isotretinoin 🐶 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 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

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 7827.01 21.81 1461 25348 4718 63457495
Abortion induced 3397.70 21.81 801 26008 9441 63452772
Exposure during pregnancy 3173.84 21.81 1461 25348 154086 63308127
Pregnancy 1814.37 21.81 654 26155 36182 63426031
Depression 1638.84 21.81 1020 25789 195472 63266741
Blood triglycerides increased 1266.25 21.81 383 26426 12105 63450108
Mood altered 1195.35 21.81 381 26428 14362 63447851
Treatment noncompliance 1186.48 21.81 482 26327 36843 63425370
Dry skin 922.67 21.81 459 26350 56428 63405785
Suicidal ideation 797.18 21.81 429 26380 61992 63400221
Lip dry 687.13 21.81 255 26554 15215 63446998
Abortion spontaneous 652.06 21.81 342 26467 46853 63415360
Pregnancy test false positive 631.28 21.81 104 26705 106 63462107
No adverse event 577.45 21.81 302 26507 41103 63421110
Mood swings 472.77 21.81 204 26605 18044 63444169
Adverse drug reaction 337.38 21.81 275 26534 79439 63382774
Selective abortion 304.09 21.81 54 26755 115 63462098
Pregnancy on oral contraceptive 301.02 21.81 73 26736 964 63461249
Drug exposure before pregnancy 298.20 21.81 71 26738 863 63461350
Chapped lips 267.24 21.81 79 26730 2291 63459922
Maternal exposure during pregnancy 266.88 21.81 392 26417 219670 63242543
Anxiety 245.87 21.81 375 26434 217166 63245047
Headache 234.88 21.81 690 26119 632551 62829662
Cheilitis 228.25 21.81 80 26729 4033 63458180
Depressed mood 223.11 21.81 163 26646 40028 63422185
Xerosis 204.55 21.81 53 26756 929 63461284
Dry eye 196.65 21.81 152 26657 40609 63421604
Maternal exposure before pregnancy 180.57 21.81 80 26729 7523 63454690
Crying 165.40 21.81 110 26699 23233 63438980
Vaginal haemorrhage 165.15 21.81 117 26692 27370 63434843
Epistaxis 160.64 21.81 175 26634 72550 63389663
Sacroiliitis 153.01 21.81 56 26753 3201 63459012
Idiopathic intracranial hypertension 151.18 21.81 54 26755 2877 63459336
Myalgia 137.04 21.81 232 26577 146297 63315916
Ectopic pregnancy 135.07 21.81 48 26761 2519 63459694
Pneumonia 132.76 21.81 18 26791 456749 63005464
Pregnancy test positive 125.90 21.81 25 26784 117 63462096
Inflammatory bowel disease 121.45 21.81 50 26759 3923 63458290
Product dispensing error 120.62 21.81 67 26742 10238 63451975
Blood cholesterol increased 120.18 21.81 172 26637 93860 63368353
Product administration interrupted 115.20 21.81 51 26758 4785 63457428
Therapy cessation 114.01 21.81 98 26711 30359 63431854
Pregnancy on contraceptive 113.99 21.81 35 26774 1157 63461056
Arthralgia 112.88 21.81 507 26302 569203 62893010
Dyspnoea 111.83 21.81 71 26738 661242 62800971
Fall 110.38 21.81 17 26792 392317 63069896
Pregnancy with contraceptive device 110.20 21.81 49 26760 4645 63457568
Self-injurious ideation 107.66 21.81 41 26768 2618 63459595
Suicide attempt 104.92 21.81 129 26680 60789 63401424
Infectious mononucleosis 104.85 21.81 37 26772 1902 63460311
Vision blurred 104.29 21.81 159 26650 91765 63370448
Acne 103.96 21.81 83 26726 23210 63439003
Adverse event 102.03 21.81 134 26675 67425 63394788
Epiphyses premature fusion 100.83 21.81 18 26791 40 63462173
Normal newborn 96.99 21.81 54 26755 8287 63453926
Diarrhoea 92.29 21.81 100 26709 715266 62746947
Product quality issue 89.24 21.81 92 26717 35773 63426440
Panic attack 87.96 21.81 74 26735 22257 63439956
Haematochezia 83.63 21.81 108 26701 53436 63408777
Night blindness 81.19 21.81 22 26787 461 63461752
Nasal dryness 80.11 21.81 39 26770 4542 63457671
Rheumatoid arthritis 78.60 21.81 8 26801 253811 63208402
Infusion related reaction 77.98 21.81 7 26802 245514 63216699
Peripheral swelling 75.93 21.81 11 26798 265931 63196282
Abortion 74.90 21.81 31 26778 2465 63459748
Acute kidney injury 70.50 21.81 13 26796 263402 63198811
Arthropathy 68.70 21.81 9 26800 234783 63227430
Joint swelling 67.47 21.81 27 26782 327639 63134574
Emotional disorder 66.90 21.81 51 26758 13328 63448885
Asthenia 66.32 21.81 40 26769 383564 63078649
Synovitis 66.23 21.81 3 26806 186915 63275298
Toxicity to various agents 64.48 21.81 13 26796 247237 63214976
Irritability 64.29 21.81 73 26736 31621 63430592
Swelling 63.04 21.81 19 26790 275359 63186854
Hypotension 62.06 21.81 19 26790 272585 63189628
Cough 60.46 21.81 24 26785 292719 63169494
Hypertension 59.17 21.81 22 26787 279281 63182932
Hidradenitis 58.24 21.81 27 26782 2819 63459394
Nasal vestibulitis 58.16 21.81 10 26799 16 63462197
Depressive symptom 57.30 21.81 30 26779 4072 63458141
Wound 56.62 21.81 3 26806 163260 63298953
Mental disorder 56.52 21.81 62 26747 25857 63436356
Infection 53.93 21.81 15 26794 229158 63233055
Affective disorder 53.53 21.81 33 26776 6113 63456100
Confusional state 52.85 21.81 17 26792 236363 63225850
Therapeutic product effect decreased 50.68 21.81 10 26799 193177 63269036
Lipids increased 50.42 21.81 19 26790 1178 63461035
Contraindicated product administered 49.83 21.81 15 26794 217633 63244580
Scar 48.84 21.81 43 26766 13739 63448474
Systemic lupus erythematosus 48.55 21.81 14 26795 208904 63253309
Pain 48.00 21.81 157 26652 740471 62721742
Product dose omission issue 47.97 21.81 211 26598 234102 63228111
Stomatitis 46.72 21.81 3 26806 138722 63323491
Anger 46.43 21.81 40 26769 12416 63449797
Drug hypersensitivity 46.27 21.81 38 26771 310649 63151564
Musculoskeletal stiffness 45.50 21.81 11 26798 184607 63277606
Pruritus 44.83 21.81 52 26757 361401 63100812
Back pain 44.67 21.81 225 26584 263920 63198293
Product use issue 44.02 21.81 19 26790 220501 63241712
Pericarditis 43.86 21.81 3 26806 131576 63330637
Rectal haemorrhage 43.59 21.81 76 26733 48954 63413259
Colitis ulcerative 42.89 21.81 54 26755 26037 63436176
Drug ineffective 42.20 21.81 264 26545 1044501 62417712
Crohn's disease 41.82 21.81 26 26783 4887 63457326
Laboratory test abnormal 41.56 21.81 54 26755 26858 63435355
Unevaluable event 41.02 21.81 76 26733 51310 63410903
General physical health deterioration 40.76 21.81 17 26792 201385 63260828
Discomfort 39.28 21.81 11 26798 167363 63294850
Nasopharyngitis 39.22 21.81 30 26779 254227 63207986
Fatigue 39.21 21.81 218 26591 887810 62574403
Pyrexia 38.43 21.81 89 26720 470389 62991824
Tearfulness 38.03 21.81 23 26786 4116 63458097
Sepsis 37.97 21.81 9 26800 153114 63309099
Social avoidant behaviour 36.53 21.81 20 26789 2968 63459245
Febrile neutropenia 35.95 21.81 4 26805 118445 63343768
Visual impairment 35.80 21.81 97 26712 84349 63377864
Menstruation irregular 35.68 21.81 27 26782 6977 63455236
Neutropenia 35.04 21.81 15 26794 174990 63287223
Intentional product use issue 34.86 21.81 6 26803 127886 63334327
Bronchitis 33.75 21.81 6 26803 124929 63337284
Pain in extremity 33.73 21.81 55 26754 331431 63130782
Drug interaction 32.90 21.81 29 26780 229102 63233111
Atrial fibrillation 32.85 21.81 5 26804 116631 63345582
Neuropathy peripheral 31.72 21.81 5 26804 113662 63348551
Anaemia 31.46 21.81 47 26762 293383 63168830
Photosensitivity reaction 31.19 21.81 35 26774 14959 63447254
Hyponatraemia 31.05 21.81 5 26804 111895 63350318
Renal failure 31.03 21.81 6 26803 117646 63344567
Oedema peripheral 31.00 21.81 21 26788 189490 63272723
Product prescribing error 30.52 21.81 46 26763 26243 63435970
Hypersensitivity 30.30 21.81 48 26761 292637 63169576
Lip exfoliation 30.13 21.81 11 26798 624 63461589
Intentional self-injury 29.90 21.81 45 26764 25642 63436571
Hypoaesthesia 29.83 21.81 17 26792 168376 63293837
Respiratory failure 29.54 21.81 4 26805 101854 63360359
Hypertriglyceridaemia 29.41 21.81 23 26786 6236 63455977
Gait disturbance 29.03 21.81 21 26788 183157 63279056
Weight increased 28.70 21.81 41 26768 260751 63201462
Skin odour abnormal 28.58 21.81 14 26795 1652 63460561
Aggression 28.54 21.81 42 26767 23456 63438757
Acne cystic 28.50 21.81 10 26799 505 63461708
Major depression 28.38 21.81 25 26784 7993 63454220
Cardiac failure congestive 28.36 21.81 3 26806 92430 63369783
Vomiting 28.23 21.81 131 26678 559486 62902727
Aspartate aminotransferase increased 28.12 21.81 93 26716 90184 63372029
Psoriatic arthropathy 28.00 21.81 3 26806 91517 63370696
Urinary tract infection 27.78 21.81 43 26766 264641 63197572
Acne fulminans 27.08 21.81 4 26805 0 63462213
Platelet count decreased 26.56 21.81 8 26801 116114 63346099
Treatment failure 26.45 21.81 27 26782 199016 63263197
Blister 26.19 21.81 11 26798 129803 63332410
Injection site pain 26.18 21.81 11 26798 129789 63332424
Dermatitis 26.14 21.81 34 26775 16924 63445289
Hypokalaemia 25.93 21.81 6 26803 103798 63358415
Loss of personal independence in daily activities 25.58 21.81 5 26804 97285 63364928
Somnolence 25.18 21.81 23 26786 178662 63283551
Loss of libido 25.14 21.81 12 26797 1337 63460876
Death 25.11 21.81 78 26731 374303 63087910
Congenital anomaly 24.84 21.81 13 26796 1763 63460450
Lip haemorrhage 24.67 21.81 9 26800 509 63461704
Injection site alopecia 24.58 21.81 5 26804 27 63462186
Renal impairment 24.40 21.81 4 26805 88351 63373862
Mononucleosis syndrome 24.33 21.81 7 26802 184 63462029
Abortion induced complete 24.31 21.81 4 26805 4 63462209
Liver function test abnormal 24.19 21.81 59 26750 48122 63414091
Vulvovaginal dryness 23.81 21.81 15 26794 2886 63459327
Device related bacteraemia 23.77 21.81 7 26802 200 63462013
Alanine aminotransferase increased 23.16 21.81 96 26713 103674 63358539
Thrombocytopenia 23.08 21.81 18 26791 151139 63311074
Anotia 23.04 21.81 4 26805 7 63462206
Balance disorder 22.92 21.81 4 26805 84418 63377795
Off label use 22.67 21.81 405 26404 674057 62788156
Blood pressure increased 22.67 21.81 21 26788 162041 63300172
C-reactive protein increased 22.63 21.81 6 26803 94701 63367512
Haemoglobin decreased 22.63 21.81 17 26792 145468 63316745
Tremor 22.50 21.81 14 26795 132225 63329988
Asthma 22.42 21.81 13 26796 127548 63334665
Anal fissure 22.35 21.81 17 26792 4426 63457787
Decreased interest 22.23 21.81 15 26794 3239 63458974
Ectopic pregnancy termination 22.08 21.81 4 26805 10 63462203
Cardiac arrest 21.86 21.81 6 26803 92539 63369674
Migraine 21.82 21.81 94 26715 103252 63358961

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 1708.64 20.80 855 15730 96243 34844103
Mood altered 1327.20 20.80 378 16207 8574 34931772
Suicidal ideation 1216.63 20.80 518 16067 39870 34900476
Lip dry 1088.82 20.80 221 16364 1033 34939313
Blood triglycerides increased 754.71 20.80 275 16310 13884 34926462
Dry skin 711.36 20.80 330 16255 30957 34909389
Mood swings 483.04 20.80 170 16415 7731 34932615
Cheilitis 390.10 20.80 109 16476 2282 34938064
Acne fulminans 343.53 20.80 63 16522 147 34940199
Chapped lips 319.43 20.80 71 16514 545 34939801
Arthralgia 301.77 20.80 386 16199 169655 34770691
Anger 277.77 20.80 128 16457 11756 34928590
Depressed mood 259.60 20.80 143 16442 19174 34921172
Sacroiliitis 252.15 20.80 70 16515 1428 34938918
Epiphyses premature fusion 243.83 20.80 40 16545 30 34940316
Epistaxis 232.37 20.80 204 16381 58047 34882299
Xerosis 213.63 20.80 51 16534 553 34939793
Anxiety 198.74 20.80 240 16345 99188 34841158
Dry eye 195.58 20.80 94 16491 9481 34930865
Inflammatory bowel disease 182.81 20.80 64 16521 2856 34937490
Suicide attempt 155.86 20.80 137 16448 38979 34901367
Myalgia 153.41 20.80 194 16391 83916 34856430
Irritability 150.62 20.80 111 16474 24579 34915767
Headache 146.69 20.80 305 16280 200330 34740016
Exposure via body fluid 144.94 20.80 28 16557 95 34940251
Aggression 142.43 20.80 130 16455 38834 34901512
Normal newborn 140.28 20.80 29 16556 150 34940196
Acne 137.89 20.80 78 16507 10988 34929358
Self-injurious ideation 133.24 20.80 44 16541 1640 34938706
SAPHO syndrome 130.99 20.80 30 16555 267 34940079
Colitis ulcerative 128.03 20.80 86 16499 16434 34923912
Treatment noncompliance 127.36 20.80 106 16479 27994 34912352
Acute kidney injury 120.19 20.80 6 16579 304982 34635364
Nasal vestibulitis 119.76 20.80 19 16566 8 34940338
Educational problem 116.73 20.80 31 16554 531 34939815
Adverse drug reaction 115.30 20.80 102 16483 29240 34911106
Hidradenitis 109.12 20.80 34 16551 1048 34939298
Aspartate aminotransferase increased 107.44 20.80 146 16439 67637 34872709
Erectile dysfunction 104.36 20.80 83 16502 20554 34919792
Pneumonia 103.44 20.80 23 16562 362604 34577742
Depressive symptom 96.76 20.80 40 16545 2819 34937527
Crohn's disease 96.74 20.80 41 16544 3076 34937270
Blood cholesterol increased 96.20 20.80 79 16506 20464 34919882
Adverse event 89.24 20.80 73 16512 18804 34921542
Alanine aminotransferase increased 87.90 20.80 146 16439 80669 34859677
Infectious mononucleosis 84.98 20.80 25 16560 631 34939715
Dyspnoea 77.97 20.80 41 16544 376741 34563605
Crying 77.58 20.80 43 16542 5819 34934527
Hepatic enzyme increased 77.30 20.80 94 16491 38986 34901360
Toxicity to various agents 75.58 20.80 5 16580 200357 34739989
Fall 73.85 20.80 6 16579 202879 34737467
Neutrophilic dermatosis 73.41 20.80 18 16567 220 34940126
Hypotension 67.38 20.80 12 16573 221637 34718709
Product quality issue 66.45 20.80 59 16526 16976 34923370
Pyogenic granuloma 65.68 20.80 17 16568 262 34940084
Disturbance in attention 64.08 20.80 70 16515 25875 34914471
Irritable bowel syndrome 63.15 20.80 32 16553 3611 34936735
Nasal dryness 61.87 20.80 22 16563 1027 34939319
Death 61.72 20.80 59 16526 397990 34542356
Personality change 60.71 20.80 35 16550 5104 34935242
Intentional self-injury 60.39 20.80 51 16534 13720 34926626
Sepsis 57.72 20.80 6 16579 166555 34773791
Dermoid cyst 57.10 20.80 14 16571 171 34940175
Therapy cessation 56.88 20.80 54 16531 16919 34923427
No adverse event 56.86 20.80 62 16523 22865 34917481
Ingrowing nail 54.77 20.80 20 16565 1008 34939338
Abnormal behaviour 54.21 20.80 63 16522 24906 34915440
Liver function test abnormal 53.88 20.80 70 16515 31004 34909342
Night blindness 53.14 20.80 14 16571 232 34940114
Pregnancy of partner 52.90 20.80 15 16570 331 34940015
Alopecia 52.12 20.80 61 16524 24294 34916052
Keloid scar 51.74 20.80 10 16575 34 34940312
Paronychia 50.67 20.80 27 16558 3378 34936968
Back pain 48.29 20.80 147 16438 121642 34818704
Emotional disorder 47.26 20.80 31 16554 5685 34934661
Anaemia 47.25 20.80 26 16559 233309 34707037
Lipids increased 46.91 20.80 18 16567 1042 34939304
Anotia 46.58 20.80 7 16578 0 34940346
Diarrhoea 46.39 20.80 71 16514 389841 34550505
Atrial fibrillation 46.27 20.80 3 16582 122390 34817956
Proctitis ulcerative 45.53 20.80 10 16575 72 34940274
Intestinal haemorrhage 44.50 20.80 25 16560 3471 34936875
Panic attack 43.57 20.80 36 16549 9396 34930950
Idiopathic intracranial hypertension 42.47 20.80 15 16570 686 34939660
Febrile neutropenia 42.44 20.80 7 16578 136842 34803504
Decreased interest 41.69 20.80 21 16564 2339 34938007
Cerebellar hypoplasia 40.80 20.80 7 16578 9 34940337
Photosensitivity reaction 39.93 20.80 36 16549 10558 34929788
Exposure during pregnancy 38.99 20.80 33 16552 8901 34931445
Paternal drugs affecting foetus 37.55 20.80 8 16577 49 34940297
Apathy 37.44 20.80 29 16556 6903 34933443
Platelet count decreased 37.39 20.80 6 16579 119711 34820635
Vision blurred 37.09 20.80 73 16512 45890 34894456
Affective disorder 36.91 20.80 24 16561 4336 34936010
Excessive granulation tissue 36.62 20.80 12 16573 436 34939910
Psychiatric symptom 36.44 20.80 22 16563 3491 34936855
Choroid melanoma 35.77 20.80 6 16579 6 34940340
Haemoglobin decreased 35.66 20.80 7 16578 120765 34819581
Thrombocytopenia 35.27 20.80 15 16570 156232 34784114
Drug interaction 34.32 20.80 34 16551 225912 34714434
Growth retardation 34.29 20.80 17 16568 1831 34938515
Mental disorder 34.05 20.80 39 16546 15170 34925176
Neutropenia 33.90 20.80 16 16569 156762 34783584
Asthenia 33.82 20.80 40 16545 245211 34695135
Renal impairment 33.78 20.80 3 16582 94510 34845836
Epiphyseal injury 33.27 20.80 5 16580 0 34940346
Pregnancy 33.14 20.80 10 16575 276 34940070
General physical health deterioration 32.88 20.80 10 16575 128259 34812087
Drug abuse 30.86 20.80 5 16580 99091 34841255
Lip haemorrhage 30.27 20.80 12 16573 758 34939588
Scar 30.23 20.80 24 16561 5920 34934426
Live birth 30.01 20.80 9 16576 243 34940103
Nervous system neoplasm 29.44 20.80 8 16577 150 34940196
Urethritis noninfective 29.33 20.80 5 16580 6 34940340
Device related bacteraemia 29.22 20.80 10 16575 416 34939930
Pyoderma gangrenosum 29.05 20.80 14 16571 1417 34938929
Cardiac failure congestive 28.81 20.80 3 16582 83267 34857079
Social avoidant behaviour 28.49 20.80 18 16567 3096 34937250
Myocardial infarction 28.33 20.80 11 16574 121074 34819272
Rosacea 28.31 20.80 13 16572 1180 34939166
Short stature 28.08 20.80 7 16578 92 34940254
Melanocytic naevus 27.78 20.80 16 16569 2328 34938018
Anomaly of external ear congenital 26.98 20.80 7 16578 109 34940237
Rectal haemorrhage 26.70 20.80 59 16526 40190 34900156
Ligament rupture 26.63 20.80 12 16573 1043 34939303
Vascular skin disorder 26.62 20.80 4 16581 0 34940346
Pustule 26.60 20.80 10 16575 547 34939799
Pyrexia 26.58 20.80 76 16509 332937 34607409
Loss of libido 26.52 20.80 16 16569 2536 34937810
Multiple organ dysfunction syndrome 25.88 20.80 3 16582 76563 34863783
Renal failure 25.74 20.80 15 16570 130542 34809804
Low density lipoprotein increased 24.92 20.80 19 16566 4417 34935929
Bone marrow oedema 24.78 20.80 10 16575 662 34939684
Colitis 24.66 20.80 55 16530 37695 34902651
Henoch-Schonlein purpura 24.23 20.80 13 16572 1649 34938697
Ear malformation 24.04 20.80 8 16577 305 34940041
Papule 23.85 20.80 18 16567 4121 34936225
Colour vision tests normal 23.85 20.80 4 16581 4 34940342
Cardiac arrest 23.74 20.80 8 16577 96151 34844195
Violence-related symptom 23.36 20.80 9 16576 527 34939819
Gun shot wound 22.79 20.80 11 16574 1117 34939229
Urethritis 22.57 20.80 8 16577 370 34939976
Gastrointestinal haemorrhage 22.48 20.80 7 16578 88470 34851876
Laboratory test abnormal 22.33 20.80 37 16548 20354 34919992
Proctitis 22.01 20.80 14 16571 2435 34937911
Hyponatraemia 22.00 20.80 6 16579 82685 34857661
Tremor 21.96 20.80 6 16579 82581 34857765
Oedema peripheral 21.91 20.80 15 16570 119797 34820549
Negative thoughts 21.66 20.80 9 16576 642 34939704
Rash pustular 21.62 20.80 19 16566 5389 34934957
Blood creatinine increased 21.60 20.80 9 16576 94967 34845379
Septic shock 21.54 20.80 4 16581 71830 34868516
Knee deformity 21.44 20.80 9 16576 659 34939687
Peripheral swelling 21.43 20.80 5 16580 76536 34863810
Psychotic disorder 21.14 20.80 40 16545 24412 34915934
Bradycardia 20.97 20.80 5 16580 75413 34864933
Acne conglobata 20.83 20.80 4 16581 13 34940333

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 4422.48 19.50 832 30141 3101 79710314
Exposure during pregnancy 2782.55 19.50 1147 29826 99985 79613430
Abortion induced 2095.83 19.50 498 30475 6611 79706804
Depression 2082.06 19.50 1196 29777 215594 79497821
Blood triglycerides increased 1610.45 19.50 510 30463 20530 79692885
Mood altered 1530.69 19.50 472 30501 17375 79696040
Treatment noncompliance 1477.98 19.50 606 30367 51662 79661753
Suicidal ideation 1260.63 19.50 607 30366 75733 79637682
Dry skin 1156.88 19.50 552 30421 67443 79645972
Lip dry 960.71 19.50 320 30653 15098 79698317
Pregnancy 867.37 19.50 343 30630 26508 79686907
Mood swings 656.05 19.50 258 30715 19622 79693793
Adverse drug reaction 535.97 19.50 329 30644 66063 79647352
Abortion spontaneous 505.37 19.50 241 30732 29266 79684149
Cheilitis 414.40 19.50 131 30842 5210 79708205
Sacroiliitis 397.73 19.50 117 30856 3637 79709778
Chapped lips 394.71 19.50 106 30867 2344 79711071
Depressed mood 380.29 19.50 236 30737 48244 79665171
Acne fulminans 359.46 19.50 64 30909 157 79713258
Xerosis 347.29 19.50 83 30890 1123 79712292
Pregnancy test false positive 332.99 19.50 56 30917 83 79713332
Epiphyses premature fusion 321.81 19.50 53 30920 63 79713352
Dry eye 302.86 19.50 185 30788 36746 79676669
Headache 291.05 19.50 723 30250 653049 79060366
Drug exposure before pregnancy 281.27 19.50 62 30911 570 79712845
Epistaxis 275.62 19.50 274 30699 111241 79602174
Pregnancy on oral contraceptive 273.87 19.50 64 30909 781 79712634
Arthralgia 263.38 19.50 641 30332 571162 79142253
Maternal exposure during pregnancy 248.16 19.50 285 30688 136253 79577162
Anxiety 246.90 19.50 386 30587 248126 79465289
Selective abortion 214.32 19.50 34 30939 25 79713390
Myalgia 212.22 19.50 308 30665 185333 79528082
Anger 210.85 19.50 112 30861 17050 79696365
Crying 187.76 19.50 115 30858 22928 79690487
Suicide attempt 185.17 19.50 193 30780 82739 79630676
Product administration interrupted 180.94 19.50 65 30908 3834 79709581
Blood cholesterol increased 176.55 19.50 189 30784 83531 79629884
Therapy cessation 169.15 19.50 130 30843 37432 79675983
Irritability 167.15 19.50 134 30839 41010 79672405
Pneumonia 158.66 19.50 32 30941 660214 79053201
Maternal exposure before pregnancy 155.63 19.50 60 30913 4313 79709102
Vaginal haemorrhage 152.96 19.50 99 30874 21718 79691697
Idiopathic intracranial hypertension 150.59 19.50 54 30919 3168 79710247
Acute kidney injury 143.24 19.50 17 30956 519387 79194028
Self-injurious ideation 136.94 19.50 52 30921 3586 79709829
Fall 134.34 19.50 16 30957 487613 79225802
Infectious mononucleosis 133.53 19.50 44 30929 1998 79711417
Aggression 127.20 19.50 126 30847 50832 79662583
Educational problem 127.04 19.50 30 30943 384 79713031
Vision blurred 125.68 19.50 179 30794 105719 79607696
Dyspnoea 124.81 19.50 91 30882 856934 78856481
Hidradenitis 123.63 19.50 46 30927 2998 79710417
Aspartate aminotransferase increased 121.93 19.50 204 30769 138437 79574978
SAPHO syndrome 121.34 19.50 29 30944 392 79713023
Ectopic pregnancy 119.79 19.50 39 30934 1704 79711711
Acne 113.50 19.50 90 30883 27100 79686315
Toxicity to various agents 113.23 19.50 15 30958 421525 79291890
Night blindness 112.97 19.50 29 30944 534 79712881
Product quality issue 111.90 19.50 98 30875 33842 79679573
Pregnancy test positive 109.97 19.50 21 30952 85 79713330
Inflammatory bowel disease 108.53 19.50 50 30923 5601 79707814
Pregnancy with contraceptive device 105.12 19.50 43 30930 3611 79709804
Alanine aminotransferase increased 101.06 19.50 206 30767 162364 79551051
Nasal dryness 99.13 19.50 44 30929 4519 79708896
Pregnancy on contraceptive 99.02 19.50 29 30944 886 79712529
Panic attack 96.48 19.50 78 30895 24138 79689277
Depressive symptom 93.52 19.50 47 30926 6376 79707039
Hypotension 92.68 19.50 28 30945 440289 79273126
Diarrhoea 89.93 19.50 127 30846 880362 78833053
Off label use 89.69 19.50 630 30343 906585 78806830
No adverse event 87.36 19.50 89 30884 37103 79676312
Erectile dysfunction 80.03 19.50 57 30916 14607 79698808
Anaemia 79.11 19.50 37 30936 444978 79268437
Adverse event 76.18 19.50 105 30868 60109 79653306
Haematochezia 75.71 19.50 128 30845 87517 79625898
Colitis ulcerative 74.17 19.50 79 30894 34663 79678752
Sepsis 73.72 19.50 9 30964 269419 79443996
Pyogenic granuloma 72.31 19.50 20 30953 495 79712920
Personality change 70.90 19.50 46 30927 10124 79703291
Emotional disorder 69.62 19.50 52 30921 14335 79699080
Asthenia 67.19 19.50 60 30913 511629 79201786
Peripheral swelling 66.86 19.50 12 30961 269605 79443810
Back pain 63.55 19.50 260 30713 303920 79409495
Scar 62.77 19.50 50 30923 15146 79698269
Neutrophilic dermatosis 60.78 19.50 18 30955 572 79712843
Infusion related reaction 59.86 19.50 9 30964 230228 79483187
Lipids increased 59.72 19.50 23 30950 1648 79711767
Crohn's disease 58.43 19.50 24 30949 2036 79711379
Death 56.42 19.50 83 30890 566431 79146984
Febrile neutropenia 55.73 19.50 11 30962 230988 79482427
Loss of libido 55.48 19.50 25 30948 2660 79710755
Rheumatoid arthritis 54.54 19.50 8 30965 208462 79504953
Device related bacteraemia 53.53 19.50 17 30956 685 79712730
Atrial fibrillation 53.17 19.50 7 30966 197879 79515536
Low density lipoprotein increased 52.86 19.50 36 30937 8586 79704829
Abortion 52.51 19.50 20 30953 1390 79712025
Respiratory failure 52.12 19.50 5 30968 180906 79532509
Drug interaction 51.75 19.50 51 30922 415132 79298283
Liver function test abnormal 51.53 19.50 91 30882 64384 79649031
Infection 51.47 19.50 15 30958 241697 79471718
Haemoglobin decreased 50.69 19.50 12 30961 222107 79491308
Joint swelling 49.72 19.50 25 30948 288621 79424794
Hypertension 49.48 19.50 34 30939 330958 79382457
Intentional self-injury 49.47 19.50 62 30911 32357 79681058
Neutropenia 49.44 19.50 25 30948 287685 79425730
Affective disorder 49.27 19.50 34 30939 8285 79705130
General physical health deterioration 48.68 19.50 23 30950 275215 79438200
Dermoid cyst 47.90 19.50 13 30960 299 79713116
Disturbance in attention 47.63 19.50 77 30896 50724 79662691
Social avoidant behaviour 46.97 19.50 27 30946 4787 79708628
Photosensitivity reaction 46.80 19.50 49 30924 21078 79692337
Confusional state 45.78 19.50 34 30939 317963 79395452
Cough 45.76 19.50 45 30928 366744 79346671
Drug abuse 45.56 19.50 5 30968 162686 79550729
Libido decreased 44.46 19.50 27 30946 5294 79708121
Renal impairment 43.80 19.50 5 30968 157778 79555637
Tearfulness 43.76 19.50 28 30945 6017 79707398
Mental disorder 43.26 19.50 57 30916 31245 79682170
Drug hypersensitivity 42.98 19.50 32 30941 298884 79414531
Product dose omission issue 42.81 19.50 200 30773 247337 79466078
Thrombocytopenia 42.72 19.50 25 30948 265234 79448181
Psychiatric symptom 42.25 19.50 29 30944 7006 79706409
Myocardial infarction 41.90 19.50 10 30963 184119 79529296
Renal failure 41.82 19.50 13 30960 200955 79512460
Synovitis 41.29 19.50 5 30968 150729 79562686
Cardiac failure congestive 40.85 19.50 4 30969 142398 79571017
Major depression 40.23 19.50 31 30942 8949 79704466
Laboratory test abnormal 40.20 19.50 52 30921 27996 79685419
Hyponatraemia 39.81 19.50 10 30963 177838 79535577
Platelet count decreased 39.78 19.50 13 30960 194651 79518764
Visual impairment 38.62 19.50 100 30873 92031 79621384
Bradycardia 38.38 19.50 4 30969 135553 79577862
Paronychia 37.28 19.50 28 30945 7780 79705635
Pleural effusion 37.02 19.50 6 30967 145256 79568159
Decreased interest 36.78 19.50 21 30952 3676 79709739
Growth retardation 36.71 19.50 17 30956 1926 79711489
Hypokalaemia 36.59 19.50 6 30967 144034 79569381
Oedema peripheral 36.27 19.50 27 30946 252261 79461154
Cardiac arrest 36.04 19.50 11 30962 172085 79541330
Oedema 35.26 19.50 3 30970 119577 79593838
Abnormal behaviour 35.23 19.50 56 30917 36365 79677050
Pyrexia 34.63 19.50 141 30832 678568 79034847
Hypertriglyceridaemia 34.58 19.50 33 30940 12707 79700708
Pyoderma gangrenosum 34.49 19.50 21 30952 4137 79709278
Lip exfoliation 34.27 19.50 12 30961 656 79712759
Epiphyseal injury 34.27 19.50 5 30968 0 79713415
Arthropathy 34.18 19.50 13 30960 177098 79536317
Swelling 34.08 19.50 21 30952 216690 79496725
Apathy 34.06 19.50 33 30940 12944 79700471
Septic shock 33.81 19.50 4 30969 122797 79590618
Neuropathy peripheral 33.51 19.50 7 30966 141298 79572117
Therapeutic product effect decreased 33.38 19.50 11 30962 163852 79549563
Ingrowing nail 33.33 19.50 18 30955 2829 79710586
Bipolar disorder 33.21 19.50 26 30947 7681 79705734
Affect lability 32.16 19.50 30 30943 11229 79702186
Bronchitis 31.97 19.50 6 30967 130638 79582777
Acne cystic 31.85 19.50 11 30962 577 79712838
Nasopharyngitis 31.81 19.50 31 30942 253850 79459565
Stomatitis 31.43 19.50 9 30964 146748 79566667
Pregnancy of partner 31.34 19.50 9 30964 256 79713159
Rectal haemorrhage 31.14 19.50 82 30891 76218 79637197
Gun shot wound 31.06 19.50 13 30960 1157 79712258
Product use issue 30.74 19.50 22 30951 209800 79503615
Urinary tract infection 29.49 19.50 38 30935 274474 79438941
Hypoxia 29.34 19.50 3 30970 103240 79610175
Pruritus 29.32 19.50 69 30904 394579 79318836
Wheezing 29.32 19.50 5 30968 116659 79596756
Weight increased 29.19 19.50 39 30934 277347 79436068
Hepatic enzyme increased 28.99 19.50 144 30829 182466 79530949
Musculoskeletal stiffness 28.87 19.50 16 30957 174992 79538423
Exposure via body fluid 28.77 19.50 9 30964 345 79713070
Menstruation irregular 28.46 19.50 20 30953 5016 79708399
Multiple organ dysfunction syndrome 28.42 19.50 6 30967 120240 79593175
Coma 28.41 19.50 3 30970 100646 79612769
Intentional product use issue 27.99 19.50 12 30961 152100 79561315
Interstitial lung disease 27.92 19.50 5 30968 112595 79600820
Epiphyseal disorder 27.42 19.50 4 30969 0 79713415
Tremor 27.41 19.50 16 30957 170067 79543348
Malaise 27.39 19.50 98 30875 489771 79223644
Tinnitus 27.29 19.50 56 30917 44277 79669138
Growth failure 27.20 19.50 8 30965 248 79713167
Vomiting 27.10 19.50 150 30823 665678 79047737
Migraine 26.95 19.50 85 30888 87408 79626007
Type 1 diabetes mellitus 26.95 19.50 22 30951 6897 79706518
Excessive granulation tissue 26.69 19.50 11 30962 941 79712474
Contraindicated product administered 26.58 19.50 14 30959 157524 79555891
Skin odour abnormal 26.36 19.50 14 30959 2127 79711288
Hypoglycaemia 26.32 19.50 4 30969 101590 79611825
Unevaluable event 26.09 19.50 63 30910 55522 79657893
Blood pressure decreased 25.58 19.50 4 30969 99462 79613953
Proctitis ulcerative 25.42 19.50 8 30965 313 79713102
Alopecia 25.22 19.50 165 30808 231190 79482225
Abortion induced complete 25.18 19.50 4 30969 3 79713412
Blood pressure increased 25.12 19.50 27 30946 211333 79502082
Melanocytic naevus 24.88 19.50 18 30955 4723 79708692
Keloid scar 24.69 19.50 7 30966 190 79713225
Papilloedema 24.66 19.50 20 30953 6213 79707202
Ectopic pregnancy termination 24.65 19.50 4 30969 4 79713411
Colour vision tests normal 24.65 19.50 4 30969 4 79713411
Product dispensing error 24.56 19.50 28 30945 13235 79700180
Blood creatinine increased 24.41 19.50 15 30958 155042 79558373
Lip haemorrhage 24.30 19.50 11 30962 1183 79712232
Injection site pain 24.28 19.50 10 30963 129828 79583587
Meibomian gland dysfunction 23.90 19.50 7 30966 214 79713201
Somnolence 23.74 19.50 35 30938 238946 79474469
Papule 23.63 19.50 21 30952 7386 79706029
Urethritis noninfective 23.53 19.50 5 30968 38 79713377
Wound 23.31 19.50 8 30965 116171 79597244
Systemic lupus erythematosus 23.19 19.50 9 30964 121140 79592275
Dehydration 23.08 19.50 38 30935 248149 79465266
Cardiac failure 22.99 19.50 16 30957 154826 79558589
Keratoconus 22.76 19.50 6 30967 123 79713292
Hypoaesthesia 22.34 19.50 22 30951 179330 79534085
Eczema 22.16 19.50 49 30924 40769 79672646
Myopia 21.88 19.50 12 30961 1944 79711471
Psychotic disorder 21.69 19.50 49 30924 41353 79672062
Foetal exposure during pregnancy 21.69 19.50 18 30955 5772 79707643
Choroid melanoma 21.47 19.50 5 30968 60 79713355
Paternal drugs affecting foetus 21.41 19.50 4 30969 14 79713401
Dyspnoea exertional 21.30 19.50 4 30969 87069 79626346
Herpes zoster 21.28 19.50 5 30968 93078 79620337
Pericarditis 21.22 19.50 7 30966 104229 79609186
Sunburn 21.14 19.50 15 30958 3818 79709597
Hyperkalaemia 21.08 19.50 9 30964 114389 79599026
Cellulitis 21.04 19.50 8 30965 109052 79604363
Vascular skin disorder 20.98 19.50 4 30969 16 79713399
Gastrointestinal haemorrhage 20.97 19.50 16 30957 147703 79565712
Dermatitis 20.91 19.50 33 30940 21288 79692127
Henoch-Schonlein purpura 20.73 19.50 13 30960 2697 79710718
Vitamin A increased 20.56 19.50 3 30970 0 79713415
Normal newborn 20.50 19.50 19 30954 7053 79706362
Knee deformity 20.48 19.50 10 30963 1275 79712140
Urethritis 20.45 19.50 8 30965 598 79712817
Pain in extremity 20.30 19.50 73 30900 364465 79348950
Aspartate aminotransferase abnormal 20.15 19.50 11 30962 1765 79711650
Contusion 20.01 19.50 17 30956 148759 79564656
Central vision loss 19.94 19.50 4 30969 22 79713393
Oxygen saturation decreased 19.60 19.50 13 30960 129034 79584381
Blister 19.59 19.50 11 30962 119465 79593950

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




🐶 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

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 0245-0570 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 0245-0571 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 0245-0573 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
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 0378-6611 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 0378-6612 CAPSULE 20 mg ORAL ANDA 25 sections
Amnesteem HUMAN PRESCRIPTION DRUG LABEL 1 0378-6614 CAPSULE 40 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 0555-1054 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 0555-1055 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 0555-1056 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
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