amoxicillin Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
antibiotics, 6-aminopenicillanic acid derivatives	192	26787-78-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: amoxicillin trihydrate amoxicillin amocilline amoxcillin amoxycillin amoxicillin sodium amoxicillin anhydrous amoxicillin hydrate	A broad-spectrum semisynthetic antibiotic similar to AMPICILLIN except that its resistance to gastric acid permits higher serum levels with oral administration. Molecular weight: 365.40 Formula: C16H19N3O5S CLOGP: -1.87 LIPINSKI: 0 HAC: 8 HDO: 4 TPSA: 132.96 ALOGS: -2.58 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

Dose	Unit	Route
1.50	g	O
3	g	P
1.50	g	O
3	g	P

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	3.50 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	86 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	68.42 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	93 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.25 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	3.30 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.85 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	1.10 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Dec. 9, 1974	FDA	APOTHECON

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 hypersensitivity	1331.41	9.50	2275	115227	241550	46327010
Drug reaction with eosinophilia and systemic symptoms	625.82	9.50	550	116952	28998	46539562
Rash maculo-papular	608.76	9.50	528	116974	27346	46541214
Pruritus	491.55	9.50	1531	115971	240821	46327739
Urticaria	461.08	9.50	956	116546	116936	46451624
Angioedema	353.82	9.50	465	117037	38877	46529683
Anaphylactic reaction	346.91	9.50	539	116963	52573	46515987
Anaphylactic shock	341.13	9.50	332	117170	19942	46548618
Erythema	340.10	9.50	956	116546	141864	46426696
Acute generalised exanthematous pustulosis	335.18	9.50	238	117264	9167	46559393
Rash	302.70	9.50	1725	115777	354787	46213773
Lip oedema	264.12	9.50	141	117361	3223	46565337
Type IV hypersensitivity reaction	259.06	9.50	127	117375	2413	46566147
Cholestasis	234.25	9.50	313	117189	26580	46541980
Lip swelling	231.12	9.50	302	117200	25093	46543467
Completed suicide	226.14	9.50	46	117456	145874	46422686
Toxic skin eruption	219.97	9.50	209	117293	12178	46556382
Hepatocellular injury	218.90	9.50	318	117184	29204	46539356
Face oedema	213.18	9.50	252	117250	18901	46549659
Drug-induced liver injury	199.45	9.50	281	117221	25087	46543473
Maternal exposure during pregnancy	196.29	9.50	636	116866	101913	46466647
Drug ineffective	191.24	9.50	969	116533	676869	45891691
Death	182.89	9.50	355	117147	335193	46233367
Abortion spontaneous	182.21	9.50	364	117138	43282	46525278
Rheumatoid arthritis	175.32	9.50	208	117294	240007	46328553
Acute kidney injury	171.37	9.50	1097	116405	234758	46333802
Jaundice	166.70	9.50	277	117225	28568	46539992
Type I hypersensitivity	158.38	9.50	89	117413	2257	46566303
Clostridium difficile infection	153.08	9.50	247	117255	24856	46543704
Hepatitis cholestatic	152.82	9.50	130	117372	6547	46562013
Stevens-Johnson syndrome	150.01	9.50	235	117267	23062	46545498
Fall	141.60	9.50	395	117107	328702	46239858
Eosinophilia	136.65	9.50	203	117299	19014	46549546
Documented hypersensitivity to administered product	134.83	9.50	52	117450	533	46568027
Tongue oedema	121.52	9.50	92	117410	3914	46564646
Tubulointerstitial nephritis	120.99	9.50	167	117335	14621	46553939
Enterocolitis haemorrhagic	119.35	9.50	64	117438	1476	46567084
Crystalluria	117.41	9.50	43	117459	377	46568183
Rash pruritic	115.98	9.50	307	117195	43908	46524652
Swollen tongue	113.93	9.50	237	117265	28995	46539565
Toxic epidermal necrolysis	113.06	9.50	202	117300	22076	46546484
Clostridium difficile colitis	112.36	9.50	182	117320	18371	46550189
Erythema multiforme	111.83	9.50	130	117372	9574	46558986
Rash macular	108.66	9.50	183	117319	19077	46549483
Infusion related reaction	103.87	9.50	63	117439	101145	46467415
Arthralgia	103.55	9.50	519	116983	364084	46204476
Pyrexia	94.66	9.50	1314	116188	347488	46221072
Rash erythematous	92.63	9.50	241	117261	34109	46534451
Toxicity to various agents	92.56	9.50	252	117250	211514	46357046
Fatigue	91.37	9.50	1037	116465	607660	45960900
Therapeutic product effect decreased	91.12	9.50	47	117455	82554	46486006
Pemphigus	87.47	9.50	7	117495	45267	46523293
Swelling face	86.44	9.50	312	117190	52747	46515813
White blood cell count abnormal	82.49	9.50	82	117420	5050	46563510
Wound closure	80.04	9.50	26	117476	152	46568408
Pseudomembranous colitis	78.89	9.50	65	117437	3130	46565430
Dermatitis allergic	75.45	9.50	123	117379	12480	46556080
Off label use	73.81	9.50	607	116895	379234	46189326
Arthropathy	73.48	9.50	63	117439	84637	46483923
Meningitis aseptic	73.03	9.50	69	117433	3990	46564570
Palatal oedema	72.14	9.50	32	117470	479	46568081
Cholecystitis chronic	71.91	9.50	109	117393	10390	46558170
Hand deformity	70.73	9.50	4	117498	34570	46533990
Eyelid oedema	70.20	9.50	107	117395	10250	46558310
Cholestatic liver injury	70.12	9.50	51	117451	2039	46566521
Dermatitis exfoliative generalised	69.64	9.50	59	117443	2954	46565606
Therapeutic product effect incomplete	69.18	9.50	57	117445	78096	46490464
Osteotomy	68.61	9.50	26	117476	253	46568307
Mixed liver injury	65.47	9.50	58	117444	3085	46565475
Diarrhoea	65.45	9.50	1856	115646	557746	46010814
Injection site pain	64.82	9.50	106	117396	107046	46461514
Injection site erythema	63.78	9.50	56	117446	74371	46494189
Rash morbilliform	63.62	9.50	56	117446	2953	46565607
Liver injury	62.65	9.50	130	117372	15871	46552689
Hypersensitivity	60.43	9.50	611	116891	149710	46418850
Drug eruption	59.93	9.50	152	117350	21177	46547383
Synovitis	59.92	9.50	40	117462	61035	46507525
Myocardial infarction	59.43	9.50	96	117406	97432	46471128
Alopecia	58.41	9.50	211	117291	162203	46406357
Weight increased	58.27	9.50	215	117287	164258	46404302
Idiosyncratic drug reaction	57.53	9.50	32	117470	795	46567765
Paraesthesia oral	57.50	9.50	105	117397	11668	46556892
Breast cancer	54.67	9.50	23	117479	45495	46523065
Joint swelling	54.41	9.50	224	117278	165849	46402711
Loss of personal independence in daily activities	54.05	9.50	39	117463	57144	46511416
Hepatitis	53.79	9.50	191	117311	32024	46536536
Kounis syndrome	53.72	9.50	35	117467	1167	46567393
Sinusitis	51.44	9.50	526	116976	129242	46439318
Arthritis	50.08	9.50	73	117429	77243	46491317
Linear IgA disease	49.77	9.50	35	117467	1326	46567234
Bronchospasm	49.51	9.50	117	117385	15590	46552970
Pain in extremity	49.41	9.50	415	117087	258265	46310295
Treatment failure	48.38	9.50	101	117401	92986	46475574
Vascular purpura	47.80	9.50	34	117468	1312	46567248
Acute hepatic failure	45.69	9.50	109	117393	14612	46553948
Device expulsion	44.06	9.50	8	117494	27534	46541026
Klebsiella infection	43.98	9.50	68	117434	6594	46561966
Glossodynia	43.61	9.50	29	117473	44344	46524216
Dermatitis bullous	43.61	9.50	73	117429	7570	46560990
Chromaturia	43.20	9.50	108	117394	14911	46553649
Injection site swelling	42.92	9.50	24	117478	40303	46528257
Periorbital oedema	42.90	9.50	58	117444	4977	46563583
Agranulocytosis	42.73	9.50	138	117364	22047	46546513
Jaundice cholestatic	39.94	9.50	56	117446	4973	46563587
Odynophagia	39.85	9.50	65	117437	6597	46561963
Systemic lupus erythematosus	38.92	9.50	65	117437	65115	46503445
Product use issue	38.09	9.50	117	117385	94527	46474033
Basilar artery occlusion	38.00	9.50	14	117488	125	46568435
Symmetrical drug-related intertriginous and flexural exanthema	37.70	9.50	17	117485	265	46568295
Laryngeal oedema	37.53	9.50	56	117446	5263	46563297
Tooth demineralisation	37.29	9.50	9	117493	12	46568548
Cardiac failure congestive	37.22	9.50	113	117389	91637	46476923
Blood pressure increased	37.15	9.50	178	117324	126488	46442072
Hyperaemia	36.10	9.50	34	117468	1958	46566602
Tryptase increased	35.51	9.50	15	117487	198	46568362
Dermatitis exfoliative	34.50	9.50	56	117446	5660	46562900
Neutrophilia	34.50	9.50	40	117462	2937	46565623
Lymphadenopathy	34.29	9.50	171	117331	33317	46535243
Injection site pruritus	33.92	9.50	30	117472	39713	46528847
Wound	33.40	9.50	35	117467	42767	46525793
Platelet count decreased	33.31	9.50	134	117368	99890	46468670
Throat tightness	33.28	9.50	121	117381	20518	46548042
Ear infection	33.04	9.50	130	117372	22883	46545677
Injury	32.58	9.50	206	117296	43821	46524739
Hepatitis acute	32.46	9.50	67	117435	8147	46560413
Choluria	32.34	9.50	13	117489	150	46568410
Trimethylaminuria	31.88	9.50	13	117489	156	46568404
Pharyngeal swelling	31.77	9.50	41	117461	3362	46565198
Knee arthroplasty	31.73	9.50	10	117492	23655	46544905
Purpura	31.19	9.50	74	117428	9884	46558676
Blood glucose increased	30.43	9.50	87	117415	71926	46496634
Peritonsillar abscess	30.24	9.50	18	117484	510	46568050
Premature baby	29.90	9.50	107	117395	18005	46550555
Drug intolerance	29.83	9.50	232	117270	146817	46421743
Premature delivery	29.56	9.50	122	117380	21947	46546613
Contraindicated product administered	29.28	9.50	103	117399	79844	46488716
Staphylococcal scalded skin syndrome	29.28	9.50	12	117490	146	46568414
Drug interaction	29.22	9.50	693	116809	202401	46366159
Candida infection	29.05	9.50	122	117380	22118	46546442
Tooth infection	28.90	9.50	82	117420	12204	46556356
Diabetes mellitus	28.90	9.50	51	117451	50014	46518546
Lower respiratory tract infection	28.75	9.50	237	117265	54852	46513708
Pain	28.42	9.50	950	116552	475998	46092562
Hyperleukocytosis	28.32	9.50	16	117486	410	46568150
Wrong technique in product usage process	28.31	9.50	59	117443	54363	46514197
Isosthenuria	27.91	9.50	11	117491	120	46568440
Hallucinations, mixed	27.84	9.50	41	117461	3808	46564752
Vomiting	27.79	9.50	1399	116103	451395	46117165
Enanthema	27.14	9.50	16	117486	445	46568115
Hypertension	27.14	9.50	340	117162	196016	46372544
Moraxella test positive	26.93	9.50	7	117495	15	46568545
Skin exfoliation	26.83	9.50	158	117344	32780	46535780
International normalised ratio increased	26.82	9.50	206	117296	46677	46521883
Skin test positive	26.81	9.50	19	117483	729	46567831
Vitiligo	26.71	9.50	22	117480	1059	46567501
Foetal exposure during pregnancy	26.68	9.50	150	117352	30597	46537963
Injection site reaction	26.50	9.50	50	117452	47799	46520761
Mobility decreased	26.50	9.50	72	117430	60522	46508038
Abdominal discomfort	25.98	9.50	249	117253	150916	46417644
Localised oedema	25.76	9.50	46	117456	5023	46563537
Skin lesion	25.67	9.50	134	117368	26579	46541981
Emotional distress	25.46	9.50	148	117354	30559	46538001
Multiple sclerosis relapse	25.15	9.50	42	117460	42083	46526477
Lemierre syndrome	25.06	9.50	10	117492	113	46568447
Laryngeal discomfort	24.96	9.50	13	117489	282	46568278
Wheezing	24.88	9.50	224	117278	53162	46515398
Swelling of eyelid	24.85	9.50	22	117480	1169	46567391
Chronic kidney disease	24.74	9.50	182	117320	40689	46527871
Malaise	24.51	9.50	1043	116459	330189	46238371
Pyelitis	24.48	9.50	11	117491	170	46568390
Salpingo-oophorectomy unilateral	24.39	9.50	14	117488	370	46568190
Fluid retention	24.37	9.50	58	117444	50988	46517572
Injection site warmth	24.33	9.50	3	117499	13769	46554791
Pharyngeal oedema	24.32	9.50	86	117416	14385	46554175
Electrocardiogram PR shortened	24.31	9.50	11	117491	173	46568387
Headache	24.17	9.50	972	116530	477380	46091180
Faeces pale	24.14	9.50	24	117478	1478	46567082
Fibromyalgia	24.03	9.50	34	117468	36429	46532131
Fracture	23.86	9.50	6	117496	16465	46552095
Drug abuse	23.69	9.50	81	117421	63327	46505233
Cardio-respiratory arrest	23.38	9.50	75	117427	59794	46508766
Erythromelalgia	23.34	9.50	10	117492	137	46568423
Peripheral circulatory failure	23.23	9.50	13	117489	327	46568233
Tongue discolouration	23.19	9.50	33	117469	2971	46565589
Exposure during pregnancy	23.17	9.50	392	117110	107820	46460740
Dental operation	23.08	9.50	21	117481	1157	46567403
Disease progression	23.02	9.50	135	117367	91165	46477395
Pericarditis	23.02	9.50	16	117486	23911	46544649
Somatic delusion	22.97	9.50	16	117486	597	46567963
Intentional product misuse	22.94	9.50	53	117449	47075	46521485
Infectious mononucleosis	22.92	9.50	24	117478	1572	46566988
Leukocytosis	22.92	9.50	118	117384	23280	46545280
Bladder hypertrophy	22.34	9.50	11	117491	211	46568349
Rash pustular	22.26	9.50	52	117450	6877	46561683
Sinusitis fungal	21.97	9.50	18	117484	860	46567700
Mental status changes	21.80	9.50	39	117463	38049	46530511
Oral discomfort	21.79	9.50	56	117446	7862	46560698
Protein C increased	21.67	9.50	10	117492	165	46568395
Haemolytic anaemia	21.53	9.50	64	117438	9778	46558782
Therapeutic response decreased	21.42	9.50	48	117454	43097	46525463
Transaminases increased	21.23	9.50	131	117371	27630	46540930
Oliguria	21.13	9.50	59	117443	8700	46559860
Respiratory symptom	21.01	9.50	26	117476	2044	46566516
Malignant neoplasm progression	20.97	9.50	88	117414	64838	46503722
Tonsillar exudate	20.95	9.50	6	117496	21	46568539
Renal papillary necrosis	20.90	9.50	11	117491	244	46568316
Gastrointestinal haemorrhage	20.81	9.50	112	117390	77261	46491299
Haematuria	20.70	9.50	127	117375	26731	46541829
Product complaint	20.51	9.50	3	117499	12098	46556462
Distributive shock	20.47	9.50	14	117488	507	46568053
Hip arthroplasty	20.42	9.50	10	117492	18102	46550458
Pharyngitis streptococcal	20.39	9.50	57	117445	8411	46560149
Rash papular	20.28	9.50	75	117427	12823	46555737
Empyema	20.23	9.50	24	117478	1806	46566754
Conjunctival hyperaemia	20.21	9.50	25	117477	1964	46566596
Eye swelling	20.12	9.50	102	117400	20001	46548559
Injection site bruising	19.94	9.50	37	117465	35599	46532961
Influenza B virus test positive	19.73	9.50	12	117490	354	46568206
Conjunctivitis	19.67	9.50	84	117418	15340	46553220
Blood cholesterol increased	19.47	9.50	45	117457	39968	46528592
Viral parotitis	19.47	9.50	5	117497	10	46568550
Inappropriate schedule of product administration	19.26	9.50	91	117411	64922	46503638
Eosinophilic pneumonia	19.06	9.50	24	117478	1920	46566640
Tonsillitis	19.04	9.50	40	117462	4924	46563636
Product dose omission issue	18.96	9.50	304	117198	168216	46400344
Cell death	18.95	9.50	26	117476	2262	46566298
Normal tension glaucoma	18.67	9.50	7	117495	66	46568494
Incorrect route of product administration	18.54	9.50	9	117493	16374	46552186
Nausea	18.52	9.50	1485	116017	685969	45882591
Otitis media	18.45	9.50	36	117466	4204	46564356
Tongue coated	18.34	9.50	19	117483	1229	46567331
Foetal non-stress test abnormal	18.34	9.50	6	117496	36	46568524
Pharyngotonsillitis	18.26	9.50	9	117493	173	46568387
Contraindicated product prescribed	18.17	9.50	15	117487	724	46567836
Hypertransaminasaemia	18.17	9.50	32	117470	3456	46565104
Biliary colic	18.10	9.50	32	117470	3466	46565094
Fixed eruption	18.09	9.50	16	117486	849	46567711
Pharyngeal erythema	18.09	9.50	21	117481	1544	46567016
Lymphocytosis	17.93	9.50	25	117477	2209	46566351
Mania	17.84	9.50	64	117438	10782	46557778
Underdose	17.63	9.50	14	117488	19544	46549016
Joint range of motion decreased	17.59	9.50	8	117494	15116	46553444
Red blood cell sedimentation rate increased	17.54	9.50	19	117483	22870	46545690
Hepatic enzyme increased	17.54	9.50	127	117375	81660	46486900
Pharyngeal paraesthesia	17.53	9.50	18	117484	1152	46567408
Cheilitis	17.52	9.50	34	117468	3954	46564606
Depression	17.46	9.50	312	117190	169792	46398768
Neisseria infection	17.43	9.50	6	117496	43	46568517
Hyperthermia	17.42	9.50	52	117450	7962	46560598
Psychotic symptom	17.39	9.50	16	117486	894	46567666
Faeces discoloured	17.38	9.50	86	117416	16701	46551859
Medication crystals in urine present	17.19	9.50	4	117498	4	46568556
Dyspnoea	17.17	9.50	1513	115989	514035	46054525
Femur fracture	16.90	9.50	43	117459	36954	46531606
Rash vesicular	16.90	9.50	31	117471	3456	46565104
Mouth swelling	16.88	9.50	32	117470	3657	46564903
Oral candidiasis	16.88	9.50	88	117414	17444	46551116
Megacolon	16.78	9.50	21	117481	1670	46566890
Blood pressure fluctuation	16.70	9.50	32	117470	30416	46538144
Gait disturbance	16.69	9.50	261	117241	145002	46423558
Tinnitus	16.61	9.50	123	117379	27550	46541010
Pyogenic granuloma	16.53	9.50	10	117492	292	46568268
Balance disorder	16.48	9.50	95	117407	64426	46504134
Multiple sclerosis	16.45	9.50	23	117479	24768	46543792
Pneumonia mycoplasmal	16.38	9.50	15	117487	833	46567727
Periorbital cellulitis	16.32	9.50	12	117490	488	46568072
Respiratory tract infection	16.20	9.50	130	117372	29842	46538718
Sputum increased	16.15	9.50	21	117481	1735	46566825
Medication error	16.13	9.50	133	117369	30778	46537782
Back pain	16.07	9.50	404	117098	209635	46358925
Injection site rash	15.99	9.50	10	117492	15803	46552757
Periorbital swelling	15.99	9.50	18	117484	1280	46567280
Phaeohyphomycosis	15.85	9.50	9	117493	233	46568327
Skin reaction	15.85	9.50	62	117440	10884	46557676
Embolism venous	15.73	9.50	25	117477	2482	46566078
Fulminant type 1 diabetes mellitus	15.51	9.50	9	117493	243	46568317
Suicidal ideation	15.50	9.50	81	117421	56301	46512259
Musculoskeletal pain	15.47	9.50	108	117394	70020	46498540
Psoriasis	15.47	9.50	125	117377	78479	46490081
Ankle fracture	15.42	9.50	10	117492	15501	46553059
Herpes zoster	15.23	9.50	104	117398	67768	46500792
Osteoporosis	15.08	9.50	52	117450	40556	46528004
Bipolar I disorder	15.02	9.50	19	117483	1527	46567033
Yellow skin	14.95	9.50	22	117480	2042	46566518
Induced abortion failed	14.93	9.50	9	117493	261	46568299
Eczema	14.81	9.50	95	117407	20305	46548255
Abnormal faeces	14.81	9.50	32	117470	4017	46564543
Joint injury	14.66	9.50	16	117486	19193	46549367
Discomfort	14.61	9.50	64	117438	46606	46521954
White blood cell count decreased	14.51	9.50	197	117305	112034	46456526
Upper limb fracture	14.48	9.50	11	117491	15702	46552858
Peripheral swelling	14.36	9.50	296	117206	157775	46410785
Memory impairment	14.31	9.50	125	117377	77212	46491348
Chronic sinusitis	14.27	9.50	36	117466	4997	46563563
Bradycardia	14.19	9.50	103	117399	66195	46502365
Blood glucose decreased	14.13	9.50	16	117486	18876	46549684
Mucosal inflammation	14.02	9.50	155	117347	38821	46529739
Thermal burn	13.95	9.50	35	117467	4842	46563718
Feeling abnormal	13.93	9.50	226	117276	124834	46443726
Pericardial effusion	13.87	9.50	27	117475	25516	46543044
Norovirus test positive	13.82	9.50	7	117495	143	46568417
Neoplasm progression	13.81	9.50	29	117473	26654	46541906
Systemic inflammatory response syndrome	13.78	9.50	37	117465	5334	46563226
Live birth	13.75	9.50	57	117445	10273	46558287
Ecthyma	13.72	9.50	8	117494	218	46568342
Amnesia	13.71	9.50	56	117446	41575	46526985
Respiratory depression	13.70	9.50	6	117496	11594	46556966
Pharyngeal abscess	13.69	9.50	8	117494	219	46568341
Deafness	13.68	9.50	78	117424	15990	46552570
Anuria	13.62	9.50	61	117441	11370	46557190
Cerebrovascular accident	13.55	9.50	176	117326	100863	46467697
Accidental exposure to product	13.55	9.50	20	117482	21061	46547499
Overdose	13.55	9.50	178	117324	101801	46466759
Diastasis recti abdominis	13.54	9.50	5	117497	45	46568515
Blood count abnormal	13.52	9.50	15	117487	17863	46550697
Metastases to lung	13.51	9.50	5	117497	10691	46557869
Prothrombin time ratio decreased	13.49	9.50	10	117492	412	46568148
Pulmonary artery stenosis congenital	13.46	9.50	8	117494	226	46568334
Parotid gland enlargement	13.34	9.50	13	117489	781	46567779
Dysbiosis	13.33	9.50	11	117491	531	46568029
Depressed level of consciousness	13.27	9.50	68	117434	47501	46521059
Bronchopleural fistula	13.21	9.50	8	117494	234	46568326
Progressive multifocal leukoencephalopathy	13.20	9.50	6	117496	11340	46557220
Urea urine increased	13.18	9.50	4	117498	18	46568542
Eosinophils urine present	13.18	9.50	4	117498	18	46568542
Drug withdrawal syndrome	13.16	9.50	31	117471	27353	46541207
Prothrombin time shortened	13.11	9.50	19	117483	1740	46566820
Femoral artery embolism	12.99	9.50	5	117497	51	46568509
Dyskinesia	12.92	9.50	34	117468	28891	46539669
Arthritis allergic	12.89	9.50	3	117499	3	46568557
Biliary sepsis	12.86	9.50	11	117491	558	46568002
Labelled drug-drug interaction medication error	12.86	9.50	51	117451	9010	46559550
Cholestasis of pregnancy	12.85	9.50	15	117487	1109	46567451
Peritonitis bacterial	12.83	9.50	3	117499	8650	46559910
Hip fracture	12.81	9.50	30	117472	26526	46542034
Erythema nodosum	12.81	9.50	29	117473	3757	46564803
Fear-related avoidance of activities	12.79	9.50	6	117496	103	46568457
Foetal hypokinesia	12.76	9.50	10	117492	448	46568112
Pulmonary hypertension	12.76	9.50	47	117455	35946	46532614
Coronary artery disease	12.68	9.50	43	117459	33709	46534851
Caffeine allergy	12.67	9.50	4	117498	21	46568539
Sedation	12.63	9.50	24	117478	22886	46545674
Oedema	12.58	9.50	238	117264	66833	46501727
Dysphonia	12.58	9.50	150	117352	38264	46530296
Adverse event	12.54	9.50	44	117458	34140	46534420
Tangentiality	12.52	9.50	4	117498	22	46568538
Duodenal ulcer perforation	12.51	9.50	3	117499	8499	46560061
Toothache	12.50	9.50	78	117424	16514	46552046
Polymenorrhagia	12.49	9.50	5	117497	57	46568503
Syncope	12.47	9.50	187	117315	104616	46463944
Nasal polyps	12.46	9.50	21	117481	2189	46566371
Lower respiratory tract infection bacterial	12.46	9.50	9	117493	356	46568204
Gait inability	12.46	9.50	46	117456	35157	46533403
Excessive eye blinking	12.43	9.50	11	117491	584	46567976
Lymphadenitis	12.42	9.50	23	117479	2582	46565978
Gallbladder disorder	12.40	9.50	81	117421	17417	46551143
Acute haemorrhagic oedema of infancy	12.37	9.50	4	117498	23	46568537
Cardiac failure	12.36	9.50	135	117367	79813	46488747
Circulatory collapse	12.35	9.50	95	117407	21529	46547031
Restless legs syndrome	12.31	9.50	13	117489	15830	46552730
Gastric disorder	12.23	9.50	31	117471	26674	46541886
Abdominal pain upper	12.20	9.50	464	117038	144841	46423719
Metastases to liver	12.18	9.50	19	117483	19566	46548994
Creatinine renal clearance increased	12.18	9.50	10	117492	479	46568081
Sebaceous gland infection	12.14	9.50	6	117496	116	46568444
Myelodysplastic syndrome	12.08	9.50	13	117489	15698	46552862
Injury corneal	12.05	9.50	5	117497	63	46568497
Budd-Chiari syndrome	12.05	9.50	5	117497	63	46568497
Otitis media acute	11.98	9.50	13	117489	887	46567673
C-reactive protein abnormal	11.97	9.50	22	117480	21248	46547312
Clostridium test positive	11.97	9.50	19	117483	1885	46566675
Pulmonary arterial hypertension	11.95	9.50	30	117472	25898	46542662
Atrial fibrillation	11.93	9.50	186	117316	103404	46465156
Abdominal pain	11.92	9.50	700	116802	229331	46339229
Pseudomyopia	11.91	9.50	5	117497	65	46568495
Device issue	11.85	9.50	20	117482	19960	46548600
Visual impairment	11.81	9.50	109	117393	66580	46501980
Neoplasm malignant	11.78	9.50	26	117476	23473	46545087
Laryngeal obstruction	11.70	9.50	4	117498	28	46568532
Prescribed underdose	11.68	9.50	8	117494	12045	46556515
Oropharyngeal discomfort	11.67	9.50	25	117477	3120	46565440
Right ventricular failure	11.63	9.50	14	117488	16079	46552481
Neonatal respiratory distress syndrome	11.63	9.50	22	117480	2511	46566049
Product colour issue	11.58	9.50	11	117491	640	46567920
Actinomycosis	11.58	9.50	14	117488	1074	46567486
Forced vital capacity abnormal	11.58	9.50	4	117498	29	46568531
Palatal swelling	11.57	9.50	5	117497	70	46568490
Anaemia	11.55	9.50	526	116976	255253	46313307
Lip pain	11.53	9.50	18	117484	1760	46566800
Cataract	11.52	9.50	67	117435	45348	46523212
Injection site urticaria	11.52	9.50	8	117494	11959	46556601
Laryngeal dyspnoea	11.48	9.50	6	117496	131	46568429
Bone pain	11.46	9.50	70	117432	46820	46521740
Sweat discolouration	11.37	9.50	3	117499	7	46568553
Status epilepticus	11.34	9.50	67	117435	13912	46554648
Inhibitory drug interaction	11.31	9.50	19	117483	1976	46566584
Liver function test abnormal	11.29	9.50	172	117330	46315	46522245
Tooth discolouration	11.29	9.50	12	117490	800	46567760
Serotonin syndrome	11.18	9.50	28	117474	24192	46544368
Macroglossia	11.16	9.50	10	117492	540	46568020
Blood test abnormal	11.13	9.50	5	117497	9515	46559045
Non-alcoholic steatohepatitis	11.11	9.50	16	117486	1456	46567104
Congenital tricuspid valve incompetence	11.09	9.50	5	117497	78	46568482
Septic pulmonary embolism	11.03	9.50	4	117498	34	46568526
Uveitis	10.98	9.50	4	117498	8637	46559923
Muscle necrosis	10.94	9.50	10	117492	554	46568006
Gingival swelling	10.94	9.50	28	117474	3922	46564638
Ureteric dilatation	10.93	9.50	4	117498	35	46568525
Infusion site nodule	10.93	9.50	13	117489	981	46567579
Reaction to excipient	10.92	9.50	14	117488	1140	46567420
Weight decreased	10.91	9.50	427	117075	210422	46358138
Glycosylated haemoglobin increased	10.83	9.50	7	117495	10869	46557691
Veillonella infection	10.83	9.50	4	117498	36	46568524
Blood catecholamines abnormal	10.83	9.50	3	117499	9	46568551
Delusion of grandeur	10.83	9.50	6	117496	148	46568412
Mucosal discolouration	10.81	9.50	9	117493	440	46568120
Abdominal wall haematoma	10.80	9.50	23	117479	2858	46565702
Cerebral infarction	10.80	9.50	27	117475	23339	46545221
Genital erosion	10.75	9.50	6	117496	150	46568410
Delayed delivery	10.73	9.50	4	117498	37	46568523
Pneumonia aspiration	10.73	9.50	42	117460	31563	46536997
Tongue pruritus	10.67	9.50	9	117493	448	46568112
Tongue exfoliation	10.65	9.50	5	117497	86	46568474
Subacute hepatic failure	10.61	9.50	6	117496	154	46568406
Impaired healing	10.55	9.50	52	117450	36691	46531869
Foot deformity	10.55	9.50	14	117488	15411	46553149
Hypothyroidism	10.41	9.50	42	117460	31296	46537264
Factor V inhibition	10.37	9.50	6	117496	161	46568399
Lip erythema	10.29	9.50	5	117497	93	46568467
Poor quality sleep	10.27	9.50	14	117488	15239	46553321
Pneumocystis jirovecii pneumonia	10.26	9.50	14	117488	15234	46553326
Flank pain	10.26	9.50	58	117444	11855	46556705
Biliary dyskinesia	10.24	9.50	22	117480	2751	46565809
Polyneuropathy	10.23	9.50	57	117445	11587	46556973
Behaviour disorder	10.23	9.50	18	117484	1943	46566617
Maternal exposure during breast feeding	10.15	9.50	22	117480	2767	46565793
Psoriatic arthropathy	10.15	9.50	52	117450	36327	46532233
Rheumatoid nodule	10.14	9.50	5	117497	9015	46559545
Stomatococcal infection	10.10	9.50	5	117497	97	46568463
Monoclonal gammopathy	10.04	9.50	10	117492	617	46567943
Foetal distress syndrome	10.02	9.50	14	117488	1239	46567321
Palmar-plantar erythrodysaesthesia syndrome	9.95	9.50	23	117479	20428	46548132
Somnolence	9.93	9.50	309	117193	156212	46412348
Sleep disorder	9.87	9.50	73	117429	46722	46521838
Glomerulonephritis acute	9.81	9.50	4	117498	48	46568512
Ureteric obstruction	9.78	9.50	17	117485	1817	46566743
Pruritus genital	9.78	9.50	10	117492	637	46567923
Upper respiratory tract infection	9.77	9.50	219	117283	63337	46505223
Rhabdomyolysis	9.77	9.50	154	117348	41755	46526805
Therapy non-responder	9.77	9.50	62	117440	41090	46527470
Pneumopericardium	9.74	9.50	4	117498	49	46568511
Genital prolapse	9.66	9.50	4	117498	50	46568510
Respiratory gas exchange disorder	9.66	9.50	8	117494	388	46568172
Helicobacter test positive	9.64	9.50	8	117494	389	46568171
Incorrect dose administered	9.63	9.50	71	117431	45479	46523081
Intentional self-injury	9.62	9.50	30	117472	24136	46544424
Coagulation factor deficiency	9.62	9.50	3	117499	15	46568545
Gamma-glutamyltransferase increased	9.55	9.50	122	117380	31618	46536942
Nasopharyngitis	9.53	9.50	305	117197	153693	46414867
Hemianopia homonymous	9.52	9.50	10	117492	657	46567903

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 reaction with eosinophilia and systemic symptoms	540.63	9.84	520	82432	27968	29841558
Anaphylactic shock	466.22	9.84	353	82599	13640	29855886
Pruritus	451.31	9.84	1004	81948	117200	29752326
Rash maculo-papular	437.59	9.84	440	82512	24978	29844548
Urticaria	384.88	9.84	604	82348	54002	29815524
Cholestasis	295.58	9.84	355	82597	24595	29844931
Hepatocellular injury	289.68	9.84	355	82597	25116	29844410
Anaphylactic reaction	277.08	9.84	364	82588	27618	29841908
Erythema	266.49	9.84	632	82320	76819	29792707
Rash	266.06	9.84	1143	81809	190746	29678780
Acute generalised exanthematous pustulosis	258.27	9.84	178	82774	5920	29863606
Eosinophilia	257.08	9.84	312	82640	21848	29847678
Drug hypersensitivity	239.88	9.84	563	82389	67956	29801570
Meningitis aseptic	208.83	9.84	110	82842	2212	29867314
Hepatitis cholestatic	207.28	9.84	173	82779	7699	29861827
Death	207.26	9.84	425	82527	356858	29512668
Lip oedema	204.10	9.84	107	82845	2130	29867396
Drug-induced liver injury	198.68	9.84	269	82683	21005	29848521
Angioedema	197.31	9.84	347	82605	34037	29835489
Kounis syndrome	181.67	9.84	90	82862	1583	29867943
Completed suicide	156.76	9.84	41	82911	99451	29770075
Mixed liver injury	144.83	9.84	82	82870	1911	29867615
Acute kidney injury	135.50	9.84	1252	81700	272590	29596936
Toxic epidermal necrolysis	135.38	9.84	205	82747	17735	29851791
Face oedema	132.08	9.84	160	82792	11174	29858352
Type I hypersensitivity	130.39	9.84	60	82892	888	29868638
Stevens-Johnson syndrome	123.21	9.84	194	82758	17362	29852164
Lip swelling	117.22	9.84	160	82792	12584	29856942
Toxicity to various agents	109.03	9.84	203	82749	176980	29692546
Toxic skin eruption	105.43	9.84	141	82811	10874	29858652
Type IV hypersensitivity reaction	99.32	9.84	53	82899	1095	29868431
Hepatitis acute	97.60	9.84	109	82843	6974	29862552
Jaundice	93.58	9.84	248	82704	32238	29837288
Enterocolitis haemorrhagic	89.89	9.84	47	82905	930	29868596
Hypersensitivity	89.74	9.84	341	82611	53687	29815839
Hepatitis	89.59	9.84	194	82758	22162	29847364
Fixed eruption	86.80	9.84	49	82903	1135	29868391
Clostridium difficile colitis	86.70	9.84	139	82813	12629	29856897
Rash erythematous	84.51	9.84	190	82762	22262	29847264
Pyrexia	81.47	9.84	1204	81748	293285	29576241
Myocardial infarction	78.92	9.84	142	82810	125483	29744043
Dermatitis exfoliative generalised	78.55	9.84	64	82888	2751	29866775
Erythema multiforme	77.62	9.84	103	82849	7882	29861644
Wound closure	76.26	9.84	24	82928	111	29869415
Idiosyncratic drug reaction	76.22	9.84	34	82918	466	29869060
Fall	74.80	9.84	256	82696	181616	29687910
Osteotomy	74.09	9.84	24	82928	124	29869402
Tongue oedema	72.97	9.84	61	82891	2719	29866807
Documented hypersensitivity to administered product	72.44	9.84	26	82926	192	29869334
Eyelid oedema	68.42	9.84	77	82875	4968	29864558
Cardiac failure congestive	67.05	9.84	81	82871	84326	29785200
Crystalluria	64.72	9.84	28	82924	355	29869171
Rash morbilliform	63.82	9.84	54	82898	2448	29867078
Liver injury	62.04	9.84	118	82834	12282	29857244
Jaundice cholestatic	60.93	9.84	69	82883	4482	29865044
Drug abuse	59.80	9.84	84	82868	81988	29787538
Tubulointerstitial nephritis	58.17	9.84	143	82809	17748	29851778
Bronchospasm	57.53	9.84	103	82849	10235	29859291
Cholestatic liver injury	56.88	9.84	42	82910	1559	29867967
Rash pruritic	55.79	9.84	163	82789	22409	29847117
Fatigue	54.10	9.84	598	82354	320075	29549451
Malignant neoplasm progression	53.65	9.84	73	82879	72214	29797312
Cerebrovascular accident	53.61	9.84	93	82859	83384	29786142
Serum sickness-like reaction	52.14	9.84	17	82935	90	29869436
Palatal oedema	51.46	9.84	30	82922	740	29868786
Rash pustular	51.11	9.84	66	82886	4917	29864609
Acute psychosis	50.98	9.84	42	82910	1834	29867692
Faeces pale	50.80	9.84	38	82914	1439	29868087
Swelling face	49.44	9.84	150	82802	21054	29848472
Agranulocytosis	48.18	9.84	152	82800	21790	29847736
Purpura	46.38	9.84	92	82860	9875	29859651
Swollen tongue	45.62	9.84	108	82844	13084	29856442
Disease progression	45.17	9.84	96	82856	79778	29789748
Rash macular	42.71	9.84	91	82861	10276	29859250
Clostridium difficile infection	41.94	9.84	117	82835	15666	29853860
Rheumatoid arthritis	41.45	9.84	32	82920	41165	29828361
Hypersensitivity vasculitis	40.85	9.84	51	82901	3672	29865854
Mouth swelling	39.74	9.84	34	82918	1565	29867961
Lower respiratory tract infection	39.00	9.84	162	82790	26552	29842974
Henoch-Schonlein purpura	37.92	9.84	32	82920	1445	29868081
Dermatitis bullous	36.80	9.84	63	82889	6041	29863485
Sensation of foreign body	36.21	9.84	31	82921	1428	29868098
Chromaturia	36.07	9.84	102	82850	13763	29855763
Premature baby	36.07	9.84	115	82837	16576	29852950
Weight increased	35.29	9.84	99	82853	74814	29794712
Vomiting	34.81	9.84	825	82127	218993	29650533
Helicobacter gastritis	34.21	9.84	24	82928	821	29868705
Laryngeal oedema	34.15	9.84	44	82908	3270	29866256
Therapeutic product effect decreased	34.11	9.84	19	82933	29057	29840469
Inflammatory marker increased	33.91	9.84	43	82909	3145	29866381
Tooth disorder	33.87	9.84	77	82875	9084	29860442
Conjunctivitis	33.86	9.84	71	82881	7929	29861597
Mononucleosis syndrome	33.31	9.84	11	82941	61	29869465
Platelet count decreased	33.18	9.84	166	82786	105963	29763563
Dizziness	32.95	9.84	363	82589	194546	29674980
Hypertension	32.91	9.84	199	82753	121155	29748371
Cerebral infarction	32.76	9.84	16	82936	26357	29843169
Cell death	32.58	9.84	36	82916	2275	29867251
Injection site pain	32.51	9.84	22	82930	30288	29839238
Blood glucose increased	32.29	9.84	77	82875	61453	29808073
Helicobacter infection	32.07	9.84	34	82918	2050	29867476
Drug eruption	31.90	9.84	114	82838	17412	29852114
Sinusitis	31.86	9.84	179	82773	33166	29836360
Tooth demineralisation	31.76	9.84	7	82945	3	29869523
Crystal nephropathy	31.10	9.84	17	82935	369	29869157
Prothrombin time shortened	30.62	9.84	29	82923	1526	29868000
Coronary artery disease	30.45	9.84	57	82895	49655	29819871
Dermatitis allergic	30.20	9.84	56	82896	5716	29863810
Eosinophilic pleural effusion	30.02	9.84	14	82938	214	29869312
Laryngeal dyspnoea	29.91	9.84	10	82942	58	29869468
Depression	29.69	9.84	139	82813	90298	29779228
Pathogen resistance	29.24	9.84	69	82883	8341	29861185
Skin test positive	28.96	9.84	16	82936	355	29869171
Haemoglobin decreased	28.93	9.84	191	82761	113907	29755619
Blood creatine phosphokinase increased	28.92	9.84	48	82904	43800	29825726
Rash vesicular	28.89	9.84	35	82917	2443	29867083
Wheezing	28.85	9.84	165	82787	30773	29838753
Epstein-Barr virus infection reactivation	28.79	9.84	14	82938	236	29869290
Cheilitis	28.17	9.84	33	82919	2223	29867303
Aortitis	28.03	9.84	12	82940	148	29869378
Oxygen saturation immeasurable	28.03	9.84	9	82943	45	29869481
Rash papular	27.99	9.84	69	82883	8576	29860950
Tooth infection	27.96	9.84	51	82901	5140	29864386
Tachycardia foetal	27.84	9.84	15	82937	316	29869210
Malaise	27.74	9.84	631	82321	166331	29703195
Drug intolerance	27.68	9.84	52	82900	45239	29824287
Factitious disorder	27.55	9.84	9	82943	48	29869478
Sensitisation	27.26	9.84	12	82940	159	29869367
Conjunctival irritation	26.98	9.84	11	82941	119	29869407
Otospondylomegaepiphyseal dysplasia	26.81	9.84	11	82941	121	29869405
Periorbital oedema	26.50	9.84	39	82913	3287	29866239
Aphthous ulcer	25.30	9.84	43	82909	4098	29865428
Pain	25.16	9.84	332	82620	172309	29697217
Angina pectoris	24.86	9.84	27	82925	29491	29840035
White blood cell count decreased	24.71	9.84	134	82818	83813	29785713
Wrong technique in product usage process	24.61	9.84	30	82922	31125	29838401
Deficiency of bile secretion	24.60	9.84	7	82945	21	29869505
Hypersensitivity myocarditis	24.56	9.84	9	82943	71	29869455
Rash scarlatiniform	24.54	9.84	10	82942	108	29869418
Product dose omission issue	24.44	9.84	151	82801	91480	29778046
Malignant mesenteric neoplasm	24.28	9.84	8	82944	44	29869482
Mental status changes	24.07	9.84	41	82911	37038	29832488
Loss of personal independence in daily activities	23.95	9.84	15	82937	21520	29848006
Macroglossia	23.92	9.84	12	82940	217	29869309
Ureteral disorder	23.36	9.84	11	82941	172	29869354
Heart rate decreased	22.83	9.84	15	82937	20979	29848547
Foetal disorder	22.79	9.84	17	82935	641	29868885
Escherichia infection	22.76	9.84	53	82899	6352	29863174
Irregular breathing	22.75	9.84	10	82942	132	29869394
Infusion related reaction	22.71	9.84	49	82903	40515	29829011
Hyperaemia	22.61	9.84	20	82932	963	29868563
Foetal exposure during pregnancy	22.51	9.84	177	82775	36694	29832832
Acute hepatic failure	22.45	9.84	78	82874	11749	29857777
Pain in extremity	22.05	9.84	197	82755	110024	29759502
Conjunctival hyperaemia	21.66	9.84	29	82923	2238	29867288
Gut fermentation syndrome	21.60	9.84	6	82946	16	29869510
Diarrhoea	21.19	9.84	1129	81823	332974	29536552
Attention-seeking behaviour	21.17	9.84	7	82945	39	29869487
Penile erythema	21.14	9.84	10	82942	158	29869368
Hyperbilirubinaemia	21.12	9.84	98	82854	16844	29852682
Jejunal ulcer perforation	21.11	9.84	8	82944	70	29869456
Neutropenia neonatal	21.06	9.84	15	82937	526	29869000
Deep vein thrombosis	21.04	9.84	91	82861	60410	29809116
Asthenia	21.02	9.84	460	82492	220830	29648696
Intentional product misuse	21.01	9.84	40	82912	34627	29834899
Ear infection	20.92	9.84	56	82896	7318	29862208
Mite allergy	20.84	9.84	11	82941	222	29869304
Metastases to stomach	20.72	9.84	8	82944	74	29869452
Cardio-respiratory arrest	20.67	9.84	85	82867	57221	29812305
Alice in wonderland syndrome	20.61	9.84	6	82946	20	29869506
Dyspnoea	20.49	9.84	1123	81829	332172	29537354
Choluria	20.49	9.84	10	82942	170	29869356
Dental operation	20.27	9.84	13	82939	382	29869144
Erysipelas	20.14	9.84	41	82911	4483	29865043
Dysbiosis	20.00	9.84	13	82939	391	29869135
Ultrasound liver abnormal	19.94	9.84	9	82943	127	29869399
Skin exfoliation	19.93	9.84	121	82831	23051	29846475
Seizure	19.70	9.84	176	82776	98299	29771227
Bradycardia	19.61	9.84	104	82848	65422	29804104
Pharyngeal erythema	19.50	9.84	14	82938	497	29869029
Dermatomyositis	19.42	9.84	19	82933	1041	29868485
Transaminases increased	19.24	9.84	121	82831	23336	29846190
Hyperleukocytosis	19.21	9.84	23	82929	1586	29867940
Oropharyngeal pain	19.19	9.84	140	82812	28356	29841170
Haematocrit decreased	18.97	9.84	35	82917	30664	29838862
Skin reaction	18.96	9.84	40	82912	4485	29865041
Odynophagia	18.95	9.84	40	82912	4487	29865039
Headache	18.76	9.84	374	82578	181932	29687594
Genital erythema	18.71	9.84	9	82943	148	29869378
Eastern Cooperative Oncology Group performance status	18.68	9.84	6	82946	30	29869496
Omental necrosis	18.68	9.84	6	82946	30	29869496
Procalcitonin increased	18.57	9.84	19	82933	1099	29868427
Ischaemic stroke	18.57	9.84	11	82941	16264	29853262
Drug dependence	18.46	9.84	19	82933	21276	29848250
Breath sounds	18.37	9.84	5	82947	12	29869514
Substance-induced mood disorder	18.37	9.84	5	82947	12	29869514
Constipation	18.36	9.84	212	82740	112694	29756832
Enterocolitis	18.19	9.84	50	82902	6637	29862889
Morganella infection	18.12	9.84	12	82940	373	29869153
Tissue infiltration	18.01	9.84	7	82945	66	29869460
Orthostatic hypotension	17.99	9.84	24	82928	23955	29845571
Skin oedema	17.96	9.84	14	82938	564	29868962
Bone disorder	17.93	9.84	50	82902	6691	29862835
Eosinophilic pneumonia acute	17.93	9.84	13	82939	469	29869057
Mycotic allergy	17.68	9.84	9	82943	168	29869358
Linear IgA disease	17.66	9.84	22	82930	1580	29867946
Faeces discoloured	17.62	9.84	81	82871	13865	29855661
Off label use	17.37	9.84	542	82410	248748	29620778
Lichenoid keratosis	17.33	9.84	25	82927	2069	29867457
Pharyngeal oedema	17.22	9.84	48	82904	6423	29863103
Papule	17.15	9.84	31	82921	3102	29866424
Hyperglycaemia	16.95	9.84	46	82906	35154	29834372
Blood pressure increased	16.93	9.84	123	82829	71805	29797721
Spinal muscular atrophy	16.90	9.84	9	82943	185	29869341
Plica syndrome	16.81	9.84	4	82948	4	29869522
Genital cyst	16.81	9.84	4	82948	4	29869522
Food intolerance	16.77	9.84	18	82934	1101	29868425
Neutrophil count decreased	16.57	9.84	61	82891	42393	29827133
Pharyngitis	16.51	9.84	49	82903	6793	29862733
Unresponsive to stimuli	16.43	9.84	30	82922	26389	29843137
Coagulation factor decreased	16.38	9.84	7	82945	86	29869440
Macule	16.35	9.84	16	82936	877	29868649
Vanishing bile duct syndrome	16.19	9.84	14	82938	654	29868872
Tachypnoea	16.13	9.84	83	82869	14869	29854657
Metastases to heart	16.13	9.84	8	82944	141	29869385
Laryngeal discomfort	15.98	9.84	8	82944	144	29869382
Hypocoagulable state	15.93	9.84	16	82936	905	29868621
Hypertransaminasaemia	15.88	9.84	34	82918	3851	29865675
Blood creatinine increased	15.87	9.84	169	82783	91206	29778320
Cerebral haemorrhage	15.82	9.84	43	82909	32844	29836682
Diabetes mellitus	15.79	9.84	61	82891	41804	29827722
Melanocytic hyperplasia	15.54	9.84	4	82948	7	29869519
Tongue eruption	15.54	9.84	4	82948	7	29869519
Drug ineffective	15.47	9.84	778	82174	339609	29529917
Synovitis	15.45	9.84	4	82948	9779	29859747
Granulomatous dermatitis	15.40	9.84	9	82943	223	29869303
Maple syrup disease	15.20	9.84	4	82948	8	29869518
Ototoxicity	15.12	9.84	19	82933	1377	29868149
Rectal polyp	14.98	9.84	13	82939	610	29868916
Inappropriate schedule of product administration	14.91	9.84	58	82894	39670	29829856
Sedation	14.90	9.84	14	82938	16359	29853167
Dermatitis	14.85	9.84	53	82899	8089	29861437
Maternal exposure during pregnancy	14.83	9.84	33	82919	3838	29865688
Antinuclear antibody negative	14.81	9.84	5	82947	30	29869496
Anaemia	14.77	9.84	451	82501	207541	29661985
Drug withdrawal syndrome	14.69	9.84	20	82932	19789	29849737
Toxocariasis	14.68	9.84	3	82949	0	29869526
Intercostal neuralgia	14.68	9.84	3	82949	0	29869526
Hepatic function abnormal	14.63	9.84	63	82889	41882	29827644
Tooth abscess	14.61	9.84	39	82913	5087	29864439
Conjunctivitis allergic	14.60	9.84	12	82940	522	29869004
Peritonitis	14.46	9.84	23	82929	21352	29848174
Ascites	14.42	9.84	51	82901	35870	29833656
Cutaneous vasculitis	14.39	9.84	28	82924	2963	29866563
Dermatosis	14.33	9.84	9	82943	255	29869271
Prostate cancer	14.20	9.84	28	82924	23929	29845597
Cardiac ventricular disorder	14.18	9.84	8	82944	185	29869341
Low birth weight baby	14.17	9.84	43	82909	6033	29863493
Hallucinations, mixed	14.15	9.84	25	82927	2458	29867068
Biliary sepsis	14.13	9.84	13	82939	659	29868867
Insomnia	14.12	9.84	178	82774	93158	29776368
Respiratory tract infection bacterial	14.09	9.84	12	82940	549	29868977
Colon cancer	14.05	9.84	3	82949	8369	29861157
Interleukin-2 receptor increased	14.03	9.84	7	82945	125	29869401
Anal abscess	13.88	9.84	38	82914	5031	29864495
Gingivitis	13.88	9.84	28	82924	3042	29866484
Balanoposthitis	13.87	9.84	16	82936	1060	29868466
Nocardiosis	13.85	9.84	30	82922	3425	29866101
Exostosis of external ear canal	13.82	9.84	4	82948	13	29869513
Osteomyelitis salmonella	13.81	9.84	5	82947	38	29869488
Mucous stools	13.77	9.84	15	82937	933	29868593
Dysentery	13.66	9.84	8	82944	199	29869327
Hepatitis C	13.61	9.84	10	82942	13195	29856331
Infusion site induration	13.59	9.84	8	82944	201	29869325
Leukocytosis	13.55	9.84	104	82848	21398	29848128
Respiratory arrest	13.52	9.84	39	82913	29219	29840307
Overdose	13.46	9.84	159	82793	84178	29785348
Device malfunction	13.43	9.84	3	82949	8108	29861418
Vesicoureteric reflux	13.41	9.84	7	82945	138	29869388
Tongue discolouration	13.41	9.84	16	82936	1099	29868427
Orbital myositis	13.40	9.84	6	82946	83	29869443
Pulmonary valve disease	13.34	9.84	6	82946	84	29869442
Spirometry abnormal	13.33	9.84	9	82943	289	29869237
Otitis media acute	13.27	9.84	10	82942	383	29869143
Superinfection bacterial	13.26	9.84	11	82941	485	29869041
Lymphadenopathy	13.25	9.84	114	82838	24262	29845264
Therapeutic response decreased	13.14	9.84	30	82922	24319	29845207
Injection site swelling	13.10	9.84	4	82948	8776	29860750
Ear swelling	13.09	9.84	10	82942	391	29869135
Endocarditis candida	13.03	9.84	6	82946	89	29869437
Blister	13.01	9.84	100	82852	20583	29848943
Blood urea increased	12.97	9.84	44	82908	31337	29838189
Dehydration	12.82	9.84	253	82699	123286	29746240
Erythema annulare	12.80	9.84	4	82948	18	29869508
Underdose	12.77	9.84	9	82943	12132	29857394
Localised oedema	12.67	9.84	27	82925	3049	29866477
Blood pressure fluctuation	12.65	9.84	18	82934	17485	29852041
Accessory auricle	12.62	9.84	4	82948	19	29869507
Human herpesvirus 6 infection reactivation	12.62	9.84	4	82948	19	29869507
Rebound acid hypersecretion	12.61	9.84	5	82947	50	29869476
Red blood cell sedimentation rate decreased	12.61	9.84	5	82947	50	29869476
Back pain	12.58	9.84	204	82748	102392	29767134
Abdominal wall haematoma	12.55	9.84	19	82933	1642	29867884
Haemolytic anaemia	12.54	9.84	58	82894	9952	29859574
Cataract	12.53	9.84	26	82926	21809	29847717
Toothache	12.52	9.84	40	82912	5771	29863755
Rotavirus infection	12.40	9.84	9	82943	325	29869201
Injection site erythema	12.39	9.84	12	82940	13822	29855704
Therapeutic product effect incomplete	12.31	9.84	50	82902	33784	29835742
Hyperthermia	12.28	9.84	58	82894	10041	29859485
Infectious mononucleosis	12.25	9.84	10	82942	431	29869095
Swelling of eyelid	12.24	9.84	9	82943	332	29869194
Alveolitis	12.08	9.84	19	82933	1698	29867828
Congenital heart valve disorder	12.03	9.84	5	82947	57	29869469
Schizophrenia	12.00	9.84	5	82947	9043	29860483
Periostosis	11.99	9.84	4	82948	23	29869503
Anal inflammation	11.98	9.84	9	82943	343	29869183
Cardiac failure	11.91	9.84	161	82791	83257	29786269
Body fat disorder	11.88	9.84	5	82947	59	29869467
Hospitalisation	11.82	9.84	73	82879	44246	29825280
Haematuria	11.78	9.84	182	82770	44652	29824874
Mobility decreased	11.76	9.84	35	82917	25964	29843562
Urinary retention	11.75	9.84	49	82903	32868	29836658
Drug interaction	11.74	9.84	670	82282	198898	29670628
Oral mucosal blistering	11.62	9.84	19	82933	1754	29867772
Sense of oppression	11.60	9.84	10	82942	465	29869061
Psoriatic arthropathy	11.60	9.84	16	82936	15745	29853781
Hordeolum	11.48	9.84	12	82940	712	29868814
Interstitial lung disease	11.42	9.84	109	82843	60088	29809438
Plasma cell myeloma	11.37	9.84	94	82858	53368	29816158
Ileal perforation	11.30	9.84	12	82940	725	29868801
Neoplasm malignant	11.28	9.84	20	82932	17794	29851732
Pyelocaliectasis	11.27	9.84	14	82938	1003	29868523
Anaphylactoid reaction	11.18	9.84	21	82931	2165	29867361
Musculoskeletal pain	11.08	9.84	46	82906	30894	29838632
Mast cell degranulation present	10.93	9.84	5	82947	73	29869453
Gastrointestinal ischaemia	10.82	9.84	7	82945	209	29869317
Transplant rejection	10.82	9.84	6	82946	9200	29860326
Gait disturbance	10.79	9.84	144	82808	74633	29794893
Ligament sprain	10.76	9.84	24	82928	2796	29866730
Blood immunoglobulin A increased	10.74	9.84	8	82944	301	29869225
Hypergammaglobulinaemia	10.67	9.84	7	82945	214	29869312
Dust allergy	10.63	9.84	9	82943	408	29869118
Ultrasound scan abnormal	10.63	9.84	5	82947	78	29869448
Anxiety	10.59	9.84	180	82772	89691	29779835
Noninfective sialoadenitis	10.54	9.84	3	82949	9	29869517
Pseudomembranous colitis	10.48	9.84	24	82928	2844	29866682
Gynaecomastia	10.47	9.84	5	82947	8346	29861180
Brain abscess	10.43	9.84	23	82929	2658	29866868
Acute myocardial infarction	10.41	9.84	95	82857	52844	29816682
Eczema	10.37	9.84	68	82884	13301	29856225
Blood pressure decreased	10.37	9.84	82	82870	46993	29822533
Contraindicated product administered	10.33	9.84	20	82932	17211	29852315
Vascular purpura	10.31	9.84	17	82935	1580	29867946
Weight decreased	10.27	9.84	329	82623	150592	29718934
Arthralgia	10.23	9.84	292	82660	135499	29734027
Multiple sclerosis relapse	10.22	9.84	9	82943	10853	29858673
Resorption bone increased	10.19	9.84	5	82947	86	29869440
Epstein-Barr virus antibody positive	10.19	9.84	8	82944	326	29869200
Pneumococcal sepsis	10.18	9.84	11	82941	678	29868848
Infusion site swelling	10.17	9.84	17	82935	1599	29867927
Stomatitis	10.16	9.84	61	82891	37218	29832308
C-reactive protein increased	10.13	9.84	173	82779	43300	29826226
Penile swelling	10.08	9.84	12	82940	822	29868704
Candida infection	10.07	9.84	75	82877	15287	29854239
Coronavirus test positive	10.06	9.84	8	82944	332	29869194
Skin graft failure	10.04	9.84	6	82946	155	29869371
Peritonitis bacterial	10.04	9.84	10	82942	11368	29858158
Glycosylated haemoglobin increased	10.03	9.84	7	82945	9484	29860042
Dermatitis exfoliative	9.94	9.84	44	82908	7412	29862114
Diarrhoea haemorrhagic	9.92	9.84	37	82915	5768	29863758
Hypersomnia	9.92	9.84	10	82942	11306	29858220
Small intestinal obstruction	9.92	9.84	14	82938	13645	29855881
Venoocclusive liver disease	9.89	9.84	3	82949	6610	29862916
Precancerous condition	9.88	9.84	3	82949	12	29869514
Genital lesion	9.86	9.84	7	82945	244	29869282
Dementia	9.84	9.84	12	82940	12449	29857077

Pharmacologic Action:

Source	Code	Description
ATC	J01CA04	ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE BETA-LACTAM ANTIBACTERIALS, PENICILLINS Penicillins with extended spectrum
ATC	A02BD01	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	A02BD03	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	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	A02BD10	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	A02BD13	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	A02BD15	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	J01CR02	ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE BETA-LACTAM ANTIBACTERIALS, PENICILLINS Combinations of penicillins, incl. beta-lactamase inhibitors
FDA CS	M0016152	Penicillins
FDA EPC	N0000175497	Penicillin-class Antibacterial
CHEBI has role	CHEBI:36047	antibacterial drugs
MeSH PA	D000900	Anti-Bacterial Agents
MeSH PA	D000890	Anti-Infective Agents

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Acute otitis media	indication	3110003
Staphylococcal tonsillitis	indication	11461005
Infection of skin AND/OR subcutaneous tissue	indication	19824006
Pneumonia due to Streptococcus	indication	34020007
Streptococcal tonsillitis	indication	41582007
Lower respiratory tract infection	indication	50417007
Bacterial pneumonia	indication	53084003	DOID:874
Klebsiella cystitis	indication	60867007
Pneumonia due to Klebsiella pneumoniae	indication	64479007
Urinary tract infectious disease	indication	68566005
Haemophilus influenzae pneumonia	indication	70036007
Infection due to Escherichia coli	indication	71057007
Rhinoscleroma	indication	72409005	DOID:11336
Acute bacterial sinusitis	indication	75498004
Staphylococcal pharyngitis	indication	82228008
Pneumococcal pneumonia	indication	233607000
Escherichia coli urinary tract infection	indication	301011002
Streptococcus pyogenes infection	indication	302809008
Bacterial urinary infection	indication	312124009
Infective otitis media	indication	312218008
Pharyngitis	indication	405737000	DOID:2275
Infection due to Staphylococcus aureus	indication	406602003
Acute exacerbation of chronic bronchitis	indication	425748003
Pneumonia due to Staphylococcus aureus	indication	441658007
Helicobacter pylori-associated gastritis	indication	708164002
Skin and Skin Structure Streptococcus Infection	indication
E. Coli Genitourinary Tract Infection	indication
Moraxella Catarrhalis Acute Otitis Media	indication
Duodenal Ulcer due to H. Pylori	indication
Haemophilus Influenzae Chronic Bronchitis	indication
Moraxella Catarrhalis Pneumonia	indication
Tonsillitis due to Haemophilus Influenzae	indication
Genitourinary Tract Infections	indication
Haemophilus Influenzae Pharyngitis	indication
Genitourinary Tract Infection due to Proteus	indication
Haemophilus Influenzae Acute Otitis Media	indication
Pneumococcal Acute Otitis Media	indication
Haemophilus Parainfluenzae Pneumonia	indication
Streptococcus Pneumoniae Chronic Bronchitis	indication
Enterococcus Genitourinary Tract Infection	indication
Typhoid fever	off-label use	4834000	DOID:13258
Pyrexia of unknown origin	off-label use	7520000
Lyme disease	off-label use	23502006	DOID:11729
Chronic purulent otitis media	off-label use	38394007	DOID:14247
Cholangitis	off-label use	82403002	DOID:9446
Human bite - wound	off-label use	262555007
Chancroid	off-label use	266143009	DOID:13778
Diverticulitis of gastrointestinal tract	off-label use	271366000
Dog bite - wound	off-label use	283734005
Cat bite - wound	off-label use	283782004
Prevention of Bacterial Endocarditis	off-label use
Diabetic Foot Infection	off-label use
Prevention of Neonatal Group B Streptococcal Infection	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

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	2.79	acidic
pKa2	9.72	acidic
pKa3	7.63	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
5-hydroxytryptamine receptor 2B	GPCR	P41595	5HT2B_HUMAN		IC50	5.96		WOMBAT-PK
5-hydroxytryptamine receptor 2A	GPCR	P28223	5HT2A_HUMAN		IC50	6.22		WOMBAT-PK
5-hydroxytryptamine receptor 2C	GPCR	P28335	5HT2C_HUMAN		IC50	5.80		WOMBAT-PK
Bacterial penicillin-binding protein	Enzyme		DACA_ECOLI DACB_ECOLI DACC_ECOLI FTSI_ECOLI PBP2_ECOLI PBPA_ECOLI PBPB_ECOLI	INHIBITOR				CHEMBL	CHEMBL
Penicillin-binding protein 1A	Enzyme		PBPA_CLOPE					WOMBAT-PK

External reference:

ID	Source
9EM05410Q9	UNII
4017605	VUID
N0000145985	NUI
D00229	KEGG_DRUG
34642-77-8	SECONDARY_CAS_RN
C0002645	UMLSCUI
CHEBI:2676	CHEBI
AXL	PDB_CHEM_ID
CHEMBL1082	ChEMBL_ID
CHEMBL2105950	ChEMBL_ID
DB01060	DRUGBANK_ID
D000658	MESH_DESCRIPTOR_UI
33613	PUBCHEM_CID
3230	INN_ID
10895	IUPHAR_LIGAND_ID
1297882	RXNORM
11786	MMSL
3600	MMSL
4187	MMSL
d00088	MMSL
002707	NDDF
003675	NDDF
003718	NDDF
27658006	SNOMEDCT_US
372687004	SNOMEDCT_US
427483001	SNOMEDCT_US
785686003	SNOMEDCT_US
96068000	SNOMEDCT_US
4017604	VANDF
4017605	VANDF

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	3	0781-1943	TABLET, MULTILAYER, EXTENDED RELEASE	437.50 mg	ORAL	ANDA	26 sections
Amoxicillin and Clavulanate Potassium Extended Release	HUMAN PRESCRIPTION DRUG LABEL	3	43598-220	TABLET, FILM COATED, EXTENDED RELEASE	437.50 mg	ORAL	NDA	27 sections