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

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

Stem definition	Drug id	CAS RN
antivirals	1904	129618-40-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: nevirapine hemihydrate nevirapine viramune nevarapine	A potent, non-nucleoside reverse transcriptase inhibitor used in combination with nucleoside analogues for treatment of HIV INFECTIONS and AIDS. Molecular weight: 266.30 Formula: C15H14N4O CLOGP: 2.72 LIPINSKI: 0 HAC: 5 HDO: 1 TPSA: 58.12 ALOGS: -3.41 ROTB: 1 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

Dose	Unit	Route
0.40	g	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.10 mg/mL	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	21.46 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	93 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	1.30 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	0.30 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.32 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	53 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Feb. 4, 1998	EMA	Boehringer Ingelheim International GmbH
June 21, 1996	FDA	BOEHRINGER INGELHEIM

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
Drug resistance	721.71	29.43	223	8946	22710	63457143
Viral mutation identified	678.39	29.43	130	9039	1680	63478173
Exposure during pregnancy	645.08	29.43	352	8817	155195	63324658
Abortion spontaneous	595.98	29.43	232	8937	46963	63432890
Virologic failure	570.57	29.43	113	9056	1749	63478104
Stillbirth	567.41	29.43	142	9027	6608	63473245
Foetal exposure during pregnancy	474.70	29.43	177	8992	31785	63448068
Pregnancy	314.32	29.43	137	9032	36699	63443154
Pathogen resistance	309.74	29.43	87	9082	6311	63473542
Caesarean section	284.69	29.43	103	9066	16929	63462924
Abortion induced	245.07	29.43	81	9088	10161	63469692
Stevens-Johnson syndrome	243.13	29.43	102	9067	24848	63455005
Maternal exposure during pregnancy	227.73	29.43	214	8955	219848	63260005
Premature baby	202.76	29.43	85	9084	20650	63459203
Lipodystrophy acquired	202.30	29.43	46	9123	1406	63478447
Immune reconstitution inflammatory syndrome	186.07	29.43	58	9111	6026	63473827
Portal hypertension	127.72	29.43	39	9130	3780	63476073
Acquired gene mutation	125.45	29.43	29	9140	954	63478899
Viral load increased	120.80	29.43	30	9139	1344	63478509
Maternal drugs affecting foetus	119.53	29.43	40	9129	5202	63474651
Ventricular septal defect	110.21	29.43	36	9133	4342	63475511
Supernumerary nipple	96.14	29.43	15	9154	48	63479805
Foetal death	94.03	29.43	41	9128	10939	63468914
Rash maculo-papular	91.15	29.43	57	9112	31839	63448014
Acoustic stimulation tests abnormal	89.82	29.43	15	9154	81	63479772
Mitochondrial toxicity	87.71	29.43	19	9150	462	63479391
Congenital naevus	86.10	29.43	16	9153	172	63479681
Amniotic cavity infection	83.65	29.43	22	9147	1241	63478612
Postpartum sepsis	82.87	29.43	11	9158	4	63479849
Immune reconstitution inflammatory syndrome associated tuberculosis	81.03	29.43	17	9152	353	63479500
Hepatic cytolysis	80.77	29.43	41	9128	15366	63464487
Low set ears	80.32	29.43	16	9153	254	63479599
Blood HIV RNA increased	79.58	29.43	19	9150	720	63479133
Hydrops foetalis	77.92	29.43	18	9151	590	63479263
Alanine aminotransferase increased	77.77	29.43	85	9084	103685	63376168
CD4 lymphocytes decreased	76.33	29.43	21	9148	1406	63478447
Premature delivery	73.88	29.43	49	9120	30232	63449621
Malaria	71.28	29.43	14	9155	206	63479647
Conjunctivalisation	70.59	29.43	9	9160	0	63479853
Pain	69.21	29.43	12	9157	740616	62739237
Toxic epidermal necrolysis	69.18	29.43	44	9125	25290	63454563
Drug ineffective	68.49	29.43	33	9136	1044732	62435121
Pre-eclampsia	65.09	29.43	30	9139	9103	63470750
Premature labour	64.74	29.43	33	9136	12471	63467382
Premature rupture of membranes	64.40	29.43	25	9144	4968	63474885
Hyperlactacidaemia	62.02	29.43	21	9148	2828	63477025
Nephropathy toxic	60.96	29.43	29	9140	9450	63470403
Hepatomegaly	60.46	29.43	31	9138	11858	63467995
Hemivertebra	59.22	29.43	11	9158	118	63479735
Low birth weight baby	59.02	29.43	26	9143	7103	63472750
Premature separation of placenta	57.96	29.43	18	9151	1843	63478010
Hepatitis	57.62	29.43	47	9122	39741	63440112
Foetal growth restriction	57.58	29.43	26	9143	7527	63472326
Aspartate aminotransferase increased	57.52	29.43	68	9101	90209	63389644
Placental disorder	57.36	29.43	17	9152	1487	63478366
Live birth	56.61	29.43	39	9130	25591	63454262
Hypertriglyceridaemia	55.63	29.43	24	9145	6235	63473618
Lactic acidosis	54.96	29.43	45	9124	38242	63441611
Eyelid scar	54.90	29.43	7	9162	0	63479853
Uveal prolapse	54.90	29.43	7	9162	0	63479853
Blood lactic acid increased	52.77	29.43	24	9145	7062	63472791
Varices oesophageal	52.40	29.43	19	9150	3129	63476724
Retinoblastoma	50.18	29.43	9	9160	78	63479775
Eyelid oedema	49.48	29.43	26	9143	10453	63469400
Lipoatrophy	49.15	29.43	11	9158	312	63479541
Congenital choroid plexus cyst	49.08	29.43	11	9158	314	63479539
Oligohydramnios	48.80	29.43	22	9147	6344	63473509
Neural tube defect	48.41	29.43	10	9159	192	63479661
Hepatotoxicity	47.92	29.43	41	9128	37000	63442853
Neonatal disorder	47.61	29.43	12	9157	571	63479282
Drug reaction with eosinophilia and systemic symptoms	46.96	29.43	39	9130	33797	63446056
Anaemia	46.57	29.43	119	9050	293311	63186542
Mitochondrial cytopathy	46.40	29.43	10	9159	237	63479616
Fat tissue increased	45.79	29.43	12	9157	667	63479186
Fatigue	45.71	29.43	37	9132	887991	62591862
Acute HIV infection	44.63	29.43	6	9163	3	63479850
Neutropenia neonatal	43.95	29.43	8	9161	76	63479777
Ulcerative keratitis	43.78	29.43	16	9153	2694	63477159
Jaundice	43.28	29.43	35	9134	29216	63450637
Pulmonary tuberculosis	42.39	29.43	18	9151	4499	63475354
Ultrasound antenatal screen	41.61	29.43	9	9160	217	63479636
Developmental delay	40.60	29.43	13	9156	1470	63478383
Pyrexia	40.36	29.43	154	9015	470324	63009529
Normal newborn	40.25	29.43	21	9148	8320	63471533
Left ventricular dilatation	39.37	29.43	10	9159	491	63479362
CD4 lymphocytes increased	38.90	29.43	8	9161	150	63479703
Astrocytoma malignant	38.74	29.43	6	9163	18	63479835
Spinocerebellar disorder	38.74	29.43	6	9163	18	63479835
Congenital anomaly	38.30	29.43	13	9156	1763	63478090
Atrial septal defect	37.93	29.43	19	9150	6919	63472934
Proteinuria	37.33	29.43	27	9142	19118	63460735
Portal vein thrombosis	36.89	29.43	14	9155	2616	63477237
Gamma-glutamyltransferase increased	36.72	29.43	34	9135	33997	63445856
Arthralgia	35.65	29.43	19	9150	569691	62910162
HIV antibody positive	35.28	29.43	5	9164	6	63479847
Fall	35.16	29.43	7	9162	392327	63087526
Alopecia	34.86	29.43	4	9165	337532	63142321
Nodular regenerative hyperplasia	34.40	29.43	9	9160	497	63479356
Hereditary optic atrophy	34.07	29.43	5	9164	9	63479844
Porphyria non-acute	33.87	29.43	8	9161	289	63479564
Encephalocele	33.85	29.43	7	9162	135	63479718
Foetal distress syndrome	33.66	29.43	11	9158	1327	63478526
Polydactyly	33.26	29.43	8	9161	313	63479540
Human immunodeficiency virus transmission	33.25	29.43	6	9163	54	63479799
Eosinophilia	33.18	29.43	27	9142	22729	63457124
Neonatal hepatomegaly	33.10	29.43	5	9164	12	63479841
Skin toxicity	32.08	29.43	15	9154	4699	63475154
Tuberculosis	31.92	29.43	20	9149	11191	63468662
Off label use	31.16	29.43	31	9138	674431	62805422
Genotype drug resistance test positive	30.88	29.43	8	9161	425	63479428
Fallot's tetralogy	30.76	29.43	6	9163	85	63479768
Breast disorder	30.27	29.43	12	9157	2518	63477335
Hepatic displacement	29.94	29.43	5	9164	27	63479826
Spina bifida	29.69	29.43	9	9160	850	63479003

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
Lipodystrophy acquired	797.94	19.27	191	11231	3153	34942356
Foetal exposure during pregnancy	654.74	19.27	295	11127	37806	34907703
Mitochondrial toxicity	627.46	19.27	151	11271	2548	34942961
Virologic failure	526.19	19.27	138	11284	3342	34942167
Eyelid ptosis	509.43	19.27	150	11272	5616	34939893
Viral mutation identified	479.74	19.27	124	11298	2830	34942679
Diplopia	342.29	19.27	147	11275	16696	34928813
Progressive external ophthalmoplegia	342.22	19.27	82	11340	1353	34944156
Exposure during pregnancy	289	19.27	109	11313	8825	34936684
Pathogen resistance	279.12	19.27	108	11314	9374	34936135
Drug resistance	270.41	19.27	143	11279	25784	34919725
Dandy-Walker syndrome	264.58	19.27	48	11374	171	34945338
Speech disorder developmental	215.23	19.27	62	11360	2138	34943371
Developmental delay	205.26	19.27	63	11359	2712	34942797
Pinealoblastoma	174.39	19.27	33	11389	156	34945353
Premature baby	162.42	19.27	93	11329	19540	34925969
Volvulus	155.21	19.27	45	11377	1587	34943922
Immune reconstitution inflammatory syndrome	153.65	19.27	69	11353	8690	34936819
Polydactyly	149.67	19.27	41	11381	1172	34944337
Trisomy 21	147.48	19.27	35	11387	552	34944957
Congenital central nervous system anomaly	140.33	19.27	34	11388	588	34944921
Stevens-Johnson syndrome	119.61	19.27	75	11347	18564	34926945
Ophthalmoplegia	116.09	19.27	37	11385	1803	34943706
Neurodevelopmental disorder	114.72	19.27	27	11395	410	34945099
Macrocephaly	110.67	19.27	27	11395	481	34945028
Ventricular septal defect	94.80	19.27	39	11383	3962	34941547
Caesarean section	90.75	19.27	32	11390	2132	34943377
Hydrops foetalis	87.31	19.27	25	11397	842	34944667
Portal hypertension	84.20	19.27	36	11386	4026	34941483
Brachydactyly	83.12	19.27	18	11404	183	34945326
Vanishing bile duct syndrome	79.05	19.27	24	11398	994	34944515
Ultrasound antenatal screen	78.95	19.27	21	11401	535	34944974
Attention deficit hyperactivity disorder	78.28	19.27	30	11392	2529	34942980
Blood lactic acid increased	75.42	19.27	39	11383	6689	34938820
Cleft lip and palate	72.96	19.27	22	11400	890	34944619
Acquired gene mutation	72.30	19.27	24	11398	1331	34944178
Trisomy 18	72.16	19.27	21	11401	750	34944759
Nodular regenerative hyperplasia	71.55	19.27	22	11400	951	34944558
Atrioventricular septal defect	69.59	19.27	16	11406	218	34945291
Neonatal disorder	66.30	19.27	20	11402	810	34944699
Maternal drugs affecting foetus	65.60	19.27	30	11392	3935	34941574
Gene mutation	63.56	19.27	22	11400	1386	34944123
Dyslipidaemia	63.29	19.27	36	11386	7452	34938057
Small for dates baby	62.74	19.27	29	11393	3898	34941611
Blood HIV RNA increased	62.50	19.27	21	11401	1209	34944300
Drug ineffective	61.20	19.27	37	11385	456714	34488795
Hypertriglyceridaemia	59.26	19.27	36	11386	8412	34937097
Product residue present	59.11	19.27	25	11397	2721	34942788
Osteonecrosis	57.82	19.27	44	11378	14846	34930663
Viral load increased	57.72	19.27	24	11398	2503	34943006
Multiple-drug resistance	57.66	19.27	30	11392	5209	34940300
Lipoatrophy	57.18	19.27	16	11406	495	34945014
Congenital neoplasm	56.42	19.27	10	11412	30	34945479
Off label use	52.06	19.27	37	11385	419487	34526022
Conjunctivalisation	49.19	19.27	7	11415	0	34945509
Fall	48.53	19.27	5	11417	202880	34742629
Hepatotoxicity	47.56	19.27	46	11376	21439	34924070
Varices oesophageal	45.66	19.27	23	11399	3732	34941777
Mitochondrial myopathy	45.19	19.27	11	11411	194	34945315
Laryngomalacia	44.59	19.27	12	11410	320	34945189
Low birth weight baby	43.75	19.27	29	11393	7876	34937633
Toxic epidermal necrolysis	43.56	19.27	44	11378	21602	34923907
Fanconi syndrome acquired	42.43	19.27	18	11404	1973	34943536
Speech disorder	42.43	19.27	47	11375	25639	34919870
Nephropathy toxic	41.97	19.27	34	11388	12554	34932955
Alanine aminotransferase increased	40.93	19.27	85	11337	80730	34864779
Aspartate aminotransferase increased	39.98	19.27	76	11346	67707	34877802
Abortion spontaneous	37.90	19.27	11	11411	389	34945120
HIV peripheral neuropathy	37.74	19.27	7	11415	29	34945480
Ataxia	37.12	19.27	33	11389	13820	34931689
Cerebellar hypoplasia	36.28	19.27	6	11416	10	34945499
Congenital umbilical hernia	36.22	19.27	10	11412	294	34945215
Treatment failure	36.14	19.27	59	11363	46638	34898871
Osteoporosis	35.59	19.27	31	11391	12637	34932872
Pre-eclampsia	34.53	19.27	7	11415	50	34945459
Portal vein thrombosis	34.14	19.27	19	11403	3769	34941740
Osteoporotic fracture	34.07	19.27	13	11409	1082	34944427
Hypotension	33.95	19.27	15	11407	221634	34723875
Bone metabolism disorder	33.48	19.27	9	11413	239	34945270
Pneumonia	33.19	19.27	42	11380	362585	34582924
Blood triglycerides abnormal	32.95	19.27	9	11413	254	34945255
Human immunodeficiency virus transmission	31.76	19.27	6	11416	28	34945481
Hepatitis	31.57	19.27	39	11383	23865	34921644
Gamma-glutamyltransferase increased	31.30	19.27	43	11379	29188	34916321
Pain	31.11	19.27	14	11408	204661	34740848
Dysphagia	30.85	19.27	65	11357	62316	34883193
Hepatic cytolysis	30.14	19.27	30	11392	14466	34931043
Death neonatal	30.11	19.27	9	11413	353	34945156
Meningitis cryptococcal	30.04	19.27	15	11407	2389	34943120
Hepatomegaly	28.32	19.27	25	11397	10371	34935138
HIV infection	28.18	19.27	12	11410	1327	34944182
Low set ears	27.81	19.27	9	11413	460	34945049
Congenital anomaly	27.73	19.27	12	11410	1381	34944128
Anaemia macrocytic	26.79	19.27	15	11407	3011	34942498
Tuberculosis	26.15	19.27	22	11400	8555	34936954
Protrusion tongue	25.82	19.27	7	11415	192	34945317
Kaposi's sarcoma	25.75	19.27	10	11412	873	34944636
Hepatic cirrhosis	25.73	19.27	30	11392	17284	34928225
Congenital nose malformation	25.72	19.27	7	11415	195	34945314
Liver function test abnormal	25.04	19.27	40	11382	31034	34914475
Meconium ileus	24.88	19.27	5	11417	34	34945475
Febrile neutropenia	24.80	19.27	7	11415	136842	34808667
Synostosis	24.74	19.27	6	11416	104	34945405
Rash	24.57	19.27	140	11282	222612	34722897
Syphilis	24.37	19.27	8	11414	428	34945081
Hepatic steatosis	24.31	19.27	30	11392	18332	34927177
Hyperlactacidaemia	24.15	19.27	14	11408	3002	34942507
Dyspnoea	24	19.27	55	11367	376727	34568782
Aplasia cutis congenita	23.98	19.27	6	11416	119	34945390
Subchondral insufficiency fracture	23.72	19.27	4	11418	8	34945501
Loss of anatomical alignment after fracture reduction	23.72	19.27	4	11418	8	34945501
Oral candidiasis	23.24	19.27	24	11398	12086	34933423
Molluscum contagiosum	23.17	19.27	7	11415	285	34945224
Retinoblastoma	23.10	19.27	4	11418	10	34945499
Constipation	23.04	19.27	8	11414	136974	34808535
Acquired immunodeficiency syndrome	23.02	19.27	8	11414	510	34944999
Fracture malunion	22.82	19.27	4	11418	11	34945498
Disease progression	22.65	19.27	4	11418	108073	34837436
Anaemia neonatal	22.60	19.27	7	11415	310	34945199
Glycosuria	22.49	19.27	10	11412	1227	34944282
Blindness	22.33	19.27	26	11396	14960	34930549
Optic nerve cupping	22.25	19.27	5	11417	61	34945448
Product dose omission issue	21.92	19.27	6	11416	119705	34825804
Acute HIV infection	21.82	19.27	5	11417	67	34945442
Blood insulin increased	21.72	19.27	7	11415	353	34945156
Hepatitis C	21.66	19.27	21	11401	9809	34935700
Hepatitis cholestatic	21.42	19.27	19	11403	7928	34937581
Primary syphilis	21.12	19.27	4	11418	19	34945490
Hyperplasia adrenal	21.08	19.27	3	11419	0	34945509
Elbow synostosis	20.95	19.27	4	11418	20	34945489
Renal tubular disorder	20.89	19.27	15	11407	4628	34940881
Atrial fibrillation	20.84	19.27	7	11415	122386	34823123
Proteinuria	20.82	19.27	28	11394	18614	34926895
Umbilical hernia	20.80	19.27	15	11407	4662	34940847
Hepatic failure	20.69	19.27	39	11383	34492	34911017
Chronic hepatitis C	20.58	19.27	7	11415	418	34945091
Pulmonary tuberculosis	20.58	19.27	15	11407	4739	34940770
Embolism venous	20.55	19.27	10	11412	1506	34944003
Neutropenia neonatal	20.54	19.27	8	11414	704	34944805
CD4 lymphocytes increased	20.46	19.27	6	11416	220	34945289
Congenital tuberculosis	20.33	19.27	4	11418	24	34945485
Hypersplenism	20.22	19.27	7	11415	441	34945068
Hypercholesterolaemia	19.83	19.27	19	11403	8743	34936766
Congenital cytomegalovirus infection	19.68	19.27	4	11418	29	34945480
Product use in unapproved indication	19.52	19.27	7	11415	117492	34828017
Immune recovery uveitis	19.44	19.27	4	11418	31	34945478
Fanconi syndrome	19.35	19.27	10	11412	1710	34943799

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
Lipodystrophy acquired	1062.26	19.45	227	14229	4098	79725834
Virologic failure	811.55	19.45	181	14275	4010	79725922
Mitochondrial toxicity	796.14	19.45	169	14287	2945	79726987
Viral mutation identified	732.64	19.45	164	14292	3694	79726238
Drug resistance	652.40	19.45	256	14200	41957	79687975
Abortion spontaneous	541.88	19.45	203	14253	29304	79700628
Eyelid ptosis	495.91	19.45	149	14307	10895	79719037
Stillbirth	424.70	19.45	106	14350	3849	79726083
Progressive external ophthalmoplegia	395.45	19.45	83	14373	1362	79728570
Exposure during pregnancy	392.14	19.45	238	14218	100894	79629038
Pathogen resistance	350.62	19.45	122	14334	14220	79715712
Immune reconstitution inflammatory syndrome	343.23	19.45	119	14337	13722	79716210
Diplopia	328.34	19.45	147	14309	33319	79696613
Stevens-Johnson syndrome	306.24	19.45	147	14309	39019	79690913
Caesarean section	232.65	19.45	87	14369	12448	79717484
Abortion induced	231.27	19.45	75	14381	7034	79722898
Pregnancy	213.52	19.45	102	14354	26749	79703183
Foetal exposure during pregnancy	212.67	19.45	67	14389	5723	79724209
Acquired gene mutation	205.86	19.45	53	14403	2180	79727752
Portal hypertension	191.29	19.45	65	14391	7043	79722889
Maternal exposure during pregnancy	165.87	19.45	161	14295	136377	79593555
Viral load increased	150.67	19.45	44	14412	2904	79727028
Maternal drugs affecting foetus	126.60	19.45	34	14422	1649	79728283
Ultrasound antenatal screen	118.15	19.45	27	14429	666	79729266
Ophthalmoplegia	116.58	19.45	36	14420	2876	79727056
Hydrops foetalis	115.04	19.45	27	14429	751	79729181
Conjunctivalisation	114.72	19.45	16	14440	9	79729923
Nephropathy toxic	105.40	19.45	58	14398	20361	79709571
Trisomy 18	105.29	19.45	24	14432	585	79729347
Toxic epidermal necrolysis	102.57	19.45	76	14380	44505	79685427
Cleft lip and palate	102.03	19.45	24	14432	674	79729258
Alanine aminotransferase increased	98.79	19.45	134	14322	162436	79567496
Hepatic cytolysis	92.57	19.45	59	14397	27092	79702840
Blood HIV RNA increased	92.46	19.45	27	14429	1781	79728151
Dyslipidaemia	88.82	19.45	43	14413	11590	79718342
Vanishing bile duct syndrome	88.49	19.45	26	14430	1752	79728180
Lipoatrophy	86.76	19.45	21	14435	668	79729264
Aspartate aminotransferase increased	83.78	19.45	114	14342	138527	79591405
Hepatotoxicity	82.69	19.45	71	14385	51281	79678651
Product residue present	74.66	19.45	27	14429	3509	79726423
Postpartum sepsis	72.80	19.45	10	14446	4	79729928
Pulmonary tuberculosis	72.14	19.45	33	14423	7832	79722100
Pain	69.09	19.45	21	14435	703781	79026151
Premature delivery	67.83	19.45	46	14410	23421	79706511
Proteinuria	67.20	19.45	52	14404	32450	79697482
Hepatomegaly	66.79	19.45	42	14414	18832	79711100
CD4 lymphocytes decreased	66.61	19.45	23	14433	2611	79727321
Retinoblastoma	66.58	19.45	12	14444	83	79729849
Ulcerative keratitis	66.22	19.45	25	14431	3664	79726268
Fat tissue increased	65.69	19.45	18	14438	942	79728990
Drug ineffective	65.58	19.45	60	14396	1080853	78649079
Varices oesophageal	64.10	19.45	28	14428	5963	79723969
Nodular regenerative hyperplasia	63.79	19.45	19	14437	1342	79728590
Hepatitis	62.51	19.45	63	14393	55664	79674268
Blood lactic acid increased	62.48	19.45	35	14421	12709	79717223
Tuberculosis	59.32	19.45	36	14420	15162	79714770
Fall	56.82	19.45	10	14446	487619	79242313
Gamma-glutamyltransferase increased	56.24	19.45	59	14397	54621	79675311
Premature baby	55.02	19.45	22	14434	3758	79726174
Immune reconstitution inflammatory syndrome associated tuberculosis	54.08	19.45	15	14441	821	79729111
Eyelid scar	53.31	19.45	7	14449	0	79729932
Osteonecrosis	52.10	19.45	44	14412	31051	79698881
Multiple-drug resistance	50.97	19.45	27	14429	8781	79721151
Uveal prolapse	50.82	19.45	7	14449	3	79729929
Pre-eclampsia	50.67	19.45	25	14431	7016	79722916
Foetal death	50.38	19.45	26	14430	8018	79721914
Acute HIV infection	49.97	19.45	9	14447	62	79729870
Rash maculo-papular	49.79	19.45	56	14400	56022	79673910
Hepatic cirrhosis	49.66	19.45	45	14411	34861	79695071
Meningitis cryptococcal	49.63	19.45	20	14436	3486	79726446
Mitochondrial cytopathy	49.09	19.45	12	14444	398	79729534
Malaria	48.75	19.45	12	14444	410	79729522
Placental disorder	48.00	19.45	14	14442	919	79729013
Mitochondrial myopathy	47.57	19.45	11	14445	286	79729646
Glycosuria	47.29	19.45	17	14439	2171	79727761
Jaundice	46.90	19.45	53	14403	53296	79676636
Oligohydramnios	46.70	19.45	19	14437	3393	79726539
Dandy-Walker syndrome	45.81	19.45	8	14448	45	79729887
Pyrexia	43.87	19.45	240	14216	678469	79051463
Anaemia	43.87	19.45	178	14278	444837	79285095
Fanconi syndrome acquired	43.85	19.45	17	14439	2677	79727255
Pinealoblastoma	43.25	19.45	8	14448	65	79729867
Portal vein thrombosis	42.86	19.45	21	14435	5806	79724126
Ventricular septal defect	41.43	19.45	11	14445	510	79729422
Off label use	41.37	19.45	63	14393	907152	78822780
HIV infection	41.20	19.45	13	14443	1114	79728818
Blindness	41.18	19.45	37	14419	28346	79701586
Joint swelling	40.83	19.45	3	14453	288643	79441289
HIV peripheral neuropathy	40.78	19.45	7	14449	35	79729897
Eyelid oedema	39.95	19.45	27	14429	13660	79716272
Hepatic failure	39.48	19.45	52	14404	61160	79668772
Drug reaction with eosinophilia and systemic symptoms	39.02	19.45	53	14403	64191	79665741
Normal newborn	39.01	19.45	21	14435	7051	79722881
Live birth	36.60	19.45	29	14427	18715	79711217
Osteoporosis	36.50	19.45	47	14409	54065	79675867
Treatment noncompliance	36.20	19.45	46	14410	52222	79677710
Premature labour	35.66	19.45	21	14435	8369	79721563
Fatigue	35.63	19.45	72	14384	929655	78800277
Genotype drug resistance test positive	35.33	19.45	12	14444	1296	79728636
Dysphagia	35.13	19.45	72	14384	122064	79607868
Congenital anomaly	34.78	19.45	9	14447	377	79729555
Hypertriglyceridaemia	34.51	19.45	24	14432	12716	79717216
Neutropenia neonatal	34.32	19.45	6	14450	34	79729898
Hepatic steatosis	34.03	19.45	38	14418	37700	79692232
Lactic acidosis	33.89	19.45	52	14404	70307	79659625
Hypercholesterolaemia	33.29	19.45	30	14426	23065	79706867
Blood triglycerides abnormal	32.60	19.45	9	14447	484	79729448
Nasopharyngitis	32.31	19.45	4	14452	253877	79476055
Bone metabolism disorder	32.16	19.45	9	14447	509	79729423
Amniotic cavity infection	32.16	19.45	10	14446	817	79729115
Hyperlactacidaemia	31.95	19.45	17	14439	5578	79724354
Completed suicide	30.97	19.45	4	14452	245763	79484169
Hypotension	30.90	19.45	21	14435	440296	79289636
Conjunctival hyperaemia	29.78	19.45	15	14441	4398	79725534
Speech disorder developmental	29.69	19.45	9	14447	675	79729257
Abdominal discomfort	29.47	19.45	5	14451	250722	79479210
Placental insufficiency	29.15	19.45	10	14446	1113	79728819
Anaemia neonatal	29.13	19.45	5	14451	25	79729907
Astrocytoma malignant	28.96	19.45	5	14451	26	79729906
Hepatitis cholestatic	28.27	19.45	22	14434	13830	79716102
Developmental delay	28.25	19.45	10	14446	1221	79728711
Molluscum contagiosum	28.11	19.45	8	14448	481	79729451
Blood pressure increased	27.72	19.45	3	14453	211357	79518575
Hereditary optic atrophy	27.33	19.45	5	14451	38	79729894
Hyperplasia adrenal	27.33	19.45	5	14451	38	79729894
Lipase increased	26.96	19.45	23	14433	16443	79713489
Toxoplasmosis	26.90	19.45	12	14444	2685	79727247
Peripheral swelling	26.46	19.45	8	14448	269609	79460323
Spina bifida	26.37	19.45	6	14450	145	79729787
Loss of anatomical alignment after fracture reduction	26.07	19.45	4	14452	8	79729924
Optic nerve cupping	25.42	19.45	5	14451	58	79729874
Lymphadenopathy	25.14	19.45	39	14417	53208	79676724
Sinusitis	25.07	19.45	3	14453	195498	79534434
Meningitis tuberculous	24.69	19.45	9	14447	1196	79728736
Symblepharon	24.66	19.45	6	14450	195	79729737
Osteoporotic fracture	24.54	19.45	13	14443	4227	79725705
Dyspnoea	24.53	19.45	77	14379	856948	78872984
Pneumonia	24.50	19.45	52	14404	660194	79069738
Hepatitis C	24.47	19.45	19	14437	11906	79718026
Premature separation of placenta	24.39	19.45	9	14447	1237	79728695
Febrile neutropenia	24.26	19.45	6	14450	230993	79498939
Cytomegalovirus chorioretinitis	24.02	19.45	14	14442	5476	79724456
Ultrasound antenatal screen abnormal	23.70	19.45	5	14451	84	79729848
Congestive hepatopathy	23.69	19.45	13	14443	4534	79725398
Retinal vasculitis	23.67	19.45	9	14447	1344	79728588
Syphilis	22.81	19.45	7	14449	547	79729385
Drug-induced liver injury	22.68	19.45	42	14414	66075	79663857
Alopecia	22.45	19.45	7	14449	231348	79498584
Splenomegaly	22.42	19.45	23	14433	20731	79709201
Borderline leprosy	22.41	19.45	4	14452	26	79729906
Back pain	22.01	19.45	14	14442	304166	79425766
Disseminated tuberculosis	21.90	19.45	12	14444	4171	79725761
Product use in unapproved indication	21.87	19.45	9	14447	250350	79479582
Immune recovery uveitis	21.79	19.45	4	14452	31	79729901
Left ventricular dilatation	21.73	19.45	8	14448	1093	79728839
Chronic hepatitis C	21.68	19.45	7	14449	646	79729286
Strabismus	21.32	19.45	10	14446	2511	79727421
Brachydactyly	21.07	19.45	4	14452	38	79729894
Liver function test abnormal	20.93	19.45	40	14416	64435	79665497
Kwashiorkor	20.77	19.45	3	14453	3	79729929
Progressive multifocal leukoencephalopathy	20.76	19.45	22	14434	20578	79709354
Urinary tract infection	20.74	19.45	12	14444	274500	79455432
Gene mutation	20.71	19.45	10	14446	2676	79727256
Kaposi's sarcoma	20.65	19.45	7	14449	752	79729180
Constipation	20.51	19.45	13	14443	283037	79446895
Transaminases increased	20.49	19.45	35	14421	51708	79678224
Arthralgia	20.40	19.45	46	14410	571757	79158175
Congenital retinoblastoma	20.31	19.45	3	14453	4	79729928
Syncope	20.18	19.45	4	14452	179445	79550487
Fanconi syndrome	20.13	19.45	10	14446	2846	79727086
Therapeutic product effect decreased	19.85	19.45	3	14453	163860	79566072
Portal hypertensive gastropathy	19.78	19.45	8	14448	1406	79728526
Psychiatric decompensation	19.74	19.45	11	14445	3952	79725980
Induced labour	19.69	19.45	7	14449	865	79729067
Rash	19.67	19.45	175	14281	578183	79151749

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	J05AG01	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Non-nucleoside reverse transcriptase inhibitors
ATC	J05AR05	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR07	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
FDA MoA	N0000009948	Non-Nucleoside Reverse Transcriptase Inhibitors
FDA EXT	N0000175460	Non-Nucleoside Analog
FDA EPC	N0000175463	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor
FDA MoA	N0000187064	Cytochrome P450 2B6 Inducers
FDA MoA	N0000190118	Cytochrome P450 3A Inducers
CHEBI has role	CHEBI:36044	antiviral drugs
CHEBI has role	CHEBI:53756	reverse transcriptase inhibitors
MeSH PA	D019380	Anti-HIV Agents
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D044966	Anti-Retroviral Agents
MeSH PA	D000998	Antiviral Agents
MeSH PA	D065701	Cytochrome P-450 CYP3A Inducers
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D065606	Metabolic Side Effects of Drugs and Substances
MeSH PA	D019384	Nucleic Acid Synthesis Inhibitors
MeSH PA	D018894	Reverse Transcriptase Inhibitors

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

Disease	Relation	SNOMED_ID	DOID
Human immunodeficiency virus infection	indication	86406008	DOID:526
Lyell's toxic epidermal necrolysis, subepidermal type	contraindication	23067006
Viral hepatitis C	contraindication	50711007	DOID:1883
Acute nephropathy	contraindication	58574008
Hepatic failure	contraindication	59927004
Chronic type B viral hepatitis	contraindication	61977001
Stevens-Johnson syndrome	contraindication	73442001	DOID:0050426
Chronic hepatitis C	contraindication	128302006
Liver function tests abnormal	contraindication	166603001
Disease of liver	contraindication	235856003	DOID:409
Drug-induced hepatitis	contraindication	235876009
Rhabdomyolysis	contraindication	240131006
Eruption of skin	contraindication	271807003	DOID:0050486
Breastfeeding (mother)	contraindication	413712001
Prevention of HIV Infection after Exposure	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	9.01	acidic
pKa2	2.45	Basic
pKa3	1.74	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
400MG	VIRAMUNE XR	BOEHRINGER INGELHEIM	N201152	March 25, 2011	RX	TABLET, EXTENDED RELEASE	ORAL	8460704	March 12, 2029	TREATMENT OF HIV-1 BY ONCE DAILY ADMINISTRATION

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
Reverse transcriptase/RNaseH	Enzyme		Q72547_9HIV1	INHIBITOR	Ki	6.40		CHEMBL	CHEMBL
Gag-Pol polyprotein	Polyprotein		POL_HV1A2		IC50	7.10		WOMBAT-PK
Pol polyprotein	Enzyme		Q72874_9HIV1		IC50	7		CHEMBL
Reverse transcriptase	Enzyme		Q9WKE8_9HIV1		IC50	6.30		CHEMBL
Reverse transcriptase protein	Unclassified		Q9WJQ2_9HIV1		Ki	5.40		CHEMBL

External reference:

ID	Source
4020991	VUID
N0000148461	NUI
D00435	KEGG_DRUG
220988-26-1	SECONDARY_CAS_RN
4020991	VANDF
C0132326	UMLSCUI
CHEBI:63613	CHEBI
NEV	PDB_CHEM_ID
CHEMBL57	ChEMBL_ID
DB00238	DRUGBANK_ID
D019829	MESH_DESCRIPTOR_UI
4463	PUBCHEM_CID
12676	IUPHAR_LIGAND_ID
6815	INN_ID
99DK7FVK1H	UNII
224890	RXNORM
175112	MMSL
5168	MMSL
6060	MMSL
d04029	MMSL
006062	NDDF
108704001	SNOMEDCT_US
386898005	SNOMEDCT_US
725663003	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Nevirapine	HUMAN PRESCRIPTION DRUG LABEL	1	0378-4050	TABLET	200 mg	ORAL	ANDA	29 sections
Nevirapine	HUMAN PRESCRIPTION DRUG LABEL	1	0378-4890	TABLET, EXTENDED RELEASE	400 mg	ORAL	ANDA	29 sections
Nevirapine	HUMAN PRESCRIPTION DRUG LABEL	1	0378-4890	TABLET, EXTENDED RELEASE	400 mg	ORAL	ANDA	29 sections
Nevirapine	HUMAN PRESCRIPTION DRUG LABEL	1	0378-6950	TABLET, EXTENDED RELEASE	100 mg	ORAL	ANDA	29 sections
Viramune	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0046	TABLET	200 mg	ORAL	NDA	27 sections
Viramune	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0046	TABLET	200 mg	ORAL	NDA	27 sections
Viramune	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0047	SUSPENSION	50 mg	ORAL	NDA	27 sections
Viramune	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0047	SUSPENSION	50 mg	ORAL	NDA	27 sections
Viramune	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0123	TABLET, EXTENDED RELEASE	400 mg	ORAL	NDA	35 sections
Viramune	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0123	TABLET, EXTENDED RELEASE	400 mg	ORAL	NDA	35 sections
Nevirapine	HUMAN PRESCRIPTION DRUG LABEL	1	0781-5893	TABLET, EXTENDED RELEASE	400 mg	ORAL	ANDA	29 sections
Nevirapine	Human Prescription Drug Label	1	31722-505	TABLET	200 mg	ORAL	ANDA	29 sections
Nevirapine	Human Prescription Drug Label	1	31722-505	TABLET	200 mg	ORAL	ANDA	29 sections
Nevirapine	Human Prescription Drug Label	1	33342-004	TABLET	200 mg	ORAL	ANDA	28 sections
Nevirapine	Human Prescription Drug Label	1	33342-004	TABLET	200 mg	ORAL	ANDA	28 sections
Nevirapine	Human Prescription Drug Label	1	33342-004	TABLET	200 mg	ORAL	ANDA	28 sections
NEVIRAPINE	Human Prescription Drug Label	1	33342-238	TABLET, EXTENDED RELEASE	400 mg	ORAL	ANDA	29 sections
NEVIRAPINE	Human Prescription Drug Label	1	33342-238	TABLET, EXTENDED RELEASE	400 mg	ORAL	ANDA	29 sections
NEVIRAPINE	Human Prescription Drug Label	1	33342-238	TABLET, EXTENDED RELEASE	400 mg	ORAL	ANDA	29 sections
NEVIRAPINE	HUMAN PRESCRIPTION DRUG LABEL	1	42571-131	TABLET	200 mg	ORAL	ANDA	27 sections
NEVIRAPINE	HUMAN PRESCRIPTION DRUG LABEL	1	42571-131	TABLET	200 mg	ORAL	ANDA	27 sections
nevirapine	HUMAN PRESCRIPTION DRUG LABEL	1	53104-0166	TABLET	200 mg	ORAL	ANDA	26 sections
Nevirapine	HUMAN PRESCRIPTION DRUG LABEL	1	53808-0680	TABLET	200 mg	ORAL	ANDA	29 sections
Viramune	HUMAN PRESCRIPTION DRUG LABEL	1	53808-0808	TABLET	200 mg	ORAL	NDA	31 sections
nevirapine	HUMAN PRESCRIPTION DRUG LABEL	1	53808-1069	TABLET	200 mg	ORAL	ANDA	28 sections
Viramune	HUMAN PRESCRIPTION DRUG LABEL	1	54868-6370	TABLET, EXTENDED RELEASE	400 mg	ORAL	NDA	29 sections
Nevirapine	HUMAN PRESCRIPTION DRUG LABEL	1	61442-470	TABLET, COATED	200 mg	ORAL	ANDA	29 sections
Nevirapine	HUMAN PRESCRIPTION DRUG LABEL	1	64380-709	TABLET	200 mg	ORAL	ANDA	28 sections
Nevirapine	HUMAN PRESCRIPTION DRUG LABEL	1	64380-709	TABLET	200 mg	ORAL	ANDA	28 sections
Nevirapine	HUMAN PRESCRIPTION DRUG LABEL	1	65162-209	TABLET	200 mg	ORAL	ANDA	27 sections