesia	40.24	14.33	67	27367	22346	34907151
Mucosal ulceration	39.27	14.33	18	27416	977	34928520
Back pain	38.51	14.33	24	27410	121765	34807732
Dyspnoea	37.77	14.33	160	27274	376622	34552875
Intestinal ischaemia	37.55	14.33	38	27396	7756	34921741
Asthenia	37.40	14.33	86	27348	245165	34684332
Acidosis	36.49	14.33	44	27390	10901	34918596
Pulseless electrical activity	36.29	14.33	36	27398	7175	34922322
Rash maculo-papular	35.85	14.33	73	27361	28378	34901119
Joint swelling	35.78	14.33	3	27431	59887	34869610
Oxygen saturation decreased	35.71	14.33	108	27326	53710	34875787
Burkholderia test positive	35.71	14.33	17	27417	1006	34928491
Kounis syndrome	35.44	14.33	23	27411	2495	34927002
Herpes simplex viraemia	35.21	14.33	9	27425	76	34929421
Intensive care	34.33	14.33	14	27420	570	34928927
Coagulopathy	33.99	14.33	58	27376	19731	34909766
Death	33.48	14.33	180	27254	397869	34531628
Long QT syndrome	33.19	14.33	23	27411	2780	34926717
Corneal reflex decreased	33.13	14.33	10	27424	163	34929334
Respiratory arrest	33.05	14.33	70	27364	27973	34901524
Apnoea	33.03	14.33	33	27401	6631	34922866
Overdose	32.80	14.33	150	27284	90909	34838588
Pruritus	32.65	14.33	38	27396	141943	34787554
Dehydration	31.85	14.33	33	27401	129936	34799561
Fall	31.84	14.33	70	27364	202815	34726682
Epilepsy	31.77	14.33	59	27375	21436	34908061
Post procedural hypotension	31.36	14.33	8	27426	67	34929430
Artery dissection	31.35	14.33	9	27425	122	34929375
Blood lactic acid increased	30.95	14.33	32	27402	6696	34922801
Superinfection	30.61	14.33	21	27413	2498	34926999
Nasopharyngitis	29.67	14.33	9	27425	69959	34859538
Anticonvulsant drug level below therapeutic	29.67	14.33	13	27421	634	34928863
Brain death	29.41	14.33	21	27413	2662	34926835
Drug withdrawal syndrome	28.76	14.33	54	27380	19780	34909717
Abdominal discomfort	28.64	14.33	6	27428	59829	34869668
Misleading laboratory test result	28.60	14.33	6	27428	18	34929479
Encephalitis autoimmune	28.60	14.33	13	27421	692	34928805
White blood cell count decreased	28.55	14.33	20	27414	95425	34834072
Leukocytosis	28.27	14.33	60	27374	24005	34905492
Myocardial infarction	28.27	14.33	32	27402	121053	34808444
Trigemino-cardiac reflex	27.92	14.33	9	27425	184	34929313
Electrocardiogram QRS complex prolonged	27.57	14.33	26	27408	4868	34924629
Product use in unapproved indication	27.55	14.33	172	27262	117327	34812170
Weight decreased	27.51	14.33	61	27373	176240	34753257
Coma neonatal	27.47	14.33	6	27428	23	34929474
Pain	27.14	14.33	77	27357	204598	34724899
Muscle rigidity	26.78	14.33	37	27397	10481	34919016
Diabetes mellitus	26.29	14.33	3	27431	46870	34882627
Intracranial pressure increased	26.18	14.33	23	27411	3932	34925565
Neuromuscular block prolonged	26.04	14.33	11	27423	490	34929007
Cholestasis	25.86	14.33	62	27372	26886	34902611
Malignant catatonia	25.77	14.33	9	27425	237	34929260
Circulatory collapse	25.35	14.33	53	27381	20985	34908512
Drug resistance	25.26	14.33	60	27374	25867	34903630
Hepatitis fulminant	25.03	14.33	23	27411	4167	34925330
Haemophagocytic lymphohistiocytosis	24.93	14.33	40	27394	12933	34916564
Vomiting	24.23	14.33	106	27328	247515	34681982
Neuroleptic malignant syndrome	23.77	14.33	47	27387	17887	34911610
Periorbital swelling	23.51	14.33	11	27423	626	34928871
Liver function test	23.44	14.33	6	27428	51	34929446
Dissociative disorder	23.39	14.33	10	27424	459	34929038
Laryngomalacia	23.14	14.33	9	27425	323	34929174
Upper airway obstruction	23.05	14.33	11	27423	654	34928843
Hyporesponsive to stimuli	23.03	14.33	13	27421	1095	34928402
Tachypnoea	23.01	14.33	47	27387	18305	34911192
Areflexia	22.86	14.33	19	27415	3012	34926485
Hyperammonaemic encephalopathy	22.78	14.33	17	27417	2307	34927190
Large intestine anastomosis	22.75	14.33	6	27428	58	34929439
Procedural complication	22.70	14.33	22	27412	4261	34925236
Cyanosis	22.70	14.33	38	27396	12726	34916771
Malaise	22.42	14.33	73	27361	185752	34743745
Ventricular tachycardia	22.20	14.33	58	27376	26521	34902976
Defect conduction intraventricular	22.15	14.33	9	27425	363	34929134
Cardiac failure congestive	21.71	14.33	20	27414	83250	34846247
Blood pressure decreased	21.70	14.33	89	27345	51426	34878071
Odynophagia	21.42	14.33	24	27410	5497	34924000
Neuromuscular blockade	21.32	14.33	8	27426	260	34929237
Hospitalisation	21.26	14.33	9	27425	56893	34872604
Weight increased	21.26	14.33	25	27409	93008	34836489
Haemoglobin decreased	21.21	14.33	39	27395	120733	34808764
Cardiogenic shock	21.13	14.33	57	27377	26561	34902936
Mixed dementia	21.04	14.33	8	27426	270	34929227
Neurological examination abnormal	20.98	14.33	8	27426	272	34929225
Mumps	20.93	14.33	6	27428	81	34929416
Illusion	20.78	14.33	11	27423	816	34928681
Encephalopathy	20.77	14.33	68	27366	35251	34894246
Bronchospasm	20.50	14.33	33	27401	10698	34918799
Urinary bladder rupture	20.47	14.33	6	27428	88	34929409
Respiratory rate decreased	20.36	14.33	16	27418	2343	34927154
Clonus	20.25	14.33	17	27417	2733	34926764
Sinusitis	20.13	14.33	4	27430	41398	34888099
Medical device site fistula	19.91	14.33	5	27429	39	34929458
Anaemia	19.83	14.33	105	27329	233230	34696267
Disease progression	19.78	14.33	34	27400	108043	34821454
Decreased appetite	19.62	14.33	66	27368	166326	34763171
Stupor	19.51	14.33	17	27417	2874	34926623
Dyspnoea paroxysmal nocturnal	19.41	14.33	13	27421	1486	34928011
Neutropenia	19.31	14.33	61	27373	156717	34772780
Ileus	19.22	14.33	41	27393	16458	34913039
Respiratory disorder	19.22	14.33	45	27389	19219	34910278
Eosinophilia	18.69	14.33	54	27380	26168	34903329
Respiratory distress	18.63	14.33	66	27368	35599	34893898
Aggression	18.58	14.33	70	27364	38894	34890603
Heart alternation	18.45	14.33	3	27431	0	34929497
Nephrogenic diabetes insipidus	18.43	14.33	12	27422	1309	34928188
Phaeochromocytoma crisis	18.13	14.33	5	27429	58	34929439
Drug withdrawal syndrome neonatal	18.08	14.33	18	27416	3601	34925896
Atonic urinary bladder	17.80	14.33	4	27430	18	34929479
Constipation	17.79	14.33	52	27382	136930	34792567
Myotonic dystrophy	17.75	14.33	6	27428	143	34929354
Systemic inflammatory response syndrome	17.68	14.33	24	27410	6685	34922812
Hypotonia	17.60	14.33	26	27408	7827	34921670
Nystagmus	17.45	14.33	20	27414	4695	34924802
Hypernatraemia	17.45	14.33	27	27407	8463	34921034
Airway complication of anaesthesia	17.44	14.33	6	27428	151	34929346
Arthrofibrosis	17.27	14.33	5	27429	70	34929427
Pupil fixed	17.26	14.33	13	27421	1788	34927709
Hypoaesthesia	16.93	14.33	14	27420	61430	34868067
Periventricular haemorrhage neonatal	16.84	14.33	4	27430	24	34929473
Bronchitis	16.73	14.33	6	27428	41957	34887540
Endotracheal intubation	16.73	14.33	16	27418	3049	34926448
Euthanasia	16.70	14.33	4	27430	25	34929472
Postresuscitation encephalopathy	16.70	14.33	4	27430	25	34929472
Electrocardiogram QT prolonged	16.66	14.33	70	27364	40882	34888615
Angle closure glaucoma	16.64	14.33	10	27424	947	34928550
Product use issue	16.37	14.33	95	27339	63121	34866376
Neuropathy peripheral	16.35	14.33	25	27409	83238	34846259
Hyperaesthesia	16.07	14.33	19	27415	4611	34924886
Haematuria traumatic	16.05	14.33	6	27428	193	34929304
Thrombosis	15.85	14.33	10	27424	50448	34879049
Fear	15.79	14.33	29	27405	10447	34919050
Administration related reaction	15.71	14.33	5	27429	98	34929399
Nervous system disorder	15.64	14.33	35	27399	14508	34914989
Hyperexplexia	15.63	14.33	4	27430	34	34929463
Asthma	15.54	14.33	7	27427	42649	34886848
Paradoxical drug reaction	15.52	14.33	16	27418	3335	34926162
Catecholamine crisis	15.52	14.33	4	27430	35	34929462
Parkinsonism	15.51	14.33	25	27409	8113	34921384
Abdominal pain upper	15.50	14.33	20	27414	71470	34858027
Acute kidney injury	15.49	14.33	330	27104	304658	34624839
Endotracheal intubation complication	15.23	14.33	7	27427	382	34929115
Reversal of sedation	15.16	14.33	3	27431	6	34929491
Dyspepsia	15.08	14.33	5	27429	36727	34892770
Aspiration	15.02	14.33	31	27403	12163	34917334
Product packaging confusion	14.95	14.33	4	27430	41	34929456
Chronic obstructive pulmonary disease	14.95	14.33	10	27424	48908	34880589
Bezoar	14.90	14.33	10	27424	1147	34928350
Hypertriglyceridaemia	14.82	14.33	25	27409	8423	34921074
Neurotoxicity	14.73	14.33	39	27395	17971	34911526
Clonic convulsion	14.49	14.33	8	27426	646	34928851
Dry mouth	14.48	14.33	3	27431	30162	34899335
Oedema peripheral	14.48	14.33	47	27387	119765	34809732
Hypoglycaemia	14.38	14.33	13	27421	54627	34874870
Chills	14.37	14.33	26	27408	81017	34848480

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
Status epilepticus	565.57	13.98	291	51461	24750	79667886
Hypotension	426.62	13.98	904	50848	439413	79253223
Multiple-drug resistance	399.17	13.98	166	51586	8642	79683994
Cardiac arrest	383.90	13.98	514	51238	171582	79521054
Serotonin syndrome	382.60	13.98	280	51472	44747	79647889
Drug ineffective	366.61	13.98	1524	50228	1079389	78613247
Anaphylactic reaction	311.30	13.98	325	51427	83418	79609218
Propofol infusion syndrome	306.44	13.98	93	51659	1890	79690746
Drug ineffective for unapproved indication	250.38	13.98	231	51521	51007	79641629
Diabetes insipidus	238.29	13.98	99	51653	5138	79687498
Metabolic acidosis	211.11	13.98	264	51488	82265	79610371
Anaphylactic shock	203.01	13.98	176	51576	35820	79656816
Hyperthermia malignant	202.89	13.98	75	51677	2842	79689794
Fatigue	201.37	13.98	185	51567	929542	78763094
Bradycardia	193.50	13.98	329	51423	135228	79557408
Tachycardia	191.43	13.98	382	51370	177386	79515250
Drug interaction	187.08	13.98	643	51109	414540	79278096
Drug reaction with eosinophilia and systemic symptoms	184.60	13.98	218	51534	64026	79628610
Respiratory acidosis	177.43	13.98	103	51649	11097	79681539
Myoclonus	176.03	13.98	145	51607	27515	79665121
Respiratory failure	173.89	13.98	371	51381	180540	79512096
Multiple organ dysfunction syndrome	169.16	13.98	290	51462	119956	79572680
Joint swelling	168.26	13.98	4	51748	288642	79403994
Myoglobin urine present	161.82	13.98	48	51704	899	79691737
Arthralgia	160.14	13.98	86	51666	571717	79120919
Agitation	157.01	13.98	253	51499	99462	79593174
Respiratory depression	147.57	13.98	131	51621	27499	79665137
Hypoxia	143.88	13.98	248	51504	102995	79589641
Generalised tonic-clonic seizure	143.00	13.98	159	51593	43751	79648885
Partial seizures	138.08	13.98	81	51671	8897	79683739
Off label use	137.31	13.98	1031	50721	906184	78786452
Unresponsive to stimuli	137.12	13.98	175	51577	55613	79637023
Seizure	136.16	13.98	346	51406	188488	79504148
Delirium	134.96	13.98	216	51536	84411	79608225
Intensive care unit acquired weakness	131.87	13.98	49	51703	1884	79690752
Diarrhoea	130.51	13.98	233	51519	880256	78812380
Peripheral swelling	125.87	13.98	14	51738	269603	79423033
Nausea	124.93	13.98	273	51479	956923	78735713
Pain	124.58	13.98	165	51587	703637	78988999
Shock	123.79	13.98	147	51605	43401	79649235
Dizziness	118.12	13.98	101	51651	526340	79166296
Haemodynamic instability	116.65	13.98	94	51658	17288	79675348
Circulatory collapse	115.16	13.98	132	51620	37536	79655100
Abdominal discomfort	114.59	13.98	14	51738	250713	79441923
Necrosis ischaemic	114.10	13.98	38	51714	1052	79691584
Pain in extremity	113.97	13.98	47	51705	364491	79328145
Alopecia	113.24	13.98	10	51742	231345	79461291
Headache	111.89	13.98	157	51595	653615	79039021
Anaesthetic complication	110.02	13.98	48	51704	2811	79689825
Delayed recovery from anaesthesia	108.99	13.98	41	51711	1632	79691004
Intestinal ischaemia	104.75	13.98	79	51673	13191	79679445
Apnoea	104.38	13.98	75	51677	11629	79681007
Toxic encephalopathy	103.62	13.98	74	51678	11366	79681270
Fall	101.71	13.98	100	51652	487529	79205107
Mitochondrial DNA mutation	101.13	13.98	28	51724	405	79692231
Acute respiratory distress syndrome	100.13	13.98	133	51619	43934	79648702
Electrocardiogram ST segment elevation	99.14	13.98	64	51688	8333	79684303
Brain oedema	99.10	13.98	101	51651	25162	79667474
Anaesthetic complication neurological	98.64	13.98	30	51722	614	79692022
Drug intolerance	98.49	13.98	25	51727	264094	79428542
Rhabdomyolysis	98.41	13.98	211	51541	102920	79589716
Encephalopathy	97.95	13.98	165	51587	67232	79625404
Pulseless electrical activity	95.92	13.98	77	51675	14083	79678553
Product dose omission issue	93.12	13.98	23	51729	247514	79445122
Labile blood pressure	90.54	13.98	39	51713	2214	79690422
Nasopharyngitis	89.11	13.98	27	51725	253854	79438782
Depressed level of consciousness	89.07	13.98	195	51557	96457	79596179
Swelling	87.87	13.98	17	51735	216694	79475942
Toxicity to various agents	85.57	13.98	516	51236	421024	79271612
Unwanted awareness during anaesthesia	85.06	13.98	23	51729	303	79692333
Toxic epidermal necrolysis	84.03	13.98	123	51629	44458	79648178
Intra-abdominal pressure increased	83.71	13.98	22	51730	258	79692378
Blood lactic acid increased	83.57	13.98	68	51684	12676	79679960
Systemic inflammatory response syndrome	83.36	13.98	65	51687	11400	79681236
Oxygen saturation decreased	82.30	13.98	226	51526	128821	79563815
Electroencephalogram abnormal	80.87	13.98	48	51704	5386	79687250
Coma	80.49	13.98	192	51560	100457	79592179
Troponin increased	79.22	13.98	79	51673	19176	79673460
Acidosis hyperchloraemic	78.86	13.98	27	51725	815	79691821
Weight increased	78.55	13.98	41	51711	277345	79415291
Blood creatine phosphokinase increased	78.30	13.98	148	51604	65942	79626694
Stress cardiomyopathy	76.23	13.98	61	51691	11105	79681531
Electrocardiogram QRS complex prolonged	71.45	13.98	58	51694	10775	79681861
Hypoventilation	70.70	13.98	49	51703	7175	79685461
Asthenia	70.65	13.98	141	51611	511548	79181088
Amylase increased	69.71	13.98	58	51694	11151	79681485
Back pain	66.13	13.98	60	51692	304120	79388516
Systemic lupus erythematosus	65.88	13.98	3	51749	121146	79571490
Hyperthermia	63.38	13.98	68	51684	17969	79674667
Epilepsy	63.34	13.98	103	51649	40757	79651879
Sinusitis	63.01	13.98	24	51728	195477	79497159
Neuromuscular block prolonged	62.61	13.98	24	51728	1006	79691630
Sedation complication	62.10	13.98	63	51689	15606	79677030
Myalgia	61.16	13.98	22	51730	185619	79507017
Septic shock	61.11	13.98	197	51555	122604	79570032
Bronchospasm	61.09	13.98	78	51674	24781	79667855
Renal ischaemia	59.81	13.98	24	51728	1138	79691498
Hypercapnia	59.27	13.98	48	51704	8887	79683749
Autonomic nervous system imbalance	58.91	13.98	37	51715	4593	79688043
Cardiogenic shock	58.75	13.98	101	51651	41813	79650823
Laryngospasm	58.68	13.98	35	51717	3962	79688674
Malaise	58.59	13.98	146	51606	489723	79202913
PCO2 increased	58.40	13.98	27	51725	1813	79690823
CSF oligoclonal band present	57.66	13.98	18	51734	403	79692233
Product administered to patient of inappropriate age	57.50	13.98	39	51713	5514	79687122
Pruritus	56.82	13.98	106	51646	394542	79298094
Oxygen saturation abnormal	56.76	13.98	36	51716	4546	79688090
Anticholinergic syndrome	56.63	13.98	33	51719	3578	79689058
Overdose	56.39	13.98	253	51499	183953	79508683
Muscle rigidity	56.30	13.98	67	51685	19815	79672821
Coagulopathy	56.13	13.98	91	51661	35915	79656721
Encephalitis autoimmune	55.66	13.98	28	51724	2266	79690370
Pneumatosis	55.07	13.98	21	51731	868	79691768
Upper airway obstruction	55.03	13.98	24	51728	1404	79691232
Seizure like phenomena	54.94	13.98	26	51726	1841	79690795
Wound	54.26	13.98	6	51746	116173	79576463
Hyperammonaemia	54.12	13.98	50	51702	11043	79681593
Respiratory arrest	54.01	13.98	117	51635	57433	79635203
Arthritis	53.48	13.98	6	51746	114874	79577762
Altered state of consciousness	52.98	13.98	99	51653	43723	79648913
Mydriasis	52.52	13.98	61	51691	17582	79675054
Hepatic ischaemia	50.46	13.98	21	51731	1094	79691542
Female genital tract fistula	50.35	13.98	37	51715	5938	79686698
Clonus	50.20	13.98	39	51713	6801	79685835
Hypoaesthesia	50.02	13.98	27	51725	179325	79513311
Abdominal pain upper	50.01	13.98	43	51709	223776	79468860
Asthma	49.91	13.98	13	51739	135082	79557554
Dyspnoea	49.81	13.98	339	51413	856686	78835950
Blood gases abnormal	49.31	13.98	21	51731	1159	79691477
Discomfort	48.54	13.98	11	51741	125606	79567030
Hyperammonaemic encephalopathy	48.12	13.98	33	51719	4749	79687887
Anaesthetic complication pulmonary	47.70	13.98	11	51741	71	79692565
Leukocytosis	47.41	13.98	94	51658	43361	79649275
Rash maculo-papular	47.01	13.98	109	51643	55969	79636667
Foetal death	46.69	13.98	40	51712	8004	79684632
Hypernatraemia	46.46	13.98	52	51700	14399	79678237
PO2 increased	46.38	13.98	22	51730	1566	79691070
Behaviour disorder	46.35	13.98	36	51716	6277	79686359
Carcinoid crisis	45.99	13.98	16	51736	507	79692129
Acute hepatic failure	45.44	13.98	75	51677	30038	79662598
Brain death	45.25	13.98	34	51718	5643	79686993
Ventricular tachycardia	44.90	13.98	90	51662	41845	79650791
Tachypnoea	44.59	13.98	77	51675	31986	79660650
Product use in unapproved indication	44.20	13.98	296	51456	250063	79442573
Ventricular extrasystoles	44.02	13.98	59	51693	19645	79672991
Bronchitis	43.85	13.98	15	51737	130629	79562007
Muscle relaxant therapy	43.84	13.98	12	51740	166	79692470
Catatonia	43.75	13.98	40	51712	8716	79683920
Hypertransaminasaemia	43.75	13.98	46	51706	11878	79680758
Gene mutation	43.33	13.98	25	51727	2661	79689975
Epileptic aura	42.91	13.98	10	51742	68	79692568
Neurotoxicity	42.51	13.98	76	51676	32442	79660194
Perforation	42.39	13.98	20	51732	1406	79691230
Disseminated intravascular coagulation	42.11	13.98	80	51672	35762	79656874
Contraindicated product administered	42.09	13.98	25	51727	157513	79535123
Dehydration	41.92	13.98	60	51692	248127	79444509
Ventricular hypokinesia	41.77	13.98	40	51712	9239	79683397
Vaginal flatulence	41.63	13.98	24	51728	2551	79690085
Weight decreased	41.54	13.98	107	51645	355091	79337545
Cholestasis	41.20	13.98	99	51653	52010	79640626
Procedural complication	40.93	13.98	37	51715	7946	79684690
Psoriasis	40.90	13.98	5	51747	89582	79603054
Acidosis	40.87	13.98	57	51695	19705	79672931
Electrocardiogram QT prolonged	40.51	13.98	140	51612	90246	79602390
Paradoxical drug reaction	40.22	13.98	35	51717	7150	79685486
Non-consummation	40.18	13.98	9	51743	50	79692586
Anorectal ulcer	40.18	13.98	9	51743	50	79692586
Infusion related reaction	39.54	13.98	55	51697	230182	79462454
Long QT syndrome	39.52	13.98	32	51720	5923	79686713
Musculoskeletal pain	39.47	13.98	9	51743	102345	79590291
Proctitis	39.41	13.98	33	51719	6399	79686237
Pleocytosis	39.18	13.98	19	51733	1420	79691216
Tonic clonic movements	39.01	13.98	22	51730	2242	79690394
Hepatic failure	38.79	13.98	107	51645	61105	79631531
Mixed liver injury	38.61	13.98	35	51717	7543	79685093
Dyskinesia	38.60	13.98	88	51664	44685	79647951
Anticonvulsant drug level below therapeutic	37.90	13.98	17	51735	1064	79691572
Posterior reversible encephalopathy syndrome	37.71	13.98	64	51688	26217	79666419
White blood cell count decreased	37.59	13.98	40	51712	188248	79504388
Musculoskeletal stiffness	37.44	13.98	35	51717	174973	79517663
Blood cholesterol increased	37.43	13.98	5	51747	83715	79608921
Aggression	37.30	13.98	94	51658	50864	79641772
Blood pH decreased	37.07	13.98	28	51724	4683	79687953
Neuromuscular blockade	37.00	13.98	14	51738	566	79692070
Sinus bradycardia	36.91	13.98	62	51690	25185	79667451
Oropharyngeal oedema	36.75	13.98	13	51739	433	79692203
Blood potassium increased	36.46	13.98	67	51685	29208	79663428
Decreased appetite	36.42	13.98	108	51644	342310	79350326
Pseudopolyp	36.39	13.98	13	51739	446	79692190
Diabetic macroangiopathy	36.29	13.98	10	51742	142	79692494
Loss of personal independence in daily activities	35.80	13.98	11	51741	102569	79590067
Ultrasound ovary abnormal	35.73	13.98	9	51743	88	79692548
Unmasking of previously unidentified disease	35.48	13.98	20	51732	2037	79690599
Dry mouth	35.45	13.98	7	51745	88012	79604624
Cardio-respiratory arrest	35.43	13.98	152	51600	108358	79584278
Kounis syndrome	34.92	13.98	26	51726	4256	79688380
Trigemino-cardiac reflex	34.75	13.98	11	51741	258	79692378
COVID-19 pneumonia	34.65	13.98	65	51687	28784	79663852
Artery dissection	34.40	13.98	11	51741	267	79692369
Fluid retention	34.18	13.98	3	51749	69806	79622830
Electrocardiogram ST segment depression	34.05	13.98	27	51725	4851	79687785
Arrhythmia	33.89	13.98	102	51650	61170	79631466
Airway complication of anaesthesia	33.69	13.98	12	51740	408	79692228
Hypotonia	32.60	13.98	41	51711	12829	79679807
Blood bicarbonate decreased	32.57	13.98	27	51725	5164	79687472
Palpitations	32.55	13.98	21	51731	126589	79566047
Herpes zoster	32.45	13.98	10	51742	93073	79599563
Paraesthesia	32.44	13.98	40	51712	176283	79516353
Diabetes mellitus	32.07	13.98	6	51746	78384	79614252
Airway peak pressure increased	32.03	13.98	11	51741	335	79692301
Neuroleptic malignant syndrome	31.74	13.98	61	51691	27498	79665138
Mucosal ulceration	31.73	13.98	18	51734	1855	79690781
Intestinal infarction	31.51	13.98	16	51736	1320	79691316
Post procedural hypotension	31.51	13.98	8	51744	81	79692555
Gait disturbance	31.38	13.98	54	51698	207452	79485184
Corneal reflex decreased	31.34	13.98	11	51741	358	79692278
Impaired healing	31.31	13.98	9	51743	87646	79604990
Ventricular fibrillation	31.21	13.98	66	51686	31860	79660776
Change in seizure presentation	31.15	13.98	12	51740	510	79692126
Cardiac failure congestive	31.02	13.98	28	51724	142374	79550262
Cardiotoxicity	31.01	13.98	39	51713	12200	79680436
Hepatocellular injury	30.96	13.98	84	51668	47509	79645127
Radiculopathy	30.53	13.98	33	51719	8791	79683845
Procedural hypotension	30.44	13.98	18	51734	2005	79690631
Respiratory distress	30.29	13.98	95	51657	58244	79634392
Blood pressure increased	30.18	13.98	57	51695	211303	79481333
Therapeutic product effect prolonged	29.94	13.98	12	51740	567	79692069
Acute kidney injury	29.86	13.98	488	51264	518916	79173720
Alanine aminotransferase increased	29.75	13.98	194	51558	162376	79530260
Eosinophilia	29.46	13.98	80	51672	45265	79647371
Epilepsy with myoclonic-atonic seizures	29.40	13.98	8	51744	108	79692528
Vulvovaginal candidiasis	29.28	13.98	19	51733	2495	79690141
Arthrofibrosis	29.27	13.98	8	51744	110	79692526
Intensive care unit delirium	29.27	13.98	7	51745	54	79692582
Blood pressure decreased	29.21	13.98	135	51617	99331	79593305
Intensive care	28.66	13.98	14	51738	1063	79691573
Transaminases increased	28.48	13.98	86	51666	51657	79640979
Feeling abnormal	28.36	13.98	37	51715	159162	79533474
Contusion	28.16	13.98	33	51719	148743	79543893
Hospitalisation	28.05	13.98	13	51739	94223	79598413
Myocardial infarction	27.77	13.98	48	51704	184081	79508555
Migraine	27.75	13.98	11	51741	87482	79605154
Injection site pain	27.72	13.98	26	51726	129812	79562824
Left ventricular dysfunction	27.58	13.98	47	51705	19314	79673322
Acid base balance abnormal	27.48	13.98	10	51742	362	79692274
Macroglossia	27.44	13.98	14	51738	1167	79691469
Acute respiratory failure	27.35	13.98	93	51659	59448	79633188
Stomatitis	27.30	13.98	33	51719	146724	79545912
Irritable bowel syndrome	27.16	13.98	4	51748	62237	79630399
Cough	27.15	13.98	134	51618	366655	79325981
Pulse absent	26.89	13.98	33	51719	10070	79682566
Intracranial pressure increased	26.85	13.98	30	51722	8292	79684344
Hepatitis fulminant	26.61	13.98	28	51724	7234	79685402
Nail dystrophy	26.46	13.98	13	51739	1000	79691636
Hyperaesthesia	26.40	13.98	36	51716	12186	79680450
Procedural vomiting	26.34	13.98	12	51740	779	79691857
Stupor	26.09	13.98	27	51725	6845	79685791
Somnolence	26.00	13.98	253	51499	238728	79453908
Inappropriate schedule of product administration	25.99	13.98	29	51723	133599	79559037
Local anaesthetic systemic toxicity	25.97	13.98	13	51739	1041	79691595
Gastrooesophageal reflux disease	25.84	13.98	18	51734	104228	79588408
Bone pain	25.72	13.98	3	51749	55739	79636897
Laryngeal stenosis	25.58	13.98	13	51739	1075	79691561
Vomiting	25.46	13.98	293	51459	665535	79027101
Mobility decreased	25.46	13.98	25	51727	122150	79570486
Urinary tract infection	25.43	13.98	92	51660	274420	79418216
Sleep disorder	25.22	13.98	12	51740	85665	79606971
Hot flush	25.20	13.98	3	51749	54874	79637762
Injection site reaction	25.15	13.98	3	51749	54782	79637854
Oliguria	25.12	13.98	41	51711	16268	79676368
Reversal of sedation	24.78	13.98	5	51747	15	79692621
Pulmonary oedema	24.60	13.98	118	51634	88136	79604500
Influenza like illness	24.46	13.98	8	51744	71699	79620937
Therapeutic product effect decreased	24.45	13.98	43	51709	163820	79528816
Atrioventricular dissociation	24.44	13.98	9	51743	337	79692299
Haemoglobin decreased	24.37	13.98	69	51683	222050	79470586
Blood lactate dehydrogenase increased	24.35	13.98	68	51684	39102	79653534
Paralysis	24.31	13.98	36	51716	13141	79679495
Gastrointestinal scarring	24.10	13.98	9	51743	351	79692285
Lower respiratory tract infection	24.10	13.98	29	51723	129191	79563445
Hepatic enzyme increased	23.72	13.98	52	51700	182558	79510078
Stridor	23.59	13.98	23	51729	5430	79687206
Muscle spasms	23.32	13.98	49	51703	174681	79517955
Areflexia	23.31	13.98	23	51729	5511	79687125
Malabsorption	23.24	13.98	22	51730	5010	79687626
Influenza	23.21	13.98	30	51722	129576	79563060
Rash	23.09	13.98	252	51500	578106	79114530
Ischaemic hepatitis	22.87	13.98	19	51733	3645	79688991
Pneumomediastinum	22.85	13.98	19	51733	3648	79688988
Endotracheal intubation complication	22.82	13.98	11	51741	811	79691825
Chest pain	22.73	13.98	100	51652	282204	79410432
Nystagmus	22.65	13.98	30	51722	9874	79682762
Large intestinal stenosis	22.53	13.98	17	51735	2839	79689797
Oedema peripheral	22.42	13.98	86	51666	252202	79440434
Hepatorenal syndrome	22.39	13.98	20	51732	4229	79688407
Manipulation	22.26	13.98	6	51746	78	79692558
Chronic obstructive pulmonary disease	22.19	13.98	14	51738	85405	79607231
Mixed dementia	22.16	13.98	8	51744	283	79692353
Herpes simplex viraemia	22.13	13.98	9	51743	442	79692194
Nasal congestion	22.11	13.98	11	51741	76541	79616095
Oral candidiasis	22.04	13.98	55	51697	29573	79663063
Cytokine release syndrome	21.89	13.98	62	51690	35936	79656700
Malignant catatonia	21.86	13.98	9	51743	456	79692180
Post procedural complication	21.84	13.98	48	51704	23781	79668855
Superinfection	21.82	13.98	21	51731	4881	79687755
Adverse drug reaction	21.63	13.98	8	51744	66384	79626252
Euthyroid sick syndrome	21.47	13.98	6	51746	90	79692546
Muscle injury	21.47	13.98	3	51749	48558	79644078
Stevens-Johnson syndrome	21.46	13.98	65	51687	39101	79653535
Gastrointestinal disorder	21.16	13.98	29	51723	122176	79570460
Cyanosis	21.16	13.98	49	51703	25133	79667503
Product contamination	21.05	13.98	12	51740	1248	79691388
Large intestine anastomosis	20.99	13.98	6	51746	98	79692538
Vasoplegia syndrome	20.96	13.98	18	51734	3612	79689024
Hypertrophic cardiomyopathy	20.87	13.98	15	51737	2325	79690311
Medical device site fistula	20.86	13.98	5	51747	39	79692597
Cellulitis	20.84	13.98	24	51728	109036	79583600
Pituitary apoplexy	20.61	13.98	7	51745	206	79692430
Pneumothorax	20.47	13.98	52	51700	28271	79664365
Skin ulcer	20.40	13.98	5	51747	54145	79638491
Renal impairment	20.17	13.98	173	51579	157610	79535026
Nervous system disorder	20.13	13.98	50	51702	26806	79665830
Symptom masked	19.96	13.98	12	51740	1378	79691258
Restlessness	19.95	13.98	71	51681	46421	79646215
Vertigo	19.84	13.98	10	51742	69072	79623564
Infection	19.83	13.98	85	51667	241627	79451009
Fear	19.83	13.98	44	51708	21942	79670694
Nephrogenic diabetes insipidus	19.77	13.98	14	51738	2120	79690516
Axillary pain	19.69	13.98	14	51738	2135	79690501
Hyperdynamic left ventricle	19.63	13.98	8	51744	395	79692241
Transient ischaemic attack	19.59	13.98	5	51747	52690	79639946
Drug resistance	19.44	13.98	66	51686	42147	79650489
Cataract	19.39	13.98	8	51744	62112	79630524
Drug withdrawal convulsions	19.28	13.98	14	51738	2206	79690430
Hypersensitivity	19.28	13.98	96	51656	262143	79430493
Vaginal discharge	19.26	13.98	24	51728	7439	79685197
C-reactive protein abnormal	19.16	13.98	4	51748	48363	79644273
Neutropenia	19.11	13.98	109	51643	287601	79405035
Post procedural haemorrhage	19.10	13.98	33	51719	13711	79678925
Visual impairment	19.03	13.98	19	51733	92112	79600524
Brain stem auditory evoked response abnormal	19.02	13.98	3	51749	0	79692636
Electrocardiogram repolarisation abnormality	19.01	13.98	14	51738	2253	79690383
Haemophagocytic lymphohistiocytosis	18.91	13.98	43	51709	21794	79670842
Ileus	18.81	13.98	48	51704	26163	79666473
Myotonic dystrophy	18.79	13.98	6	51746	145	79692491
Injection site erythema	18.73	13.98	14	51738	78183	79614453
Apnoeic attack	18.66	13.98	9	51743	665	79691971
Wrong product administered	18.64	13.98	26	51726	8986	79683650
Balance disorder	18.63	13.98	22	51730	98835	79593801
Injection site swelling	18.46	13.98	4	51748	47128	79645508
Drug withdrawal syndrome	18.45	13.98	57	51695	34661	79657975
Abdominal compartment syndrome	18.43	13.98	12	51740	1585	79691051
Adverse event	18.40	13.98	8	51744	60206	79632430
Procedural pain	18.40	13.98	44	51708	23040	79669596
Dystonia	18.38	13.98	42	51710	21357	79671279
Rash pruritic	18.25	13.98	12	51740	71617	79621019
Polyuria	18.24	13.98	34	51718	14980	79677656
Dermatitis exfoliative generalised	18.23	13.98	23	51729	7218	79685418
Liver function test	18.23	13.98	6	51746	160	79692476
Anticonvulsant drug level therapeutic	18.21	13.98	4	51748	20	79692616
Thrombocytopenia	18.20	13.98	257	51495	265002	79427634
Gastrointestinal mucosa hyperaemia	18.20	13.98	8	51744	477	79692159
Oedema	18.18	13.98	31	51721	119549	79573087
Sinus tachycardia	18.15	13.98	59	51693	36849	79655787
Lactic acidosis	18.13	13.98	92	51660	70267	79622369
Infection parasitic	18.00	13.98	8	51744	490	79692146
Psychomotor hyperactivity	17.84	13.98	36	51716	16813	79675823
Coronary artery embolism	17.79	13.98	7	51745	315	79692321
Defect conduction intraventricular	17.77	13.98	8	51744	505	79692131
Ventricular arrhythmia	17.54	13.98	25	51727	8815	79683821
Vision blurred	17.47	13.98	26	51726	105872	79586764
Renal failure	17.29	13.98	203	51549	200765	79491871
Haematuria traumatic	17.22	13.98	6	51746	191	79692445
Blood magnesium decreased	17.15	13.98	35	51717	16477	79676159
Drug level below therapeutic	17.03	13.98	26	51726	9744	79682892
Dyspnoea paroxysmal nocturnal	17.00	13.98	13	51739	2215	79690421
Postoperative delirium	16.98	13.98	7	51745	356	79692280
Dissociative disorder	16.98	13.98	9	51743	812	79691824
Premature delivery	16.87	13.98	43	51709	23424	79669212
Dysgeusia	16.84	13.98	8	51744	57169	79635467
Ill-defined disorder	16.83	13.98	11	51741	65864	79626772
Full blood count abnormal	16.76	13.98	3	51749	40471	79652165
Neurological examination abnormal	16.61	13.98	8	51744	589	79692047
Bradypnoea	16.48	13.98	20	51732	6032	79686604
Systolic dysfunction	16.41	13.98	16	51736	3779	79688857
Completed suicide	16.37	13.98	93	51659	245674	79446962
Blister	16.37	13.98	33	51719	119443	79573193
Seizure cluster	16.29	13.98	7	51745	395	79692241
Osteonecrosis of jaw	16.27	13.98	4	51748	43222	79649414
Neck pain	16.22	13.98	15	51737	75402	79617234
Brain herniation	16.14	13.98	22	51730	7441	79685195
Post procedural stroke	16.14	13.98	5	51747	109	79692527
Accelerated idioventricular rhythm	16.14	13.98	6	51746	231	79692405
Cystitis	16.12	13.98	7	51745	52725	79639911
Hyperexplexia	15.98	13.98	4	51748	38	79692598
Hypokalaemia	15.90	13.98	153	51599	143887	79548749
End-tidal CO2 decreased	15.89	13.98	4	51748	39	79692597
Osteoarthritis	15.85	13.98	20	51732	87289	79605347
Clonic convulsion	15.84	13.98	10	51742	1252	79691384
Drug chemical incompatibility	15.81	13.98	5	51747	117	79692519
Hepatic cytolysis	15.77	13.98	46	51706	27105	79665531
Pseudomonas infection	15.76	13.98	39	51713	20864	79671772
Dermatitis bullous	15.76	13.98	31	51721	14214	79678422
Catheter site haemorrhage	15.75	13.98	18	51734	5099	79687537
Injection site pruritus	15.74	13.98	4	51748	42279	79650357
Cardiovascular insufficiency	15.64	13.98	14	51738	2967	79689669
Angina pectoris	15.61	13.98	7	51745	51725	79640911
Neutrophil count decreased	15.57	13.98	23	51729	93936	79598700
Delayed graft function	15.56	13.98	15	51737	3492	79689144
Gastric ulcer perforation	15.29	13.98	12	51740	2123	79690513
No adverse event	15.28	13.98	56	51696	37136	79655500
Frequent bowel movements	15.24	13.98	48	51704	29491	79663145
Abdominal rigidity	15.22	13.98	14	51738	3074	79689562
Eye pain	15.11	13.98	3	51749	37575	79655061
Catecholamine crisis	14.99	13.98	4	51748	50	79692586
Myoglobin blood increased	14.98	13.98	14	51738	3137	79689499
C-reactive protein increased	14.96	13.98	39	51713	128988	79563648
Blood pressure fluctuation	14.86	13.98	13	51739	67132	79625504
Colitis ulcerative	14.86	13.98	53	51699	34689	79657947
Febrile infection-related epilepsy syndrome	14.84	13.98	4	51748	52	79692584
Syncope	14.78	13.98	63	51689	179386	79513250
Laryngeal oedema	14.69	13.98	22	51730	8107	79684529
Hyperbilirubinaemia	14.68	13.98	42	51710	24476	79668160
Cardiac output decreased	14.63	13.98	11	51741	1827	79690809
Acute pulmonary oedema	14.59	13.98	30	51722	14200	79678436
Anaphylactoid shock	14.58	13.98	8	51744	773	79691863
Long QT syndrome congenital	14.57	13.98	5	51747	152	79692484
Thrombosis	14.51	13.98	20	51732	84080	79608556
Intentional overdose	14.51	13.98	118	51634	105842	79586794
Illness	14.50	13.98	6	51746	46505	79646131
Hypertriglyceridaemia	14.43	13.98	28	51724	12712	79679924
Peroneal nerve injury	14.31	13.98	4	51748	60	79692576
Psychotic disorder	14.29	13.98	59	51693	41343	79651293
Nephrocalcinosis	14.26	13.98	10	51742	1492	79691144
Central nervous system stimulation	14.25	13.98	4	51748	61	79692575
Teratoma	14.24	13.98	5	51747	163	79692473
Paradoxical pain	14.20	13.98	3	51749	12	79692624
Buttock injury	14.04	13.98	5	51747	170	79692466
Heart alternation	14.01	13.98	3	51749	13	79692623

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
Drug ineffective	61.12	27.94	31	127	1021	88613
Epilepsy	34.62	27.94	11	147	93	89541

Pharmacologic Action:

Source	Code	Description
ATC	N05CD08	NERVOUS SYSTEM PSYCHOLEPTICS HYPNOTICS AND SEDATIVES Benzodiazepine derivatives
FDA CS	M0002356	Benzodiazepines
MeSH PA	D000759	Adjuvants, Anesthesia
MeSH PA	D000777	Anesthetics
MeSH PA	D018686	Anesthetics, Intravenous
MeSH PA	D014151	Anti-Anxiety Agents
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D002492	Central Nervous System Depressants
MeSH PA	D018682	GABA Agents
MeSH PA	D018757	GABA Modulators
MeSH PA	D006993	Hypnotics and Sedatives
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D011619	Psychotropic Drugs
MeSH PA	D014149	Tranquilizing Agents
CHEBI has role	CHEBI:35474	anti-anxiety agents
CHEBI has role	CHEBI:35488	central nervous system depressants
CHEBI has role	CHEBI:35610	antineoplastic agents
CHEBI has role	CHEBI:35623	anticonvulsants
CHEBI has role	CHEBI:35717	hypnotics
CHEBI has role	CHEBI:38869	general anaesthetic
CHEBI has role	CHEBI:51371	muscle relaxants
CHEBI has role	CHEBI:68495	Type I cell-death inducers
CHEBI has role	CHEBI:91016	GABAA receptor agonists
FDA EPC	N0000175694	Benzodiazepine

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

Disease	Relation	SNOMED_ID	DOID
Feeling agitated	indication	24199005
Anxiety	indication	48694002
General anesthesia	indication	50697003
Sedation	indication	72641008
Status epilepticus	indication	230456007	DOID:1824
Conscious sedation	indication	314271007
Local anesthesia	indication	386761002
Sedation as Adjunct to Anesthesia	indication
Induce Anterograde Amnesia	indication
Sedation in Intubated Patients	indication
Preoperative Anxiety	indication
Insomnia	off-label use	193462001
Cocaine-Associated Acute Ischemic Heart Disease	off-label use
Chronic obstructive lung disease	contraindication	13645005	DOID:3083
Cirrhosis of liver	contraindication	19943007	DOID:5082
Shock	contraindication	27942005
End stage renal disease	contraindication	46177005	DOID:784
Chronic heart failure	contraindication	48447003
Pregnancy, function	contraindication	289908002
Coma	contraindication	371632003
Angle-closure glaucoma	contraindication	392291006	DOID:13550
Hemodynamic instability	contraindication	422773005
Peripheral Vasoconstriction	contraindication

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	6.07	Basic
pKa2	2.36	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
5MG/SPRAY	NAYZILAM	UCB INC	N211321	May 17, 2019	RX	SPRAY	NASAL	8217033	Jan. 18, 2028	ACUTE TREATMENT OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY (I.E., SEIZURE CLUSTERS, ACUTE REPETITIVE SEIZURES) THAT ARE DISTINCT FROM A PATIENTS USUAL SEIZURE PATTERN IN PATIENTS WITH EPILEPSY 12 YEARS OF AGE AND OLDER
5MG/SPRAY	NAYZILAM	UCB INC	N211321	May 17, 2019	RX	SPRAY	NASAL	9289432	Jan. 18, 2028	ACUTE TREATMENT OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY (I.E., SEIZURE CLUSTERS, ACUTE REPETITIVE SEIZURES) THAT ARE DISTINCT FROM A PATIENTS USUAL SEIZURE PATTERN IN PATIENTS WITH EPILEPSY 12 YEARS OF AGE AND OLDER
5MG/SPRAY	NAYZILAM	UCB INC	N211321	May 17, 2019	RX	SPRAY	NASAL	9687495	Jan. 18, 2028	ACUTE TREATMENT OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY (I.E., SEIZURE CLUSTERS, ACUTE REPETITIVE SEIZURES) THAT ARE DISTINCT FROM A PATIENTS USUAL SEIZURE PATTERN IN PATIENTS WITH EPILEPSY 12 YEARS OF AGE AND OLDER

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
100MG/100ML (1MG/ML)	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	HIKMA	A216159	April 17, 2023	RX	SOLUTION	INTRAVENOUS	Jan. 2, 2024	PATENT CHALLENGE
50MG/50ML (1MG/ML)	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	HIKMA	A216159	April 17, 2023	RX	SOLUTION	INTRAVENOUS	Jan. 2, 2024	PATENT CHALLENGE
EQ 50MG BASE/10ML (EQ 5MG BASE/ML)	SEIZALAM	MMT	N209566	Sept. 14, 2018	RX	SOLUTION	INTRAMUSCULAR	Sept. 14, 2025	TREATMENT OF STATUS EPILEPTICUS IN ADULTS
5MG/SPRAY	NAYZILAM	UCB INC	N211321	May 17, 2019	RX	SPRAY	NASAL	May 17, 2026	ACUTE TREATMENT OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY (I.E., SEIZURE CLUSTERS, ACUTE REPETITIVE SEIZURES) THAT ARE DISTINCT FROM A PATIENTS USUAL SEIZURE PATTERN IN PATIENTS WITH EPILEPSY 12 YEARS OF AGE AND OLDER

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	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 ALLOSTERIC MODULATOR	Ki	8.26	WOMBAT-PK	CHEMBL
GABA-A receptor alpha-1/beta-2/gamma-3	Ion channel	P14867 P47870 Q99928	GBRA1_HUMAN GBRB2_HUMAN GBRG3_HUMAN	POSITIVE ALLOSTERIC MODULATOR	Ki	7.75	WOMBAT-PK	CHEMBL
GABA A receptor alpha-3/beta-2/gamma-2	Ion channel	P18507 P34903 P47870	GBRG2_HUMAN GBRA3_HUMAN GBRB2_HUMAN	POSITIVE ALLOSTERIC MODULATOR	Ki	8.44	WOMBAT-PK	CHEMBL
GABA A receptor alpha-3/beta-2/gamma-3	Ion channel	P34903 P47870 Q99928	GBRA3_HUMAN GBRB2_HUMAN GBRG3_HUMAN	POSITIVE ALLOSTERIC MODULATOR	Ki	7.61	WOMBAT-PK	CHEMBL
GABA A receptor alpha-5/beta-3/gamma-3	Ion channel	P28472 P31644 Q99928	GBRB3_HUMAN GBRA5_HUMAN GBRG3_HUMAN	POSITIVE ALLOSTERIC MODULATOR	Ki	8.26	WOMBAT-PK	CHEMBL
GABA A receptor alpha-5/beta-2/gamma-2	Ion channel	P18507 P31644 P47870	GBRG2_HUMAN GBRA5_HUMAN GBRB2_HUMAN	POSITIVE ALLOSTERIC MODULATOR	Ki	9.13	WOMBAT-PK	CHEMBL
GABA-A receptor alpha-1/beta-2/gamma-2	Ion channel	P14867 P18507 P47870	GBRA1_HUMAN GBRG2_HUMAN GBRB2_HUMAN	POSITIVE ALLOSTERIC MODULATOR	Ki	8.75	WOMBAT-PK	CHEMBL
GABA-A receptor alpha-5/beta-3/gamma-2	Ion channel	P18507 P28472 P31644	GBRG2_HUMAN GBRB3_HUMAN GBRA5_HUMAN	POSITIVE ALLOSTERIC MODULATOR	Ki	9.13	WOMBAT-PK	CHEMBL
Multidrug resistance protein 1	Transporter	P08183	MDR1_HUMAN		Km	4.35	WOMBAT-PK
Cytochrome P450 3A4	Enzyme	P08684	CP3A4_HUMAN		Km	6	WOMBAT-PK
Translocator protein	Membrane receptor		TSPO_RAT		Ki	8.70	CHEMBL
Thyrotropin-releasing hormone receptor	GPCR		TRFR_RAT	ANTAGONIST	Ki	5.49	IUPHAR
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		Ki	8.70	CHEMBL

External reference:

ID	Source
4019839	VUID
N0000147927	NUI
D00550	KEGG_DRUG
59467-96-8	SECONDARY_CAS_RN
4017813	VANDF
4019839	VANDF
C0026056	UMLSCUI
CHEBI:6931	CHEBI
08J	PDB_CHEM_ID
CHEMBL655	ChEMBL_ID
CHEMBL1200420	ChEMBL_ID
DB00683	DRUGBANK_ID
D008874	MESH_DESCRIPTOR_UI
4192	PUBCHEM_CID
3342	IUPHAR_LIGAND_ID
4497	INN_ID
R60L0SM5BC	UNII
203128	RXNORM
130935	MMSL
24970	MMSL
32073	MMSL
5114	MMSL
d00301	MMSL
001467	NDDF
004585	NDDF
26800000	SNOMEDCT_US
373476007	SNOMEDCT_US
84213009	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Midazolam Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0054-3566	SYRUP	2 mg	ORAL	ANDA	25 sections
Midazolam Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0054-3566	SYRUP	2 mg	ORAL	ANDA	25 sections
Midazolam Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0054-3566	SYRUP	2 mg	ORAL	ANDA	25 sections
Midazolam in Sodium Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9379	INJECTION	1 mg	INTRAVENOUS	ANDA	28 sections
Midazolam in Sodium Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9380	INJECTION	1 mg	INTRAVENOUS	ANDA	28 sections
Midazolam	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9912	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	14 sections
Midazolam	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9912	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	14 sections
Midazolam	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9913	INJECTION	1 mg	INTRAMUSCULAR	ANDA	15 sections
Midazolam	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9913	INJECTION	1 mg	INTRAMUSCULAR	ANDA	15 sections
Midazolam	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9913	INJECTION	1 mg	INTRAMUSCULAR	ANDA	15 sections
MIDAZOLAM	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9914	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	15 sections
MIDAZOLAM	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9914	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	15 sections
Midazolam	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9915	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	14 sections
Midazolam	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9915	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	14 sections
Midazolam Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9916	INJECTION, SOLUTION	5 mg	INTRAMUSCULAR	ANDA	15 sections
Midazolam Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9916	INJECTION, SOLUTION	5 mg	INTRAMUSCULAR	ANDA	15 sections
Midazolam Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0409-2305	INJECTION, SOLUTION	1 mg	INTRAMUSCULAR	ANDA	29 sections
Midazolam Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0409-2305	INJECTION, SOLUTION	1 mg	INTRAMUSCULAR	ANDA	29 sections
Midazolam Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0409-2305	INJECTION, SOLUTION	1 mg	INTRAMUSCULAR	ANDA	29 sections
Midazolam Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0409-2305	INJECTION, SOLUTION	1 mg	INTRAMUSCULAR	ANDA	29 sections
Midazolam Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0409-2305	INJECTION, SOLUTION	1 mg	INTRAMUSCULAR	ANDA	29 sections
Midazolam Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0409-2305	INJECTION, SOLUTION	1 mg	INTRAMUSCULAR	ANDA	29 sections
Midazolam Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0409-2308	INJECTION, SOLUTION	5 mg	INTRAMUSCULAR	ANDA	29 sections
Midazolam Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0409-2308	INJECTION, SOLUTION	5 mg	INTRAMUSCULAR	ANDA	29 sections
Midazolam Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0409-2308	INJECTION, SOLUTION	5 mg	INTRAMUSCULAR	ANDA	29 sections
Midazolam Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0409-2308	INJECTION, SOLUTION	5 mg	INTRAMUSCULAR	ANDA	29 sections
Midazolam Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0409-2308	INJECTION, SOLUTION	5 mg	INTRAMUSCULAR	ANDA	29 sections
Midazolam Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0409-2308	INJECTION, SOLUTION	5 mg	INTRAMUSCULAR	ANDA	29 sections
Midazolam Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0409-2587	INJECTION, SOLUTION	1 mg	INTRAMUSCULAR	ANDA	28 sections
Midazolam Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0409-2587	INJECTION, SOLUTION	1 mg	INTRAMUSCULAR	ANDA	28 sections