Tox | Related Drugs | 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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value	Unit	Confidence	Similarity
azlogd74	LogD at pH 7.4	-1.174		High	1
caco2-efflux	Caco-2 efflux ratio (BA/AB)	5.943		High	1
caco2-intrinsic-papp	Caco-2 intrinsic apparent permeability	0.454	10^-6 cm/s	High	1
dh-clint	Dog hepatocyte intrinsic clearance	1.016	uL/min/10^6 cells	High	1
dppb	Dog plasma protein binding (% unbound)	94.530	%	High	1
fcs-ppb	Fetal calf serum protein binding (% unbound)	93.200	%	High	1
herg	hERG pIC50	3.331	pIC50	High	1
hh-clint	Human hepatocyte intrinsic clearance	1.265	uL/min/10^6 cells	High	1
hlm-clint	Human liver microsomal intrinsic clearance	3.342	uL/min/mg protein	High	1
hppb	Human plasma protein binding (% unbound)	87.940	%	High	1
kinase-safety-class	ACVR2B,BRAF,CAMK2D,CDK5,EIF2AK3,ERBB2,GRK2,ITK,MAP3K21,MAPK7,NTRK2,PDK1,PDK2,PRKDC,TEK	15
kinase-selectivity-class	GRK2,MAP2K6	2
mdck-mdr1-bcrp-efflux	MDCK-MDR1-BCRP efflux ratio	0.533		High	1
mdck-mdr1-efflux	MDCK-MDR1 efflux ratio	2.312		High	1
mh-clint	Mouse hepatocyte intrinsic clearance	2.793		High	1
mppb	Mouse plasma protein binding (% unbound)	95.830		High	1
nih-mdck-mdr1-efflux	NIH MDCK-MDR1 efflux ratio	1.758		High	1
pfas-class	PFAS structural alert (1 = True, 0 = False)	0
pld-class	Phospholipidosis risk class (1 = positive, 0 = negative)	0		High	1
pppb	Pig plasma protein binding (% unbound)	94.940	%	High	1
rat-kpuu-brain	Rat brain Kpuu	0.014	%	High	1
rh-clint	Rat hepatocyte intrinsic clearance	2.070	uL/min/10^6 cells	High	1
rh-fuinc	Rat hepatocyte fraction unbound in incubation	98.220	%	High	1
rppb	Rat plasma protein binding (% unbound)	94.520	%	High	1
solubility-dd	Solubility at pH 7.4 in DMSO	924.698	uM	High	1

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	1771.98	18.39	1093	32097	237317	90357940
Virologic failure	1498.56	18.39	304	32886	1920	90593337
Viral mutation identified	1407.16	18.39	284	32906	1741	90593516
Abortion spontaneous	1219.56	18.39	525	32665	53531	90541726
Drug resistance	1110.47	18.39	418	32772	30031	90565226
Stillbirth	1039.45	18.39	284	32906	7159	90588098
Pathogen resistance	951.54	18.39	270	32920	7845	90587412
Foetal exposure during pregnancy	866.91	18.39	386	32804	42589	90552668
Immune reconstitution inflammatory syndrome	834.05	18.39	236	32954	6783	90588474
Abortion induced	632.35	18.39	216	32974	11672	90583585
Schizophrenia	614.09	18.39	224	32966	14690	90580567
Hypomania	482.31	18.39	164	33026	8733	90586524
Jaundice cholestatic	428.89	18.39	155	33035	9888	90585369
Blood bilirubin increased	395.49	18.39	228	32962	43242	90552015
Hepatotoxicity	389.48	18.39	230	32960	45612	90549645
Premature baby	389.24	18.39	188	33002	24889	90570368
Blood HIV RNA increased	378.00	18.39	82	33108	742	90594515
Hepatitis B reactivation	376.08	18.39	112	33078	3862	90591395
Foetal death	363.42	18.39	169	33021	20554	90574703
Cholelithiasis	360.68	18.39	230	32960	52276	90542981
Fanconi syndrome acquired	326.97	18.39	79	33111	1195	90594062
Caesarean section	318.00	18.39	149	33041	18428	90576829
Psychotic disorder	297.94	18.39	169	33021	31061	90564196
Lipodystrophy acquired	288.78	18.39	74	33116	1440	90593817
Maternal exposure during pregnancy	260.96	18.39	470	32720	359593	90235664
Asthma-chronic obstructive pulmonary disease overlap syndrome	260.38	18.39	89	33101	4810	90590447
Pregnancy	260.37	18.39	201	32989	61846	90533411
Treatment noncompliance	258.24	18.39	186	33004	51541	90543716
Total lung capacity increased	258.23	18.39	89	33101	4932	90590325
Cardiac murmur	230.88	18.39	119	33071	18075	90577182
CD4 lymphocytes decreased	197.27	18.39	55	33135	1492	90593765
Sarcoidosis	196.32	18.39	90	33100	10583	90584674
Nasal polyps	191.55	18.39	89	33101	10791	90584466
Maternal drugs affecting foetus	184.87	18.39	70	33120	5085	90590172
Premature rupture of membranes	162.23	18.39	65	33125	5493	90589764
Rhinitis allergic	155.12	18.39	89	33101	16696	90578561
Premature labour	151.23	18.39	81	33109	13295	90581962
Hepatitis B	146.44	18.39	57	33133	4462	90590795
Live birth	144.37	18.39	161	33029	78946	90516311
Anaemia	140.98	18.39	362	32828	352440	90242817
Bronchiectasis	138.96	18.39	92	33098	22238	90573019
Mitochondrial toxicity	134.28	18.39	34	33156	629	90594628
Nasopharyngitis	127.43	18.39	5	33185	407099	90188158
Peripheral swelling	126.24	18.39	6	33184	413100	90182157
Fanconi syndrome	125.94	18.39	41	33149	1902	90593355
Human immunodeficiency virus transmission	123.14	18.39	21	33169	39	90595218
Pre-eclampsia	122.37	18.39	66	33124	10982	90584275
Viral load increased	122.19	18.39	38	33152	1518	90593739
Foetal growth restriction	120.86	18.39	62	33128	9318	90585939
Acquired gene mutation	120.80	18.39	36	33154	1243	90594014
Abdominal discomfort	118.57	18.39	17	33173	477311	90117946
Temperature regulation disorder	118.13	18.39	71	33119	14508	90580749
Portal hypertension	116.84	18.39	49	33141	4652	90590605
Systemic lupus erythematosus	114.78	18.39	4	33186	361892	90233365
Hepatitis B DNA increased	111.65	18.39	25	33165	265	90594992
Alopecia	111.20	18.39	23	33167	495048	90100209
Osteomalacia	105.84	18.39	30	33160	865	90594392
Lipoatrophy	103.48	18.39	24	33166	301	90594956
Premature delivery	101.79	18.39	96	33094	38666	90556591
Lung neoplasm malignant	100.37	18.39	78	33112	24195	90571062
Dyslipidaemia	99.88	18.39	56	33134	10051	90585206
Fall	99.10	18.39	27	33163	481783	90113474
Nephropathy toxic	98.19	18.39	60	33130	12628	90582629
Alanine aminotransferase increased	96.48	18.39	163	33027	118175	90477082
Drug interaction	94.55	18.39	268	32922	276185	90319072
Lactic acidosis	94.27	18.39	104	33086	50359	90544898
Renal tubular dysfunction	92.60	18.39	24	33166	489	90594768
Genotype drug resistance test positive	90.81	18.39	23	33167	426	90594831
Aspartate aminotransferase increased	89.56	18.39	146	33044	102791	90492466
Swelling	89.00	18.39	22	33168	419036	90176221
Hyperbilirubinaemia	88.11	18.39	58	33132	13878	90581379
Sinusitis	85.66	18.39	12	33178	343076	90252181
Trisomy 21	85.46	18.39	22	33168	436	90594821
Hypophosphataemia	84.75	18.39	58	33132	14796	90580461
Discomfort	83.71	18.39	4	33186	274331	90320926
Immune reconstitution inflammatory syndrome associated tuberculosis	83.41	18.39	22	33168	481	90594776
Mitochondrial cytopathy	82.47	18.39	19	33171	231	90595026
Pericarditis	82.24	18.39	4	33186	270147	90325110
Congenital umbilical hernia	81.95	18.39	20	33170	316	90594941
Proteinuria	81.75	18.39	68	33122	23223	90572034
Hepatic enzyme increased	81.07	18.39	303	32887	360433	90234824
Hepatomegaly	80.72	18.39	54	33136	13272	90581985
Ectopic kidney	80.61	18.39	15	33175	55	90595202
Fatigue	79.95	18.39	192	32998	1153831	89441426
Glycosuria	79.77	18.39	27	33163	1415	90593842
Pain	78.71	18.39	154	33036	996187	89599070
Arthralgia	77.74	18.39	103	33087	778419	89816838
Birth mark	77.65	18.39	17	33173	161	90595096
Polydactyly	77.51	18.39	19	33171	306	90594951
Amniotic cavity infection	76.68	18.39	26	33164	1370	90593887
Ventricular septal defect	76.27	18.39	38	33152	5369	90589888
Product dose omission issue	75.70	18.39	9	33181	291678	90303579
CSF HIV escape syndrome	73.98	18.39	15	33175	94	90595163
Premature separation of placenta	73.73	18.39	29	33161	2333	90592924
Meningitis cryptococcal	73.43	18.39	27	33163	1806	90593451
Hyperlactacidaemia	73.31	18.39	34	33156	4102	90591155
Jaundice	73.15	18.39	74	33116	32443	90562814
Lymphadenopathy	73.10	18.39	87	33103	45688	90549569
Impaired healing	72.81	18.39	3	33187	234196	90361061
Food allergy	72.50	18.39	66	33124	25412	90569845
Retinoblastoma	71.89	18.39	14	33176	69	90595188
Pulmonary tuberculosis	71.23	18.39	35	33155	4799	90590458
Dyspnoea	69.67	18.39	136	33054	880819	89714438
Placental disorder	69.26	18.39	25	33165	1586	90593671
Chronic disease	69.11	18.39	16	33174	199	90595058
Atrial septal defect	69.04	18.39	41	33149	8193	90587064
Fat tissue increased	65.22	18.39	20	33170	762	90594495
Vomiting	64.56	18.39	501	32689	787792	89807465
Blood lactic acid increased	64.08	18.39	40	33150	8738	90586519
Ergot poisoning	64.04	18.39	13	33177	82	90595175
Blister	63.44	18.39	9	33181	254989	90340268
Contusion	62.18	18.39	9	33181	251207	90344050
Hepatic failure	60.97	18.39	74	33116	39654	90555603
Drug ineffective	60.93	18.39	281	32909	1384017	89211240
Fibromyalgia	59.86	18.39	4	33186	206265	90388992
Rash maculo-papular	59.20	18.39	74	33116	40859	90554398
Alpha 1 foetoprotein abnormal	58.76	18.39	11	33179	42	90595215
Arnold-Chiari malformation	58.34	18.39	18	33172	700	90594557
Blood cholesterol increased	57.64	18.39	5	33185	208007	90387250
Cleft lip and palate	57.42	18.39	18	33172	738	90594519
Stevens-Johnson syndrome	57.39	18.39	62	33128	29314	90565943
Hydrops foetalis	56.79	18.39	17	33173	596	90594661
Rash erythematous	56.14	18.39	92	33098	65012	90530245
Weight increased	55.64	18.39	43	33147	417884	90177373
Umbilical cord abnormality	55.00	18.39	17	33173	665	90594592
Pruritus	54.63	18.39	71	33119	541454	90053803
Malaria	53.59	18.39	13	33177	200	90595057
Lower respiratory tract infection	53.48	18.39	13	33177	250646	90344611
Chronic obstructive pulmonary disease	52.75	18.39	96	33094	73733	90521524
Renal tubular disorder	52.64	18.39	25	33165	3182	90592075
Therapeutic product effect decreased	50.89	18.39	19	33171	277552	90317705
Sleep disorder	49.22	18.39	7	33183	198023	90397234
Migraine	49.07	18.39	6	33184	190386	90404871
Tuberculosis	49.01	18.39	39	33151	12510	90582747
Injury	49.00	18.39	7	33183	197342	90397915
Normal newborn	48.63	18.39	51	33139	23311	90571946
Osteoarthritis	48.46	18.39	7	33183	195723	90399534
Immunodeficiency	48.44	18.39	69	33121	43165	90552092
Hypertriglyceridaemia	47.86	18.39	32	33158	7857	90587400
Hypophosphataemic osteomalacia	46.56	18.39	12	33178	239	90595018
Foetal distress syndrome	46.52	18.39	19	33171	1686	90593571
Ectopic pregnancy	46.37	18.39	23	33167	3218	90592039
Muscle spasms	44.92	18.39	18	33172	251865	90343392
Ocular icterus	44.70	18.39	24	33166	3956	90591301
Memory impairment	44.55	18.39	9	33181	197235	90398022
Mitochondrial DNA deletion	44.06	18.39	7	33183	6	90595251
Cushing's syndrome	43.58	18.39	14	33176	622	90594635
Cystostomy	43.28	18.39	9	33181	65	90595192
Oligohydramnios	43.18	18.39	29	33161	7172	90588085
Ultrasound antenatal screen abnormal	42.93	18.39	10	33180	128	90595129
Musculoskeletal stiffness	42.74	18.39	28	33162	296504	90298753
Coeliac disease	42.53	18.39	66	33124	44544	90550713
Malaise	42.40	18.39	95	33095	585891	90009366
Small for dates baby	42.16	18.39	25	33165	4982	90590275
Completed suicide	41.54	18.39	3	33187	145055	90450202
Neutropenia neonatal	41.52	18.39	9	33181	81	90595176
Blood bilirubin unconjugated increased	40.52	18.39	12	33178	405	90594852
Low birth weight baby	40.39	18.39	31	33159	9436	90585821
Influenza	39.54	18.39	3	33187	139261	90455996
Gene mutation	39.28	18.39	18	33172	2112	90593145
Dizziness	39.09	18.39	100	33090	589184	90006073
Patent ductus arteriosus	38.96	18.39	23	33167	4546	90590711
Anaemia macrocytic	38.94	18.39	23	33167	4549	90590708
Ill-defined disorder	38.64	18.39	10	33180	184881	90410376
Joint swelling	38.56	18.39	79	33111	503221	90092036
Dry mouth	38.37	18.39	10	33180	184049	90411208
Musculoskeletal pain	38.29	18.39	8	33182	171243	90424014
Foetal growth abnormality	38.20	18.39	8	33182	60	90595197
Stomatitis	38.17	18.39	27	33163	274671	90320586
Metabolic acidosis	38.01	18.39	71	33119	55605	90539652
Diarrhoea	37.49	18.39	197	32993	938993	89656264
Pregnancy on contraceptive	37.29	18.39	15	33175	1280	90593977
Hepatic cytolysis	37.10	18.39	51	33139	30865	90564392
Type 2 diabetes mellitus	37.10	18.39	14	33176	203230	90392027
Cleft palate	37.06	18.39	15	33175	1301	90593956
Hepatitis C	36.86	18.39	24	33166	5636	90589621
Rickets	36.81	18.39	8	33182	73	90595184
Placental insufficiency	36.80	18.39	16	33174	1659	90593598
Genetic polymorphism	36.40	18.39	6	33184	8	90595249
Neonatal disorder	36.38	18.39	12	33178	580	90594677
Anxiety	36.22	18.39	36	33154	309736	90285521
Isosporiasis	36.03	18.39	7	33183	34	90595223
Lymphadenitis	35.73	18.39	21	33169	4116	90591141
Joint range of motion decreased	35.63	18.39	4	33186	135639	90459618
Thrombocytopenia	35.48	18.39	161	33029	208564	90386693
Meningomyelocele	35.43	18.39	12	33178	630	90594627
Hydrocephalus	35.25	18.39	24	33166	6070	90589187
Isoimmune haemolytic disease	35.07	18.39	7	33183	40	90595217
Hydromyelia	34.89	18.39	6	33184	12	90595245
Placental infarction	34.77	18.39	10	33180	304	90594953
Confusional state	34.60	18.39	55	33135	386150	90209107
Insomnia	34.33	18.39	43	33147	333431	90261826
Cardiac malposition	34.11	18.39	7	33183	47	90595210
AIDS cholangiopathy	33.97	18.39	6	33184	15	90595242
Hypoaesthesia	33.96	18.39	39	33151	314171	90281086
Macrocephaly	33.77	18.39	9	33181	205	90595052
Urticaria	33.60	18.39	39	33151	312695	90282562
Neutropenia	33.52	18.39	167	33023	224737	90370520
Necrotising colitis	33.43	18.39	14	33176	1324	90593933
Ultrasound antenatal screen	33.29	18.39	9	33181	217	90595040
Gestational diabetes	33.25	18.39	29	33161	10553	90584704
Tuberculoma of central nervous system	33.10	18.39	10	33180	362	90594895
Dermatitis allergic	32.85	18.39	36	33154	17291	90577966
Pain in extremity	32.59	18.39	73	33117	450456	90144801
HIV-associated neurocognitive disorder	32.57	18.39	8	33182	130	90595127
Congenital anomaly	32.05	18.39	23	33167	6324	90588933
Hepatitis A	31.95	18.39	11	33179	607	90594650
Hypouricaemia	31.90	18.39	9	33181	255	90595002
Spina bifida	31.73	18.39	12	33178	868	90594389
Treatment failure	31.64	18.39	205	32985	303723	90291534
Postpartum haemorrhage	31.30	18.39	16	33174	2385	90592872
Neck pain	30.86	18.39	3	33187	113960	90481297
Liver injury	30.71	18.39	12	33178	170555	90424702
Hepatosplenomegaly	30.62	18.39	17	33173	2992	90592265
General physical health deterioration	30.48	18.39	52	33138	355063	90240194
Bilirubin conjugated increased	29.99	18.39	17	33173	3113	90592144
Mobility decreased	29.46	18.39	29	33161	250705	90344552
Congenital teratoma	29.42	18.39	5	33185	9	90595248
Adverse drug reaction	29.29	18.39	4	33186	116697	90478560
CD4 lymphocytes increased	29.27	18.39	8	33182	201	90595056
Loss of personal independence in daily activities	29.13	18.39	7	33183	136098	90459159
Renal tubular acidosis	28.95	18.39	15	33175	2300	90592957
Lymph node tuberculosis	28.87	18.39	11	33179	812	90594445
Double outlet right ventricle	28.77	18.39	6	33184	44	90595213
Anembryonic gestation	28.53	18.39	10	33180	582	90594675
Drug reaction with eosinophilia and systemic symptoms	28.53	18.39	54	33136	42704	90552553
Renal failure	28.48	18.39	109	33081	130898	90464359
Infertility	28.32	18.39	11	33179	856	90594401
Dyspepsia	28.15	18.39	19	33171	198141	90397116
Feeling abnormal	28.13	18.39	13	33177	167222	90428035
Necrotising enterocolitis neonatal	27.98	18.39	8	33182	238	90595019
Multiple-drug resistance	27.90	18.39	23	33167	7753	90587504
Gastroschisis	27.82	18.39	9	33181	409	90594848
Bicuspid pulmonary valve	27.65	18.39	4	33186	0	90595257
Hepatitis	27.54	18.39	72	33118	70667	90524590
Tetany	27.40	18.39	15	33175	2569	90592688
Funisitis	27.39	18.39	5	33185	16	90595241
Eyelid oedema	27.32	18.39	27	33163	11507	90583750
Hepatic displacement	27.16	18.39	5	33185	17	90595240
Ballismus	27.13	18.39	7	33183	140	90595117
COVID-19	27.07	18.39	14	33176	168829	90426428
Intentional product misuse	26.87	18.39	83	33107	89521	90505736
Ultrasound scan abnormal	26.71	18.39	8	33182	281	90594976
Gamma-glutamyltransferase increased	26.66	18.39	49	33141	37903	90557354
Oropharyngeal pain	26.54	18.39	5	33185	115182	90480075
Abdominal pain upper	26.50	18.39	51	33139	332623	90262634
Lung neoplasm	26.45	18.39	21	33169	6714	90588543
Fallot's tetralogy	26.43	18.39	6	33184	68	90595189
Kaposi's sarcoma	26.41	18.39	7	33183	156	90595101
Lipohypertrophy	26.37	18.39	10	33180	729	90594528
Retinal toxicity	26.17	18.39	12	33178	1410	90593847
Exposure via breast milk	26.11	18.39	14	33176	2301	90592956
Paraesthesia	26.05	18.39	32	33158	250294	90344963
Hepatitis B surface antigen positive	25.96	18.39	6	33184	74	90595183
Infusion related reaction	25.89	18.39	73	33117	416707	90178550
Obesity	25.59	18.39	4	33186	105503	90489754
Ascites	25.54	18.39	55	33135	47685	90547572
Alpha 1 foetoprotein increased	25.42	18.39	7	33183	181	90595076
Acquired aminoaciduria	25.41	18.39	4	33186	3	90595254
Benign hydatidiform mole	25.31	18.39	7	33183	184	90595073
Abortion missed	25.24	18.39	13	33177	1969	90593288
Congenital intestinal malformation	25.13	18.39	6	33184	86	90595171
Gestational hypertension	25.03	18.39	15	33175	3047	90592210
Cholestasis of pregnancy	24.99	18.39	12	33178	1565	90593692
Neonatal respiratory distress syndrome	24.85	18.39	15	33175	3086	90592171
Pyrexia	24.85	18.39	359	32831	660126	89935131
Renal impairment	24.82	18.39	90	33100	105331	90489926
Neural tube defect	24.72	18.39	7	33183	201	90595056
Drug level below therapeutic	24.72	18.39	19	33171	5795	90589462
Headache	24.70	18.39	200	32990	862546	89732711
Anaemia neonatal	24.66	18.39	8	33182	367	90594890
Blood creatine phosphokinase MB increased	24.58	18.39	11	33179	1221	90594036
Varices oesophageal	24.55	18.39	16	33174	3763	90591494
Ovarian failure	24.52	18.39	12	33178	1631	90593626
Twin pregnancy	24.49	18.39	11	33179	1232	90594025
Lipase increased	24.46	18.39	25	33165	11086	90584171
Congenital hydrocephalus	24.43	18.39	7	33183	210	90595047
Visual impairment	24.34	18.39	9	33181	132356	90462901
Sciatica	24.23	18.39	4	33186	101378	90493879
Blood pressure increased	24.11	18.39	22	33168	197195	90398062
Road traffic accident	24.11	18.39	5	33185	107621	90487636
Haemorrhage in pregnancy	24.05	18.39	13	33177	2172	90593085
Blood creatine phosphokinase increased	23.99	18.39	44	33146	33979	90561278
AIDS related complication	23.99	18.39	4	33186	6	90595251
Cachexia	23.96	18.39	20	33170	6858	90588399
Diastasis recti abdominis	23.94	18.39	5	33185	37	90595220
Malignant neoplasm progression	23.87	18.39	5	33185	106865	90488392
Hepatitis B DNA assay positive	23.82	18.39	5	33185	38	90595219
Gait inability	23.69	18.39	12	33178	146444	90448813
Adverse event	23.31	18.39	7	33183	117411	90477846
Type III hyperlipidaemia	23.26	18.39	4	33186	8	90595249
Inappropriate schedule of product administration	23.21	18.39	13	33177	149920	90445337
Cerebral toxoplasmosis	23.20	18.39	11	33179	1394	90593863
Atrial fibrillation	23.08	18.39	10	33180	133601	90461656
Hyperphosphaturia	22.97	18.39	5	33185	46	90595211
Aminoaciduria	22.84	18.39	6	33184	129	90595128
Fat redistribution	22.64	18.39	4	33186	10	90595247
HIV infection	22.54	18.39	8	33182	483	90594774
Foetal anaemia	22.54	18.39	6	33184	136	90595121
Gait disturbance	22.47	18.39	38	33152	260458	90334799
Neonatal aspiration	22.38	18.39	6	33184	140	90595117
Intentional product use issue	22.28	18.39	28	33162	216864	90378393
Respiratory distress	22.14	18.39	46	33144	38900	90556357
Therapeutic product effect incomplete	22.12	18.39	23	33167	193873	90401384
Renal glycosuria	22.11	18.39	4	33186	12	90595245
Trisomy 18	22.10	18.39	6	33184	147	90595110
Hepatitis cholestatic	22.08	18.39	21	33169	8540	90586717
Cholestatic liver injury	22.07	18.39	15	33175	3782	90591475
Rhodococcus infection	22.06	18.39	6	33184	148	90595109
Breast neoplasm	21.98	18.39	11	33179	1569	90593688
Micrognathia	21.94	18.39	7	33183	304	90594953
Pubertal failure	21.87	18.39	4	33186	13	90595244
Antiviral drug level below therapeutic	21.69	18.39	5	33185	61	90595196
Bovine tuberculosis	21.54	18.39	5	33185	63	90595194
Defaecation urgency	21.43	18.39	18	33172	6224	90589033
Diaphragmatic aplasia	21.42	18.39	4	33186	15	90595242
Transaminases increased	21.23	18.39	44	33146	37148	90558109
Gingival hypertrophy	21.22	18.39	12	33178	2188	90593069
Developmental delay	21.21	18.39	11	33179	1689	90593568
Injection site reaction	21.21	18.39	4	33186	92076	90503181
Ventricular hypoplasia	21.17	18.39	6	33184	173	90595084
Lower limb fracture	21.13	18.39	3	33187	85010	90510247
Social avoidant behaviour	21.08	18.39	14	33176	3399	90591858
Pharyngotonsillitis	21.07	18.39	6	33184	176	90595081
Carnitine deficiency	21.00	18.39	6	33184	178	90595079
Blood alkaline phosphatase increased	20.86	18.39	51	33139	48028	90547229
Acute lymphocytic leukaemia	20.84	18.39	13	33177	2835	90592422
Pulmonary artery atresia	20.84	18.39	4	33186	18	90595239
Myopathy toxic	20.80	18.39	8	33182	606	90594651
Dyschezia	20.77	18.39	13	33177	2852	90592405
Vertical infection transmission	20.74	18.39	3	33187	0	90595257
Liver transplant	20.64	18.39	12	33178	2305	90592952
Amnesia	20.60	18.39	7	33183	108498	90486759
Lactate pyruvate ratio increased	20.43	18.39	5	33185	80	90595177
Meningitis tuberculous	20.26	18.39	8	33182	650	90594607
Pallor	20.19	18.39	41	33149	34124	90561133
Cytomegalovirus chorioretinitis	20.16	18.39	12	33178	2407	90592850
Pleocytosis	20.11	18.39	9	33181	999	90594258
Bronchitis	19.98	18.39	16	33174	152911	90442346
Amenorrhoea	19.91	18.39	23	33167	11699	90583558
Pneumonia	19.87	18.39	336	32854	637723	89957534
Decreased immune responsiveness	19.84	18.39	20	33170	8728	90586529
Intentional overdose	19.74	18.39	5	33185	93829	90501428
Placental necrosis	19.74	18.39	4	33186	25	90595232
Splenomegaly	19.70	18.39	24	33166	12900	90582357
Thyroid tuberculosis	19.60	18.39	4	33186	26	90595231
Aqueductal stenosis	19.47	18.39	4	33186	27	90595230
Hemiataxia	19.47	18.39	4	33186	27	90595230
Hypotension	19.46	18.39	58	33132	325339	90269918
Spinal cord injury	19.29	18.39	9	33181	1100	90594157
Nervous system disorder	19.27	18.39	31	33159	21562	90573695
Blood albumin decreased	19.09	18.39	27	33163	16776	90578481
Muscular weakness	18.90	18.39	29	33161	206637	90388620
CSF protein increased	18.89	18.39	8	33182	778	90594479
Acquired immunodeficiency syndrome	18.88	18.39	5	33185	111	90595146
Bowel movement irregularity	18.77	18.39	17	33173	6497	90588760
Mycobacterium avium complex infection	18.77	18.39	14	33176	4084	90591173
Autoimmune hepatitis	18.75	18.39	21	33169	10330	90584927
Prescribed overdose	18.63	18.39	78	33112	97547	90497710
Myelopathy	18.59	18.39	13	33177	3431	90591826
Neuroendocrine tumour of the lung metastatic	18.51	18.39	5	33185	120	90595137
HELLP syndrome	18.50	18.39	9	33181	1208	90594049

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	2002.27	13.11	511	47901	2820	42570103
Virologic failure	1778.47	13.11	483	47929	3511	42569412
Immune reconstitution inflammatory syndrome	1613.98	13.11	556	47856	9587	42563336
Pathogen resistance	1469.36	13.11	535	47877	10915	42562008
Lipodystrophy acquired	993.21	13.11	297	48115	3153	42569770
Drug resistance	985.92	13.11	564	47848	33684	42539239
Depression	847.94	13.11	822	47590	110541	42462382
Drug interaction	825.81	13.11	1245	47167	265754	42307169
Foetal exposure during pregnancy	746.03	13.11	533	47879	46778	42526145
Hepatitis B	673.04	13.11	262	48150	6449	42566474
Exposure during pregnancy	559.42	13.11	246	48166	8302	42564621
Mitochondrial toxicity	525.33	13.11	171	48241	2444	42570479
Hepatitis B reactivation	495.64	13.11	189	48223	4389	42568534
Osteomalacia	393.68	13.11	107	48305	777	42572146
Hepatitis B DNA increased	386.50	13.11	97	48315	492	42572431
Eyelid ptosis	373.15	13.11	172	48240	6489	42566434
Fanconi syndrome acquired	362.29	13.11	122	48290	1948	42570975
Acquired gene mutation	332.33	13.11	107	48305	1473	42571450
Psychiatric decompensation	300.64	13.11	129	48283	4093	42568830
Progressive external ophthalmoplegia	262.18	13.11	87	48325	1324	42571599
Viral load increased	258.55	13.11	105	48307	2892	42570031
Depression suicidal	250.48	13.11	105	48307	3140	42569783
Tearfulness	249.40	13.11	107	48305	3393	42569530
Depressive symptom	245.94	13.11	109	48303	3744	42569179
Blood HIV RNA increased	244.21	13.11	85	48327	1506	42571417
Lipoatrophy	222.37	13.11	59	48353	386	42572537
Pinealoblastoma	217.85	13.11	49	48363	138	42572785
Psychomotor skills impaired	214.70	13.11	109	48303	5095	42567828
Hypertriglyceridaemia	196.90	13.11	130	48282	9996	42562927
Hepatic failure	192.84	13.11	227	48185	37873	42535050
Premature baby	185.10	13.11	176	48236	22977	42549946
Off label use	183.62	13.11	277	48135	638058	41934865
Fanconi syndrome	179.65	13.11	70	48342	1724	42571199
Diplopia	173.09	13.11	160	48252	20156	42552767
Polydactyly	166.84	13.11	60	48352	1174	42571749
Genotype drug resistance test	164.20	13.11	33	48379	41	42572882
Multiple-drug resistance	162.09	13.11	102	48310	7220	42565703
Renal tubular disorder	160.43	13.11	88	48324	4821	42568102
CD4 lymphocytes decreased	154.46	13.11	64	48348	1857	42571066
Hepatic fibrosis	147.36	13.11	83	48329	4789	42568134
Treatment noncompliance	143.78	13.11	195	48217	37477	42535446
Loss of personal independence in daily activities	142.46	13.11	225	48187	49591	42523332
Trisomy 21	141.40	13.11	44	48368	538	42572385
Kaposi's sarcoma	139.68	13.11	47	48365	748	42572175
Alanine aminotransferase increased	139.19	13.11	309	48103	88097	42484826
Portal hypertension	129.93	13.11	76	48336	4711	42568212
Paranoia	128.35	13.11	115	48297	13911	42559012
Gene mutation	125.41	13.11	54	48358	1727	42571196
Osteoporosis	122.35	13.11	115	48297	14791	42558132
Hypophosphataemia	118.10	13.11	132	48280	20813	42552110
Product dose omission issue	112.17	13.11	20	48392	154345	42418578
Maternal drugs affecting foetus	109.64	13.11	63	48349	3776	42569147
HIV-associated neurocognitive disorder	109.01	13.11	32	48380	316	42572607
Blood lactic acid increased	107.18	13.11	82	48330	7957	42564966
Retinal toxicity	103.95	13.11	34	48378	493	42572430
Osteonecrosis	103.49	13.11	108	48304	15757	42557166
Volvulus	103.48	13.11	49	48363	1964	42570959
Treatment failure	103.18	13.11	223	48189	62401	42510522
Psychotic disorder	102.17	13.11	145	48267	29063	42543860
Blood phosphorus decreased	100.05	13.11	58	48354	3535	42569388
Hepatic cirrhosis	97.35	13.11	116	48296	19586	42553337
Meningitis cryptococcal	96.77	13.11	55	48357	3228	42569695
Hepatitis C	94.53	13.11	84	48328	10049	42562874
Renal tubular dysfunction	92.43	13.11	30	48382	424	42572499
Aspartate aminotransferase increased	91.68	13.11	242	48170	76921	42496002
Jaundice	90.37	13.11	150	48262	34439	42538484
Dyslipidaemia	89.70	13.11	79	48333	9339	42563584
Caesarean section	89.46	13.11	45	48367	2061	42570862
Nephropathy toxic	87.94	13.11	102	48310	16736	42556187
Ophthalmoplegia	87.60	13.11	45	48367	2155	42570768
CSF HIV escape syndrome	87.14	13.11	24	48388	184	42572739
Dyspnoea	85.26	13.11	241	48171	442380	42130543
Pneumonia	84.17	13.11	226	48186	421923	42151000
Hypouricaemia	83.74	13.11	25	48387	263	42572660
Fall	83.49	13.11	86	48326	234434	42338489
Mycobacterium avium complex infection	82.00	13.11	48	48364	2979	42569944
Hyperlactacidaemia	80.63	13.11	55	48357	4461	42568462
Mitochondrial cytopathy	78.80	13.11	21	48391	140	42572783
Dandy-Walker syndrome	75.95	13.11	23	48389	255	42572668
Neonatal disorder	75.57	13.11	30	48382	777	42572146
Tuberculosis	75.47	13.11	74	48338	10025	42562898
Varices oesophageal	75.19	13.11	52	48360	4313	42568610
Death	75.14	13.11	279	48133	470906	42102017
Cytomegalovirus chorioretinitis	74.93	13.11	53	48359	4558	42568365
Peripheral swelling	74.22	13.11	8	48404	90262	42482661
Acquired immunodeficiency syndrome	73.59	13.11	26	48386	482	42572441
Pulmonary tuberculosis	73.08	13.11	56	48356	5445	42567478
Hepatic function abnormal	73.07	13.11	173	48239	51394	42521529
Blood alkaline phosphatase increased	72.56	13.11	134	48278	33463	42539460
Renal impairment	72.43	13.11	282	48130	109946	42462977
Pain	72.13	13.11	104	48308	244744	42328179
Fatigue	71.38	13.11	255	48157	435386	42137537
Hepatitis	70.78	13.11	118	48294	27182	42545741
Inappropriate schedule of product administration	70.56	13.11	12	48400	95890	42477033
Human immunodeficiency virus transmission	69.89	13.11	16	48396	50	42572873
Glycosuria	69.36	13.11	33	48379	1337	42571586
Drug abuse	69.03	13.11	17	48395	104754	42468169
Birth mark	68.28	13.11	19	48393	152	42572771
Lymphadenopathy	68.23	13.11	130	48282	33235	42539688
Progressive multifocal leukoencephalopathy	67.25	13.11	74	48338	11462	42561461
Congenital umbilical hernia	66.33	13.11	22	48390	334	42572589
Anaemia macrocytic	65.15	13.11	44	48368	3511	42569412
Proteinuria	64.54	13.11	103	48309	22880	42550043
Drug-induced liver injury	62.67	13.11	136	48276	38137	42534786
Hepatomegaly	62.56	13.11	72	48340	11713	42561210
Blood pressure increased	62.54	13.11	19	48393	101909	42471014
Hypotension	62.46	13.11	124	48288	257507	42315416
Constipation	61.79	13.11	56	48356	162235	42410688
Hepatocellular carcinoma	61.15	13.11	60	48352	8134	42564789
HIV infection	60.94	13.11	31	48381	1454	42571469
Genotype drug resistance test positive	57.91	13.11	28	48384	1176	42571747
Hepatic cancer	57.59	13.11	59	48353	8421	42564502
Completed suicide	57.37	13.11	19	48393	96446	42476477
Oesophageal candidiasis	57.16	13.11	49	48363	5586	42567337
Hyperlipidaemia	57.12	13.11	94	48318	21422	42551501
Hepatosplenomegaly	56.62	13.11	45	48367	4615	42568308
Hydrops foetalis	55.82	13.11	25	48387	880	42572043
Pregnancy	55.74	13.11	18	48394	250	42572673
Brain stem stroke	54.93	13.11	19	48393	330	42572593
Congenital anomaly	54.18	13.11	29	48383	1512	42571411
Suicidal ideation	54.09	13.11	148	48264	48013	42524910
Lipohypertrophy	53.57	13.11	18	48394	285	42572638
Calculus urinary	53.31	13.11	30	48382	1727	42571196
Ultrasound antenatal screen	52.93	13.11	21	48391	543	42572380
Blood bilirubin increased	52.69	13.11	135	48277	42117	42530806
Malignant neoplasm progression	52.29	13.11	29	48383	108371	42464552
Atrioventricular septal defect	51.69	13.11	17	48395	251	42572672
Gamma-glutamyltransferase increased	50.40	13.11	113	48299	32384	42540539
Facial wasting	49.98	13.11	14	48398	115	42572808
Blood triglycerides increased	49.89	13.11	75	48337	15821	42557102
Lactic acidosis	49.75	13.11	138	48274	45123	42527800
Urine phosphorus increased	49.67	13.11	14	48398	118	42572805
Nodular regenerative hyperplasia	49.29	13.11	24	48388	1024	42571899
Immune reconstitution inflammatory syndrome associated tuberculosis	48.89	13.11	20	48392	561	42572362
Congenital central nervous system anomaly	48.41	13.11	21	48391	684	42572239
Hyperbilirubinaemia	47.98	13.11	85	48327	20550	42552373
Basedow's disease	47.90	13.11	11	48401	35	42572888
Atrial fibrillation	47.60	13.11	53	48359	139540	42433383
Nasopharyngitis	47.45	13.11	18	48394	83978	42488945
Trisomy 18	47.38	13.11	22	48390	843	42572080
Bone density decreased	46.99	13.11	30	48382	2176	42570747
Hepatitis B virus test	46.25	13.11	8	48404	0	42572923
Cleft lip and palate	45.81	13.11	22	48390	910	42572013
Multiple fractures	45.80	13.11	26	48386	1522	42571401
Cryptococcosis	45.56	13.11	34	48378	3177	42569746
Optic nerve neoplasm	45.04	13.11	10	48402	26	42572897
Cryptorchism	44.26	13.11	28	48384	1999	42570924
Talipes	44.17	13.11	29	48383	2207	42570716
Psychomotor retardation	44.10	13.11	38	48374	4361	42568562
Congenital neoplasm	43.99	13.11	10	48402	30	42572893
Hepatic encephalopathy	43.87	13.11	72	48340	16370	42556553
Cerebral toxoplasmosis	43.38	13.11	28	48384	2070	42570853
Urine calcium increased	43.04	13.11	10	48402	34	42572889
Joint swelling	42.96	13.11	12	48400	68010	42504913
Pyelocaliectasis	42.59	13.11	24	48388	1385	42571538
Oral candidiasis	42.44	13.11	66	48346	14339	42558584
Blood bilirubin unconjugated increased	42.23	13.11	19	48393	676	42572247
Wheezing	42.22	13.11	6	48406	54775	42518148
Cachexia	42.15	13.11	49	48363	8055	42564868
Oesophageal varices haemorrhage	42.05	13.11	34	48378	3573	42569350
Macrocephaly	41.79	13.11	17	48395	470	42572453
Somnolence	41.43	13.11	60	48352	141045	42431878
Pruritus	41.42	13.11	96	48316	188675	42384248
Osteopenia	41.41	13.11	43	48369	6235	42566688
Thrombosis	39.85	13.11	14	48398	68497	42504426
Mycobacterium avium complex immune restoration disease	39.59	13.11	9	48403	27	42572896
Mitochondrial myopathy	39.52	13.11	13	48399	192	42572731
Drug ineffective	39.49	13.11	493	47919	629704	41943219
Stress	38.79	13.11	3	48409	44209	42528714
Renal tubular acidosis	38.75	13.11	29	48383	2721	42570202
CD4 lymphocytes increased	38.25	13.11	12	48400	151	42572772
Splenomegaly	38.07	13.11	69	48343	16978	42555945
Confusional state	37.76	13.11	84	48328	167513	42405410
Anaemia neonatal	37.48	13.11	15	48397	397	42572526
Pneumocystis jirovecii pneumonia	37.31	13.11	86	48326	25095	42547828
Optic atrophy	37.01	13.11	21	48391	1228	42571695
Injection site pain	36.87	13.11	10	48402	57788	42515135
COVID-19	36.35	13.11	47	48365	115901	42457022
Life expectancy shortened	36.30	13.11	9	48403	43	42572880
Neurodevelopmental disorder	35.95	13.11	15	48397	443	42572480
Death neonatal	35.80	13.11	14	48398	348	42572575
Prescribed overdose	35.01	13.11	57	48355	12870	42560053
Febrile neutropenia	34.95	13.11	102	48310	185601	42387322
Opportunistic infection	34.85	13.11	24	48388	1977	42570946
Rhabdomyosarcoma	34.58	13.11	9	48403	54	42572869
Infusion related reaction	34.39	13.11	13	48399	60793	42512130
Dizziness	34.31	13.11	156	48256	249098	42323825
Disease progression	34.02	13.11	70	48342	143586	42429337
Intentional product misuse	33.75	13.11	14	48398	61886	42511037
Blood phosphorus abnormal	33.66	13.11	11	48401	159	42572764
Feeling abnormal	33.17	13.11	19	48393	69767	42503156
Visceral leishmaniasis	33.12	13.11	19	48393	1135	42571788
White matter lesion	32.91	13.11	18	48394	980	42571943
Blood pyruvic acid increased	32.80	13.11	7	48405	14	42572909
HIV associated nephropathy	32.59	13.11	13	48399	341	42572582
Aminoaciduria	32.57	13.11	12	48400	252	42572671
Haematochezia	32.21	13.11	13	48399	58423	42514500
Cardiac disorder	32.10	13.11	8	48404	48924	42523999
Speech disorder developmental	31.98	13.11	24	48388	2261	42570662
Acute hepatitis C	31.79	13.11	10	48402	127	42572796
Lactate pyruvate ratio increased	31.63	13.11	6	48406	4	42572919
HIV lipodystrophy	31.58	13.11	7	48405	18	42572905
Hydrocele	31.50	13.11	25	48387	2558	42570365
Flushing	31.15	13.11	3	48409	37025	42535898
Hepatotoxicity	30.94	13.11	80	48332	25087	42547836
Abortion spontaneous	30.93	13.11	13	48399	391	42572532
Ascites	30.90	13.11	137	48275	56541	42516382
Congenital hydronephrosis	30.86	13.11	16	48396	781	42572142
Osteoporotic fracture	30.83	13.11	20	48392	1491	42571432
Mycobacterial infection	30.79	13.11	25	48387	2643	42570280
Beta 2 microglobulin urine increased	30.74	13.11	9	48403	88	42572835
Lymph node tuberculosis	30.73	13.11	14	48398	513	42572410
Incorrect dose administered	30.50	13.11	11	48401	52963	42519960
Meningomyelocele	30.40	13.11	11	48401	219	42572704
Secondary syphilis	30.38	13.11	9	48403	92	42572831
Viraemia	30.28	13.11	21	48391	1749	42571174
Transaminases increased	30.14	13.11	94	48318	32791	42540132
Cerebrovascular accident	29.82	13.11	40	48372	97120	42475803
HIV viraemia	29.81	13.11	8	48404	55	42572868
Cardiac failure congestive	29.71	13.11	32	48380	85570	42487353
Asthma	29.56	13.11	17	48395	62297	42510626
Mitochondrial DNA depletion	28.91	13.11	5	48407	0	42572923
Stevens-Johnson syndrome	28.83	13.11	72	48340	22106	42550817
Urticaria	28.80	13.11	25	48387	74011	42498912
Bone metabolism disorder	28.61	13.11	11	48401	261	42572662
Bone pain	28.60	13.11	75	48337	23717	42549206
Lower respiratory tract infection	28.50	13.11	6	48406	41200	42531723
Heart rate decreased	28.15	13.11	4	48408	36528	42536395
Retroviral rebound syndrome	28.11	13.11	6	48406	12	42572911
Low set ears	28.05	13.11	13	48399	496	42572427
Cushing's syndrome	28.03	13.11	12	48400	378	42572545
Muscle spasms	27.88	13.11	34	48378	86010	42486913
Cardio-respiratory arrest	27.81	13.11	16	48396	58620	42514303
Foetal growth restriction	27.57	13.11	32	48380	5251	42567672
Hepatitis cholestatic	27.54	13.11	44	48368	9780	42563143
HIV wasting syndrome	27.53	13.11	8	48404	76	42572847
Hypersplenism	27.34	13.11	13	48399	526	42572397
Contusion	27.28	13.11	7	48405	41978	42530945
Anaemia	27.13	13.11	458	47954	279820	42293103
Pre-eclampsia	26.90	13.11	7	48405	42	42572881
Blood creatinine increased	26.72	13.11	215	48197	109788	42463135
Hepatitis A	26.69	13.11	13	48399	555	42572368
Limb deformity	26.45	13.11	13	48399	566	42572357
Product use issue	26.29	13.11	29	48383	76722	42496201
Cytokine release syndrome	26.06	13.11	9	48403	44518	42528405
Granulomatous rosacea	26.03	13.11	9	48403	156	42572767
HIV test positive	25.93	13.11	9	48403	158	42572765
Angioedema	25.89	13.11	8	48404	42469	42530454
Tremor	25.79	13.11	44	48368	96885	42476038
Hypophosphataemic osteomalacia	25.72	13.11	9	48403	162	42572761
Spider naevus	25.69	13.11	6	48406	21	42572902
Syncope	25.65	13.11	46	48366	99360	42473563
Astrocytoma, low grade	25.55	13.11	8	48404	100	42572823
Influenza	25.42	13.11	20	48392	62155	42510768
Blood triglycerides abnormal	25.33	13.11	10	48402	255	42572668
Congenital cytomegalovirus infection	25.26	13.11	6	48406	23	42572900
Cardiac arrest	25.26	13.11	54	48358	109266	42463657
Hypospadias	24.55	13.11	25	48387	3542	42569381
Therapeutic product effect decreased	24.54	13.11	7	48405	39143	42533780
Meningitis tuberculous	24.49	13.11	13	48399	666	42572257
Small for dates baby	24.38	13.11	30	48382	5233	42567690
Tuberculoid leprosy	24.33	13.11	7	48405	64	42572859
Drug ineffective for unapproved indication	24.27	13.11	11	48401	46152	42526771
Blood creatine phosphokinase increased	24.23	13.11	114	48298	48224	42524699
Oxygen saturation decreased	23.79	13.11	23	48389	64664	42508259
Cardiac failure	23.69	13.11	54	48358	106802	42466121
Viral load decreased	23.65	13.11	6	48406	32	42572891
Hepatitis B surface antigen positive	23.45	13.11	8	48404	133	42572790
Trimethylaminuria	23.43	13.11	5	48407	10	42572913
Withdrawal hepatitis	23.13	13.11	4	48408	0	42572923
Genital herpes	23.09	13.11	13	48399	749	42572174
Chest discomfort	22.96	13.11	23	48389	63593	42509330
Antimitochondrial antibody positive	22.92	13.11	6	48406	37	42572886
Prostate cancer	22.91	13.11	11	48401	44632	42528291
Portal vein thrombosis	22.82	13.11	27	48385	4522	42568401
Drug intolerance	22.81	13.11	35	48377	80389	42492534
Vertical infection transmission	22.52	13.11	5	48407	13	42572910
Pancreatitis	22.39	13.11	103	48309	43165	42529758
Urine phosphorus decreased	22.39	13.11	6	48406	41	42572882
Nausea	22.34	13.11	317	48095	396482	42176441
Prenatal screening test abnormal	22.25	13.11	5	48407	14	42572909
Intracranial pressure increased	22.23	13.11	27	48385	4647	42568276
Cataract	22.12	13.11	4	48408	30600	42542323
Retroperitoneal disorder	22.02	13.11	6	48406	44	42572879
Hepatitis D RNA positive	21.99	13.11	5	48407	15	42572908
Night blindness	21.95	13.11	9	48403	254	42572669
Liver transplant rejection	21.80	13.11	20	48392	2493	42570430
Liver disorder	21.73	13.11	96	48316	39548	42533375
Disseminated tuberculosis	21.67	13.11	21	48391	2803	42570120
Bradycardia	21.66	13.11	40	48372	85444	42487479
Oesophageal atresia	21.58	13.11	11	48401	518	42572405
Nervous system disorder	21.49	13.11	55	48357	17140	42555783
Amylase increased	21.47	13.11	32	48380	6697	42566226
Chronic obstructive pulmonary disease	21.45	13.11	24	48388	63090	42509833
Gastroschisis	21.41	13.11	8	48404	175	42572748
Cellulitis	21.39	13.11	23	48389	61562	42511361
Fat tissue increased	21.29	13.11	11	48401	533	42572390
Rhinorrhoea	21.24	13.11	5	48407	31789	42541134
Anaphylactic reaction	21.23	13.11	11	48401	42732	42530191
Cardiogenic shock	21.21	13.11	7	48405	35633	42537290
Transient ischaemic attack	21.21	13.11	6	48406	33733	42539190
Abdominal discomfort	21.10	13.11	33	48379	75222	42497701
Fluid retention	21.07	13.11	5	48407	31614	42541309
Visual field defect	21.04	13.11	27	48385	4911	42568012
Taeniasis	21.04	13.11	6	48406	53	42572870
Oropharyngeal pain	21.03	13.11	11	48401	42499	42530424
Macrocytosis	20.89	13.11	14	48398	1103	42571820
Pulmonary embolism	20.85	13.11	68	48344	119544	42453379
Nephrolithiasis	20.81	13.11	90	48322	36740	42536183
Neuromyopathy	20.69	13.11	14	48398	1120	42571803
Heart rate increased	20.69	13.11	18	48394	53237	42519686
Psoriasis	20.68	13.11	15	48397	48589	42524334
Hyperhidrosis	20.66	13.11	45	48367	90467	42482456
Hepatitis C virus test	20.55	13.11	6	48406	58	42572865
Hepatitis D	20.46	13.11	6	48406	59	42572864
Dry skin	20.46	13.11	15	48397	48323	42524600
Perinatal HIV infection	20.36	13.11	4	48408	4	42572919
Maternal condition affecting foetus	20.36	13.11	4	48408	4	42572919
Herpes virus infection	20.34	13.11	23	48389	3669	42569254
Erythema	20.27	13.11	60	48352	108733	42464190
Exomphalos	20.09	13.11	8	48404	209	42572714
Malaria	20.05	13.11	8	48404	210	42572713
Attention deficit hyperactivity disorder	19.98	13.11	21	48391	3087	42569836
Strongyloidiasis	19.98	13.11	22	48390	3409	42569514
Unevaluable event	19.94	13.11	7	48405	34281	42538642
Back pain	19.92	13.11	88	48324	141688	42431235
Headache	19.88	13.11	175	48237	239194	42333729
Diaphragmatic hernia	19.88	13.11	9	48403	325	42572598
Lipids abnormal	19.88	13.11	10	48402	458	42572465
Primary syphilis	19.82	13.11	5	48407	26	42572897
Gynaecomastia	19.82	13.11	44	48368	12523	42560400
Bacterial pyelonephritis	19.80	13.11	9	48403	328	42572595
C-reactive protein increased	19.66	13.11	26	48386	63534	42509389
Bronchitis	19.52	13.11	15	48397	47186	42525737
Asymptomatic viral hepatitis	19.50	13.11	5	48407	28	42572895
Cerebral ventricle dilatation	19.37	13.11	13	48399	1026	42571897
Persistent foetal circulation	19.35	13.11	9	48403	346	42572577
Molluscum contagiosum	19.31	13.11	9	48403	348	42572575
Blood glucose increased	19.10	13.11	34	48378	73665	42499258
Crystal urine	19.09	13.11	6	48406	76	42572847
Epistaxis	19.02	13.11	29	48383	66797	42506126
Hepatitis B DNA assay positive	19.01	13.11	6	48406	77	42572846
Contraindicated product administered	18.94	13.11	3	48409	25269	42547654
Live birth	18.93	13.11	8	48404	244	42572679
Renal atrophy	18.90	13.11	14	48398	1293	42571630
Meconium ileus	18.80	13.11	5	48407	33	42572890
Liver transplant	18.78	13.11	19	48393	2672	42570251
Chest pain	18.77	13.11	88	48324	139442	42433481
Loss of anatomical alignment after fracture reduction	18.74	13.11	4	48408	8	42572915
Chordee	18.67	13.11	6	48406	82	42572841
Drug dependence	18.61	13.11	5	48407	29089	42543834
Illness	18.59	13.11	3	48409	24927	42547996
Chronic kidney disease	18.51	13.11	104	48308	47137	42525786
Neonatal pneumothorax	18.42	13.11	4	48408	9	42572914
Toxoplasmosis	18.42	13.11	15	48397	1592	42571331
Urinary tract infection	18.32	13.11	55	48357	99229	42473694
Floppy eyelid syndrome	18.31	13.11	5	48407	37	42572886
Optic nerve disorder	18.30	13.11	11	48401	717	42572206
Tracheo-oesophageal fistula	18.25	13.11	10	48402	546	42572377
Oropharyngeal candidiasis	18.23	13.11	12	48400	917	42572006
Anogenital warts	18.20	13.11	11	48401	724	42572199
Cryoglobulinaemia	18.19	13.11	10	48402	550	42572373
Hyponatraemia	18.15	13.11	57	48355	101405	42471518
Nephropathy	18.08	13.11	30	48382	6881	42566042
Amoebiasis	17.98	13.11	6	48406	93	42572830
Toxicity to various agents	17.95	13.11	170	48242	228966	42343957
Acquired aminoaciduria	17.85	13.11	4	48408	11	42572912
Fracture malunion	17.85	13.11	4	48408	11	42572912
Rectal haemorrhage	17.82	13.11	18	48394	49588	42523335
Sickle cell disease	17.79	13.11	7	48405	177	42572746
Ventricular fibrillation	17.78	13.11	6	48406	30117	42542806
Colitis ulcerative	17.71	13.11	4	48408	26171	42546752
Bulbar palsy	17.69	13.11	8	48404	288	42572635
Gout	17.61	13.11	5	48407	28050	42544873
Rectosigmoid cancer metastatic	17.60	13.11	4	48408	12	42572911
Creutzfeldt-Jakob disease	17.55	13.11	5	48407	44	42572879
Parotid gland enlargement	17.50	13.11	10	48402	593	42572330
Musculoskeletal stiffness	17.49	13.11	24	48388	57741	42515182
Endocardial fibroelastosis	17.35	13.11	4	48408	13	42572910
Meconium stain	17.35	13.11	3	48409	0	42572923
Adrenal androgen excess	17.35	13.11	3	48409	0	42572923
Gianotti-Crosti syndrome	17.35	13.11	3	48409	0	42572923
Gonadal dysgenesis	17.35	13.11	3	48409	0	42572923
Agitation	17.28	13.11	29	48383	64285	42508638
Micrognathia	17.24	13.11	8	48404	306	42572617
Nasal congestion	17.20	13.11	6	48406	29495	42543428
Adrenogenital syndrome	17.16	13.11	5	48407	48	42572875
Strabismus	17.16	13.11	17	48395	2331	42570592
Retinoblastoma	17.13	13.11	4	48408	14	42572909
Interstitial lung disease	17.10	13.11	40	48372	78422	42494501
Hepatitis B e antigen positive	17.07	13.11	5	48407	49	42572874
Anal cancer	17.05	13.11	9	48403	456	42572467
Middle ear inflammation	17.02	13.11	7	48405	199	42572724
Erosive duodenitis	17.02	13.11	15	48397	1774	42571149
Intentional overdose	17.01	13.11	20	48392	51436	42521487
Toxic optic neuropathy	17.00	13.11	12	48400	1028	42571895
Renal glycosuria	16.91	13.11	4	48408	15	42572908
Histoplasmosis disseminated	16.90	13.11	16	48396	2075	42570848
Renal aneurysm	16.89	13.11	7	48405	203	42572720
Blood uric acid decreased	16.89	13.11	9	48403	465	42572458
Polyneuropathy chronic	16.80	13.11	5	48407	52	42572871
Goitre	16.73	13.11	15	48397	1815	42571108
Glucose tolerance impaired	16.72	13.11	22	48390	4102	42568821
Hepatic steatosis	16.68	13.11	58	48354	21390	42551533
Developmental hip dysplasia	16.61	13.11	8	48404	333	42572590
Coccidioidomycosis	16.59	13.11	11	48401	851	42572072
Umbilical cord abnormality	16.55	13.11	5	48407	55	42572868
Orthostatic hypotension	16.52	13.11	7	48405	30563	42542360
AIDS related complication	16.51	13.11	4	48408	17	42572906
Blood triglycerides decreased	16.51	13.11	6	48406	121	42572802
Portal fibrosis	16.50	13.11	8	48404	338	42572585
Dehydration	16.48	13.11	94	48318	141673	42431250
Microalbuminuria	16.45	13.11	11	48401	863	42572060
Vanishing bile duct syndrome	16.44	13.11	15	48397	1856	42571067
Diverticulitis	16.41	13.11	3	48409	22770	42550153
Ear malformation	16.37	13.11	8	48404	344	42572579
Femoral neck fracture	16.37	13.11	22	48390	4187	42568736
Rash	16.36	13.11	219	48193	276735	42296188
Drug hypersensitivity	16.30	13.11	58	48354	99331	42473592
Clostridium difficile infection	16.30	13.11	3	48409	22656	42550267
Mobility decreased	16.22	13.11	10	48402	35296	42537627
Atypical mycobacterial infection	16.19	13.11	13	48399	1353	42571570
Glucose urine present	16.11	13.11	13	48399	1362	42571561
Memory impairment	16.10	13.11	20	48392	50202	42522721
Dry mouth	16.08	13.11	13	48399	39866	42533057
Optic nerve cupping	16.08	13.11	5	48407	61	42572862
Blood pressure decreased	15.95	13.11	26	48386	58306	42514617
Protrusion tongue	15.91	13.11	7	48405	236	42572687
Anogenital dysplasia	15.86	13.11	6	48406	136	42572787
Neurosyphilis	15.86	13.11	5	48407	64	42572859
Blood pressure systolic increased	15.78	13.11	6	48406	27962	42544961
Lymphocytic infiltration	15.66	13.11	11	48401	935	42571988
International normalised ratio increased	15.63	13.11	19	48393	48149	42524774
Transplant rejection	15.49	13.11	42	48370	13546	42559377
ADAMTS13 activity decreased	15.46	13.11	6	48406	146	42572777
Latent autoimmune diabetes in adults	15.39	13.11	6	48406	148	42572775
Congenital tuberculosis	15.37	13.11	4	48408	24	42572899
Glomerulonephritis proliferative	15.30	13.11	7	48405	259	42572664
Retroviral infection	15.27	13.11	3	48409	3	42572920
Tracheal fistula repair	15.27	13.11	3	48409	3	42572920
Hepatitis B DNA decreased	15.27	13.11	3	48409	3	42572920
Osteocalcin increased	15.27	13.11	3	48409	3	42572920
Musculoskeletal toxicity	15.24	13.11	6	48406	152	42572771
Hyperphosphatasaemia	15.13	13.11	5	48407	75	42572848
Neuroleptic malignant syndrome	15.11	13.11	3	48409	21469	42551454
Anal cancer stage 0	15.10	13.11	4	48408	26	42572897
Erythema elevatum diutinum	15.10	13.11	4	48408	26	42572897
Productive cough	15.04	13.11	22	48390	51545	42521378
Cryptosporidiosis infection	15.04	13.11	10	48402	777	42572146
Toxic neuropathy	14.98	13.11	9	48403	586	42572337
Hypercholesterolaemia	14.93	13.11	40	48372	12809	42560114
Hepatic enzyme increased	14.87	13.11	96	48316	45688	42527235
Subacute sclerosing panencephalitis	14.84	13.11	4	48408	28	42572895
Late developer	14.81	13.11	3	48409	4	42572919
Tubulointerstitial nephritis	14.79	13.11	73	48339	31475	42541448
Hyperphosphaturia	14.72	13.11	5	48407	82	42572841
Myopia	14.69	13.11	12	48400	1279	42571644
Psoriatic arthropathy	14.69	13.11	5	48407	24962	42547961
Ultrasound antenatal screen abnormal	14.66	13.11	5	48407	83	42572840
Sickle cell anaemia	14.66	13.11	7	48405	286	42572637
Hypomagnesaemia	14.65	13.11	7	48405	28481	42544442
Spermatozoa progressive motility abnormal	14.60	13.11	4	48408	30	42572893
Pulmonary fibrosis	14.60	13.11	6	48406	26675	42546248
Hepatitis viral	14.57	13.11	10	48402	819	42572104
Graft infection	14.45	13.11	8	48404	446	42572477
Optic neuropathy	14.44	13.11	16	48396	2496	42570427
White blood cell count increased	14.40	13.11	18	48394	45069	42527854
Urinary retention	14.40	13.11	16	48396	42198	42530725
Pain in extremity	14.38	13.11	106	48306	150498	42422425
Infection	14.30	13.11	72	48340	111996	42460927
Full blood count decreased	14.20	13.11	3	48409	20557	42552366
Plasma cell myeloma	14.17	13.11	20	48392	47558	42525365
Arthropathy	14.14	13.11	8	48404	29589	42543334
Gastrointestinal haemorrhage	14.12	13.11	60	48352	97666	42475257
Neutrophil count decreased	14.08	13.11	32	48380	63383	42509540
Product prescribing error	14.08	13.11	6	48406	26106	42546817
Tracheal stenosis	14.07	13.11	7	48405	313	42572610
Bone marrow oedema	14.06	13.11	10	48402	867	42572056
Lymphangiectasia	14.06	13.11	4	48408	35	42572888
Osteodystrophy	14.06	13.11	3	48409	6	42572917
Benign hepatic neoplasm	14.06	13.11	3	48409	6	42572917
Congenital pigmentation disorder	14.06	13.11	3	48409	6	42572917
Paraesthesia	14.05	13.11	40	48372	73419	42499504
Sinusitis	13.97	13.11	20	48392	47272	42525651
Dysgeusia	13.97	13.11	11	48401	34178	42538745
Product use in unapproved indication	13.95	13.11	138	48274	184318	42388605
Malaise	13.93	13.11	164	48248	211992	42360931
Borderline leprosy	13.86	13.11	4	48408	37	42572886
Post inflammatory pigmentation change	13.85	13.11	8	48404	484	42572439
Injection site erythema	13.84	13.11	3	48409	20192	42552731
Stillbirth	13.81	13.11	6	48406	196	42572727
Extensor plantar response	13.81	13.11	9	48403	676	42572247
Birth trauma	13.74	13.11	3	48409	7	42572916
Ergot poisoning	13.67	13.11	4	48408	39	42572884
Therapy partial responder	13.67	13.11	3	48409	20018	42552905
Wrong technique in product usage process	13.64	13.11	17	48395	42618	42530305
Non-Hodgkin's lymphoma	13.50	13.11	12	48400	1435	42571488
Coronary ostial stenosis	13.48	13.11	5	48407	107	42572816
Red blood cell schistocytes present	13.48	13.11	7	48405	343	42572580
Congenital anaemia	13.46	13.11	3	48409	8	42572915
Pancreas transplant rejection	13.45	13.11	6	48406	209	42572714
Foetal distress syndrome	13.45	13.11	11	48401	1175	42571748
Pneumococcal sepsis	13.44	13.11	12	48400	1443	42571480
Weight increased	13.42	13.11	70	48342	107913	42465010
Fat tissue decreased	13.36	13.11	5	48407	110	42572813
Anaphylactic shock	13.34	13.11	5	48407	23512	42549411
Arthralgia	13.34	13.11	159	48253	205079	42367844
COVID-19 pneumonia	13.30	13.11	4	48408	21609	42551314
Encephalitis	13.26	13.11	31	48381	9127	42563796
Stomatitis	13.24	13.11	23	48389	50306	42522617
Alpha 1 foetoprotein increased	13.16	13.11	9	48403	733	42572190
Respiratory arrest	13.13	13.11	8	48404	28416	42544507
Normal newborn	13.13	13.11	7	48405	362	42572561

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
Virologic failure	2695.76	14.20	621	66453	4331	110517894
Viral mutation identified	2608.67	14.20	592	66482	3827	110518398
Immune reconstitution inflammatory syndrome	2531.44	14.20	754	66320	15472	110506753
Pathogen resistance	1941.90	14.20	628	66446	17044	110505181
Drug resistance	1757.52	14.20	799	66275	55575	110466650
Lipodystrophy acquired	1282.97	14.20	336	66738	4188	110518037
Abortion spontaneous	922.01	14.20	439	66635	33843	110488382
Hepatitis B reactivation	899.96	14.20	285	66789	7199	110515026
Exposure during pregnancy	886.69	14.20	766	66308	166658	110355567
Stillbirth	832.21	14.20	236	66838	4028	110518197
Hepatitis B	798.89	14.20	277	66797	9335	110512890
Blood HIV RNA increased	779.66	14.20	195	66879	1993	110520232
Drug interaction	776.30	14.20	1212	65862	498971	110023254
Mitochondrial toxicity	717.27	14.20	198	66876	3047	110519178
Fanconi syndrome acquired	619.62	14.20	174	66900	2860	110519365
Abortion induced	515.19	14.20	191	66883	7828	110514397
Acquired gene mutation	490.70	14.20	142	66932	2612	110519613
Hepatitis B DNA increased	479.90	14.20	110	66964	745	110521480
Osteomalacia	469.82	14.20	122	66952	1465	110520760
Schizophrenia	445.97	14.20	232	66842	21594	110500631
Psychotic disorder	436.34	14.20	310	66764	50627	110471598
Hypomania	396.20	14.20	169	66905	10041	110512184
Foetal exposure during pregnancy	385.98	14.20	152	66922	7353	110514872
Blood bilirubin increased	374.29	14.20	334	66740	75638	110446587
Eyelid ptosis	365.28	14.20	173	66901	13154	110509071
Psychiatric decompensation	340.05	14.20	129	66945	5636	110516589
Progressive external ophthalmoplegia	320.07	14.20	88	66986	1332	110520893
Treatment noncompliance	318.80	14.20	300	66774	72690	110449535
Depression	318.13	14.20	636	66438	316699	110205526
Jaundice cholestatic	317.82	14.20	162	66912	14446	110507779
Hepatotoxicity	312.80	14.20	279	66795	63121	110459104
Viral load increased	298.36	14.20	102	66972	3288	110518937
Cholelithiasis	293.05	14.20	269	66805	63153	110459072
Hepatic failure	289.67	14.20	277	66797	68462	110453763
CD4 lymphocytes decreased	279.49	14.20	94	66980	2880	110519345
Lipoatrophy	279.17	14.20	67	67007	567	110521658
Depression suicidal	273.94	14.20	105	66969	4719	110517506
Fanconi syndrome	271.60	14.20	96	66978	3423	110518802
Portal hypertension	257.98	14.20	119	66955	8518	110513707
Tearfulness	252.96	14.20	112	66962	7283	110514942
Psychomotor skills impaired	244.99	14.20	108	66966	6950	110515275
Depressive symptom	229.89	14.20	109	66965	8305	110513920
Nephropathy toxic	223.25	14.20	162	66912	27316	110494909
Foetal death	222.02	14.20	132	66942	15913	110506312
Total lung capacity increased	219.67	14.20	91	66983	5021	110517204
Caesarean section	218.59	14.20	124	66950	13693	110508532
Alanine aminotransferase increased	213.02	14.20	392	66682	183381	110338844
CSF HIV escape syndrome	211.49	14.20	48	67026	309	110521916
Hypophosphataemia	210.91	14.20	169	66905	33013	110489212
Dyslipidaemia	209.66	14.20	127	66947	15838	110506387
Asthma-chronic obstructive pulmonary disease overlap syndrome	200.77	14.20	91	66983	6253	110515972
Peripheral swelling	197.26	14.20	12	67062	404022	110118203
Multiple-drug resistance	178.23	14.20	107	66967	13128	110509097
Nasopharyngitis	177.61	14.20	17	67057	394344	110127881
Renal tubular disorder	172.17	14.20	86	66988	7343	110514882
Hepatic fibrosis	171.24	14.20	88	66986	7978	110514247
Meningitis cryptococcal	165.70	14.20	73	67001	4689	110517536
Aspartate aminotransferase increased	164.13	14.20	324	66750	159612	110362613
Pulmonary tuberculosis	163.67	14.20	89	66985	9050	110513175
Jaundice	160.89	14.20	189	66885	59047	110463178
Hepatitis C	159.92	14.20	98	66976	12475	110509750
Hypertriglyceridaemia	158.67	14.20	107	66967	16047	110506178
Diplopia	158.12	14.20	159	66915	41735	110480490
Lymphadenopathy	155.93	14.20	193	66881	63642	110458583
Kaposi's sarcoma	155.89	14.20	43	67031	659	110521566
Arthropathy	151.84	14.20	5	67069	287517	110234708
Sarcoidosis	147.24	14.20	93	66981	12486	110509739
Proteinuria	145.77	14.20	149	66925	39869	110482356
Maternal drugs affecting foetus	143.65	14.20	49	67025	1568	110520657
Genotype drug resistance test positive	142.31	14.20	47	67027	1359	110520866
Renal tubular dysfunction	141.43	14.20	42	67032	848	110521377
Tuberculosis	140.32	14.20	103	66971	17671	110504554
Paranoia	140.15	14.20	113	66961	22261	110499964
Mitochondrial cytopathy	139.70	14.20	35	67039	360	110521865
HIV-associated neurocognitive disorder	138.57	14.20	35	67039	373	110521852
Nasal polyps	138.25	14.20	91	66983	13109	110509116
Glycosuria	137.81	14.20	54	67020	2576	110519649
Pregnancy	135.47	14.20	161	66913	50906	110471319
Pain	134.92	14.20	233	66841	954722	109567503
Fall	132.94	14.20	103	66971	603379	109918846
Abdominal discomfort	131.32	14.20	38	67036	393820	110128405
Retinal toxicity	130.85	14.20	46	67028	1613	110520612
Systemic lupus erythematosus	125.77	14.20	7	67067	254331	110267894
Cardiac murmur	124.63	14.20	110	66964	24518	110497707
Product dose omission issue	123.21	14.20	23	67051	321759	110200466
Hyperbilirubinaemia	122.38	14.20	120	66954	30551	110491674
Immune reconstitution inflammatory syndrome associated tuberculosis	121.98	14.20	39	67035	1015	110521210
Rhinitis allergic	117.55	14.20	93	66981	17829	110504396
Lactic acidosis	115.12	14.20	204	66870	92607	110429618
Alopecia	113.06	14.20	40	67034	364713	110157512
Anaemia	112.94	14.20	640	66434	546446	109975779
Hepatomegaly	111.08	14.20	97	66977	21317	110500908
Osteonecrosis	109.27	14.20	118	66956	33623	110488602
Gene mutation	107.92	14.20	49	67025	3380	110518845
Dyspnoea	107.85	14.20	330	66744	1106542	109415683
Sinusitis	107.78	14.20	24	67050	296664	110225561
Mycobacterium avium complex infection	107.37	14.20	58	67016	5819	110516406
Swelling	106.26	14.20	40	67034	351001	110171224
Fatigue	105.82	14.20	381	66693	1215577	109306648
Wound	105.77	14.20	10	67064	234427	110287798
Psoriatic arthropathy	105.39	14.20	3	67071	196758	110325467
Completed suicide	105.08	14.20	12	67062	242369	110279856
Hyperlactacidaemia	103.89	14.20	64	67010	8222	110514003
Hepatic function abnormal	101.51	14.20	189	66885	89106	110433119
Maternal exposure during pregnancy	100.07	14.20	361	66713	254522	110267703
Renal impairment	99.26	14.20	295	66779	188150	110334075
Hepatocellular carcinoma	98.36	14.20	66	67008	9814	110512411
Pinealoblastoma	96.22	14.20	19	67055	54	110522171
Impaired healing	95.47	14.20	6	67068	196711	110325514
Contusion	95.27	14.20	14	67060	233347	110288878
Hypouricaemia	95.01	14.20	28	67046	550	110521675
Premature rupture of membranes	93.86	14.20	49	67025	4588	110517637
Blood alkaline phosphatase increased	91.96	14.20	159	66915	70776	110451449
Ophthalmoplegia	90.93	14.20	44	67030	3506	110518719
Helicobacter infection	89.92	14.20	5	67069	181872	110340353
Temperature regulation disorder	89.41	14.20	69	67005	12757	110509468
Pericarditis	87.49	14.20	14	67060	219100	110303125
Fibromyalgia	86.71	14.20	4	67070	170905	110351320
Hydrops foetalis	86.70	14.20	28	67046	753	110521472
Irritable bowel syndrome	86.16	14.20	3	67071	164212	110358013
Lower respiratory tract infection	85.64	14.20	21	67053	243085	110279140
Ultrasound antenatal screen	85.32	14.20	27	67047	679	110521546
Blood lactic acid increased	84.75	14.20	73	67001	15748	110506477
Acquired immunodeficiency syndrome	84.46	14.20	23	67051	335	110521890
Therapeutic product effect decreased	84.34	14.20	22	67052	244294	110277931
Stevens-Johnson syndrome	84.15	14.20	122	66952	46779	110475446
Blister	83.36	14.20	18	67056	227358	110294867
Stomatitis	83.10	14.20	30	67044	270212	110252013
Off label use	82.98	14.20	552	66522	1499633	109022592
Joint swelling	82.64	14.20	88	66986	442757	110079468
Pruritus	80.95	14.20	143	66931	581417	109940808
Fat tissue increased	80.86	14.20	29	67045	1079	110521146
HIV viraemia	80.68	14.20	18	67056	106	110522119
Blood phosphorus decreased	80.65	14.20	53	67021	7612	110514613
Cleft lip and palate	80.27	14.20	26	67048	706	110521519
Gamma-glutamyltransferase increased	80.23	14.20	138	66936	61171	110461054
Urine phosphorus increased	79.89	14.20	19	67055	154	110522071
Injection site pain	79.17	14.20	8	67066	177914	110344311
Premature labour	78.90	14.20	56	67018	9116	110513109
Hepatosplenomegaly	78.10	14.20	50	67024	6869	110515356
Arthralgia	76.81	14.20	231	66843	779401	109742824
Varices oesophageal	76.19	14.20	50	67024	7165	110515060
Trisomy 18	76.09	14.20	24	67050	597	110521628
Hypophosphataemic osteomalacia	75.48	14.20	22	67052	415	110521810
Blood bilirubin unconjugated increased	75.37	14.20	28	67046	1153	110521072
Retinoblastoma	74.60	14.20	16	67058	76	110522149
Ergot poisoning	73.54	14.20	17	67057	120	110522105
Pre-eclampsia	70.25	14.20	51	67023	8599	110513626
Progressive multifocal leukoencephalopathy	70.04	14.20	81	66993	24875	110497350
Bronchiectasis	69.99	14.20	98	66976	36395	110485830
Cytomegalovirus chorioretinitis	69.49	14.20	47	67027	7081	110515144
Loss of personal independence in daily activities	68.92	14.20	224	66850	149796	110372429
Folliculitis	68.55	14.20	10	67064	167643	110354582
Premature baby	67.31	14.20	40	67034	4815	110517410
Injury	67.12	14.20	13	67061	177252	110344973
Weight increased	67.08	14.20	94	66980	419550	110102675
Hepatic encephalopathy	66.69	14.20	84	66990	28172	110494053
Blood pressure increased	66.41	14.20	37	67037	258336	110263889
Dry mouth	65.30	14.20	20	67054	199928	110322297
Lipohypertrophy	64.75	14.20	24	67050	982	110521243
Urticaria	64.48	14.20	59	67015	318798	110203427
Muscle spasms	64.35	14.20	45	67029	278112	110244113
Migraine	64.13	14.20	13	67061	171639	110350586
Cryptococcosis	63.80	14.20	38	67036	4593	110517632
Malaise	63.34	14.20	203	66871	671616	109850609
Infusion related reaction	63.32	14.20	83	66991	381079	110141146
Renal tubular acidosis	63.17	14.20	38	67036	4677	110517548
Lymph node tuberculosis	62.57	14.20	24	67050	1080	110521145
Pneumocystis jirovecii pneumonia	62.33	14.20	101	66973	42634	110479591
Hepatic cirrhosis	62.20	14.20	131	66943	67495	110454730
Inappropriate schedule of product administration	61.93	14.20	23	67051	203614	110318611
Cachexia	61.67	14.20	56	67018	12949	110509276
Osteoporosis	60.43	14.20	151	66923	87001	110435224
Blood creatinine increased	60.20	14.20	245	66829	182644	110339581
Calculus urinary	60.09	14.20	32	67042	3120	110519105
Chronic disease	59.95	14.20	16	67058	215	110522010
Arthritis	59.95	14.20	14	67060	167572	110354653
Splenomegaly	59.69	14.20	74	67000	24424	110497801
Facial wasting	59.10	14.20	13	67061	71	110522154
Renal failure	59.02	14.20	283	66791	226291	110295934
Musculoskeletal stiffness	58.72	14.20	50	67024	279772	110242453
Ascites	58.37	14.20	155	66919	92653	110429572
Hepatitis cholestatic	57.87	14.20	62	67012	17504	110504721
Lung neoplasm malignant	57.77	14.20	86	66988	33756	110488469
Dizziness	57.76	14.20	223	66851	697970	109824255
Discomfort	57.74	14.20	29	67045	214678	110307547
Live birth	57.52	14.20	129	66945	69355	110452870
Confusional state	56.75	14.20	125	66949	468555	110053670
Osteoarthritis	56.59	14.20	20	67054	182603	110339622
Food allergy	56.40	14.20	65	67009	19883	110502342
Suicidal ideation	56.18	14.20	154	66920	93783	110428442
Amniotic cavity infection	56.04	14.20	21	67053	886	110521339
Cushing's syndrome	55.53	14.20	21	67053	909	110521316
Joint range of motion decreased	55.46	14.20	5	67069	121827	110400398
Mobility decreased	55.46	14.20	38	67036	237384	110284841
HIV infection	55.32	14.20	23	67051	1280	110520945
Blood triglycerides increased	54.68	14.20	70	67004	23856	110498369
Cerebral toxoplasmosis	54.60	14.20	30	67044	3112	110519113
Hepatitis A	54.54	14.20	22	67052	1133	110521092
Hepatic enzyme increased	54.40	14.20	357	66717	320535	110201690
Transaminases increased	53.95	14.20	119	66955	63271	110458954
Memory impairment	53.87	14.20	26	67048	196918	110325307
Influenza	53.29	14.20	18	67056	169083	110353142
Mitochondrial DNA deletion	53.08	14.20	9	67065	6	110522219
Feeling abnormal	52.33	14.20	22	67052	180689	110341536
Hepatitis	52.23	14.20	146	66928	89908	110432317
Brain stem stroke	51.62	14.20	19	67055	762	110521463
Premature delivery	51.08	14.20	77	66997	30555	110491670
Sleep disorder	50.24	14.20	29	67045	198615	110323610
Oesophageal varices haemorrhage	49.15	14.20	33	67041	4912	110517313
Meningitis tuberculous	49.06	14.20	21	67053	1257	110520968
Drug-induced liver injury	48.73	14.20	172	66902	119895	110402330
HIV associated nephropathy	48.58	14.20	15	67059	347	110521878
Hepatitis B surface antigen positive	48.48	14.20	13	67061	178	110522047
Ocular icterus	47.60	14.20	35	67039	6018	110516207
Basedow's disease	46.96	14.20	13	67061	202	110522023
Wound infection	46.62	14.20	3	67071	96462	110425763
Rickets	46.49	14.20	11	67063	87	110522138
Granulomatous rosacea	46.32	14.20	13	67061	213	110522012
Hypotension	46.11	14.20	163	66911	523686	109998539
Injection site erythema	45.30	14.20	3	67071	94173	110428052
Hepatic cancer	45.16	14.20	44	67030	11112	110511113
Oropharyngeal pain	45.13	14.20	13	67061	135263	110386962
Paraesthesia	45.10	14.20	61	67013	276460	110245765
Premature separation of placenta	44.79	14.20	21	67053	1559	110520666
Tuberculoma of central nervous system	44.46	14.20	16	67058	601	110521624
Sciatica	44.28	14.20	3	67071	92396	110429829
Nodular regenerative hyperplasia	44.16	14.20	21	67053	1610	110520615
Pyrexia	44.05	14.20	777	66297	897488	109624737
Ill-defined disorder	43.99	14.20	20	67054	156833	110365392
Oesophageal candidiasis	43.92	14.20	44	67030	11490	110510735
Aminoaciduria	43.87	14.20	14	67060	362	110521863
Acquired aminoaciduria	42.83	14.20	8	67066	15	110522210
Umbilical cord abnormality	42.79	14.20	12	67062	196	110522029
Immunodeficiency	42.62	14.20	81	66993	38757	110483468
Hepatitis B virus test	42.36	14.20	7	67067	3	110522222
Hyperlipidaemia	42.14	14.20	77	66997	35771	110486454
Malaria	42.12	14.20	14	67060	413	110521812
Treatment failure	41.96	14.20	300	66774	276934	110245291
Obesity	41.48	14.20	9	67065	113342	110408883
Gynaecomastia	41.39	14.20	39	67035	9451	110512774
Prescribed overdose	41.32	14.20	132	66942	87449	110434776
Mycobacterium avium complex immune restoration disease	41.26	14.20	8	67066	20	110522205
Alpha 1 foetoprotein abnormal	41.25	14.20	9	67065	47	110522178
Type 2 diabetes mellitus	40.55	14.20	29	67045	177203	110345022
Drug intolerance	40.26	14.20	120	66954	406392	110115833
Optic nerve neoplasm	40.19	14.20	8	67066	24	110522201
Nasal congestion	39.86	14.20	6	67068	98276	110423949
CD4 lymphocytes increased	39.79	14.20	13	67061	363	110521862
Chronic kidney disease	39.72	14.20	119	66955	76172	110446053
Pulmonary fibrosis	39.66	14.20	7	67067	102035	110420190
Urine calcium increased	39.39	14.20	10	67064	109	110522116
Pancreatitis	38.82	14.20	135	66939	93398	110428827
Disseminated tuberculosis	38.77	14.20	29	67045	5117	110517108
Headache	38.53	14.20	346	66728	882031	109640194
Opportunistic infection	38.50	14.20	25	67049	3518	110518707
Withdrawal hepatitis	38.45	14.20	6	67068	0	110522225
Mitochondrial DNA depletion	38.45	14.20	6	67068	0	110522225
Nervous system disorder	38.38	14.20	69	67005	31652	110490573
Road traffic accident	38.35	14.20	9	67065	107389	110414836
Oligohydramnios	38.13	14.20	26	67048	3968	110518257
COVID-19	38.03	14.20	56	67018	245004	110277221
Musculoskeletal pain	38.02	14.20	33	67041	182990	110339235
Rhinorrhoea	37.87	14.20	8	67066	102658	110419567
Rheumatoid arthritis	37.83	14.20	78	66996	299535	110222690
Psychomotor retardation	37.82	14.20	34	67040	7758	110514467
Dyspepsia	37.80	14.20	36	67038	190929	110331296
Bone metabolism disorder	37.69	14.20	14	67060	576	110521649
Abdominal pain upper	37.57	14.20	99	66975	349012	110173213
Cystostomy	37.41	14.20	9	67065	77	110522148
Grip strength decreased	37.29	14.20	3	67071	80171	110442054
Stress	37.28	14.20	9	67065	105339	110416886
Neck pain	37.27	14.20	14	67060	123116	110399109
Liver transplant	37.14	14.20	27	67047	4562	110517663
Malignant neoplasm progression	36.84	14.20	31	67043	174536	110347689
Pain in extremity	36.84	14.20	161	66913	486957	110035268
Placental disorder	36.65	14.20	16	67058	1005	110521220
Pancytopenia	36.59	14.20	235	66839	209378	110312847
White matter lesion	36.39	14.20	22	67052	2732	110519493
Blood cholesterol increased	36.39	14.20	35	67039	184750	110337475
Anaphylactic reaction	36.30	14.20	12	67062	114288	110407937
Nephrolithiasis	36.11	14.20	105	66969	66107	110456118
Illness	35.76	14.20	4	67070	82167	110440058
Death	35.54	14.20	263	66811	698606	109823619
Bronchitis	35.52	14.20	26	67048	157006	110365219
Secondary syphilis	35.29	14.20	9	67065	100	110522125
Hepatitis B DNA assay positive	35.29	14.20	9	67065	100	110522125
Spina bifida	35.23	14.20	10	67064	171	110522054
Viraemia	35.18	14.20	25	67049	4077	110518148
Ectopic pregnancy	34.68	14.20	20	67054	2277	110519948
Drug hypersensitivity	34.39	14.20	150	66924	453940	110068285
Renal glycosuria	34.24	14.20	7	67067	25	110522200
Oxygen saturation decreased	34.22	14.20	27	67047	156955	110365270
Pregnancy on contraceptive	33.62	14.20	15	67059	993	110521232
Mitochondrial myopathy	33.57	14.20	12	67062	442	110521783
Haematochezia	33.55	14.20	14	67060	115510	110406715
Mycobacterial infection	33.52	14.20	25	67049	4392	110517833
Gastroschisis	33.22	14.20	7	67067	30	110522195
Somnolence	33.04	14.20	83	66991	297366	110224859
Hyperphosphaturia	32.99	14.20	9	67065	132	110522093
Strongyloidiasis	32.97	14.20	26	67048	4960	110517265
Neutropenia neonatal	32.68	14.20	7	67067	33	110522192
Blood phosphorus abnormal	32.58	14.20	11	67063	341	110521884
Insomnia	32.51	14.20	111	66963	360479	110161746
Retroviral rebound syndrome	32.21	14.20	6	67068	11	110522214
Rash erythematous	32.14	14.20	116	66958	81716	110440509
Vertical infection transmission	32.04	14.20	5	67069	0	110522225
Anaemia macrocytic	31.82	14.20	30	67044	7273	110514952
Beta 2 microglobulin urine increased	31.81	14.20	9	67065	152	110522073
HIV test positive	31.59	14.20	9	67065	156	110522069
Metabolic acidosis	31.52	14.20	132	66942	99612	110422613
Heart rate decreased	31.46	14.20	6	67068	82750	110439475
Drug ineffective	31.30	14.20	694	66380	1519846	109002379
Red blood cell sedimentation rate increased	31.25	14.20	5	67069	78297	110443928
Contraindicated product administered	31.03	14.20	65	67009	248202	110274023
HIV lipodystrophy	30.94	14.20	6	67068	15	110522210
AIDS cholangiopathy	30.94	14.20	6	67068	15	110522210
C-reactive protein increased	30.79	14.20	53	67021	217866	110304359
Hepatic cytolysis	30.69	14.20	88	66986	54965	110467260
Rash maculo-papular	30.69	14.20	107	66967	74115	110448110
Diarrhoea	30.53	14.20	497	66577	1139008	109383217
Atrial fibrillation	30.52	14.20	58	67016	229584	110292641
Oral candidiasis	30.44	14.20	77	66997	44683	110477542
Optic atrophy	30.41	14.20	19	67055	2502	110519723
Urinary tract infection	30.40	14.20	99	66975	326183	110196042
Acute hepatitis C	30.31	14.20	10	67064	288	110521937
Diabetes mellitus	30.23	14.20	130	66944	99251	110422974
Night blindness	30.14	14.20	12	67062	597	110521628
Placental insufficiency	30.04	14.20	15	67059	1279	110520946
Vomiting	29.94	14.20	743	66331	909932	109612293
Bilirubin conjugated increased	29.90	14.20	27	67047	6197	110516028
Tuberculoid leprosy	29.87	14.20	8	67066	109	110522116
Molluscum contagiosum	29.71	14.20	12	67062	620	110521605
Congenital intestinal malformation	29.67	14.20	6	67068	20	110522205
Blood pressure fluctuation	29.37	14.20	5	67069	74819	110447406
Thrombocytopenia	29.25	14.20	332	66742	348553	110173672
Genetic polymorphism	29.11	14.20	5	67069	4	110522221
Hepatitis E	28.94	14.20	23	67051	4436	110517789
Adverse event	28.79	14.20	15	67059	108794	110413431
Foetal growth abnormality	28.61	14.20	6	67068	25	110522200
Colitis ulcerative	28.59	14.20	6	67068	77357	110444868
Placental infarction	28.45	14.20	8	67066	132	110522093
Visceral leishmaniasis	28.42	14.20	16	67058	1740	110520485
Toxoplasmosis	28.38	14.20	20	67054	3219	110519006
Hyperphosphatasaemia	28.28	14.20	8	67066	135	110522090
Rectal haemorrhage	28.21	14.20	19	67055	119814	110402411
Chest pain	28.08	14.20	125	66949	376250	110145975
Drug abuse	28.05	14.20	40	67034	177371	110344854
HIV wasting syndrome	27.94	14.20	7	67067	72	110522153
Genital herpes	27.75	14.20	18	67056	2529	110519696
Amylase increased	27.63	14.20	36	67038	12483	110509742
Lower limb fracture	27.53	14.20	6	67068	75342	110446883
Hypoaesthesia	27.46	14.20	98	66976	314125	110208100
Intentional overdose	27.38	14.20	24	67050	132477	110389748
Blood creatine phosphokinase increased	27.36	14.20	102	66972	72975	110449250
Dermatitis exfoliative	27.20	14.20	34	67040	11313	110510912
Liver transplant rejection	27.14	14.20	21	67053	3897	110518328
Lung disorder	27.10	14.20	42	67032	180005	110342220
Blood triglycerides abnormal	27.06	14.20	11	67063	578	110521647
Portal vein thrombosis	27.01	14.20	27	67047	7031	110515194
Strabismus	26.99	14.20	20	67054	3479	110518746
Normal newborn	26.97	14.20	48	67026	21848	110500377
Therapeutic product effect incomplete	26.80	14.20	60	67014	223745	110298480
Incorrect dose administered	26.38	14.20	15	67059	103626	110418599
Prescribed underdose	26.38	14.20	4	67070	65170	110457055
Burning sensation	26.35	14.20	5	67069	69207	110453018
Bone density decreased	26.28	14.20	40	67034	16002	110506223
Hepatitis fulminant	26.08	14.20	29	67045	8531	110513694
Rhabdomyosarcoma	26.08	14.20	8	67066	181	110522044
Benign hydatidiform mole	26.03	14.20	7	67067	97	110522128
Constipation	25.98	14.20	120	66954	357666	110164559
Herpes virus infection	25.87	14.20	29	67045	8609	110513616
Adverse drug reaction	25.85	14.20	16	67058	105543	110416682
Central nervous system lesion	25.79	14.20	39	67035	15514	110506711
Urine phosphorus decreased	25.76	14.20	6	67068	44	110522181
Retroperitoneal disorder	25.76	14.20	6	67068	44	110522181
Blood bicarbonate decreased	25.62	14.20	24	67050	5773	110516452
Dry skin	25.43	14.20	17	67057	107636	110414589
Hepatic steatosis	25.26	14.20	76	66998	48755	110473470
Cardio-respiratory arrest	25.15	14.20	20	67054	115816	110406409
Taeniasis	24.77	14.20	6	67068	53	110522172
Visual impairment	24.72	14.20	27	67047	134401	110387824
Cystitis	24.66	14.20	5	67069	66031	110456194
Viral load decreased	24.64	14.20	5	67069	17	110522208
Injection site swelling	24.54	14.20	4	67070	61786	110460439
Night sweats	24.54	14.20	27	67047	133956	110388269
Glucose urine present	24.50	14.20	16	67058	2273	110519952
Hepatitis D RNA positive	24.42	14.20	5	67069	18	110522207
Post inflammatory pigmentation change	24.13	14.20	11	67063	766	110521459
General physical health deterioration	24.08	14.20	155	66919	425140	110097085
Herpes simplex	24.00	14.20	38	67036	15726	110506499
Lung neoplasm	23.99	14.20	27	67047	8049	110514176
Lymphocytic infiltration	23.77	14.20	15	67059	2010	110520215
Swollen tongue	23.76	14.20	4	67070	60358	110461867
Osteoporotic fracture	23.40	14.20	22	67052	5315	110516910
Gait inability	23.34	14.20	29	67045	136347	110385878
Cough	23.30	14.20	174	66900	461467	110060758
Leukopenia	23.07	14.20	162	66912	148629	110373596
Anembryonic gestation	23.05	14.20	9	67065	425	110521800
Anogenital warts	22.98	14.20	12	67062	1124	110521101
Primary syphilis	22.94	14.20	5	67069	26	110522199
Ear infection	22.91	14.20	5	67069	62727	110459498
Amoebiasis	22.88	14.20	7	67067	157	110522068
Lymphadenitis	22.86	14.20	22	67052	5471	110516754
Encephalitis	22.82	14.20	41	67033	18798	110503427
Intracranial pressure increased	22.79	14.20	30	67044	10505	110511720
Tremor	22.78	14.20	56	67018	202176	110320049
Parotid gland enlargement	22.69	14.20	12	67062	1153	110521072
Hot flush	22.67	14.20	6	67068	66030	110456195
Foetal growth restriction	22.56	14.20	17	67057	3033	110519192
Injection site reaction	22.52	14.20	13	67061	89057	110433168
Red blood cells urine	22.47	14.20	10	67064	658	110521567
Visual field defect	22.28	14.20	29	67045	10043	110512182
Erosive duodenitis	22.08	14.20	15	67059	2276	110519949
Portal hypertensive gastropathy	22.06	14.20	14	67060	1894	110520331
Vanishing bile duct syndrome	21.99	14.20	17	67057	3151	110519074
Atypical mycobacterial lymphadenitis	21.92	14.20	5	67069	33	110522192
HIV infection CDC category C	21.92	14.20	5	67069	33	110522192
Anaemia neonatal	21.92	14.20	5	67069	33	110522192
Isosporiasis	21.72	14.20	7	67067	187	110522038
Rhodococcus infection	21.71	14.20	9	67065	497	110521728
Joint stiffness	21.46	14.20	7	67067	67236	110454989
Floppy eyelid syndrome	21.42	14.20	5	67069	37	110522188
Cerebrovascular accident	21.38	14.20	49	67025	181235	110340990
Nephropathy	21.25	14.20	33	67041	13434	110508791
Unmasking of previously unidentified disease	21.25	14.20	16	67058	2852	110519373
Type III hyperlipidaemia	21.24	14.20	4	67070	8	110522217
Loss of anatomical alignment after fracture reduction	21.24	14.20	4	67070	8	110522217
Acute hepatic failure	21.02	14.20	59	67015	36409	110485816
Bulbar palsy	20.92	14.20	8	67066	357	110521868
Hepatitis D	20.90	14.20	6	67068	107	110522118
Liver function test increased	20.90	14.20	14	67060	88534	110433691
Balance disorder	20.78	14.20	24	67050	116536	110405689
Transplant rejection	20.76	14.20	46	67028	24521	110497704
Gestational diabetes	20.76	14.20	24	67050	7365	110514860
Antimitochondrial antibody positive	20.75	14.20	6	67068	110	110522115
Hospitalisation	20.73	14.20	34	67040	142459	110379766
Brain oedema	20.63	14.20	53	67021	31045	110491180
Respiratory arrest	20.59	14.20	5	67069	58294	110463931
Renal injury	20.50	14.20	39	67035	18674	110503551
Neuromyopathy	20.44	14.20	13	67061	1766	110520459
Coeliac disease	20.28	14.20	65	67009	43122	110479103
Non-Hodgkin's lymphoma	20.17	14.20	12	67062	1447	110520778
Astrocytoma, low grade	20.12	14.20	6	67068	123	110522102
Hydrocephalus	20.10	14.20	28	67046	10347	110511878
Fat redistribution	20.03	14.20	6	67068	125	110522100
Middle ear inflammation	19.90	14.20	7	67067	246	110521979
Dermatitis allergic	19.87	14.20	42	67032	21682	110500543
Retroviral infection	19.85	14.20	4	67070	13	110522212
Postpartum haemorrhage	19.72	14.20	13	67061	1876	110520349
Bone pain	19.65	14.20	85	66989	65048	110457177
Abortion missed	19.59	14.20	12	67062	1525	110520700
Medication error	19.55	14.20	21	67053	105345	110416880
Borderline leprosy	19.49	14.20	5	67069	57	110522168
Cardiac disorder	19.47	14.20	11	67063	76269	110445956
Pubertal failure	19.41	14.20	4	67070	15	110522210
Blood lactate dehydrogenase increased	19.27	14.20	65	67009	44269	110477956
AIDS related complex	19.23	14.20	3	67071	0	110522225
Adrenal androgen excess	19.23	14.20	3	67071	0	110522225
Gianotti-Crosti syndrome	19.23	14.20	3	67071	0	110522225
Unevaluable event	19.19	14.20	6	67068	59221	110463004
Inflammation	19.14	14.20	57	67017	193181	110329044
Erythema elevatum diutinum	19.01	14.20	4	67070	17	110522208
Cryoglobulinaemia	18.95	14.20	11	67063	1268	110520957
Oropharyngeal candidiasis	18.90	14.20	13	67061	2013	110520212
Central nervous system immune reconstitution inflammatory response	18.75	14.20	5	67069	67	110522158
Cytomegalovirus infection	18.75	14.20	74	67000	54370	110467855
Renal aneurysm	18.69	14.20	7	67067	295	110521930
Infection	18.52	14.20	136	66938	362064	110160161
Paraparesis	18.46	14.20	18	67056	4548	110517677
Ballismus	18.40	14.20	7	67067	308	110521917
Acute lymphocytic leukaemia	18.38	14.20	20	67054	5745	110516480
Bradycardia	18.36	14.20	42	67032	155475	110366750
Colitis	18.32	14.20	21	67053	102302	110419923
Paradoxical drug reaction	18.28	14.20	26	67048	9791	110512434
Gastrointestinal disorder	18.25	14.20	80	66994	241872	110280353
Eyelid oedema	18.21	14.20	33	67041	15229	110506996
Congenital anomaly	18.17	14.20	10	67064	1041	110521184
Optic nerve cupping	18.16	14.20	5	67069	76	110522149
Meningomyelocele	18.16	14.20	4	67070	22	110522203
Diverticulitis	18.11	14.20	5	67069	53517	110468708
Ultrasound antenatal screen abnormal	17.93	14.20	5	67069	80	110522145
Disseminated Bacillus Calmette-Guerin infection	17.88	14.20	7	67067	333	110521892
Pneumococcal sepsis	17.87	14.20	13	67061	2199	110520026
Syncope	17.80	14.20	63	67011	202473	110319752
Ileal ulcer	17.76	14.20	12	67062	1805	110520420
Cardiac failure congestive	17.65	14.20	41	67033	150959	110371266
Benign hepatic neoplasm	17.53	14.20	5	67069	87	110522138
Acute hepatitis B	17.52	14.20	8	67066	559	110521666
Cholestatic liver injury	17.52	14.20	22	67052	7354	110514871
Bacterial pyelonephritis	17.51	14.20	9	67065	816	110521409
Hepatitis viral	17.50	14.20	11	67063	1464	110520761
Dry eye	17.47	14.20	6	67068	55787	110466438
Drug ineffective for unapproved indication	17.46	14.20	22	67052	102816	110419409
Cryptosporidiosis infection	17.38	14.20	10	67064	1133	110521092
Blood uric acid decreased	17.38	14.20	11	67063	1482	110520743
Trisomy 21	17.38	14.20	5	67069	90	110522135
Blood pressure systolic increased	17.19	14.20	15	67059	82976	110439249
Renal atrophy	17.18	14.20	13	67061	2333	110519892
Flushing	17.17	14.20	23	67051	104713	110417512
Hepatitis B DNA decreased	17.15	14.20	3	67071	3	110522222
Kwashiorkor	17.15	14.20	3	67071	3	110522222
Funisitis	17.15	14.20	3	67071	3	110522222
Cervix operation	17.15	14.20	3	67071	3	110522222
Multiple fractures	17.13	14.20	24	67050	8916	110513309
Influenza like illness	17.10	14.20	17	67057	88395	110433830
Spermatozoa progressive motility abnormal	17.09	14.20	4	67070	30	110522195
Feeling hot	17.08	14.20	18	67056	91088	110431137
Anal cancer stage 0	16.98	14.20	4	67070	31	110522194
Histoplasmosis disseminated	16.96	14.20	16	67058	3883	110518342
Pathological fracture	16.95	14.20	28	67046	12004	110510221
Transplant dysfunction	16.92	14.20	23	67051	8305	110513920
Heart rate increased	16.86	14.20	39	67035	143795	110378430
Nail disorder	16.85	14.20	7	67067	57928	110464297
Blood creatine phosphokinase MB increased	16.79	14.20	14	67060	2889	110519336
Viral hepatitis carrier	16.76	14.20	4	67070	33	110522192
Thrombosis	16.68	14.20	25	67049	108637	110413588
Disseminated intravascular coagulation	16.62	14.20	59	67015	41227	110480998
Musculoskeletal toxicity	16.61	14.20	6	67068	228	110521997
Choroiditis	16.59	14.20	11	67063	1604	110520621
Small for dates baby	16.34	14.20	8	67066	654	110521571
Drug dependence	16.33	14.20	5	67069	50015	110472210
Renal tubular necrosis	16.30	14.20	48	67026	30427	110491798
Orthostatic hypotension	16.28	14.20	10	67064	66239	110455986
Obstructive airways disorder	16.21	14.20	4	67070	46145	110476080
Blood albumin decreased	16.19	14.20	45	67029	27607	110494618
Crystal urine	16.14	14.20	5	67069	117	110522108
Tetany	16.08	14.20	15	67059	3589	110518636
Lipids abnormal	16.08	14.20	8	67066	677	110521548
Toxic optic neuropathy	16.00	14.20	10	67064	1318	110520907
Burkitt's lymphoma	15.94	14.20	5	67069	122	110522103
Hyperbilirubinaemia neonatal	15.93	14.20	3	67071	6	110522219
Glycocholic acid increased	15.93	14.20	3	67071	6	110522219
Carbon dioxide combining power abnormal	15.93	14.20	3	67071	6	110522219
Hydromyelia	15.93	14.20	3	67071	6	110522219
Acute fatty liver of pregnancy	15.89	14.20	4	67070	42	110522183
Portal fibrosis	15.86	14.20	8	67066	697	110521528
Asthma	15.85	14.20	88	66986	250203	110272022
Lipase increased	15.82	14.20	35	67039	18637	110503588
Albuminuria	15.79	14.20	9	67065	1002	110521223
Clostridium difficile infection	15.65	14.20	6	67068	52123	110470102
Cholestasis	15.64	14.20	79	66995	64439	110457786
Haematoma	15.56	14.20	8	67066	58468	110463757
Drug reaction with eosinophilia and systemic symptoms	15.54	14.20	94	66980	82001	110440224
Gestational hypertension	15.53	14.20	12	67062	2222	110520003
Prurigo	15.51	14.20	10	67064	1390	110520835
Product use issue	15.47	14.20	118	66956	311577	110210648
Limb discomfort	15.45	14.20	3	67071	40851	110481374
Lupus-like syndrome	15.42	14.20	3	67071	40789	110481436
Anaphylactic shock	15.36	14.20	6	67068	51540	110470685
Myopia	15.36	14.20	12	67062	2259	110519966
Multiple organ dysfunction syndrome	15.34	14.20	150	66924	151560	110370665
Osteocalcin increased	15.33	14.20	3	67071	8	110522217
Rectosigmoid cancer metastatic	15.33	14.20	4	67070	49	110522176
Osteonecrosis of jaw	15.32	14.20	5	67069	48012	110474213
Product prescribing error	15.26	14.20	6	67068	51325	110470900
Hypersplenism	15.23	14.20	8	67066	758	110521467
Sleep apnoea syndrome	15.23	14.20	3	67071	40444	110481781
Glomerulonephritis proliferative	15.22	14.20	7	67067	497	110521728
Leishmaniasis	15.16	14.20	7	67067	502	110521723
Developmental delay	15.10	14.20	10	67064	1455	110520770
Carnitine deficiency	15.04	14.20	6	67068	300	110521925
Disseminated mycobacterium avium complex infection	15.04	14.20	7	67067	511	110521714
AIDS related complication	15.04	14.20	4	67070	53	110522172
Graft infection	15.02	14.20	8	67066	780	110521445
Myopathy	14.99	14.20	41	67033	24919	110497306
Tubulointerstitial nephritis	14.99	14.20	69	67005	54215	110468010
Portal venous gas	14.86	14.20	7	67067	525	110521700
Pharyngotonsillitis	14.84	14.20	6	67068	311	110521914
Hypoglycaemia	14.83	14.20	30	67044	116074	110406151
CD4 lymphocytes	14.83	14.20	3	67071	10	110522215
Immunosuppressant drug level increased	14.82	14.20	26	67048	11698	110510527
Plasmablastic lymphoma	14.81	14.20	8	67066	802	110521423
Antiviral drug level below therapeutic	14.77	14.20	4	67070	57	110522168
Throat irritation	14.74	14.20	7	67067	53545	110468680
Chest discomfort	14.67	14.20	55	67019	173793	110348432
Hyponatraemia	14.63	14.20	75	66999	217578	110304647
ADAMTS13 activity decreased	14.62	14.20	6	67068	323	110521902
Macrocephaly	14.58	14.20	4	67070	60	110522165
Melanaemia	14.52	14.20	4	67070	61	110522164
Bovine tuberculosis	14.48	14.20	5	67069	166	110522059
Aplasia pure red cell	14.46	14.20	23	67051	9555	110512670
Liver injury	14.44	14.20	45	67029	150368	110371857
Acute stress disorder	14.44	14.20	7	67067	560	110521665
Infected vasculitis	14.40	14.20	3	67071	12	110522213
Anogenital dysplasia	14.34	14.20	5	67069	171	110522054
Alpha 1 foetoprotein increased	14.33	14.20	8	67066	856	110521369
Vaccination failure	14.32	14.20	12	67062	2494	110519731
Dehydration	14.26	14.20	105	66969	279406	110242819
Hepatitis C virus test	14.23	14.20	4	67070	66	110522159
Onychomycosis	14.21	14.20	3	67071	38528	110483697

FDA Adverse Event Reporting System (Pediatric)

None

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
ATC	J05AR28	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
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D000998	Antiviral Agents
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D018894	Reverse Transcriptase Inhibitors
MeSH PA	D019380	Anti-HIV Agents
MeSH PA	D019384	Nucleic Acid Synthesis Inhibitors
CHEBI has role	CHEBI:22587	antiviral agent
CHEBI has role	CHEBI:33231	antitubercular agent
CHEBI has role	CHEBI:35441	antiinfective agent
CHEBI has role	CHEBI:35610	antineoplastic agent
CHEBI has role	CHEBI:36044	antiviral drug
CHEBI has role	CHEBI:50266	prodrug
CHEBI has role	CHEBI:50904	allergen
CHEBI has role	CHEBI:53756	HIV-1 reverse transcriptase inhibitor
CHEBI has role	CHEBI:59897	EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor
CHEBI has role	CHEBI:62868	hepatoprotective agent
CHEBI has role	CHEBI:64946	anti-HIV agent
CHEBI has role	CHEBI:64951	anti-HBV agent
CHEBI has role	CHEBI:67079	anti-inflammatory agent

Related Drugs by ATC class:

J05AF Nucleoside and nucleotide reverse transcriptase inhibitors 12 drugs

abacavir adefovir dipivoxil clevudine didanosine emtricitabine entecavir stavudine telbivudine tenofovir alafenamide tenofovir disoproxil zalcitabine zidovudine

J05AR Antivirals for treatment of HIV infections, combinations 19 drugs

abacavir atazanavir bictegravir cobicistat darunavir dolutegravir doravirine efavirenz elvitegravir emtricitabine lopinavir nevirapine show all 19 →

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	Aug. 30, 2032	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	Aug. 30, 2032	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	Aug. 30, 2032	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 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
EQ 50MG BASE;300MG	DOVATO	VIIV HLTHCARE	N211994	April 8, 2019	RX	TABLET	ORAL	April 5, 2027	NEW PATIENT POPULATION

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	Structural		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
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	24 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
ABACAVIR and LAMIVUDINE	HUMAN PRESCRIPTION DRUG LABEL	2	31722-838	TABLET, FILM COATED	300 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 and Zidovudine	Human Prescription Drug Label	2	33342-003	TABLET	150 mg	ORAL	ANDA	25 sections
Abacavir and Lamivudine	Human Prescription Drug Label	2	33342-440	TABLET, FILM COATED	300 mg	ORAL	ANDA	27 sections
Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate	Human Prescription Drug Label	3	42385-928	TABLET, FILM COATED	300 mg	ORAL	ANDA	30 sections
Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate	Human Prescription Drug Label	3	42385-929	TABLET, FILM COATED	300 mg	ORAL	ANDA	30 sections
Abacavir and Lamivudine	Human Prescription Drug Label	2	42385-962	TABLET, FILM COATED	300 mg	ORAL	ANDA	28 sections
LAMIVUDINE and ZIDOVUDINE	HUMAN PRESCRIPTION DRUG LABEL	2	43063-900	TABLET, FILM COATED	150 mg	ORAL	ANDA	24 sections
LAMIVUDINE and ZIDOVUDINE	HUMAN PRESCRIPTION DRUG LABEL	2	43063-900	TABLET, FILM COATED	150 mg	ORAL	ANDA	24 sections
SYMFI LO	HUMAN PRESCRIPTION DRUG LABEL	3	49502-425	TABLET, FILM COATED	300 mg	ORAL	NDA	32 sections
CIMDUO	HUMAN PRESCRIPTION DRUG LABEL	2	49502-450	TABLET, FILM COATED	300 mg	ORAL	NDA	29 sections
SYMFI	HUMAN PRESCRIPTION DRUG LABEL	3	49502-475	TABLET, FILM COATED	300 mg	ORAL	NDA	31 sections
COMBIVIR	HUMAN PRESCRIPTION DRUG LABEL	2	49702-202	TABLET, FILM COATED	150 mg	ORAL	NDA	25 sections
EPIVIR	HUMAN PRESCRIPTION DRUG LABEL	1	49702-203	TABLET, FILM COATED	150 mg	ORAL	NDA	25 sections
EPIVIR	HUMAN PRESCRIPTION DRUG LABEL	1	49702-204	TABLET, FILM COATED	300 mg	ORAL	NDA	25 sections

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lamivudine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Description:

Drug dosage:

ADMET properties:

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Approvals:

FDA Adverse Event Reporting System (Female)

FDA Adverse Event Reporting System (Male)

FDA Adverse Event Reporting System (Geriatric)

FDA Adverse Event Reporting System (Pediatric)

Pharmacologic Action:

Related Drugs by ATC class:

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

🐶 Veterinary Drug Use

🐶 Veterinary products

Acid dissociation constants calculated using MoKa v3.0.0

Orange Book patent data (new drug applications)

Orange Book exclusivity data (new drug applications)

Bioactivity Summary:

External reference:

Pharmaceutical products: