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

Stem definition	Drug id	CAS RN
antivirals	2593	201341-05-1

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: viread tenofovir disoproxil tenofovir disoproxil fumarate	Tenofovir disoproxil fumarate is the fumarate salt of the prodrug tenofovir disoproxil. Tenofovir disoproxil is absorbed and converted to the active substance tenofovir, which is a nucleoside monophosphate (nucleotide) analogue. Tenofovir is then converted to the active metabolite, tenofovir diphosphate, an obligate chain terminator, by constitutively expressed cellular enzymes. Tenofovir diphosphate has an intracellular half-life of 10 hours in activated and 50 hours in resting peripheral blood mononuclear cells (PBMCs). Tenofovir diphosphate inhibits HIV-1 reverse transcriptase and the HBV polymerase by direct binding competition with the natural deoxyribonucleotide substrate and, after incorporation into DNA, by DNA chain termination. Tenofovir diphosphate is a weak inhibitor of cellular polymerases alpha, beta, and gamma. At concentrations of up to 300 umol/l, tenofovir has also shown no effect on the synthesis of mitochondrial DNA or the production of lactic acid in in vitro assays. Molecular weight: 519.45 Formula: C19H30N5O10P CLOGP: 0.80 LIPINSKI: 2 HAC: 15 HDO: 1 TPSA: 185.44 ALOGS: -2.86 ROTB: 17 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

viread
tenofovir disoproxil
tenofovir disoproxil fumarate

Tenofovir disoproxil fumarate is the fumarate salt of the prodrug tenofovir disoproxil. Tenofovir disoproxil is absorbed and converted to the active substance tenofovir, which is a nucleoside monophosphate (nucleotide) analogue. Tenofovir is then converted to the active metabolite, tenofovir diphosphate, an obligate chain terminator, by constitutively expressed cellular enzymes. Tenofovir diphosphate has an intracellular half-life of 10 hours in activated and 50 hours in resting peripheral blood mononuclear cells (PBMCs). Tenofovir diphosphate inhibits HIV-1 reverse transcriptase and the HBV polymerase by direct binding competition with the natural deoxyribonucleotide substrate and, after incorporation into DNA, by DNA chain termination. Tenofovir diphosphate is a weak inhibitor of cellular polymerases alpha, beta, and gamma. At concentrations of up to 300 umol/l, tenofovir has also shown no effect on the synthesis of mitochondrial DNA or the production of lactic acid in in vitro assays.

Molecular weight: 519.45
Formula: C19H30N5O10P
CLOGP: 0.80
LIPINSKI: 2
HAC: 15
HDO: 1
TPSA: 185.44
ALOGS: -2.86
ROTB: 17

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.25	g	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Bocci G, Oprea TI, Benet LZ
S (Water solubility)	16.67 mg/mL	Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine)	82 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	6.43 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	0.25 %	Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Approvals:

Date	Agency	Company	Orphan
Feb. 4, 2002	EMA	Gilead Sciences Ireland UC
Oct. 26, 2001	FDA	GILEAD SCIENCES INC

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
Abortion spontaneous	1316.41	17.98	498	17750	46697	63424077
Exposure during pregnancy	718.91	17.98	484	17764	155063	63315711
Foetal exposure during pregnancy	674.28	17.98	276	17972	31686	63439088
Maternal exposure during pregnancy	518.30	17.98	459	17789	219603	63251171
Virologic failure	508.84	17.98	116	18132	1746	63469028
Fanconi syndrome acquired	505.60	17.98	104	18144	932	63469842
Stillbirth	461.51	17.98	140	18108	6610	63464164
Viral mutation identified	431.93	17.98	101	18147	1709	63469065
Pregnancy	381.70	17.98	194	18054	36642	63434132
Abortion induced	354.46	17.98	127	18121	10115	63460659
Drug resistance	319.64	17.98	148	18100	22785	63447989
Immune reconstitution inflammatory syndrome	302.60	17.98	99	18149	5985	63464789
Premature baby	270.95	17.98	128	18120	20607	63450167
Viral load increased	257.05	17.98	63	18185	1311	63469463
Blood HIV RNA increased	256.48	17.98	56	18192	683	63470091
Pathogen resistance	254.44	17.98	88	18160	6310	63464464
Osteoporosis	202.69	17.98	152	18096	57186	63413588
Renal tubular disorder	197.79	17.98	59	18189	2623	63468151
Caesarean section	185.93	17.98	93	18155	16939	63453835
Genotype drug resistance test positive	185.31	17.98	39	18209	394	63470380
Nephropathy toxic	179.84	17.98	76	18172	9403	63461371
Hepatitis B DNA increased	172.54	17.98	34	18214	239	63470535
Premature labour	171.98	17.98	80	18168	12424	63458350
Premature delivery	167.94	17.98	106	18142	30175	63440599
Renal tubular acidosis	159.28	17.98	45	18203	1647	63469127
Fanconi syndrome	149.26	17.98	41	18207	1351	63469423
Lipodystrophy acquired	147.55	17.98	41	18207	1411	63469363
Arthrodesis	145.01	17.98	47	18201	2754	63468020
Hepatic cytolysis	136.14	17.98	73	18175	15334	63455440
Hyperandrogenism	134.57	17.98	24	18224	89	63470685
CD4 lymphocytes decreased	134.54	17.98	38	18210	1389	63469385
Enlarged clitoris	132.83	17.98	25	18223	133	63470641
Glycosuria	132.73	17.98	36	18212	1130	63469644
Renal tubular dysfunction	129.10	17.98	29	18219	406	63470368
Live birth	127.97	17.98	84	18164	25546	63445228
Hypophosphataemia	126.49	17.98	63	18185	11363	63459411
Proteinuria	121.35	17.98	73	18175	19072	63451702
Osteomalacia	118.51	17.98	30	18218	715	63470059
Acute kidney injury	118.03	17.98	244	18004	263171	63207603
Hepatitis B reactivation	112.64	17.98	40	18208	3097	63467677
Premature rupture of membranes	104.68	17.98	43	18205	4950	63465824
Foetal death	102.57	17.98	54	18194	10926	63459848
Rebound effect	101.82	17.98	41	18207	4485	63466289
Renal failure	93.03	17.98	140	18108	117512	63353262
Cushing's syndrome	91.42	17.98	24	18224	663	63470111
Alanine aminotransferase increased	90.01	17.98	129	18119	103641	63367133
Treatment noncompliance	85.61	17.98	77	18171	37248	63433526
Renal tubular necrosis	85.00	17.98	49	18199	11829	63458945
Hydrops foetalis	84.57	17.98	22	18226	586	63470188
Pain	81.44	17.98	57	18191	740571	62730203
Oligohydramnios	76.11	17.98	37	18211	6329	63464445
Jaundice	74.40	17.98	64	18184	29187	63441587
Fatigue	74.30	17.98	88	18160	887940	62582834
Joint swelling	71.87	17.98	6	18242	327660	63143114
CSF HIV escape syndrome	71.73	17.98	14	18234	93	63470681
Hyperbilirubinaemia	71.32	17.98	43	18205	11271	63459503
Aspartate aminotransferase increased	67.90	17.98	105	18143	90172	63380602
Ultrasound antenatal screen abnormal	67.29	17.98	14	18234	133	63470641
Malaria	67.10	17.98	15	18233	205	63470569
Meningomyelocele	65.32	17.98	18	18230	600	63470174
Placental disorder	64.90	17.98	22	18226	1482	63469292
Maternal drugs affecting foetus	64.28	17.98	31	18217	5211	63465563
Osteonecrosis	63.05	17.98	54	18194	24476	63446298
Hypophosphataemic osteomalacia	61.67	17.98	14	18234	206	63470568
Pre-eclampsia	60.92	17.98	36	18212	9097	63461677
Placenta praevia	60.49	17.98	19	18229	1005	63469769
Blood phosphorus decreased	59.69	17.98	28	18220	4425	63466349
Infusion related reaction	58.22	17.98	3	18245	245518	63225256
Placental insufficiency	57.97	17.98	20	18228	1421	63469353
Congenital anomaly	57.58	17.98	21	18227	1755	63469019
Haemolytic anaemia	57.49	17.98	36	18212	10089	63460685
Hepatitis B	57.45	17.98	26	18222	3786	63466988
Renal colic	57.43	17.98	20	18228	1461	63469313
Foetal growth restriction	56.30	17.98	32	18216	7521	63463253
Congenital choroid plexus cyst	56.24	17.98	14	18234	311	63470463
Macrocephaly	55.37	17.98	11	18237	81	63470693
Blood creatinine increased	54.95	17.98	94	18154	87750	63383024
Hepatitis fulminant	53.39	17.98	24	18224	3440	63467334
Shoulder arthroplasty	53.14	17.98	25	18223	3977	63466797
Peripheral swelling	52.84	17.98	7	18241	265935	63204839
Fall	51.85	17.98	24	18224	392310	63078464
Hemivertebra	51.66	17.98	11	18237	118	63470656
Cleft lip and palate	51.32	17.98	15	18233	620	63470154
Limb operation	49.91	17.98	24	18224	4007	63466767
Nasopharyngitis	49.78	17.98	7	18241	254250	63216524
Neonatal respiratory distress syndrome	48.18	17.98	21	18227	2797	63467977
Congenital umbilical hernia	46.81	17.98	12	18236	301	63470473
Ectopic pregnancy	46.74	17.98	20	18228	2547	63468227
Arnold-Chiari malformation	46.31	17.98	14	18234	651	63470123
Lactic acidosis	46.18	17.98	56	18192	38231	63432543
Systemic lupus erythematosus	45.30	17.98	4	18244	208914	63261860
Metabolic acidosis	43.47	17.98	59	18189	45010	63425764
HIV infection	43.23	17.98	12	18236	411	63470363
Congenital hydrocephalus	42.86	17.98	10	18238	167	63470607
Sinusitis	42.62	17.98	7	18241	226646	63244128
Birth mark	42.32	17.98	10	18238	177	63470597
Gestational diabetes	40.63	17.98	27	18221	8369	63462405
Ultrasound antenatal screen	40.43	17.98	10	18238	216	63470558
Dyspnoea	40.31	17.98	81	18167	661232	62809542
Ventricular septal defect	39.38	17.98	21	18227	4357	63466417
Multiple-drug resistance	38.79	17.98	22	18226	5148	63465626
Hepatitis B DNA assay positive	38.63	17.98	7	18241	29	63470745
Transaminases increased	38.02	17.98	46	18202	31321	63439453
Acquired immunodeficiency syndrome	37.99	17.98	8	18240	81	63470693
Drug interaction	37.88	17.98	148	18100	228983	63241791
Patent ductus arteriosus	37.14	17.98	20	18228	4230	63466544
Arthralgia	37.13	17.98	67	18181	569643	62901131
Foetal distress syndrome	36.72	17.98	14	18234	1324	63469450
Hydromyelia	36.34	17.98	6	18242	12	63470762
Musculoskeletal stiffness	36.32	17.98	5	18243	184613	63286161
Drug intolerance	36.16	17.98	22	18226	308639	63162135
Normal newborn	36.02	17.98	25	18223	8316	63462458
Polyhydramnios	35.85	17.98	16	18232	2255	63468519
Rash maculo-papular	35.80	17.98	45	18203	31851	63438923
Immune reconstitution inflammatory syndrome associated tuberculosis	35.55	17.98	10	18238	360	63470414
AIDS cholangiopathy	35.42	17.98	6	18242	15	63470759
Antiviral drug level below therapeutic	35.18	17.98	7	18241	52	63470722
Human immunodeficiency virus transmission	35.06	17.98	7	18241	53	63470721
Spina bifida	34.86	17.98	12	18236	847	63469927
Blood creatine phosphokinase MB increased	34.36	17.98	13	18235	1203	63469571
Cholestasis of pregnancy	34.27	17.98	13	18235	1212	63469562
Adrenal suppression	34.00	17.98	12	18236	912	63469862
Hepatitis	33.77	17.98	49	18199	39739	63431035
Anaemia	33.71	17.98	170	18078	293260	63177514
Pulmonary tuberculosis	33.29	17.98	19	18229	4498	63466276
Pneumonia	33.20	17.98	50	18198	456717	63014057
Swelling	33.14	17.98	19	18229	275359	63195415
Viral load decreased	33.08	17.98	6	18242	25	63470749
Melanoderma	31.31	17.98	8	18240	198	63470576
Autoimmune hepatitis	31.00	17.98	23	18225	8487	63462287
Drug reaction with eosinophilia and systemic symptoms	30.67	17.98	43	18205	33793	63436981
Hepatitis D	30.59	17.98	6	18242	41	63470733
Cough	30.13	17.98	24	18224	292719	63178055
Umbilical cord abnormality	29.80	17.98	10	18238	653	63470121
Discomfort	29.67	17.98	6	18242	167368	63303406
Congenital pulmonary valve disorder	29.23	17.98	6	18242	53	63470721
Stomatitis	29.15	17.98	3	18245	138722	63332052
Rickets	28.74	17.98	6	18242	58	63470716
Hepatitis A	28.51	17.98	9	18239	484	63470290
Sudden infant death syndrome	28.10	17.98	8	18240	301	63470473
Blood creatine phosphokinase increased	28.07	17.98	39	18209	30391	63440383
Constipation	27.81	17.98	15	18233	224928	63245846
Polydactyly	27.80	17.98	8	18240	313	63470461
Condition aggravated	27.35	17.98	46	18202	402171	63068603
Oesophageal candidiasis	26.89	17.98	18	18230	5645	63465129
Eyelid oedema	26.78	17.98	23	18225	10456	63460318
Renal impairment	26.43	17.98	70	18178	88285	63382489
Foetal cardiac disorder	26.20	17.98	5	18243	29	63470745
Nephrogenic diabetes insipidus	26.19	17.98	10	18238	949	63469825
Hepatic failure	26.12	17.98	41	18207	35615	63435159
Headache	26.11	17.98	94	18154	633147	62837627
Lipohypertrophy	25.86	17.98	9	18239	656	63470118
HIV test positive	25.64	17.98	5	18243	33	63470741
Small for dates baby	25.58	17.98	15	18233	3736	63467038
Hydrocephalus	25.54	17.98	17	18231	5283	63465491
Abortion infected	25.39	17.98	5	18243	35	63470739
Vaginal ulceration	25.38	17.98	8	18240	428	63470346
Portal hypertension	25.33	17.98	15	18233	3804	63466970
Albuminuria	25.32	17.98	7	18241	236	63470538
Blood bilirubin increased	24.87	17.98	41	18207	37099	63433675
Gamma-glutamyltransferase increased	24.75	17.98	39	18209	33992	63436782
Benign hydatidiform mole	24.70	17.98	6	18242	120	63470654
Cholestasis	24.62	17.98	36	18212	29398	63441376
Mitochondrial toxicity	24.61	17.98	8	18240	473	63470301
Injection site pain	24.41	17.98	4	18244	129796	63340978
Congenital knee dislocation	24.23	17.98	4	18244	8	63470766
Type III hyperlipidaemia	24.23	17.98	4	18244	8	63470766
HIV-associated neurocognitive disorder	24.16	17.98	6	18242	132	63470642
Neonatal respiratory arrest	23.71	17.98	5	18243	51	63470723
Hepatotoxicity	23.62	17.98	40	18208	37001	63433773
Trisomy 18	23.46	17.98	6	18242	149	63470625
Congenital genital malformation	23.43	17.98	6	18242	150	63470624
Ocular icterus	23.31	17.98	14	18234	3642	63467132
Arthropathy	23.22	17.98	20	18228	234772	63236002
Coarctation of the aorta	23.15	17.98	8	18240	571	63470203
Cloacal exstrophy	23.06	17.98	6	18242	160	63470614
Chronic papillomatous dermatitis	22.89	17.98	5	18243	61	63470713
Product use issue	22.78	17.98	18	18230	220502	63250272
Caudal regression syndrome	22.67	17.98	6	18242	171	63470603
Ectopic kidney	22.60	17.98	5	18243	65	63470709
Nephrolithiasis	22.47	17.98	42	18206	41942	63428832
Rash	22.47	17.98	253	17995	560618	62910156
Blood bilirubin unconjugated increased	22.20	17.98	7	18241	375	63470399
ACTH stimulation test abnormal	22.19	17.98	4	18244	16	63470758
Trisomy 21	21.97	17.98	7	18241	388	63470386
Hepatic cirrhosis	21.78	17.98	31	18217	24703	63446071
Asthma	21.73	17.98	5	18243	127556	63343218
Mental disability	21.40	17.98	5	18243	84	63470690
Chronic kidney disease	21.35	17.98	43	18205	45355	63425419
Feeling abnormal	21.30	17.98	8	18240	148384	63322390
Blood pressure increased	21.23	17.98	10	18238	162052	63308722
Pulmonary embolism	21.06	17.98	4	18244	116680	63354094
Atrial fibrillation	21.04	17.98	4	18244	116632	63354142
Twin pregnancy	20.90	17.98	9	18239	1164	63469610
Blood alkaline phosphatase increased	20.57	17.98	41	18207	42926	63427848
Dermatitis exfoliative	20.44	17.98	15	18233	5444	63465330
COVID-19	20.15	17.98	4	18244	113099	63357675
Thymus hypoplasia	20.07	17.98	4	18244	30	63470744
Alopecia	19.94	17.98	42	18206	337494	63133280
Pulmonary valve sclerosis	19.62	17.98	4	18244	34	63470740
Eosinophilia	19.27	17.98	28	18220	22728	63448046
Lower respiratory tract infection	19.21	17.98	7	18241	132300	63338474
Tubulointerstitial nephritis	19.10	17.98	26	18222	19877	63450897
CSF test abnormal	19.05	17.98	6	18242	320	63470454
Influenza	19.05	17.98	4	18244	108718	63362056
Amniorrhoea	19.01	17.98	5	18243	139	63470635
Arthritis	18.86	17.98	5	18243	115916	63354858
Gait disturbance	18.85	17.98	15	18233	183163	63287611
Generalised anxiety disorder	18.80	17.98	10	18238	2064	63468710
Face oedema	18.79	17.98	26	18222	20186	63450588
Hypouricaemia	18.65	17.98	5	18243	150	63470624
Blister	18.62	17.98	7	18241	129807	63340967
Pregnancy on oral contraceptive	18.62	17.98	8	18240	1029	63469745
Bladder agenesis	18.52	17.98	5	18243	154	63470620
Chronic hepatitis B	18.52	17.98	6	18242	351	63470423
Genitalia external ambiguous	18.31	17.98	5	18243	161	63470613
Growth hormone-producing pituitary tumour	18.17	17.98	3	18245	6	63470768
Carbon dioxide combining power abnormal	18.17	17.98	3	18245	6	63470768
Glycocholic acid increased	18.17	17.98	3	18245	6	63470768
Product use in unapproved indication	18.01	17.98	15	18233	179065	63291709

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
Virologic failure	1033.24	12.61	295	33058	3185	34920393
Immune reconstitution inflammatory syndrome	926.28	12.61	339	33014	8420	34915158
Viral mutation identified	879.55	12.61	251	33102	2703	34920875
Fanconi syndrome acquired	832.81	12.61	221	33132	1770	34921808
Pathogen resistance	687.77	12.61	279	33074	9203	34914375
Lipodystrophy acquired	582.04	12.61	188	33165	3156	34920422
Mitochondrial toxicity	462.61	12.61	150	33203	2549	34921029
Renal tubular disorder	440.34	12.61	166	33187	4477	34919101
Osteoporosis	425.26	12.61	218	33135	12450	34911128
Viral load increased	403.04	12.61	133	33220	2394	34921184
Drug resistance	349.16	12.61	248	33105	25679	34897899
Fanconi syndrome	333.46	12.61	105	33248	1615	34921963
Hepatitis B	323.58	12.61	143	33210	5840	34917738
Foetal exposure during pregnancy	314.62	12.61	273	33080	37828	34885750
Eyelid ptosis	309.21	12.61	137	33216	5629	34917949
Blood HIV RNA increased	280.30	12.61	85	33268	1145	34922433
Hypophosphataemia	243.57	12.61	144	33209	10882	34912696
Progressive external ophthalmoplegia	238.77	12.61	78	33275	1357	34922221
Genotype drug resistance test positive	230.72	12.61	72	33281	1073	34922505
Nephropathy toxic	223.49	12.61	143	33210	12445	34911133
Acquired gene mutation	187.08	12.61	64	33289	1291	34922287
Glycosuria	184.84	12.61	62	33291	1175	34922403
Osteomalacia	177.82	12.61	56	33297	861	34922717
Proteinuria	175.18	12.61	144	33209	18498	34905080
Diplopia	172.88	12.61	137	33216	16706	34906872
Blood phosphorus decreased	168.66	12.61	75	33278	3106	34920472
Blood creatinine increased	162.62	12.61	310	33043	94666	34828912
Renal tubular dysfunction	161.94	12.61	44	33309	388	34923190
CD4 lymphocytes decreased	156.92	12.61	60	33293	1681	34921897
Hepatitis B DNA increased	154.67	12.61	45	33308	520	34923058
Osteonecrosis	148.30	12.61	119	33234	14771	34908807
Hepatitis B reactivation	133.51	12.61	68	33285	3823	34919755
Renal colic	129.42	12.61	53	33300	1786	34921792
Renal failure	125.65	12.61	339	33014	130218	34793360
Treatment failure	116.15	12.61	180	33173	46517	34877061
Renal tubular acidosis	114.42	12.61	52	33301	2267	34921311
Hepatic failure	107.49	12.61	148	33205	34383	34889195
Exposure during pregnancy	101.07	12.61	77	33276	8857	34914721
Jaundice	99.76	12.61	137	33216	31745	34891833
Renal impairment	97.54	12.61	252	33101	94261	34829317
HIV-associated neurocognitive disorder	96.84	12.61	28	33325	316	34923262
Pneumonia	91.43	12.61	128	33225	362499	34561079
Osteopenia	90.81	12.61	57	33296	4792	34918786
Renal tubular necrosis	82.97	12.61	88	33265	15592	34907986
Alanine aminotransferase increased	82.86	12.61	215	33138	80600	34842978
Volvulus	81.80	12.61	37	33316	1595	34921983
Nephrolithiasis	81.16	12.61	121	33232	30212	34893366
Hepatic cirrhosis	79.17	12.61	90	33263	17224	34906354
Acquired immunodeficiency syndrome	77.54	12.61	26	33327	492	34923086
Multiple-drug resistance	77.17	12.61	53	33300	5186	34918392
Hepatitis B DNA assay positive	76.07	12.61	17	33336	58	34923520
Osteoporotic fracture	75.15	12.61	31	33322	1064	34922514
Acute HIV infection	71.28	12.61	16	33337	56	34923522
Chronic kidney disease	70.99	12.61	135	33218	41075	34882503
Kaposi's sarcoma	70.95	12.61	28	33325	855	34922723
Dyspnoea	70.57	12.61	160	33193	376622	34546956
Hepatocellular carcinoma	70.50	12.61	58	33295	7451	34916127
Lactic acidosis	70.16	12.61	122	33231	34650	34888928
Aspartate aminotransferase increased	70.15	12.61	181	33172	67602	34855976
Hypotension	67.78	12.61	67	33286	221582	34701996
Premature baby	66.95	12.61	88	33265	19545	34904033
Treatment noncompliance	65.24	12.61	105	33248	27995	34895583
Hepatic cytolysis	64.00	12.61	74	33279	14422	34909156
Brain stem stroke	63.59	12.61	20	33333	306	34923272
Hepatitis	63.43	12.61	95	33258	23809	34899769
Ophthalmoplegia	62.66	12.61	32	33321	1808	34921770
Lipoatrophy	62.30	12.61	22	33331	489	34923089
Acute kidney injury	61.76	12.61	499	32854	304489	34619089
Drug interaction	61.49	12.61	397	32956	225549	34698029
Febrile neutropenia	61.18	12.61	27	33326	136822	34786756
Glomerular filtration rate decreased	60.32	12.61	68	33285	12893	34910685
Mitochondrial cytopathy	60.21	12.61	17	33336	175	34923403
Gene mutation	58.39	12.61	28	33325	1380	34922198
Death	57.35	12.61	192	33161	397857	34525721
Malignant neoplasm progression	57.28	12.61	8	33345	88038	34835540
HIV infection	56.66	12.61	27	33326	1312	34922266
Psychiatric decompensation	56.19	12.61	35	33318	2902	34920676
Off label use	56.02	12.61	209	33144	419315	34504263
Trisomy 21	55.68	12.61	21	33332	566	34923012
Portal hypertension	54.94	12.61	39	33314	4023	34919555
Depressive symptom	54.52	12.61	34	33319	2825	34920753
Tearfulness	54.12	12.61	33	33320	2634	34920944
Creatinine renal clearance decreased	51.69	12.61	35	33318	3346	34920232
Depression suicidal	50.85	12.61	31	33322	2474	34921104
Syphilis	50.24	12.61	18	33335	418	34923160
Anal cancer	49.18	12.61	18	33335	445	34923133
Fall	48.63	12.61	74	33279	202811	34720767
Varices oesophageal	48.37	12.61	35	33318	3720	34919858
Atrial fibrillation	47.50	12.61	29	33324	122364	34801214
Cytomegalovirus chorioretinitis	47.48	12.61	34	33319	3555	34920023
Beta 2 microglobulin urine increased	47.23	12.61	12	33341	79	34923499
Product dose omission issue	46.97	12.61	28	33325	119683	34803895
CSF HIV escape syndrome	46.26	12.61	14	33339	187	34923391
Ultrasound antenatal screen	45.97	12.61	18	33335	538	34923040
Disease progression	45.71	12.61	23	33330	108054	34815524
Drug abuse	45.15	12.61	19	33334	99077	34824501
Hyperbilirubinaemia	44.77	12.61	67	33286	16776	34906802
Congenital umbilical hernia	44.48	12.61	15	33338	289	34923289
Cleft lip and palate	43.57	12.61	20	33333	892	34922686
Constipation	43.46	12.61	40	33313	136942	34786636
Toxicity to various agents	43.44	12.61	78	33275	200284	34723294
Peripheral swelling	43.21	12.61	10	33343	76531	34847047
Completed suicide	42.87	12.61	20	33333	98148	34825430
Blood phosphorus abnormal	42.63	12.61	12	33341	122	34923456
Blood bilirubin increased	42.45	12.61	105	33248	38191	34885387
Blood lactic acid increased	41.46	12.61	41	33312	6687	34916891
Psychomotor skills impaired	40.55	12.61	32	33321	3874	34919704
Trisomy 18	40.29	12.61	18	33335	753	34922825
Blood pressure increased	39.96	12.61	17	33336	88085	34835493
Blood creatine phosphokinase increased	39.58	12.61	113	33240	44744	34878834
Lymphoma	39.48	12.61	54	33299	12453	34911125
Hypophosphataemic osteomalacia	37.89	12.61	11	33342	126	34923452
Brachydactyly	37.83	12.61	12	33341	189	34923389
Infusion related reaction	36.50	12.61	4	33349	53053	34870525
Congenital hearing disorder	36.14	12.61	10	33343	95	34923483
Hepatic cancer	36.11	12.61	42	33311	8233	34915345
Abnormal dreams	35.67	12.61	40	33313	7538	34916040
Hydrops foetalis	35.22	12.61	17	33336	850	34922728
COVID-19	35.11	12.61	15	33338	77535	34846043
Hepatitis C	34.97	12.61	45	33308	9785	34913793
Hyperphosphaturia	34.01	12.61	9	33344	71	34923507
Hepatic steatosis	33.91	12.61	62	33291	18300	34905278
Fatigue	33.47	12.61	212	33141	370441	34553137
Oesophageal atresia	33.44	12.61	14	33339	499	34923079
Oesophageal candidiasis	33.23	12.61	30	33323	4366	34919212
Congenital anomaly	32.87	12.61	19	33334	1374	34922204
Nephropathy	32.71	12.61	34	33319	5883	34917695
HIV wasting syndrome	32.57	12.61	9	33344	85	34923493
Polydactyly	32.56	12.61	18	33335	1195	34922383
Lymphadenopathy	32.56	12.61	79	33274	28384	34895194
Nasopharyngitis	32.53	12.61	13	33340	69955	34853623
Megakaryocytes increased	32.41	12.61	8	33345	46	34923532
Progressive multifocal leukoencephalopathy	32.10	12.61	43	33310	9721	34913857
Hemivertebra	32.04	12.61	10	33343	149	34923429
Blood alkaline phosphatase increased	31.96	12.61	83	33270	31092	34892486
Joint swelling	31.54	12.61	9	33344	59881	34863697
Anogenital warts	31.40	12.61	14	33339	583	34922995
Liver disorder	30.95	12.61	85	33268	32912	34890666
Hepatosplenomegaly	30.63	12.61	28	33325	4141	34919437
Cardiac failure congestive	30.56	12.61	21	33332	83249	34840329
Nodular regenerative hyperplasia	30.48	12.61	16	33337	957	34922621
Sepsis	30.03	12.61	72	33281	166489	34757089
Pain	29.86	12.61	98	33255	204577	34719001
Maternal drugs affecting foetus	29.85	12.61	27	33326	3938	34919640
Paranoia	29.25	12.61	46	33307	12022	34911556
Neurosyphilis	28.86	12.61	7	33346	37	34923541
Ocular icterus	28.78	12.61	23	33330	2834	34920744
Laryngomalacia	28.34	12.61	11	33342	321	34923257
Dysphagia	28.08	12.61	126	33227	62255	34861323
Tubulointerstitial nephritis	28.05	12.61	62	33291	20962	34902616
Hepatorenal syndrome	28.01	12.61	22	33331	2644	34920934
HIV test positive	27.74	12.61	9	33344	153	34923425
Bone pain	27.59	12.61	61	33292	20625	34902953
Haemophilic arthropathy	27.52	12.61	9	33344	157	34923421
Pulmonary tuberculosis	27.51	12.61	28	33325	4726	34918852
Hypertriglyceridaemia	27.46	12.61	37	33316	8411	34915167
Porphyria non-acute	27.44	12.61	12	33341	477	34923101
Product use issue	27.40	12.61	13	33340	63203	34860375
Birth mark	27.31	12.61	9	33344	161	34923417
Pulmonary oedema	27.24	12.61	6	33347	47523	34876055
Blood antidiuretic hormone increased	27.18	12.61	7	33346	49	34923529
Plasma cell myeloma	26.91	12.61	4	33349	42033	34881545
Diaphragmatic hernia	26.85	12.61	10	33343	260	34923318
Nervous system disorder	26.72	12.61	49	33304	14494	34909084
Oxygen saturation decreased	26.70	12.61	9	33344	53809	34869769
Hepatic fibrosis	26.41	12.61	27	33326	4580	34918998
Hodgkin's disease	26.22	12.61	14	33339	867	34922711
Hydrocele	25.85	12.61	19	33334	2068	34921510
Back pain	25.83	12.61	48	33305	121741	34801837
Cerebellar syndrome	25.73	12.61	20	33333	2368	34921210
Developmental hip dysplasia	25.66	12.61	10	33343	295	34923283
Meningomyelocele	25.53	12.61	9	33344	199	34923379
Influenza	25.18	12.61	8	33345	49658	34873920
CSF virus identified	25.01	12.61	6	33347	30	34923548
Talipes	24.94	12.61	18	33335	1905	34921673
Wheezing	24.19	12.61	5	33348	41397	34882181
Bradycardia	23.92	12.61	22	33331	75396	34848182
Hepatic encephalopathy	23.91	12.61	47	33306	14638	34908940
Epistaxis	23.72	12.61	13	33340	58238	34865340
Protein urine present	23.59	12.61	27	33326	5201	34918377
Retroviral rebound syndrome	23.39	12.61	5	33348	13	34923565
Liver function test abnormal	23.36	12.61	74	33279	31000	34892578
Atypical mycobacterial infection	23.28	12.61	13	33340	880	34922698
Dyslipidaemia	23.14	12.61	32	33321	7456	34916122
Abortion spontaneous	23.04	12.61	10	33343	390	34923188
Acute hepatitis C	22.96	12.61	7	33346	96	34923482
Therapeutic product effect decreased	22.96	12.61	3	33350	34740	34888838
Infection	22.88	12.61	32	33321	90883	34832695
Prostate cancer	22.73	12.61	5	33348	39644	34883934
Cachexia	22.64	12.61	31	33322	7155	34916423
Hepatitis B e antigen positive	22.60	12.61	6	33347	48	34923530
Gamma-glutamyltransferase increased	22.33	12.61	70	33283	29161	34894417
Pneumonitis	22.21	12.61	3	33350	33875	34889703
Injection site pain	22.19	12.61	5	33348	39000	34884578
Dialysis	22.17	12.61	39	33314	11169	34912409
Cerebral toxoplasmosis	22.07	12.61	16	33337	1705	34921873
Cryptorchism	21.79	12.61	17	33336	2024	34921554
AIDS related complication	21.75	12.61	5	33348	20	34923558
Burkitt's lymphoma	21.74	12.61	7	33346	116	34923462
Inappropriate schedule of product administration	21.19	12.61	17	33336	62279	34861299
Musculoskeletal stiffness	21.17	12.61	9	33344	46671	34876907
Cough	21.11	12.61	73	33280	150067	34773511
Secondary syphilis	21.06	12.61	6	33347	64	34923514
Oesophageal varices haemorrhage	20.94	12.61	20	33333	3126	34920452
Anaphylactic reaction	20.84	12.61	3	33350	32298	34891280
Polydipsia	20.75	12.61	22	33331	3893	34919685
Hyperhidrosis	20.73	12.61	25	33328	75667	34847911
Bone density decreased	20.44	12.61	16	33337	1913	34921665
Asymptomatic viral hepatitis	20.37	12.61	5	33348	28	34923550
Heart rate decreased	20.36	12.61	3	33350	31742	34891836
Blood pressure decreased	20.25	12.61	12	33341	51503	34872075
Cardiac failure	20.21	12.61	35	33318	91213	34832365
Creatinine renal clearance abnormal	20.10	12.61	8	33345	250	34923328
Myalgia	19.92	12.61	143	33210	83967	34839611
Polyuria	19.84	12.61	32	33321	8542	34915036
Chest discomfort	19.67	12.61	14	33339	54516	34869062
End stage AIDS	19.54	12.61	5	33348	34	34923544
Haematochezia	19.51	12.61	10	33343	46524	34877054
Syncope	19.42	12.61	36	33317	91415	34832163
Supernumerary nipple	19.06	12.61	5	33348	38	34923540
Blood bicarbonate decreased	18.85	12.61	17	33336	2470	34921108
Haemodialysis	18.75	12.61	35	33318	10491	34913087
Polyneuropathy chronic	18.72	12.61	5	33348	41	34923537
Immune reconstitution inflammatory syndrome associated tuberculosis	18.66	12.61	9	33344	449	34923129
Rhabdomyolysis	18.59	12.61	120	33233	68043	34855535
Cardiac arrest	18.58	12.61	40	33313	96119	34827459
Interstitial lung disease	18.48	12.61	21	33332	65261	34858317
Protrusion tongue	18.44	12.61	7	33346	192	34923386
Kidney fibrosis	18.42	12.61	16	33337	2212	34921366
Psychotic disorder	18.17	12.61	58	33295	24394	34899184
HIV associated nephropathy	18.13	12.61	8	33345	325	34923253
Portal fibrosis	18.13	12.61	8	33345	325	34923253
Lower respiratory tract infection	18.11	12.61	4	33349	31633	34891945
C-reactive protein increased	18.10	12.61	15	33338	54083	34869495
Rash maculo-papular	18.06	12.61	64	33289	28387	34895191
Blood triglycerides increased	18.04	12.61	41	33312	14118	34909460
Hepatic function abnormal	18.04	12.61	87	33266	44276	34879302
Perihepatic discomfort	17.87	12.61	3	33350	0	34923578
Pneumocystis jirovecii pneumonia	17.71	12.61	50	33303	19660	34903918
CD4 lymphocytes increased	17.58	12.61	7	33346	219	34923359
Lymphocytic infiltration	17.53	12.61	10	33343	705	34922873
Malaise	17.37	12.61	105	33248	185720	34737858
International normalised ratio increased	17.27	12.61	12	33341	47315	34876263
Small for dates baby	17.25	12.61	20	33333	3907	34919671
Pathological fracture	17.04	12.61	21	33332	4370	34919208
Adrenogenital syndrome	17.01	12.61	5	33348	60	34923518
Viraemia	17.00	12.61	12	33341	1226	34922352
Ventricular septal defect	16.94	12.61	20	33333	3981	34919597
Viral load	16.94	12.61	5	33348	61	34923517
Musculoskeletal toxicity	16.92	12.61	6	33347	135	34923443
Mycobacterium avium complex infection	16.78	12.61	16	33337	2495	34921083
Congenital naevus	16.68	12.61	4	33349	20	34923558
Tachycardia	16.60	12.61	35	33318	84737	34838841
Incorrect dose administered	16.55	12.61	9	33344	40506	34883072
Pleural effusion	16.53	12.61	33	33320	81513	34842065
Cushing's syndrome	16.48	12.61	8	33345	405	34923173
Pancreatitis	16.34	12.61	77	33276	38814	34884764
White matter lesion	16.33	12.61	10	33343	804	34922774
Glucose urine present	16.22	12.61	11	33342	1054	34922524
Lipohypertrophy	16.18	12.61	7	33346	271	34923307
Hepatic enzyme increased	16.15	12.61	77	33276	39003	34884575
Pneumonia aspiration	16.14	12.61	10	33343	41893	34881685
Congenital tuberculosis	16.06	12.61	4	33349	24	34923554
Pulmonary embolism	15.99	12.61	39	33314	89707	34833871
Neck deformity	15.93	12.61	5	33348	76	34923502
Antiviral drug level below therapeutic	15.79	12.61	3	33350	3	34923575
Congenital gastric anomaly	15.79	12.61	3	33350	3	34923575
Calculus urinary	15.63	12.61	12	33341	1395	34922183
White blood cell count increased	15.60	12.61	10	33343	41141	34882437
CSF glucose decreased	15.53	12.61	4	33349	28	34923550
Low set ears	15.52	12.61	8	33345	461	34923117
Muscle spasms	15.51	12.61	30	33323	74971	34848607
Haemoglobin decreased	15.48	12.61	61	33292	120711	34802867
Meningitis cryptococcal	15.46	12.61	15	33338	2389	34921189
Disseminated mycobacterium avium complex infection	15.46	12.61	5	33348	84	34923494
Hepatomegaly	15.41	12.61	32	33321	10364	34913214
Micrognathia	15.36	12.61	7	33346	307	34923271
Gastrointestinal haemorrhage	15.33	12.61	39	33314	88438	34835140
Meningitis tuberculous	15.26	12.61	9	33344	676	34922902
Amyotrophy	15.23	12.61	8	33345	479	34923099
Stress	15.18	12.61	5	33348	30342	34893236
Mucosal inflammation	15.18	12.61	9	33344	38613	34884965
Cellulitis	15.02	12.61	17	33336	52934	34870644
Platelet count decreased	15.00	12.61	61	33292	119656	34803922
Hepatitis B surface antibody positive	14.99	12.61	5	33348	93	34923485
Caesarean section	14.86	12.61	14	33339	2150	34921428
Transient ischaemic attack	14.81	12.61	4	33349	27609	34895969
Mitochondrial myopathy	14.74	12.61	6	33347	199	34923379
Chronic obstructive pulmonary disease	14.66	12.61	15	33338	48903	34874675
Therapeutic product effect incomplete	14.59	12.61	16	33337	50525	34873053
Laryngeal erythema	14.58	12.61	3	33350	6	34923572
Neonatal asphyxia	14.54	12.61	7	33346	348	34923230
Thrombosis	14.53	12.61	16	33337	50442	34873136
Sinusitis	14.45	12.61	11	33342	41391	34882187
Hemiparaesthesia	14.29	12.61	5	33348	108	34923470
Pleocytosis	14.29	12.61	8	33345	544	34923034
Viral load decreased	14.27	12.61	4	33349	40	34923538
Suicidal ideation	14.17	12.61	76	33277	40312	34883266
Cardiogenic shock	14.01	12.61	4	33349	26614	34896964
CD4 lymphocytes abnormal	14.01	12.61	4	33349	43	34923535
Drug dependence	13.99	12.61	3	33350	24214	34899364
Pharyngeal cancer	13.84	12.61	4	33349	45	34923533
Optic neuritis	13.72	12.61	17	33336	3557	34920021
VIIIth nerve injury	13.72	12.61	3	33350	9	34923569
Eagle Barrett syndrome	13.72	12.61	3	33350	9	34923569
Phosphorus metabolism disorder	13.72	12.61	3	33350	9	34923569
Vth nerve injury	13.72	12.61	3	33350	9	34923569
Blood creatinine abnormal	13.69	12.61	14	33339	2376	34921202
Stevens-Johnson syndrome	13.65	12.61	44	33309	18595	34904983
Hypospadias	13.55	12.61	16	33337	3185	34920393
Urine calcium increased	13.46	12.61	4	33349	50	34923528
Psychomotor retardation	13.44	12.61	17	33336	3633	34919945
Antiviral drug level above therapeutic	13.39	12.61	4	33349	51	34923527
Urine phosphorus increased	13.39	12.61	4	33349	51	34923527
Respiratory arrest	13.38	12.61	5	33348	28038	34895540
Cortisol decreased	13.38	12.61	10	33343	1117	34922461
Hypouricaemia	13.32	12.61	6	33347	256	34923322
Rhinorrhoea	13.25	12.61	4	33349	25664	34897914
Splenomegaly	13.24	12.61	38	33315	15079	34908499
Anogenital dysplasia	13.21	12.61	5	33348	136	34923442
Dizziness	13.21	12.61	139	33214	218382	34705196
Femoral neck fracture	13.13	12.61	16	33337	3291	34920287
Upper gastrointestinal haemorrhage	13.13	12.61	4	33349	25514	34898064
Congenital diaphragmatic hernia	13.13	12.61	6	33347	265	34923313
Vitamin D deficiency	13.08	12.61	23	33330	6585	34916993
Somnolence	13.07	12.61	58	33295	111058	34812520
Seroconversion test positive	13.05	12.61	3	33350	12	34923566
Cranial nerve palsies multiple	13.04	12.61	4	33349	56	34923522
Hypersplenism	13.00	12.61	7	33346	441	34923137
Blood pressure systolic increased	12.94	12.61	3	33350	22949	34900629
Cytokine release syndrome	12.88	12.61	3	33350	22874	34900704
Optic nerve cupping	12.67	12.61	4	33349	62	34923516
Hyperlactacidaemia	12.65	12.61	15	33338	3001	34920577
Renal disorder	12.63	12.61	53	33300	25427	34898151
Ureterolithiasis	12.62	12.61	13	33340	2226	34921352
Delirium	12.61	12.61	14	33339	43977	34879601

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	1151.58	13.48	288	37085	3903	79703112
Immune reconstitution inflammatory syndrome	1122.30	13.48	367	37006	13474	79693541
Fanconi syndrome acquired	1058.30	13.48	247	37126	2447	79704568
Abortion spontaneous	978.62	13.48	405	36968	29102	79677913
Viral mutation identified	848.37	13.48	222	37151	3636	79703379
Lipodystrophy acquired	725.51	13.48	201	37172	4124	79702891
Pathogen resistance	668.81	13.48	252	37121	14090	79692925
Blood HIV RNA increased	560.83	13.48	137	37236	1671	79705344
Drug resistance	550.19	13.48	305	37068	41908	79665107
Mitochondrial toxicity	546.65	13.48	150	37223	2964	79704051
Viral load increased	498.98	13.48	138	37235	2810	79704205
Renal tubular disorder	461.70	13.48	156	37217	6330	79700685
Exposure during pregnancy	447.40	13.48	374	36999	100758	79606257
Nephropathy toxic	439.44	13.48	207	37166	20212	79686803
Fanconi syndrome	416.55	13.48	119	37254	2737	79704278
Osteoporosis	371.25	13.48	260	37113	53852	79653163
Genotype drug resistance test positive	369.75	13.48	92	37281	1216	79705799
Stillbirth	365.86	13.48	116	37257	3839	79703176
Hepatitis B	333.32	13.48	131	37242	8201	79698814
Eyelid ptosis	310.67	13.48	135	37238	10909	79696106
Maternal exposure during pregnancy	301.31	13.48	345	37028	136193	79570822
Hypophosphataemia	298.63	13.48	158	37215	19755	79687260
Abortion induced	295.77	13.48	115	37258	6994	79700021
Progressive external ophthalmoplegia	292.98	13.48	78	37295	1367	79705648
Hepatitis B reactivation	265.47	13.48	102	37271	6006	79701009
Proteinuria	262.93	13.48	173	37200	32329	79674686
Glycosuria	260.97	13.48	78	37295	2110	79704905
CD4 lymphocytes decreased	242.57	13.48	77	37296	2557	79704458
Renal tubular dysfunction	236.51	13.48	58	37315	719	79706296
Hepatitis B DNA increased	233.75	13.48	58	37315	757	79706258
Acquired gene mutation	200.36	13.48	64	37309	2169	79704846
Blood creatinine increased	197.30	13.48	299	37074	154758	79552257
Renal tubular acidosis	192.27	13.48	70	37303	3544	79703471
Osteomalacia	186.26	13.48	55	37318	1425	79705590
Diplopia	171.48	13.48	135	37238	33331	79673684
Blood phosphorus decreased	160.22	13.48	73	37300	6595	79700420
Jaundice	156.69	13.48	157	37216	53192	79653823
Renal failure	155.32	13.48	311	37062	200657	79506358
Pregnancy	154.38	13.48	116	37257	26735	79680280
Caesarean section	148.08	13.48	85	37288	12450	79694565
Foetal exposure during pregnancy	144.21	13.48	65	37308	5725	79701290
Acute kidney injury	143.01	13.48	550	36823	518854	79188161
Treatment noncompliance	142.91	13.48	148	37225	52120	79654895
Osteonecrosis	141.43	13.48	117	37256	30978	79676037
Alanine aminotransferase increased	140.74	13.48	264	37109	162306	79544709
Renal tubular necrosis	134.76	13.48	104	37269	24935	79682080
Aspartate aminotransferase increased	132.47	13.48	235	37138	138406	79568609
Renal impairment	122.83	13.48	245	37128	157538	79549477
Chronic kidney disease	122.44	13.48	153	37220	66001	79641014
Hepatic failure	120.44	13.48	146	37227	61066	79645949
Drug interaction	117.71	13.48	444	36929	414739	79292276
CSF HIV escape syndrome	116.33	13.48	28	37345	319	79706696
Renal colic	114.99	13.48	45	37328	2782	79704233
Hepatic cytolysis	106.79	13.48	94	37279	27057	79679958
HIV-associated neurocognitive disorder	105.74	13.48	26	37347	326	79706689
Multiple-drug resistance	104.76	13.48	60	37313	8748	79698267
Joint swelling	102.10	13.48	9	37364	288637	79418378
Hypophosphataemic osteomalacia	95.16	13.48	24	37349	336	79706679
Pain	94.29	13.48	115	37258	703687	79003328
Arthrodesis	93.29	13.48	37	37336	2370	79704645
Hepatocellular carcinoma	92.95	13.48	56	37317	8965	79698050
Premature labour	91.44	13.48	54	37319	8336	79698679
Live birth	90.42	13.48	73	37300	18671	79688344
Lactic acidosis	86.99	13.48	134	37239	70225	79636790
Hepatitis B DNA assay positive	84.84	13.48	17	37356	74	79706941
Infusion related reaction	84.71	13.48	6	37367	230231	79476784
Ultrasound antenatal screen	83.92	13.48	25	37348	668	79706347
Premature delivery	83.91	13.48	77	37296	23390	79683625
Nephrolithiasis	82.65	13.48	113	37260	53178	79653837
Hepatic cirrhosis	81.60	13.48	91	37282	34815	79672200
Hyperbilirubinaemia	81.02	13.48	77	37296	24441	79682574
Peripheral swelling	77.46	13.48	16	37357	269601	79437414
Blood bilirubin increased	76.14	13.48	122	37251	66110	79640905
Nasopharyngitis	75.17	13.48	14	37359	253867	79453148
Cushing's syndrome	75.02	13.48	25	37348	970	79706045
Premature rupture of membranes	74.64	13.48	37	37336	4032	79702983
Pneumonia	73.43	13.48	123	37250	660123	79046892
Hydrops foetalis	72.69	13.48	23	37350	755	79706260
Acute HIV infection	70.62	13.48	14	37359	57	79706958
Rebound effect	69.69	13.48	43	37330	7183	79699832
Psychiatric decompensation	69.64	13.48	35	37338	3928	79703087
Dyspnoea	69.28	13.48	191	37182	856834	78850181
Ophthalmoplegia	67.19	13.48	31	37342	2881	79704134
Cleft lip and palate	66.73	13.48	21	37352	677	79706338
Gene mutation	66.40	13.48	30	37343	2656	79704359
Trisomy 18	65.28	13.48	20	37353	589	79706426
Portal hypertension	65.27	13.48	41	37332	7067	79699948
Pulmonary tuberculosis	63.90	13.48	42	37331	7823	79699192
Fall	63.81	13.48	81	37292	487548	79219467
Hepatitis	63.16	13.48	102	37271	55625	79651390
Lipoatrophy	62.85	13.48	20	37353	669	79706346
Brain stem stroke	62.01	13.48	20	37353	699	79706316
Blood creatine phosphokinase increased	61.74	13.48	111	37262	65979	79641036
Depression suicidal	59.03	13.48	31	37342	3811	79703204
Malaria	58.92	13.48	17	37356	405	79706610
Completed suicide	58.56	13.48	21	37352	245746	79461269
Tearfulness	58.37	13.48	36	37337	6009	79701006
Synovitis	58.23	13.48	3	37370	150731	79556284
Fatigue	58.06	13.48	232	37141	929495	78777520
Haemolytic anaemia	57.05	13.48	55	37318	17765	79689250
Placental disorder	56.90	13.48	20	37353	913	79706102
Oligohydramnios	56.65	13.48	29	37344	3383	79703632
Cytomegalovirus chorioretinitis	56.35	13.48	34	37339	5456	79701559
Psychomotor skills impaired	55.22	13.48	33	37340	5204	79701811
Mitochondrial cytopathy	54.95	13.48	16	37357	394	79706621
Foetal death	53.59	13.48	38	37335	8006	79699009
Placenta praevia	53.09	13.48	18	37355	737	79706278
Hypotension	52.69	13.48	78	37295	440239	79266776
Megakaryocytes increased	52.62	13.48	12	37361	106	79706909
Sinusitis	51.40	13.48	14	37359	195487	79511528
Immune reconstitution inflammatory syndrome associated tuberculosis	51.29	13.48	18	37355	818	79706197
Musculoskeletal stiffness	51.05	13.48	10	37363	174998	79532017
Blood pressure increased	50.45	13.48	18	37355	211342	79495673
Acquired immunodeficiency syndrome	50.24	13.48	14	37359	293	79706722
Glomerular filtration rate decreased	49.34	13.48	57	37316	22645	79684370
Depressive symptom	49.04	13.48	33	37340	6390	79700625
Constipation	47.27	13.48	38	37335	283012	79424003
Placental insufficiency	46.11	13.48	18	37355	1105	79705910
Blood alkaline phosphatase increased	44.92	13.48	95	37278	63569	79643446
Hepatic encephalopathy	44.86	13.48	56	37317	24110	79682905
Osteopenia	44.85	13.48	49	37324	18315	79688700
Hepatic cancer	44.52	13.48	38	37335	10491	79696524
Arthralgia	44.20	13.48	130	37243	571673	79135342
Varices oesophageal	43.88	13.48	30	37343	5961	79701054
Ocular icterus	43.78	13.48	29	37344	5471	79701544
Osteoporotic fracture	42.85	13.48	26	37347	4214	79702801
Oesophageal candidiasis	42.56	13.48	35	37338	9183	79697832
Hepatic function abnormal	42.51	13.48	101	37272	73006	79634009
Kaposi's sarcoma	41.48	13.48	15	37358	744	79706271
Malignant neoplasm progression	41.32	13.48	7	37366	135983	79571032
Contusion	40.35	13.48	10	37363	148766	79558249
Swelling	40.21	13.48	26	37347	216685	79490330
Nervous system disorder	40.21	13.48	56	37317	26800	79680215
Blood lactic acid increased	40.17	13.48	39	37334	12705	79694310
Wound	40.04	13.48	4	37369	116175	79590840
Systemic lupus erythematosus	39.67	13.48	5	37368	121144	79585871
Adrenal suppression	39	13.48	17	37356	1382	79705633
Febrile neutropenia	38.57	13.48	31	37342	230968	79476047
Wheezing	37.75	13.48	5	37368	116659	79590356
Pericarditis	37.51	13.48	3	37370	104233	79602782
Blood phosphorus abnormal	37.28	13.48	11	37362	284	79706731
Injection site pain	36.66	13.48	8	37365	129830	79577185
Hepatitis fulminant	36.55	13.48	29	37344	7233	79699782
Product use issue	36.51	13.48	27	37346	209795	79497220
Hepatic fibrosis	36.48	13.48	29	37344	7251	79699764
Atrial fibrillation	36.36	13.48	24	37349	197862	79509153
Oxygen saturation decreased	36.33	13.48	8	37365	129039	79577976
Paranoia	36.02	13.48	45	37328	19387	79687628
Cough	35.66	13.48	74	37299	366715	79340300
Beta 2 microglobulin urine increased	35.04	13.48	9	37364	136	79706879
COVID-19	35.02	13.48	15	37358	157659	79549356
Lymphadenopathy	34.75	13.48	77	37296	53170	79653845
Hepatic steatosis	34.75	13.48	63	37310	37675	79669340
Spina bifida	34.68	13.48	9	37364	142	79706873
Polydipsia	34.58	13.48	27	37346	6578	79700437
Abnormal dreams	34.25	13.48	34	37339	11378	79695637
Stomatitis	34.16	13.48	13	37360	146744	79560271
CSF virus identified	34.14	13.48	7	37366	35	79706980
Retroviral rebound syndrome	33.75	13.48	6	37367	11	79707004
Product dose omission issue	33.50	13.48	40	37333	247497	79459518
Gamma-glutamyltransferase increased	33.38	13.48	77	37296	54603	79652412
Anal cancer	33.37	13.48	13	37360	794	79706221
Rash maculo-papular	33.17	13.48	78	37295	56000	79651015
Hepatitis D	33.01	13.48	8	37365	94	79706921
Transaminases increased	32.84	13.48	74	37299	51669	79655346
Influenza	32.74	13.48	10	37363	129596	79577419
Lower respiratory tract infection	32.58	13.48	10	37363	129210	79577805
AIDS cholangiopathy	32.49	13.48	6	37367	15	79707000
Toxicity to various agents	32.42	13.48	96	37277	421444	79285571
Tubulointerstitial nephritis	31.67	13.48	61	37312	38174	79668841
Pulmonary embolism	31.29	13.48	21	37352	171633	79535382
Hepatitis C	31.20	13.48	33	37340	11892	79695123
Hypertriglyceridaemia	31.12	13.48	34	37339	12706	79694309
Psychotic disorder	30.62	13.48	63	37310	41339	79665676
Cerebral toxoplasmosis	30.55	13.48	17	37356	2345	79704670
Hepatorenal syndrome	30.47	13.48	21	37352	4228	79702787
Blood creatine phosphokinase MB increased	30.39	13.48	18	37355	2793	79704222
Malaise	29.97	13.48	123	37250	489746	79217269
Bradycardia	29.94	13.48	13	37360	135544	79571471
Polyuria	29.82	13.48	36	37337	14978	79692037
Off label use	29.78	13.48	277	37096	906938	78800077
Polyhydramnios	29.66	13.48	15	37358	1705	79705310
Blood antidiuretic hormone increased	29.56	13.48	7	37366	74	79706941
Progressive multifocal leukoencephalopathy	29.42	13.48	42	37331	20558	79686457
Ultrasound antenatal screen abnormal	28.90	13.48	7	37366	82	79706933
Blood bicarbonate decreased	28.88	13.48	22	37351	5169	79701846
Asthma	28.22	13.48	14	37359	135081	79571934
Arthropathy	28.05	13.48	25	37348	177086	79529929
Hepatosplenomegaly	27.92	13.48	23	37350	6046	79700969
Premature baby	27.86	13.48	19	37354	3761	79703254
HIV associated nephropathy	27.54	13.48	9	37364	328	79706687
Cholestasis	27.12	13.48	69	37304	52040	79654975
Lymphoma	27.02	13.48	37	37336	17423	79689592
Pre-eclampsia	26.93	13.48	24	37349	7017	79699998
Disease progression	26.90	13.48	28	37345	184334	79522681
Dialysis	26.89	13.48	38	37335	18424	79688591
Dysphagia	26.87	13.48	121	37252	122015	79585000
Syphilis	26.77	13.48	10	37363	544	79706471
Stress	26.77	13.48	3	37370	79609	79627406
Myalgia	26.41	13.48	163	37210	185478	79521537
Drug reaction with eosinophilia and systemic symptoms	26.39	13.48	78	37295	64166	79642849
Autoimmune hepatitis	26.30	13.48	30	37343	11753	79695262
HIV test positive	26.06	13.48	7	37366	127	79706888
Toxoplasmosis	25.88	13.48	16	37357	2681	79704334
Melanoderma	25.81	13.48	9	37364	401	79706614
Hepatotoxicity	25.69	13.48	67	37306	51285	79655730
Metabolic acidosis	25.57	13.48	91	37282	82438	79624577
Shoulder arthroplasty	25.39	13.48	17	37356	3265	79703750
Pain in extremity	25.23	13.48	87	37286	364451	79342564
Secondary syphilis	25.04	13.48	6	37367	67	79706948
Viraemia	24.97	13.48	16	37357	2853	79704162
Foetal cardiac disorder	24.91	13.48	5	37368	22	79706993
Calculus urinary	24.64	13.48	15	37358	2445	79704570
Blood HIV RNA	24.55	13.48	5	37368	24	79706991
Viral load decreased	24.55	13.48	5	37368	24	79706991
Rickets	24.42	13.48	6	37367	75	79706940
Maternal drugs affecting foetus	24.22	13.48	13	37360	1670	79705345
Drug-induced liver injury	24.11	13.48	77	37296	66040	79640975
Anaphylactic reaction	23.96	13.48	5	37368	83738	79623277
Cardiac failure congestive	23.90	13.48	19	37354	142383	79564632
Arthritis	23.85	13.48	12	37361	114868	79592147
Pathological fracture	23.81	13.48	27	37346	10510	79696505
Nephropathy	23.81	13.48	26	37347	9712	79697303
Pulmonary oedema	23.79	13.48	6	37367	88248	79618767
Ectopic pregnancy	23.79	13.48	13	37360	1730	79705285
Bronchitis	23.78	13.48	16	37357	130628	79576387
Back pain	23.56	13.48	69	37304	304111	79402904
Impaired healing	23.55	13.48	6	37367	87649	79619366
Benign hydatidiform mole	23.53	13.48	6	37367	88	79706927
Inappropriate schedule of product administration	23.49	13.48	17	37356	133611	79573404
Hepatomegaly	23.39	13.48	36	37337	18838	79688177
CSF test abnormal	23.35	13.48	9	37364	534	79706481
Heart rate decreased	22.78	13.48	3	37370	70313	79636702
Blister	22.61	13.48	14	37359	119462	79587553
Acute hepatitis C	22.47	13.48	7	37366	218	79706797
Urine calcium increased	22.43	13.48	6	37367	107	79706908
Mycobacterium avium complex infection	22.36	13.48	18	37355	4582	79702433
Pneumocystis jirovecii pneumonia	22.33	13.48	48	37325	32460	79674555
Hyperphosphaturia	22.33	13.48	6	37367	109	79706906
Type III hyperlipidaemia	22.27	13.48	4	37369	8	79707007
Urinary tract infection	22.19	13.48	61	37312	274451	79432564
Meningitis cryptococcal	22.06	13.48	16	37357	3490	79703525
Discomfort	22.05	13.48	16	37357	125601	79581414
Kidney fibrosis	21.94	13.48	16	37357	3519	79703496
Antiviral drug level below therapeutic	21.84	13.48	5	37368	45	79706970
Injection site erythema	21.70	13.48	5	37368	78192	79628823
Dyslipidaemia	21.66	13.48	27	37346	11606	79695409
Hypouricaemia	21.62	13.48	8	37365	424	79706591
Cerebellar syndrome	21.60	13.48	19	37354	5461	79701554
Dermatitis exfoliative	21.56	13.48	26	37347	10803	79696212
Hepatitis A	21.45	13.48	10	37363	951	79706064
Injury	21.42	13.48	5	37368	77491	79629524
Blood pressure systolic increased	21.36	13.48	3	37370	66983	79640032
Hyperlactacidaemia	21.25	13.48	19	37354	5576	79701439
Chest discomfort	21.24	13.48	20	37353	138024	79568991
Therapeutic product effect incomplete	21.24	13.48	21	37352	141624	79565391
Feeling abnormal	21.23	13.48	26	37347	159173	79547842
Eyelid oedema	21.17	13.48	29	37344	13658	79693357
Cholestasis of pregnancy	21.14	13.48	10	37363	983	79706032
Aplasia pure red cell	21.12	13.48	22	37351	7788	79699227
Normal newborn	21.09	13.48	21	37352	7051	79699964
Nasal congestion	21.04	13.48	5	37368	76547	79630468
Hyperhidrosis	21.00	13.48	24	37349	151468	79555547
Haemophilic arthropathy	20.91	13.48	6	37367	140	79706875
Loss of personal independence in daily activities	20.87	13.48	11	37362	102569	79604446
Liver function test abnormal	20.76	13.48	72	37301	64403	79642612
Dizziness	20.73	13.48	153	37220	526288	79180727
C-reactive protein increased	20.68	13.48	18	37355	129009	79578006
Retinal toxicity	20.59	13.48	11	37362	1400	79705615
Alopecia	20.56	13.48	49	37324	231306	79475709
Oropharyngeal pain	20.44	13.48	13	37360	109340	79597675
Red blood cell abnormality	20.40	13.48	9	37364	753	79706262
Rhabdomyolysis	20.35	13.48	99	37274	103032	79603983
Death	20.29	13.48	169	37204	566345	79140670
Helicobacter infection	20.28	13.48	4	37369	69700	79637315
Vitamin D deficiency	20.22	13.48	29	37344	14250	79692765
Pancreatitis acute	20.16	13.48	60	37313	49544	79657471
Limb operation	20.13	13.48	15	37358	3411	79703604
Pancreatitis	19.88	13.48	74	37299	68501	79638514
Lymphocytic infiltration	19.60	13.48	11	37362	1542	79705473
White matter lesion	19.41	13.48	12	37361	2010	79705005
Musculoskeletal pain	19.36	13.48	12	37361	102342	79604673
Syncope	19.34	13.48	34	37339	179415	79527600
Anaemia macrocytic	19.30	13.48	18	37355	5579	79701436
Drug abuse	19.24	13.48	29	37344	162662	79544353
Liver disorder	19.23	13.48	76	37297	72341	79634674
Blood triglycerides increased	19.21	13.48	35	37338	21005	79686010
Hyperphosphataemia	19.14	13.48	19	37354	6357	79700658
Cellulitis	19.00	13.48	14	37359	109046	79597969
Meningomyelocele	18.89	13.48	4	37369	24	79706991
Urine phosphorus increased	18.86	13.48	5	37368	86	79706929
Loss of consciousness	18.85	13.48	31	37342	167912	79539103
Portal fibrosis	18.80	13.48	8	37365	613	79706402
ACTH stimulation test abnormal	18.75	13.48	4	37369	25	79706990
Anogenital warts	18.65	13.48	9	37364	925	79706090
Weight increased	18.64	13.48	67	37306	277319	79429696
Cortisol decreased	18.63	13.48	12	37361	2160	79704855
Bone pain	18.60	13.48	63	37310	55679	79651336
Neurosyphilis	18.36	13.48	4	37369	28	79706987
Splenomegaly	18.29	13.48	34	37339	20720	79686295
Acute respiratory failure	18.22	13.48	3	37370	59538	79647477
Cardiac arrest	18.19	13.48	33	37340	172063	79534952
Nodular regenerative hyperplasia	18.16	13.48	10	37363	1351	79705664
Abortion infected	18.12	13.48	4	37369	30	79706985
Cachexia	17.93	13.48	24	37349	11059	79695956
Rash	17.93	13.48	375	36998	577983	79129032
Gynaecomastia	17.90	13.48	20	37353	7661	79699354
Abdominal pain upper	17.89	13.48	50	37323	223769	79483246
Creatinine renal clearance decreased	17.84	13.48	32	37341	18970	79688045
Blood bilirubin unconjugated increased	17.76	13.48	9	37364	1028	79705987
Disseminated tuberculosis	17.49	13.48	15	37358	4168	79702847
Ascites	17.47	13.48	76	37297	75486	79631529
Oesophageal varices haemorrhage	17.32	13.48	15	37358	4221	79702794
Mobility decreased	17.32	13.48	19	37354	122156	79584859
Rhinorrhoea	17.27	13.48	7	37366	76067	79630948
Nephrocalcinosis	17.24	13.48	10	37363	1492	79705523
Burkitt's lymphoma	17.14	13.48	5	37368	124	79706891
HIV infection	17.05	13.48	9	37364	1118	79705897
Pancytopenia	16.79	13.48	134	37239	165611	79541404
Ill-defined disorder	16.78	13.48	5	37368	65870	79641145
Liver transplant	16.76	13.48	15	37358	4408	79702607
Mitochondrial myopathy	16.72	13.48	6	37367	291	79706724
Hyperbilirubinaemia neonatal	16.71	13.48	3	37370	6	79707009
Hydromyelia	16.71	13.48	3	37370	6	79707009
Carbon dioxide combining power abnormal	16.71	13.48	3	37370	6	79707009
Glycocholic acid increased	16.71	13.48	3	37370	6	79707009
Pneumonitis	16.67	13.48	4	37369	60856	79646159
Chromaturia	16.53	13.48	37	37336	25709	79681306
Meningitis tuberculous	16.48	13.48	9	37364	1196	79705819
Pregnancy on oral contraceptive	16.44	13.48	8	37365	837	79706178
Urine uric acid increased	16.43	13.48	4	37369	48	79706967
Nephrogenic diabetes insipidus	16.38	13.48	11	37362	2123	79704892
Hodgkin's disease	16.31	13.48	8	37365	852	79706163
Psoriasis	16.27	13.48	11	37362	89576	79617439
Amylase increased	16.22	13.48	23	37350	11186	79695829
Blood corticotrophin decreased	16.20	13.48	7	37366	557	79706458
Lipohypertrophy	16.10	13.48	8	37365	876	79706139
CD4 lymphocytes abnormal	15.99	13.48	4	37369	54	79706961
Psychomotor retardation	15.98	13.48	17	37356	6167	79700848
Vth nerve injury	15.84	13.48	3	37370	9	79707006
Necrotising enterocolitis neonatal	15.84	13.48	3	37370	9	79707006
Glucose urine present	15.80	13.48	10	37363	1746	79705269
AIDS related complication	15.73	13.48	4	37369	58	79706957
Pharyngeal cancer	15.73	13.48	4	37369	58	79706957
Dry mouth	15.72	13.48	11	37362	88008	79619007
Optic nerve cupping	15.67	13.48	4	37369	59	79706956
Haematochezia	15.60	13.48	11	37362	87634	79619381
Muscle spasms	15.52	13.48	37	37336	174693	79532322
Upper respiratory tract infection	15.50	13.48	12	37361	91156	79615859
Erectile dysfunction	15.47	13.48	26	37347	14638	79692377
Pneumonia aspiration	15.47	13.48	6	37367	66961	79640054
Hyperproteinaemia	15.44	13.48	5	37368	177	79706838
Cystitis	15.39	13.48	3	37370	52729	79654286
Hypersensitivity	15.30	13.48	67	37306	262172	79444843
Anaemia	15.26	13.48	293	37080	444722	79262293
Prognathism	15.18	13.48	3	37370	12	79707003
Antiviral drug level above therapeutic	15.08	13.48	4	37369	69	79706946
Haemodialysis	15.06	13.48	29	37344	18139	79688876
HIV wasting syndrome	14.92	13.48	4	37369	72	79706943
Chronic obstructive pulmonary disease	14.83	13.48	11	37362	85408	79621607
Tuberculosis	14.79	13.48	26	37347	15172	79691843
Anembryonic gestation	14.76	13.48	6	37367	410	79706605
Congenital diaphragmatic hernia	14.63	13.48	3	37370	15	79707000
Blood pressure decreased	14.62	13.48	15	37358	99451	79607564
Disseminated mycobacterium avium complex infection	14.58	13.48	5	37368	212	79706803
Lipase increased	14.54	13.48	27	37346	16439	79690576
Bone density decreased	14.53	13.48	24	37349	13323	79693692
Unmasking of previously unidentified disease	14.36	13.48	10	37363	2047	79704968
Albuminuria	14.30	13.48	7	37366	742	79706273
Chronic hepatitis B	14.29	13.48	6	37367	445	79706570
Hemiparaesthesia	14.09	13.48	5	37368	235	79706780
Gestational diabetes	14.01	13.48	16	37357	6277	79700738
Bone marrow disorder	14.00	13.48	12	37361	3331	79703684
Total bile acids increased	13.96	13.48	4	37369	93	79706922
Hepatitis cholestatic	13.88	13.48	24	37349	13828	79693187
Haemorrhoids thrombosed	13.83	13.48	5	37368	248	79706767
Generalised anxiety disorder	13.76	13.48	10	37363	2187	79704828
Skin lesion	13.70	13.48	47	37326	41797	79665218
Muscle injury	13.69	13.48	3	37370	48558	79658457
Plasma cell myeloma	13.64	13.48	4	37369	53255	79653760
Cervix haemorrhage uterine	13.53	13.48	3	37370	23	79706992
Bone metabolism disorder	13.49	13.48	6	37367	512	79706503

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	J05AF07	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Nucleoside and nucleotide reverse transcriptase inhibitors
ATC	J05AR03	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR06	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR08	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR09	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	J05AR24	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
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
CHEBI has role	CHEBI:36044	antiviral drugs
CHEBI has role	CHEBI:53756	reverse transcriptase inhibitors
CHEBI has role	CHEBI:50266	Prodrugs

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 HIV Infection after Exposure	off-label use
Osteomalacia	contraindication	4598005	DOID:10573
Hypophosphatemia	contraindication	4996001
Suicidal thoughts	contraindication	6471006
Hypercholesterolemia	contraindication	13644009
Torsades de pointes	contraindication	31722008
Depressive disorder	contraindication	35489007
Fanconi syndrome	contraindication	40488004	DOID:1062
Acute nephropathy	contraindication	58574008
Hepatic failure	contraindication	59927004
Aggressive behavior	contraindication	61372001
Kidney disease	contraindication	90708001	DOID:557
Lactic acidosis	contraindication	91273001	DOID:3650
Prolonged QT interval	contraindication	111975006
Chronic hepatitis C	contraindication	128302006
Seizure disorder	contraindication	128613002
Liver function tests abnormal	contraindication	166603001
Paranoid disorder	contraindication	191667009
Steatosis of liver	contraindication	197321007
Mania	contraindication	231494001
Disease of liver	contraindication	235856003	DOID:409
Pathological fracture	contraindication	268029009
Pregnancy, function	contraindication	289908002
Hypertriglyceridemia	contraindication	302870006
Severe depression	contraindication	310497006
Osteopenia	contraindication	312894000
Breastfeeding (mother)	contraindication	413712001
Obesity	contraindication	414916001	DOID:9970
Congenital long QT syndrome	contraindication	442917000

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	4.86	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
200MG;300MG	TRUVADA	GILEAD	N021752	Aug. 2, 2004	RX	TABLET	ORAL	8592397	Jan. 13, 2024	METHOD OF TREATMENT OF ADULTS INFECTED WITH HIV-1
200MG;300MG	TRUVADA	GILEAD	N021752	Aug. 2, 2004	RX	TABLET	ORAL	8592397	Jan. 13, 2024	TREATMENT OF HIV
200MG;300MG	TRUVADA	GILEAD	N021752	Aug. 2, 2004	RX	TABLET	ORAL	8592397	Jan. 13, 2024	TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
200MG;300MG	TRUVADA	GILEAD	N021752	Aug. 2, 2004	RX	TABLET	ORAL	8716264	Jan. 13, 2024	TREATMENT OF HIV INFECTION
200MG;300MG	TRUVADA	GILEAD	N021752	Aug. 2, 2004	RX	TABLET	ORAL	9457036	Jan. 13, 2024	TREATMENT OF HIV INFECTION
200MG;300MG	TRUVADA	GILEAD	N021752	Aug. 2, 2004	RX	TABLET	ORAL	9744181	Jan. 13, 2024	TREATMENT OF HIV INFECTION
600MG;200MG;300MG	ATRIPLA	GILEAD SCIENCES	N021937	July 12, 2006	RX	TABLET	ORAL	8592397	Jan. 13, 2024	TREATMENT OF HIV-1 INFECTION IN ADULTS
600MG;200MG;300MG	ATRIPLA	GILEAD SCIENCES	N021937	July 12, 2006	RX	TABLET	ORAL	8592397	Jan. 13, 2024	TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
600MG;200MG;300MG	ATRIPLA	GILEAD SCIENCES	N021937	July 12, 2006	RX	TABLET	ORAL	8716264	Jan. 13, 2024	TREATMENT OF HIV INFECTION
600MG;200MG;300MG	ATRIPLA	GILEAD SCIENCES	N021937	July 12, 2006	RX	TABLET	ORAL	9457036	Jan. 13, 2024	TREATMENT OF HIV INFECTION
600MG;200MG;300MG	ATRIPLA	GILEAD SCIENCES	N021937	July 12, 2006	RX	TABLET	ORAL	9744181	Jan. 13, 2024	TREATMENT OF HIV INFECTION
200MG;EQ 25MG BASE;300MG	COMPLERA	GILEAD SCIENCES INC	N202123	Aug. 10, 2011	RX	TABLET	ORAL	8592397	Jan. 13, 2024	TREATMENT OF HIV INFECTION
200MG;EQ 25MG BASE;300MG	COMPLERA	GILEAD SCIENCES INC	N202123	Aug. 10, 2011	RX	TABLET	ORAL	8716264	Jan. 13, 2024	TREATMENT OF HIV INFECTION
200MG;EQ 25MG BASE;300MG	COMPLERA	GILEAD SCIENCES INC	N202123	Aug. 10, 2011	RX	TABLET	ORAL	9457036	Jan. 13, 2024	TREATMENT OF HIV INFECTION
200MG;EQ 25MG BASE;300MG	COMPLERA	GILEAD SCIENCES INC	N202123	Aug. 10, 2011	RX	TABLET	ORAL	9744181	Jan. 13, 2024	TREATMENT OF HIV INFECTION
150MG;150MG;200MG;300MG	STRIBILD	GILEAD SCIENCES INC	N203100	Aug. 27, 2012	RX	TABLET	ORAL	8592397	Jan. 13, 2024	TREATMENT OF HIV INFECTION
150MG;150MG;200MG;300MG	STRIBILD	GILEAD SCIENCES INC	N203100	Aug. 27, 2012	RX	TABLET	ORAL	8716264	Jan. 13, 2024	TREATMENT OF HIV INFECTION
150MG;150MG;200MG;300MG	STRIBILD	GILEAD SCIENCES INC	N203100	Aug. 27, 2012	RX	TABLET	ORAL	9457036	Jan. 13, 2024	TREATMENT OF HIV INFECTION
150MG;150MG;200MG;300MG	STRIBILD	GILEAD SCIENCES INC	N203100	Aug. 27, 2012	RX	TABLET	ORAL	9744181	Jan. 13, 2024	TREATMENT OF HIV INFECTION
200MG;EQ 25MG BASE;300MG	COMPLERA	GILEAD SCIENCES INC	N202123	Aug. 10, 2011	RX	TABLET	ORAL	7125879	April 21, 2025	TREATMENT OF HIV INFECTION
200MG;EQ 25MG BASE;300MG	COMPLERA	GILEAD SCIENCES INC	N202123	Aug. 10, 2011	RX	TABLET	ORAL	8841310	Dec. 9, 2025	TREATMENT OF HIV INFECTION
600MG;200MG;300MG	ATRIPLA	GILEAD SCIENCES	N021937	July 12, 2006	RX	TABLET	ORAL	9018192	June 13, 2026	TREATMENT OF HIV-1 INFECTION IN ADULTS
600MG;200MG;300MG	ATRIPLA	GILEAD SCIENCES	N021937	July 12, 2006	RX	TABLET	ORAL	9018192	June 13, 2026	TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
600MG;200MG;300MG	ATRIPLA	GILEAD SCIENCES	N021937	July 12, 2006	RX	TABLET	ORAL	9545414	June 13, 2026	TREATMENT OF HIV-1 INFECTION IN ADULTS
600MG;200MG;300MG	ATRIPLA	GILEAD SCIENCES	N021937	July 12, 2006	RX	TABLET	ORAL	9545414	June 13, 2026	TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
150MG;150MG;200MG;300MG	STRIBILD	GILEAD SCIENCES INC	N203100	Aug. 27, 2012	RX	TABLET	ORAL	7176220	Aug. 27, 2026	TREATMENT OF HIV INFECTION
150MG;150MG;200MG;300MG	STRIBILD	GILEAD SCIENCES INC	N203100	Aug. 27, 2012	RX	TABLET	ORAL	7635704	Oct. 26, 2026	TREATMENT OF HIV INFECTION
150MG;150MG;200MG;300MG	STRIBILD	GILEAD SCIENCES INC	N203100	Aug. 27, 2012	RX	TABLET	ORAL	8148374	Sept. 3, 2029	TREATMENT OF HIV INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE
150MG;150MG;200MG;300MG	STRIBILD	GILEAD SCIENCES INC	N203100	Aug. 27, 2012	RX	TABLET	ORAL	9891239	Sept. 3, 2029	TREATMENT OF HIV INFECTION
150MG;150MG;200MG;300MG	STRIBILD	GILEAD SCIENCES INC	N203100	Aug. 27, 2012	RX	TABLET	ORAL	8633219	April 30, 2030	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
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])	Mechanism action	Bioact source	MoA source
Reverse transcriptase/RNaseH	Enzyme		Q72547_9HIV1	INHIBITOR				CHEMBL	CHEMBL
Gag-Pol polyprotein	Polyprotein		POL_HV1A2					WOMBAT-PK

External reference:

ID	Source
D01982	KEGG_DRUG
202138-50-9	SECONDARY_CAS_RN
4021279	VANDF
4021280	VANDF
C0384228	UMLSCUI
CHEBI:63718	CHEBI
CHEBI:63625	CHEBI
TFO	PDB_CHEM_ID
CHEMBL1538	ChEMBL_ID
CHEMBL1486	ChEMBL_ID
D000068698	MESH_DESCRIPTOR_UI
DB00300	DRUGBANK_ID
F4YU4LON7I	UNII
5481350	PUBCHEM_CID
DB14126	DRUGBANK_ID
117466	RXNORM
16193	MMSL
267164	MMSL
29323	MMSL
42402	MMSL
d04774	MMSL
009357	NDDF
009358	NDDF
017389	NDDF
385556006	SNOMEDCT_US
395264002	SNOMEDCT_US
421203005	SNOMEDCT_US
422091007	SNOMEDCT_US
206184-49-8	SECONDARY_CAS_RN
464205	PUBCHEM_CID

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
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate	HUMAN PRESCRIPTION DRUG LABEL	3	0093-5234	TABLET, FILM COATED	300 mg	ORAL	ANDA	30 sections
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate	HUMAN PRESCRIPTION DRUG LABEL	3	0093-5234	TABLET, FILM COATED	300 mg	ORAL	ANDA	30 sections
Emtricitabine and Tenofovir Disoproxil Fumarate	HUMAN PRESCRIPTION DRUG LABEL	2	0093-7607	TABLET, FILM COATED	300 mg	ORAL	ANDA	29 sections
Emtricitabine and Tenofovir Disoproxil Fumarate	HUMAN PRESCRIPTION DRUG LABEL	2	0093-7704	TABLET, FILM COATED	300 mg	ORAL	ANDA	29 sections
Emtricitabine and Tenofovir Disoproxil Fumarate	HUMAN PRESCRIPTION DRUG LABEL	2	0093-7704	TABLET, FILM COATED	300 mg	ORAL	ANDA	29 sections
Emtricitabine and Tenofovir Disoproxil Fumarate	HUMAN PRESCRIPTION DRUG LABEL	2	0378-1930	TABLET, FILM COATED	300 mg	ORAL	ANDA	30 sections
tenofovir disproxil fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6821	TABLET	300 mg	ORAL	ANDA	27 sections
Emtricitabine and Tenofovir Disoproxil Fumarate	HUMAN PRESCRIPTION DRUG LABEL	2	0904-7172	TABLET, FILM COATED	300 mg	ORAL	ANDA	28 sections
Emtricitabine and Tenofovir Disoproxil Fumarate	HUMAN PRESCRIPTION DRUG LABEL	2	0904-7172	TABLET, FILM COATED	300 mg	ORAL	ANDA	28 sections
Atripla	HUMAN PRESCRIPTION DRUG LABEL	3	15584-0101	TABLET, FILM COATED	300 mg	ORAL	NDA	34 sections
Emtricitabine and tenofovir disoproxil fumarate	Human Prescription Drug Label	2	16714-534	TABLET, FILM COATED	300 mg	ORAL	ANDA	28 sections
Emtricitabine and tenofovir disoproxil fumarate	Human Prescription Drug Label	2	16714-534	TABLET, FILM COATED	300 mg	ORAL	ANDA	28 sections
Tenofovir Disoproxil Fumarate	Human Prescription Drug Label	1	16714-820	TABLET, FILM COATED	300 mg	ORAL	ANDA	27 sections
Tenofovir Disoproxil Fumarate	Human Prescription Drug Label	1	31722-535	TABLET, FILM COATED	300 mg	ORAL	ANDA	30 sections
Tenofovir Disoproxil Fumarate	Human Prescription Drug Label	1	31722-535	TABLET, FILM COATED	300 mg	ORAL	ANDA	30 sections
Emtricitabine and tenofovir disoproxil fumarate	HUMAN PRESCRIPTION DRUG LABEL	2	31722-560	TABLET, FILM COATED	300 mg	ORAL	ANDA	27 sections
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate	HUMAN PRESCRIPTION DRUG LABEL	3	31722-736	TABLET, FILM COATED	300 mg	ORAL	ANDA	28 sections
tenofovir disproxil fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	33342-096	TABLET	300 mg	ORAL	ANDA	28 sections
tenofovir disproxil fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	33342-096	TABLET	300 mg	ORAL	ANDA	28 sections
tenofovir disproxil fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	33342-096	TABLET	300 mg	ORAL	ANDA	28 sections
Emtricitabine and tenofovir disoproxil fumarate	Human Prescription Drug Label	2	33342-106	TABLET, FILM COATED	300 mg	ORAL	ANDA	28 sections
Emtricitabine and tenofovir disoproxil fumarate	Human Prescription Drug Label	2	33342-106	TABLET, FILM COATED	300 mg	ORAL	ANDA	28 sections
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate	Human Prescription Drug Label	3	33342-138	TABLET, FILM COATED	300 mg	ORAL	ANDA	30 sections
Emtricitabine and Tenofovir Disoproxil Fumarate	HUMAN PRESCRIPTION DRUG LABEL	2	42291-439	TABLET, FILM COATED	300 mg	ORAL	ANDA	26 sections
Emtricitabine and Tenofovir Disoproxil Fumarate	HUMAN PRESCRIPTION DRUG LABEL	2	42291-439	TABLET, FILM COATED	300 mg	ORAL	ANDA	26 sections
Tenofovir Disoproxil Fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	42291-800	TABLET, FILM COATED	300 mg	ORAL	ANDA	27 sections
Tenofovir Disoproxil Fumarate	Human Prescription Drug Label	1	42385-901	TABLET, FILM COATED	300 mg	ORAL	ANDA	28 sections
Efavirenz, emtricitabine and tenofovir disoproxil fumarate	Human Prescription Drug Label	3	42385-915	TABLET, FILM COATED	300 mg	ORAL	ANDA	30 sections