biotin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
373 58-85-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • biotin
  • coenzyme R
  • D-Biotin
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.
  • Molecular weight: 244.31
  • Formula: C10H16N2O3S
  • CLOGP: -0.08
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 3
  • TPSA: 78.43
  • ALOGS: -2.30
  • ROTB: 5
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
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):

PropertyDescriptionValueUnitConfidenceSimilarity
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:

DateAgencyCompanyOrphan
Feb. 20, 1953 FDA HOSPIRA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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:

SourceCodeDescription
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
calcium pantothenatedexpanthenolinositolnicotinamidepantethinepyridoxal phosphatepyridoxineriboflavintocofersolanVitamin E

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

DiseaseRelationSNOMED_IDDOID
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 levelDissociation constantType (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 strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Insulin-degrading enzyme Enzyme EC50 5.60 CHEMBL

External reference:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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