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

Stem definition	Drug id	CAS RN
uridine derivatives used as antiviral agents and as antineoplastics	1539	134678-17-4

Description:

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

Molecule

Description

Molfile Inchi Smiles

Synonyms:

lamivudine
virolam
zeffix

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

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

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.30	g	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	70 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	67 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	21.81 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	86 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	1.30 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	4.80 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.94 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	9.10 hours	Lombardo F, Berellini G, Obach RS

Approvals:

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

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Exposure during pregnancy	2114.40	15.83	1095	25269	119920	50458840
Abortion spontaneous	1276.25	15.83	557	25807	41215	50537545
Virologic failure	1218.05	15.83	256	26108	1308	50577452
Viral mutation identified	1201.94	15.83	255	26109	1374	50577386
Drug resistance	1063.02	15.83	392	25972	18597	50560163
Stillbirth	1017.12	15.83	287	26077	5665	50573095
Pathogen resistance	814.23	15.83	239	26125	5450	50573310
Immune reconstitution inflammatory syndrome	781.83	15.83	230	26134	5286	50573474
Foetal exposure during pregnancy	745.20	15.83	337	26027	27022	50551738
Abortion induced	658.71	15.83	229	26135	9115	50569645
Premature baby	376.36	15.83	186	26178	18151	50560609
Pregnancy	367.84	15.83	215	26149	29362	50549398
Blood HIV RNA increased	348.66	15.83	76	26288	473	50578287
Live birth	294.42	15.83	152	26212	16256	50562504
Maternal exposure during pregnancy	274.31	15.83	375	25989	159403	50419357
Caesarean section	266.63	15.83	140	26224	15499	50563261
Fanconi syndrome acquired	264.34	15.83	67	26297	856	50577904
Foetal death	245.58	15.83	108	26256	8072	50570688
Lipodystrophy acquired	235.55	15.83	66	26298	1263	50577497
Hepatitis B reactivation	231.08	15.83	72	26292	2015	50576745
Hepatotoxicity	215.95	15.83	149	26215	27077	50551683
Maternal drugs affecting foetus	181.96	15.83	76	26288	5001	50573759
Blood bilirubin increased	179.01	15.83	142	26222	31896	50546864
CD4 lymphocytes decreased	177.26	15.83	53	26311	1286	50577474
Treatment noncompliance	173.54	15.83	136	26228	30014	50548746
Hypomania	170.11	15.83	70	26294	4435	50574325
Jaundice cholestatic	161.59	15.83	70	26294	5041	50573719
Premature rupture of membranes	158.91	15.83	67	26297	4513	50574247
Premature labour	154.75	15.83	88	26276	11388	50567372
Schizophrenia	145.67	15.83	73	26291	7324	50571436
Anaemia	128.97	15.83	354	26010	252102	50326658
Pre-eclampsia	128.56	15.83	69	26295	7975	50570785
Drug ineffective	127.92	15.83	144	26220	819189	49759571
Mitochondrial toxicity	127.72	15.83	31	26333	327	50578433
Pain	126.03	15.83	73	26291	578830	49999930
Acquired gene mutation	123.60	15.83	36	26328	795	50577965
Viral load increased	119.90	15.83	38	26326	1125	50577635
Hepatitis B	117.90	15.83	50	26314	3416	50575344
Hepatitis B DNA increased	116.03	15.83	25	26339	146	50578614
Human immunodeficiency virus transmission	115.75	15.83	21	26343	39	50578721
Fatigue	112.90	15.83	122	26242	707479	49871281
Fanconi syndrome	112.51	15.83	36	26328	1100	50577660
Foetal growth restriction	106.33	15.83	57	26307	6570	50572190
Trisomy 21	106	15.83	27	26337	352	50578408
Lactic acidosis	101.40	15.83	105	26259	33250	50545510
Fall	101.34	15.83	25	26339	334907	50243853
Joint swelling	100.73	15.83	7	26357	245279	50333481
Premature delivery	99.37	15.83	89	26275	23574	50555186
Hypophosphataemia	96.23	15.83	58	26306	8356	50570404
Lipoatrophy	95.97	15.83	24	26340	289	50578471
Nephropathy toxic	93.52	15.83	56	26308	7973	50570787
Psychotic disorder	89.54	15.83	81	26283	21731	50557029
Normal newborn	89.37	15.83	51	26313	6640	50572120
Portal hypertension	86.58	15.83	40	26324	3352	50575408
Osteomalacia	86.36	15.83	26	26338	646	50578114
Polydactyly	86.21	15.83	22	26342	289	50578471
Glycosuria	85.54	15.83	29	26335	1065	50577695
Proteinuria	85.11	15.83	70	26294	16527	50562233
Hyperbilirubinaemia	84.49	15.83	56	26308	9514	50569246
Genotype drug resistance test positive	82.78	15.83	21	26343	269	50578491
Renal tubular dysfunction	82.25	15.83	22	26342	351	50578409
Mitochondrial cytopathy	82.05	15.83	20	26344	215	50578545
Peripheral swelling	81.37	15.83	7	26357	205929	50372831
Off label use	80.92	15.83	77	26287	474349	50104411
Ventricular septal defect	79.91	15.83	40	26324	4001	50574759
Placental disorder	77.95	15.83	29	26335	1401	50577359
Nasopharyngitis	77.77	15.83	6	26358	192921	50385839
Rheumatoid arthritis	77.07	15.83	8	26356	202542	50376218
Congenital umbilical hernia	76.36	15.83	20	26344	293	50578467
Amniotic cavity infection	76.14	15.83	27	26337	1136	50577624
Birth mark	76.00	15.83	17	26347	121	50578639
Hyperlactacidaemia	75.85	15.83	33	26331	2400	50576360
Ectopic kidney	75.33	15.83	15	26349	55	50578705
Infusion related reaction	75.33	15.83	3	26361	169554	50409206
Alpha 1 foetoprotein abnormal	71.50	15.83	14	26350	46	50578714
Abdominal discomfort	70.57	15.83	17	26347	231624	50347136
Premature separation of placenta	69.96	15.83	28	26336	1650	50577110
Product dose omission issue	68.06	15.83	8	26356	183830	50394930
Blood lactic acid increased	67.77	15.83	40	26324	5545	50573215
Retinoblastoma	66.47	15.83	14	26350	72	50578688
Jaundice	65.97	15.83	75	26289	26354	50552406
Rash maculo-papular	65.48	15.83	75	26289	26566	50552194
Alopecia	65.45	15.83	23	26341	245024	50333736
Fat tissue increased	64.54	15.83	20	26344	549	50578211
CSF HIV escape syndrome	64.37	15.83	14	26350	86	50578674
Hepatomegaly	62.74	15.83	49	26315	10744	50568016
Pulmonary tuberculosis	60.93	15.83	34	26330	4239	50574521
Systemic lupus erythematosus	60.77	15.83	3	26361	140619	50438141
Alanine aminotransferase increased	59.70	15.83	138	26226	88221	50490539
Oligohydramnios	59.03	15.83	37	26327	5713	50573047
Ergot poisoning	58.68	15.83	13	26351	88	50578672
Congenital anomaly	58.66	15.83	24	26340	1497	50577263
Small for dates baby	58.63	15.83	31	26333	3474	50575286
Ectopic pregnancy	58.01	15.83	27	26337	2300	50576460
Renal tubular disorder	56.82	15.83	27	26337	2410	50576350
Cholelithiasis	55.88	15.83	83	26281	37890	50540870
Placental insufficiency	55.58	15.83	22	26342	1259	50577501
Sinusitis	54.99	15.83	11	26353	170547	50408213
Stevens-Johnson syndrome	54.75	15.83	62	26302	21690	50557070
Meningitis cryptococcal	54.39	15.83	21	26343	1124	50577636
Hepatic failure	54.01	15.83	75	26289	32208	50546552
Aspartate aminotransferase increased	53.99	15.83	123	26241	77875	50500885
Completed suicide	53.42	15.83	4	26360	131885	50446875
Lymphadenopathy	53.33	15.83	76	26288	33423	50545337
Arthralgia	53.19	15.83	92	26272	438610	50140150
Hypertriglyceridaemia	53.04	15.83	34	26330	5457	50573303
Foetal distress syndrome	52.68	15.83	21	26343	1224	50577536
Umbilical cord abnormality	51.17	15.83	17	26347	586	50578174
Atrial septal defect	50.94	15.83	35	26329	6306	50572454
Malaria	49.10	15.83	13	26351	199	50578561
Constipation	48.60	15.83	18	26346	185690	50393070
Swelling	48.47	15.83	22	26342	200850	50377910
Drug intolerance	48.37	15.83	27	26337	219077	50359683
Hepatitis	48.09	15.83	70	26294	31383	50547377
Pain in extremity	47.93	15.83	43	26321	272822	50305938
Drug interaction	47.59	15.83	218	26146	199403	50379357
Anaemia macrocytic	46.72	15.83	24	26340	2535	50576225
Tuberculosis	46.48	15.83	40	26324	10043	50568717
Cleft lip and palate	46.46	15.83	14	26350	349	50578411
Ultrasound antenatal screen abnormal	45.49	15.83	11	26353	114	50578646
Dyspnoea	43.22	15.83	144	26220	547464	50031296
Cushing's syndrome	42.25	15.83	15	26349	633	50578127
Discomfort	41.93	15.83	4	26360	108376	50470384
Ultrasound scan abnormal	41.72	15.83	12	26352	253	50578507
Mitochondrial DNA deletion	41.59	15.83	7	26357	6	50578754
Low birth weight baby	41.52	15.83	30	26334	5851	50572909
HIV infection	40.90	15.83	12	26352	272	50578488
Ocular icterus	39.85	15.83	24	26340	3451	50575309
Blood bilirubin unconjugated increased	39.60	15.83	12	26352	305	50578455
Immune reconstitution inflammatory syndrome associated tuberculosis	39.05	15.83	12	26352	320	50578440
Rickets	38.17	15.83	8	26356	40	50578720
Drug hypersensitivity	37.91	15.83	45	26319	250965	50327795
Patent ductus arteriosus	37.76	15.83	24	26340	3796	50574964
Therapeutic product effect decreased	37.63	15.83	12	26352	136038	50442722
Neonatal disorder	36.61	15.83	13	26351	549	50578211
Cleft palate	36.47	15.83	15	26349	948	50577812
Gene mutation	35.62	15.83	16	26348	1255	50577505
Headache	35.44	15.83	140	26224	506395	50072365
Gestational diabetes	35.19	15.83	30	26334	7435	50571325
Pregnancy on contraceptive	35.19	15.83	15	26349	1037	50577723
Tuberculoma of central nervous system	34.82	15.83	11	26353	322	50578438
Death neonatal	34.28	15.83	10	26354	222	50578538
CD4 lymphocytes increased	33.92	15.83	9	26355	139	50578621
Hypouricaemia	33.92	15.83	9	26355	139	50578621
Isosporiasis	32.92	15.83	7	26357	38	50578722
Hepatic enzyme increased	32.68	15.83	150	26214	137230	50441530
Contusion	32.65	15.83	9	26355	112174	50466586
Hepatitis A	32.42	15.83	11	26353	405	50578355
Metabolic acidosis	32.32	15.83	66	26298	38759	50540001
Placental infarction	32.25	15.83	10	26354	275	50578485
Benign hydatidiform mole	32.01	15.83	8	26356	96	50578664
Atrial fibrillation	31.88	15.83	7	26357	101738	50477022
AIDS cholangiopathy	31.85	15.83	6	26358	15	50578745
Neural tube defect	31.60	15.83	9	26355	183	50578577
Cardiac malposition	30.91	15.83	7	26357	53	50578707
Multiple-drug resistance	30.73	15.83	20	26344	3294	50575466
Weight increased	30.67	15.83	36	26328	201855	50376905
Infection	30.64	15.83	27	26337	172927	50405833
Back pain	30.56	15.83	42	26322	219988	50358772
Influenza	30.51	15.83	5	26359	89533	50489227
Hydrops foetalis	30.37	15.83	10	26354	335	50578425
HIV-associated neurocognitive disorder	30.18	15.83	8	26356	123	50578637
Pericarditis	30.18	15.83	3	26361	78686	50500074
Renal tubular acidosis	29.79	15.83	15	26349	1519	50577241
Neutropenia	29.77	15.83	154	26210	147811	50430949
Lymphadenitis	29.55	15.83	18	26346	2642	50576118
Hepatosplenomegaly	29.21	15.83	17	26347	2295	50576465
Hepatic cytolysis	29.21	15.83	28	26336	8075	50570685
Neutropenia neonatal	28.57	15.83	7	26357	77	50578683
Bilirubin conjugated increased	28.41	15.83	17	26347	2415	50576345
Feeling abnormal	28.34	15.83	15	26349	125477	50453283
Chronic disease	28.33	15.83	7	26357	80	50578680
Infertility	28.25	15.83	11	26353	602	50578158
Ballismus	28.25	15.83	7	26357	81	50578679
Drug reaction with eosinophilia and systemic symptoms	28.15	15.83	52	26312	28372	50550388
Dyslipidaemia	28.10	15.83	24	26340	5964	50572796
Twin pregnancy	28.01	15.83	13	26351	1100	50577660
Postpartum haemorrhage	27.89	15.83	15	26349	1739	50577021
Gamma-glutamyltransferase increased	27.85	15.83	53	26311	29570	50549190
Prenatal screening test abnormal	27.66	15.83	5	26359	9	50578751
Gestational hypertension	27.51	15.83	16	26348	2157	50576603
Double outlet right ventricle	27.03	15.83	6	26358	41	50578719
Cerebral toxoplasmosis	26.86	15.83	11	26353	688	50578072
Ascites	26.42	15.83	58	26306	35803	50542957
Pruritus	26.32	15.83	69	26295	283499	50295261
Bicuspid pulmonary valve	26.24	15.83	4	26360	0	50578760
Anembryonic gestation	26.10	15.83	10	26354	524	50578236
Lymph node tuberculosis	26.02	15.83	11	26353	745	50578015
Hepatitis B surface antigen positive	25.99	15.83	6	26358	50	50578710
Diarrhoea	25.93	15.83	190	26174	588286	49990474
Cholestatic liver injury	25.90	15.83	15	26349	2006	50576754
Product use issue	25.68	15.83	24	26340	149451	50429309
Funisitis	25.64	15.83	5	26359	16	50578744
Vomiting	25.41	15.83	358	26006	460400	50118360
Malignant neoplasm progression	25.10	15.83	3	26361	68121	50510639
Ovarian failure	24.96	15.83	12	26352	1099	50577661
Hyperphosphaturia	24.57	15.83	5	26359	21	50578739
Blood pressure increased	24.53	15.83	20	26344	133112	50445648
Urinary tract infection	24.41	15.83	50	26314	223970	50354790
Neonatal aspiration	24.36	15.83	7	26357	147	50578613
Cytomegalovirus chorioretinitis	24.28	15.83	13	26351	1494	50577266
Muscle spasms	24.23	15.83	18	26346	125535	50453225
Retinal toxicity	24.20	15.83	12	26352	1176	50577584
Acquired aminoaciduria	24.01	15.83	4	26360	3	50578757
Fat redistribution	24.01	15.83	4	26360	3	50578757
Eyelid oedema	23.85	15.83	27	26337	9439	50569321
Kaposi's sarcoma	23.76	15.83	7	26357	161	50578599
Abortion missed	23.64	15.83	13	26351	1575	50577185
Alpha 1 foetoprotein increased	23.64	15.83	7	26357	164	50578596
Hypophosphataemic osteomalacia	23.64	15.83	7	26357	164	50578596
Hepatic displacement	23.54	15.83	5	26359	27	50578733
Fallot's tetralogy	23.50	15.83	6	26358	79	50578681
Foetal anaemia	23.09	15.83	5	26359	30	50578730
Cachexia	22.98	15.83	19	26345	4514	50574246
Isoimmune haemolytic disease	22.95	15.83	5	26359	31	50578729
Hepatitis B DNA assay positive	22.95	15.83	5	26359	31	50578729
Anaemia neonatal	22.87	15.83	8	26356	323	50578437
Musculoskeletal stiffness	22.82	15.83	20	26344	128461	50450299
Asthma	22.78	15.83	9	26355	89328	50489432
Haemorrhage in pregnancy	22.75	15.83	13	26351	1696	50577064
Lipase increased	22.61	15.83	25	26339	8516	50570244
Anxiety	22.61	15.83	36	26328	177570	50401190
Cardiac murmur	22.60	15.83	28	26336	10756	50568004
AIDS related complication	22.20	15.83	4	26360	7	50578753
Diastasis recti abdominis	22.18	15.83	5	26359	37	50578723
Pleocytosis	22.16	15.83	9	26355	551	50578209
Renal failure	22.14	15.83	112	26252	106521	50472239
Dyschezia	22.09	15.83	13	26351	1791	50576969
Migraine	21.98	15.83	6	26358	75274	50503486
Type III hyperlipidaemia	21.85	15.83	4	26360	8	50578752
Cholestasis of pregnancy	21.79	15.83	11	26353	1120	50577640
Blood creatine phosphokinase MB increased	21.69	15.83	11	26353	1131	50577629
Breech delivery	21.62	15.83	5	26359	42	50578718
Dizziness	21.55	15.83	100	26264	346269	50232491
Lipohypertrophy	21.37	15.83	9	26355	604	50578156
Antiviral drug level below therapeutic	21.31	15.83	5	26359	45	50578715
Myopathy toxic	21.22	15.83	8	26356	401	50578359
Blister	21.14	15.83	9	26355	85409	50493351
Psoriasis	21.10	15.83	5	26359	68995	50509765
Respiratory distress	20.99	15.83	48	26316	30441	50548319
Blood creatine phosphokinase increased	20.98	15.83	44	26320	26323	50552437
Aminoaciduria	20.97	15.83	6	26358	124	50578636
Intentional product use issue	20.88	15.83	7	26357	76911	50501849
Bovine tuberculosis	20.66	15.83	5	26359	52	50578708
Placenta praevia	20.60	15.83	10	26354	936	50577824
Lower respiratory tract infection	20.60	15.83	12	26352	95189	50483571
Pubertal failure	20.46	15.83	4	26360	13	50578747
Developmental delay	20.39	15.83	11	26353	1283	50577477
Spinal cord injury	20.27	15.83	9	26355	687	50578073
Breast neoplasm	20.24	15.83	11	26353	1302	50577458
Hydrocephalus	20.07	15.83	18	26346	4770	50573990
Influenza like illness	20.05	15.83	3	26361	57456	50521304
CSF protein increased	19.99	15.83	8	26356	471	50578289
Wheezing	19.98	15.83	4	26360	62043	50516717
Pallor	19.97	15.83	40	26324	23159	50555601
Ventricular hypoplasia	19.97	15.83	6	26358	148	50578612
Pyrexia	19.96	15.83	293	26071	379910	50198850
Osteoporosis	19.95	15.83	60	26304	44819	50533941
Hypotension	19.84	15.83	60	26304	235409	50343351
Carnitine deficiency	19.74	15.83	6	26358	154	50578606
Vertical infection transmission	19.68	15.83	3	26361	0	50578760
Loss of personal independence in daily activities	19.68	15.83	6	26358	70044	50508716
Portal vein thrombosis	19.66	15.83	13	26351	2199	50576561
Malaise	19.63	15.83	99	26265	335433	50243327
Death	19.61	15.83	95	26269	325284	50253476
Pharyngotonsillitis	19.60	15.83	6	26358	158	50578602
Disseminated Bacillus Calmette-Guerin infection	19.43	15.83	4	26360	18	50578742
Renal glycosuria	19.43	15.83	4	26360	18	50578742
Ebstein's anomaly	19.43	15.83	4	26360	18	50578742
Necrotising colitis	19.43	15.83	8	26356	507	50578253
Transaminases increased	19.37	15.83	44	26320	27780	50550980
Amenorrhoea	19.36	15.83	23	26341	8461	50570299
Varices oesophageal	19.17	15.83	14	26350	2775	50575985
Social avoidant behaviour	19.14	15.83	14	26350	2783	50575977
Meningitis tuberculous	19.08	15.83	8	26356	531	50578229
Insomnia	19.06	15.83	39	26325	174826	50403934
Eclampsia	19.02	15.83	7	26357	328	50578432
Pulmonary artery atresia	18.77	15.83	4	26360	22	50578738
Thyroid tuberculosis	18.77	15.83	4	26360	22	50578738
Toxicity to various agents	18.73	15.83	53	26311	212446	50366314
Acquired immunodeficiency syndrome	18.62	15.83	5	26359	81	50578679
Diaphragmatic aplasia	18.62	15.83	4	26360	23	50578737
Hemiataxia	18.47	15.83	4	26360	24	50578736
Aqueductal stenosis	18.47	15.83	4	26360	24	50578736
Placental necrosis	18.20	15.83	4	26360	26	50578734
Cryptococcosis	18.18	15.83	9	26355	879	50577881
Lactate pyruvate ratio increased	18.08	15.83	5	26359	91	50578669
Mycobacterium avium complex infection	18.08	15.83	13	26351	2517	50576243
Myelopathy	17.93	15.83	13	26351	2548	50576212
Acute stress disorder	17.89	15.83	6	26358	213	50578547
HELLP syndrome	17.88	15.83	9	26355	910	50577850
Therapeutic product effect incomplete	17.81	15.83	13	26351	91502	50487258
Hepatitis C	17.74	15.83	17	26347	4900	50573860
Delayed puberty	17.73	15.83	5	26359	98	50578662
Oxygen saturation decreased	17.68	15.83	8	26356	73240	50505520
Secondary hypogonadism	17.63	15.83	5	26359	100	50578660
Cervix operation	17.60	15.83	3	26361	3	50578757
Delivery	17.58	15.83	8	26356	647	50578113
Bronchitis	17.56	15.83	17	26347	104142	50474618
Osteoarthritis	17.35	15.83	7	26357	68599	50510161
Micrognathia	17.33	15.83	6	26358	235	50578525
Cleft lip	17.27	15.83	5	26359	108	50578652
Thrombosis	17.16	15.83	4	26360	55829	50522931
Acute lymphocytic leukaemia	17.13	15.83	12	26352	2229	50576531
Nasal congestion	17.09	15.83	3	26361	51117	50527643
Cervical dysplasia	16.96	15.83	13	26351	2772	50575988
Persistent left superior vena cava	16.86	15.83	4	26360	38	50578722
Developmental coordination disorder	16.86	15.83	4	26360	38	50578722
Acute fatty liver of pregnancy	16.76	15.83	4	26360	39	50578721
Genital prolapse	16.67	15.83	4	26360	40	50578720
Nodular regenerative hyperplasia	16.62	15.83	6	26358	266	50578494
Oropharyngeal pain	16.56	15.83	10	26354	77791	50500969
Blood alkaline phosphatase increased	16.52	15.83	50	26314	37476	50541284
Intentional overdose	16.43	15.83	6	26358	62498	50516262
Glycocholic acid increased	16.39	15.83	3	26361	6	50578754
Carbon dioxide combining power abnormal	16.39	15.83	3	26361	6	50578754
Growth hormone-producing pituitary tumour	16.39	15.83	3	26361	6	50578754
Infected vasculitis	16.39	15.83	3	26361	6	50578754
Anaphylactic reaction	16.37	15.83	4	26360	54051	50524709
Threatened labour	16.18	15.83	8	26356	779	50577981
Defaecation urgency	15.98	15.83	13	26351	3020	50575740
Foetal heart rate abnormal	15.96	15.83	7	26357	519	50578241
Neck pain	15.83	15.83	5	26359	57062	50521698

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	1707.49	12.38	450	44412	2038	29527627
Virologic failure	1494.97	12.38	417	44445	2430	29527235
Immune reconstitution inflammatory syndrome	1465.56	12.38	521	44341	7281	29522384
Pathogen resistance	1263.81	12.38	472	44390	7644	29522021
Drug resistance	926.61	12.38	510	44352	21030	29508635
Lipodystrophy acquired	793.22	12.38	261	44601	2833	29526832
Foetal exposure during pregnancy	691.37	12.38	500	44362	33367	29496298
Hepatitis B	609.14	12.38	250	44612	5247	29524418
Drug interaction	569.41	12.38	1047	43815	196338	29333327
Exposure during pregnancy	554.15	12.38	267	44595	8287	29521378
Depression	553.84	12.38	663	44199	84484	29445181
Mitochondrial toxicity	463.66	12.38	164	44698	2247	29527418
Hepatitis B DNA increased	365.12	12.38	95	44767	403	29529262
Osteomalacia	346.54	12.38	103	44759	773	29528892
Hepatitis B reactivation	337.85	12.38	141	44721	3088	29526577
Acquired gene mutation	313.84	12.38	104	44758	1154	29528511
Eyelid ptosis	291.47	12.38	147	44715	5039	29524626
Fanconi syndrome acquired	282.32	12.38	106	44756	1736	29527929
Viral load increased	257.29	12.38	102	44760	1947	29527718
Blood HIV RNA increased	248.84	12.38	83	44779	941	29528724
Progressive external ophthalmoplegia	217.27	12.38	80	44782	1237	29528428
Lipoatrophy	208.77	12.38	61	44801	428	29529237
Pinealoblastoma	199.64	12.38	48	44814	135	29529530
Premature baby	191.36	12.38	179	44683	17101	29512564
Hypophosphataemia	189.32	12.38	129	44733	7795	29521870
Hypertriglyceridaemia	188.90	12.38	126	44736	7349	29522316
Hepatic failure	177.94	12.38	229	44633	31283	29498382
Diplopia	171.18	12.38	151	44711	13367	29516298
Fanconi syndrome	164.53	12.38	69	44793	1529	29528136
Hepatic fibrosis	159.13	12.38	84	44778	3168	29526497
Genotype drug resistance test	154.68	12.38	33	44829	41	29529624
Renal tubular disorder	151.80	12.38	90	44772	4262	29525403
Kaposi's sarcoma	148.26	12.38	54	44808	808	29528857
CD4 lymphocytes decreased	147.97	12.38	64	44798	1534	29528131
Multiple-drug resistance	129.14	12.38	78	44784	3822	29525843
Osteoporosis	123.93	12.38	114	44748	10655	29519010
Off label use	121.36	12.38	168	44694	300632	29229033
Polydactyly	119.97	12.38	50	44812	1090	29528575
Meningitis cryptococcal	119.37	12.38	60	44802	2040	29527625
Treatment failure	118.48	12.38	206	44656	36733	29492932
Fall	117.79	12.38	61	44801	177117	29352548
Alanine aminotransferase increased	116.63	12.38	301	44561	70643	29459022
Gene mutation	114.09	12.38	47	44815	994	29528671
Retinal toxicity	111.26	12.38	36	44826	368	29529297
Trisomy 21	107.10	12.38	37	44825	470	29529195
Maternal drugs affecting foetus	104.12	12.38	68	44794	3825	29525840
Portal hypertension	100.91	12.38	64	44798	3422	29526243
HIV-associated neurocognitive disorder	98.45	12.38	31	44831	288	29529377
Treatment noncompliance	97.87	12.38	150	44712	24077	29505588
Blood phosphorus decreased	95.58	12.38	57	44805	2728	29526937
Loss of personal independence in daily activities	95.11	12.38	152	44710	25288	29504377
Product dose omission issue	95.00	12.38	16	44846	96367	29433298
Hepatic cirrhosis	94.37	12.38	113	44749	14331	29515334
Nephropathy toxic	94.09	12.38	98	44764	10658	29519007
Completed suicide	93.46	12.38	13	44849	90233	29439432
Blood lactic acid increased	92.81	12.38	74	44788	5692	29523973
Mycobacterium avium complex infection	92.66	12.38	52	44810	2217	29527448
Hyperlactacidaemia	92.40	12.38	55	44807	2623	29527042
Osteonecrosis	92.02	12.38	108	44754	13411	29516254
Death	90.89	12.38	245	44617	341839	29187826
Jaundice	89.56	12.38	160	44702	29136	29500529
Cytomegalovirus chorioretinitis	85.23	12.38	56	44806	3182	29526483
Pneumonia	84.49	12.38	230	44632	319942	29209723
Mitochondrial cytopathy	83.58	12.38	24	44838	157	29529508
Hyperlipidaemia	83.08	12.38	99	44763	12491	29517174
Renal tubular dysfunction	82.85	12.38	29	44833	384	29529281
Hypouricaemia	79.23	12.38	25	44837	234	29529431
Aspartate aminotransferase increased	77.92	12.38	233	44629	59492	29470173
Hypotension	77.75	12.38	109	44753	194245	29335420
Volvulus	77.20	12.38	37	44825	1132	29528533
Drug abuse	77.09	12.38	14	44848	79869	29449796
Peripheral swelling	76.97	12.38	5	44857	63734	29465931
Drug-induced liver injury	76.34	12.38	126	44736	21529	29508136
Dyspnoea	75.91	12.38	249	44613	326483	29203182
CSF HIV escape syndrome	74.13	12.38	22	44840	164	29529501
Neonatal disorder	73.82	12.38	32	44830	771	29528894
Proteinuria	72.66	12.38	104	44758	15700	29513965
Hepatitis C	72.29	12.38	78	44784	8832	29520833
Pulmonary tuberculosis	70.78	12.38	56	44806	4259	29525406
Acquired immunodeficiency syndrome	70.66	12.38	26	44836	401	29529264
Anaemia macrocytic	68.07	12.38	45	44817	2583	29527082
Hepatitis	68.04	12.38	117	44745	20666	29508999
HIV infection	67.88	12.38	34	44828	1147	29528518
Hepatomegaly	66.02	12.38	76	44786	9241	29520424
Renal impairment	65.08	12.38	270	44592	81063	29448602
Blood alkaline phosphatase increased	64.66	12.38	137	44725	28269	29501396
Fatigue	63.92	12.38	256	44606	316565	29213100
Lymphadenopathy	63.13	12.38	126	44736	24923	29504742
Glycosuria	62.54	12.38	32	44830	1130	29528535
Caesarean section	62.48	12.38	38	44824	1885	29527780
Ophthalmoplegia	61.85	12.38	36	44826	1646	29528019
Hepatic function abnormal	61.81	12.38	164	44698	39095	29490570
Oesophageal candidiasis	61.41	12.38	49	44813	3772	29525893
Hyperbilirubinaemia	61.05	12.38	93	44769	14841	29514824
Varices oesophageal	60.76	12.38	45	44817	3101	29526564
Congenital umbilical hernia	60.41	12.38	21	44841	272	29529393
Tuberculosis	60.14	12.38	64	44798	7132	29522533
Dyslipidaemia	59.90	12.38	59	44803	6002	29523663
Malignant neoplasm progression	59.42	12.38	19	44843	73840	29455825
Birth mark	58.79	12.38	18	44844	151	29529514
Congenital anomaly	58.52	12.38	32	44830	1296	29528369
Pain	58.29	12.38	107	44755	171325	29358340
Progressive multifocal leukoencephalopathy	58.24	12.38	69	44793	8650	29521015
Urine phosphorus increased	57.81	12.38	14	44848	41	29529624
Lactic acidosis	57.75	12.38	136	44726	30111	29499554
Blood pressure increased	57.60	12.38	20	44842	73783	29455882
Blood bilirubin increased	55.82	12.38	144	44718	33749	29495916
Constipation	55.25	12.38	55	44807	114105	29415560
Hepatocellular carcinoma	54.28	12.38	60	44802	6978	29522687
Lipohypertrophy	54.28	12.38	18	44844	200	29529465
Hepatosplenomegaly	52.06	12.38	44	44818	3673	29525992
Hepatic cancer	51.46	12.38	56	44806	6400	29523265
Calculus urinary	51.45	12.38	28	44834	1123	29528542
Pregnancy	51.10	12.38	18	44844	243	29529422
Atrial fibrillation	51.00	12.38	51	44811	105595	29424070
Blood triglycerides increased	49.77	12.38	78	44784	12756	29516909
Talipes	49.63	12.38	32	44830	1760	29527905
Genotype drug resistance test positive	48.84	12.38	26	44836	997	29528668
Human immunodeficiency virus transmission	48.04	12.38	11	44851	23	29529642
CD4 lymphocytes increased	46.26	12.38	16	44846	204	29529461
Gamma-glutamyltransferase increased	45.47	12.38	115	44747	26622	29503043
Cachexia	45.34	12.38	52	44810	6297	29523368
Hepatic encephalopathy	44.80	12.38	75	44787	12960	29516705
Cryptococcosis	44.77	12.38	31	44831	1921	29527744
Dandy-Walker syndrome	44.37	12.38	14	44848	131	29529534
Oesophageal varices haemorrhage	44.17	12.38	35	44827	2667	29526998
Pyelocaliectasis	44.16	12.38	25	44837	1084	29528581
Hepatitis B virus test	43.94	12.38	8	44854	0	29529665
Facial wasting	43.81	12.38	14	44848	137	29529528
Nasopharyngitis	43.49	12.38	18	44844	59647	29470018
Multiple fractures	42.87	12.38	26	44836	1283	29528382
Inappropriate schedule of product administration	42.44	12.38	8	44854	44464	29485201
Opportunistic infection	42.25	12.38	27	44835	1462	29528203
Optic nerve neoplasm	42.16	12.38	10	44852	26	29529639
Nephrolithiasis	42.08	12.38	108	44754	25226	29504439
Anaemia neonatal	42.00	12.38	16	44846	273	29529392
Infusion related reaction	41.66	12.38	8	44854	43878	29485787
Oral candidiasis	41.34	12.38	65	44797	10657	29519008
Congenital neoplasm	41.11	12.38	10	44852	30	29529635
Cerebral toxoplasmosis	40.99	12.38	26	44836	1390	29528275
Blood bilirubin unconjugated increased	40.93	12.38	19	44843	540	29529125
Basedow's disease	40.79	12.38	11	44851	55	29529610
Cryptorchism	40.27	12.38	29	44833	1913	29527752
Splenomegaly	39.89	12.38	72	44790	13207	29516458
Immune reconstitution inflammatory syndrome associated tuberculosis	39.82	12.38	17	44845	394	29529271
Small for dates baby	39.45	12.38	37	44825	3542	29526123
Bone density decreased	39.29	12.38	27	44835	1653	29528012
Cardiac failure congestive	39.25	12.38	35	44827	76546	29453119
Feeling abnormal	38.77	12.38	17	44845	54428	29475237
Ascites	38.74	12.38	133	44729	36486	29493179
Urine calcium increased	38.70	12.38	10	44852	41	29529624
Confusional state	38.16	12.38	86	44776	127791	29401874
Joint swelling	37.78	12.38	14	44848	49616	29480049
Rhabdomyosarcoma	37.51	12.38	9	44853	25	29529640
Mycobacterium avium complex immune restoration disease	37.25	12.38	9	44853	26	29529639
Aminoaciduria	37.14	12.38	12	44850	122	29529543
Pneumocystis jirovecii pneumonia	37.10	12.38	80	44782	16699	29512966
Mycobacterial infection	36.86	12.38	27	44835	1829	29527836
Acute hepatitis C	36.06	12.38	11	44851	91	29529574
Mitochondrial myopathy	35.90	12.38	13	44849	191	29529474
Cardio-respiratory arrest	35.71	12.38	16	44846	50585	29479080
Nodular regenerative hyperplasia	34.43	12.38	18	44844	665	29529000
Liver disorder	34.04	12.38	106	44756	27643	29502022
Wheezing	33.89	12.38	5	44857	33235	29496430
Hepatotoxicity	33.73	12.38	80	44782	17787	29511878
Blood phosphorus abnormal	33.69	12.38	11	44851	116	29529549
Osteoporotic fracture	33.27	12.38	20	44842	971	29528694
Cardiac arrest	33.16	12.38	49	44813	85542	29444123
Renal tubular acidosis	33.06	12.38	25	44837	1778	29527887
Transaminases increased	32.98	12.38	92	44770	22570	29507095
Cerebrovascular accident	32.86	12.38	41	44821	76870	29452795
Death neonatal	32.77	12.38	14	44848	325	29529340
Blood pyruvic acid increased	32.25	12.38	7	44855	10	29529655
Viraemia	31.79	12.38	20	44842	1054	29528611
Dizziness	31.71	12.38	164	44698	189520	29340145
Intentional product misuse	31.49	12.38	7	44855	34654	29495011
Thrombosis	31.34	12.38	13	44849	43032	29486633
Oesophageal atresia	31.32	12.38	15	44847	458	29529207
Hydrocele	31.29	12.38	25	44837	1928	29527737
Congenital hydronephrosis	31.14	12.38	17	44845	686	29528979
Anaemia	31.13	12.38	452	44410	200499	29329166
Contusion	30.97	12.38	5	44857	31090	29498575
Toxicity to various agents	30.83	12.38	147	44715	173514	29356151
Disease progression	30.67	12.38	48	44814	81868	29447797
Cushing's syndrome	30.52	12.38	14	44848	387	29529278
Flushing	30.41	12.38	4	44858	28988	29500677
Epistaxis	29.80	12.38	21	44841	51683	29477982
Hepatitis cholestatic	29.70	12.38	44	44818	6849	29522816
White matter lesion	29.58	12.38	16	44846	634	29529031
HIV lipodystrophy	29.57	12.38	7	44855	18	29529647
Osteopenia	29.53	12.38	34	44828	4134	29525531
Stevens-Johnson syndrome	29.14	12.38	72	44790	16425	29513240
Astrocytoma, low grade	29.03	12.38	8	44854	44	29529621
Therapeutic product effect decreased	28.74	12.38	5	44857	29446	29500219
HIV viraemia	28.74	12.38	8	44854	46	29529619
Tremor	28.58	12.38	42	44820	73496	29456169
Febrile neutropenia	28.44	12.38	82	44780	112158	29417507
Lactate pyruvate ratio increased	28.33	12.38	6	44856	7	29529658
Vanishing bile duct syndrome	28.23	12.38	15	44847	573	29529092
Somnolence	28.16	12.38	63	44799	93892	29435773
Drug ineffective	27.54	12.38	387	44475	362783	29166882
Muscle spasms	27.48	12.38	35	44827	65047	29464618
Mitochondrial DNA depletion	27.46	12.38	5	44857	0	29529665
Chronic obstructive pulmonary disease	27.29	12.38	14	44848	40941	29488724
Tubulointerstitial nephritis	27.04	12.38	73	44789	17570	29512095
Atrioventricular septal defect	27.01	12.38	10	44852	157	29529508
Hyperhidrosis	26.94	12.38	35	44827	64505	29465160
Injection site pain	26.70	12.38	8	44854	32438	29497227
Meningomyelocele	26.61	12.38	10	44852	164	29529501
Blood uric acid increased	26.57	12.38	38	44824	5730	29523935
Bone metabolism disorder	26.55	12.38	11	44851	236	29529429
Retroviral rebound syndrome	26.38	12.38	6	44856	12	29529653
Low set ears	26.35	12.38	13	44849	424	29529241
Product use in unapproved indication	26.24	12.38	58	44804	86817	29442848
Lymph node tuberculosis	26.16	12.38	13	44849	431	29529234
Hepatitis A	26.05	12.38	13	44849	435	29529230
Viral load decreased	25.96	12.38	7	44855	35	29529630
Cardiac disorder	25.95	12.38	12	44850	37251	29492414
Fat tissue increased	25.95	12.38	12	44850	338	29529327
Hypophosphataemic osteomalacia	25.86	12.38	9	44853	117	29529548
Congenital central nervous system anomaly	25.86	12.38	13	44849	442	29529223
Neurosyphilis	25.80	12.38	7	44855	36	29529629
Prenatal screening test abnormal	25.75	12.38	6	44856	14	29529651
Hypospadias	25.62	12.38	27	44835	2975	29526690
Beta 2 microglobulin urine increased	25.25	12.38	8	44854	76	29529589
Bone pain	24.99	12.38	73	44789	18379	29511286
Anxiety	24.97	12.38	58	44804	85307	29444358
HIV test positive	24.93	12.38	9	44853	131	29529534
Syncope	24.84	12.38	54	44808	81317	29448348
Neonatal asphyxia	24.78	12.38	11	44851	281	29529384
Limb deformity	24.46	12.38	13	44849	497	29529168
HIV wasting syndrome	24.45	12.38	8	44854	85	29529580
Pyrexia	24.32	12.38	589	44273	287033	29242632
Plasma cell myeloma	24.27	12.38	13	44849	37102	29492563
Cardiac failure	23.89	12.38	53	44809	79234	29450431
Blood glucose increased	23.59	12.38	33	44829	58951	29470714
Product use issue	23.49	12.38	26	44836	51418	29478247
Unevaluable event	23.43	12.38	8	44854	29843	29499822
Cellulitis	23.42	12.38	21	44841	45819	29483846
Congenital cytomegalovirus infection	23.34	12.38	6	44856	24	29529641
Toxoplasmosis	23.23	12.38	17	44845	1150	29528515
Anogenital warts	23.21	12.38	13	44849	552	29529113
Atypical mycobacterial infection	23.15	12.38	14	44848	687	29528978
Spider naevus	22.95	12.38	6	44856	26	29529639
Tuberculoid leprosy	22.83	12.38	7	44855	59	29529606
Anal cancer	22.46	12.38	11	44851	353	29529312
Stress	22.45	12.38	3	44859	21487	29508178
Incorrect dose administered	22.39	12.38	11	44851	32973	29496692
Amoebiasis	22.33	12.38	7	44855	64	29529601
Intracranial pressure increased	22.32	12.38	27	44835	3458	29526207
Urinary tract infection	22.10	12.38	48	44814	72306	29457359
Meningitis tuberculous	21.99	12.38	13	44849	612	29529053
Trimethylaminuria	21.99	12.38	5	44857	10	29529655
Withdrawal hepatitis	21.97	12.38	4	44858	0	29529665
Strongyloidiasis	21.91	12.38	22	44840	2290	29527375
Hepatitis D	21.63	12.38	6	44856	34	29529631
Live birth	21.47	12.38	9	44853	199	29529466
Parotid gland enlargement	21.45	12.38	10	44852	287	29529378
Hypercholesterolaemia	21.42	12.38	39	44823	7199	29522466
Cardiac murmur	21.33	12.38	37	44825	6576	29523089
Histoplasmosis disseminated	21.28	12.38	16	44846	1128	29528537
Chest discomfort	21.26	12.38	23	44839	45960	29483705
Antimitochondrial antibody positive	21.20	12.38	6	44856	37	29529628
Hepatitis B surface antigen positive	21.19	12.38	8	44854	133	29529532
Angioedema	21.13	12.38	11	44851	31904	29497761
Night blindness	20.95	12.38	9	44853	212	29529453
Blood creatine phosphokinase increased	20.94	12.38	119	44743	40525	29489140
Cryoglobulinaemia	20.92	12.38	10	44852	304	29529361
Blood creatinine increased	20.86	12.38	209	44653	84893	29444772
Umbilical cord abnormality	20.80	12.38	6	44856	40	29529625
Granulomatous rosacea	20.76	12.38	8	44854	141	29529524
Foetal growth restriction	20.65	12.38	27	44835	3739	29525926
Macrocytosis	20.46	12.38	14	44848	851	29528814
Influenza	20.44	12.38	20	44842	41861	29487804
Chest pain	20.30	12.38	94	44768	111879	29417786
Gynaecomastia	20.29	12.38	41	44821	8176	29521489
Urine phosphorus decreased	20.18	12.38	6	44856	45	29529620
Haematochezia	20.05	12.38	16	44846	36967	29492698
Neuromyopathy	19.97	12.38	14	44848	885	29528780
Exomphalos	19.97	12.38	8	44854	157	29529508
Primary syphilis	19.86	12.38	5	44857	18	29529647
Bacterial pyelonephritis	19.81	12.38	9	44853	243	29529422
Prostate cancer	19.76	12.38	7	44855	25520	29504145
Bradycardia	19.66	12.38	44	44818	65585	29464080
AIDS related complication	19.65	12.38	5	44857	19	29529646
Normal newborn	19.56	12.38	8	44854	166	29529499
Urticaria	19.54	12.38	33	44829	54627	29475038
Oropharyngeal pain	19.52	12.38	10	44852	29275	29500390
Diaphragmatic hernia	19.45	12.38	9	44853	254	29529411
Weight increased	19.41	12.38	56	44806	76611	29453054
Taeniasis	19.32	12.38	6	44856	53	29529612
Pulmonary embolism	19.31	12.38	56	44806	76478	29453187
Perinatal HIV infection	19.20	12.38	4	44858	4	29529661
Maternal condition affecting foetus	19.20	12.38	4	44858	4	29529661
Liver transplant rejection	19.10	12.38	19	44843	1955	29527710
Pancreatitis	19.08	12.38	103	44759	34411	29495254
Oropharyngeal candidiasis	18.93	12.38	12	44850	641	29529024
Pilonidal cyst congenital	18.88	12.38	5	44857	23	29529642
Hyperphosphatasaemia	18.88	12.38	5	44857	23	29529642
Visual field defect	18.78	12.38	27	44835	4089	29525576
Malaria	18.68	12.38	8	44854	187	29529478
Rectal haemorrhage	18.66	12.38	15	44847	34534	29495131
International normalised ratio increased	18.58	12.38	24	44838	44348	29485317
Developmental hip dysplasia	18.58	12.38	9	44853	282	29529383
Hyperkalaemia	18.52	12.38	41	44821	61351	29468314
Chordee	18.48	12.38	6	44856	62	29529603
Pruritus	18.40	12.38	103	44759	116746	29412919
Cerebral ventricle dilatation	18.33	12.38	13	44849	837	29528828
Agitation	18.31	12.38	31	44831	51273	29478392
Borderline leprosy	18.31	12.38	4	44858	6	29529659
Hepatitis C virus test	18.31	12.38	6	44856	64	29529601
Hospitalisation	18.12	12.38	26	44836	45962	29483703
Oxygen saturation decreased	18.11	12.38	25	44837	44912	29484753
Gastrointestinal haemorrhage	18.08	12.38	61	44801	79472	29450193
Asymptomatic viral hepatitis	18.07	12.38	5	44857	28	29529637
Blood uric acid decreased	18.06	12.38	9	44853	300	29529365
Hepatitis B DNA assay positive	17.99	12.38	6	44856	68	29529597
Abdominal discomfort	17.99	12.38	28	44834	47875	29481790
Interstitial lung disease	17.86	12.38	38	44824	57680	29471985
Wrong technique in product usage process	17.79	12.38	13	44849	31415	29498250
Lower respiratory tract infection	17.74	12.38	9	44853	26493	29503172
Sickle cell disease	17.73	12.38	7	44855	132	29529533
Meconium ileus	17.64	12.38	5	44857	31	29529634
Crystal urine	17.60	12.38	6	44856	73	29529592
Renal atrophy	17.60	12.38	14	44848	1073	29528592
Loss of anatomical alignment after fracture reduction	17.59	12.38	4	44858	8	29529657
Neonatal pneumothorax	17.59	12.38	4	44858	8	29529657
Subchondral insufficiency fracture	17.59	12.38	4	44858	8	29529657
Drug dependence	17.58	12.38	5	44857	20976	29508689
Cataract	17.56	12.38	6	44856	22372	29507293
Hepatic cytolysis	17.54	12.38	39	44823	8308	29521357
Bronchitis	17.54	12.38	18	44844	36850	29492815
Heart rate increased	17.42	12.38	20	44842	38918	29490747
Pneumonia aspiration	17.40	12.38	18	44844	36719	29492946
Psoriasis	17.39	12.38	14	44848	32213	29497452
Erosive duodenitis	17.34	12.38	15	44847	1292	29528373
Diverticulitis	17.29	12.38	3	44859	17701	29511964
Creutzfeldt-Jakob disease	17.24	12.38	5	44857	34	29529631
Lymphocytic infiltration	17.24	12.38	11	44851	594	29529071
Persistent foetal circulation	17.18	12.38	9	44853	334	29529331
Bulbar palsy	17.12	12.38	8	44854	231	29529434
White blood cell count increased	17.08	12.38	19	44843	37497	29492168
Optic atrophy	17.07	12.38	12	44850	762	29528903
ADAMTS13 activity decreased	17.03	12.38	6	44856	81	29529584
Encephalitis	16.98	12.38	33	44829	6397	29523268
Retinoblastoma	16.98	12.38	4	44858	10	29529655
Acquired aminoaciduria	16.98	12.38	4	44858	10	29529655
Haematoma	16.91	12.38	7	44855	23205	29506460
Alpha 1 foetoprotein increased	16.82	12.38	11	44851	620	29529045
Delirium	16.82	12.38	21	44841	39376	29490289
Femoral neck fracture	16.80	12.38	21	44841	2782	29526883
Hepatic enzyme increased	16.79	12.38	98	44764	33701	29495964
Glucose urine present	16.76	12.38	13	44849	960	29528705
Coccidioidomycosis	16.74	12.38	11	44851	625	29529040
Fracture malunion	16.70	12.38	4	44858	11	29529654
Blood pressure decreased	16.68	12.38	27	44835	45450	29484215
Bone marrow oedema	16.61	12.38	10	44852	487	29529178
Liver transplant	16.59	12.38	19	44843	2297	29527368
Dehydration	16.56	12.38	104	44758	114644	29415021
Arthropathy	16.53	12.38	6	44856	21548	29508117
Meconium stain	16.48	12.38	3	44859	0	29529665
Atypical mycobacterial lymphadenitis	16.48	12.38	3	44859	0	29529665
Gonadal dysgenesis	16.48	12.38	3	44859	0	29529665
Life expectancy shortened	16.43	12.38	5	44857	41	29529624
Polyneuropathy chronic	16.43	12.38	5	44857	41	29529624
Melaena	16.26	12.38	14	44848	31162	29498503
Optic nerve cupping	16.22	12.38	5	44857	43	29529622
Hepatitis viral	16.21	12.38	10	44852	509	29529156
Endocardial fibroelastosis	16.20	12.38	4	44858	13	29529652
Anaphylactic reaction	16.15	12.38	11	44851	27562	29502103
Speech disorder developmental	16.00	12.38	17	44845	1890	29527775
Acute on chronic liver failure	15.93	12.38	6	44856	99	29529566
Neutrophil count decreased	15.85	12.38	26	44836	43541	29486124
Dysmorphism	15.83	12.38	21	44841	2950	29526715
Optic disc haemorrhage	15.83	12.38	5	44857	47	29529618
Anaemia megaloblastic	15.80	12.38	7	44855	178	29529487
Depressive symptom	15.65	12.38	16	44846	1701	29527964
Back pain	15.65	12.38	91	44771	102193	29427472
Hepatitis B e antigen positive	15.64	12.38	5	44857	49	29529616
Protrusion tongue	15.62	12.38	7	44855	183	29529482
Non-Hodgkin's lymphoma	15.59	12.38	15	44847	1482	29528183
COVID-19	15.58	12.38	19	44843	35995	29493670
Anal cancer stage 0	15.56	12.38	4	44858	16	29529649
Respiratory arrest	15.54	12.38	10	44852	25823	29503842
Psychiatric decompensation	15.53	12.38	15	44847	1489	29528176
Optic neuropathy	15.51	12.38	16	44846	1719	29527946
Transient ischaemic attack	15.43	12.38	8	44854	23262	29506403
Macrocephaly	15.41	12.38	9	44853	414	29529251
Infection	15.39	12.38	62	44800	76689	29452976
Micrognathia	15.19	12.38	8	44854	300	29529365
Clostridium difficile infection	15.19	12.38	3	44859	16138	29513527
Ear malformation	15.17	12.38	8	44854	301	29529364
Aggression	15.11	12.38	19	44843	35522	29494143
Sepsis	15.08	12.38	141	44721	142541	29387124
Amylase increased	15.06	12.38	28	44834	5252	29524413
Glomerulonephritis proliferative	15.04	12.38	7	44855	200	29529465
Sickle cell anaemia	15.04	12.38	7	44855	200	29529465
Dyspnoea exertional	15.01	12.38	20	44842	36470	29493195
Renal glycosuria	15.00	12.38	4	44858	19	29529646
Full blood count decreased	14.99	12.38	3	44859	15989	29513676
Sinusitis	14.99	12.38	18	44844	34332	29495333
Musculoskeletal toxicity	14.96	12.38	6	44856	118	29529547
Adrenogenital syndrome	14.96	12.38	5	44857	57	29529608
Portal fibrosis	14.88	12.38	8	44854	313	29529352
Rhinorrhoea	14.87	12.38	7	44855	21512	29508153
Drug intolerance	14.85	12.38	32	44830	48347	29481318
Urinary retention	14.69	12.38	16	44846	31882	29497783
Liver tenderness	14.69	12.38	6	44856	124	29529541
Subacute sclerosing panencephalitis	14.67	12.38	4	44858	21	29529644
Creatinine renal clearance abnormal	14.61	12.38	7	44855	214	29529451
Anogenital dysplasia	14.60	12.38	6	44856	126	29529539
Myopia	14.59	12.38	12	44850	964	29528701
Overdose	14.46	12.38	67	44795	79752	29449913
Hepatitis B DNA decreased	14.40	12.38	3	44859	3	29529662
Tracheal fistula repair	14.40	12.38	3	44859	3	29529662
Retroviral infection	14.40	12.38	3	44859	3	29529662
Osteocalcin increased	14.40	12.38	3	44859	3	29529662
Hyperphosphaturia	14.37	12.38	5	44857	65	29529600
Fluid retention	14.34	12.38	9	44853	23551	29506114
Plasmablastic lymphoma	14.31	12.38	7	44855	224	29529441
Nervous system disorder	14.25	12.38	47	44815	12627	29517038
Central pain syndrome	14.23	12.38	5	44857	67	29529598
Congenital tuberculosis	14.22	12.38	4	44858	24	29529641
Basal cell carcinoma	14.22	12.38	4	44858	16906	29512759
Erythema elevatum diutinum	14.08	12.38	4	44858	25	29529640
Pancytopenia	14.01	12.38	190	44672	82978	29446687
Red blood cell schistocytes present	14.00	12.38	7	44855	235	29529430
Erythema	13.98	12.38	63	44799	75543	29454122
Scleral discolouration	13.95	12.38	7	44855	237	29529428
Osteodystrophy	13.94	12.38	3	44859	4	29529661
Late developer	13.94	12.38	3	44859	4	29529661
Nephropathy	13.89	12.38	27	44835	5236	29524429
Neck deformity	13.84	12.38	5	44857	73	29529592
Portal hypertensive gastropathy	13.78	12.38	9	44853	506	29529159
Glucose tolerance impaired	13.75	12.38	19	44843	2775	29526890
Developmental delay	13.73	12.38	18	44844	2500	29527165
Full blood count abnormal	13.70	12.38	3	44859	15010	29514655
Cardiogenic shock	13.64	12.38	6	44856	19184	29510481
Tracheal stenosis	13.38	12.38	6	44856	157	29529508
Spermatozoa progressive motility abnormal	13.34	12.38	4	44858	31	29529634
Graft infection	13.33	12.38	8	44854	387	29529278
Sleep apnoea syndrome	13.33	12.38	5	44857	17594	29512071
Molluscum contagiosum	13.30	12.38	7	44855	262	29529403
Nasal congestion	13.27	12.38	6	44856	18873	29510792
Hypoglycaemia	13.22	12.38	34	44828	48312	29481353
Ocular icterus	13.19	12.38	18	44844	2597	29527068
Hereditary optic atrophy	13.19	12.38	3	44859	6	29529659
Benign hepatic neoplasm	13.19	12.38	3	44859	6	29529659
Congenital pigmentation disorder	13.19	12.38	3	44859	6	29529659
Intentional overdose	13.10	12.38	24	44838	38504	29491161
Genital herpes	13.08	12.38	9	44853	552	29529113
Memory impairment	13.05	12.38	22	44840	36448	29493217
Musculoskeletal stiffness	13.03	12.38	23	44839	37435	29492230
Hepatic steatosis	13.03	12.38	51	44811	14895	29514770
C-reactive protein increased	12.99	12.38	30	44832	44233	29485432
Mobility decreased	12.94	12.38	12	44850	25768	29503897
Diabetes mellitus	12.92	12.38	104	44758	39727	29489938
Headache	12.92	12.38	186	44676	173821	29355844
Congenital hydrocephalus	12.88	12.38	5	44857	90	29529575
Birth trauma	12.88	12.38	3	44859	7	29529658
Total lung capacity decreased	12.86	12.38	9	44853	567	29529098
Body fat disorder	12.82	12.38	4	44858	36	29529629
Ergot poisoning	12.82	12.38	4	44858	36	29529629
Vision blurred	12.81	12.38	26	44836	40150	29489515
Stomatitis	12.72	12.38	23	44839	37090	29492575
Tracheo-oesophageal fistula	12.71	12.38	8	44854	422	29529243
Skin candida	12.67	12.38	8	44854	424	29529241
HIV associated nephropathy	12.63	12.38	7	44855	291	29529374
CD4 lymphocytes abnormal	12.62	12.38	4	44858	38	29529627
Pain in extremity	12.60	12.38	107	44755	110326	29419339
Congenital anaemia	12.59	12.38	3	44859	8	29529657
Extensor plantar response	12.59	12.38	9	44853	587	29529078
Diarrhoea	12.53	12.38	397	44465	332301	29197364
Congenital hearing disorder	12.53	12.38	5	44857	97	29529568
Asthma	12.50	12.38	20	44842	33829	29495836
Blood lactate dehydrogenase increased	12.49	12.38	60	44802	19149	29510516
Gout	12.48	12.38	5	44857	16906	29512759
Viral infection	12.48	12.38	50	44812	14760	29514905
Lymphoma	12.47	12.38	38	44824	9790	29519875
Choroiditis	12.43	12.38	11	44851	977	29528688
Blood pressure systolic increased	12.40	12.38	5	44857	16840	29512825

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Immune reconstitution inflammatory syndrome	2252.33	12.57	706	55793	11764	64430469
Viral mutation identified	2141.85	12.57	513	55986	2833	64439400
Virologic failure	2108.47	12.57	510	55989	2956	64439277
Drug resistance	1617.16	12.57	730	55769	34372	64407861
Pathogen resistance	1607.97	12.57	548	55951	11995	64430238
Exposure during pregnancy	1112.51	12.57	746	55753	76929	64365304
Lipodystrophy acquired	1023.93	12.57	297	56202	3730	64438503
Abortion spontaneous	961.70	12.57	460	56039	24683	64417550
Stillbirth	788.24	12.57	237	56262	3396	64438837
Blood HIV RNA increased	738.80	12.57	186	56313	1298	64440935
Hepatitis B	713.63	12.57	265	56234	7480	64434753
Mitochondrial toxicity	636.87	12.57	188	56311	2518	64439715
Hepatitis B reactivation	573.37	12.57	200	56299	4689	64437544
Abortion induced	539.16	12.57	205	56294	6183	64436050
Drug interaction	484.82	12.57	1013	55486	361070	64081163
Fanconi syndrome acquired	482.64	12.57	148	56351	2273	64439960
Hepatitis B DNA increased	473.10	12.57	110	56389	520	64441713
Acquired gene mutation	471.83	12.57	139	56360	1847	64440386
Osteomalacia	409.28	12.57	115	56384	1276	64440957
Eyelid ptosis	286.12	12.57	148	56351	9377	64432856
Viral load increased	281.09	12.57	99	56400	2388	64439845
Hypophosphataemia	268.71	12.57	165	56334	14555	64427678
Foetal exposure during pregnancy	267.47	12.57	112	56387	4364	64437869
Progressive external ophthalmoplegia	263.98	12.57	81	56418	1246	64440987
Hepatic failure	258.01	12.57	279	56220	55115	64387118
Lipoatrophy	248.80	12.57	66	56433	579	64441654
CD4 lymphocytes decreased	245.27	12.57	89	56410	2346	64439887
Fanconi syndrome	242.95	12.57	89	56410	2412	64439821
Depression	242.24	12.57	511	55988	182780	64259453
Pregnancy	223.15	12.57	168	56331	20697	64421536
Treatment noncompliance	216.61	12.57	227	56272	43255	64398978
Blood bilirubin increased	209.14	12.57	255	56244	57298	64384935
Nephropathy toxic	207.51	12.57	150	56349	17364	64424869
Live birth	197.91	12.57	123	56376	11081	64431152
Meningitis cryptococcal	192.31	12.57	79	56420	2930	64439303
Portal hypertension	187.84	12.57	97	56402	6122	64436111
CSF HIV escape syndrome	183.14	12.57	45	56454	280	64441953
Hepatic fibrosis	174.64	12.57	89	56410	5463	64436770
Hepatotoxicity	173.43	12.57	194	56305	39768	64402465
Fall	172.17	12.57	75	56424	416751	64025482
Renal tubular disorder	171.15	12.57	90	56409	5897	64436336
Multiple-drug resistance	169.72	12.57	92	56407	6410	64435823
Pain	157.53	12.57	152	56347	553359	63888874
Hypertriglyceridaemia	156.12	12.57	106	56393	11099	64431134
Kaposi's sarcoma	154.44	12.57	47	56452	702	64441531
Caesarean section	153.16	12.57	105	56394	11169	64431064
Alanine aminotransferase increased	152.47	12.57	360	56139	138671	64303562
Diplopia	151.98	12.57	150	56349	26615	64415618
Completed suicide	148.57	12.57	13	56486	224401	64217832
Jaundice	147.87	12.57	197	56302	48315	64393918
Proteinuria	147.54	12.57	150	56349	27573	64414660
Pulmonary tuberculosis	147.18	12.57	87	56412	7157	64435076
Peripheral swelling	144.40	12.57	10	56489	209143	64233090
Mitochondrial cytopathy	136.42	12.57	37	56462	356	64441877
Maternal exposure during pregnancy	135.48	12.57	275	56224	95609	64346624
Maternal drugs affecting foetus	133.11	12.57	51	56448	1569	64440664
Retinal toxicity	131.67	12.57	48	56451	1282	64440951
Genotype drug resistance test positive	131.25	12.57	45	56454	999	64441234
Joint swelling	131.02	12.57	17	56482	215365	64226868
Glycosuria	131.01	12.57	54	56445	2020	64440213
Hypomania	128.40	12.57	73	56426	5581	64436652
Lymphadenopathy	126.33	12.57	179	56320	46507	64395726
Hyperbilirubinaemia	126.30	12.57	122	56377	21083	64421150
Off label use	125.61	12.57	227	56272	632579	63809654
Renal tubular dysfunction	123.58	12.57	39	56460	661	64441572
Foetal death	122.53	12.57	72	56427	5858	64436375
Tuberculosis	117.73	12.57	95	56404	12943	64429290
Hepatitis C	114.02	12.57	87	56412	10928	64431305
Lactic acidosis	114.00	12.57	198	56301	61212	64381021
Hyperlactacidaemia	113.94	12.57	64	56435	4780	64437453
Rheumatoid arthritis	112.96	12.57	8	56491	164286	64277947
Mycobacterium avium complex infection	111.97	12.57	59	56440	3881	64438352
Aspartate aminotransferase increased	111.07	12.57	291	56208	119497	64322736
Fatigue	110.89	12.57	315	56184	748415	63693818
Gene mutation	110.82	12.57	48	56451	2034	64440199
Product dose omission issue	110.10	12.57	19	56480	194728	64247505
Nasopharyngitis	108.95	12.57	20	56479	196053	64246180
Hepatic cirrhosis	107.85	12.57	124	56375	26174	64416059
Infusion related reaction	107.55	12.57	10	56489	164457	64277776
HIV-associated neurocognitive disorder	105.29	12.57	29	56470	297	64441936
Jaundice cholestatic	104.39	12.57	75	56424	8595	64433638
Hepatomegaly	98.42	12.57	96	56403	16786	64425447
Immune reconstitution inflammatory syndrome associated tuberculosis	95.94	12.57	33	56466	740	64441493
Hypouricaemia	94.34	12.57	28	56471	382	64441851
Dyslipidaemia	93.48	12.57	72	56427	9170	64433063
Drug-induced liver injury	92.87	12.57	157	56342	47486	64394747
Premature rupture of membranes	92.25	12.57	51	56448	3693	64438540
Anaemia	92.17	12.57	607	55892	378073	64064160
Schizophrenia	91.69	12.57	77	56422	11091	64431142
Pinealoblastoma	89.26	12.57	19	56480	54	64442179
Premature labour	87.38	12.57	64	56435	7556	64434677
Hepatic function abnormal	86.73	12.57	181	56318	64132	64378101
Dyspnoea	85.90	12.57	332	56167	718342	63723891
Arthropathy	85.79	12.57	5	56494	120962	64321271
Urine phosphorus increased	85.51	12.57	19	56480	70	64442163
Osteoporosis	85.12	12.57	141	56358	41939	64400294
Osteonecrosis	85.02	12.57	114	56385	28115	64414118
Hepatocellular carcinoma	83.98	12.57	65	56434	8338	64433895
Psychotic disorder	81.14	12.57	124	56375	34454	64407779
Hepatitis	80.74	12.57	144	56355	45438	64396795
Renal impairment	80.68	12.57	281	56218	134736	64307497
Pre-eclampsia	79.86	12.57	56	56443	6175	64436058
Stevens-Johnson syndrome	79.22	12.57	122	56377	34127	64408106
Blood alkaline phosphatase increased	78.95	12.57	161	56338	56118	64386115
Constipation	78.81	12.57	52	56447	229285	64212948
Fat tissue increased	78.19	12.57	29	56470	814	64441419
Gamma-glutamyltransferase increased	75.56	12.57	145	56354	48365	64393868
Injection site pain	74.93	12.57	6	56493	111402	64330831
Blood phosphorus decreased	74.82	12.57	52	56447	5653	64436580
Synovitis	73.77	12.57	3	56496	99087	64343146
Abdominal discomfort	73.25	12.57	34	56465	182288	64259945
Blood bilirubin unconjugated increased	72.25	12.57	28	56471	889	64441344
Cytomegalovirus chorioretinitis	72.09	12.57	48	56451	4864	64437369
Blood lactic acid increased	71.86	12.57	65	56434	10336	64431897
Sinusitis	70.83	12.57	20	56479	145908	64296325
Hepatosplenomegaly	70.77	12.57	49	56450	5294	64436939
Retinoblastoma	68.40	12.57	16	56483	78	64442155
Ergot poisoning	66.73	12.57	17	56482	125	64442108
Varices oesophageal	65.50	12.57	46	56453	5084	64437149
Hypotension	64.88	12.57	149	56350	380825	64061408
Drug ineffective	64.86	12.57	451	56048	839796	63602437
Normal newborn	64.00	12.57	47	56452	5570	64436663
Blood pressure increased	63.62	12.57	36	56463	172516	64269717
Cachexia	62.50	12.57	57	56442	9160	64433073
Contusion	62.48	12.57	12	56487	113953	64328280
Ophthalmoplegia	61.66	12.57	35	56464	2667	64439566
Cryptococcosis	61.03	12.57	35	56464	2720	64439513
Hepatic encephalopathy	60.29	12.57	83	56416	20983	64421250
Calculus urinary	59.07	12.57	30	56469	1827	64440406
Acquired immunodeficiency syndrome	59.05	12.57	17	56482	207	64442026
Drug intolerance	58.87	12.57	47	56452	187945	64254288
Ascites	58.83	12.57	152	56347	61849	64380384
Lipohypertrophy	58.22	12.57	23	56476	769	64441464
Premature baby	57.98	12.57	36	56463	3236	64438997
Pneumocystis jirovecii pneumonia	57.78	12.57	94	56405	27540	64414693
Hyperlipidaemia	57.62	12.57	85	56414	22891	64419342
Therapeutic product effect decreased	57.50	12.57	15	56484	115336	64326897
HIV infection	56.75	12.57	24	56475	958	64441275
Feeling abnormal	56.69	12.57	23	56476	133579	64308654
Death	56.24	12.57	225	56274	482480	63959753
Systemic lupus erythematosus	55.66	12.57	3	56496	77609	64364624
Amniotic cavity infection	55.23	12.57	22	56477	752	64441481
Blood triglycerides increased	55.00	12.57	75	56424	18791	64423442
Alopecia	54.99	12.57	39	56460	165651	64276582
Splenomegaly	54.79	12.57	73	56426	17888	64424345
Drug abuse	54.23	12.57	24	56475	132350	64309883
Cushing's syndrome	54.16	12.57	23	56476	928	64441305
Lymph node tuberculosis	54.04	12.57	23	56476	933	64441300
Hepatitis A	53.90	12.57	22	56477	802	64441431
Cerebral toxoplasmosis	53.76	12.57	28	56471	1798	64440435
Facial wasting	53.31	12.57	13	56486	78	64442155
Cholelithiasis	53.28	12.57	121	56378	45385	64396848
Progressive multifocal leukoencephalopathy	50.92	12.57	71	56428	18161	64424072
Renal tubular acidosis	50.83	12.57	32	56467	2947	64439286
Transaminases increased	50.47	12.57	117	56382	44477	64397756
Urinary tract infection	50.45	12.57	78	56421	231518	64210715
Swelling	50.23	12.57	40	56459	160178	64282055
Injection site erythema	49.96	12.57	3	56496	70797	64371436
Premature delivery	49.86	12.57	71	56428	18518	64423715
Hypophosphataemic osteomalacia	49.85	12.57	16	56483	287	64441946
Mitochondrial DNA deletion	49.78	12.57	9	56490	6	64442227
Nodular regenerative hyperplasia	49.41	12.57	21	56478	849	64441384
Wound	49.05	12.57	5	56494	76472	64365761
Nephrolithiasis	48.77	12.57	114	56385	43569	64398664
Pyrexia	47.87	12.57	720	55779	557924	63884309
Alpha 1 foetoprotein abnormal	47.65	12.57	11	56488	50	64442183
Oesophageal varices haemorrhage	47.41	12.57	33	56466	3596	64438637
Oligohydramnios	46.99	12.57	31	56468	3093	64439140
Malignant neoplasm progression	46.97	12.57	20	56479	112851	64329382
Hepatic cancer	46.52	12.57	44	56455	7404	64434829
Blood creatinine increased	46.15	12.57	238	56261	135544	64306689
Ectopic pregnancy	46.09	12.57	24	56475	1540	64440693
Oesophageal candidiasis	45.62	12.57	45	56454	7972	64434261
Arthritis	45.57	12.57	9	56490	83805	64358428
Arthralgia	45.48	12.57	216	56283	442044	64000189
Rickets	45.25	12.57	11	56488	65	64442168
Aminoaciduria	45.17	12.57	14	56485	223	64442010
Hepatitis B surface antigen positive	44.73	12.57	13	56486	164	64442069
Pancreatitis	44.57	12.57	134	56365	59473	64382760
Meningitis tuberculous	44.48	12.57	21	56478	1090	64441143
Weight increased	44.44	12.57	74	56425	213274	64228959
Basedow's disease	44.21	12.57	14	56485	240	64441993
HIV viraemia	44.15	12.57	11	56488	73	64442160
Premature separation of placenta	43.90	12.57	21	56478	1123	64441110
Toxicity to various agents	43.85	12.57	167	56332	363346	64078887
Loss of personal independence in daily activities	43.42	12.57	151	56348	72303	64369930
Wheezing	43.08	12.57	9	56490	80570	64361663
Placental insufficiency	43.06	12.57	20	56479	1000	64441233
Atrial fibrillation	42.91	12.57	52	56447	171037	64271196
Placental disorder	42.87	12.57	19	56480	851	64441382
Pain in extremity	42.83	12.57	130	56369	302955	64139278
CD4 lymphocytes increased	42.82	12.57	14	56485	267	64441966
Renal failure	42.71	12.57	289	56210	181399	64260834
Influenza	42.56	12.57	20	56479	106511	64335722
Rash maculo-papular	42.27	12.57	113	56386	46913	64395320
Ocular icterus	41.54	12.57	35	56464	5063	64437170
Umbilical cord abnormality	41.18	12.57	12	56487	153	64442080
Product use issue	40.33	12.57	44	56455	151671	64290562
Headache	40.30	12.57	285	56214	529182	63913051
Acquired aminoaciduria	40.25	12.57	8	56491	14	64442219
Hepatitis B virus test	39.79	12.57	7	56492	3	64442230
Anaemia macrocytic	39.60	12.57	32	56467	4366	64437867
Hepatitis cholestatic	39.55	12.57	51	56448	12104	64430129
Mycobacterium avium complex immune restoration disease	38.92	12.57	8	56491	18	64442215
Malaria	38.86	12.57	14	56485	361	64441872
Oxygen saturation decreased	38.58	12.57	23	56476	107153	64335080
Granulomatous rosacea	38.38	12.57	12	56487	197	64442036
Oropharyngeal pain	38.18	12.57	15	56484	88852	64353381
Hepatic cytolysis	38.18	12.57	54	56445	13995	64428238
Urine calcium increased	37.87	12.57	10	56489	86	64442147
Inappropriate schedule of product administration	37.37	12.57	17	56482	92269	64349964
Pruritus	37.35	12.57	144	56355	312256	64129977
Optic nerve neoplasm	37.26	12.57	8	56491	24	64442209
Tuberculoma of central nervous system	36.95	12.57	15	56484	539	64441694
Intentional product misuse	36.79	12.57	9	56490	72286	64369947
Opportunistic infection	36.64	12.57	25	56474	2637	64439596
Withdrawal hepatitis	36.25	12.57	6	56493	0	64442233
Mitochondrial DNA depletion	36.25	12.57	6	56493	0	64442233
Impaired healing	36.19	12.57	5	56494	60468	64381765
Stomatitis	36.09	12.57	26	56473	109579	64332654
Gynaecomastia	34.67	12.57	34	56465	5982	64436251
Mitochondrial myopathy	34.56	12.57	12	56487	277	64441956
Oral candidiasis	34.45	12.57	68	56431	23144	64419089
Drug hypersensitivity	34.30	12.57	101	56398	237714	64204519
Heart rate decreased	34.30	12.57	4	56495	55063	64387170
Mycobacterial infection	34.04	12.57	25	56474	2963	64439270
Dizziness	33.96	12.57	229	56270	429934	64012299
Hepatitis B DNA assay positive	33.92	12.57	9	56490	79	64442154
Pancytopenia	33.69	12.57	228	56271	143081	64299152
Acute hepatitis C	33.68	12.57	11	56488	209	64442024
Nasal congestion	33.29	12.57	6	56493	59652	64382581
Muscle spasms	33.14	12.57	45	56454	140978	64301255
Hypercholesterolaemia	33.10	12.57	53	56446	15320	64426913
Lower respiratory tract infection	33.08	12.57	21	56478	94593	64347640
Anxiety	33.04	12.57	81	56418	202568	64239665
Hyperphosphaturia	32.78	12.57	9	56490	91	64442142
Malaise	32.76	12.57	208	56291	396039	64046194
Psoriasis	32.67	12.57	11	56488	71692	64370541
HIV test positive	32.43	12.57	9	56490	95	64442138
Viraemia	32.19	12.57	22	56477	2327	64439906
Treatment failure	31.86	12.57	193	56306	116623	64325610
Pregnancy on contraceptive	31.82	12.57	15	56484	776	64441457
Bronchitis	31.81	12.57	29	56470	108714	64333519
Liver disorder	31.79	12.57	111	56388	53240	64388993
Disseminated tuberculosis	31.72	12.57	26	56473	3619	64438614
Toxoplasmosis	31.40	12.57	22	56477	2422	64439811
Back pain	31.40	12.57	113	56386	250058	64192175
Diabetes mellitus	31.09	12.57	128	56371	66346	64375887
Strongyloidiasis	31.09	12.57	24	56475	3066	64439167
Blood phosphorus abnormal	30.89	12.57	11	56488	274	64441959
Asthma	30.82	12.57	23	56476	95202	64347031
Hepatic enzyme increased	30.70	12.57	207	56292	129736	64312497
Renal glycosuria	30.66	12.57	7	56492	30	64442203
White matter lesion	30.65	12.57	19	56480	1703	64440530
Anaphylactic reaction	30.48	12.57	11	56488	68653	64373580
Vanishing bile duct syndrome	30.38	12.57	17	56482	1260	64440973
Bilirubin conjugated increased	30.36	12.57	29	56470	4939	64437294
Neutropenia neonatal	30.29	12.57	7	56492	32	64442201
Cardio-respiratory arrest	30.28	12.57	25	56474	98368	64343865
Benign hydatidiform mole	30.28	12.57	8	56491	69	64442164
Cerebrovascular accident	30.26	12.57	46	56453	137537	64304696
Retroviral rebound syndrome	30.01	12.57	6	56493	11	64442222
Stress	29.91	12.57	8	56491	60526	64381707
Bone metabolism disorder	29.89	12.57	12	56487	419	64441814
Hyperphosphatasaemia	29.68	12.57	8	56491	75	64442158
Bone density decreased	29.67	12.57	40	56459	9912	64432321
Blood pressure fluctuation	29.42	12.57	5	56494	51866	64390367
Night blindness	29.26	12.57	12	56487	443	64441790
Somnolence	28.99	12.57	87	56412	203558	64238675
AIDS cholangiopathy	28.74	12.57	6	56493	15	64442218
HIV lipodystrophy	28.74	12.57	6	56493	15	64442218
Infection	28.52	12.57	76	56423	184804	64257429
Cardiac failure congestive	28.39	12.57	44	56455	130536	64311697
Musculoskeletal stiffness	28.26	12.57	40	56459	123166	64319067
Congenital anomaly	28.16	12.57	10	56489	247	64441986
Respiratory arrest	28.15	12.57	6	56493	52979	64389254
Confusional state	27.71	12.57	126	56373	261018	64181215
Rhinorrhoea	27.67	12.57	9	56490	59960	64382273
Amoebiasis	27.38	12.57	8	56491	103	64442130
Psoriatic arthropathy	27.31	12.57	3	56496	43278	64398955
Tuberculoid leprosy	27.31	12.57	8	56491	104	64442129
Cardiac arrest	27.19	12.57	59	56440	154005	64288228
Liver transplant	27.15	12.57	25	56474	4067	64438166
Thrombosis	27.10	12.57	14	56485	70628	64371605
Placental infarction	26.83	12.57	8	56491	111	64442122
Tremor	26.80	12.57	56	56443	148174	64294059
Flushing	26.76	12.57	18	56481	78630	64363603
Encephalitis	26.60	12.57	43	56456	12528	64429705
Hepatic steatosis	26.35	12.57	73	56426	30934	64411299
Unevaluable event	26.25	12.57	6	56493	50483	64391750
Migraine	26.24	12.57	11	56488	62666	64379567
HIV wasting syndrome	26.23	12.57	7	56492	63	64442170
Diarrhoea	26.11	12.57	461	56038	722243	63719990
Chronic obstructive pulmonary disease	25.91	12.57	15	56484	71033	64371200
Chronic kidney disease	25.89	12.57	110	56389	57809	64384424
Atypical mycobacterial lymphadenitis	25.83	12.57	5	56494	7	64442226
Beta 2 microglobulin urine increased	25.78	12.57	8	56491	128	64442105
Blister	25.63	12.57	20	56479	80947	64361286
Anogenital warts	25.49	12.57	13	56486	799	64441434
Epistaxis	25.48	12.57	29	56470	98102	64344131
Borderline leprosy	25.44	12.57	5	56494	8	64442225
Erythema	25.16	12.57	82	56417	186988	64255245
Rhabdomyosarcoma	24.95	12.57	8	56491	143	64442090
Blood uric acid increased	24.62	12.57	33	56466	8130	64434103
Hospitalisation	24.55	12.57	18	56481	75189	64367044
Hepatitis D	24.46	12.57	6	56493	37	64442196
Syncope	24.16	12.57	65	56434	157570	64284663
Glucose urine present	24.08	12.57	16	56483	1616	64440617
Intentional overdose	23.99	12.57	26	56473	89918	64352315
Cellulitis	23.97	12.57	28	56471	93629	64348604
Metabolic acidosis	23.83	12.57	124	56375	70834	64371399
Lymphocytic infiltration	23.75	12.57	15	56484	1389	64440844
Herpes simplex	23.61	12.57	37	56462	10499	64431734
Cholestatic liver injury	23.48	12.57	22	56477	3657	64438576
Chronic disease	23.48	12.57	7	56492	97	64442136
Liver transplant rejection	23.23	12.57	20	56479	2979	64439254
Urine phosphorus decreased	23.11	12.57	6	56493	48	64442185
Astrocytoma, low grade	23.11	12.57	6	56493	48	64442185
Hepatitis fulminant	23.09	12.57	28	56471	6246	64435987
Parotid gland enlargement	23.06	12.57	12	56487	769	64441464
Central nervous system lesion	23.01	12.57	39	56460	11810	64430423
Primary syphilis	22.81	12.57	5	56494	17	64442216
Bradycardia	22.80	12.57	43	56456	118176	64324057
Dermatitis exfoliative	22.71	12.57	36	56463	10316	64431917
Tubulointerstitial nephritis	22.64	12.57	69	56430	30840	64411393
Fluid retention	22.58	12.57	12	56487	59594	64382639
Taeniasis	22.58	12.57	6	56493	53	64442180
Molluscum contagiosum	22.56	12.57	10	56489	448	64441785
Hepatitis E	22.55	12.57	18	56481	2413	64439820
Isosporiasis	22.55	12.57	7	56492	112	64442121
Intracranial pressure increased	22.23	12.57	29	56470	6960	64435273
Osteoporotic fracture	21.98	12.57	21	56478	3577	64438656
Burning sensation	21.97	12.57	8	56491	49656	64392577
Blood bicarbonate decreased	21.89	12.57	24	56475	4805	64437428
Pericarditis	21.68	12.57	14	56485	62502	64379731
Viral load decreased	21.61	12.57	5	56494	23	64442210
Blood creatine phosphokinase increased	21.54	12.57	105	56394	58453	64383780
Cryoglobulinaemia	21.52	12.57	11	56488	679	64441554
Erosive duodenitis	21.32	12.57	15	56484	1663	64440570
Diverticulitis	21.30	12.57	4	56495	38614	64403619
Placenta praevia	21.28	12.57	11	56488	695	64441538
Anaemia neonatal	21.27	12.57	5	56494	25	64442208
Haematoma	21.23	12.57	7	56492	46243	64395990
Hot flush	21.22	12.57	7	56492	46228	64396005
Hyperhidrosis	21.09	12.57	49	56450	124871	64317362
Nephropathy	20.99	12.57	31	56468	8355	64433878
Anembryonic gestation	20.76	12.57	9	56490	382	64441851
Gestational diabetes	20.66	12.57	25	56474	5565	64436668
Swollen tongue	20.66	12.57	3	56496	34951	64407282
Hyponatraemia	20.66	12.57	64	56435	148275	64293958
Breech delivery	20.65	12.57	5	56494	29	64442204
Bulbar palsy	20.64	12.57	8	56491	254	64441979
Non-Hodgkin's lymphoma	20.60	12.57	14	56485	1467	64440766
Chest pain	20.44	12.57	122	56377	235858	64206375
Haematochezia	20.25	12.57	17	56482	66356	64375877
Retroviral infection	20.12	12.57	4	56495	7	64442226
Hypoglycaemia	19.81	12.57	30	56469	89862	64352371
Type III hyperlipidaemia	19.78	12.57	4	56495	8	64442225
Loss of anatomical alignment after fracture reduction	19.78	12.57	4	56495	8	64442225
Pneumonia aspiration	19.58	12.57	14	56485	59257	64382976
HIV associated nephropathy	19.56	12.57	8	56491	293	64441940
Cough	19.49	12.57	170	56329	301978	64140255
Memory impairment	19.47	12.57	28	56471	85654	64356579
Dehydration	19.34	12.57	111	56388	216652	64225581
Antimitochondrial antibody positive	19.27	12.57	6	56493	97	64442136
Lymphadenitis	19.26	12.57	20	56479	3765	64438468
Neuromyopathy	19.19	12.57	13	56486	1355	64440878
Helicobacter infection	19.09	12.57	5	56494	38357	64403876
Fibromyalgia	19.08	12.57	4	56495	35727	64406506
Histoplasmosis disseminated	18.98	12.57	15	56484	1983	64440250
Ballismus	18.92	12.57	7	56492	195	64442038
Disseminated Bacillus Calmette-Guerin infection	18.92	12.57	7	56492	195	64442038
Pneumonia	18.90	12.57	361	56138	559215	63883018
Urticaria	18.83	12.57	66	56433	147251	64294982
Discomfort	18.80	12.57	26	56473	80852	64361381
Hepatitis viral	18.73	12.57	11	56488	894	64441339
Cystitis	18.66	12.57	7	56492	42668	64399565
Abortion missed	18.53	12.57	12	56487	1160	64441073
Portal hypertensive gastropathy	18.53	12.57	12	56487	1160	64441073
Postpartum haemorrhage	18.53	12.57	13	56486	1434	64440799
Neck pain	18.48	12.57	16	56483	61517	64380716
Chest discomfort	18.45	12.57	47	56452	116059	64326174
Disease progression	18.43	12.57	63	56436	141617	64300616
Central nervous system immune reconstitution inflammatory response	18.35	12.57	5	56494	49	64442184
Lip swelling	18.26	12.57	3	56496	31904	64410329
Optic nerve cupping	18.17	12.57	5	56494	51	64442182
Blood lactate dehydrogenase increased	18.15	12.57	67	56432	33011	64409222
AIDS related complex	18.12	12.57	3	56496	0	64442233
Vertical infection transmission	18.12	12.57	3	56496	0	64442233
Prenatal screening test abnormal	18.12	12.57	3	56496	0	64442233
Alpha 1 foetoprotein increased	18.01	12.57	10	56489	730	64441503
Incorrect dose administered	18.01	12.57	16	56483	60749	64381484
Oropharyngeal candidiasis	17.99	12.57	13	56486	1502	64440731
Pubertal failure	17.95	12.57	4	56495	15	64442218
Erythema elevatum diutinum	17.95	12.57	4	56495	15	64442218
Trisomy 21	17.91	12.57	5	56494	54	64442179
Ultrasound scan abnormal	17.89	12.57	7	56492	228	64442005
Bacterial pyelonephritis	17.85	12.57	9	56490	540	64441693
CD4 lymphocytes	17.74	12.57	4	56495	16	64442217
Product use in unapproved indication	17.67	12.57	87	56412	176531	64265702
AIDS related complication	17.67	12.57	5	56494	57	64442176
Amylase increased	17.66	12.57	31	56468	9654	64432579
Balance disorder	17.56	12.57	29	56470	83897	64358336
Injury	17.51	12.57	14	56485	55978	64386255
Clostridium difficile infection	17.45	12.57	5	56494	36158	64406075
Nervous system disorder	17.35	12.57	52	56447	23026	64419207
Plasmodium falciparum infection	17.21	12.57	5	56494	63	64442170
Plasmablastic lymphoma	17.21	12.57	8	56491	401	64441832
Post inflammatory pigmentation change	17.13	12.57	8	56491	405	64441828
Paraparesis	16.92	12.57	18	56481	3484	64438749
Renal atrophy	16.91	12.57	13	56486	1651	64440582
International normalised ratio increased	16.90	12.57	27	56472	79140	64363093
Acute lymphocytic leukaemia	16.89	12.57	20	56479	4351	64437882
Choroiditis	16.87	12.57	11	56488	1076	64441157
Orthostatic hypotension	16.85	12.57	10	56489	46728	64395505
Anal cancer stage 0	16.85	12.57	4	56495	21	64442212
Vomiting	16.81	12.57	615	55884	550502	63891731
Gestational hypertension	16.79	12.57	13	56486	1668	64440565
Hypersplenism	16.70	12.57	8	56491	429	64441804
Blood uric acid decreased	16.70	12.57	11	56488	1095	64441138
Small for dates baby	16.67	12.57	8	56491	431	64441802
ADAMTS13 activity decreased	16.65	12.57	6	56493	155	64442078
Benign hepatic neoplasm	16.47	12.57	5	56494	74	64442159
Intentional product use issue	16.42	12.57	37	56462	95327	64346906
Albuminuria	16.39	12.57	9	56490	643	64441590
Drug reaction with eosinophilia and systemic symptoms	16.34	12.57	92	56407	54125	64388108
Rectal haemorrhage	16.34	12.57	18	56481	61799	64380434
Portal vein thrombosis	16.33	12.57	21	56478	4970	64437263
Red blood cells urine	16.32	12.57	9	56490	648	64441585
Influenza like illness	16.27	12.57	18	56481	61684	64380549
Neurosyphilis	16.26	12.57	4	56495	25	64442208
Musculoskeletal toxicity	16.26	12.57	6	56493	166	64442067
Psychiatric decompensation	16.25	12.57	15	56484	2448	64439785
Visual field defect	16.07	12.57	27	56472	8119	64434114
Paraesthesia	16.05	12.57	62	56437	134460	64307773
Kwashiorkor	16.05	12.57	3	56496	3	64442230
Funisitis	16.05	12.57	3	56496	3	64442230
Hepatitis B DNA decreased	16.05	12.57	3	56496	3	64442230
Cervix operation	16.05	12.57	3	56496	3	64442230
Wrong technique in product usage process	16.01	12.57	20	56479	64954	64377279
Bone pain	15.88	12.57	83	56416	47489	64394744
Eclampsia	15.74	12.57	6	56493	182	64442051
Dry skin	15.74	12.57	13	56486	51148	64391085
Ultrasound antenatal screen abnormal	15.63	12.57	4	56495	30	64442203
Viral hepatitis carrier	15.52	12.57	4	56495	31	64442202
Spermatozoa progressive motility abnormal	15.52	12.57	4	56495	31	64442202
Genital herpes	15.42	12.57	13	56486	1882	64440351
Drug dependence	15.37	12.57	5	56494	33307	64408926
Acute hepatic failure	15.27	12.57	54	56445	26058	64416175
Insomnia	15.23	12.57	106	56393	197730	64244503
Blood pressure decreased	15.21	12.57	33	56466	86166	64356067
Cardiac failure	15.17	12.57	62	56437	132311	64309922
Ileal ulcer	15.15	12.57	10	56489	998	64441235
Carnitine deficiency	15.12	12.57	6	56493	203	64442030
Osteoarthritis	15.09	12.57	20	56479	63316	64378917
Product prescribing error	15.07	12.57	6	56493	35263	64406970
Hyperphosphataemia	15.03	12.57	18	56481	3963	64438270
Ovarian failure	15.03	12.57	8	56491	537	64441696
Atypical mycobacterial infection	15.03	12.57	11	56488	1297	64440936
Portal vein occlusion	14.99	12.57	4	56495	36	64442197
Brain oedema	14.99	12.57	48	56451	22027	64420206
Dyspnoea exertional	14.94	12.57	26	56473	73704	64368529
Secondary adrenocortical insufficiency	14.92	12.57	14	56485	2331	64439902
Developmental delay	14.90	12.57	10	56489	1027	64441206
Subacute sclerosing panencephalitis	14.89	12.57	4	56495	37	64442196
Anogenital dysplasia	14.89	12.57	5	56494	104	64442129
Therapeutic product effect incomplete	14.86	12.57	44	56455	103438	64338795
Infected vasculitis	14.83	12.57	3	56496	6	64442227
Carbon dioxide combining power abnormal	14.83	12.57	3	56496	6	64442227
Glycocholic acid increased	14.83	12.57	3	56496	6	64442227
Acute fatty liver of pregnancy	14.79	12.57	4	56495	38	64442195
Heart rate irregular	14.78	12.57	3	56496	27410	64414823
Eyelid oedema	14.76	12.57	33	56466	12246	64429987
Glomerulonephritis proliferative	14.74	12.57	7	56492	368	64441865
Hepatitis B surface antibody positive	14.69	12.57	6	56493	219	64442014
Death neonatal	14.61	12.57	4	56495	40	64442193
Blood glucose increased	14.60	12.57	41	56458	98032	64344201
Limb discomfort	14.60	12.57	3	56496	27172	64415061
Gastrointestinal haemorrhage	14.52	12.57	63	56436	132249	64309984
Antiviral drug level below therapeutic	14.52	12.57	4	56495	41	64442192
Portal fibrosis	14.43	12.57	8	56491	582	64441651
Fat redistribution	14.38	12.57	5	56494	116	64442117
Lipase increased	14.37	12.57	36	56463	14366	64427867
CSF protein increased	14.32	12.57	10	56489	1095	64441138
Pleocytosis	14.30	12.57	10	56489	1097	64441136
Acute stress disorder	14.26	12.57	7	56492	396	64441837
Crystal urine	14.26	12.57	5	56494	119	64442114
Osteocalcin increased	14.23	12.57	3	56496	8	64442225
Visual impairment	14.23	12.57	27	56472	74050	64368183
Cytomegalovirus oesophagitis	14.18	12.57	8	56491	602	64441631
Myopia	14.18	12.57	12	56487	1746	64440487
Heart rate increased	14.14	12.57	42	56457	98633	64343600
Burkitt's lymphoma	14.14	12.57	5	56494	122	64442111
Breast cancer	14.12	12.57	4	56495	29144	64413089
Cholestasis	14.10	12.57	77	56422	44795	64397438
Hypervolaemia	14.08	12.57	8	56491	38277	64403956
Emotional distress	14.03	12.57	7	56492	36031	64406202
Hepatic necrosis	14.02	12.57	26	56473	8447	64433786
Bone marrow oedema	13.96	12.57	10	56489	1140	64441093
Antiviral drug level above therapeutic	13.95	12.57	4	56495	48	64442185
Graft infection	13.93	12.57	8	56491	623	64441610
Acute hepatitis B	13.90	12.57	7	56492	419	64441814
Red blood cell sedimentation rate increased	13.87	12.57	5	56494	31230	64411003
Genital ulceration	13.79	12.57	8	56491	635	64441598
Optic neuropathy	13.71	12.57	15	56484	2996	64439237
Blood creatine phosphokinase MB increased	13.61	12.57	14	56485	2607	64439626
Hyperintensity in brain deep nuclei	13.58	12.57	4	56495	53	64442180
Basal cell carcinoma	13.58	12.57	5	56494	30833	64411400
Upper respiratory tract infection	13.57	12.57	27	56472	72758	64369475
Blood pressure systolic increased	13.51	12.57	14	56485	49439	64392794
Osteodystrophy	13.51	12.57	3	56496	11	64442222
Pharyngotonsillitis	13.47	12.57	6	56493	272	64441961
Prurigo	13.45	12.57	10	56489	1207	64441026
Cervical dysplasia	13.39	12.57	12	56487	1884	64440349
Head injury	13.37	12.57	6	56493	32836	64409397
Colour vision tests abnormal	13.31	12.57	3	56496	12	64442221
Multiple fractures	13.24	12.57	21	56478	6019	64436214
Anaphylactic shock	13.22	12.57	5	56494	30323	64411910
Cerebellar syndrome	13.22	12.57	19	56480	4997	64437236
Acute on chronic liver failure	13.21	12.57	6	56493	285	64441948
COVID-19	13.17	12.57	23	56476	65117	64377116
Bovine tuberculosis	13.17	12.57	5	56494	150	64442083
Spinal cord injury	13.17	12.57	9	56490	952	64441281
Agitation	13.11	12.57	37	56462	88330	64353903
Spermatozoa progressive motility decreased	13.07	12.57	4	56495	61	64442172
Ear pain	13.04	12.57	3	56496	25133	64417100
Pulmonary embolism	13.02	12.57	75	56424	146281	64295952
Trimethylaminuria	12.98	12.57	5	56494	156	64442077
Acute HIV infection	12.95	12.57	4	56495	63	64442170
Subchondral insufficiency fracture	12.95	12.57	4	56495	63	64442170
Gastrooesophageal reflux disease	12.94	12.57	34	56465	83109	64359124
Pneumonitis	12.94	12.57	15	56484	50350	64391883
Neuroleptic malignant syndrome	12.94	12.57	3	56496	24993	64417240
Pathological fracture	12.90	12.57	26	56473	8979	64433254
Mesenteric vein thrombosis	12.85	12.57	10	56489	1292	64440941
Musculoskeletal pain	12.84	12.57	33	56466	81261	64360972
Melanaemia	12.83	12.57	4	56495	65	64442168
Fungal infection	12.82	12.57	7	56492	34244	64407989
Hepatitis D RNA positive	12.76	12.57	3	56496	15	64442218
Congenital diaphragmatic hernia	12.76	12.57	3	56496	15	64442218
Herpes virus infection	12.72	12.57	21	56478	6223	64436010
Neurocryptococcosis	12.60	12.57	3	56496	16	64442217

FDA Adverse Event Reporting System (Pediatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Neutropenia	40.77	39.38	22	527	190	83939

Pharmacologic Action:

Source	Code	Description
ATC	J05AF05	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Nucleoside and nucleotide reverse transcriptase inhibitors
ATC	J05AR01	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR02	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR04	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR05	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR07	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR11	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR12	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR13	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR16	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR24	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR25	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR27	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
FDA MoA	N0000009947	Nucleoside Reverse Transcriptase Inhibitors
FDA EPC	N0000175462	Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
FDA EPC	N0000175656	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor
CHEBI has role	CHEBI:36044	antiviral drugs
CHEBI has role	CHEBI:50266	Prodrugs
CHEBI has role	CHEBI:50904	alergeno
CHEBI has role	CHEBI:53756	reverse transcriptase inhibitors
CHEBI has role	CHEBI:64951	anti-HBV agents
MeSH PA	D019380	Anti-HIV Agents
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D044966	Anti-Retroviral Agents
MeSH PA	D000998	Antiviral Agents
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D019384	Nucleic Acid Synthesis Inhibitors
MeSH PA	D018894	Reverse Transcriptase Inhibitors

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

Disease	Relation	SNOMED_ID	DOID
Chronic type B viral hepatitis	indication	61977001
Human immunodeficiency virus infection	indication	86406008	DOID:526
Prevention of Hepatitis B Reactivation in Immunocompromised Patients	off-label use
Prevention of HIV Infection after Exposure	off-label use
Toxic amblyopia	contraindication	965003
Myositis	contraindication	26889001	DOID:633
Hepatic failure	contraindication	59927004
Pancreatitis	contraindication	75694006	DOID:4989
Large liver	contraindication	80515008
Kidney disease	contraindication	90708001	DOID:557
Lactic acidosis	contraindication	91273001	DOID:3650
Disorder of muscle	contraindication	129565002	DOID:423
Steatosis of liver	contraindication	197321007
Acute pancreatitis	contraindication	197456007	DOID:2913
Chronic pancreatitis	contraindication	235494005
Disease of liver	contraindication	235856003	DOID:409
Anemia	contraindication	271737000	DOID:2355
Hypertriglyceridemia	contraindication	302870006
Neutropenic disorder	contraindication	303011007	DOID:1227
Bone marrow depression	contraindication	307762000
Breastfeeding (mother)	contraindication	413712001
Obesity	contraindication	414916001	DOID:9970
Drug Resistance to Anti-retroviral Therapy	contraindication
HLA-B 5701 Positive Status	contraindication

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	12.95	acidic
pKa2	4.18	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
150MG;EQ 300MG BASE	DUTREBIS	MERCK SHARP DOHME	N206510	Feb. 6, 2015	DISCN	TABLET	ORAL	7217713	Oct. 21, 2022	TREATMENT OF HIV-1 INFECTION
150MG;EQ 300MG BASE	DUTREBIS	MERCK SHARP DOHME	N206510	Feb. 6, 2015	DISCN	TABLET	ORAL	7435734	Oct. 21, 2022	TREATMENT OF HIV-1 INFECTION
150MG;EQ 300MG BASE	DUTREBIS	MERCK SHARP DOHME	N206510	Feb. 6, 2015	DISCN	TABLET	ORAL	7754731	March 11, 2029	TREATMENT OF HIV-1 INFECTION
EQ 50MG BASE;300MG	DOVATO	VIIV HLTHCARE	N211994	April 8, 2019	RX	TABLET	ORAL	11234985	Jan. 24, 2031	TREATMENT OF HIV INFECTION
100MG;300MG;300MG	DELSTRIGO	MSD MERCK CO	N210807	Aug. 30, 2018	RX	TABLET	ORAL	8486975	Oct. 7, 2031	FOR THE TREATMENT OF HIV-1 INFECTION IN ADULT PATIENTS WITH NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY
100MG;300MG;300MG	DELSTRIGO	MSD MERCK CO	N210807	Aug. 30, 2018	RX	TABLET	ORAL	8486975	Oct. 7, 2031	TREATMENT OF HIV-1 INFECTION IN ADULT PATIENTS AS A REPLACEMENT THERAPY IN VIROLOGICALLY SUPPRESSED ADULTS WITH NO HISTORY OF TREATMENT FAILURE AND NO KNOWN SUBSTITUTIONS ASSOCIATED WITH RESISTANCE TO THE INDIVIDUAL COMPONENTS OF DELSTRIGO
100MG;300MG;300MG	DELSTRIGO	MSD MERCK CO	N210807	Aug. 30, 2018	RX	TABLET	ORAL	8486975	Oct. 7, 2031	TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS WEIGHING AT LEAST 35KG WITH NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR TO REPLACE THE CURRENT ANTIRETROVIRAL REGIMEN IN THOSE WHO ARE VIROLOGICALLY SUPPRESSED

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
EQ 50MG BASE;300MG	DOVATO	VIIV HLTHCARE	N211994	April 8, 2019	RX	TABLET	ORAL	April 8, 2022	NEW COMBINATION
100MG;300MG;300MG	DELSTRIGO	MSD MERCK CO	N210807	Aug. 30, 2018	RX	TABLET	ORAL	Sept. 19, 2022	EXPANDED INDICATION FOR PTS WHO ARE VIROLOGICALLY SUPPRESSED (HIV-1 RNA LESS THAN 50 COPIES/ML) ON A STABLE ARV REGIMEN WITH NO HX OF TX FAILURE AND NO KNOWN SUBSTITUTIONS ASSOCIATED W RESISTANCE TO DORAVIRINE, LAMIVUDINE OR TENOFOVIR DISOPROXIL FUMARATE
EQ 50MG BASE;300MG	DOVATO	VIIV HLTHCARE	N211994	April 8, 2019	RX	TABLET	ORAL	Aug. 6, 2023	TO REPLACE THE CURRENT ANTIRETROVIRAL REGIMEN IN THOSE WHO ARE VIROLOGICALLY SUPRESSED (HIV-1 RNA LESS THAN 50 COPIES PER ML) ON A STABLE ANTIRETROVIRAL REGIMEN WITH NO HISTORY OF TREATMENT FAILURE
100MG;300MG;300MG	DELSTRIGO	MSD MERCK CO	N210807	Aug. 30, 2018	RX	TABLET	ORAL	Aug. 30, 2023	NEW CHEMICAL ENTITY
100MG;300MG;300MG	DELSTRIGO	MSD MERCK CO	N210807	Aug. 30, 2018	RX	TABLET	ORAL	Jan. 27, 2025	NEW PATIENT POPULATION

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

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
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
EPIVIRHBV	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0662	TABLET, FILM COATED	100 mg	ORAL	NDA	26 sections
EPIVIRHBV	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0663	SOLUTION	5 mg	ORAL	NDA	26 sections
LAMIVUDINE	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6583	TABLET, FILM COATED	150 mg	ORAL	ANDA	27 sections
Lamivudine	HUMAN PRESCRIPTION DRUG LABEL	1	10135-605	SOLUTION	10 mg	ORAL	ANDA	25 sections
Combivir	HUMAN PRESCRIPTION DRUG LABEL	2	16590-061	TABLET, FILM COATED	150 mg	ORAL	NDA	16 sections
EPIVIR	HUMAN PRESCRIPTION DRUG LABEL	1	21695-367	TABLET, FILM COATED	150 mg	ORAL	NDA	26 sections
COMBIVIR	HUMAN PRESCRIPTION DRUG LABEL	2	21695-846	TABLET, FILM COATED	150 mg	ORAL	NDA	26 sections
Lamivudine and Zidovudine	HUMAN PRESCRIPTION DRUG LABEL	2	21695-996	TABLET, FILM COATED	150 mg	ORAL	ANDA	26 sections
lamivudine	Human Prescription Drug Label	1	31722-001	TABLET, FILM COATED	100 mg	ORAL	ANDA	25 sections
LAMIVUDINE and ZIDOVUDINE	Human Prescription Drug Label	2	31722-506	TABLET, FILM COATED	150 mg	ORAL	ANDA	25 sections
Lamivudine and Zidovudine	HUMAN PRESCRIPTION DRUG LABEL	2	31722-739	TABLET, FILM COATED	150 mg	ORAL	ANDA	24 sections
Lamivudine	Human Prescription Drug Label	1	31722-752	TABLET, FILM COATED	100 mg	ORAL	ANDA	28 sections
Lamivudine	Human Prescription Drug Label	1	31722-753	TABLET, FILM COATED	150 mg	ORAL	ANDA	25 sections
Lamivudine	Human Prescription Drug Label	1	31722-754	TABLET, FILM COATED	300 mg	ORAL	ANDA	25 sections
Lamivudine	Human Prescription Drug Label	1	33342-001	TABLET, FILM COATED	150 mg	ORAL	ANDA	26 sections
Lamivudine	Human Prescription Drug Label	1	33342-002	TABLET, FILM COATED	300 mg	ORAL	ANDA	26 sections
Lamivudine and Zidovudine	Human Prescription Drug Label	2	33342-003	TABLET	150 mg	ORAL	ANDA	25 sections
Abacavir and Lamivudine	Human Prescription Drug Label	2	35573-402	TABLET, FILM COATED	300 mg	ORAL	ANDA	29 sections
Abacavir and Lamivudine	Human Prescription Drug Label	2	35573-430	TABLET, FILM COATED	300 mg	ORAL	ANDA	27 sections
Abacavir and Lamivudine	HUMAN PRESCRIPTION DRUG LABEL	2	42291-115	TABLET, FILM COATED	300 mg	ORAL	ANDA	28 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
LAMIVUDINE and ZIDOVUDINE	HUMAN PRESCRIPTION DRUG LABEL	2	43063-900	TABLET, FILM COATED	150 mg	ORAL	ANDA	25 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