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 |
|---|---|
|
Synonyms:
|
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.
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 | Orphan |
|---|---|---|---|
| Dec. 20, 1985 | FDA | ||
| Sept. 25, 2020 | PMDA | TAKEDA PHARMACEUTICAL COMPANY LIMITED |
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 | 271.44 | 14.44 | 130 | 23401 | 13276 | 50568317 |
| Hypotension | 237.44 | 14.44 | 406 | 23125 | 235063 | 50346530 |
| Multiple-drug resistance | 214.15 | 14.44 | 74 | 23457 | 3240 | 50578353 |
| Cardiac arrest | 213.09 | 14.44 | 227 | 23304 | 83424 | 50498169 |
| Serotonin syndrome | 204.49 | 14.44 | 133 | 23398 | 24580 | 50557013 |
| Anaphylactic reaction | 190.21 | 14.44 | 175 | 23356 | 53880 | 50527713 |
| Propofol infusion syndrome | 149.24 | 14.44 | 40 | 23491 | 726 | 50580867 |
| Drug interaction | 137.48 | 14.44 | 293 | 23238 | 199328 | 50382265 |
| Fatigue | 128.90 | 14.44 | 86 | 23445 | 707515 | 49874078 |
| Diabetes insipidus | 115.80 | 14.44 | 43 | 23488 | 2321 | 50579272 |
| Tachycardia | 114.94 | 14.44 | 183 | 23348 | 99580 | 50482013 |
| Respiratory acidosis | 111.58 | 14.44 | 55 | 23476 | 5973 | 50575620 |
| Labile blood pressure | 103.13 | 14.44 | 36 | 23495 | 1624 | 50579969 |
| Metabolic acidosis | 99.85 | 14.44 | 106 | 23425 | 38719 | 50542874 |
| Multiple organ dysfunction syndrome | 99.74 | 14.44 | 120 | 23411 | 50217 | 50531376 |
| Drug ineffective | 99.25 | 14.44 | 684 | 22847 | 818649 | 49762944 |
| Seizure | 97.68 | 14.44 | 187 | 23344 | 117687 | 50463906 |
| Joint swelling | 96.91 | 14.44 | 4 | 23527 | 245282 | 50336311 |
| Generalised tonic-clonic seizure | 96.02 | 14.44 | 87 | 23444 | 26223 | 50555370 |
| Encephalopathy | 95.61 | 14.44 | 97 | 23434 | 33614 | 50547979 |
| Myoglobin urine present | 93.44 | 14.44 | 24 | 23507 | 366 | 50581227 |
| Drug ineffective for unapproved indication | 88.93 | 14.44 | 76 | 23455 | 21205 | 50560388 |
| Circulatory collapse | 88.87 | 14.44 | 74 | 23457 | 19926 | 50561667 |
| Agitation | 86.31 | 14.44 | 115 | 23416 | 53269 | 50528324 |
| Anaphylactic shock | 86.31 | 14.44 | 73 | 23458 | 20082 | 50561511 |
| Unwanted awareness during anaesthesia | 85.52 | 14.44 | 21 | 23510 | 264 | 50581329 |
| Alopecia | 84.93 | 14.44 | 8 | 23523 | 245039 | 50336554 |
| Toxic encephalopathy | 80.84 | 14.44 | 43 | 23488 | 5472 | 50576121 |
| Intra-abdominal pressure increased | 80.46 | 14.44 | 19 | 23512 | 200 | 50581393 |
| Pain | 80.17 | 14.44 | 91 | 23440 | 578812 | 50002781 |
| Mitochondrial DNA mutation | 77.96 | 14.44 | 19 | 23512 | 231 | 50581362 |
| Myoclonus | 75.89 | 14.44 | 59 | 23472 | 14411 | 50567182 |
| Renal ischaemia | 75.04 | 14.44 | 22 | 23509 | 560 | 50581033 |
| Abdominal discomfort | 74.15 | 14.44 | 10 | 23521 | 231631 | 50349962 |
| Bradycardia | 73.89 | 14.44 | 118 | 23413 | 64308 | 50517285 |
| Shock | 70.90 | 14.44 | 66 | 23465 | 20584 | 50561009 |
| Oxygen saturation abnormal | 69.65 | 14.44 | 31 | 23500 | 2671 | 50578922 |
| Swelling | 68.43 | 14.44 | 7 | 23524 | 200865 | 50380728 |
| Pneumatosis | 67.69 | 14.44 | 19 | 23512 | 412 | 50581181 |
| Intestinal ischaemia | 64.93 | 14.44 | 40 | 23491 | 6717 | 50574876 |
| Delirium | 64.38 | 14.44 | 84 | 23447 | 38108 | 50543485 |
| PCO2 increased | 64.20 | 14.44 | 23 | 23508 | 1120 | 50580473 |
| Ventricular hypokinesia | 63.94 | 14.44 | 33 | 23498 | 3947 | 50577646 |
| PO2 increased | 63.52 | 14.44 | 21 | 23510 | 801 | 50580792 |
| Partial seizures | 63.15 | 14.44 | 35 | 23496 | 4830 | 50576763 |
| Fall | 63.03 | 14.44 | 39 | 23492 | 334893 | 50246700 |
| Arthralgia | 62.80 | 14.44 | 67 | 23464 | 438635 | 50142958 |
| Unresponsive to stimuli | 62.30 | 14.44 | 74 | 23457 | 30535 | 50551058 |
| Systemic inflammatory response syndrome | 61.94 | 14.44 | 35 | 23496 | 5014 | 50576579 |
| Hepatic ischaemia | 61.33 | 14.44 | 19 | 23512 | 586 | 50581007 |
| Arthropathy | 60.94 | 14.44 | 3 | 23528 | 157903 | 50423690 |
| Off label use | 60.55 | 14.44 | 402 | 23129 | 474024 | 50107569 |
| Nausea | 60.54 | 14.44 | 151 | 23380 | 705247 | 49876346 |
| Drug intolerance | 60.26 | 14.44 | 14 | 23517 | 219090 | 50362503 |
| Blood pH decreased | 59.57 | 14.44 | 27 | 23504 | 2428 | 50579165 |
| Pulseless electrical activity | 59.46 | 14.44 | 38 | 23493 | 6803 | 50574790 |
| Electrocardiogram QRS complex prolonged | 57.45 | 14.44 | 34 | 23497 | 5310 | 50576283 |
| Delayed recovery from anaesthesia | 57.34 | 14.44 | 19 | 23512 | 730 | 50580863 |
| Necrosis ischaemic | 56.14 | 14.44 | 19 | 23512 | 780 | 50580813 |
| Respiratory failure | 55.98 | 14.44 | 128 | 23403 | 91053 | 50490540 |
| Peripheral swelling | 54.98 | 14.44 | 14 | 23517 | 205922 | 50375671 |
| Anaesthetic complication | 54.94 | 14.44 | 23 | 23508 | 1707 | 50579886 |
| Anticholinergic syndrome | 54.12 | 14.44 | 23 | 23508 | 1772 | 50579821 |
| Malaise | 54.10 | 14.44 | 46 | 23485 | 335486 | 50246107 |
| Apnoea | 53.96 | 14.44 | 36 | 23495 | 6930 | 50574663 |
| Pain in extremity | 53.82 | 14.44 | 30 | 23501 | 272835 | 50308758 |
| Diarrhoea | 53.58 | 14.44 | 122 | 23409 | 588354 | 49993239 |
| Foetal death | 53.29 | 14.44 | 38 | 23493 | 8142 | 50573451 |
| Systemic lupus erythematosus | 53.23 | 14.44 | 3 | 23528 | 140619 | 50440974 |
| Hepatic failure | 52.85 | 14.44 | 70 | 23461 | 32213 | 50549380 |
| Perforation | 52.65 | 14.44 | 19 | 23512 | 945 | 50580648 |
| Cardiogenic shock | 51.90 | 14.44 | 49 | 23482 | 15550 | 50566043 |
| Neuromuscular block prolonged | 51.60 | 14.44 | 16 | 23515 | 495 | 50581098 |
| Acute respiratory distress syndrome | 51.40 | 14.44 | 56 | 23475 | 21043 | 50560550 |
| Respiratory depression | 50.39 | 14.44 | 43 | 23488 | 11967 | 50569626 |
| Oropharyngeal oedema | 48.14 | 14.44 | 13 | 23518 | 243 | 50581350 |
| Muscle relaxant therapy | 47.94 | 14.44 | 12 | 23519 | 164 | 50581429 |
| Blood creatine phosphokinase increased | 47.59 | 14.44 | 60 | 23471 | 26307 | 50555286 |
| Renal impairment | 47.31 | 14.44 | 107 | 23424 | 75554 | 50506039 |
| Epileptic aura | 47.17 | 14.44 | 10 | 23521 | 61 | 50581532 |
| Ventricular extrasystoles | 46.89 | 14.44 | 39 | 23492 | 10477 | 50571116 |
| Nasopharyngitis | 46.24 | 14.44 | 16 | 23515 | 192911 | 50388682 |
| Headache | 46.07 | 14.44 | 105 | 23426 | 506430 | 50075163 |
| Electrocardiogram ST segment depression | 45.80 | 14.44 | 23 | 23508 | 2597 | 50578996 |
| Epilepsy | 45.31 | 14.44 | 53 | 23478 | 21514 | 50560079 |
| Oxygen saturation decreased | 45.14 | 14.44 | 103 | 23428 | 73145 | 50508448 |
| Electrocardiogram ST segment elevation | 45.12 | 14.44 | 25 | 23506 | 3448 | 50578145 |
| Blood bicarbonate decreased | 44.95 | 14.44 | 23 | 23508 | 2702 | 50578891 |
| Anaesthetic complication pulmonary | 44.65 | 14.44 | 9 | 23522 | 41 | 50581552 |
| Infusion related reaction | 44.35 | 14.44 | 12 | 23519 | 169545 | 50412048 |
| Hypoxia | 43.38 | 14.44 | 82 | 23449 | 51041 | 50530552 |
| Anorectal ulcer | 43.17 | 14.44 | 9 | 23522 | 50 | 50581543 |
| Non-consummation | 42.72 | 14.44 | 9 | 23522 | 53 | 50581540 |
| Mydriasis | 42.45 | 14.44 | 37 | 23494 | 10590 | 50571003 |
| Electroencephalogram abnormal | 42.23 | 14.44 | 24 | 23507 | 3475 | 50578118 |
| Cardiotoxicity | 42.03 | 14.44 | 31 | 23500 | 6996 | 50574597 |
| Female genital tract fistula | 41.19 | 14.44 | 24 | 23507 | 3642 | 50577951 |
| Product dose omission issue | 41.13 | 14.44 | 17 | 23514 | 183821 | 50397772 |
| Diabetic macroangiopathy | 41.00 | 14.44 | 10 | 23521 | 122 | 50581471 |
| Intestinal infarction | 40.90 | 14.44 | 16 | 23515 | 996 | 50580597 |
| Blood gases abnormal | 40.24 | 14.44 | 14 | 23517 | 625 | 50580968 |
| Toxicity to various agents | 40.05 | 14.44 | 200 | 23331 | 212299 | 50369294 |
| Brain oedema | 39.52 | 14.44 | 38 | 23493 | 12332 | 50569261 |
| Amylase increased | 39.52 | 14.44 | 27 | 23504 | 5403 | 50576190 |
| Colitis | 39.34 | 14.44 | 67 | 23464 | 38462 | 50543131 |
| Disseminated intravascular coagulation | 39.18 | 14.44 | 44 | 23487 | 17091 | 50564502 |
| Bronchospasm | 38.95 | 14.44 | 41 | 23490 | 14813 | 50566780 |
| Ultrasound ovary abnormal | 38.80 | 14.44 | 9 | 23522 | 87 | 50581506 |
| Weight increased | 38.64 | 14.44 | 23 | 23508 | 201868 | 50379725 |
| Hepatorenal syndrome | 38.63 | 14.44 | 18 | 23513 | 1725 | 50579868 |
| Pseudopolyp | 38.62 | 14.44 | 11 | 23520 | 252 | 50581341 |
| Altered state of consciousness | 38.18 | 14.44 | 49 | 23482 | 21861 | 50559732 |
| Contraindicated product administered | 38.10 | 14.44 | 11 | 23520 | 148947 | 50432646 |
| Upper airway obstruction | 37.81 | 14.44 | 13 | 23518 | 560 | 50581033 |
| Sinusitis | 37.78 | 14.44 | 16 | 23515 | 170542 | 50411051 |
| Unmasking of previously unidentified disease | 37.55 | 14.44 | 14 | 23517 | 764 | 50580829 |
| Gene mutation | 37.37 | 14.44 | 16 | 23515 | 1255 | 50580338 |
| Airway peak pressure increased | 37.37 | 14.44 | 11 | 23520 | 284 | 50581309 |
| Stress cardiomyopathy | 36.73 | 14.44 | 30 | 23501 | 7857 | 50573736 |
| Blood lactic acid increased | 36.51 | 14.44 | 26 | 23505 | 5559 | 50576034 |
| Discomfort | 36.31 | 14.44 | 4 | 23527 | 108376 | 50473217 |
| Troponin increased | 35.98 | 14.44 | 30 | 23501 | 8088 | 50573505 |
| Systolic dysfunction | 35.12 | 14.44 | 16 | 23515 | 1456 | 50580137 |
| Left ventricular dysfunction | 34.94 | 14.44 | 33 | 23498 | 10473 | 50571120 |
| Acid base balance abnormal | 34.78 | 14.44 | 10 | 23521 | 237 | 50581356 |
| Sinus bradycardia | 33.88 | 14.44 | 36 | 23495 | 13147 | 50568446 |
| Laryngeal stenosis | 33.62 | 14.44 | 13 | 23518 | 784 | 50580809 |
| Anaesthetic complication neurological | 32.99 | 14.44 | 9 | 23522 | 175 | 50581418 |
| Acute coronary syndrome | 32.24 | 14.44 | 30 | 23501 | 9344 | 50572249 |
| Haemodynamic instability | 32.18 | 14.44 | 28 | 23503 | 7996 | 50573597 |
| Encephalitis autoimmune | 31.04 | 14.44 | 14 | 23517 | 1244 | 50580349 |
| Proctitis | 31.01 | 14.44 | 16 | 23515 | 1912 | 50579681 |
| Gastrointestinal scarring | 30.77 | 14.44 | 9 | 23522 | 227 | 50581366 |
| Hyperammonaemic encephalopathy | 30.47 | 14.44 | 16 | 23515 | 1983 | 50579610 |
| Hepatocellular injury | 30.38 | 14.44 | 48 | 23483 | 25899 | 50555694 |
| Weight decreased | 30.24 | 14.44 | 35 | 23496 | 221210 | 50360383 |
| Drug-induced liver injury | 30.20 | 14.44 | 50 | 23481 | 28045 | 50553548 |
| Vaginal flatulence | 30.19 | 14.44 | 9 | 23522 | 243 | 50581350 |
| Product use in unapproved indication | 30.09 | 14.44 | 120 | 23411 | 115699 | 50465894 |
| Sinus tachycardia | 29.98 | 14.44 | 43 | 23488 | 21311 | 50560282 |
| Bulimia nervosa | 29.86 | 14.44 | 10 | 23521 | 397 | 50581196 |
| Tachyphylaxis | 29.78 | 14.44 | 9 | 23522 | 255 | 50581338 |
| Dizziness | 29.67 | 14.44 | 74 | 23457 | 346295 | 50235298 |
| Arthritis | 29.56 | 14.44 | 3 | 23528 | 86718 | 50494875 |
| Hypernatraemia | 29.35 | 14.44 | 24 | 23507 | 6297 | 50575296 |
| Drug resistance | 29.28 | 14.44 | 40 | 23491 | 18949 | 50562644 |
| Macroglossia | 29.04 | 14.44 | 11 | 23520 | 627 | 50580966 |
| Restlessness | 28.69 | 14.44 | 46 | 23485 | 25127 | 50556466 |
| Paradoxical drug reaction | 28.61 | 14.44 | 19 | 23512 | 3628 | 50577965 |
| Procedural vomiting | 28.54 | 14.44 | 10 | 23521 | 456 | 50581137 |
| Musculoskeletal stiffness | 28.53 | 14.44 | 12 | 23519 | 128469 | 50453124 |
| Lower respiratory tract infection | 28.40 | 14.44 | 5 | 23526 | 95196 | 50486397 |
| Gastrointestinal mucosa hyperaemia | 28.22 | 14.44 | 8 | 23523 | 180 | 50581413 |
| Hyperaesthesia | 27.81 | 14.44 | 26 | 23505 | 8147 | 50573446 |
| Myoglobin blood increased | 27.56 | 14.44 | 13 | 23518 | 1280 | 50580313 |
| Muscle rigidity | 27.34 | 14.44 | 28 | 23503 | 9801 | 50571792 |
| Pituitary apoplexy | 26.77 | 14.44 | 7 | 23524 | 115 | 50581478 |
| Acute respiratory failure | 26.71 | 14.44 | 48 | 23483 | 28734 | 50552859 |
| Arrhythmia | 26.69 | 14.44 | 52 | 23479 | 33080 | 50548513 |
| Rash | 26.60 | 14.44 | 109 | 23422 | 437362 | 50144231 |
| Carcinoid crisis | 26.59 | 14.44 | 8 | 23523 | 223 | 50581370 |
| Depressed level of consciousness | 26.57 | 14.44 | 68 | 23463 | 51885 | 50529708 |
| Exposure during pregnancy | 26.48 | 14.44 | 119 | 23412 | 120896 | 50460697 |
| Product administered to patient of inappropriate age | 26.37 | 14.44 | 16 | 23515 | 2614 | 50578979 |
| Procedural hypotension | 26.36 | 14.44 | 12 | 23519 | 1090 | 50580503 |
| Clonus | 26.29 | 14.44 | 19 | 23512 | 4156 | 50577437 |
| Dyschezia | 26.25 | 14.44 | 14 | 23517 | 1790 | 50579803 |
| Left ventricular hypertrophy | 25.93 | 14.44 | 20 | 23511 | 4825 | 50576768 |
| Oliguria | 25.79 | 14.44 | 25 | 23506 | 8191 | 50573402 |
| Back pain | 25.78 | 14.44 | 39 | 23492 | 219991 | 50361602 |
| Contusion | 25.68 | 14.44 | 10 | 23521 | 112173 | 50469420 |
| Frequent bowel movements | 25.63 | 14.44 | 32 | 23499 | 13886 | 50567707 |
| Ventricular tachycardia | 25.42 | 14.44 | 34 | 23497 | 15787 | 50565806 |
| Delayed graft function | 25.03 | 14.44 | 11 | 23520 | 919 | 50580674 |
| Infection parasitic | 24.28 | 14.44 | 8 | 23523 | 302 | 50581291 |
| Myalgia | 24.00 | 14.44 | 14 | 23517 | 124305 | 50457288 |
| Asthma | 23.96 | 14.44 | 6 | 23525 | 89331 | 50492262 |
| Premature delivery | 23.95 | 14.44 | 41 | 23490 | 23622 | 50557971 |
| Asthenia | 23.71 | 14.44 | 73 | 23458 | 318969 | 50262624 |
| Acidosis hyperchloraemic | 23.60 | 14.44 | 8 | 23523 | 330 | 50581263 |
| Drug reaction with eosinophilia and systemic symptoms | 23.37 | 14.44 | 45 | 23486 | 28379 | 50553214 |
| Patent ductus arteriosus | 23.18 | 14.44 | 17 | 23514 | 3803 | 50577790 |
| Nail dystrophy | 23.16 | 14.44 | 10 | 23521 | 801 | 50580792 |
| Cardio-respiratory arrest | 23.01 | 14.44 | 66 | 23465 | 53826 | 50527767 |
| Tachypnoea | 22.92 | 14.44 | 31 | 23500 | 14546 | 50567047 |
| Atrioventricular dissociation | 22.50 | 14.44 | 7 | 23524 | 219 | 50581374 |
| Mixed liver injury | 22.40 | 14.44 | 16 | 23515 | 3435 | 50578158 |
| Intensive care unit delirium | 22.40 | 14.44 | 5 | 23526 | 40 | 50581553 |
| Electrocardiogram repolarisation abnormality | 22.36 | 14.44 | 11 | 23520 | 1189 | 50580404 |
| Palpitations | 22.34 | 14.44 | 8 | 23523 | 94498 | 50487095 |
| Tonic clonic movements | 22.04 | 14.44 | 11 | 23520 | 1226 | 50580367 |
| Abdominal pain upper | 21.97 | 14.44 | 25 | 23506 | 159284 | 50422309 |
| Methaemoglobinaemia | 21.97 | 14.44 | 13 | 23518 | 2029 | 50579564 |
| Myocardial ischaemia | 21.87 | 14.44 | 27 | 23504 | 11586 | 50570007 |
| White matter lesion | 21.82 | 14.44 | 12 | 23519 | 1630 | 50579963 |
| Overdose | 21.76 | 14.44 | 98 | 23433 | 99629 | 50481964 |
| Procedural complication | 21.74 | 14.44 | 18 | 23513 | 4805 | 50576788 |
| Hypersensitivity | 21.67 | 14.44 | 42 | 23489 | 215119 | 50366474 |
| Intentional overdose | 21.52 | 14.44 | 71 | 23460 | 62433 | 50519160 |
| Apnoeic attack | 21.40 | 14.44 | 7 | 23524 | 258 | 50581335 |
| Nephrocalcinosis | 21.40 | 14.44 | 10 | 23521 | 964 | 50580629 |
| Blood lactate dehydrogenase increased | 21.27 | 14.44 | 35 | 23496 | 19527 | 50562066 |
| Intensive care unit acquired weakness | 21.24 | 14.44 | 9 | 23522 | 688 | 50580905 |
| Bronchitis | 21.16 | 14.44 | 11 | 23520 | 104148 | 50477445 |
| Neurotoxicity | 21.16 | 14.44 | 30 | 23501 | 14710 | 50566883 |
| Paralysis | 21.10 | 14.44 | 23 | 23508 | 8641 | 50572952 |
| Laryngospasm | 21.08 | 14.44 | 14 | 23517 | 2674 | 50578919 |
| Anuria | 20.94 | 14.44 | 26 | 23505 | 11218 | 50570375 |
| Post procedural stroke | 20.89 | 14.44 | 5 | 23526 | 56 | 50581537 |
| Granulomatous liver disease | 20.69 | 14.44 | 9 | 23522 | 734 | 50580859 |
| Hypoventilation | 20.58 | 14.44 | 16 | 23515 | 3905 | 50577688 |
| Haematemesis | 20.52 | 14.44 | 42 | 23489 | 27683 | 50553910 |
| Therapeutic product effect prolonged | 20.26 | 14.44 | 7 | 23524 | 306 | 50581287 |
| Impaired healing | 20.09 | 14.44 | 4 | 23527 | 69782 | 50511811 |
| C-reactive protein decreased | 20.02 | 14.44 | 9 | 23522 | 794 | 50580799 |
| Pulmonary oedema | 19.99 | 14.44 | 59 | 23472 | 48879 | 50532714 |
| Euthyroid sick syndrome | 19.93 | 14.44 | 5 | 23526 | 69 | 50581524 |
| Hypoaesthesia | 19.79 | 14.44 | 18 | 23513 | 127239 | 50454354 |
| Psoriasis | 19.77 | 14.44 | 4 | 23527 | 68996 | 50512597 |
| Coronary artery embolism | 19.69 | 14.44 | 6 | 23525 | 175 | 50581418 |
| Blood magnesium decreased | 19.51 | 14.44 | 25 | 23506 | 11135 | 50570458 |
| Hypovolaemia | 19.44 | 14.44 | 23 | 23508 | 9442 | 50572151 |
| Posterior reversible encephalopathy syndrome | 19.42 | 14.44 | 29 | 23502 | 14899 | 50566694 |
| Large intestinal ulcer | 19.40 | 14.44 | 14 | 23517 | 3055 | 50578538 |
| Tonsillar hypertrophy | 19.37 | 14.44 | 9 | 23522 | 857 | 50580736 |
| Immunosuppressant drug level increased | 19.35 | 14.44 | 14 | 23517 | 3068 | 50578525 |
| Pneumonia fungal | 19.21 | 14.44 | 16 | 23515 | 4304 | 50577289 |
| Hypochloraemia | 19.08 | 14.44 | 11 | 23520 | 1636 | 50579957 |
| Intermittent claudication | 19.03 | 14.44 | 11 | 23520 | 1644 | 50579949 |
| Ventricular dysfunction | 18.99 | 14.44 | 13 | 23518 | 2608 | 50578985 |
| Local anaesthetic systemic toxicity | 18.98 | 14.44 | 8 | 23523 | 604 | 50580989 |
| Neonatal seizure | 18.90 | 14.44 | 7 | 23524 | 375 | 50581218 |
| Septic shock | 18.84 | 14.44 | 64 | 23467 | 57111 | 50524482 |
| Airway complication of anaesthesia | 18.78 | 14.44 | 6 | 23525 | 205 | 50581388 |
| Sinus arrest | 18.77 | 14.44 | 11 | 23520 | 1687 | 50579906 |
| Stevens-Johnson syndrome | 18.58 | 14.44 | 35 | 23496 | 21717 | 50559876 |
| Hepatic enzyme increased | 18.47 | 14.44 | 22 | 23509 | 137358 | 50444235 |
| Hypertrophic cardiomyopathy | 18.35 | 14.44 | 10 | 23521 | 1335 | 50580258 |
| Acute hepatic failure | 18.34 | 14.44 | 29 | 23502 | 15648 | 50565945 |
| Symptom masked | 18.29 | 14.44 | 8 | 23523 | 661 | 50580932 |
| Renal infarct | 18.24 | 14.44 | 10 | 23521 | 1350 | 50580243 |
| Colitis ulcerative | 18.12 | 14.44 | 30 | 23501 | 16824 | 50564769 |
| Coronary artery bypass | 18.12 | 14.44 | 12 | 23519 | 2281 | 50579312 |
| Burkholderia test positive | 18.02 | 14.44 | 6 | 23525 | 234 | 50581359 |
| Selective eating disorder | 17.99 | 14.44 | 11 | 23520 | 1821 | 50579772 |
| Hyperammonaemia | 17.97 | 14.44 | 16 | 23515 | 4708 | 50576885 |
| Resuscitation | 17.96 | 14.44 | 9 | 23522 | 1012 | 50580581 |
| Pseudomonas infection | 17.88 | 14.44 | 22 | 23509 | 9408 | 50572185 |
| Device related sepsis | 17.85 | 14.44 | 14 | 23517 | 3461 | 50578132 |
| Gastrointestinal vascular malformation | 17.71 | 14.44 | 4 | 23527 | 34 | 50581559 |
| Respiratory rate increased | 17.58 | 14.44 | 24 | 23507 | 11361 | 50570232 |
| Extremity necrosis | 17.51 | 14.44 | 10 | 23521 | 1461 | 50580132 |
| Foetal exposure during pregnancy | 17.43 | 14.44 | 39 | 23492 | 27320 | 50554273 |
| Stomatitis | 17.41 | 14.44 | 13 | 23518 | 101331 | 50480262 |
| Blood potassium increased | 17.38 | 14.44 | 29 | 23502 | 16369 | 50565224 |
| Musculoskeletal pain | 17.25 | 14.44 | 6 | 23525 | 72171 | 50509422 |
| Epileptic encephalopathy | 17.20 | 14.44 | 6 | 23525 | 270 | 50581323 |
| Post procedural haemorrhage | 17.19 | 14.44 | 19 | 23512 | 7251 | 50574342 |
| Influenza like illness | 17.17 | 14.44 | 3 | 23528 | 57456 | 50524137 |
| Hypotonia | 17.10 | 14.44 | 20 | 23511 | 8114 | 50573479 |
| Electrocardiogram QT prolonged | 17.02 | 14.44 | 58 | 23473 | 51828 | 50529765 |
| Injection site pain | 16.91 | 14.44 | 16 | 23515 | 111008 | 50470585 |
| Neuromuscular blockade | 16.91 | 14.44 | 6 | 23525 | 284 | 50581309 |
| Teratoma | 16.88 | 14.44 | 5 | 23526 | 132 | 50581461 |
| Axillary pain | 16.82 | 14.44 | 10 | 23521 | 1574 | 50580019 |
| Coagulopathy | 16.74 | 14.44 | 30 | 23501 | 17914 | 50563679 |
| Oral candidiasis | 16.72 | 14.44 | 29 | 23502 | 16886 | 50564707 |
| Hypokalaemia | 16.66 | 14.44 | 83 | 23448 | 87909 | 50493684 |
| Tracheal injury | 16.62 | 14.44 | 4 | 23527 | 46 | 50581547 |
| Drug chemical incompatibility | 16.54 | 14.44 | 4 | 23527 | 47 | 50581546 |
| Loss of personal independence in daily activities | 16.44 | 14.44 | 6 | 23525 | 70044 | 50511549 |
| Vulvovaginal candidiasis | 16.38 | 14.44 | 12 | 23519 | 2680 | 50578913 |
| Anaphylactoid shock | 16.37 | 14.44 | 6 | 23525 | 312 | 50581281 |
| Hyperthermia | 16.30 | 14.44 | 19 | 23512 | 7677 | 50573916 |
| Infantile apnoea | 16.26 | 14.44 | 8 | 23523 | 865 | 50580728 |
| Wrong product administered | 16.25 | 14.44 | 16 | 23515 | 5344 | 50576249 |
| Blood cholesterol increased | 16.25 | 14.44 | 3 | 23528 | 55212 | 50526381 |
| Gait disturbance | 16.23 | 14.44 | 28 | 23503 | 149977 | 50431616 |
| Procedural intestinal perforation | 16.18 | 14.44 | 5 | 23526 | 153 | 50581440 |
| Ill-defined disorder | 16.01 | 14.44 | 3 | 23528 | 54651 | 50526942 |
| Catheter site haemorrhage | 15.92 | 14.44 | 12 | 23519 | 2798 | 50578795 |
| Sepsis | 15.85 | 14.44 | 111 | 23420 | 132814 | 50448779 |
| Rash morbilliform | 15.78 | 14.44 | 12 | 23519 | 2834 | 50578759 |
| Enzyme induction | 15.76 | 14.44 | 4 | 23527 | 58 | 50581535 |
| Manipulation | 15.76 | 14.44 | 4 | 23527 | 58 | 50581535 |
| Gaze palsy | 15.70 | 14.44 | 9 | 23522 | 1324 | 50580269 |
| Coma hepatic | 15.66 | 14.44 | 7 | 23524 | 609 | 50580984 |
| Oxygen saturation immeasurable | 15.63 | 14.44 | 3 | 23528 | 10 | 50581583 |
| Radiculopathy | 15.44 | 14.44 | 15 | 23516 | 4926 | 50576667 |
| Urinary tract infection | 15.41 | 14.44 | 53 | 23478 | 223967 | 50357626 |
| White blood cell count decreased | 15.36 | 14.44 | 19 | 23512 | 116703 | 50464890 |
| Dyspnoea | 15.30 | 14.44 | 172 | 23359 | 547436 | 50034157 |
| Cor pulmonale | 15.21 | 14.44 | 10 | 23521 | 1877 | 50579716 |
| Respiratory arrest | 15.05 | 14.44 | 39 | 23492 | 29970 | 50551623 |
| Premature baby | 15.04 | 14.44 | 29 | 23502 | 18308 | 50563285 |
| Coma | 14.81 | 14.44 | 59 | 23472 | 56820 | 50524773 |
| Influenza | 14.73 | 14.44 | 12 | 23519 | 89526 | 50492067 |
| Pruritus | 14.61 | 14.44 | 75 | 23456 | 283493 | 50298100 |
| Therapeutic product effect variable | 14.58 | 14.44 | 8 | 23523 | 1082 | 50580511 |
| Fear | 14.45 | 14.44 | 25 | 23506 | 14524 | 50567069 |
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 | 216.04 | 14.24 | 123 | 22846 | 10671 | 29540887 |
| Drug ineffective | 160.20 | 14.24 | 629 | 22340 | 362541 | 29189017 |
| Hypotension | 153.12 | 14.24 | 411 | 22558 | 193943 | 29357615 |
| Drug reaction with eosinophilia and systemic symptoms | 148.43 | 14.24 | 143 | 22826 | 27849 | 29523709 |
| Hyperthermia malignant | 141.59 | 14.24 | 53 | 22916 | 1731 | 29549827 |
| Anaphylactic reaction | 140.83 | 14.24 | 138 | 22831 | 27435 | 29524123 |
| Cardiac arrest | 139.15 | 14.24 | 243 | 22726 | 85348 | 29466210 |
| Bradycardia | 133.20 | 14.24 | 206 | 22763 | 65423 | 29486135 |
| Serotonin syndrome | 119.31 | 14.24 | 103 | 22866 | 17409 | 29534149 |
| Multiple-drug resistance | 110.45 | 14.24 | 56 | 22913 | 3844 | 29547714 |
| Propofol infusion syndrome | 102.43 | 14.24 | 34 | 22935 | 773 | 29550785 |
| Intensive care unit acquired weakness | 97.24 | 14.24 | 34 | 22935 | 909 | 29550649 |
| Myoclonus | 92.11 | 14.24 | 79 | 22890 | 13230 | 29538328 |
| Fatigue | 91.30 | 14.24 | 68 | 22901 | 316753 | 29234805 |
| Delirium | 87.43 | 14.24 | 129 | 22840 | 39268 | 29512290 |
| Metabolic acidosis | 86.00 | 14.24 | 125 | 22844 | 37537 | 29514021 |
| Drug ineffective for unapproved indication | 83.70 | 14.24 | 77 | 22892 | 14137 | 29537421 |
| Anaphylactic shock | 81.96 | 14.24 | 74 | 22895 | 13262 | 29538296 |
| Respiratory failure | 79.81 | 14.24 | 209 | 22760 | 96922 | 29454636 |
| Diarrhoea | 71.99 | 14.24 | 92 | 22877 | 332606 | 29218952 |
| Coma | 71.92 | 14.24 | 118 | 22851 | 39332 | 29512226 |
| Off label use | 71.20 | 14.24 | 437 | 22532 | 300363 | 29251195 |
| Dizziness | 69.88 | 14.24 | 30 | 22939 | 189654 | 29361904 |
| Respiratory depression | 67.73 | 14.24 | 67 | 22902 | 13456 | 29538102 |
| Autonomic nervous system imbalance | 66.93 | 14.24 | 34 | 22935 | 2342 | 29549216 |
| Diabetes insipidus | 66.16 | 14.24 | 34 | 22935 | 2400 | 29549158 |
| Tachycardia | 65.88 | 14.24 | 162 | 22807 | 72248 | 29479310 |
| Acute respiratory distress syndrome | 61.10 | 14.24 | 82 | 22887 | 22853 | 29528705 |
| Hypoxia | 58.80 | 14.24 | 120 | 22849 | 47259 | 29504299 |
| Brain oedema | 58.35 | 14.24 | 59 | 22910 | 12161 | 29539397 |
| Multiple organ dysfunction syndrome | 58.24 | 14.24 | 142 | 22827 | 62974 | 29488584 |
| Rhabdomyolysis | 57.38 | 14.24 | 138 | 22831 | 60670 | 29490888 |
| Acidosis hyperchloraemic | 56.72 | 14.24 | 18 | 22951 | 353 | 29551205 |
| Generalised tonic-clonic seizure | 56.53 | 14.24 | 72 | 22897 | 19067 | 29532491 |
| Product dose omission issue | 56.43 | 14.24 | 5 | 22964 | 96378 | 29455180 |
| Sedation | 53.83 | 14.24 | 67 | 22902 | 17338 | 29534220 |
| Depressed level of consciousness | 53.66 | 14.24 | 100 | 22869 | 36842 | 29514716 |
| COVID-19 pneumonia | 52.99 | 14.24 | 50 | 22919 | 9472 | 29542086 |
| Septic shock | 52.74 | 14.24 | 136 | 22833 | 62424 | 29489134 |
| Drug interaction | 52.51 | 14.24 | 296 | 22673 | 197089 | 29354469 |
| Unresponsive to stimuli | 52.47 | 14.24 | 80 | 22889 | 25046 | 29526512 |
| Delayed recovery from anaesthesia | 52.03 | 14.24 | 20 | 22949 | 703 | 29550855 |
| Headache | 51.74 | 14.24 | 36 | 22933 | 173971 | 29377587 |
| Seizure like phenomena | 51.14 | 14.24 | 19 | 22950 | 607 | 29550951 |
| Anaesthetic complication neurological | 50.65 | 14.24 | 16 | 22953 | 309 | 29551249 |
| Agitation | 50.09 | 14.24 | 118 | 22851 | 51186 | 29500372 |
| Nausea | 50.01 | 14.24 | 93 | 22876 | 289162 | 29262396 |
| Necrosis ischaemic | 46.77 | 14.24 | 14 | 22955 | 224 | 29551334 |
| Hyperthermia | 45.88 | 14.24 | 46 | 22923 | 9384 | 29542174 |
| Respiratory acidosis | 45.76 | 14.24 | 33 | 22936 | 4295 | 29547263 |
| Catatonia | 44.82 | 14.24 | 33 | 22936 | 4435 | 29547123 |
| Anaesthetic complication | 42.79 | 14.24 | 19 | 22950 | 967 | 29550591 |
| Haemodynamic instability | 42.29 | 14.24 | 41 | 22928 | 8032 | 29543526 |
| Hypertransaminasaemia | 41.60 | 14.24 | 29 | 22940 | 3577 | 29547981 |
| Shock | 40.31 | 14.24 | 65 | 22904 | 21339 | 29530219 |
| Arthralgia | 40.02 | 14.24 | 30 | 22939 | 139587 | 29411971 |
| Hyperammonaemia | 39.95 | 14.24 | 34 | 22935 | 5629 | 29545929 |
| Sedation complication | 38.03 | 14.24 | 19 | 22950 | 1263 | 29550295 |
| Long QT syndrome | 37.96 | 14.24 | 23 | 22946 | 2235 | 29549323 |
| Laryngospasm | 37.92 | 14.24 | 19 | 22950 | 1271 | 29550287 |
| Toxicity to various agents | 37.60 | 14.24 | 247 | 22722 | 173414 | 29378144 |
| Fall | 37.16 | 14.24 | 50 | 22919 | 177128 | 29374430 |
| Product administered to patient of inappropriate age | 36.98 | 14.24 | 24 | 22945 | 2631 | 29548927 |
| Pain in extremity | 36.74 | 14.24 | 20 | 22949 | 110413 | 29441145 |
| Stress cardiomyopathy | 36.54 | 14.24 | 20 | 22949 | 1604 | 29549954 |
| Seizure | 36.40 | 14.24 | 156 | 22813 | 92967 | 29458591 |
| Burkholderia test positive | 36.26 | 14.24 | 17 | 22952 | 982 | 29550576 |
| Pulseless electrical activity | 36.21 | 14.24 | 34 | 22935 | 6400 | 29545158 |
| Myalgia | 35.80 | 14.24 | 7 | 22962 | 74012 | 29477546 |
| Herpes simplex viraemia | 35.73 | 14.24 | 9 | 22960 | 72 | 29551486 |
| Asthenia | 35.58 | 14.24 | 71 | 22898 | 215179 | 29336379 |
| Peripheral swelling | 35.49 | 14.24 | 4 | 22965 | 63735 | 29487823 |
| Mucosal ulceration | 35.00 | 14.24 | 16 | 22953 | 872 | 29550686 |
| Electroencephalogram abnormal | 34.73 | 14.24 | 22 | 22947 | 2313 | 29549245 |
| Coagulopathy | 34.56 | 14.24 | 55 | 22914 | 17852 | 29533706 |
| Kounis syndrome | 34.32 | 14.24 | 20 | 22949 | 1809 | 29549749 |
| Artery dissection | 33.68 | 14.24 | 9 | 22960 | 93 | 29551465 |
| Pruritus | 33.61 | 14.24 | 25 | 22944 | 116824 | 29434734 |
| Corneal reflex decreased | 33.47 | 14.24 | 10 | 22959 | 159 | 29551399 |
| Toxic epidermal necrolysis | 32.65 | 14.24 | 54 | 22915 | 18099 | 29533459 |
| Apnoea | 31.98 | 14.24 | 31 | 22938 | 6071 | 29545487 |
| Rash maculo-papular | 31.88 | 14.24 | 63 | 22906 | 24226 | 29527332 |
| Dyspnoea | 31.38 | 14.24 | 139 | 22830 | 326593 | 29224965 |
| Intestinal ischaemia | 31.38 | 14.24 | 32 | 22937 | 6660 | 29544898 |
| Dyskinesia | 31.26 | 14.24 | 56 | 22913 | 20005 | 29531553 |
| Back pain | 30.57 | 14.24 | 21 | 22948 | 102263 | 29449295 |
| Cardiogenic shock | 30.46 | 14.24 | 54 | 22915 | 19136 | 29532422 |
| Hypercapnia | 29.68 | 14.24 | 24 | 22945 | 3702 | 29547856 |
| Blood lactic acid increased | 29.67 | 14.24 | 29 | 22940 | 5737 | 29545821 |
| Death | 29.65 | 14.24 | 151 | 22818 | 341933 | 29209625 |
| Respiratory arrest | 29.19 | 14.24 | 63 | 22906 | 25770 | 29525788 |
| Circulatory collapse | 28.93 | 14.24 | 52 | 22917 | 18621 | 29532937 |
| Trigemino-cardiac reflex | 28.67 | 14.24 | 9 | 22960 | 170 | 29551388 |
| Haemophagocytic lymphohistiocytosis | 28.64 | 14.24 | 38 | 22931 | 10466 | 29541092 |
| Behaviour disorder | 28.18 | 14.24 | 23 | 22946 | 3593 | 29547965 |
| Post procedural hypotension | 27.68 | 14.24 | 7 | 22962 | 57 | 29551501 |
| Superinfection | 27.65 | 14.24 | 18 | 22951 | 1983 | 29549575 |
| Dehydration | 27.64 | 14.24 | 29 | 22940 | 114719 | 29436839 |
| Myocardial infarction | 27.56 | 14.24 | 27 | 22942 | 110269 | 29441289 |
| Neuromuscular block prolonged | 26.99 | 14.24 | 11 | 22958 | 452 | 29551106 |
| Anticonvulsant drug level below therapeutic | 26.93 | 14.24 | 12 | 22957 | 616 | 29550942 |
| Intracranial pressure increased | 26.81 | 14.24 | 22 | 22947 | 3463 | 29548095 |
| Oxygen saturation decreased | 26.52 | 14.24 | 86 | 22883 | 44851 | 29506707 |
| Malignant catatonia | 26.42 | 14.24 | 9 | 22960 | 222 | 29551336 |
| Intensive care | 26.03 | 14.24 | 10 | 22959 | 351 | 29551207 |
| Muscle rigidity | 25.59 | 14.24 | 34 | 22935 | 9377 | 29542181 |
| Ventricular tachycardia | 25.44 | 14.24 | 55 | 22914 | 22519 | 29529039 |
| Neuroleptic malignant syndrome | 25.06 | 14.24 | 45 | 22924 | 16103 | 29535455 |
| Odynophagia | 24.99 | 14.24 | 24 | 22945 | 4646 | 29546912 |
| Drug resistance | 24.88 | 14.24 | 53 | 22916 | 21487 | 29530071 |
| Acidosis | 24.77 | 14.24 | 34 | 22935 | 9671 | 29541887 |
| Overdose | 24.74 | 14.24 | 125 | 22844 | 79694 | 29471864 |
| Liver function test | 24.53 | 14.24 | 6 | 22963 | 42 | 29551516 |
| Nasopharyngitis | 24.32 | 14.24 | 8 | 22961 | 59657 | 29491901 |
| Abdominal discomfort | 24.31 | 14.24 | 4 | 22965 | 47899 | 29503659 |
| Hepatitis fulminant | 24.29 | 14.24 | 21 | 22948 | 3550 | 29548008 |
| Hypoventilation | 24.12 | 14.24 | 19 | 22950 | 2822 | 29548736 |
| Upper airway obstruction | 23.97 | 14.24 | 11 | 22958 | 605 | 29550953 |
| Laryngomalacia | 23.75 | 14.24 | 9 | 22960 | 304 | 29551254 |
| Leukocytosis | 23.25 | 14.24 | 51 | 22918 | 21091 | 29530467 |
| Hyperammonaemic encephalopathy | 22.95 | 14.24 | 16 | 22953 | 1974 | 29549584 |
| Drug withdrawal syndrome | 22.82 | 14.24 | 46 | 22923 | 17938 | 29533620 |
| Large intestine anastomosis | 22.81 | 14.24 | 6 | 22963 | 58 | 29551500 |
| Periorbital swelling | 22.53 | 14.24 | 9 | 22960 | 351 | 29551207 |
| White blood cell count decreased | 22.50 | 14.24 | 19 | 22950 | 83343 | 29468215 |
| Cyanosis | 22.28 | 14.24 | 35 | 22934 | 11232 | 29540326 |
| Tachypnoea | 22.03 | 14.24 | 41 | 22928 | 15074 | 29536484 |
| Neuropathy peripheral | 22.00 | 14.24 | 14 | 22955 | 71013 | 29480545 |
| Blood pressure decreased | 21.60 | 14.24 | 81 | 22888 | 45396 | 29506162 |
| Decreased appetite | 21.44 | 14.24 | 51 | 22918 | 145291 | 29406267 |
| Neurological examination abnormal | 21.37 | 14.24 | 8 | 22961 | 261 | 29551297 |
| Mixed dementia | 21.14 | 14.24 | 8 | 22961 | 269 | 29551289 |
| Mumps | 20.99 | 14.24 | 6 | 22963 | 81 | 29551477 |
| Diabetes mellitus | 20.95 | 14.24 | 3 | 22966 | 39828 | 29511730 |
| Urinary bladder rupture | 20.79 | 14.24 | 6 | 22963 | 84 | 29551474 |
| Partial seizures | 20.77 | 14.24 | 20 | 22949 | 3883 | 29547675 |
| Hypoglycaemia | 20.57 | 14.24 | 6 | 22963 | 48340 | 29503218 |
| Brain death | 20.44 | 14.24 | 16 | 22953 | 2354 | 29549204 |
| Dyspnoea paroxysmal nocturnal | 20.40 | 14.24 | 13 | 22956 | 1381 | 29550177 |
| Areflexia | 20.38 | 14.24 | 17 | 22952 | 2737 | 29548821 |
| Procedural complication | 20.11 | 14.24 | 20 | 22949 | 4040 | 29547518 |
| Medical device site fistula | 19.96 | 14.24 | 5 | 22964 | 39 | 29551519 |
| Illusion | 19.64 | 14.24 | 10 | 22959 | 692 | 29550866 |
| Product use in unapproved indication | 19.62 | 14.24 | 125 | 22844 | 86750 | 29464808 |
| Neutropenia | 19.60 | 14.24 | 46 | 22923 | 131665 | 29419893 |
| Hepatic cytolysis | 19.46 | 14.24 | 28 | 22941 | 8319 | 29543239 |
| Drug withdrawal syndrome neonatal | 19.22 | 14.24 | 18 | 22951 | 3377 | 29548181 |
| Hypernatraemia | 19.04 | 14.24 | 26 | 22943 | 7360 | 29544198 |
| Hospitalisation | 19.03 | 14.24 | 6 | 22963 | 45982 | 29505576 |
| Hyperaesthesia | 18.89 | 14.24 | 18 | 22951 | 3451 | 29548107 |
| Encephalopathy | 18.84 | 14.24 | 60 | 22909 | 30983 | 29520575 |
| Cardiac failure congestive | 18.83 | 14.24 | 19 | 22950 | 76562 | 29474996 |
| Respiratory disorder | 18.71 | 14.24 | 41 | 22928 | 16942 | 29534616 |
| Respiratory rate decreased | 18.69 | 14.24 | 14 | 22955 | 1931 | 29549627 |
| COVID-19 | 18.66 | 14.24 | 66 | 22903 | 35948 | 29515610 |
| Heart alternation | 18.48 | 14.24 | 3 | 22966 | 0 | 29551558 |
| Weight decreased | 18.48 | 14.24 | 58 | 22911 | 150847 | 29400711 |
| Postresuscitation encephalopathy | 18.43 | 14.24 | 4 | 22965 | 15 | 29551543 |
| Electrocardiogram ST segment elevation | 18.42 | 14.24 | 20 | 22949 | 4472 | 29547086 |
| Stupor | 18.39 | 14.24 | 16 | 22953 | 2728 | 29548830 |
| Disease progression | 18.30 | 14.24 | 22 | 22947 | 81894 | 29469664 |
| Angle closure glaucoma | 18.12 | 14.24 | 10 | 22959 | 815 | 29550743 |
| Neurotoxicity | 18.09 | 14.24 | 37 | 22932 | 14576 | 29536982 |
| Atonic urinary bladder | 17.84 | 14.24 | 4 | 22965 | 18 | 29551540 |
| Parkinsonism | 17.83 | 14.24 | 25 | 22944 | 7253 | 29544305 |
| Constipation | 17.69 | 14.24 | 39 | 22930 | 114121 | 29437437 |
| Vomiting | 17.60 | 14.24 | 95 | 22874 | 212165 | 29339393 |
| Arthrofibrosis | 17.32 | 14.24 | 5 | 22964 | 70 | 29551488 |
| Ventricular fibrillation | 17.19 | 14.24 | 38 | 22931 | 15795 | 29535763 |
| Anaemia | 17.18 | 14.24 | 89 | 22880 | 200862 | 29350696 |
| Malaise | 17.07 | 14.24 | 65 | 22904 | 159537 | 29392021 |
| Periventricular haemorrhage neonatal | 16.88 | 14.24 | 4 | 22965 | 24 | 29551534 |
| Psychotic disorder | 16.87 | 14.24 | 44 | 22925 | 20310 | 29531248 |
| Electrocardiogram QT prolonged | 16.85 | 14.24 | 64 | 22905 | 36073 | 29515485 |
| Respiratory distress | 16.78 | 14.24 | 59 | 22910 | 32047 | 29519511 |
| Administration related reaction | 16.59 | 14.24 | 5 | 22964 | 82 | 29551476 |
| Haematuria traumatic | 16.41 | 14.24 | 6 | 22963 | 183 | 29551375 |
| Encephalitis autoimmune | 16.24 | 14.24 | 8 | 22961 | 516 | 29551042 |
| Klebsiella infection | 16.19 | 14.24 | 24 | 22945 | 7325 | 29544233 |
| Muscle spasms | 16.17 | 14.24 | 16 | 22953 | 65066 | 29486492 |
| Neuromuscular blockade | 16.05 | 14.24 | 6 | 22963 | 195 | 29551363 |
| Haemoglobin decreased | 16.00 | 14.24 | 38 | 22931 | 108337 | 29443221 |
| Product packaging confusion | 15.88 | 14.24 | 4 | 22965 | 32 | 29551526 |
| Aggression | 15.80 | 14.24 | 62 | 22907 | 35479 | 29516079 |
| Pain | 15.76 | 14.24 | 74 | 22895 | 171358 | 29380200 |
| Weight increased | 15.67 | 14.24 | 22 | 22947 | 76645 | 29474913 |
| Hyperexplexia | 15.67 | 14.24 | 4 | 22965 | 34 | 29551524 |
| Catecholamine crisis | 15.56 | 14.24 | 4 | 22965 | 35 | 29551523 |
| Pneumomediastinum | 15.46 | 14.24 | 12 | 22957 | 1744 | 29549814 |
| Epilepsy | 15.43 | 14.24 | 40 | 22929 | 18392 | 29533166 |
| Systemic inflammatory response syndrome | 15.33 | 14.24 | 21 | 22948 | 5960 | 29545598 |
| Abdominal compartment syndrome | 15.28 | 14.24 | 9 | 22960 | 830 | 29550728 |
| Abdominal pain upper | 15.14 | 14.24 | 15 | 22954 | 60978 | 29490580 |
| Sinusitis | 15.10 | 14.24 | 4 | 22965 | 34346 | 29517212 |
| Product contamination | 14.98 | 14.24 | 8 | 22961 | 611 | 29550947 |
| Bronchitis | 14.92 | 14.24 | 5 | 22964 | 36863 | 29514695 |
| Endotracheal intubation | 14.82 | 14.24 | 14 | 22955 | 2655 | 29548903 |
| Cardio-respiratory arrest | 14.80 | 14.24 | 78 | 22891 | 50523 | 29501035 |
| Asthma | 14.77 | 14.24 | 4 | 22965 | 33845 | 29517713 |
| Hypoaesthesia | 14.65 | 14.24 | 12 | 22957 | 53455 | 29498103 |
| Postoperative delirium | 14.50 | 14.24 | 4 | 22965 | 47 | 29551511 |
| Hypertriglyceridaemia | 14.48 | 14.24 | 23 | 22946 | 7452 | 29544106 |
| Chest pain | 14.44 | 14.24 | 42 | 22927 | 111931 | 29439627 |
| Nervous system disorder | 14.42 | 14.24 | 31 | 22938 | 12643 | 29538915 |
| Buttock injury | 14.27 | 14.24 | 4 | 22965 | 50 | 29551508 |
| Somnolence | 14.25 | 14.24 | 123 | 22846 | 93832 | 29457726 |
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 | 441.55 | 13.74 | 237 | 42680 | 21426 | 64434389 |
| Hypotension | 337.65 | 13.74 | 766 | 42151 | 380208 | 64075607 |
| Cardiac arrest | 327.06 | 13.74 | 455 | 42462 | 153609 | 64302206 |
| Anaphylactic reaction | 299.76 | 13.74 | 294 | 42623 | 68370 | 64387445 |
| Serotonin syndrome | 283.81 | 13.74 | 224 | 42693 | 39058 | 64416757 |
| Multiple-drug resistance | 266.69 | 13.74 | 115 | 42802 | 6387 | 64449428 |
| Drug ineffective | 263.55 | 13.74 | 1178 | 41739 | 839069 | 63616746 |
| Propofol infusion syndrome | 244.46 | 13.74 | 75 | 42842 | 1542 | 64454273 |
| Fatigue | 183.28 | 13.74 | 139 | 42778 | 748591 | 63707224 |
| Diabetes insipidus | 175.74 | 13.74 | 77 | 42840 | 4444 | 64451371 |
| Metabolic acidosis | 175.47 | 13.74 | 226 | 42691 | 70732 | 64385083 |
| Bradycardia | 172.82 | 13.74 | 294 | 42623 | 117925 | 64337890 |
| Tachycardia | 166.91 | 13.74 | 331 | 42586 | 149248 | 64306567 |
| Myoclonus | 161.81 | 13.74 | 134 | 42783 | 24984 | 64430831 |
| Anaphylactic shock | 159.34 | 13.74 | 144 | 42773 | 30184 | 64425631 |
| Drug reaction with eosinophilia and systemic symptoms | 157.05 | 13.74 | 187 | 42730 | 54030 | 64401785 |
| Drug interaction | 155.30 | 13.74 | 561 | 42356 | 361522 | 64094293 |
| Drug ineffective for unapproved indication | 152.23 | 13.74 | 142 | 42775 | 30991 | 64424824 |
| Hyperthermia malignant | 150.62 | 13.74 | 58 | 42859 | 2401 | 64453414 |
| Respiratory acidosis | 144.56 | 13.74 | 87 | 42830 | 9768 | 64446047 |
| Multiple organ dysfunction syndrome | 137.47 | 13.74 | 244 | 42673 | 101169 | 64354646 |
| Respiratory failure | 134.31 | 13.74 | 317 | 42600 | 160866 | 64294949 |
| Delirium | 127.03 | 13.74 | 191 | 42726 | 69003 | 64386812 |
| Generalised tonic-clonic seizure | 126.31 | 13.74 | 144 | 42773 | 39713 | 64416102 |
| Joint swelling | 125.23 | 13.74 | 4 | 42913 | 215378 | 64240437 |
| Agitation | 124.14 | 13.74 | 216 | 42701 | 88151 | 64367664 |
| Arthralgia | 121.49 | 13.74 | 72 | 42845 | 442188 | 64013627 |
| Diarrhoea | 121.15 | 13.74 | 184 | 42733 | 722520 | 63733295 |
| Off label use | 120.97 | 13.74 | 776 | 42141 | 632030 | 63823785 |
| Nausea | 117.91 | 13.74 | 215 | 42702 | 785585 | 63670230 |
| Intensive care unit acquired weakness | 113.92 | 13.74 | 43 | 42874 | 1684 | 64454131 |
| Anaesthetic complication | 113.64 | 13.74 | 48 | 42869 | 2531 | 64453284 |
| Unresponsive to stimuli | 111.43 | 13.74 | 152 | 42765 | 50241 | 64405574 |
| Seizure | 108.61 | 13.74 | 299 | 42618 | 166593 | 64289222 |
| Circulatory collapse | 107.10 | 13.74 | 122 | 42795 | 33610 | 64422205 |
| Fall | 106.07 | 13.74 | 74 | 42843 | 416752 | 64039063 |
| Pain | 104.64 | 13.74 | 129 | 42788 | 553382 | 63902433 |
| Headache | 101.55 | 13.74 | 122 | 42795 | 529345 | 63926470 |
| Hypoxia | 100.55 | 13.74 | 197 | 42720 | 87952 | 64367863 |
| Respiratory depression | 99.63 | 13.74 | 99 | 42818 | 23344 | 64432471 |
| Necrosis ischaemic | 97.06 | 13.74 | 33 | 42884 | 950 | 64454865 |
| Delayed recovery from anaesthesia | 97.02 | 13.74 | 37 | 42880 | 1491 | 64454324 |
| Intestinal ischaemia | 96.83 | 13.74 | 72 | 42845 | 11477 | 64444338 |
| Peripheral swelling | 95.54 | 13.74 | 13 | 42904 | 209140 | 64246675 |
| Shock | 94.79 | 13.74 | 122 | 42795 | 38118 | 64417697 |
| Acute respiratory distress syndrome | 94.61 | 13.74 | 123 | 42794 | 38812 | 64417003 |
| Dizziness | 92.55 | 13.74 | 90 | 42827 | 430073 | 64025742 |
| Pain in extremity | 92.51 | 13.74 | 43 | 42874 | 303042 | 64152773 |
| Encephalopathy | 86.81 | 13.74 | 147 | 42770 | 58672 | 64397143 |
| Pulseless electrical activity | 86.31 | 13.74 | 70 | 42847 | 12669 | 64443146 |
| Apnoea | 85.20 | 13.74 | 64 | 42853 | 10358 | 64445457 |
| Labile blood pressure | 82.71 | 13.74 | 36 | 42881 | 2044 | 64453771 |
| Brain oedema | 82.51 | 13.74 | 87 | 42830 | 21988 | 64433827 |
| Abdominal discomfort | 81.69 | 13.74 | 12 | 42905 | 182310 | 64273505 |
| Anaesthetic complication neurological | 81.20 | 13.74 | 25 | 42892 | 520 | 64455295 |
| Haemodynamic instability | 80.66 | 13.74 | 72 | 42845 | 14840 | 64440975 |
| Alopecia | 78.82 | 13.74 | 9 | 42908 | 165681 | 64290134 |
| Product dose omission issue | 78.20 | 13.74 | 17 | 42900 | 194730 | 64261085 |
| Electroencephalogram abnormal | 76.48 | 13.74 | 46 | 42871 | 5157 | 64450658 |
| Acidosis hyperchloraemic | 75.33 | 13.74 | 25 | 42892 | 667 | 64455148 |
| Depressed level of consciousness | 75.30 | 13.74 | 167 | 42750 | 81269 | 64374546 |
| Drug intolerance | 74.30 | 13.74 | 17 | 42900 | 187975 | 64267840 |
| Partial seizures | 73.76 | 13.74 | 51 | 42866 | 7256 | 64448559 |
| Nasopharyngitis | 73.10 | 13.74 | 20 | 42897 | 196053 | 64259762 |
| Coma | 72.54 | 13.74 | 172 | 42745 | 87443 | 64368372 |
| Intra-abdominal pressure increased | 71.42 | 13.74 | 19 | 42898 | 228 | 64455587 |
| Myoglobin urine present | 71.02 | 13.74 | 23 | 42894 | 567 | 64455248 |
| Mitochondrial DNA mutation | 70.53 | 13.74 | 19 | 42898 | 240 | 64455575 |
| Rhabdomyolysis | 69.47 | 13.74 | 174 | 42743 | 91552 | 64364263 |
| Systemic inflammatory response syndrome | 68.83 | 13.74 | 56 | 42861 | 10179 | 64445636 |
| Cardiogenic shock | 65.98 | 13.74 | 94 | 42823 | 32333 | 64423482 |
| Unwanted awareness during anaesthesia | 64.15 | 13.74 | 18 | 42899 | 267 | 64455548 |
| Blood lactic acid increased | 63.89 | 13.74 | 54 | 42863 | 10347 | 64445468 |
| Neuromuscular block prolonged | 63.27 | 13.74 | 24 | 42893 | 953 | 64454862 |
| Septic shock | 62.76 | 13.74 | 183 | 42734 | 105254 | 64350561 |
| Stress cardiomyopathy | 60.88 | 13.74 | 50 | 42867 | 9207 | 64446608 |
| Asthenia | 60.55 | 13.74 | 121 | 42796 | 427923 | 64027892 |
| Malaise | 60.45 | 13.74 | 107 | 42810 | 396140 | 64059675 |
| Swelling | 58.49 | 13.74 | 17 | 42900 | 160201 | 64295614 |
| Electrocardiogram ST segment elevation | 58.06 | 13.74 | 44 | 42873 | 7215 | 64448600 |
| Toxicity to various agents | 57.97 | 13.74 | 427 | 42490 | 363086 | 64092729 |
| Hyperthermia | 57.60 | 13.74 | 61 | 42856 | 15489 | 64440326 |
| Myalgia | 57.59 | 13.74 | 17 | 42900 | 158600 | 64297215 |
| Upper airway obstruction | 57.39 | 13.74 | 24 | 42893 | 1234 | 64454581 |
| Laryngospasm | 57.31 | 13.74 | 33 | 42884 | 3412 | 64452403 |
| Oxygen saturation decreased | 57.18 | 13.74 | 179 | 42738 | 106997 | 64348818 |
| Oxygen saturation abnormal | 56.21 | 13.74 | 33 | 42884 | 3538 | 64452277 |
| Weight increased | 55.34 | 13.74 | 37 | 42880 | 213311 | 64242504 |
| Autonomic nervous system imbalance | 54.27 | 13.74 | 34 | 42883 | 4098 | 64451717 |
| Renal ischaemia | 53.94 | 13.74 | 22 | 42895 | 1061 | 64454754 |
| Hyperammonaemia | 53.92 | 13.74 | 48 | 42869 | 9856 | 64445959 |
| Infusion related reaction | 53.86 | 13.74 | 21 | 42896 | 164446 | 64291369 |
| Muscle rigidity | 53.44 | 13.74 | 62 | 42855 | 17411 | 64438404 |
| Back pain | 52.96 | 13.74 | 53 | 42864 | 250118 | 64205697 |
| Electrocardiogram QRS complex prolonged | 52.72 | 13.74 | 46 | 42871 | 9198 | 64446617 |
| Pneumatosis | 52.68 | 13.74 | 20 | 42897 | 796 | 64455019 |
| Ventricular tachycardia | 51.02 | 13.74 | 86 | 42831 | 34179 | 64421636 |
| Product administered to patient of inappropriate age | 50.93 | 13.74 | 34 | 42883 | 4567 | 64451248 |
| PCO2 increased | 50.90 | 13.74 | 24 | 42893 | 1643 | 64454172 |
| Coagulopathy | 50.05 | 13.74 | 82 | 42835 | 31838 | 64423977 |
| Hyperammonaemic encephalopathy | 49.83 | 13.74 | 32 | 42885 | 4026 | 64451789 |
| Anaesthetic complication pulmonary | 49.16 | 13.74 | 11 | 42906 | 59 | 64455756 |
| Pruritus | 48.85 | 13.74 | 83 | 42834 | 312317 | 64143498 |
| Seizure like phenomena | 48.05 | 13.74 | 23 | 42894 | 1629 | 64454186 |
| Foetal death | 47.55 | 13.74 | 36 | 42881 | 5894 | 64449921 |
| Sinusitis | 47.18 | 13.74 | 19 | 42898 | 145909 | 64309906 |
| Hypoventilation | 47.14 | 13.74 | 36 | 42881 | 5970 | 64449845 |
| Mydriasis | 46.27 | 13.74 | 54 | 42863 | 15258 | 64440557 |
| Catatonia | 45.65 | 13.74 | 39 | 42878 | 7581 | 64448234 |
| Hepatic ischaemia | 44.96 | 13.74 | 19 | 42898 | 1003 | 64454812 |
| COVID-19 pneumonia | 44.62 | 13.74 | 55 | 42862 | 16449 | 64439366 |
| Toxic encephalopathy | 44.59 | 13.74 | 43 | 42874 | 9772 | 64446043 |
| PO2 increased | 44.09 | 13.74 | 21 | 42896 | 1471 | 64454344 |
| Dyspnoea | 44.08 | 13.74 | 289 | 42628 | 718385 | 63737430 |
| Muscle relaxant therapy | 43.67 | 13.74 | 12 | 42905 | 164 | 64455651 |
| Oropharyngeal oedema | 43.58 | 13.74 | 13 | 42904 | 242 | 64455573 |
| Epileptic aura | 42.92 | 13.74 | 10 | 42907 | 66 | 64455749 |
| Perforation | 42.83 | 13.74 | 19 | 42898 | 1129 | 64454686 |
| Weight decreased | 42.78 | 13.74 | 78 | 42839 | 285661 | 64170154 |
| Encephalitis autoimmune | 42.29 | 13.74 | 22 | 42895 | 1862 | 64453953 |
| Ventricular extrasystoles | 41.98 | 13.74 | 55 | 42862 | 17474 | 64438341 |
| Hypernatraemia | 41.96 | 13.74 | 46 | 42871 | 12143 | 64443672 |
| Hypertransaminasaemia | 41.45 | 13.74 | 36 | 42881 | 7155 | 64448660 |
| Tachypnoea | 41.31 | 13.74 | 68 | 42849 | 26503 | 64429312 |
| Toxic epidermal necrolysis | 41.06 | 13.74 | 82 | 42835 | 37084 | 64418731 |
| Abdominal pain upper | 40.68 | 13.74 | 34 | 42883 | 174996 | 64280819 |
| Leukocytosis | 40.19 | 13.74 | 82 | 42835 | 37658 | 64418157 |
| Systemic lupus erythematosus | 40.13 | 13.74 | 3 | 42914 | 77609 | 64378206 |
| Anorectal ulcer | 39.95 | 13.74 | 9 | 42908 | 50 | 64455765 |
| Non-consummation | 39.95 | 13.74 | 9 | 42908 | 50 | 64455765 |
| Neurotoxicity | 39.77 | 13.74 | 68 | 42849 | 27336 | 64428479 |
| Rash maculo-papular | 39.64 | 13.74 | 93 | 42824 | 46933 | 64408882 |
| Troponin increased | 39.52 | 13.74 | 50 | 42867 | 15349 | 64440466 |
| Epilepsy | 39.49 | 13.74 | 76 | 42841 | 33455 | 64422360 |
| Procedural complication | 39.13 | 13.74 | 35 | 42882 | 7230 | 64448585 |
| Ventricular hypokinesia | 39.05 | 13.74 | 36 | 42881 | 7733 | 64448082 |
| Product use in unapproved indication | 38.79 | 13.74 | 225 | 42692 | 176393 | 64279422 |
| Arthritis | 38.74 | 13.74 | 5 | 42912 | 83809 | 64372006 |
| Long QT syndrome | 38.58 | 13.74 | 30 | 42887 | 5109 | 64450706 |
| Bronchospasm | 38.55 | 13.74 | 59 | 42858 | 21623 | 64434192 |
| Clonus | 38.29 | 13.74 | 32 | 42885 | 6035 | 64449780 |
| Pseudopolyp | 37.73 | 13.74 | 13 | 42904 | 390 | 64455425 |
| Anticholinergic syndrome | 37.69 | 13.74 | 23 | 42894 | 2646 | 64453169 |
| Overdose | 37.49 | 13.74 | 207 | 42710 | 159359 | 64296456 |
| Respiratory arrest | 37.49 | 13.74 | 98 | 42819 | 52887 | 64402928 |
| Artery dissection | 37.17 | 13.74 | 11 | 42906 | 199 | 64455616 |
| Bronchitis | 37.08 | 13.74 | 13 | 42904 | 108730 | 64347085 |
| Altered state of consciousness | 36.46 | 13.74 | 79 | 42838 | 37823 | 64417992 |
| Diabetic macroangiopathy | 36.37 | 13.74 | 10 | 42907 | 137 | 64455678 |
| Hypoaesthesia | 36.22 | 13.74 | 24 | 42893 | 139084 | 64316731 |
| Carcinoid crisis | 36.21 | 13.74 | 13 | 42904 | 441 | 64455374 |
| Sinus bradycardia | 36.15 | 13.74 | 59 | 42858 | 22834 | 64432981 |
| Electrocardiogram ST segment depression | 35.98 | 13.74 | 27 | 42890 | 4362 | 64451453 |
| Herpes zoster | 35.94 | 13.74 | 5 | 42912 | 79182 | 64376633 |
| Ultrasound ovary abnormal | 35.60 | 13.74 | 9 | 42908 | 87 | 64455728 |
| Trigemino-cardiac reflex | 35.54 | 13.74 | 11 | 42906 | 233 | 64455582 |
| Anticonvulsant drug level below therapeutic | 35.18 | 13.74 | 16 | 42901 | 1008 | 64454807 |
| Blood creatine phosphokinase increased | 35.17 | 13.74 | 102 | 42815 | 58456 | 64397359 |
| Asthma | 34.93 | 13.74 | 10 | 42907 | 95215 | 64360600 |
| Dehydration | 34.40 | 13.74 | 57 | 42860 | 216706 | 64239109 |
| Disseminated intravascular coagulation | 34.10 | 13.74 | 70 | 42847 | 32278 | 64423537 |
| Blood pH decreased | 33.70 | 13.74 | 26 | 42891 | 4376 | 64451439 |
| Urinary tract infection | 33.09 | 13.74 | 65 | 42852 | 231531 | 64224284 |
| Tonic clonic movements | 32.95 | 13.74 | 19 | 42898 | 1970 | 64453845 |
| Hepatic failure | 32.80 | 13.74 | 96 | 42821 | 55298 | 64400517 |
| Kounis syndrome | 32.63 | 13.74 | 22 | 42895 | 3003 | 64452812 |
| Discomfort | 32.56 | 13.74 | 7 | 42910 | 80871 | 64374944 |
| Dyskinesia | 32.22 | 13.74 | 77 | 42840 | 39311 | 64416504 |
| Aggression | 32.19 | 13.74 | 85 | 42832 | 46147 | 64409668 |
| Decreased appetite | 32.12 | 13.74 | 89 | 42828 | 281200 | 64174615 |
| Wound | 32.08 | 13.74 | 6 | 42911 | 76471 | 64379344 |
| Paradoxical drug reaction | 32.01 | 13.74 | 29 | 42888 | 6091 | 64449724 |
| Corneal reflex decreased | 31.67 | 13.74 | 11 | 42906 | 338 | 64455477 |
| Intestinal infarction | 31.65 | 13.74 | 16 | 42901 | 1275 | 64454540 |
| Psoriasis | 31.45 | 13.74 | 5 | 42912 | 71698 | 64384117 |
| Procedural hypotension | 31.20 | 13.74 | 18 | 42899 | 1868 | 64453947 |
| Neuroleptic malignant syndrome | 31.10 | 13.74 | 58 | 42859 | 24938 | 64430877 |
| Neuromuscular blockade | 31.04 | 13.74 | 12 | 42905 | 502 | 64455313 |
| Acute respiratory failure | 30.97 | 13.74 | 88 | 42829 | 49846 | 64405969 |
| Musculoskeletal pain | 30.83 | 13.74 | 8 | 42909 | 81286 | 64374529 |
| Unmasking of previously unidentified disease | 30.71 | 13.74 | 17 | 42900 | 1630 | 64454185 |
| Injection site pain | 30.69 | 13.74 | 18 | 42899 | 111390 | 64344425 |
| Cardiotoxicity | 30.65 | 13.74 | 36 | 42881 | 10238 | 64445577 |
| White blood cell count decreased | 30.54 | 13.74 | 36 | 42881 | 157801 | 64298014 |
| Ventricular fibrillation | 30.48 | 13.74 | 56 | 42861 | 23804 | 64432011 |
| Cardio-respiratory arrest | 30.43 | 13.74 | 138 | 42779 | 98255 | 64357560 |
| Palpitations | 30.05 | 13.74 | 16 | 42901 | 104472 | 64351343 |
| Hypercapnia | 29.96 | 13.74 | 31 | 42886 | 7663 | 64448152 |
| Airway complication of anaesthesia | 29.89 | 13.74 | 11 | 42906 | 401 | 64455414 |
| Hyperaesthesia | 29.73 | 13.74 | 35 | 42882 | 9979 | 64445836 |
| Acidosis | 29.65 | 13.74 | 47 | 42870 | 17748 | 64438067 |
| Blood gases abnormal | 29.55 | 13.74 | 14 | 42903 | 969 | 64454846 |
| Blood bicarbonate decreased | 29.51 | 13.74 | 25 | 42892 | 4804 | 64451011 |
| Behaviour disorder | 29.13 | 13.74 | 24 | 42893 | 4438 | 64451377 |
| Arthrofibrosis | 29.07 | 13.74 | 8 | 42909 | 110 | 64455705 |
| Laryngeal stenosis | 28.97 | 13.74 | 13 | 42904 | 794 | 64455021 |
| Fluid retention | 28.93 | 13.74 | 3 | 42914 | 59603 | 64396212 |
| Acid base balance abnormal | 28.80 | 13.74 | 10 | 42907 | 307 | 64455508 |
| Respiratory distress | 28.44 | 13.74 | 88 | 42829 | 52243 | 64403572 |
| Airway peak pressure increased | 28.20 | 13.74 | 10 | 42907 | 327 | 64455488 |
| Hypotonia | 28.13 | 13.74 | 36 | 42881 | 11176 | 64444639 |
| Electrocardiogram QT prolonged | 28.07 | 13.74 | 116 | 42801 | 79332 | 64376483 |
| Post procedural hypotension | 27.94 | 13.74 | 7 | 42910 | 65 | 64455750 |
| Lower respiratory tract infection | 27.94 | 13.74 | 14 | 42903 | 94600 | 64361215 |
| Procedural vomiting | 27.89 | 13.74 | 12 | 42905 | 662 | 64455153 |
| Myocardial infarction | 27.82 | 13.74 | 42 | 42875 | 165779 | 64290036 |
| Blood pressure decreased | 27.48 | 13.74 | 122 | 42795 | 86077 | 64369738 |
| Gastrointestinal scarring | 27.37 | 13.74 | 9 | 42908 | 233 | 64455582 |
| Hepatocellular injury | 27.36 | 13.74 | 79 | 42838 | 45156 | 64410659 |
| Mucosal ulceration | 27.29 | 13.74 | 16 | 42901 | 1711 | 64454104 |
| Therapeutic product effect prolonged | 27.26 | 13.74 | 11 | 42906 | 516 | 64455299 |
| Cardiac failure congestive | 27.22 | 13.74 | 28 | 42889 | 130552 | 64325263 |
| Gene mutation | 27.01 | 13.74 | 17 | 42900 | 2065 | 64453750 |
| Acute hepatic failure | 26.93 | 13.74 | 56 | 42861 | 26056 | 64429759 |
| Intracranial pressure increased | 26.92 | 13.74 | 28 | 42889 | 6961 | 64448854 |
| Herpes simplex viraemia | 26.84 | 13.74 | 9 | 42908 | 248 | 64455567 |
| Pneumomediastinum | 26.39 | 13.74 | 19 | 42898 | 2881 | 64452934 |
| Oliguria | 26.39 | 13.74 | 40 | 42877 | 14536 | 64441279 |
| Diabetes mellitus | 26.26 | 13.74 | 6 | 42911 | 66468 | 64389347 |
| Hepatitis fulminant | 25.74 | 13.74 | 26 | 42891 | 6248 | 64449567 |
| Pulmonary oedema | 25.57 | 13.74 | 112 | 42805 | 78562 | 64377253 |
| Acute kidney injury | 25.47 | 13.74 | 430 | 42487 | 448810 | 64007005 |
| Brain death | 25.36 | 13.74 | 23 | 42894 | 4838 | 64450977 |
| Intensive care unit delirium | 25.20 | 13.74 | 6 | 42911 | 44 | 64455771 |
| Dyspepsia | 25.07 | 13.74 | 11 | 42906 | 80301 | 64375514 |
| Musculoskeletal stiffness | 25.03 | 13.74 | 27 | 42890 | 123179 | 64332636 |
| Contraindicated product administered | 24.98 | 13.74 | 21 | 42896 | 107808 | 64348007 |
| Atrioventricular dissociation | 24.77 | 13.74 | 9 | 42908 | 316 | 64455499 |
| Large intestinal stenosis | 24.57 | 13.74 | 17 | 42900 | 2420 | 64453395 |
| Feeling abnormal | 24.24 | 13.74 | 32 | 42885 | 133570 | 64322245 |
| Blood pressure increased | 24.14 | 13.74 | 49 | 42868 | 172503 | 64283312 |
| Loss of personal independence in daily activities | 24.12 | 13.74 | 9 | 42908 | 72445 | 64383370 |
| Sedation complication | 24.04 | 13.74 | 32 | 42885 | 10322 | 64445493 |
| Influenza like illness | 23.53 | 13.74 | 6 | 42911 | 61696 | 64394119 |
| Malignant catatonia | 23.47 | 13.74 | 9 | 42908 | 368 | 64455447 |
| Left ventricular dysfunction | 23.20 | 13.74 | 41 | 42876 | 16913 | 64438902 |
| Gait disturbance | 23.15 | 13.74 | 50 | 42867 | 172105 | 64283710 |
| Cough | 23.03 | 13.74 | 113 | 42804 | 302035 | 64153780 |
| Paralysis | 22.68 | 13.74 | 33 | 42884 | 11562 | 64444253 |
| Product contamination | 22.62 | 13.74 | 12 | 42905 | 1057 | 64454758 |
| Macroglossia | 22.59 | 13.74 | 12 | 42905 | 1060 | 64454755 |
| Arrhythmia | 22.53 | 13.74 | 82 | 42835 | 52862 | 64402953 |
| Chest pain | 22.47 | 13.74 | 81 | 42836 | 235899 | 64219916 |
| Stomatitis | 22.28 | 13.74 | 24 | 42893 | 109581 | 64346234 |
| Migraine | 22.23 | 13.74 | 7 | 42910 | 62670 | 64393145 |
| Manipulation | 22.11 | 13.74 | 6 | 42911 | 78 | 64455737 |
| Rash | 22.07 | 13.74 | 197 | 42720 | 458352 | 63997463 |
| Mixed dementia | 21.99 | 13.74 | 8 | 42909 | 282 | 64455533 |
| Intensive care | 21.92 | 13.74 | 10 | 42907 | 635 | 64455180 |
| Pituitary apoplexy | 21.71 | 13.74 | 7 | 42910 | 170 | 64455645 |
| Paraesthesia | 21.68 | 13.74 | 35 | 42882 | 134487 | 64321328 |
| Dermatitis exfoliative generalised | 21.54 | 13.74 | 23 | 42894 | 5893 | 64449922 |
| Muscle spasms | 21.52 | 13.74 | 38 | 42879 | 140985 | 64314830 |
| Malabsorption | 21.35 | 13.74 | 20 | 42897 | 4383 | 64451432 |
| Amylase increased | 21.07 | 13.74 | 29 | 42888 | 9656 | 64446159 |
| Injection site reaction | 21.05 | 13.74 | 3 | 42914 | 46661 | 64409154 |
| Dry mouth | 20.98 | 13.74 | 7 | 42910 | 60411 | 64395404 |
| Contusion | 20.98 | 13.74 | 27 | 42890 | 113938 | 64341877 |
| Hospitalisation | 20.92 | 13.74 | 12 | 42905 | 75195 | 64380620 |
| Large intestine anastomosis | 20.85 | 13.74 | 6 | 42911 | 98 | 64455717 |
| Blood cholesterol increased | 20.85 | 13.74 | 4 | 42913 | 50062 | 64405753 |
| Haemophagocytic lymphohistiocytosis | 20.84 | 13.74 | 40 | 42877 | 17569 | 64438246 |
| Hot flush | 20.79 | 13.74 | 3 | 42914 | 46232 | 64409583 |
| Restlessness | 20.79 | 13.74 | 66 | 42851 | 39719 | 64416096 |
| Gastrooesophageal reflux disease | 20.77 | 13.74 | 15 | 42902 | 83128 | 64372687 |
| Medical device site fistula | 20.73 | 13.74 | 5 | 42912 | 39 | 64455776 |
| Haemoglobin decreased | 20.59 | 13.74 | 64 | 42853 | 194999 | 64260816 |
| Cholestasis | 20.38 | 13.74 | 71 | 42846 | 44801 | 64411014 |
| Hepatorenal syndrome | 20.08 | 13.74 | 18 | 42899 | 3728 | 64452087 |
| Drug resistance | 19.98 | 13.74 | 60 | 42857 | 35042 | 64420773 |
| Post procedural complication | 19.96 | 13.74 | 44 | 42873 | 21309 | 64434506 |
| Nervous system disorder | 19.84 | 13.74 | 46 | 42871 | 23032 | 64432783 |
| Pulse absent | 19.78 | 13.74 | 27 | 42890 | 8919 | 64446896 |
| Nail dystrophy | 19.71 | 13.74 | 10 | 42907 | 803 | 64455012 |
| Infection parasitic | 19.61 | 13.74 | 8 | 42909 | 386 | 64455429 |
| Superinfection | 19.52 | 13.74 | 18 | 42899 | 3868 | 64451947 |
| Nystagmus | 19.50 | 13.74 | 27 | 42890 | 9041 | 64446774 |
| Drug withdrawal convulsions | 19.50 | 13.74 | 14 | 42903 | 2114 | 64453701 |
| Completed suicide | 19.45 | 13.74 | 80 | 42837 | 224334 | 64231481 |
| Stupor | 19.44 | 13.74 | 22 | 42895 | 6013 | 64449802 |
| Liver function test | 19.43 | 13.74 | 6 | 42911 | 126 | 64455689 |
| Abdominal compartment syndrome | 19.38 | 13.74 | 12 | 42905 | 1416 | 64454399 |
| Gastrointestinal mucosa hyperaemia | 19.04 | 13.74 | 8 | 42909 | 416 | 64455399 |
| Brain stem auditory evoked response abnormal | 18.95 | 13.74 | 3 | 42914 | 0 | 64455815 |
| Euthyroid sick syndrome | 18.87 | 13.74 | 5 | 42912 | 59 | 64455756 |
| Cyanosis | 18.87 | 13.74 | 44 | 42873 | 22111 | 64433704 |
| Vomiting | 18.85 | 13.74 | 256 | 42661 | 550861 | 63904954 |
| Oedema peripheral | 18.84 | 13.74 | 74 | 42843 | 210243 | 64245572 |
| Eosinophilia | 18.84 | 13.74 | 62 | 42855 | 38014 | 64417801 |
| Electrocardiogram repolarisation abnormality | 18.67 | 13.74 | 13 | 42904 | 1869 | 64453946 |
| Symptom masked | 18.62 | 13.74 | 11 | 42906 | 1193 | 64454622 |
| Constipation | 18.51 | 13.74 | 84 | 42833 | 229253 | 64226562 |
| Drug chemical incompatibility | 18.36 | 13.74 | 5 | 42912 | 66 | 64455749 |
| Renal impairment | 18.35 | 13.74 | 153 | 42764 | 134864 | 64320951 |
| Coronary artery embolism | 18.19 | 13.74 | 7 | 42910 | 289 | 64455526 |
| Dyspnoea paroxysmal nocturnal | 17.94 | 13.74 | 13 | 42904 | 1991 | 64453824 |
| Influenza | 17.85 | 13.74 | 27 | 42890 | 106504 | 64349311 |
| Stridor | 17.84 | 13.74 | 19 | 42898 | 4855 | 64450960 |
| Impaired healing | 17.77 | 13.74 | 9 | 42908 | 60464 | 64395351 |
| Somnolence | 17.57 | 13.74 | 210 | 42707 | 203435 | 64252380 |
| Neurological examination abnormal | 17.53 | 13.74 | 8 | 42909 | 508 | 64455307 |
| Neutropenia | 17.46 | 13.74 | 91 | 42826 | 239533 | 64216282 |
| Cellulitis | 17.43 | 13.74 | 22 | 42895 | 93635 | 64362180 |
| Incorrect route of product administration | 17.41 | 13.74 | 44 | 42873 | 23254 | 64432561 |
| Injection site erythema | 17.39 | 13.74 | 13 | 42904 | 70787 | 64385028 |
| Nasal congestion | 17.35 | 13.74 | 9 | 42908 | 59649 | 64396166 |
| Cytokine release syndrome | 17.34 | 13.74 | 41 | 42876 | 20788 | 64435027 |
| Skin ulcer | 17.31 | 13.74 | 4 | 42913 | 43970 | 64411845 |
| Haematuria traumatic | 17.29 | 13.74 | 6 | 42911 | 184 | 64455631 |
| Transaminases increased | 17.26 | 13.74 | 67 | 42850 | 44527 | 64411288 |
| Delayed graft function | 17.10 | 13.74 | 15 | 42902 | 3021 | 64452794 |
| Alanine aminotransferase increased | 17.04 | 13.74 | 154 | 42763 | 138877 | 64316938 |
| Post procedural haemorrhage | 16.93 | 13.74 | 30 | 42887 | 12401 | 64443414 |
| Paradoxical pain | 16.87 | 13.74 | 3 | 42914 | 3 | 64455812 |
| Inappropriate schedule of product administration | 16.84 | 13.74 | 22 | 42895 | 92264 | 64363551 |
| Psychotic disorder | 16.83 | 13.74 | 56 | 42861 | 34522 | 64421293 |
| Burning sensation | 16.82 | 13.74 | 6 | 42911 | 49658 | 64406157 |
| Polyuria | 16.56 | 13.74 | 30 | 42887 | 12613 | 64443202 |
| Hepatitis | 16.45 | 13.74 | 67 | 42850 | 45515 | 64410300 |
| No adverse event | 16.43 | 13.74 | 49 | 42868 | 28512 | 64427303 |
| Systolic dysfunction | 16.41 | 13.74 | 15 | 42902 | 3187 | 64452628 |
| Myoglobin blood increased | 16.33 | 13.74 | 14 | 42903 | 2733 | 64453082 |
| End-tidal CO2 decreased | 16.28 | 13.74 | 4 | 42913 | 34 | 64455781 |
| Chronic obstructive pulmonary disease | 16.25 | 13.74 | 14 | 42903 | 71034 | 64384781 |
| Ischaemic hepatitis | 16.23 | 13.74 | 15 | 42902 | 3231 | 64452584 |
| Catecholamine crisis | 16.18 | 13.74 | 4 | 42913 | 35 | 64455780 |
| Post procedural stroke | 16.06 | 13.74 | 5 | 42912 | 108 | 64455707 |
| Cataract | 16.03 | 13.74 | 7 | 42910 | 51255 | 64404560 |
| Fear | 16.03 | 13.74 | 39 | 42878 | 20132 | 64435683 |
| Vision blurred | 16.01 | 13.74 | 22 | 42895 | 90294 | 64365521 |
| Hyperexplexia | 15.88 | 13.74 | 4 | 42913 | 38 | 64455777 |
| Injection site swelling | 15.81 | 13.74 | 4 | 42913 | 41349 | 64414466 |
| Injection site pruritus | 15.79 | 13.74 | 3 | 42914 | 37823 | 64417992 |
| Posterior reversible encephalopathy syndrome | 15.78 | 13.74 | 42 | 42875 | 22904 | 64432911 |
| Syncope | 15.74 | 13.74 | 53 | 42864 | 157582 | 64298233 |
| Areflexia | 15.70 | 13.74 | 18 | 42899 | 4989 | 64450826 |
| Vertigo | 15.60 | 13.74 | 10 | 42907 | 59001 | 64396814 |
| Transient ischaemic attack | 15.55 | 13.74 | 5 | 42912 | 44177 | 64411638 |
| Febrile infection-related epilepsy syndrome | 15.52 | 13.74 | 4 | 42913 | 42 | 64455773 |
| Local anaesthetic systemic toxicity | 15.38 | 13.74 | 8 | 42909 | 677 | 64455138 |
| Administration related reaction | 15.33 | 13.74 | 5 | 42912 | 126 | 64455689 |
| Balance disorder | 15.32 | 13.74 | 20 | 42897 | 83906 | 64371909 |
| Wrong product administered | 15.14 | 13.74 | 22 | 42895 | 7698 | 64448117 |
| Cardiac output decreased | 15.13 | 13.74 | 11 | 42906 | 1693 | 64454122 |
| Nephrocalcinosis | 15.11 | 13.74 | 10 | 42907 | 1324 | 64454491 |
| Vulvovaginal candidiasis | 15.05 | 13.74 | 12 | 42905 | 2118 | 64453697 |
| Endotracheal intubation complication | 15.04 | 13.74 | 8 | 42909 | 708 | 64455107 |
| Buttock injury | 14.97 | 13.74 | 5 | 42912 | 136 | 64455679 |
| Axillary pain | 14.97 | 13.74 | 11 | 42906 | 1721 | 64454094 |
| Osteonecrosis of jaw | 14.94 | 13.74 | 4 | 42913 | 39821 | 64415994 |
| Poor feeding infant | 14.90 | 13.74 | 5 | 42912 | 138 | 64455677 |
| Maternal exposure during pregnancy | 14.85 | 13.74 | 112 | 42805 | 95772 | 64360043 |
| Rash pruritic | 14.80 | 13.74 | 10 | 42907 | 57394 | 64398421 |
| Amaurosis | 14.75 | 13.74 | 9 | 42908 | 1035 | 64454780 |
| Angle closure glaucoma | 14.71 | 13.74 | 13 | 42904 | 2644 | 64453171 |
| Female genital tract fistula | 14.70 | 13.74 | 13 | 42904 | 2645 | 64453170 |
| Anaphylactoid shock | 14.66 | 13.74 | 8 | 42909 | 746 | 64455069 |
| Renal failure | 14.65 | 13.74 | 185 | 42732 | 181503 | 64274312 |
| Teratoma | 14.64 | 13.74 | 5 | 42912 | 146 | 64455669 |
| Gastric ulcer perforation | 14.63 | 13.74 | 11 | 42906 | 1782 | 64454033 |
| Sleep disorder | 14.61 | 13.74 | 11 | 42906 | 59698 | 64396117 |
| Exposure during pregnancy | 14.54 | 13.74 | 95 | 42822 | 77580 | 64378235 |
| Stevens-Johnson syndrome | 14.53 | 13.74 | 53 | 42864 | 34196 | 64421619 |
| Ejection fraction decreased | 14.43 | 13.74 | 47 | 42870 | 28660 | 64427155 |
| Mixed liver injury | 14.39 | 13.74 | 18 | 42899 | 5463 | 64450352 |
| Left ventricular hypertrophy | 14.33 | 13.74 | 24 | 42893 | 9482 | 64446333 |
| Abdominal pain | 14.23 | 13.74 | 136 | 42781 | 312239 | 64143576 |
| Visual impairment | 14.21 | 13.74 | 17 | 42900 | 74060 | 64381755 |
| Clonic convulsion | 14.18 | 13.74 | 9 | 42908 | 1110 | 64454705 |
| Tracheal injury | 14.15 | 13.74 | 4 | 42913 | 61 | 64455754 |
| Acanthosis nigricans | 14.14 | 13.74 | 5 | 42912 | 162 | 64455653 |
| Mobility decreased | 14.14 | 13.74 | 22 | 42895 | 85818 | 64369997 |
| Nephrogenic diabetes insipidus | 14.13 | 13.74 | 11 | 42906 | 1876 | 64453939 |
| Thrombophlebitis | 13.94 | 13.74 | 18 | 42899 | 5636 | 64450179 |
| Heart alternation | 13.93 | 13.74 | 3 | 42914 | 13 | 64455802 |
| Postoperative delirium | 13.92 | 13.74 | 5 | 42912 | 170 | 64455645 |
| Atrioventricular block | 13.86 | 13.74 | 27 | 42890 | 11988 | 64443827 |
| Ammonia increased | 13.86 | 13.74 | 20 | 42897 | 6957 | 64448858 |
| Sinus tachycardia | 13.82 | 13.74 | 50 | 42867 | 32138 | 64423677 |
| Apnoeic attack | 13.78 | 13.74 | 7 | 42910 | 564 | 64455251 |
| Hyperbilirubinaemia | 13.76 | 13.74 | 38 | 42879 | 21167 | 64434648 |
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 | 53.78 | 30.84 | 27 | 118 | 890 | 83643 |
| Epilepsy | 31.19 | 30.84 | 10 | 135 | 90 | 84443 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 5MG/SPRAY | NAYZILAM | UCB INC | N211321 | May 17, 2019 | RX | SPRAY | NASAL | May 21, 2022 | NEW PRODUCT |
| 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]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| GABA A receptor alpha-5/beta-2/gamma-3 | Ion channel | POSITIVE ALLOSTERIC MODULATOR | Ki | 8.26 | WOMBAT-PK | CHEMBL | |||
| GABA-A receptor alpha-1/beta-2/gamma-3 | Ion channel | POSITIVE ALLOSTERIC MODULATOR | Ki | 7.75 | WOMBAT-PK | CHEMBL | |||
| GABA A receptor alpha-3/beta-2/gamma-2 | Ion channel | POSITIVE ALLOSTERIC MODULATOR | Ki | 8.44 | WOMBAT-PK | CHEMBL | |||
| GABA A receptor alpha-3/beta-2/gamma-3 | Ion channel | POSITIVE ALLOSTERIC MODULATOR | Ki | 7.61 | WOMBAT-PK | CHEMBL | |||
| GABA A receptor alpha-5/beta-3/gamma-3 | Ion channel | POSITIVE ALLOSTERIC MODULATOR | Ki | 8.26 | WOMBAT-PK | CHEMBL | |||
| GABA A receptor alpha-5/beta-2/gamma-2 | Ion channel | POSITIVE ALLOSTERIC MODULATOR | Ki | 9.13 | WOMBAT-PK | CHEMBL | |||
| GABA-A receptor alpha-1/beta-2/gamma-2 | Ion channel | POSITIVE ALLOSTERIC MODULATOR | Ki | 8.75 | WOMBAT-PK | CHEMBL | |||
| GABA-A receptor alpha-5/beta-3/gamma-2 | Ion channel | POSITIVE ALLOSTERIC MODULATOR | Ki | 9.13 | WOMBAT-PK | CHEMBL | |||
| Multidrug resistance protein 1 | Transporter | Km | 4.35 | WOMBAT-PK | |||||
| Cytochrome P450 3A4 | Enzyme | Km | 6 | WOMBAT-PK | |||||
| Translocator protein | Membrane receptor | Ki | 8.70 | CHEMBL | |||||
| Thyrotropin-releasing hormone receptor | GPCR | ANTAGONIST | Ki | 5.49 | IUPHAR | ||||
| GABA-A receptor; anion channel | Ion channel | 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 | 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 | 0404-9914 | 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 | 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 | 0409-2587 | INJECTION, SOLUTION | 1 mg | INTRAMUSCULAR | ANDA | 28 sections |
| Midazolam Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-2596 | INJECTION, SOLUTION | 5 mg | INTRAMUSCULAR | ANDA | 28 sections |
| Midazolam Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0574-0150 | SYRUP | 2 mg | ORAL | ANDA | 27 sections |
| Midazolam | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6056 | INJECTION | 1 mg | INTRAMUSCULAR | ANDA | 27 sections |
| Midazolam | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6057 | INJECTION | 1 mg | INTRAMUSCULAR | ANDA | 27 sections |
| Midazolam | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6059 | INJECTION | 1 mg | INTRAMUSCULAR | ANDA | 27 sections |
| Midazolam | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6060 | INJECTION | 5 mg | INTRAMUSCULAR | ANDA | 27 sections |
| Midazolam | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6061 | INJECTION | 5 mg | INTRAMUSCULAR | ANDA | 27 sections |
| Midazolam | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6063 | INJECTION | 5 mg | INTRAMUSCULAR | ANDA | 27 sections |
| Midazolam | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6190 | INJECTION | 5 mg | INTRAMUSCULAR | ANDA | 27 sections |
| Midazolam | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6190 | INJECTION | 5 mg | INTRAMUSCULAR | ANDA | 27 sections |
| Midazolam | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6209 | INJECTION | 1 mg | INTRAMUSCULAR | ANDA | 27 sections |
| Midazolam | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6210 | INJECTION | 1 mg | INTRAMUSCULAR | ANDA | 27 sections |
| Midazolam | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6211 | INJECTION | 5 mg | INTRAMUSCULAR | ANDA | 27 sections |
| Midazolam Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-7113 | SYRUP | 2 mg | ORAL | ANDA | 25 sections |
| Midazolam Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-7114 | SYRUP | 2 mg | ORAL | ANDA | 25 sections |
| Seizalam | HUMAN PRESCRIPTION DRUG LABEL | 1 | 11704-650 | INJECTION, SOLUTION | 5 mg | INTRAMUSCULAR | NDA | 32 sections |
| Midazolam | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17478-523 | INJECTION | 1 mg | INTRAVENOUS | ANDA | 28 sections |
| Midazolam | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17478-524 | INJECTION | 5 mg | INTRAVENOUS | ANDA | 28 sections |
| Midazolam Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17856-0146 | SYRUP | 2 mg | ORAL | ANDA | 27 sections |