lamivudine 🐶 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	1539	134678-17-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: lamivudine virolam zeffix	A reverse transcriptase inhibitor and ZALCITABINE analog in which a sulfur atom replaces the 3' carbon of the pentose ring. It is used to treat HIV disease. Molecular weight: 229.25 Formula: C8H11N3O3S CLOGP: -1.46 LIPINSKI: 0 HAC: 6 HDO: 2 TPSA: 88.15 ALOGS: -1.92 ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

lamivudine
virolam
zeffix

A reverse transcriptase inhibitor and ZALCITABINE analog in which a sulfur atom replaces the 3' carbon of the pentose ring. It is used to treat HIV disease.

Molecular weight: 229.25
Formula: C8H11N3O3S
CLOGP: -1.46
LIPINSKI: 0
HAC: 6
HDO: 2
TPSA: 88.15
ALOGS: -1.92
ROTB: 2

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
0.30	g	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	70 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	67 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	21.81 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	86 %	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)	4.80 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.94 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	9.10 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company
Aug. 8, 1996	EMA	VIIV HLTHCARE
Nov. 17, 1995	FDA	VIIV HLTHCARE
Jan. 14, 2020	PMDA	ViiV Healthcare K.K.

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	2121.32	16.80	1142	27840	154405	63305635
Abortion spontaneous	1380.09	16.80	587	28395	46608	63413432
Virologic failure	1328.05	16.80	277	28705	1585	63458455
Viral mutation identified	1277.81	16.80	267	28715	1543	63458497
Drug resistance	1103.34	16.80	409	28573	22524	63437516
Stillbirth	1059.81	16.80	296	28686	6454	63453586
Foetal exposure during pregnancy	915.10	16.80	392	28590	31570	63428470
Pathogen resistance	879.79	16.80	253	28729	6145	63453895
Immune reconstitution inflammatory syndrome	811.67	16.80	235	28747	5849	63454191
Abortion induced	687.23	16.80	234	28748	10008	63450032
Premature baby	438.66	16.80	206	28776	20529	63439511
Pregnancy	352.95	16.80	216	28766	36620	63423420
Blood HIV RNA increased	341.58	16.80	77	28905	662	63459378
Hepatitis B reactivation	334.73	16.80	102	28880	3035	63457005
Maternal exposure during pregnancy	319.84	16.80	445	28537	219617	63240423
Caesarean section	316.99	16.80	155	28827	16877	63443163
Hypomania	289.78	16.80	109	28873	6221	63453819
Live birth	283.76	16.80	165	28817	25465	63434575
Hepatotoxicity	282.23	16.80	188	28794	36853	63423187
Fanconi syndrome acquired	280.37	16.80	70	28912	966	63459074
Lipodystrophy acquired	275.69	16.80	74	28908	1378	63458662
Jaundice cholestatic	274.33	16.80	109	28873	7215	63452825
Blood bilirubin increased	269.79	16.80	183	28799	36957	63423083
Schizophrenia	254.91	16.80	113	28869	9839	63450201
Foetal death	253.66	16.80	116	28866	10864	63449176
Treatment noncompliance	197.99	16.80	152	28830	37173	63422867
Maternal drugs affecting foetus	189.31	16.80	76	28906	5166	63454874
CD4 lymphocytes decreased	180.84	16.80	53	28929	1374	63458666
Psychotic disorder	175.58	16.80	122	28860	25590	63434450
Premature rupture of membranes	168.66	16.80	69	28913	4924	63455116
Premature labour	161.29	16.80	89	28893	12415	63447625
Mitochondrial toxicity	147.83	16.80	36	28946	445	63459595
Pain	142.50	16.80	81	28901	740547	62719493
Foetal growth restriction	138.28	16.80	68	28914	7485	63452555
Pre-eclampsia	137.37	16.80	72	28910	9061	63450979
Anaemia	135.77	16.80	365	28617	293065	63166975
Fatigue	130.00	16.80	129	28853	887899	62572141
Drug ineffective	126.05	16.80	177	28805	1044588	62415452
Acquired gene mutation	122.33	16.80	36	28946	947	63459093
Cholelithiasis	120.34	16.80	123	28859	43802	63416238
Hepatitis B	119.68	16.80	50	28932	3762	63456278
Viral load increased	118.61	16.80	38	28944	1336	63458704
Human immunodeficiency virus transmission	118.52	16.80	21	28961	39	63460001
Fanconi syndrome	118.12	16.80	38	28944	1354	63458686
Trisomy 21	113.46	16.80	28	28954	367	63459673
Joint swelling	112.86	16.80	10	28972	327656	63132384
Hepatitis B DNA increased	107.67	16.80	25	28957	248	63459792
Premature delivery	105.94	16.80	97	28885	30184	63429856
Asthma-chronic obstructive pulmonary disease overlap syndrome	103.51	16.80	38	28944	2023	63458017
Fall	103.33	16.80	26	28956	392308	63067732
Lactic acidosis	100.88	16.80	105	28877	38182	63421858
Portal hypertension	99.82	16.80	44	28938	3775	63456265
Nephropathy toxic	99.53	16.80	59	28923	9420	63450620
Total lung capacity increased	99.29	16.80	38	28944	2272	63457768
Lipoatrophy	98.37	16.80	24	28958	299	63459741
Osteomalacia	95.86	16.80	28	28954	717	63459323
Infusion related reaction	94.95	16.80	4	28978	245517	63214523
Peripheral swelling	94.65	16.80	7	28975	265935	63194105
Polydactyly	93.44	16.80	23	28959	298	63459742
Nasopharyngitis	92.50	16.80	6	28976	254251	63205789
Hyperbilirubinaemia	92.37	16.80	60	28922	11254	63448786
Abdominal discomfort	91.03	16.80	18	28964	320867	63139173
Cardiac murmur	89.96	16.80	65	28917	14487	63445553
Alanine aminotransferase increased	88.52	16.80	165	28817	103605	63356435
Normal newborn	87.79	16.80	52	28930	8289	63451751
Glycosuria	87.49	16.80	29	28953	1137	63458903
Hypophosphataemia	86.97	16.80	58	28924	11368	63448672
Genotype drug resistance test positive	86.61	16.80	23	28959	410	63459630
Alopecia	85.75	16.80	24	28958	337512	63122528
Proteinuria	84.45	16.80	70	28912	19075	63440965
Rheumatoid arthritis	84.07	16.80	9	28973	253810	63206230
Mitochondrial cytopathy	83.69	16.80	20	28962	227	63459813
Aspartate aminotransferase increased	82.63	16.80	148	28834	90129	63369911
Systemic lupus erythematosus	82.14	16.80	3	28979	208915	63251125
Ventricular septal defect	81.88	16.80	40	28942	4338	63455702
Renal tubular dysfunction	81.78	16.80	22	28960	413	63459627
Placental disorder	80.26	16.80	29	28953	1475	63458565
Congenital umbilical hernia	78.98	16.80	20	28962	293	63459747
Product dose omission issue	78.39	16.80	8	28974	234305	63225735
Hyperlactacidaemia	78.28	16.80	34	28948	2815	63457225
Alpha 1 foetoprotein abnormal	77.74	16.80	15	28967	53	63459987
Amniotic cavity infection	77.45	16.80	27	28955	1236	63458804
Ectopic kidney	77.31	16.80	15	28967	55	63459985
Hepatomegaly	75.54	16.80	54	28928	11835	63448205
Off label use	75.43	16.80	120	28862	674342	62785698
Birth mark	73.09	16.80	17	28965	170	63459870
Jaundice	71.33	16.80	77	28905	29174	63430866
CSF HIV escape syndrome	70.96	16.80	15	28967	92	63459948
Premature separation of placenta	70.73	16.80	28	28954	1833	63458207
Retinoblastoma	68.15	16.80	14	28968	73	63459967
Sinusitis	67.96	16.80	11	28971	226642	63233398
Oligohydramnios	67.81	16.80	40	28942	6326	63453714
Atrial septal defect	67.18	16.80	41	28941	6897	63453143
Small for dates baby	66.37	16.80	33	28949	3718	63456322
Drug intolerance	66.28	16.80	29	28953	308632	63151408
Swelling	65.55	16.80	22	28960	275356	63184684
Arthralgia	64.94	16.80	100	28882	569610	62890430
Nasal polyps	64.47	16.80	38	28944	6001	63454039
Blood lactic acid increased	63.86	16.80	40	28942	7046	63452994
Fat tissue increased	63.66	16.80	20	28962	659	63459381
Pulmonary tuberculosis	63.37	16.80	34	28948	4483	63455557
Rash maculo-papular	62.56	16.80	75	28907	31821	63428219
Dyslipidaemia	62.30	16.80	40	28942	7353	63452687
Ectopic pregnancy	62.05	16.80	28	28954	2539	63457501
Lymphadenopathy	62.02	16.80	82	28900	38376	63421664
Congenital anomaly	61.54	16.80	25	28957	1751	63458289
Stevens-Johnson syndrome	61.40	16.80	66	28916	24884	63435156
Sarcoidosis	61.17	16.80	39	28943	7083	63452957
Hepatic cytolysis	61.11	16.80	53	28929	15354	63444686
Cleft lip and palate	60.77	16.80	19	28963	616	63459424
Discomfort	60.70	16.80	4	28978	167370	63292670
Hepatic failure	60.57	16.80	78	28904	35578	63424462
Ergot poisoning	60.39	16.80	13	28969	88	63459952
Arnold-Chiari malformation	59.91	16.80	19	28963	646	63459394
Renal tubular disorder	57.76	16.80	27	28955	2655	63457385
Hydrops foetalis	57.38	16.80	18	28964	590	63459450
Immune reconstitution inflammatory syndrome associated tuberculosis	56.99	16.80	16	28966	354	63459686
Placental insufficiency	55.88	16.80	22	28960	1419	63458621
Drug interaction	54.53	16.80	228	28754	228903	63231137
Foetal distress syndrome	53.91	16.80	21	28961	1317	63458723
Low birth weight baby	53.80	16.80	36	28946	7093	63452947
Meningitis cryptococcal	53.32	16.80	21	28961	1356	63458684
Hypertriglyceridaemia	53.08	16.80	34	28948	6225	63453815
Pain in extremity	51.94	16.80	45	28937	331441	63128599
Umbilical cord abnormality	51.79	16.80	17	28965	646	63459394
Constipation	51.75	16.80	19	28963	224924	63235116
Completed suicide	51.32	16.80	4	28978	145669	63314371
Dyspnoea	50.98	16.80	145	28837	661168	62798872
Malaria	50.33	16.80	13	28969	207	63459833
Ultrasound antenatal screen abnormal	50.31	16.80	12	28970	135	63459905
Chronic disease	49.00	16.80	12	28970	152	63459888
Pericarditis	48.13	16.80	3	28979	131576	63328464
Tuberculosis	47.39	16.80	40	28942	11171	63448869
Cushing's syndrome	47.23	16.80	16	28966	671	63459369
Therapeutic product effect decreased	46.71	16.80	15	28967	193172	63266868
Headache	46.51	16.80	142	28840	633099	62826941
Anaemia macrocytic	45.68	16.80	25	28957	3429	63456611
Meningomyelocele	44.89	16.80	15	28967	603	63459437
Hepatitis	44.01	16.80	71	28911	39717	63420323
Drug hypersensitivity	43.07	16.80	47	28935	310640	63149400
Mitochondrial DNA deletion	42.52	16.80	7	28975	6	63460034
Ultrasound scan abnormal	42.38	16.80	12	28970	274	63459766
Rhinitis allergic	41.85	16.80	38	28944	11689	63448351
Ocular icterus	41.66	16.80	24	28958	3632	63456408
Contusion	41.29	16.80	9	28973	150035	63310005
Necrotising colitis	41.29	16.80	14	28968	589	63459451
Product use issue	40.94	16.80	25	28957	220495	63239545
Hepatic enzyme increased	40.31	16.80	191	28791	202137	63257903
Cystostomy	39.95	16.80	9	28973	77	63459963
Macrocephaly	39.35	16.80	9	28973	83	63459957
Blood bilirubin unconjugated increased	38.95	16.80	12	28970	370	63459670
Patent ductus arteriosus	38.32	16.80	24	28958	4226	63455814
Neonatal disorder	37.82	16.80	13	28969	570	63459470
HIV infection	37.75	16.80	12	28970	411	63459629
Cleft palate	37.67	16.80	15	28967	997	63459043
Metabolic acidosis	37.56	16.80	71	28911	44998	63415042
Rickets	36.93	16.80	8	28974	56	63459984
Foetal growth abnormality	36.81	16.80	8	28974	57	63459983
Bronchiectasis	36.76	16.80	41	28941	16101	63443939
Weight increased	36.64	16.80	39	28943	260753	63199287
Spina bifida	36.45	16.80	14	28968	845	63459195
Renal tubular acidosis	36.33	16.80	17	28965	1675	63458365
Hydrocephalus	35.81	16.80	25	28957	5275	63454765
Tuberculoma of central nervous system	35.81	16.80	11	28971	336	63459704
Impaired healing	35.60	16.80	3	28979	102539	63357501
Gestational diabetes	35.57	16.80	30	28952	8366	63451674
Pregnancy on contraceptive	35.30	16.80	15	28967	1177	63458863
Vomiting	35.18	16.80	400	28582	559217	62900823
Hypouricaemia	34.68	16.80	9	28973	146	63459894
CD4 lymphocytes increased	34.51	16.80	9	28973	149	63459891
Isosporiasis	33.84	16.80	7	28975	38	63460002
Hydromyelia	33.57	16.80	6	28976	12	63460028
Gene mutation	33.52	16.80	16	28966	1649	63458391
Back pain	33.35	16.80	43	28939	264102	63195938
Blister	33.34	16.80	9	28973	129805	63330235
Influenza	33.19	16.80	5	28977	108717	63351323
AIDS cholangiopathy	32.65	16.80	6	28976	15	63460025
Pruritus	32.62	16.80	73	28909	361380	63098660
Placental infarction	32.57	16.80	10	28972	305	63459735
Infection	32.49	16.80	34	28948	229139	63230901
Neural tube defect	32.32	16.80	9	28973	193	63459847
Atrial fibrillation	32.08	16.80	7	28975	116629	63343411
Hepatitis A	32.01	16.80	11	28971	482	63459558
Cardiac malposition	31.60	16.80	7	28975	55	63459985
Drug reaction with eosinophilia and systemic symptoms	31.60	16.80	56	28926	33780	63426260
Hypophosphataemic osteomalacia	31.56	16.80	9	28973	211	63459829
Benign hydatidiform mole	31.54	16.80	8	28974	118	63459922
Ultrasound antenatal screen	31.32	16.80	9	28973	217	63459823
Postpartum haemorrhage	30.88	16.80	16	28966	1965	63458075
HIV-associated neurocognitive disorder	30.82	16.80	8	28974	130	63459910
Feeling abnormal	30.17	16.80	15	28967	148377	63311663
Trisomy 18	29.90	16.80	8	28974	147	63459893
Neutropenia neonatal	29.49	16.80	7	28975	77	63459963
Multiple-drug resistance	29.48	16.80	22	28960	5148	63454892
Congenital intestinal malformation	29.42	16.80	6	28976	30	63460010
Hepatosplenomegaly	29.36	16.80	17	28965	2597	63457443
Diarrhoea	29.28	16.80	199	28783	715167	62744873
Neutropenia	29.06	16.80	157	28825	174848	63285192
Lower respiratory tract infection	29.05	16.80	12	28970	132295	63327745
Twin pregnancy	29.00	16.80	13	28969	1160	63458880
Asthma	28.94	16.80	11	28971	127550	63332490
Fallot's tetralogy	28.93	16.80	7	28975	84	63459956
Ascites	28.92	16.80	60	28922	40668	63419372
Gamma-glutamyltransferase increased	28.84	16.80	54	28928	33977	63426063
Migraine	28.83	16.80	6	28976	103340	63356700
COVID-19	28.75	16.80	8	28974	113095	63346945
Isoimmune haemolytic disease	28.36	16.80	6	28976	37	63460003
Lymphadenitis	28.29	16.80	18	28964	3257	63456783
Bilirubin conjugated increased	28.09	16.80	17	28965	2817	63457223
Gestational hypertension	27.90	16.80	16	28966	2401	63457639
Blood pressure increased	27.87	16.80	20	28962	162042	63297998
Double outlet right ventricle	27.82	16.80	6	28976	41	63459999
Musculoskeletal stiffness	27.76	16.80	26	28956	184592	63275448
Prenatal screening test abnormal	27.35	16.80	5	28977	12	63460028
Necrotising enterocolitis neonatal	27.31	16.80	8	28974	207	63459833
Muscle spasms	27.21	16.80	19	28963	156131	63303909
Infertility	27.08	16.80	11	28971	770	63459270
Malignant neoplasm progression	26.93	16.80	3	28979	82118	63377922
Lymph node tuberculosis	26.84	16.80	11	28971	788	63459252
Anembryonic gestation	26.84	16.80	10	28972	555	63459485
Bicuspid pulmonary valve	26.77	16.80	4	28978	0	63460040
Loss of personal independence in daily activities	26.43	16.80	6	28976	97284	63362756
Dizziness	26.36	16.80	104	28878	429821	63030219
Funisitis	26.29	16.80	5	28977	16	63460024
Hepatitis B surface antigen positive	26.07	16.80	6	28976	57	63459983
Gastroschisis	25.77	16.80	9	28973	414	63459626
Ballismus	25.70	16.80	7	28975	138	63459902
Transaminases increased	25.62	16.80	49	28933	31318	63428722
Cholestasis of pregnancy	25.36	16.80	12	28970	1213	63458827
Blood cholesterol increased	25.14	16.80	6	28976	94026	63366014
Retinal toxicity	24.90	16.80	12	28970	1263	63458777
Micrognathia	24.89	16.80	8	28974	284	63459756
Anxiety	24.87	16.80	38	28944	217503	63242537
Renal failure	24.82	16.80	113	28869	117539	63342501
Neonatal aspiration	24.80	16.80	7	28975	158	63459882
Cerebral toxoplasmosis	24.70	16.80	11	28971	967	63459073
Kaposi's sarcoma	24.68	16.80	7	28975	161	63459879
Ovarian failure	24.59	16.80	12	28970	1298	63458742
Acquired aminoaciduria	24.53	16.80	4	28978	3	63460037
Eyelid oedema	24.52	16.80	27	28955	10452	63449588
Hyperphosphaturia	24.35	16.80	5	28977	26	63460014
Congenital hydrocephalus	24.31	16.80	7	28975	170	63459870
Abortion missed	24.28	16.80	13	28969	1706	63458334
Hepatic displacement	24.19	16.80	5	28977	27	63460013
Cholestatic liver injury	24.19	16.80	15	28967	2595	63457445
Fibromyalgia	23.86	16.80	4	28978	80416	63379624
Cytomegalovirus chorioretinitis	23.77	16.80	13	28969	1780	63458260
Osteoarthritis	23.75	16.80	7	28975	95336	63364704
Alpha 1 foetoprotein increased	23.68	16.80	7	28975	187	63459853
Hepatitis B DNA assay positive	23.61	16.80	5	28977	31	63460009
Anaemia neonatal	23.54	16.80	8	28974	339	63459701
Malaise	23.40	16.80	104	28878	415850	63044190
Foetal anaemia	23.20	16.80	6	28976	96	63459944
Neonatal respiratory distress syndrome	23.13	16.80	15	28967	2803	63457237
Genetic polymorphism	23.11	16.80	4	28978	6	63460034
Haemorrhage in pregnancy	22.91	16.80	13	28969	1912	63458128
Diastasis recti abdominis	22.84	16.80	5	28977	37	63460003
Fat redistribution	22.73	16.80	4	28978	7	63460033
AIDS related complication	22.73	16.80	4	28978	7	63460033
Congenital teratoma	22.73	16.80	4	28978	7	63460033
Blood creatine phosphokinase MB increased	22.41	16.80	11	28971	1205	63458835
Type III hyperlipidaemia	22.38	16.80	4	28978	8	63460032
Psoriasis	22.38	16.80	6	28976	86951	63373089
Lipase increased	22.29	16.80	25	28957	9875	63450165
Lipohypertrophy	21.81	16.80	9	28973	656	63459384
Respiratory distress	21.78	16.80	48	28934	33903	63426137
Aminoaciduria	21.76	16.80	6	28976	124	63459916
Varices oesophageal	21.62	16.80	15	28967	3133	63456907
Death neonatal	21.57	16.80	10	28972	965	63459075
Fontanelle bulging	21.49	16.80	4	28978	11	63460029
Insomnia	21.48	16.80	41	28941	215211	63244829
Bovine tuberculosis	21.32	16.80	5	28977	52	63459988
Cachexia	21.31	16.80	19	28963	5707	63454333
Osteoporosis	21.24	16.80	66	28916	57272	63402768
Antiviral drug level below therapeutic	21.15	16.80	5	28977	54	63459986
Placenta praevia	21.10	16.80	10	28972	1014	63459026
Pubertal failure	20.99	16.80	4	28978	13	63460027
HELLP syndrome	20.92	16.80	10	28972	1034	63459006
Dyschezia	20.80	16.80	13	28969	2281	63457759
Ventricular hypoplasia	20.75	16.80	6	28976	148	63459892
Breast neoplasm	20.71	16.80	11	28971	1421	63458619
Blood creatine phosphokinase increased	20.64	16.80	44	28938	30386	63429654
Influenza like illness	20.56	16.80	3	28979	66821	63393219
Memory impairment	20.50	16.80	11	28971	104247	63355793
Inappropriate schedule of product administration	20.40	16.80	11	28971	103954	63356086
Pharyngotonsillitis	20.38	16.80	6	28976	158	63459882
CSF protein increased	20.36	16.80	8	28974	513	63459527
Developmental delay	20.35	16.80	11	28971	1472	63458568
Carnitine deficiency	20.24	16.80	6	28976	162	63459878
Myopathy toxic	20.23	16.80	8	28974	522	63459518
Nasal congestion	20.08	16.80	3	28979	65657	63394383
Vertical infection transmission	20.08	16.80	3	28979	0	63460040
Hypotension	20.02	16.80	61	28921	272543	63187497
Social avoidant behaviour	19.97	16.80	14	28968	2974	63457066
Ebstein's anomaly	19.96	16.80	4	28978	18	63460022
Renal glycosuria	19.96	16.80	4	28978	18	63460022
Defaecation urgency	19.95	16.80	16	28966	4159	63455881
Breech delivery	19.89	16.80	5	28977	71	63459969
Pleocytosis	19.74	16.80	9	28973	836	63459204
Death	19.63	16.80	96	28886	374285	63085755
Therapeutic product effect incomplete	19.52	16.80	17	28965	125039	63335001
Exposure via breast milk	19.52	16.80	12	28970	2045	63457995
Oxygen saturation decreased	19.49	16.80	8	28974	88577	63371463
Meningitis tuberculous	19.36	16.80	8	28974	585	63459455
Thyroid tuberculosis	19.29	16.80	4	28978	22	63460018
Spinal cord injury	19.26	16.80	9	28973	884	63459156
Musculoskeletal pain	19.25	16.80	9	28973	92268	63367772
Portal vein thrombosis	19.17	16.80	13	28969	2617	63457423
Diaphragmatic aplasia	19.14	16.80	4	28978	23	63460017
Acquired immunodeficiency syndrome	19.11	16.80	5	28977	84	63459956
Eclampsia	19.02	16.80	7	28975	375	63459665
Hemiataxia	19.00	16.80	4	28978	24	63460016
Aqueductal stenosis	19.00	16.80	4	28978	24	63460016
Lung neoplasm malignant	18.99	16.80	33	28949	19600	63440440
Amenorrhoea	18.92	16.80	23	28959	9891	63450149
Lactate pyruvate ratio increased	18.73	16.80	5	28977	91	63459949
Placental necrosis	18.72	16.80	4	28978	26	63460014
Pulmonary artery atresia	18.72	16.80	4	28978	26	63460014
Hepatitis C	18.64	16.80	17	28965	5257	63454783
Sleep disorder	18.55	16.80	7	28975	81559	63378481
Oropharyngeal pain	18.53	16.80	10	28972	94477	63365563
Disseminated Bacillus Calmette-Guerin infection	18.47	16.80	4	28978	28	63460012
Blood alkaline phosphatase increased	18.33	16.80	52	28930	42915	63417125
Acute stress disorder	18.33	16.80	6	28976	226	63459814
Myelopathy	18.33	16.80	13	28969	2813	63457227
Bronchitis	18.30	16.80	18	28964	124917	63335123
Secondary hypogonadism	18.29	16.80	5	28977	100	63459940
Pallor	18.25	16.80	42	28940	30526	63429514
Urinary tract infection	18.20	16.80	61	28921	264623	63195417
Anaphylactic reaction	18.10	16.80	4	28978	66096	63393944
Delayed puberty	18.01	16.80	5	28977	106	63459934
Cervix operation	18.00	16.80	3	28979	3	63460037
Visual impairment	17.99	16.80	8	28974	84438	63375602
Adverse drug reaction	17.87	16.80	7	28975	79707	63380333
Rhodococcus infection	17.50	16.80	5	28977	118	63459922
Intentional overdose	17.48	16.80	6	28976	74146	63385894
Cleft lip	17.46	16.80	5	28977	119	63459921
Neck pain	17.43	16.80	5	28977	69313	63390727
Persistent left superior vena cava	17.38	16.80	4	28978	38	63460002
Developmental coordination disorder	17.38	16.80	4	28978	38	63460002
Acute lymphocytic leukaemia	17.31	16.80	12	28970	2504	63457536
Mycobacterium avium complex infection	17.29	16.80	13	28969	3075	63456965
Genital prolapse	17.20	16.80	4	28978	40	63460000
Cryptococcosis	17.05	16.80	9	28973	1148	63458892
Acute fatty liver of pregnancy	16.93	16.80	4	28978	43	63459997
Cervical dysplasia	16.83	16.80	13	28969	3201	63456839

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
Viral mutation identified	1896.03	12.37	497	47825	2457	34906152
Virologic failure	1640.19	12.37	459	47863	3021	34905588
Immune reconstitution inflammatory syndrome	1590.79	12.37	557	47765	8202	34900407
Pathogen resistance	1409.72	12.37	520	47802	8962	34899647
Drug resistance	968.69	12.37	542	47780	25385	34883224
Lipodystrophy acquired	841.73	12.37	272	48050	3072	34905537
Depression	772.34	12.37	803	47519	96295	34812314
Foetal exposure during pregnancy	753.38	12.37	532	47790	37569	34871040
Drug interaction	752.24	12.37	1212	47110	224734	34683875
Hepatitis B	624.76	12.37	254	48068	5729	34902880
Exposure during pregnancy	585.22	12.37	273	48049	8661	34899948
Mitochondrial toxicity	502.46	12.37	175	48147	2524	34906085
Hepatitis B reactivation	415.83	12.37	168	48154	3723	34904886
Osteomalacia	369.00	12.37	107	48215	810	34907799
Hepatitis B DNA increased	361.97	12.37	95	48227	470	34908139
Acquired gene mutation	327.83	12.37	107	48215	1248	34907361
Eyelid ptosis	319.14	12.37	157	48165	5609	34903000
Fanconi syndrome acquired	287.53	12.37	107	48215	1884	34906725
Viral load increased	266.19	12.37	108	48214	2419	34906190
Blood HIV RNA increased	249.28	12.37	85	48237	1145	34907464
Progressive external ophthalmoplegia	240.23	12.37	86	48236	1349	34907260
Lipoatrophy	216.18	12.37	62	48260	449	34908160
Pinealoblastoma	213	12.37	50	48272	139	34908470
Hypertriglyceridaemia	197.52	12.37	131	48191	8317	34900292
Psychiatric decompensation	193.02	12.37	90	48232	2847	34905762
Premature baby	189.84	12.37	181	48141	19452	34889157
Hepatic failure	182.90	12.37	232	48090	34299	34874310
Diplopia	173.81	12.37	161	48161	16682	34891927
Fanconi syndrome	172.58	12.37	71	48251	1649	34906960
Hypophosphataemia	166.18	12.37	131	48191	10895	34897714
Multiple-drug resistance	164.62	12.37	98	48224	5141	34903468
Genotype drug resistance test	157.74	12.37	33	48289	41	34908568
CD4 lymphocytes decreased	155.00	12.37	66	48256	1675	34906934
Renal tubular disorder	154.15	12.37	90	48232	4553	34904056
Kaposi's sarcoma	151.89	12.37	54	48268	829	34907780
Polydactyly	149.24	12.37	58	48264	1155	34907454
Loss of personal independence in daily activities	146.58	12.37	204	48118	32975	34875634
Off label use	146.09	12.37	222	48100	419302	34489307
Depressive symptom	143.89	12.37	73	48249	2786	34905823
Hepatic fibrosis	141.69	12.37	85	48237	4522	34904087
Trisomy 21	136.54	12.37	45	48277	542	34908067
Depression suicidal	135.00	12.37	67	48255	2438	34906171
Tearfulness	133.94	12.37	68	48254	2599	34906010
Gene mutation	130.75	12.37	55	48267	1353	34907256
Alanine aminotransferase increased	129.99	12.37	321	48001	80494	34828115
Osteoporosis	122.84	12.37	117	48205	12551	34896058
Portal hypertension	119.91	12.37	73	48249	3989	34904620
Treatment noncompliance	118.51	12.37	169	48153	27931	34880678
Psychomotor skills impaired	117.37	12.37	71	48251	3835	34904774
Meningitis cryptococcal	116.96	12.37	60	48262	2344	34906265
Retinal toxicity	111.53	12.37	36	48286	404	34908205
Maternal drugs affecting foetus	111.29	12.37	69	48253	3896	34904713
Treatment failure	110.89	12.37	217	48105	46480	34862129
HIV-associated neurocognitive disorder	107.40	12.37	33	48289	311	34908298
Product dose omission issue	105.58	12.37	19	48303	119692	34788917
Cytomegalovirus chorioretinitis	99.58	12.37	62	48260	3527	34905082
Volvulus	94.97	12.37	46	48276	1586	34907023
Mycobacterium avium complex infection	94.97	12.37	53	48269	2458	34906151
Jaundice	94.41	12.37	163	48159	31719	34876890
Fall	94.38	12.37	85	48237	202800	34705809
Hyperlactacidaemia	93.67	12.37	56	48266	2960	34905649
Blood phosphorus decreased	93.47	12.37	57	48265	3124	34905485
Blood lactic acid increased	93.00	12.37	76	48246	6652	34901957
Completed suicide	92.37	12.37	13	48309	98155	34810454
Osteonecrosis	91.69	12.37	108	48214	14782	34893827
Aspartate aminotransferase increased	91.27	12.37	252	48070	67531	34841078
Hepatic cirrhosis	91.11	12.37	116	48206	17198	34891411
Nephropathy toxic	90.59	12.37	99	48223	12489	34896120
Hepatitis C	90.04	12.37	88	48234	9742	34898867
Pneumonia	89.75	12.37	234	48088	362393	34546216
Drug abuse	88.96	12.37	15	48307	99081	34809528
Peripheral swelling	85.65	12.37	5	48317	76536	34832073
Caesarean section	85.47	12.37	47	48275	2117	34906492
Dyspnoea	85.18	12.37	254	48068	376528	34532081
Mitochondrial cytopathy	84.38	12.37	24	48298	168	34908441
Renal tubular dysfunction	84.21	12.37	29	48293	403	34908206
Hyperlipidaemia	83.91	12.37	102	48220	14427	34894182
CSF HIV escape syndrome	83.29	12.37	24	48298	177	34908432
Acquired immunodeficiency syndrome	82.78	12.37	30	48292	488	34908121
Death	81.84	12.37	280	48042	397769	34510840
Hypouricaemia	81.23	12.37	25	48297	237	34908372
Fatigue	75.98	12.37	261	48061	370392	34538217
Neonatal disorder	75.66	12.37	32	48290	798	34907811
Hypotension	74.27	12.37	120	48202	221529	34687080
Varices oesophageal	73.04	12.37	52	48270	3703	34904906
Ophthalmoplegia	72.77	12.37	40	48282	1800	34906809
Dandy-Walker syndrome	72.60	12.37	22	48300	197	34908412
Dyslipidaemia	72.28	12.37	69	48253	7419	34901190
Progressive multifocal leukoencephalopathy	70.62	12.37	77	48245	9687	34898922
Pulmonary tuberculosis	70.58	12.37	56	48266	4698	34903911
HIV infection	69.75	12.37	35	48287	1304	34907305
Pain	69.32	12.37	110	48212	204565	34704044
Hepatitis	67.88	12.37	120	48202	23784	34884825
Drug-induced liver injury	67.22	12.37	133	48189	28699	34879910
Proteinuria	66.93	12.37	104	48218	18538	34890071
Anaemia macrocytic	66.10	12.37	45	48277	2981	34905628
Lymphadenopathy	66.00	12.37	131	48191	28332	34880277
Constipation	65.32	12.37	56	48266	136926	34771683
Hepatomegaly	64.99	12.37	76	48246	10320	34898289
Blood alkaline phosphatase increased	64.64	12.37	137	48185	31038	34877571
Tuberculosis	64.42	12.37	69	48253	8508	34900101
Blood pressure increased	63.98	12.37	21	48301	88081	34820528
Glycosuria	63.46	12.37	32	48290	1205	34907404
Hyperbilirubinaemia	63.34	12.37	96	48226	16747	34891862
Lactic acidosis	63.27	12.37	145	48177	34627	34873982
Hepatic function abnormal	62.75	12.37	168	48154	44195	34864414
Malignant neoplasm progression	62.18	12.37	22	48300	88024	34820585
Renal impairment	62.04	12.37	277	48045	94236	34814373
Congenital umbilical hernia	61.57	12.37	21	48301	283	34908326
Birth mark	60.33	12.37	18	48304	152	34908457
Congenital anomaly	59.87	12.37	32	48290	1361	34907248
Oesophageal candidiasis	59.38	12.37	49	48273	4347	34904262
Inappropriate schedule of product administration	59.17	12.37	8	48314	62288	34846321
Urine phosphorus increased	59.10	12.37	14	48308	41	34908568
Paranoia	59.03	12.37	78	48244	11990	34896619
Brain stem stroke	56.31	12.37	20	48302	306	34908303
Blood bilirubin increased	56.16	12.37	147	48175	38149	34870460
Hepatocellular carcinoma	55.67	12.37	60	48262	7449	34901160
Atrioventricular septal defect	54.67	12.37	18	48304	216	34908393
Atrial fibrillation	53.66	12.37	54	48268	122339	34786270
Ultrasound antenatal screen	52.57	12.37	22	48300	534	34908075
Psychotic disorder	52.48	12.37	109	48213	24343	34884266
Hydrops foetalis	52.15	12.37	25	48297	842	34907767
Lipohypertrophy	51.63	12.37	18	48304	260	34908349
Hepatosplenomegaly	51.22	12.37	44	48278	4125	34904484
Pregnancy	51.13	12.37	18	48304	268	34908341
Blood triglycerides increased	50.84	12.37	79	48243	14080	34894529
Talipes	50.29	12.37	32	48290	1891	34906718
Human immunodeficiency virus transmission	49.06	12.37	11	48311	23	34908586
Calculus urinary	48.63	12.37	28	48294	1379	34907230
Genotype drug resistance test positive	48.36	12.37	26	48296	1119	34907490
Infusion related reaction	47.66	12.37	8	48314	53049	34855560
CD4 lymphocytes increased	47.29	12.37	16	48306	210	34908399
Congenital central nervous system anomaly	46.97	12.37	21	48301	601	34908008
Gamma-glutamyltransferase increased	46.80	12.37	116	48206	29115	34879494
Nodular regenerative hyperplasia	46.51	12.37	24	48298	949	34907660
Hepatic cancer	46.01	12.37	57	48265	8218	34900391
Pyelocaliectasis	45.89	12.37	25	48297	1105	34907504
Trisomy 18	45.67	12.37	22	48300	749	34907860
Nasopharyngitis	45.26	12.37	20	48302	69948	34838661
Multiple fractures	45.19	12.37	27	48295	1425	34907184
Hepatitis B virus test	44.68	12.37	8	48314	0	34908609
Facial wasting	44.55	12.37	14	48308	143	34908466
Cachexia	44.03	12.37	52	48270	7134	34901475
Joint swelling	43.96	12.37	14	48308	59876	34848733
Pneumocystis jirovecii pneumonia	43.64	12.37	89	48233	19621	34888988
Cryptococcosis	43.63	12.37	32	48290	2387	34906222
Hepatic encephalopathy	43.35	12.37	75	48247	14610	34893999
Optic nerve neoplasm	43.08	12.37	10	48312	26	34908583
Oesophageal varices haemorrhage	42.35	12.37	35	48287	3111	34905498
Cleft lip and palate	42.17	12.37	22	48300	890	34907719
Congenital neoplasm	42.03	12.37	10	48312	30	34908579
Anaemia neonatal	42.00	12.37	16	48306	301	34908308
Opportunistic infection	41.89	12.37	27	48295	1631	34906978
Splenomegaly	41.77	12.37	75	48247	15042	34893567
Basedow's disease	41.64	12.37	11	48311	56	34908553
Cryptorchism	41.40	12.37	29	48293	2012	34906597
Cerebral toxoplasmosis	40.97	12.37	27	48295	1694	34906915
Blood bilirubin unconjugated increased	40.74	12.37	19	48303	601	34908008
Oral candidiasis	39.94	12.37	65	48257	12045	34896564
Psychomotor retardation	39.80	12.37	36	48286	3614	34904995
Immune reconstitution inflammatory syndrome associated tuberculosis	39.57	12.37	17	48305	441	34908168
Confusional state	39.48	12.37	88	48234	144072	34764537
Small for dates baby	39.45	12.37	37	48285	3890	34904719
Optic atrophy	39.29	12.37	21	48301	893	34907716
Urine calcium increased	39.05	12.37	10	48312	44	34908565
Bone density decreased	38.18	12.37	27	48295	1902	34906707
Osteopenia	38.17	12.37	40	48282	4809	34903800
Macrocephaly	37.88	12.37	17	48305	491	34908118
COVID-19	37.80	12.37	31	48291	77519	34831090
Wheezing	37.73	12.37	6	48316	41396	34867213
Life expectancy shortened	37.37	12.37	10	48312	54	34908555
Mycobacterium avium complex immune restoration disease	37.11	12.37	9	48313	30	34908579
Mitochondrial myopathy	37.02	12.37	13	48309	192	34908417
Acute hepatitis C	36.96	12.37	11	48311	92	34908517
Disease progression	36.61	12.37	58	48264	108019	34800590
Cardiac failure congestive	36.18	12.37	37	48285	83233	34825376
Nephrolithiasis	36.16	12.37	108	48214	30225	34878384
Rhabdomyosarcoma	35.45	12.37	9	48313	38	34908571
Cardio-respiratory arrest	35.43	12.37	16	48306	55257	34853352
Mycobacterial infection	35.32	12.37	28	48294	2346	34906263
Hepatotoxicity	35.17	12.37	86	48236	21399	34887210
Toxicity to various agents	35.15	12.37	150	48172	200212	34708397
Intentional product misuse	34.67	12.37	10	48312	45601	34863008
Blood phosphorus abnormal	34.11	12.37	11	48311	123	34908486
Hydrocele	34.05	12.37	26	48296	2061	34906548
Dizziness	33.95	12.37	171	48151	218350	34690259
Neurodevelopmental disorder	33.79	12.37	15	48307	422	34908187
Renal tubular acidosis	33.75	12.37	27	48295	2292	34906317
Somnolence	33.65	12.37	64	48258	111052	34797557
Prostate cancer	33.43	12.37	7	48315	39642	34868967
Death neonatal	33.14	12.37	14	48308	348	34908261
Osteoporotic fracture	33.14	12.37	20	48302	1075	34907534
White matter lesion	33.03	12.37	18	48304	796	34907813
Congenital hydronephrosis	31.96	12.37	17	48305	716	34907893
Therapeutic product effect decreased	31.73	12.37	5	48317	34738	34873871
Thrombosis	31.73	12.37	15	48307	50443	34858166
Liver disorder	31.61	12.37	109	48213	32888	34875721
Oesophageal atresia	31.49	12.37	15	48307	498	34908111
Blood pyruvic acid increased	31.43	12.37	7	48315	14	34908595
Cushing's syndrome	31.37	12.37	14	48308	399	34908210
Flushing	31.17	12.37	4	48318	32416	34876193
Feeling abnormal	31.16	12.37	25	48297	63210	34845399
Stress	31.05	12.37	3	48319	30344	34878265
Stevens-Johnson syndrome	30.93	12.37	75	48247	18564	34890045
HIV associated nephropathy	30.89	12.37	13	48309	320	34908289
Viraemia	30.88	12.37	20	48302	1218	34907391
Speech disorder developmental	30.71	12.37	25	48297	2175	34906434
Transaminases increased	30.56	12.37	94	48228	26729	34881880
Febrile neutropenia	30.23	12.37	93	48229	136756	34771853
HIV lipodystrophy	30.21	12.37	7	48315	18	34908591
Chronic obstructive pulmonary disease	30.06	12.37	15	48307	48903	34859706
Drug ineffective	30.02	12.37	448	47874	456303	34452306
Epistaxis	30.01	12.37	22	48300	58229	34850380
Astrocytoma, low grade	29.77	12.37	8	48314	44	34908565
Muscle spasms	29.64	12.37	36	48286	74965	34833644
HIV viraemia	29.47	12.37	8	48314	46	34908563
Ascites	29.40	12.37	135	48187	46436	34862173
Meningomyelocele	29.38	12.37	11	48311	197	34908412
Anaemia	29.34	12.37	469	47853	232866	34675743
Cerebrovascular accident	29.20	12.37	45	48277	84766	34823843
Aminoaciduria	29.19	12.37	12	48310	278	34908331
Lactate pyruvate ratio increased	28.88	12.37	6	48316	7	34908602
Injection site pain	28.83	12.37	9	48313	38996	34869613
Product use issue	28.71	12.37	27	48295	63189	34845420
Abortion spontaneous	28.60	12.37	13	48309	387	34908222
Cardiac arrest	28.58	12.37	56	48266	96103	34812506
Tremor	28.26	12.37	44	48278	82543	34826066
HIV test positive	28.22	12.37	10	48312	152	34908457
Hepatic cytolysis	28.09	12.37	62	48260	14434	34894175
Hepatitis cholestatic	28.05	12.37	44	48278	7903	34900706
Mitochondrial DNA depletion	27.93	12.37	5	48317	0	34908609
Contusion	27.58	12.37	8	48314	36356	34872253
Bone metabolism disorder	27.50	12.37	11	48311	237	34908372
Hypersplenism	27.20	12.37	13	48309	435	34908174
Retroviral rebound syndrome	26.94	12.37	6	48316	12	34908597
Cardiac disorder	26.84	12.37	13	48309	43113	34865496
Lymph node tuberculosis	26.73	12.37	13	48309	452	34908157
Low set ears	26.63	12.37	13	48309	456	34908153
Syncope	26.54	12.37	54	48268	91397	34817212
Pruritus	26.31	12.37	104	48218	141877	34766732
Neurosyphilis	26.28	12.37	7	48315	37	34908572
Viral load decreased	26.28	12.37	7	48315	37	34908572
Hypospadias	26.26	12.37	27	48295	3174	34905435
Haematochezia	26.09	12.37	16	48306	46518	34862091
Hypophosphataemic osteomalacia	25.94	12.37	9	48313	128	34908481
Bone pain	25.94	12.37	75	48247	20611	34887998
Hepatitis A	25.89	12.37	13	48309	485	34908124
Incorrect dose administered	25.54	12.37	12	48310	40503	34868106
Cardiac failure	25.54	12.37	55	48267	91193	34817416
Prenatal screening test abnormal	25.47	12.37	6	48316	17	34908592
Beta 2 microglobulin urine increased	25.35	12.37	8	48314	83	34908526
HIV wasting syndrome	25.09	12.37	8	48314	86	34908523
Urinary tract infection	24.95	12.37	49	48273	84032	34824577
Granulomatous rosacea	24.80	12.37	9	48313	147	34908462
Fat tissue increased	24.79	12.37	12	48310	413	34908196
Cellulitis	24.78	12.37	22	48300	52929	34855680
Pre-eclampsia	24.49	12.37	7	48315	50	34908559
Plasma cell myeloma	24.20	12.37	14	48308	42023	34866586
Chest discomfort	23.94	12.37	24	48298	54506	34854103
Limb deformity	23.77	12.37	13	48309	579	34908030
Neonatal asphyxia	23.70	12.37	11	48311	344	34908265
Anogenital warts	23.67	12.37	13	48309	584	34908025
Angioedema	23.67	12.37	11	48311	37363	34871246
Visual field defect	23.52	12.37	30	48292	4453	34904156
Blood triglycerides abnormal	23.51	12.37	10	48312	253	34908356
Spider naevus	23.51	12.37	6	48316	26	34908583
Tuberculoid leprosy	23.47	12.37	7	48315	59	34908550
Hyperhidrosis	23.43	12.37	43	48279	75649	34832960
Congenital cytomegalovirus infection	23.32	12.37	6	48316	27	34908582
Tubulointerstitial nephritis	23.32	12.37	73	48249	20951	34887658
Suicidal ideation	23.25	12.37	114	48208	40274	34868335
Secondary syphilis	23.07	12.37	7	48315	63	34908546
Amoebiasis	22.97	12.37	7	48315	64	34908545
Genital herpes	22.92	12.37	13	48309	622	34907987
Toxoplasmosis	22.81	12.37	17	48305	1299	34907310
Influenza	22.80	12.37	21	48301	49645	34858964
Strongyloidiasis	22.48	12.37	23	48299	2688	34905921
Trimethylaminuria	22.45	12.37	5	48317	10	34908599
Blood glucose increased	22.39	12.37	36	48286	66682	34841927
Hypercholesterolaemia	22.35	12.37	42	48280	8720	34899889
Withdrawal hepatitis	22.34	12.37	4	48318	0	34908609
Foetal growth restriction	22.31	12.37	28	48294	4089	34904520
Weight increased	22.15	12.37	61	48261	92972	34815637
Meningitis tuberculous	22.00	12.37	13	48309	672	34907937
Blood creatinine increased	21.92	12.37	214	48108	94762	34813847
Hepatitis B surface antigen positive	21.91	12.37	8	48314	133	34908476
Vanishing bile duct syndrome	21.91	12.37	15	48307	1003	34907606
Antimitochondrial antibody positive	21.75	12.37	6	48316	37	34908572
Oropharyngeal pain	21.62	12.37	11	48311	35474	34873135
Intracranial pressure increased	21.59	12.37	27	48295	3928	34904681
Unevaluable event	21.57	12.37	9	48313	32581	34876028
Chest pain	21.53	12.37	96	48226	126666	34781943
Bradycardia	21.48	12.37	45	48277	75373	34833236
Pulmonary embolism	21.25	12.37	59	48263	89687	34818922
Atypical mycobacterial infection	21.23	12.37	14	48308	879	34907730
Prescribed overdose	21.15	12.37	46	48276	10601	34898008
Pancreatitis	21.13	12.37	108	48214	38783	34869826
Oxygen saturation decreased	21.09	12.37	26	48296	53792	34854817
Anal cancer	20.93	12.37	11	48311	452	34908157
Psoriasis	20.86	12.37	14	48308	38798	34869811
Night blindness	20.82	12.37	9	48313	237	34908372
Urine phosphorus decreased	20.73	12.37	6	48316	45	34908564
Umbilical cord abnormality	20.62	12.37	6	48316	46	34908563
Live birth	20.62	12.37	9	48313	243	34908366
Blood creatine phosphokinase increased	20.61	12.37	119	48203	44738	34863871
Urticaria	20.61	12.37	34	48288	62343	34846266
Cardiac murmur	20.53	12.37	38	48284	7799	34900810
Lower respiratory tract infection	20.52	12.37	9	48313	31628	34876981
Hepatitis D	20.51	12.37	6	48316	47	34908562
Bacterial pyelonephritis	20.41	12.37	9	48313	249	34908360
Abdominal discomfort	20.35	12.37	32	48290	59803	34848806
Primary syphilis	20.32	12.37	5	48317	18	34908591
Histoplasmosis disseminated	20.11	12.37	16	48306	1347	34907262
Pyrexia	20.06	12.37	602	47720	332411	34576198
Normal newborn	20.06	12.37	8	48314	171	34908438
Diaphragmatic hernia	20.02	12.37	9	48313	261	34908348
Cardiogenic shock	19.92	12.37	6	48316	26612	34881997
AIDS related complication	19.91	12.37	5	48317	20	34908589
Macrocytosis	19.87	12.37	14	48308	980	34907629
Taeniasis	19.87	12.37	6	48316	53	34908556
Contraindicated product administered	19.82	12.37	3	48319	21478	34887131
Back pain	19.63	12.37	94	48228	121695	34786914
Perinatal HIV infection	19.58	12.37	4	48318	4	34908605
Maternal condition affecting foetus	19.58	12.37	4	48318	4	34908605
Liver transplant rejection	19.46	12.37	19	48303	2100	34906509
Cataract	19.42	12.37	6	48316	26180	34882429
Interstitial lung disease	19.40	12.37	38	48284	65244	34843365
Neuromyopathy	19.38	12.37	14	48308	1020	34907589
Agitation	19.23	12.37	31	48291	57368	34851241
Infection	19.21	12.37	63	48259	90852	34817757
Drug dependence	18.98	12.37	5	48317	24212	34884397
Developmental hip dysplasia	18.97	12.37	9	48313	296	34908313
Bronchitis	18.96	12.37	18	48304	41945	34866664
Hepatitis C virus test	18.86	12.37	6	48316	64	34908545
Pilonidal cyst congenital	18.84	12.37	5	48317	26	34908583
Borderline leprosy	18.69	12.37	4	48318	6	34908603
Exomphalos	18.60	12.37	8	48314	208	34908401
Heart rate increased	18.57	12.37	22	48300	46321	34862288
Asymptomatic viral hepatitis	18.53	12.37	5	48317	28	34908581
Rectal haemorrhage	18.50	12.37	17	48305	40232	34868377
Nervous system disorder	18.49	12.37	53	48269	14490	34894119
Hepatitis B DNA assay positive	18.45	12.37	6	48316	69	34908540
Malaria	18.36	12.37	8	48314	215	34908394
Cryoglobulinaemia	18.29	12.37	10	48312	445	34908164
Sickle cell disease	18.26	12.37	7	48315	134	34908475
Anaphylactic reaction	18.25	12.37	11	48311	32290	34876319
Blood pressure decreased	18.05	12.37	27	48295	51488	34857121
Gynaecomastia	18.01	12.37	42	48280	10138	34898471
Diverticulitis	18.00	12.37	3	48319	20001	34888608
Loss of anatomical alignment after fracture reduction	17.96	12.37	4	48318	8	34908601
Neonatal pneumothorax	17.96	12.37	4	48318	8	34908601
Subchondral insufficiency fracture	17.96	12.37	4	48318	8	34908601
Crystal urine	17.93	12.37	6	48316	76	34908533
Cerebral ventricle dilatation	17.92	12.37	13	48309	953	34907656
Blood uric acid decreased	17.82	12.37	9	48313	340	34908269
Pneumonia aspiration	17.76	12.37	19	48303	41884	34866725
Chordee	17.72	12.37	6	48316	79	34908530
Meconium ileus	17.70	12.37	5	48317	34	34908575
Transient ischaemic attack	17.68	12.37	8	48314	27605	34881004
Renal atrophy	17.68	12.37	14	48308	1171	34907438
Cryptosporidiosis infection	17.68	12.37	10	48312	476	34908133
Gastrointestinal haemorrhage	17.55	12.37	63	48259	88414	34820195
Bulbar palsy	17.51	12.37	8	48314	241	34908368
Delirium	17.50	12.37	21	48301	43970	34864639
Blood pressure systolic increased	17.50	12.37	5	48317	22947	34885662
Persistent foetal circulation	17.44	12.37	9	48313	356	34908253
C-reactive protein increased	17.40	12.37	30	48292	54068	34854541
International normalised ratio increased	17.37	12.37	24	48298	47303	34861306
Oropharyngeal candidiasis	17.36	12.37	12	48310	815	34907794
Asthma	17.36	12.37	20	48302	42636	34865973
Sepsis	17.36	12.37	147	48175	166414	34742195
Retinoblastoma	17.34	12.37	4	48318	10	34908599
Acquired aminoaciduria	17.34	12.37	4	48318	10	34908599
Sinusitis	17.30	12.37	19	48303	41383	34867226
Dehydration	17.26	12.37	107	48215	129862	34778747
Rhinorrhoea	17.13	12.37	7	48315	25661	34882948
Optic nerve disorder	17.12	12.37	11	48311	661	34907948
Creutzfeldt-Jakob disease	17.11	12.37	5	48317	39	34908570
Fracture malunion	17.07	12.37	4	48318	11	34908598
White blood cell count increased	17.06	12.37	19	48303	41132	34867477
ADAMTS13 activity decreased	17.06	12.37	6	48316	89	34908520
Toxic optic neuropathy	17.06	12.37	12	48310	838	34907771
Haematoma	17.06	12.37	7	48315	25598	34883011
Distributive shock	16.98	12.37	14	48308	1240	34907369
Parotid gland enlargement	16.98	12.37	10	48312	514	34908095
Polyneuropathy chronic	16.89	12.37	5	48317	41	34908568
Hepatic enzyme increased	16.88	12.37	102	48220	38978	34869631
Dyspnoea exertional	16.86	12.37	21	48301	43258	34865351
Rectosigmoid cancer metastatic	16.81	12.37	4	48318	12	34908597
Glucose urine present	16.79	12.37	13	48309	1052	34907557
Meconium stain	16.76	12.37	3	48319	0	34908609
Gonadal dysgenesis	16.76	12.37	3	48319	0	34908609
Clostridium difficile infection	16.64	12.37	3	48319	18895	34889714
Liver transplant	16.63	12.37	19	48303	2515	34906094
Alpha 1 foetoprotein increased	16.61	12.37	11	48311	696	34907913
Drug intolerance	16.58	12.37	36	48286	59534	34849075
Endocardial fibroelastosis	16.57	12.37	4	48318	13	34908596
Non-Hodgkin's lymphoma	16.54	12.37	15	48307	1510	34907099
Lymphocytic infiltration	16.50	12.37	11	48311	704	34907905
Acute on chronic liver failure	16.48	12.37	6	48316	99	34908510
Hyperphosphatasaemia	16.38	12.37	5	48317	46	34908563
Dysmorphism	16.37	12.37	21	48301	3135	34905474
Full blood count abnormal	16.36	12.37	3	48319	18665	34889944
Molluscum contagiosum	16.30	12.37	8	48314	284	34908325
Encephalitis	16.27	12.37	33	48289	7244	34901365
Melaena	16.19	12.37	15	48307	35365	34873244
Hepatitis B e antigen positive	16.10	12.37	5	48317	49	34908560
Protrusion tongue	15.93	12.37	7	48315	192	34908417
Anaemia megaloblastic	15.93	12.37	7	48315	192	34908417
Anal cancer stage 0	15.93	12.37	4	48318	16	34908593
Urinary retention	15.89	12.37	16	48306	36272	34872337
Nephropathy	15.89	12.37	29	48293	5888	34902721
Memory impairment	15.87	12.37	22	48300	43296	34865313
Nasal congestion	15.86	12.37	6	48316	23051	34885558
Neutrophil count decreased	15.84	12.37	29	48293	51075	34857534
Musculoskeletal stiffness	15.84	12.37	25	48297	46655	34861954
Hepatitis viral	15.83	12.37	10	48312	583	34908026
Coccidioidomycosis	15.80	12.37	11	48311	756	34907853
Ear malformation	15.77	12.37	8	48314	305	34908304
Micrognathia	15.75	12.37	8	48314	306	34908303
Product prescribing error	15.71	12.37	6	48316	22921	34885688
Hyponatraemia	15.67	12.37	60	48262	82631	34825978
Cytokine release syndrome	15.66	12.37	6	48316	22871	34885738
Full blood count decreased	15.65	12.37	3	48319	18085	34890524
Femoral neck fracture	15.59	12.37	21	48301	3286	34905323
Headache	15.56	12.37	190	48132	200445	34708164
Visceral leishmaniasis	15.55	12.37	10	48312	602	34908007
Glomerulonephritis proliferative	15.54	12.37	7	48315	204	34908405
Basal cell carcinoma	15.52	12.37	4	48318	19654	34888955
Neuroleptic malignant syndrome	15.46	12.37	3	48319	17931	34890678
Arthropathy	15.43	12.37	9	48313	26898	34881711
Renal glycosuria	15.37	12.37	4	48318	19	34908590
Paraesthesia	15.33	12.37	42	48280	64130	34844479
Portal fibrosis	15.30	12.37	8	48314	325	34908284
Disseminated tuberculosis	15.27	12.37	17	48305	2188	34906421
Respiratory arrest	15.22	12.37	10	48312	28033	34880576
Blood uric acid increased	15.19	12.37	38	48284	9586	34899023
Adrenogenital syndrome	15.19	12.37	5	48317	60	34908549
Optic nerve cupping	15.11	12.37	5	48317	61	34908548
Sickle cell anaemia	15.11	12.37	7	48315	218	34908391
Optic neuropathy	15.09	12.37	16	48306	1949	34906660
Subacute sclerosing panencephalitis	15.04	12.37	4	48318	21	34908588
Erosive duodenitis	14.98	12.37	15	48307	1709	34906900
Product use in unapproved indication	14.95	12.37	98	48224	117401	34791208
Liver tenderness	14.76	12.37	6	48316	135	34908474
Anogenital dysplasia	14.76	12.37	6	48316	135	34908474
Musculoskeletal toxicity	14.76	12.37	6	48316	135	34908474
Mobility decreased	14.72	12.37	12	48310	30116	34878493
Bone marrow oedema	14.69	12.37	10	48312	662	34907947
Hepatitis B DNA decreased	14.68	12.37	3	48319	3	34908606
Retroviral infection	14.68	12.37	3	48319	3	34908606
Osteocalcin increased	14.68	12.37	3	48319	3	34908606
Tracheal fistula repair	14.68	12.37	3	48319	3	34908606
Erythema	14.61	12.37	68	48254	88712	34819897
Congenital tuberculosis	14.59	12.37	4	48318	24	34908585
Red blood cell schistocytes present	14.54	12.37	7	48315	238	34908371
Hospitalisation	14.54	12.37	36	48286	56866	34851743
Central pain syndrome	14.48	12.37	5	48317	70	34908539
Amylase increased	14.47	12.37	28	48294	5940	34902669
Product quality issue	14.37	12.37	3	48319	17032	34891577
Vision blurred	14.32	12.37	26	48296	45937	34862672
Erythema elevatum diutinum	14.32	12.37	4	48318	26	34908583
Malabsorption	14.26	12.37	17	48305	2355	34906254
Overdose	14.25	12.37	71	48251	90988	34817621
Intentional overdose	14.25	12.37	24	48298	43650	34864959
Late developer	14.22	12.37	3	48319	4	34908605
Atypical mycobacterial lymphadenitis	14.22	12.37	3	48319	4	34908605
Creatinine renal clearance abnormal	14.20	12.37	7	48315	251	34908358
Hyperphosphaturia	14.17	12.37	5	48317	75	34908534
Ventricular fibrillation	14.16	12.37	7	48315	22947	34885662
Neck deformity	14.11	12.37	5	48317	76	34908533
Glucose tolerance impaired	14.11	12.37	20	48302	3284	34905325
Fluid retention	14.05	12.37	10	48312	26877	34881732
Scleral discolouration	14.04	12.37	7	48315	257	34908352
Myopia	13.98	12.37	12	48310	1124	34907485
Arthralgia	13.96	12.37	159	48163	169882	34738727
Pain in extremity	13.93	12.37	110	48212	126403	34782206
Optic disc haemorrhage	13.87	12.37	5	48317	80	34908529
Toxic neuropathy	13.87	12.37	9	48313	550	34908059
Ultrasound antenatal screen abnormal	13.82	12.37	5	48317	81	34908528
Lipids abnormal	13.71	12.37	8	48314	404	34908205
Spermatozoa progressive motility abnormal	13.71	12.37	4	48318	31	34908578
Lymphangiectasia	13.71	12.37	4	48318	31	34908578
Developmental delay	13.67	12.37	18	48304	2757	34905852
Pneumonitis	13.66	12.37	16	48306	33862	34874747
Disseminated mycobacterium avium complex infection	13.65	12.37	5	48317	84	34908525
Hypoglycaemia	13.63	12.37	35	48287	54605	34854004
Goitre	13.49	12.37	14	48308	1664	34906945
Benign hepatic neoplasm	13.47	12.37	3	48319	6	34908603
Congenital pigmentation disorder	13.47	12.37	3	48319	6	34908603
Wrong technique in product usage process	13.46	12.37	18	48304	35968	34872641
Osteonecrosis of jaw	13.45	12.37	4	48318	17885	34890724
Diarrhoea	13.38	12.37	424	47898	389488	34519121
Hyperkalaemia	13.37	12.37	50	48272	69339	34839270
Syphilis	13.29	12.37	8	48314	428	34908181
Stomatitis	13.29	12.37	24	48298	42490	34866119
Oedema peripheral	13.27	12.37	104	48218	119708	34788901
Post inflammatory pigmentation change	13.26	12.37	7	48315	290	34908319
Gout	13.26	12.37	5	48317	19248	34889361
Ocular icterus	13.25	12.37	18	48304	2839	34905770
Lip swelling	13.22	12.37	3	48319	16077	34892532
Congenital hydrocephalus	13.18	12.37	5	48317	93	34908516
Birth trauma	13.15	12.37	3	48319	7	34908602
Osteodystrophy	13.15	12.37	3	48319	7	34908602
Aggression	13.09	12.37	21	48301	38943	34869666
Orthostatic hypotension	13.07	12.37	10	48312	25909	34882700
Anaphylactic shock	13.06	12.37	3	48319	15938	34892671
Injection site erythema	13.01	12.37	3	48319	15896	34892713
Pancytopenia	12.96	12.37	194	48128	94963	34813646
Portal hypertensive gastropathy	12.93	12.37	9	48313	618	34907991
Hepatic steatosis	12.92	12.37	55	48267	18307	34890302
Heart rate irregular	12.90	12.37	3	48319	15804	34892805
Ergot poisoning	12.90	12.37	4	48318	39	34908570
Congenital anaemia	12.87	12.37	3	48319	8	34908601
Graft infection	12.86	12.37	8	48314	454	34908155
Congenital hearing disorder	12.84	12.37	5	48317	100	34908509
Sleep apnoea syndrome	12.83	12.37	6	48316	20315	34888294
Nausea	12.80	12.37	365	47957	339543	34569066
Platelet count decreased	12.76	12.37	105	48217	119612	34788997
Chronic kidney disease	12.70	12.37	99	48223	41111	34867498
Tracheo-oesophageal fistula	12.67	12.37	8	48314	466	34908143
Neutrophil count increased	12.59	12.37	4	48318	17142	34891467
Intestinal obstruction	12.58	12.37	8	48314	22814	34885795
Malaise	12.57	12.37	181	48141	185644	34722965
CD4 lymphocytes abnormal	12.55	12.37	4	48318	43	34908566
Skin candida	12.52	12.37	8	48314	476	34908133
Arthritis	12.43	12.37	15	48307	31331	34877278
COVID-19 pneumonia	12.38	12.37	4	48318	16963	34891646
Glucose urine	12.37	12.37	3	48319	10	34908599

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
Immune reconstitution inflammatory syndrome	2422.54	12.93	743	60920	13098	79669627
Viral mutation identified	2382.31	12.93	561	61102	3297	79679428
Virologic failure	2377.48	12.93	569	61094	3622	79679103
Pathogen resistance	1800.44	12.93	598	61065	13744	79668981
Drug resistance	1691.38	12.93	767	60896	41446	79641279
Exposure during pregnancy	1100.85	12.93	782	60881	100350	79582375
Lipodystrophy acquired	1089.13	12.93	308	61355	4017	79678708
Abortion spontaneous	1058.95	12.93	497	61166	29010	79653715
Stillbirth	832.47	12.93	245	61418	3710	79679015
Hepatitis B reactivation	771.37	12.93	256	61407	5852	79676873
Blood HIV RNA increased	740.04	12.93	189	61474	1619	79681106
Hepatitis B	738.11	12.93	268	61395	8064	79674661
Mitochondrial toxicity	695.49	12.93	202	61461	2912	79679813
Drug interaction	654.35	12.93	1158	60505	414025	79268700
Abortion induced	560.84	12.93	210	61453	6899	79675826
Fanconi syndrome acquired	502.35	12.93	152	61511	2542	79680183
Acquired gene mutation	486.05	12.93	142	61521	2091	79680634
Hepatitis B DNA increased	458.57	12.93	110	61553	705	79682020
Osteomalacia	434.92	12.93	119	61544	1361	79681364
Foetal exposure during pregnancy	377.89	12.93	149	61514	5641	79677084
Depression	368.14	12.93	626	61037	216164	79466561
Eyelid ptosis	311.74	12.93	158	61505	10886	79671839
Viral load increased	299.51	12.93	105	61558	2843	79679882
Progressive external ophthalmoplegia	293.06	12.93	87	61576	1358	79681367
Blood bilirubin increased	276.75	12.93	297	61366	65935	79616790
Hepatic failure	270.86	12.93	283	61380	60929	79621796
Lipoatrophy	267.17	12.93	69	61594	620	79682105
Fanconi syndrome	257.13	12.93	93	61570	2763	79679962
CD4 lymphocytes decreased	256.86	12.93	91	61572	2543	79680182
Treatment noncompliance	248.16	12.93	251	61412	52017	79630708
Hypophosphataemia	244.29	12.93	166	61497	19747	79662978
Psychotic disorder	240.21	12.93	222	61441	41180	79641545
Hepatotoxicity	231.81	12.93	240	61423	51112	79631613
Hypomania	224.87	12.93	112	61551	7432	79675293
Psychiatric decompensation	213.95	12.93	89	61574	3874	79678851
Nephropathy toxic	212.70	12.93	154	61509	20265	79662460
Caesarean section	209.55	12.93	127	61536	12408	79670317
Portal hypertension	207.37	12.93	104	61559	7004	79675721
Pregnancy	206.29	12.93	169	61494	26682	79656043
CSF HIV escape syndrome	201.25	12.93	48	61615	299	79682426
Alanine aminotransferase increased	192.82	12.93	403	61260	162167	79520558
Meningitis cryptococcal	190.16	12.93	79	61584	3427	79679298
Pain	188.33	12.93	161	61502	703641	78979084
Jaundice cholestatic	187.79	12.93	114	61549	11170	79671555
Multiple-drug resistance	180.94	12.93	102	61561	8706	79674019
Renal tubular disorder	174.93	12.93	90	61573	6396	79676329
Live birth	174.20	12.93	132	61531	18612	79664113
Peripheral swelling	168.43	12.93	10	61653	269607	79413118
Hypertriglyceridaemia	165.35	12.93	110	61553	12630	79670095
Maternal exposure during pregnancy	162.48	12.93	339	61324	136199	79546526
Hepatic fibrosis	162.38	12.93	89	61574	7191	79675534
Schizophrenia	162.06	12.93	117	61546	15323	79667402
Joint swelling	160.22	12.93	18	61645	288628	79394097
Kaposi's sarcoma	159.61	12.93	47	61616	712	79682013
Diplopia	157.51	12.93	160	61503	33306	79649419
Dyslipidaemia	157.18	12.93	103	61560	11530	79671195
Jaundice	157.18	12.93	200	61463	53149	79629576
Aspartate aminotransferase increased	150.91	12.93	332	61331	138309	79544416
Pulmonary tuberculosis	150.61	12.93	87	61576	7778	79674947
Fall	144.96	12.93	100	61563	487529	79195196
Proteinuria	143.23	12.93	150	61513	32352	79650373
Completed suicide	142.43	12.93	13	61650	245754	79436971
Depression suicidal	141.66	12.93	66	61597	3776	79678949
Infusion related reaction	139.47	12.93	10	61653	230227	79452498
Mitochondrial cytopathy	139.44	12.93	37	61626	373	79682352
Lymphadenopathy	138.85	12.93	188	61475	53059	79629666
Maternal drugs affecting foetus	137.41	12.93	51	61612	1632	79681093
Fatigue	136.37	12.93	326	61337	929401	78753324
Hepatitis C	135.86	12.93	95	61568	11830	79670895
Retinal toxicity	134.74	12.93	48	61615	1363	79681362
Glycosuria	134.72	12.93	54	61609	2134	79680591
Genotype drug resistance test positive	134.45	12.93	47	61616	1261	79681464
Nasopharyngitis	130.89	12.93	20	61643	253861	79428864
Psychomotor skills impaired	130.73	12.93	69	61594	5168	79677557
Tearfulness	129.60	12.93	72	61591	5973	79676752
Rheumatoid arthritis	129.37	12.93	8	61655	208462	79474263
Off label use	129.17	12.93	323	61340	906892	78775833
Foetal death	128.05	12.93	79	61584	7965	79674760
Hyperbilirubinaemia	127.92	12.93	124	61539	24394	79658331
Tuberculosis	125.93	12.93	100	61563	15098	79667627
Depressive symptom	125.53	12.93	72	61591	6351	79676374
Renal tubular dysfunction	124.36	12.93	39	61624	738	79681987
Lactic acidosis	124.20	12.93	207	61456	70152	79612573
Product dose omission issue	122.05	12.93	22	61641	247515	79435210
Hyperlactacidaemia	118.20	12.93	66	61597	5529	79677196
HIV-associated neurocognitive disorder	116.07	12.93	31	61632	321	79682404
Mycobacterium avium complex infection	113.11	12.93	60	61603	4540	79678185
Arthropathy	112.33	12.93	6	61657	177105	79505620
Hepatomegaly	107.11	12.93	100	61563	18774	79663951
Gene mutation	104.83	12.93	48	61615	2638	79680087
Synovitis	102.68	12.93	3	61660	150731	79531994
Cholelithiasis	101.15	12.93	161	61502	52503	79630222
Hepatic cirrhosis	99.87	12.93	129	61534	34777	79647948
Dyspnoea	98.00	12.93	338	61325	856687	78826038
Anaemia	97.61	12.93	633	61030	444382	79238343
Immune reconstitution inflammatory syndrome associated tuberculosis	97.44	12.93	33	61630	803	79681922
Premature rupture of membranes	97.03	12.93	52	61611	4017	79678708
Hypouricaemia	96.34	12.93	28	61635	404	79682321
Abdominal discomfort	95.79	12.93	37	61626	250690	79432035
Osteonecrosis	95.43	12.93	119	61544	30976	79651749
Pinealoblastoma	91.62	12.93	19	61644	54	79682671
Constipation	90.93	12.93	53	61610	282997	79399728
Premature labour	89.01	12.93	64	61599	8326	79674399
Sinusitis	88.86	12.93	21	61642	195480	79487245
Hepatic function abnormal	88.63	12.93	183	61480	72924	79609801
Stevens-Johnson syndrome	88.30	12.93	129	61534	39037	79643688
Urine phosphorus increased	87.44	12.93	19	61644	72	79682653
Hepatocellular carcinoma	87.08	12.93	65	61598	8956	79673769
Renal impairment	84.19	12.93	291	61372	157492	79525233
Drug intolerance	82.66	12.93	51	61612	264068	79418657
Cytomegalovirus chorioretinitis	82.55	12.93	52	61611	5438	79677287
Pre-eclampsia	82.33	12.93	57	61606	6984	79675741
Osteoporosis	82.17	12.93	149	61514	53963	79628762
Blood alkaline phosphatase increased	81.49	12.93	163	61500	63501	79619224
Systemic lupus erythematosus	80.42	12.93	3	61660	121146	79561579
Total lung capacity increased	80.17	12.93	38	61625	2260	79680465
Hydrops foetalis	80.14	12.93	28	61635	750	79681975
HIV viraemia	79.65	12.93	18	61645	85	79682640
Ultrasound antenatal screen	79.37	12.93	27	61636	666	79682059
Fat tissue increased	78.04	12.93	29	61634	931	79681794
Alopecia	77.65	12.93	41	61622	231314	79451411
Gamma-glutamyltransferase increased	77.30	12.93	146	61517	54534	79628191
Drug-induced liver injury	77.22	12.93	163	61500	65954	79616771
Hepatitis	76.56	12.93	147	61516	55580	79627145
Hepatic cytolysis	75.58	12.93	99	61564	27052	79655673
Cleft lip and palate	75.29	12.93	26	61637	672	79682053
Injection site pain	74.83	12.93	7	61656	129831	79552894
Ophthalmoplegia	74.49	12.93	39	61624	2873	79679852
Therapeutic product effect decreased	73.68	12.93	18	61645	163845	79518880
Acquired immunodeficiency syndrome	73.38	12.93	21	61642	286	79682439
Blood phosphorus decreased	73.35	12.93	52	61611	6616	79676109
Blood pressure increased	73.10	12.93	36	61627	211324	79471401
Blood bilirubin unconjugated increased	72.29	12.93	28	61635	1009	79681716
Blood lactic acid increased	71.31	12.93	67	61596	12677	79670048
Trisomy 18	70.82	12.93	24	61639	585	79682140
Hepatosplenomegaly	70.65	12.93	49	61614	6020	79676705
Swelling	70.40	12.93	40	61623	216671	79466054
Premature baby	70.22	12.93	41	61622	3739	79678986
Retinoblastoma	70.21	12.93	16	61647	79	79682646
Contusion	69.57	12.93	15	61648	148761	79533964
Varices oesophageal	68.88	12.93	48	61615	5943	79676782
Ergot poisoning	68.71	12.93	17	61646	126	79682599
Asthma-chronic obstructive pulmonary disease overlap syndrome	68.05	12.93	38	61625	3183	79679542
Wound	67.66	12.93	6	61657	116173	79566552
Pneumocystis jirovecii pneumonia	67.46	12.93	103	61560	32405	79650320
Loss of personal independence in daily activities	67.21	12.93	203	61460	102377	79580348
Arthralgia	66.90	12.93	223	61440	571580	79111145
Progressive multifocal leukoencephalopathy	66.69	12.93	81	61582	20519	79662206
Hyperlipidaemia	61.82	12.93	88	61575	26005	79656720
Normal newborn	61.75	12.93	48	61615	7024	79675701
Product use issue	60.94	12.93	44	61619	209778	79472947
Paranoia	60.63	12.93	75	61588	19357	79663368
Cryptococcosis	59.95	12.93	36	61627	3457	79679268
HIV infection	59.79	12.93	25	61638	1102	79681623
Cachexia	59.59	12.93	57	61606	11026	79671699
Hepatic encephalopathy	59.48	12.93	83	61580	24083	79658642
Cushing's syndrome	59.34	12.93	24	61639	971	79681754
Arthritis	59.28	12.93	9	61654	114871	79567854
Hypotension	59.16	12.93	161	61502	440156	79242569
Renal tubular acidosis	58.81	12.93	36	61627	3578	79679147
Lipohypertrophy	58.55	12.93	23	61640	861	79681864
Splenomegaly	58.27	12.93	76	61587	20678	79662047
Oligohydramnios	58.13	12.93	35	61628	3377	79679348
Drug ineffective	57.60	12.93	547	61116	1080366	78602359
Blood triglycerides increased	57.45	12.93	76	61587	20964	79661761
Hypophosphataemic osteomalacia	57.33	12.93	18	61645	342	79682383
Feeling abnormal	56.75	12.93	26	61637	159173	79523552
Amniotic cavity infection	56.48	12.93	22	61641	805	79681920
Inappropriate schedule of product administration	55.71	12.93	17	61646	133611	79549114
Ascites	55.71	12.93	156	61507	75406	79607319
Lymph node tuberculosis	55.50	12.93	23	61640	991	79681734
Headache	54.75	12.93	290	61373	653482	79029243
Calculus urinary	54.65	12.93	30	61633	2430	79680295
Facial wasting	54.50	12.93	13	61650	81	79682644
Transaminases increased	54.08	12.93	122	61541	51621	79631104
Premature delivery	53.92	12.93	78	61585	23389	79659336
Weight increased	53.79	12.93	82	61581	277304	79405421
Hepatitis A	53.28	12.93	22	61641	939	79681786
Alpha 1 foetoprotein abnormal	53.22	12.93	12	61651	56	79682669
Cerebral toxoplasmosis	53.02	12.93	29	61634	2333	79680392
Brain stem stroke	52.21	12.93	20	61643	699	79682026
Mitochondrial DNA deletion	50.90	12.93	9	61654	6	79682719
Renal failure	49.65	12.93	295	61368	200673	79482052
Pruritus	49.54	12.93	149	61514	394499	79288226
Blood creatinine increased	48.68	12.93	243	61420	154814	79527911
Injection site erythema	48.48	12.93	3	61660	78194	79604531
Nephrolithiasis	48.46	12.93	119	61544	53172	79629553
Psoriatic arthropathy	48.34	12.93	3	61660	77996	79604729
Pain in extremity	47.67	12.93	135	61528	364403	79318322
Death	47.56	12.93	251	61412	566263	79116462
Impaired healing	47.26	12.93	6	61657	87649	79595076
Malignant neoplasm progression	47.25	12.93	23	61640	135967	79546758
Pancreatitis	47.08	12.93	138	61525	68437	79614288
Oesophageal varices haemorrhage	46.51	12.93	33	61630	4203	79678522
Ectopic pregnancy	46.46	12.93	24	61639	1719	79681006
Influenza	46.45	12.93	21	61642	129585	79553140
Stomatitis	46.36	12.93	28	61635	146729	79535996
Lower respiratory tract infection	46.21	12.93	21	61642	129199	79553526
Hepatitis B surface antigen positive	46.19	12.93	13	61650	166	79682559
Drug abuse	46.09	12.93	35	61628	162656	79520069
Rickets	45.92	12.93	11	61652	70	79682655
Drug hypersensitivity	45.83	12.93	102	61561	298814	79383911
Basedow's disease	45.72	12.93	14	61649	244	79682481
Meningitis tuberculous	45.35	12.93	21	61642	1184	79681541
Asthma	45.22	12.93	24	61639	135071	79547654
Urinary tract infection	45.17	12.93	90	61573	274422	79408303
Oesophageal candidiasis	45.06	12.93	45	61618	9173	79673552
Tuberculoma of central nervous system	45.05	12.93	17	61646	570	79682155
Premature separation of placenta	44.68	12.93	21	61642	1225	79681500
Placental disorder	43.87	12.93	19	61644	914	79681811
Granulomatous rosacea	43.78	12.93	13	61650	203	79682522
CD4 lymphocytes increased	43.73	12.93	14	61649	284	79682441
Placental insufficiency	43.61	12.93	20	61643	1103	79681622
Toxicity to various agents	43.56	12.93	173	61490	421367	79261358
Ocular icterus	43.03	12.93	35	61628	5465	79677260
Nodular regenerative hyperplasia	42.92	12.93	21	61642	1340	79681385
Malaise	42.25	12.93	215	61448	489654	79193071
Pericarditis	42.13	12.93	14	61649	104222	79578503
HIV associated nephropathy	42.04	12.93	14	61649	323	79682402
Oropharyngeal pain	41.96	12.93	16	61647	109337	79573388
Atrial fibrillation	41.82	12.93	55	61608	197831	79484894
Oxygen saturation decreased	41.63	12.93	24	61639	129023	79553702
Acquired aminoaciduria	41.24	12.93	8	61655	14	79682711
Dizziness	41.03	12.93	239	61424	526202	79156523
Umbilical cord abnormality	40.80	12.93	12	61651	181	79682544
Hepatitis B virus test	40.67	12.93	7	61656	3	79682722
Rash maculo-papular	40.57	12.93	115	61548	55963	79626762
Blister	40.32	12.93	21	61642	119455	79563270
Nasal polyps	39.99	12.93	38	61625	7289	79675436
Heart rate decreased	39.96	12.93	4	61659	70312	79612413
Mycobacterium avium complex immune restoration disease	39.91	12.93	8	61655	18	79682707
Aminoaciduria	39.89	12.93	14	61649	380	79682345
COVID-19	39.68	12.93	38	61625	157636	79525089
Nasal congestion	39.48	12.93	6	61657	76546	79606179
Sarcoidosis	39.48	12.93	40	61623	8295	79674430
Pyrexia	39.46	12.93	740	60923	677969	79004756
Hepatitis cholestatic	39.31	12.93	51	61612	13801	79668924
Malaria	38.95	12.93	14	61649	408	79682317
Musculoskeletal stiffness	38.69	12.93	47	61616	174961	79507764
Muscle spasms	38.55	12.93	47	61616	174683	79508042
Chronic disease	38.42	12.93	11	61652	150	79682575
Hepatic cancer	38.39	12.93	44	61619	10485	79672240
Anaemia macrocytic	38.37	12.93	33	61630	5564	79677161
Optic nerve neoplasm	38.25	12.93	8	61655	24	79682701
Intentional product misuse	38.08	12.93	13	61650	95152	79587573
Psoriasis	38.06	12.93	11	61652	89576	79593149
White matter lesion	37.74	12.93	22	61641	2000	79680725
Urine calcium increased	37.49	12.93	10	61653	103	79682622
Back pain	37.33	12.93	116	61547	304064	79378661
Opportunistic infection	37.14	12.93	25	61638	2925	79679800
Helicobacter infection	37.03	12.93	5	61658	69699	79613026
Withdrawal hepatitis	36.99	12.93	6	61657	0	79682725
Mitochondrial DNA depletion	36.99	12.93	6	61657	0	79682725
Cardiac murmur	36.94	12.93	53	61610	15771	79666954
Infection	36.62	12.93	83	61580	241629	79441096
Bone metabolism disorder	36.16	12.93	14	61649	504	79682221
HIV test positive	35.80	12.93	10	61653	124	79682601
Pancytopenia	35.73	12.93	235	61428	165510	79517215
Mitochondrial myopathy	35.70	12.93	12	61651	285	79682440
Fibromyalgia	35.69	12.93	4	61659	64336	79618389
Disseminated tuberculosis	35.67	12.93	28	61635	4155	79678570
Psychomotor retardation	35.53	12.93	33	61630	6151	79676574
Stress	35.28	12.93	9	61654	79603	79603122
Blood pressure fluctuation	35.24	12.93	5	61658	67140	79615585
Strongyloidiasis	35.22	12.93	27	61636	3871	79678854
Acute hepatitis C	34.79	12.93	11	61652	214	79682511
Hepatitis B DNA assay positive	34.73	12.93	9	61654	82	79682643
Bronchitis	34.64	12.93	30	61633	130614	79552111
Cystostomy	34.64	12.93	9	61654	83	79682642
Spina bifida	34.62	12.93	10	61653	141	79682584
Mycobacterial infection	34.45	12.93	26	61637	3642	79679083
Confusional state	34.44	12.93	128	61535	317869	79364856
Anaphylactic reaction	34.28	12.93	11	61652	83732	79598993
Migraine	33.24	12.93	13	61650	87480	79595245
Discomfort	33.12	12.93	29	61634	125588	79557137
Gynaecomastia	33.03	12.93	35	61628	7646	79675079
Hepatic enzyme increased	32.98	12.93	248	61415	182362	79500363
Rhinorrhoea	32.95	12.93	9	61654	76065	79606660
Hyperphosphaturia	32.64	12.93	9	61654	106	79682619
Toxoplasmosis	31.92	12.93	22	61641	2675	79680050
Blood phosphorus abnormal	31.86	12.93	11	61652	284	79682441
Somnolence	31.58	12.93	88	61575	238893	79443832
Gastroschisis	31.53	12.93	7	61656	30	79682695
Renal glycosuria	31.53	12.93	7	61656	30	79682695
Pregnancy on contraceptive	31.52	12.93	15	61648	900	79681825
Chronic kidney disease	30.99	12.93	117	61546	66037	79616688
Neutropenia neonatal	30.99	12.93	7	61656	33	79682692
Optic atrophy	30.81	12.93	19	61644	1914	79680811
Bilirubin conjugated increased	30.75	12.93	29	61634	5510	79677215
Retroviral rebound syndrome	30.75	12.93	6	61657	11	79682714
Viraemia	30.70	12.93	22	61641	2847	79679878
Liver transplant	30.16	12.93	26	61637	4397	79678328
Diabetes mellitus	29.84	12.93	130	61533	78260	79604465
Benign hydatidiform mole	29.68	12.93	8	61655	86	79682639
AIDS cholangiopathy	29.49	12.93	6	61657	15	79682710
HIV lipodystrophy	29.49	12.93	6	61657	15	79682710
Cerebrovascular accident	29.04	12.93	47	61616	155245	79527480
Oral candidiasis	28.91	12.93	68	61595	29560	79653165
Cardio-respiratory arrest	28.66	12.93	25	61638	108485	79574240
Diarrhoea	28.66	12.93	494	61169	879995	78802730
Metabolic acidosis	28.52	12.93	133	61530	82396	79600329
Tuberculoid leprosy	28.29	12.93	8	61655	104	79682621
Night blindness	28.24	12.93	12	61651	551	79682174
Hyperphosphatasaemia	28.22	12.93	8	61655	105	79682620
Congenital intestinal malformation	28.21	12.93	6	61657	20	79682705
Amoebiasis	27.43	12.93	8	61655	117	79682608
Haematochezia	27.28	12.93	17	61646	87628	79595097
Foetal growth abnormality	27.16	12.93	6	61657	25	79682700
Vanishing bile duct syndrome	27.13	12.93	17	61646	1761	79680964
Placental infarction	27.12	12.93	8	61655	122	79682603
Rhinitis allergic	27.05	12.93	40	61623	12229	79670496
Memory impairment	26.88	12.93	28	61635	111706	79571019
Secondary syphilis	26.80	12.93	7	61656	66	79682659
Foetal growth restriction	26.78	12.93	18	61645	2101	79680624
Nervous system disorder	26.60	12.93	62	61601	26794	79655931
HIV wasting syndrome	26.52	12.93	7	61656	69	79682656
Respiratory arrest	26.49	12.93	6	61657	57544	79625181
Molluscum contagiosum	26.45	12.93	11	61652	478	79682247
Blood triglycerides abnormal	26.37	12.93	11	61652	482	79682243
Beta 2 microglobulin urine increased	26.25	12.93	8	61655	137	79682588
Intentional overdose	26.12	12.93	26	61637	105934	79576791
Erythema	26.09	12.93	87	61576	223203	79459522
Tremor	26.08	12.93	58	61605	170025	79512700
Injection site swelling	25.96	12.93	3	61660	47129	79635596
Hypercholesterolaemia	25.87	12.93	56	61607	23039	79659686
Herpes simplex	25.82	12.93	39	61624	12148	79670577
Injury	25.59	12.93	14	61649	77482	79605243
Paraesthesia	25.53	12.93	62	61601	176261	79506464
Illness	25.52	12.93	3	61660	46508	79636217
Encephalitis	25.46	12.93	43	61620	14717	79668008
Congenital anomaly	25.42	12.93	10	61653	376	79682349
Urticaria	25.36	12.93	67	61596	185134	79497591
Anogenital warts	25.30	12.93	13	61650	921	79681804
Rhabdomyosarcoma	25.28	12.93	8	61655	156	79682569
Thrombosis	25.24	12.93	17	61646	84083	79598642
Cough	25.20	12.93	173	61490	366616	79316109
Atypical mycobacterial lymphadenitis	25.02	12.93	5	61658	11	79682714
Hepatic steatosis	25.00	12.93	75	61588	37663	79645062
Dermatitis exfoliative	24.88	12.93	36	61627	10793	79671932
Glucose urine present	24.83	12.93	16	61647	1740	79680985
Genital herpes	24.67	12.93	17	61646	2067	79680658
Hyponatraemia	24.61	12.93	64	61599	177784	79504941
Bone density decreased	24.52	12.93	40	61623	13307	79669418
Syncope	24.51	12.93	65	61598	179384	79503341
Hepatitis fulminant	24.23	12.93	29	61634	7233	79675492
Suicidal ideation	24.19	12.93	120	61543	76220	79606505
Lymphocytic infiltration	24.08	12.93	15	61648	1538	79681187
Liver transplant rejection	24.01	12.93	20	61643	3228	79679497
Cardiac failure congestive	24.00	12.93	46	61617	142356	79540369
Urine phosphorus decreased	23.85	12.93	6	61657	48	79682677
Liver disorder	23.78	12.93	115	61548	72302	79610423
Epistaxis	23.54	12.93	31	61632	111484	79571241
Burning sensation	23.47	12.93	8	61655	58624	79624101
Post inflammatory pigmentation change	23.47	12.93	10	61653	462	79682263
Primary syphilis	23.43	12.93	5	61658	17	79682708
Astrocytoma, low grade	23.42	12.93	6	61657	52	79682673
Hepatitis E	23.36	12.93	19	61644	2967	79679758
Taeniasis	23.32	12.93	6	61657	53	79682672
Nephropathy	23.30	12.93	33	61630	9705	79673020
Osteoarthritis	23.20	12.93	20	61643	87289	79595436
Central nervous system lesion	23.13	12.93	39	61624	13329	79669396
Chest pain	23.12	12.93	126	61537	282178	79400547
Treatment failure	23.04	12.93	217	61446	170269	79512456
Blood bicarbonate decreased	22.94	12.93	24	61639	5167	79677558
Swollen tongue	22.74	12.93	3	61660	42567	79640158
Bradycardia	22.66	12.93	44	61619	135513	79547212
Flushing	22.52	12.93	21	61642	88247	79594478
Fluid retention	22.49	12.93	13	61650	69796	79612929
Meningomyelocele	22.23	12.93	5	61658	23	79682702
Viral load decreased	22.06	12.93	5	61658	24	79682701
Non-Hodgkin's lymphoma	21.97	12.93	14	61649	1493	79681232
Borderline leprosy	21.89	12.93	5	61658	25	79682700
Anaemia neonatal	21.89	12.93	5	61658	25	79682700
Placenta praevia	21.88	12.93	11	61652	744	79681981
Blood creatine phosphokinase increased	21.74	12.93	105	61558	65985	79616740
Parotid gland enlargement	21.70	12.93	12	61651	986	79681739
Neck pain	21.64	12.93	16	61647	75401	79607324
Lip swelling	21.57	12.93	3	61660	40908	79641817
Unevaluable event	21.54	12.93	8	61655	55577	79627148
Cystitis	21.45	12.93	7	61656	52725	79630000
Anembryonic gestation	21.31	12.93	9	61654	407	79682318
Osteoporotic fracture	21.28	12.93	21	61642	4219	79678506
Bulbar palsy	21.26	12.93	8	61655	266	79682459
Haematoma	21.11	12.93	7	61656	52188	79630537
Intracranial pressure increased	21.10	12.93	29	61634	8293	79674432
Hot flush	21.10	12.93	8	61655	54869	79627856
Incorrect dose administered	21.04	12.93	17	61646	76613	79606112
Mobility decreased	20.99	12.93	39	61624	122136	79560589
Osteonecrosis of jaw	20.94	12.93	4	61659	43222	79639503
Cryoglobulinaemia	20.86	12.93	11	61652	822	79681903
Breech delivery	20.85	12.93	5	61658	32	79682693
Gestational diabetes	20.78	12.93	25	61638	6268	79676457
Red blood cell sedimentation rate increased	20.73	12.93	5	61658	45937	79636788
Diverticulitis	20.73	12.93	5	61658	45931	79636794
Visual field defect	20.68	12.93	30	61633	9015	79673710
Cholestatic liver injury	20.34	12.93	22	61641	4919	79677806
Ileal ulcer	20.31	12.93	12	61651	1118	79681607
Type III hyperlipidaemia	20.28	12.93	4	61659	8	79682717
Loss of anatomical alignment after fracture reduction	20.28	12.93	4	61659	8	79682717
Isosporiasis	20.27	12.93	7	61656	181	79682544
Small for dates baby	20.14	12.93	9	61654	467	79682258
Dry mouth	20.13	12.93	23	61640	87996	79594729
Hospitalisation	20.09	12.93	26	61637	94210	79588515
Hepatitis D	20.07	12.93	6	61657	96	79682629
Erosive duodenitis	19.87	12.93	15	61648	2102	79680623
Hydrocephalus	19.60	12.93	29	61634	8871	79673854
Rhodococcus infection	19.54	12.93	8	61655	334	79682391
Red blood cells urine	19.53	12.93	10	61653	703	79682022
Blood pressure systolic increased	19.49	12.93	14	61649	66972	79615753
Cellulitis	19.47	12.93	34	61629	109026	79573699
Balance disorder	19.35	12.93	29	61634	98828	79583897
Localised infection	19.25	12.93	3	61660	37572	79645153
Antimitochondrial antibody positive	19.21	12.93	6	61657	112	79682613
Vomiting	19.19	12.93	661	61002	665167	79017558
Acute hepatic failure	19.15	12.93	59	61604	30054	79652671
Neuromyopathy	19.13	12.93	13	61650	1545	79681180
Disseminated Bacillus Calmette-Guerin infection	19.10	12.93	7	61656	216	79682509
Tubulointerstitial nephritis	19.06	12.93	69	61594	38166	79644559
Fat redistribution	18.96	12.93	6	61657	117	79682608
Abortion missed	18.91	12.93	12	61651	1271	79681454
Retroviral infection	18.89	12.93	4	61659	13	79682712
Postpartum haemorrhage	18.85	12.93	13	61650	1582	79681143
Chest discomfort	18.85	12.93	50	61613	137994	79544731
Therapeutic product effect incomplete	18.82	12.93	52	61611	141593	79541132
Orthostatic hypotension	18.75	12.93	10	61653	56154	79626571
Hypoglycaemia	18.75	12.93	31	61632	101563	79581162
Central nervous system immune reconstitution inflammatory response	18.62	12.93	5	61658	53	79682672
Bacterial pyelonephritis	18.61	12.93	9	61654	560	79682165
AIDS related complex	18.50	12.93	3	61660	0	79682725
Genetic polymorphism	18.50	12.93	3	61660	0	79682725
Vertical infection transmission	18.50	12.93	3	61660	0	79682725
Sleep apnoea syndrome	18.49	12.93	3	61660	36475	79646250
Histoplasmosis disseminated	18.46	12.93	15	61648	2338	79680387
Pubertal failure	18.44	12.93	4	61659	15	79682710
Hepatitis viral	18.40	12.93	11	61652	1047	79681678
Alpha 1 foetoprotein increased	18.36	12.93	10	61653	798	79681927
AIDS related complication	18.28	12.93	5	61658	57	79682668
Ultrasound scan abnormal	18.24	12.93	7	61656	246	79682479
Erythema elevatum diutinum	18.24	12.93	4	61659	16	79682709
CD4 lymphocytes	18.24	12.93	4	61659	16	79682709
Pneumonia aspiration	18.21	12.93	15	61648	66952	79615773
Optic nerve cupping	18.21	12.93	5	61658	58	79682667
Insomnia	18.16	12.93	113	61550	245057	79437668
Product prescribing error	18.14	12.93	6	61657	44807	79637918
Dehydration	18.07	12.93	115	61548	248072	79434653
Visual impairment	18.06	12.93	27	61636	92104	79590621
Trisomy 21	17.98	12.93	5	61658	61	79682664
Lymphadenitis	17.90	12.93	20	61643	4635	79678090
Portal hypertensive gastropathy	17.84	12.93	12	61651	1402	79681323
Oropharyngeal candidiasis	17.72	12.93	13	61650	1744	79680981
Hyperhidrosis	17.71	12.93	59	61604	151433	79531292
Upper respiratory tract infection	17.60	12.93	27	61636	91141	79591584
Paraparesis	17.55	12.93	18	61645	3785	79678940
Cardiac arrest	17.50	12.93	71	61592	172025	79510700
Brain oedema	17.48	12.93	51	61612	25212	79657513
Rectal haemorrhage	17.38	12.93	20	61643	76280	79606445
Anal cancer stage 0	17.35	12.93	4	61659	21	79682704
Drug dependence	17.32	12.93	5	61658	40764	79641961
Musculoskeletal pain	17.30	12.93	33	61630	102321	79580404
Blood lactate dehydrogenase increased	17.29	12.93	68	61595	39102	79643623
Renal atrophy	17.28	12.93	13	61650	1812	79680913
Amylase increased	17.18	12.93	31	61632	11178	79671547
Disease progression	16.96	12.93	79	61584	184283	79498442
Ballismus	16.95	12.93	7	61656	299	79682426
Gestational hypertension	16.94	12.93	13	61650	1866	79680859
Drug reaction with eosinophilia and systemic symptoms	16.94	12.93	96	61567	64148	79618577
Benign hepatic neoplasm	16.90	12.93	5	61658	77	79682648
Folliculitis	16.88	12.93	11	61652	55369	79627356
Acute lymphocytic leukaemia	16.84	12.93	20	61643	4949	79677776
Acute hepatitis B	16.79	12.93	8	61655	481	79682244
Clostridium difficile infection	16.78	12.93	6	61657	42679	79640046
Dyspepsia	16.71	12.93	37	61626	108650	79574075
Acute on chronic liver failure	16.62	12.93	7	61656	314	79682411
Ultrasound antenatal screen abnormal	16.50	12.93	5	61658	84	79682641
Ill-defined disorder	16.42	12.93	16	61647	65859	79616866
Kwashiorkor	16.42	12.93	3	61660	3	79682722
Hepatitis B DNA decreased	16.42	12.93	3	61660	3	79682722
Cervix operation	16.42	12.93	3	61660	3	79682722
Funisitis	16.42	12.93	3	61660	3	79682722
Blood uric acid decreased	16.42	12.93	11	61652	1277	79681448
Dry skin	16.39	12.93	17	61646	67978	79614747
Neurosyphilis	16.37	12.93	4	61659	28	79682697
ADAMTS13 activity decreased	16.34	12.93	6	61657	186	79682539
Cryptosporidiosis infection	16.34	12.93	9	61654	734	79681991
Heart rate increased	16.28	12.93	44	61619	120680	79562045
Albuminuria	16.27	12.93	9	61654	740	79681985
Sciatica	16.25	12.93	3	61660	33219	79649506
Plasmablastic lymphoma	16.23	12.93	8	61655	519	79682206
Abdominal pain upper	16.14	12.93	104	61559	223715	79459010
Influenza like illness	16.11	12.93	19	61644	71688	79611037
Pulmonary fibrosis	16.03	12.93	7	61656	44105	79638620
Viral hepatitis carrier	16.01	12.93	4	61659	31	79682694
Spermatozoa progressive motility abnormal	16.01	12.93	4	61659	31	79682694
Ear pain	16.01	12.93	3	61660	32866	79649859
Blood pressure decreased	16.01	12.93	33	61630	99433	79583292
Limb discomfort	16.00	12.93	3	61660	32847	79649878
Pathological fracture	15.97	12.93	29	61634	10508	79672217
Plasmodium falciparum infection	15.92	12.93	5	61658	95	79682630
Heart rate irregular	15.88	12.93	3	61660	32676	79650049
Bone pain	15.84	12.93	85	61578	55657	79627068
Portal vein thrombosis	15.83	12.93	21	61642	5806	79676919
Musculoskeletal toxicity	15.82	12.93	6	61657	204	79682521
Choroiditis	15.72	12.93	11	61652	1370	79681355
Dyspnoea exertional	15.67	12.93	27	61636	87046	79595679
Cardiac failure	15.67	12.93	64	61599	154778	79527947
Blood uric acid increased	15.66	12.93	33	61630	13327	79669398
Eclampsia	15.66	12.93	6	61657	210	79682515
Disseminated intravascular coagulation	15.64	12.93	62	61601	35780	79646945
Prenatal screening test abnormal	15.56	12.93	3	61660	5	79682720
Hypersensitivity	15.48	12.93	129	61534	262110	79420615
Hypersplenism	15.40	12.93	8	61655	580	79682145
Subacute sclerosing panencephalitis	15.38	12.93	4	61659	37	79682688
Bronchiectasis	15.31	12.93	45	61618	22341	79660384
Acute fatty liver of pregnancy	15.29	12.93	4	61659	38	79682687
Hyperbilirubinaemia neonatal	15.21	12.93	3	61660	6	79682719
Glycocholic acid increased	15.21	12.93	3	61660	6	79682719
Hydromyelia	15.21	12.93	3	61660	6	79682719
Carbon dioxide combining power abnormal	15.21	12.93	3	61660	6	79682719
Cholestasis	15.17	12.93	80	61583	52029	79630696
Transplant dysfunction	15.15	12.93	23	61640	7198	79675527
Basal cell carcinoma	15.13	12.93	5	61658	37370	79645355
Eyelid oedema	15.12	12.93	33	61630	13654	79669071
Toxic optic neuropathy	15.07	12.93	10	61653	1143	79681582
Ear infection	15.05	12.93	4	61659	34428	79648297
Hepatic necrosis	15.02	12.93	26	61637	9074	79673651
Glomerulonephritis proliferative	15.01	12.93	7	61656	401	79682324
Lipids abnormal	14.99	12.93	8	61655	613	79682112
Portal fibrosis	14.99	12.93	8	61655	613	79682112
Renal tubular necrosis	14.95	12.93	48	61615	24991	79657734
Dry eye	14.85	12.93	5	61658	36926	79645799
Colitis	14.84	12.93	21	61642	73286	79609439
Distributive shock	14.79	12.93	14	61649	2673	79680052
Burkitt's lymphoma	14.67	12.93	5	61658	124	79682601
Breast cancer	14.62	12.93	4	61659	33777	79648948
Osteocalcin increased	14.61	12.93	3	61660	8	79682717
Crystal urine	14.60	12.93	5	61658	126	79682599
Antiviral drug level below therapeutic	14.60	12.93	4	61659	46	79682679
International normalised ratio increased	14.59	12.93	27	61636	84694	79598031
Developmental delay	14.47	12.93	10	61653	1221	79681504
Hypertension	14.47	12.93	175	61488	330817	79351908
Acute stress disorder	14.45	12.93	7	61656	437	79682288
Rectosigmoid cancer metastatic	14.44	12.93	4	61659	48	79682677
CSF protein increased	14.41	12.93	10	61653	1230	79681495
Anogenital dysplasia	14.38	12.93	5	61658	132	79682593
Myopia	14.37	12.93	12	61651	1944	79680781
Ovarian failure	14.35	12.93	8	61655	668	79682057
Infected vasculitis	14.35	12.93	3	61660	9	79682716
Necrotising enterocolitis neonatal	14.35	12.93	3	61660	9	79682716
Hepatitis B surface antibody positive	14.27	12.93	6	61657	268	79682457
Anaphylactic shock	14.25	12.93	5	61658	35991	79646734
Blood creatine phosphokinase MB increased	14.25	12.93	14	61649	2797	79679928
Lipase increased	14.15	12.93	36	61627	16430	79666295
Herpes virus infection	14.15	12.93	22	61641	7027	79675698
Sleep disorder	14.15	12.93	28	61635	85649	79597076
Optic nerve disorder	14.14	12.93	10	61653	1267	79681458
Carnitine deficiency	14.13	12.93	6	61657	275	79682450
Pharyngotonsillitis	14.13	12.93	6	61657	275	79682450
Throat irritation	14.10	12.93	7	61656	40939	79641786
Blood glucose increased	13.97	12.93	44	61619	114931	79567794
Graft infection	13.97	12.93	8	61655	703	79682022
Portal vein occlusion	13.94	12.93	4	61659	55	79682670
Cerebellar syndrome	13.75	12.93	19	61644	5461	79677264
Limb injury	13.75	12.93	3	61660	29525	79653200
Obesity	13.70	12.93	5	61658	35120	79647605
Therapeutic response decreased	13.69	12.93	19	61644	66834	79615891
Colour vision tests abnormal	13.68	12.93	3	61660	12	79682713
Macrocephaly	13.62	12.93	4	61659	60	79682665
Medication error	13.57	12.93	20	61643	68622	79614103
Spermatozoa progressive motility decreased	13.56	12.93	4	61659	61	79682664
Prurigo	13.52	12.93	10	61653	1359	79681366
Emotional distress	13.52	12.93	7	61656	39962	79642763
Cytomegalovirus oesophagitis	13.48	12.93	8	61655	752	79681973
Colitis ulcerative	13.46	12.93	5	61658	34737	79647988
Optic neuropathy	13.45	12.93	15	61648	3469	79679256
Atypical mycobacterial infection	13.44	12.93	11	61652	1732	79680993
Secondary adrenocortical insufficiency	13.43	12.93	14	61649	3000	79679725
Hypomagnesaemia	13.40	12.93	10	61653	46901	79635824
Bovine tuberculosis	13.38	12.93	5	61658	163	79682562
Skin laceration	13.37	12.93	3	61660	28959	79653766
Multiple fractures	13.34	12.93	23	61640	8003	79674722
Cervical dysplasia	13.33	12.93	12	61651	2149	79680576
Melanaemia	13.32	12.93	4	61659	65	79682660
Pulmonary embolism	13.29	12.93	78	61585	171576	79511149
Wheezing	13.25	12.93	46	61617	116618	79566107
Vision blurred	13.24	12.93	40	61623	105858	79576867
Wrong technique in product usage process	13.21	12.93	23	61640	73852	79608873
Acute HIV infection	13.21	12.93	4	61659	67	79682658
Subchondral insufficiency fracture	13.21	12.93	4	61659	67	79682658
Leukopenia	13.18	12.93	143	61520	116370	79566355
Congenital diaphragmatic hernia	13.13	12.93	3	61660	15	79682710
Hepatitis D RNA positive	13.13	12.93	3	61660	15	79682710
Fungal infection	13.13	12.93	8	61655	41740	79640985
Obstructive airways disorder	13.11	12.93	4	61659	31455	79651270
Antiviral drug level above therapeutic	13.10	12.93	4	61659	69	79682656
Pleocytosis	13.07	12.93	10	61653	1429	79681296
Myelopathy	13.06	12.93	17	61646	4616	79678109
Interstitial lung disease	13.05	12.93	44	61619	112556	79570169
Joint injury	13.03	12.93	4	61659	31331	79651394
Syphilis	12.98	12.93	7	61656	547	79682178
Agitation	12.95	12.93	37	61626	99678	79583047

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
Neutropenia	37.65	36.60	22	638	195	88937

Pharmacologic Action:

Source	Code	Description
ATC	J05AF05	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	J05AR02	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
ATC	J05AR07	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR11	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR12	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR13	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR16	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR24	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR25	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR27	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
FDA EPC	N0000175656	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor
CHEBI has role	CHEBI:36044	antiviral drugs
CHEBI has role	CHEBI:50266	Prodrugs
CHEBI has role	CHEBI:50904	alergeno
CHEBI has role	CHEBI:53756	reverse transcriptase inhibitors
CHEBI has role	CHEBI:64951	anti-HBV agents
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	D004791	Enzyme Inhibitors
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
Chronic type B viral hepatitis	indication	61977001
Human immunodeficiency virus infection	indication	86406008	DOID:526
Prevention of Hepatitis B Reactivation in Immunocompromised Patients	off-label use
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
Drug Resistance to Anti-retroviral Therapy	contraindication
HLA-B 5701 Positive Status	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	12.95	acidic
pKa2	4.18	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
150MG;EQ 300MG BASE	DUTREBIS	MERCK SHARP DOHME	N206510	Feb. 6, 2015	DISCN	TABLET	ORAL	7754731	March 11, 2029	TREATMENT OF HIV-1 INFECTION
EQ 50MG BASE;300MG	DOVATO	VIIV HLTHCARE	N211994	April 8, 2019	RX	TABLET	ORAL	11234985	Jan. 24, 2031	TREATMENT OF HIV INFECTION
100MG;300MG;300MG	DELSTRIGO	MSD MERCK CO	N210807	Aug. 30, 2018	RX	TABLET	ORAL	8486975	Oct. 7, 2031	FOR THE TREATMENT OF HIV-1 INFECTION IN ADULT PATIENTS WITH NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY
100MG;300MG;300MG	DELSTRIGO	MSD MERCK CO	N210807	Aug. 30, 2018	RX	TABLET	ORAL	8486975	Oct. 7, 2031	TREATMENT OF HIV-1 INFECTION IN ADULT PATIENTS AS A REPLACEMENT THERAPY IN VIROLOGICALLY SUPPRESSED ADULTS WITH NO HISTORY OF TREATMENT FAILURE AND NO KNOWN SUBSTITUTIONS ASSOCIATED WITH RESISTANCE TO THE INDIVIDUAL COMPONENTS OF DELSTRIGO
100MG;300MG;300MG	DELSTRIGO	MSD MERCK CO	N210807	Aug. 30, 2018	RX	TABLET	ORAL	8486975	Oct. 7, 2031	TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS WEIGHING AT LEAST 35KG WITH NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR TO REPLACE THE CURRENT ANTIRETROVIRAL REGIMEN IN THOSE WHO ARE VIROLOGICALLY SUPPRESSED

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
EQ 50MG BASE;300MG	DOVATO	VIIV HLTHCARE	N211994	April 8, 2019	RX	TABLET	ORAL	Aug. 6, 2023	TO REPLACE THE CURRENT ANTIRETROVIRAL REGIMEN IN THOSE WHO ARE VIROLOGICALLY SUPRESSED (HIV-1 RNA LESS THAN 50 COPIES PER ML) ON A STABLE ANTIRETROVIRAL REGIMEN WITH NO HISTORY OF TREATMENT FAILURE
100MG;300MG;300MG	DELSTRIGO	MSD MERCK CO	N210807	Aug. 30, 2018	RX	TABLET	ORAL	Aug. 30, 2023	NEW CHEMICAL ENTITY
100MG;300MG;300MG	DELSTRIGO	MSD MERCK CO	N210807	Aug. 30, 2018	RX	TABLET	ORAL	Jan. 27, 2025	NEW PATIENT POPULATION
EQ 600MG BASE;EQ 50MG BASE;300MG	TRIUMEQ	VIIV HLTHCARE	N205551	Aug. 22, 2014	RX	TABLET	ORAL	June 15, 2026	INFORMATION ADDED TO THE LABELING REGARDING THE RESULT OF STUDY 205860
EQ 60MG BASE;EQ 5MG BASE;30MG	TRIUMEQ PD	VIIV HLTHCARE	N215413	March 30, 2022	RX	TABLET, FOR SUSPENSION	ORAL	June 15, 2026	NEW PATIENT POPULATION
EQ 600MG BASE;EQ 50MG BASE;300MG	TRIUMEQ	VIIV HLTHCARE	N205551	Aug. 22, 2014	RX	TABLET	ORAL	Dec. 15, 2026	PEDIATRIC EXCLUSIVITY
EQ 60MG BASE;EQ 5MG BASE;30MG	TRIUMEQ PD	VIIV HLTHCARE	N215413	March 30, 2022	RX	TABLET, FOR SUSPENSION	ORAL	Dec. 15, 2026	PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Deoxycytidine kinase	Kinase	P27707	DCK_HUMAN				WOMBAT-PK
Protein P	Polyprotein		Q9IF40_HBV	INHIBITOR			CHEMBL	CHEMBL
Reverse transcriptase/RNaseH	Enzyme		Q72547_9HIV1	INHIBITOR	EC50	7.38	CHEMBL	CHEMBL
Capsid protein	Unclassified		Q03732_HBV		EC50	6.43	CHEMBL

External reference:

ID	Source
4020938	VUID
N0000148418	NUI
D00353	KEGG_DRUG
4020938	VANDF
C0209738	UMLSCUI
CHEBI:63577	CHEBI
3TC	PDB_CHEM_ID
CHEMBL141	ChEMBL_ID
DB00709	DRUGBANK_ID
D019259	MESH_DESCRIPTOR_UI
60825	PUBCHEM_CID
12673	IUPHAR_LIGAND_ID
6908	INN_ID
2T8Q726O95	UNII
68244	RXNORM
186277	MMSL
4956	MMSL
d03858	MMSL
005079	NDDF
108698001	SNOMEDCT_US
386897000	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
DELSTRIGO	HUMAN PRESCRIPTION DRUG LABEL	3	0006-5007	TABLET, FILM COATED	300 mg	ORAL	NDA	32 sections
DELSTRIGO	HUMAN PRESCRIPTION DRUG LABEL	3	0006-5007	TABLET, FILM COATED	300 mg	ORAL	NDA	32 sections
EPIVIRHBV	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0662	TABLET, FILM COATED	100 mg	ORAL	NDA	26 sections
EPIVIRHBV	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0662	TABLET, FILM COATED	100 mg	ORAL	NDA	26 sections
EPIVIRHBV	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0663	SOLUTION	5 mg	ORAL	NDA	26 sections
EPIVIRHBV	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0663	SOLUTION	5 mg	ORAL	NDA	26 sections
LAMIVUDINE	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6583	TABLET, FILM COATED	150 mg	ORAL	ANDA	27 sections
Lamivudine	HUMAN PRESCRIPTION DRUG LABEL	1	10135-605	SOLUTION	10 mg	ORAL	ANDA	25 sections
Combivir	HUMAN PRESCRIPTION DRUG LABEL	2	16590-061	TABLET, FILM COATED	150 mg	ORAL	NDA	16 sections
EPIVIR	HUMAN PRESCRIPTION DRUG LABEL	1	21695-367	TABLET, FILM COATED	150 mg	ORAL	NDA	26 sections
COMBIVIR	HUMAN PRESCRIPTION DRUG LABEL	2	21695-846	TABLET, FILM COATED	150 mg	ORAL	NDA	26 sections
Lamivudine and Zidovudine	HUMAN PRESCRIPTION DRUG LABEL	2	21695-996	TABLET, FILM COATED	150 mg	ORAL	ANDA	26 sections
lamivudine	Human Prescription Drug Label	1	31722-001	TABLET, FILM COATED	100 mg	ORAL	ANDA	25 sections
LAMIVUDINE and ZIDOVUDINE	Human Prescription Drug Label	2	31722-506	TABLET, FILM COATED	150 mg	ORAL	ANDA	25 sections
LAMIVUDINE and ZIDOVUDINE	Human Prescription Drug Label	2	31722-506	TABLET, FILM COATED	150 mg	ORAL	ANDA	25 sections
Lamivudine and Zidovudine	HUMAN PRESCRIPTION DRUG LABEL	2	31722-739	TABLET, FILM COATED	150 mg	ORAL	ANDA	24 sections
Lamivudine	Human Prescription Drug Label	1	31722-752	TABLET, FILM COATED	100 mg	ORAL	ANDA	28 sections
Lamivudine	Human Prescription Drug Label	1	31722-753	TABLET, FILM COATED	150 mg	ORAL	ANDA	25 sections
Lamivudine	Human Prescription Drug Label	1	31722-754	TABLET, FILM COATED	300 mg	ORAL	ANDA	25 sections
Lamivudine	Human Prescription Drug Label	1	33342-001	TABLET, FILM COATED	150 mg	ORAL	ANDA	27 sections
Lamivudine	Human Prescription Drug Label	1	33342-001	TABLET, FILM COATED	150 mg	ORAL	ANDA	27 sections
Lamivudine	Human Prescription Drug Label	1	33342-002	TABLET, FILM COATED	300 mg	ORAL	ANDA	27 sections
Lamivudine	Human Prescription Drug Label	1	33342-002	TABLET, FILM COATED	300 mg	ORAL	ANDA	27 sections
Lamivudine and Zidovudine	Human Prescription Drug Label	2	33342-003	TABLET	150 mg	ORAL	ANDA	25 sections
Lamivudine and Zidovudine	Human Prescription Drug Label	2	33342-003	TABLET	150 mg	ORAL	ANDA	25 sections
Lamivudine and Zidovudine	Human Prescription Drug Label	2	33342-003	TABLET	150 mg	ORAL	ANDA	25 sections
Abacavir and Lamivudine	Human Prescription Drug Label	2	35573-402	TABLET, FILM COATED	300 mg	ORAL	ANDA	29 sections
Abacavir and Lamivudine	Human Prescription Drug Label	2	35573-430	TABLET, FILM COATED	300 mg	ORAL	ANDA	27 sections
Abacavir and Lamivudine	Human Prescription Drug Label	2	35573-430	TABLET, FILM COATED	300 mg	ORAL	ANDA	27 sections
Abacavir and Lamivudine	HUMAN PRESCRIPTION DRUG LABEL	2	42291-115	TABLET, FILM COATED	300 mg	ORAL	ANDA	28 sections