All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

isotretinoin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
retinol derivatives	1508	4759-48-2

Description:

Molecule	Description
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:

Dose	Unit	Route
30	mg	O

ADMET properties:

Property	Value	Reference
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:

Date	Agency	Company	Orphan
May 7, 1982	FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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:

Source	Code	Description
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|

Disease	Relation	SNOMED_ID	DOID
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 level	Dissociation constant	Type (acidic/basic)
pKa1	4.17	acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Retinoic acid receptor beta	Nuclear hormone receptor	P10826	RARB_HUMAN	INHIBITOR				CHEMBL	CHEMBL
Alpha-2B adrenergic receptor	GPCR	P18089	ADA2B_HUMAN		Ki	5.52		DRUG MATRIX
Adenosine receptor A3	GPCR	P0DMS8	AA3R_HUMAN		Ki	5.63		DRUG MATRIX
Retinoic acid receptor alpha	Nuclear hormone receptor	P10276	RARA_HUMAN		ED50	8.23		WOMBAT-PK
Alcohol dehydrogenase 4	Enzyme	P08319	ADH4_HUMAN		Ki	5.52		WOMBAT-PK
Dehydrogenase/reductase SDR family member 9	Enzyme	Q9BPW9	DHRS9_HUMAN		Ki	4.52		WOMBAT-PK
11-cis retinol dehydrogenase	Enzyme	Q92781	RDH1_HUMAN		Ki	7		WOMBAT-PK
17-beta-hydroxysteroid dehydrogenase type 6	Enzyme	O14756	H17B6_HUMAN		Ki	5.40		WOMBAT-PK
Mitogen-activated protein kinase 14	Kinase	Q16539	MK14_HUMAN		IC50	5.60		DRUG MATRIX
Mitogen-activated protein kinase 1	Kinase	P28482	MK01_HUMAN		IC50	6.34		DRUG MATRIX
5-hydroxytryptamine receptor 2B	GPCR	P41595	5HT2B_HUMAN		Ki	6.27		DRUG MATRIX
Olfactory receptor 51E2	GPCR	Q9H255	O51E2_HUMAN		IC50	6.80		CHEMBL
Cellular retinoic acid-binding protein 1	Cytosolic other		RABP1_CHICK		IC50	6.05		CHEMBL

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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