nicotinic acid ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
nicotinic acid or nicotinoyl alcohol derivatives 2835 59-67-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • niacin potassium
  • niacin magnesium
  • nicotinic acid
  • vitamin b3 (niacin)
  • 3-pyridinecarboxylic acid
  • niaspan
  • niacin
  • niacor
  • Vitamin B3
A water-soluble vitamin of the B complex occurring in various animal and plant tissues. It is required by the body for the formation of coenzymes NAD and NADP. It has PELLAGRA-curative, vasodilating, and antilipemic properties.
  • Molecular weight: 123.11
  • Formula: C6H5NO2
  • CLOGP: 0.80
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 1
  • TPSA: 50.19
  • ALOGS: -0.17
  • ROTB: 1

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.20 g O
0.20 g P
2 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 18 mg/mL Bocci G, Oprea TI, Benet LZ
MRTD (Maximum Recommended Therapeutic Daily Dose) 101.53 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 68 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 -3.146 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.635 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 2.529 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 1.637 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 71.010 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 76.760 % High 1
herg hERG pIC50 4.588 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 2.642 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 3.319 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 78.090 % High 1
kinase-safety-class ACVR2A,ACVR2B,ALK,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GRK3,GSK3B,ITK,JAK1,JAK2,KDR,MAP2K6,MAP3K14,MAP3K21,MAP3K7,MAPK12,MAPK7,MAPK9,MAPKAPK2,MTOR,NTRK2,PDK1,PDK2,PIK3CB,PIK3CD,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ULK1 51
kinase-selectivity-class ACVR2B,AXL,BRAF,CDK9,DYRK1B,EIF2AK3,EPHB4,GRK2,MAPK7,PIK3CD,PRKDC,SIK2,STK33,TGFBR1,TTK 15
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 0.389 High 1
mh-clint Mouse hepatocyte intrinsic clearance 1.321 High 1
mppb Mouse plasma protein binding (% unbound) 93.860 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 0.318 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1
pppb Pig plasma protein binding (% unbound) 71.990 % High 1
rh-clint Rat hepatocyte intrinsic clearance 1.189 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 91.450 % High 1
rppb Rat plasma protein binding (% unbound) 63.950 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 950.605 uM High 1

Approvals:

DateAgencyCompanyOrphan
July 24, 1957 FDA MEDPOINTE PHARM HLC

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
Pemphigus 164.73 9.84 6 52999 326858 90248584
Synovitis 159.72 9.84 8 52997 329744 90245698
Hand deformity 154.53 9.84 4 53001 296358 90279084
Contraindicated product administered 142.56 9.84 12 52993 320127 90255315
Systemic lupus erythematosus 137.95 9.84 23 52982 361873 90213569
Glossodynia 133.04 9.84 16 52989 321763 90253679
Infusion related reaction 128.29 9.84 42 52963 416738 90158704
Anti-cyclic citrullinated peptide antibody positive 120.28 9.84 4 53001 236429 90339013
Product dose omission issue 119.77 9.84 409 52596 291278 90284164
Pericarditis 117.89 9.84 11 52994 270140 90305302
Off label use 114.01 9.84 303 52702 1101949 89473493
Product use in unapproved indication 108.64 9.84 31 52974 336205 90239237
Wound 107.47 9.84 23 52982 302957 90272485
Duodenal ulcer perforation 102.14 9.84 7 52998 221281 90354161
Fall 99.62 9.84 549 52456 481261 90094181
Helicobacter infection 99.60 9.84 9 52996 226841 90348601
Treatment failure 98.22 9.84 28 52977 303900 90271542
Maternal exposure during pregnancy 96.40 9.84 45 52960 360018 90215424
Diarrhoea 89.42 9.84 889 52116 938301 89637141
Drug intolerance 84.90 9.84 82 52923 447509 90127933
Folliculitis 84.82 9.84 10 52995 204343 90371099
Rheumatoid factor positive 83.59 9.84 4 53001 171646 90403796
Lower respiratory tract infection 77.52 9.84 25 52980 250634 90324808
Muscle injury 74.94 9.84 8 52997 176646 90398796
General physical health deterioration 73.40 9.84 60 52945 355055 90220387
Rheumatic fever 73.19 9.84 4 53001 153117 90422325
Unevaluable event 71.79 9.84 121 52884 54727 90520715
Product use issue 71.66 9.84 53 52952 329866 90245576
Therapy cessation 65.54 9.84 93 52912 36268 90539174
Feeling abnormal 65.50 9.84 231 52774 167004 90408438
Type 2 diabetes mellitus 65.13 9.84 19 52986 203225 90372217
Liver injury 62.42 9.84 12 52993 170555 90404887
Fatigue 61.68 9.84 981 52024 1153042 89422400
Device expulsion 61.40 9.84 96 52909 40790 90534652
C-reactive protein abnormal 58.88 9.84 4 53001 127425 90448017
Hepatic enzyme increased 58.58 9.84 75 52930 360661 90214781
Irritable bowel syndrome 58.53 9.84 24 52981 207424 90368018
Muscle spasms 58.07 9.84 296 52709 251587 90323855
Arthropathy 57.58 9.84 78 52927 366164 90209278
Sleep disorder due to general medical condition, insomnia type 56.76 9.84 5 53000 128689 90446753
C-reactive protein increased 56.23 9.84 18 52987 181371 90394071
Deep vein thrombosis 53.01 9.84 145 52860 91475 90483967
Back pain 52.95 9.84 342 52663 316833 90258609
Full blood count decreased 52.13 9.84 75 52930 29614 90545828
Neuropathy peripheral 50.90 9.84 186 52819 136784 90438658
Impaired healing 50.34 9.84 38 52967 234161 90341281
Intentional product use issue 49.50 9.84 33 52972 216859 90358583
Dizziness 48.86 9.84 543 52462 588741 89986701
Drug ineffective 48.40 9.84 548 52457 1383750 89191692
Ill-defined disorder 48.07 9.84 24 52981 184867 90390575
Therapeutic product effect decreased 47.92 9.84 55 52950 277516 90297926
Therapeutic product effect incomplete 47.73 9.84 27 52978 193869 90381573
Nausea 47.43 9.84 911 52094 1109405 89466037
Discomfort 46.67 9.84 55 52950 274280 90301162
Constipation 45.97 9.84 301 52704 280094 90295348
Joint swelling 45.49 9.84 147 52858 503153 90072289
Myalgia 45.49 9.84 213 52792 174912 90400530
Fibromyalgia 44.93 9.84 33 52972 206236 90369206
Swollen joint count increased 44.77 9.84 6 52999 111200 90464242
Blister 44.59 9.84 50 52955 254948 90320494
Flushing 43.41 9.84 132 52873 88359 90487083
Device dislocation 43.26 9.84 71 52934 31411 90544031
Toxicity to various agents 41.59 9.84 65 52940 287781 90287661
Discoloured vomit 41.22 9.84 18 52987 1174 90574268
Cardiac failure congestive 40.94 9.84 139 52866 98555 90476887
Facet joint syndrome 40.35 9.84 5 53000 98384 90477058
Wheezing 38.11 9.84 50 52955 238030 90337412
Dehydration 37.68 9.84 218 52787 194229 90381213
Alopecia 37.24 9.84 156 52849 494915 90080527
Hypercholesterolaemia 37.11 9.84 7 52998 100885 90474557
Plasma cell myeloma 37.06 9.84 77 52928 40751 90534691
Drug abuse 36.85 9.84 3 53002 82344 90493098
Urticaria thermal 35.81 9.84 13 52992 520 90574922
Tremor 35.26 9.84 180 52825 152993 90422449
Lip dry 35.08 9.84 8 52997 100947 90474495
Injection site pain 33.82 9.84 195 52810 173504 90401938
Haemoglobin decreased 33.64 9.84 185 52820 161771 90413671
Injection site bruising 33.51 9.84 86 52919 52221 90523221
Headache 33.43 9.84 698 52307 862048 89713394
Hot flush 33.26 9.84 93 52912 59395 90516047
Urinary tract infection 33.19 9.84 298 52707 305334 90270108
Rheumatoid arthritis 31.98 9.84 107 52898 362507 90212935
Flatulence 31.84 9.84 73 52932 41294 90534148
Nervousness 31.82 9.84 65 52940 33991 90541451
Obesity 31.76 9.84 11 52994 105496 90469946
Prescribed overdose 31.49 9.84 9 52996 97616 90477826
Joint range of motion decreased 30.45 9.84 21 52984 135622 90439820
Asthenia 29.55 9.84 457 52548 533294 90042148
Administration site erythema 29.09 9.84 13 52992 896 90574546
Injection site erythema 28.71 9.84 124 52881 98378 90477064
Nasal congestion 28.26 9.84 110 52895 83304 90492138
Psoriasis 28.19 9.84 165 52840 147589 90427853
Exposure during pregnancy 28.06 9.84 61 52944 238349 90337093
Epilepsy 27.61 9.84 7 52998 82199 90493243
Injection site haemorrhage 27.59 9.84 55 52950 28263 90547179
Pulmonary embolism 27.54 9.84 150 52855 130670 90444772
Grip strength decreased 27.27 9.84 10 52995 92566 90482876
Femoral artery dissection 26.87 9.84 6 52999 37 90575405
Condition aggravated 26.47 9.84 222 52783 595323 89980119
Pulmonary fibrosis 26.40 9.84 15 52990 107488 90467954
Wound infection 25.91 9.84 15 52990 106387 90469055
Pelvic pain 25.80 9.84 38 52967 15319 90560123
Stomatitis 25.65 9.84 79 52926 274619 90300823
Abdominal discomfort 25.46 9.84 169 52836 477159 90098283
Influenza like illness 25.46 9.84 104 52901 80507 90494935
Body height decreased 25.22 9.84 33 52972 11916 90563526
Hip fracture 25.04 9.84 58 52947 33019 90542423
Internal haemorrhage 24.92 9.84 24 52981 6196 90569246
Swelling 24.61 9.84 144 52861 418914 90156528
COVID-19 24.49 9.84 38 52967 168805 90406637
Mobility decreased 24.20 9.84 71 52934 250663 90324779
Atrial fibrillation 24.08 9.84 147 52858 133464 90441978
Gastrointestinal disorder 23.83 9.84 74 52931 256613 90318829
Chills 23.65 9.84 145 52860 131836 90443606
Skin discolouration 23.53 9.84 68 52937 44247 90531195
Lung disorder 23.44 9.84 32 52973 149851 90425591
Pneumonia 23.29 9.84 512 52493 637547 89937895
Sleep disorder 23.03 9.84 51 52954 197979 90377463
Thrombosis 21.95 9.84 93 52912 73158 90502284
Peripheral venous disease 21.64 9.84 11 52994 83910 90491532
Hypervolaemia 21.13 9.84 54 52951 32703 90542739
Red blood cell sedimentation rate increased 21.04 9.84 11 52994 82584 90492858
Cyst 20.96 9.84 36 52969 16525 90558917
Dyspnoea 20.91 9.84 668 52337 880287 89695155
Tooth disorder 20.83 9.84 52 52953 31038 90544404
Dizziness postural 20.68 9.84 26 52979 9027 90566415
Eye swelling 20.59 9.84 50 52955 29336 90546106
Blood potassium decreased 20.48 9.84 68 52937 47659 90527783
Hypersensitivity 20.40 9.84 169 52836 454508 90120934
Dislocation of vertebra 20.33 9.84 4 53001 55964 90519478
White blood cell count decreased 20.25 9.84 167 52838 166942 90408500
Balance disorder 20.22 9.84 111 52894 96969 90478473
Drug hypersensitivity 20.20 9.84 382 52623 463227 90112215
Laboratory test abnormal 20.11 9.84 62 52943 41792 90533650
Blood cholesterol increased 20.00 9.84 59 52946 207953 90367489
Autoimmune disorder 19.88 9.84 10 52995 76734 90498708
Bursitis 19.70 9.84 29 52976 131625 90443817
Live birth 19.48 9.84 11 52994 79096 90496346
Multiple sclerosis relapse 19.39 9.84 71 52934 52234 90523208
Dysgeusia 19.19 9.84 71 52934 52489 90522953
Rhinorrhoea 19.08 9.84 102 52903 88214 90487228
International normalised ratio increased 19.05 9.84 66 52939 47250 90528192
Sinoatrial block 18.93 9.84 10 52995 995 90574447
Dyspnoea exertional 18.81 9.84 88 52917 72200 90503242
Vaginal haemorrhage 18.58 9.84 50 52955 31221 90544221
Bone pain 18.03 9.84 78 52927 61905 90513537
Vision blurred 17.80 9.84 118 52887 110175 90465267
Cardiac disorder 16.88 9.84 72 52933 56800 90518642
Product complaint 16.63 9.84 29 52976 13471 90561971
Dry skin 16.56 9.84 98 52907 87975 90487467
Pain in extremity 16.56 9.84 362 52643 450167 90125275
Lethargy 16.53 9.84 77 52928 63062 90512380
Infection 16.50 9.84 134 52871 361960 90213482
Influenza 15.72 9.84 137 52868 139127 90436315
Overdose 15.69 9.84 44 52961 157665 90417777
Burning sensation 15.60 9.84 76 52929 63376 90512066
Bronchitis 15.51 9.84 147 52858 152780 90422662
Hypertension 15.51 9.84 182 52823 457350 90118092
Drug-induced liver injury 15.46 9.84 18 52987 90300 90485142
Asthma 15.40 9.84 81 52924 242079 90333363
Fluid retention 15.29 9.84 96 52909 87995 90487447
Pigmentation disorder 15.07 9.84 18 52987 5931 90569511
Hypoacusis 15.04 9.84 43 52962 27807 90547635
Injection site mass 14.86 9.84 37 52968 22053 90553389
Intentional overdose 14.70 9.84 20 52985 93814 90481628
Pulmonary arterial hypertension 14.69 9.84 41 52964 26146 90549296
Coeliac disease 14.59 9.84 4 53001 44606 90530836
Depression 14.59 9.84 252 52753 300349 90275093
Injection site reaction 14.54 9.84 98 52907 91982 90483460
Hypophagia 14.36 9.84 50 52955 35887 90539555
Pulmonary hypertension 14.33 9.84 56 52949 42467 90532975
Ageusia 14.21 9.84 30 52975 16046 90559396
Gallbladder disorder 14.20 9.84 34 52971 19769 90555673
Platelet count decreased 14.06 9.84 132 52873 136837 90438605
Cough 14.04 9.84 298 52707 368664 90206778
Nocturia 13.92 9.84 23 52982 10232 90565210
Oedema peripheral 13.91 9.84 220 52785 257695 90317747
Hypoxia 13.90 9.84 81 52924 72318 90503124
Adverse event 13.84 9.84 30 52975 117388 90458054
Adjustment disorder with depressed mood 13.82 9.84 8 52997 56745 90518697
Cellulitis 13.71 9.84 96 52909 91241 90484201
Small intestinal obstruction 13.69 9.84 35 52970 21199 90554243
Hepatic function abnormal 13.63 9.84 5 53000 46283 90529159
Inflammation 13.57 9.84 56 52949 178536 90396906
Blood glucose decreased 13.46 9.84 37 52968 23392 90552050
Nail disorder 13.45 9.84 9 52996 59058 90516384
Blepharospasm 13.24 9.84 8 52997 55437 90520005
X-ray abnormal 13.22 9.84 5 53000 45419 90530023
Multiple sclerosis 13.15 9.84 41 52964 27799 90547643
Multiple allergies 13.09 9.84 28 52977 15118 90560324
Aspartate aminotransferase increased 13.07 9.84 104 52901 102833 90472609
Pleural effusion 13.07 9.84 111 52894 111880 90463562
Anxiety 13.05 9.84 254 52751 309518 90265924
Pain in jaw 12.91 9.84 59 52946 47926 90527516
Sleep disorder due to a general medical condition 12.90 9.84 5 53000 44733 90530709
Administration site swelling 12.84 9.84 9 52996 1490 90573952
Plasma cell myeloma recurrent 12.75 9.84 14 52991 4214 90571228
Cerebrovascular accident 12.65 9.84 119 52886 123414 90452028
Dry eye 12.57 9.84 67 52938 57864 90517578
Gait disturbance 12.50 9.84 218 52787 260278 90315164
Musculoskeletal stiffness 12.49 9.84 112 52893 296420 90279022
Restless legs syndrome 12.43 9.84 35 52970 22435 90553007
Chest pain 12.43 9.84 259 52746 319386 90256056
Pollakiuria 12.40 9.84 45 52960 32960 90542482
Upper limb fracture 12.32 9.84 34 52971 21544 90553898
Confusional state 12.18 9.84 156 52849 386049 90189393
Hospice care 12.15 9.84 21 52984 9683 90565759
Rotator cuff syndrome 12.14 9.84 28 52977 15891 90559551
Eustachian tube obstruction 11.82 9.84 3 53002 34 90575408
Lupus-like syndrome 11.73 9.84 7 52998 48839 90526603
Agranulocytosis 11.71 9.84 3 53002 34999 90540443
Haematocrit decreased 11.68 9.84 52 52953 41780 90533662
Chest discomfort 11.64 9.84 128 52877 138237 90437205
International normalised ratio decreased 11.48 9.84 14 52991 4710 90570732
Blood triglycerides increased 11.39 9.84 25 52980 13736 90561706
Intestinal dilatation 11.37 9.84 10 52995 2300 90573142
Very low density lipoprotein increased 11.34 9.84 4 53001 147 90575295
Endometriosis 11.28 9.84 16 52989 6232 90569210
Febrile neutropenia 11.20 9.84 51 52954 158298 90417144
Blood potassium increased 11.17 9.84 32 52973 20717 90554725
Coronary artery disease 11.11 9.84 44 52961 33579 90541863
Therapeutic response unexpected 11.06 9.84 33 52972 21847 90553595
Insomnia 11.01 9.84 264 52741 333210 90242232
Cold sweat 11.00 9.84 25 52980 14056 90561386
Scratch 10.63 9.84 20 52985 9846 90565596
Psoriatic arthropathy 10.62 9.84 84 52921 228251 90347191
Cardiac pacemaker insertion 10.61 9.84 13 52992 4394 90571048
Laryngeal pain 10.58 9.84 13 52992 4409 90571033
Meniscus injury 10.55 9.84 18 52987 8219 90567223
Haematoma 10.50 9.84 48 52957 39000 90536442
Complication associated with device 10.47 9.84 30 52975 19419 90556023
Cholecystectomy 10.47 9.84 22 52983 11733 90563709
Heavy menstrual bleeding 10.41 9.84 31 52974 20499 90554943
Blood glucose increased 10.38 9.84 93 52912 95153 90480289
Anaemia 10.38 9.84 275 52730 352527 90222915
Pulmonary oedema 10.37 9.84 67 52938 62013 90513429
Interstitial lung disease 10.33 9.84 18 52987 76387 90499055
Adverse drug reaction 10.29 9.84 109 52896 116592 90458850
Pulse absent 10.20 9.84 15 52990 6040 90569402
Chronic kidney disease 10.19 9.84 57 52948 50134 90525308
Breast cancer stage II 10.10 9.84 4 53001 35330 90540112
Osteopenia 10.07 9.84 33 52972 22969 90552473
Night sweats 10.01 9.84 40 52965 128726 90446716
Stress fracture 9.97 9.84 18 52987 8593 90566849
Injury 9.94 9.84 71 52934 197278 90378164
Rib fracture 9.89 9.84 36 52969 26399 90549043
Rash pruritic 9.86 9.84 82 52923 82132 90493310
Liver disorder 9.86 9.84 37 52968 121232 90454210

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
Off label use 171.34 11.57 175 36042 638160 41946958
Product use in unapproved indication 100.05 11.57 18 36199 184438 42400680
Drug abuse 72.72 11.57 4 36213 104767 42480351
Flushing 69.54 11.57 118 36099 36910 42548208
Fatigue 61.17 11.57 601 35616 435040 42150078
Asthenia 53.17 11.57 414 35803 280379 42304739
Plasma cell myeloma 51.07 11.57 120 36097 47458 42537660
Diarrhoea 50.85 11.57 606 35611 460243 42124875
Toxicity to various agents 47.40 11.57 76 36141 229060 42356058
Product dose omission issue 45.90 11.57 255 35962 154110 42431008
General physical health deterioration 44.33 11.57 38 36179 151208 42433910
Dizziness 42.54 11.57 359 35858 248895 42336223
Completed suicide 39.89 11.57 16 36201 96449 42488669
Myalgia 39.43 11.57 174 36043 95906 42489212
Laboratory test abnormal 38.94 11.57 70 36147 22908 42562210
Full blood count decreased 35.30 11.57 63 36154 20497 42564621
Fall 34.95 11.57 328 35889 234192 42350926
Muscle spasms 33.18 11.57 153 36064 85891 42499227
Febrile neutropenia 31.83 11.57 69 36148 185634 42399484
Drug interaction 31.25 11.57 119 36098 266880 42318238
Drug hypersensitivity 30.05 11.57 165 36052 99224 42485894
Intentional product use issue 27.97 11.57 13 36204 71820 42513298
Cytokine release syndrome 27.25 11.57 3 36214 44524 42540594
COVID-19 26.34 11.57 36 36181 115912 42469206
Intentional overdose 25.83 11.57 6 36211 51450 42533668
Blood testosterone decreased 25.79 11.57 26 36191 4876 42580242
White blood cell count decreased 25.56 11.57 171 36046 110225 42474893
Psoriasis 25.48 11.57 95 36122 48509 42536609
Treatment failure 24.90 11.57 11 36206 62613 42522505
Adverse drug reaction 23.80 11.57 78 36139 37356 42547762
Gastrointestinal haemorrhage 23.61 11.57 153 36064 97573 42487545
Myocardial infarction 23.47 11.57 183 36034 123826 42461292
Drug ineffective 23.45 11.57 386 35831 629811 41955307
Hypoaesthesia 23.20 11.57 121 36096 71342 42513776
Sinusitis 22.79 11.57 90 36127 47202 42537916
Interstitial lung disease 22.62 11.57 20 36197 78442 42506676
Cardiac disorder 21.89 11.57 91 36126 48841 42536277
Product use issue 21.61 11.57 20 36197 76731 42508387
Mental status changes 20.98 11.57 81 36136 42034 42543084
Meningitis cryptococcal 20.25 11.57 19 36198 3264 42581854
Multiple organ dysfunction syndrome 20.20 11.57 32 36185 97003 42488115
Myelosuppression 19.75 11.57 5 36212 40456 42544662
Condition aggravated 19.29 11.57 136 36081 260618 42324500
Therapy cessation 19.19 11.57 49 36168 20401 42564717
Memory impairment 19.12 11.57 89 36128 50133 42534985
Hepatic function abnormal 19.06 11.57 10 36207 51557 42533561
Haemoglobin decreased 19.05 11.57 184 36033 132287 42452831
Coma 18.90 11.57 11 36206 53543 42531575
Drug ineffective for unapproved indication 18.52 11.57 8 36209 46155 42538963
Dehydration 18.51 11.57 193 36024 141574 42443544
Flatulence 18.38 11.57 55 36162 25097 42560021
Cerebrovascular accident 17.62 11.57 142 36075 97018 42488100
Drug resistance 17.17 11.57 4 36213 34244 42550874
Suicide attempt 16.95 11.57 9 36208 46091 42539027
Muscular weakness 16.78 11.57 125 36092 83373 42501745
Atelectasis 16.74 11.57 45 36172 19316 42565802
Coronary artery occlusion 16.74 11.57 32 36185 10965 42574153
Feeling abnormal 16.69 11.57 109 36108 69677 42515441
Cardiac failure congestive 16.56 11.57 127 36090 85475 42499643
Agranulocytosis 16.54 11.57 3 36214 30609 42554509
Viral infection 16.27 11.57 49 36168 22434 42562684
Leukopenia 16.18 11.57 24 36193 74722 42510396
Transaminases abnormal 16.09 11.57 7 36210 309 42584809
Rash 16.02 11.57 327 35890 276627 42308491
Fluid retention 15.90 11.57 61 36156 31558 42553560
Oedema peripheral 15.80 11.57 181 36036 135895 42449223
High density lipoprotein decreased 15.79 11.57 18 36199 3879 42581239
Weight decreased 15.69 11.57 256 35961 207692 42377426
Cardiac failure 15.69 11.57 43 36174 106813 42478305
Constipation 15.46 11.57 208 36009 162083 42423035
Influenza 15.41 11.57 98 36119 62077 42523041
Renal impairment 14.99 11.57 46 36171 110182 42474936
Cerebral small vessel ischaemic disease 14.97 11.57 8 36209 558 42584560
Nausea 14.44 11.57 440 35777 396359 42188759
Muscle fatigue 14.42 11.57 12 36205 1759 42583359
Neuropathy peripheral 14.41 11.57 141 36076 101712 42483406
Increased tendency to bruise 14.13 11.57 18 36199 4352 42580766
Dyspepsia 14.10 11.57 71 36146 41281 42543837
Unevaluable event 13.97 11.57 62 36155 34226 42550892
International normalised ratio increased 13.90 11.57 79 36138 48089 42537029
Altered state of consciousness 13.56 11.57 4 36213 29255 42555863
Influenza like illness 13.30 11.57 58 36159 31782 42553336
Headache 13.30 11.57 281 35936 239088 42346030
Back pain 13.20 11.57 181 36036 141595 42443523
Coronary artery disease 12.90 11.57 84 36133 53636 42531482
Cholestasis 12.72 11.57 6 36211 32873 42552245
Haematocrit decreased 12.66 11.57 61 36156 34847 42550271
Paraesthesia 12.58 11.57 106 36111 73353 42511765
Contraindicated product administered 12.58 11.57 3 36214 25269 42559849
Foetal exposure during pregnancy 12.54 11.57 13 36204 47298 42537820
C-reactive protein increased 12.27 11.57 22 36195 63538 42521580
Cellulitis 12.26 11.57 92 36125 61493 42523625
Obstructive airways disorder 12.20 11.57 3 36214 24756 42560362
Small intestinal obstruction 12.17 11.57 37 36180 17024 42568094
Gait disturbance 12.11 11.57 132 36085 97868 42487250
Bronchitis 12.07 11.57 75 36142 47126 42537992
Pneumonia 12.03 11.57 455 35762 421694 42163424
Application site exfoliation 12.01 11.57 5 36212 198 42584920
Blood glucose increased 11.91 11.57 105 36112 73594 42511524
Drug reaction with eosinophilia and systemic symptoms 11.80 11.57 11 36206 42064 42543054
Therapeutic product effect incomplete 11.61 11.57 27 36190 70912 42514206

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
Off label use 228.24 9.78 374 69475 1499811 109019639
Product use in unapproved indication 166.76 9.78 39 69810 447338 110072112
Synovitis 143.86 9.78 7 69842 274085 110245365
Product dose omission issue 117.82 9.78 458 69391 321324 110198126
Hand deformity 116.55 9.78 5 69844 218501 110300949
Contraindicated product administered 111.59 9.78 13 69836 248254 110271196
Pemphigus 105.00 9.78 8 69841 214562 110304888
Fall 104.35 9.78 695 69154 602787 109916663
Systemic lupus erythematosus 103.39 9.78 18 69831 254320 110265130
Treatment failure 101.60 9.78 25 69824 277209 110242241
Infusion related reaction 100.43 9.78 58 69791 381104 110138346
Completed suicide 98.86 9.78 17 69832 242364 110277086
Anti-cyclic citrullinated peptide antibody positive 97.60 9.78 4 69845 181980 110337470
Drug abuse 94.81 9.78 4 69845 177407 110342043
General physical health deterioration 90.77 9.78 81 69768 425214 110094236
Glossodynia 89.60 9.78 16 69833 221988 110297462
Drug intolerance 81.38 9.78 82 69767 406430 110113020
Dizziness 81.06 9.78 733 69116 697460 109821990
Duodenal ulcer perforation 80.60 9.78 9 69840 177691 110341759
Pericarditis 79.81 9.78 20 69829 219094 110300356
Helicobacter infection 78.15 9.78 11 69838 181866 110337584
Lower respiratory tract infection 74.67 9.78 30 69819 243076 110276374
Therapy cessation 73.10 9.78 114 69735 44743 110474707
Diarrhoea 71.34 9.78 1061 68788 1138444 109381006
Toxicity to various agents 70.56 9.78 122 69727 480433 110039017
C-reactive protein abnormal 69.04 9.78 3 69846 129692 110389758
Folliculitis 67.82 9.78 12 69837 167641 110351809
Rheumatoid factor positive 67.05 9.78 4 69845 131636 110387814
Product use issue 66.91 9.78 59 69790 311636 110207814
Myalgia 66.79 9.78 298 69551 222083 110297367
Fatigue 65.83 9.78 1105 68744 1214853 109304597
Device expulsion 65.62 9.78 89 69760 30802 110488648
Plasma cell myeloma 65.04 9.78 131 69718 62805 110456645
Maternal exposure during pregnancy 64.01 9.78 41 69808 254842 110264608
Flushing 62.46 9.78 176 69673 104560 110414890
Intentional product use issue 62.09 9.78 40 69809 247866 110271584
Muscle injury 61.71 9.78 8 69841 140799 110378651
Cardiac failure congestive 60.21 9.78 221 69628 150779 110368671
C-reactive protein increased 59.03 9.78 32 69817 217887 110301563
Dehydration 58.91 9.78 339 69510 279172 110240278
Rheumatic fever 58.76 9.78 5 69844 122574 110396876
Asthenia 57.78 9.78 677 69172 688322 109831128
Wound 55.80 9.78 40 69809 234397 110285053
Deep vein thrombosis 55.15 9.78 204 69645 139683 110379767
Drug ineffective 54.62 9.78 657 69192 1519883 108999567
Irritable bowel syndrome 52.52 9.78 19 69830 164196 110355254
Therapeutic product effect incomplete 50.93 9.78 40 69809 223765 110295685
Haemoglobin decreased 50.67 9.78 299 69550 248428 110271022
Feeling abnormal 50.41 9.78 237 69612 180474 110338976
Sleep disorder due to general medical condition, insomnia type 48.80 9.78 5 69844 105638 110413812
Fibromyalgia 47.91 9.78 24 69825 170885 110348565
Full blood count decreased 46.05 9.78 77 69772 32022 110487428
Hepatic enzyme increased 45.68 9.78 83 69766 320809 110198641
Liver injury 45.46 9.78 19 69830 150394 110369056
Myelosuppression 44.80 9.78 4 69845 94336 110425114
COVID-19 43.99 9.78 54 69795 245006 110274444
Unevaluable event 41.85 9.78 106 69743 59121 110460329
Joint swelling 41.58 9.78 142 69707 442703 110076747
Facet joint syndrome 41.25 9.78 6 69843 96822 110422628
Ill-defined disorder 41.08 9.78 24 69825 156829 110362621
Lip dry 40.83 9.78 7 69842 100076 110419374
International normalised ratio increased 40.65 9.78 134 69715 86638 110432812
Type 2 diabetes mellitus 39.92 9.78 32 69817 177200 110342250
Muscle spasms 39.60 9.78 306 69543 277851 110241599
Nausea 38.08 9.78 1035 68814 1234655 109284795
Arthropathy 36.09 9.78 80 69769 287442 110232008
Mental status changes 36.06 9.78 118 69731 76004 110443446
Dyspnoea exertional 35.50 9.78 145 69704 103915 110415535
Dyspnoea 34.90 9.78 930 68919 1105942 109413508
Urticaria thermal 34.88 9.78 13 69836 518 110518932
Back pain 34.86 9.78 373 69476 370623 110148827
Hypervolaemia 34.40 9.78 88 69761 49372 110470078
Fluid retention 34.25 9.78 134 69715 94173 110425277
Myocardial infarction 34.14 9.78 223 69626 191860 110327590
Swollen joint count increased 33.80 9.78 6 69843 83655 110435795
Administration site erythema 33.49 9.78 12 69837 427 110519023
Epilepsy 33.06 9.78 11 69838 100198 110419252
Device dislocation 32.76 9.78 66 69783 31638 110487812
Impaired healing 32.58 9.78 46 69803 196671 110322779
Gastrointestinal haemorrhage 32.43 9.78 197 69652 165321 110354129
Condition aggravated 32.11 9.78 303 69546 734533 109784917
Blister 31.30 9.78 60 69789 227316 110292134
Wheezing 31.23 9.78 72 69777 255158 110264292
Discoloured vomit 30.94 9.78 18 69831 1999 110517451
Obesity 30.17 9.78 17 69832 113334 110406116
Mobility decreased 29.84 9.78 66 69783 237356 110282094
Nasal congestion 29.70 9.78 132 69717 98150 110421300
Stomatitis 29.37 9.78 81 69768 270161 110249289
Cerebrovascular accident 28.96 9.78 205 69644 181079 110338371
Flatulence 28.54 9.78 85 69764 52064 110467386
Cytokine release syndrome 28.50 9.78 5 69844 70301 110449149
Rheumatoid arthritis 28.15 9.78 96 69753 299517 110219933
Tremor 27.95 9.78 221 69628 202011 110317439
Multiple sclerosis relapse 27.60 9.78 82 69767 50158 110469292
Discomfort 27.55 9.78 59 69790 214648 110304802
Cardiac disorder 27.38 9.78 108 69741 76172 110443278
Blood triglycerides increased 27.38 9.78 52 69797 23874 110495576
Intentional overdose 27.32 9.78 26 69823 132475 110386975
Pneumonia 27.11 9.78 735 69114 875979 109643471
Gastrointestinal disorder 26.68 9.78 72 69777 241880 110277570
Hypercholesterolaemia 26.61 9.78 12 69837 90825 110428625
Haematocrit decreased 26.53 9.78 97 69752 66020 110453430
Peripheral venous disease 26.44 9.78 10 69839 84107 110435343
Bursitis 26.20 9.78 26 69823 129892 110389558
Chills 26.19 9.78 208 69641 190372 110329078
Grip strength decreased 26.10 9.78 9 69840 80165 110439285
Hip fracture 25.97 9.78 64 69785 35087 110484363
Blood glucose increased 25.51 9.78 157 69692 132339 110387111
Alopecia 25.50 9.78 131 69718 364622 110154828
Injection site haemorrhage 25.33 9.78 61 69788 32967 110486483
Femoral artery dissection 25.28 9.78 6 69843 46 110519404
Therapeutic product effect decreased 25.25 9.78 75 69774 244241 110275209
Dysgeusia 25.05 9.78 99 69750 69886 110449564
Injection site pain 24.90 9.78 195 69654 177727 110341723
Influenza like illness 24.67 9.78 116 69733 88296 110431154
Internal haemorrhage 24.46 9.78 31 69818 10040 110509410
Febrile neutropenia 24.33 9.78 110 69739 316657 110202793
Headache 24.30 9.78 729 69120 881648 109637802
Pelvic pain 23.89 9.78 39 69810 15903 110503547
Coronary artery disease 23.74 9.78 99 69750 71591 110447859
Hospice care 23.60 9.78 34 69815 12439 110507011
Lung disorder 23.50 9.78 49 69800 179998 110339452
Cellulitis 23.43 9.78 148 69701 125868 110393582
Bronchitis 23.03 9.78 174 69675 156858 110362592
Constipation 22.95 9.78 335 69514 357451 110161999
Oedema peripheral 22.79 9.78 312 69537 328348 110191102
Joint range of motion decreased 22.76 9.78 26 69823 121806 110397644
Urinary tract infection 22.32 9.78 309 69540 325973 110193477
Coma 22.18 9.78 25 69824 117844 110401606
Injection site bruising 22.10 9.78 77 69772 51186 110468264
Small intestinal obstruction 22.08 9.78 57 69792 32156 110487294
Nervousness 22.03 9.78 62 69787 36789 110482661
Autoimmune disorder 21.93 9.78 7 69842 65476 110453974
Agranulocytosis 21.78 9.78 6 69843 61754 110457696
Eosinophilia 21.65 9.78 5 69844 57931 110461519
Hepatic function abnormal 21.55 9.78 15 69834 89280 110430170
Intentional product misuse 21.10 9.78 32 69817 132872 110386578
Pulmonary fibrosis 21.06 9.78 20 69829 102022 110417428
Wound infection 20.99 9.78 18 69831 96447 110423003
Complication associated with device 20.99 9.78 42 69807 20031 110499419
Inflammation 20.93 9.78 58 69791 193180 110326270
Dizziness postural 20.89 9.78 35 69814 14574 110504876
Blood testosterone decreased 20.77 9.78 16 69833 2832 110516618
Prescribed overdose 20.75 9.78 15 69834 87566 110431884
Interstitial lung disease 20.75 9.78 35 69814 139299 110380151
Atrial fibrillation 20.68 9.78 229 69620 229413 110290037
Drug interaction 20.65 9.78 209 69640 499974 110019476
Chest pain 20.56 9.78 343 69506 376032 110143418
Blood potassium decreased 20.55 9.78 78 69771 54036 110465414
Drug ineffective for unapproved indication 20.26 9.78 21 69828 102817 110416633
Coronary artery occlusion 20.22 9.78 36 69813 15736 110503714
Weight decreased 20.15 9.78 411 69438 467646 110051804
Blood glucose decreased 20.02 9.78 52 69797 29436 110490014
Hypoacusis 19.87 9.78 58 69791 35133 110484317
White blood cell count decreased 19.86 9.78 227 69622 229163 110290287
Rotator cuff syndrome 19.84 9.78 37 69812 16757 110502693
Asthma 19.77 9.78 86 69763 250205 110269245
Injection site erythema 19.66 9.78 114 69735 94062 110425388
Aspartate aminotransferase increased 19.54 9.78 170 69679 159766 110359684
Influenza 19.25 9.78 177 69672 168924 110350526
Thrombosis 19.20 9.78 126 69723 108536 110410914
Eye swelling 19.17 9.78 55 69794 32993 110486457
Live birth 19.11 9.78 10 69839 69474 110449976
Neuropathy peripheral 19.09 9.78 185 69664 179092 110340358
Drug resistance 18.93 9.78 6 69843 56368 110463082
Viral infection 18.88 9.78 75 69774 53064 110466386
Overdose 18.67 9.78 80 69769 233714 110285736
Low density lipoprotein increased 18.63 9.78 28 69821 10638 110508812
Pulmonary embolism 18.46 9.78 212 69637 214262 110305188
Atelectasis 18.37 9.78 58 69791 36654 110482796
Exposure during pregnancy 18.32 9.78 50 69799 167374 110352076
Product complaint 18.05 9.78 32 69817 13940 110505510
Nail disorder 18.02 9.78 7 69842 57928 110461522
Dislocation of vertebra 17.96 9.78 3 69846 43718 110475732
Sleep disorder 17.75 9.78 65 69784 198579 110320871
Hepatocellular injury 17.71 9.78 5 69844 50637 110468813
Coeliac disease 17.66 9.78 3 69846 43184 110476266
Pleural effusion 17.29 9.78 180 69669 177529 110341921
Meningitis cryptococcal 17.22 9.78 18 69831 4744 110514706
Platelet count decreased 16.89 9.78 221 69628 230222 110289228
Cholestasis 16.71 9.78 10 69839 64508 110454942
Occult blood positive 16.65 9.78 22 69827 7423 110512027
Hypersensitivity 16.59 9.78 169 69680 403829 110115621
Red blood cell sedimentation rate increased 16.57 9.78 15 69834 78287 110441163
Blepharospasm 16.46 9.78 7 69842 54844 110464606
Infection 16.36 9.78 148 69701 362052 110157398
Pain in extremity 16.35 9.78 413 69436 486705 110032745
Acute respiratory failure 16.30 9.78 92 69757 75168 110444282
Altered state of consciousness 16.28 9.78 8 69841 57618 110461832
Lethargy 16.23 9.78 108 69741 93468 110425982
Gait disturbance 16.10 9.78 256 69593 277952 110241498
Swelling 16.05 9.78 143 69706 350898 110168552
Muscle fatigue 16.04 9.78 16 69833 3991 110515459
Pulmonary arterial hypertension 15.88 9.78 51 69798 32517 110486933
Pulmonary hypertension 15.81 9.78 73 69776 55147 110464303
Pain in jaw 15.66 9.78 69 69780 51108 110468342
Bone erosion 15.45 9.78 5 69844 46366 110473084
Hypertension 15.41 9.78 228 69621 509856 110009594
Depression 15.11 9.78 283 69566 317052 110202398
Neurotoxicity 15.08 9.78 4 69845 42203 110477247
Transient ischaemic attack 15.06 9.78 80 69769 63902 110455548
Haemodialysis 14.98 9.78 34 69815 17685 110501765
Hypoxia 14.96 9.78 136 69713 129379 110390071
Drug reaction with eosinophilia and systemic symptoms 14.82 9.78 18 69831 82077 110437373
Anaphylactic shock 14.80 9.78 7 69842 51539 110467911
Sinoatrial block 14.73 9.78 10 69839 1455 110517995
Cytomegalovirus infection 14.73 9.78 8 69841 54436 110465014
Body height decreased 14.70 9.78 25 69824 10538 110508912
Psoriatic arthropathy 14.70 9.78 69 69780 196692 110322758
Psoriasis 14.67 9.78 144 69705 139849 110379601
Multiple organ dysfunction syndrome 14.66 9.78 48 69801 151662 110367788
Liver disorder 14.45 9.78 44 69805 142199 110377251
Leukopenia 14.43 9.78 47 69802 148744 110370706
Transfusion 14.40 9.78 42 69807 25430 110494020
Blood potassium increased 14.38 9.78 50 69799 33199 110486251
Myopathy 13.96 9.78 41 69808 24919 110494531
Skin laceration 13.95 9.78 50 69799 33703 110485747
Hypophagia 13.92 9.78 68 69781 52558 110466892
Vaginal haemorrhage 13.84 9.78 41 69808 25033 110494417
Hot flush 13.82 9.78 80 69769 65956 110453494
Mitral valve repair 13.80 9.78 6 69843 358 110519092
Failure to thrive 13.72 9.78 28 69821 13546 110505904
Sleep disorder due to a general medical condition 13.60 9.78 8 69841 52104 110467346
Eustachian tube obstruction 13.25 9.78 4 69845 82 110519368
Vision blurred 13.17 9.78 132 69717 128890 110390560
Bone pain 13.05 9.78 78 69771 65055 110454395
Transaminases abnormal 13.03 9.78 8 69841 980 110518470
Neoplasm progression 12.94 9.78 13 69836 64582 110454868
Rash pruritic 12.90 9.78 106 69743 97963 110421487
Depressed level of consciousness 12.68 9.78 33 69816 112245 110407205
Pericardial haemorrhage 12.58 9.78 16 69833 5201 110514249
Radioisotope scan abnormal 12.44 9.78 7 69842 730 110518720
Laryngeal pain 12.36 9.78 17 69832 5958 110513492
Post procedural haemorrhage 12.27 9.78 29 69820 15483 110503967
Rib fracture 12.27 9.78 48 69801 33722 110485728
Sinus headache 12.24 9.78 17 69832 6015 110513435
Therapeutic response unexpected 12.24 9.78 38 69811 23805 110495645
Scratch 12.21 9.78 26 69823 12953 110506497
Hepatitis 12.18 9.78 24 69825 90030 110429420
Obstructive airways disorder 12.17 9.78 7 69842 46142 110473308
Chronic kidney disease 12.01 9.78 86 69763 76205 110443245
Red blood cell count decreased 11.99 9.78 77 69772 65846 110453604
Suicide attempt 11.98 9.78 30 69819 103364 110416086
Toxic epidermal necrolysis 11.84 9.78 11 69838 56716 110462734
Ageusia 11.69 9.78 33 69816 19612 110499838
Retinitis 11.67 9.78 3 69846 32324 110487126
Application site erythema 11.67 9.78 16 69833 5594 110513856
Ventricular hypertrophy 11.61 9.78 18 69831 7027 110512423
Onychomycosis 11.43 9.78 5 69844 38526 110480924
Sciatica 11.35 9.78 26 69823 92373 110427077
Balance disorder 11.30 9.78 118 69731 116442 110403008
Heavy menstrual bleeding 11.26 9.78 29 69820 16336 110503114
Gallbladder disorder 11.24 9.78 34 69815 20995 110498455
X-ray abnormal 11.22 9.78 5 69844 38112 110481338
Syncope 11.20 9.78 185 69664 202351 110317099
Infective pulmonary exacerbation of cystic fibrosis 11.02 9.78 27 69822 14744 110504706
Wound drainage 11.01 9.78 8 69841 1296 110518154
Drug-induced liver injury 10.91 9.78 39 69810 120028 110399422
Delirium 10.90 9.78 46 69803 134979 110384471
Sedation 10.85 9.78 17 69832 69666 110449784
Injection site nodule 10.81 9.78 14 69835 4632 110514818
Very low density lipoprotein increased 10.79 9.78 5 69844 347 110519103
Lactic acidosis 10.70 9.78 27 69822 92784 110426666
Drug withdrawal syndrome 10.67 9.78 50 69799 38004 110481446
Multiple sclerosis 10.56 9.78 38 69811 25660 110493790
Application site pain 10.42 9.78 15 69834 5484 110513966
Tricuspid valve incompetence 10.41 9.78 36 69813 23837 110495613
Renal impairment 10.35 9.78 73 69776 188372 110331078
Left atrial dilatation 10.35 9.78 12 69837 3548 110515902
Abdominal pain 10.34 9.78 409 69440 512580 110006870
Diabetic retinopathy 10.33 9.78 12 69837 3552 110515898
Granulocytopenia 10.31 9.78 24 69825 12691 110506759
Musculoskeletal stiffness 10.30 9.78 120 69729 279702 110239748
Meniscus injury 10.26 9.78 18 69831 7775 110511675
Cardiac pacemaker insertion 10.24 9.78 16 69833 6285 110513165
Metabolic encephalopathy 10.23 9.78 22 69827 11038 110508412
Application site discolouration 10.17 9.78 7 69842 1042 110518408
Cyst 10.10 9.78 28 69821 16468 110502982
High density lipoprotein decreased 9.94 9.78 15 69834 5718 110513732
Pulse absent 9.92 9.78 22 69827 11270 110508180
Rash maculo-papular 9.85 9.78 20 69829 74202 110445248

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C04AC01 CARDIOVASCULAR SYSTEM
PERIPHERAL VASODILATORS
PERIPHERAL VASODILATORS
Nicotinic acid and derivatives
ATC C10AD02 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, PLAIN
Nicotinic acid and derivatives
ATC C10AD52 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, PLAIN
Nicotinic acid and derivatives
ATC C10BA01 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Combinations of various lipid modifying agents
FDA CS M0014839 Nicotinic Acids
MeSH PA D000960 Hypolipidemic Agents
MeSH PA D000963 Antimetabolites
MeSH PA D002317 Cardiovascular Agents
MeSH PA D014665 Vasodilator Agents
MeSH PA D014803 Vitamin B Complex
MeSH PA D014815 Vitamins
MeSH PA D018977 Micronutrients
MeSH PA D057847 Lipid Regulating Agents
FDA EPC N0000175594 Nicotinic Acid
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:25212 metabolite
CHEBI has role CHEBI:33231 antitubercular agent
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35474 anxiolytic drug
CHEBI has role CHEBI:35476 antipsychotic agent
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35620 vasodilator agent
CHEBI has role CHEBI:35679 antilipemic drug
CHEBI has role CHEBI:35821 anticholesteremic drug
CHEBI has role CHEBI:50247 antidote
CHEBI has role CHEBI:64946 anti-HIV agent
CHEBI has role CHEBI:74518 anti-obesity agent
CHEBI has role CHEBI:75771 mouse metabolite
CHEBI has role CHEBI:75835 anti-anaemic agent
CHEBI has role CHEBI:76924 plant metabolite
CHEBI has role CHEBI:76971 <em>Escherichia coli</em> metabolite
CHEBI has role CHEBI:84087 human urinary metabolite
CHEBI has role CHEBI:84264 EC 3.5.1.19 (nicotinamidase) inhibitor
CHEBI has role CHEBI:145947 antiatherosclerotic agent
CHEBI has role CHEBI:231911 renoprotective agent

Related Drugs by ATC class:

C04AC Nicotinic acid and derivatives 3 drugs
C10AD Nicotinic acid and derivatives 5 drugs
C10BA Combinations of various lipid modifying agents 9 drugs

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

DiseaseRelationSNOMED_IDDOID
Hypercholesterolemia indication 13644009
Hyperlipidemia indication 55822004 DOID:1168
Vitamin deficiency indication 85670002
Familial hypercholesterolemia - heterozygous indication 238079002
Mixed hyperlipidemia indication 267434003
Hypertriglyceridemia indication 302870006




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 2.31 acidic
pKa2 4.85 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Hydroxycarboxylic acid receptor 2 GPCR AGONIST Ki 7.30 CHEMBL SCIENTIFIC LITERATURE
Nicotinamide N-methyltransferase Enzyme WOMBAT-PK
Nicotinate-nucleotide pyrophosphorylase [carboxylating] Enzyme WOMBAT-PK
Nicotinamide phosphoribosyltransferase Enzyme WOMBAT-PK
Hydroxycarboxylic acid receptor 3 GPCR AGONIST EC50 6.52 IUPHAR
Amyloid beta A4 protein Membrane other IC50 4.88 CHEMBL
Hydroxycarboxylic acid receptor 2 GPCR IC50 6.85 CHEMBL
Hydroxycarboxylic acid receptor 2 GPCR Ki 7.48 CHEMBL

External reference:

IDSource
4019440 VUID
N0000147570 NUI
D00049 KEGG_DRUG
4017632 VANDF
4017661 VANDF
4017718 VANDF
4019440 VANDF
4020285 VANDF
4021898 VANDF
C0027996 UMLSCUI
CHEBI:15940 CHEBI
NIO PDB_CHEM_ID
CHEMBL573 ChEMBL_ID
938 PUBCHEM_CID
DB00627 DRUGBANK_ID
1588 IUPHAR_LIGAND_ID
218728 RXNORM
2275 MMSL
43641 MMSL
4947 MMSL
5169 MMSL
5170 MMSL
5684 MMSL
59920 MMSL
7159 MMSL
7161 MMSL
72420 MMSL
d00314 MMSL
d03739 MMSL
001052 NDDF
001055 NDDF
173196005 SNOMEDCT_US
273943001 SNOMEDCT_US
63639004 SNOMEDCT_US
D009525 MESH_DESCRIPTOR_UI
373 INN_ID
2679MF687A UNII
2679MF687A INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Niacin HUMAN PRESCRIPTION DRUG LABEL 1 0378-3901 TABLET, FILM COATED, EXTENDED RELEASE 500 mg ORAL ANDA 28 sections
Niacin HUMAN PRESCRIPTION DRUG LABEL 1 0378-3902 TABLET, FILM COATED, EXTENDED RELEASE 750 mg ORAL ANDA 28 sections
Niacin HUMAN PRESCRIPTION DRUG LABEL 1 0378-3903 TABLET, FILM COATED, EXTENDED RELEASE 1000 mg ORAL ANDA 28 sections
VitafolOne HUMAN PRESCRIPTION DRUG LABEL 16 0642-0070 CAPSULE, GELATIN COATED 15 mg ORAL unapproved drug other 14 sections
Select OB HUMAN PRESCRIPTION DRUG LABEL 15 0642-0077 TABLET, CHEWABLE 15 mg ORAL UNAPPROVED DRUG OTHER 14 sections
Vitafol OBCaplet HUMAN PRESCRIPTION DRUG LABEL 15 0642-0079 TABLET 18 mg ORAL unapproved drug other 14 sections
Vitafol Plus HUMAN PRESCRIPTION DRUG LABEL 17 0642-0092 CAPSULE, LIQUID FILLED 15 mg ORAL UNAPPROVED DRUG OTHER 13 sections
Reaphirm Plant Source DHA HUMAN PRESCRIPTION DRUG LABEL 16 0642-3010 CAPSULE, GELATIN COATED 15 mg ORAL unapproved drug other 7 sections
O-Cal Prenatal Vitamin HUMAN PRESCRIPTION DRUG LABEL 16 0813-0202 TABLET 17 mg ORAL UNAPPROVED DRUG OTHER 6 sections
Niacin HUMAN PRESCRIPTION DRUG LABEL 1 10135-612 TABLET, EXTENDED RELEASE 500 mg ORAL ANDA 25 sections
Niacin HUMAN PRESCRIPTION DRUG LABEL 1 10135-613 TABLET, EXTENDED RELEASE 750 mg ORAL ANDA 25 sections
Niacin HUMAN PRESCRIPTION DRUG LABEL 1 10135-614 TABLET, EXTENDED RELEASE 1000 mg ORAL ANDA 25 sections
JBA Collagen-Electrolyte Mocktail HUMAN OTC DRUG LABEL 12 13411-848 POWDER 18 mg ORAL unapproved drug other 6 sections
TriStart DHA HUMAN PRESCRIPTION DRUG LABEL 15 15370-250 CAPSULE, LIQUID FILLED 5 mg ORAL UNAPPROVED DRUG OTHER 12 sections
Niaspan HUMAN PRESCRIPTION DRUG LABEL 1 21695-852 TABLET, FILM COATED, EXTENDED RELEASE 500 mg ORAL NDA 26 sections
Niaspan HUMAN PRESCRIPTION DRUG LABEL 1 21695-865 TABLET, FILM COATED, EXTENDED RELEASE 1000 mg ORAL NDA 26 sections
Niacin HUMAN PRESCRIPTION DRUG LABEL 1 33342-187 TABLET 500 mg ORAL ANDA 25 sections
Niacin HUMAN PRESCRIPTION DRUG LABEL 1 33342-189 TABLET 1000 mg ORAL ANDA 25 sections
NIACIN Human Prescription Drug Label 1 47335-539 TABLET, FILM COATED, EXTENDED RELEASE 500 mg ORAL ANDA 27 sections
NIACIN Human Prescription Drug Label 1 47335-613 TABLET, FILM COATED, EXTENDED RELEASE 1000 mg ORAL ANDA 27 sections
NIACIN Human Prescription Drug Label 1 47335-614 TABLET, FILM COATED, EXTENDED RELEASE 750 mg ORAL ANDA 27 sections
Multivitamin with fluoride HUMAN PRESCRIPTION DRUG LABEL 11 50090-0356 TABLET, CHEWABLE 13.50 mg ORAL UNAPPROVED DRUG OTHER 8 sections
Multivitamin with fluoride HUMAN PRESCRIPTION DRUG LABEL 11 50090-0435 TABLET, CHEWABLE 13.50 mg ORAL UNAPPROVED DRUG OTHER 8 sections
Multivitamin with Fluoride HUMAN PRESCRIPTION DRUG LABEL 12 50090-4475 TABLET, CHEWABLE 13.50 mg ORAL unapproved drug other 10 sections
Niacin HUMAN PRESCRIPTION DRUG LABEL 1 50268-584 TABLET, EXTENDED RELEASE 500 mg ORAL ANDA 19 sections
Niacin HUMAN PRESCRIPTION DRUG LABEL 1 50268-584 TABLET, EXTENDED RELEASE 500 mg ORAL ANDA 19 sections
Niacin HUMAN PRESCRIPTION DRUG LABEL 1 50268-586 TABLET, EXTENDED RELEASE 1000 mg ORAL ANDA 19 sections
Niacin HUMAN PRESCRIPTION DRUG LABEL 1 50268-586 TABLET, EXTENDED RELEASE 1000 mg ORAL ANDA 19 sections
Niacin HUMAN PRESCRIPTION DRUG LABEL 1 51407-267 TABLET, EXTENDED RELEASE 500 mg ORAL ANDA 25 sections
Niacin HUMAN PRESCRIPTION DRUG LABEL 1 51407-268 TABLET, EXTENDED RELEASE 1000 mg ORAL ANDA 25 sections