promethazine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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 |
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 | 6783.21 | 10.44 | 2029 | 65012 | 23658 | 63398323 |
| Intentional overdose | 5402.75 | 10.44 | 2245 | 64796 | 71907 | 63350074 |
| Akathisia | 541.15 | 10.44 | 240 | 66801 | 8906 | 63413075 |
| Tachycardia | 465.60 | 10.44 | 598 | 66443 | 117558 | 63304423 |
| Depressed level of consciousness | 384.41 | 10.44 | 397 | 66644 | 61681 | 63360300 |
| Cholecystitis chronic | 310.24 | 10.44 | 171 | 66870 | 10190 | 63411791 |
| Drug ineffective | 281.14 | 10.44 | 420 | 66621 | 1044345 | 62377636 |
| Mydriasis | 279.64 | 10.44 | 168 | 66873 | 11788 | 63410193 |
| Contraindicated product administered | 210.00 | 10.44 | 4 | 67037 | 217644 | 63204337 |
| Anxiety | 198.18 | 10.44 | 591 | 66450 | 216950 | 63205031 |
| Synovitis | 167.27 | 10.44 | 7 | 67034 | 186911 | 63235070 |
| Glossodynia | 149.74 | 10.44 | 10 | 67031 | 178866 | 63243115 |
| Hand deformity | 149.62 | 10.44 | 4 | 67037 | 159453 | 63262528 |
| Drug intolerance | 147.21 | 10.44 | 71 | 66970 | 308590 | 63113391 |
| Treatment failure | 145.79 | 10.44 | 19 | 67022 | 199024 | 63222957 |
| Hallucination | 142.67 | 10.44 | 228 | 66813 | 54589 | 63367392 |
| Somnolence | 141.86 | 10.44 | 463 | 66578 | 178222 | 63243759 |
| Joint swelling | 133.95 | 10.44 | 91 | 66950 | 327575 | 63094406 |
| Arthropathy | 131.68 | 10.44 | 42 | 66999 | 234750 | 63187231 |
| Agitation | 120.56 | 10.44 | 222 | 66819 | 59535 | 63362446 |
| Off label use | 118.88 | 10.44 | 344 | 66697 | 674118 | 62747863 |
| Poisoning | 117.65 | 10.44 | 105 | 66936 | 13595 | 63408386 |
| Systemic lupus erythematosus | 114.27 | 10.44 | 39 | 67002 | 208879 | 63213102 |
| Pericarditis | 111.15 | 10.44 | 7 | 67034 | 131572 | 63290409 |
| Rheumatoid arthritis | 108.44 | 10.44 | 67 | 66974 | 253752 | 63168229 |
| Therapeutic product effect decreased | 102.34 | 10.44 | 38 | 67003 | 193149 | 63228832 |
| Biliary dyskinesia | 101.33 | 10.44 | 52 | 66989 | 2677 | 63419304 |
| Emotional distress | 98.20 | 10.44 | 145 | 66896 | 32404 | 63389577 |
| Gallbladder disorder | 96.35 | 10.44 | 109 | 66932 | 18733 | 63403248 |
| Abdominal discomfort | 95.68 | 10.44 | 119 | 66922 | 320766 | 63101215 |
| Vomiting | 92.93 | 10.44 | 950 | 66091 | 558667 | 62863314 |
| Suicide attempt | 92.47 | 10.44 | 201 | 66840 | 60717 | 63361264 |
| Wound | 90.09 | 10.44 | 30 | 67011 | 163233 | 63258748 |
| Sinus tachycardia | 89.42 | 10.44 | 119 | 66922 | 24149 | 63397832 |
| Product use issue | 86.41 | 10.44 | 64 | 66977 | 220456 | 63201525 |
| Gallbladder injury | 86.27 | 10.44 | 38 | 67003 | 1385 | 63420596 |
| Hepatic enzyme increased | 85.57 | 10.44 | 54 | 66987 | 202274 | 63219707 |
| Alopecia | 80.45 | 10.44 | 146 | 66895 | 337390 | 63084591 |
| Toxicity to various agents | 79.96 | 10.44 | 490 | 66551 | 246760 | 63175221 |
| Helicobacter infection | 78.16 | 10.44 | 5 | 67036 | 92780 | 63329201 |
| Infusion related reaction | 77.48 | 10.44 | 87 | 66954 | 245434 | 63176547 |
| Cholelithiasis | 72.52 | 10.44 | 150 | 66891 | 43775 | 63378206 |
| Migraine | 71.57 | 10.44 | 256 | 66785 | 103090 | 63318891 |
| Rash | 69.77 | 10.44 | 330 | 66711 | 560541 | 62861440 |
| Drug abuse | 68.70 | 10.44 | 200 | 66841 | 72318 | 63349663 |
| Respiratory arrest | 67.99 | 10.44 | 123 | 66918 | 32522 | 63389459 |
| Nasopharyngitis | 67.97 | 10.44 | 102 | 66939 | 254155 | 63167826 |
| Incoherent | 65.19 | 10.44 | 47 | 66994 | 4483 | 63417498 |
| Injury | 64.63 | 10.44 | 197 | 66844 | 73050 | 63348931 |
| Accidental overdose | 60.68 | 10.44 | 97 | 66944 | 23212 | 63398769 |
| Arthralgia | 59.80 | 10.44 | 355 | 66686 | 569355 | 62852626 |
| Loss of consciousness | 58.82 | 10.44 | 264 | 66777 | 117857 | 63304124 |
| Therapeutic product effect incomplete | 57.67 | 10.44 | 30 | 67011 | 125026 | 63296955 |
| Snoring | 56.85 | 10.44 | 42 | 66999 | 4160 | 63417821 |
| Peripheral swelling | 56.47 | 10.44 | 123 | 66918 | 265819 | 63156162 |
| Lethargy | 54.52 | 10.44 | 156 | 66885 | 55851 | 63366130 |
| Muscle twitching | 54.18 | 10.44 | 84 | 66957 | 19584 | 63402397 |
| Folliculitis | 53.19 | 10.44 | 6 | 67035 | 70311 | 63351670 |
| Swelling | 53.15 | 10.44 | 134 | 66907 | 275244 | 63146737 |
| Hypersensitivity | 52.28 | 10.44 | 148 | 66893 | 292537 | 63129444 |
| Impaired healing | 51.27 | 10.44 | 22 | 67019 | 102520 | 63319461 |
| C-reactive protein increased | 51.19 | 10.44 | 18 | 67023 | 94689 | 63327292 |
| Lower respiratory tract infection | 49.76 | 10.44 | 40 | 67001 | 132267 | 63289714 |
| Dependence | 48.08 | 10.44 | 29 | 67012 | 2048 | 63419933 |
| Formication | 47.35 | 10.44 | 38 | 67003 | 4253 | 63417728 |
| Nausea | 47.18 | 10.44 | 1207 | 65834 | 853264 | 62568717 |
| Discomfort | 46.81 | 10.44 | 65 | 66976 | 167309 | 63254672 |
| Serotonin syndrome | 46.23 | 10.44 | 97 | 66944 | 28585 | 63393396 |
| Deep vein thrombosis | 46.08 | 10.44 | 193 | 66848 | 83607 | 63338374 |
| Pulmonary haemorrhage neonatal | 45.76 | 10.44 | 10 | 67031 | 26 | 63421955 |
| Opisthotonus | 44.39 | 10.44 | 16 | 67025 | 340 | 63421641 |
| Suicidal ideation | 44.37 | 10.44 | 156 | 66885 | 62265 | 63359716 |
| General physical health deterioration | 43.69 | 10.44 | 92 | 66949 | 201310 | 63220671 |
| Mobility decreased | 42.67 | 10.44 | 39 | 67002 | 121120 | 63300861 |
| Cardiac arrest | 42.48 | 10.44 | 202 | 66839 | 92343 | 63329638 |
| Hereditary angioedema | 40.80 | 10.44 | 45 | 66996 | 7517 | 63414464 |
| Abdominal pain | 39.71 | 10.44 | 479 | 66562 | 292977 | 63129004 |
| Maternal exposure during pregnancy | 39.48 | 10.44 | 111 | 66930 | 219951 | 63202030 |
| Accidental death | 39.18 | 10.44 | 25 | 67016 | 1951 | 63420030 |
| Drug abuser | 39.06 | 10.44 | 29 | 67012 | 2894 | 63419087 |
| Pupillary reflex impaired | 38.37 | 10.44 | 25 | 67016 | 2022 | 63419959 |
| Drug hypersensitivity | 38.14 | 10.44 | 498 | 66543 | 310189 | 63111792 |
| Completed suicide | 37.54 | 10.44 | 273 | 66768 | 145400 | 63276581 |
| Mental status changes | 37.28 | 10.44 | 109 | 66932 | 39490 | 63382491 |
| Dysarthria | 35.93 | 10.44 | 113 | 66928 | 42598 | 63379383 |
| Congenital tricuspid valve incompetence | 35.42 | 10.44 | 10 | 67031 | 92 | 63421889 |
| Depression | 33.58 | 10.44 | 336 | 66705 | 196156 | 63225825 |
| Electrocardiogram QRS complex shortened | 33.28 | 10.44 | 14 | 67027 | 455 | 63421526 |
| Neonatal hypotension | 32.36 | 10.44 | 10 | 67031 | 129 | 63421852 |
| Liver injury | 31.86 | 10.44 | 12 | 67029 | 60508 | 63361473 |
| Psoriatic arthropathy | 31.58 | 10.44 | 30 | 67011 | 91490 | 63330491 |
| Hip arthroplasty | 31.57 | 10.44 | 6 | 67035 | 47640 | 63374341 |
| Drug screen positive | 31.52 | 10.44 | 28 | 67013 | 3601 | 63418380 |
| Seizure | 31.03 | 10.44 | 243 | 66798 | 132391 | 63289590 |
| Cholecystitis | 30.83 | 10.44 | 57 | 66984 | 15320 | 63406661 |
| Musculoskeletal stiffness | 30.31 | 10.44 | 97 | 66944 | 184521 | 63237460 |
| Product use in unapproved indication | 30.17 | 10.44 | 93 | 66948 | 178987 | 63242994 |
| Fear | 29.81 | 10.44 | 57 | 66984 | 15709 | 63406272 |
| Poor feeding infant | 29.49 | 10.44 | 12 | 67029 | 358 | 63421623 |
| Dehydration | 29.40 | 10.44 | 296 | 66745 | 173058 | 63248923 |
| Blister | 29.24 | 10.44 | 58 | 66983 | 129756 | 63292225 |
| Cardiac failure | 28.73 | 10.44 | 31 | 67010 | 89111 | 63332870 |
| Gallbladder hypofunction | 27.37 | 10.44 | 13 | 67028 | 565 | 63421416 |
| Intentional product use issue | 27.23 | 10.44 | 59 | 66982 | 127833 | 63294148 |
| Newborn persistent pulmonary hypertension | 27.21 | 10.44 | 10 | 67031 | 225 | 63421756 |
| Paranoia | 26.90 | 10.44 | 46 | 66995 | 11633 | 63410348 |
| Pulmonary embolism | 26.87 | 10.44 | 213 | 66828 | 116471 | 63305510 |
| Ill-defined disorder | 26.83 | 10.44 | 28 | 67013 | 81727 | 63340254 |
| Stomatitis | 26.35 | 10.44 | 68 | 66973 | 138657 | 63283324 |
| Gallbladder cholesterolosis | 26.06 | 10.44 | 14 | 67027 | 792 | 63421189 |
| Biliary colic | 25.79 | 10.44 | 25 | 67016 | 3592 | 63418389 |
| Impaired gastric emptying | 25.53 | 10.44 | 42 | 66999 | 10290 | 63411691 |
| Drug reaction with eosinophilia and systemic symptoms | 25.31 | 10.44 | 3 | 67038 | 33833 | 63388148 |
| Respiratory disorder neonatal | 25.30 | 10.44 | 16 | 67025 | 1229 | 63420752 |
| Gastrointestinal disorder | 25.18 | 10.44 | 64 | 66977 | 131175 | 63290806 |
| Neonatal respiratory failure | 25.07 | 10.44 | 10 | 67031 | 283 | 63421698 |
| Anhedonia | 24.98 | 10.44 | 43 | 66998 | 10931 | 63411050 |
| Restlessness | 24.84 | 10.44 | 78 | 66963 | 29375 | 63392606 |
| Exposure via ingestion | 24.39 | 10.44 | 22 | 67019 | 2887 | 63419094 |
| Red blood cell sedimentation rate increased | 24.38 | 10.44 | 8 | 67033 | 43974 | 63378007 |
| Infection | 24.37 | 10.44 | 142 | 66899 | 229031 | 63192950 |
| Tremor | 23.98 | 10.44 | 229 | 66812 | 132010 | 63289971 |
| Illness anxiety disorder | 23.97 | 10.44 | 8 | 67033 | 134 | 63421847 |
| Tardive dyskinesia | 22.98 | 10.44 | 36 | 67005 | 8466 | 63413515 |
| Atrial septal defect | 22.51 | 10.44 | 32 | 67009 | 6906 | 63415075 |
| Pulmonary fibrosis | 22.50 | 10.44 | 7 | 67034 | 39802 | 63382179 |
| Cardio-respiratory arrest | 22.02 | 10.44 | 123 | 66918 | 59836 | 63362145 |
| Therapeutic response decreased | 21.42 | 10.44 | 20 | 67021 | 61505 | 63360476 |
| Electrocardiogram QT prolonged | 21.13 | 10.44 | 121 | 66920 | 59409 | 63362572 |
| Drug withdrawal syndrome | 21.10 | 10.44 | 70 | 66971 | 27124 | 63394857 |
| Miosis | 21.09 | 10.44 | 32 | 67009 | 7321 | 63414660 |
| Cholesterosis | 20.84 | 10.44 | 10 | 67031 | 445 | 63421536 |
| Illness | 20.31 | 10.44 | 104 | 66937 | 48955 | 63373026 |
| Hyperreflexia | 20.19 | 10.44 | 28 | 67013 | 5906 | 63416075 |
| Arthritis | 19.66 | 10.44 | 60 | 66981 | 115861 | 63306120 |
| Condition aggravated | 19.51 | 10.44 | 303 | 66738 | 401914 | 63020067 |
| Mental disorder | 19.48 | 10.44 | 66 | 66975 | 25853 | 63396128 |
| Irritable bowel syndrome | 19.27 | 10.44 | 36 | 67005 | 82376 | 63339605 |
| Coma blister | 19.24 | 10.44 | 7 | 67034 | 153 | 63421828 |
| Unresponsive to stimuli | 18.67 | 10.44 | 78 | 66963 | 33738 | 63388243 |
| Knee arthroplasty | 18.43 | 10.44 | 18 | 67023 | 54188 | 63367793 |
| Differential white blood cell count abnormal | 18.26 | 10.44 | 11 | 67030 | 775 | 63421206 |
| Blood pressure fluctuation | 17.41 | 10.44 | 14 | 67027 | 46303 | 63375678 |
| Cholecystectomy | 17.08 | 10.44 | 36 | 67005 | 10641 | 63411340 |
| Renal impairment | 17.01 | 10.44 | 43 | 66998 | 88312 | 63333669 |
| Therapy non-responder | 17.01 | 10.44 | 34 | 67007 | 75867 | 63346114 |
| Cholestasis | 16.95 | 10.44 | 5 | 67036 | 29429 | 63392552 |
| Ventricular septal defect | 16.95 | 10.44 | 22 | 67019 | 4356 | 63417625 |
| Aggression | 16.93 | 10.44 | 59 | 66982 | 23439 | 63398542 |
| Type 2 diabetes mellitus | 16.67 | 10.44 | 26 | 67015 | 63842 | 63358139 |
| Device expulsion | 16.66 | 10.44 | 8 | 67033 | 34914 | 63387067 |
| Blood cholesterol increased | 16.42 | 10.44 | 48 | 66993 | 93984 | 63327997 |
| Fatigue | 16.39 | 10.44 | 1117 | 65924 | 886911 | 62535070 |
| Cough | 16.12 | 10.44 | 215 | 66826 | 292528 | 63129453 |
| Intestinal obstruction | 16.07 | 10.44 | 70 | 66971 | 30829 | 63391152 |
| Loss of personal independence in daily activities | 16.04 | 10.44 | 51 | 66990 | 97239 | 63324742 |
| Pupil fixed | 15.80 | 10.44 | 14 | 67027 | 1795 | 63420186 |
| Cyanosis neonatal | 15.79 | 10.44 | 8 | 67033 | 401 | 63421580 |
| Jaw clicking | 15.52 | 10.44 | 4 | 67037 | 25 | 63421956 |
| Attention-seeking behaviour | 15.49 | 10.44 | 5 | 67036 | 75 | 63421906 |
| Fear of disease | 15.12 | 10.44 | 12 | 67029 | 1322 | 63420659 |
| pH body fluid increased | 15.03 | 10.44 | 3 | 67038 | 4 | 63421977 |
| Overdose | 14.73 | 10.44 | 186 | 66855 | 114892 | 63307089 |
| Vasoplegia syndrome | 14.54 | 10.44 | 13 | 67028 | 1686 | 63420295 |
| Sitting disability | 14.47 | 10.44 | 7 | 67034 | 317 | 63421664 |
| Melaena | 14.42 | 10.44 | 7 | 67034 | 30358 | 63391623 |
| Inflammation | 14.37 | 10.44 | 42 | 66999 | 82231 | 63339750 |
| Neutropenia | 14.35 | 10.44 | 117 | 66924 | 174888 | 63247093 |
| Long QT syndrome congenital | 14.16 | 10.44 | 5 | 67036 | 100 | 63421881 |
| Drug-induced liver injury | 14.09 | 10.44 | 13 | 67028 | 40209 | 63381772 |
| Base excess increased | 14.05 | 10.44 | 4 | 67037 | 38 | 63421943 |
| Respiratory rate decreased | 14.05 | 10.44 | 18 | 67023 | 3517 | 63418464 |
| Psychotic disorder | 13.95 | 10.44 | 59 | 66982 | 25653 | 63396328 |
| Pancreatitis chronic | 13.78 | 10.44 | 15 | 67026 | 2469 | 63419512 |
| Adverse event | 13.70 | 10.44 | 32 | 67009 | 67527 | 63354454 |
| Finger amputation | 13.44 | 10.44 | 8 | 67033 | 551 | 63421430 |
| Musculoskeletal pain | 13.44 | 10.44 | 51 | 66990 | 92226 | 63329755 |
| Wrong patient received product | 13.43 | 10.44 | 14 | 67027 | 2193 | 63419788 |
| Pre-existing condition improved | 13.42 | 10.44 | 28 | 67013 | 8216 | 63413765 |
| Acute lung injury | 13.41 | 10.44 | 12 | 67029 | 1559 | 63420422 |
| Nephrolithiasis | 13.40 | 10.44 | 83 | 66958 | 41901 | 63380080 |
| Blastocystis infection | 13.29 | 10.44 | 4 | 67037 | 47 | 63421934 |
| Respiratory rate increased | 13.26 | 10.44 | 38 | 67003 | 13610 | 63408371 |
| Small intestinal obstruction | 13.17 | 10.44 | 46 | 66995 | 18291 | 63403690 |
| Cytomegalovirus infection | 13.13 | 10.44 | 3 | 67038 | 20949 | 63401032 |
| Suicidal behaviour | 13.04 | 10.44 | 15 | 67026 | 2624 | 63419357 |
| Drug resistance | 13.02 | 10.44 | 4 | 67037 | 22929 | 63399052 |
| Uterine perforation | 12.95 | 10.44 | 25 | 67016 | 6938 | 63415043 |
| Prolonged rupture of membranes | 12.92 | 10.44 | 4 | 67037 | 52 | 63421929 |
| Patent ductus arteriosus | 12.91 | 10.44 | 19 | 67022 | 4231 | 63417750 |
| Postpartum haemorrhage | 12.84 | 10.44 | 13 | 67028 | 1968 | 63420013 |
| Ventricular extrasystoles | 12.80 | 10.44 | 34 | 67007 | 11653 | 63410328 |
| Blood potassium decreased | 12.74 | 10.44 | 82 | 66959 | 41944 | 63380037 |
| Insurance issue | 12.66 | 10.44 | 23 | 67018 | 6098 | 63415883 |
| Hepatitis | 12.64 | 10.44 | 14 | 67027 | 39774 | 63382207 |
| Jugular vein thrombosis | 12.59 | 10.44 | 16 | 67025 | 3102 | 63418879 |
| Neuroleptic malignant syndrome | 12.13 | 10.44 | 34 | 67007 | 12022 | 63409959 |
| Obsessive-compulsive disorder | 12.11 | 10.44 | 18 | 67023 | 4042 | 63417939 |
| Constipation | 12.07 | 10.44 | 317 | 66724 | 224626 | 63197355 |
| Hypophagia | 12.06 | 10.44 | 65 | 66976 | 31194 | 63390787 |
| Hyperkinetic heart syndrome | 12.04 | 10.44 | 3 | 67038 | 16 | 63421965 |
| Neonatal tachycardia | 12.04 | 10.44 | 3 | 67038 | 16 | 63421965 |
| Panic attack | 11.93 | 10.44 | 51 | 66990 | 22280 | 63399701 |
| Activated partial thromboplastin time prolonged | 11.92 | 10.44 | 24 | 67017 | 6869 | 63415112 |
| Osteoporosis | 11.75 | 10.44 | 27 | 67014 | 57311 | 63364670 |
| Retching | 11.63 | 10.44 | 38 | 67003 | 14607 | 63407374 |
| Malnutrition | 11.53 | 10.44 | 39 | 67002 | 15259 | 63406722 |
| Arm amputation | 11.47 | 10.44 | 3 | 67038 | 20 | 63421961 |
| Weight increased | 11.46 | 10.44 | 200 | 66841 | 260592 | 63161389 |
| Scar | 11.16 | 10.44 | 36 | 67005 | 13746 | 63408235 |
| Cholecystitis acute | 11.12 | 10.44 | 26 | 67015 | 8234 | 63413747 |
| Slow response to stimuli | 11.09 | 10.44 | 9 | 67032 | 1023 | 63420958 |
| Fallot's tetralogy | 11.01 | 10.44 | 4 | 67037 | 87 | 63421894 |
| Adverse drug reaction | 11.01 | 10.44 | 45 | 66996 | 79669 | 63342312 |
| Infusion site pain | 11.00 | 10.44 | 41 | 67000 | 16828 | 63405153 |
| Lentigo | 11.00 | 10.44 | 6 | 67035 | 350 | 63421631 |
| Withdrawal syndrome | 10.94 | 10.44 | 46 | 66995 | 19951 | 63402030 |
| Appetite disorder | 10.92 | 10.44 | 24 | 67017 | 7297 | 63414684 |
| Transverse sinus thrombosis | 10.91 | 10.44 | 7 | 67034 | 551 | 63421430 |
| Visceral oedema | 10.89 | 10.44 | 3 | 67038 | 25 | 63421956 |
| Prescribed overdose | 10.86 | 10.44 | 12 | 67029 | 34141 | 63387840 |
| Catatonia | 10.79 | 10.44 | 18 | 67023 | 4459 | 63417522 |
| Patient uncooperative | 10.76 | 10.44 | 5 | 67036 | 207 | 63421774 |
| Pickwickian syndrome | 10.74 | 10.44 | 6 | 67035 | 367 | 63421614 |
| Radial pulse abnormal | 10.68 | 10.44 | 3 | 67038 | 27 | 63421954 |
| Hepatocellular injury | 10.64 | 10.44 | 8 | 67033 | 27373 | 63394608 |
| Intestinal ischaemia | 10.60 | 10.44 | 24 | 67017 | 7444 | 63414537 |
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 | 2129.99 | 12.14 | 662 | 24800 | 13109 | 34918360 |
| Intentional overdose | 1659.05 | 12.14 | 749 | 24713 | 42925 | 34888544 |
| Akathisia | 163.92 | 12.14 | 91 | 25371 | 8018 | 34923451 |
| Depressed level of consciousness | 116.99 | 12.14 | 150 | 25312 | 42691 | 34888778 |
| Respiratory arrest | 90.77 | 12.14 | 107 | 25355 | 27936 | 34903533 |
| Tachycardia | 89.04 | 12.14 | 193 | 25269 | 84579 | 34846890 |
| Sinus tachycardia | 71.24 | 12.14 | 75 | 25387 | 17285 | 34914184 |
| Drug ineffective | 67.14 | 12.14 | 146 | 25316 | 456605 | 34474864 |
| Off label use | 64.22 | 12.14 | 131 | 25331 | 419393 | 34512076 |
| Somnolence | 62.15 | 12.14 | 200 | 25262 | 110916 | 34820553 |
| Mydriasis | 56.80 | 12.14 | 45 | 25417 | 7192 | 34924277 |
| Dystonia | 53.93 | 12.14 | 52 | 25410 | 10793 | 34920676 |
| Vomiting | 51.39 | 12.14 | 332 | 25130 | 247289 | 34684180 |
| Poisoning | 50.48 | 12.14 | 53 | 25409 | 12173 | 34919296 |
| Agitation | 48.46 | 12.14 | 120 | 25342 | 57279 | 34874190 |
| Dysarthria | 39.71 | 12.14 | 82 | 25380 | 34700 | 34896769 |
| Hallucination | 38.64 | 12.14 | 103 | 25359 | 51395 | 34880074 |
| Loss of consciousness | 37.62 | 12.14 | 139 | 25323 | 82528 | 34848941 |
| Exposure during pregnancy | 37.36 | 12.14 | 39 | 25423 | 8895 | 34922574 |
| Neuroleptic malignant syndrome | 35.73 | 12.14 | 54 | 25408 | 17880 | 34913589 |
| Anxiety | 31.76 | 12.14 | 150 | 25312 | 99278 | 34832191 |
| Consciousness fluctuating | 31.56 | 12.14 | 16 | 25446 | 1171 | 34930298 |
| Interstitial lung disease | 31.32 | 12.14 | 5 | 25457 | 65277 | 34866192 |
| Cardio-respiratory arrest | 30.41 | 12.14 | 99 | 25363 | 55174 | 34876295 |
| Autoscopy | 29.97 | 12.14 | 10 | 25452 | 247 | 34931222 |
| Dehydration | 29.20 | 12.14 | 178 | 25284 | 129791 | 34801678 |
| Toxicity to various agents | 27.54 | 12.14 | 244 | 25218 | 200118 | 34731351 |
| Lethargy | 26.65 | 12.14 | 78 | 25384 | 41044 | 34890425 |
| Cardiac arrest | 25.04 | 12.14 | 137 | 25325 | 96022 | 34835447 |
| Failure to thrive | 24.85 | 12.14 | 31 | 25431 | 8570 | 34922899 |
| General symptom | 23.75 | 12.14 | 12 | 25450 | 872 | 34930597 |
| Dextrocardia | 23.66 | 12.14 | 7 | 25455 | 115 | 34931354 |
| Foetal alcohol syndrome | 22.46 | 12.14 | 7 | 25455 | 138 | 34931331 |
| Condition aggravated | 22.28 | 12.14 | 69 | 25393 | 192127 | 34739342 |
| Overdose | 21.25 | 12.14 | 126 | 25336 | 90933 | 34840536 |
| Opisthotonus | 20.82 | 12.14 | 9 | 25453 | 458 | 34931011 |
| Drug withdrawal syndrome | 20.59 | 12.14 | 45 | 25417 | 19789 | 34911680 |
| Confusional state | 20.53 | 12.14 | 177 | 25285 | 143983 | 34787486 |
| Unresponsive to stimuli | 20.52 | 12.14 | 55 | 25407 | 27514 | 34903955 |
| Atrial septal defect | 20.33 | 12.14 | 26 | 25436 | 7366 | 34924103 |
| Nasopharyngitis | 20.23 | 12.14 | 13 | 25449 | 69955 | 34861514 |
| Psychotic disorder | 19.44 | 12.14 | 50 | 25412 | 24402 | 34907067 |
| Respiratory depression | 19.36 | 12.14 | 39 | 25423 | 16206 | 34915263 |
| Completed suicide | 18.69 | 12.14 | 129 | 25333 | 98039 | 34833430 |
| Acute kidney injury | 18.59 | 12.14 | 138 | 25324 | 304850 | 34626619 |
| Drug hypersensitivity | 18.51 | 12.14 | 111 | 25351 | 80418 | 34851051 |
| Patent ductus arteriosus | 18.43 | 12.14 | 17 | 25445 | 3337 | 34928132 |
| Cardiomegaly | 18.33 | 12.14 | 37 | 25425 | 15401 | 34916068 |
| Nausea | 18.26 | 12.14 | 348 | 25114 | 339560 | 34591909 |
| Therapeutic product effect incomplete | 18.21 | 12.14 | 7 | 25455 | 50534 | 34880935 |
| Hepatic ischaemia | 18.18 | 12.14 | 8 | 25454 | 425 | 34931044 |
| Exposure via ingestion | 18.06 | 12.14 | 14 | 25448 | 2167 | 34929302 |
| Product use in unapproved indication | 17.60 | 12.14 | 37 | 25425 | 117462 | 34814007 |
| Accidental overdose | 16.86 | 12.14 | 42 | 25420 | 20098 | 34911371 |
| Fallot's tetralogy | 16.73 | 12.14 | 6 | 25456 | 185 | 34931284 |
| Obsessive thoughts | 16.71 | 12.14 | 9 | 25453 | 746 | 34930723 |
| Extrapyramidal disorder | 16.66 | 12.14 | 32 | 25430 | 12848 | 34918621 |
| Tracheobronchitis | 16.55 | 12.14 | 10 | 25452 | 1031 | 34930438 |
| Psychomotor hyperactivity | 16.43 | 12.14 | 27 | 25435 | 9595 | 34921874 |
| Upper respiratory tract irritation | 15.25 | 12.14 | 4 | 25458 | 41 | 34931428 |
| Skin swelling | 14.08 | 12.14 | 10 | 25452 | 1355 | 34930114 |
| Foetal exposure during pregnancy | 14.04 | 12.14 | 60 | 25402 | 38041 | 34893428 |
| Congenital aortic valve stenosis | 14.00 | 12.14 | 5 | 25457 | 152 | 34931317 |
| Sedation | 13.75 | 12.14 | 40 | 25422 | 20966 | 34910503 |
| Pupil fixed | 13.71 | 12.14 | 11 | 25451 | 1790 | 34929679 |
| Intentional product use issue | 13.69 | 12.14 | 14 | 25448 | 59802 | 34871667 |
| Fatigue | 13.44 | 12.14 | 359 | 25103 | 370294 | 34561175 |
| Restlessness | 13.43 | 12.14 | 45 | 25417 | 25437 | 34906032 |
| Multiple organ dysfunction syndrome | 13.33 | 12.14 | 22 | 25440 | 76544 | 34854925 |
| Aggression | 13.32 | 12.14 | 60 | 25402 | 38904 | 34892565 |
| Gallbladder enlargement | 13.22 | 12.14 | 9 | 25453 | 1139 | 34930330 |
| Mucosal haemorrhage | 12.53 | 12.14 | 10 | 25452 | 1615 | 34929854 |
| Ventricular septal defect | 12.49 | 12.14 | 15 | 25447 | 3986 | 34927483 |
| Angioedema | 12.16 | 12.14 | 6 | 25456 | 37368 | 34894101 |
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 | 5502.25 | 10.31 | 1743 | 67326 | 30676 | 79644643 |
| Intentional overdose | 4203.96 | 10.31 | 1975 | 67094 | 103985 | 79571334 |
| Akathisia | 575.58 | 10.31 | 264 | 68805 | 12995 | 79662324 |
| Tachycardia | 377.00 | 10.31 | 604 | 68465 | 177164 | 79498155 |
| Depressed level of consciousness | 343.55 | 10.31 | 421 | 68648 | 96231 | 79579088 |
| Cholecystitis chronic | 287.91 | 10.31 | 150 | 68919 | 9756 | 79665563 |
| Mydriasis | 226.51 | 10.31 | 158 | 68911 | 17485 | 79657834 |
| Drug ineffective | 206.87 | 10.31 | 390 | 68679 | 1080523 | 78594796 |
| Anxiety | 174.56 | 10.31 | 542 | 68527 | 247970 | 79427349 |
| Poisoning | 174.35 | 10.31 | 157 | 68912 | 25115 | 79650204 |
| Respiratory arrest | 173.32 | 10.31 | 231 | 68838 | 57319 | 79618000 |
| Off label use | 172.74 | 10.31 | 328 | 68741 | 906887 | 78768432 |
| Hallucination | 136.55 | 10.31 | 257 | 68812 | 85488 | 79589831 |
| Somnolence | 129.58 | 10.31 | 478 | 68591 | 238503 | 79436816 |
| Vomiting | 123.48 | 10.31 | 991 | 68078 | 664837 | 79010482 |
| Synovitis | 116.35 | 10.31 | 3 | 69066 | 150731 | 79524588 |
| Agitation | 114.23 | 10.31 | 261 | 68808 | 99454 | 79575865 |
| Toxicity to various agents | 109.35 | 10.31 | 681 | 68388 | 420859 | 79254460 |
| Biliary dyskinesia | 108.30 | 10.31 | 50 | 69019 | 2495 | 79672824 |
| Sinus tachycardia | 107.82 | 10.31 | 146 | 68923 | 36762 | 79638557 |
| Gallbladder injury | 95.60 | 10.31 | 37 | 69032 | 1184 | 79674135 |
| Emotional distress | 94.54 | 10.31 | 143 | 68926 | 39826 | 79635493 |
| Gallbladder disorder | 93.69 | 10.31 | 99 | 68970 | 19241 | 79656078 |
| Suicide attempt | 90.50 | 10.31 | 213 | 68856 | 82719 | 79592600 |
| Drug intolerance | 83.44 | 10.31 | 64 | 69005 | 264055 | 79411264 |
| Contraindicated product administered | 80.09 | 10.31 | 19 | 69050 | 157519 | 79517800 |
| Hand deformity | 76.86 | 10.31 | 3 | 69066 | 103916 | 79571403 |
| Cardiac arrest | 76.84 | 10.31 | 324 | 68745 | 171772 | 79503547 |
| Joint swelling | 74.59 | 10.31 | 84 | 68985 | 288562 | 79386757 |
| Treatment failure | 73.21 | 10.31 | 28 | 69041 | 170458 | 79504861 |
| Drug abuse | 73.18 | 10.31 | 307 | 68762 | 162384 | 79512935 |
| Injury | 71.83 | 10.31 | 187 | 68882 | 77309 | 79598010 |
| Rheumatoid arthritis | 70.43 | 10.31 | 47 | 69022 | 208423 | 79466896 |
| Completed suicide | 69.29 | 10.31 | 406 | 68663 | 245361 | 79429958 |
| Nasopharyngitis | 67.67 | 10.31 | 72 | 68997 | 253809 | 79421510 |
| Pericarditis | 65.43 | 10.31 | 7 | 69062 | 104229 | 79571090 |
| Accidental overdose | 63.43 | 10.31 | 119 | 68950 | 39462 | 79635857 |
| Opisthotonus | 61.36 | 10.31 | 23 | 69046 | 673 | 79674646 |
| Drug hypersensitivity | 61.30 | 10.31 | 456 | 68613 | 298460 | 79376859 |
| Arthropathy | 61.09 | 10.31 | 39 | 69030 | 177072 | 79498247 |
| Lethargy | 59.45 | 10.31 | 180 | 68889 | 81112 | 79594207 |
| Loss of consciousness | 56.40 | 10.31 | 291 | 68778 | 167652 | 79507667 |
| Serotonin syndrome | 56.19 | 10.31 | 122 | 68947 | 44905 | 79630414 |
| Nausea | 56.13 | 10.31 | 1150 | 67919 | 956046 | 78719273 |
| Therapeutic product effect decreased | 53.93 | 10.31 | 38 | 69031 | 163825 | 79511494 |
| Cholelithiasis | 52.87 | 10.31 | 131 | 68938 | 52533 | 79622786 |
| Glossodynia | 51.46 | 10.31 | 13 | 69056 | 103324 | 79571995 |
| Drug abuser | 50.89 | 10.31 | 42 | 69027 | 5971 | 79669348 |
| Cardio-respiratory arrest | 50.52 | 10.31 | 207 | 68862 | 108303 | 79567016 |
| Dysarthria | 48.76 | 10.31 | 149 | 68920 | 67473 | 79607846 |
| Dystonia | 47.01 | 10.31 | 74 | 68995 | 21325 | 79653994 |
| Arthralgia | 45.65 | 10.31 | 299 | 68770 | 571504 | 79103815 |
| Systemic lupus erythematosus | 45.57 | 10.31 | 24 | 69045 | 121125 | 79554194 |
| Hepatic enzyme increased | 45.15 | 10.31 | 55 | 69014 | 182555 | 79492764 |
| C-reactive protein increased | 45.05 | 10.31 | 28 | 69041 | 128999 | 79546320 |
| Dependence | 44.09 | 10.31 | 27 | 69042 | 2395 | 79672924 |
| Peripheral swelling | 43.92 | 10.31 | 106 | 68963 | 269511 | 79405808 |
| Incoherent | 43.86 | 10.31 | 43 | 69026 | 7649 | 79667670 |
| Therapeutic product effect incomplete | 43.84 | 10.31 | 35 | 69034 | 141610 | 79533709 |
| Exposure via ingestion | 43.50 | 10.31 | 36 | 69033 | 5138 | 79670181 |
| Migraine | 43.20 | 10.31 | 170 | 68899 | 87323 | 79587996 |
| Product use in unapproved indication | 42.73 | 10.31 | 96 | 68973 | 250263 | 79425056 |
| Formication | 42.33 | 10.31 | 35 | 69034 | 4988 | 79670331 |
| Drug withdrawal syndrome | 42.10 | 10.31 | 93 | 68976 | 34625 | 79640694 |
| Dehydration | 41.79 | 10.31 | 362 | 68707 | 247825 | 79427494 |
| Mental status changes | 41.42 | 10.31 | 140 | 68929 | 66819 | 79608500 |
| Snoring | 39.21 | 10.31 | 35 | 69034 | 5531 | 79669788 |
| Muscle twitching | 39.11 | 10.31 | 74 | 68995 | 24690 | 79650629 |
| Intentional product use issue | 38.46 | 10.31 | 45 | 69024 | 152067 | 79523252 |
| Pupillary reflex impaired | 38.36 | 10.31 | 28 | 69041 | 3325 | 79671994 |
| Helicobacter infection | 38.31 | 10.31 | 7 | 69062 | 69697 | 79605622 |
| Impaired healing | 38.28 | 10.31 | 14 | 69055 | 87641 | 79587678 |
| Neuroleptic malignant syndrome | 38.25 | 10.31 | 78 | 68991 | 27481 | 79647838 |
| Deep vein thrombosis | 38.16 | 10.31 | 206 | 68863 | 120713 | 79554606 |
| Abdominal discomfort | 36.69 | 10.31 | 104 | 68965 | 250623 | 79424696 |
| General physical health deterioration | 36.12 | 10.31 | 120 | 68949 | 275118 | 79400201 |
| Cardiac failure | 33.85 | 10.31 | 51 | 69018 | 154791 | 79520528 |
| Acute kidney injury | 32.72 | 10.31 | 290 | 68779 | 519114 | 79156205 |
| Product use issue | 32.21 | 10.31 | 85 | 68984 | 209737 | 79465582 |
| Mobility decreased | 32.13 | 10.31 | 35 | 69034 | 122140 | 79553179 |
| Wound | 32.00 | 10.31 | 32 | 69037 | 116147 | 79559172 |
| Overdose | 31.68 | 10.31 | 270 | 68799 | 183936 | 79491383 |
| Unresponsive to stimuli | 31.35 | 10.31 | 113 | 68956 | 55675 | 79619644 |
| Drug screen positive | 31.09 | 10.31 | 32 | 69037 | 6031 | 79669288 |
| Abdominal pain | 30.78 | 10.31 | 491 | 68578 | 389078 | 79286241 |
| Hereditary angioedema | 30.74 | 10.31 | 30 | 69039 | 5305 | 79670014 |
| Condition aggravated | 30.60 | 10.31 | 282 | 68787 | 500842 | 79174477 |
| Alopecia | 30.26 | 10.31 | 101 | 68968 | 231254 | 79444065 |
| Interstitial lung disease | 29.90 | 10.31 | 32 | 69037 | 112568 | 79562751 |
| Restlessness | 29.45 | 10.31 | 98 | 68971 | 46394 | 79628925 |
| Hypersensitivity | 29.39 | 10.31 | 122 | 68947 | 262117 | 79413202 |
| Rash | 29.36 | 10.31 | 340 | 68729 | 578018 | 79097301 |
| Illness anxiety disorder | 28.12 | 10.31 | 10 | 69059 | 251 | 79675068 |
| Folliculitis | 27.51 | 10.31 | 7 | 69062 | 55373 | 79619946 |
| Depression | 27.50 | 10.31 | 298 | 68771 | 216492 | 79458827 |
| Electrocardiogram QRS complex shortened | 26.94 | 10.31 | 13 | 69056 | 717 | 79674602 |
| Lower respiratory tract infection | 26.88 | 10.31 | 44 | 69025 | 129176 | 79546143 |
| Accidental death | 26.37 | 10.31 | 25 | 69044 | 4266 | 79671053 |
| Drug resistance | 26.07 | 10.31 | 3 | 69066 | 42210 | 79633109 |
| Fatigue | 26.00 | 10.31 | 1017 | 68052 | 928710 | 78746609 |
| Inflammation | 25.61 | 10.31 | 26 | 69043 | 93727 | 79581592 |
| Infusion related reaction | 25.24 | 10.31 | 108 | 68961 | 230129 | 79445190 |
| Cholestasis | 25.10 | 10.31 | 7 | 69062 | 52102 | 79623217 |
| Suicidal ideation | 24.72 | 10.31 | 131 | 68938 | 76209 | 79599110 |
| Pupil fixed | 24.28 | 10.31 | 22 | 69047 | 3544 | 79671775 |
| Gallbladder hypofunction | 24.07 | 10.31 | 11 | 69058 | 536 | 79674783 |
| Seizure | 23.68 | 10.31 | 259 | 68810 | 188575 | 79486744 |
| Stomatitis | 23.64 | 10.31 | 58 | 69011 | 146699 | 79528620 |
| Tremor | 23.54 | 10.31 | 238 | 68831 | 169845 | 79505474 |
| Cholecystectomy | 22.66 | 10.31 | 34 | 69035 | 9398 | 79665921 |
| Tardive dyskinesia | 22.45 | 10.31 | 36 | 69033 | 10535 | 79664784 |
| Psychotic disorder | 21.70 | 10.31 | 82 | 68987 | 41320 | 79633999 |
| Impaired gastric emptying | 21.64 | 10.31 | 35 | 69034 | 10318 | 79665001 |
| Fear | 21.34 | 10.31 | 54 | 69015 | 21932 | 79653387 |
| Paranoia | 21.28 | 10.31 | 50 | 69019 | 19382 | 79655937 |
| Cholesterosis | 21.20 | 10.31 | 9 | 69060 | 367 | 79674952 |
| Pulmonary fibrosis | 21.11 | 10.31 | 6 | 69063 | 44106 | 79631213 |
| Drug reaction with eosinophilia and systemic symptoms | 20.99 | 10.31 | 15 | 69054 | 64229 | 79611090 |
| Infection | 20.99 | 10.31 | 123 | 68946 | 241589 | 79433730 |
| Cholecystitis | 20.98 | 10.31 | 54 | 69015 | 22158 | 79653161 |
| Pulmonary embolism | 20.86 | 10.31 | 234 | 68835 | 171420 | 79503899 |
| Osteonecrosis of jaw | 20.46 | 10.31 | 6 | 69063 | 43220 | 79632099 |
| Arthritis | 20.45 | 10.31 | 43 | 69026 | 114837 | 79560482 |
| Pain | 20.37 | 10.31 | 773 | 68296 | 703029 | 78972290 |
| Loss of personal independence in daily activities | 20.35 | 10.31 | 36 | 69033 | 102544 | 79572775 |
| Electrocardiogram QT prolonged | 20.28 | 10.31 | 141 | 68928 | 90245 | 79585074 |
| Blood pressure fluctuation | 20.26 | 10.31 | 17 | 69052 | 67128 | 79608191 |
| Renal impairment | 19.20 | 10.31 | 71 | 68998 | 157712 | 79517607 |
| Red blood cell sedimentation rate increased | 18.97 | 10.31 | 8 | 69061 | 45934 | 79629385 |
| Miosis | 18.81 | 10.31 | 42 | 69027 | 15747 | 79659572 |
| Psoriatic arthropathy | 18.73 | 10.31 | 24 | 69045 | 77975 | 79597344 |
| Pancytopenia | 18.62 | 10.31 | 77 | 68992 | 165668 | 79509651 |
| Hyperkalaemia | 18.59 | 10.31 | 45 | 69024 | 114353 | 79560966 |
| Hepatocellular injury | 18.53 | 10.31 | 9 | 69060 | 47584 | 79627735 |
| Uterine perforation | 18.50 | 10.31 | 25 | 69044 | 6278 | 79669041 |
| Hepatitis | 18.22 | 10.31 | 13 | 69056 | 55714 | 79619605 |
| Psychomotor hyperactivity | 18.07 | 10.31 | 43 | 69026 | 16806 | 79658513 |
| Coma blister | 17.80 | 10.31 | 7 | 69062 | 234 | 79675085 |
| Melaena | 17.66 | 10.31 | 16 | 69053 | 60874 | 79614445 |
| Aggression | 17.57 | 10.31 | 89 | 68980 | 50869 | 79624450 |
| Bradycardia | 17.15 | 10.31 | 60 | 69009 | 135497 | 79539822 |
| Anhedonia | 17.05 | 10.31 | 39 | 69030 | 14859 | 79660460 |
| Respiratory rate increased | 16.90 | 10.31 | 49 | 69020 | 21551 | 79653768 |
| Musculoskeletal stiffness | 16.87 | 10.31 | 86 | 68983 | 174922 | 79500397 |
| Drug dependence | 16.82 | 10.31 | 75 | 68994 | 40694 | 79634625 |
| Cytomegalovirus infection | 16.70 | 10.31 | 8 | 69061 | 42636 | 79632683 |
| Angioedema | 16.65 | 10.31 | 25 | 69044 | 76010 | 79599309 |
| Jaw clicking | 16.59 | 10.31 | 4 | 69065 | 23 | 79675296 |
| Obsessive thoughts | 16.58 | 10.31 | 11 | 69058 | 1121 | 79674198 |
| Gallbladder cholesterolosis | 16.56 | 10.31 | 9 | 69060 | 637 | 79674682 |
| Respiratory depression | 16.41 | 10.31 | 57 | 69012 | 27573 | 79647746 |
| Extrapyramidal disorder | 16.37 | 10.31 | 50 | 69019 | 22629 | 79652690 |
| Weight increased | 16.08 | 10.31 | 158 | 68911 | 277228 | 79398091 |
| General symptom | 16.03 | 10.31 | 15 | 69054 | 2519 | 79672800 |
| Finger amputation | 15.96 | 10.31 | 9 | 69060 | 685 | 79674634 |
| Inappropriate schedule of product administration | 15.69 | 10.31 | 61 | 69008 | 133567 | 79541752 |
| Therapeutic response decreased | 15.61 | 10.31 | 21 | 69048 | 66832 | 79608487 |
| Cough | 15.48 | 10.31 | 224 | 68845 | 366565 | 79308754 |
| Reversible cerebral vasoconstriction syndrome | 15.43 | 10.31 | 16 | 69053 | 3041 | 79672278 |
| Chest pain | 15.37 | 10.31 | 336 | 68733 | 281968 | 79393351 |
| Biliary colic | 15.27 | 10.31 | 18 | 69051 | 3944 | 79671375 |
| Hip arthroplasty | 15.13 | 10.31 | 6 | 69063 | 35750 | 79639569 |
| Infusion site pain | 15.01 | 10.31 | 36 | 69033 | 14140 | 79661179 |
| Heart rate decreased | 14.56 | 10.31 | 24 | 69045 | 70292 | 79605027 |
| Pulmonary congestion | 14.47 | 10.31 | 54 | 69015 | 27046 | 79648273 |
| Discomfort | 14.33 | 10.31 | 58 | 69011 | 125559 | 79549760 |
| Toxic epidermal necrolysis | 13.81 | 10.31 | 11 | 69058 | 44570 | 79630749 |
| Prolonged rupture of membranes | 13.77 | 10.31 | 4 | 69065 | 51 | 79675268 |
| Blood pressure systolic increased | 13.75 | 10.31 | 23 | 69046 | 66963 | 79608356 |
| Fall | 13.62 | 10.31 | 320 | 68749 | 487309 | 79188010 |
| Gas gangrene | 13.51 | 10.31 | 6 | 69063 | 273 | 79675046 |
| Arm amputation | 13.45 | 10.31 | 5 | 69064 | 143 | 79675176 |
| Jugular vein thrombosis | 13.32 | 10.31 | 18 | 69051 | 4520 | 79670799 |
| Ill-defined disorder | 13.17 | 10.31 | 23 | 69046 | 65852 | 79609467 |
| Long QT syndrome congenital | 13.16 | 10.31 | 5 | 69064 | 152 | 79675167 |
| Lymphopenia | 13.14 | 10.31 | 5 | 69064 | 30552 | 79644767 |
| Intentional product misuse | 13.08 | 10.31 | 133 | 68936 | 95032 | 79580287 |
| Pneumocystis jirovecii pneumonia | 12.88 | 10.31 | 6 | 69063 | 32502 | 79642817 |
| Swelling | 12.74 | 10.31 | 123 | 68946 | 216588 | 79458731 |
| Neutropenia | 12.74 | 10.31 | 174 | 68895 | 287536 | 79387783 |
| Respiratory rate decreased | 12.74 | 10.31 | 19 | 69050 | 5224 | 79670095 |
| Differential white blood cell count abnormal | 12.57 | 10.31 | 12 | 69057 | 2065 | 79673254 |
| Blood potassium decreased | 12.54 | 10.31 | 76 | 68993 | 46436 | 79628883 |
| Musculoskeletal pain | 12.49 | 10.31 | 46 | 69023 | 102308 | 79573011 |
| Mental disorder | 12.47 | 10.31 | 57 | 69012 | 31245 | 79644074 |
| Failure to thrive | 12.45 | 10.31 | 30 | 69039 | 11814 | 79663505 |
| Psychological trauma | 12.27 | 10.31 | 10 | 69059 | 1396 | 79673923 |
| Drug eruption | 12.21 | 10.31 | 12 | 69057 | 43923 | 79631396 |
| Hypophagia | 12.14 | 10.31 | 74 | 68995 | 45293 | 79630026 |
| Drug interaction | 12.00 | 10.31 | 271 | 68798 | 414912 | 79260407 |
| Hyperreflexia | 11.95 | 10.31 | 24 | 69045 | 8361 | 79666958 |
| Mental impairment | 11.94 | 10.31 | 40 | 69029 | 18996 | 79656323 |
| Prostate cancer | 11.91 | 10.31 | 7 | 69062 | 33261 | 79642058 |
| Panic attack | 11.90 | 10.31 | 47 | 69022 | 24169 | 79651150 |
| Sopor | 11.74 | 10.31 | 7 | 69062 | 33003 | 79642316 |
| Wrong patient received product | 11.60 | 10.31 | 17 | 69052 | 4601 | 79670718 |
| Inadequate analgesia | 11.57 | 10.31 | 17 | 69052 | 4612 | 79670707 |
| Muscle spasms | 11.51 | 10.31 | 214 | 68855 | 174516 | 79500803 |
| Compulsions | 11.35 | 10.31 | 6 | 69063 | 402 | 79674917 |
| Irritable bowel syndrome | 11.32 | 10.31 | 23 | 69046 | 62218 | 79613101 |
| Malnutrition | 11.32 | 10.31 | 44 | 69025 | 22458 | 79652861 |
| Suicidal behaviour | 11.28 | 10.31 | 14 | 69055 | 3233 | 79672086 |
| Postpartum haemorrhage | 11.18 | 10.31 | 10 | 69059 | 1585 | 79673734 |
| Confusional state | 11.09 | 10.31 | 357 | 68712 | 317640 | 79357679 |
| Transverse sinus thrombosis | 11.06 | 10.31 | 7 | 69062 | 658 | 79674661 |
| Cholecystitis acute | 10.99 | 10.31 | 31 | 69038 | 13420 | 79661899 |
| Fear of disease | 10.88 | 10.31 | 9 | 69060 | 1283 | 79674036 |
| Base excess increased | 10.84 | 10.31 | 4 | 69065 | 112 | 79675207 |
| Osteoarthritis | 10.81 | 10.31 | 39 | 69030 | 87270 | 79588049 |
| Withdrawal syndrome | 10.78 | 10.31 | 49 | 69020 | 26805 | 79648514 |
| CSF pressure increased | 10.75 | 10.31 | 5 | 69064 | 254 | 79675065 |
| Osteoporosis | 10.72 | 10.31 | 19 | 69050 | 54093 | 79621226 |
| Knee arthroplasty | 10.71 | 10.31 | 13 | 69056 | 43235 | 79632084 |
| Illness | 10.69 | 10.31 | 73 | 68996 | 46438 | 79628881 |
| Gallbladder enlargement | 10.67 | 10.31 | 10 | 69059 | 1683 | 79673636 |
| Psoriasis | 10.45 | 10.31 | 41 | 69028 | 89546 | 79585773 |
| Angina pectoris | 10.40 | 10.31 | 18 | 69051 | 51714 | 79623605 |
| Schizoaffective disorder | 10.39 | 10.31 | 11 | 69058 | 2141 | 79673178 |
| Haemophagocytic lymphohistiocytosis | 10.39 | 10.31 | 3 | 69066 | 21834 | 79653485 |
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 | 47.43 | 26.23 | 11 | 217 | 11 | 89553 |
| Pulmonary haemorrhage neonatal | 43.10 | 26.23 | 10 | 218 | 10 | 89554 |
| Congenital tricuspid valve incompetence | 32.89 | 26.23 | 10 | 218 | 46 | 89518 |
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 | D018926 | Anti-Allergic Agents |
| MeSH PA | D000982 | Antipruritics |
| MeSH PA | D003879 | Dermatologic Agents |
| MeSH PA | D018494 | Histamine Agents |
| MeSH PA | D006633 | Histamine Antagonists |
| MeSH PA | D006634 | Histamine H1 Antagonists |
| MeSH PA | D018377 | Neurotransmitter Agents |
| CHEBI has role | CHEBI:35717 | hypnotics |
| CHEBI has role | CHEBI:36333 | local anesthetics |
| CHEBI has role | CHEBI:37955 | H1 receptor antagonists |
| CHEBI has role | CHEBI:50857 | anti-allergic drugs |
| CHEBI has role | CHEBI:50919 | antiemetico |
| CHEBI has role | CHEBI:59683 | antipruritic drugs |
| CHEBI has role | CHEBI:149553 | anticoronaviral drug |
| CHEBI has role | CHEBI:176497 | geroprotectors |
| FDA EPC | N0000175746 | Phenothiazine |
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(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 | |||||
| D(1A) dopamine receptor | GPCR | Ki | 5.86 | DRUG MATRIX | |||||
| Calmodulin-1 | Cytosolic other | IC50 | 4.22 | CHEMBL | |||||
| Alpha-1B adrenergic receptor | GPCR | Ki | 7.68 | DRUG MATRIX | |||||
| Alpha-1A adrenergic receptor | GPCR | IC50 | 7.10 | CHEMBL | |||||
| 5-hydroxytryptamine receptor 1A | GPCR | IC50 | 5.59 | 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 |
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 |
| CHEMBL1200750 | ChEMBL_ID |
| CHEMBL251904 | ChEMBL_ID |
| CHEMBL643 | 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 |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0121-0547 | SYRUP | 6.25 mg | ORAL | ANDA | 30 sections |
| Promethazine VC with Codeine Oral Solution | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0121-0925 | SOLUTION | 6.25 mg | ORAL | ANDA | 29 sections |
| Promethazine VC with Codeine Oral Solution | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0121-0925 | SOLUTION | 6.25 mg | ORAL | ANDA | 29 sections |
| Promethazine VC | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0121-0926 | SOLUTION | 6.25 mg | ORAL | ANDA | 25 sections |
| Promethazine VC | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0121-0926 | SOLUTION | 6.25 mg | ORAL | ANDA | 25 sections |
| Promethazine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0121-0927 | SOLUTION | 6.25 mg | ORAL | ANDA | 25 sections |
| Promethazine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0121-0927 | SOLUTION | 6.25 mg | ORAL | ANDA | 25 sections |
| Promethazine with Codeine | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0121-0928 | SOLUTION | 6.25 mg | ORAL | ANDA | 29 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 | 0404-9940 | 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 | 0404-9941 | 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 | 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 | 0641-0928 | 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 | 0641-0929 | 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 | 0641-0948 | 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 | 0641-0949 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 25 sections |