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

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

Stem definition	Drug id	CAS RN
anti-infectives, sulfonamides	2514	723-46-6

Description:

Molecule

Description

Molfile Inchi Smiles Synonyms: sulfamethoxazole sulfamethalazole sulfamethoxazol sulfisomezole sulphamethoxazole

A bacteriostatic antibacterial agent that interferes with folic acid synthesis in susceptible bacteria. Its broad spectrum of activity has been limited by the development of resistance. (From Martindale, The Extra Pharmacopoeia, 30th ed, p208) Molecular weight: 253.28 Formula: C10H11N3O3S CLOGP: 0.56 LIPINSKI: 0 HAC: 6 HDO: 2 TPSA: 98.22 ALOGS: -2.74 ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

Dose	Unit	Route
2	g	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.39 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	14 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	394.82 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	99 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.30 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	0.36 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)	9.80 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
July 30, 1973	FDA	MONARCH PHARMS

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
Muscle injury	1104.19	11.97	632	58841	36479	50509172
Folliculitis	1092.71	11.97	640	58833	38585	50507066
Sleep disorder due to general medical condition, insomnia type	1067.40	11.97	584	58889	30863	50514788
Irritable bowel syndrome	959.57	11.97	651	58822	50790	50494861
Impaired healing	771.98	11.97	646	58827	69140	50476511
Blister	706.87	11.97	671	58802	84747	50460904
Gastrointestinal disorder	677.20	11.97	686	58787	93770	50451881
Stomatitis	642.22	11.97	689	58784	100655	50444996
Lower respiratory tract infection	623.99	11.97	659	58814	94542	50451109
Duodenal ulcer perforation	532.70	11.97	436	59037	45175	50500476
Ill-defined disorder	531.03	11.97	470	59003	54184	50491467
Helicobacter infection	510.14	11.97	441	59032	49261	50496390
Infection	416.70	11.97	736	58737	172218	50373433
Therapeutic product effect decreased	405.33	11.97	637	58836	135413	50410238
Confusional state	398.32	11.97	752	58721	185176	50360475
Sinusitis	371.66	11.97	695	58778	169863	50375788
Pyrexia	356.15	11.97	1116	58357	379087	50166564
Anti-cyclic citrullinated peptide antibody positive	345.13	11.97	420	59053	70167	50475484
Pericarditis	344.52	11.97	443	59030	78246	50467405
Nasopharyngitis	290.91	11.97	676	58797	192251	50353400
Weight increased	289.89	11.97	694	58779	201197	50344454
Hypersensitivity	287.06	11.97	719	58754	214442	50331209
Peripheral swelling	280.84	11.97	694	58779	205242	50340409
Contusion	274.41	11.97	481	58992	111702	50433949
Swelling	272.90	11.97	676	58797	200196	50345455
Synovitis	254.98	11.97	493	58980	123372	50422279
Hand deformity	248.10	11.97	432	59041	99767	50445884
Discomfort	244.95	11.97	449	59024	107931	50437720
Joint swelling	218.84	11.97	709	58764	244577	50301074
Pruritus	217.38	11.97	779	58694	282789	50262862
Arthropathy	206.47	11.97	524	58949	157382	50388269
Glossodynia	205.59	11.97	433	59040	115136	50430515
Hepatic enzyme increased	202.03	11.97	477	58996	136903	50408748
Wound	200.65	11.97	407	59066	105387	50440264
Pemphigus	196.33	11.97	435	59038	119731	50425920
Infusion related reaction	163.73	11.97	504	58969	169053	50376598
Systemic lupus erythematosus	161.71	11.97	445	59028	140177	50405474
Fall	151.91	11.97	104	59369	334828	50210823
Rash	146.55	11.97	946	58527	436525	50109126
Product dose omission issue	146.42	11.97	21	59452	183817	50361834
Death	129.83	11.97	115	59358	325264	50220387
Dizziness	112.97	11.97	145	59328	346224	50199427
Toxicity to various agents	110.33	11.97	56	59417	212443	50333208
Completed suicide	109.95	11.97	13	59460	131876	50413775
Contraindicated product administered	109.36	11.97	404	59069	148554	50397097
Off label use	108.65	11.97	249	59224	474177	50071474
Pain in extremity	102.25	11.97	102	59371	272763	50272888
Abdominal discomfort	102.00	11.97	539	58934	231102	50314549
Malaise	97.92	11.97	152	59321	335380	50210271
Nausea	97.45	11.97	463	59010	704935	49840716
Pre-engraftment immune reaction	92.12	11.97	26	59447	212	50545439
Drug intolerance	89.79	11.97	500	58973	218604	50327047
Headache	89.08	11.97	302	59171	506233	50039418
Injection site pain	85.34	11.97	14	59459	111010	50434641
Blood pressure increased	72.23	11.97	33	59440	133099	50412552
Feeling abnormal	69.82	11.97	30	59443	125462	50420189
Diarrhoea	67.38	11.97	411	59062	588065	49957586
Alanine aminotransferase abnormal	66.59	11.97	48	59425	4108	50541543
Rheumatoid arthritis	66.24	11.97	436	59037	202114	50343537
Cough	64.10	11.97	116	59357	241148	50304503
Encephalitis viral	63.49	11.97	33	59440	1564	50544087
Red blood cell sedimentation rate	63.44	11.97	44	59429	3542	50542109
Intentional overdose	60.91	11.97	3	59470	62501	50483150
Arthralgia	59.94	11.97	782	58691	437920	50107731
Human herpesvirus 6 infection	55.78	11.97	36	59437	2570	50543081
Therapeutic product effect incomplete	53.97	11.97	20	59453	91495	50454156
Condition aggravated	53.51	11.97	175	59298	296883	50248768
Pneumonia	53.39	11.97	246	59227	378155	50167496
Fear of injection	50.43	11.97	48	59425	6055	50539596
Injection site erythema	50.24	11.97	13	59460	74923	50470728
Medication error	49.33	11.97	122	59351	35982	50509669
Muscle spasms	49.20	11.97	45	59428	125508	50420143
Alopecia	48.48	11.97	470	59003	244577	50301074
Drug abuse	47.22	11.97	7	59466	59839	50485812
Inappropriate schedule of product administration	47.14	11.97	13	59460	71818	50473833
Injection site reaction	46.90	11.97	3	59470	50029	50495622
Tongue disorder	46.85	11.97	56	59417	9160	50536491
Psoriasis	46.20	11.97	12	59461	68988	50476663
Enthesopathy	45.57	11.97	49	59424	7144	50538507
Weight decreased	45.10	11.97	123	59350	221122	50324529
Back pain	45.10	11.97	122	59351	219908	50325743
Cytomegalovirus infection	45.08	11.97	78	59395	17884	50527767
Gait disturbance	44.57	11.97	67	59406	149938	50395713
Depression	44.38	11.97	79	59394	165344	50380307
Blood parathyroid hormone decreased	44.26	11.97	48	59425	7066	50538585
Pregnancy	41.53	11.97	101	59372	29476	50516175
Wrong technique in product usage process	40.48	11.97	8	59465	55502	50490149
COVID-19	40.39	11.97	4	59469	46658	50498993
Dyspnoea	39.39	11.97	880	58593	546728	49998923
Balance disorder	39.05	11.97	17	59456	70573	50475078
Panniculitis	38.91	11.97	49	59424	8454	50537197
Suicide attempt	38.69	11.97	7	59466	51725	50493926
Visual impairment	36.89	11.97	17	59456	68258	50477393
Memory impairment	36.73	11.97	24	59449	79336	50466315
Skin necrosis	36.64	11.97	54	59419	10813	50534838
Kidney transplant rejection	36.11	11.97	33	59440	3954	50541697
Myocardial infarction	35.96	11.97	31	59442	88996	50456655
Intentional product misuse	35.66	11.97	6	59467	46728	50498923
Constipation	34.37	11.97	108	59365	185600	50360051
Flushing	34.22	11.97	18	59455	66997	50478654
Migraine	33.20	11.97	24	59449	75256	50470395
Maternal exposure timing unspecified	32.86	11.97	30	59443	3590	50542061
Oropharyngeal pain	32.78	11.97	26	59447	77775	50467876
Hyperhidrosis	32.77	11.97	34	59439	89392	50456259
Syncope	32.57	11.97	44	59429	102958	50442693
Hypertension	32.34	11.97	133	59340	211070	50334581
Injection site bruising	32.22	11.97	3	59470	36765	50508886
Tenosynovitis	32.08	11.97	50	59423	10515	50535136
Therapy non-responder	31.38	11.97	131	59342	50891	50494760
Influenza	30.66	11.97	36	59437	89502	50456149
Injection site swelling	30.50	11.97	6	59467	41767	50503884
Anxiety	30.32	11.97	107	59366	177499	50368152
Fluid retention	29.97	11.97	11	59462	50638	50495013
Asthenia	29.85	11.97	236	59237	318806	50226845
Breast cancer	29.60	11.97	7	59466	42883	50502768
Suicidal ideation	29.60	11.97	14	59459	55371	50490280
Cerebrovascular accident	29.38	11.97	41	59432	94639	50451012
Paraesthesia	29.12	11.97	61	59412	120182	50425469
Meningoencephalitis herpetic	28.50	11.97	17	59456	1055	50544596
Loss of consciousness	27.82	11.97	50	59423	104303	50441348
Granuloma skin	27.38	11.97	34	59439	5784	50539867
Urinary tract infection	27.34	11.97	153	59320	223867	50321784
Injection site pruritus	27.10	11.97	7	59466	40404	50505247
Deafness transitory	27.09	11.97	20	59453	1776	50543875
Hepatic cytolysis	26.94	11.97	40	59433	8063	50537588
Depressed mood	26.79	11.97	4	59469	34019	50511632
Stress	26.66	11.97	15	59458	53778	50491873
Vomiting	26.43	11.97	382	59091	460376	50085275
Overdose	26.39	11.97	48	59425	99679	50445972
Blood creatinine increased	26.09	11.97	166	59307	75994	50469657
Chest discomfort	26.02	11.97	43	59430	92679	50452972
Multiple sclerosis relapse	25.99	11.97	9	59464	42955	50502696
Complications of transplanted kidney	25.80	11.97	21	59452	2152	50543499
Unevaluable event	25.62	11.97	11	59462	46055	50499596
Palpitations	25.45	11.97	45	59428	94461	50451190
Rheumatoid nodule	25.29	11.97	50	59423	12685	50532966
Cataract	25.21	11.97	12	59461	47288	50498363
Febrile bone marrow aplasia	25.19	11.97	34	59439	6277	50539374
Dyspepsia	25.14	11.97	30	59443	74067	50471584
Blood pressure fluctuation	24.42	11.97	6	59467	35817	50509834
Maternal exposure during pregnancy	24.35	11.97	291	59182	159487	50386164
HIV infection	24.33	11.97	10	59463	274	50545377
Atrial fibrillation	24.31	11.97	52	59421	101693	50443958
Nasal congestion	24.28	11.97	15	59458	51105	50494546
Stevens-Johnson syndrome	24.11	11.97	68	59405	21684	50523967
Myalgia	23.92	11.97	71	59402	124248	50421403
Deep vein thrombosis postoperative	23.90	11.97	18	59455	1647	50544004
Hot flush	23.86	11.97	11	59462	44158	50501493
Hospitalisation	23.59	11.97	27	59446	67910	50477741
Drug eruption	23.48	11.97	71	59402	23535	50522116
Haematochezia	23.03	11.97	9	59464	39873	50505778
Osteoporosis	22.99	11.97	12	59461	44867	50500784
Cardiac disorder	22.76	11.97	11	59462	42968	50502683
Femur fracture	22.40	11.97	8	59465	37456	50508195
Dysphonia	22.09	11.97	9	59464	38883	50506768
Foetal exposure during pregnancy	22.05	11.97	3	59470	27356	50518295
Rhinorrhoea	22.02	11.97	17	59456	51566	50494085
Aspartate aminotransferase increased	21.96	11.97	162	59311	77836	50467815
Incorrect dose administered	21.92	11.97	15	59458	48399	50497252
Asthma	21.90	11.97	45	59428	89292	50456359
Agranulocytosis	21.84	11.97	65	59408	21356	50524295
Neck pain	21.70	11.97	21	59452	57046	50488605
Coma	21.38	11.97	127	59346	56752	50488899
Cardiac failure congestive	21.11	11.97	42	59431	84340	50461311
Throat irritation	20.74	11.97	5	59468	30234	50515417
Musculoskeletal pain	20.69	11.97	33	59440	72144	50473507
Granuloma	20.66	11.97	27	59446	4831	50540820
No adverse event	20.37	11.97	7	59466	33571	50512080
Tendonitis	20.28	11.97	54	59419	16651	50529000
Exposure during pregnancy	19.92	11.97	74	59399	120941	50424710
Influenza like illness	19.77	11.97	23	59450	57436	50488215
Injury	19.54	11.97	111	59362	48814	50496837
Osteoarthritis	19.08	11.97	32	59441	68574	50477077
Pancytopenia	19.00	11.97	166	59307	83864	50461787
Dry eye	18.94	11.97	7	59466	32088	50513563
Heart rate increased	18.86	11.97	39	59434	77211	50468440
Dry mouth	18.79	11.97	23	59450	56155	50489496
Oxygen saturation decreased	18.72	11.97	36	59437	73212	50472439
Vertigo	18.65	11.97	20	59453	51812	50493839
Acquired immunodeficiency syndrome	18.60	11.97	6	59467	80	50545571
Full blood count abnormal	17.85	11.97	3	59470	23385	50522266
Drug hypersensitivity	17.82	11.97	403	59070	250607	50295044
Pneumonia aspiration	17.82	11.97	78	59395	30926	50514725
Autoimmune disorder	17.81	11.97	28	59445	5932	50539719
Product quality issue	17.76	11.97	7	59466	30851	50514800
Device expulsion	17.49	11.97	6	59467	28816	50516835
Mobility decreased	17.37	11.97	43	59430	79905	50465746
Pain in jaw	17.27	11.97	12	59461	38416	50507235
Alanine aminotransferase increased	17.19	11.97	169	59304	88190	50457461
Surgery	17.14	11.97	7	59466	30198	50515453
Hypoaesthesia	17.14	11.97	84	59389	127173	50418478
Cardio-respiratory arrest	17.05	11.97	23	59450	53869	50491782
Bradycardia	17.05	11.97	31	59442	64395	50481256
Transplant rejection	17.04	11.97	36	59437	9573	50536078
Cytomegalovirus test positive	17.03	11.97	18	59455	2574	50543077
Bronchitis	16.94	11.97	64	59409	104095	50441556
Intestinal obstruction	16.89	11.97	5	59468	26378	50519273
Bacterial sepsis	16.82	11.97	21	59452	3591	50542060
Abdominal distension	16.80	11.97	38	59435	72865	50472786
Abdominal pain	16.80	11.97	187	59286	236041	50309610
Limb discomfort	16.76	11.97	4	59469	24353	50521298
Vision blurred	16.54	11.97	43	59430	78604	50467047
Muscular weakness	16.36	11.97	57	59416	94956	50450695
Toxic epidermal necrolysis	16.26	11.97	58	59415	20934	50524717
Renal tubular disorder	16.14	11.97	17	59456	2420	50543231
Sedation	15.95	11.97	8	59465	30602	50515049
Hypotension	15.73	11.97	189	59284	235280	50310371
Chemotherapeutic drug level increased	15.70	11.97	6	59467	135	50545516
Fibromyalgia	15.48	11.97	18	59455	44960	50500691
Nephrolithiasis	15.37	11.97	11	59462	34682	50510969
Product prescribing error	15.32	11.97	3	59470	20958	50524693
Abdominal pain upper	15.26	11.97	117	59356	159192	50386459
Drug reaction with eosinophilia and systemic symptoms	15.20	11.97	70	59403	28354	50517297
Dysgeusia	15.17	11.97	14	59459	38902	50506749
Ulcer	14.96	11.97	55	59418	20145	50525506
Hypothyroidism	14.88	11.97	11	59462	34114	50511537
Cognitive disorder	14.82	11.97	18	59455	44105	50501546
Cholecystitis chronic	14.63	11.97	34	59439	9635	50536016
Hepatitis fulminant	14.55	11.97	18	59455	3050	50542601
Anaphylactic shock	14.49	11.97	3	59470	20152	50525499
Immunosuppressant drug level increased	14.48	11.97	18	59455	3064	50542587
Functional gastrointestinal disorder	14.44	11.97	19	59454	3423	50542228
Disease progression	14.26	11.97	61	59412	95805	50449846
Bronchopulmonary aspergillosis	14.11	11.97	29	59444	7563	50538088
Drug dependence	14.09	11.97	3	59470	19756	50525895
Arrhythmia	14.04	11.97	11	59462	33121	50512530
Oral pain	13.89	11.97	6	59467	25027	50520624
Chronic obstructive pulmonary disease	13.88	11.97	26	59447	53409	50492242
Wheezing	13.77	11.97	33	59440	62014	50483637
Serotonin syndrome	13.59	11.97	6	59467	24707	50520944
Osteonecrosis of jaw	13.53	11.97	11	59462	32515	50513136
Herpes zoster	13.20	11.97	41	59432	70745	50474906
Feeling hot	13.16	11.97	16	59457	39186	50506465
Upper respiratory tract infection	13.13	11.97	37	59436	65861	50479790
Dry skin	13.10	11.97	19	59454	43172	50502479
Purpura senile	13.06	11.97	8	59465	521	50545130
Joint stiffness	12.92	11.97	10	59463	30298	50515353
Tarsal tunnel syndrome	12.92	11.97	8	59465	531	50545120
Drug ineffective	12.87	11.97	811	58662	818522	49727129
Blood glucose increased	12.81	11.97	42	59431	71282	50474369
Pneumocystis jirovecii pneumonia	12.65	11.97	42	59431	14621	50531030
Lung transplant rejection	12.59	11.97	9	59464	760	50544891
Trimethylaminuria	12.31	11.97	5	59468	133	50545518
Device dislocation	12.21	11.97	5	59468	21541	50524110
Diabetic ketoacidosis	12.17	11.97	3	59470	17869	50527782
Angina pectoris	12.00	11.97	8	59465	26180	50519471

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
Pyrexia	138.01	11.59	681	33851	286941	29253054
Drug ineffective	116.15	11.59	153	34379	363017	29176978
Cytomegalovirus infection	99.50	11.59	129	34403	23086	29516909
Lymphocyte count decreased	93.60	11.59	114	34418	19157	29520838
Immune reconstitution inflammatory syndrome	90.18	11.59	74	34458	7728	29532267
Hyperkalaemia	87.68	11.59	210	34322	61182	29478813
Death	85.84	11.59	169	34363	341915	29198080
Off label use	83.11	11.59	140	34392	300660	29239335
Neutropenia	81.66	11.59	337	34195	131374	29408621
Aspartate aminotransferase increased	80.70	11.59	200	34332	59525	29480470
Alanine aminotransferase increased	78.98	11.59	221	34311	70723	29469272
Blood creatinine increased	77.59	11.59	247	34285	84855	29455140
Pancytopenia	77.31	11.59	243	34289	82925	29457070
Stevens-Johnson syndrome	75.94	11.59	95	34437	16402	29523593
Hepatic cytolysis	73.89	11.59	68	34464	8279	29531716
Transplant rejection	73.80	11.59	71	34461	9141	29530854
Clear cell renal cell carcinoma	71.39	11.59	31	34501	984	29539011
Lymphoproliferative disorder	64.65	11.59	39	34493	2488	29537507
Acute kidney injury	60.33	11.59	521	34011	264746	29275249
Kidney transplant rejection	58.03	11.59	55	34477	6950	29533045
Product dose omission issue	56.41	11.59	21	34511	96362	29443633
Blood urea increased	49.99	11.59	105	34427	28007	29511988
Pneumocystis jirovecii pneumonia	49.41	11.59	78	34454	16701	29523294
Renal tubular necrosis	45.58	11.59	69	34463	14246	29525749
Cytomegalovirus viraemia	43.76	11.59	45	34487	6275	29533720
Blood lactate dehydrogenase increased	42.94	11.59	79	34453	19130	29520865
Alanine aminotransferase abnormal	42.72	11.59	32	34500	2925	29537070
Agranulocytosis	40.95	11.59	80	34452	20260	29519735
Pre-engraftment immune reaction	39.23	11.59	11	34521	88	29539907
Tenosynovitis	38.17	11.59	33	34499	3700	29536295
Fall	37.35	11.59	96	34436	177082	29362913
Hospitalisation	36.86	11.59	5	34527	45983	29494012
Rash maculo-papular	36.71	11.59	85	34447	24204	29515791
Thrombocytopenia	36.59	11.59	276	34256	134547	29405448
Cholestasis	36.44	11.59	83	34449	23379	29516616
Leukopenia	36.30	11.59	144	34388	55059	29484936
Enthesopathy	36.09	11.59	32	34500	3711	29536284
Product use issue	35.98	11.59	8	34524	51436	29488559
Tongue disorder	35.75	11.59	35	34497	4601	29535394
Inappropriate schedule of product administration	35.26	11.59	5	34527	44467	29495528
Blood bilirubin increased	35.16	11.59	103	34429	33790	29506205
Hepatitis	33.93	11.59	75	34457	20708	29519287
Rash	33.66	11.59	354	34178	189465	29350530
Platelet count decreased	33.47	11.59	223	34309	104449	29435546
Haemodialysis	33.15	11.59	49	34483	9905	29530090
Aplasia pure red cell	32.54	11.59	36	34496	5455	29534540
Toxicity to various agents	32.23	11.59	100	34432	173561	29366434
Liver transplant rejection	29.94	11.59	22	34510	1952	29538043
Incision site pain	29.62	11.59	21	34511	1762	29538233
Toxic skin eruption	29.61	11.59	46	34486	9711	29530284
Haemoglobin decreased	28.90	11.59	221	34311	108154	29431841
Foetal exposure during pregnancy	28.83	11.59	3	34529	33864	29506131
White blood cell count decreased	28.10	11.59	180	34352	83182	29456813
Encephalitis viral	27.75	11.59	17	34515	1115	29538880
Sphincter of Oddi dysfunction	27.50	11.59	9	34523	127	29539868
Osteoporotic fracture	27.19	11.59	16	34516	975	29539020
HIV infection	27.08	11.59	17	34515	1164	29538831
Plasma cell myeloma	27.00	11.59	100	34432	37015	29502980
Fatigue	26.77	11.59	239	34293	316582	29223413
Red blood cells urine positive	26.18	11.59	19	34513	1654	29538341
Delayed graft function	25.95	11.59	20	34512	1907	29538088
Cerebrovascular accident	25.88	11.59	31	34501	76880	29463115
Blood antidiuretic hormone increased	25.78	11.59	7	34525	49	29539946
C-reactive protein increased	25.58	11.59	111	34421	44152	29495843
Intentional overdose	24.98	11.59	7	34525	38521	29501474
Tendonitis	24.81	11.59	38	34494	7923	29532072
Granuloma skin	24.73	11.59	13	34519	635	29539360
Aspergillus infection	24.26	11.59	44	34488	10537	29529458
Asthma	24.20	11.59	5	34527	33844	29506151
Dialysis	24.11	11.59	43	34489	10165	29529830
Pneumonia cytomegaloviral	24.03	11.59	22	34510	2660	29537335
Therapeutic product effect incomplete	23.94	11.59	8	34524	39297	29500698
Kaposi's sarcoma	23.87	11.59	14	34518	848	29539147
Red blood cell sedimentation rate	23.70	11.59	12	34520	542	29539453
Acquired immunodeficiency syndrome	23.53	11.59	11	34521	416	29539579
Drug reaction with eosinophilia and systemic symptoms	23.44	11.59	79	34453	27913	29512082
Graft versus host disease	23.31	11.59	41	34491	9587	29530408
Peripheral swelling	23.30	11.59	24	34508	63715	29476280
Hepatitis cholestatic	23.05	11.59	34	34498	6859	29533136
Lymphocele	22.85	11.59	16	34516	1316	29538679
Human herpesvirus 6 infection	22.22	11.59	18	34514	1845	29538150
Neutrophil count decreased	22.01	11.59	105	34427	43462	29496533
Gamma-glutamyltransferase increased	21.98	11.59	75	34457	26662	29513333
Blood alkaline phosphatase increased	21.90	11.59	78	34454	28328	29511667
Panniculitis	21.73	11.59	15	34517	1206	29538789
Hepatomegaly	21.68	11.59	39	34493	9278	29530717
Tubulointerstitial nephritis	21.63	11.59	57	34475	17586	29522409
C-reactive protein abnormal	21.51	11.59	32	34500	6504	29533491
Dizziness	21.28	11.59	132	34400	189552	29350443
Dyspnoea	21.26	11.59	262	34270	326470	29213525
Serum sickness	20.94	11.59	17	34515	1748	29538247
Weight increased	20.77	11.59	36	34496	76631	29463364
Syncope	20.45	11.59	40	34492	81331	29458664
Renal failure	20.42	11.59	220	34312	118379	29421616
Chronic lymphocytic leukaemia	20.13	11.59	23	34509	3610	29536385
Culture urine positive	20.02	11.59	14	34518	1149	29538846
Parvovirus infection	20.01	11.59	10	34522	439	29539556
Therapeutic product effect decreased	19.76	11.59	5	34527	29446	29510549
Intentional product misuse	19.52	11.59	8	34524	34653	29505342
Blood parathyroid hormone decreased	19.25	11.59	12	34520	812	29539183
Intentional product use issue	19.23	11.59	13	34519	42485	29497510
Dermatitis exfoliative	19.09	11.59	30	34502	6395	29533600
Biopsy liver abnormal	18.77	11.59	7	34525	148	29539847
Enterovirus infection	18.76	11.59	11	34521	666	29539329
Complications of transplanted kidney	18.56	11.59	23	34509	3931	29536064
Wrong technique in product usage process	18.11	11.59	7	34525	31421	29508574
Hepatosplenomegaly	18.05	11.59	22	34510	3695	29536300
Blood pressure increased	17.93	11.59	37	34495	73766	29466229
Cytomegalovirus test positive	17.84	11.59	21	34511	3402	29536593
Joint swelling	17.78	11.59	19	34513	49611	29490384
Blood immunoglobulin G decreased	17.77	11.59	13	34519	1146	29538849
Rash morbilliform	17.71	11.59	18	34514	2475	29537520
Injection site pain	17.46	11.59	8	34524	32438	29507557
Hepatic steatosis	17.03	11.59	47	34485	14899	29525096
Protein urine present	16.93	11.59	24	34508	4670	29535325
Rash pruritic	16.89	11.59	61	34471	22302	29517693
Culture stool positive	16.49	11.59	7	34525	210	29539785
Lung infiltration	16.47	11.59	40	34492	11739	29528256
Vena cava injury	16.46	11.59	7	34525	211	29539784
Skin exfoliation	16.45	11.59	61	34471	22584	29517411
Bronchopulmonary aspergillosis	16.29	11.59	41	34491	12303	29527692
Arthralgia	16.25	11.59	96	34436	139521	29400474
Lymphadenopathy	16.17	11.59	65	34467	24984	29515011
Myocardial infarction	16.16	11.59	70	34462	110226	29429769
SARS-CoV-2 antibody test positive	16.01	11.59	7	34525	226	29539769
Oesophageal candidiasis	16.00	11.59	21	34511	3800	29536195
Bone marrow failure	15.98	11.59	69	34463	27380	29512615
Drug hypersensitivity	15.77	11.59	135	34397	68271	29471724
Blood potassium increased	15.64	11.59	45	34487	14606	29525389
Blood albumin decreased	15.59	11.59	39	34493	11656	29528339
Cellulitis enterococcal	15.58	11.59	5	34527	66	29539929
Cytomegalovirus chorioretinitis	15.46	11.59	19	34513	3219	29536776
Renal tubular disorder	15.33	11.59	22	34510	4330	29535665
Rectal prolapse	14.99	11.59	7	34525	264	29539731
Leukaemia recurrent	14.99	11.59	13	34519	1464	29538531
Cystitis haemorrhagic	14.93	11.59	23	34509	4819	29535176
Erythema infectiosum	14.90	11.59	6	34526	157	29539838
Suicide attempt	14.69	11.59	11	34521	34099	29505896
Anaemia	14.67	11.59	322	34210	200629	29339366
Lymphocytic infiltration	14.61	11.59	9	34523	596	29539399
Blood culture positive	14.48	11.59	22	34510	4555	29535440
HIV wasting syndrome	14.26	11.59	5	34527	88	29539907
Traumatic liver injury	14.26	11.59	6	34526	176	29539819
Acute graft versus host disease in skin	14.17	11.59	22	34510	4642	29535353
Somnolence	14.15	11.59	59	34473	93896	29446099
Mental status changes	14.04	11.59	79	34453	34848	29505147
Cystic lymphangioma	13.97	11.59	3	34529	6	29539989
Phlebitis	13.97	11.59	19	34513	3557	29536438
Light chain analysis decreased	13.85	11.59	4	34528	36	29539959
Immunosuppressant drug level increased	13.81	11.59	22	34510	4743	29535252
Mycobacterium avium complex infection	13.66	11.59	15	34517	2254	29537741
Wound evisceration	13.57	11.59	5	34527	102	29539893
Intraductal papillary mucinous neoplasm	13.49	11.59	7	34525	333	29539662
Hepatitis A antibody positive	13.47	11.59	4	34528	40	29539955
Liver transplant	13.41	11.59	15	34517	2301	29537694
Febrile neutropenia	13.21	11.59	194	34338	112046	29427949
Cytomegalovirus test	13.13	11.59	4	34528	44	29539951
Eosinophilia	13.12	11.59	56	34476	22105	29517890
Psoriasis	13.11	11.59	11	34521	32216	29507779
Lymphopenia	12.96	11.59	40	34492	13493	29526502
Autoimmune haemolytic anaemia	12.89	11.59	19	34513	3829	29536166
Blood bilirubin unconjugated increased	12.70	11.59	8	34524	551	29539444
Thrombotic microangiopathy	12.70	11.59	30	34502	8651	29531344
Stent removal	12.65	11.59	3	34529	11	29539984
Therapeutic product effect prolonged	12.64	11.59	6	34526	235	29539760
Feeling abnormal	12.63	11.59	28	34504	54417	29485578
Enterococcal infection	12.56	11.59	29	34503	8239	29531756
Idiopathic pneumonia syndrome	12.52	11.59	6	34526	240	29539755
Hypercalcaemia	12.49	11.59	38	34494	12721	29527274
Total lung capacity decreased	12.48	11.59	8	34524	568	29539427
Hepatitis B antibody positive	12.45	11.59	4	34528	53	29539942
Renal cyst haemorrhage	12.34	11.59	7	34525	398	29539597
Abdominal wall haemorrhage	12.30	11.59	6	34526	250	29539745
Contusion	12.18	11.59	11	34521	31084	29508911
Chills	12.13	11.59	132	34400	71168	29468827
Acute graft versus host disease in liver	12.03	11.59	11	34521	1327	29538668
Granulomatous rosacea	11.97	11.59	5	34527	144	29539851
Transplant dysfunction	11.95	11.59	14	34518	2256	29537739
Haematocrit decreased	11.90	11.59	66	34466	28956	29511039
Pyelonephritis acute	11.67	11.59	12	34520	1672	29538323
Hepatitis C virus test	11.64	11.59	4	34528	66	29539929

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
Muscle injury	886.61	11.17	482	72901	25955	64399394
Folliculitis	839.17	11.17	486	72897	29591	64395758
Sleep disorder due to general medical condition, insomnia type	804.11	11.17	451	72932	25819	64399530
Irritable bowel syndrome	759.06	11.17	493	72890	36876	64388473
Impaired healing	551.83	11.17	495	72888	59978	64365371
Duodenal ulcer perforation	516.94	11.17	378	73005	34247	64391102
Helicobacter infection	493.28	11.17	383	73000	37979	64387370
Blister	482.06	11.17	525	72858	80442	64344907
Gastrointestinal disorder	441.41	11.17	527	72856	89182	64336167
Stomatitis	401.11	11.17	556	72827	109049	64316300
Lower respiratory tract infection	381.21	11.17	503	72880	94111	64331238
Ill-defined disorder	375.13	11.17	347	73036	43705	64381644
Anti-cyclic citrullinated peptide antibody positive	371.85	11.17	364	73019	49198	64376151
Pericarditis	347.18	11.17	391	72992	62125	64363224
Pemphigus	330.87	11.17	376	73007	60325	64365024
Hand deformity	315.62	11.17	373	73010	62398	64362951
Glossodynia	311.43	11.17	376	73007	64320	64361029
Synovitis	308.90	11.17	466	72917	98624	64326725
Pyrexia	300.75	11.17	1343	72040	557301	63868048
Infection	281.51	11.17	638	72745	184242	64241107
Discomfort	278.98	11.17	399	72984	80479	64344870
Sinusitis	275.80	11.17	550	72833	145378	64279971
Systemic lupus erythematosus	273.77	11.17	387	72996	77225	64348124
Therapeutic product effect decreased	273.22	11.17	479	72904	114872	64310477
Hypersensitivity	232.04	11.17	615	72768	195837	64229512
Wound	230.25	11.17	354	73029	76123	64349226
Arthropathy	228.58	11.17	456	72927	120511	64304838
Swelling	223.08	11.17	534	72849	159684	64265665
Hepatic enzyme increased	207.24	11.17	457	72926	129486	64295863
Completed suicide	201.08	11.17	14	73369	224400	64200949
Death	191.67	11.17	161	73222	482544	63942805
Contraindicated product administered	183.07	11.17	389	72994	107440	64317909
Confusional state	176.99	11.17	675	72708	260469	64164880
Rash	162.90	11.17	983	72400	457566	63967783
Contusion	158.68	11.17	380	73003	113585	64311764
Infusion related reaction	155.18	11.17	475	72908	163992	64261357
Fall	154.62	11.17	148	73235	416678	64008671
Nasopharyngitis	151.49	11.17	529	72854	195544	64229805
Product dose omission issue	149.03	11.17	22	73361	194725	64230624
Joint swelling	142.78	11.17	553	72830	214829	64210520
Peripheral swelling	141.92	11.17	541	72842	208612	64216737
Weight increased	139.98	11.17	546	72837	212802	64212547
Off label use	135.95	11.17	327	73056	632479	63792870
Toxicity to various agents	133.68	11.17	130	73253	363383	64061966
Pre-engraftment immune reaction	132.03	11.17	37	73346	304	64425045
Abdominal discomfort	130.65	11.17	480	72903	181842	64243507
Pruritus	122.58	11.17	688	72695	311712	64113637
Drug abuse	122.27	11.17	7	73376	132367	64292982
Drug intolerance	120.76	11.17	478	72905	187514	64237835
Alanine aminotransferase abnormal	113.73	11.17	80	73303	6808	64418541
Dizziness	101.42	11.17	211	73172	429952	63995397
Alopecia	96.64	11.17	409	72974	165281	64260068
Encephalitis viral	95.61	11.17	49	73334	2331	64423018
Red blood cell sedimentation rate	92.96	11.17	56	73327	3658	64421691
Enthesopathy	91.97	11.17	81	73302	9557	64415792
Tongue disorder	89.18	11.17	88	73295	11992	64413357
Injection site pain	86.56	11.17	12	73371	111396	64313953
Malaise	86.28	11.17	203	73180	396044	64029305
Rheumatoid arthritis	84.77	11.17	391	72992	163903	64261446
Cytomegalovirus infection	82.20	11.17	150	73233	37049	64388300
Tenosynovitis	81.47	11.17	83	73300	11750	64413599
Human herpesvirus 6 infection	76.71	11.17	54	73329	4600	64420749
Blood creatinine increased	73.65	11.17	328	73055	135454	64289895
Kidney transplant rejection	73.41	11.17	71	73312	9440	64415909
Intentional overdose	71.51	11.17	9	73374	89935	64335414
Alanine aminotransferase increased	70.31	11.17	329	73054	138702	64286647
Pain in extremity	70.23	11.17	150	73233	302935	64122414
Blood pressure increased	70.21	11.17	56	73327	172496	64252853
Aspartate aminotransferase increased	67.72	11.17	293	73090	119495	64305854
Inappropriate schedule of product administration	67.03	11.17	12	73371	92274	64333075
Blood parathyroid hormone decreased	66.50	11.17	60	73323	7306	64418043
Immune reconstitution inflammatory syndrome	65.77	11.17	76	73307	12394	64412955
Stevens-Johnson syndrome	64.45	11.17	129	73254	34120	64391229
Feeling abnormal	64.24	11.17	36	73347	133566	64291783
Transplant rejection	63.11	11.17	88	73295	17313	64408036
Panniculitis	62.44	11.17	63	73320	8816	64416533
Hyperkalaemia	61.54	11.17	253	73130	100876	64324473
Wrong technique in product usage process	58.29	11.17	4	73379	64970	64360379
Pregnancy	56.40	11.17	92	73291	20773	64404576
Intentional product misuse	55.65	11.17	8	73375	72287	64353062
Tendonitis	55.60	11.17	90	73293	20192	64405157
Fear of injection	55.04	11.17	49	73334	5863	64419486
Therapeutic product effect incomplete	54.06	11.17	25	73358	103457	64321892
Maternal exposure during pregnancy	53.77	11.17	234	73149	95650	64329699
Clear cell renal cell carcinoma	52.34	11.17	32	73351	2147	64423202
Granuloma skin	48.12	11.17	46	73337	6028	64419321
Back pain	47.60	11.17	137	73246	250034	64175315
Skin necrosis	46.87	11.17	69	73314	14260	64411089
Headache	46.73	11.17	382	73001	529085	63896264
Therapy non-responder	46.69	11.17	173	73210	65726	64359623
Syncope	46.46	11.17	67	73316	157568	64267781
Lymphoproliferative disorder	44.96	11.17	41	73342	5062	64420287
Cough	44.94	11.17	184	73199	301964	64123385
Pancytopenia	43.68	11.17	296	73087	143013	64282336
Drug hypersensitivity	43.26	11.17	437	72946	237378	64187971
Rheumatoid nodule	42.95	11.17	62	73321	12589	64412760
Psoriasis	42.94	11.17	14	73369	71689	64353660
Cerebrovascular accident	41.02	11.17	58	73325	137525	64287824
Diarrhoea	40.58	11.17	579	72804	722125	63703224
Maternal exposure timing unspecified	39.11	11.17	29	73354	2678	64422671
Suicide attempt	38.91	11.17	16	73367	70991	64354358
Nausea	38.55	11.17	646	72737	785154	63640195
Myocardial infarction	38.41	11.17	82	73301	165739	64259610
Gait disturbance	38.35	11.17	87	73296	172068	64253281
Hepatic cytolysis	38.04	11.17	62	73321	13987	64411362
Renal tubular necrosis	37.73	11.17	80	73303	22030	64403319
Injection site erythema	37.13	11.17	17	73366	70783	64354566
Balance disorder	37.02	11.17	25	73358	83901	64341448
Overdose	36.88	11.17	79	73304	159487	64265862
Cytomegalovirus viraemia	36.66	11.17	53	73330	10775	64414574
Oropharyngeal pain	35.93	11.17	29	73354	88838	64336511
Weight decreased	35.37	11.17	186	73197	285553	64139796
Condition aggravated	34.52	11.17	265	73118	372161	64053188
Blood urea increased	33.90	11.17	119	73264	44034	64381315
Nasal congestion	33.41	11.17	13	73370	59645	64365704
C-reactive protein abnormal	33.24	11.17	90	73293	28957	64396392
Rhinorrhoea	32.08	11.17	14	73369	59955	64365394
Constipation	32.02	11.17	143	73240	229194	64196155
Cardio-respiratory arrest	31.86	11.17	39	73344	98354	64326995
Drug eruption	31.82	11.17	102	73281	36034	64389315
Hypertension	31.40	11.17	170	73213	259091	64166258
Hospitalisation	31.08	11.17	24	73359	75183	64350166
Pneumocystis jirovecii pneumonia	31.00	11.17	85	73298	27549	64397800
Memory impairment	31.00	11.17	31	73352	85651	64339698
Incision site pain	30.87	11.17	25	73358	2629	64422720
Haemodialysis	30.55	11.17	63	73320	17014	64408335
Depressed mood	30.51	11.17	5	73378	41007	64384342
Pneumonia	30.40	11.17	451	72932	559125	63866224
Meningoencephalitis herpetic	30.35	11.17	21	73362	1740	64423609
Complications of transplanted kidney	30.14	11.17	34	73349	5401	64419948
Loss of consciousness	29.87	11.17	79	73304	148286	64277063
Asthma	29.53	11.17	39	73344	95186	64330163
Fluid retention	28.73	11.17	16	73367	59590	64365759
Multiple sclerosis relapse	28.49	11.17	6	73377	41129	64384220
Muscle spasms	28.46	11.17	75	73308	140948	64284401
Depression	28.24	11.17	110	73273	183181	64242168
Injection site reaction	28.13	11.17	9	73374	46655	64378694
Haematochezia	27.66	11.17	21	73362	66352	64358997
Agranulocytosis	27.61	11.17	101	73282	38128	64387221
Cardiac failure congestive	27.47	11.17	68	73315	130512	64294837
Hypotension	27.45	11.17	289	73094	380685	64044664
Drug reaction with eosinophilia and systemic symptoms	27.15	11.17	128	73255	54089	64371260
Influenza	26.97	11.17	50	73333	106481	64318868
Febrile bone marrow aplasia	26.93	11.17	47	73336	11208	64414141
Product prescribing error	26.91	11.17	4	73379	35265	64390084
Serotonin syndrome	26.66	11.17	6	73377	39276	64386073
COVID-19	26.65	11.17	21	73362	65119	64360230
Visual impairment	26.57	11.17	27	73356	74050	64351299
Drug ineffective	26.54	11.17	741	72642	839506	63585843
Suicidal ideation	26.54	11.17	22	73361	66520	64358829
Liver transplant rejection	26.23	11.17	24	73359	2975	64422374
Granuloma	26.22	11.17	35	73348	6606	64418743
Cardiac failure	25.51	11.17	72	73311	132301	64293048
Stress	25.42	11.17	19	73364	60515	64364834
Blood lactate dehydrogenase increased	25.26	11.17	89	73294	32989	64392360
Haematemesis	25.09	11.17	11	73372	46988	64378361
Anxiety	25.01	11.17	132	73251	202517	64222832
Sedation	24.99	11.17	8	73375	41454	64383895
Cytomegalovirus test positive	24.89	11.17	30	73353	5114	64420235
Injection site swelling	24.89	11.17	8	73375	41345	64384004
Palpitations	24.75	11.17	51	73332	104437	64320912
Drug interaction	24.35	11.17	279	73104	361804	64063545
Ulcer	24.10	11.17	69	73314	22921	64402428
Arthralgia	23.51	11.17	664	72719	441596	63983753
Chest discomfort	23.24	11.17	62	73321	116044	64309305
Chronic obstructive pulmonary disease	23.17	11.17	28	73355	71020	64354329
Serum sickness	23.11	11.17	23	73360	3166	64422183
Breast cancer	22.96	11.17	3	73380	29145	64396204
Deep vein thrombosis postoperative	22.81	11.17	16	73367	1355	64423994
Flushing	22.60	11.17	34	73349	78614	64346735
Neck pain	22.56	11.17	22	73361	61511	64363838
Atrial fibrillation	22.50	11.17	109	73274	170980	64254369
Unevaluable event	22.32	11.17	15	73368	50474	64374875
Dyspepsia	21.86	11.17	36	73347	80276	64345073
Hypercalcaemia	21.85	11.17	82	73301	31334	64394015
Blood pressure fluctuation	20.87	11.17	17	73366	51854	64373495
Rash pruritic	20.83	11.17	124	73259	57280	64368069
Bronchopulmonary aspergillosis	20.71	11.17	58	73325	19027	64406322
Intentional self-injury	20.60	11.17	4	73379	29040	64396309
Paraesthesia	20.55	11.17	81	73302	134441	64290908
Delayed graft function	20.36	11.17	21	73362	3015	64422334
Lymphocyte count decreased	20.32	11.17	96	73287	40603	64384746
Osteonecrosis of jaw	20.21	11.17	10	73373	39815	64385534
Hot flush	20.08	11.17	14	73369	46221	64379128
Liver transplant	20.02	11.17	24	73359	4068	64421281
Cardiogenic shock	20.00	11.17	6	73377	32421	64392928
Hyperhidrosis	19.86	11.17	74	73309	124846	64300503
Pain in jaw	19.55	11.17	11	73372	40744	64384605
Platelet count decreased	19.42	11.17	283	73100	167428	64257921
Basal cell carcinoma	19.41	11.17	78	73305	30760	64394589
Wheezing	19.36	11.17	39	73344	80540	64344809
Somnolence	19.26	11.17	144	73239	203501	64221848
Cataract	19.17	11.17	18	73365	51244	64374105
Blood antidiuretic hormone increased	19.15	11.17	6	73377	75	64425274
Blood culture positive	19.01	11.17	33	73350	7835	64417514
Plasma cell myeloma	19.01	11.17	103	73280	45972	64379377
Asthenia	18.95	11.17	358	73025	427686	63997663
Dialysis	18.93	11.17	52	73331	16868	64408481
Limb discomfort	18.74	11.17	4	73379	27171	64398178
Injection site pruritus	18.45	11.17	10	73373	37816	64387533
Renal tubular disorder	18.40	11.17	28	73355	5959	64419390
Blood bilirubin unconjugated increased	18.35	11.17	12	73371	905	64424444
Acute myocardial infarction	18.29	11.17	32	73351	69686	64355663
Cardiac disorder	18.20	11.17	22	73361	55794	64369555
Sphincter of Oddi dysfunction	18.17	11.17	9	73374	398	64424951
Bradycardia	18.17	11.17	71	73312	118148	64307201
Cardiac arrest	18.10	11.17	102	73281	153962	64271387
Incorrect dose administered	17.72	11.17	26	73357	60739	64364610
Autoimmune disorder	17.59	11.17	27	73356	5789	64419560
Diabetic ketoacidosis	17.56	11.17	6	73377	29839	64395510
Product quality issue	17.52	11.17	6	73377	29793	64395556
Biopsy liver abnormal	17.43	11.17	9	73374	435	64424914
Influenza like illness	17.42	11.17	27	73356	61675	64363674
Abdominal pain upper	17.40	11.17	122	73261	174908	64250441
Muscular weakness	17.40	11.17	80	73303	127258	64298091
Musculoskeletal pain	17.35	11.17	42	73341	81252	64344097
Acute kidney injury	17.25	11.17	649	72734	448591	63976758
Psychotic disorder	17.07	11.17	9	73374	34569	64390780
Graft versus host disease	17.02	11.17	44	73339	13769	64411580
Aspergillus infection	17.01	11.17	49	73334	16330	64409019
Perinephric collection	17.01	11.17	8	73375	315	64425034
Cytomegalovirus test	16.97	11.17	5	73378	50	64425299
Cephalhaematoma	16.90	11.17	4	73379	15	64425334
Ischaemic stroke	16.81	11.17	6	73377	29029	64396320
Red blood cells urine positive	16.76	11.17	23	73360	4455	64420894
Rash maculo-papular	16.69	11.17	101	73282	46925	64378424
Osteoporosis	16.67	11.17	14	73369	42066	64383283
Dyspnoea exertional	16.62	11.17	37	73346	73693	64351656
Toxic skin eruption	16.58	11.17	54	73329	19230	64406119
Culture urine positive	16.58	11.17	22	73361	4129	64421220
Dysphonia	16.52	11.17	17	73366	46365	64378984
Acquired immunodeficiency syndrome	16.45	11.17	7	73376	217	64425132
Gastrointestinal haemorrhage	16.42	11.17	86	73297	132226	64293123
Aggression	16.41	11.17	17	73366	46215	64379134
Anaphylactic shock	16.34	11.17	7	73376	30321	64395028
Vena cava injury	16.27	11.17	7	73376	223	64425126
Migraine	16.23	11.17	29	73354	62648	64362701
Autoimmune haemolytic anaemia	16.22	11.17	29	73354	7047	64418302
Dermatitis exfoliative	16.00	11.17	36	73347	10316	64415033
Drug dependence	15.97	11.17	9	73374	33303	64392046
Chronic lymphocytic leukaemia	15.91	11.17	22	73361	4293	64421056
Blood bilirubin increased	15.83	11.17	116	73267	57437	64367912
HIV wasting syndrome	15.78	11.17	5	73378	65	64425284
Lung infiltration	15.77	11.17	56	73327	20833	64404516
SARS-CoV-2 antibody test positive	15.73	11.17	7	73376	242	64425107
Labelled drug-drug interaction medication error	15.73	11.17	3	73380	22059	64403290
Poisoning	15.55	11.17	3	73380	21876	64403473
Enterovirus infection	15.43	11.17	13	73370	1444	64423905
Culture stool positive	15.43	11.17	9	73374	554	64424795
Hypothyroidism	15.37	11.17	14	73369	40443	64384906
Delirium	15.37	11.17	35	73348	69159	64356190
Heart rate increased	15.33	11.17	59	73324	98616	64326733
Withdrawal syndrome	15.13	11.17	4	73379	23488	64401861
Vomiting	15.11	11.17	495	72888	550622	63874727
Thrombocytopenia	15.09	11.17	347	73036	223454	64201895
Tumour flare	15.03	11.17	10	73373	777	64424572
Cystitis haemorrhagic	15.00	11.17	30	73353	7926	64417423
Osteoarthritis	14.92	11.17	31	73352	63305	64362044
Neuroleptic malignant syndrome	14.75	11.17	5	73378	24991	64400358
Hepatitis fulminant	14.75	11.17	26	73357	6248	64419101
Acne	14.74	11.17	4	73379	23077	64402272
Cerebral infarction	14.67	11.17	15	73368	41029	64384320
Melaena	14.58	11.17	24	73359	53524	64371825
Urinary tract infection	14.57	11.17	181	73202	231415	64193934
Neutropenia	14.48	11.17	366	73017	239258	64186091
Surgery	14.44	11.17	7	73376	28206	64397143
Full blood count abnormal	14.32	11.17	8	73375	29749	64395600
Tooth disorder	14.08	11.17	4	73379	22398	64402951
Femur fracture	13.97	11.17	11	73372	34124	64391225
Toxic epidermal necrolysis	13.95	11.17	81	73302	37085	64388264
Aplasia pure red cell	13.89	11.17	27	73356	6987	64418362
Oral pain	13.81	11.17	7	73376	27486	64397863
Heart rate decreased	13.79	11.17	26	73357	55041	64370308
Thrombotic microangiopathy	13.75	11.17	46	73337	16609	64408740
Heart rate irregular	13.73	11.17	7	73376	27406	64397943
Tarsal tunnel syndrome	13.64	11.17	8	73375	497	64424852
Granulomatous rosacea	13.61	11.17	6	73377	203	64425146
Blood alkaline phosphatase increased	13.57	11.17	110	73273	56169	64369180
Purpura senile	13.56	11.17	8	73375	503	64424846
Pulmonary arterial hypertension	13.44	11.17	6	73377	25361	64399988
Chemotherapeutic drug level increased	13.43	11.17	7	73376	345	64425004
Hepatomegaly	13.39	11.17	46	73337	16836	64408513
Tubulointerstitial nephritis	13.36	11.17	70	73313	30839	64394510
Epistaxis	13.20	11.17	62	73321	98069	64327280
Complications of transplant surgery	13.18	11.17	9	73374	730	64424619
Oxygen saturation decreased	13.11	11.17	70	73313	107106	64318243
Depressed level of consciousness	13.10	11.17	48	73335	81388	64343961
HIV infection	13.04	11.17	10	73373	972	64424377
Enterococcal infection	13.00	11.17	40	73343	13826	64411523
Leukopenia	12.99	11.17	174	73209	101068	64324281
Dysphagia	12.93	11.17	70	73313	106742	64318607
Speech disorder	12.92	11.17	22	73361	48419	64376930
Chest pain	12.83	11.17	190	73193	235790	64189559
Wound evisceration	12.79	11.17	5	73378	124	64425225
Vision blurred	12.78	11.17	56	73327	90260	64335089
Injury	12.73	11.17	108	73275	55884	64369465
Fracture	12.46	11.17	3	73380	18752	64406597
Respiratory arrest	12.43	11.17	26	73357	52959	64372390
Hepatosplenomegaly	12.38	11.17	22	73361	5321	64420028
Renal failure	12.33	11.17	282	73101	181406	64243943
Deafness transitory	12.30	11.17	9	73374	814	64424535
Lymphocele	12.19	11.17	12	73371	1629	64423720
Frequent bowel movements	12.02	11.17	3	73380	18302	64407047
Mental status changes	11.87	11.17	114	73269	61048	64364301
Lymphocytic infiltration	11.82	11.17	11	73372	1393	64423956
Psoriatic arthropathy	11.77	11.17	87	73296	43194	64382155
Clostridial infection	11.76	11.17	21	73362	5098	64420251
Trimethylaminuria	11.72	11.17	5	73378	156	64425193
Transfusion	11.71	11.17	3	73380	17991	64407358
Bronchitis	11.71	11.17	74	73309	108669	64316680
Rash morbilliform	11.69	11.17	21	73362	5120	64420229
Pneumonia fungal	11.69	11.17	29	73354	8848	64416501
Renal cyst haemorrhage	11.65	11.17	7	73376	455	64424894
Throat irritation	11.64	11.17	12	73371	32699	64392650
Arrhythmia	11.58	11.17	27	73356	52917	64372432
Drug ineffective for unapproved indication	11.56	11.17	11	73372	31122	64394227
Lung neoplasm malignant	11.48	11.17	5	73378	21443	64403906
Electrocardiogram QT prolonged	11.40	11.17	49	73334	79399	64345950
Pain	11.27	11.17	752	72631	552759	63872590
Acute graft versus host disease	11.26	11.17	29	73354	9055	64416294
Device dislocation	11.24	11.17	5	73378	21173	64404176
Agitation	11.21	11.17	57	73326	88310	64337039
Hepatitis C virus test	11.17	11.17	4	73379	77	64425272

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	J01EC01	ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE SULFONAMIDES AND TRIMETHOPRIM Intermediate-acting sulfonamides
ATC	J01EE01	ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE SULFONAMIDES AND TRIMETHOPRIM Combinations of sulfonamides and trimethoprim, incl. derivatives
ATC	J04AM08	ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOBACTERIALS DRUGS FOR TREATMENT OF TUBERCULOSIS Combinations of drugs for treatment of tuberculosis
FDA CS	M0020790	Sulfonamides
FDA EPC	N0000175504	Sulfonamide Antimicrobial
MeSH PA	D000890	Anti-Infective Agents
CHEBI has role	CHEBI:33281	antibiotics
CHEBI has role	CHEBI:33282	bactericides
CHEBI has role	CHEBI:35441	antiinfective agents
CHEBI has role	CHEBI:35703	Xenobiotic
CHEBI has role	CHEBI:50183	P450 inhibitors
CHEBI has role	CHEBI:50502	dihydropteroate synthase inhibitors
CHEBI has role	CHEBI:53000	epitope role
CHEBI has role	CHEBI:74234	sepiapterin reductase inhibitors
CHEBI has role	CHEBI:78298	environmental contaminants
CHEBI has role	CHEBI:88188	allergenic drug
FDA MoA	N0000185504	Cytochrome P450 2C9 Inhibitors

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

Disease	Relation	SNOMED_ID	DOID
Acute otitis media	indication	3110003
Nocardiosis	indication	29227009	DOID:2312
Shigellosis	indication	36188001
Klebsiella cystitis	indication	60867007
Toxoplasmosis	indication	187192000	DOID:9965
Chlamydial conjunctivitis	indication	231861005	DOID:13800
Escherichia coli urinary tract infection	indication	301011002
Proteus urinary tract infection	indication	301012009
Bacterial urinary infection	indication	312124009
Infective otitis media	indication	312218008
Pneumocystosis jiroveci pneumonia	indication	415125002	DOID:11339
Acute exacerbation of chronic bronchitis	indication	425748003
Streptococcus Pneumoniae Chronic Bronchitis	indication
Haemophilus Influenzae Chronic Bronchitis	indication
Aerobic Gram-Positive Cocci Infection	indication
Pneumocystis Carinii Pneumonia Prevention	indication
Aerobic Gram-Negative Bacillary Infection	indication
Haemophilus Influenzae Acute Otitis Media	indication
Morganella Morganii Urinary Tract Infection	indication
Typhoid fever	off-label use	4834000	DOID:13258
Infection of skin AND/OR subcutaneous tissue	off-label use	19824006
Pertussis	off-label use	27836007
Granuloma inguinale	off-label use	28867007	DOID:9113
Listeria meningitis	off-label use	31568009	DOID:11572
Sinusitis	off-label use	36971009
Whipple's disease	off-label use	41545003	DOID:8476
Bacterial pneumonia	off-label use	53084003	DOID:874
Paracoccidioidomycosis	off-label use	59925007	DOID:12662
Cholera	off-label use	63650001	DOID:1498
Brucellosis	off-label use	75702008	DOID:11077
Paratyphoid fever	off-label use	85904008	DOID:3055
Chlamydial infection	off-label use	105629000
Infection of bone	off-label use	111253001
Meningococcus carrier	off-label use	170486006
Lymphogranuloma venereum	off-label use	186946009	DOID:13819
Chancroid	off-label use	266143009	DOID:13778
Diverticulitis of gastrointestinal tract	off-label use	271366000
Bacterial endocarditis	off-label use	301183007
Toxoplasmosis associated with acquired immunodeficiency syndrome	off-label use	421666009
Chronic Bacterial Prostatitis	off-label use
Toxoplasmosis Prevention	off-label use
Postexposure Plague Prophylaxis	off-label use
Diabetic Foot Infection	off-label use
Glomerulonephritis	contraindication	36171008	DOID:2921
Acute hepatitis	contraindication	37871000
Third trimester pregnancy	contraindication	41587001
Uremia	contraindication	44730006	DOID:4676
Megaloblastic anemia due to folate deficiency	contraindication	85649008	DOID:14026
Kidney disease	contraindication	90708001	DOID:557
Anemia due to enzyme deficiency	contraindication	111577008
Deficiency of glucose-6-phosphate dehydrogenase	contraindication	124134002	DOID:2862
Folic acid deficiency	contraindication	190633005
Disease of liver	contraindication	235856003	DOID:409
Thrombocytopenic disorder	contraindication	302215000	DOID:1588
Neutropenic disorder	contraindication	303011007	DOID:1227
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	5.79	acidic
pKa2	2.08	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
Dihydropteroate synthase	Enzyme		DHPS_ECOLI	INHIBITOR	IC50	5.33		CHEMBL	CHEMBL
Bifunctional protein FolC	Enzyme		FOLC_ECOLI					WOMBAT-PK
Dihydrofolate reductase	Enzyme		DYR_PNECA		IC50	7		CHEMBL
Pol polyprotein	Enzyme		Q72874_9HIV1		Ki	8		CHEMBL
Endothelin-1 receptor	GPCR		EDNRA_RAT		IC50	5.40		CHEMBL

External reference:

ID	Source
4017734	VUID
N0000146102	NUI
D00447	KEGG_DRUG
4017734	VANDF
C0038689	UMLSCUI
CHEBI:9332	CHEBI
08D	PDB_CHEM_ID
CHEMBL443	ChEMBL_ID
DB01015	DRUGBANK_ID
D013420	MESH_DESCRIPTOR_UI
5329	PUBCHEM_CID
10933	IUPHAR_LIGAND_ID
1386	INN_ID
JE42381TNV	UNII
10180	RXNORM
2035	MMSL
5526	MMSL
d00119	MMSL
002827	NDDF
363528007	SNOMEDCT_US
70047000	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Sulfamethoxazole and Trimethoprim	HUMAN PRESCRIPTION DRUG LABEL	2	0121-0853	SUSPENSION	200 mg	ORAL	NDA	28 sections
SULFATRIM	HUMAN PRESCRIPTION DRUG LABEL	2	0121-0854	SUSPENSION	200 mg	ORAL	NDA	28 sections
Sulfamethoxazole and Trimethoprim	HUMAN PRESCRIPTION DRUG LABEL	2	0121-4793	SUSPENSION	200 mg	ORAL	ANDA	28 sections
Sulfamethoxazole and Trimethoprim	HUMAN PRESCRIPTION DRUG LABEL	2	0440-2406	TABLET	800 mg	ORAL	ANDA	13 sections
Sulfamethoxazole and Trimethoprim	HUMAN PRESCRIPTION DRUG LABEL	2	0527-5180	SUSPENSION	200 mg	ORAL	ANDA	21 sections
Sulfamethoxazole and Trimethoprim	HUMAN PRESCRIPTION DRUG LABEL	2	0527-5181	SUSPENSION	200 mg	ORAL	ANDA	21 sections
Sulfamethoxazole and Trimethoprim	HUMAN PRESCRIPTION DRUG LABEL	2	0615-8121	TABLET	800 mg	ORAL	ANDA	26 sections
Sulfamethoxazole and Trimethoprim	HUMAN PRESCRIPTION DRUG LABEL	2	0703-9503	INJECTION, SOLUTION, CONCENTRATE	80 mg	INTRAVENOUS	ANDA	22 sections
Sulfamethoxazole and Trimethoprim	HUMAN PRESCRIPTION DRUG LABEL	2	0703-9514	INJECTION, SOLUTION, CONCENTRATE	80 mg	INTRAVENOUS	ANDA	22 sections
Sulfamethoxazole and Trimethoprim	HUMAN PRESCRIPTION DRUG LABEL	2	0703-9514	INJECTION, SOLUTION, CONCENTRATE	80 mg	INTRAVENOUS	ANDA	22 sections
Sulfamethoxazole and Trimethoprim	HUMAN PRESCRIPTION DRUG LABEL	2	0703-9526	INJECTION, SOLUTION, CONCENTRATE	80 mg	INTRAVENOUS	ANDA	22 sections
Sulfamethoxazole and Trimethoprim	HUMAN PRESCRIPTION DRUG LABEL	2	0904-2725	TABLET	800 mg	ORAL	ANDA	13 sections
Sulfamethoxazole and Trimethoprim	HUMAN PRESCRIPTION DRUG LABEL	2	10544-053	TABLET	800 mg	ORAL	ANDA	26 sections
Sulfamethoxazole and Trimethoprim	HUMAN PRESCRIPTION DRUG LABEL	2	10544-092	TABLET	800 mg	ORAL	ANDA	25 sections
Sulfamethoxazole and Trimethoprim	HUMAN PRESCRIPTION DRUG LABEL	2	10544-525	TABLET	800 mg	ORAL	ANDA	13 sections
Sulfamethoxazole and Trimethoprim	HUMAN PRESCRIPTION DRUG LABEL	2	10544-926	TABLET	800 mg	ORAL	ANDA	13 sections
Sulfamethoxazole and Trimethoprim	HUMAN PRESCRIPTION DRUG LABEL	2	10544-940	TABLET	800 mg	ORAL	ANDA	27 sections
Sulfamethoxazole and Trimethoprim DS	HUMAN PRESCRIPTION DRUG LABEL	2	12634-177	TABLET	800 mg	ORAL	ANDA	21 sections
SULFAMETHOXAZOLE and TRIMETHOPRIM	HUMAN PRESCRIPTION DRUG LABEL	2	12634-779	SUSPENSION	200 mg	ORAL	ANDA	21 sections
Sulfamethoxazole and Trimethoprim	HUMAN PRESCRIPTION DRUG LABEL	2	16590-210	TABLET	800 mg	ORAL	ANDA	29 sections
SULFATRIM	HUMAN PRESCRIPTION DRUG LABEL	2	17856-0007	SUSPENSION	200 mg	ORAL	NDA	21 sections
Sulfamethoxazole and Trimethoprim	Human Prescription Drug Label	2	17856-0496	SUSPENSION	200 mg	ORAL	ANDA	26 sections
Sulfamethoxazole and Trimethoprim	HUMAN PRESCRIPTION DRUG LABEL	2	17856-0823	SUSPENSION	200 mg	ORAL	ANDA	20 sections
Sulfamethoxazole and Trimethoprim	HUMAN PRESCRIPTION DRUG LABEL	2	17856-5181	SUSPENSION	200 mg	ORAL	ANDA	21 sections
Sulfamethoxazole and Trimethoprim	HUMAN PRESCRIPTION DRUG LABEL	2	21695-125	TABLET	800 mg	ORAL	ANDA	13 sections
Sulfamethoxazole and Trimethoprim	HUMAN PRESCRIPTION DRUG LABEL	2	21695-701	SUSPENSION	200 mg	ORAL	ANDA	20 sections
Sulfamethoxazole and Trimethoprim	HUMAN PRESCRIPTION DRUG LABEL	2	33261-148	TABLET	800 mg	ORAL	ANDA	13 sections
Sulfamethoxazole and Trimethoprim	HUMAN PRESCRIPTION DRUG LABEL	2	33261-396	TABLET	400 mg	ORAL	ANDA	13 sections
Sulfamethoxazole and Trimethoprim	HUMAN PRESCRIPTION DRUG LABEL	2	42291-758	TABLET	400 mg	ORAL	ANDA	13 sections
Sulfamethoxazole and Trimethoprim	HUMAN PRESCRIPTION DRUG LABEL	2	42291-759	TABLET	800 mg	ORAL	ANDA	13 sections