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biotin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 373 | 58-85-5 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A water-soluble, enzyme co-factor present in minute amounts in every living cell. It occurs mainly bound to proteins or polypeptides and is abundant in liver, kidney, pancreas, yeast, and milk.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 3 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 0.22 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 43 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 0.01 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 99 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | -2.145 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 0.445 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 1.135 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 1.483 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 75.590 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 73.320 | % | High | 1 |
| herg | hERG pIC50 | 4.365 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 1.432 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 3.258 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 69.370 | % | High | 1 |
| kinase-safety-class | AAK1,ABL2,ACVR2A,ACVR2B,ACVRL1,AKT1,AKT2,AKT3,ALK,AURKA,AURKB,AURKC,AXL,BLK,BMX,BRAF,BTK,CAMK1,CAMK2A,CAMK2B,CAMK2D,CAMK2G,CDK1,CDK14,CDK16,CDK19,CDK2,CDK3,CDK4,CDK5,CDK6,CDK7,CDK9,CHEK1,CHEK2,CHUK,CLK2,CLK4,CSF1R,CSK,CSNK2A2,DDR1,DYRK1A,DYRK1B,DYRK2,DYRK3,EGFR,EIF2AK3,EPHA2,EPHB1,EPHB4,ERBB2,ERBB4,FGFR1,FGFR4,FLT1,FLT3,FLT4,FYN,GAK,GRK1,GRK2,GSK3A,GSK3B,HASPIN,HIPK2,IGF1R,IKBKB,INSR,IRAK1,IRAK3,IRAK4,ITK,JAK1,JAK2,JAK3,KDR,KIT,LCK,LRRK2,LYN,MAP2K1,MAP2K6,MAP3K1,MAP3K10,MAP3K11,MAP3K14,MAP3K19,MAP3K2,MAP3K21,MAP3K3,MAP3K7,MAP3K9,MAP4K1,MAP4K2,MAP4K3,MAP4K5,MAPK1,MAPK10,MAPK12,MAPK3,MAPK7,MAPK8,MAPK9,MAPKAPK2,MAPKAPK5,MARK1,MARK2,MARK3,MARK4,MELK,MET,MINK1,MKNK2,MST1R,MTOR,NTRK1,NTRK2,NTRK3,NUAK1,PAK1,PAK2,PAK4,PAK5,PDGFRB,PDK1,PDK2,PDK4,PDPK1,PIK3CA,PIK3CB,PIK3CD,PIK3CG,PIM1,PIM2,PIM3,PLK1,PRKAA1,PRKAA2,PRKACA,PRKCA,PRKCD,PRKCI,PRKCZ,PRKD1,PRKDC,PTK2,RET,ROCK1,ROCK2,RPS6KA1,SGK1,SIK2,SIK3,SRC,STK10,STK16,STK17A,STK33,STK4,SYK,TBK1,TEK,TGFBR1,TNIK,TNK1,TTK,TYRO3,UHMK1,ULK1,ULK2,YES1,ZAP70 | 173 | |||
| kinase-selectivity-class | AAK1,ABL2,ACVR2A,ACVR2B,ALK,AURKA,AURKB,AURKC,AXL,BLK,BMX,BRAF,BTK,CAMK2A,CAMK2B,CAMK2D,CDK1,CDK16,CDK3,CDK4,CDK6,CDK7,CDK9,CHEK1,CLK2,CLK4,CSF1R,CSK,DDR1,DYRK1B,EGFR,EIF2AK3,EPHA2,EPHB4,ERBB2,ERBB4,FLT3,FLT4,FYN,GAK,GRK2,GSK3A,IGF1R,INSR,IRAK1,IRAK3,IRAK4,JAK1,JAK2,KIT,LCK,LYN,MAP2K1,MAP2K3,MAP2K6,MAP3K1,MAP3K10,MAP3K11,MAP3K14,MAP3K2,MAP3K21,MAP3K7,MAP3K9,MAP4K1,MAP4K3,MAP4K5,MAPK1,MAPK10,MAPK12,MAPK7,MAPK8,MARK1,MARK2,MARK4,MELK,MET,MINK1,MKNK1,MKNK2,NTRK1,NTRK3,NUAK1,PAK1,PAK2,PAK4,PDGFRB,PDK1,PDK4,PDPK1,PLK1,PLK2,PLK3,PLK4,PRKAA1,PRKAA2,PRKCD,PRKCI,PRKCZ,PRKDC,PTK2,RET,RIPK3,SIK2,SIK3,SRC,STK10,STK17A,STK33,STK4,SYK,TEK,TNIK,TNK1,TTK,TYRO3,UHMK1,ULK1,ULK2,YES1 | 119 | |||
| mdck-mdr1-bcrp-efflux | MDCK-MDR1-BCRP efflux ratio | 0.378 | High | 1 | |
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 0.513 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 1.151 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 82.780 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 0.320 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 57.030 | % | High | 1 |
| rat-kpuu-brain | Rat brain Kpuu | 0.011 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 1.626 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 92.590 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 65.010 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 881.049 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Feb. 20, 1953 | FDA | HOSPIRA |
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 |
|---|---|---|---|---|---|---|
| Synovitis | 288.79 | 10.11 | 5 | 86275 | 329747 | 90212420 |
| Hand deformity | 257.42 | 10.11 | 5 | 86275 | 296357 | 90245810 |
| Pericarditis | 232.86 | 10.11 | 5 | 86275 | 270146 | 90272021 |
| Product dose omission issue | 232.47 | 10.11 | 707 | 85573 | 290980 | 90251187 |
| Glossodynia | 229.53 | 10.11 | 21 | 86259 | 321758 | 90220409 |
| Systemic lupus erythematosus | 225.53 | 10.11 | 37 | 86243 | 361859 | 90180308 |
| Contraindicated product administered | 215.23 | 10.11 | 26 | 86254 | 320113 | 90222054 |
| Duodenal ulcer perforation | 195.17 | 10.11 | 3 | 86277 | 221285 | 90320882 |
| Maternal exposure during pregnancy | 191.33 | 10.11 | 53 | 86227 | 360010 | 90182157 |
| Helicobacter infection | 185.22 | 10.11 | 7 | 86273 | 226843 | 90315324 |
| Wound | 173.78 | 10.11 | 38 | 86242 | 302942 | 90239225 |
| Infusion related reaction | 162.26 | 10.11 | 98 | 86182 | 416682 | 90125485 |
| Folliculitis | 161.22 | 10.11 | 8 | 86272 | 204345 | 90337822 |
| Fatigue | 148.27 | 10.11 | 1712 | 84568 | 1152311 | 89389856 |
| Type 2 diabetes mellitus | 132.92 | 10.11 | 18 | 86262 | 203226 | 90338941 |
| General physical health deterioration | 132.00 | 10.11 | 88 | 86192 | 355027 | 90187140 |
| Hypertrichosis | 129.91 | 10.11 | 50 | 86230 | 1429 | 90540738 |
| Hepatic enzyme increased | 129.30 | 10.11 | 93 | 86187 | 360643 | 90181524 |
| Drug intolerance | 126.35 | 10.11 | 144 | 86136 | 447447 | 90094720 |
| Liver injury | 124.64 | 10.11 | 10 | 86270 | 170557 | 90371610 |
| Lower respiratory tract infection | 117.12 | 10.11 | 46 | 86234 | 250613 | 90291554 |
| Diarrhoea | 117.07 | 10.11 | 1386 | 84894 | 937804 | 89604363 |
| Toxicity to various agents | 115.76 | 10.11 | 65 | 86215 | 287781 | 90254386 |
| C-reactive protein increased | 109.71 | 10.11 | 20 | 86260 | 181369 | 90360798 |
| Sleep disorder due to general medical condition, insomnia type | 108.47 | 10.11 | 3 | 86277 | 128691 | 90413476 |
| Product use issue | 108.19 | 10.11 | 93 | 86187 | 329826 | 90212341 |
| Completed suicide | 99.36 | 10.11 | 11 | 86269 | 145047 | 90397120 |
| Irritable bowel syndrome | 98.68 | 10.11 | 37 | 86243 | 207411 | 90334756 |
| Arthropathy | 95.73 | 10.11 | 125 | 86155 | 366117 | 90176050 |
| Impaired healing | 93.98 | 10.11 | 53 | 86227 | 234146 | 90308021 |
| Treatment failure | 92.16 | 10.11 | 92 | 86188 | 303836 | 90238331 |
| Fall | 91.28 | 10.11 | 776 | 85504 | 481034 | 90061133 |
| Back pain | 90.73 | 10.11 | 564 | 85716 | 316611 | 90225556 |
| Feeling abnormal | 87.50 | 10.11 | 353 | 85927 | 166882 | 90375285 |
| Full blood count decreased | 86.20 | 10.11 | 123 | 86157 | 29566 | 90512601 |
| Injection site pain | 82.55 | 10.11 | 356 | 85924 | 173343 | 90368824 |
| Headache | 81.81 | 10.11 | 1212 | 85068 | 861534 | 89680633 |
| Ill-defined disorder | 79.88 | 10.11 | 38 | 86242 | 184853 | 90357314 |
| Unevaluable event | 75.98 | 10.11 | 164 | 86116 | 54684 | 90487483 |
| Dry skin | 75.21 | 10.11 | 219 | 86061 | 87854 | 90454313 |
| Off label use | 75.15 | 10.11 | 680 | 85600 | 1101572 | 89440595 |
| Blister | 73.01 | 10.11 | 81 | 86199 | 254917 | 90287250 |
| Injection site erythema | 72.95 | 10.11 | 233 | 86047 | 98269 | 90443898 |
| Fibromyalgia | 72.77 | 10.11 | 54 | 86226 | 206215 | 90335952 |
| Joint range of motion decreased | 71.90 | 10.11 | 20 | 86260 | 135623 | 90406544 |
| Urinary tract infection | 71.45 | 10.11 | 517 | 85763 | 305115 | 90237052 |
| White blood cell count decreased | 69.30 | 10.11 | 329 | 85951 | 166780 | 90375387 |
| Discomfort | 69.25 | 10.11 | 96 | 86184 | 274239 | 90267928 |
| Constipation | 68.26 | 10.11 | 479 | 85801 | 279916 | 90262251 |
| Therapeutic product effect decreased | 67.24 | 10.11 | 100 | 86180 | 277471 | 90264696 |
| Exposure during pregnancy | 65.79 | 10.11 | 78 | 86202 | 238332 | 90303835 |
| Dry eye | 65.63 | 10.11 | 160 | 86120 | 57771 | 90484396 |
| Joint swelling | 65.52 | 10.11 | 252 | 86028 | 503048 | 90039119 |
| Pleural thickening | 62.95 | 10.11 | 39 | 86241 | 3209 | 90538958 |
| Bursitis | 61.73 | 10.11 | 24 | 86256 | 131630 | 90410537 |
| Wheezing | 61.41 | 10.11 | 82 | 86198 | 237998 | 90304169 |
| Lip dry | 61.31 | 10.11 | 11 | 86269 | 100944 | 90441223 |
| Blood magnesium increased | 61.23 | 10.11 | 39 | 86241 | 3369 | 90538798 |
| Muscle spasms | 61.12 | 10.11 | 430 | 85850 | 251453 | 90290714 |
| Presbyacusis | 60.16 | 10.11 | 37 | 86243 | 3005 | 90539162 |
| Hot flush | 59.78 | 10.11 | 157 | 86123 | 59331 | 90482836 |
| Intentional overdose | 59.71 | 10.11 | 9 | 86271 | 93825 | 90448342 |
| Drug abuse | 59.67 | 10.11 | 5 | 86275 | 82342 | 90459825 |
| Flatulence | 58.80 | 10.11 | 125 | 86155 | 41242 | 90500925 |
| Dizziness | 58.52 | 10.11 | 835 | 85445 | 588449 | 89953718 |
| Nausea | 58.18 | 10.11 | 1424 | 84856 | 1108892 | 89433275 |
| Swelling | 57.01 | 10.11 | 206 | 86074 | 418852 | 90123315 |
| Pleural fibrosis | 56.89 | 10.11 | 38 | 86242 | 3558 | 90538609 |
| Live birth | 56.78 | 10.11 | 5 | 86275 | 79102 | 90463065 |
| Prescribed overdose | 56.41 | 10.11 | 12 | 86268 | 97613 | 90444554 |
| Neuropathy peripheral | 56.30 | 10.11 | 269 | 86011 | 136701 | 90405466 |
| Hypercholesterolaemia | 55.13 | 10.11 | 14 | 86266 | 100878 | 90441289 |
| Therapy cessation | 54.16 | 10.11 | 112 | 86168 | 36249 | 90505918 |
| Cyst | 53.14 | 10.11 | 72 | 86208 | 16489 | 90525678 |
| Grip strength decreased | 52.24 | 10.11 | 12 | 86268 | 92564 | 90449603 |
| Peripheral venous disease | 51.27 | 10.11 | 9 | 86271 | 83912 | 90458255 |
| Drug interaction | 50.65 | 10.11 | 118 | 86162 | 276335 | 90265832 |
| Wound infection | 50.54 | 10.11 | 19 | 86261 | 106383 | 90435784 |
| Multiple sclerosis relapse | 49.48 | 10.11 | 135 | 86145 | 52170 | 90489997 |
| Confusional state | 49.18 | 10.11 | 195 | 86085 | 386010 | 90156157 |
| Device expulsion | 46.39 | 10.11 | 113 | 86167 | 40773 | 90501394 |
| Intentional product use issue | 46.13 | 10.11 | 85 | 86195 | 216807 | 90325360 |
| Lung disorder | 45.82 | 10.11 | 45 | 86235 | 149838 | 90392329 |
| Dermatitis atopic | 45.68 | 10.11 | 81 | 86199 | 23391 | 90518776 |
| Autoimmune disorder | 45.24 | 10.11 | 9 | 86271 | 76735 | 90465432 |
| Red blood cell sedimentation rate increased | 44.10 | 10.11 | 12 | 86268 | 82583 | 90459584 |
| Epilepsy | 43.79 | 10.11 | 12 | 86268 | 82194 | 90459973 |
| Onychoclasis | 43.66 | 10.11 | 44 | 86236 | 7355 | 90534812 |
| Obesity | 43.58 | 10.11 | 23 | 86257 | 105484 | 90436683 |
| Drug-induced liver injury | 43.11 | 10.11 | 16 | 86264 | 90302 | 90451865 |
| Epigastric discomfort | 42.83 | 10.11 | 44 | 86236 | 7524 | 90534643 |
| Vision blurred | 42.73 | 10.11 | 213 | 86067 | 110080 | 90432087 |
| Device dislocation | 42.30 | 10.11 | 93 | 86187 | 31389 | 90510778 |
| Balance disorder | 41.59 | 10.11 | 193 | 86087 | 96887 | 90445280 |
| Deafness neurosensory | 40.95 | 10.11 | 41 | 86239 | 6800 | 90535367 |
| Osteopenia | 40.48 | 10.11 | 76 | 86204 | 22926 | 90519241 |
| Psoriasis | 39.85 | 10.11 | 259 | 86021 | 147495 | 90394672 |
| Myelosuppression | 39.53 | 10.11 | 3 | 86277 | 53588 | 90488579 |
| Pulmonary fibrosis | 39.40 | 10.11 | 27 | 86253 | 107476 | 90434691 |
| Product formulation issue | 39.13 | 10.11 | 17 | 86263 | 666 | 90541501 |
| Drug ineffective | 38.90 | 10.11 | 1013 | 85267 | 1383285 | 89158882 |
| Skin discolouration | 38.60 | 10.11 | 111 | 86169 | 44204 | 90497963 |
| Abdominal discomfort | 38.53 | 10.11 | 281 | 85999 | 477047 | 90065120 |
| Mobility decreased | 38.36 | 10.11 | 117 | 86163 | 250617 | 90291550 |
| Drug hypersensitivity | 38.35 | 10.11 | 271 | 86009 | 463338 | 90078829 |
| Overdose | 37.99 | 10.11 | 57 | 86223 | 157652 | 90384515 |
| Blood potassium decreased | 37.26 | 10.11 | 115 | 86165 | 47612 | 90494555 |
| Flushing | 37.23 | 10.11 | 175 | 86105 | 88316 | 90453851 |
| Influenza like illness | 35.08 | 10.11 | 161 | 86119 | 80450 | 90461717 |
| Dysgeusia | 35.03 | 10.11 | 120 | 86160 | 52440 | 90489727 |
| Hip fracture | 34.98 | 10.11 | 89 | 86191 | 32988 | 90509179 |
| Injection site bruising | 34.49 | 10.11 | 119 | 86161 | 52188 | 90489979 |
| Nasal congestion | 34.39 | 10.11 | 164 | 86116 | 83250 | 90458917 |
| Injury | 33.96 | 10.11 | 87 | 86193 | 197262 | 90344905 |
| Blood potassium increased | 33.38 | 10.11 | 66 | 86214 | 20683 | 90521484 |
| Therapeutic response unexpected | 33.29 | 10.11 | 68 | 86212 | 21812 | 90520355 |
| Eye swelling | 33.10 | 10.11 | 81 | 86199 | 29305 | 90512862 |
| Injection site mass | 32.84 | 10.11 | 68 | 86212 | 22022 | 90520145 |
| Rheumatoid arthritis | 32.46 | 10.11 | 207 | 86073 | 362407 | 90179760 |
| Therapeutic product effect incomplete | 32.20 | 10.11 | 87 | 86193 | 193809 | 90348358 |
| Multiple sclerosis | 31.64 | 10.11 | 77 | 86203 | 27763 | 90514404 |
| Burning sensation | 31.62 | 10.11 | 132 | 86148 | 63320 | 90478847 |
| Plasma cell myeloma | 30.60 | 10.11 | 97 | 86183 | 40731 | 90501436 |
| Inflammation | 30.52 | 10.11 | 79 | 86201 | 178513 | 90363654 |
| Blood cholesterol increased | 30.45 | 10.11 | 99 | 86181 | 207913 | 90334254 |
| Psoriatic arthropathy | 29.86 | 10.11 | 114 | 86166 | 228221 | 90313946 |
| Cough | 29.73 | 10.11 | 505 | 85775 | 368457 | 90173710 |
| Tremor | 29.58 | 10.11 | 248 | 86032 | 152925 | 90389242 |
| Intentional dose omission | 29.14 | 10.11 | 57 | 86223 | 17726 | 90524441 |
| Skin exfoliation | 29.07 | 10.11 | 135 | 86145 | 67778 | 90474389 |
| Coeliac disease | 29.03 | 10.11 | 4 | 86276 | 44606 | 90497561 |
| Hypersensitivity | 28.88 | 10.11 | 285 | 85995 | 454392 | 90087775 |
| Deep vein thrombosis | 28.73 | 10.11 | 167 | 86113 | 91453 | 90450714 |
| Weight decreased | 28.11 | 10.11 | 513 | 85767 | 379397 | 90162770 |
| Pre-existing condition improved | 28.11 | 10.11 | 39 | 86241 | 9130 | 90533037 |
| Blepharospasm | 27.88 | 10.11 | 9 | 86271 | 55436 | 90486731 |
| Pain in extremity | 27.20 | 10.11 | 590 | 85690 | 449939 | 90092228 |
| Liver disorder | 27.15 | 10.11 | 46 | 86234 | 121223 | 90420944 |
| Haemoglobin decreased | 26.54 | 10.11 | 253 | 86027 | 161703 | 90380464 |
| Lupus-like syndrome | 26.26 | 10.11 | 7 | 86273 | 48839 | 90493328 |
| Asthenia | 26.13 | 10.11 | 679 | 85601 | 533072 | 90009095 |
| Anxiety | 26.05 | 10.11 | 427 | 85853 | 309345 | 90232822 |
| Onychomadesis | 25.87 | 10.11 | 6 | 86274 | 45992 | 90496175 |
| Hepatic cirrhosis | 25.81 | 10.11 | 14 | 86266 | 63239 | 90478928 |
| Ageusia | 25.70 | 10.11 | 51 | 86229 | 16025 | 90526142 |
| Acne | 25.40 | 10.11 | 72 | 86208 | 28435 | 90513732 |
| Influenza | 25.06 | 10.11 | 222 | 86058 | 139042 | 90403125 |
| Suicide attempt | 24.99 | 10.11 | 21 | 86259 | 75378 | 90466789 |
| COVID-19 | 24.87 | 10.11 | 258 | 86022 | 168585 | 90373582 |
| Stomatitis | 24.47 | 10.11 | 157 | 86123 | 274541 | 90267626 |
| Hip arthroplasty | 24.32 | 10.11 | 22 | 86258 | 76186 | 90465981 |
| Injection site swelling | 24.19 | 10.11 | 117 | 86163 | 59722 | 90482445 |
| Adverse event | 24.09 | 10.11 | 47 | 86233 | 117371 | 90424796 |
| Pruritus | 23.70 | 10.11 | 679 | 85601 | 540846 | 90001321 |
| Myalgia | 23.66 | 10.11 | 263 | 86017 | 174862 | 90367305 |
| Bone pain | 23.50 | 10.11 | 119 | 86161 | 61864 | 90480303 |
| Pollakiuria | 23.45 | 10.11 | 77 | 86203 | 32928 | 90509239 |
| Febrile neutropenia | 23.42 | 10.11 | 75 | 86205 | 158274 | 90383893 |
| Breast cancer stage II | 23.39 | 10.11 | 3 | 86277 | 35331 | 90506836 |
| Depressed level of consciousness | 23.24 | 10.11 | 21 | 86259 | 72763 | 90469404 |
| Dehydration | 23.15 | 10.11 | 285 | 85995 | 194162 | 90348005 |
| Increased tendency to bruise | 23.09 | 10.11 | 41 | 86239 | 11849 | 90530318 |
| Delirium | 22.98 | 10.11 | 40 | 86240 | 104319 | 90437848 |
| Product administration interrupted | 22.89 | 10.11 | 42 | 86238 | 12450 | 90529717 |
| Cardiac disorder | 22.14 | 10.11 | 110 | 86170 | 56762 | 90485405 |
| Surgery | 22.07 | 10.11 | 93 | 86187 | 44794 | 90497373 |
| Hepatitis | 21.89 | 10.11 | 21 | 86259 | 70718 | 90471449 |
| Somnolence | 21.77 | 10.11 | 299 | 85981 | 208785 | 90333382 |
| Body height decreased | 21.68 | 10.11 | 40 | 86240 | 11909 | 90530258 |
| Bone cyst | 21.58 | 10.11 | 18 | 86262 | 2360 | 90539807 |
| Foetal exposure during pregnancy | 21.56 | 10.11 | 7 | 86273 | 42968 | 90499199 |
| Rotator cuff syndrome | 21.36 | 10.11 | 47 | 86233 | 15872 | 90526295 |
| Chills | 21.04 | 10.11 | 205 | 86075 | 131776 | 90410391 |
| Cellulitis | 21.00 | 10.11 | 154 | 86126 | 91183 | 90450984 |
| Sinus disorder | 20.68 | 10.11 | 76 | 86204 | 34371 | 90507796 |
| Red blood cell count decreased | 20.48 | 10.11 | 93 | 86187 | 46258 | 90495909 |
| Epistaxis | 20.42 | 10.11 | 145 | 86135 | 84980 | 90457187 |
| Hypervolaemia | 20.28 | 10.11 | 73 | 86207 | 32684 | 90509483 |
| Pelvic pain | 20.22 | 10.11 | 45 | 86235 | 15312 | 90526855 |
| Atrial fibrillation | 20.07 | 10.11 | 205 | 86075 | 133406 | 90408761 |
| Eosinophilic pleural effusion | 19.95 | 10.11 | 7 | 86273 | 153 | 90542014 |
| Infusion site nodule | 19.84 | 10.11 | 15 | 86265 | 1708 | 90540459 |
| Hypoacusis | 19.81 | 10.11 | 65 | 86215 | 27785 | 90514382 |
| Stress | 19.73 | 10.11 | 139 | 86141 | 81256 | 90460911 |
| Limb discomfort | 19.61 | 10.11 | 80 | 86200 | 37980 | 90504187 |
| Sleep disorder | 19.30 | 10.11 | 110 | 86170 | 197920 | 90344247 |
| Rhinorrhoea | 19.23 | 10.11 | 147 | 86133 | 88169 | 90453998 |
| Pyrexia | 19.04 | 10.11 | 481 | 85799 | 660004 | 89882163 |
| Tooth disorder | 19.01 | 10.11 | 69 | 86211 | 31021 | 90511146 |
| Osteosclerosis | 19.01 | 10.11 | 22 | 86258 | 4298 | 90537869 |
| Thrombosis | 18.89 | 10.11 | 127 | 86153 | 73124 | 90469043 |
| Agranulocytosis | 18.84 | 10.11 | 5 | 86275 | 34997 | 90507170 |
| Skin lesion | 18.82 | 10.11 | 78 | 86202 | 37287 | 90504880 |
| Injection site alopecia | 18.63 | 10.11 | 5 | 86275 | 42 | 90542125 |
| Laboratory test abnormal | 18.50 | 10.11 | 84 | 86196 | 41770 | 90500397 |
| Neuralgia | 18.49 | 10.11 | 69 | 86211 | 31431 | 90510736 |
| Laryngitis | 18.26 | 10.11 | 13 | 86267 | 50740 | 90491427 |
| Depression | 18.22 | 10.11 | 394 | 85886 | 300207 | 90241960 |
| Cardiac failure congestive | 18.10 | 10.11 | 158 | 86122 | 98536 | 90443631 |
| Meniscus injury | 18.10 | 10.11 | 30 | 86250 | 8207 | 90533960 |
| Interstitial lung disease | 18.02 | 10.11 | 28 | 86252 | 76377 | 90465790 |
| Infusion site erythema | 17.93 | 10.11 | 40 | 86240 | 13630 | 90528537 |
| Spinal osteoarthritis | 17.69 | 10.11 | 49 | 86231 | 19099 | 90523068 |
| Abdominal distension | 17.57 | 10.11 | 196 | 86084 | 130405 | 90411762 |
| Injection site urticaria | 17.54 | 10.11 | 47 | 86233 | 17964 | 90524203 |
| Inappropriate schedule of product administration | 17.52 | 10.11 | 219 | 86061 | 149714 | 90392453 |
| Injection site haemorrhage | 17.44 | 10.11 | 63 | 86217 | 28255 | 90513912 |
| Full blood count abnormal | 17.35 | 10.11 | 75 | 86205 | 36522 | 90505645 |
| Gait inability | 17.33 | 10.11 | 76 | 86204 | 146380 | 90395787 |
| Gait disturbance | 17.28 | 10.11 | 346 | 85934 | 260150 | 90282017 |
| Administration site swelling | 17.15 | 10.11 | 13 | 86267 | 1486 | 90540681 |
| Finger deformity | 17.15 | 10.11 | 5 | 86275 | 32892 | 90509275 |
| Hyperphagia | 17.07 | 10.11 | 17 | 86263 | 2801 | 90539366 |
| Hospice care | 17.00 | 10.11 | 32 | 86248 | 9672 | 90532495 |
| Asthma | 16.99 | 10.11 | 148 | 86132 | 242012 | 90300155 |
| Dermatitis contact | 16.97 | 10.11 | 39 | 86241 | 13556 | 90528611 |
| Product preparation error | 16.94 | 10.11 | 33 | 86247 | 10228 | 90531939 |
| Upper limb fracture | 16.84 | 10.11 | 52 | 86228 | 21526 | 90520641 |
| Drug reaction with eosinophilia and systemic symptoms | 16.67 | 10.11 | 10 | 86270 | 42748 | 90499419 |
| Gastrointestinal disorder | 16.65 | 10.11 | 160 | 86120 | 256527 | 90285640 |
| Hair growth abnormal | 16.65 | 10.11 | 19 | 86261 | 3657 | 90538510 |
| Palpitations | 16.53 | 10.11 | 201 | 86079 | 136527 | 90405640 |
| Gout | 16.43 | 10.11 | 44 | 86236 | 16815 | 90525352 |
| Platelet count decreased | 16.40 | 10.11 | 201 | 86079 | 136768 | 90405399 |
| Urinary incontinence | 16.31 | 10.11 | 75 | 86205 | 37491 | 90504676 |
| Multiple allergies | 16.27 | 10.11 | 41 | 86239 | 15105 | 90527062 |
| Injection site pruritus | 16.15 | 10.11 | 97 | 86183 | 53737 | 90488430 |
| Dysphonia | 16.04 | 10.11 | 109 | 86171 | 62975 | 90479192 |
| Hair texture abnormal | 15.99 | 10.11 | 21 | 86259 | 4666 | 90537501 |
| Musculoskeletal discomfort | 15.84 | 10.11 | 50 | 86230 | 20941 | 90521226 |
| Electrocardiogram QT prolonged | 15.74 | 10.11 | 28 | 86252 | 72428 | 90469739 |
| Sciatica | 15.71 | 10.11 | 47 | 86233 | 101335 | 90440832 |
| Drug eruption | 15.71 | 10.11 | 7 | 86273 | 35400 | 90506767 |
| Gastric bypass | 15.51 | 10.11 | 14 | 86266 | 2040 | 90540127 |
| Thrombocytopenia | 15.34 | 10.11 | 126 | 86154 | 208599 | 90333568 |
| Vitamin D deficiency | 15.31 | 10.11 | 44 | 86236 | 17512 | 90524655 |
| Joint dislocation | 15.29 | 10.11 | 12 | 86268 | 44570 | 90497597 |
| Musculoskeletal stiffness | 15.20 | 10.11 | 195 | 86085 | 296337 | 90245830 |
| Rosacea | 15.20 | 10.11 | 23 | 86257 | 5824 | 90536343 |
| Memory impairment | 15.15 | 10.11 | 268 | 86012 | 196976 | 90345191 |
| Injection site rash | 15.08 | 10.11 | 54 | 86226 | 24119 | 90518048 |
| Cytokine release syndrome | 15.05 | 10.11 | 4 | 86276 | 27969 | 90514198 |
| Hypocalcaemia | 15.05 | 10.11 | 11 | 86269 | 42357 | 90499810 |
| Bronchitis | 14.83 | 10.11 | 216 | 86064 | 152711 | 90389456 |
| Blood iron decreased | 14.69 | 10.11 | 44 | 86236 | 17915 | 90524252 |
| Bladder disorder | 14.67 | 10.11 | 32 | 86248 | 10740 | 90531427 |
| Hypogeusia | 14.63 | 10.11 | 12 | 86268 | 1537 | 90540630 |
| Muscle strain | 14.61 | 10.11 | 30 | 86250 | 9657 | 90532510 |
| Serotonin syndrome | 14.58 | 10.11 | 9 | 86271 | 37878 | 90504289 |
| Spinal stenosis | 14.55 | 10.11 | 43 | 86237 | 17381 | 90524786 |
| Night sweats | 14.53 | 10.11 | 68 | 86212 | 128698 | 90413469 |
| Hospitalisation | 14.49 | 10.11 | 186 | 86094 | 127914 | 90414253 |
| Lactic acidosis | 14.46 | 10.11 | 16 | 86264 | 50447 | 90491720 |
| Skin swelling | 14.41 | 10.11 | 24 | 86256 | 6590 | 90535577 |
| Incorrect dose administered | 14.29 | 10.11 | 126 | 86154 | 78804 | 90463363 |
| Gastroenteritis viral | 14.23 | 10.11 | 62 | 86218 | 30293 | 90511874 |
| Lower limb fracture | 14.22 | 10.11 | 38 | 86242 | 84975 | 90457192 |
| Fluid retention | 14.12 | 10.11 | 137 | 86143 | 87954 | 90454213 |
| Seasonal allergy | 14.04 | 10.11 | 51 | 86229 | 22932 | 90519235 |
| Condition aggravated | 14.02 | 10.11 | 446 | 85834 | 595099 | 89947068 |
| Vaginal haemorrhage | 14.00 | 10.11 | 63 | 86217 | 31208 | 90510959 |
| Relapsing-remitting multiple sclerosis | 14.00 | 10.11 | 9 | 86271 | 790 | 90541377 |
| Infusion site swelling | 13.95 | 10.11 | 33 | 86247 | 11687 | 90530480 |
| Skin cancer | 13.90 | 10.11 | 36 | 86244 | 13483 | 90528684 |
| Gallbladder disorder | 13.89 | 10.11 | 46 | 86234 | 19757 | 90522410 |
| Premature delivery | 13.85 | 10.11 | 10 | 86270 | 38752 | 90503415 |
| Alopecia areata | 13.80 | 10.11 | 13 | 86267 | 2002 | 90540165 |
| Hypokalaemia | 13.78 | 10.11 | 71 | 86209 | 131045 | 90411122 |
| Micturition urgency | 13.77 | 10.11 | 32 | 86248 | 11201 | 90530966 |
| Dyspnoea | 13.71 | 10.11 | 994 | 85286 | 879961 | 89662206 |
| Chest discomfort | 13.64 | 10.11 | 196 | 86084 | 138169 | 90403998 |
| Pulmonary embolism | 13.57 | 10.11 | 187 | 86093 | 130633 | 90411534 |
| Cholestasis | 13.45 | 10.11 | 9 | 86271 | 36290 | 90505877 |
| Oropharyngeal pain | 13.35 | 10.11 | 168 | 86112 | 115019 | 90427148 |
| Eczema | 13.23 | 10.11 | 91 | 86189 | 52779 | 90489388 |
| Acute kidney injury | 13.18 | 10.11 | 220 | 86060 | 320167 | 90222000 |
| Restless legs syndrome | 13.01 | 10.11 | 49 | 86231 | 22421 | 90519746 |
| Therapy interrupted | 12.99 | 10.11 | 87 | 86193 | 50021 | 90492146 |
| Plasma cell myeloma recurrent | 12.99 | 10.11 | 18 | 86262 | 4210 | 90537957 |
| Disturbance in attention | 12.95 | 10.11 | 83 | 86197 | 47026 | 90495141 |
| Heavy menstrual bleeding | 12.92 | 10.11 | 46 | 86234 | 20484 | 90521683 |
| Hepatic function abnormal | 12.91 | 10.11 | 15 | 86265 | 46273 | 90495894 |
| Insomnia | 12.91 | 10.11 | 412 | 85868 | 333062 | 90209105 |
| Skin laceration | 12.84 | 10.11 | 54 | 86226 | 25981 | 90516186 |
| Osteonecrosis of jaw | 12.82 | 10.11 | 11 | 86269 | 39092 | 90503075 |
| Premature baby | 12.73 | 10.11 | 4 | 86276 | 25073 | 90517094 |
| Endometriosis | 12.73 | 10.11 | 22 | 86258 | 6226 | 90535941 |
| Intentional self-injury | 12.70 | 10.11 | 6 | 86274 | 29328 | 90512839 |
| Eye infection | 12.70 | 10.11 | 36 | 86244 | 14218 | 90527949 |
| Pneumonia | 12.64 | 10.11 | 735 | 85545 | 637324 | 89904843 |
| Anal incontinence | 12.56 | 10.11 | 39 | 86241 | 16191 | 90525976 |
| Decreased interest | 12.41 | 10.11 | 18 | 86262 | 4389 | 90537778 |
| Dyspnoea exertional | 12.37 | 10.11 | 114 | 86166 | 72174 | 90469993 |
| Oroticaciduria | 12.35 | 10.11 | 3 | 86277 | 16 | 90542151 |
| Intervertebral disc protrusion | 12.34 | 10.11 | 55 | 86225 | 27141 | 90515026 |
| Haematocrit decreased | 12.31 | 10.11 | 75 | 86205 | 41757 | 90500410 |
| Prescribed underdose | 12.19 | 10.11 | 34 | 86246 | 74985 | 90467182 |
| Paraesthesia | 12.08 | 10.11 | 318 | 85962 | 250008 | 90292159 |
| Polyarteritis nodosa | 12.05 | 10.11 | 6 | 86274 | 322 | 90541845 |
| Drug resistance | 12.04 | 10.11 | 7 | 86273 | 30442 | 90511725 |
| Cold sweat | 12.00 | 10.11 | 35 | 86245 | 14046 | 90528121 |
| Liver function test increased | 11.99 | 10.11 | 41 | 86239 | 84814 | 90457353 |
| Madarosis | 11.98 | 10.11 | 16 | 86264 | 3613 | 90538554 |
| Injection site induration | 11.94 | 10.11 | 29 | 86251 | 10439 | 90531728 |
| Hypertension | 11.91 | 10.11 | 338 | 85942 | 457194 | 90084973 |
| Product use in unapproved indication | 11.91 | 10.11 | 237 | 86043 | 335999 | 90206168 |
| Concussion | 11.89 | 10.11 | 30 | 86250 | 11061 | 90531106 |
| Rash pruritic | 11.80 | 10.11 | 125 | 86155 | 82089 | 90460078 |
| Metabolic acidosis | 11.67 | 10.11 | 22 | 86258 | 55654 | 90486513 |
| Vanishing bile duct syndrome | 11.66 | 10.11 | 10 | 86270 | 1362 | 90540805 |
| Nasal disorder | 11.62 | 10.11 | 15 | 86265 | 3277 | 90538890 |
| Hepatotoxicity | 11.59 | 10.11 | 16 | 86264 | 45826 | 90496341 |
| Skin disorder | 11.56 | 10.11 | 67 | 86213 | 36639 | 90505528 |
| Blood cholesterol abnormal | 11.53 | 10.11 | 14 | 86266 | 2876 | 90539291 |
| Application site pruritus | 11.46 | 10.11 | 17 | 86263 | 4230 | 90537937 |
| Infusion site pain | 11.39 | 10.11 | 43 | 86237 | 19695 | 90522472 |
| Respiratory arrest | 11.38 | 10.11 | 9 | 86271 | 33302 | 90508865 |
| Weight loss poor | 11.21 | 10.11 | 10 | 86270 | 1435 | 90540732 |
| Knee arthroplasty | 11.21 | 10.11 | 41 | 86239 | 83141 | 90459026 |
| Oral pain | 11.19 | 10.11 | 61 | 86219 | 32622 | 90509545 |
| Pulmonary arterial hypertension | 11.16 | 10.11 | 52 | 86228 | 26135 | 90516032 |
| Mucosal inflammation | 11.02 | 10.11 | 24 | 86256 | 57601 | 90484566 |
| Infusion site haemorrhage | 10.95 | 10.11 | 19 | 86261 | 5392 | 90536775 |
| Skin fissures | 10.93 | 10.11 | 44 | 86236 | 20765 | 90521402 |
| Complication associated with device | 10.92 | 10.11 | 42 | 86238 | 19407 | 90522760 |
| Initial insomnia | 10.85 | 10.11 | 26 | 86254 | 9284 | 90532883 |
| Skin irritation | 10.82 | 10.11 | 33 | 86247 | 13570 | 90528597 |
| Glomerulonephritis acute | 10.78 | 10.11 | 4 | 86276 | 103 | 90542064 |
| Bone marrow failure | 10.64 | 10.11 | 9 | 86271 | 32212 | 90509955 |
| Blood uric acid increased | 10.62 | 10.11 | 23 | 86257 | 7681 | 90534486 |
| Ependymoma | 10.61 | 10.11 | 4 | 86276 | 108 | 90542059 |
| Infection | 10.60 | 10.11 | 263 | 86017 | 361831 | 90180336 |
| Animal bite | 10.60 | 10.11 | 14 | 86266 | 3129 | 90539038 |
| Nail bed bleeding | 10.56 | 10.11 | 6 | 86274 | 421 | 90541746 |
| Immune system disorder | 10.54 | 10.11 | 30 | 86250 | 11875 | 90530292 |
| Foot deformity | 10.48 | 10.11 | 26 | 86254 | 59625 | 90482542 |
| Blood glucose decreased | 10.34 | 10.11 | 47 | 86233 | 23382 | 90518785 |
| Milk allergy | 10.33 | 10.11 | 6 | 86274 | 439 | 90541728 |
| Food interaction | 10.31 | 10.11 | 9 | 86271 | 1255 | 90540912 |
| Blood calcium increased | 10.30 | 10.11 | 30 | 86250 | 12028 | 90530139 |
| Diverticulitis | 10.28 | 10.11 | 76 | 86204 | 45111 | 90497056 |
| Cerebrovascular accident | 10.26 | 10.11 | 170 | 86110 | 123363 | 90418804 |
| Dysmenorrhoea | 10.24 | 10.11 | 17 | 86263 | 4655 | 90537512 |
| Anal pruritus | 10.22 | 10.11 | 8 | 86272 | 959 | 90541208 |
| Altered state of consciousness | 10.18 | 10.11 | 9 | 86271 | 31523 | 90510644 |
| Sedation | 10.12 | 10.11 | 19 | 86261 | 48152 | 90494015 |
| Application site pain | 10.11 | 10.11 | 17 | 86263 | 4703 | 90537464 |
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 |
|---|---|---|---|---|---|---|
| Hypertrichosis | 161.39 | 11.91 | 47 | 40215 | 551 | 42580522 |
| Fractional exhaled nitric oxide increased | 154.78 | 11.91 | 58 | 40204 | 1551 | 42579522 |
| Product formulation issue | 139.63 | 11.91 | 45 | 40217 | 756 | 42580317 |
| Myoglobin blood increased | 117.25 | 11.91 | 61 | 40201 | 3621 | 42577452 |
| Plantar fasciitis | 112.73 | 11.91 | 56 | 40206 | 3014 | 42578059 |
| Sensation of foreign body | 112.60 | 11.91 | 59 | 40203 | 3554 | 42577519 |
| Brain natriuretic peptide increased | 92.16 | 11.91 | 65 | 40197 | 6705 | 42574368 |
| Off label use | 87.15 | 11.91 | 311 | 39951 | 638024 | 41943049 |
| Pericardial effusion | 86.84 | 11.91 | 122 | 40140 | 29153 | 42551920 |
| Drug abuse | 85.60 | 11.91 | 3 | 40259 | 104768 | 42476305 |
| Exostosis | 76.50 | 11.91 | 54 | 40208 | 5577 | 42575496 |
| Drug interaction | 75.12 | 11.91 | 85 | 40177 | 266914 | 42314159 |
| Cardiac disorder | 65.97 | 11.91 | 144 | 40118 | 48788 | 42532285 |
| Hyperphosphataemia | 65.89 | 11.91 | 71 | 40191 | 12933 | 42568140 |
| Analgesic therapy | 60.86 | 11.91 | 50 | 40212 | 6474 | 42574599 |
| Secretion discharge | 59.95 | 11.91 | 53 | 40209 | 7582 | 42573491 |
| Toxicity to various agents | 59.08 | 11.91 | 78 | 40184 | 229058 | 42352015 |
| Myasthenia gravis | 58.20 | 11.91 | 74 | 40188 | 16063 | 42565010 |
| Appendicolith | 57.12 | 11.91 | 67 | 40195 | 13389 | 42567684 |
| Drug therapy | 55.58 | 11.91 | 47 | 40215 | 6333 | 42574740 |
| Sleep disorder therapy | 54.41 | 11.91 | 48 | 40214 | 6846 | 42574227 |
| Dysphonia | 53.16 | 11.91 | 96 | 40166 | 28354 | 42552719 |
| Activated partial thromboplastin time prolonged | 51.25 | 11.91 | 69 | 40193 | 15834 | 42565239 |
| Blood phosphorus increased | 50.91 | 11.91 | 61 | 40201 | 12464 | 42568609 |
| Thrombosis | 50.56 | 11.91 | 161 | 40101 | 68350 | 42512723 |
| Swelling | 47.09 | 11.91 | 136 | 40126 | 54749 | 42526324 |
| Febrile neutropenia | 46.04 | 11.91 | 65 | 40197 | 185638 | 42395435 |
| Muscle spasms | 45.31 | 11.91 | 181 | 40081 | 85863 | 42495210 |
| Coronary artery disease | 45.02 | 11.91 | 132 | 40130 | 53588 | 42527485 |
| Anticoagulant therapy | 44.93 | 11.91 | 36 | 40226 | 4499 | 42576574 |
| Dyspnoea exertional | 44.71 | 11.91 | 126 | 40136 | 50022 | 42531051 |
| Antacid therapy | 43.68 | 11.91 | 36 | 40226 | 4681 | 42576392 |
| Fatigue | 43.31 | 11.91 | 613 | 39649 | 435028 | 42146045 |
| Incorrect route of product administration | 42.86 | 11.91 | 80 | 40182 | 24225 | 42556848 |
| Dry mouth | 42.43 | 11.91 | 107 | 40155 | 39772 | 42541301 |
| Micturition urgency | 42.02 | 11.91 | 54 | 40208 | 11844 | 42569229 |
| Appendicitis | 40.36 | 11.91 | 71 | 40191 | 20542 | 42560531 |
| Hypophosphataemia | 39.54 | 11.91 | 71 | 40191 | 20874 | 42560199 |
| Abdominal distension | 38.65 | 11.91 | 152 | 40110 | 71583 | 42509490 |
| Neuralgia | 38.64 | 11.91 | 79 | 40183 | 25568 | 42555505 |
| Intentional overdose | 37.28 | 11.91 | 3 | 40259 | 51453 | 42529620 |
| Interstitial lung disease | 36.83 | 11.91 | 14 | 40248 | 78448 | 42502625 |
| Oedema peripheral | 36.07 | 11.91 | 236 | 40026 | 135840 | 42445233 |
| Increased upper airway secretion | 35.86 | 11.91 | 25 | 40237 | 2531 | 42578542 |
| Blood calcium increased | 35.72 | 11.91 | 42 | 40220 | 8412 | 42572661 |
| Blood test abnormal | 35.64 | 11.91 | 52 | 40210 | 12854 | 42568219 |
| Sleep disorder | 34.54 | 11.91 | 112 | 40150 | 47983 | 42533090 |
| Blood uric acid increased | 33.66 | 11.91 | 56 | 40206 | 15491 | 42565582 |
| Bacterial infection | 33.06 | 11.91 | 78 | 40184 | 27801 | 42553272 |
| Product dose omission issue | 32.93 | 11.91 | 254 | 40008 | 154111 | 42426962 |
| Gait spastic | 32.85 | 11.91 | 19 | 40243 | 1390 | 42579683 |
| Needle fatigue | 32.73 | 11.91 | 18 | 40244 | 1195 | 42579878 |
| Iron deficiency | 32.64 | 11.91 | 46 | 40216 | 11015 | 42570058 |
| Drug ineffective | 32.47 | 11.91 | 411 | 39851 | 629786 | 41951287 |
| End stage renal disease | 32.37 | 11.91 | 57 | 40205 | 16501 | 42564572 |
| Bronchopulmonary aspergillosis allergic | 32.33 | 11.91 | 30 | 40232 | 4568 | 42576505 |
| Congenital hiatus hernia | 31.78 | 11.91 | 34 | 40228 | 6140 | 42574933 |
| Cytokine release syndrome | 31.16 | 11.91 | 3 | 40259 | 44524 | 42536549 |
| Plasma cell myeloma | 30.81 | 11.91 | 107 | 40155 | 47471 | 42533602 |
| Stress | 30.00 | 11.91 | 101 | 40161 | 44111 | 42536962 |
| Renal cyst haemorrhage | 29.59 | 11.91 | 14 | 40248 | 676 | 42580397 |
| Relapsing-remitting multiple sclerosis | 29.23 | 11.91 | 18 | 40244 | 1477 | 42579596 |
| Aspiration | 29.23 | 11.91 | 57 | 40205 | 17829 | 42563244 |
| Multiple sclerosis relapse | 29.05 | 11.91 | 50 | 40212 | 14214 | 42566859 |
| Blood cholesterol increased | 28.70 | 11.91 | 72 | 40190 | 26669 | 42554404 |
| Laboratory test abnormal | 28.02 | 11.91 | 65 | 40197 | 22913 | 42558160 |
| Obstructive airways disorder | 27.99 | 11.91 | 68 | 40194 | 24691 | 42556382 |
| Troponin increased | 27.87 | 11.91 | 58 | 40204 | 19004 | 42562069 |
| Product label on wrong product | 26.89 | 11.91 | 7 | 40255 | 52 | 42581021 |
| Treatment failure | 26.49 | 11.91 | 13 | 40249 | 62611 | 42518462 |
| Total lung capacity decreased | 26.48 | 11.91 | 24 | 40238 | 3546 | 42577527 |
| Hepatic function abnormal | 26.28 | 11.91 | 8 | 40254 | 51559 | 42529514 |
| Ventricular fibrillation | 26.17 | 11.91 | 75 | 40187 | 30048 | 42551025 |
| Foreign body in throat | 26.07 | 11.91 | 12 | 40250 | 544 | 42580529 |
| Hyperlipidaemia | 25.29 | 11.91 | 60 | 40202 | 21456 | 42559617 |
| Memory impairment | 25.11 | 11.91 | 104 | 40158 | 50118 | 42530955 |
| Full blood count decreased | 24.90 | 11.91 | 58 | 40204 | 20502 | 42560571 |
| Coma | 24.40 | 11.91 | 10 | 40252 | 53544 | 42527529 |
| Mixed anxiety and depressive disorder | 24.25 | 11.91 | 9 | 40253 | 234 | 42580839 |
| Muscle spasticity | 24.15 | 11.91 | 31 | 40231 | 6791 | 42574282 |
| Hypertonic bladder | 23.80 | 11.91 | 19 | 40243 | 2362 | 42578711 |
| Suicide attempt | 23.77 | 11.91 | 7 | 40255 | 46093 | 42534980 |
| Thrombocytopenia | 23.62 | 11.91 | 96 | 40166 | 190183 | 42390890 |
| Ascites | 23.51 | 11.91 | 111 | 40151 | 56567 | 42524506 |
| Intentional product use issue | 23.45 | 11.91 | 20 | 40242 | 71813 | 42509260 |
| Asthenia | 23.12 | 11.91 | 383 | 39879 | 280410 | 42300663 |
| Pneumothorax | 22.81 | 11.91 | 61 | 40201 | 23482 | 42557591 |
| Dizziness | 22.79 | 11.91 | 346 | 39916 | 248908 | 42332165 |
| Rectal prolapse | 22.76 | 11.91 | 11 | 40251 | 557 | 42580516 |
| Gout | 22.60 | 11.91 | 68 | 40194 | 27987 | 42553086 |
| Hypervolaemia | 22.49 | 11.91 | 60 | 40202 | 23065 | 42558008 |
| Cardiac tamponade | 22.03 | 11.91 | 29 | 40233 | 6511 | 42574562 |
| Leukopenia | 21.84 | 11.91 | 23 | 40239 | 74723 | 42506350 |
| Septic shock | 21.80 | 11.91 | 33 | 40229 | 91639 | 42489434 |
| Ulcer | 21.71 | 11.91 | 48 | 40214 | 16393 | 42564680 |
| Completed suicide | 20.81 | 11.91 | 37 | 40225 | 96428 | 42484645 |
| Acute kidney injury | 20.57 | 11.91 | 235 | 40027 | 367102 | 42213971 |
| Chronic obstructive pulmonary disease | 20.21 | 11.91 | 115 | 40147 | 62999 | 42518074 |
| Pleural effusion | 20.20 | 11.91 | 159 | 40103 | 97007 | 42484066 |
| Blood testosterone decreased | 20.12 | 11.91 | 24 | 40238 | 4878 | 42576195 |
| Cardiac failure | 19.63 | 11.91 | 45 | 40217 | 106811 | 42474262 |
| Agranulocytosis | 19.13 | 11.91 | 3 | 40259 | 30609 | 42550464 |
| Cholestasis | 18.87 | 11.91 | 4 | 40258 | 32875 | 42548198 |
| Depressed level of consciousness | 18.76 | 11.91 | 11 | 40251 | 47959 | 42533114 |
| Vascular anastomotic haemorrhage | 18.68 | 11.91 | 8 | 40254 | 305 | 42580768 |
| Bacteroides infection | 18.42 | 11.91 | 17 | 40245 | 2570 | 42578503 |
| Hypoaesthesia | 18.34 | 11.91 | 123 | 40139 | 71340 | 42509733 |
| Monoparesis | 18.32 | 11.91 | 18 | 40244 | 2942 | 42578131 |
| Foetal exposure during pregnancy | 18.29 | 11.91 | 11 | 40251 | 47300 | 42533773 |
| Atrial fibrillation | 18.28 | 11.91 | 207 | 40055 | 139386 | 42441687 |
| Product use in unapproved indication | 18.23 | 11.91 | 101 | 40161 | 184355 | 42396718 |
| Loss of libido | 17.76 | 11.91 | 18 | 40244 | 3052 | 42578021 |
| Cardiac failure congestive | 17.75 | 11.91 | 140 | 40122 | 85462 | 42495611 |
| Rhabdomyolysis | 17.68 | 11.91 | 29 | 40233 | 77990 | 42503083 |
| Electrocardiogram ST-T segment depression | 17.64 | 11.91 | 4 | 40258 | 15 | 42581058 |
| Nephrogenic systemic fibrosis | 17.53 | 11.91 | 19 | 40243 | 3482 | 42577591 |
| Pleuritic pain | 17.38 | 11.91 | 27 | 40235 | 7050 | 42574023 |
| Rash maculo-papular | 17.09 | 11.91 | 7 | 40255 | 37496 | 42543577 |
| Dyspnoea | 16.96 | 11.91 | 542 | 39720 | 442079 | 42138994 |
| Vascular compression | 16.92 | 11.91 | 8 | 40254 | 386 | 42580687 |
| Neutropenia | 16.70 | 11.91 | 115 | 40147 | 199316 | 42381757 |
| Overdose | 16.51 | 11.91 | 48 | 40214 | 105216 | 42475857 |
| Cardiogenic shock | 16.42 | 11.91 | 72 | 40190 | 35568 | 42545505 |
| Drug resistance | 16.25 | 11.91 | 6 | 40256 | 34242 | 42546831 |
| Nasopharyngitis | 16.13 | 11.91 | 135 | 40127 | 83861 | 42497212 |
| Ceruloplasmin increased | 16.10 | 11.91 | 4 | 40258 | 24 | 42581049 |
| COVID-19 | 16.00 | 11.91 | 56 | 40206 | 115892 | 42465181 |
| Drug reaction with eosinophilia and systemic symptoms | 15.96 | 11.91 | 10 | 40252 | 42065 | 42539008 |
| Malignant neoplasm progression | 15.88 | 11.91 | 51 | 40211 | 108349 | 42472724 |
| Drug dependence | 15.78 | 11.91 | 4 | 40258 | 29090 | 42551983 |
| Neoplasm progression | 15.71 | 11.91 | 4 | 40258 | 28996 | 42552077 |
| Aortic stenosis | 15.68 | 11.91 | 29 | 40233 | 8716 | 42572357 |
| Intervertebral disc space narrowing | 15.60 | 11.91 | 11 | 40251 | 1134 | 42579939 |
| White blood cell count decreased | 15.50 | 11.91 | 166 | 40096 | 110230 | 42470843 |
| Renal impairment | 15.37 | 11.91 | 53 | 40209 | 110175 | 42470898 |
| Blood copper increased | 15.33 | 11.91 | 4 | 40258 | 30 | 42581043 |
| Adverse drug reaction | 15.29 | 11.91 | 73 | 40189 | 37361 | 42543712 |
| Joint injury | 15.21 | 11.91 | 39 | 40223 | 14637 | 42566436 |
| Hypokalaemia | 15.03 | 11.91 | 28 | 40234 | 71693 | 42509380 |
| Pollakiuria | 14.90 | 11.91 | 51 | 40211 | 22454 | 42558619 |
| Abdominal wall haemorrhage | 14.84 | 11.91 | 8 | 40254 | 510 | 42580563 |
| Pleuropericarditis | 14.84 | 11.91 | 7 | 40255 | 336 | 42580737 |
| Blood 25-hydroxycholecalciferol decreased | 14.84 | 11.91 | 7 | 40255 | 336 | 42580737 |
| Vena cava injury | 14.82 | 11.91 | 7 | 40255 | 337 | 42580736 |
| Acute respiratory distress syndrome | 14.76 | 11.91 | 5 | 40257 | 30103 | 42550970 |
| Wheezing | 14.48 | 11.91 | 95 | 40167 | 54686 | 42526387 |
| Delirium | 14.42 | 11.91 | 17 | 40245 | 52502 | 42528571 |
| Left ventricular hypertrophy | 14.38 | 11.91 | 29 | 40233 | 9290 | 42571783 |
| Constipation | 14.31 | 11.91 | 224 | 40038 | 162067 | 42419006 |
| Viral infection | 14.06 | 11.91 | 50 | 40212 | 22433 | 42558640 |
| Headache | 14.02 | 11.91 | 310 | 39952 | 239059 | 42342014 |
| Central nervous system lesion | 13.99 | 11.91 | 26 | 40236 | 7844 | 42573229 |
| Hepatic cytolysis | 13.98 | 11.91 | 4 | 40258 | 26840 | 42554233 |
| Lung opacity | 13.96 | 11.91 | 22 | 40240 | 5815 | 42575258 |
| Spinal stenosis | 13.77 | 11.91 | 23 | 40239 | 6383 | 42574690 |
| Chest discomfort | 13.71 | 11.91 | 105 | 40157 | 63511 | 42517562 |
| Rheumatoid arthritis | 13.63 | 11.91 | 12 | 40250 | 42428 | 42538645 |
| Abdominal pain | 13.57 | 11.91 | 254 | 40008 | 190217 | 42390856 |
| Eosinophilia | 13.32 | 11.91 | 64 | 40198 | 32835 | 42548238 |
| Drug-induced liver injury | 13.31 | 11.91 | 10 | 40252 | 38263 | 42542810 |
| Psoriasis | 13.28 | 11.91 | 85 | 40177 | 48519 | 42532554 |
| Fall | 13.19 | 11.91 | 302 | 39960 | 234218 | 42346855 |
| Myocardial necrosis | 12.91 | 11.91 | 6 | 40256 | 278 | 42580795 |
| Balance disorder | 12.82 | 11.91 | 83 | 40179 | 47562 | 42533511 |
| Erectile dysfunction | 12.77 | 11.91 | 52 | 40210 | 24861 | 42556212 |
| Chorioretinopathy | 12.77 | 11.91 | 11 | 40251 | 1520 | 42579553 |
| Insomnia | 12.72 | 11.91 | 169 | 40093 | 118084 | 42462989 |
| Pneumocystis jirovecii pneumonia | 12.66 | 11.91 | 4 | 40258 | 25177 | 42555896 |
| Scrotal oedema | 12.60 | 11.91 | 12 | 40250 | 1887 | 42579186 |
| Intraductal papillary mucinous neoplasm | 12.46 | 11.91 | 7 | 40255 | 484 | 42580589 |
| Regurgitation | 12.38 | 11.91 | 12 | 40250 | 1928 | 42579145 |
| Bone marrow failure | 12.36 | 11.91 | 8 | 40254 | 33085 | 42547988 |
| Application site infection | 12.31 | 11.91 | 4 | 40258 | 69 | 42581004 |
| C-reactive protein increased | 12.30 | 11.91 | 26 | 40236 | 63534 | 42517539 |
| Carotid arteriosclerosis | 12.28 | 11.91 | 13 | 40249 | 2319 | 42578754 |
| Therapeutic product effect incomplete | 12.13 | 11.91 | 31 | 40231 | 70908 | 42510165 |
| Aortic dilatation | 11.95 | 11.91 | 11 | 40251 | 1658 | 42579415 |
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 |
|---|---|---|---|---|---|---|
| Hypertrichosis | 282.11 | 10.28 | 92 | 99755 | 1686 | 110487766 |
| Synovitis | 231.53 | 10.28 | 3 | 99844 | 274089 | 110215363 |
| Product dose omission issue | 192.99 | 10.28 | 684 | 99163 | 321098 | 110168354 |
| Hand deformity | 174.09 | 10.28 | 5 | 99842 | 218501 | 110270951 |
| Product formulation issue | 171.82 | 10.28 | 59 | 99788 | 1275 | 110488177 |
| Toxicity to various agents | 155.05 | 10.28 | 124 | 99723 | 480431 | 110009021 |
| Systemic lupus erythematosus | 138.77 | 10.28 | 30 | 99817 | 254308 | 110235144 |
| Duodenal ulcer perforation | 138.22 | 10.28 | 5 | 99842 | 177695 | 110311757 |
| Fatigue | 137.35 | 10.28 | 1687 | 98160 | 1214271 | 109275181 |
| Off label use | 134.78 | 10.28 | 800 | 99047 | 1499385 | 108990067 |
| Drug abuse | 134.59 | 10.28 | 6 | 99841 | 177405 | 110312047 |
| Helicobacter infection | 132.16 | 10.28 | 8 | 99839 | 181869 | 110307583 |
| Contraindicated product administered | 132.01 | 10.28 | 31 | 99816 | 248236 | 110241216 |
| Glossodynia | 125.66 | 10.28 | 24 | 99823 | 221980 | 110267472 |
| Drug interaction | 123.94 | 10.28 | 162 | 99685 | 500021 | 109989431 |
| Pericarditis | 123.36 | 10.28 | 24 | 99823 | 219090 | 110270362 |
| Infusion related reaction | 117.18 | 10.28 | 103 | 99744 | 381059 | 110108393 |
| Maternal exposure during pregnancy | 111.86 | 10.28 | 45 | 99802 | 254838 | 110234614 |
| Folliculitis | 109.05 | 10.28 | 12 | 99835 | 167641 | 110321811 |
| Wound | 98.69 | 10.28 | 44 | 99803 | 234393 | 110255059 |
| Completed suicide | 98.16 | 10.28 | 48 | 99799 | 242333 | 110247119 |
| C-reactive protein increased | 94.76 | 10.28 | 39 | 99808 | 217880 | 110271572 |
| Type 2 diabetes mellitus | 92.50 | 10.28 | 23 | 99824 | 177209 | 110312243 |
| Liver injury | 90.07 | 10.28 | 14 | 99833 | 150399 | 110339053 |
| Hepatic enzyme increased | 87.87 | 10.28 | 96 | 99751 | 320796 | 110168656 |
| Treatment failure | 87.51 | 10.28 | 73 | 99774 | 277161 | 110212291 |
| Intentional overdose | 82.44 | 10.28 | 11 | 99836 | 132490 | 110356962 |
| Sleep disorder due to general medical condition, insomnia type | 82.05 | 10.28 | 3 | 99844 | 105640 | 110383812 |
| Irritable bowel syndrome | 77.08 | 10.28 | 26 | 99821 | 164189 | 110325263 |
| Dizziness | 75.57 | 10.28 | 962 | 98885 | 697231 | 109792221 |
| Pericardial effusion | 74.88 | 10.28 | 162 | 99685 | 57055 | 110432397 |
| Headache | 74.72 | 10.28 | 1164 | 98683 | 881213 | 109608239 |
| Fall | 74.68 | 10.28 | 853 | 98994 | 602629 | 109886823 |
| Analgesic therapy | 72.68 | 10.28 | 57 | 99790 | 7227 | 110482225 |
| Hyperphosphataemia | 71.55 | 10.28 | 81 | 99766 | 16300 | 110473152 |
| Product use issue | 69.18 | 10.28 | 109 | 99738 | 311586 | 110177866 |
| Fibromyalgia | 68.95 | 10.28 | 34 | 99813 | 170875 | 110318577 |
| Appendicolith | 68.33 | 10.28 | 74 | 99773 | 14181 | 110475271 |
| Sleep disorder therapy | 67.17 | 10.28 | 55 | 99792 | 7416 | 110482036 |
| Feeling abnormal | 67.16 | 10.28 | 332 | 99515 | 180379 | 110309073 |
| Intentional product use issue | 66.93 | 10.28 | 75 | 99772 | 247831 | 110241621 |
| Multiple sclerosis relapse | 66.60 | 10.28 | 143 | 99704 | 50097 | 110439355 |
| Drug therapy | 66.24 | 10.28 | 54 | 99793 | 7237 | 110482215 |
| Myelosuppression | 66.03 | 10.28 | 5 | 99842 | 94335 | 110395117 |
| Lip dry | 65.49 | 10.28 | 7 | 99840 | 100076 | 110389376 |
| Fractional exhaled nitric oxide increased | 65.07 | 10.28 | 25 | 99822 | 751 | 110488701 |
| Ill-defined disorder | 63.59 | 10.28 | 31 | 99816 | 156822 | 110332630 |
| Bursitis | 61.97 | 10.28 | 20 | 99827 | 129898 | 110359554 |
| Injection site pain | 61.30 | 10.28 | 320 | 99527 | 177602 | 110311850 |
| Device expulsion | 59.48 | 10.28 | 103 | 99744 | 30788 | 110458664 |
| Full blood count decreased | 59.18 | 10.28 | 105 | 99742 | 31994 | 110457458 |
| Myasthenia gravis | 58.46 | 10.28 | 84 | 99763 | 21427 | 110468025 |
| Injection site erythema | 57.89 | 10.28 | 202 | 99645 | 93974 | 110395478 |
| Nausea | 57.77 | 10.28 | 1491 | 98356 | 1234199 | 109255253 |
| Arthropathy | 56.99 | 10.28 | 108 | 99739 | 287414 | 110202038 |
| Blood phosphorus increased | 56.91 | 10.28 | 72 | 99775 | 16268 | 110473184 |
| Diarrhoea | 56.21 | 10.28 | 1385 | 98462 | 1138120 | 109351332 |
| Impaired healing | 55.90 | 10.28 | 57 | 99790 | 196660 | 110292792 |
| Lower respiratory tract infection | 55.87 | 10.28 | 83 | 99764 | 243023 | 110246429 |
| Drug intolerance | 55.45 | 10.28 | 185 | 99662 | 406327 | 110083125 |
| Thrombosis | 55.04 | 10.28 | 219 | 99628 | 108443 | 110381009 |
| Presbyacusis | 54.11 | 10.28 | 33 | 99814 | 2786 | 110486666 |
| Urinary tract infection | 54.11 | 10.28 | 490 | 99357 | 325792 | 110163660 |
| Anticoagulant therapy | 53.60 | 10.28 | 42 | 99805 | 5319 | 110484133 |
| Pleural thickening | 53.27 | 10.28 | 35 | 99812 | 3364 | 110486088 |
| Activated partial thromboplastin time prolonged | 53.12 | 10.28 | 82 | 99765 | 22286 | 110467166 |
| Joint swelling | 52.87 | 10.28 | 213 | 99634 | 442632 | 110046820 |
| Antacid therapy | 52.76 | 10.28 | 42 | 99805 | 5442 | 110484010 |
| Blood uric acid increased | 52.64 | 10.28 | 80 | 99767 | 21449 | 110468003 |
| Febrile neutropenia | 52.06 | 10.28 | 132 | 99715 | 316635 | 110172817 |
| Blood magnesium increased | 51.87 | 10.28 | 36 | 99811 | 3787 | 110485665 |
| Micturition urgency | 51.85 | 10.28 | 75 | 99772 | 19245 | 110470207 |
| Drug ineffective | 51.66 | 10.28 | 1016 | 98831 | 1519524 | 108969928 |
| Neuralgia | 51.03 | 10.28 | 126 | 99721 | 48352 | 110441100 |
| Back pain | 50.21 | 10.28 | 534 | 99313 | 370462 | 110118990 |
| Peripheral venous disease | 49.97 | 10.28 | 8 | 99839 | 84109 | 110405343 |
| Drug-induced liver injury | 49.78 | 10.28 | 23 | 99824 | 120044 | 110369408 |
| Stress | 49.15 | 10.28 | 207 | 99640 | 105141 | 110384311 |
| Therapy cessation | 48.72 | 10.28 | 118 | 99729 | 44739 | 110444713 |
| Blister | 48.11 | 10.28 | 82 | 99765 | 227294 | 110262158 |
| White blood cell count decreased | 47.93 | 10.28 | 363 | 99484 | 229027 | 110260425 |
| Relapsing-remitting multiple sclerosis | 46.83 | 10.28 | 27 | 99820 | 2055 | 110487397 |
| Epilepsy | 46.78 | 10.28 | 16 | 99831 | 100193 | 110389259 |
| Prescribed overdose | 46.40 | 10.28 | 11 | 99836 | 87570 | 110401882 |
| Hypervolaemia | 46.31 | 10.28 | 123 | 99724 | 49337 | 110440115 |
| Dry skin | 45.99 | 10.28 | 206 | 99641 | 107447 | 110382005 |
| Blood potassium increased | 45.64 | 10.28 | 96 | 99751 | 33153 | 110456299 |
| Blood calcium increased | 45.48 | 10.28 | 68 | 99779 | 17972 | 110471480 |
| Unevaluable event | 45.40 | 10.28 | 137 | 99710 | 59090 | 110430362 |
| Abdominal distension | 45.35 | 10.28 | 292 | 99555 | 174811 | 110314641 |
| Overdose | 45.30 | 10.28 | 89 | 99758 | 233705 | 110255747 |
| Live birth | 45.10 | 10.28 | 5 | 99842 | 69479 | 110419973 |
| General physical health deterioration | 43.86 | 10.28 | 216 | 99631 | 425079 | 110064373 |
| Cardiac disorder | 43.78 | 10.28 | 160 | 99687 | 76120 | 110413332 |
| Pleural fibrosis | 43.61 | 10.28 | 34 | 99813 | 4274 | 110485178 |
| Therapeutic product effect decreased | 43.15 | 10.28 | 98 | 99749 | 244218 | 110245234 |
| Grip strength decreased | 42.61 | 10.28 | 10 | 99837 | 80164 | 110409288 |
| Suicide attempt | 42.57 | 10.28 | 20 | 99827 | 103374 | 110386078 |
| Appendicitis | 42.39 | 10.28 | 85 | 99762 | 28379 | 110461073 |
| Joint range of motion decreased | 42.37 | 10.28 | 29 | 99818 | 121803 | 110367649 |
| Obesity | 42.14 | 10.28 | 25 | 99822 | 113326 | 110376126 |
| Dyspnoea exertional | 42.13 | 10.28 | 196 | 99651 | 103864 | 110385588 |
| Muscle spasms | 41.74 | 10.28 | 409 | 99438 | 277748 | 110211704 |
| Interstitial lung disease | 41.16 | 10.28 | 39 | 99808 | 139295 | 110350157 |
| Cytokine release syndrome | 41.06 | 10.28 | 7 | 99840 | 70299 | 110419153 |
| Exposure during pregnancy | 40.60 | 10.28 | 55 | 99792 | 167369 | 110322083 |
| Gout | 40.58 | 10.28 | 97 | 99750 | 36469 | 110452983 |
| Iron deficiency | 40.10 | 10.28 | 65 | 99782 | 18411 | 110471041 |
| Depressed level of consciousness | 40.02 | 10.28 | 26 | 99821 | 112252 | 110377200 |
| Device dislocation | 39.47 | 10.28 | 88 | 99759 | 31616 | 110457836 |
| Therapeutic product effect incomplete | 39.34 | 10.28 | 90 | 99757 | 223715 | 110265737 |
| Inflammation | 38.80 | 10.28 | 72 | 99775 | 193166 | 110296286 |
| Plasma cell myeloma | 38.67 | 10.28 | 135 | 99712 | 62801 | 110426651 |
| Cyst | 38.51 | 10.28 | 60 | 99787 | 16436 | 110473016 |
| Constipation | 37.75 | 10.28 | 491 | 99356 | 357295 | 110132157 |
| Wound infection | 37.69 | 10.28 | 20 | 99827 | 96445 | 110393007 |
| Asthenia | 36.75 | 10.28 | 847 | 99000 | 688152 | 109801300 |
| Epigastric discomfort | 36.72 | 10.28 | 43 | 99804 | 8972 | 110480480 |
| Hip fracture | 36.61 | 10.28 | 91 | 99756 | 35060 | 110454392 |
| Osteopenia | 36.33 | 10.28 | 69 | 99778 | 22140 | 110467312 |
| Cardiac failure congestive | 36.18 | 10.28 | 247 | 99600 | 150753 | 110338699 |
| Bacterial infection | 35.76 | 10.28 | 107 | 99740 | 45929 | 110443523 |
| Hepatic cytolysis | 35.64 | 10.28 | 4 | 99843 | 55049 | 110434403 |
| Needle fatigue | 35.58 | 10.28 | 19 | 99828 | 1245 | 110488207 |
| Dermatitis atopic | 35.35 | 10.28 | 74 | 99773 | 25467 | 110463985 |
| Gait spastic | 34.61 | 10.28 | 20 | 99827 | 1529 | 110487923 |
| Product use in unapproved indication | 34.58 | 10.28 | 249 | 99598 | 447128 | 110042324 |
| Congenital hiatus hernia | 34.48 | 10.28 | 35 | 99812 | 6224 | 110483228 |
| End stage renal disease | 34.25 | 10.28 | 66 | 99781 | 21407 | 110468045 |
| Hepatic function abnormal | 34.18 | 10.28 | 19 | 99828 | 89276 | 110400176 |
| Troponin increased | 34.16 | 10.28 | 80 | 99767 | 29686 | 110459766 |
| Red blood cell sedimentation rate increased | 34.04 | 10.28 | 14 | 99833 | 78288 | 110411164 |
| Onychoclasis | 33.69 | 10.28 | 37 | 99810 | 7200 | 110482252 |
| Pollakiuria | 33.65 | 10.28 | 102 | 99745 | 44093 | 110445359 |
| Autoimmune disorder | 33.19 | 10.28 | 9 | 99838 | 65474 | 110423978 |
| Flatulence | 33.03 | 10.28 | 113 | 99734 | 52036 | 110437416 |
| Dyspnoea | 32.66 | 10.28 | 1264 | 98583 | 1105608 | 109383844 |
| Balance disorder | 32.43 | 10.28 | 198 | 99649 | 116362 | 110373090 |
| Brain natriuretic peptide increased | 32.27 | 10.28 | 45 | 99802 | 11164 | 110478288 |
| Agranulocytosis | 32.24 | 10.28 | 8 | 99839 | 61752 | 110427700 |
| Increased upper airway secretion | 32.05 | 10.28 | 31 | 99816 | 5201 | 110484251 |
| Myoglobin blood increased | 31.59 | 10.28 | 28 | 99819 | 4204 | 110485248 |
| Mobility decreased | 31.03 | 10.28 | 110 | 99737 | 237312 | 110252140 |
| Bone erosion | 30.97 | 10.28 | 3 | 99844 | 46368 | 110443084 |
| Plantar fasciitis | 30.83 | 10.28 | 30 | 99817 | 5071 | 110484381 |
| Psoriatic arthropathy | 30.78 | 10.28 | 84 | 99763 | 196677 | 110292775 |
| Burning sensation | 30.74 | 10.28 | 134 | 99713 | 69078 | 110420374 |
| Drug reaction with eosinophilia and systemic symptoms | 30.66 | 10.28 | 18 | 99829 | 82077 | 110407375 |
| Nasal congestion | 30.61 | 10.28 | 172 | 99675 | 98110 | 110391342 |
| Hepatitis | 30.57 | 10.28 | 22 | 99825 | 90032 | 110399420 |
| Hypophosphataemia | 30.54 | 10.28 | 82 | 99765 | 33100 | 110456352 |
| Dry eye | 30.32 | 10.28 | 115 | 99732 | 55678 | 110433774 |
| Vision blurred | 30.29 | 10.28 | 210 | 99637 | 128812 | 110360640 |
| Discomfort | 29.74 | 10.28 | 97 | 99750 | 214610 | 110274842 |
| Acute kidney injury | 29.24 | 10.28 | 401 | 99446 | 635029 | 109854423 |
| Cholestasis | 28.93 | 10.28 | 11 | 99836 | 64507 | 110424945 |
| Haemoglobin decreased | 28.64 | 10.28 | 347 | 99500 | 248380 | 110241072 |
| Wheezing | 28.43 | 10.28 | 126 | 99721 | 255104 | 110234348 |
| Delirium | 28.27 | 10.28 | 49 | 99798 | 134976 | 110354476 |
| Oedema peripheral | 27.84 | 10.28 | 434 | 99413 | 328226 | 110161226 |
| Eye swelling | 27.77 | 10.28 | 79 | 99768 | 32969 | 110456483 |
| Influenza like illness | 27.71 | 10.28 | 155 | 99692 | 88257 | 110401195 |
| Dehydration | 27.57 | 10.28 | 379 | 99468 | 279132 | 110210320 |
| Sensation of foreign body | 27.55 | 10.28 | 35 | 99812 | 7940 | 110481512 |
| Thrombocytopenia | 27.53 | 10.28 | 193 | 99654 | 348692 | 110140760 |
| Flushing | 27.31 | 10.28 | 175 | 99672 | 104561 | 110384891 |
| Pulmonary embolism | 27.27 | 10.28 | 305 | 99542 | 214169 | 110275283 |
| Hot flush | 27.18 | 10.28 | 125 | 99722 | 65911 | 110423541 |
| Aortic stenosis | 27.07 | 10.28 | 45 | 99802 | 13014 | 110476438 |
| Pleural effusion | 26.98 | 10.28 | 262 | 99585 | 177447 | 110312005 |
| Blepharospasm | 26.95 | 10.28 | 8 | 99839 | 54843 | 110434609 |
| Product label on wrong product | 26.86 | 10.28 | 7 | 99840 | 55 | 110489397 |
| Deep vein thrombosis | 26.79 | 10.28 | 217 | 99630 | 139670 | 110349782 |
| Cytomegalovirus infection | 26.64 | 10.28 | 8 | 99839 | 54436 | 110435016 |
| Blood potassium decreased | 26.54 | 10.28 | 108 | 99739 | 54006 | 110435446 |
| Anxiety | 26.01 | 10.28 | 447 | 99400 | 344631 | 110144821 |
| Renal cyst haemorrhage | 25.91 | 10.28 | 13 | 99834 | 748 | 110488704 |
| Lung disorder | 25.87 | 10.28 | 80 | 99767 | 179967 | 110309485 |
| Blood test abnormal | 25.71 | 10.28 | 70 | 99777 | 28484 | 110460968 |
| Hyperlipidaemia | 25.68 | 10.28 | 81 | 99766 | 35767 | 110453685 |
| Stomatitis | 25.18 | 10.28 | 142 | 99705 | 270100 | 110219352 |
| Dysgeusia | 24.87 | 10.28 | 127 | 99720 | 69858 | 110419594 |
| Septic shock | 24.82 | 10.28 | 67 | 99780 | 157461 | 110331991 |
| Ascites | 24.77 | 10.28 | 156 | 99691 | 92652 | 110396800 |
| Multiple sclerosis | 24.15 | 10.28 | 64 | 99783 | 25634 | 110463818 |
| Rhabdomyolysis | 24.04 | 10.28 | 45 | 99802 | 120356 | 110369096 |
| Ventricular fibrillation | 23.99 | 10.28 | 87 | 99760 | 41226 | 110448226 |
| Weight decreased | 23.87 | 10.28 | 572 | 99275 | 467485 | 110021967 |
| Dysphonia | 23.72 | 10.28 | 133 | 99714 | 75796 | 110413656 |
| Red blood cell count decreased | 23.68 | 10.28 | 120 | 99727 | 65803 | 110423649 |
| Onychomadesis | 23.67 | 10.28 | 6 | 99841 | 45657 | 110443795 |
| Confusional state | 23.67 | 10.28 | 290 | 99557 | 468390 | 110021062 |
| Hypokalaemia | 23.52 | 10.28 | 85 | 99762 | 182363 | 110307089 |
| Pneumocystis jirovecii pneumonia | 23.37 | 10.28 | 5 | 99842 | 42730 | 110446722 |
| Skin discolouration | 23.36 | 10.28 | 97 | 99750 | 48949 | 110440503 |
| Pulmonary fibrosis | 23.27 | 10.28 | 35 | 99812 | 102007 | 110387445 |
| Total lung capacity decreased | 22.67 | 10.28 | 30 | 99817 | 7084 | 110482368 |
| Osteosclerosis | 22.63 | 10.28 | 24 | 99823 | 4491 | 110484961 |
| Rheumatoid arthritis | 22.54 | 10.28 | 168 | 99679 | 299445 | 110190007 |
| Rotator cuff syndrome | 22.48 | 10.28 | 48 | 99799 | 16746 | 110472706 |
| Deafness neurosensory | 22.47 | 10.28 | 35 | 99812 | 9584 | 110479868 |
| Fluid retention | 22.43 | 10.28 | 154 | 99693 | 94153 | 110395299 |
| Tremor | 22.35 | 10.28 | 280 | 99567 | 201952 | 110287500 |
| Incorrect route of product administration | 21.89 | 10.28 | 115 | 99732 | 63946 | 110425506 |
| Injection site swelling | 21.86 | 10.28 | 112 | 99735 | 61678 | 110427774 |
| Spinal osteoarthritis | 21.81 | 10.28 | 53 | 99794 | 20130 | 110469322 |
| Bronchopulmonary aspergillosis allergic | 21.58 | 10.28 | 32 | 99815 | 8394 | 110481058 |
| Drug resistance | 21.57 | 10.28 | 12 | 99835 | 56362 | 110433090 |
| Sedation | 21.18 | 10.28 | 19 | 99828 | 69664 | 110419788 |
| Bone pain | 20.95 | 10.28 | 115 | 99732 | 65018 | 110424434 |
| Hospice care | 20.71 | 10.28 | 39 | 99808 | 12434 | 110477018 |
| Cardiac failure | 20.66 | 10.28 | 93 | 99754 | 187533 | 110301919 |
| Electrocardiogram QT prolonged | 20.65 | 10.28 | 42 | 99805 | 108918 | 110380534 |
| Spinal stenosis | 20.55 | 10.28 | 50 | 99797 | 19006 | 110470446 |
| Pyrexia | 20.32 | 10.28 | 637 | 99210 | 897628 | 109591824 |
| Somnolence | 20.17 | 10.28 | 379 | 99468 | 297070 | 110192382 |
| Lactic acidosis | 20.06 | 10.28 | 33 | 99814 | 92778 | 110396674 |
| Therapeutic response unexpected | 20.04 | 10.28 | 57 | 99790 | 23786 | 110465666 |
| Finger deformity | 19.99 | 10.28 | 3 | 99844 | 33089 | 110456363 |
| Mental status changes | 19.73 | 10.28 | 127 | 99720 | 75995 | 110413457 |
| Atrial fibrillation | 19.72 | 10.28 | 304 | 99543 | 229338 | 110260114 |
| Drug eruption | 19.71 | 10.28 | 12 | 99835 | 53647 | 110435805 |
| Anaphylactic shock | 19.68 | 10.28 | 11 | 99836 | 51535 | 110437917 |
| Chronic obstructive pulmonary disease | 19.65 | 10.28 | 167 | 99680 | 108991 | 110380461 |
| Pain in extremity | 19.56 | 10.28 | 577 | 99270 | 486541 | 110002911 |
| Hypertonic bladder | 19.48 | 10.28 | 24 | 99823 | 5278 | 110484174 |
| Pulmonary hypertension | 19.47 | 10.28 | 100 | 99747 | 55120 | 110434332 |
| Leukopenia | 19.39 | 10.28 | 69 | 99778 | 148722 | 110340730 |
| Serotonin syndrome | 19.37 | 10.28 | 15 | 99832 | 59138 | 110430314 |
| Foreign body in throat | 19.27 | 10.28 | 12 | 99835 | 1051 | 110488401 |
| Neutropenia | 19.21 | 10.28 | 231 | 99616 | 374389 | 110115063 |
| Aspiration | 19.20 | 10.28 | 66 | 99781 | 30467 | 110458985 |
| Mucosal inflammation | 19.13 | 10.28 | 36 | 99811 | 96105 | 110393347 |
| Vascular anastomotic haemorrhage | 19.03 | 10.28 | 8 | 99839 | 305 | 110489147 |
| Injection site bruising | 18.90 | 10.28 | 94 | 99753 | 51169 | 110438283 |
| Haematocrit decreased | 18.82 | 10.28 | 113 | 99734 | 66004 | 110423448 |
| Haemophagocytic lymphohistiocytosis | 18.74 | 10.28 | 3 | 99844 | 31556 | 110457896 |
| Cellulitis | 18.74 | 10.28 | 185 | 99662 | 125831 | 110363621 |
| Osteonecrosis of jaw | 18.69 | 10.28 | 10 | 99837 | 48007 | 110441445 |
| Influenza | 18.63 | 10.28 | 234 | 99613 | 168867 | 110320585 |
| Bone marrow failure | 18.52 | 10.28 | 15 | 99832 | 57833 | 110431619 |
| Hypocalcaemia | 18.49 | 10.28 | 19 | 99828 | 65347 | 110424105 |
| Skin exfoliation | 18.45 | 10.28 | 139 | 99708 | 87512 | 110401940 |
| Cardiac tamponade | 18.34 | 10.28 | 35 | 99812 | 11272 | 110478180 |
| Acute respiratory distress syndrome | 18.05 | 10.28 | 13 | 99834 | 53185 | 110436267 |
| Complication associated with device | 17.87 | 10.28 | 49 | 99798 | 20024 | 110469428 |
| Meniscus injury | 17.71 | 10.28 | 28 | 99819 | 7765 | 110481687 |
| Neuropathy peripheral | 17.63 | 10.28 | 243 | 99604 | 179034 | 110310418 |
| Coronary artery disease | 17.60 | 10.28 | 118 | 99729 | 71572 | 110417880 |
| Pelvic pain | 17.38 | 10.28 | 42 | 99805 | 15900 | 110473552 |
| Bacteroides infection | 17.33 | 10.28 | 17 | 99830 | 2902 | 110486550 |
| Application site pain | 17.23 | 10.28 | 23 | 99824 | 5476 | 110483976 |
| Intervertebral disc space narrowing | 17.13 | 10.28 | 14 | 99833 | 1882 | 110487570 |
| Injection site mass | 17.07 | 10.28 | 55 | 99792 | 24558 | 110464894 |
| Restless legs syndrome | 17.05 | 10.28 | 55 | 99792 | 24571 | 110464881 |
| Respiratory depression | 16.99 | 10.28 | 4 | 99843 | 31997 | 110457455 |
| Left ventricular hypertrophy | 16.75 | 10.28 | 37 | 99810 | 13207 | 110476245 |
| Benign prostatic hyperplasia | 16.72 | 10.28 | 45 | 99802 | 18189 | 110471263 |
| Lupus-like syndrome | 16.62 | 10.28 | 8 | 99839 | 40784 | 110448668 |
| Viral infection | 16.54 | 10.28 | 93 | 99754 | 53046 | 110436406 |
| Rash maculo-papular | 16.40 | 10.28 | 26 | 99821 | 74196 | 110415256 |
| Myalgia | 16.36 | 10.28 | 287 | 99560 | 222094 | 110267358 |
| Depression | 16.22 | 10.28 | 388 | 99459 | 316947 | 110172505 |
| Electrocardiogram ST-T segment depression | 16.14 | 10.28 | 4 | 99843 | 25 | 110489427 |
| Bone cyst | 16.05 | 10.28 | 18 | 99829 | 3585 | 110485867 |
| Neutropenic sepsis | 16.01 | 10.28 | 4 | 99843 | 30742 | 110458710 |
| Psoriasis | 15.97 | 10.28 | 195 | 99652 | 139798 | 110349654 |
| Central nervous system lesion | 15.92 | 10.28 | 40 | 99807 | 15513 | 110473939 |
| Ceruloplasmin increased | 15.88 | 10.28 | 4 | 99843 | 27 | 110489425 |
| Product preparation error | 15.62 | 10.28 | 32 | 99815 | 10847 | 110478605 |
| Hospitalisation | 15.62 | 10.28 | 197 | 99650 | 142296 | 110347156 |
| Night sweats | 15.61 | 10.28 | 65 | 99782 | 133918 | 110355534 |
| Hyperparathyroidism secondary | 15.57 | 10.28 | 17 | 99830 | 3287 | 110486165 |
| Small intestinal obstruction | 15.57 | 10.28 | 64 | 99783 | 32149 | 110457303 |
| Gallbladder disorder | 15.51 | 10.28 | 48 | 99799 | 20981 | 110468471 |
| Memory impairment | 15.51 | 10.28 | 257 | 99590 | 196687 | 110292765 |
| Disseminated intravascular coagulation | 15.49 | 10.28 | 9 | 99838 | 41277 | 110448175 |
| Liver disorder | 15.36 | 10.28 | 71 | 99776 | 142172 | 110347280 |
| Squamous cell carcinoma of skin | 15.32 | 10.28 | 42 | 99805 | 17161 | 110472291 |
| Injection site urticaria | 15.30 | 10.28 | 42 | 99805 | 17173 | 110472279 |
| Erectile dysfunction | 15.24 | 10.28 | 44 | 99803 | 18512 | 110470940 |
| Joint injury | 15.21 | 10.28 | 74 | 99773 | 39920 | 110449532 |
| Hypersensitivity | 15.14 | 10.28 | 265 | 99582 | 403733 | 110085719 |
| Acute hepatic failure | 15.09 | 10.28 | 7 | 99840 | 36461 | 110452991 |
| Increased tendency to bruise | 15.05 | 10.28 | 33 | 99814 | 11725 | 110477727 |
| Upper respiratory tract infection | 15.01 | 10.28 | 183 | 99664 | 131145 | 110358307 |
| Gamma-glutamyltransferase increased | 15 | 10.28 | 20 | 99827 | 61289 | 110428163 |
| Insomnia | 14.98 | 10.28 | 429 | 99418 | 360161 | 110129291 |
| Vena cava injury | 14.96 | 10.28 | 7 | 99840 | 345 | 110489107 |
| Neuroleptic malignant syndrome | 14.95 | 10.28 | 6 | 99841 | 34053 | 110455399 |
| Altered state of consciousness | 14.93 | 10.28 | 18 | 99829 | 57608 | 110431844 |
| Alopecia | 14.89 | 10.28 | 433 | 99414 | 364320 | 110125132 |
| Carotid arteriosclerosis | 14.88 | 10.28 | 16 | 99831 | 3041 | 110486411 |
| Hypercholesterolaemia | 14.79 | 10.28 | 38 | 99809 | 90799 | 110398653 |
| Sciatica | 14.78 | 10.28 | 39 | 99808 | 92360 | 110397092 |
| Poisoning | 14.75 | 10.28 | 4 | 99843 | 29101 | 110460351 |
| Hair texture abnormal | 14.69 | 10.28 | 18 | 99829 | 3936 | 110485516 |
| Hepatic cirrhosis | 14.65 | 10.28 | 24 | 99823 | 67602 | 110421850 |
| Heavy menstrual bleeding | 14.62 | 10.28 | 40 | 99807 | 16325 | 110473127 |
| Blood copper increased | 14.49 | 10.28 | 4 | 99843 | 40 | 110489412 |
| Dermatitis contact | 14.40 | 10.28 | 36 | 99811 | 13917 | 110475535 |
| Scrotal oedema | 14.33 | 10.28 | 12 | 99835 | 1669 | 110487783 |
| Haemorrhoids | 14.29 | 10.28 | 67 | 99780 | 35605 | 110453847 |
| Intentional self-injury | 14.27 | 10.28 | 8 | 99839 | 37421 | 110452031 |
| Eructation | 14.23 | 10.28 | 36 | 99811 | 14021 | 110475431 |
| Cough | 14.21 | 10.28 | 530 | 99317 | 461111 | 110028341 |
| Injection site pruritus | 14.20 | 10.28 | 87 | 99760 | 51171 | 110438281 |
| Monoparesis | 14.20 | 10.28 | 19 | 99828 | 4534 | 110484918 |
| Abdominal pain | 14.16 | 10.28 | 582 | 99265 | 512407 | 109977045 |
| Blood testosterone decreased | 14.03 | 10.28 | 15 | 99832 | 2833 | 110486619 |
| Application site pruritus | 13.96 | 10.28 | 18 | 99829 | 4142 | 110485310 |
| Injection site haemorrhage | 13.95 | 10.28 | 63 | 99784 | 32965 | 110456487 |
| Body height decreased | 13.92 | 10.28 | 30 | 99817 | 10533 | 110478919 |
| Bronchitis | 13.91 | 10.28 | 209 | 99638 | 156823 | 110332629 |
| Vaginal haemorrhage | 13.89 | 10.28 | 52 | 99795 | 25022 | 110464430 |
| Gait disturbance | 13.86 | 10.28 | 339 | 99508 | 277869 | 110211583 |
| Transient ischaemic attack | 13.77 | 10.28 | 102 | 99745 | 63880 | 110425572 |
| Abdominal discomfort | 13.61 | 10.28 | 262 | 99585 | 393596 | 110095856 |
| Anaphylactic reaction | 13.60 | 10.28 | 55 | 99792 | 114245 | 110375207 |
| Cardiac arrest | 13.54 | 10.28 | 113 | 99734 | 196640 | 110292812 |
| Injury | 13.51 | 10.28 | 99 | 99748 | 177166 | 110312286 |
| Hypogeusia | 13.48 | 10.28 | 13 | 99834 | 2174 | 110487278 |
| Toxic epidermal necrolysis | 13.38 | 10.28 | 19 | 99828 | 56708 | 110432744 |
| Palpitations | 13.37 | 10.28 | 210 | 99637 | 159002 | 110330450 |
| Application site dryness | 13.25 | 10.28 | 6 | 99841 | 274 | 110489178 |
| Madarosis | 13.25 | 10.28 | 16 | 99831 | 3447 | 110486005 |
| Skin laceration | 13.23 | 10.28 | 63 | 99784 | 33690 | 110455762 |
| Aortic dilatation | 13.18 | 10.28 | 13 | 99834 | 2233 | 110487219 |
| Urinary incontinence | 13.17 | 10.28 | 82 | 99765 | 48505 | 110440947 |
| Vitamin D decreased | 13.12 | 10.28 | 32 | 99815 | 12183 | 110477269 |
| Malignant neoplasm progression | 13.06 | 10.28 | 98 | 99749 | 174469 | 110314983 |
| Hair growth abnormal | 12.98 | 10.28 | 16 | 99831 | 3521 | 110485931 |
| Blood 25-hydroxycholecalciferol decreased | 12.96 | 10.28 | 7 | 99840 | 469 | 110488983 |
| Dialysis | 12.85 | 10.28 | 43 | 99804 | 19576 | 110469876 |
| Ageusia | 12.82 | 10.28 | 43 | 99804 | 19602 | 110469850 |
| Blood creatinine increased | 12.73 | 10.28 | 234 | 99613 | 182655 | 110306797 |
| Skin burning sensation | 12.71 | 10.28 | 46 | 99801 | 21779 | 110467673 |
| Therapy partial responder | 12.65 | 10.28 | 9 | 99838 | 37052 | 110452400 |
| Product administration interrupted | 12.58 | 10.28 | 30 | 99817 | 11262 | 110478190 |
| Swelling face | 12.51 | 10.28 | 133 | 99714 | 92188 | 110397264 |
| Full blood count abnormal | 12.43 | 10.28 | 90 | 99757 | 55962 | 110433490 |
| Abdominal wall haemorrhage | 12.40 | 10.28 | 8 | 99839 | 745 | 110488707 |
| Oroticaciduria | 12.36 | 10.28 | 3 | 99844 | 17 | 110489435 |
| Occupational asthma | 12.36 | 10.28 | 3 | 99844 | 17 | 110489435 |
| Respiratory arrest | 12.35 | 10.28 | 21 | 99826 | 58278 | 110431174 |
| Eosinophilic pleural effusion | 12.28 | 10.28 | 7 | 99840 | 521 | 110488931 |
| Blood glucose decreased | 12.27 | 10.28 | 56 | 99791 | 29432 | 110460020 |
| Dystonia | 12.25 | 10.28 | 4 | 99843 | 25801 | 110463651 |
| Neurotoxicity | 12.25 | 10.28 | 12 | 99835 | 42195 | 110447257 |
| Application site discolouration | 12.21 | 10.28 | 9 | 99838 | 1040 | 110488412 |
| Concussion | 12.15 | 10.28 | 30 | 99817 | 11508 | 110477944 |
| Upper limb fracture | 12.14 | 10.28 | 44 | 99803 | 20844 | 110468608 |
| Vascular compression | 12.14 | 10.28 | 8 | 99839 | 773 | 110488679 |
| Pancytopenia | 12.02 | 10.28 | 126 | 99721 | 209487 | 110279965 |
| Application site erosion | 12.01 | 10.28 | 6 | 99841 | 342 | 110489110 |
| Polyneuropathy | 11.98 | 10.28 | 7 | 99840 | 32005 | 110457447 |
| Adverse event | 11.93 | 10.28 | 54 | 99793 | 108755 | 110380697 |
| Lower limb fracture | 11.90 | 10.28 | 32 | 99815 | 75316 | 110414136 |
| Vasculitis | 11.87 | 10.28 | 9 | 99838 | 35864 | 110453588 |
| Appendicectomy | 11.84 | 10.28 | 15 | 99832 | 3392 | 110486060 |
| Nocturia | 11.81 | 10.28 | 38 | 99809 | 16952 | 110472500 |
| Skin irritation | 11.81 | 10.28 | 37 | 99810 | 16282 | 110473170 |
| Drug hypersensitivity | 11.75 | 10.28 | 316 | 99531 | 453774 | 110035678 |
| Taste disorder | 11.72 | 10.28 | 26 | 99821 | 65361 | 110424091 |
| Chronic sinusitis | 11.71 | 10.28 | 4 | 99843 | 25080 | 110464372 |
| Ventricular hypertrophy | 11.66 | 10.28 | 22 | 99825 | 7023 | 110482429 |
| Cardiac stress test abnormal | 11.64 | 10.28 | 8 | 99839 | 828 | 110488624 |
| Shock | 11.63 | 10.28 | 19 | 99828 | 53569 | 110435883 |
| Circulatory collapse | 11.60 | 10.28 | 13 | 99834 | 42980 | 110446472 |
| Vitamin D deficiency | 11.57 | 10.28 | 40 | 99807 | 18512 | 110470940 |
| Pulmonary arterial hypertension | 11.50 | 10.28 | 59 | 99788 | 32509 | 110456943 |
| Pruritus | 11.42 | 10.28 | 638 | 99209 | 580922 | 109908530 |
| Intentional dose omission | 11.42 | 10.28 | 42 | 99805 | 20038 | 110469414 |
| Parkinsonism | 11.34 | 10.28 | 3 | 99844 | 22184 | 110467268 |
| Cardio-respiratory arrest | 11.26 | 10.28 | 60 | 99787 | 115776 | 110373676 |
| Laryngitis | 11.25 | 10.28 | 13 | 99834 | 42398 | 110447054 |
| Heart valve replacement | 11.16 | 10.28 | 9 | 99838 | 1187 | 110488265 |
| Aplastic anaemia | 11.14 | 10.28 | 4 | 99843 | 24304 | 110465148 |
| Polyarteritis nodosa | 11.09 | 10.28 | 7 | 99840 | 628 | 110488824 |
| Tubulointerstitial nephritis | 11.09 | 10.28 | 20 | 99827 | 54264 | 110435188 |
| Intervertebral disc protrusion | 11.08 | 10.28 | 52 | 99795 | 27646 | 110461806 |
| Breast cancer | 11.05 | 10.28 | 66 | 99781 | 38476 | 110450976 |
| Skin wrinkling | 11.05 | 10.28 | 10 | 99837 | 1543 | 110487909 |
| Application site irritation | 10.98 | 10.28 | 11 | 99836 | 1926 | 110487526 |
| Gait inability | 10.96 | 10.28 | 75 | 99772 | 136301 | 110353151 |
| Acute generalised exanthematous pustulosis | 10.94 | 10.28 | 3 | 99844 | 21661 | 110467791 |
| Lung opacity | 10.93 | 10.28 | 29 | 99818 | 11623 | 110477829 |
| Perineal cyst | 10.83 | 10.28 | 5 | 99842 | 239 | 110489213 |
| Surgery | 10.77 | 10.28 | 69 | 99778 | 41214 | 110448238 |
| Asthma | 10.76 | 10.28 | 160 | 99687 | 250131 | 110239321 |
| Hepatotoxicity | 10.73 | 10.28 | 26 | 99821 | 63374 | 110426078 |
| Pleuropericarditis | 10.73 | 10.28 | 7 | 99840 | 665 | 110488787 |
| Peritonitis bacterial | 10.69 | 10.28 | 27 | 99820 | 10506 | 110478946 |
| Chills | 10.65 | 10.28 | 236 | 99611 | 190344 | 110299108 |
| Hypoacusis | 10.57 | 10.28 | 61 | 99786 | 35130 | 110454322 |
| Inappropriate antidiuretic hormone secretion | 10.56 | 10.28 | 9 | 99838 | 33842 | 110455610 |
| Limb discomfort | 10.49 | 10.28 | 68 | 99779 | 40786 | 110448666 |
| Product complaint | 10.40 | 10.28 | 32 | 99815 | 13940 | 110475512 |
| Coma | 10.40 | 10.28 | 63 | 99784 | 117806 | 110371646 |
| Progressive multiple sclerosis | 10.36 | 10.28 | 9 | 99838 | 1315 | 110488137 |
| Injection site induration | 10.34 | 10.28 | 28 | 99819 | 11355 | 110478097 |
| Pre-existing condition improved | 10.34 | 10.28 | 20 | 99827 | 6506 | 110482946 |
| Gastrointestinal disorder | 10.29 | 10.28 | 155 | 99692 | 241797 | 110247655 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | A11HA05 | ALIMENTARY TRACT AND METABOLISM VITAMINS OTHER PLAIN VITAMIN PREPARATIONS Other plain vitamin preparations |
| MeSH PA | D014803 | Vitamin B Complex |
| MeSH PA | D014815 | Vitamins |
| MeSH PA | D018977 | Micronutrients |
| CHEBI has role | CHEBI:23354 | coenzyme |
| CHEBI has role | CHEBI:23357 | cofactor |
| CHEBI has role | CHEBI:26348 | prosthetic group |
| CHEBI has role | CHEBI:35526 | hypoglycemic agent |
| CHEBI has role | CHEBI:35554 | cardiovascular drug |
| CHEBI has role | CHEBI:35705 | immunosuppressive agent |
| CHEBI has role | CHEBI:50733 | nutraceutical |
| CHEBI has role | CHEBI:65023 | anti-asthmatic agent |
| CHEBI has role | CHEBI:75771 | mouse metabolite |
| CHEBI has role | CHEBI:75772 | <em>Saccharomyces cerevisiae </em> metabolite |
| CHEBI has role | CHEBI:75835 | anti-anaemic agent |
| CHEBI has role | CHEBI:76971 | <em>Escherichia coli</em> metabolite |
| CHEBI has role | CHEBI:77746 | human metabolite |
| CHEBI has role | CHEBI:78675 | fundamental metabolite |
| CHEBI has role | CHEBI:231911 | renoprotective agent |
Related Drugs by ATC class:
A11HA Other plain vitamin preparations 10 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Biotin deficiency disease | indication | 49607006 | |
| Biotinidase deficiency | off-label use | 8808004 | DOID:856 |
| Propionic acidemia | off-label use | 69080001 | DOID:14701 |
| Holocarboxylase synthase deficiency | off-label use | 360369003 | DOID:859 |
| Constipation | contraindication | 14760008 | DOID:2089 |
| Sarcoidosis | contraindication | 31541009 | DOID:11335 |
| Dehydration | contraindication | 34095006 | |
| Hypercalcemia | contraindication | 66931009 | DOID:12678 |
| Hyperparathyroidism | contraindication | 66999008 | DOID:13543 |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Kidney stone | contraindication | 95570007 | |
| Osteolysis | contraindication | 203522001 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 4.79 | acidic |
| pKa2 | 13.37 | acidic |
Orange Book patent data (new drug applications)
None
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML | MULTIPLE VITAMINS INJECTION ADULT | APOTEX | A210672 | April 9, 2026 | RX | SOLUTION | INTRAVENOUS | Dec. 1, 2026 | COMPETITIVE GENERIC THERAPY |
| 80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL | MULTIPLE VITAMINS INJECTION PEDIATRIC | APOTEX | A210671 | April 21, 2026 | RX | INJECTABLE | INTRAVENOUS | Dec. 21, 2026 | COMPETITIVE GENERIC THERAPY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Insulin-degrading enzyme | Enzyme | EC50 | 5.60 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4017638 | VUID |
| N0000146018 | NUI |
| D00029 | KEGG_DRUG |
| 1588 | RXNORM |
| C0005575 | UMLSCUI |
| CHEBI:15956 | CHEBI |
| BTN | PDB_CHEM_ID |
| CHEMBL857 | ChEMBL_ID |
| DB00121 | DRUGBANK_ID |
| D001710 | MESH_DESCRIPTOR_UI |
| 171548 | PUBCHEM_CID |
| 4787 | IUPHAR_LIGAND_ID |
| 1203 | INN_ID |
| 6SO6U10H04 | UNII |
| 11819 | MMSL |
| 118935 | MMSL |
| 118941 | MMSL |
| 41034 | MMSL |
| d06867 | MMSL |
| 13813003 | SNOMEDCT_US |
| 8919000 | SNOMEDCT_US |
| 4017638 | VANDF |
| 4020110 | VANDF |
| 001035 | NDDF |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Strovite OneCaplets | HUMAN PRESCRIPTION DRUG LABEL | 20 | 0642-0207 | TABLET | 100 ug | ORAL | unapproved drug other | 14 sections |
| BACMIN | HUMAN PRESCRIPTION DRUG LABEL | 19 | 0682-3001 | TABLET, COATED | 150 ug | ORAL | UNAPPROVED DRUG OTHER | 10 sections |
| Dialyvite Supreme D | HUMAN PRESCRIPTION DRUG LABEL | 13 | 10542-009 | TABLET, COATED | 300 ug | ORAL | Unapproved drug other | 7 sections |
| Dialyvite | HUMAN PRESCRIPTION DRUG LABEL | 9 | 10542-010 | TABLET, COATED | 300 ug | ORAL | Unapproved drug other | 7 sections |
| Dialyvite 5000 | HUMAN PRESCRIPTION DRUG LABEL | 12 | 10542-011 | TABLET, COATED | 300 ug | ORAL | Unapproved drug other | 7 sections |
| Dialyvite with Zinc | HUMAN PRESCRIPTION DRUG LABEL | 10 | 10542-012 | TABLET, COATED | 300 ug | ORAL | Unapproved drug other | 7 sections |
| Dialyvite 3000 | HUMAN PRESCRIPTION DRUG LABEL | 12 | 10542-014 | TABLET, COATED | 300 ug | ORAL | Unapproved drug other | 7 sections |
| JBA Collagen-Electrolyte Mocktail | HUMAN OTC DRUG LABEL | 12 | 13411-848 | POWDER | 80 ug | ORAL | unapproved drug other | 6 sections |
| Quflora FE Pediatric Drops | HUMAN PRESCRIPTION DRUG LABEL | 14 | 15370-102 | LIQUID | 3 ug | ORAL | UNAPPROVED DRUG OTHER | 11 sections |
| Dialyvite | HUMAN PRESCRIPTION DRUG LABEL | 9 | 17856-0010 | TABLET, COATED | 300 ug | ORAL | Unapproved drug other | 8 sections |
| PNV-Select | HUMAN PRESCRIPTION DRUG LABEL | 18 | 42192-320 | TABLET, FILM COATED | 300 ug | ORAL | unapproved drug other | 10 sections |
| PNV-Omega | HUMAN PRESCRIPTION DRUG LABEL | 13 | 42192-332 | CAPSULE, GELATIN COATED | 250 ug | ORAL | unapproved drug other | 12 sections |
| HairQ-Plus | HUMAN OTC DRUG LABEL | 1 | 49658-2001 | SHAMPOO | 0.06 mL | TOPICAL | unapproved drug other | 8 sections |
| HairQ-Plus | HUMAN OTC DRUG LABEL | 1 | 49658-4001 | SOLUTION | 0.06 mL | TOPICAL | unapproved drug other | 8 sections |
| Bonogenhair care shampoo | HUMAN OTC DRUG LABEL | 4 | 50653-1001 | SHAMPOO | 0.06 g | TOPICAL | unapproved drug other | 2 sections |
| Bonogen Plushair care shampoo | HUMAN OTC DRUG LABEL | 4 | 50653-2001 | SHAMPOO | 0.06 g | TOPICAL | unapproved drug other | 2 sections |
| Bonogen Activatorhair loss treatment | HUMAN OTC DRUG LABEL | 1 | 50653-3001 | LIQUID | 0.00 mL | TOPICAL | unapproved drug other | 3 sections |
| Born Hair | HUMAN OTC DRUG LABEL | 4 | 50653-4001 | SHAMPOO | 0.06 g | TOPICAL | unapproved drug other | 7 sections |
| Doll Lash | HUMAN OTC DRUG LABEL | 4 | 51329-1001 | LIQUID | 0.06 mL | TOPICAL | unapproved drug other | 8 sections |
| Concept OB | HUMAN PRESCRIPTION DRUG LABEL | 15 | 52747-620 | CAPSULE | 300 ug | ORAL | unapproved drug other | 13 sections |
| Concept DHA | HUMAN PRESCRIPTION DRUG LABEL | 15 | 52747-621 | CAPSULE, LIQUID FILLED | 300 ug | ORAL | unapproved drug other | 7 sections |
| Integra Plus | HUMAN PRESCRIPTION DRUG LABEL | 10 | 52747-712 | CAPSULE | 300 ug | ORAL | unapproved drug other | 12 sections |
| Floriva | HUMAN PRESCRIPTION DRUG LABEL | 16 | 52796-173 | TABLET, CHEWABLE | 40 ug | ORAL | UNAPPROVED DRUG OTHER | 6 sections |
| Floriva | HUMAN PRESCRIPTION DRUG LABEL | 16 | 52796-174 | TABLET, CHEWABLE | 40 ug | ORAL | UNAPPROVED DRUG OTHER | 6 sections |
| Floriva | HUMAN PRESCRIPTION DRUG LABEL | 16 | 52796-177 | TABLET, CHEWABLE | 40 ug | ORAL | UNAPPROVED DRUG OTHER | 7 sections |
| Adult Infuvite Multiple Vitamins | HUMAN PRESCRIPTION DRUG LABEL | 13 | 54643-9007 | INJECTION, SOLUTION | 60 ug | INTRAVENOUS | NDA | 20 sections |
| Adult Infuvite Multiple Vitamins | HUMAN PRESCRIPTION DRUG LABEL | 13 | 54643-9015 | INJECTION, SOLUTION | 60 ug | INTRAVENOUS | NDA | 20 sections |
| Pediatric Infuvite Multiple Vitamins | HUMAN PRESCRIPTION DRUG LABEL | 13 | 54643-9023 | INJECTION, SOLUTION | 20 ug | INTRAVENOUS | NDA | 19 sections |
| Pediatric Infuvite Multiple Vitamins | HUMAN PRESCRIPTION DRUG LABEL | 13 | 54643-9023 | INJECTION, SOLUTION | 20 ug | INTRAVENOUS | NDA | 19 sections |
| healthy mamaBE WELL ROUNDED BE WELL ROUNDED | HUMAN PRESCRIPTION DRUG LABEL | 17 | 58154-107 | TABLET, FILM COATED | 30 ug | ORAL | unapproved drug other | 8 sections |