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promethazine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 2286 | 60-87-7 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A phenothiazine derivative with histamine H1-blocking, antimuscarinic, and sedative properties. It is used as an antiallergic, in pruritus, for motion sickness and sedation, and also in animals.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 25 | mg | O |
| 25 | mg | P |
| 25 | mg | R |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 2 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 5.03 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 25 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
| Vd (Volume of distribution) | 14 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 14 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.09 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 14 hours | Lombardo F, Berellini G, Obach RS |
| S (Water solubility) | 100 mg/mL | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 2.998 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 0.303 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 38.994 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 69.663 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 7.680 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 16.960 | % | High | 1 |
| herg | hERG pIC50 | 5.576 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 8.395 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 33.266 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 7.960 | % | High | 1 |
| kinase-safety-class | ACVR2B,AKT2,AKT3,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,ITK,JAK2,JAK3,MAP3K7,MAPK10,MAPK12,MAPK7,MET,NTRK2,PDK2,PDK4,PDPK1,PIM2,PRKDC,SIK2,STK33,TEK,TTK | 34 | |||
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 0.344 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 181.970 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 9.860 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 1.774 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pld-class | Phospholipidosis risk class (1 = positive, 0 = negative) | 1 | High | 1 | |
| pppb | Pig plasma protein binding (% unbound) | 22.950 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 338.844 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 46.670 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 9.050 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 803.526 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| March 29, 1951 | FDA | DELCOR ASSET CORP |
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 |
|---|---|---|---|---|---|---|
| Intentional self-injury | 7398.76 | 10.68 | 2034 | 60413 | 27300 | 90538700 |
| Intentional overdose | 5807.76 | 10.68 | 2241 | 60206 | 91593 | 90474407 |
| Akathisia | 580.18 | 10.68 | 236 | 62211 | 10923 | 90555077 |
| Tachycardia | 468.61 | 10.68 | 560 | 61887 | 157113 | 90408887 |
| Depressed level of consciousness | 442.60 | 10.68 | 381 | 62066 | 72403 | 90493597 |
| Mydriasis | 280.53 | 10.68 | 157 | 62290 | 14855 | 90551145 |
| Synovitis | 192.83 | 10.68 | 8 | 62439 | 329744 | 90236256 |
| Glossodynia | 187.51 | 10.68 | 8 | 62439 | 321771 | 90244229 |
| Contraindicated product administered | 186.42 | 10.68 | 8 | 62439 | 320131 | 90245869 |
| Hand deformity | 184.80 | 10.68 | 4 | 62443 | 296358 | 90269642 |
| Hallucination | 180.60 | 10.68 | 225 | 62222 | 65734 | 90500266 |
| Somnolence | 177.30 | 10.68 | 423 | 62024 | 208661 | 90357339 |
| Pericarditis | 156.44 | 10.68 | 7 | 62440 | 270144 | 90295856 |
| Agitation | 145.25 | 10.68 | 204 | 62243 | 66894 | 90499106 |
| Anxiety | 144.89 | 10.68 | 506 | 61941 | 309266 | 90256734 |
| Human rhinovirus test positive | 144.02 | 10.68 | 44 | 62403 | 859 | 90565141 |
| Systemic lupus erythematosus | 142.13 | 10.68 | 37 | 62410 | 361859 | 90204141 |
| Respiratory syncytial virus test positive | 141.27 | 10.68 | 45 | 62402 | 1013 | 90564987 |
| Arthropathy | 140.90 | 10.68 | 39 | 62408 | 366203 | 90199797 |
| Helicobacter infection | 137.83 | 10.68 | 4 | 62443 | 226846 | 90339154 |
| Drug ineffective | 132.57 | 10.68 | 500 | 61947 | 1383798 | 89182202 |
| Joint swelling | 131.91 | 10.68 | 93 | 62354 | 503207 | 90062793 |
| Hepatic enzyme increased | 123.61 | 10.68 | 47 | 62400 | 360689 | 90205311 |
| Folliculitis | 119.27 | 10.68 | 5 | 62442 | 204348 | 90361652 |
| Suicide attempt | 119.03 | 10.68 | 198 | 62249 | 75201 | 90490799 |
| Cholecystitis chronic | 117.01 | 10.68 | 77 | 62370 | 9749 | 90556251 |
| Drug intolerance | 116.87 | 10.68 | 83 | 62364 | 447508 | 90118492 |
| Treatment failure | 115.69 | 10.68 | 33 | 62414 | 303895 | 90262105 |
| Toxicity to various agents | 109.40 | 10.68 | 440 | 62007 | 287406 | 90278594 |
| Wound | 107.98 | 10.68 | 37 | 62410 | 302943 | 90263057 |
| Infusion related reaction | 107.87 | 10.68 | 78 | 62369 | 416702 | 90149298 |
| Viral test positive | 105.41 | 10.68 | 32 | 62415 | 611 | 90565389 |
| Impaired healing | 104.06 | 10.68 | 18 | 62429 | 234181 | 90331819 |
| General physical health deterioration | 96.47 | 10.68 | 63 | 62384 | 355052 | 90210948 |
| Therapeutic product effect decreased | 93.67 | 10.68 | 37 | 62410 | 277534 | 90288466 |
| Pneumonia haemophilus | 92.79 | 10.68 | 36 | 62411 | 1467 | 90564533 |
| Rheumatoid arthritis | 87.29 | 10.68 | 73 | 62374 | 362541 | 90203459 |
| Sinus tachycardia | 84.06 | 10.68 | 101 | 62346 | 28412 | 90537588 |
| Vomiting | 81.03 | 10.68 | 864 | 61583 | 787429 | 89778571 |
| Tongue biting | 80.62 | 10.68 | 36 | 62411 | 2097 | 90563903 |
| Type 2 diabetes mellitus | 79.31 | 10.68 | 21 | 62426 | 203223 | 90362777 |
| Loss of consciousness | 78.82 | 10.68 | 244 | 62203 | 139994 | 90426006 |
| Liver injury | 73.83 | 10.68 | 14 | 62433 | 170553 | 90395447 |
| Lower respiratory tract infection | 72.89 | 10.68 | 41 | 62406 | 250618 | 90315382 |
| Mouth haemorrhage | 71.82 | 10.68 | 54 | 62393 | 8447 | 90557553 |
| C-reactive protein increased | 68.42 | 10.68 | 20 | 62427 | 181369 | 90384631 |
| Product use issue | 67.15 | 10.68 | 77 | 62370 | 329842 | 90236158 |
| Psoriatic arthropathy | 66.89 | 10.68 | 37 | 62410 | 228298 | 90337702 |
| Abdominal discomfort | 66.24 | 10.68 | 144 | 62303 | 477184 | 90088816 |
| Nausea | 66.13 | 10.68 | 1102 | 61345 | 1109214 | 89456786 |
| Ill-defined disorder | 65.11 | 10.68 | 23 | 62424 | 184868 | 90381132 |
| Blood cholesterol increased | 63.45 | 10.68 | 32 | 62415 | 207980 | 90358020 |
| Nasopharyngitis | 63.19 | 10.68 | 115 | 62332 | 406989 | 90159011 |
| Off label use | 62.69 | 10.68 | 474 | 61973 | 1101778 | 89464222 |
| Swelling | 61.87 | 10.68 | 122 | 62325 | 418936 | 90147064 |
| Alopecia | 61.02 | 10.68 | 159 | 62288 | 494912 | 90071088 |
| Suicidal ideation | 60.96 | 10.68 | 148 | 62299 | 73707 | 90492293 |
| Snoring | 60.62 | 10.68 | 40 | 62407 | 5086 | 90560914 |
| Lethargy | 60.32 | 10.68 | 134 | 62313 | 63005 | 90502995 |
| Mobility decreased | 59.66 | 10.68 | 51 | 62396 | 250683 | 90315317 |
| Joint range of motion decreased | 58.98 | 10.68 | 11 | 62436 | 135632 | 90430368 |
| Fatigue | 58.62 | 10.68 | 1117 | 61330 | 1152906 | 89413094 |
| Hypercholesterolaemia | 57.13 | 10.68 | 3 | 62444 | 100889 | 90465111 |
| Irritable bowel syndrome | 56.03 | 10.68 | 37 | 62410 | 207411 | 90358589 |
| Muscle twitching | 55.98 | 10.68 | 76 | 62371 | 24126 | 90541874 |
| Lip dry | 54.17 | 10.68 | 4 | 62443 | 100951 | 90465049 |
| Seizure | 52.17 | 10.68 | 226 | 62221 | 152403 | 90413597 |
| Incoherent | 52.08 | 10.68 | 36 | 62411 | 4941 | 90561059 |
| Migraine | 51.95 | 10.68 | 264 | 62183 | 190128 | 90375872 |
| Blister | 51.35 | 10.68 | 60 | 62387 | 254938 | 90311062 |
| Mast cell activation syndrome | 51.13 | 10.68 | 24 | 62423 | 1570 | 90564430 |
| Mental status changes | 51.01 | 10.68 | 102 | 62345 | 44577 | 90521423 |
| Emotional distress | 50.92 | 10.68 | 91 | 62356 | 36571 | 90529429 |
| Bursitis | 50.60 | 10.68 | 14 | 62433 | 131640 | 90434360 |
| Hypersensitivity | 50.13 | 10.68 | 154 | 62293 | 454523 | 90111477 |
| Drug hypersensitivity | 49.75 | 10.68 | 513 | 61934 | 463096 | 90102904 |
| Therapeutic product effect incomplete | 49.17 | 10.68 | 37 | 62410 | 193859 | 90372141 |
| Formication | 48.60 | 10.68 | 34 | 62413 | 4757 | 90561243 |
| Stomatitis | 47.80 | 10.68 | 72 | 62375 | 274626 | 90291374 |
| Serotonin syndrome | 47.53 | 10.68 | 90 | 62357 | 37797 | 90528203 |
| Facet joint syndrome | 47.28 | 10.68 | 6 | 62441 | 98383 | 90467617 |
| Discomfort | 46.68 | 10.68 | 73 | 62374 | 274262 | 90291738 |
| Rash | 45.79 | 10.68 | 341 | 62106 | 795759 | 89770241 |
| Opisthotonus | 45.72 | 10.68 | 15 | 62432 | 372 | 90565628 |
| Peripheral swelling | 44.76 | 10.68 | 141 | 62306 | 412965 | 90153035 |
| Pulmonary haemorrhage neonatal | 44.76 | 10.68 | 10 | 62437 | 51 | 90565949 |
| Pulmonary fibrosis | 44.08 | 10.68 | 10 | 62437 | 107493 | 90458507 |
| Grip strength decreased | 43.63 | 10.68 | 6 | 62441 | 92570 | 90473430 |
| Wound infection | 43.43 | 10.68 | 10 | 62437 | 106392 | 90459608 |
| Illness | 42.72 | 10.68 | 139 | 62308 | 81830 | 90484170 |
| Deep vein thrombosis | 42.14 | 10.68 | 149 | 62298 | 91471 | 90474529 |
| Fibromyalgia | 42.09 | 10.68 | 48 | 62399 | 206221 | 90359779 |
| Tremor | 41.50 | 10.68 | 212 | 62235 | 152961 | 90413039 |
| Lung disorder | 41.46 | 10.68 | 26 | 62421 | 149857 | 90416143 |
| Electrocardiogram QT prolonged | 40.62 | 10.68 | 126 | 62321 | 72330 | 90493670 |
| Inflammation | 40.46 | 10.68 | 38 | 62409 | 178554 | 90387446 |
| Red blood cell sedimentation rate increased | 39.77 | 10.68 | 5 | 62442 | 82590 | 90483410 |
| Tongue injury | 39.36 | 10.68 | 15 | 62432 | 582 | 90565418 |
| Gastrointestinal disorder | 39.35 | 10.68 | 73 | 62374 | 256614 | 90309386 |
| Peripheral venous disease | 38.25 | 10.68 | 6 | 62441 | 83915 | 90482085 |
| Anaphylactic reaction | 37.42 | 10.68 | 139 | 62308 | 87385 | 90478615 |
| Electrocardiogram QRS complex shortened | 36.86 | 10.68 | 14 | 62433 | 538 | 90565462 |
| Dehydration | 36.35 | 10.68 | 244 | 62203 | 194203 | 90371797 |
| Congenital tricuspid valve incompetence | 35.96 | 10.68 | 10 | 62437 | 138 | 90565862 |
| Cholelithiasis | 35.87 | 10.68 | 98 | 62349 | 52408 | 90513592 |
| Hereditary angioedema | 35.84 | 10.68 | 38 | 62409 | 9327 | 90556673 |
| Sciatica | 35.02 | 10.68 | 13 | 62434 | 101369 | 90464631 |
| Biliary dyskinesia | 34.98 | 10.68 | 22 | 62425 | 2577 | 90563423 |
| Musculoskeletal pain | 34.78 | 10.68 | 40 | 62407 | 171211 | 90394789 |
| Neonatal hypotension | 34.71 | 10.68 | 10 | 62437 | 158 | 90565842 |
| Arthralgia | 34.32 | 10.68 | 357 | 62090 | 778165 | 89787835 |
| Gallbladder injury | 33.86 | 10.68 | 17 | 62430 | 1289 | 90564711 |
| Musculoskeletal stiffness | 32.96 | 10.68 | 100 | 62347 | 296432 | 90269568 |
| Accidental overdose | 31.62 | 10.68 | 64 | 62383 | 28209 | 90537791 |
| Craniofacial fracture | 31.50 | 10.68 | 12 | 62435 | 465 | 90565535 |
| Hip arthroplasty | 31.42 | 10.68 | 7 | 62440 | 76201 | 90489799 |
| Maternal exposure during pregnancy | 31.05 | 10.68 | 135 | 62312 | 359928 | 90206072 |
| Constipation | 30.37 | 10.68 | 311 | 62136 | 280084 | 90285916 |
| Gallbladder disorder | 29.90 | 10.68 | 51 | 62396 | 19752 | 90546248 |
| Respiratory disorder neonatal | 29.89 | 10.68 | 16 | 62431 | 1385 | 90564615 |
| Poor feeding infant | 29.89 | 10.68 | 12 | 62435 | 536 | 90565464 |
| Prescribed overdose | 29.78 | 10.68 | 15 | 62432 | 97610 | 90468390 |
| Blood creatine phosphokinase | 29.39 | 10.68 | 9 | 62438 | 177 | 90565823 |
| Impaired gastric emptying | 29.28 | 10.68 | 40 | 62407 | 12769 | 90553231 |
| Newborn persistent pulmonary hypertension | 29.06 | 10.68 | 10 | 62437 | 288 | 90565712 |
| Restlessness | 28.85 | 10.68 | 71 | 62376 | 35649 | 90530351 |
| Neonatal respiratory failure | 28.37 | 10.68 | 10 | 62437 | 310 | 90565690 |
| Prescription drug used without a prescription | 28.22 | 10.68 | 21 | 62426 | 3234 | 90562766 |
| Obsessive-compulsive disorder | 28.20 | 10.68 | 24 | 62423 | 4480 | 90561520 |
| Intestinal obstruction | 28.10 | 10.68 | 72 | 62375 | 37059 | 90528941 |
| Ataxia | 27.95 | 10.68 | 47 | 62400 | 17995 | 90548005 |
| Abdominal pain | 27.25 | 10.68 | 403 | 62044 | 395318 | 90170682 |
| Pre-existing condition improved | 26.24 | 10.68 | 32 | 62415 | 9137 | 90556863 |
| Foetal exposure during pregnancy | 26.21 | 10.68 | 77 | 62370 | 42898 | 90523102 |
| Chills | 26.10 | 10.68 | 168 | 62279 | 131813 | 90434187 |
| Paranoia | 26.08 | 10.68 | 38 | 62409 | 12870 | 90553130 |
| Neutrophil count decreased | 26.04 | 10.68 | 108 | 62339 | 71424 | 90494576 |
| Pupillary reflex impaired | 25.67 | 10.68 | 18 | 62429 | 2527 | 90563473 |
| Intentional product use issue | 25.65 | 10.68 | 71 | 62376 | 216821 | 90349179 |
| Obesity | 25.64 | 10.68 | 21 | 62426 | 105486 | 90460514 |
| Skin warm | 25.61 | 10.68 | 29 | 62418 | 7658 | 90558342 |
| Miosis | 25.38 | 10.68 | 32 | 62415 | 9452 | 90556548 |
| Wheezing | 25.24 | 10.68 | 82 | 62365 | 237998 | 90328002 |
| Appetite disorder | 24.73 | 10.68 | 31 | 62416 | 9102 | 90556898 |
| Impaired quality of life | 24.25 | 10.68 | 51 | 62396 | 23093 | 90542907 |
| Pharyngeal swelling | 24.18 | 10.68 | 32 | 62415 | 9912 | 90556088 |
| Completed suicide | 24.15 | 10.68 | 177 | 62270 | 144881 | 90421119 |
| Product administration interrupted | 24.13 | 10.68 | 36 | 62411 | 12456 | 90553544 |
| Atrial septal defect | 23.99 | 10.68 | 29 | 62418 | 8205 | 90557795 |
| Infection | 23.77 | 10.68 | 149 | 62298 | 361945 | 90204055 |
| Hyperreflexia | 23.70 | 10.68 | 26 | 62421 | 6631 | 90559369 |
| Prescribed underdose | 23.68 | 10.68 | 11 | 62436 | 75008 | 90490992 |
| Dysphoria | 23.60 | 10.68 | 25 | 62422 | 6129 | 90559871 |
| Feeling abnormal | 23.39 | 10.68 | 196 | 62251 | 167039 | 90398961 |
| Upper respiratory tract infection | 23.36 | 10.68 | 160 | 62287 | 128158 | 90437842 |
| COVID-19 | 23.15 | 10.68 | 197 | 62250 | 168646 | 90397354 |
| Heart rate | 23.13 | 10.68 | 8 | 62439 | 234 | 90565766 |
| Autoimmune disorder | 23.10 | 10.68 | 12 | 62435 | 76732 | 90489268 |
| Blepharospasm | 23.05 | 10.68 | 5 | 62442 | 55440 | 90510560 |
| Respiratory failure | 22.96 | 10.68 | 150 | 62297 | 118268 | 90447732 |
| Neuroleptic malignant syndrome | 22.95 | 10.68 | 39 | 62408 | 15057 | 90550943 |
| Hepatitis | 22.92 | 10.68 | 10 | 62437 | 70729 | 90495271 |
| Gait inability | 22.13 | 10.68 | 42 | 62405 | 146414 | 90419586 |
| Mental disorder | 21.75 | 10.68 | 60 | 62387 | 32258 | 90533742 |
| Exostosis | 21.67 | 10.68 | 5 | 62442 | 53129 | 90512871 |
| Pre-eclampsia | 21.57 | 10.68 | 32 | 62415 | 11016 | 90554984 |
| Hypokalaemia | 21.26 | 10.68 | 159 | 62288 | 130957 | 90435043 |
| Night sweats | 21.19 | 10.68 | 35 | 62412 | 128731 | 90437269 |
| Adverse event | 21.16 | 10.68 | 30 | 62417 | 117388 | 90448612 |
| Liver disorder | 20.87 | 10.68 | 32 | 62415 | 121237 | 90444763 |
| Lymphocyte count decreased | 20.62 | 10.68 | 62 | 62385 | 34988 | 90531012 |
| Urinary retention | 20.56 | 10.68 | 65 | 62382 | 37679 | 90528321 |
| Epilepsy | 20.43 | 10.68 | 16 | 62431 | 82190 | 90483810 |
| Fear | 20.25 | 10.68 | 39 | 62408 | 16583 | 90549417 |
| Osteoarthritis | 19.66 | 10.68 | 69 | 62378 | 195661 | 90370339 |
| Dysarthria | 19.62 | 10.68 | 82 | 62365 | 54400 | 90511600 |
| Drug abuse | 19.58 | 10.68 | 110 | 62337 | 82237 | 90483763 |
| Drug-induced liver injury | 19.54 | 10.68 | 20 | 62427 | 90298 | 90475702 |
| Accidental death | 19.54 | 10.68 | 14 | 62433 | 2034 | 90563966 |
| Uterine perforation | 19.44 | 10.68 | 25 | 62422 | 7529 | 90558471 |
| Anhedonia | 19.35 | 10.68 | 31 | 62416 | 11400 | 90554600 |
| White blood cell count decreased | 19.35 | 10.68 | 188 | 62259 | 166921 | 90399079 |
| Lupus-like syndrome | 19.13 | 10.68 | 5 | 62442 | 48841 | 90517159 |
| Therapy non-responder | 19.11 | 10.68 | 41 | 62406 | 136663 | 90429337 |
| Urticaria | 18.85 | 10.68 | 132 | 62315 | 312602 | 90253398 |
| Haemorrhagic diathesis | 18.67 | 10.68 | 21 | 62426 | 5503 | 90560497 |
| Retching | 18.67 | 10.68 | 41 | 62406 | 19118 | 90546882 |
| Knee arthroplasty | 18.48 | 10.68 | 18 | 62429 | 83164 | 90482836 |
| Acute lung injury | 18.47 | 10.68 | 12 | 62435 | 1486 | 90564514 |
| Oral pain | 18.46 | 10.68 | 57 | 62390 | 32626 | 90533374 |
| Cyanosis neonatal | 18.43 | 10.68 | 8 | 62439 | 435 | 90565565 |
| Fear of falling | 18.23 | 10.68 | 9 | 62438 | 658 | 90565342 |
| Arthritis | 18.17 | 10.68 | 57 | 62390 | 167258 | 90398742 |
| Photophobia | 17.95 | 10.68 | 43 | 62404 | 21226 | 90544774 |
| Attention-seeking behaviour | 17.78 | 10.68 | 5 | 62442 | 72 | 90565928 |
| Pulmonary embolism | 17.59 | 10.68 | 152 | 62295 | 130668 | 90435332 |
| Weight increased | 17.41 | 10.68 | 194 | 62253 | 417733 | 90148267 |
| Sepsis | 17.38 | 10.68 | 195 | 62252 | 179619 | 90386381 |
| Lower limb fracture | 17.10 | 10.68 | 20 | 62427 | 84993 | 90481007 |
| Nephrolithiasis | 17.00 | 10.68 | 73 | 62374 | 49012 | 90516988 |
| Psychomotor hyperactivity | 16.77 | 10.68 | 31 | 62416 | 12782 | 90553218 |
| Nail disorder | 16.67 | 10.68 | 10 | 62437 | 59057 | 90506943 |
| Bronchoalveolar lavage abnormal | 16.66 | 10.68 | 6 | 62441 | 198 | 90565802 |
| Somnambulism | 16.64 | 10.68 | 21 | 62426 | 6207 | 90559793 |
| Blood potassium decreased | 16.54 | 10.68 | 71 | 62376 | 47656 | 90518344 |
| Sitting disability | 16.52 | 10.68 | 7 | 62440 | 359 | 90565641 |
| Dysphagia | 16.45 | 10.68 | 133 | 62314 | 112145 | 90453855 |
| pH body fluid increased | 16.30 | 10.68 | 3 | 62444 | 4 | 90565996 |
| Intestinal ischaemia | 16.30 | 10.68 | 25 | 62422 | 8858 | 90557142 |
| Thinking abnormal | 16.13 | 10.68 | 29 | 62418 | 11703 | 90554297 |
| Long QT syndrome congenital | 15.76 | 10.68 | 5 | 62442 | 111 | 90565889 |
| Adverse drug reaction | 15.50 | 10.68 | 36 | 62411 | 116665 | 90449335 |
| Live birth | 15.49 | 10.68 | 19 | 62428 | 79088 | 90486912 |
| Suicidal behaviour | 15.49 | 10.68 | 14 | 62433 | 2830 | 90563170 |
| Drug withdrawal syndrome | 15.22 | 10.68 | 49 | 62398 | 28674 | 90537326 |
| Liver function test increased | 14.98 | 10.68 | 22 | 62425 | 84833 | 90481167 |
| Cholecystitis | 14.97 | 10.68 | 35 | 62412 | 17005 | 90548995 |
| Blood pressure systolic increased | 14.95 | 10.68 | 11 | 62436 | 58334 | 90507666 |
| Condition aggravated | 14.95 | 10.68 | 305 | 62142 | 595240 | 89970760 |
| Wrong patient received product | 14.91 | 10.68 | 15 | 62432 | 3462 | 90562538 |
| Dependence | 14.86 | 10.68 | 12 | 62435 | 2083 | 90563917 |
| Patient uncooperative | 14.73 | 10.68 | 6 | 62441 | 278 | 90565722 |
| Macular degeneration | 14.66 | 10.68 | 4 | 62443 | 37966 | 90528034 |
| Heart rate increased | 14.57 | 10.68 | 130 | 62317 | 112772 | 90453228 |
| Prolonged rupture of membranes | 14.46 | 10.68 | 4 | 62443 | 54 | 90565946 |
| Mental impairment | 14.32 | 10.68 | 34 | 62413 | 16686 | 90549314 |
| Onychomycosis | 14.31 | 10.68 | 4 | 62443 | 37372 | 90528628 |
| Neuralgia | 14.28 | 10.68 | 51 | 62396 | 31449 | 90534551 |
| Surgery | 14.21 | 10.68 | 65 | 62382 | 44822 | 90521178 |
| Streptococcal endocarditis | 14.18 | 10.68 | 5 | 62442 | 155 | 90565845 |
| Onychomadesis | 14.13 | 10.68 | 7 | 62440 | 45991 | 90520009 |
| Cardiac septal defect | 14.09 | 10.68 | 8 | 62439 | 777 | 90565223 |
| Substance abuse | 14.08 | 10.68 | 18 | 62429 | 5388 | 90560612 |
| Ventricular septal defect | 14.08 | 10.68 | 18 | 62429 | 5389 | 90560611 |
| Arthritis infective | 13.98 | 10.68 | 22 | 62425 | 7970 | 90558030 |
| Catatonia | 13.98 | 10.68 | 19 | 62428 | 6037 | 90559963 |
| Fear of disease | 13.88 | 10.68 | 10 | 62437 | 1466 | 90564534 |
| Small intestinal obstruction | 13.87 | 10.68 | 39 | 62408 | 21195 | 90544805 |
| Tardive dyskinesia | 13.75 | 10.68 | 26 | 62421 | 10904 | 90555096 |
| Aggression | 13.69 | 10.68 | 45 | 62402 | 26623 | 90539377 |
| Vasoplegia syndrome | 13.68 | 10.68 | 13 | 62434 | 2801 | 90563199 |
| Tic | 13.67 | 10.68 | 11 | 62436 | 1900 | 90564100 |
| Finger deformity | 13.60 | 10.68 | 3 | 62444 | 32894 | 90533106 |
| Muscular weakness | 13.57 | 10.68 | 85 | 62362 | 206581 | 90359419 |
| Fallot's tetralogy | 13.50 | 10.68 | 4 | 62443 | 70 | 90565930 |
| Osteoporosis | 13.45 | 10.68 | 29 | 62418 | 96502 | 90469498 |
| Blastocystis infection | 13.40 | 10.68 | 4 | 62443 | 72 | 90565928 |
| Joint dislocation | 13.37 | 10.68 | 7 | 62440 | 44575 | 90521425 |
| Neonatal tachycardia | 13.32 | 10.68 | 3 | 62444 | 16 | 90565984 |
| Walking aid user | 13.23 | 10.68 | 4 | 62443 | 35502 | 90530498 |
| Depression | 13.14 | 10.68 | 285 | 62162 | 300316 | 90265684 |
| Transverse sinus thrombosis | 13.03 | 10.68 | 7 | 62440 | 610 | 90565390 |
| Oedema | 12.83 | 10.68 | 83 | 62364 | 200212 | 90365788 |
| Major depression | 12.78 | 10.68 | 24 | 62423 | 10011 | 90555989 |
| Oropharyngeal swelling | 12.77 | 10.68 | 8 | 62439 | 930 | 90565070 |
| Gestational hypertension | 12.75 | 10.68 | 13 | 62434 | 3049 | 90562951 |
| Drug-disease interaction | 12.68 | 10.68 | 8 | 62439 | 942 | 90565058 |
| Post concussion syndrome | 12.61 | 10.68 | 7 | 62440 | 651 | 90565349 |
| Thyroiditis | 12.59 | 10.68 | 14 | 62433 | 3623 | 90562377 |
| Ventricular extrasystoles | 12.51 | 10.68 | 28 | 62419 | 13222 | 90552778 |
| Product use in unapproved indication | 12.49 | 10.68 | 160 | 62287 | 336076 | 90229924 |
| Withdrawal syndrome | 12.46 | 10.68 | 39 | 62408 | 22485 | 90543515 |
| Laryngitis | 12.46 | 10.68 | 10 | 62437 | 50743 | 90515257 |
| Ileus | 12.43 | 10.68 | 32 | 62415 | 16514 | 90549486 |
| Cholecystectomy | 12.43 | 10.68 | 26 | 62421 | 11729 | 90554271 |
| Colitis ulcerative | 12.31 | 10.68 | 14 | 62433 | 60252 | 90505748 |
| Product dose omission issue | 12.25 | 10.68 | 275 | 62172 | 291412 | 90274588 |
| Gastritis | 12.15 | 10.68 | 59 | 62388 | 41694 | 90524306 |
| Bruxism | 12.12 | 10.68 | 15 | 62432 | 4348 | 90561652 |
| Foot deformity | 12.03 | 10.68 | 14 | 62433 | 59637 | 90506363 |
| Infantile haemangioma | 12.01 | 10.68 | 4 | 62443 | 104 | 90565896 |
| Jaw clicking | 11.94 | 10.68 | 4 | 62443 | 106 | 90565894 |
| Hypopnoea | 11.93 | 10.68 | 15 | 62432 | 4416 | 90561584 |
| Neonatal hypoxia | 11.93 | 10.68 | 7 | 62440 | 724 | 90565276 |
| Arteriovenous fistula thrombosis | 11.77 | 10.68 | 5 | 62442 | 258 | 90565742 |
| Vision blurred | 11.76 | 10.68 | 122 | 62325 | 110171 | 90455829 |
| Tenderness | 11.76 | 10.68 | 43 | 62404 | 26825 | 90539175 |
| Therapeutic response decreased | 11.66 | 10.68 | 28 | 62419 | 89701 | 90476299 |
| Patent ductus arteriosus | 11.57 | 10.68 | 15 | 62432 | 4554 | 90561446 |
| Postpartum haemorrhage | 11.49 | 10.68 | 11 | 62436 | 2390 | 90563610 |
| Sports injury | 11.41 | 10.68 | 3 | 62444 | 33 | 90565967 |
| Anion gap | 11.34 | 10.68 | 8 | 62439 | 1134 | 90564866 |
| Depressive symptom | 11.33 | 10.68 | 16 | 62431 | 5269 | 90560731 |
| Crying | 11.18 | 10.68 | 41 | 62406 | 25604 | 90540396 |
| Selective eating disorder | 10.97 | 10.68 | 10 | 62437 | 2043 | 90563957 |
| Back pain | 10.91 | 10.68 | 291 | 62156 | 316884 | 90249116 |
| Post-traumatic stress disorder | 10.86 | 10.68 | 18 | 62429 | 6810 | 90559190 |
| Frequent bowel movements | 10.81 | 10.68 | 14 | 62433 | 56921 | 90509079 |
| Coeliac disease | 10.69 | 10.68 | 9 | 62438 | 44601 | 90521399 |
| Cardiac arrest | 10.68 | 10.68 | 115 | 62332 | 104820 | 90461180 |
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 |
|---|---|---|---|---|---|---|
| Intentional self-injury | 2237.15 | 12.48 | 659 | 22757 | 14543 | 42583376 |
| Intentional overdose | 1751.54 | 12.48 | 751 | 22665 | 50705 | 42547214 |
| Akathisia | 163.58 | 12.48 | 90 | 23326 | 10361 | 42587558 |
| Depressed level of consciousness | 148.12 | 12.48 | 156 | 23260 | 47814 | 42550105 |
| Tachycardia | 100.86 | 12.48 | 191 | 23225 | 100896 | 42497023 |
| Sinus tachycardia | 63.39 | 12.48 | 67 | 23349 | 20586 | 42577333 |
| Dystonia | 63.19 | 12.48 | 54 | 23362 | 12736 | 42585183 |
| Neuroleptic malignant syndrome | 57.78 | 12.48 | 65 | 23351 | 21407 | 42576512 |
| Somnolence | 52.81 | 12.48 | 184 | 23232 | 140921 | 42456998 |
| Mydriasis | 49.50 | 12.48 | 40 | 23376 | 8730 | 42589189 |
| Drug ineffective | 47.77 | 12.48 | 182 | 23234 | 630015 | 41967904 |
| Lymphocyte count decreased | 47.38 | 12.48 | 67 | 23349 | 27742 | 42570177 |
| Loss of consciousness | 42.24 | 12.48 | 129 | 23287 | 92225 | 42505694 |
| Vomiting | 38.78 | 12.48 | 282 | 23134 | 289441 | 42308478 |
| Poor feeding infant | 37.65 | 12.48 | 15 | 23401 | 827 | 42597092 |
| Drug dependence | 35.39 | 12.48 | 60 | 23356 | 29034 | 42568885 |
| Consciousness fluctuating | 34.29 | 12.48 | 16 | 23400 | 1299 | 42596620 |
| Dehiscence | 34.17 | 12.48 | 13 | 23403 | 633 | 42597286 |
| Schizophrenia | 33.75 | 12.48 | 35 | 23381 | 10515 | 42587404 |
| Sedation | 33.37 | 12.48 | 60 | 23356 | 30415 | 42567504 |
| Dysarthria | 33.36 | 12.48 | 70 | 23346 | 39737 | 42558182 |
| Autoscopy | 32.48 | 12.48 | 10 | 23406 | 254 | 42597665 |
| Slow speech | 32.44 | 12.48 | 17 | 23399 | 1773 | 42596146 |
| Gas poisoning | 32.40 | 12.48 | 8 | 23408 | 86 | 42597833 |
| Red blood cell sedimentation rate decreased | 32.08 | 12.48 | 10 | 23406 | 265 | 42597654 |
| Hallucination | 31.78 | 12.48 | 86 | 23330 | 57421 | 42540498 |
| Agitation | 30.49 | 12.48 | 91 | 23325 | 64223 | 42533696 |
| Neutrophil count decreased | 30.32 | 12.48 | 90 | 23326 | 63325 | 42534594 |
| Neglect of personal appearance | 29.16 | 12.48 | 10 | 23406 | 360 | 42597559 |
| Hypoalbuminaemia | 28.67 | 12.48 | 39 | 23377 | 15571 | 42582348 |
| Foetal exposure during pregnancy | 28.42 | 12.48 | 73 | 23343 | 47238 | 42550681 |
| White blood cell count decreased | 28.35 | 12.48 | 128 | 23288 | 110268 | 42487651 |
| Tardive dyskinesia | 27.79 | 12.48 | 26 | 23390 | 6898 | 42591021 |
| Mental impairment | 27.67 | 12.48 | 34 | 23382 | 12283 | 42585636 |
| Drug hypersensitivity | 27.62 | 12.48 | 118 | 23298 | 99271 | 42498648 |
| Antidepressant therapy | 27.05 | 12.48 | 5 | 23411 | 10 | 42597909 |
| Psychomotor hyperactivity | 25.84 | 12.48 | 31 | 23385 | 10927 | 42586992 |
| Lethargy | 24.78 | 12.48 | 69 | 23347 | 46821 | 42551098 |
| Eosinophil count decreased | 23.84 | 12.48 | 18 | 23398 | 3558 | 42594361 |
| Blood prolactin increased | 23.39 | 12.48 | 15 | 23401 | 2283 | 42595636 |
| Exposure during pregnancy | 23.20 | 12.48 | 26 | 23390 | 8522 | 42589397 |
| Drug use disorder | 22.37 | 12.48 | 28 | 23388 | 10305 | 42587614 |
| Middle ear inflammation | 21.99 | 12.48 | 7 | 23409 | 199 | 42597720 |
| General symptom | 21.80 | 12.48 | 11 | 23405 | 1060 | 42596859 |
| Respiratory depression | 21.75 | 12.48 | 38 | 23378 | 18830 | 42579089 |
| Eating disorder | 21.74 | 12.48 | 27 | 23389 | 9858 | 42588061 |
| Anxiety | 21.69 | 12.48 | 125 | 23291 | 118435 | 42479484 |
| Extrapyramidal disorder | 21.50 | 12.48 | 35 | 23381 | 16377 | 42581542 |
| Overdose | 21.27 | 12.48 | 114 | 23302 | 105150 | 42492769 |
| Multiple organ dysfunction syndrome | 20.63 | 12.48 | 14 | 23402 | 97021 | 42500898 |
| Coagulation factor VIII level decreased | 20.40 | 12.48 | 5 | 23411 | 52 | 42597867 |
| Methaemoglobinaemia | 20.00 | 12.48 | 20 | 23396 | 5754 | 42592165 |
| Patent ductus arteriosus | 19.92 | 12.48 | 16 | 23400 | 3460 | 42594459 |
| Condition aggravated | 19.82 | 12.48 | 75 | 23341 | 260679 | 42337240 |
| Fatigue | 19.64 | 12.48 | 342 | 23074 | 435299 | 42162620 |
| Suicidal ideation | 19.02 | 12.48 | 64 | 23352 | 48097 | 42549822 |
| Aggression | 18.61 | 12.48 | 60 | 23356 | 44103 | 42553816 |
| Body temperature increased | 18.47 | 12.48 | 37 | 23379 | 20321 | 42577598 |
| Drug withdrawal syndrome neonatal | 18.38 | 12.48 | 17 | 23399 | 4444 | 42593475 |
| Strabismus | 18.33 | 12.48 | 13 | 23403 | 2335 | 42595584 |
| Hyperkalaemia | 17.93 | 12.48 | 11 | 23405 | 80447 | 42517472 |
| Labelled drug-drug interaction medication error | 17.46 | 12.48 | 31 | 23385 | 15551 | 42582368 |
| Depressed mood | 17.17 | 12.48 | 39 | 23377 | 23345 | 42574574 |
| Jaundice neonatal | 16.86 | 12.48 | 12 | 23404 | 2167 | 42595752 |
| Tracheobronchitis | 16.74 | 12.48 | 10 | 23406 | 1343 | 42596576 |
| Off label use | 16.65 | 12.48 | 249 | 23167 | 638086 | 41959833 |
| Upper respiratory tract irritation | 16.65 | 12.48 | 4 | 23412 | 38 | 42597881 |
| Atrial septal defect | 16.42 | 12.48 | 21 | 23395 | 7898 | 42590021 |
| Acute kidney injury | 16.11 | 12.48 | 127 | 23289 | 367210 | 42230709 |
| Interstitial lung disease | 15.78 | 12.48 | 12 | 23404 | 78450 | 42519469 |
| Exposure via breast milk | 15.49 | 12.48 | 12 | 23404 | 2465 | 42595454 |
| Delusion of grandeur | 15.46 | 12.48 | 11 | 23405 | 1985 | 42595934 |
| Congenital aortic valve stenosis | 15.39 | 12.48 | 5 | 23411 | 152 | 42597767 |
| Electrocardiogram high voltage | 15.37 | 12.48 | 3 | 23413 | 9 | 42597910 |
| Obsessive thoughts | 15.13 | 12.48 | 8 | 23408 | 850 | 42597069 |
| Delusion | 14.85 | 12.48 | 28 | 23388 | 14706 | 42583213 |
| Gallbladder enlargement | 14.71 | 12.48 | 9 | 23407 | 1262 | 42596657 |
| Mucosal haemorrhage | 14.18 | 12.48 | 10 | 23406 | 1780 | 42596139 |
| Suicide attempt | 13.78 | 12.48 | 56 | 23360 | 46044 | 42551875 |
| Blood osmolarity increased | 13.65 | 12.48 | 6 | 23410 | 424 | 42597495 |
| Failure to thrive | 13.59 | 12.48 | 21 | 23395 | 9401 | 42588518 |
| Psychotic disorder | 13.52 | 12.48 | 41 | 23375 | 29167 | 42568752 |
| Formication | 13.00 | 12.48 | 10 | 23406 | 2031 | 42595888 |
| Breath holding | 12.83 | 12.48 | 4 | 23412 | 106 | 42597813 |
| Hyperlactacidaemia | 12.71 | 12.48 | 14 | 23402 | 4502 | 42593417 |
| Platelet count decreased | 12.67 | 12.48 | 124 | 23292 | 138457 | 42459462 |
| Postmortem blood drug level increased | 12.54 | 12.48 | 6 | 23410 | 515 | 42597404 |
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 |
|---|---|---|---|---|---|---|
| Intentional self-injury | 5900.50 | 11.05 | 1749 | 65093 | 35680 | 110486777 |
| Intentional overdose | 4491.68 | 11.05 | 1984 | 64858 | 130517 | 110391940 |
| Akathisia | 598.84 | 11.05 | 263 | 66579 | 16850 | 110505607 |
| Depressed level of consciousness | 390.80 | 11.05 | 407 | 66435 | 111871 | 110410586 |
| Tachycardia | 389.70 | 11.05 | 576 | 66266 | 226069 | 110296388 |
| Mydriasis | 211.54 | 11.05 | 144 | 66698 | 22013 | 110500444 |
| Hallucination | 167.21 | 11.05 | 253 | 66589 | 101179 | 110421278 |
| Synovitis | 150.83 | 11.05 | 3 | 66839 | 274089 | 110248368 |
| Human rhinovirus test positive | 139.44 | 11.05 | 45 | 66797 | 1212 | 110521245 |
| Respiratory syncytial virus test positive | 135.73 | 11.05 | 46 | 66796 | 1448 | 110521009 |
| Somnolence | 133.20 | 11.05 | 439 | 66403 | 297010 | 110225447 |
| Suicide attempt | 120.83 | 11.05 | 221 | 66621 | 103173 | 110419284 |
| Hand deformity | 117.84 | 11.05 | 3 | 66839 | 218503 | 110303954 |
| Drug ineffective | 116.01 | 11.05 | 500 | 66342 | 1520040 | 109002417 |
| Anxiety | 113.68 | 11.05 | 461 | 66381 | 344617 | 110177840 |
| Cholecystitis chronic | 113.33 | 11.05 | 71 | 66771 | 9429 | 110513028 |
| Agitation | 109.28 | 11.05 | 223 | 66619 | 112828 | 110409629 |
| Sinus tachycardia | 106.58 | 11.05 | 133 | 66709 | 44360 | 110478097 |
| Toxicity to various agents | 103.98 | 11.05 | 568 | 66274 | 479987 | 110042470 |
| Viral test positive | 103.83 | 11.05 | 33 | 66809 | 845 | 110521612 |
| Vomiting | 103.01 | 11.05 | 918 | 65924 | 909757 | 109612700 |
| Pericarditis | 96.71 | 11.05 | 10 | 66832 | 219104 | 110303353 |
| Glossodynia | 93.32 | 11.05 | 12 | 66830 | 221992 | 110300465 |
| Helicobacter infection | 89.56 | 11.05 | 5 | 66837 | 181872 | 110340585 |
| Pneumonia haemophilus | 86.21 | 11.05 | 39 | 66803 | 2676 | 110519781 |
| Arthropathy | 86.11 | 11.05 | 33 | 66809 | 287489 | 110234968 |
| Contraindicated product administered | 82.19 | 11.05 | 24 | 66818 | 248243 | 110274214 |
| Folliculitis | 81.36 | 11.05 | 5 | 66837 | 167648 | 110354809 |
| Lymphocyte count decreased | 80.76 | 11.05 | 133 | 66709 | 57110 | 110465347 |
| Systemic lupus erythematosus | 79.88 | 11.05 | 27 | 66815 | 254311 | 110268146 |
| Loss of consciousness | 77.54 | 11.05 | 278 | 66564 | 196028 | 110326429 |
| Impaired healing | 77.21 | 11.05 | 13 | 66829 | 196704 | 110325753 |
| Tongue biting | 77.13 | 11.05 | 37 | 66805 | 2902 | 110519555 |
| Joint swelling | 76.58 | 11.05 | 93 | 66749 | 442752 | 110079705 |
| Off label use | 72.99 | 11.05 | 570 | 66272 | 1499615 | 109022842 |
| Neutrophil count decreased | 72.51 | 11.05 | 198 | 66644 | 120743 | 110401714 |
| Neuroleptic malignant syndrome | 70.91 | 11.05 | 95 | 66747 | 33964 | 110488493 |
| Fatigue | 66.57 | 11.05 | 1067 | 65775 | 1214891 | 109307566 |
| Drug intolerance | 66.51 | 11.05 | 89 | 66753 | 406423 | 110116034 |
| Hepatic enzyme increased | 64.88 | 11.05 | 59 | 66783 | 320833 | 110201624 |
| Nausea | 64.55 | 11.05 | 1076 | 65766 | 1234614 | 109287843 |
| Drug hypersensitivity | 62.53 | 11.05 | 479 | 66363 | 453611 | 110068846 |
| Therapeutic product effect decreased | 62.38 | 11.05 | 35 | 66807 | 244281 | 110278176 |
| Formication | 61.87 | 11.05 | 40 | 66802 | 5608 | 110516849 |
| Serotonin syndrome | 61.11 | 11.05 | 120 | 66722 | 59033 | 110463424 |
| Treatment failure | 60.93 | 11.05 | 47 | 66795 | 277187 | 110245270 |
| Mouth haemorrhage | 60.08 | 11.05 | 56 | 66786 | 13432 | 110509025 |
| Nasopharyngitis | 58.94 | 11.05 | 92 | 66750 | 394269 | 110128188 |
| Lethargy | 57.89 | 11.05 | 155 | 66687 | 93421 | 110429036 |
| General physical health deterioration | 56.44 | 11.05 | 107 | 66735 | 425188 | 110097269 |
| Rheumatoid arthritis | 56.04 | 11.05 | 59 | 66783 | 299554 | 110222903 |
| Mast cell activation syndrome | 55.11 | 11.05 | 24 | 66818 | 1504 | 110520953 |
| Wound | 55.10 | 11.05 | 37 | 66805 | 234400 | 110288057 |
| White blood cell count decreased | 54.89 | 11.05 | 279 | 66563 | 229111 | 110293346 |
| C-reactive protein increased | 53.11 | 11.05 | 33 | 66809 | 217886 | 110304571 |
| Dystonia | 50.72 | 11.05 | 70 | 66772 | 25735 | 110496722 |
| Type 2 diabetes mellitus | 50.35 | 11.05 | 22 | 66820 | 177210 | 110345247 |
| Joint range of motion decreased | 50.20 | 11.05 | 7 | 66835 | 121825 | 110400632 |
| Emotional distress | 48.79 | 11.05 | 93 | 66749 | 44754 | 110477703 |
| Lip dry | 48.51 | 11.05 | 3 | 66839 | 100080 | 110422377 |
| Opisthotonus | 47.90 | 11.05 | 18 | 66824 | 768 | 110521689 |
| Suicidal ideation | 47.79 | 11.05 | 145 | 66697 | 93792 | 110428665 |
| Inflammation | 47.45 | 11.05 | 29 | 66813 | 193209 | 110329248 |
| Bursitis | 45.94 | 11.05 | 11 | 66831 | 129907 | 110392550 |
| Irritable bowel syndrome | 45.68 | 11.05 | 21 | 66821 | 164194 | 110358263 |
| Ill-defined disorder | 45.31 | 11.05 | 19 | 66823 | 156834 | 110365623 |
| Psoriatic arthropathy | 43.68 | 11.05 | 33 | 66809 | 196728 | 110325729 |
| Mobility decreased | 43.00 | 11.05 | 48 | 66794 | 237374 | 110285083 |
| Lower respiratory tract infection | 42.04 | 11.05 | 51 | 66791 | 243055 | 110279402 |
| Snoring | 42.03 | 11.05 | 34 | 66808 | 6750 | 110515707 |
| Electrocardiogram QT prolonged | 41.04 | 11.05 | 152 | 66690 | 108808 | 110413649 |
| Infusion related reaction | 40.67 | 11.05 | 108 | 66734 | 381054 | 110141403 |
| Hypercholesterolaemia | 40.45 | 11.05 | 4 | 66838 | 90833 | 110431624 |
| Tongue injury | 40.44 | 11.05 | 15 | 66827 | 617 | 110521840 |
| Lung disorder | 40.21 | 11.05 | 30 | 66812 | 180017 | 110342440 |
| Therapeutic product effect incomplete | 38.64 | 11.05 | 47 | 66795 | 223758 | 110298699 |
| Tardive dyskinesia | 38.10 | 11.05 | 44 | 66798 | 13535 | 110508922 |
| Hypoalbuminaemia | 37.78 | 11.05 | 65 | 66777 | 28909 | 110493548 |
| Stomatitis | 37.60 | 11.05 | 66 | 66776 | 270176 | 110252281 |
| Dehydration | 37.39 | 11.05 | 293 | 66549 | 279218 | 110243239 |
| Mental status changes | 37.32 | 11.05 | 116 | 66726 | 76006 | 110446451 |
| Intentional product use issue | 36.85 | 11.05 | 58 | 66784 | 247848 | 110274609 |
| Biliary dyskinesia | 36.41 | 11.05 | 21 | 66821 | 2400 | 110520057 |
| Liver injury | 36.34 | 11.05 | 23 | 66819 | 150390 | 110372067 |
| Chills | 36.33 | 11.05 | 218 | 66624 | 190362 | 110332095 |
| Gallbladder injury | 36.20 | 11.05 | 17 | 66825 | 1271 | 110521186 |
| Incoherent | 35.88 | 11.05 | 34 | 66808 | 8324 | 110514133 |
| Anaphylactic reaction | 35.43 | 11.05 | 150 | 66692 | 114150 | 110408307 |
| Grip strength decreased | 34.50 | 11.05 | 4 | 66838 | 80170 | 110442287 |
| Musculoskeletal pain | 34.25 | 11.05 | 36 | 66806 | 182987 | 110339470 |
| Psychomotor hyperactivity | 33.98 | 11.05 | 51 | 66791 | 20226 | 110502231 |
| Muscle twitching | 33.71 | 11.05 | 63 | 66779 | 29872 | 110492585 |
| Condition aggravated | 33.34 | 11.05 | 284 | 66558 | 734552 | 109787905 |
| Abdominal discomfort | 33.28 | 11.05 | 124 | 66718 | 393734 | 110128723 |
| Fibromyalgia | 32.68 | 11.05 | 33 | 66809 | 170876 | 110351581 |
| Mental impairment | 32.46 | 11.05 | 53 | 66789 | 22586 | 110499871 |
| Upper respiratory tract infection | 32.29 | 11.05 | 161 | 66681 | 131167 | 110391290 |
| Deep vein thrombosis | 31.95 | 11.05 | 168 | 66674 | 139719 | 110382738 |
| Pulmonary fibrosis | 31.73 | 11.05 | 11 | 66831 | 102031 | 110420426 |
| Gas poisoning | 31.39 | 11.05 | 8 | 66834 | 89 | 110522368 |
| Alopecia | 31.36 | 11.05 | 114 | 66728 | 364639 | 110157818 |
| Red blood cell sedimentation rate increased | 31.10 | 11.05 | 5 | 66837 | 78297 | 110444160 |
| Seizure | 30.76 | 11.05 | 234 | 66608 | 220951 | 110301506 |
| Dysarthria | 30.56 | 11.05 | 116 | 66726 | 84005 | 110438452 |
| Electrocardiogram QRS complex shortened | 29.97 | 11.05 | 13 | 66829 | 807 | 110521650 |
| Peripheral swelling | 29.87 | 11.05 | 134 | 66708 | 403900 | 110118557 |
| Hepatitis | 29.25 | 11.05 | 9 | 66833 | 90045 | 110432412 |
| Product use issue | 29.11 | 11.05 | 94 | 66748 | 311601 | 110210856 |
| Drug dependence | 29.08 | 11.05 | 81 | 66761 | 49939 | 110472518 |
| Hypokalaemia | 28.81 | 11.05 | 199 | 66643 | 182249 | 110340208 |
| Craniofacial fracture | 28.79 | 11.05 | 13 | 66829 | 888 | 110521569 |
| Hereditary angioedema | 28.77 | 11.05 | 28 | 66814 | 7086 | 110515371 |
| Swelling | 28.69 | 11.05 | 112 | 66730 | 350929 | 110171528 |
| Cholelithiasis | 28.67 | 11.05 | 94 | 66748 | 63328 | 110459129 |
| Blister | 28.59 | 11.05 | 59 | 66783 | 227317 | 110295140 |
| Miosis | 28.24 | 11.05 | 49 | 66793 | 21934 | 110500523 |
| Hypersensitivity | 28.09 | 11.05 | 137 | 66705 | 403861 | 110118596 |
| Dehiscence | 27.65 | 11.05 | 12 | 66830 | 746 | 110521711 |
| Gallbladder disorder | 27.18 | 11.05 | 47 | 66795 | 20982 | 110501475 |
| Arthralgia | 27.16 | 11.05 | 321 | 66521 | 779311 | 109743146 |
| Neglect of personal appearance | 27.13 | 11.05 | 10 | 66832 | 404 | 110522053 |
| Product use in unapproved indication | 27.07 | 11.05 | 159 | 66683 | 447218 | 110075239 |
| Restlessness | 26.90 | 11.05 | 85 | 66757 | 56174 | 110466283 |
| Blood cholesterol increased | 26.74 | 11.05 | 44 | 66798 | 184741 | 110337716 |
| Impaired gastric emptying | 26.07 | 11.05 | 36 | 66806 | 13239 | 110509218 |
| Withdrawal syndrome | 25.81 | 11.05 | 58 | 66784 | 31322 | 110491135 |
| Sciatica | 25.41 | 11.05 | 12 | 66830 | 92387 | 110430070 |
| Drug abuse | 25.40 | 11.05 | 189 | 66653 | 177222 | 110345235 |
| Antidepressant therapy | 25.39 | 11.05 | 5 | 66837 | 14 | 110522443 |
| Blood creatine phosphokinase | 25.15 | 11.05 | 9 | 66833 | 334 | 110522123 |
| Prescription drug used without a prescription | 24.83 | 11.05 | 23 | 66819 | 5473 | 110516984 |
| Tremor | 24.33 | 11.05 | 207 | 66635 | 202025 | 110320432 |
| Arthritis | 24.16 | 11.05 | 40 | 66802 | 167546 | 110354911 |
| Uterine perforation | 24.13 | 11.05 | 25 | 66817 | 6815 | 110515642 |
| Hyperkalaemia | 23.99 | 11.05 | 28 | 66814 | 135768 | 110386689 |
| Rash | 23.85 | 11.05 | 351 | 66491 | 820613 | 109701844 |
| Paranoia | 23.85 | 11.05 | 46 | 66796 | 22328 | 110500129 |
| Hypocalcaemia | 23.62 | 11.05 | 90 | 66752 | 65276 | 110457181 |
| Dysphoria | 23.59 | 11.05 | 24 | 66818 | 6404 | 110516053 |
| Drug withdrawal syndrome | 23.49 | 11.05 | 63 | 66779 | 37991 | 110484466 |
| Hypoproteinaemia | 23.29 | 11.05 | 23 | 66819 | 5922 | 110516535 |
| Gastrointestinal disorder | 23.26 | 11.05 | 72 | 66770 | 241880 | 110280577 |
| Appetite disorder | 23.06 | 11.05 | 29 | 66813 | 9740 | 110512717 |
| Slow speech | 22.90 | 11.05 | 18 | 66824 | 3430 | 110519027 |
| Accidental overdose | 22.69 | 11.05 | 76 | 66766 | 51758 | 110470699 |
| Heart rate | 22.66 | 11.05 | 8 | 66834 | 285 | 110522172 |
| Pupillary reflex impaired | 22.53 | 11.05 | 19 | 66823 | 3996 | 110518461 |
| Blood pressure systolic increased | 22.48 | 11.05 | 11 | 66831 | 82980 | 110439477 |
| Thinking abnormal | 22.46 | 11.05 | 36 | 66806 | 15104 | 110507353 |
| Wheezing | 22.44 | 11.05 | 79 | 66763 | 255151 | 110267306 |
| Therapy non-responder | 22.25 | 11.05 | 38 | 66804 | 157269 | 110365188 |
| Platelet count decreased | 22.25 | 11.05 | 225 | 66617 | 230218 | 110292239 |
| Epilepsy | 21.98 | 11.05 | 17 | 66825 | 100192 | 110422265 |
| Cholestasis | 21.77 | 11.05 | 6 | 66836 | 64512 | 110457945 |
| Osteoarthritis | 21.62 | 11.05 | 49 | 66793 | 182574 | 110339883 |
| Drug resistance | 21.51 | 11.05 | 4 | 66838 | 56370 | 110466087 |
| Skin warm | 21.30 | 11.05 | 27 | 66815 | 9143 | 110513314 |
| Pharyngeal swelling | 21.22 | 11.05 | 31 | 66811 | 12001 | 110510456 |
| Extrapyramidal disorder | 21.16 | 11.05 | 51 | 66791 | 28816 | 110493641 |
| Urinary retention | 20.48 | 11.05 | 90 | 66752 | 69593 | 110452864 |
| Abdominal pain | 20.46 | 11.05 | 429 | 66413 | 512560 | 110009897 |
| Wound infection | 20.37 | 11.05 | 17 | 66825 | 96448 | 110426009 |
| Migraine | 20.28 | 11.05 | 175 | 66667 | 171477 | 110350980 |
| Oral pain | 20.17 | 11.05 | 59 | 66783 | 37385 | 110485072 |
| Aggression | 20.16 | 11.05 | 80 | 66762 | 59130 | 110463327 |
| Coagulation factor VIII level decreased | 19.92 | 11.05 | 5 | 66837 | 52 | 110522405 |
| Middle ear inflammation | 19.92 | 11.05 | 7 | 66835 | 246 | 110522211 |
| Weight increased | 19.53 | 11.05 | 161 | 66681 | 419483 | 110102974 |
| Wrong patient received product | 19.36 | 11.05 | 22 | 66820 | 6652 | 110515805 |
| Fear | 19.22 | 11.05 | 43 | 66799 | 23150 | 110499307 |
| Electrocardiogram high voltage | 19.22 | 11.05 | 4 | 66838 | 16 | 110522441 |
| Pancytopenia | 19.02 | 11.05 | 64 | 66778 | 209549 | 110312908 |
| Sedation | 18.98 | 11.05 | 88 | 66754 | 69595 | 110452862 |
| Urticaria | 18.91 | 11.05 | 114 | 66728 | 318743 | 110203714 |
| Obsessive thoughts | 18.76 | 11.05 | 11 | 66831 | 1296 | 110521161 |
| Acute kidney injury | 18.67 | 11.05 | 271 | 66571 | 635159 | 109887298 |
| Colitis ulcerative | 18.45 | 11.05 | 12 | 66830 | 77351 | 110445106 |
| Nail disorder | 18.44 | 11.05 | 6 | 66836 | 57929 | 110464528 |
| Obesity | 18.32 | 11.05 | 25 | 66817 | 113326 | 110409131 |
| Constipation | 18.32 | 11.05 | 311 | 66531 | 357475 | 110164982 |
| Illness | 18.29 | 11.05 | 98 | 66744 | 82073 | 110440384 |
| Pre-eclampsia | 17.81 | 11.05 | 24 | 66818 | 8626 | 110513831 |
| Prescribed overdose | 17.80 | 11.05 | 16 | 66826 | 87565 | 110434892 |
| Drug abuser | 17.71 | 11.05 | 19 | 66823 | 5390 | 110517067 |
| Musculoskeletal stiffness | 17.69 | 11.05 | 98 | 66744 | 279724 | 110242733 |
| Borderline personality disorder | 17.67 | 11.05 | 10 | 66832 | 1102 | 110521355 |
| Blepharospasm | 16.90 | 11.05 | 6 | 66836 | 54845 | 110467612 |
| Postmortem blood drug level increased | 16.83 | 11.05 | 10 | 66832 | 1207 | 110521250 |
| Fear of falling | 16.68 | 11.05 | 9 | 66833 | 904 | 110521553 |
| Respiratory arrest | 16.15 | 11.05 | 74 | 66768 | 58225 | 110464232 |
| Supraventricular extrasystoles | 16.01 | 11.05 | 22 | 66820 | 8051 | 110514406 |
| Red blood cell sedimentation rate decreased | 15.99 | 11.05 | 10 | 66832 | 1324 | 110521133 |
| Autoimmune disorder | 15.83 | 11.05 | 10 | 66832 | 65473 | 110456984 |
| Night sweats | 15.81 | 11.05 | 36 | 66806 | 133947 | 110388510 |
| Hip arthroplasty | 15.73 | 11.05 | 7 | 66835 | 55806 | 110466651 |
| Haemorrhagic diathesis | 15.71 | 11.05 | 21 | 66821 | 7487 | 110514970 |
| Dependence | 15.49 | 11.05 | 13 | 66829 | 2716 | 110519741 |
| Photophobia | 15.24 | 11.05 | 42 | 66800 | 25729 | 110496728 |
| Blood potassium decreased | 15.23 | 11.05 | 69 | 66773 | 54045 | 110468412 |
| Bradycardia | 15.14 | 11.05 | 46 | 66796 | 155471 | 110366986 |
| Intestinal obstruction | 15.07 | 11.05 | 68 | 66774 | 53159 | 110469298 |
| Prolonged rupture of membranes | 15.05 | 11.05 | 4 | 66838 | 53 | 110522404 |
| Feeling abnormal | 14.91 | 11.05 | 171 | 66671 | 180540 | 110341917 |
| Body temperature increased | 14.83 | 11.05 | 69 | 66773 | 54644 | 110467813 |
| Blood pressure fluctuation | 14.82 | 11.05 | 14 | 66828 | 74810 | 110447647 |
| Hyperreflexia | 14.69 | 11.05 | 23 | 66819 | 9462 | 110512995 |
| Liver disorder | 14.63 | 11.05 | 41 | 66801 | 142202 | 110380255 |
| Hallucination, auditory | 14.61 | 11.05 | 42 | 66800 | 26355 | 110496102 |
| Suicidal behaviour | 14.58 | 11.05 | 14 | 66828 | 3483 | 110518974 |
| Strabismus | 14.58 | 11.05 | 14 | 66828 | 3485 | 110518972 |
| Frequent bowel movements | 14.56 | 11.05 | 13 | 66829 | 71377 | 110451080 |
| Respiratory failure | 14.43 | 11.05 | 196 | 66646 | 215136 | 110307321 |
| Long QT syndrome congenital | 14.39 | 11.05 | 5 | 66837 | 170 | 110522287 |
| Reversible cerebral vasoconstriction syndrome | 14.33 | 11.05 | 16 | 66826 | 4745 | 110517712 |
| Catatonia | 14.27 | 11.05 | 25 | 66817 | 11275 | 110511182 |
| Gait inability | 14.26 | 11.05 | 39 | 66803 | 136337 | 110386120 |
| Discomfort | 14.23 | 11.05 | 74 | 66768 | 214633 | 110307824 |
| Overdose | 14.14 | 11.05 | 209 | 66633 | 233585 | 110288872 |
| COVID-19 | 14.02 | 11.05 | 217 | 66625 | 244843 | 110277614 |
| Hypophosphataemia | 13.95 | 11.05 | 48 | 66794 | 33134 | 110489323 |
| Live birth | 13.76 | 11.05 | 13 | 66829 | 69471 | 110452986 |
| Angioedema | 13.74 | 11.05 | 24 | 66818 | 98476 | 110423981 |
| Mental disorder | 13.68 | 11.05 | 53 | 66789 | 38738 | 110483719 |
| Bronchoalveolar lavage abnormal | 13.67 | 11.05 | 6 | 66836 | 383 | 110522074 |
| Cytomegalovirus infection | 13.60 | 11.05 | 8 | 66834 | 54436 | 110468021 |
| Tubulointerstitial nephritis | 13.52 | 11.05 | 8 | 66834 | 54276 | 110468181 |
| Pneumococcal sepsis | 13.52 | 11.05 | 11 | 66831 | 2201 | 110520256 |
| Delusion of grandeur | 13.31 | 11.05 | 11 | 66831 | 2249 | 110520208 |
| Obsessive-compulsive disorder | 13.27 | 11.05 | 19 | 66823 | 7222 | 110515235 |
| Hyperuricaemia | 13.25 | 11.05 | 28 | 66814 | 14503 | 110507954 |
| Anhedonia | 13.23 | 11.05 | 29 | 66813 | 15399 | 110507058 |
| Compulsions | 13.23 | 11.05 | 6 | 66836 | 414 | 110522043 |
| Pulmonary congestion | 13.20 | 11.05 | 45 | 66797 | 30921 | 110491536 |
| Impaired quality of life | 13.13 | 11.05 | 44 | 66798 | 29973 | 110492484 |
| Ataxia | 13.05 | 11.05 | 44 | 66798 | 30064 | 110492393 |
| Blood prolactin increased | 12.95 | 11.05 | 15 | 66827 | 4627 | 110517830 |
| Lower limb fracture | 12.81 | 11.05 | 16 | 66826 | 75332 | 110447125 |
| Loss of personal independence in daily activities | 12.80 | 11.05 | 47 | 66795 | 149973 | 110372484 |
| Chest discomfort | 12.80 | 11.05 | 161 | 66681 | 173687 | 110348770 |
| Neutrophil count increased | 12.76 | 11.05 | 48 | 66794 | 34604 | 110487853 |
| Fibrin D dimer increased | 12.72 | 11.05 | 22 | 66820 | 9823 | 110512634 |
| Jaw clicking | 12.68 | 11.05 | 4 | 66838 | 100 | 110522357 |
| Surgery | 12.65 | 11.05 | 54 | 66788 | 41229 | 110481228 |
| Hypophagia | 12.56 | 11.05 | 64 | 66778 | 52562 | 110469895 |
| Methaemoglobinaemia | 12.52 | 11.05 | 21 | 66821 | 9147 | 110513310 |
| Dysphagia | 12.51 | 11.05 | 145 | 66697 | 153455 | 110369002 |
| Ventricular extrasystoles | 12.51 | 11.05 | 36 | 66806 | 22605 | 110499852 |
| Restless legs syndrome | 12.51 | 11.05 | 38 | 66804 | 24588 | 110497869 |
| Cholecystectomy | 12.48 | 11.05 | 23 | 66819 | 10786 | 110511671 |
| Transverse sinus thrombosis | 12.37 | 11.05 | 7 | 66835 | 771 | 110521686 |
| Respiratory depression | 12.34 | 11.05 | 45 | 66797 | 31956 | 110490501 |
| Substance use | 12.33 | 11.05 | 11 | 66831 | 2495 | 110519962 |
| Drug use disorder | 12.26 | 11.05 | 31 | 66811 | 18043 | 110504414 |
| Completed suicide | 12.15 | 11.05 | 210 | 66632 | 242171 | 110280286 |
| Gallbladder enlargement | 12.07 | 11.05 | 10 | 66832 | 2052 | 110520405 |
| Accidental death | 12.03 | 11.05 | 15 | 66827 | 4994 | 110517463 |
| Mucosal inflammation | 12.03 | 11.05 | 25 | 66817 | 96116 | 110426341 |
| Acute lung injury | 11.99 | 11.05 | 12 | 66830 | 3139 | 110519318 |
| Prescribed underdose | 11.99 | 11.05 | 13 | 66829 | 65161 | 110457296 |
| Streptococcal endocarditis | 11.96 | 11.05 | 5 | 66837 | 283 | 110522174 |
| Knee arthroplasty | 11.89 | 11.05 | 13 | 66829 | 64935 | 110457522 |
| Tenderness | 11.87 | 11.05 | 42 | 66800 | 29395 | 110493062 |
| Infection | 11.87 | 11.05 | 151 | 66691 | 362049 | 110160408 |
| Sleep disorder | 11.78 | 11.05 | 71 | 66771 | 198573 | 110323884 |
| Muscular weakness | 11.70 | 11.05 | 95 | 66747 | 248373 | 110274084 |
| Heart rate decreased | 11.69 | 11.05 | 20 | 66822 | 82736 | 110439721 |
| Lupus-like syndrome | 11.68 | 11.05 | 5 | 66837 | 40787 | 110481670 |
| Retching | 11.52 | 11.05 | 35 | 66807 | 22647 | 110499810 |
| Adverse event | 11.46 | 11.05 | 31 | 66811 | 108778 | 110413679 |
| Underdose | 11.33 | 11.05 | 13 | 66829 | 63541 | 110458916 |
| Gastritis | 11.25 | 11.05 | 63 | 66779 | 53636 | 110468821 |
| Depressed mood | 11.22 | 11.05 | 69 | 66773 | 60740 | 110461717 |
| Gastric ulcer | 11.22 | 11.05 | 5 | 66837 | 39822 | 110482635 |
| Dental cyst | 11.20 | 11.05 | 3 | 66839 | 41 | 110522416 |
| Exostosis | 11.13 | 11.05 | 7 | 66835 | 45949 | 110476508 |
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 |
|---|---|---|---|---|---|---|
| Pleural effusion | 41.93 | 29.70 | 11 | 258 | 28 | 113656 |
| Pulmonary haemorrhage neonatal | 35.74 | 29.70 | 10 | 259 | 35 | 113649 |
| Poor feeding infant | 33.25 | 29.70 | 15 | 254 | 258 | 113426 |
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | D04AA10 | DERMATOLOGICALS ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC. ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC. Antihistamines for topical use |
| ATC | R06AD02 | RESPIRATORY SYSTEM ANTIHISTAMINES FOR SYSTEMIC USE ANTIHISTAMINES FOR SYSTEMIC USE Phenothiazine derivatives |
| ATC | R06AD52 | RESPIRATORY SYSTEM ANTIHISTAMINES FOR SYSTEMIC USE ANTIHISTAMINES FOR SYSTEMIC USE Phenothiazine derivatives |
| ATC | V03AB05 | VARIOUS ALL OTHER THERAPEUTIC PRODUCTS ALL OTHER THERAPEUTIC PRODUCTS Antidotes |
| FDA CS | M0016525 | Phenothiazines |
| MeSH PA | D000982 | Antipruritics |
| MeSH PA | D003879 | Dermatologic Agents |
| MeSH PA | D006633 | Histamine Antagonists |
| MeSH PA | D006634 | Histamine H1 Antagonists |
| MeSH PA | D018377 | Neurotransmitter Agents |
| MeSH PA | D018926 | Anti-Allergic Agents |
| FDA EPC | N0000175746 | Phenothiazine |
| CHEBI has role | CHEBI:35469 | antidepressant |
| CHEBI has role | CHEBI:35474 | anxiolytic drug |
| CHEBI has role | CHEBI:35476 | antipsychotic agent |
| CHEBI has role | CHEBI:35480 | analgesic |
| CHEBI has role | CHEBI:35717 | sedative |
| CHEBI has role | CHEBI:36333 | local anaesthetic |
| CHEBI has role | CHEBI:37955 | H<small><sub>1</sub></small>-receptor antagonist |
| CHEBI has role | CHEBI:50857 | anti-allergic agent |
| CHEBI has role | CHEBI:50919 | antiemetic |
| CHEBI has role | CHEBI:55324 | gastrointestinal drug |
| CHEBI has role | CHEBI:59683 | antipruritic drug |
| CHEBI has role | CHEBI:149553 | anticoronaviral agent |
| CHEBI has role | CHEBI:50177 | dermatologic drug |
| CHEBI has role | CHEBI:66981 | ophthalmology drug |
| CHEBI has role | CHEBI:176497 | geroprotector |
Related Drugs by ATC class:
D04AA Antihistamines for topical use 13 drugs
R06AD Phenothiazine derivatives 8 drugs
V03AB Antidotes 28 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Vasomotor rhinitis | indication | 8229003 | DOID:4730 |
| Nausea and vomiting | indication | 16932000 | |
| General anesthesia | indication | 50697003 | |
| Sedation | indication | 72641008 | |
| Urticaria | indication | 126485001 | |
| Seasonal allergic rhinitis | indication | 367498001 | |
| Allergic conjunctivitis | indication | 473460002 | DOID:11204 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 9.19 | Basic |
| pKa2 | 3.55 | Basic |
Orange Book patent data (new drug applications)
None
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Histamine H1 receptor | GPCR | ANTAGONIST | Ki | 9.62 | WOMBAT-PK | CHEMBL | |||
| D(1A) dopamine receptor | GPCR | Ki | 5.86 | DRUG MATRIX | |||||
| D(2) dopamine receptor | GPCR | Ki | 6.61 | WOMBAT-PK | |||||
| Alpha-2A adrenergic receptor | GPCR | Ki | 6.59 | DRUG MATRIX | |||||
| Sigma non-opioid intracellular receptor 1 | Membrane receptor | Ki | 6.92 | DRUG MATRIX | |||||
| Sodium-dependent serotonin transporter | Transporter | IC50 | 5.12 | CHEMBL | |||||
| Sodium-dependent noradrenaline transporter | Transporter | Ki | 5.38 | DRUG MATRIX | |||||
| 5-hydroxytryptamine receptor 1A | GPCR | Ki | 5.83 | DRUG MATRIX | |||||
| 5-hydroxytryptamine receptor 2A | GPCR | Ki | 6.77 | WOMBAT-PK | |||||
| 5-hydroxytryptamine receptor 2B | GPCR | Ki | 7.37 | DRUG MATRIX | |||||
| 5-hydroxytryptamine receptor 2C | GPCR | Ki | 8.19 | DRUG MATRIX | |||||
| 5-hydroxytryptamine receptor 6 | GPCR | Ki | 5.95 | DRUG MATRIX | |||||
| Alpha-1A adrenergic receptor | GPCR | WOMBAT-PK | |||||||
| Alpha-2B adrenergic receptor | GPCR | Ki | 7.62 | DRUG MATRIX | |||||
| D(3) dopamine receptor | GPCR | Ki | 6.72 | DRUG MATRIX | |||||
| Histamine H2 receptor | GPCR | Ki | 5.94 | DRUG MATRIX | |||||
| Histamine H4 receptor | GPCR | Ki | 6.82 | WOMBAT-PK | |||||
| Muscarinic acetylcholine receptor M1 | GPCR | Ki | 8.48 | DRUG MATRIX | |||||
| Muscarinic acetylcholine receptor M2 | GPCR | Ki | 7.92 | DRUG MATRIX | |||||
| Muscarinic acetylcholine receptor M3 | GPCR | Ki | 8.38 | DRUG MATRIX | |||||
| Muscarinic acetylcholine receptor M4 | GPCR | Ki | 8.98 | DRUG MATRIX | |||||
| Muscarinic acetylcholine receptor M5 | GPCR | Ki | 8.48 | DRUG MATRIX | |||||
| Aldehyde oxidase | Enzyme | IC50 | 6.29 | WOMBAT-PK | |||||
| Alpha-2C adrenergic receptor | GPCR | Ki | 6.45 | DRUG MATRIX | |||||
| Cytochrome P450 2D6 | Enzyme | Ki | 5.42 | WOMBAT-PK | |||||
| Alpha-1D adrenergic receptor | GPCR | Ki | 7.50 | DRUG MATRIX | |||||
| Cholinesterase | Enzyme | Ki | 7.10 | WOMBAT-PK | |||||
| Voltage-dependent N-type calcium channel subunit alpha-1B | Ion channel | IC50 | 4.75 | CHEMBL | |||||
| Major prion protein | Surface antigen | EC50 | 5.10 | CHEMBL | |||||
| Solute carrier family 22 member 1 | Transporter | IC50 | 4.45 | CHEMBL | |||||
| Sodium channel alpha subunits; brain (Types I, II, III) | Ion channel | IC50 | 5.16 | CHEMBL | |||||
| FAD-linked sulfhydryl oxidase ALR | Enzyme | AC50 | 6.44 | CHEMBL | |||||
| Calmodulin-1 | Cytosolic other | IC50 | 4.22 | CHEMBL | |||||
| 5-hydroxytryptamine receptor 1A | GPCR | IC50 | 5.59 | CHEMBL | |||||
| Alpha-1B adrenergic receptor | GPCR | Ki | 7.68 | DRUG MATRIX | |||||
| Histamine H1 receptor | GPCR | Ki | 9 | CHEMBL | |||||
| Pleiotropic ABC efflux transporter of multiple drugs | Transporter | IC50 | 4.75 | CHEMBL | |||||
| Chloroquine resistance transporter | Transporter | IC50 | 4.07 | CHEMBL | |||||
| Calmodulin | Cytosolic other | Kd | 4.30 | CHEMBL | |||||
| Alpha-1A adrenergic receptor | GPCR | IC50 | 7.10 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4019910 | VUID |
| N0000147995 | NUI |
| D00480 | KEGG_DRUG |
| 58-33-3 | SECONDARY_CAS_RN |
| 4017846 | VANDF |
| 4019910 | VANDF |
| C0033405 | UMLSCUI |
| CHEBI:8461 | CHEBI |
| CHEMBL643 | ChEMBL_ID |
| CHEMBL1200750 | ChEMBL_ID |
| DB01069 | DRUGBANK_ID |
| D011398 | MESH_DESCRIPTOR_UI |
| 4927 | PUBCHEM_CID |
| 7282 | IUPHAR_LIGAND_ID |
| 516 | INN_ID |
| FF28EJQ494 | UNII |
| 142445 | RXNORM |
| 2141 | MMSL |
| 5367 | MMSL |
| d00787 | MMSL |
| 001483 | NDDF |
| 004459 | NDDF |
| 14905007 | SNOMEDCT_US |
| 372871004 | SNOMEDCT_US |
| 8372007 | SNOMEDCT_US |
| FF28EJQ494 | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0116-4023 | SYRUP | 6.25 mg | ORAL | ANDA | 25 sections |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0116-4024 | SYRUP | 6.25 mg | ORAL | ANDA | 25 sections |
| Promethazine DM | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0121-1070 | SOLUTION | 6.25 mg | ORAL | ANDA | 23 sections |
| Promethazine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0121-1854 | SOLUTION | 6.25 mg | ORAL | ANDA | 26 sections |
| PROMETHAZINE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0404-9940 | INJECTION | 25 mg | INTRAMUSCULAR | ANDA | 12 sections |
| PROMETHAZINE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0404-9940 | INJECTION | 25 mg | INTRAMUSCULAR | ANDA | 12 sections |
| Promethazine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0404-9941 | INJECTION | 25 mg | INTRAMUSCULAR | ANDA | 12 sections |
| Promethazine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0404-9941 | INJECTION | 25 mg | INTRAMUSCULAR | ANDA | 12 sections |
| Promethazine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0404-9942 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 12 sections |
| Promethazine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0404-9942 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 12 sections |
| Promethazine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0440-5195 | TABLET | 25 mg | ORAL | ANDA | 11 sections |
| Promethazine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0440-8195 | TABLET | 25 mg | ORAL | ANDA | 12 sections |
| Promethazine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0591-5307 | TABLET | 25 mg | ORAL | ANDA | 24 sections |
| Promethazine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0591-5319 | TABLET | 50 mg | ORAL | ANDA | 24 sections |
| Promethazine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0615-8154 | TABLET | 25 mg | ORAL | ANDA | 21 sections |
| Promethazine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-0928 | INJECTION | 25 mg | INTRAMUSCULAR | ANDA | 25 sections |
| Promethazine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-0929 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 25 sections |
| Promethazine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-0948 | INJECTION | 25 mg | INTRAMUSCULAR | ANDA | 25 sections |
| Promethazine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-0949 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 25 sections |
| Promethazine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-0955 | INJECTION | 25 mg | INTRAMUSCULAR | ANDA | 25 sections |
| Promethazine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-0956 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 25 sections |
| Promethazine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-1495 | INJECTION | 25 mg | INTRAMUSCULAR | ANDA | 25 sections |
| Promethazine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-1496 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 25 sections |
| PHENERGAN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6082 | INJECTION | 25 mg | INTRAMUSCULAR | ANDA | 25 sections |
| PHENERGAN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6083 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 25 sections |
| PHENERGAN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6084 | INJECTION | 25 mg | INTRAMUSCULAR | ANDA | 26 sections |
| PHENERGAN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6085 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 26 sections |
| Promethazine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6208 | INJECTION | 25 mg | INTRAMUSCULAR | ANDA | 25 sections |
| PROMETHEGAN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0713-0132 | SUPPOSITORY | 50 mg | RECTAL | ANDA | 21 sections |
| PROMETHEGAN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0713-0526 | SUPPOSITORY | 25 mg | RECTAL | ANDA | 21 sections |