isotretinoin ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 40 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

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 7323.88 21.20 1349 21639 3597 50578539
Abortion induced 2991.70 21.20 720 22268 8624 50573512
Exposure during pregnancy 2779.94 21.20 1262 21726 119753 50462383
Pregnancy 1893.72 21.20 650 22338 28927 50553209
Depression 1307.72 21.20 853 22135 164570 50417566
Blood triglycerides increased 1097.13 21.20 341 22647 10971 50571165
Lip dry 826.75 21.20 226 22762 4561 50577575
Mood altered 816.77 21.20 281 22707 12492 50569644
Dry skin 759.71 21.20 377 22611 42814 50539322
Treatment noncompliance 678.92 21.20 312 22676 29838 50552298
Suicidal ideation 676.86 21.20 379 22609 55006 50527130
No adverse event 601.76 21.20 297 22691 33281 50548855
Pregnancy test false positive 583.37 21.20 96 22892 83 50582053
Abortion spontaneous 551.67 21.20 301 22687 41471 50540665
Mood swings 380.54 21.20 172 22816 15782 50566354
Selective abortion 302.78 21.20 54 22934 107 50582029
Pregnancy on oral contraceptive 301.49 21.20 73 22915 885 50581251
Drug exposure before pregnancy 299.84 21.20 69 22919 660 50581476
Maternal exposure during pregnancy 216.83 21.20 312 22676 159466 50422670
Chapped lips 215.46 21.20 65 22923 1877 50580259
Maternal exposure before pregnancy 191.70 21.20 78 22910 5519 50576617
Depressed mood 184.31 21.20 140 22848 33883 50548253
Dry eye 180.36 21.20 135 22853 31960 50550176
Headache 176.04 21.20 566 22422 505969 50076167
Anxiety 174.40 21.20 299 22689 177307 50404829
Sacroiliitis 161.41 21.20 56 22932 2541 50579595
Idiopathic intracranial hypertension 155.11 21.20 53 22935 2296 50579840
Crying 154.44 21.20 103 22885 20313 50561823
Blood cholesterol increased 152.75 21.20 155 22833 55060 50527076
Cheilitis 146.97 21.20 57 22931 3553 50578583
Product administration interrupted 134.04 21.20 39 22949 990 50581146
Pregnancy test positive 127.26 21.20 25 22963 100 50582036
Inflammatory bowel disease 124.76 21.20 50 22938 3400 50578736
Xerosis 118.90 21.20 32 22956 605 50581531
Adverse drug reaction 117.55 21.20 135 22853 55087 50527049
Pneumonia 113.79 21.20 18 22970 378383 50203753
Ectopic pregnancy 113.75 21.20 42 22946 2285 50579851
Pregnancy with contraceptive device 113.38 21.20 49 22939 4030 50578106
Pregnancy on contraceptive 111.50 21.20 34 22954 1018 50581118
Adverse event 110.46 21.20 117 22871 43646 50538490
Vaginal haemorrhage 109.22 21.20 90 22898 24461 50557675
Therapy cessation 108.77 21.20 92 22896 25919 50556217
Product dispensing error 108.72 21.20 61 22927 8830 50573306
Myalgia 106.04 21.20 197 22791 124122 50458014
Fall 102.81 21.20 15 22973 334917 50247219
Epistaxis 100.15 21.20 134 22854 63820 50518316
Dyspnoea 94.59 21.20 67 22921 547541 50034595
Vision blurred 92.71 21.20 144 22844 78503 50503633
Infectious mononucleosis 92.36 21.20 33 22955 1633 50580503
Diarrhoea 87.99 21.20 83 22905 588393 49993743
Normal newborn 87.54 21.20 48 22940 6643 50575493
Arthralgia 87.51 21.20 412 22576 438290 50143846
Self-injurious ideation 86.51 21.20 34 22954 2195 50579941
Haematochezia 84.01 21.20 97 22891 39785 50542351
Suicide attempt 81.90 21.20 109 22879 51623 50530513
Acne 75.20 21.20 66 22922 19529 50562607
Acute kidney injury 72.80 21.20 9 22979 228049 50354087
Epiphyses premature fusion 70.38 21.20 13 22975 34 50582102
Product quality issue 69.99 21.20 78 22910 30780 50551356
Rheumatoid arthritis 69.79 21.20 6 22982 202544 50379592
Night blindness 69.73 21.20 19 22969 377 50581759
Emotional disorder 66.92 21.20 50 22938 11786 50570350
Panic attack 64.11 21.20 60 22928 19282 50562854
Nasal dryness 62.03 21.20 31 22957 3548 50578588
Peripheral swelling 61.34 21.20 10 22978 205926 50376210
Abortion 60.62 21.20 26 22962 2098 50580038
Asthenia 60.46 21.20 35 22953 319007 50263129
Nasal vestibulitis 59.10 21.20 10 22978 12 50582124
Toxicity to various agents 57.62 21.20 13 22975 212486 50369650
Colitis ulcerative 57.24 21.20 53 22935 16801 50565335
Hypotension 57.06 21.20 18 22970 235451 50346685
Irritability 56.29 21.20 67 22921 28359 50553777
Contraindicated product administered 55.41 21.20 3 22985 148955 50433181
Infusion related reaction 53.34 21.20 7 22981 169550 50412586
Hidradenitis 52.52 21.20 23 22965 1952 50580184
Cough 50.85 21.20 23 22965 241241 50340895
Joint swelling 50.74 21.20 24 22964 245262 50336874
Infection 48.06 21.20 10 22978 172944 50409192
Arthropathy 46.27 21.20 8 22980 157898 50424238
Rectal haemorrhage 45.95 21.20 71 22917 38487 50543649
Synovitis 44.54 21.20 3 22985 123862 50458274
Swelling 44.15 21.20 18 22970 200854 50381282
Lipids increased 43.59 21.20 17 22971 1075 50581061
Pruritus 43.39 21.20 39 22949 283529 50298607
Hypertension 43.16 21.20 21 22967 211182 50370954
Scar 41.76 21.20 38 22950 11780 50570356
Drug ineffective 41.44 21.20 212 22776 819121 49763015
Crohn's disease 40.97 21.20 26 22962 4707 50577429
Confusional state 40.31 21.20 17 22971 185911 50396225
Pain 38.32 21.20 135 22853 578768 50003368
Affective disorder 36.44 21.20 25 22963 5156 50576980
Sepsis 36.27 21.20 8 22980 132917 50449219
Drug hypersensitivity 35.51 21.20 37 22951 250973 50331163
Anger 35.35 21.20 34 22954 11299 50570837
Stomatitis 34.89 21.20 3 22985 101341 50480795
Fatigue 34.09 21.20 186 22802 707415 49874721
Depressive symptom 33.89 21.20 20 22968 3180 50578956
Therapeutic product effect decreased 33.65 21.20 10 22978 136040 50446096
Back pain 33.48 21.20 192 22796 219838 50362298
Product prescribing error 32.89 21.20 44 22944 20917 50561219
Menstruation irregular 32.55 21.20 25 22963 6137 50575999
Lip exfoliation 31.64 21.20 11 22977 502 50581634
Neutropenia 31.31 21.20 14 22974 147951 50434185
Bronchitis 31.12 21.20 5 22983 104154 50477982
Drug interaction 31.06 21.20 27 22961 199594 50382542
Social avoidant behaviour 30.99 21.20 18 22970 2779 50579357
General physical health deterioration 30.90 21.20 13 22975 142421 50439715
Febrile neutropenia 30.78 21.20 4 22984 97663 50484473
Discomfort 30.65 21.20 6 22982 108374 50473762
Respiratory failure 30.58 21.20 3 22985 91178 50490958
Neuropathy peripheral 30.40 21.20 4 22984 96753 50485383
Product use issue 30.31 21.20 15 22973 149460 50432676
Atrial fibrillation 30.14 21.20 5 22983 101740 50480396
Renal failure 29.95 21.20 6 22982 106627 50475509
Visual impairment 29.78 21.20 83 22905 68192 50513944
Device related bacteraemia 29.12 21.20 7 22981 82 50582054
Musculoskeletal stiffness 29.06 21.20 11 22977 128470 50453666
Systemic lupus erythematosus 28.68 21.20 14 22974 140608 50441528
Pyrexia 28.34 21.20 84 22904 380119 50202017
Intentional self-injury 28.15 21.20 43 22945 23069 50559067
Major depression 28.05 21.20 24 22964 6860 50575276
Laboratory test abnormal 28.01 21.20 43 22945 23165 50558971
Hyponatraemia 27.87 21.20 5 22983 96134 50486002
Cardiac failure congestive 27.72 21.20 3 22985 84379 50497757
Anaemia 27.69 21.20 45 22943 252411 50329725
Unevaluable event 27.40 21.20 63 22925 46003 50536133
Off label use 27.27 21.20 332 22656 474094 50108042
Pain in extremity 26.90 21.20 52 22936 272813 50309323
Aggression 26.73 21.20 40 22948 21076 50561060
Nasopharyngitis 26.64 21.20 29 22959 192898 50389238
Somnolence 26.58 21.20 19 22969 154966 50427170
Tearfulness 26.42 21.20 18 22970 3669 50578467
Oedema peripheral 26.26 21.20 20 22968 157941 50424195
Skin odour abnormal 26.25 21.20 13 22975 1459 50580677
Hypertriglyceridaemia 26.24 21.20 21 22967 5470 50576666
Mononucleosis syndrome 25.97 21.20 7 22981 133 50582003
Vomiting 25.63 21.20 115 22873 460643 50121493
Mental disorder 25.50 21.20 40 22948 21951 50560185
Urinary tract infection 25.45 21.20 39 22949 223981 50358155
Pericarditis 25.34 21.20 3 22985 78686 50503450
Aspartate aminotransferase increased 24.86 21.20 85 22903 77913 50504223
Abortion induced complete 24.55 21.20 4 22984 3 50582133
Injection site pain 24.29 21.20 10 22978 111014 50471122
Anal fissure 24.27 21.20 16 22972 3089 50579047
Pleural effusion 24.13 21.20 4 22984 81450 50500686
Renal impairment 24.08 21.20 3 22985 75658 50506478
Haemoglobin decreased 23.98 21.20 14 22974 127202 50454934
Vulvovaginal dryness 23.86 21.20 14 22974 2203 50579933
Platelet count decreased 23.84 21.20 8 22980 100718 50481418
Gait disturbance 23.68 21.20 20 22968 149985 50432151
Liver function test abnormal 23.52 21.20 58 22930 44281 50537855
Congenital anomaly 22.95 21.20 12 22976 1509 50580627
Anotia 22.75 21.20 4 22984 7 50582129
Death 22.73 21.20 74 22914 325305 50256831
Hypokalaemia 22.62 21.20 6 22982 87986 50494150
Hypoaesthesia 22.61 21.20 15 22973 127242 50454894
Loss of libido 22.40 21.20 11 22977 1212 50580924
Acne cystic 22.12 21.20 8 22980 410 50581726
Weight increased 22.12 21.20 36 22952 201855 50380281
Hypersensitivity 22.08 21.20 40 22948 215121 50367015
Blood creatinine increased 21.99 21.20 4 22984 76156 50505980
Loss of personal independence in daily activities 21.76 21.20 3 22985 70047 50512089
Meibomian gland dysfunction 21.74 21.20 6 22982 125 50582011
Photosensitivity reaction 21.65 21.20 28 22960 12883 50569253
Proctitis ulcerative 21.64 21.20 7 22981 255 50581881
Hysterectomy 21.51 21.20 22 22966 7868 50574268
Migraine 21.39 21.20 79 22909 75201 50506935
Keratoconus 21.25 21.20 4 22984 12 50582124

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 1505.16 22.63 767 14142 84380 29475238
Suicidal ideation 1130.95 22.63 479 14430 34237 29525381
Mood altered 1069.55 22.63 317 14592 7794 29551824
Lip dry 984.30 22.63 201 14708 905 29558713
Blood triglycerides increased 716.39 22.63 262 14647 12572 29547046
Dry skin 667.05 22.63 294 14615 23013 29536605
Mood swings 419.01 22.63 152 14757 7099 29552519
Cheilitis 348.23 22.63 98 14811 1978 29557640
Acne fulminans 286.53 22.63 52 14857 102 29559516
Chapped lips 279.40 22.63 61 14848 398 29559220
Arthralgia 257.27 22.63 333 14576 139284 29420334
Sacroiliitis 248.55 22.63 66 14843 1061 29558557
Anger 246.84 22.63 117 14792 10773 29548845
Depressed mood 239.35 22.63 131 14778 16317 29543301
Epistaxis 200.54 22.63 183 14726 51521 29508097
Dry eye 192.14 22.63 87 14822 7209 29552409
Inflammatory bowel disease 189.69 22.63 63 14846 2248 29557370
Anxiety 157.36 22.63 204 14705 85161 29474457
Suicide attempt 150.60 22.63 130 14779 33980 29525638
Xerosis 148.63 22.63 37 14872 453 29559165
Exposure via body fluid 143.24 22.63 28 14881 95 29559523
Colitis ulcerative 140.99 22.63 85 14824 12684 29546934
Acne 138.39 22.63 75 14834 9145 29550473
Normal newborn 133.56 22.63 28 14881 146 29559472
Self-injurious ideation 130.15 22.63 43 14866 1508 29558110
Aggression 128.39 22.63 121 14788 35420 29524198
Myalgia 125.70 22.63 170 14739 73849 29485769
Headache 124.68 22.63 272 14637 173735 29385883
Irritability 124.10 22.63 97 14812 22055 29537563
Nasal vestibulitis 118.61 22.63 19 14890 8 29559610
Educational problem 116.84 22.63 31 14878 496 29559122
SAPHO syndrome 115.42 22.63 21 14888 42 29559576
Acute kidney injury 112.85 22.63 5 14904 265262 29294356
Blood cholesterol increased 109.01 22.63 78 14831 15517 29544101
Aspartate aminotransferase increased 104.13 22.63 139 14770 59586 29500032
Erectile dysfunction 101.16 22.63 79 14830 17930 29541688
Crohn's disease 95.74 22.63 41 14868 2968 29556650
Pneumonia 94.24 22.63 23 14886 320149 29239469
Epiphyses premature fusion 92.54 22.63 16 14893 20 29559598
Adverse event 92.27 22.63 70 14839 15221 29544397
Depressive symptom 91.71 22.63 34 14875 1683 29557935
Infectious mononucleosis 88.20 22.63 25 14884 517 29559101
Adverse drug reaction 87.12 22.63 82 14827 23938 29535680
Alanine aminotransferase increased 81.76 22.63 136 14773 70808 29488810
Treatment noncompliance 80.85 22.63 79 14830 24148 29535470
Hepatic enzyme increased 73.69 22.63 88 14821 33711 29525907
Neutrophilic dermatosis 73.17 22.63 18 14891 209 29559409
Toxicity to various agents 68.46 22.63 5 14904 173656 29385962
Pyogenic granuloma 68.14 22.63 17 14892 210 29559408
Crying 67.92 22.63 39 14870 5312 29554306
Fall 67.35 22.63 6 14903 177172 29382446
Dyspnoea 67.21 22.63 41 14868 326691 29232927
Irritable bowel syndrome 65.16 22.63 31 14878 2870 29556748
Hidradenitis 64.14 22.63 21 14888 715 29558903
No adverse event 64 22.63 60 14849 17418 29542200
Hypotension 63.18 22.63 11 14898 194343 29365275
Disturbance in attention 62.56 22.63 65 14844 21359 29538259
Product quality issue 60.97 22.63 56 14853 15839 29543779
Personality change 59.39 22.63 34 14875 4604 29555014
Therapy cessation 57.52 22.63 52 14857 14410 29545208
Dermoid cyst 56.95 22.63 14 14895 162 29559456
Intentional self-injury 53.93 22.63 47 14862 12414 29547204
Sepsis 53.75 22.63 5 14904 142677 29416941
Ingrowing nail 53.71 22.63 19 14890 821 29558797
Pregnancy of partner 53.16 22.63 15 14894 305 29559313
Liver function test abnormal 52.94 22.63 69 14840 28849 29530769
Death 52.80 22.63 57 14852 342027 29217591
Nasal dryness 51.94 22.63 19 14890 905 29558713
Abnormal behaviour 50.04 22.63 60 14849 23067 29536551
Back pain 49.67 22.63 138 14771 102146 29457472
Night blindness 48.99 22.63 13 14896 208 29559410
Alopecia 48.84 22.63 54 14855 19030 29540588
Lipids increased 46.67 22.63 17 14892 800 29558818
Anotia 46.15 22.63 7 14902 0 29559618
Intestinal haemorrhage 46.05 22.63 25 14884 3054 29556564
Proctitis ulcerative 45.82 22.63 10 14899 65 29559553
Emotional disorder 44.75 22.63 29 14880 4902 29554716
Anaemia 44.41 22.63 23 14886 200928 29358690
Atrial fibrillation 41.71 22.63 3 14906 105643 29453975
Paronychia 41.47 22.63 23 14886 2930 29556688
Keloid scar 40.95 22.63 8 14901 27 29559591
Photosensitivity reaction 40.22 22.63 35 14874 9223 29550395
Diarrhoea 38.67 22.63 68 14841 332630 29226988
Exposure during pregnancy 38.50 22.63 33 14876 8521 29551097
Device related bacteraemia 37.63 22.63 10 14899 161 29559457
Affective disorder 37.59 22.63 22 14887 3104 29556514
Paternal drugs affecting foetus 37.06 22.63 8 14901 49 29559569
Idiopathic intracranial hypertension 36.30 22.63 13 14896 582 29559036
Haemoglobin decreased 35.46 22.63 6 14903 108369 29451249
Choroid melanoma 35.41 22.63 6 14903 6 29559612
Febrile neutropenia 35.04 22.63 7 14902 112233 29447385
Vision blurred 34.69 22.63 68 14841 40108 29519510
Platelet count decreased 33.80 22.63 6 14903 104666 29454952
Decreased interest 33.77 22.63 18 14891 2120 29557498
Pregnancy 33.44 22.63 10 14899 251 29559367
Panic attack 33.22 22.63 30 14879 8296 29551322
Epiphyseal injury 32.97 22.63 5 14904 0 29559618
Pyoderma gangrenosum 31.90 22.63 14 14895 1075 29558543
Live birth 31.18 22.63 9 14900 199 29559419
Product administration interrupted 30.98 22.63 10 14899 325 29559293
Asthenia 30.81 22.63 38 14871 215212 29344406
Rectal haemorrhage 30.46 22.63 59 14850 34490 29525128
Thrombocytopenia 30.40 22.63 15 14894 134808 29424810
Short stature 30.37 22.63 7 14902 60 29559558
Apathy 30.23 22.63 25 14884 6146 29553472
Melanocytic naevus 29.97 22.63 16 14893 1890 29557728
Rosacea 29.67 22.63 13 14896 994 29558624
Colitis 29.57 22.63 55 14854 31193 29528425
Drug interaction 29.14 22.63 34 14875 197351 29362267
Urethritis noninfective 29.03 22.63 5 14904 6 29559612
Nervous system neoplasm 29.01 22.63 8 14901 149 29559469
Mental disorder 28.76 22.63 34 14875 12871 29546747
Social avoidant behaviour 28.42 22.63 18 14891 2924 29556694
Cardiac failure congestive 27.98 22.63 3 14906 76578 29483040
Cerebellar hypoplasia 27.82 22.63 5 14904 9 29559609
Neutropenia 27.71 22.63 16 14893 131695 29427923
Loss of libido 27.19 22.63 16 14893 2280 29557338
General physical health deterioration 27.15 22.63 9 14900 102848 29456770
Bone marrow oedema 27.12 22.63 10 14899 487 29559131
Drug abuse 27.08 22.63 4 14905 79879 29479739
Renal failure 27.03 22.63 13 14896 118586 29441032
Myocardial infarction 26.85 22.63 11 14898 110285 29449333
Anomaly of external ear congenital 26.80 22.63 7 14902 105 29559513
Lip haemorrhage 26.53 22.63 11 14898 734 29558884
Vascular skin disorder 26.37 22.63 4 14905 0 29559618
Henoch-Schonlein purpura 26.35 22.63 13 14896 1303 29558315
Pustule 24.97 22.63 8 14901 254 29559364
Ligament rupture 24.77 22.63 11 14898 869 29558749
Low density lipoprotein increased 23.82 22.63 18 14891 3886 29555732
Urethritis 23.67 22.63 8 14901 301 29559317
Ear malformation 23.67 22.63 8 14901 301 29559317
Colour vision tests normal 23.60 22.63 4 14905 4 29559614
Cardiac arrest 23.46 22.63 7 14902 85584 29474034
Psychotic disorder 23.36 22.63 39 14870 20315 29539303
Proctitis 23.10 22.63 14 14895 2105 29557513

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 3941.76 19.52 736 25987 2398 64469611
Exposure during pregnancy 2420.48 19.52 981 25742 76694 64395315
Depression 1817.89 19.52 1056 25667 182235 64289774
Abortion induced 1759.89 19.52 429 26294 5959 64466050
Blood triglycerides increased 1430.25 19.52 461 26262 18405 64453604
Mood altered 1192.68 19.52 386 26337 15593 64456416
Suicidal ideation 1122.96 19.52 548 26175 65994 64406015
Lip dry 1106.87 19.52 281 26442 4637 64467372
Dry skin 977.32 19.52 459 26264 50702 64421307
Pregnancy 915.50 19.52 339 26384 20526 64451483
Treatment noncompliance 690.61 19.52 344 26379 43138 64428871
Mood swings 542.68 19.52 221 26502 17247 64454762
Abortion spontaneous 410.97 19.52 203 26520 24940 64447069
Sacroiliitis 397.65 19.52 113 26610 2899 64469110
Depressed mood 333.19 19.52 209 26514 40803 64431206
Chapped lips 331.20 19.52 90 26633 1948 64470061
Cheilitis 300.88 19.52 101 26622 4555 64467454
Acne fulminans 288.04 19.52 51 26672 109 64471900
Dry eye 287.52 19.52 168 26555 28851 64443158
Pregnancy test false positive 287.03 19.52 48 26675 60 64471949
Drug exposure before pregnancy 280.99 19.52 60 26663 435 64471574
Pregnancy on oral contraceptive 275.60 19.52 64 26659 707 64471302
Headache 242.37 19.52 616 26107 528851 63943158
Blood cholesterol increased 219.39 19.52 175 26548 49891 64422118
Selective abortion 217.08 19.52 34 26689 17 64471992
Arthralgia 214.14 19.52 526 26197 441734 64030275
Xerosis 210.70 19.52 54 26669 923 64471086
Anxiety 208.16 19.52 331 26392 202318 64269691
Adverse drug reaction 197.23 19.52 158 26565 45306 64426703
Epistaxis 196.12 19.52 222 26501 97909 64374100
Maternal exposure during pregnancy 193.46 19.52 218 26505 95666 64376343
Anger 179.69 19.52 100 26623 15641 64456368
Crying 174.76 19.52 107 26616 19983 64452026
Myalgia 172.37 19.52 266 26457 158351 64313658
Product administration interrupted 169.81 19.52 47 26676 1091 64470918
Therapy cessation 167.26 19.52 125 26598 32364 64439645
Suicide attempt 157.99 19.52 170 26553 70837 64401172
Maternal exposure before pregnancy 157.74 19.52 58 26665 3425 64468584
Irritability 147.33 19.52 122 26601 36624 64435385
Idiopathic intracranial hypertension 146.99 19.52 51 26672 2542 64469467
Acute kidney injury 141.80 19.52 12 26711 449228 64022781
Pneumonia 137.22 19.52 32 26691 559544 63912465
Epiphyses premature fusion 135.00 19.52 24 26699 53 64471956
Infectious mononucleosis 129.65 19.52 42 26681 1691 64470318
Self-injurious ideation 129.29 19.52 49 26674 3148 64468861
Educational problem 125.84 19.52 30 26693 374 64471635
Fall 124.00 19.52 14 26709 416812 64055197
Aggression 121.38 19.52 121 26602 46111 64425898
Vision blurred 117.54 19.52 165 26558 90151 64381858
Aspartate aminotransferase increased 116.41 19.52 191 26532 119597 64352412
Inflammatory bowel disease 112.68 19.52 49 26674 4489 64467520
Pregnancy test positive 112.05 19.52 21 26702 69 64471940
Pregnancy with contraceptive device 108.30 19.52 43 26680 3131 64468878
Vaginal haemorrhage 107.59 19.52 78 26645 19266 64452743
Night blindness 107.24 19.52 27 26696 428 64471581
SAPHO syndrome 106.62 19.52 22 26701 132 64471877
Dyspnoea 105.80 19.52 86 26637 718588 63753421
Ectopic pregnancy 105.29 19.52 35 26688 1529 64470480
Toxicity to various agents 101.36 19.52 15 26708 363498 64108511
Pregnancy on contraceptive 96.88 19.52 28 26695 763 64471246
No adverse event 94.53 19.52 85 26638 28476 64443533
Off label use 94.04 19.52 512 26211 632294 63839715
Adverse event 93.91 19.52 98 26625 39391 64432618
Colitis ulcerative 93.42 19.52 77 26646 22951 64449058
Alanine aminotransferase increased 91.12 19.52 187 26536 138844 64333165
Acne 85.02 19.52 73 26650 23008 64449001
Hypotension 83.49 19.52 27 26696 380947 64091062
Depressive symptom 81.51 19.52 39 26684 4457 64467552
Hidradenitis 81.03 19.52 32 26691 2297 64469712
Haematochezia 80.07 19.52 117 26606 66256 64405753
Erectile dysfunction 79.67 19.52 55 26668 12572 64459437
Panic attack 78.66 19.52 67 26656 20886 64451123
Nasal dryness 77.65 19.52 35 26688 3491 64468518
Diarrhoea 75.02 19.52 115 26608 722589 63749420
Pyogenic granuloma 73.31 19.52 20 26703 439 64471570
Personality change 72.75 19.52 45 26678 8548 64463461
Emotional disorder 68.21 19.52 50 26673 12557 64459452
Anaemia 68.18 19.52 36 26687 378644 64093365
Sepsis 67.75 19.52 8 26715 230333 64241676
Device related bacteraemia 64.88 19.52 17 26706 318 64471691
Neutrophilic dermatosis 60.72 19.52 18 26705 537 64471472
Asthenia 60.62 19.52 53 26670 427991 64044018
Product quality issue 58.72 19.52 67 26656 29732 64442277
Crohn's disease 57.75 19.52 24 26699 1965 64470044
Back pain 57.27 19.52 230 26493 249941 64222068
Peripheral swelling 55.17 19.52 10 26713 209143 64262866
Loss of libido 53.38 19.52 24 26699 2380 64469629
Scar 52.67 19.52 44 26679 13354 64458655
Respiratory failure 51.59 19.52 4 26719 161179 64310830
Liver function test abnormal 51.39 19.52 90 26633 59311 64412698
Disturbance in attention 50.38 19.52 73 26650 41001 64431008
Low density lipoprotein increased 49.50 19.52 34 26689 7706 64464303
Haemoglobin decreased 47.97 19.52 11 26712 195052 64276957
Dermoid cyst 47.84 19.52 13 26710 281 64471728
Atrial fibrillation 47.76 19.52 7 26716 171082 64300927
Lipids increased 47.66 19.52 19 26704 1398 64470611
Rheumatoid arthritis 47.57 19.52 6 26717 164288 64307721
Febrile neutropenia 45.32 19.52 11 26712 187646 64284363
Intentional self-injury 45.29 19.52 58 26665 28986 64443023
Drug interaction 45.27 19.52 50 26673 362033 64109976
Death 45.15 19.52 82 26641 482623 63989386
Infection 44.33 19.52 11 26712 184869 64287140
Social avoidant behaviour 44.09 19.52 26 26697 4531 64467478
Infusion related reaction 43.07 19.52 8 26715 164459 64307550
Abortion 43.06 19.52 17 26706 1219 64470790
Renal impairment 41.44 19.52 4 26719 135013 64336996
Renal failure 41.32 19.52 12 26711 181676 64290333
Neutropenia 41.31 19.52 24 26699 239600 64232409
Tearfulness 40.90 19.52 25 26698 4648 64467361
Drug abuse 40.42 19.52 4 26719 132370 64339639
Affective disorder 39.96 19.52 28 26695 6552 64465457
Cardiac failure congestive 39.73 19.52 4 26719 130576 64341433
Myocardial infarction 39.50 19.52 10 26713 165811 64306198
General physical health deterioration 38.90 19.52 18 26705 204407 64267602
Pyoderma gangrenosum 38.86 19.52 21 26702 3097 64468912
Cough 38.55 19.52 41 26682 302107 64169902
Libido decreased 37.85 19.52 24 26699 4760 64467249
Major depression 37.83 19.52 29 26694 7787 64464222
Bradycardia 37.64 19.52 3 26720 118216 64353793
Confusional state 37.32 19.52 32 26691 261112 64210897
Thrombocytopenia 36.38 19.52 24 26699 223777 64248232
Photosensitivity reaction 36.04 19.52 41 26682 18132 64453877
Hypertension 35.57 19.52 33 26690 259228 64212781
Cardiac arrest 35.35 19.52 10 26713 154054 64317955
Joint swelling 35.14 19.52 23 26700 215359 64256650
Hepatic enzyme increased 35.07 19.52 126 26597 129817 64342192
Platelet count decreased 34.76 19.52 13 26710 167698 64304311
Rectal haemorrhage 34.53 19.52 78 26645 61739 64410270
Epiphyseal injury 33.95 19.52 5 26718 0 64472009
Ingrowing nail 33.72 19.52 17 26706 2174 64469835
Hyponatraemia 33.35 19.52 10 26713 148329 64323680
Abnormal behaviour 33.13 19.52 54 26669 33568 64438441
Bipolar disorder 32.53 19.52 25 26698 6736 64465273
Decreased interest 32.06 19.52 19 26704 3341 64468668
Drug hypersensitivity 31.77 19.52 31 26692 237784 64234225
Hypokalaemia 31.76 19.52 6 26717 121897 64350112
Lip exfoliation 31.66 19.52 11 26712 550 64471459
Gun shot wound 31.44 19.52 13 26710 1051 64470958
Pregnancy of partner 31.29 19.52 9 26714 241 64471768
Tinnitus 31.19 19.52 53 26670 34080 64437929
Exposure via body fluid 31.04 19.52 9 26714 248 64471761
Mental disorder 30.98 19.52 46 26677 26399 64445610
Blood creatinine increased 30.80 19.52 9 26714 135773 64336236
Hypertriglyceridaemia 30.63 19.52 30 26693 11175 64460834
Visual impairment 30.32 19.52 83 26640 73994 64398015
Affect lability 30.22 19.52 27 26696 8963 64463046
Neuropathy peripheral 30.16 19.52 6 26717 117519 64354490
Septic shock 30.15 19.52 4 26719 105433 64366576
Oedema peripheral 29.76 19.52 26 26697 210291 64261718
Bronchitis 29.09 19.52 5 26718 108738 64363271
Contraindicated product administered 28.76 19.52 5 26718 107824 64364185
Pruritus 28.33 19.52 54 26669 312346 64159663
Growth failure 27.54 19.52 8 26715 222 64471787
Oedema 27.49 19.52 3 26720 91932 64380077
Migraine 27.43 19.52 72 26651 62605 64409404
Abortion induced complete 27.16 19.52 4 26719 0 64472009
Alopecia 27.10 19.52 138 26585 165552 64306457
Paronychia 26.93 19.52 22 26701 6470 64465539
Meibomian gland dysfunction 26.71 19.52 7 26716 131 64471878
Product use issue 26.41 19.52 15 26708 151700 64320309
Proctitis ulcerative 26.16 19.52 8 26715 266 64471743
Melanocytic naevus 26.11 19.52 18 26705 4102 64467907
Hypoxia 26.05 19.52 3 26720 88146 64383863
Coma 25.84 19.52 3 26720 87612 64384397
Urinary tract infection 25.73 19.52 35 26688 231561 64240448
Synovitis 25.55 19.52 5 26718 99085 64372924
Stomatitis 25.35 19.52 7 26716 109598 64362411
Urethritis noninfective 25.34 19.52 5 26718 23 64471986
Keratoconus 25.15 19.52 6 26717 75 64471934
Apathy 25.13 19.52 27 26696 11205 64460804
Interstitial lung disease 25.06 19.52 5 26718 97727 64374282
Menstruation irregular 24.92 19.52 18 26705 4417 64467592
Malaise 24.68 19.52 83 26640 396164 64075845
Colour vision tests normal 24.39 19.52 4 26719 4 64472005
Psychotic disorder 24.39 19.52 48 26675 34530 64437479
Multiple organ dysfunction syndrome 24.36 19.52 6 26717 101407 64370602
Hypoglycaemia 24.34 19.52 4 26719 89888 64382121
Tremor 23.93 19.52 16 26707 148214 64323795
Pyrexia 23.85 19.52 135 26588 558509 63913500
Nasopharyngitis 23.47 19.52 28 26695 196045 64275964
Blood pressure decreased 22.98 19.52 4 26719 86195 64385814
Laboratory test abnormal 22.83 19.52 38 26685 24025 64447984
Keloid scar 22.76 19.52 6 26717 115 64471894
Myopia 22.35 19.52 12 26711 1746 64470263
Choroid melanoma 22.07 19.52 5 26718 49 64471960
Vomiting 22.03 19.52 136 26587 550981 63921028
Cardiac failure 21.76 19.52 14 26709 132359 64339650
Skin odour abnormal 21.68 19.52 12 26711 1855 64470154
Wound 21.63 19.52 3 26720 76474 64395535
Somnolence 21.40 19.52 32 26691 203613 64268396
Urethritis 21.31 19.52 8 26715 500 64471509
Swelling 21.25 19.52 21 26702 160197 64311812
Paternal drugs affecting foetus 21.15 19.52 4 26719 14 64471995
Aspartate aminotransferase abnormal 21.14 19.52 11 26712 1503 64470506
Weight increased 21.02 19.52 35 26688 213313 64258696
Lip haemorrhage 21.01 19.52 10 26713 1129 64470880
Bone marrow oedema 20.92 19.52 10 26713 1140 64470869
Type 1 diabetes mellitus 20.91 19.52 18 26705 5687 64466322
Injection site pain 20.89 19.52 10 26713 111398 64360611
Vascular skin disorder 20.73 19.52 4 26719 16 64471993
Cerebrovascular accident 20.71 19.52 16 26707 137567 64334442
Therapeutic product effect decreased 20.66 19.52 11 26712 115340 64356669
Vulvovaginal dryness 20.51 19.52 11 26712 1597 64470412
Gastrointestinal haemorrhage 20.41 19.52 15 26708 132297 64339712
Vitamin A increased 20.37 19.52 3 26720 0 64472009
Blood pressure increased 20.26 19.52 25 26698 172527 64299482
Central vision loss 20.17 19.52 4 26719 19 64471990
Dehydration 20.05 19.52 37 26686 216726 64255283
Henoch-Schonlein purpura 19.81 19.52 12 26711 2194 64469815
Arthropathy 19.60 19.52 13 26710 120954 64351055

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
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:50176 keratolytic drugs
CHEBI has role CHEBI:50905 teratogeno
FDA EPC N0000175607 Retinoid
MeSH PA D003879 Dermatologic Agents
MeSH PA D009676 Noxae
MeSH PA D013723 Teratogens

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




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 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
3KV PDB_CHEM_ID
REA PDB_CHEM_ID
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

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 0378-6614 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
Absorica LD HUMAN PRESCRIPTION DRUG LABEL 1 10631-002 CAPSULE 8 mg ORAL NDA 30 sections
Absorica LD HUMAN PRESCRIPTION DRUG LABEL 1 10631-002 CAPSULE 8 mg ORAL NDA 30 sections
Absorica LD HUMAN PRESCRIPTION DRUG LABEL 1 10631-003 CAPSULE 16 mg ORAL NDA 30 sections
Absorica LD HUMAN PRESCRIPTION DRUG LABEL 1 10631-003 CAPSULE 16 mg ORAL NDA 30 sections
Absorica LD HUMAN PRESCRIPTION DRUG LABEL 1 10631-004 CAPSULE 20 mg ORAL NDA 30 sections
Absorica LD HUMAN PRESCRIPTION DRUG LABEL 1 10631-004 CAPSULE 20 mg ORAL NDA 30 sections
Absorica LD HUMAN PRESCRIPTION DRUG LABEL 1 10631-005 CAPSULE 24 mg ORAL NDA 30 sections
Absorica LD HUMAN PRESCRIPTION DRUG LABEL 1 10631-005 CAPSULE 24 mg ORAL NDA 30 sections
Absorica LD HUMAN PRESCRIPTION DRUG LABEL 1 10631-006 CAPSULE 28 mg ORAL NDA 30 sections
Absorica LD HUMAN PRESCRIPTION DRUG LABEL 1 10631-006 CAPSULE 28 mg ORAL NDA 30 sections
Absorica LD HUMAN PRESCRIPTION DRUG LABEL 1 10631-007 CAPSULE 32 mg ORAL NDA 30 sections
Absorica LD HUMAN PRESCRIPTION DRUG LABEL 1 10631-007 CAPSULE 32 mg ORAL NDA 30 sections
Absorica HUMAN PRESCRIPTION DRUG LABEL 1 10631-115 CAPSULE 10 mg ORAL NDA 30 sections