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

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

Stem definition	Drug id	CAS RN
antibiotics, produced by Streptomyces strains	668	81103-11-9

Description:

Molecule

Description

Molfile Inchi Smiles Synonyms: clarithromycin 6-O-Methylerythromycin A biaxin clamicin clathromycin

A semisynthetic macrolide antibiotic derived from ERYTHROMYCIN that is active against a variety of microorganisms. It can inhibit PROTEIN SYNTHESIS in BACTERIA by reversibly binding to the 50S ribosomal subunits. This inhibits the translocation of aminoacyl transfer-RNA and prevents peptide chain elongation. Molecular weight: 747.96 Formula: C38H69NO13 CLOGP: 2.39 LIPINSKI: 2 HAC: 14 HDO: 4 TPSA: 182.91 ALOGS: -3.54 ROTB: 8 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

Dose	Unit	Route
0.50	g	O
1	g	P

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	2 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	35 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	11.14 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	55 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	1.50 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	7.30 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.23 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	2.80 hours	Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value	Unit	Confidence	Similarity
azlogd74	LogD at pH 7.4	1.842		Moderate	0.77
caco2-efflux	Caco-2 efflux ratio (BA/AB)	47.753		Moderate	0.77
caco2-intrinsic-papp	Caco-2 intrinsic apparent permeability	1.374	10^-6 cm/s	Moderate	0.77
dh-clint	Dog hepatocyte intrinsic clearance	8.395	uL/min/10^6 cells	Moderate	0.77
dppb	Dog plasma protein binding (% unbound)	34.940	%	Moderate	0.77
fcs-ppb	Fetal calf serum protein binding (% unbound)	38.090	%	Moderate	0.77
herg	hERG pIC50	4.237	pIC50	Moderate	0.77
hh-clint	Human hepatocyte intrinsic clearance	2.193	uL/min/10^6 cells	Moderate	0.77
hlm-clint	Human liver microsomal intrinsic clearance	29.992	uL/min/mg protein	Moderate	0.77
hppb	Human plasma protein binding (% unbound)	43.640	%	Moderate	0.77
kinase-safety-class	ACVR2B,AXL,CAMK2D,CDK5,EIF2AK3,ERBB2,GRK2,ITK,MAP2K6,MAP3K21,MAPK7,NTRK2,PDK1,PDK2,PDK4,PRKDC,TEK	17
mdck-mdr1-bcrp-efflux	MDCK-MDR1-BCRP efflux ratio	4.955		High	1
mdck-mdr1-efflux	MDCK-MDR1 efflux ratio	7.534		Moderate	0.77
mh-clint	Mouse hepatocyte intrinsic clearance	5.023		Moderate	0.77
mppb	Mouse plasma protein binding (% unbound)	41.900		Moderate	0.77
nih-mdck-mdr1-efflux	NIH MDCK-MDR1 efflux ratio	9.683		Moderate	0.77
pfas-class	PFAS structural alert (1 = True, 0 = False)	0
pld-class	Phospholipidosis risk class (1 = positive, 0 = negative)	0		High	1
pppb	Pig plasma protein binding (% unbound)	47.580	%	Moderate	0.77
rat-kpuu-brain	Rat brain Kpuu	0.015	%	High	1
rh-clint	Rat hepatocyte intrinsic clearance	4.775	uL/min/10^6 cells	Moderate	0.77
rh-fuinc	Rat hepatocyte fraction unbound in incubation	75.250	%	Moderate	0.77
rppb	Rat plasma protein binding (% unbound)	34.470	%	Moderate	0.77
solubility-dd	Solubility at pH 7.4 in DMSO	778.037	uM	Moderate	0.77

Approvals:

Date	Agency	Company	Orphan
Oct. 31, 1991	FDA	ABBVIE

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
Drug interaction	1147.14	11.15	1209	66117	275244	90285877
Macular degeneration	759.92	11.15	426	66900	37544	90523577
Swollen tongue	448.90	11.15	328	66998	45628	90515493
Chronic sinusitis	390.99	11.15	235	67091	23567	90537554
Drug hypersensitivity	348.85	11.15	938	66388	462671	90098450
Abortion spontaneous	345.97	11.15	301	67025	53755	90507366
Paraesthesia oral	339.03	11.15	239	67087	31420	90529701
Swelling face	327.55	11.15	351	66975	81001	90480120
Female genital tract fistula	321.17	11.15	187	67139	17681	90543440
Angioedema	308.28	11.15	306	67020	64570	90496551
Vaginal flatulence	264.17	11.15	146	67180	12492	90548629
Proctitis	238.60	11.15	146	67180	15113	90546008
Radiculopathy	229.56	11.15	153	67173	18352	90542769
Pemphigus	222.82	11.15	4	67322	326860	90234261
Dysgeusia	220.75	11.15	232	67094	52328	90508793
Oral candidiasis	213.96	11.15	191	67135	35264	90525857
Vaginal discharge	208.50	11.15	147	67179	19317	90541804
Systemic lupus erythematosus	202.65	11.15	18	67308	361878	90199243
Erythema	198.91	11.15	490	66836	228756	90332365
Hand deformity	192.89	11.15	6	67320	296356	90264765
Erythema multiforme	191.03	11.15	117	67209	12129	90548992
Drug resistance	187.64	11.15	166	67160	30283	90530838
Lip swelling	186.85	11.15	184	67142	38426	90522695
Arthropathy	185.48	11.15	26	67300	366216	90194905
Labelled drug-drug interaction medication error	181.92	11.15	121	67205	14461	90546660
Glossodynia	174.85	11.15	18	67308	321761	90239360
Procedural pain	170.84	11.15	164	67162	33196	90527925
Synovitis	170.31	11.15	22	67304	329730	90231391
Joint swelling	169.64	11.15	81	67245	503219	90057902
Dysphonia	167.29	11.15	220	67106	62864	90498257
Wound	161.93	11.15	18	67308	302962	90258159
Drug eruption	160.76	11.15	163	67163	35244	90525877
Alopecia	154.51	11.15	88	67238	494983	90066138
Loss of employment	153.41	11.15	64	67262	2923	90558198
Duodenal ulcer perforation	145.72	11.15	4	67322	221284	90339837
Malaise	134.40	11.15	818	66508	585168	89975953
Mania	133.75	11.15	99	67227	14025	90547096
Pericarditis	130.29	11.15	22	67304	270129	90290992
Folliculitis	129.90	11.15	5	67321	204348	90356773
Rheumatoid arthritis	128.94	11.15	54	67272	362560	90198561
Haematochezia	126.40	11.15	205	67121	70708	90490413
Psoriatic arthropathy	126.03	11.15	12	67314	228323	90332798
Rhabdomyolysis	119.57	11.15	168	67158	51088	90510033
Muscle injury	117.02	11.15	3	67323	176651	90384470
Irritable bowel syndrome	116.91	11.15	10	67316	207438	90353683
Blood cholesterol increased	112.01	11.15	12	67314	208000	90353121
Fatigue	111.48	11.15	461	66865	1153562	89407559
Electrocardiogram QT prolonged	111.28	11.15	196	67130	72260	90488861
Death	110.29	11.15	106	67220	456445	90104676
Drug ineffective for unapproved indication	108.51	11.15	185	67141	66459	90494662
Impaired healing	106.66	11.15	22	67304	234177	90326944
Frequent bowel movements	106.13	11.15	168	67158	56767	90504354
Pneumatosis intestinalis	101.30	11.15	50	67276	3387	90557734
Type 2 diabetes mellitus	99.21	11.15	16	67310	203228	90357893
Sputum increased	96.13	11.15	46	67280	2911	90558210
General physical health deterioration	96.01	11.15	74	67252	355041	90206080
Peripheral swelling	95.08	11.15	100	67226	413006	90148115
Musculoskeletal stiffness	94.88	11.15	51	67275	296481	90264640
Completed suicide	94.10	11.15	3	67323	145055	90416066
Ill-defined disorder	93.82	11.15	13	67313	184878	90376243
Mobility decreased	91.26	11.15	36	67290	250698	90310423
Hepatic enzyme increased	89.14	11.15	82	67244	360654	90200467
Discomfort	88.03	11.15	47	67279	274288	90286833
Rectal haemorrhage	84.88	11.15	189	67137	82555	90478566
Colitis	84.76	11.15	171	67155	69771	90491350
Stevens-Johnson syndrome	81.83	11.15	105	67221	29271	90531850
Colitis ulcerative	79.88	11.15	153	67173	60113	90501008
Mycobacterium abscessus infection	79.59	11.15	30	67296	1045	90560076
Abdominal pain	79.15	11.15	534	66792	395187	90165934
Salpingo-oophorectomy unilateral	78.94	11.15	29	67297	939	90560182
Sinusitis fungal	77.68	11.15	35	67291	1929	90559192
Helicobacter infection	77.09	11.15	36	67290	226814	90334307
Hallucination	76.07	11.15	158	67168	65801	90495320
Palpitations	76.01	11.15	249	67077	136479	90424642
Psychotic disorder	75.27	11.15	104	67222	31126	90529995
Embolism venous	73.40	11.15	41	67285	3579	90557542
Hepatic steatosis	73.00	11.15	112	67214	36833	90524288
Rash maculo-papular	72.47	11.15	118	67208	40815	90520306
Enterocolitis haemorrhagic	72.13	11.15	32	67294	1700	90559421
Psoriasis	71.27	11.15	12	67314	147742	90413379
Nausea	70.89	11.15	1187	66139	1109129	89451992
Agitation	68.52	11.15	153	67173	66945	90494176
Intentional product use issue	68.34	11.15	38	67288	216854	90344267
Joint range of motion decreased	67.73	11.15	10	67316	135633	90425488
Tongue oedema	67.40	11.15	45	67281	5409	90555712
Long QT syndrome	66.63	11.15	40	67286	3997	90557124
Tongue discolouration	66.60	11.15	38	67288	3455	90557666
Drug level increased	66.23	11.15	92	67234	27670	90533451
Treatment failure	66.11	11.15	77	67249	303851	90257270
Injury	66	11.15	32	67294	197317	90363804
Acute psychosis	65.53	11.15	36	67290	3042	90558079
Paranoia	65.21	11.15	63	67263	12845	90548276
Acute kidney injury	62.62	11.15	430	66896	319957	90241164
Lip dry	62.38	11.15	3	67323	100952	90460169
Pathogen resistance	61.82	11.15	50	67276	8065	90553056
Infection	61.72	11.15	109	67217	361985	90199136
International normalised ratio increased	61.32	11.15	119	67207	47197	90513924
Bursitis	60.68	11.15	12	67314	131642	90429479
Toxic epidermal necrolysis	60.63	11.15	96	67230	32432	90528689
Pain	60.53	11.15	463	66863	995878	89565243
Hallucination, visual	60.37	11.15	80	67246	23012	90538109
Torsade de pointes	60.15	11.15	65	67261	15117	90546004
Cough	60.02	11.15	474	66852	368488	90192633
Hypoaesthesia	58.76	11.15	89	67237	314121	90247000
Prescribed overdose	56.97	11.15	4	67322	97621	90463500
Jaundice	56.56	11.15	93	67233	32424	90528697
Ototoxicity	56.19	11.15	28	67298	1936	90559185
Paradoxical drug reaction	55.91	11.15	41	67285	5725	90555396
Respiratory symptom	54.77	11.15	36	67290	4216	90556905
Lip oedema	54.28	11.15	37	67289	4602	90556519
Immunosuppressant drug level increased	53.98	11.15	37	67289	4643	90556478
Face oedema	53.73	11.15	76	67250	23242	90537879
Road traffic accident	53.58	11.15	8	67318	107618	90453503
Wound infection	52.76	11.15	8	67318	106394	90454727
Hepatic function abnormal	52.34	11.15	110	67216	46178	90514943
Weight increased	52.28	11.15	149	67177	417778	90143343
Fibromyalgia	51.97	11.15	46	67280	206223	90354898
Swelling	51.25	11.15	151	67175	418907	90142214
Hypoglycaemia	50.90	11.15	140	67186	69708	90491413
Product dose omission issue	50.42	11.15	87	67239	291600	90269521
Eosinophilic pneumonia	49.76	11.15	29	67297	2744	90558377
Sciatica	49.41	11.15	8	67318	101374	90459747
Tinnitus	49.40	11.15	103	67223	42999	90518122
Nightmare	48.87	11.15	70	67256	21655	90539466
Pyrexia	47.95	11.15	722	66604	659763	89901358
Obesity	47.82	11.15	10	67316	105497	90455624
Adverse event	47.66	11.15	14	67312	117404	90443717
Stomatitis	47.42	11.15	82	67244	274616	90286505
Fall	47.18	11.15	191	67135	481619	90079502
Dyspnoea	46.95	11.15	916	66410	880039	89681082
Red blood cell sedimentation rate increased	46.46	11.15	4	67322	82591	90478530
Pneumonia mycoplasmal	46.19	11.15	20	67306	1002	90560119
Potentiating drug interaction	45.50	11.15	36	67290	5626	90555495
Memory impairment	45.03	11.15	48	67278	197196	90363925
Hypercholesterolaemia	44.84	11.15	10	67316	100882	90460239
Gait inability	44.22	11.15	27	67299	146429	90414692
Mycobacterium chelonae infection	43.85	11.15	17	67309	640	90560481
Lower limb fracture	43.06	11.15	6	67320	85007	90476114
Night sweats	42.86	11.15	21	67305	128745	90432376
Hallucination, auditory	42.77	11.15	56	67270	15919	90545202
Immune reconstitution inflammatory syndrome	42.70	11.15	38	67288	6981	90554140
Hallucinations, mixed	42.16	11.15	35	67291	5854	90555267
Hip arthroplasty	42.03	11.15	4	67322	76204	90484917
Pharyngeal oedema	41.17	11.15	51	67275	13720	90547401
Hepatic ischaemia	40.92	11.15	17	67309	768	90560353
Pharyngeal swelling	40.14	11.15	43	67283	9901	90551220
Diastolic dysfunction	39.34	11.15	37	67289	7296	90553825
Throat tightness	38.01	11.15	74	67252	29410	90531711
Deafness	37.29	11.15	63	67263	22451	90538670
Gait disturbance	37.05	11.15	87	67239	260409	90300712
Arthralgia	36.96	11.15	385	66941	778137	89782984
Purpura	36.80	11.15	50	67276	14728	90546393
Blister	36.40	11.15	85	67241	254913	90306208
Arthritis	35.70	11.15	43	67283	167272	90393849
Injection site pain	35.64	11.15	46	67280	173653	90387468
Mycobacterium avium complex infection	34.98	11.15	27	67299	4071	90557050
Product quality issue	34.97	11.15	8	67318	79317	90481804
Inflammation	34.92	11.15	49	67277	178543	90382578
Dermatitis allergic	34.89	11.15	53	67273	17274	90543847
Pressure of speech	34.57	11.15	15	67311	755	90560366
Atypical mycobacterial infection	34.57	11.15	19	67307	1607	90559514
Toxic skin eruption	34.27	11.15	50	67276	15724	90545397
Contusion	34.07	11.15	86	67240	251130	90309991
Dyspepsia	34.07	11.15	258	67068	197902	90363219
Musculoskeletal pain	33.47	11.15	47	67279	171204	90389917
Pain in extremity	33.42	11.15	197	67129	450332	90110789
Palatal oedema	33.03	11.15	14	67312	665	90560456
Blood creatine phosphokinase increased	32.96	11.15	76	67250	33947	90527174
Hepatocellular injury	32.95	11.15	69	67257	28889	90532232
Candida infection	32.91	11.15	76	67250	33981	90527140
Weber tuning fork test abnormal	32.70	11.15	9	67317	110	90561011
Brief psychotic disorder with marked stressors	32.57	11.15	8	67318	60	90561061
Mouth ulceration	32.03	11.15	83	67243	39891	90521230
Pseudomembranous colitis	31.96	11.15	25	67301	3843	90557278
Circulatory collapse	31.49	11.15	62	67264	24842	90536279
Live birth	31.08	11.15	10	67316	79097	90482024
Drug monitoring procedure not performed	31.05	11.15	14	67312	773	90560348
Disease recurrence	31.01	11.15	79	67247	37574	90523547
Acinetobacter infection	30.84	11.15	19	67307	1989	90559132
Foot deformity	30.71	11.15	4	67322	59647	90501474
Ventricular tachycardia	30.63	11.15	61	67265	24647	90536474
Euphoric mood	30.38	11.15	28	67298	5381	90555740
Bipolar I disorder	30.21	11.15	19	67307	2063	90559058
Staphylococcal scalded skin syndrome	30.17	11.15	9	67317	149	90560972
Muscle necrosis	30.11	11.15	14	67312	830	90560291
Oral mucosal blistering	29.83	11.15	31	67295	6893	90554228
Rash macular	29.73	11.15	68	67258	30212	90530909
Product use issue	29.67	11.15	135	67191	329784	90231337
Pharyngeal erythema	29.57	11.15	18	67308	1844	90559277
Coagulopathy	29.48	11.15	58	67268	23231	90537890
Muscle relaxant therapy	29.37	11.15	9	67317	164	90560957
Labile blood pressure	29.15	11.15	18	67308	1892	90559229
Nasal polyps	28.91	11.15	38	67288	10842	90550279
Labelled drug-drug interaction issue	28.80	11.15	19	67307	2239	90558882
Contraindicated product administered	28.79	11.15	131	67195	320008	90241113
Diverticulum	28.68	11.15	40	67286	12073	90549048
Emphysema	28.57	11.15	40	67286	12115	90549006
Vomiting	28.33	11.15	776	66550	787517	89773604
Myositis	28.05	11.15	58	67268	24070	90537051
Abnormal dreams	27.89	11.15	38	67288	11219	90549902
Pregnancy	27.87	11.15	6	67320	62041	90499080
Mouth swelling	27.41	11.15	27	67299	5635	90555486
Weight decreased	27.37	11.15	415	66911	379495	90181626
Oesophageal pain	27.24	11.15	24	67302	4350	90556771
Stenotrophomonas infection	26.84	11.15	19	67307	2510	90558611
Lymphocyte stimulation test positive	26.84	11.15	11	67315	480	90560641
Tongue necrosis	26.80	11.15	7	67319	69	90561052
Liver injury	26.69	11.15	54	67272	170513	90390608
Sleep disorder	26.68	11.15	68	67258	197962	90363159
Diarrhoea	26.64	11.15	898	66428	938292	89622829
Antimicrobial susceptibility test intermediate	26.51	11.15	6	67320	30	90561091
Renal impairment	26.49	11.15	151	67175	105270	90455851
Rash erythematous	25.57	11.15	106	67220	64998	90496123
Infusion related reaction	25.50	11.15	193	67133	416587	90144534
Urticaria	25.45	11.15	349	66977	312385	90248736
Disseminated mycobacterium avium complex infection	25.37	11.15	9	67317	263	90560858
Myopathy	25.33	11.15	40	67286	13478	90547643
Oropharyngeal discomfort	25.33	11.15	30	67296	7705	90553416
Serum sickness-like reaction	24.93	11.15	11	67315	577	90560544
Hepatic cirrhosis	24.84	11.15	8	67318	63245	90497876
Chest discomfort	24.82	11.15	182	67144	138183	90422938
Jarisch-Herxheimer reaction	24.62	11.15	10	67316	426	90560695
Neck pain	24.61	11.15	29	67297	113934	90447187
Back injury	24.30	11.15	3	67323	46619	90514502
Headache	24.22	11.15	824	66502	861922	89699199
Nasopharyngitis	24.21	11.15	190	67136	406914	90154207
Hypersensitivity	24.18	11.15	473	66853	454204	90106917
Therapeutic product effect incomplete	24.13	11.15	235	67091	193661	90367460
Bone erosion	24.08	11.15	5	67321	53016	90508105
Henoch-Schonlein purpura	23.99	11.15	15	67311	1612	90559509
Prescribed underdose	23.82	11.15	13	67313	75006	90486115
Liver function test increased	23.77	11.15	17	67309	84838	90476283
Gastric disorder	23.41	11.15	66	67260	33318	90527803
Anaemia	23.36	11.15	380	66946	352422	90208699
Malignant neoplasm progression	23.29	11.15	27	67299	106843	90454278
Hepatitis fulminant	23.29	11.15	21	67305	3924	90557197
Muscle spasms	23.28	11.15	102	67224	251781	90309340
Lipoedema	23.18	11.15	9	67317	340	90560781
Eczema	23.10	11.15	89	67237	52781	90508340
Tongue haematoma	23.03	11.15	7	67319	124	90560997
Delusional perception	22.54	11.15	8	67318	234	90560887
Tangentiality	22.54	11.15	6	67320	64	90561057
Acute hepatic failure	22.52	11.15	51	67275	22510	90538611
Therapy non-responder	22.50	11.15	42	67284	136662	90424459
Febrile neutropenia	22.41	11.15	53	67273	158296	90402825
Haemostasis	22.35	11.15	9	67317	375	90560746
Meningitis streptococcal	22.33	11.15	7	67319	138	90560983
Agitation neonatal	22.28	11.15	10	67316	546	90560575
Chromaturia	22.16	11.15	46	67280	19141	90541980
Lymphoedema	22.14	11.15	38	67288	13715	90547406
Productive cough	21.80	11.15	114	67212	76949	90484172
Delusion of grandeur	21.69	11.15	8	67318	262	90560859
Nephropathy toxic	21.67	11.15	36	67290	12652	90548469
Rash	21.49	11.15	757	66569	795343	89765778
Psychomotor hyperactivity	21.41	11.15	36	67290	12777	90548344
Lupus-like syndrome	21.38	11.15	5	67321	48841	90512280
Lung disorder	21.34	11.15	50	67276	149833	90411288
Ocular toxicity	21.30	11.15	12	67314	1065	90560056
Superinfection	21.26	11.15	18	67308	3094	90558027
Pharyngitis	21.23	11.15	49	67277	21898	90539223
Cardioactive drug level increased	20.99	11.15	16	67310	2368	90558753
Photosensitivity reaction	20.93	11.15	43	67283	17764	90543357
Hypovolaemia	20.87	11.15	35	67291	12396	90548725
Deafness bilateral	20.85	11.15	14	67312	1699	90559422
Trichoglossia	20.73	11.15	9	67317	454	90560667
Joint dislocation	20.67	11.15	4	67322	44578	90516543
Tricuspid valve incompetence	20.37	11.15	41	67285	16690	90544431
Injection site reaction	20.35	11.15	23	67303	92057	90469064
Disability	20.34	11.15	3	67323	40742	90520379
Osteoarthritis	20.13	11.15	76	67250	195654	90365467
Amnesia	20.00	11.15	31	67295	108474	90452647
No adverse event	19.87	11.15	13	67313	67969	90493152
Tongue exfoliation	19.86	11.15	6	67320	104	90561017
Anaphylactic reaction	19.82	11.15	122	67204	87402	90473719
Pneumococcal infection	19.68	11.15	12	67314	1233	90559888
Petechiae	19.68	11.15	39	67287	15702	90545419
Psychotic symptom	19.55	11.15	15	67311	2241	90558880
Abdominal tenderness	19.46	11.15	29	67297	9295	90551826
Liver function test abnormal	19.35	11.15	82	67244	50763	90510358
Injection site erythema	19.27	11.15	27	67299	98475	90462646
Polyuria	19.22	11.15	30	67296	10010	90551111
Condition aggravated	19.20	11.15	319	67007	595226	89965895
Depersonalisation/derealisation disorder	19.05	11.15	13	67313	1619	90559502
Iron deficiency anaemia	18.82	11.15	49	67277	23613	90537508
Iridocyclitis	18.74	11.15	18	67308	3643	90557478
Disinhibition	18.72	11.15	11	67315	1057	90560064
Therapeutic product effect decreased	18.68	11.15	125	67201	277446	90283675
Bronchial obstruction	18.65	11.15	13	67313	1676	90559445
Morganella infection	18.64	11.15	10	67316	806	90560315
Hiatus hernia	18.64	11.15	51	67275	25310	90535811
Excessive eye blinking	18.61	11.15	12	67314	1360	90559761
Multiple organ dysfunction syndrome	18.58	11.15	100	67226	68236	90492885
Abdominal pain upper	18.32	11.15	348	66978	332326	90228795
Repetitive speech	18.27	11.15	8	67318	412	90560709
Oscillopsia	18.23	11.15	6	67320	139	90560982
Multiple sclerosis relapse	18.22	11.15	8	67318	52297	90508824
Uveitis	18.22	11.15	38	67288	15865	90545256
Therapeutic response decreased	18.16	11.15	24	67302	89705	90471416
Oesophageal spasm	18.11	11.15	17	67309	3344	90557777
Depression	17.99	11.15	140	67186	300461	90260660
Forced vital capacity abnormal	17.95	11.15	5	67321	64	90561057
Mucosal discolouration	17.88	11.15	9	67317	636	90560485
Hyperleukocytosis	17.86	11.15	10	67316	877	90560244
Tremor	17.78	11.15	183	67143	152990	90408131
Cerebrovascular accident	17.76	11.15	41	67285	123492	90437629
Mycobacterial infection	17.65	11.15	14	67312	2196	90558925
Drug ineffective	17.64	11.15	1223	66103	1383075	89178046
Acute respiratory distress syndrome	17.53	11.15	54	67272	28632	90532489
Lip discolouration	17.49	11.15	9	67317	666	90560455
Gastroenteritis eosinophilic	17.40	11.15	6	67320	161	90560960
Oculomucocutaneous syndrome	17.36	11.15	6	67320	162	90560959
Hysterectomy	17.34	11.15	31	67295	11553	90549568
Upper respiratory tract inflammation	17.32	11.15	15	67311	2657	90558464
Acute generalised exanthematous pustulosis	17.19	11.15	34	67292	13669	90547452
Pruritus	17.17	11.15	525	66801	541000	90020121
Abnormal behaviour	17.12	11.15	46	67280	22582	90538539
Developmental hip dysplasia	17.04	11.15	12	67314	1573	90559548
Agranulocytosis	17.03	11.15	61	67265	34941	90526180
Haemoptysis	17.01	11.15	59	67267	33261	90527860
Eosinophilic pneumonia acute	17.00	11.15	9	67317	706	90560415
Erythrosis	16.92	11.15	5	67321	80	90561041
Transfusion-related acute lung injury	16.76	11.15	6	67320	180	90560941
Pterygium	16.59	11.15	7	67319	329	90560792
Patient isolation	16.53	11.15	4	67322	28	90561093
Oedema	16.23	11.15	85	67241	200210	90360911
Tongue coated	16.20	11.15	12	67314	1701	90559420
Functional residual capacity increased	16.17	11.15	5	67321	94	90561027
Vertebral artery occlusion	16.11	11.15	6	67320	202	90560919
Rales	16.05	11.15	36	67290	15791	90545330
Dermatitis bullous	15.95	11.15	28	67298	10288	90550833
Gynaecological chlamydia infection	15.74	11.15	4	67322	35	90561086
Gingival swelling	15.69	11.15	19	67307	4994	90556127
Joint stiffness	15.66	11.15	21	67305	78021	90483100
Oral discomfort	15.62	11.15	28	67298	10455	90550666
Gastrointestinal disorder	15.62	11.15	119	67207	256568	90304553
Dermatitis exfoliative generalised	15.59	11.15	20	67306	5573	90555548
Bradycardia	15.44	11.15	111	67215	83736	90477385
Skin reaction	15.35	11.15	39	67287	18514	90542607
Blood pressure fluctuation	15.35	11.15	10	67316	52403	90508718
Glossitis	15.35	11.15	16	67310	3571	90557550
Loss of personal independence in daily activities	15.23	11.15	51	67275	136054	90425067
Optic neuropathy	15.22	11.15	14	67312	2684	90558437
Behaviour disorder	15.22	11.15	18	67308	4617	90556504
Disorganised speech	15.18	11.15	12	67314	1873	90559248
Inhibitory drug interaction	15.16	11.15	15	67311	3148	90557973
Decreased appetite	15.16	11.15	193	67133	376347	90184774
Status asthmaticus	15.08	11.15	9	67317	890	90560231
Tongue dry	15.03	11.15	10	67316	1195	90559926
COVID-19 treatment	15.02	11.15	5	67321	120	90561001
Blood catecholamines abnormal	15.01	11.15	3	67323	7	90561114
Iris atrophy	14.83	11.15	5	67321	125	90560996
Tubulointerstitial nephritis	14.83	11.15	47	67279	25296	90535825
Calculus bladder	14.82	11.15	8	67318	653	90560468
Oedema mouth	14.68	11.15	13	67313	2373	90558748
Jejunectomy	14.52	11.15	4	67322	49	90561072
Disorientation	14.42	11.15	68	67258	44046	90517075
Neuropsychiatric symptoms	14.38	11.15	8	67318	693	90560428
Allergy to animal	14.34	11.15	11	67315	1643	90559478
Injection site swelling	14.29	11.15	14	67312	59825	90501296
Prothrombin time ratio decreased	14.24	11.15	9	67317	986	90560135
Device dislocation	14.23	11.15	3	67323	31479	90529642
Acidosis	14.08	11.15	30	67296	12706	90548415
COVID-19	14.05	11.15	71	67255	168772	90392349
Eosinophilic granulomatosis with polyangiitis	14.02	11.15	13	67313	2517	90558604
Sputum discoloured	13.99	11.15	40	67286	20351	90540770
Accidental exposure to product	13.96	11.15	7	67319	42359	90518762
Hypervigilance	13.95	11.15	7	67319	491	90560630
Quadriparesis	13.94	11.15	13	67313	2536	90558585
Keratitis	13.89	11.15	16	67310	3990	90557131
Oral mucosal erythema	13.84	11.15	11	67315	1731	90559390
Hospitalisation	13.65	11.15	49	67277	128051	90433070
Cognitive disorder	13.60	11.15	19	67307	69388	90491733
Fistula discharge	13.60	11.15	9	67317	1066	90560055
Therapy cessation	13.58	11.15	5	67321	36356	90524765
Amblyopia	13.57	11.15	6	67320	316	90560805
Ageusia	13.52	11.15	34	67292	16042	90545079
Intentional product misuse	13.48	11.15	29	67297	89575	90471546
Tendinous contracture	13.46	11.15	5	67321	167	90560954
Hepatosplenic abscess	13.42	11.15	3	67323	14	90561107
Poor feeding infant	13.32	11.15	7	67319	541	90560580
Scab	13.27	11.15	25	67301	9696	90551425
White blood cells urine positive	13.26	11.15	20	67306	6478	90554643
Otitis media fungal	13.25	11.15	3	67323	15	90561106
Affective disorder	13.16	11.15	22	67304	7771	90553350
Rash papular	13.08	11.15	39	67287	20316	90540805
Abdominal discomfort	13.07	11.15	263	67063	477065	90084056
Constipation	13.01	11.15	286	67040	280109	90281012
Axillary pain	13.01	11.15	12	67314	2309	90558812
Nosocomial infection	12.93	11.15	11	67315	1902	90559219
Maternal exposure during pregnancy	12.89	11.15	189	67137	359874	90201247
Carcinoembryonic antigen increased	12.88	11.15	12	67314	2338	90558783
Diarrhoea haemorrhagic	12.83	11.15	26	67300	10637	90550484
Therapy interrupted	12.82	11.15	11	67315	50097	90511024
Cardiac failure	12.79	11.15	131	67195	109365	90451756
Sleep apnoea syndrome	12.71	11.15	52	67274	31695	90529426
Anterograde amnesia	12.63	11.15	7	67319	602	90560519
Metastases to liver	12.51	11.15	3	67323	28804	90532317
Deafness neurosensory	12.48	11.15	20	67306	6821	90554300
Vision blurred	12.43	11.15	131	67195	110162	90450959
Injection site pruritus	12.39	11.15	13	67313	53821	90507300
Bladder spasm	12.37	11.15	11	67315	2019	90559102
Chemotherapeutic drug level increased	12.36	11.15	5	67321	211	90560910
Breast cancer	12.35	11.15	13	67313	53748	90507373
Neoplasm progression	12.35	11.15	9	67317	44477	90516644
Suspiciousness	12.32	11.15	6	67320	395	90560726
Hypomania	12.29	11.15	23	67303	8874	90552247
Flushing	12.21	11.15	30	67296	88461	90472660
Urinary tract infection	12.17	11.15	157	67169	305475	90255646
Staring	12.11	11.15	10	67316	1660	90559461
Tooth disorder	12.09	11.15	4	67322	31086	90530035
C-reactive protein increased	12.04	11.15	82	67244	181307	90379814
Forced expiratory volume decreased	12.03	11.15	18	67308	5790	90555331
Haemangioma	12.01	11.15	13	67313	3029	90558092
Temporal lobe epilepsy	11.98	11.15	6	67320	419	90560702
Gastroenteritis clostridial	11.96	11.15	7	67319	668	90560453
Psychotic behaviour	11.95	11.15	7	67319	669	90560452
Coronary artery disease	11.94	11.15	5	67321	33618	90527503
Hepatic pain	11.87	11.15	14	67312	3581	90557540
Blood glucose increased	11.85	11.15	34	67292	95212	90465909
Fixed eruption	11.80	11.15	10	67316	1720	90559401
Wound infection bacterial	11.79	11.15	7	67319	685	90560436
Lymphadenopathy	11.78	11.15	66	67260	45709	90515412
Aggression	11.74	11.15	45	67281	26623	90534498
Cardiac disorder	11.72	11.15	15	67311	56857	90504264
Obstructive airways disorder	11.67	11.15	44	67282	25825	90535296
Foetal malnutrition	11.65	11.15	4	67322	106	90561015
Vulval haemorrhage	11.63	11.15	3	67323	28	90561093
Restlessness	11.63	11.15	55	67271	35665	90525456
Tachycardia	11.62	11.15	173	67153	157500	90403621
Insomnia	11.56	11.15	327	66999	333147	90227974
Acarodermatitis	11.54	11.15	9	67317	1377	90559744
Arrhythmia	11.54	11.15	62	67264	42270	90518851
Walking aid user	11.50	11.15	6	67320	35500	90525621
Cardiac failure congestive	11.49	11.15	118	67208	98576	90462545
Persecutory delusion	11.44	11.15	13	67313	3195	90557926
Screaming	11.39	11.15	14	67312	3736	90557385
Central nervous system haemorrhage	11.37	11.15	5	67321	260	90560861
Beta 2 microglobulin increased	11.32	11.15	5	67321	263	90560858
Fungal infection	11.31	11.15	62	67264	42599	90518522
Oropharyngeal pain	11.24	11.15	133	67193	115054	90446067
Genital pain	11.21	11.15	7	67319	751	90560370
Partial seizures with secondary generalisation	11.19	11.15	6	67320	483	90560638
Systemic toxicity	11.18	11.15	5	67321	271	90560850

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
Drug interaction	916.97	11.45	1227	41625	265772	42312711
Labelled drug-drug interaction medication error	280.34	11.45	182	42670	15400	42563083
Immunosuppressant drug level increased	186.73	11.45	109	42743	7622	42570861
Death	168.10	11.45	137	42715	471048	42107435
Rhabdomyolysis	124.43	11.45	255	42597	77764	42500719
Drug level increased	122.04	11.45	141	42711	26059	42552424
Drug resistance	102.40	11.45	148	42704	34100	42544383
Immune reconstitution inflammatory syndrome	97.11	11.45	81	42771	10062	42568421
Neuropsychiatric lupus	89.67	11.45	20	42832	63	42578420
Atypical mycobacterial infection	89.56	11.45	38	42814	1328	42577155
Lip swelling	87.82	11.45	102	42750	18951	42559532
Paradoxical drug reaction	86.80	11.45	56	42796	4682	42573801
Electrocardiogram QT prolonged	83.94	11.45	163	42689	47782	42530701
Oesophageal perforation	79.84	11.45	34	42818	1199	42577284
Erythema	74.77	11.45	260	42592	108533	42469950
Acute kidney injury	73.36	11.45	624	42228	366713	42211770
Acute psychosis	73.13	11.45	38	42814	2111	42576372
Soft tissue mass	72.54	11.45	30	42822	982	42577501
Mycobacterium chelonae infection	71.40	11.45	31	42821	1147	42577336
Multimorbidity	71.33	11.45	29	42823	908	42577575
Lip oedema	69.33	11.45	42	42810	3142	42575341
Fatigue	67.07	11.45	220	42632	435421	42143062
Febrile neutropenia	65.92	11.45	54	42798	185649	42392834
Mucocutaneous disorder	64.78	11.45	18	42834	164	42578319
Hypocoagulable state	62.52	11.45	27	42825	986	42577497
Inflammatory marker increased	60.66	11.45	52	42800	6704	42571779
Off label use	60.31	11.45	386	42466	637949	41940534
Contraindicated product prescribed	57.94	11.45	23	42829	676	42577807
Pathogen resistance	55.63	11.45	63	42789	11387	42567096
Ototoxicity	54.08	11.45	32	42820	2293	42576190
Completed suicide	52.23	11.45	16	42836	96449	42482034
Nephropathy toxic	52.12	11.45	74	42778	16764	42561719
Mycobacterial infection	50.02	11.45	32	42820	2636	42575847
Superinfection	49.47	11.45	33	42819	2918	42575565
Drug abuse	48.96	11.45	22	42830	104749	42473734
Stevens-Johnson syndrome	48.43	11.45	83	42769	22095	42556388
Torsade de pointes	48.21	11.45	51	42801	8543	42569940
Drug-induced liver injury	47.27	11.45	113	42739	38160	42540323
Drug eruption	46.04	11.45	83	42769	22992	42555491
Hepatic function abnormal	45.17	11.45	134	42718	51433	42527050
Lung consolidation	43.59	11.45	43	42809	6634	42571849
Pyrexia	43.22	11.45	594	42258	393448	42185035
Mycobacterium avium complex infection	41.70	11.45	30	42822	2997	42575486
Drug reaction with eosinophilia and systemic symptoms	41.38	11.45	114	42738	41961	42536522
Frontal lobe epilepsy	41.19	11.45	9	42843	25	42578458
International normalised ratio increased	41.08	11.45	124	42728	48044	42530439
Potentiating drug interaction	41.01	11.45	41	42811	6427	42572056
Malaise	40.93	11.45	358	42494	211798	42366685
Oropharyngeal blistering	40.65	11.45	13	42839	199	42578284
Transplant failure	40.17	11.45	33	42819	4011	42574472
Product dose omission issue	39.25	11.45	59	42793	154306	42424177
Hospitalisation	39.04	11.45	13	42839	74317	42504166
Phalangeal hypoplasia	38.31	11.45	10	42842	70	42578413
Mania	38.16	11.45	50	42802	10497	42567986
Cardioactive drug level increased	38.04	11.45	23	42829	1714	42576769
Swelling face	36.92	11.45	84	42768	27470	42551013
Pain	36.63	11.45	125	42727	244723	42333760
Blindness cortical	36.62	11.45	15	42837	479	42578004
Face oedema	36.44	11.45	56	42796	13610	42564873
Enterocolitis haemorrhagic	36.29	11.45	19	42833	1072	42577411
Fixed eruption	35.37	11.45	25	42827	2429	42576054
Renal impairment	35.16	11.45	210	42642	110018	42468465
Helicobacter gastritis	35.07	11.45	20	42832	1337	42577146
Productive cough	33.45	11.45	121	42731	51446	42527037
Myopathy	33.39	11.45	54	42798	13707	42564776
Tachycardia foetal	32.91	11.45	13	42839	377	42578106
Liver disorder	32.81	11.45	101	42751	39543	42538940
Erythema multiforme	32.59	11.45	45	42807	9932	42568551
Pseudomembranous colitis	32.03	11.45	26	42826	3107	42575376
Long QT syndrome	31.79	11.45	26	42826	3141	42575342
Inhibitory drug interaction	31.52	11.45	21	42831	1853	42576630
Tongue discolouration	31.09	11.45	18	42834	1238	42577245
Mycobacterial peritonitis	30.69	11.45	10	42842	163	42578320
Pulmonary cavitation	30.47	11.45	18	42834	1286	42577197
Clostridium difficile infection	30.27	11.45	69	42783	22590	42555893
Liver function test abnormal	30.11	11.45	86	42766	32305	42546178
Contraindicated product administered	29.48	11.45	73	42779	25199	42553284
Myocardial infarction	29.06	11.45	50	42802	123959	42454524
Deep vein thrombosis	29.02	11.45	21	42831	76936	42501547
Prostate cancer	28.93	11.45	5	42847	44638	42533845
Cerebrovascular accident	28.92	11.45	33	42819	97127	42481356
Hypoglycaemia	28.84	11.45	128	42724	59726	42518757
Haemoptysis	28.82	11.45	107	42745	46060	42532423
Tongue oedema	28.75	11.45	25	42827	3285	42575198
Urinary tract inflammation	27.17	11.45	10	42842	238	42578245
Hallucination	26.97	11.45	122	42730	57385	42521098
Rash maculovesicular	26.94	11.45	7	42845	48	42578435
Bradyarrhythmia	26.93	11.45	22	42830	2653	42575830
Rash macular	26.63	11.45	55	42797	16836	42561647
Infusion related reaction	26.53	11.45	14	42838	60792	42517691
Substance-induced mood disorder	26.22	11.45	7	42845	54	42578429
Pulmonary physical examination abnormal	26.20	11.45	6	42846	22	42578461
Urticaria	26.18	11.45	145	42707	73891	42504592
Irregular breathing	26.16	11.45	10	42842	265	42578218
Urine alcohol test positive	26.11	11.45	7	42845	55	42578428
Hepatitis cholestatic	25.83	11.45	40	42812	9784	42568699
Diffuse alveolar damage	25.43	11.45	21	42831	2571	42575912
Helicobacter infection	25.15	11.45	21	42831	2611	42575872
Malignant neoplasm progression	25.13	11.45	44	42808	108356	42470127
Acid fast bacilli infection	24.99	11.45	8	42844	123	42578360
Weight increased	24.88	11.45	44	42808	107939	42470544
Injection site phlebitis	24.87	11.45	6	42846	29	42578454
Oesophageal carcinoma	24.83	11.45	39	42813	9657	42568826
Neuromyopathy	24.80	11.45	15	42837	1119	42577364
Dyspnoea	24.59	11.45	600	42252	442021	42136462
Dysgeusia	24.57	11.45	83	42769	34106	42544377
Hypertension	24.55	11.45	86	42766	167118	42411365
Swollen tongue	24.42	11.45	61	42791	21170	42557313
Nasal mucosal disorder	24.35	11.45	8	42844	134	42578349
Deafness bilateral	24.33	11.45	16	42836	1381	42577102
Inappropriate schedule of product administration	24.02	11.45	37	42815	95865	42482618
Toxic epidermal necrolysis	23.88	11.45	70	42782	26680	42551803
Cardiac disorder	23.28	11.45	10	42842	48922	42529561
Myositis	22.96	11.45	48	42804	14818	42563665
Asthenia	22.81	11.45	177	42675	280616	42297867
Purpura	22.77	11.45	42	42810	11837	42566646
Rash maculo-papular	22.64	11.45	86	42766	37417	42541066
Primary hypoparathyroidism	22.18	11.45	6	42846	49	42578434
Urticaria papular	22.15	11.45	7	42845	103	42578380
Mycobacterium fortuitum infection	22.14	11.45	10	42842	407	42578076
Lip erythema	22.02	11.45	7	42845	105	42578378
Congenital foot malformation	21.65	11.45	10	42842	429	42578054
Nosocomial infection	21.56	11.45	15	42837	1421	42577062
Wrong technique in product usage process	21.45	11.45	8	42844	42627	42535856
Lip discolouration	21.18	11.45	8	42844	205	42578278
Deafness neurosensory	20.60	11.45	22	42830	3724	42574759
HIV associated nephropathy	20.43	11.45	9	42843	345	42578138
Hallucinations, mixed	20.36	11.45	21	42831	3414	42575069
Mononucleosis syndrome	20.34	11.45	7	42845	136	42578347
Coronary artery disease	19.81	11.45	15	42837	53705	42524778
Lower respiratory tract infection	19.75	11.45	88	42764	41118	42537365
Rash	19.32	11.45	388	42464	276566	42301917
Foetal distress syndrome	19.25	11.45	13	42839	1173	42577310
Cardiothoracic ratio increased	19.16	11.45	5	42847	35	42578448
Fall	18.95	11.45	148	42704	234372	42344111
Diffuse panbronchiolitis	18.91	11.45	4	42848	9	42578474
Cytokine release syndrome	18.34	11.45	11	42841	44516	42533967
Helicobacter test positive	18.28	11.45	11	42841	813	42577670
Circumoral oedema	18.24	11.45	6	42846	101	42578382
Hepatomegaly	18.14	11.45	38	42814	11747	42566736
Measles	18.05	11.45	8	42844	311	42578172
Coagulopathy	17.90	11.45	56	42796	22106	42556377
Pulmonary embolism	17.90	11.45	61	42791	119551	42458932
Upper respiratory tract inflammation	17.85	11.45	15	42837	1881	42576602
Arthropathy	17.74	11.45	4	42848	29593	42548890
Pleocytosis	17.72	11.45	10	42842	655	42577828
Angioedema	17.63	11.45	87	42765	42390	42536093
Anticonvulsant drug level increased	17.57	11.45	14	42838	1629	42576854
Intentional product misuse	17.38	11.45	22	42830	61878	42516605
Cross sensitivity reaction	17.34	11.45	14	42838	1661	42576822
Conductive deafness	17.18	11.45	9	42843	508	42577975
Penile erythema	16.99	11.45	7	42845	227	42578256
Sitting disability	16.93	11.45	7	42845	229	42578254
Photopsia	16.73	11.45	16	42836	2376	42576107
Jaundice	16.67	11.45	74	42778	34515	42543968
Pneumomediastinum	16.61	11.45	18	42834	3098	42575385
Anamnestic reaction	16.53	11.45	5	42847	63	42578420
Mycobacterium abscessus infection	16.48	11.45	10	42842	750	42577733
Neuropsychiatric symptoms	16.34	11.45	10	42842	762	42577721
Pharyngeal erythema	16.30	11.45	10	42842	765	42577718
Constipation	16.30	11.45	96	42756	162195	42416288
Panic attack	16.29	11.45	35	42817	11010	42567473
Bladder irrigation	16.25	11.45	5	42847	67	42578416
Pneumonia mycoplasmal	16.24	11.45	10	42842	770	42577713
Oral candidiasis	16.16	11.45	41	42811	14364	42564119
Chloasma	16.15	11.45	4	42848	22	42578461
Jarisch-Herxheimer reaction	15.97	11.45	10	42842	793	42577690
Respiratory tract infection bacterial	15.74	11.45	14	42838	1895	42576588
Pearly penile papules	15.63	11.45	3	42849	3	42578480
Sensitisation	15.63	11.45	7	42845	279	42578204
Rales	15.54	11.45	35	42817	11365	42567118
Connective tissue disorder	15.50	11.45	7	42845	285	42578198
Rheumatoid arthritis	15.46	11.45	12	42840	42428	42536055
Derealisation	15.40	11.45	10	42842	845	42577638
Lymphocyte stimulation test positive	15.39	11.45	9	42843	631	42577852
Oculomucocutaneous syndrome	15.39	11.45	6	42846	168	42578315
Blood creatine phosphokinase increased	15.33	11.45	92	42760	48246	42530237
CD4/CD8 ratio decreased	15.32	11.45	4	42848	28	42578455
Repetitive speech	15.32	11.45	5	42847	82	42578401
Pharyngeal swelling	15.29	11.45	18	42834	3389	42575094
Renal ischaemia	15.29	11.45	13	42839	1657	42576826
Symmetrical drug-related intertriginous and flexural exanthema	15.26	11.45	10	42842	858	42577625
Blood pressure increased	15.23	11.45	52	42800	101876	42476607
Hepatosplenomegaly	15.19	11.45	21	42831	4639	42573844
Ataxia	15.16	11.45	43	42809	16082	42562401
School refusal	15.08	11.45	4	42848	30	42578453
Depersonalisation/derealisation disorder	14.98	11.45	9	42843	663	42577820
Skin wrinkling	14.92	11.45	8	42844	474	42578009
Granulomatous dermatitis	14.90	11.45	7	42845	312	42578171
Cholestasis	14.85	11.45	69	42783	32810	42545673
Agitation	14.77	11.45	113	42739	64201	42514282
Injection site pain	14.76	11.45	22	42830	57776	42520707
Acinetobacter bacteraemia	14.72	11.45	6	42846	189	42578294
Bronchopulmonary aspergillosis	14.70	11.45	48	42804	19381	42559102
Delusion	14.55	11.45	40	42812	14694	42563789
Psychotic disorder	14.47	11.45	63	42789	29145	42549338
Myocardial ischaemia	14.46	11.45	45	42807	17717	42560766
Urinary bladder rupture	14.44	11.45	5	42847	99	42578384
Mucosal inflammation	14.44	11.45	17	42835	49357	42529126
Blood glucose increased	14.43	11.45	33	42819	73666	42504817
Transient ischaemic attack	14.37	11.45	8	42844	33731	42544752
Oral mucosal blistering	14.31	11.45	15	42837	2486	42575997
Antineutrophil cytoplasmic antibody	14.25	11.45	4	42848	38	42578445
Intentional product use issue	14.19	11.45	32	42820	71801	42506682
Delusional disorder, persecutory type	14.19	11.45	7	42845	348	42578135
Dysphagia	14.12	11.45	123	42729	72596	42505887
Cutaneous vasculitis	14.10	11.45	25	42827	6835	42571648
Vanishing bile duct syndrome	14.01	11.45	13	42839	1858	42576625
Pneumonia bacterial	13.94	11.45	41	42811	15651	42562832
Clumsiness	13.84	11.45	13	42839	1887	42576596
Intravascular haemolysis	13.82	11.45	8	42844	550	42577933
Infusion site thrombosis	13.78	11.45	5	42847	114	42578369
Chillblains	13.72	11.45	4	42848	44	42578439
Loss of personal independence in daily activities	13.68	11.45	18	42834	49798	42528685
Hypo HDL cholesterolaemia	13.56	11.45	3	42849	9	42578474
Eosinophil count increased	13.52	11.45	32	42820	10731	42567752
Blood urine	13.51	11.45	8	42844	574	42577909
Abdominal wall haematoma	13.41	11.45	14	42838	2308	42576175
Pneumothorax	13.40	11.45	53	42799	23490	42554993
Pulmonary haemorrhage	13.37	11.45	33	42819	11364	42567119
Necrosis	13.36	11.45	24	42828	6627	42571856
Toxic neuropathy	13.35	11.45	8	42844	587	42577896
Cardiomegaly	13.21	11.45	42	42810	16724	42561759
Stress	13.17	11.45	15	42837	44197	42534286
Hypoglycaemic coma	13.16	11.45	15	42837	2729	42575754
Therapeutic product effect decreased	13.12	11.45	12	42840	39138	42539345
Speech disorder	13.07	11.45	61	42791	29060	42549423
Induration	13.05	11.45	10	42842	1100	42577383
No adverse event	13.03	11.45	12	42840	39009	42539474
Product use issue	12.99	11.45	37	42815	76714	42501769
Tongue exfoliation	12.89	11.45	3	42849	12	42578471
Paradoxical pain	12.89	11.45	3	42849	12	42578471
Paraparesis	12.89	11.45	13	42839	2058	42576425
Disease progression	12.87	11.45	88	42764	143568	42434915
Meningitis aseptic	12.85	11.45	19	42833	4463	42574020
Histoplasmosis disseminated	12.79	11.45	13	42839	2078	42576405
Atrial fibrillation	12.76	11.45	85	42767	139508	42438975
Corynebacterium infection	12.74	11.45	9	42843	874	42577609
Laryngeal inflammation	12.72	11.45	5	42847	143	42578340
Shoulder deformity	12.70	11.45	3	42849	13	42578470
Disseminated intravascular coagulation	12.68	11.45	54	42798	24740	42553743
Necrotising panniculitis	12.65	11.45	4	42848	59	42578424
Biopsy liver abnormal	12.63	11.45	5	42847	146	42578337
Mononeuropathy	12.58	11.45	6	42846	277	42578206
Heart rate decreased	12.48	11.45	11	42841	36521	42541962
Leukoplakia oral	12.38	11.45	5	42847	154	42578329
pH body fluid increased	12.29	11.45	4	42848	65	42578418
Hypophosphataemia	12.22	11.45	3	42849	20942	42557541
Arthralgia	12.09	11.45	140	42712	205098	42373385
Thrombocytopenia	12.07	11.45	263	42589	190016	42388467
Chronic kidney disease	12.04	11.45	18	42834	47223	42531260
Acute respiratory distress syndrome	12.02	11.45	61	42791	30047	42548436
Blood pressure fluctuation	12.02	11.45	6	42846	26902	42551581
Cardiac valve sclerosis	12.01	11.45	4	42848	70	42578413
Adrenoleukodystrophy	11.96	11.45	4	42848	71	42578412
Psoriasis	11.93	11.45	19	42833	48585	42529898
Haemorrhage subcutaneous	11.91	11.45	14	42838	2632	42575851
Respiratory papilloma	11.89	11.45	3	42849	18	42578465
Skin exfoliation	11.87	11.45	77	42775	41476	42537007
Acute hepatic failure	11.87	11.45	41	42811	17032	42561451
Bronchospasm	11.77	11.45	34	42818	12851	42565632
Arthritis	11.75	11.45	15	42837	42050	42536433
Neurosis	11.70	11.45	5	42847	178	42578305
Hepatocellular injury	11.67	11.45	51	42801	23627	42554856
Eosinophilic pneumonia	11.65	11.45	19	42833	4855	42573628
Rash papular	11.60	11.45	32	42820	11779	42566704
Therapy interrupted	11.49	11.45	4	42848	22246	42556237
Atypical mycobacterium test positive	11.47	11.45	4	42848	81	42578402

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
Drug interaction	1923.72	11.05	2294	96460	497889	109992656
Labelled drug-drug interaction medication error	468.14	11.05	304	98450	28998	110461547
Swollen tongue	404.89	11.05	374	98380	59988	110430557
Swelling face	356.69	11.05	426	98328	91895	110398650
Chronic sinusitis	349.45	11.05	239	98515	24845	110465700
Female genital tract fistula	297.77	11.05	185	98569	16334	110474211
Lip swelling	270.42	11.05	277	98477	50390	110440155
Paraesthesia oral	268.24	11.05	230	98524	33441	110457104
Angioedema	260.06	11.05	377	98377	98123	110392422
Erythema	242.01	11.05	688	98066	290759	110199786
Vaginal flatulence	241.93	11.05	145	98609	11999	110478546
Rhabdomyolysis	232.17	11.05	399	98355	120002	110370543
Macular degeneration	227.71	11.05	174	98580	21485	110469060
Immunosuppressant drug level increased	223.28	11.05	136	98618	11588	110478957
Dysgeusia	205.66	11.05	282	98472	69703	110420842
Proctitis	202.59	11.05	147	98607	16780	110473765
Oral candidiasis	200.49	11.05	223	98531	44537	110446008
Electrocardiogram QT prolonged	196.96	11.05	351	98403	108609	110381936
Radiculopathy	195.97	11.05	152	98602	19184	110471361
Death	194.00	11.05	203	98551	698666	109791879
Vaginal discharge	192.96	11.05	146	98608	17762	110472783
Drug level increased	190.51	11.05	224	98530	47495	110443050
Drug resistance	182.24	11.05	238	98516	56136	110434409
Erythema multiforme	178.06	11.05	149	98605	20948	110469597
Mania	175.78	11.05	147	98607	20649	110469896
Arthropathy	173.79	11.05	25	98729	287497	110203048
Pemphigus	172.31	11.05	4	98750	214566	110275979
Hand deformity	168.41	11.05	6	98748	218500	110272045
Synovitis	165.27	11.05	24	98730	274068	110216477
Completed suicide	161.61	11.05	15	98739	242366	110248179
Systemic lupus erythematosus	156.33	11.05	21	98733	254317	110236228
Joint swelling	155.67	11.05	102	98652	442743	110047802
Malaise	150.17	11.05	1070	97684	670749	109819796
Fatigue	148.55	11.05	572	98182	1215386	109275159
Drug eruption	148.36	11.05	210	98544	53449	110437096
Drug hypersensitivity	142.45	11.05	789	97965	453301	110037244
Loss of employment	138.23	11.05	65	98689	3279	110487266
Duodenal ulcer perforation	136.52	11.05	5	98749	177695	110312850
Acute kidney injury	136.17	11.05	1002	97752	634428	109856117
Immune reconstitution inflammatory syndrome	135.70	11.05	114	98640	16112	110474433
Alopecia	135.12	11.05	79	98675	364674	110125871
Acute psychosis	132.85	11.05	72	98682	4915	110485630
Rheumatoid arthritis	132.26	11.05	51	98703	299562	110190983
Procedural pain	132.18	11.05	161	98593	35404	110455141
Paradoxical drug reaction	130.74	11.05	91	98663	9726	110480819
Wound	129.29	11.05	26	98728	234411	110256134
Ototoxicity	125.20	11.05	65	98689	4066	110486479
Dysphonia	123.80	11.05	234	98520	75695	110414850
Glossodynia	123.72	11.05	24	98730	221980	110268565
Psoriatic arthropathy	121.49	11.05	16	98738	196745	110293800
Pericarditis	119.37	11.05	25	98729	219089	110271456
Muscle injury	111.61	11.05	3	98751	140804	110349741
Stevens-Johnson syndrome	111.53	11.05	171	98583	46730	110443815
Irritable bowel syndrome	107.24	11.05	11	98743	164204	110326341
Lip oedema	107.22	11.05	73	98681	7527	110483018
Pathogen resistance	106.04	11.05	103	98651	17569	110472976
Enterocolitis haemorrhagic	105.75	11.05	50	98704	2554	110487991
Impaired healing	102.04	11.05	25	98729	196692	110293853
Folliculitis	100.29	11.05	15	98739	167638	110322907
Type 2 diabetes mellitus	99.09	11.05	19	98735	177213	110313332
Long QT syndrome	94.83	11.05	66	98688	7052	110483493
Hallucination	94.52	11.05	250	98504	101182	110389363
Mobility decreased	94.35	11.05	47	98707	237375	110253170
General physical health deterioration	92.58	11.05	148	98606	425147	110065398
Torsade de pointes	91.70	11.05	107	98647	22493	110468052
Blood cholesterol increased	91.06	11.05	26	98728	184759	110305786
Tongue discolouration	89.88	11.05	52	98702	4029	110486516
Atypical mycobacterial infection	88.83	11.05	45	98709	2673	110487872
Pneumatosis intestinalis	84.15	11.05	66	98688	8463	110482082
Potentiating drug interaction	83.62	11.05	75	98679	11568	110478977
Febrile neutropenia	83.30	11.05	96	98658	316671	110173874
International normalised ratio increased	82.00	11.05	215	98539	86557	110403988
Psychotic disorder	81.81	11.05	156	98598	50781	110439764
Pyrexia	81.09	11.05	1187	97567	897078	109593467
Rash maculo-papular	80.72	11.05	194	98560	74028	110416517
Toxic epidermal necrolysis	79.39	11.05	164	98590	56563	110433982
Product dose omission issue	78.84	11.05	103	98651	321679	110168866
Weight increased	77.11	11.05	162	98592	419482	110071063
Intentional product use issue	76.84	11.05	65	98689	247841	110242704
Hypoglycaemia	76.49	11.05	253	98501	115851	110374694
Ill-defined disorder	75.58	11.05	23	98731	156830	110333715
Tongue oedema	75.29	11.05	61	98693	8195	110482350
Maternal exposure during pregnancy	75.19	11.05	70	98684	254813	110235732
Nephropathy toxic	75.14	11.05	107	98647	27371	110463174
Agitation	75.06	11.05	247	98507	112804	110377741
Salpingo-oophorectomy unilateral	74.40	11.05	28	98726	803	110489742
Oesophageal perforation	74.02	11.05	34	98720	1625	110488920
Palpitations	73.19	11.05	309	98445	158903	110331642
Drug ineffective for unapproved indication	73.10	11.05	230	98524	102608	110387937
Joint range of motion decreased	70.39	11.05	12	98742	121820	110368725
Myopathy	69.44	11.05	98	98656	24862	110465683
Superinfection	68.84	11.05	50	98704	5713	110484832
Face oedema	68.54	11.05	114	98640	33355	110457190
Bursitis	68.37	11.05	16	98738	129902	110360643
Pain	67.92	11.05	537	98217	954418	109536127
Mycobacterium chelonae infection	67.41	11.05	39	98715	3021	110487524
Lip dry	67.20	11.05	6	98748	100077	110390468
Soft tissue mass	67.09	11.05	31	98723	1502	110489043
Psoriasis	66.60	11.05	21	98733	139972	110350573
Sinusitis fungal	66.20	11.05	37	98717	2683	110487862
Injury	64.73	11.05	39	98715	177226	110313319
Discomfort	64.47	11.05	58	98696	214649	110275896
Musculoskeletal stiffness	64.10	11.05	94	98660	279728	110210817
Rash macular	64.01	11.05	120	98634	38566	110451979
Mycobacterium avium complex infection	63.50	11.05	48	98706	5829	110484716
Hepatic function abnormal	62.81	11.05	199	98555	89096	110401449
Frequent bowel movements	62.52	11.05	172	98582	71218	110419327
Myositis	62.41	11.05	105	98649	31011	110459534
Musculoskeletal pain	61.77	11.05	44	98710	182979	110307566
Hypoaesthesia	61.39	11.05	117	98637	314106	110176439
Fall	61.14	11.05	304	98450	603178	109887367
Helicobacter infection	61.02	11.05	44	98710	181833	110308712
Hallucinations, mixed	60.46	11.05	55	98699	8638	110481907
Sputum increased	60.00	11.05	46	98708	5705	110484840
Obesity	59.56	11.05	14	98740	113337	110377208
Peripheral swelling	59.35	11.05	175	98579	403859	110086686
Wound infection	59.16	11.05	8	98746	96457	110394088
Mucocutaneous disorder	58.95	11.05	17	98737	204	110490341
Sciatica	58.27	11.05	7	98747	92392	110398153
Multimorbidity	58.11	11.05	28	98726	1492	110489053
Contraindicated product prescribed	58.02	11.05	32	98722	2261	110488284
Pneumonia mycoplasmal	57.41	11.05	29	98725	1712	110488833
Dyspnoea	56.53	11.05	1339	97415	1105533	109385012
Cardioactive drug level increased	56.46	11.05	38	98716	3844	110486701
Inflammatory marker increased	56.21	11.05	67	98687	14402	110476143
Jaundice	56.19	11.05	147	98607	59089	110431456
Liver function test abnormal	55.38	11.05	161	98593	68789	110421756
Mycobacterium abscessus infection	55.04	11.05	28	98726	1678	110488867
Paranoia	53.78	11.05	82	98672	22292	110468253
Haematochezia	52.92	11.05	224	98530	115300	110375245
Renal impairment	52.78	11.05	318	98436	188127	110302418
Pharyngeal swelling	52.24	11.05	59	98695	11973	110478572
Clostridium difficile infection	52.17	11.05	132	98622	51997	110438548
Rash	52.08	11.05	1025	97729	819939	109670606
Mycobacterial infection	52.03	11.05	38	98716	4379	110486166
Embolism venous	52.01	11.05	40	98714	4983	110485562
Prescribed overdose	51.99	11.05	8	98746	87573	110402972
Lung consolidation	51.79	11.05	55	98699	10421	110480124
Hepatic enzyme increased	51.58	11.05	133	98621	320759	110169786
Pseudomembranous colitis	51.58	11.05	44	98710	6347	110484198
Purpura	51.19	11.05	84	98670	24304	110466241
Drug abuse	50.82	11.05	50	98704	177361	110313184
Fibromyalgia	50.32	11.05	47	98707	170862	110319683
Infection	50.26	11.05	161	98593	362039	110128506
Grip strength decreased	48.34	11.05	7	98747	80167	110410378
Colitis	48.11	11.05	200	98554	102123	110388422
Deafness bilateral	48.01	11.05	30	98724	2674	110487871
Colitis ulcerative	47.78	11.05	165	98589	77198	110413347
Oral mucosal blistering	47.14	11.05	46	98708	7888	110482657
Arthritis	47.12	11.05	48	98706	167538	110323007
Eosinophilic pneumonia	46.92	11.05	44	98710	7183	110483362
Arthralgia	46.69	11.05	458	98296	779174	109711371
Injection site pain	46.66	11.05	54	98700	177868	110312677
Hypocoagulable state	46.40	11.05	29	98725	2586	110487959
Rectal haemorrhage	46.36	11.05	221	98533	119612	110370933
Product quality issue	46.03	11.05	7	98747	77292	110413253
Hallucination, visual	45.75	11.05	106	98648	39499	110451046
Drug reaction with eosinophilia and systemic symptoms	45.51	11.05	169	98585	81926	110408619
Red blood cell sedimentation rate increased	44.60	11.05	8	98746	78294	110412251
Fixed eruption	44.48	11.05	34	98720	4198	110486347
Gait inability	44.44	11.05	34	98720	136342	110354203
Nightmare	43.78	11.05	103	98651	38760	110451785
Stomatitis	43.43	11.05	112	98642	270130	110220415
Knee arthroplasty	43.32	11.05	4	98750	64944	110425601
Throat tightness	42.44	11.05	93	98661	33396	110457149
Lower limb fracture	42.27	11.05	8	98746	75340	110415205
Blood creatine phosphokinase increased	41.82	11.05	152	98602	72925	110417620
Cough	41.47	11.05	610	98144	461031	110029514
Hepatocellular injury	41.39	11.05	119	98635	50523	110440022
Adverse event	41.05	11.05	23	98731	108786	110381759
Abdominal pain	40.79	11.05	664	98090	512325	109978220
Productive cough	40.78	11.05	206	98548	114099	110376446
Drug-induced liver injury	40.49	11.05	213	98541	119854	110370691
Pharyngeal erythema	40.19	11.05	25	98729	2210	110488335
Frontal lobe epilepsy	39.95	11.05	9	98745	35	110490510
Jarisch-Herxheimer reaction	39.34	11.05	20	98734	1197	110489348
Coagulopathy	39.28	11.05	102	98652	40809	110449736
Hypercholesterolaemia	39.16	11.05	16	98738	90821	110399724
Autoimmune disorder	38.83	11.05	6	98748	65477	110425068
Road traffic accident	38.68	11.05	24	98730	107374	110383171
Rash erythematous	38.50	11.05	160	98594	81672	110408873
Pain in extremity	38.31	11.05	266	98488	486852	110003693
Haemoptysis	37.98	11.05	145	98609	71209	110419336
Injection site reaction	37.90	11.05	16	98738	89054	110401491
Blepharospasm	37.61	11.05	3	98751	54848	110435697
Labelled drug-drug interaction issue	36.76	11.05	30	98724	4071	110486474
Candida infection	36.55	11.05	110	98644	47899	110442646
Product use issue	36.31	11.05	149	98605	311546	110178999
Deafness	35.94	11.05	76	98678	26633	110463912
Urticaria	35.92	11.05	439	98315	318418	110172127
Inhibitory drug interaction	35.79	11.05	32	98722	4915	110485630
Palatal oedema	35.69	11.05	21	98733	1679	110488866
Live birth	35.69	11.05	9	98745	69475	110421070
Brief psychotic disorder with marked stressors	35.42	11.05	13	98741	347	110490198
Hepatic steatosis	35.41	11.05	110	98644	48721	110441824
Memory impairment	35.32	11.05	77	98677	196867	110293678
Nosocomial infection	34.28	11.05	26	98728	3173	110487372
Infusion related reaction	34.13	11.05	200	98554	380962	110109583
Cerebrovascular accident	34.09	11.05	69	98685	181215	110309330
Tinnitus	33.86	11.05	125	98629	60415	110430130
Pharyngeal oedema	33.69	11.05	56	98698	16372	110474173
Hospitalisation	33.47	11.05	47	98707	142446	110348099
Hip arthroplasty	33.35	11.05	5	98749	55808	110434737
Asthenia	33.21	11.05	425	98329	688574	109801971
Hepatic ischaemia	33.15	11.05	18	98736	1233	110489312
Dermatitis allergic	33.01	11.05	65	98689	21659	110468886
Rales	31.69	11.05	69	98685	24670	110465875
Deafness neurosensory	31.68	11.05	41	98713	9578	110480967
Malignant neoplasm progression	31.51	11.05	68	98686	174499	110316046
Back injury	31.39	11.05	3	98751	47396	110443149
Euphoric mood	31.25	11.05	39	98715	8788	110481757
Weber tuning fork test abnormal	31.06	11.05	9	98745	110	110490435
Dyspepsia	30.95	11.05	283	98471	190682	110299863
Diffuse alveolar damage	30.92	11.05	27	98727	4020	110486525
Depersonalisation/derealisation disorder	30.89	11.05	21	98733	2160	110488385
Osteoarthritis	30.65	11.05	74	98680	182549	110307996
Transplant failure	30.40	11.05	31	98723	5604	110484941
Swelling	29.95	11.05	187	98567	350854	110139691
Neuropsychiatric symptoms	29.94	11.05	17	98737	1271	110489274
Helicobacter gastritis	29.68	11.05	22	98732	2594	110487951
Pregnancy	29.56	11.05	5	98749	51062	110439483
Drug monitoring procedure not performed	29.43	11.05	17	98737	1313	110489232
Blood pressure fluctuation	29.42	11.05	15	98739	74809	110415736
Pressure of speech	29.41	11.05	17	98737	1315	110489230
Oropharyngeal blistering	29.35	11.05	15	98739	908	110489637
Hypertension	29.10	11.05	303	98451	509781	109980764
Substance-induced mood disorder	28.97	11.05	8	98746	81	110490464
Hypersensitivity	28.84	11.05	514	98240	403484	110087061
Injection site erythema	28.79	11.05	25	98729	94151	110396394
Neck pain	28.53	11.05	41	98713	123089	110367456
Mycobacterial peritonitis	28.52	11.05	10	98744	233	110490312
Intentional product misuse	28.17	11.05	47	98707	132857	110357688
Abnormal dreams	28.16	11.05	45	98709	12735	110477810
Oculomucocutaneous syndrome	28.12	11.05	11	98743	351	110490194
Urine alcohol test positive	27.89	11.05	7	98747	47	110490498
Lung disorder	27.87	11.05	76	98678	179971	110310574
Night sweats	27.83	11.05	48	98706	133935	110356610
Muscle relaxant therapy	27.79	11.05	9	98745	163	110490382
Cytokine release syndrome	27.79	11.05	14	98740	70292	110420253
Tongue exfoliation	27.64	11.05	9	98745	166	110490379
Rash maculovesicular	27.40	11.05	7	98747	51	110490494
Hepatitis cholestatic	27.22	11.05	53	98701	17513	110473032
Muscle spasms	27.04	11.05	142	98612	278015	110212530
Pulmonary physical examination abnormal	26.91	11.05	6	98748	22	110490523
Delusional perception	26.82	11.05	11	98743	398	110490147
Multiple organ dysfunction syndrome	26.73	11.05	229	98525	151481	110339064
Psychomotor hyperactivity	26.48	11.05	57	98697	20220	110470325
Disease recurrence	26.40	11.05	116	98638	60668	110429877
Eosinophilic pneumonia acute	25.91	11.05	17	98737	1648	110488897
No adverse event	25.91	11.05	17	98737	73822	110416723
Exposure during pregnancy	25.67	11.05	71	98683	167353	110323192
Serum sickness-like reaction	25.62	11.05	13	98741	775	110489770
COVID-19	25.60	11.05	122	98632	244938	110245607
Bipolar I disorder	25.45	11.05	19	98735	2264	110488281
Antimicrobial susceptibility test intermediate	25.41	11.05	6	98748	30	110490515
Petechiae	25.40	11.05	61	98693	23256	110467289
Acute hepatic failure	25.39	11.05	81	98673	36387	110454158
Therapeutic product effect decreased	25.30	11.05	122	98632	244194	110246351
Mouth swelling	25.25	11.05	32	98722	7322	110483223
Skin lesion	25.11	11.05	102	98652	51529	110439016
Loss of personal independence in daily activities	25.00	11.05	61	98693	149959	110340586
Cardiac disorder	24.87	11.05	19	98735	76261	110414284
Multiple sclerosis relapse	24.87	11.05	7	98747	50233	110440312
Abnormal behaviour	24.75	11.05	84	98670	38955	110451590
Lymphocyte stimulation test positive	24.71	11.05	14	98740	1042	110489503
Mycobacterium fortuitum infection	24.69	11.05	11	98743	489	110490056
Bradyarrhythmia	24.56	11.05	26	98728	4908	110485637
Photopsia	24.51	11.05	29	98725	6185	110484360
Injection site phlebitis	24.35	11.05	8	98746	152	110490393
Mouth ulceration	24.13	11.05	96	98658	48042	110442503
Onychomycosis	24.09	11.05	3	98751	38528	110452017
Pulmonary cavitation	23.88	11.05	18	98736	2176	110488369
Nasopharyngitis	23.83	11.05	231	98523	394130	110096415
Bone erosion	23.82	11.05	6	98748	46365	110444180
Diastolic dysfunction	23.74	11.05	41	98713	12363	110478182
Dermatitis bullous	23.73	11.05	50	98704	17479	110473066
Urinary tract inflammation	23.73	11.05	10	98744	388	110490157
Anaphylactic reaction	23.65	11.05	179	98575	114121	110376424
Lupus-like syndrome	23.60	11.05	4	98750	40788	110449757
Upper respiratory tract inflammation	23.50	11.05	24	98730	4347	110486198
Coronary artery disease	23.19	11.05	18	98736	71672	110418873
Pruritus	23.03	11.05	681	98073	580879	109909666
Diarrhoea	22.97	11.05	1240	97514	1138265	109352280
Blood pressure increased	22.88	11.05	136	98618	258237	110232308
Conductive deafness	22.67	11.05	9	98745	299	110490246
Primary hypoparathyroidism	22.57	11.05	6	98748	52	110490493
Nausea	22.45	11.05	1332	97422	1234358	109256187
COVID-19 treatment	22.27	11.05	10	98744	453	110490092
Inflammation	22.10	11.05	93	98661	193145	110297400
Labile blood pressure	21.99	11.05	18	98736	2453	110488092
Injection site swelling	21.99	11.05	14	98740	61776	110428769
Acute respiratory distress syndrome	21.95	11.05	100	98654	53098	110437447
Otitis media fungal	21.89	11.05	5	98749	21	110490524
Hepatic cirrhosis	21.85	11.05	17	98737	67609	110422936
Acid fast bacilli infection	21.71	11.05	8	98746	216	110490329
Mononucleosis syndrome	21.71	11.05	8	98746	216	110490329
Rash papular	21.67	11.05	64	98690	27575	110462970
Symmetrical drug-related intertriginous and flexural exanthema	21.62	11.05	16	98738	1881	110488664
Tongue necrosis	21.55	11.05	7	98747	128	110490417
Hallucination, auditory	21.54	11.05	62	98692	26335	110464210
Therapeutic response decreased	21.51	11.05	33	98721	96466	110394079
Trichoglossia	21.50	11.05	12	98742	868	110489677
Hepatitis fulminant	21.47	11.05	32	98722	8528	110482017
HIV associated nephropathy	21.26	11.05	9	98745	353	110490192
Disorganised speech	21.23	11.05	20	98734	3283	110487262
Intentional overdose	21.21	11.05	55	98699	132446	110358099
Disseminated mycobacterium avium complex infection	21.20	11.05	10	98744	508	110490037
Ataxia	21.07	11.05	67	98687	30041	110460504
Urinary tract infection	21.05	11.05	188	98566	326094	110164451
Device issue	20.85	11.05	3	98751	34532	110456013
Bronchostenosis	20.78	11.05	12	98742	926	110489619
Heart rate decreased	20.75	11.05	26	98728	82730	110407815
Sleep disorder	20.68	11.05	99	98655	198545	110292000
Nasal polyps	20.67	11.05	40	98714	13160	110477385
Oesophageal carcinoma	20.64	11.05	37	98717	11487	110479058
Contusion	20.58	11.05	123	98631	233238	110257307
Oesophageal pain	20.35	11.05	24	98730	5101	110485444
Myelosuppression	20.33	11.05	33	98721	94307	110396238
Prescribed underdose	20.29	11.05	17	98737	65157	110425388
Neuromyopathy	20.27	11.05	15	98739	1764	110488781
Vomiting	19.95	11.05	999	97755	909676	109580869
Neoplasm progression	19.92	11.05	17	98737	64578	110425967
Acinetobacter infection	19.90	11.05	20	98734	3553	110486992
Inappropriate schedule of product administration	19.76	11.05	104	98650	203533	110287012
Agranulocytosis	19.75	11.05	108	98646	61652	110428893
Anticonvulsant drug level increased	19.72	11.05	18	98736	2840	110487705
Transaminases increased	19.70	11.05	110	98644	63280	110427265
Gingival swelling	19.59	11.05	24	98730	5306	110485239
Skin reaction	19.57	11.05	52	98702	21092	110469453
Bleeding time prolonged	19.55	11.05	13	98741	1289	110489256
Urticaria papular	19.52	11.05	8	98746	289	110490256
Metastases to liver	19.34	11.05	4	98750	35382	110455163
Penile erythema	19.32	11.05	7	98747	180	110490365
Ocular toxicity	19.23	11.05	13	98741	1325	110489220
Irregular breathing	19.18	11.05	10	98744	631	110489914
Prostate cancer	19.09	11.05	5	98749	37636	110452909
Respiratory failure	19.09	11.05	284	98470	215048	110275497
Retinitis	19.08	11.05	3	98751	32324	110458221
Toxic skin eruption	19.05	11.05	61	98693	27454	110463091
Hepatosplenomegaly	19.00	11.05	27	98727	6892	110483653
Hypervigilance	18.95	11.05	10	98744	647	110489898
Device dislocation	18.58	11.05	3	98751	31701	110458844
Hypomania	18.57	11.05	33	98721	10177	110480368
Respiratory symptom	18.37	11.05	41	98713	14904	110475641
Disorientation	18.35	11.05	117	98637	70554	110419991
Oropharyngeal discomfort	18.30	11.05	33	98721	10294	110480251
Abdominal wall haematoma	18.29	11.05	24	98730	5681	110484864
Thought insertion	18.26	11.05	5	98749	49	110490496
Respiratory tract infection bacterial	18.22	11.05	16	98738	2400	110488145
Pneumothorax	18.20	11.05	71	98683	35214	110455331
Cholestasis	18.13	11.05	109	98645	64409	110426136
Therapy interrupted	18.13	11.05	11	98743	49811	110440734
Panic attack	18.11	11.05	62	98692	28878	110461667
Tubulointerstitial nephritis	18.08	11.05	96	98658	54188	110436357
Disseminated intravascular coagulation	18.08	11.05	79	98675	41207	110449338
Gait disturbance	18.07	11.05	160	98594	278048	110212497
Myalgia	18.06	11.05	289	98465	222092	110268453
Palmar-plantar erythrodysaesthesia syndrome	18.05	11.05	7	98747	41018	110449527
Granulomatous dermatitis	18.05	11.05	9	98745	517	110490028
Skin exfoliation	17.98	11.05	137	98617	87514	110403031
Muscle necrosis	17.93	11.05	14	98740	1783	110488762
Sinusitis	17.82	11.05	174	98580	296514	110194031
Meningitis streptococcal	17.79	11.05	7	98747	227	110490318
Acute generalised exanthematous pustulosis	17.79	11.05	51	98703	21613	110468932
Staphylococcal scalded skin syndrome	17.74	11.05	9	98745	536	110490009
Derealisation	17.71	11.05	15	98739	2143	110488402
Therapy cessation	17.62	11.05	9	98745	44848	110445697
Chromaturia	17.59	11.05	62	98692	29298	110461247
Haemostasis	17.57	11.05	9	98745	547	110489998
Anamnestic reaction	17.49	11.05	5	98749	58	110490487
Blister	17.44	11.05	125	98629	227251	110263294
Treatment failure	17.33	11.05	161	98593	277073	110213472
Bladder irrigation	17.26	11.05	5	98749	61	110490484
Clumsiness	17.21	11.05	19	98735	3761	110486784
Hysterectomy	17.10	11.05	28	98726	8086	110482459
Migraine	17.03	11.05	87	98667	171565	110318980
Tongue haematoma	17.00	11.05	7	98747	256	110490289
Joint stiffness	16.99	11.05	21	98733	67222	110423323
Tongue dry	16.86	11.05	12	98742	1328	110489217
Legionella test positive	16.78	11.05	4	98750	21	110490524
Helicobacter test positive	16.76	11.05	12	98742	1341	110489204
Wrong technique in product usage process	16.62	11.05	33	98721	87315	110403230
Joint dislocation	16.49	11.05	5	98749	34185	110456360
Coeliac disease	16.47	11.05	9	98745	43178	110447367
Repetitive speech	16.42	11.05	8	98746	437	110490108
Injection site pruritus	16.41	11.05	13	98741	51245	110439300
Liver function test increased	16.39	11.05	34	98720	88514	110402031
Phalangeal hypoplasia	16.33	11.05	4	98750	24	110490521
Depression	16.29	11.05	193	98561	317142	110173403
Blood glucose increased	16.27	11.05	62	98692	132434	110358111
Hepatomegaly	16.23	11.05	49	98705	21365	110469180
Iridocyclitis	16.19	11.05	22	98732	5386	110485159
Oral discomfort	16.17	11.05	33	98721	11278	110479267
Transient ischaemic attack	16.15	11.05	20	98734	63962	110426583
Hypersensitivity vasculitis	16.08	11.05	25	98729	6912	110483633
Mental status changes	16.06	11.05	27	98727	76095	110414450
Muscle spasticity	16.02	11.05	6	98748	35909	110454636
Pearly penile papules	15.99	11.05	3	98751	3	110490542
Paraparesis	15.88	11.05	20	98734	4546	110485999
Pneumomediastinum	15.86	11.05	21	98733	5015	110485530
Sitting disability	15.86	11.05	8	98746	471	110490074
Delusion	15.84	11.05	52	98702	23703	110466842
Hypoglycaemic coma	15.80	11.05	22	98732	5511	110485034
Cutaneous vasculitis	15.73	11.05	35	98719	12694	110477851
Motion sickness	15.68	11.05	11	98743	1190	110489355
Lymphadenopathy	15.55	11.05	104	98650	63731	110426814
Pancytopenia	15.40	11.05	268	98486	209345	110281200
Dysphagia	15.38	11.05	207	98547	153393	110337152
Lip erosion	15.37	11.05	13	98741	1853	110488692
Mucosal discolouration	15.29	11.05	10	98744	964	110489581
Rash pruritic	15.21	11.05	144	98610	97925	110392620
Stress	15.18	11.05	46	98708	105302	110385243
Congenital foot malformation	15.11	11.05	4	98750	34	110490511
Eosinophilia	15.09	11.05	96	98658	57840	110432705
Persecutory delusion	15.04	11.05	23	98731	6268	110484277
Functional residual capacity increased	14.98	11.05	5	98749	100	110490445
Overdose	14.94	11.05	135	98619	233659	110256886
Stenotrophomonas infection	14.83	11.05	22	98732	5836	110484709
Necrosis	14.82	11.05	32	98722	11374	110479171
Abdominal discomfort	14.76	11.05	255	98499	393603	110096942
Disinhibition	14.70	11.05	16	98738	3118	110487427
Toxic optic neuropathy	14.69	11.05	11	98743	1317	110489228
Tangentiality	14.69	11.05	6	98748	215	110490330
Blood creatine increased	14.60	11.05	32	98722	11489	110479056
Post procedural complication	14.59	11.05	3	98751	26655	110463890
Sleep disorder due to a general medical condition	14.56	11.05	15	98739	52097	110438448
School refusal	14.53	11.05	4	98750	40	110490505
Bronchopulmonary aspergillosis	14.53	11.05	59	98695	29804	110460741
Pneumonia bacterial	14.50	11.05	54	98700	26207	110464338
Blood catecholamines abnormal	14.46	11.05	3	98751	7	110490538
Lip discolouration	14.43	11.05	9	98745	799	110489746
Accidental exposure to product	14.42	11.05	14	98740	49994	110440551
Blood pressure systolic increased	14.42	11.05	33	98721	82958	110407587
Nephrolithiasis	14.42	11.05	23	98731	66189	110424356
Gastroenteritis eosinophilic	14.34	11.05	7	98747	384	110490161
Henoch-Schonlein purpura	14.31	11.05	17	98737	3640	110486905
Joint injury	14.31	11.05	9	98745	39985	110450560
Oesophageal spasm	14.28	11.05	17	98737	3649	110486896
Jejunectomy	14.27	11.05	4	98750	43	110490502
Corneal deposits	14.21	11.05	8	98746	588	110489957
Cryptococcosis	14.11	11.05	19	98735	4612	110485933
Neuropsychiatric lupus	14.06	11.05	6	98748	240	110490305
Neurosis	14.04	11.05	8	98746	602	110489943
Appendicitis	14.02	11.05	4	98750	28460	110462085
Optic neuropathy	14.02	11.05	19	98735	4639	110485906
Hyperkalaemia	14.01	11.05	184	98570	135612	110354933
Psychotic behaviour	14.00	11.05	11	98743	1414	110489131
Lipoedema	13.99	11.05	6	98748	243	110490302
Staring	13.97	11.05	15	98739	2877	110487668
Hypo HDL cholesterolaemia	13.92	11.05	3	98751	9	110490536
Dry mouth	13.88	11.05	113	98641	199835	110290710
Dysarthria	13.79	11.05	125	98629	83996	110406549
Pigmentation disorder	13.78	11.05	24	98730	7287	110483258
Cardiomegaly	13.73	11.05	57	98697	29073	110461472
Gastrointestinal disorder	13.66	11.05	144	98610	241808	110248737
Pneumococcal infection	13.62	11.05	12	98742	1807	110488738
Circulatory collapse	13.62	11.05	75	98679	42918	110447627
Abdominal pain upper	13.58	11.05	408	98346	348703	110141842
Panic reaction	13.50	11.05	20	98734	5302	110485243
Unevaluable event	13.45	11.05	20	98734	59207	110431338
Small intestinal obstruction	13.36	11.05	6	98748	32207	110458338
Measles	13.33	11.05	8	98746	663	110489882
Laryngitis	13.28	11.05	11	98743	42400	110448145
Delusion of grandeur	13.24	11.05	13	98741	2247	110488298
Bronchial obstruction	13.20	11.05	15	98739	3064	110487481
Tongue coated	13.19	11.05	12	98742	1884	110488661
Diverticulum	13.19	11.05	37	98717	15489	110475056
Insomnia	13.12	11.05	418	98336	360172	110130373
Pterygium	13.06	11.05	7	98747	467	110490078
Hiatus hernia	13	11.05	54	98700	27552	110462993
Transplant rejection	12.97	11.05	3	98751	24564	110465981
Emphysema	12.96	11.05	43	98711	19713	110470832
Haemorrhage subcutaneous	12.89	11.05	20	98734	5519	110485026
Headache	12.88	11.05	934	97820	881443	109609102
Flushing	12.86	11.05	49	98705	104687	110385858
Photosensitivity reaction	12.80	11.05	51	98703	25538	110465007
Eosinophilic granulomatosis with polyangiitis	12.78	11.05	29	98725	10657	110479888
Liver disorder	12.75	11.05	188	98566	142055	110348490
Swelling of eyelid	12.74	11.05	22	98732	6631	110483914
Basal cell carcinoma	12.68	11.05	13	98741	45257	110445288
Papule	12.68	11.05	28	98726	10105	110480440
Urinary bladder rupture	12.63	11.05	5	98749	165	110490380
Ischaemic stroke	12.55	11.05	11	98743	41252	110449293
Hypophosphataemia	12.53	11.05	7	98747	33175	110457370
CD4/CD8 ratio decreased	12.53	11.05	4	98750	69	110490476
Intravascular haemolysis	12.47	11.05	9	98745	1018	110489527
Neoplasm malignant	12.43	11.05	9	98745	37134	110453411
Adrenoleukodystrophy	12.43	11.05	4	98750	71	110490474
Lip erythema	12.41	11.05	7	98747	517	110490028
Forced vital capacity abnormal	12.37	11.05	4	98750	72	110490473
Clostridium difficile colitis	12.32	11.05	74	98680	43704	110446841
Therapy non-responder	12.29	11.05	86	98668	157221	110333324
Urosepsis	12.28	11.05	6	98748	30669	110459876
Patient isolation	12.27	11.05	4	98750	74	110490471
pH body fluid increased	12.27	11.05	4	98750	74	110490471
Tremor	12.25	11.05	251	98503	201981	110288564
Oxygen saturation decreased	12.18	11.05	86	98668	156896	110333649
Morganella infection	12.18	11.05	10	98744	1369	110489176
Laryngeal oedema	12.16	11.05	27	98727	9780	110480765
Conjunctival hyperaemia	12.12	11.05	20	98734	5811	110484734
Acinetobacter bacteraemia	12.11	11.05	6	98748	340	110490205
Injection site rash	12.09	11.05	3	98751	23416	110467129
Necrotising panniculitis	12.08	11.05	4	98750	78	110490467
Dysbiosis	12.00	11.05	12	98742	2120	110488425
Thrombosis	11.99	11.05	53	98701	108609	110381936
Hepatic necrosis	11.95	11.05	27	98727	9895	110480650
Speech disorder	11.94	11.05	95	98659	61474	110429071
Diabetes mellitus	11.88	11.05	47	98707	99334	110391211
Metastases to lung	11.82	11.05	3	98751	23060	110467485
Substance-induced psychotic disorder	11.81	11.05	19	98735	5405	110485140
Myocardial infarction	11.81	11.05	112	98642	191971	110298574
Pharyngitis	11.75	11.05	49	98705	25049	110465496
Tachycardia	11.73	11.05	275	98479	226370	110264175
Mononeuropathy	11.68	11.05	6	98748	367	110490178
Antineutrophil cytoplasmic antibody	11.67	11.05	4	98750	87	110490458
Fluid retention	11.66	11.05	44	98710	94263	110396282
Incorrect route of product administration	11.52	11.05	25	98729	64036	110426509
Blood bilirubin abnormal	11.51	11.05	11	98743	1839	110488706
Iris atrophy	11.49	11.05	5	98749	210	110490335
Tooth disorder	11.48	11.05	6	98748	29503	110461042
Ulcer haemorrhage	11.44	11.05	3	98751	22568	110467977
Excessive eye blinking	11.41	11.05	11	98743	1859	110488686
Eye swelling	11.39	11.05	59	98695	32989	110457556
Tuberculosis gastrointestinal	11.36	11.05	7	98747	609	110489936
Oedema mouth	11.35	11.05	14	98740	3116	110487429
Cardio-respiratory arrest	11.32	11.05	59	98695	115777	110374768
Thrombocytopenia	11.30	11.05	399	98355	348486	110142059
Chest discomfort	11.28	11.05	218	98536	173630	110316915
Erythrosis	11.27	11.05	5	98749	220	110490325
Drug dependence	11.25	11.05	17	98737	50003	110440542
Thrombotic microangiopathy	11.23	11.05	6	98748	29143	110461402
Vanishing bile duct syndrome	11.22	11.05	14	98740	3154	110487391
Mental disorder	11.19	11.05	66	98688	38725	110451820
Community acquired infection	11.18	11.05	3	98751	27	110490518
Skin bacterial infection	11.18	11.05	8	98746	893	110489652
Delusional disorder, persecutory type	11.17	11.05	7	98747	627	110489918
Hip fracture	11.15	11.05	9	98745	35142	110455403
Renal ischaemia	11.14	11.05	12	98742	2311	110488234
Therapeutic product effect incomplete	11.11	11.05	270	98484	223535	110267010
Vulval haemorrhage	11.08	11.05	3	98751	28	110490517
Hypotension	11.07	11.05	370	98384	523479	109967066

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	A02BD04	ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) Combinations for eradication of Helicobacter pylori
ATC	A02BD05	ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) Combinations for eradication of Helicobacter pylori
ATC	A02BD06	ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) Combinations for eradication of Helicobacter pylori
ATC	A02BD07	ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) Combinations for eradication of Helicobacter pylori
ATC	A02BD09	ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) Combinations for eradication of Helicobacter pylori
ATC	A02BD11	ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) Combinations for eradication of Helicobacter pylori
ATC	A02BD12	ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) Combinations for eradication of Helicobacter pylori
ATC	A02BD14	ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) Combinations for eradication of Helicobacter pylori
ATC	J01FA09	ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS Macrolides
FDA CS	M0028311	Macrolides
CHEBI has role	CHEBI:35703	xenobiotic
CHEBI has role	CHEBI:36047	antibacterial drug
CHEBI has role	CHEBI:48001	protein synthesis inhibitor
CHEBI has role	CHEBI:78298	environmental contaminant
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D000900	Anti-Bacterial Agents
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D011500	Protein Synthesis Inhibitors
MeSH PA	D065607	Cytochrome P-450 Enzyme Inhibitors
MeSH PA	D065692	Cytochrome P-450 CYP3A Inhibitors
FDA EPC	N0000175935	Macrolide Antimicrobial
FDA MoA	N0000182141	Cytochrome P450 3A4 Inhibitors
FDA MoA	N0000185503	P-Glycoprotein Inhibitors
FDA MoA	N0000190114	Cytochrome P450 3A Inhibitors

Related Drugs by ATC class:

A02BD Combinations for eradication of Helicobacter pylori 13 drugs

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

Disease	Relation	SNOMED_ID	DOID
Acute otitis media	indication	3110003
Haemophilus Influenzae Acute Otitis Media	indication	19021002
Infection of skin AND/OR subcutaneous tissue	indication	19824006
Streptococcal tonsillitis	indication	41582007
Pneumonia due to Mycoplasma pneumoniae	indication	46970008
Bacterial pneumonia	indication	53084003	DOID:874
Acute maxillary sinusitis	indication	68272006	DOID:2050
Haemophilus influenzae pneumonia	indication	70036007
Acute bacterial sinusitis	indication	75498004
Pulmonary Mycobacterium avium complex infection	indication	186342000
Acute Moraxella catarrhalis bronchitis	indication	195722003
Acute bacterial bronchitis	indication	233598009
Pneumococcal pneumonia	indication	233607000
Chlamydial pneumonia	indication	233609002
Streptococcus pyogenes infection	indication	302809008
Infective otitis media	indication	312218008
Infection due to Staphylococcus aureus	indication	406602003
Acute exacerbation of chronic bronchitis	indication	425748003
Moraxella Catarrhalis Acute Otitis Media	indication	703469002
Infection caused by Helicobacter pylori	indication	721730009
Duodenal Ulcer due to H. Pylori	indication
Haemophilus Influenzae Bronchitis	indication
Haemophilus Parainfluenzae Pneumonia	indication
Streptococcus Pneumoniae Bronchitis	indication
Moraxella Catarrhalis Pneumonia	indication
Inhalational anthrax	off-label use	11389007
Lyme disease	off-label use	23502006	DOID:11729
Pertussis	off-label use	27836007
Gastrointestinal anthrax	off-label use	111798006	DOID:13386
Boutonneuse fever	off-label use	186774005	DOID:14095
Legionnaires' Disease	off-label use
Prevention of Bacterial Endocarditis	off-label use
Ventricular tachycardia	contraindication	25569003
Obstruction of bile duct	contraindication	30144000
Torsades de pointes	contraindication	31722008
Acute nephropathy	contraindication	58574008
Hepatic failure	contraindication	59927004
Osteoporosis	contraindication	64859006	DOID:11476
Kidney disease	contraindication	90708001	DOID:557
Myasthenia gravis	contraindication	91637004	DOID:437
Cholestatic hepatitis	contraindication	95556007
Prolonged QT interval	contraindication	111975006
Fracture of bone	contraindication	125605004
Liver function tests abnormal	contraindication	166603001
Hypomagnesemia	contraindication	190855004
Disease of liver	contraindication	235856003	DOID:409
Infectious mononucleosis	contraindication	271558008	DOID:8568
Pseudomembranous enterocolitis	contraindication	397683000
Porphyria	contraindication	418470004

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	12.66	acidic
pKa2	8.65	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
500MG;500MG;EQ 20MG BASE	VOQUEZNA TRIPLE PAK	PHATHOM	N215152	May 3, 2022	RX	CAPSULE, TABLET, TABLET	ORAL	May 3, 2027	NEW CHEMICAL ENTITY
500MG;500MG;EQ 20MG BASE	VOQUEZNA TRIPLE PAK	PHATHOM	N215152	May 3, 2022	RX	CAPSULE, TABLET, TABLET	ORAL	May 3, 2032	GENERATING ANTIBIOTIC INCENTIVES NOW

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Potassium voltage-gated channel subfamily H member 2	Ion channel	Q12809	KCNH2_HUMAN		IC50	4.23		WOMBAT-PK

External reference:

ID	Source
4020086	VUID
N0000148093	NUI
D00276	KEGG_DRUG
203729	RXNORM
C0055856	UMLSCUI
CHEBI:3732	CHEBI
CTY	PDB_CHEM_ID
CHEMBL1741	ChEMBL_ID
D017291	MESH_DESCRIPTOR_UI
DB01211	DRUGBANK_ID
10903	IUPHAR_LIGAND_ID
C040934	MESH_SUPPLEMENTAL_RECORD_UI
6252	INN_ID
H1250JIK0A	UNII
84029	PUBCHEM_CID
3947	MMSL
4462	MMSL
68470	MMSL
d00097	MMSL
003608	NDDF
387487009	SNOMEDCT_US
83999008	SNOMEDCT_US
4020086	VANDF

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Clarithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1930	TABLET, FILM COATED, EXTENDED RELEASE	500 mg	ORAL	ANDA	26 sections
Clarithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1931	TABLET, FILM COATED	250 mg	ORAL	ANDA	28 sections
Clarithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1932	TABLET, FILM COATED	500 mg	ORAL	ANDA	28 sections
clarithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	0591-2805	TABLET, FILM COATED, EXTENDED RELEASE	500 mg	ORAL	ANDA	25 sections
Clarithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	0781-1961	TABLET	250 mg	ORAL	ANDA	29 sections
Clarithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	0781-1962	TABLET	500 mg	ORAL	ANDA	29 sections
Clarithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	0781-6022	FOR SUSPENSION	125 mg	ORAL	ANDA	28 sections
Clarithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	0781-6023	FOR SUSPENSION	250 mg	ORAL	ANDA	28 sections
Clarithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6872	TABLET, FILM COATED	500 mg	ORAL	ANDA	28 sections
Clarithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	10544-522	TABLET, FILM COATED	500 mg	ORAL	ANDA	22 sections
Clarithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	10544-952	TABLET, COATED	500 mg	ORAL	ANDA	23 sections
Clarithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	21695-557	TABLET	250 mg	ORAL	ANDA	26 sections
Clarithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	21695-558	TABLET	500 mg	ORAL	ANDA	26 sections
Clarithromycin	Human Prescription Drug Label	1	27241-064	TABLET	250 mg	ORAL	ANDA	28 sections
Clarithromycin	Human Prescription Drug Label	1	27241-065	TABLET	500 mg	ORAL	ANDA	28 sections
Clarithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	33261-618	TABLET, FILM COATED	500 mg	ORAL	ANDA	22 sections
Clarithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	33261-631	TABLET, FILM COATED	250 mg	ORAL	ANDA	22 sections
Clarithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	42254-188	TABLET, FILM COATED	500 mg	ORAL	ANDA	21 sections
Clarithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	43063-530	TABLET	500 mg	ORAL	ANDA	29 sections
Clarithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	43063-530	TABLET	500 mg	ORAL	ANDA	29 sections
Clarithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	43063-752	TABLET, FILM COATED	500 mg	ORAL	ANDA	28 sections
Clarithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	43063-752	TABLET, FILM COATED	500 mg	ORAL	ANDA	28 sections
Clarithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	43063-823	TABLET, FILM COATED	500 mg	ORAL	ANDA	28 sections
Clarithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	43063-942	TABLET, FILM COATED, EXTENDED RELEASE	500 mg	ORAL	ANDA	26 sections
Clarithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	43063-942	TABLET, FILM COATED, EXTENDED RELEASE	500 mg	ORAL	ANDA	26 sections
Clarithromycin	Human Prescription Drug Label	1	46708-344	TABLET, FILM COATED	250 mg	ORAL	ANDA	28 sections
Clarithromycin	Human Prescription Drug Label	1	46708-345	TABLET, FILM COATED	500 mg	ORAL	ANDA	28 sections
Clarithromycin	Human Prescription Drug Label	1	50090-0927	TABLET, FILM COATED	250 mg	ORAL	ANDA	28 sections
Clarithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	50090-0994	FOR SUSPENSION	250 mg	ORAL	ANDA	28 sections
Clarithromycin	Human Prescription Drug Label	1	50090-1830	TABLET, FILM COATED	500 mg	ORAL	ANDA	28 sections