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

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

Stem definition	Drug id	CAS RN
uridine derivatives used as antiviral agents and as antineoplastics	2861	30516-87-1

Description:

Molecule

Description

Molfile Inchi Smiles Synonyms: zidovudine azidothymidine azitidin AZT

A dideoxynucleoside compound in which the 3'-hydroxy group on the sugar moiety has been replaced by an azido group. This modification prevents the formation of phosphodiester linkages which are needed for the completion of nucleic acid chains. The compound is a potent inhibitor of HIV replication, acting as a chain-terminator of viral DNA during reverse transcription. It improves immunologic function, partially reverses the HIV-induced neurological dysfunction, and improves certain other clinical abnormalities associated with AIDS. Its principal toxic effect is dose-dependent suppression of bone marrow, resulting in anemia and leukopenia. Molecular weight: 267.25 Formula: C10H13N5O4 CLOGP: 0.04 LIPINSKI: 0 HAC: 9 HDO: 2 TPSA: 108.30 ALOGS: -1.21 ROTB: 3 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

Dose	Unit	Route
0.60	g	O
0.60	g	P

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	20.10 mg/mL	Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine)	2.80 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	37.42 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	63 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	1.80 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	25 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.80 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	1.30 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
March 18, 1998	EMA	ViiV Healthcare BV
March 19, 1987	FDA	VIIV HLTHCARE

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
Exposure during pregnancy	2270.07	24.31	984	14773	154563	63318702
Foetal exposure during pregnancy	1450.88	24.31	467	15290	31495	63441770
Stillbirth	875.89	24.31	224	15533	6526	63466739
Premature baby	814.60	24.31	272	15485	20463	63452802
Abortion spontaneous	803.45	24.31	335	15422	46860	63426405
Viral mutation identified	501.42	24.31	111	15646	1699	63471566
Virologic failure	492.81	24.31	110	15647	1752	63471513
Caesarean section	441.01	24.31	164	15593	16868	63456397
Drug resistance	438.00	24.31	177	15580	22756	63450509
Abortion induced	432.42	24.31	142	15615	10100	63463165
Pregnancy	378.49	24.31	184	15573	36652	63436613
Immune reconstitution inflammatory syndrome	367.91	24.31	111	15646	5973	63467292
Pathogen resistance	341.24	24.31	106	15651	6292	63466973
Premature rupture of membranes	310.09	24.31	93	15664	4900	63468365
Maternal drugs affecting foetus	305.63	24.31	93	15664	5149	63468116
Maternal exposure during pregnancy	279.70	24.31	307	15450	219755	63253510
Live birth	257.07	24.31	126	15631	25504	63447761
Foetal death	241.83	24.31	94	15663	10886	63462379
Premature labour	233.41	24.31	95	15662	12409	63460856
Lipodystrophy acquired	227.03	24.31	56	15701	1396	63471869
Foetal growth restriction	192.71	24.31	72	15685	7481	63465784
Anaemia	185.06	24.31	290	15467	293140	63180125
Pre-eclampsia	169.10	24.31	69	15688	9064	63464201
Treatment noncompliance	154.63	24.31	103	15654	37222	63436043
Premature delivery	138.71	24.31	89	15668	30192	63443073
Congenital anomaly	136.32	24.31	39	15718	1737	63471528
Patent ductus arteriosus	132.57	24.31	47	15710	4203	63469062
Polydactyly	124.59	24.31	26	15731	295	63472970
Blood HIV RNA increased	123.13	24.31	30	15727	709	63472556
Amniotic cavity infection	121.02	24.31	33	15724	1230	63472035
Sudden infant death syndrome	119.77	24.31	25	15732	284	63472981
Trisomy 21	119.21	24.31	26	15731	369	63472896
Human immunodeficiency virus transmission	116.90	24.31	19	15738	41	63473224
Atrial septal defect	116.86	24.31	49	15708	6889	63466376
Hypertriglyceridaemia	114.88	24.31	47	15710	6212	63467053
Hydrops foetalis	113.22	24.31	27	15730	581	63472684
Ventricular septal defect	112.64	24.31	42	15715	4336	63468929
Meningomyelocele	107.63	24.31	26	15731	592	63472673
Drug ineffective	105.58	24.31	65	15692	1044700	62428565
Neonatal disorder	103.97	24.31	25	15732	558	63472707
CD4 lymphocytes decreased	103.56	24.31	30	15727	1397	63471868
Foetal distress syndrome	100.98	24.31	29	15728	1309	63471956
Umbilical cord abnormality	100.77	24.31	25	15732	638	63472627
Alpha 1 foetoprotein abnormal	100.58	24.31	17	15740	51	63473214
Pain	98.38	24.31	31	15726	740597	62732668
Small for dates baby	89.30	24.31	34	15723	3717	63469548
Blood lactic acid increased	86.78	24.31	40	15717	7046	63466219
Low birth weight baby	86.55	24.31	40	15717	7089	63466176
Fatigue	85.81	24.31	58	15699	887970	62585295
Normal newborn	83.54	24.31	41	15716	8300	63464965
Neonatal respiratory distress syndrome	83.49	24.31	30	15727	2788	63470477
Neural tube defect	82.11	24.31	17	15740	185	63473080
Acquired gene mutation	81.82	24.31	23	15734	960	63472305
Hepatomegaly	80.62	24.31	45	15712	11844	63461421
Gestational diabetes	80.32	24.31	40	15717	8356	63464909
Mitochondrial toxicity	77.46	24.31	19	15738	462	63472803
Congenital heart valve disorder	77.33	24.31	14	15743	69	63473196
Meconium stain	76.39	24.31	16	15741	185	63473080
Placental disorder	76.32	24.31	24	15733	1480	63471785
Anal atresia	75.80	24.31	18	15739	380	63472885
Congenital pulmonary valve disorder	75.27	24.31	13	15744	46	63473219
Lipoatrophy	74.16	24.31	17	15740	306	63472959
Anaemia macrocytic	74.00	24.31	29	15728	3425	63469840
Genitalia external ambiguous	73.51	24.31	15	15742	151	63473114
Necrotising colitis	73.19	24.31	19	15738	584	63472681
Off label use	69.23	24.31	41	15716	674421	62798844
Bladder agenesis	68.25	24.31	14	15743	145	63473120
Portal hypertension	67.77	24.31	28	15729	3791	63469474
Premature separation of placenta	67.36	24.31	23	15734	1838	63471427
Fall	67.19	24.31	9	15748	392325	63080940
Arthralgia	66.85	24.31	29	15728	569681	62903584
Viral load increased	65.88	24.31	21	15736	1353	63471912
Exomphalos	64.95	24.31	17	15740	540	63472725
Hepatic cytolysis	64.93	24.31	43	15714	15364	63457901
Abdominal discomfort	63.86	24.31	4	15753	320881	63152384
Ultrasound antenatal screen abnormal	63.43	24.31	13	15744	134	63473131
Congenital genital malformation	62.66	24.31	13	15744	143	63473122
Anaemia neonatal	62.49	24.31	15	15742	332	63472933
Cardiac murmur	62.26	24.31	41	15716	14511	63458754
Cloacal exstrophy	61.85	24.31	13	15744	153	63473112
CSF HIV escape syndrome	61.39	24.31	12	15745	95	63473170
Aspartate aminotransferase increased	60.51	24.31	92	15665	90185	63383080
Gastrointestinal malformation	60.24	24.31	13	15744	175	63473090
Alanine aminotransferase increased	58.89	24.31	98	15659	103672	63369593
Malaria	58.20	24.31	13	15744	207	63473058
Neutropenia neonatal	57.98	24.31	11	15746	73	63473192
Spina bifida	57.66	24.31	17	15740	842	63472423
Mitochondrial cytopathy	56.71	24.31	13	15744	234	63473031
Neonatal respiratory arrest	55.80	24.31	10	15747	46	63473219
Caudal regression syndrome	55.37	24.31	12	15745	165	63473100
Tethered cord syndrome	54.90	24.31	13	15744	271	63472994
Necrotising enterocolitis neonatal	53.05	24.31	12	15745	203	63473062
Gastrointestinal disorder congenital	52.06	24.31	11	15746	133	63473132
Rheumatoid arthritis	50.98	24.31	3	15754	253816	63219449
Hyperlactacidaemia	50.93	24.31	21	15736	2828	63470437
Meningitis cryptococcal	49.77	24.31	17	15740	1360	63471905
Astrocytoma malignant	49.63	24.31	8	15749	16	63473249
Cleft lip and palate	48.98	24.31	14	15743	621	63472644
Twin pregnancy	48.41	24.31	16	15741	1157	63472108
Hyperbilirubinaemia	46.28	24.31	31	15726	11283	63461982
Pulmonary valve sclerosis	45.96	24.31	8	15749	30	63473235
Enlarged clitoris	45.46	24.31	10	15747	148	63473117
Macrocephaly	44.82	24.31	9	15748	83	63473182
Developmental delay	44.73	24.31	16	15741	1467	63471798
Arnold-Chiari malformation	43.94	24.31	13	15744	652	63472613
Anencephaly	43.78	24.31	11	15746	296	63472969
Sepsis neonatal	43.57	24.31	12	15745	464	63472801
Product dose omission issue	43.54	24.31	4	15753	234309	63238956
Congenital ectopic bladder	43.46	24.31	9	15748	98	63473167
Condition aggravated	43.25	24.31	23	15734	402194	63071071
Hepatotoxicity	42.24	24.31	49	15708	36992	63436273
Rickets	41.79	24.31	8	15749	56	63473209
Alopecia	41.43	24.31	16	15741	337520	63135745
Coarctation of the aorta	41.25	24.31	12	15745	567	63472698
Swelling	41.21	24.31	9	15748	275369	63197896
Ventricular hypertrophy	40.83	24.31	19	15738	3417	63469848
Pain in extremity	40.21	24.31	16	15741	331470	63141795
HIV antibody positive	40.18	24.31	6	15751	5	63473260
Genotype drug resistance test positive	40.03	24.31	11	15746	422	63472843
Neonatal aspiration	39.58	24.31	9	15748	156	63473109
Ultrasound scan abnormal	39.55	24.31	10	15747	276	63472989
Complication of delivery	39.05	24.31	9	15748	166	63473099
Large for dates baby	38.84	24.31	11	15746	472	63472793
Cleft palate	38.56	24.31	13	15744	999	63472266
Isoimmune haemolytic disease	38.42	24.31	7	15750	36	63473229
Fanconi syndrome acquired	38.26	24.31	13	15744	1023	63472242
Adrenogenital syndrome	37.79	24.31	7	15750	40	63473225
Rash maculo-papular	37.72	24.31	43	15714	31853	63441412
Oligohydramnios	37.53	24.31	22	15735	6344	63466921
Hydromyelia	37.22	24.31	6	15751	12	63473253
Ultrasound antenatal screen	36.76	24.31	9	15748	217	63473048
Acute lymphocytic leukaemia	36.53	24.31	16	15741	2500	63470765
AIDS cholangiopathy	36.30	24.31	6	15751	15	63473250
Single umbilical artery	35.44	24.31	9	15748	253	63473012
Trisomy 18	34.74	24.31	8	15749	147	63473118
Placenta praevia	34.52	24.31	12	15745	1012	63472253
Arthropathy	34.47	24.31	8	15749	234784	63238481
Pruritus	34.20	24.31	24	15733	361429	63111836
Congenital anomaly in offspring	34.19	24.31	8	15749	158	63473107
Drug intolerance	34.13	24.31	17	15740	308644	63164621
Congenital genital malformation female	33.77	24.31	6	15751	26	63473239
Haemorrhage in pregnancy	33.77	24.31	14	15743	1911	63471354
Stevens-Johnson syndrome	33.59	24.31	36	15721	24914	63448351
Fallot's tetralogy	33.18	24.31	7	15750	84	63473181
Hydrocephalus	33.06	24.31	19	15738	5281	63467984
Neutropenia	33.03	24.31	107	15650	174898	63298367
HIV test positive	32.74	24.31	6	15751	32	63473233
Ergot poisoning	32.45	24.31	7	15750	94	63473171
Dyspnoea	32.25	24.31	73	15684	661240	62812025
Jaundice	32.19	24.31	38	15719	29213	63444052
Urinary tract infection	31.72	24.31	13	15744	264671	63208594
Hyperandrogenism	31.67	24.31	7	15750	106	63473159
Hepatitis	31.66	24.31	44	15713	39744	63433521
Foetal heart rate abnormal	31.63	24.31	10	15747	627	63472638
Microcephaly	31.62	24.31	11	15746	929	63472336
Product use issue	31.42	24.31	8	15749	220512	63252753
Pneumonia	30.83	24.31	41	15716	456726	63016539
Respiratory distress	30.76	24.31	40	15717	33911	63439354
Gestational hypertension	30.71	24.31	14	15743	2403	63470862
Neonatal hepatomegaly	30.39	24.31	5	15752	12	63473253
Ectopic pregnancy	29.90	24.31	14	15743	2553	63470712
Cardiac malposition	29.81	24.31	6	15751	56	63473209
Musculoskeletal stiffness	29.80	24.31	5	15752	184613	63288652
Micrognathia	29.71	24.31	8	15749	284	63472981
Infection	29.56	24.31	10	15747	229163	63244102
Weight increased	29.37	24.31	14	15743	260778	63212487
Anxiety	28.93	24.31	9	15748	217532	63255733
Heart disease congenital	28.16	24.31	11	15746	1288	63471977
Alpha 1 foetoprotein increased	27.91	24.31	7	15750	187	63473078
Chlamydial infection	27.81	24.31	8	15749	363	63472902
Hypotonia	27.72	24.31	21	15736	9264	63464001
Induced labour	27.70	24.31	10	15747	941	63472324
Hepatic displacement	27.23	24.31	5	15752	27	63473238
Placental insufficiency	27.05	24.31	11	15746	1430	63471835
Foetal cardiac disorder	26.93	24.31	5	15752	29	63473236
Foetal anaemia	26.84	24.31	6	15751	96	63473169
Pallor	26.13	24.31	35	15722	30533	63442732
Diastasis recti abdominis	25.88	24.31	5	15752	37	63473228
Glycosuria	25.72	24.31	10	15747	1156	63472109
Constipation	25.44	24.31	12	15745	224931	63248334
Polyhydramnios	25.27	24.31	12	15745	2259	63471006
Pulmonary tuberculosis	25.03	24.31	15	15742	4502	63468763
Proteinuria	24.68	24.31	27	15730	19118	63454147
Anembryonic gestation	24.49	24.31	8	15749	557	63472708
Bovine tuberculosis	24.35	24.31	5	15752	52	63473213

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
Foetal exposure during pregnancy	1208.39	16.11	528	18513	37573	34900317
Exposure during pregnancy	947.74	16.11	301	18740	8633	34929257
Lipodystrophy acquired	818.57	16.11	216	18825	3128	34934762
Viral mutation identified	624.58	16.11	170	18871	2784	34935106
Mitochondrial toxicity	620.80	16.11	166	18875	2533	34935357
Virologic failure	588.01	16.11	168	18873	3312	34934578
Pathogen resistance	530.13	16.11	198	18843	9284	34928606
Immune reconstitution inflammatory syndrome	471.78	16.11	178	18863	8581	34929309
Eyelid ptosis	441.40	16.11	152	18889	5614	34932276
Premature baby	403.25	16.11	202	18839	19431	34918459
Progressive external ophthalmoplegia	305.17	16.11	83	18958	1352	34936538
Diplopia	284.45	16.11	152	18889	16691	34921199
Pinealoblastoma	271.86	16.11	52	18989	137	34937753
Drug resistance	243.07	16.11	160	18881	25767	34912123
Lipoatrophy	209.89	16.11	50	18991	461	34937429
Maternal drugs affecting foetus	182.77	16.11	72	18969	3893	34933997
Caesarean section	153.78	16.11	54	18987	2110	34935780
Blood lactic acid increased	152.19	16.11	74	18967	6654	34931236
Hypertriglyceridaemia	144.68	16.11	77	18964	8371	34929519
Volvulus	136.48	16.11	46	18995	1586	34936304
Anaemia	124.85	16.11	342	18699	232993	34704897
Neonatal disorder	122.07	16.11	36	19005	794	34937096
Hyperlactacidaemia	119.08	16.11	49	18992	2967	34934923
Hepatic fibrosis	114.30	16.11	54	18987	4553	34933337
Blood HIV RNA increased	108.13	16.11	36	19005	1194	34936696
HIV-associated neurocognitive disorder	102.46	16.11	26	19015	318	34937572
Ophthalmoplegia	101.18	16.11	38	19003	1802	34936088
CSF HIV escape syndrome	100.12	16.11	23	19018	178	34937712
Anaemia macrocytic	95.69	16.11	42	18999	2984	34934906
CD4 lymphocytes decreased	88.68	16.11	34	19007	1707	34936183
Congenital anomaly	88.52	16.11	32	19009	1361	34936529
Trisomy 18	85.85	16.11	27	19014	744	34937146
Small for dates baby	82.26	16.11	41	19000	3886	34934004
Pregnancy	82.15	16.11	21	19020	265	34937625
Polydactyly	81.35	16.11	29	19012	1184	34936706
Off label use	81.25	16.11	66	18975	419458	34518432
Trisomy 21	79.97	16.11	24	19017	563	34937327
Cleft lip and palate	77.42	16.11	26	19015	886	34937004
Osteonecrosis	76.40	16.11	64	18977	14826	34923064
Anaemia neonatal	75.23	16.11	20	19021	297	34937593
Hydrops foetalis	74.72	16.11	25	19016	842	34937048
Ultrasound antenatal screen	72.60	16.11	22	19019	534	34937356
Hyperlipidaemia	69.53	16.11	60	18981	14469	34923421
Hypospadias	65.81	16.11	33	19008	3168	34934722
Low birth weight baby	64.95	16.11	45	18996	7860	34930030
Aspartate aminotransferase increased	64.57	16.11	125	18916	67658	34870232
Multiple-drug resistance	63.27	16.11	38	19003	5201	34932689
Acquired immunodeficiency syndrome	61.28	16.11	19	19022	499	34937391
Treatment noncompliance	59.59	16.11	75	18966	28025	34909865
Human immunodeficiency virus transmission	59.28	16.11	11	19030	23	34937867
Kaposi's sarcoma	58.80	16.11	21	19020	862	34937028
Cryptorchism	57.09	16.11	26	19015	2015	34935875
Fall	56.54	16.11	20	19021	202865	34735025
Hydrocele	56.53	16.11	26	19015	2061	34935829
Drug-induced liver injury	56.50	16.11	74	18967	28758	34909132
Ventricular septal defect	56.18	16.11	32	19009	3969	34933921
Alanine aminotransferase increased	54.99	16.11	130	18911	80685	34857205
Viral load increased	54.76	16.11	27	19014	2500	34935390
Chordee	54.74	16.11	12	19029	73	34937817
Drug ineffective	53.76	16.11	105	18936	456646	34481244
Dyslipidaemia	53.16	16.11	39	19002	7449	34930441
Optic nerve neoplasm	52.37	16.11	10	19031	26	34937864
Cardiac murmur	51.58	16.11	39	19002	7798	34930092
Congenital neoplasm	51.31	16.11	10	19031	30	34937860
Product dose omission issue	50.14	16.11	4	19037	119707	34818183
Blood antidiuretic hormone increased	47.96	16.11	10	19031	46	34937844
Portal hypertension	47.85	16.11	29	19012	4033	34933857
Pain	47.83	16.11	26	19015	204649	34733241
Patent ductus arteriosus	47.56	16.11	27	19014	3327	34934563
Foetal distress syndrome	47.28	16.11	19	19022	1081	34936809
Atrial septal defect	46.92	16.11	36	19005	7356	34930534
Splenomegaly	44.90	16.11	48	18993	15069	34922821
Pneumonia	44.68	16.11	81	18960	362546	34575344
Death	44.66	16.11	94	18947	397955	34539935
Mitochondrial myopathy	44.24	16.11	12	19029	193	34937697
Osteoporotic fracture	43.93	16.11	18	19023	1077	34936813
Product use in unapproved indication	43.89	16.11	6	19035	117493	34820397
Rhabdomyosarcoma	43.79	16.11	9	19032	38	34937852
HIV infection	43.68	16.11	19	19022	1320	34936570
Congenital naevus	43.35	16.11	8	19033	16	34937874
Nodular regenerative hyperplasia	42.50	16.11	17	19024	956	34936934
Cytomegalovirus chorioretinitis	40.68	16.11	25	19016	3564	34934326
Lipohypertrophy	40.63	16.11	12	19029	266	34937624
Congenital hydronephrosis	39.80	16.11	15	19026	718	34937172
Atrial fibrillation	39.73	16.11	9	19032	122384	34815506
Lymphadenopathy	39.50	16.11	62	18979	28401	34909489
Meningomyelocele	39.45	16.11	11	19030	197	34937693
Hypotension	38.99	16.11	38	19003	221611	34716279
Blood creatine phosphokinase increased	38.22	16.11	79	18962	44778	34893112
Hepatomegaly	38.14	16.11	37	19004	10359	34927531
Blood pyruvic acid increased	37.93	16.11	7	19034	14	34937876
Mycobacterium avium complex infection	37.74	16.11	21	19020	2490	34935400
Foetal growth restriction	37.54	16.11	25	19016	4092	34933798
Febrile neutropenia	37.23	16.11	14	19027	136835	34801055
Astrocytoma, low grade	37.18	16.11	8	19033	44	34937846
Hypertonia	36.84	16.11	25	19016	4221	34933669
Malignant neoplasm progression	36.70	16.11	3	19038	88043	34849847
Abortion spontaneous	36.33	16.11	12	19029	388	34937502
Oesophageal candidiasis	36.05	16.11	25	19016	4371	34933519
Jaundice	35.60	16.11	63	18978	31819	34906071
Limb deformity	35.38	16.11	13	19028	579	34937311
White matter lesion	34.78	16.11	14	19027	800	34937090
Congenital cytomegalovirus infection	34.77	16.11	7	19034	26	34937864
Pulmonary tuberculosis	34.29	16.11	25	19016	4729	34933161
Gamma-glutamyltransferase increased	34.25	16.11	59	18982	29172	34908718
Blood pressure increased	34.10	16.11	4	19037	88098	34849792
Constipation	34.07	16.11	16	19025	136966	34800924
Acquired gene mutation	33.97	16.11	16	19025	1339	34936551
Neutropenia neonatal	33.05	16.11	13	19028	699	34937191
Neonatal hyponatraemia	32.99	16.11	8	19033	80	34937810
Macrocytosis	32.08	16.11	14	19027	980	34936910
Speech disorder developmental	31.98	16.11	18	19023	2182	34935708
Blood triglycerides increased	31.95	16.11	39	19002	14120	34923770
Talipes	31.43	16.11	17	19024	1906	34935984
COVID-19	31.35	16.11	3	19038	77547	34860343
Dyspnoea	30.81	16.11	104	18937	376678	34561212
Hepatic cytolysis	29.63	16.11	38	19003	14458	34923432
Congenital mitral valve incompetence	28.81	16.11	8	19033	141	34937749
Live birth	28.79	16.11	9	19032	243	34937647
Congenital anaemia	28.64	16.11	5	19036	6	34937884
Facial wasting	28.40	16.11	8	19033	149	34937741
Developmental delay	28.11	16.11	18	19023	2757	34935133
Congenital hydrocephalus	27.19	16.11	7	19034	91	34937799
Genotype drug resistance test positive	27.11	16.11	13	19028	1132	34936758
Ear malformation	26.87	16.11	9	19032	304	34937586
Mitochondrial cytopathy	26.80	16.11	8	19033	184	34937706
Completed suicide	26.76	16.11	10	19031	98158	34839732
Transaminases increased	26.16	16.11	50	18991	26773	34911117
Pneumocystis jirovecii pneumonia	26.05	16.11	42	18999	19668	34918222
Enophthalmos	25.91	16.11	5	19036	14	34937876
Exomphalos	25.88	16.11	8	19033	208	34937682
Death neonatal	25.59	16.11	9	19032	353	34937537
Sickle cell anaemia	25.55	16.11	8	19033	217	34937673
Drug abuse	25.53	16.11	11	19030	99085	34838805
CD4 lymphocytes increased	25.52	16.11	8	19033	218	34937672
Post streptococcal glomerulonephritis	25.39	16.11	7	19034	120	34937770
Meningitis cryptococcal	25.36	16.11	16	19025	2388	34935502
Cachexia	25.28	16.11	25	19016	7161	34930729
Hepatitis B	25.21	16.11	23	19018	5960	34931930
Prenatal screening test abnormal	24.96	16.11	5	19036	18	34937872
Sudden infant death syndrome	24.79	16.11	8	19033	240	34937650
Lactic acidosis	24.78	16.11	57	18984	34715	34903175
Tuberculoid leprosy	24.74	16.11	6	19035	60	34937830
Heart disease congenital	24.72	16.11	13	19028	1377	34936513
Strabismus	24.72	16.11	14	19027	1717	34936173
Fatigue	24.71	16.11	111	18930	370542	34567348
Anogenital warts	24.59	16.11	10	19031	587	34937303
Hepatitis C virus test	24.39	16.11	6	19035	64	34937826
Cerebrovascular accident	24.21	16.11	8	19033	84803	34853087
Pancytopenia	23.94	16.11	109	18932	95048	34842842
Retinal toxicity	23.87	16.11	9	19032	431	34937459
Late developer	23.83	16.11	4	19037	3	34937887
Hyperbilirubinaemia	23.79	16.11	37	19004	16806	34921084
Oral candidiasis	23.58	16.11	31	19010	12079	34925811
Hepatic function abnormal	23.53	16.11	65	18976	44298	34893592
Maternal condition affecting foetus	23.29	16.11	4	19037	4	34937886
Perinatal HIV infection	23.29	16.11	4	19037	4	34937886
Gastroschisis	23.25	16.11	7	19034	166	34937724
Ultrasound antenatal screen abnormal	23.16	16.11	6	19035	80	34937810
Normal newborn	23.02	16.11	7	19034	172	34937718
HIV wasting syndrome	22.64	16.11	6	19035	88	34937802
ADAMTS13 activity decreased	22.57	16.11	6	19035	89	34937801
Dysphagia	22.54	16.11	80	18961	62301	34875589
Treatment failure	22.41	16.11	66	18975	46631	34891259
Birth trauma	22.40	16.11	4	19037	6	34937884
Progressive multifocal leukoencephalopathy	22.20	16.11	27	19014	9737	34928153
Lagophthalmos	22.15	16.11	6	19035	96	34937794
Acute lymphocytic leukaemia	22.01	16.11	16	19025	3013	34934877
Hepatosplenomegaly	21.54	16.11	18	19023	4151	34933739
Polyneuropathy chronic	21.51	16.11	5	19036	41	34937849
Malaria	21.50	16.11	7	19034	216	34937674
Lactate pyruvate ratio increased	21.35	16.11	4	19037	9	34937881
Cardiac arrest	21.30	16.11	13	19028	96146	34841744
Genitalia external ambiguous	21.26	16.11	7	19034	224	34937666
Nervous system disorder	20.61	16.11	32	19009	14511	34923379
Leukopenia	20.51	16.11	78	18963	62778	34875112
Heart transplant rejection	20.45	16.11	11	19030	1220	34936670
Cryptococcosis	20.41	16.11	14	19027	2405	34935485
Hepatitis	20.23	16.11	42	18999	23862	34914028
Sickle cell disease	20.23	16.11	6	19035	135	34937755
Back pain	20.11	16.11	22	19019	121767	34816123
Meconium peritonitis	20.06	16.11	4	19037	14	34937876
Meningitis tuberculous	20.02	16.11	9	19032	676	34937214
Tuberculosis	19.96	16.11	24	19017	8553	34929337
Lymphocytic infiltration	19.65	16.11	9	19032	706	34937184
Disease progression	19.58	16.11	18	19023	108059	34829831
Congenital retinoblastoma	19.55	16.11	3	19038	0	34937890
Neonatal intestinal obstruction	19.55	16.11	3	19038	0	34937890
Vision abnormal neonatal	19.55	16.11	3	19038	0	34937890
Hypercholesterolaemia	19.55	16.11	24	19017	8738	34929152
Congenital abdominal hernia	19.26	16.11	4	19037	18	34937872
Maternal exposure during pregnancy	18.98	16.11	18	19023	4900	34932990
Abnormal dreams	18.95	16.11	22	19019	7556	34930334
Abdominal hernia	18.82	16.11	14	19027	2730	34935160
Subacute sclerosing panencephalitis	18.75	16.11	4	19037	21	34937869
Neck deformity	18.70	16.11	5	19036	76	34937814
Cleft lip	18.67	16.11	7	19034	330	34937560
Neonatal asphyxia	18.32	16.11	7	19034	348	34937542
Hypotonia	18.31	16.11	22	19019	7831	34930059
Blood bilirubin increased	18.25	16.11	54	18987	38242	34899648
Blood insulin increased	18.22	16.11	7	19034	353	34937537
Anaemia megaloblastic	18.19	16.11	6	19035	193	34937697
Congenital aortic anomaly	18.07	16.11	5	19036	87	34937803
Thalassaemia alpha	18.02	16.11	4	19037	26	34937864
Neutropenia	17.79	16.11	146	18895	156632	34781258
Nasopharyngitis	17.65	16.11	8	19033	69960	34867930
Congenital central nervous system anomaly	17.64	16.11	8	19033	614	34937276
Arthralgia	17.47	16.11	42	18999	169999	34767891
Congenital hearing disorder	17.41	16.11	5	19036	100	34937790
Immune recovery uveitis	17.40	16.11	4	19037	31	34937859
CSF virus identified	17.29	16.11	4	19037	32	34937858
Acute kidney injury	17.06	16.11	97	18944	304891	34632999
Twin pregnancy	17.01	16.11	3	19038	4	34937886
Red blood cell schistocytes present	16.97	16.11	6	19035	239	34937651
Lipase increased	16.65	16.11	23	19018	9393	34928497
Immune reconstitution inflammatory syndrome associated tuberculosis	16.59	16.11	7	19034	451	34937439
Scleral discolouration	16.53	16.11	6	19035	258	34937632
Joint swelling	16.48	16.11	6	19035	59884	34878006
Hydronephrosis	16.42	16.11	24	19017	10322	34927568
Feeling abnormal	16.31	16.11	7	19034	63228	34874662
Trisomy 15	16.26	16.11	3	19038	6	34937884
Glucose-6-phosphate dehydrogenase deficiency	16.21	16.11	5	19036	129	34937761
Reticulocytosis	16.19	16.11	6	19035	274	34937616

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
Exposure during pregnancy	1309.91	16.77	620	22458	100512	79620798
Virologic failure	1058.03	16.77	245	22833	3946	79717364
Lipodystrophy acquired	1008.19	16.77	237	22841	4088	79717222
Viral mutation identified	981.67	16.77	227	22851	3631	79717679
Immune reconstitution inflammatory syndrome	868.22	16.77	269	22809	13572	79707738
Pathogen resistance	804.75	16.77	256	22822	14086	79707224
Abortion spontaneous	788.85	16.77	303	22775	29204	79692106
Stillbirth	783.20	16.77	190	22888	3765	79717545
Mitochondrial toxicity	738.06	16.77	173	22905	2941	79718369
Foetal exposure during pregnancy	640.83	16.77	175	22903	5615	79715695
Drug resistance	588.82	16.77	273	22805	41940	79679370
Eyelid ptosis	434.83	16.77	151	22927	10893	79710417
Abortion induced	411.41	16.77	130	22948	6979	79714331
Progressive external ophthalmoplegia	361.99	16.77	84	22994	1361	79719949
Blood HIV RNA increased	313.00	16.77	78	23000	1730	79719580
Caesarean section	289.84	16.77	116	22962	12419	79708891
Diplopia	279.39	16.77	153	22925	33313	79687997
Lipoatrophy	254.35	16.77	55	23023	634	79720676
Pregnancy	247.16	16.77	131	22947	26720	79694590
Anaemia	226.55	16.77	436	22642	444579	79276731
Live birth	223.70	16.77	109	22969	18635	79702675
Maternal exposure during pregnancy	213.66	16.77	229	22849	136309	79585001
Premature rupture of membranes	196.98	16.77	65	23013	4004	79717306
Treatment noncompliance	175.93	16.77	135	22943	52133	79669177
Maternal drugs affecting foetus	172.88	16.77	48	23030	1635	79719675
CSF HIV escape syndrome	170.01	16.77	35	23043	312	79720998
CD4 lymphocytes decreased	155.81	16.77	49	23029	2585	79718725
Foetal death	147.19	16.77	63	23015	7981	79713329
Premature baby	138.44	16.77	49	23029	3731	79717579
Premature labour	138.15	16.77	61	23017	8329	79712981
Pre-eclampsia	131.66	16.77	56	23022	6985	79714325
Portal hypertension	124.57	16.77	54	23024	7054	79714256
Pinealoblastoma	123.97	16.77	21	23057	52	79721258
Hepatic fibrosis	123.33	16.77	54	23024	7226	79714084
Acquired gene mutation	121.58	16.77	39	23039	2194	79719116
Hydrops foetalis	107.29	16.77	28	23050	750	79720560
HIV-associated neurocognitive disorder	107.21	16.77	24	23054	328	79720982
Ultrasound antenatal screen	105.58	16.77	27	23051	666	79720644
Ophthalmoplegia	103.81	16.77	37	23041	2875	79718435
Cleft lip and palate	100.51	16.77	26	23052	672	79720638
Premature delivery	100.18	16.77	70	23008	23397	79697913
Aspartate aminotransferase increased	96.25	16.77	156	22922	138485	79582825
Pain	95.94	16.77	42	23036	703760	79017550
Alanine aminotransferase increased	94.48	16.77	169	22909	162401	79558909
Trisomy 18	94.12	16.77	24	23054	585	79720725
Hepatic cytolysis	93.23	16.77	71	23007	27080	79694230
Hypertriglyceridaemia	92.01	16.77	53	23025	12687	79708623
Viral load increased	81.25	16.77	31	23047	2917	79718393
Meningitis cryptococcal	79.47	16.77	32	23046	3474	79717836
Alpha 1 foetoprotein abnormal	77.97	16.77	14	23064	54	79721256
Dyslipidaemia	77.68	16.77	46	23032	11587	79709723
Hyperlactacidaemia	77.30	16.77	36	23042	5559	79715751
Fall	73.15	16.77	25	23053	487604	79233706
Lymphadenopathy	72.27	16.77	83	22995	53164	79668146
Genotype drug resistance test positive	71.85	16.77	23	23055	1285	79720025
Hepatomegaly	70.69	16.77	52	23026	18822	79702488
Normal newborn	69.30	16.77	36	23042	7036	79714274
Osteonecrosis	68.66	16.77	63	23015	31032	79690278
Pulmonary tuberculosis	68.48	16.77	37	23041	7828	79713482
Kaposi's sarcoma	65.97	16.77	19	23059	740	79720570
Peripheral swelling	65.37	16.77	3	23075	269614	79451696
Amniotic cavity infection	64.36	16.77	19	23059	808	79720502
Drug-induced liver injury	62.48	16.77	86	22992	66031	79655279
Joint swelling	61.86	16.77	6	23072	288640	79432670
Off label use	61.86	16.77	105	22973	907110	78814200
Multiple-drug resistance	59.26	16.77	35	23043	8773	79712537
Jaundice	59.06	16.77	75	23003	53274	79668036
Drug ineffective	58.51	16.77	143	22935	1080770	78640540
Nasopharyngitis	57.94	16.77	4	23074	253877	79467433
Mycobacterium avium complex infection	55.61	16.77	27	23051	4573	79716737
HIV viraemia	54.05	16.77	11	23067	92	79721218
Splenomegaly	51.66	16.77	45	23033	20709	79700601
Product dose omission issue	50.85	16.77	6	23072	247531	79473779
Acute lymphocytic leukaemia	50.72	16.77	26	23052	4943	79716367
Rickets	50.58	16.77	10	23068	71	79721239
Facial wasting	49.10	16.77	10	23068	84	79721226
Premature separation of placenta	48.87	16.77	17	23061	1229	79720081
Tuberculosis	48.37	16.77	38	23040	15160	79706150
Cytomegalovirus chorioretinitis	48.28	16.77	26	23052	5464	79715846
Malaria	47.81	16.77	13	23065	409	79720901
Blood lactic acid increased	47.47	16.77	35	23043	12709	79708601
Mitochondrial myopathy	47.36	16.77	12	23066	285	79721025
Acquired immunodeficiency syndrome	46.96	16.77	12	23066	295	79721015
Hyperlipidaemia	46.52	16.77	47	23031	26046	79695264
Optic nerve neoplasm	46.10	16.77	8	23070	24	79721286
Completed suicide	45.73	16.77	8	23070	245759	79475551
Gestational diabetes	44.96	16.77	26	23052	6267	79715043
Arthralgia	44.85	16.77	60	23018	571743	79149567
Proteinuria	44.66	16.77	51	23027	32451	79688859
Hepatotoxicity	44.36	16.77	64	23014	51288	79670022
White matter lesion	44.26	16.77	18	23060	2004	79719306
Pancytopenia	43.79	16.77	126	22952	165619	79555691
Nodular regenerative hyperplasia	43.67	16.77	16	23062	1345	79719965
Mitochondrial cytopathy	43.52	16.77	12	23066	398	79720912
Constipation	43.28	16.77	14	23064	283036	79438274
Stevens-Johnson syndrome	43.25	16.77	55	23023	39111	79682199
Rheumatoid arthritis	42.95	16.77	5	23073	208465	79512845
Abdominal discomfort	42.83	16.77	10	23068	250717	79470593
Gamma-glutamyltransferase increased	42.71	16.77	65	23013	54615	79666695
Anaemia macrocytic	42.33	16.77	24	23054	5573	79715737
Fatigue	42.05	16.77	134	22944	929593	78791717
Placental disorder	41.55	16.77	14	23064	919	79720391
Blood triglycerides increased	41.41	16.77	40	23038	21000	79700310
Placenta praevia	40.34	16.77	13	23065	742	79720568
Cachexia	40.30	16.77	30	23048	11053	79710257
Astrocytoma malignant	39.63	16.77	7	23071	24	79721286
Product use in unapproved indication	38.96	16.77	12	23066	250347	79470963
Blood antidiuretic hormone increased	38.69	16.77	8	23070	73	79721237
Twin pregnancy	38.15	16.77	13	23065	883	79720427
Pneumocystis jirovecii pneumonia	38.04	16.77	47	23031	32461	79688849
Hepatitis	37.66	16.77	62	23016	55665	79665645
Sinusitis	37.17	16.77	6	23072	195495	79525815
Fanconi syndrome acquired	36.18	16.77	17	23061	2677	79718633
Leukopenia	36.17	16.77	94	22984	116419	79604891
Pyrexia	35.95	16.77	326	22752	678383	79042927
AIDS cholangiopathy	35.38	16.77	6	23072	15	79721295
Rash maculo-papular	34.72	16.77	60	23018	56018	79665292
Hypotension	34.70	16.77	46	23032	440271	79281039
COVID-19	34.50	16.77	3	23075	157671	79563639
Lipohypertrophy	34.44	16.77	12	23066	872	79720438
Meningitis tuberculous	34.39	16.77	13	23065	1192	79720118
Transaminases increased	34.21	16.77	57	23021	51686	79669624
Oesophageal candidiasis	33.62	16.77	25	23053	9193	79712117
Atrial fibrillation	33.57	16.77	8	23070	197878	79523432
Rhabdomyosarcoma	33.07	16.77	8	23070	156	79721154
Arthropathy	32.43	16.77	6	23072	177105	79544205
Oligohydramnios	32.37	16.77	17	23061	3395	79717915
Pneumonia	32.05	16.77	92	22986	660154	79061156
Retinoblastoma	31.81	16.77	7	23071	88	79721222
Umbilical cord abnormality	31.77	16.77	8	23070	185	79721125
HIV infection	31.59	16.77	12	23066	1115	79720195
Osteoporotic fracture	31.58	16.77	18	23060	4222	79717088
Neutropenia neonatal	31.52	16.77	6	23072	34	79721276
Immune reconstitution inflammatory syndrome associated tuberculosis	31.23	16.77	11	23067	825	79720485
Blood bilirubin increased	31.17	16.77	63	23015	66169	79655141
Tuberculoid leprosy	30.66	16.77	7	23071	105	79721205
Congenital anomaly	30.62	16.77	9	23069	377	79720933
Synovitis	30.10	16.77	4	23074	150730	79570580
Glycosuria	29.98	16.77	14	23064	2174	79719136
Drug interaction	29.87	16.77	214	22864	414969	79306341
Ectopic pregnancy	29.75	16.77	13	23065	1730	79719580
Fat tissue increased	29.75	16.77	11	23067	949	79720361
Post streptococcal glomerulonephritis	29.57	16.77	7	23071	124	79721186
Amylase increased	29.31	16.77	25	23053	11184	79710126
Astrocytoma, low grade	29.29	16.77	6	23072	52	79721258
Cryptococcosis	29.20	16.77	16	23062	3477	79717833
Hepatic function abnormal	29.16	16.77	65	23013	73042	79648268
Retinal toxicity	28.98	16.77	12	23066	1399	79719911
Ergot poisoning	28.96	16.77	7	23071	136	79721174
Brain oedema	28.72	16.77	36	23042	25227	79696083
Foetal distress syndrome	28.46	16.77	9	23069	483	79720827
Gynaecomastia	28.39	16.77	21	23057	7660	79713650
Varices oesophageal	28.23	16.77	19	23059	5972	79715338
Febrile neutropenia	28.03	16.77	16	23062	230983	79490327
Ileal ulcer	28.00	16.77	11	23067	1119	79720191
Nephropathy toxic	27.98	16.77	32	23046	20387	79700923
Hyperbilirubinaemia	27.97	16.77	35	23043	24483	79696827
Swelling	27.77	16.77	14	23064	216697	79504613
Dyspnoea	27.08	16.77	142	22936	856883	78864427
Induced labour	27.05	16.77	10	23068	862	79720448
Influenza	26.96	16.77	3	23075	129603	79591707
Oxygen saturation decreased	26.81	16.77	3	23075	129044	79592266
Anaemia neonatal	26.79	16.77	5	23073	25	79721285
Ultrasound antenatal screen abnormal	26.73	16.77	6	23072	83	79721227
Pruritus	26.48	16.77	46	23032	394602	79326708
Anogenital warts	26.38	16.77	10	23068	924	79720386
Congenital retinoblastoma	26.36	16.77	4	23074	3	79721307
Musculoskeletal stiffness	26.14	16.77	9	23069	174999	79546311
Feeling abnormal	25.92	16.77	7	23071	159192	79562118
Condition aggravated	25.65	16.77	68	23010	501056	79220254
Hepatosplenomegaly	25.65	16.77	18	23060	6051	79715259
Speech disorder developmental	25.55	16.77	9	23069	675	79720635
Therapeutic product effect incomplete	25.50	16.77	5	23073	141640	79579670
Death	25.28	16.77	82	22996	566432	79154878
Blood pressure increased	25.13	16.77	15	23063	211345	79509965
Stomatitis	24.76	16.77	6	23072	146751	79574559
Hepatitis B	24.73	16.77	20	23058	8312	79712998
Blood alkaline phosphatase increased	24.71	16.77	56	23022	63608	79657702
Torsade de pointes	24.35	16.77	29	23049	19283	79702027
Antiviral drug level below therapeutic	24.24	16.77	5	23073	45	79721265
CD4 lymphocytes increased	23.86	16.77	7	23071	291	79721019
Infection	23.74	16.77	21	23057	241691	79479619
Wheezing	23.52	16.77	3	23075	116661	79604649
Inappropriate schedule of product administration	23.47	16.77	5	23073	133623	79587687
Wound	23.39	16.77	3	23075	116176	79605134
Chlamydial infection	23.37	16.77	8	23070	551	79720759
Dysphagia	23.25	16.77	83	22995	122053	79599257
Cerebral toxoplasmosis	23.07	16.77	12	23066	2350	79718960
Macrocephaly	23.01	16.77	5	23073	59	79721251
Lipase increased	22.89	16.77	26	23052	16440	79704870
Progressive multifocal leukoencephalopathy	22.85	16.77	29	23049	20571	79700739
Gestational hypertension	22.62	16.77	11	23067	1868	79719442
Insulin resistance	22.61	16.77	10	23068	1369	79719941
Congestive cardiomyopathy	22.44	16.77	22	23056	11758	79709552
Portal hypertensive gastropathy	22.37	16.77	10	23068	1404	79719906
HIV wasting syndrome	22.16	16.77	5	23073	71	79721239
ADAMTS13 activity decreased	22.15	16.77	6	23072	186	79721124
Enophthalmos	21.90	16.77	5	23073	75	79721235
Alopecia	21.65	16.77	21	23057	231334	79489976
Anembryonic gestation	21.56	16.77	7	23071	409	79720901
Vaginal haemorrhage	21.54	16.77	29	23049	21788	79699522
Human immunodeficiency virus transmission	21.44	16.77	3	23075	0	79721310
Acute stress disorder	21.11	16.77	7	23071	437	79720873
Neonatal disorder	21.11	16.77	4	23074	22	79721288
Nervous system disorder	21.07	16.77	32	23046	26824	79694486
Foetal cardiac disorder	20.96	16.77	4	23074	23	79721287
Product use issue	20.88	16.77	18	23060	209804	79511506
Meningomyelocele	20.82	16.77	4	23074	24	79721286
Arthritis	20.79	16.77	4	23074	114876	79606434
Opportunistic infection	20.57	16.77	12	23066	2938	79718372
Pericarditis	20.26	16.77	3	23075	104233	79617077
Patent ductus arteriosus	20.10	16.77	5	23073	110	79721200
Erythema	20.06	16.77	21	23057	223269	79498041
Ventricular septal defect	20.02	16.77	7	23071	514	79720796
Encephalitis	20	16.77	23	23055	14737	79706573
Immune recovery uveitis	19.93	16.77	4	23074	31	79721279
Back pain	19.90	16.77	36	23042	304144	79417166
Calculus urinary	19.83	16.77	11	23067	2449	79718861
Sudden infant death syndrome	19.81	16.77	6	23072	279	79721031
Amniotic fluid volume decreased	19.58	16.77	6	23072	290	79721020
Discomfort	19.56	16.77	6	23072	125611	79595699
Anxiety	19.51	16.77	26	23052	248486	79472824
Oropharyngeal pain	19.39	16.77	4	23074	109349	79611961
Urinary tract infection	19.32	16.77	31	23047	274481	79446829
Subacute sclerosing panencephalitis	19.29	16.77	4	23074	37	79721273
CSF virus identified	19.20	16.77	4	23074	38	79721272
Hepatitis A	19.15	16.77	8	23070	953	79720357
Pain in extremity	18.99	16.77	49	23029	364489	79356821
Cushing's syndrome	18.88	16.77	8	23070	987	79720323
HIV associated nephropathy	18.82	16.77	6	23072	331	79720979
Hypercholesterolaemia	18.81	16.77	28	23050	23067	79698243
Lymph node tuberculosis	18.74	16.77	8	23070	1006	79720304
Non-Hodgkin's lymphoma	18.68	16.77	9	23069	1498	79719812
Malignant neoplasm progression	18.63	16.77	8	23070	135982	79585328
Hepatic cirrhosis	18.61	16.77	35	23043	34871	79686439
Atrophy	18.55	16.77	10	23068	2104	79719206
Drug intolerance	18.43	16.77	30	23048	264089	79457221
Lymphocytic infiltration	18.42	16.77	9	23069	1544	79719766
Liver transplant	18.42	16.77	13	23065	4410	79716900
Fanconi syndrome	18.30	16.77	11	23067	2845	79718465
Herpes simplex	18.24	16.77	20	23058	12167	79709143
Bovine tuberculosis	18.22	16.77	5	23073	163	79721147
Hydromyelia	18.15	16.77	3	23075	6	79721304
Hyperbilirubinaemia neonatal	18.15	16.77	3	23075	6	79721304
Amylase abnormal	18.05	16.77	4	23074	52	79721258
Foetal heart rate abnormal	18.05	16.77	6	23072	378	79720932
Ocular icterus	18.04	16.77	14	23064	5486	79715824
Hyponatraemia	18.00	16.77	15	23063	177833	79543477
Pancreatitis	17.96	16.77	52	23026	68523	79652787
Placental insufficiency	17.95	16.77	8	23070	1115	79720195
Intentional product misuse	17.90	16.77	3	23075	95162	79626148
Delivery	17.61	16.77	7	23071	735	79720575
Aplasia pure red cell	17.58	16.77	16	23062	7794	79713516
Lipomatosis	17.53	16.77	6	23072	413	79720897
Trisomy 21	17.40	16.77	4	23074	62	79721248
Erythropenia	17.37	16.77	6	23072	425	79720885
Cellulitis	17.37	16.77	5	23073	109055	79612255
Hepatic necrosis	17.34	16.77	17	23061	9083	79712227
Necrotising enterocolitis neonatal	17.29	16.77	3	23075	9	79721301
Vanishing bile duct syndrome	17.27	16.77	9	23069	1769	79719541
Developmental delay	17.25	16.77	8	23070	1223	79720087
Lagophthalmos	17.20	16.77	6	23072	437	79720873
Cerebrovascular accident	17.12	16.77	12	23066	155280	79566030
Acute HIV infection	17.11	16.77	4	23074	67	79721243
Abortion missed	16.93	16.77	8	23070	1275	79720035
Strabismus	16.91	16.77	10	23068	2511	79718799
Hepatitis C	16.87	16.77	19	23059	11906	79709404
Small for dates baby	16.78	16.77	6	23072	470	79720840

FDA Adverse Event Reporting System (Pediatric)

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
Blood lactic acid increased	56.43	33.21	27	1001	87	88677
Neutropenia	55.30	33.21	33	995	184	88580
Aspartate aminotransferase increased	38.47	33.21	18	1010	54	88710
Hypertriglyceridaemia	38.24	33.21	18	1010	55	88709
Pregnancy	37.90	33.21	15	1013	25	88739
Blood creatine phosphokinase increased	33.77	33.21	14	1014	28	88736

Pharmacologic Action:

Source	Code	Description
ATC	J05AF01	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Nucleoside and nucleotide reverse transcriptase inhibitors
ATC	J05AR01	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR04	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR05	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
FDA MoA	N0000009947	Nucleoside Reverse Transcriptase Inhibitors
FDA EPC	N0000175462	Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
CHEBI has role	CHEBI:35221	antimetabolite
CHEBI has role	CHEBI:36044	antiviral drugs
CHEBI has role	CHEBI:53756	reverse transcriptase inhibitors
CHEBI has role	CHEBI:36047	antibacterial drugs
CHEBI has role	CHEBI:50696	PBP3 inhibitor
CHEBI has role	CHEBI:88188	allergenic drug
MeSH PA	D019380	Anti-HIV Agents
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D044966	Anti-Retroviral Agents
MeSH PA	D000963	Antimetabolites
MeSH PA	D000998	Antiviral Agents
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D009676	Noxae
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
Prevention of Maternal-Fetal Transmission of HIV	indication
Prevention of HIV Infection after Exposure	off-label use
Toxic amblyopia	contraindication	965003
Myositis	contraindication	26889001	DOID:633
Hepatic failure	contraindication	59927004
Pancreatitis	contraindication	75694006	DOID:4989
Large liver	contraindication	80515008
Kidney disease	contraindication	90708001	DOID:557
Lactic acidosis	contraindication	91273001	DOID:3650
Disorder of muscle	contraindication	129565002	DOID:423
Steatosis of liver	contraindication	197321007
Acute pancreatitis	contraindication	197456007	DOID:2913
Chronic pancreatitis	contraindication	235494005
Disease of liver	contraindication	235856003	DOID:409
Anemia	contraindication	271737000	DOID:2355
Hypertriglyceridemia	contraindication	302870006
Neutropenic disorder	contraindication	303011007	DOID:1227
Bone marrow depression	contraindication	307762000
Breastfeeding (mother)	contraindication	413712001
Obesity	contraindication	414916001	DOID:9970
HLA-B 5701 Positive Status	contraindication
Drug Resistance to Anti-retroviral Therapy	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	9.17	acidic
pKa2	13.72	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
Sigma non-opioid intracellular receptor 1	Membrane receptor	Q99720	SGMR1_HUMAN		Ki	4		WOMBAT-PK
5-hydroxytryptamine receptor 2A	GPCR	P28223	5HT2A_HUMAN		IC50	5.51		WOMBAT-PK
Thymidine kinase, cytosolic	Kinase	P04183	KITH_HUMAN		Ki	5.54		CHEMBL
Thymidylate kinase	Kinase	P23919	KTHY_HUMAN		Ki	4.55		WOMBAT-PK
Reverse transcriptase/RNaseH	Enzyme		Q72547_9HIV1	INHIBITOR	IC50	8.52		CHEMBL	CHEMBL
Reverse transcriptase	Enzyme		Q9WKE8_9HIV1		IC50	4.74		CHEMBL
Pol polyprotein	Enzyme		Q72874_9HIV1		IC50	8.22		CHEMBL
Gag-Pro-Pol polyprotein	Polyprotein		POL_HTL1A		EC50	8.31		WOMBAT-PK
Thymidylate kinase	Kinase		KTHY_MYCTU		Ki	4.55		CHEMBL
Thymidine kinase	Kinase		KITH_UREPA		IC50	4.90		CHEMBL
Reverse transcriptase/RNaseH	Enzyme		Q72549_9HIV1		IC50	6.11		WOMBAT-PK
Reverse transcriptase protein	Unclassified		Q9WJQ2_9HIV1		IC50	5.44		CHEMBL

External reference:

ID	Source
4019502	VUID
N0000147622	NUI
D00413	KEGG_DRUG
4019502	VANDF
C0043474	UMLSCUI
CHEBI:10110	CHEBI
AZZ	PDB_CHEM_ID
CHEMBL129	ChEMBL_ID
DB00495	DRUGBANK_ID
D015215	MESH_DESCRIPTOR_UI
35370	PUBCHEM_CID
4825	IUPHAR_LIGAND_ID
6118	INN_ID
4B9XT59T7S	UNII
11413	RXNORM
5703	MMSL
71929	MMSL
d00034	MMSL
003019	NDDF
27479000	SNOMEDCT_US
387151007	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Combivir	HUMAN PRESCRIPTION DRUG LABEL	2	16590-061	TABLET, FILM COATED	300 mg	ORAL	NDA	16 sections
Zidovudine	HUMAN PRESCRIPTION DRUG LABEL	1	21695-369	TABLET, FILM COATED	300 mg	ORAL	ANDA	27 sections
COMBIVIR	HUMAN PRESCRIPTION DRUG LABEL	2	21695-846	TABLET, FILM COATED	300 mg	ORAL	NDA	26 sections
Lamivudine and Zidovudine	HUMAN PRESCRIPTION DRUG LABEL	2	21695-996	TABLET, FILM COATED	300 mg	ORAL	ANDA	26 sections
LAMIVUDINE and ZIDOVUDINE	Human Prescription Drug Label	2	31722-506	TABLET, FILM COATED	300 mg	ORAL	ANDA	25 sections
LAMIVUDINE and ZIDOVUDINE	Human Prescription Drug Label	2	31722-506	TABLET, FILM COATED	300 mg	ORAL	ANDA	25 sections
Zidovudine	Human Prescription Drug Label	1	31722-509	TABLET	300 mg	ORAL	ANDA	27 sections
Zidovudine	Human Prescription Drug Label	1	31722-509	TABLET	300 mg	ORAL	ANDA	27 sections
Lamivudine and Zidovudine	HUMAN PRESCRIPTION DRUG LABEL	2	31722-739	TABLET, FILM COATED	300 mg	ORAL	ANDA	24 sections
Lamivudine and Zidovudine	Human Prescription Drug Label	2	33342-003	TABLET	300 mg	ORAL	ANDA	25 sections
Lamivudine and Zidovudine	Human Prescription Drug Label	2	33342-003	TABLET	300 mg	ORAL	ANDA	25 sections
Lamivudine and Zidovudine	Human Prescription Drug Label	2	33342-003	TABLET	300 mg	ORAL	ANDA	25 sections
LAMIVUDINE and ZIDOVUDINE	HUMAN PRESCRIPTION DRUG LABEL	2	43063-900	TABLET, FILM COATED	300 mg	ORAL	ANDA	25 sections
LAMIVUDINE and ZIDOVUDINE	HUMAN PRESCRIPTION DRUG LABEL	2	43063-900	TABLET, FILM COATED	300 mg	ORAL	ANDA	25 sections
LAMIVUDINE and ZIDOVUDINE	HUMAN PRESCRIPTION DRUG LABEL	2	43063-900	TABLET, FILM COATED	300 mg	ORAL	ANDA	25 sections
COMBIVIR	HUMAN PRESCRIPTION DRUG LABEL	2	49702-202	TABLET, FILM COATED	300 mg	ORAL	NDA	25 sections
COMBIVIR	HUMAN PRESCRIPTION DRUG LABEL	2	49702-202	TABLET, FILM COATED	300 mg	ORAL	NDA	25 sections
RETROVIR	HUMAN PRESCRIPTION DRUG LABEL	1	49702-211	CAPSULE	100 mg	ORAL	NDA	25 sections
RETROVIR	HUMAN PRESCRIPTION DRUG LABEL	1	49702-211	CAPSULE	100 mg	ORAL	NDA	25 sections
RETROVIR	HUMAN PRESCRIPTION DRUG LABEL	1	49702-211	CAPSULE	100 mg	ORAL	NDA	25 sections
RETROVIR	HUMAN PRESCRIPTION DRUG LABEL	1	49702-212	SOLUTION	10 mg	ORAL	NDA	25 sections
RETROVIR	HUMAN PRESCRIPTION DRUG LABEL	1	49702-212	SOLUTION	10 mg	ORAL	NDA	25 sections
RETROVIR	HUMAN PRESCRIPTION DRUG LABEL	1	49702-212	SOLUTION	10 mg	ORAL	NDA	25 sections
RETROVIR	HUMAN PRESCRIPTION DRUG LABEL	1	49702-213	INJECTION, SOLUTION	10 mg	INTRAVENOUS	NDA	25 sections
RETROVIR	HUMAN PRESCRIPTION DRUG LABEL	1	49702-213	INJECTION, SOLUTION	10 mg	INTRAVENOUS	NDA	25 sections
RETROVIR	HUMAN PRESCRIPTION DRUG LABEL	1	49702-213	INJECTION, SOLUTION	10 mg	INTRAVENOUS	NDA	25 sections
TRIZIVIR	HUMAN PRESCRIPTION DRUG LABEL	3	49702-217	TABLET, FILM COATED	300 mg	ORAL	NDA	26 sections
TRIZIVIR	HUMAN PRESCRIPTION DRUG LABEL	3	49702-217	TABLET, FILM COATED	300 mg	ORAL	NDA	26 sections
TRIZIVIR	HUMAN PRESCRIPTION DRUG LABEL	3	49702-217	TABLET, FILM COATED	300 mg	ORAL	NDA	26 sections
LAMIVUDINE and ZIDOVUDINE	HUMAN PRESCRIPTION DRUG LABEL	2	50268-456	TABLET, FILM COATED	300 mg	ORAL	ANDA	25 sections