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

Stem definitionDrug idCAS RN
retinol derivatives 1508 4759-48-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • isotretinoin
  • 13-cis-retinoic acid
  • 13-cis-vitamin A acid
  • accure
  • accutane
  • isotrex
  • neovitamin A acid
  • roaccutan
  • roaccutane
A topical dermatologic agent that is used in the treatment of ACNE VULGARIS and several other skin diseases. The drug has teratogenic and other adverse effects.
  • Molecular weight: 300.44
  • Formula: C20H28O2
  • CLOGP: 6.74
  • LIPINSKI: 1
  • HAC: 2
  • HDO: 1
  • TPSA: 37.30
  • ALOGS: -4.80
  • ROTB: 5
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
30 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 6.66 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 40 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
S (Water solubility) 0.01 mg/mL Bocci G, Oprea TI, Benet LZ

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 3.446 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 1.897 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 8.670 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 37.068 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 0.130 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 0.270 % High 1
herg hERG pIC50 4.709 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 47.315 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 11.376 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 0.370 % High 1
kinase-safety-class ACVR2A,ACVR2B,AURKA,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,DYRK1B,EGFR,EIF2AK3,ERBB2,GRK2,GSK3B,IKBKB,ITK,MAP2K6,MAP3K7,MAPK7,MAPKAPK2,PDK1,PDK2,PDK4,PIK3CB,PRKDC,STK33,SYK,TEK,TGFBR1 30
kinase-selectivity-class ACVR2B,AXL,BRAF,EIF2AK3,EPHB4,GRK2,MAP2K6,MAPK7,STK33,TEK,TTK 11
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 1.722 High 1
mh-clint Mouse hepatocyte intrinsic clearance 44.157 High 1
mppb Mouse plasma protein binding (% unbound) 0.150 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 3.622 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 0.110 % High 1
rh-clint Rat hepatocyte intrinsic clearance 26.915 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 5.680 % High 1
rppb Rat plasma protein binding (% unbound) 0.130 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 80.724 uM High 1

Approvals:

DateAgencyCompanyOrphan
May 7, 1982 FDA

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
Unintended pregnancy 8876.47 21.85 1653 32822 5984 90587988
Abortion induced 4271.62 21.85 973 33502 10915 90583057
Exposure during pregnancy 4212.26 21.85 1962 32513 236448 90357524
Depression 1902.05 21.85 1262 33213 299339 90294633
Mood altered 1842.27 21.85 537 33938 16607 90577365
Pregnancy 1577.95 21.85 663 33812 61384 90532588
Blood triglycerides increased 1540.08 21.85 445 34030 13316 90580656
Treatment noncompliance 1512.96 21.85 611 33864 51116 90542856
Dry skin 1236.55 21.85 623 33852 87450 90506522
Adverse drug reaction 1000.74 21.85 596 33879 116105 90477867
Suicidal ideation 988.25 21.85 506 33969 73349 90520623
Pregnancy test false positive 939.03 21.85 150 34325 128 90593844
Abortion spontaneous 918.69 21.85 436 34039 53620 90540352
Mood swings 588.73 21.85 240 34235 20462 90573510
Therapy cessation 496.99 21.85 253 34222 36108 90557864
No adverse event 489.53 21.85 311 34164 67671 90526301
Xerosis 416.61 21.85 100 34375 1411 90592561
Lip dry 404.42 21.85 323 34152 100632 90493340
Drug exposure before pregnancy 367.32 21.85 83 34392 883 90593089
Cheilitis 354.56 21.85 114 34361 4893 90589079
Chapped lips 352.87 21.85 100 34375 2773 90591199
Pregnancy on oral contraceptive 324.02 21.85 77 34398 1038 90592934
Anxiety 316.74 21.85 482 33993 309290 90284682
Headache 305.74 21.85 865 33610 861881 89732091
Maternal exposure during pregnancy 303.47 21.85 513 33962 359550 90234422
Selective abortion 296.90 21.85 52 34423 115 90593857
Dry eye 281.46 21.85 208 34267 57723 90536249
Depressed mood 277.56 21.85 195 34280 50027 90543945
Epistaxis 273.74 21.85 240 34235 84885 90509087
Vaginal haemorrhage 268.06 21.85 160 34315 31111 90562861
Product dispensing error 239.23 21.85 109 34366 12164 90581808
Myalgia 226.46 21.85 305 34170 174820 90419152
Product dispensing issue 226.27 21.85 49 34426 421 90593551
Acne 219.02 21.85 136 34339 28371 90565601
Maternal exposure before pregnancy 198.01 21.85 93 34382 11120 90582852
Pregnancy test positive 177.91 21.85 34 34441 142 90593830
Crying 173.71 21.85 113 34362 25532 90568440
Pneumonia 171.04 21.85 21 34454 638038 89955934
Product dose omission issue 170.85 21.85 356 34119 291331 90302641
Arthralgia 170.26 21.85 664 33811 777858 89816114
Sacroiliitis 169.87 21.85 63 34412 4156 90589816
Ectopic pregnancy 166.64 21.85 58 34417 3183 90590789
Vision blurred 162.56 21.85 205 34270 110088 90483884
Idiopathic intracranial hypertension 153.52 21.85 56 34419 3525 90590447
Pregnancy test negative 139.23 21.85 22 34453 16 90593956
Mental disorder 136.94 21.85 107 34368 32211 90561761
Adverse event 135.91 21.85 194 34281 117224 90476748
Dyspnoea 133.05 21.85 86 34389 880869 89713103
Abortion 132.17 21.85 47 34428 2748 90591224
Pregnancy on contraceptive 132.01 21.85 39 34436 1256 90592716
Infectious mononucleosis 130.83 21.85 43 34432 1978 90591994
Suicide attempt 125.40 21.85 149 34326 75250 90518722
Inflammatory bowel disease 123.57 21.85 53 34422 5118 90588854
Fall 119.36 21.85 20 34455 481790 90112182
Circumstance or information capable of leading to medication error 119.00 21.85 51 34424 4916 90589056
Self-injurious ideation 118.66 21.85 45 34430 3158 90590814
Pregnancy with contraceptive device 118.03 21.85 51 34424 5015 90588957
Infusion related reaction 115.88 21.85 12 34463 416768 90177204
Product administration interrupted 115.10 21.85 67 34408 12425 90581547
Diarrhoea 113.91 21.85 114 34361 939076 89654896
Peripheral swelling 112.05 21.85 13 34462 413093 90180879
Synovitis 111.46 21.85 3 34472 329749 90264223
Epiphyses premature fusion 106.14 21.85 19 34456 50 90593922
Rheumatoid arthritis 104.61 21.85 9 34466 362605 90231367
Nasal dryness 103.82 21.85 48 34427 5535 90588437
Night blindness 101.81 21.85 26 34449 479 90593493
Wound 101.49 21.85 3 34472 302977 90290995
Panic attack 100.40 21.85 82 34393 26283 90567689
Irritability 97.77 21.85 92 34383 35570 90558402
Hypertension 97.05 21.85 27 34448 457505 90136467
Joint swelling 92.35 21.85 38 34437 503262 90090710
Affective disorder 91.45 21.85 49 34426 7744 90586228
Arthropathy 91.11 21.85 15 34460 366227 90227745
Haematochezia 90.73 21.85 123 34352 70790 90523182
Systemic lupus erythematosus 89.63 21.85 15 34460 361881 90232091
Pericarditis 89.31 21.85 3 34472 270148 90323824
Confusional state 89.29 21.85 19 34456 386186 90207786
Asthenia 86.16 21.85 48 34427 533703 90060269
Infection 85.39 21.85 17 34458 362077 90231895
Emotional disorder 82.25 21.85 58 34417 14939 90579033
Stomatitis 81.49 21.85 6 34469 274692 90319280
Swelling 81.24 21.85 29 34446 419029 90174943
Back pain 81.02 21.85 285 34190 316890 90277082
General physical health deterioration 81.01 21.85 18 34457 355097 90238875
Scar 80.89 21.85 58 34417 15337 90578635
Depressive symptom 78.67 21.85 39 34436 5246 90588726
Acute kidney injury 77.75 21.85 14 34461 320373 90273599
Hidradenitis 76.57 21.85 36 34439 4311 90589661
Wheezing 74.20 21.85 4 34471 238076 90355896
Dermatitis 70.04 21.85 62 34413 22158 90571814
Toxicity to various agents 68.93 21.85 13 34462 287833 90306139
Lipids increased 65.27 21.85 23 34452 1309 90592663
Laboratory test abnormal 65.13 21.85 80 34395 41774 90552198
Drug hypersensitivity 64.84 21.85 49 34426 463560 90130412
Type 2 diabetes mellitus 64.65 21.85 3 34472 203241 90390731
Contraindicated product administered 64.02 21.85 21 34454 320118 90273854
Unevaluable event 63.96 21.85 91 34384 54757 90539215
Therapeutic product effect decreased 63.42 21.85 14 34461 277557 90316415
Hypotension 62.22 21.85 23 34452 325374 90268598
Normal newborn 61.61 21.85 59 34416 23303 90570669
Menstruation irregular 60.74 21.85 38 34437 8022 90585950
Discomfort 60.38 21.85 15 34460 274320 90319652
Blood cholesterol increased 60.20 21.85 195 34280 207817 90386155
Musculoskeletal stiffness 60.09 21.85 19 34456 296513 90297459
Psoriatic arthropathy 59.87 21.85 8 34467 228327 90365645
Fibromyalgia 59.78 21.85 5 34470 206264 90387708
Cough 58.31 21.85 34 34441 368928 90225044
Nasopharyngitis 58.24 21.85 42 34433 407062 90186910
Pruritus 57.52 21.85 73 34402 541452 90052520
Folliculitis 56.44 21.85 6 34469 204347 90389625
Blister 56.00 21.85 14 34461 254984 90338988
Hypoaesthesia 55.54 21.85 25 34450 314185 90279787
Impaired healing 55.17 21.85 11 34464 234188 90359784
Investigation noncompliance 53.05 21.85 9 34466 15 90593957
Hypersensitivity 52.88 21.85 57 34418 454620 90139352
Hypertriglyceridaemia 51.55 21.85 34 34441 7855 90586117
Product quality issue 51.27 21.85 101 34374 79224 90514748
Mobility decreased 50.91 21.85 16 34459 250718 90343254
Product prescribing error 50.79 21.85 60 34415 30085 90563887
Pyrexia 50.68 21.85 110 34365 660375 89933597
Pain 50.35 21.85 202 34273 996139 89597833
Acne fulminans 48.97 21.85 8 34467 9 90593963
Anger 48.75 21.85 41 34434 13679 90580293
Pain in extremity 48.59 21.85 60 34415 450469 90143503
Liver injury 47.12 21.85 5 34470 170562 90423410
Weight increased 46.83 21.85 54 34421 417873 90176099
Vomiting 46.29 21.85 150 34325 788143 89805829
C-reactive protein increased 46.04 21.85 7 34468 181382 90412590
Photosensitivity reaction 45.12 21.85 44 34431 17763 90576209
Oedema peripheral 44.82 21.85 21 34454 257894 90336078
Crohn's disease 44.64 21.85 26 34449 4825 90589147
Eyelid irritation 44.09 21.85 16 34459 992 90592980
Acne cystic 43.87 21.85 15 34460 780 90593192
Nasal vestibulitis 43.62 21.85 10 34465 114 90593858
Fatigue 43.27 21.85 260 34215 1153763 89440209
Asthma 43.20 21.85 19 34456 242141 90351831
Papule 41.70 21.85 30 34445 7972 90586000
Gait disturbance 41.14 21.85 24 34451 260472 90333500
Osteoarthritis 40.61 21.85 12 34463 195718 90398254
Loss of personal independence in daily activities 40.26 21.85 3 34472 136102 90457870
Tearfulness 39.75 21.85 24 34451 4756 90589216
Contusion 38.48 21.85 24 34451 251192 90342780
Aggression 38.34 21.85 49 34426 26619 90567353
Sinusitis 37.70 21.85 45 34430 343043 90250929
Eosinophilic pneumonia acute 37.55 21.85 13 34462 702 90593270
Inflammation 36.96 21.85 11 34464 178581 90415391
Neutropenia 36.55 21.85 20 34455 224884 90369088
Visual impairment 36.40 21.85 122 34353 132243 90461729
Bronchitis 36.39 21.85 7 34468 152920 90441052
Social avoidant behaviour 36.00 21.85 20 34455 3393 90590579
Memory impairment 35.94 21.85 15 34460 197229 90396743
Aspartate aminotransferase increased 35.83 21.85 103 34372 102834 90491138
Intentional product use issue 35.66 21.85 19 34456 216873 90377099
Lip haemorrhage 35.51 21.85 12 34463 602 90593370
Neuropathy peripheral 35.42 21.85 5 34470 136965 90457007
Intentional self-injury 34.68 21.85 49 34426 29285 90564687
Atrial fibrillation 34.26 21.85 5 34470 133606 90460366
Hyponatraemia 34.24 21.85 5 34470 133533 90460439
Ill-defined disorder 33.78 21.85 14 34461 184877 90409095
Major depression 33.63 21.85 29 34446 10006 90583966
Thrombocytopenia 33.28 21.85 19 34456 208706 90385266
Low density lipoprotein increased 32.58 21.85 26 34449 8059 90585913
SAPHO syndrome 32.09 21.85 8 34467 133 90593839
Anaemia 32.06 21.85 53 34422 352749 90241223
Drug interaction 31.73 21.85 35 34440 276418 90317554
Skin odour abnormal 31.71 21.85 15 34460 1820 90592152
Blood triglycerides abnormal 31.34 21.85 10 34465 418 90593554
Muscular weakness 31.29 21.85 20 34455 206646 90387326
Renal failure 31.16 21.85 6 34469 131001 90462971
Sepsis 30.68 21.85 15 34460 179799 90414173
Death 30.26 21.85 82 34393 456469 90137503
Dyspepsia 30.24 21.85 19 34456 198141 90395831
Wound infection 29.69 21.85 3 34472 106399 90487573
Decreased appetite 29.42 21.85 62 34413 376478 90217494
Loss of libido 29.37 21.85 13 34462 1354 90592618
Lip exfoliation 29.18 21.85 11 34464 759 90593213
Hypokalaemia 29.16 21.85 7 34468 131109 90462863
Respiratory failure 29.08 21.85 5 34470 118413 90475559
Injury 28.66 21.85 20 34455 197329 90396643
Alanine aminotransferase increased 28.15 21.85 104 34371 118234 90475738
Rectal haemorrhage 28.03 21.85 82 34393 82662 90511310
Ectopic pregnancy termination 27.97 21.85 5 34470 13 90593959
Surgery 27.61 21.85 56 34419 44831 90549141
Foetal retinoid syndrome 27.50 21.85 4 34471 0 90593972
Platelet count decreased 27.33 21.85 9 34466 136960 90457012
Blood pressure increased 27.33 21.85 21 34454 197196 90396776
Liver function test abnormal 27.29 21.85 60 34415 50785 90543187
Cardiac failure congestive 26.98 21.85 3 34472 98691 90495281
Injection site erythema 26.91 21.85 3 34472 98499 90495473
Gait inability 26.90 21.85 11 34464 146445 90447527
Tinnitus 26.78 21.85 54 34421 43048 90550924
Treatment failure 26.38 21.85 47 34428 303881 90290091
Sunburn 26.13 21.85 16 34459 3251 90590721
Injection site pain 26.03 21.85 17 34458 173682 90420290
Malaise 25.74 21.85 125 34350 585861 90008111
Pancytopenia 25.63 21.85 7 34468 120256 90473716
Lipids abnormal 25.61 21.85 8 34467 312 90593660
Obesity 24.74 21.85 5 34470 105502 90488470
Abortion induced complete 24.73 21.85 4 34471 4 90593968
Renal impairment 24.71 21.85 5 34470 105416 90488556
Weight decreased 24.59 21.85 69 34406 379841 90214131
Urinary tract infection 24.14 21.85 50 34425 305582 90288390
Mononucleosis syndrome 24.13 21.85 7 34468 211 90593761
Balance disorder 24.05 21.85 4 34471 97076 90496896
Intracranial pressure increased 23.47 21.85 20 34455 6791 90587181
Inappropriate schedule of product administration 23.44 21.85 116 34359 149817 90444155
Stress 23.24 21.85 76 34399 81319 90512653
Injection site alopecia 23.19 21.85 5 34470 42 90593930
Pleural effusion 22.98 21.85 7 34468 111984 90481988
Vulvovaginal dryness 22.93 21.85 15 34460 3416 90590556
Anotia 22.79 21.85 4 34471 9 90593963
Meibomian gland dysfunction 22.76 21.85 7 34468 259 90593713
Pustule 22.75 21.85 14 34461 2869 90591103
Cardiac arrest 22.56 21.85 6 34469 104929 90489043
Paraesthesia 22.36 21.85 38 34437 250288 90343684
Libido decreased 22.32 21.85 14 34461 2968 90591004
Post inflammatory pigmentation change 22.31 21.85 8 34467 479 90593493
Condition aggravated 22.31 21.85 134 34341 595411 89998561
Pregnancy with contraceptive patch 21.96 21.85 4 34471 12 90593960
Septic shock 21.92 21.85 3 34472 84157 90509815

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
Depression 1895.95 20.52 943 18233 110420 42491739
Mood altered 1605.80 20.52 451 18725 10267 42591892
Suicidal ideation 1264.29 20.52 552 18624 47609 42554550
Lip dry 1184.86 20.52 247 18929 1436 42600723
Blood triglycerides increased 796.70 20.52 291 18885 15605 42586554
Dry skin 758.19 20.52 389 18787 47949 42554210
Acne fulminans 556.57 20.52 99 19077 195 42601964
Mood swings 530.48 20.52 185 18991 8641 42593518
Cheilitis 450.79 20.52 123 19053 2485 42599674
Chapped lips 364.16 20.52 85 19091 880 42601279
Epiphyses premature fusion 333.42 20.52 55 19121 50 42602109
Arthralgia 326.82 20.52 430 18746 204808 42397351
Anger 291.73 20.52 134 19042 12884 42589275
Depressed mood 283.87 20.52 159 19017 23225 42578934
Xerosis 259.42 20.52 64 19112 852 42601307
Epistaxis 254.88 20.52 223 18953 66603 42535556
Sacroiliitis 249.60 20.52 73 19103 1909 42600250
Anxiety 238.95 20.52 280 18896 118280 42483879
Hidradenitis 231.98 20.52 67 19109 1674 42600485
Adverse drug reaction 217.59 20.52 160 19016 37274 42564885
Dry eye 214.56 20.52 115 19061 15391 42586768
Myalgia 185.30 20.52 222 18954 95858 42506301
Inflammatory bowel disease 174.27 20.52 64 19112 3465 42598694
Acne 166.11 20.52 93 19083 13551 42588608
Irritability 160.64 20.52 119 19057 28009 42574150
Headache 155.37 20.52 336 18840 239033 42363126
Self-injurious ideation 155.20 20.52 50 19126 1818 42600341
Suicide attempt 150.37 20.52 141 19035 45959 42556200
SAPHO syndrome 147.24 20.52 35 19141 394 42601765
Exposure via body fluid 146.42 20.52 28 19148 95 42602064
Treatment noncompliance 144.02 20.52 126 19050 37546 42564613
Therapy cessation 140.88 20.52 97 19079 20353 42581806
Erectile dysfunction 139.11 20.52 104 19072 24809 42577350
Aggression 138.16 20.52 132 19044 44031 42558128
Acute kidney injury 127.85 20.52 10 19166 367327 42234832
Nasal vestibulitis 120.08 20.52 19 19157 9 42602150
Pneumonia 119.11 20.52 23 19153 422126 42180033
Educational problem 117.49 20.52 31 19145 547 42601612
Normal newborn 115.77 20.52 28 19148 341 42601818
Aspartate aminotransferase increased 109.02 20.52 153 19023 77010 42525149
Depressive symptom 106.60 20.52 46 19130 3807 42598352
Crohn's disease 100.56 20.52 41 19135 2943 42599216
Colitis ulcerative 96.91 20.52 86 19090 26089 42576070
Alanine aminotransferase increased 95.95 20.52 155 19021 88251 42513908
Adverse event 90.17 20.52 79 19097 23561 42578598
Blood cholesterol increased 87.54 20.52 82 19094 26659 42575500
Dyspnoea 86.35 20.52 46 19130 442575 42159584
Infectious mononucleosis 83.69 20.52 25 19151 704 42601455
Crying 81.67 20.52 45 19131 6349 42595810
Death 79.44 20.52 58 19118 471127 42131032
Hepatic enzyme increased 78.76 20.52 100 19076 45684 42556475
Fall 77.13 20.52 8 19168 234512 42367647
Pyogenic granuloma 75.01 20.52 19 19157 283 42601876
Neutrophilic dermatosis 73.17 20.52 19 19157 314 42601845
Toxicity to various agents 72.38 20.52 9 19167 229127 42373032
Product quality issue 70.69 20.52 61 19115 17821 42584338
Hypotension 70.51 20.52 15 19161 257616 42344543
Nasal dryness 67.73 20.52 25 19151 1372 42600787
Sepsis 67.64 20.52 6 19170 199328 42402831
Mental disorder 66.25 20.52 59 19117 17970 42584189
Dermoid cyst 63.41 20.52 15 19161 165 42601994
Liver function test abnormal 62.54 20.52 75 19101 32316 42569843
Alopecia 61.87 20.52 71 19105 29205 42572954
Disturbance in attention 60.71 20.52 71 19105 29795 42572364
Intentional self-injury 60.38 20.52 52 19124 15150 42587009
Abnormal behaviour 59.04 20.52 66 19110 26385 42575774
Personality change 58.96 20.52 35 19141 5684 42596475
Night blindness 57.76 20.52 15 19161 248 42601911
Febrile neutropenia 56.93 20.52 8 19168 185695 42416464
Back pain 56.83 20.52 166 19010 141610 42460549
Irritable bowel syndrome 54.49 20.52 31 19145 4650 42597509
Ingrowing nail 54.24 20.52 20 19156 1094 42601065
Diarrhoea 52.55 20.52 79 19097 460770 42141389
Paronychia 51.75 20.52 29 19147 4226 42597933
Anaemia 50.45 20.52 32 19144 280246 42321913
Pregnancy of partner 50.29 20.52 15 19161 420 42601739
Photosensitivity reaction 49.53 20.52 43 19133 12659 42589500
Scar 49.06 20.52 33 19143 6655 42595504
Lipids increased 49.02 20.52 19 19157 1193 42600966
Decreased interest 48.46 20.52 24 19152 2721 42599438
Emotional disorder 48.36 20.52 32 19144 6282 42595877
Keloid scar 48.23 20.52 10 19166 56 42602103
Atrial fibrillation 47.88 20.52 4 19172 139589 42462570
Affective disorder 47.58 20.52 31 19145 5929 42596230
Anotia 46.95 20.52 7 19169 0 42602159
Neutropenia 46.28 20.52 16 19160 199415 42402744
Intestinal haemorrhage 45.55 20.52 26 19150 3925 42598234
Thrombocytopenia 44.61 20.52 15 19161 190264 42411895
Panic attack 44.30 20.52 38 19138 11007 42591152
Exposure during pregnancy 43.97 20.52 34 19142 8514 42593645
Vision blurred 43.68 20.52 83 19093 53616 42548543
Platelet count decreased 42.39 20.52 6 19170 138575 42463584
Apathy 42.29 20.52 33 19143 8373 42593786
Cerebellar hypoplasia 41.17 20.52 7 19169 9 42602150
Idiopathic intracranial hypertension 40.78 20.52 15 19161 815 42601344
Asthenia 39.39 20.52 41 19135 280752 42321407
Drug interaction 38.57 20.52 38 19138 266961 42335198
Paternal drugs affecting foetus 38.40 20.52 8 19168 46 42602113
Haemoglobin decreased 37.68 20.52 7 19169 132464 42469695
Proctitis ulcerative 37.60 20.52 10 19166 182 42601977
Renal impairment 35.58 20.52 4 19172 110224 42491935
Excessive granulation tissue 35.38 20.52 12 19164 513 42601646
Pregnancy 34.30 20.52 10 19166 258 42601901
Acne conglobata 34.26 20.52 7 19169 36 42602123
Pyoderma gangrenosum 34.13 20.52 17 19159 1950 42600209
Neuroblastoma recurrent 34.11 20.52 11 19165 401 42601758
Papule 34.02 20.52 25 19151 5801 42596358
No adverse event 33.84 20.52 62 19114 38959 42563200
Psychiatric symptom 33.71 20.52 22 19154 4219 42597940
Epiphyseal injury 33.54 20.52 5 19171 0 42602159
Growth retardation 33.51 20.52 18 19158 2414 42599745
Multiple organ dysfunction syndrome 32.67 20.52 3 19173 97032 42505127
Urethritis 32.12 20.52 11 19165 484 42601675
Pyrexia 31.53 20.52 83 19093 393959 42208200
Drug abuse 30.97 20.52 5 19171 104766 42497393
Choroid melanoma 30.60 20.52 6 19170 24 42602135
Social avoidant behaviour 30.59 20.52 19 19157 3345 42598814
Live birth 30.48 20.52 9 19167 243 42601916
General physical health deterioration 30.44 20.52 15 19161 151231 42450928
Sunburn 30.11 20.52 16 19160 2099 42600060
Nervous system neoplasm 29.86 20.52 8 19168 150 42602009
Loss of libido 29.60 20.52 18 19158 3052 42599107
Urethritis noninfective 29.60 20.52 5 19171 6 42602153
Completed suicide 29.51 20.52 103 19073 96362 42505797
Pustule 29.12 20.52 13 19163 1166 42600993
Lip haemorrhage 28.82 20.52 12 19164 908 42601251
Septic shock 27.95 20.52 4 19172 91668 42510491
Cardiac failure congestive 27.89 20.52 3 19173 85599 42516560
Libido decreased 27.81 20.52 21 19155 5077 42597082
Ear malformation 27.52 20.52 9 19167 343 42601816
Hyponatraemia 27.52 20.52 6 19170 101456 42500703
Lip exfoliation 27.42 20.52 8 19168 207 42601952
Violence-related symptom 27.38 20.52 10 19166 532 42601627
Rosacea 27.27 20.52 13 19163 1355 42600804
Anomaly of external ear congenital 27.05 20.52 7 19169 114 42602045
Myocardial infarction 26.99 20.52 11 19165 123998 42478161
Cyst 26.92 20.52 21 19155 5325 42596834
Cardiac arrest 26.70 20.52 8 19168 109312 42492847
Renal failure 26.38 20.52 16 19160 143710 42458449
Alopecia scarring 26.37 20.52 5 19171 16 42602143
Product dispensing issue 26.07 20.52 8 19168 247 42601912
Tremor 25.75 20.52 6 19170 96923 42505236
Bradycardia 25.44 20.52 4 19172 85480 42516679
Device related bacteraemia 25.19 20.52 10 19166 669 42601490
Melanocytic naevus 24.96 20.52 16 19160 2976 42599183
Urinary tract infection 24.73 20.52 7 19169 99277 42502882
Laboratory test abnormal 24.48 20.52 40 19136 22938 42579221
Henoch-Schonlein purpura 24.38 20.52 14 19162 2136 42600023
Gun shot wound 24.23 20.52 11 19165 1026 42601133
Ligament rupture 24.16 20.52 12 19164 1368 42600791
Gastrointestinal haemorrhage 24.14 20.52 7 19169 97719 42504440
Colour vision tests normal 24.06 20.52 4 19172 4 42602155
Confusional state 24.00 20.52 24 19152 167573 42434586
Oedema peripheral 23.81 20.52 16 19160 136060 42466099
Hyperkalaemia 23.42 20.52 4 19172 80454 42521705
Peripheral swelling 23.17 20.52 6 19170 90264 42511895
Vascular skin disorder 23.17 20.52 4 19172 6 42602153
Bone marrow oedema 22.72 20.52 10 19166 867 42601292
Low density lipoprotein increased 22.65 20.52 19 19157 5336 42596823
Neuropathy peripheral 22.21 20.52 9 19167 101844 42500315
Rectal haemorrhage 21.69 20.52 60 19116 49546 42552613
Renal hypertension 21.45 20.52 7 19169 265 42601894
Hypoxia 21.37 20.52 3 19173 69783 42532376
Negative thoughts 21.22 20.52 9 19167 713 42601446
COVID-19 21.14 20.52 13 19163 115935 42486224
Psychotic disorder 21.14 20.52 43 19133 29165 42572994
Colitis 21.03 20.52 57 19119 46515 42555644
Skin lesion inflammation 20.81 20.52 5 19171 59 42602100
Affect lability 20.61 20.52 16 19160 4028 42598131
Central vision loss 20.60 20.52 4 19172 15 42602144
Knee deformity 20.56 20.52 9 19167 770 42601389
Blood creatinine increased 20.53 20.52 12 19164 109991 42492168

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
Unintended pregnancy 5579.63 20.18 1029 38004 3779 110546487
Exposure during pregnancy 3614.90 20.18 1554 37479 165870 110384396
Abortion induced 2919.29 20.18 655 38378 7364 110542902
Depression 2259.28 20.18 1396 37637 315939 110234327
Mood altered 2072.92 20.18 608 38425 20767 110529499
Treatment noncompliance 1957.90 20.18 793 38240 72197 110478069
Blood triglycerides increased 1834.94 20.18 568 38465 23358 110526908
Dry skin 1433.19 20.18 717 38316 106936 110443330
Suicidal ideation 1431.00 20.18 686 38347 93251 110457015
Adverse drug reaction 1302.52 20.18 668 38365 104891 110445375
Mood swings 780.05 20.18 296 38737 22516 110527750
Abortion spontaneous 764.41 20.18 327 38706 33955 110516311
Pregnancy 698.70 20.18 347 38686 50720 110499546
Xerosis 639.42 20.18 142 38891 1507 110548759
Therapy cessation 632.03 20.18 311 38722 44546 110505720
Cheilitis 598.55 20.18 177 38856 6188 110544078
Lip dry 593.22 20.18 394 38639 99689 110450577
Pregnancy test false positive 547.74 20.18 88 38945 94 110550172
Acne fulminans 520.95 20.18 90 38943 198 110550068
Chapped lips 476.95 20.18 127 38906 3001 110547265
Depressed mood 458.92 20.18 279 38754 60530 110489736
Sacroiliitis 418.59 20.18 127 38906 4851 110545415
Epiphyses premature fusion 418.41 20.18 68 38965 83 110550183
Epistaxis 377.12 20.18 335 38698 130037 110420229
Dry eye 370.42 20.18 236 38797 55557 110494709
Drug exposure before pregnancy 338.03 20.18 72 38961 617 110549649
Headache 311.53 20.18 843 38190 881534 109668732
Anxiety 310.06 20.18 486 38547 344592 110205674
Arthralgia 309.04 20.18 778 38255 778854 109771412
Myalgia 294.25 20.18 377 38656 222004 110328262
Pregnancy on oral contraceptive 289.88 20.18 67 38966 861 110549405
Product dispensing issue 268.35 20.18 59 38974 595 110549671
Maternal exposure during pregnancy 248.47 20.18 373 38660 254510 110295756
Vaginal haemorrhage 244.64 20.18 136 38897 24938 110525328
Acne 243.06 20.18 150 38883 33370 110516896
Anger 215.80 20.18 114 38919 18893 110531373
Suicide attempt 208.56 20.18 218 38815 103176 110447090
Selective abortion 203.93 20.18 32 39001 25 110550241
Irritability 197.02 20.18 151 38882 47658 110502608
Pneumonia 196.96 20.18 36 38997 876678 109673588
Crying 191.70 20.18 117 38916 25511 110524755
Hidradenitis 187.05 20.18 70 38963 5110 110545156
Circumstance or information capable of leading to medication error 179.11 20.18 68 38965 5165 110545101
Product dose omission issue 177.86 20.18 367 38666 321415 110228851
Vision blurred 175.61 20.18 222 38811 128800 110421466
Product dispensing error 165.87 20.18 91 38942 16254 110534012
SAPHO syndrome 164.97 20.18 39 38994 556 110549710
Self-injurious ideation 161.57 20.18 60 38973 4286 110545980
Maternal exposure before pregnancy 160.80 20.18 69 38964 7196 110543070
Product administration interrupted 155.06 20.18 77 38956 11215 110539051
Acute kidney injury 154.07 20.18 21 39012 635409 109914857
Infectious mononucleosis 153.99 20.18 49 38984 2193 110548073
Idiopathic intracranial hypertension 152.22 20.18 56 38977 3896 110546370
Dyspnoea 150.09 20.18 104 38929 1106768 109443498
Ectopic pregnancy 148.73 20.18 48 38985 2249 110548017
Fall 148.57 20.18 19 39014 603463 109946803
Aggression 136.06 20.18 134 38899 59076 110491190
Aspartate aminotransferase increased 136.05 20.18 220 38813 159716 110390550
Nasal dryness 122.37 20.18 53 38980 5653 110544613
Educational problem 121.53 20.18 30 39003 518 110549748
Adverse event 121.52 20.18 170 38863 108639 110441627
Pregnancy on contraceptive 121.40 20.18 34 38999 974 110549292
Night blindness 118.38 20.18 30 39003 579 110549687
Alanine aminotransferase increased 117.56 20.18 223 38810 183550 110366716
Mental disorder 110.64 20.18 99 38934 38692 110511574
Diarrhoea 110.12 20.18 145 38888 1139360 109410906
Pregnancy with contraceptive device 109.77 20.18 44 38989 3863 110546403
Erectile dysfunction 109.62 20.18 73 38960 18483 110531783
Toxicity to various agents 109.31 20.18 19 39014 480536 110069730
Pregnancy test positive 108.69 20.18 21 39012 103 110550163
Scar 106.01 20.18 69 38964 16812 110533454
Depressive symptom 105.63 20.18 54 38979 8360 110541906
Blood cholesterol increased 104.59 20.18 213 38820 184572 110365694
Inflammatory bowel disease 104.30 20.18 51 38982 7183 110543083
Panic attack 103.27 20.18 84 38949 28856 110521410
Abortion 96.72 20.18 32 39001 1622 110548644
Hypotension 91.93 20.18 35 38998 523814 110026452
Peripheral swelling 91.81 20.18 16 39017 404018 110146248
Asthenia 91.51 20.18 66 38967 688933 109861333
Back pain 91.13 20.18 313 38720 370683 110179583
Affective disorder 90.99 20.18 54 38979 11187 110539079
Infusion related reaction 89.04 20.18 14 39019 381148 110169118
Hypertension 86.36 20.18 36 38997 510048 110040218
Sepsis 81.21 20.18 10 39023 327336 110222930
General physical health deterioration 80.50 20.18 25 39008 425270 110124996
Anaemia 79.96 20.18 47 38986 547039 110003227
Pyogenic granuloma 77.83 20.18 21 39012 522 110549744
Confusional state 76.28 20.18 35 38998 468645 110081621
Lipids increased 76.14 20.18 28 39005 1945 110548321
Rheumatoid arthritis 74.70 20.18 9 39024 299604 110250662
Emotional disorder 73.12 20.18 54 38979 16106 110534160
Low density lipoprotein increased 72.93 20.18 46 38987 10620 110539646
Product quality issue 72.14 20.18 111 38922 77188 110473078
Personality change 71.62 20.18 46 38987 10956 110539310
Synovitis 71.46 20.18 7 39026 274085 110276181
Acne cystic 71.27 20.18 22 39011 890 110549376
Febrile neutropenia 68.84 20.18 14 39019 316753 110233513
Haematochezia 68.72 20.18 136 38897 115388 110434878
Wheezing 67.92 20.18 6 39027 255224 110295042
Joint swelling 67.63 20.18 36 38997 442809 110107457
Death 66.24 20.18 90 38943 698779 109851487
Laboratory test abnormal 64.98 20.18 79 38954 44000 110506266
Loss of libido 63.60 20.18 28 39005 3105 110547161
Libido decreased 62.86 20.18 34 38999 5901 110544365
Papule 62.60 20.18 41 38992 10092 110540174
Neutropenia 62.47 20.18 27 39006 374593 110175673
Drug hypersensitivity 62.21 20.18 42 38991 454048 110096218
Infection 62.18 20.18 25 39008 362175 110188091
Neutrophilic dermatosis 61.45 20.18 19 39014 773 110549493
Crohn's disease 60.91 20.18 24 39009 2014 110548252
Photosensitivity reaction 60.79 20.18 59 38974 25530 110524736
Dermatitis 60.24 20.18 61 38972 27776 110522490
Liver function test abnormal 60.15 20.18 96 38937 68854 110481412
Thrombocytopenia 58.40 20.18 25 39008 348860 110201406
Pregnancy test negative 57.95 20.18 9 39024 6 110550260
Systemic lupus erythematosus 57.91 20.18 10 39023 254328 110295938
No adverse event 56.61 20.18 97 38936 73742 110476524
Stomatitis 56.56 20.18 13 39020 270229 110280037
Wound 56.13 20.18 8 39025 234429 110315837
Intentional self-injury 55.03 20.18 67 38966 37362 110512904
Respiratory failure 54.83 20.18 6 39027 215326 110334940
Atrial fibrillation 54.60 20.18 8 39025 229634 110320632
Drug interaction 54.16 20.18 58 38975 500125 110050141
Hypertriglyceridaemia 53.69 20.18 45 38988 16109 110534157
Oedema 53.09 20.18 6 39027 209970 110340296
Social avoidant behaviour 52.02 20.18 29 39004 5340 110544926
Swelling 51.47 20.18 30 39003 351011 110199255
Pericarditis 51.25 20.18 8 39025 219106 110331160
Oedema peripheral 49.74 20.18 27 39006 328633 110221633
Cough 49.45 20.18 54 38979 461587 110088679
Arthropathy 49.08 20.18 20 39013 287502 110262764
Fibromyalgia 48.36 20.18 3 39030 170906 110379360
Investigation noncompliance 48.28 20.18 9 39024 35 110550231
Nasopharyngitis 48.20 20.18 41 38992 394320 110155946
Dermoid cyst 47.38 20.18 14 39019 487 110549779
Therapeutic product effect decreased 46.85 20.18 14 39019 244302 110305964
Hyponatraemia 46.49 20.18 10 39023 217643 110332623
Haemoglobin decreased 46.35 20.18 15 39018 248712 110301554
Renal impairment 46.13 20.18 6 39027 188439 110361827
Device related bacteraemia 45.79 20.18 17 39016 1213 110549053
Paronychia 45.63 20.18 35 38998 11046 110539220
Apathy 45.42 20.18 41 38992 16198 110534068
Drug abuse 45.02 20.18 5 39028 177406 110372860
Major depression 44.73 20.18 34 38999 10587 110539679
Menstruation irregular 44.71 20.18 27 39006 5770 110544496
Colitis ulcerative 44.70 20.18 90 38943 77273 110472993
Vomiting 44.08 20.18 169 38864 910506 109639760
Eyelid irritation 43.46 20.18 16 39017 1115 110549151
Tearfulness 43.45 20.18 29 39004 7366 110542900
Bradycardia 43.21 20.18 3 39030 155514 110394752
Hypoaesthesia 43.09 20.18 29 39004 314194 110236072
Weight increased 42.86 20.18 51 38982 419593 110130673
Platelet count decreased 42.76 20.18 14 39019 230429 110319837
Off label use 42.67 20.18 754 38279 1499431 109050835
Pyrexia 42.64 20.18 168 38865 898097 109652169
Blister 41.86 20.18 14 39019 227362 110322904
Renal failure 41.63 20.18 14 39019 226560 110323706
Septic shock 41.11 20.18 4 39029 157524 110392742
Pyoderma gangrenosum 40.94 20.18 25 39008 5451 110544815
Musculoskeletal stiffness 40.88 20.18 24 39009 279798 110270468
Pleural effusion 40.41 20.18 7 39026 177702 110372564
Pruritus 40.41 20.18 91 38942 581469 109968797
Psychiatric symptom 39.92 20.18 30 39003 9183 110541083
Sunburn 39.84 20.18 23 39010 4525 110545741
Mobility decreased 39.74 20.18 17 39016 237405 110312861
Pustule 39.71 20.18 21 39012 3483 110546783
Intentional product use issue 39.54 20.18 19 39014 247887 110302379
Abnormal behaviour 39.17 20.18 58 38975 38981 110511285
Cardiac failure congestive 38.97 20.18 4 39029 150996 110399270
Visual impairment 38.86 20.18 120 38913 134308 110415958
Neuropathy peripheral 38.77 20.18 8 39025 179269 110370997
Malaise 38.37 20.18 116 38917 671703 109878563
Cardiac arrest 38.22 20.18 11 39022 196742 110353524
Decreased interest 38.22 20.18 23 39010 4885 110545381
Contraindicated product administered 38.14 20.18 20 39013 248247 110302019
Disturbance in attention 38.08 20.18 74 38959 61921 110488345
Hypokalaemia 37.73 20.18 9 39024 182439 110367827
Lip exfoliation 37.39 20.18 13 39020 767 110549499
Blood triglycerides abnormal 36.88 20.18 12 39021 577 110549689
Myocardial infarction 36.83 20.18 11 39022 192072 110358194
Growth retardation 36.61 20.18 18 39015 2564 110547702
Psoriatic arthropathy 36.42 20.18 12 39021 196749 110353517
Unevaluable event 35.53 20.18 70 38963 59157 110491109
Multiple organ dysfunction syndrome 34.44 20.18 6 39027 151704 110398562
Tinnitus 33.28 20.18 69 38964 60471 110489795
Gun shot wound 32.90 20.18 13 39020 1099 110549167
Ingrowing nail 32.65 20.18 18 39015 3244 110547022
Epiphyseal injury 32.40 20.18 5 39028 3 110550263
Bronchitis 31.97 20.18 8 39025 157024 110393242
Contusion 31.37 20.18 22 39011 233339 110316927
Pregnancy of partner 30.74 20.18 9 39024 303 110549963
Coma 30.73 20.18 3 39030 117866 110432400
Interstitial lung disease 30.58 20.18 6 39027 139328 110410938
Ectopic pregnancy termination 30.37 20.18 5 39028 7 110550259
C-reactive protein increased 30.02 20.18 20 39013 217899 110332367
Loss of personal independence in daily activities 29.86 20.18 8 39025 150012 110400254
Exposure via body fluid 29.75 20.18 9 39024 340 110549926
Bipolar disorder 29.74 20.18 25 39008 8982 110541284
Excessive granulation tissue 29.63 20.18 12 39021 1082 110549184
Product prescribing issue 29.50 20.18 29 39004 12743 110537523
Foetal exposure during pregnancy 29.37 20.18 23 39010 7482 110542784
Obesity 29.25 20.18 3 39030 113348 110436918
Osteoarthritis 29.11 20.18 14 39019 182609 110367657
Hypersensitivity 29.04 20.18 62 38971 403936 110146330
Blood pressure increased 29.02 20.18 29 39004 258344 110291922
Purging 28.76 20.18 6 39027 46 110550220
Surgery 28.74 20.18 52 38981 41231 110509035
Skin odour abnormal 28.65 20.18 15 39018 2439 110547827
Keloid scar 28.50 20.18 8 39025 231 110550035
Liver injury 28.14 20.18 9 39024 150404 110399862
Pain in extremity 27.86 20.18 84 38949 487034 110063232
Eosinophilic pneumonia acute 27.85 20.18 13 39020 1652 110548614
Epiphyseal disorder 27.80 20.18 4 39029 0 110550266
Growth failure 27.39 20.18 8 39025 267 110549999
Urethritis 27.30 20.18 10 39023 687 110549579
Asthma 27.08 20.18 29 39004 250262 110300004
Bone hypertrophy 26.49 20.18 10 39023 747 110549519
Somnolence 26.44 20.18 40 38993 297409 110252857
Injection site pain 26.35 20.18 15 39018 177907 110372359
Meibomian gland dysfunction 26.25 20.18 8 39025 310 110549956
Cardiac failure 26.14 20.18 17 39016 187609 110362657
Urinary tract infection 26.10 20.18 47 38986 326235 110224031
Tremor 25.97 20.18 20 39013 202212 110348054
Neuroblastoma recurrent 25.89 20.18 9 39024 531 110549735
Melanocytic naevus 25.82 20.18 19 39014 5635 110544631
Type 1 diabetes mellitus 25.61 20.18 23 39010 9024 110541242
Hypoxia 25.60 20.18 7 39026 129508 110420758
Pulmonary fibrosis 25.57 20.18 3 39030 102039 110448227
Abortion induced complete 25.56 20.18 4 39029 3 110550263
Muscular weakness 25.56 20.18 30 39003 248438 110301828
Papilloedema 25.37 20.18 21 39012 7388 110542878
Therapeutic product effect incomplete 25.27 20.18 25 39008 223780 110326486
Affect lability 25.21 20.18 32 39001 18605 110531661
Colour vision tests normal 25.03 20.18 4 39029 4 110550262
Folliculitis 25.02 20.18 14 39019 167639 110382627
Rosacea 24.82 20.18 18 39015 5218 110545048
Dyspepsia 24.37 20.18 19 39014 190946 110359320
Discomfort 24.22 20.18 24 39009 214683 110335583
Hyperkalaemia 23.90 20.18 9 39024 135787 110414479
Dyspnoea exertional 23.87 20.18 4 39029 104056 110446210
Drug ineffective for unapproved indication 23.66 20.18 85 38948 102753 110447513
Dehydration 23.51 20.18 39 38994 279472 110270794
Sinusitis 23.49 20.18 43 38990 296645 110253621
Psychotic disorder 23.39 20.18 54 38979 50883 110499383
Renal hypertension 23.25 20.18 7 39026 260 110550006
Lip haemorrhage 23.24 20.18 11 39022 1441 110548825
Myelosuppression 23.09 20.18 3 39030 94337 110455929
Proctitis ulcerative 23.04 20.18 8 39025 470 110549796
Urethritis noninfective 22.87 20.18 5 39028 49 110550217
Pulmonary oedema 22.81 20.18 4 39029 100655 110449611
Liver disorder 22.53 20.18 11 39022 142232 110408034
Therapeutic product ineffective 22.36 20.18 13 39020 2591 110547675
Gait disturbance 22.32 20.18 40 38993 278168 110272098
Ill-defined disorder 22.14 20.18 14 39019 156839 110393427
Negative thoughts 21.93 20.18 11 39022 1635 110548631
Paternal drugs affecting foetus 21.79 20.18 4 39029 14 110550252
Hypoglycaemia 21.62 20.18 7 39026 116097 110434169
Wound infection 21.49 20.18 4 39029 96461 110453805
Keratoconus 21.35 20.18 6 39027 174 110550092
Myopia 21.28 20.18 12 39021 2259 110548007
Granulomatosis with polyangiitis 21.26 20.18 14 39019 3476 110546790
Paraesthesia 21.08 20.18 41 38992 276480 110273786
Drug-induced liver injury 21.06 20.18 8 39025 120059 110430207
Vitamin A increased 20.99 20.18 4 39029 18 110550248
Choroid melanoma 20.85 20.18 5 39028 76 110550190
Injection site erythema 20.78 20.18 4 39029 94172 110456094
Henoch-Schonlein purpura 20.67 20.18 14 39019 3643 110546623
Vascular skin disorder 20.64 20.18 4 39029 20 110550246
Spinal ligament ossification 20.32 20.18 4 39029 22 110550244
Genital hypoaesthesia 20.30 20.18 6 39027 209 110550057
Malignant neoplasm progression 20.29 20.18 19 39014 174548 110375718
Night sweats 20.26 20.18 11 39022 133972 110416294

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC D10AD04 DERMATOLOGICALS
ANTI-ACNE PREPARATIONS
ANTI-ACNE PREPARATIONS FOR TOPICAL USE
Retinoids for topical use in acne
ATC D10AD54 DERMATOLOGICALS
ANTI-ACNE PREPARATIONS
ANTI-ACNE PREPARATIONS FOR TOPICAL USE
Retinoids for topical use in acne
ATC D10BA01 DERMATOLOGICALS
ANTI-ACNE PREPARATIONS
ANTI-ACNE PREPARATIONS FOR SYSTEMIC USE
Retinoids for treatment of acne
FDA CS M0018962 Retinoids
MeSH PA D003879 Dermatologic Agents
MeSH PA D013723 Teratogens
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35441 antiinfective agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35718 antifungal agent
CHEBI has role CHEBI:50176 keratolytic drug
CHEBI has role CHEBI:50905 teratogenic agent
CHEBI has role CHEBI:64946 anti-HIV agent
FDA EPC N0000175607 Retinoid

Related Drugs by ATC class:

D10AD Retinoids for topical use in acne 5 drugs
adapalenemotretinideretinoltretinointrifarotene

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

DiseaseRelationSNOMED_IDDOID
Hypertensive disorder indication 38341003 DOID:10763
Severe Recalcitrant Nodular Acne indication
Primary cutaneous T-cell lymphoma off-label use 400122007
Severe Recalcitrant Nodular Rosacea off-label use
Anuria contraindication 2472002 DOID:2983
Osteomalacia contraindication 4598005 DOID:10573
Suicidal thoughts contraindication 6471006
Alcoholism contraindication 7200002
Rectal hemorrhage contraindication 12063002
Hypercholesterolemia contraindication 13644009
Hyperkalemia contraindication 14140009
Hearing loss contraindication 15188001
Agranulocytosis contraindication 17182001 DOID:12987
Secondary angle-closure glaucoma contraindication 21571006
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Hypovolemia contraindication 28560003
Acute cerebrovascular insufficiency contraindication 29322000
Dehydration contraindication 34095006
Depressive disorder contraindication 35489007
Hyperuricemia contraindication 35885006 DOID:1920
Immunosuppression contraindication 38013005
Angioedema contraindication 41291007 DOID:1558
Hypokalemia contraindication 43339004
Low blood pressure contraindication 45007003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Anorexia nervosa contraindication 56882008 DOID:8689
Sympathectomy contraindication 57071006
Tinnitus contraindication 60862001
Corneal opacity contraindication 64634000
Osteoporosis contraindication 64859006 DOID:11476
Hypercalcemia contraindication 66931009 DOID:12678
Hyperparathyroidism contraindication 66999008 DOID:13543
Benign intracranial hypertension contraindication 68267002 DOID:11459
Psychotic disorder contraindication 69322001
Hypochloremic alkalosis contraindication 70134007
Hepatic coma contraindication 72836002 DOID:12550
Diabetes mellitus contraindication 73211009 DOID:9351
Disorder of bone contraindication 76069003 DOID:0080001
Hereditary angioneurotic edema contraindication 82966003 DOID:14735
Hyponatremia contraindication 89627008
Congenital neutropenia contraindication 89655007
Gout contraindication 90560007 DOID:13189
Kidney disease contraindication 90708001 DOID:557
Disorder of connective tissue contraindication 105969002 DOID:65
Inflammatory disease of liver contraindication 128241005
Hypomagnesemia contraindication 190855004
Acute pancreatitis contraindication 197456007 DOID:2913
Disease of liver contraindication 235856003 DOID:409
Neonatal hyperbilirubinemia contraindication 281610001
Pregnancy, function contraindication 289908002
Renal artery stenosis contraindication 302233006
Hypertriglyceridemia contraindication 302870006
Keratoconjunctivitis sicca contraindication 302896008 DOID:12895
Neutropenic disorder contraindication 303011007 DOID:1227
Bone marrow depression contraindication 307762000
Severe diarrhea contraindication 409587002
Breastfeeding (mother) contraindication 413712001
Myocardial ischemia contraindication 414795007 DOID:3393
Obesity contraindication 414916001 DOID:9970
Azotemia contraindication 445009001
Predisposition To Hypertriglyceridemia contraindication
Hemodialysis with High-Flux Membrane contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.17 acidic

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
Retinoic acid receptor beta Nuclear hormone receptor INHIBITOR CHEMBL CHEMBL
Alpha-2B adrenergic receptor GPCR Ki 5.52 DRUG MATRIX
Adenosine receptor A3 GPCR Ki 5.63 DRUG MATRIX
Retinoic acid receptor alpha Nuclear hormone receptor ED50 8.23 WOMBAT-PK
Alcohol dehydrogenase 4 Enzyme Ki 5.52 WOMBAT-PK
Dehydrogenase/reductase SDR family member 9 Enzyme Ki 4.52 WOMBAT-PK
11-cis retinol dehydrogenase Enzyme Ki 7 WOMBAT-PK
17-beta-hydroxysteroid dehydrogenase type 6 Enzyme Ki 5.40 WOMBAT-PK
Mitogen-activated protein kinase 14 Kinase IC50 5.60 DRUG MATRIX
Mitogen-activated protein kinase 1 Kinase IC50 6.34 DRUG MATRIX
5-hydroxytryptamine receptor 2B GPCR Ki 6.27 DRUG MATRIX
Olfactory receptor 51E2 GPCR IC50 6.80 CHEMBL
Cellular retinoic acid-binding protein 1 Cytosolic other IC50 6.05 CHEMBL

External reference:

IDSource
4017801 VUID
N0000146162 NUI
D00348 KEGG_DRUG
4017801 VANDF
C0022265 UMLSCUI
CHEBI:6067 CHEBI
CHEMBL547 ChEMBL_ID
DB00982 DRUGBANK_ID
D015474 MESH_DESCRIPTOR_UI
5282379 PUBCHEM_CID
7600 IUPHAR_LIGAND_ID
4617 INN_ID
EH28UP18IF UNII
202795 RXNORM
4937 MMSL
58 MMSL
71962 MMSL
d01245 MMSL
001961 NDDF
38314008 SNOMEDCT_US
387208003 SNOMEDCT_US
3KV PDB_CHEM_ID
REA PDB_CHEM_ID
EH28UP18IF INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Isotretinoin HUMAN PRESCRIPTION DRUG LABEL 1 0245-0570 CAPSULE, LIQUID FILLED 10 mg ORAL ANDA 31 sections
Isotretinoin HUMAN PRESCRIPTION DRUG LABEL 1 0245-0571 CAPSULE, LIQUID FILLED 20 mg ORAL ANDA 31 sections
Isotretinoin HUMAN PRESCRIPTION DRUG LABEL 1 0245-0573 CAPSULE, LIQUID FILLED 30 mg ORAL ANDA 31 sections
Isotretinoin HUMAN PRESCRIPTION DRUG LABEL 1 0245-0575 CAPSULE, LIQUID FILLED 40 mg ORAL ANDA 31 sections
Amnesteem HUMAN PRESCRIPTION DRUG LABEL 1 0378-6611 CAPSULE 10 mg ORAL ANDA 25 sections
Amnesteem HUMAN PRESCRIPTION DRUG LABEL 1 0378-6612 CAPSULE 20 mg ORAL ANDA 25 sections
Amnesteem HUMAN PRESCRIPTION DRUG LABEL 1 0378-6613 CAPSULE 30 mg ORAL ANDA 25 sections
Amnesteem HUMAN PRESCRIPTION DRUG LABEL 1 0378-6614 CAPSULE 40 mg ORAL ANDA 25 sections
Claravis HUMAN PRESCRIPTION DRUG LABEL 1 0555-1054 CAPSULE, LIQUID FILLED 10 mg ORAL ANDA 23 sections
Claravis HUMAN PRESCRIPTION DRUG LABEL 1 0555-1055 CAPSULE, LIQUID FILLED 20 mg ORAL ANDA 23 sections
Claravis HUMAN PRESCRIPTION DRUG LABEL 1 0555-1056 CAPSULE, LIQUID FILLED 30 mg ORAL ANDA 23 sections
Claravis HUMAN PRESCRIPTION DRUG LABEL 1 0555-1057 CAPSULE, LIQUID FILLED 40 mg ORAL ANDA 23 sections
Isotretinoin HUMAN PRESCRIPTION DRUG LABEL 1 0591-2433 CAPSULE 10 mg ORAL ANDA 30 sections
Isotretinoin HUMAN PRESCRIPTION DRUG LABEL 1 0591-2434 CAPSULE 20 mg ORAL ANDA 30 sections
Isotretinoin HUMAN PRESCRIPTION DRUG LABEL 1 0591-2435 CAPSULE 30 mg ORAL ANDA 30 sections
Isotretinoin HUMAN PRESCRIPTION DRUG LABEL 1 0591-2436 CAPSULE 40 mg ORAL ANDA 30 sections
Isotretinoin HUMAN PRESCRIPTION DRUG LABEL 1 0591-2451 CAPSULE 25 mg ORAL ANDA 30 sections
Isotretinoin HUMAN PRESCRIPTION DRUG LABEL 1 0591-2501 CAPSULE 35 mg ORAL ANDA 30 sections
Isotretinoin HUMAN PRESCRIPTION DRUG LABEL 1 0832-8301 CAPSULE, LIQUID FILLED 10 mg ORAL ANDA 24 sections
Isotretinoin HUMAN PRESCRIPTION DRUG LABEL 1 0832-8302 CAPSULE, LIQUID FILLED 20 mg ORAL ANDA 24 sections
Isotretinoin HUMAN PRESCRIPTION DRUG LABEL 1 0832-8303 CAPSULE, LIQUID FILLED 30 mg ORAL ANDA 24 sections
Isotretinoin HUMAN PRESCRIPTION DRUG LABEL 1 0832-8304 CAPSULE, LIQUID FILLED 40 mg ORAL ANDA 24 sections
Absorica LD HUMAN PRESCRIPTION DRUG LABEL 1 10631-002 CAPSULE 8 mg ORAL NDA 29 sections
Absorica LD HUMAN PRESCRIPTION DRUG LABEL 1 10631-003 CAPSULE 16 mg ORAL NDA 29 sections
Absorica LD HUMAN PRESCRIPTION DRUG LABEL 1 10631-004 CAPSULE 20 mg ORAL NDA 29 sections
Absorica LD HUMAN PRESCRIPTION DRUG LABEL 1 10631-005 CAPSULE 24 mg ORAL NDA 29 sections
Absorica LD HUMAN PRESCRIPTION DRUG LABEL 1 10631-006 CAPSULE 28 mg ORAL NDA 29 sections
Absorica LD HUMAN PRESCRIPTION DRUG LABEL 1 10631-007 CAPSULE 32 mg ORAL NDA 29 sections
Absorica HUMAN PRESCRIPTION DRUG LABEL 1 10631-115 CAPSULE 10 mg ORAL NDA 29 sections
Absorica HUMAN PRESCRIPTION DRUG LABEL 1 10631-116 CAPSULE 20 mg ORAL NDA 29 sections