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

Stem definition	Drug id	CAS RN
systemic antifungal agents, miconazole derivatives	1187	86386-73-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: fluconazole difluconazole flunazol diflucan	Triazole antifungal agent that is used to treat oropharyngeal CANDIDIASIS and cryptococcal MENINGITIS in AIDS. Molecular weight: 306.28 Formula: C13H12F2N6O CLOGP: -0.44 LIPINSKI: 0 HAC: 7 HDO: 1 TPSA: 81.65 ALOGS: -2.34 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

Dose	Unit	Route
0.20	g	O
0.20	g	P

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	1 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	75 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	9.33 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	90 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.75 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	0.31 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.89 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	30 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Jan. 29, 1990	FDA	PFIZER

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
Febrile neutropenia	461.79	9.64	645	71270	93982	46520165
Candida infection	336.62	9.64	277	71638	21963	46592184
Drug interaction	276.11	9.64	811	71104	202283	46411864
Fungal infection	216.75	9.64	247	71668	29273	46584874
Rheumatoid arthritis	216.69	9.64	52	71863	240163	46373984
Mucosal inflammation	169.78	9.64	252	71663	38724	46575423
Multiple organ dysfunction syndrome	158.27	9.64	285	71630	51425	46562722
Sepsis	157.44	9.64	514	71401	135500	46478647
Oral candidiasis	144.71	9.64	156	71759	17376	46596771
Septic shock	130.94	9.64	281	71634	57612	46556535
Neutropenia	119.77	9.64	487	71428	142717	46471430
Stevens-Johnson syndrome	119.68	9.64	163	71752	23134	46591013
Pyrexia	118.61	9.64	930	70985	347872	46266275
Thrombocytopenia	114.32	9.64	441	71474	126140	46488007
Pancytopenia	112.69	9.64	337	71578	84721	46529426
Cytomegalovirus infection	108.81	9.64	137	71778	18007	46596140
Cytokine release syndrome	101.49	9.64	81	71834	6142	46608005
Mucormycosis	99.57	9.64	55	71860	2237	46611910
Graft versus host disease	99.52	9.64	82	71833	6506	46607641
Aspergillus infection	94.27	9.64	81	71834	6809	46607338
Fall	90.25	9.64	237	71678	328860	46285287
Arthralgia	90.12	9.64	276	71639	364327	46249820
Abortion spontaneous	89.80	9.64	204	71711	43442	46570705
Contraindicated product administered	85.67	9.64	11	71904	79936	46534211
Systemic candida	85.58	9.64	53	71862	2674	46611473
Platelet count decreased	84.22	9.64	341	71574	99683	46514464
Cryptococcosis	81.24	9.64	35	71880	817	46613330
Toxic epidermal necrolysis	78.86	9.64	131	71784	22147	46592000
Fixed eruption	77.48	9.64	34	71881	831	46613316
Joint swelling	75.18	9.64	87	71828	165986	46448161
Pathogen resistance	70.50	9.64	65	71850	5995	46608152
Immune reconstitution inflammatory syndrome	65.81	9.64	61	71854	5664	46608483
Bronchopulmonary aspergillosis	64.14	9.64	68	71847	7428	46606719
Fungaemia	63.25	9.64	39	71876	1952	46612195
Oesophageal candidiasis	62.88	9.64	57	71858	5143	46609004
Enterococcal infection	62.67	9.64	65	71850	6922	46607225
Drug resistance	62.64	9.64	103	71812	17265	46596882
Drug intolerance	62.36	9.64	81	71834	146968	46467179
Deep vein thrombosis	61.68	9.64	265	71650	79508	46534639
Laryngitis fungal	60.40	9.64	18	71897	134	46614013
Infective aneurysm	58.85	9.64	23	71892	415	46613732
Injury	58.79	9.64	175	71740	43852	46570295
Drug ineffective	58.01	9.64	718	71197	677120	45937027
Therapeutic product effect incomplete	56.15	9.64	25	71890	78128	46536019
Torsade de pointes	54.93	9.64	80	71835	12074	46602073
Disseminated mucormycosis	54.91	9.64	16	71899	109	46614038
Intentional overdose	54.76	9.64	16	71899	64928	46549219
Therapeutic product effect decreased	53.96	9.64	30	71885	82571	46531576
Sinusitis fungal	52.22	9.64	26	71889	852	46613295
Pneumonia fungal	49.13	9.64	45	71870	4115	46610032
Vulvovaginal candidiasis	49.01	9.64	37	71878	2584	46611563
Bacterial sepsis	48.93	9.64	42	71873	3525	46610622
Cytomegalovirus viraemia	48.19	9.64	46	71869	4432	46609715
Acute myeloid leukaemia	47.01	9.64	86	71829	15692	46598455
Pemphigus	46.68	9.64	7	71908	45267	46568880
Neutrophil count decreased	46.49	9.64	160	71755	43266	46570881
Suicide attempt	45.60	9.64	14	71901	55022	46559125
Injection site pain	45.44	9.64	59	71856	107093	46507054
Uterine perforation	45.37	9.64	56	71859	7211	46606936
Nasopharyngitis	45.15	9.64	107	71808	153891	46460256
Bone marrow failure	43.53	9.64	122	71793	29547	46584600
Arthropathy	43.24	9.64	40	71875	84660	46529487
Maternal exposure during pregnancy	42.94	9.64	57	71858	102492	46511655
Acute graft versus host disease in skin	42.72	9.64	36	71879	2946	46611201
Blood lactate dehydrogenase increased	42.35	9.64	96	71819	20404	46593743
Meningitis cryptococcal	42.06	9.64	25	71890	1170	46612977
Infusion related reaction	41.62	9.64	57	71858	101151	46512996
Fatigue	41.62	9.64	674	71241	608023	46006124
Abdominal discomfort	41.22	9.64	109	71806	151056	46463091
Mouth ulceration	41.02	9.64	112	71803	26720	46587427
Pseudomonas infection	40.90	9.64	62	71853	9696	46604451
Salpingo-oophorectomy unilateral	40.68	9.64	17	71898	367	46613780
Jarisch-Herxheimer reaction	40.57	9.64	16	71899	296	46613851
Dermatitis bullous	40.04	9.64	54	71861	7589	46606558
Acute generalised exanthematous pustulosis	39.77	9.64	60	71855	9345	46604802
Immune effector cell-associated neurotoxicity syndrome	39.65	9.64	20	71895	674	46613473
Systemic lupus erythematosus	39.31	9.64	26	71889	65154	46548993
Respiratory failure	39.03	9.64	265	71650	94551	46519596
Blood bilirubin increased	38.39	9.64	128	71787	34056	46580091
Fungal sepsis	37.80	9.64	23	71892	1124	46613023
Treatment failure	37.70	9.64	53	71862	93034	46521113
Headache	37.35	9.64	516	71399	477836	46136311
Geotrichum infection	37.31	9.64	17	71898	455	46613692
Injection site erythema	36.99	9.64	36	71879	74391	46539756
Breast cancer	36.96	9.64	12	71903	45506	46568641
Hand deformity	36.45	9.64	5	71910	34569	46579578
Cytomegalovirus test positive	36.25	9.64	32	71883	2788	46611359
International normalised ratio increased	35.64	9.64	155	71760	46728	46567419
White blood cell count decreased	35.63	9.64	295	71620	111936	46502211
Aspartate aminotransferase increased	35.45	9.64	225	71690	78475	46535672
Coccidioidomycosis	35.13	9.64	20	71895	863	46613284
Oral fungal infection	35.09	9.64	30	71885	2504	46611643
Cholecystitis chronic	34.85	9.64	60	71855	10439	46603708
Blood pressure increased	34.78	9.64	91	71824	126575	46487572
Pulmonary embolism	34.78	9.64	286	71629	108299	46505848
Female genital tract fistula	34.34	9.64	33	71882	3206	46610941
Fungal oesophagitis	34.31	9.64	17	71898	551	46613596
Toxicity to various agents	34.18	9.64	189	71726	211577	46402570
Glossodynia	33.80	9.64	13	71902	44360	46569787
Wrong technique in product usage process	33.79	9.64	21	71894	54401	46559746
Shock haemorrhagic	33.63	9.64	53	71862	8571	46605576
Acute graft versus host disease	33.49	9.64	36	71879	3994	46610153
Drug abuse	33.49	9.64	29	71886	63379	46550768
Staphylococcal infection	33.35	9.64	126	71789	35645	46578502
Hepatic function abnormal	32.72	9.64	122	71793	34299	46579848
Neurotoxicity	32.63	9.64	68	71847	13649	46600498
Bacteraemia	32.23	9.64	69	71846	14110	46600037
Tonsillar haemorrhage	32.20	9.64	12	71903	189	46613958
Peripheral swelling	32	9.64	130	71785	157941	46456206
Cystitis haemorrhagic	31.82	9.64	33	71882	3514	46610633
Enterobacter infection	31.71	9.64	25	71890	1862	46612285
Neutropenic sepsis	31.57	9.64	63	71852	12261	46601886
Sputum increased	31.10	9.64	24	71891	1732	46612415
Renal failure	31.08	9.64	289	71626	113305	46500842
Toxic neuropathy	30.82	9.64	14	71901	372	46613775
Keratitis fungal	29.69	9.64	10	71905	115	46614032
Respiratory symptom	29.67	9.64	25	71890	2045	46612102
Dizziness	29.55	9.64	359	71556	340055	46274092
Toxoplasmosis	29.04	9.64	21	71894	1373	46612774
Gastrointestinal fungal infection	28.76	9.64	12	71903	258	46613889
Drug eruption	28.67	9.64	85	71830	21244	46592903
Immunosuppressant drug level increased	28.48	9.64	30	71885	3252	46610895
Epstein-Barr virus infection	28.29	9.64	43	71872	6741	46607406
Overdose	28.19	9.64	73	71842	101906	46512241
Adrenal insufficiency	27.71	9.64	62	71853	13062	46601085
Agranulocytosis	27.56	9.64	86	71829	22099	46592048
Klebsiella infection	27.46	9.64	42	71873	6620	46607527
Inappropriate schedule of product administration	27.34	9.64	36	71879	64977	46549170
Injection site swelling	27.28	9.64	14	71901	40313	46573834
Musculoskeletal stiffness	27.20	9.64	70	71845	97923	46516224
Congenital absence of cranial vault	27.12	9.64	7	71908	28	46614119
Loss of personal independence in daily activities	26.89	9.64	29	71886	57154	46556993
Respiratory tract infection fungal	26.74	9.64	13	71902	404	46613743
Erythema multiforme	26.55	9.64	51	71864	9653	46604494
Pneumonia	26.02	9.64	761	71154	375559	46238588
Clostridium difficile colitis	25.96	9.64	75	71840	18478	46595669
Product dose omission issue	25.78	9.64	153	71762	168367	46445780
Blood alkaline phosphatase increased	25.69	9.64	125	71790	39484	46574663
Chronic graft versus host disease	25.61	9.64	26	71889	2699	46611448
Embolism venous	25.56	9.64	25	71890	2482	46611665
Abscess neck	25.53	9.64	14	71901	561	46613586
Puerperal pyrexia	25.37	9.64	7	71908	38	46614109
Drug level increased	25.27	9.64	74	71841	18367	46595780
Alanine aminotransferase increased	25.18	9.64	227	71688	88224	46525923
Oral disorder	25.05	9.64	44	71871	7778	46606369
Symmetrical drug-related intertriginous and flexural exanthema	24.98	9.64	11	71904	271	46613876
Acute myeloid leukaemia recurrent	24.55	9.64	19	71896	1377	46612770
Vaginal infection	24.53	9.64	38	71877	6055	46608092
Plasma cell myeloma	24.43	9.64	134	71781	44344	46569803
Eosinophilia	24.34	9.64	75	71840	19142	46595005
Drug reaction with eosinophilia and systemic symptoms	24.25	9.64	100	71815	29448	46584699
Systemic mycosis	24.06	9.64	16	71899	913	46613234
Hypomagnesaemia	23.91	9.64	82	71833	22128	46592019
Sinus polyp	23.72	9.64	11	71904	307	46613840
Septic embolus	23.70	9.64	15	71900	786	46613361
Alopecia	23.52	9.64	150	71765	162264	46451883
Acute kidney injury	23.44	9.64	501	71414	235354	46378793
Enterococcal sepsis	23.05	9.64	18	71897	1322	46612825
Gastrointestinal mucormycosis	23.05	9.64	9	71906	162	46613985
BK virus infection	22.89	9.64	25	71890	2824	46611323
Pain in extremity	22.72	9.64	272	71643	258408	46355739
Encephalitis fungal	22.68	9.64	6	71909	27	46614120
Stem cell transplant	22.62	9.64	20	71895	1746	46612401
Liver abscess	22.53	9.64	24	71891	2635	46611512
Encephalopathy	22.51	9.64	107	71808	33482	46580665
Nasal polyps	22.46	9.64	22	71893	2188	46611959
Sepsis syndrome	22.35	9.64	15	71900	869	46613278
Feeling abnormal	22.19	9.64	108	71807	124952	46489195
Hepatic failure	22.07	9.64	106	71809	33310	46580837
Failure to thrive	22.01	9.64	38	71877	6626	46607521
Acute lymphocytic leukaemia	21.70	9.64	24	71891	2749	46611398
Hyperbilirubinaemia	21.69	9.64	49	71866	10389	46603758
Focal myositis	21.24	9.64	6	71909	36	46614111
Oropharyngeal candidiasis	21.15	9.64	15	71900	951	46613196
Staphylococcal sepsis	21.12	9.64	40	71875	7492	46606655
Candida sepsis	20.92	9.64	17	71898	1322	46612825
Electrocardiogram QT prolonged	20.84	9.64	143	71772	51182	46562965
Congestive cardiomyopathy	20.76	9.64	34	71881	5679	46608468
Prothrombin time shortened	20.72	9.64	19	71896	1740	46612407
Gait disturbance	20.60	9.64	135	71780	145128	46469019
Gastritis fungal	20.52	9.64	7	71908	84	46614063
Device related infection	20.35	9.64	75	71840	20966	46593181
Cystic fibrosis related diabetes	20.33	9.64	6	71909	43	46614104
Rash maculo-papular	20.31	9.64	91	71824	27783	46586364
Nasal abscess	20.28	9.64	8	71907	148	46613999
Hypersensitivity	20.17	9.64	142	71773	150179	46463968
Accidental exposure to product	20.10	9.64	4	71911	21077	46593070
Psoriatic arthropathy	19.99	9.64	16	71899	36363	46577784
Tongue coated	19.83	9.64	16	71899	1232	46612915
Wound	19.80	9.64	22	71893	42780	46571367
Tumour lysis syndrome	19.76	9.64	38	71877	7198	46606949
Tongue blistering	19.66	9.64	17	71898	1441	46612706
Oral pain	19.63	9.64	83	71832	24714	46589433
Urinary tract infection fungal	19.62	9.64	12	71903	592	46613555
Disseminated intravascular coagulation	19.44	9.64	69	71846	18936	46595211
Mucosal disorder	19.44	9.64	19	71896	1885	46612262
Graft versus host disease in skin	19.42	9.64	21	71894	2346	46611801
Acute graft versus host disease in intestine	19.36	9.64	18	71897	1677	46612470
Blastomycosis	19.31	9.64	9	71906	254	46613893
Basal cell carcinoma	19.30	9.64	4	71911	20483	46593664
Engraft failure	19.22	9.64	10	71905	360	46613787
Pain	18.95	9.64	575	71340	476373	46137774
Delayed graft function	18.73	9.64	14	71901	963	46613184
Necrotising enterocolitis neonatal	18.72	9.64	8	71907	183	46613964
Inhibitory drug interaction	18.69	9.64	19	71896	1976	46612171
Arthritis	18.68	9.64	59	71856	77257	46536890
Engraftment syndrome	18.62	9.64	9	71906	276	46613871
Herpes simplex	18.59	9.64	37	71878	7186	46606961
Diastolic dysfunction	18.56	9.64	31	71884	5261	46608886
Thrombotic microangiopathy	18.39	9.64	40	71875	8266	46605881
Plasma cell leukaemia	18.33	9.64	15	71900	1178	46612969
Antithrombin III decreased	18.33	9.64	9	71906	286	46613861
Death	18.30	9.64	386	71529	335162	46278985
Hypertension	18.19	9.64	204	71711	196152	46417995
Blood pressure systolic increased	18.02	9.64	11	71904	28776	46585371
Injection site bruising	17.98	9.64	17	71898	35619	46578528
Knee arthroplasty	17.91	9.64	7	71908	23658	46590489
Venoocclusive liver disease	17.80	9.64	27	71888	4224	46609923
Leukopenia	17.74	9.64	172	71743	68171	46545976
Aplastic anaemia	17.65	9.64	36	71879	7117	46607030
Diabetic macroangiopathy	17.48	9.64	7	71908	135	46614012
Growth failure	17.48	9.64	9	71906	317	46613830
Pleural effusion	17.42	9.64	200	71715	82752	46531395
Incorrect dose administered	17.39	9.64	27	71888	45523	46568624
Graft versus host disease in lung	17.27	9.64	9	71906	325	46613822
Generalised oedema	17.14	9.64	55	71860	14344	46599803
Lung infiltration	17.04	9.64	54	71861	13989	46600158
Coagulation factor V level decreased	17.00	9.64	9	71906	336	46613811
Red blood cell sedimentation rate increased	16.95	9.64	7	71908	22882	46591265
Candida test positive	16.94	9.64	13	71902	930	46613217
Hepatic artery aneurysm	16.91	9.64	4	71911	10	46614137
Overgrowth fungal	16.88	9.64	6	71909	82	46614065
Post transplant lymphoproliferative disorder	16.87	9.64	25	71890	3831	46610316
Myocardial infarction	16.85	9.64	85	71830	97443	46516704
Injection site pruritus	16.72	9.64	22	71893	39721	46574426
Aeromonas infection	16.68	9.64	6	71909	85	46614062
Transplant rejection	16.65	9.64	42	71873	9554	46604593
Malaise	16.63	9.64	386	71529	330846	46283301
Blast cell count increased	16.61	9.64	9	71906	352	46613795
Purpura senile	16.60	9.64	11	71904	624	46613523
Stress	16.58	9.64	34	71881	51517	46562630
Renal tubular acidosis	16.54	9.64	16	71899	1567	46612580
Dysphagia	16.50	9.64	187	71728	77125	46537022
Graft versus host disease in gastrointestinal tract	16.48	9.64	20	71895	2530	46611617
Vulvovaginal disorder	16.43	9.64	3	71912	0	46614147
Neuropathy peripheral	16.42	9.64	213	71702	90680	46523467
Hypokalaemia	16.20	9.64	207	71708	87817	46526330
Central nervous system leukaemia	16.19	9.64	6	71909	93	46614054
Nightmare	16.14	9.64	3	71912	16595	46597552
Acquired macroglossia	16.13	9.64	6	71909	94	46614053
Cholestasis	16.12	9.64	83	71832	26810	46587337
Condition aggravated	16.09	9.64	273	71642	244779	46369368
Therapeutic response decreased	16.07	9.64	26	71889	43119	46571028
Haemophagocytic lymphohistiocytosis	16.06	9.64	38	71877	8304	46605843
Cushingoid	16.01	9.64	32	71883	6234	46607913
Blood pressure fluctuation	15.98	9.64	14	71901	30434	46583713
Arteritis infective	15.94	9.64	5	71910	45	46614102
Capillary leak syndrome	15.86	9.64	17	71898	1880	46612267
Suicidal ideation	15.85	9.64	40	71875	56342	46557805
Odynophagia	15.81	9.64	33	71882	6629	46607518
Pulmonary infarction	15.74	9.64	20	71895	2651	46611496
Disease recurrence	15.54	9.64	63	71852	18408	46595739
Mobility decreased	15.52	9.64	45	71870	60549	46553598
Infective chondritis	15.50	9.64	4	71911	16	46614131
Disseminated cryptococcosis	15.45	9.64	8	71907	285	46613862
Stomatitis	15.40	9.64	167	71748	68130	46546017
Hepatitis acute	15.36	9.64	37	71878	8177	46605970
Splenic vein thrombosis	15.32	9.64	8	71907	290	46613857
Respiratory syncytial virus infection	15.22	9.64	27	71888	4808	46609339
Emotional distress	15.21	9.64	90	71825	30617	46583530
Fat necrosis	15.17	9.64	10	71905	562	46613585
Neural tube defect	15.17	9.64	7	71908	193	46613954
Enterocolitis	15.16	9.64	31	71884	6137	46608010
Pseudomonal sepsis	15.11	9.64	17	71898	1985	46612162
Balance disorder	15.05	9.64	50	71865	64471	46549676
Long QT syndrome	14.99	9.64	21	71894	3059	46611088
HIV infection	14.85	9.64	10	71905	583	46613564
Pulmonary arterial hypertension	14.76	9.64	11	71904	25917	46588230
Thrombophlebitis superficial	14.56	9.64	27	71888	4976	46609171
Status epilepticus	14.51	9.64	51	71864	13928	46600219
Chronic sinusitis	14.45	9.64	27	71888	5006	46609141
Encephalitis	14.41	9.64	34	71881	7414	46606733
Stenotrophomonas infection	14.40	9.64	15	71900	1605	46612542
Intentional product misuse	14.39	9.64	32	71883	47096	46567051
Oesophagitis	14.34	9.64	50	71865	13601	46600546
Restlessness	14.31	9.64	11	71904	25513	46588634
Post procedural bile leak	14.25	9.64	6	71909	132	46614015
Swelling	14.19	9.64	123	71792	124388	46489759
Herpes simplex oesophagitis	14.05	9.64	6	71909	137	46614010
Feeling hot	13.99	9.64	23	71892	37905	46576242
Colitis	13.96	9.64	102	71813	37245	46576902
Tarsal tunnel syndrome	13.95	9.64	10	71905	645	46613502
Angina bullosa haemorrhagica	13.93	9.64	6	71909	140	46614007
Vulvovaginal pruritus	13.91	9.64	18	71897	2429	46611718
Leukaemia	13.90	9.64	21	71894	3274	46610873
Product use issue	13.90	9.64	87	71828	94557	46519590
Insomnia	13.86	9.64	175	71740	164749	46449398
Muscle spasms	13.86	9.64	122	71793	122991	46491156
Posterior reversible encephalopathy syndrome	13.83	9.64	53	71862	15088	46599059
Blood creatinine increased	13.78	9.64	179	71736	76224	46537923
Anhedonia	13.71	9.64	41	71874	10294	46603853
Hyperhidrosis	13.69	9.64	81	71834	89227	46524920
Respiratory tract haemorrhage	13.62	9.64	8	71907	366	46613781
Neutropenic colitis	13.61	9.64	17	71898	2215	46611932
Livedo reticularis	13.54	9.64	17	71898	2227	46611920
Multiple sclerosis	13.50	9.64	11	71904	24780	46589367
Dyspnoea	13.50	9.64	653	71262	514895	46099252
Right ventricular failure	13.50	9.64	4	71911	16089	46598058
Rhinocerebral mucormycosis	13.44	9.64	6	71909	153	46613994
Myalgia	13.41	9.64	123	71792	122965	46491182
Sleep disorder	13.31	9.64	33	71882	46762	46567385
Renal impairment	13.31	9.64	174	71741	74198	46539949
Stoma site candida	13.28	9.64	4	71911	31	46614116
Proteus infection	13.28	9.64	11	71904	879	46613268
Xanthopsia	13.26	9.64	6	71909	158	46613989
Gamma-glutamyltransferase increased	13.22	9.64	89	71826	31651	46582496
Acid base balance abnormal	13.18	9.64	7	71908	263	46613884
Acinetobacter test positive	13.18	9.64	5	71910	83	46614064
Product deposit	13.09	9.64	6	71909	163	46613984
Labelled drug-drug interaction medication error	13.03	9.64	37	71878	9024	46605123
Septic pulmonary embolism	12.96	9.64	4	71911	34	46614113
Varicella zoster virus infection	12.96	9.64	17	71898	2326	46611821
Pulmonary haemorrhage	12.92	9.64	30	71885	6475	46607672
Cachexia	12.86	9.64	25	71890	4774	46609373
Pharyngeal stenosis	12.83	9.64	3	71912	7	46614140
Shock	12.80	9.64	67	71848	21778	46592369
Anaemia	12.73	9.64	498	71417	255281	46358866
Chronic hepatitis C	12.73	9.64	6	71909	174	46613973
Withdrawal syndrome	12.71	9.64	6	71909	18128	46596019
Injection site reaction	12.65	9.64	35	71880	47814	46566333
Haemodialysis	12.64	9.64	37	71878	9180	46604967
Mucosal erosion	12.53	9.64	13	71902	1385	46612762
Duodenal stenosis	12.52	9.64	9	71906	583	46613564
Refractory anaemia with an excess of blasts	12.51	9.64	8	71907	427	46613720
Angiodermatitis	12.41	9.64	5	71910	98	46614049
Cushing's syndrome	12.38	9.64	10	71905	771	46613376
Vulvovaginitis	12.36	9.64	7	71908	299	46613848
Viral haemorrhagic cystitis	12.24	9.64	9	71906	604	46613543
Vulvovaginal discomfort	12.09	9.64	16	71899	2208	46611939
Skin maceration	11.96	9.64	4	71911	45	46614102
Epstein-Barr virus associated lymphoproliferative disorder	11.92	9.64	13	71902	1466	46612681
Gallbladder disorder	11.91	9.64	56	71859	17442	46596705
Mucosal toxicity	11.89	9.64	7	71908	322	46613825
Weight increased	11.86	9.64	180	71735	164293	46449854
Cardiomyopathy acute	11.63	9.64	6	71909	212	46613935
CSF culture positive	11.62	9.64	3	71912	12	46614135
Pneumothorax	11.60	9.64	49	71866	14580	46599567
Poikiloderma	11.58	9.64	4	71911	50	46614097
Oral mucosal blistering	11.45	9.64	24	71891	4836	46609311
Cytopenia	11.45	9.64	32	71883	7736	46606411
Flushing	11.34	9.64	56	71859	64558	46549589
Palatal oedema	11.34	9.64	8	71907	503	46613644
Nausea	11.32	9.64	909	71006	686545	45927602
Hallucination, tactile	11.31	9.64	6	71909	225	46613922
Aplasia	11.30	9.64	20	71895	3556	46610591
Subdiaphragmatic abscess	11.30	9.64	4	71911	54	46614093
Atelectasis	11.26	9.64	58	71857	18732	46595415
Hypoglossal nerve paresis	11.22	9.64	5	71910	127	46614020
Acute febrile neutrophilic dermatosis	11.17	9.64	17	71898	2668	46611479
Exposure via breast milk	11.10	9.64	12	71903	1340	46612807
Hepatic enzyme increased	11.09	9.64	77	71838	81710	46532437
Herpes dermatitis	11.08	9.64	3	71912	15	46614132
Encephalitis protozoal	11.08	9.64	3	71912	15	46614132
Gallbladder fibrosis	11.08	9.64	3	71912	15	46614132
Contusion	11.08	9.64	84	71831	87403	46526744
Product quality issue	11.05	9.64	24	71891	35624	46578523
Urinary tract infection enterococcal	11.05	9.64	16	71899	2402	46611745
Resorption bone increased	11.05	9.64	11	71904	1116	46613031
Vomiting projectile	11.00	9.64	12	71903	1353	46612794
Cytomegalovirus oesophagitis	10.98	9.64	6	71909	239	46613908
Pulmonary cavitation	10.95	9.64	9	71906	711	46613436
Systemic inflammatory response syndrome	10.92	9.64	25	71890	5346	46608801
Vaginal mucosal blistering	10.92	9.64	3	71912	16	46614131
Meningitis coccidioides	10.92	9.64	3	71912	16	46614131
Eye irritation	10.89	9.64	6	71909	16608	46597539
Infection	10.85	9.64	276	71639	133316	46480831
Marrow hyperplasia	10.78	9.64	8	71907	544	46613603
Citrobacter test positive	10.77	9.64	3	71912	17	46614130
Bradycardia	10.77	9.64	59	71856	66239	46547908
Biliary dyskinesia	10.75	9.64	17	71898	2756	46611391
Fracture	10.72	9.64	6	71909	16465	46597682
Somnolence	10.71	9.64	173	71742	156348	46457799
Fungal test positive	10.71	9.64	8	71907	550	46613597
Fungal endocarditis	10.66	9.64	6	71909	253	46613894
Psoriasis	10.66	9.64	74	71841	78530	46535617
Lichenification	10.64	9.64	7	71908	392	46613755
Perihepatic abscess	10.62	9.64	3	71912	18	46614129
Idiopathic intracranial hypertension	10.60	9.64	16	71899	2493	46611654
Premature delivery	10.59	9.64	11	71904	22058	46592089
Opsoclonus myoclonus	10.57	9.64	5	71910	146	46614001
Herpes virus infection	10.56	9.64	23	71892	4759	46609388
Gastrointestinal necrosis	10.55	9.64	17	71898	2801	46611346
Sepsis neonatal	10.49	9.64	7	71908	402	46613745
Palpitations	10.45	9.64	95	71820	95164	46518983
Rhinorrhoea	10.40	9.64	38	71877	47627	46566520
Cholelithiasis	10.36	9.64	98	71817	38583	46575564
Mastitis fungal	10.35	9.64	4	71911	70	46614077
Blood culture positive	10.30	9.64	22	71893	4490	46609657
Bone marrow myelogram abnormal	10.23	9.64	3	71912	21	46614126
Rash erythematous	10.20	9.64	89	71826	34261	46579886
Pain in jaw	10.19	9.64	28	71887	38344	46575803
Staphylococcal bacteraemia	10.16	9.64	23	71892	4881	46609266
Tricuspid valve incompetence	10.15	9.64	45	71870	13672	46600475
Fibromyalgia	10.15	9.64	26	71889	36437	46577710
Off label use	10.14	9.64	480	71435	379361	46234786
Heart rate decreased	10.14	9.64	21	71894	31702	46582445
Skin hyperpigmentation	10.10	9.64	24	71891	5258	46608889
Drug ineffective for unapproved indication	10.07	9.64	51	71864	16362	46597785
Herpes simplex viraemia	10.04	9.64	5	71910	164	46613983
Vertigo positional	10.03	9.64	16	71899	2614	46611533
Musculoskeletal pain	10.02	9.64	65	71850	70063	46544084
Oliguria	10.01	9.64	33	71882	8726	46605421
Injection site urticaria	9.99	9.64	3	71912	11964	46602183
Leukocytosis	9.98	9.64	66	71849	23332	46590815
Low cardiac output syndrome	9.94	9.64	6	71909	289	46613858
Fungal skin infection	9.94	9.64	19	71896	3583	46610564
Acute sinusitis	9.90	9.64	20	71895	3927	46610220
Hepatorenal failure	9.89	9.64	8	71907	618	46613529
Device expulsion	9.88	9.64	17	71898	27525	46586622
Diabetic hyperosmolar coma	9.88	9.64	7	71908	443	46613704
Anal candidiasis	9.88	9.64	3	71912	24	46614123
Depressed mood	9.87	9.64	23	71892	33296	46580851
Thrombocytosis	9.86	9.64	23	71892	4979	46609168
Exposure during pregnancy	9.78	9.64	113	71802	108099	46506048
Ileus paralytic	9.78	9.64	21	71894	4302	46609845
Jaundice	9.78	9.64	77	71838	28768	46585379
Balamuthia infection	9.77	9.64	3	71912	25	46614122
Product storage error	9.76	9.64	3	71912	11789	46602358
Drug withdrawal syndrome	9.74	9.64	17	71898	27367	46586780
Petechiae	9.71	9.64	42	71873	12628	46601519
Hypoalbuminaemia	9.71	9.64	36	71879	10091	46604056
Haemochromatosis	9.69	9.64	7	71908	457	46613690
Pruritus genital	9.66	9.64	8	71907	639	46613508
Clostridial infection	9.64	9.64	21	71894	4344	46609803

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
Febrile neutropenia	442.65	10.46	785	60279	105908	29785506
Candida infection	288.61	10.46	244	60820	15118	29876296
Immune reconstitution inflammatory syndrome	220.89	10.46	168	60896	8933	29882481
Pyrexia	215.05	10.46	1172	59892	293317	29598097
Pancytopenia	178.83	10.46	476	60588	84576	29806838
Mucormycosis	161.41	10.46	112	60952	5156	29886258
Drug interaction	151.11	10.46	803	60261	198765	29692649
Neutropenia	148.51	10.46	586	60478	127954	29763460
Completed suicide	143.97	10.46	17	61047	99475	29791939
Cytokine release syndrome	143.37	10.46	136	60928	9797	29881617
Multiple organ dysfunction syndrome	142.26	10.46	364	60700	63123	29828291
Meningitis cryptococcal	140.90	10.46	73	60991	1951	29889463
Graft versus host disease	138.99	10.46	135	60929	10015	29881399
Drug abuse	138.31	10.46	7	61057	82065	29809349
Sepsis	133.33	10.46	621	60443	145774	29745640
Septic shock	129.59	10.46	352	60712	63255	29828159
Enterococcal infection	115.65	10.46	111	60953	8113	29883301
Cryptococcosis	111.29	10.46	60	61004	1742	29889672
Aspergillus infection	111.07	10.46	120	60944	10094	29881320
Toxic epidermal necrolysis	108.43	10.46	157	60907	17783	29873631
Platelet count decreased	106.10	10.46	463	60601	105666	29785748
Fungal infection	103.36	10.46	133	60931	13467	29877947
Thrombocytopenia	95.79	10.46	540	60524	136504	29754910
Pathogen resistance	95.32	10.46	101	60963	8309	29883105
Bronchopulmonary aspergillosis	91.58	10.46	119	60945	12165	29879249
Oral candidiasis	90.04	10.46	112	60952	10959	29880455
Cytomegalovirus infection	88.68	10.46	167	60897	23507	29867907
Myocardial infarction	88.05	10.46	76	60988	125549	29765865
Systemic candida	87.58	10.46	60	61004	2704	29888710
Neutrophil count decreased	83.48	10.46	232	60832	42222	29849192
Fall	81.86	10.46	154	60910	181718	29709696
Drug resistance	75.37	10.46	142	60922	19991	29871423
Mucosal inflammation	74.71	10.46	181	60883	30313	29861101
Oesophageal candidiasis	67.23	10.46	61	61003	4149	29887265
Dyspnoea	67.12	10.46	402	60662	332893	29558521
Hepatotoxicity	66.71	10.46	127	60937	18018	29873396
Intentional overdose	65.48	10.46	5	61059	41476	29849938
Blood bilirubin increased	65.03	10.46	193	60871	36443	29854971
Disseminated intravascular coagulation	64.69	10.46	141	60923	22030	29869384
Dizziness	64.61	10.46	194	60870	194715	29696699
Overdose	64.11	10.46	47	61017	84290	29807124
Arthralgia	63.71	10.46	112	60952	135679	29755735
White blood cell count decreased	61.36	10.46	335	60729	83612	29807802
Torsade de pointes	60.50	10.46	74	60990	7116	29884298
Rheumatoid arthritis	59.64	10.46	7	61057	41190	29850224
Candida sepsis	58.01	10.46	33	61031	1066	29890348
Death	55.73	10.46	464	60600	356819	29534595
Product dose omission issue	55.46	10.46	63	61001	91568	29799846
Peripheral swelling	54.81	10.46	28	61036	61046	29830368
Cytomegalovirus viraemia	53.20	10.46	62	61002	5667	29885747
Alanine aminotransferase increased	51.99	10.46	293	60771	73983	29817431
Fungaemia	51.52	10.46	40	61024	2191	29889223
Cardiac failure congestive	51.11	10.46	58	61006	84349	29807065
Fatigue	51.09	10.46	414	60650	320259	29571155
Encephalitis	48.98	10.46	63	61001	6373	29885041
Toxicity to various agents	48.11	10.46	192	60872	176991	29714423
Stevens-Johnson syndrome	47.11	10.46	108	60956	17448	29873966
Pain	46.29	10.46	188	60876	172453	29718961
Acute graft versus host disease	45.57	10.46	58	61006	5806	29885608
Bone marrow failure	45.53	10.46	149	60915	29636	29861778
Immunosuppressant drug level increased	45.53	10.46	52	61012	4650	29886764
Pneumonia	44.65	10.46	941	60123	333365	29558049
Insomnia	44.64	10.46	76	60988	93260	29798154
Acinetobacter infection	44.55	10.46	27	61037	983	29890431
Porphyria acute	44.48	10.46	14	61050	93	29891321
Joint swelling	44.44	10.46	20	61044	46926	29844488
Nasopharyngitis	44.44	10.46	33	61031	58816	29832598
Acute myeloid leukaemia	44.22	10.46	107	60957	17899	29873515
Electrocardiogram QT prolonged	44.20	10.46	167	60897	35668	29855746
Cytomegalovirus chorioretinitis	43.86	10.46	43	61021	3225	29888189
Acute graft versus host disease in skin	43.83	10.46	50	61014	4466	29886948
Wrong technique in product usage process	43.39	10.46	6	61058	31149	29860265
Cerebrovascular accident	41.76	10.46	66	60998	83411	29808003
Cystitis haemorrhagic	41.46	10.46	50	61014	4737	29886677
Gait disturbance	41.45	10.46	55	61009	74722	29816692
Clostridium test positive	41.37	10.46	34	61030	2022	29889392
Trichosporon infection	41.04	10.46	22	61042	631	29890783
Aspartate aminotransferase increased	41.00	10.46	245	60819	63177	29828237
Respiratory failure	40.67	10.46	347	60717	100295	29791119
Pseudomonas infection	39.31	10.46	74	60990	10408	29881006
Intentional product misuse	39.24	10.46	11	61053	34656	29856758
Pruritus genital	38.79	10.46	19	61045	449	29890965
Pain in extremity	38.43	10.46	107	60957	110114	29781300
Lymphocyte count decreased	38.29	10.46	105	60959	18950	29872464
Acute myocardial infarction	37.07	10.46	32	61032	52907	29838507
Bacteraemia	36.65	10.46	91	60973	15469	29875945
Tumour lysis syndrome	36.51	10.46	81	60983	12804	29878610
Toxic neuropathy	36.24	10.46	17	61047	364	29891050
Fusarium infection	35.86	10.46	24	61040	1040	29890374
Pneumonia fungal	35.74	10.46	50	61014	5483	29885931
Injection site pain	35.48	10.46	9	61055	30301	29861113
Chest pain	35.47	10.46	122	60942	117505	29773909
Systemic mycosis	35.26	10.46	25	61039	1191	29890223
Leukopenia	35.05	10.46	215	60849	55944	29835470
Psoriasis	34.53	10.46	22	61042	42484	29848930
Blood lactate dehydrogenase increased	34.17	10.46	106	60958	20495	29870919
Acute myeloid leukaemia recurrent	34.06	10.46	27	61037	1525	29889889
Chronic graft versus host disease	34.02	10.46	42	61022	4077	29887337
Depression	33.64	10.46	85	60979	90352	29801062
Pseudomembranous colitis	33.48	10.46	35	61029	2833	29888581
Suicidal ideation	33.23	10.46	16	61048	36098	29855316
Venoocclusive liver disease	33.05	10.46	53	61011	6560	29884854
Therapeutic product effect incomplete	32.68	10.46	14	61050	33820	29857594
Staphylococcal infection	32.55	10.46	135	60929	30089	29861325
Anxiety	32.25	10.46	86	60978	89785	29801629
Feeling abnormal	32.22	10.46	41	61023	56715	29834699
Drug level increased	31.90	10.46	96	60968	18258	29873156
Aplasia	31.48	10.46	40	61024	3997	29887417
Fungal skin infection	30.79	10.46	31	61033	2401	29889013
Liver disorder	30.64	10.46	131	60933	29591	29861823
Coccidioidomycosis	30.60	10.46	18	61046	620	29890794
Meningitis coccidioides	30.54	10.46	8	61056	24	29891390
Acute respiratory distress syndrome	30.28	10.46	111	60953	23361	29868053
Hyperferritinaemia	30.26	10.46	15	61049	364	29891050
Graft versus host disease in gastrointestinal tract	29.82	10.46	34	61030	3035	29888379
Penis injury	29.77	10.46	13	61051	234	29891180
C-reactive protein increased	29.41	10.46	170	60894	43303	29848111
Agranulocytosis	29.35	10.46	105	60959	21837	29869577
Fungal test positive	28.81	10.46	16	61048	493	29890921
Encephalitis viral	28.77	10.46	22	61042	1178	29890236
Acquired immunodeficiency syndrome	28.66	10.46	16	61048	498	29890916
Stem cell transplant	28.52	10.46	28	61036	2103	29889311
Hypoalbuminaemia	28.40	10.46	67	60997	11025	29880389
Epidermolysis bullosa	28.20	10.46	10	61054	100	29891314
Long QT syndrome	28.19	10.46	29	61035	2304	29889110
Memory impairment	27.86	10.46	21	61043	37153	29854261
Hepatic function abnormal	27.71	10.46	163	60901	41782	29849632
Enterococcal bacteraemia	27.62	10.46	23	61041	1393	29890021
Headache	27.29	10.46	239	60825	182067	29709347
Differentiation syndrome	27.23	10.46	21	61043	1139	29890275
Cerebral toxoplasmosis	26.85	10.46	23	61041	1449	29889965
Malaise	26.74	10.46	215	60849	166747	29724667
Inappropriate schedule of product administration	26.63	10.46	25	61039	39703	29851711
Hyperhidrosis	26.57	10.46	61	61003	67029	29824385
Penile haemorrhage	26.05	10.46	16	61048	597	29890817
Blood corticosterone increased	25.99	10.46	5	61059	0	29891414
Immune effector cell-associated neurotoxicity syndrome	25.75	10.46	18	61046	838	29890576
Foetal exposure during pregnancy	24.95	10.46	23	61041	36848	29854566
Abdominal discomfort	24.94	10.46	38	61026	48753	29842661
Infection	24.90	10.46	256	60808	77818	29813596
Bacterial infection	24.85	10.46	69	60995	12541	29878873
Stomatitis	24.71	10.46	145	60919	37134	29854280
Blood alkaline phosphatase increased	24.56	10.46	128	60936	31359	29860055
Adrenal insufficiency	24.44	10.46	61	61003	10402	29881012
Weight increased	24.44	10.46	75	60989	74838	29816576
Aplastic anaemia	24.38	10.46	42	61022	5514	29885900
Hyperbilirubinaemia	24.33	10.46	83	60981	16859	29874555
Clostridium difficile colitis	24.31	10.46	69	60995	12699	29878715
Device related infection	24.12	10.46	83	60981	16932	29874482
Wound infection fungal	24.08	10.46	7	61057	34	29891380
Asthma	23.97	10.46	23	61041	36151	29855263
Bacterial sepsis	23.96	10.46	39	61025	4887	29886527
Aggression	23.84	10.46	24	61040	36883	29854531
Musculoskeletal pain	23.81	10.46	17	61047	30923	29860491
Haematotoxicity	23.68	10.46	44	61020	6126	29885288
Syncope	23.64	10.46	91	60973	84812	29806602
Portal fibrosis	23.60	10.46	13	61051	394	29891020
Pneumonia cryptococcal	23.57	10.46	16	61048	710	29890704
Chronic obstructive pulmonary disease	23.50	10.46	36	61028	46090	29845324
Cardiac disorder	23.50	10.46	28	61036	39865	29851549
Mycetoma mycotic	23.44	10.46	7	61057	38	29891376
Perivascular dermatitis	23.37	10.46	10	61054	171	29891243
Coronary artery disease	23.27	10.46	41	61023	49671	29841743
Oropharyngeal candidiasis	23.14	10.46	16	61048	732	29890682
Disseminated cryptococcosis	23.10	10.46	18	61046	991	29890423
Angina pectoris	23.00	10.46	16	61048	29502	29861912
Neurotoxicity	22.95	10.46	69	60995	13113	29878301
Hypertension	22.93	10.46	149	60915	121205	29770209
Staphylococcal sepsis	22.87	10.46	56	61008	9435	29881979
Aspartate aminotransferase	22.86	10.46	9	61055	123	29891291
Myalgia	22.77	10.46	80	60984	76587	29814827
Blood pressure increased	22.77	10.46	73	60991	71855	29819559
Cachexia	22.74	10.46	45	61019	6566	29884848
Arthropathy	22.68	10.46	7	61057	20720	29870694
Gallstone ileus	21.99	10.46	6	61058	22	29891392
Endocarditis candida	21.96	10.46	8	61056	87	29891327
CD4 lymphocytes decreased	21.94	10.46	24	61040	2046	29889368
Stress	21.85	10.46	7	61057	20228	29871186
Enterococcal sepsis	21.73	10.46	21	61043	1547	29889867
Blood culture positive	21.34	10.46	37	61027	4882	29886532
Hospitalisation	21.25	10.46	36	61028	44283	29847131
Pulmonary haemorrhage	21.15	10.46	54	61010	9338	29882076
Fluorosis	21.12	10.46	7	61057	56	29891358
Adenovirus infection	21.05	10.46	34	61030	4234	29887180
Chest discomfort	20.85	10.46	38	61026	45442	29845972
Secondary adrenocortical insufficiency	20.84	10.46	17	61047	1000	29890414
Anterior displaced anus	20.79	10.46	4	61060	0	29891414
Kaposi's sarcoma	20.68	10.46	17	61047	1011	29890403
Adrenal suppression	20.67	10.46	14	61050	619	29890795
Drug intolerance	20.62	10.46	38	61026	45253	29846161
Osteoarthritis	20.44	10.46	6	61058	18343	29873071
Acute generalised exanthematous pustulosis	20.36	10.46	41	61023	6057	29885357
Drug dependence	20.26	10.46	9	61055	21286	29870128
Coagulopathy	20.23	10.46	83	60981	18404	29873010
Acute lymphocytic leukaemia	20.20	10.46	28	61036	3044	29888370
Road traffic accident	20.11	10.46	5	61059	17066	29874348
Respiratory tract infection fungal	20.08	10.46	14	61050	649	29890765
Graft versus host disease in skin	20.06	10.46	29	61035	3278	29888136
Prostate cancer	20.01	10.46	12	61052	23945	29867469
Choreoathetosis	19.83	10.46	16	61048	927	29890487
Wound dehiscence	19.83	10.46	29	61035	3312	29888102
Skin necrosis	19.78	10.46	35	61029	4692	29886722
Acute hepatic failure	19.74	10.46	61	61003	11766	29879648
Encephalitis fungal	19.61	10.46	9	61055	183	29891231
Pseudomonal sepsis	19.21	10.46	27	61037	2973	29888441
Klebsiella infection	19.18	10.46	43	61021	6844	29884570
Arthritis fungal	19.07	10.46	7	61057	78	29891336
HIV infection	18.84	10.46	20	61044	1648	29889766
Nephropathy toxic	18.82	10.46	56	61008	10583	29880831
Therapy cessation	18.69	10.46	4	61060	15133	29876281
Therapeutic product effect decreased	18.67	10.46	19	61045	29057	29862357
Cough	18.65	10.46	165	60899	125477	29765937
Streptococcal infection	18.61	10.46	34	61030	4674	29886740
Blast cell count increased	18.34	10.46	16	61048	1033	29890381
Dysbiosis	18.34	10.46	11	61053	393	29891021
Mycobacterium avium complex infection	18.26	10.46	25	61039	2686	29888728
Pulmonary alveolar haemorrhage	18.22	10.46	41	61023	6540	29884874
Multiple chemical sensitivity	18.03	10.46	4	61060	4	29891410
Hepatic necrosis	18.00	10.46	30	61034	3833	29887581
Hepatic failure	17.98	10.46	125	60939	33918	29857496
Sleep apnoea syndrome	17.90	10.46	6	61058	16851	29874563
Stenotrophomonas test positive	17.83	10.46	10	61054	314	29891100
Drug reaction with eosinophilia and systemic symptoms	17.72	10.46	109	60955	28379	29863035
Muscle spasms	17.72	10.46	70	60994	64768	29826646
Loss of personal independence in daily activities	17.69	10.46	11	61053	21524	29869890
Drug-induced liver injury	17.65	10.46	88	60976	21186	29870228
Central venous pressure increased	17.60	10.46	5	61059	22	29891392
Pulmonary mucormycosis	17.49	10.46	11	61053	428	29890986
Vision blurred	17.39	10.46	37	61027	41779	29849635
Brachycephaly	17.38	10.46	6	61058	55	29891359
Musculoskeletal stiffness	17.34	10.46	29	61035	35852	29855562
Ocular icterus	17.33	10.46	26	61038	3038	29888376
Atelectasis	17.30	10.46	72	60992	16066	29875348
Elbow synostosis	17.25	10.46	5	61059	24	29891390
Engraftment syndrome	17.23	10.46	14	61050	819	29890595
Opportunistic infection	17.20	10.46	17	61047	1287	29890127
Swelling face	17.18	10.46	11	61053	21193	29870221
Engraft failure	17.18	10.46	11	61053	442	29890972
Odynophagia	17.02	10.46	32	61032	4495	29886919
Enterococcus test positive	16.96	10.46	14	61050	838	29890576
Synostosis	16.95	10.46	7	61057	109	29891305
Rash maculo-papular	16.93	10.46	99	60965	25319	29866095
Gamma-glutamyltransferase increased	16.83	10.46	110	60954	29240	29862174
Eschar	16.75	10.46	12	61052	581	29890833
HIV associated nephropathy	16.67	10.46	9	61055	262	29891152
Klebsiella sepsis	16.64	10.46	19	61045	1698	29889716
Gastrooesophageal reflux disease	16.59	10.46	25	61039	32230	29859184
Geotrichum infection	16.59	10.46	11	61053	469	29890945
Cytomegalovirus test positive	16.58	10.46	28	61036	3617	29887797
Acanthamoeba infection	16.45	10.46	11	61053	476	29890938
Jaundice	16.40	10.46	118	60946	32368	29859046
Idiosyncratic drug reaction	16.19	10.46	11	61053	489	29890925
Anticonvulsant drug level abnormal	16.18	10.46	5	61059	31	29891383
Epstein-Barr viraemia	16.07	10.46	14	61050	902	29890512
Irritability	16.05	10.46	14	61050	23036	29868378
Plasma cell myeloma	15.95	10.46	173	60891	53289	29838125
Transplant rejection	15.85	10.46	48	61016	9158	29882256
Oedema	15.67	10.46	145	60919	42848	29848566
Heart rate irregular	15.64	10.46	3	61061	12256	29879158
Disseminated coccidioidomycosis	15.59	10.46	3	61061	0	29891414
Stiff person syndrome	15.50	10.46	7	61057	137	29891277
Sedation	15.45	10.46	7	61057	16366	29875048
Culture stool positive	15.36	10.46	8	61056	216	29891198
Hypertransaminasaemia	15.28	10.46	28	61036	3857	29887557
Swollen tongue	15.28	10.46	4	61060	13188	29878226
Blood glucose increased	15.22	10.46	69	60995	61461	29829953
Central nervous system lesion	15.22	10.46	32	61032	4874	29886540
Pulmonary valve disease	15.11	10.46	6	61058	84	29891330
Neurological symptom	15.05	10.46	26	61038	3421	29887993
Haemodynamic instability	14.95	10.46	43	61021	7972	29883442
Product quality issue	14.86	10.46	10	61054	18764	29872650
Pseudomonas test positive	14.83	10.46	14	61050	1002	29890412
Hypokalaemia	14.78	10.46	162	60902	50030	29841384
Escherichia sepsis	14.73	10.46	28	61036	3966	29887448
Sputum purulent	14.73	10.46	10	61054	444	29890970
Nosocomial infection	14.66	10.46	15	61049	1184	29890230
Osteonecrosis of jaw	14.62	10.46	10	61054	18608	29872806
Familial periodic paralysis	14.61	10.46	6	61058	92	29891322
Mobility decreased	14.52	10.46	19	61045	25980	29865434
Gastrointestinal wall thinning	14.39	10.46	4	61060	16	29891398
Cytomegalovirus test	14.37	10.46	5	61059	47	29891367
Blood pressure fluctuation	14.29	10.46	9	61055	17494	29873920
Hyperadrenocorticism	14.27	10.46	6	61058	98	29891316
Unevaluable event	14.17	10.46	27	61037	31758	29859656
Application site haematoma	14.10	10.46	5	61059	50	29891364
Flushing	14.10	10.46	24	61040	29468	29861946
Incorrect dose administered	14.06	10.46	27	61037	31659	29859755
Ventricular tachycardia	14.03	10.46	90	60974	23772	29867642
Contraindicated product administered	13.88	10.46	9	61055	17222	29874192
Hepatic enzyme increased	13.77	10.46	116	60948	33378	29858036
Angina unstable	13.75	10.46	4	61060	12306	29879108
Cardio-respiratory arrest	13.74	10.46	65	60999	57241	29834173
Peritoneal candidiasis	13.66	10.46	4	61060	20	29891394
Drug ineffective for unapproved indication	13.65	10.46	51	61013	10829	29880585
Anger	13.61	10.46	3	61061	11117	29880297
Intracranial pressure increased	13.53	10.46	25	61039	3465	29887949
Generalised oedema	13.51	10.46	54	61010	11831	29879583
Arthritis	13.46	10.46	18	61046	24383	29867031
Diabetic ketoacidosis	13.36	10.46	8	61056	15978	29875436
Strabismus	13.34	10.46	14	61050	1138	29890276
Meningism	13.28	10.46	7	61057	194	29891220
Venoocclusive disease	13.27	10.46	21	61043	2569	29888845
Oral mucosal erythema	13.11	10.46	9	61055	407	29891007
Neutropenic sepsis	13.10	10.46	52	61012	11357	29880057
Cytomegalovirus enterocolitis	13.08	10.46	12	61052	828	29890586
Viraemia	13.07	10.46	14	61050	1165	29890249
Ischaemic hepatitis	13.04	10.46	16	61048	1543	29889871
Angioedema	13.02	10.46	32	61032	34352	29857062
Organ failure	12.98	10.46	19	61045	2172	29889242
Enterobacter test positive	12.83	10.46	7	61057	208	29891206
Psychotic disorder	12.77	10.46	15	61049	21500	29869914
Brain abscess	12.73	10.46	21	61043	2660	29888754
Dermatitis	12.68	10.46	41	61023	8101	29883313
Bradycardia	12.59	10.46	80	60984	65446	29825968
Respiratory paralysis	12.59	10.46	5	61059	70	29891344
Epstein-Barr virus infection	12.53	10.46	36	61028	6670	29884744
Hepatomegaly	12.53	10.46	47	61017	10000	29881414
Viral test positive	12.51	10.46	7	61057	219	29891195
Macule	12.45	10.46	12	61052	881	29890533
Proteus infection	12.41	10.46	11	61053	725	29890689
Haemophagocytic lymphohistiocytosis	12.37	10.46	46	61018	9745	29881669
Periorbital cellulitis	12.34	10.46	7	61057	225	29891189
Product administration error	12.29	10.46	7	61057	14370	29877044
Streptococcal bacteraemia	12.17	10.46	16	61048	1654	29889760
Pneumonia pseudomonal	12.16	10.46	24	61040	3494	29887920
Faeces pale	12.10	10.46	15	61049	1462	29889952
Pleocytosis	12.08	10.46	9	61055	463	29890951
Heart rate decreased	12.08	10.46	15	61049	20979	29870435
End stage AIDS	12.07	10.46	4	61060	32	29891382
Mucosal infection	12.06	10.46	7	61057	235	29891179
Lung neoplasm malignant	12.06	10.46	8	61056	15124	29876290
Gastroduodenal ulcer	12.05	10.46	8	61056	342	29891072
Drug hypersensitivity	12.00	10.46	86	60978	68433	29822981
Strongyloidiasis	11.99	10.46	19	61045	2327	29889087
Oral fungal infection	11.88	10.46	14	61050	1294	29890120
Somnolence	11.87	10.46	133	60931	96630	29794784
Renal impairment	11.81	10.46	239	60825	83945	29807469
Mycobacterial infection	11.79	10.46	16	61048	1705	29889709
Skull malformation	11.71	10.46	8	61056	359	29891055
Constipation	11.67	10.46	161	60903	112745	29778669
Accidental overdose	11.67	10.46	12	61052	18263	29873151
Nightmare	11.65	10.46	5	61059	12071	29879343
Acute graft versus host disease in intestine	11.64	10.46	19	61045	2386	29889028
Sleep disorder	11.63	10.46	20	61044	24459	29866955
Blood creatine phosphokinase increased	11.56	10.46	48	61016	43800	29847614
Haemodialysis	11.56	10.46	49	61015	11024	29880390
Prostatic specific antigen increased	11.54	10.46	5	61059	11999	29879415
Liver transplant rejection	11.51	10.46	18	61046	2180	29889234
Oral herpes	11.50	10.46	27	61037	4428	29886986
Eosinophilia	11.48	10.46	81	60983	22079	29869335
Back pain	11.44	10.46	144	60920	102452	29788962
Central nervous system fungal infection	11.38	10.46	7	61057	262	29891152
Cholangitis infective	11.38	10.46	7	61057	262	29891152
Citrobacter infection	11.33	10.46	9	61055	510	29890904
Hyperuricaemia	11.30	10.46	37	61027	7357	29884057
Prothrombin time prolonged	11.17	10.46	43	61021	9260	29882154
Paraesthesia	11.13	10.46	65	60999	54262	29837152
Type 2 diabetes mellitus	11.13	10.46	7	61057	13615	29877799
Cholestasis	11.11	10.46	88	60976	24862	29866552
Hyperleukocytosis	11.08	10.46	15	61049	1594	29889820
Candida pneumonia	11.05	10.46	7	61057	276	29891138
Monocytopenia	11.02	10.46	5	61059	99	29891315
Diffuse alopecia	10.99	10.46	3	61061	11	29891403
Transmission of an infectious agent via transplant	10.99	10.46	3	61061	11	29891403
Stenotrophomonas infection	10.98	10.46	15	61049	1609	29889805
Liver abscess	10.97	10.46	22	61042	3240	29888174
Enterobacter infection	10.93	10.46	17	61047	2049	29889365
Asthenia	10.90	10.46	356	60708	220934	29670480
Basal cell carcinoma	10.90	10.46	10	61054	16058	29875356
Candida endophthalmitis	10.88	10.46	5	61059	102	29891312
Precocious puberty	10.88	10.46	5	61059	102	29891312
Candida test positive	10.85	10.46	8	61056	405	29891009
Graft loss	10.85	10.46	11	61053	859	29890555
Eyelid ptosis congenital	10.83	10.46	5	61059	103	29891311
Pneumonia cytomegaloviral	10.81	10.46	20	61044	2776	29888638
Product prescribing error	10.67	10.46	11	61053	16722	29874692
Autonomic neuropathy	10.66	10.46	11	61053	877	29890537
Pleural effusion	10.63	10.46	211	60853	73855	29817559
Addison's disease	10.60	10.46	3	61061	13	29891401
Hepatitis	10.60	10.46	80	60984	22276	29869138
Loss of consciousness	10.58	10.46	107	60957	79268	29812146
Drug withdrawal syndrome	10.53	10.46	15	61049	19794	29871620
Poisoning	10.53	10.46	5	61059	11377	29880037
Gastroenteritis cryptosporidial	10.51	10.46	6	61058	195	29891219
HIV wasting syndrome	10.49	10.46	5	61059	111	29891303
Congenital eyelid malformation	10.48	10.46	4	61060	50	29891364
T-cell lymphoma recurrent	10.48	10.46	4	61060	50	29891364
Staphylococcal bacteraemia	10.46	10.46	34	61030	6734	29884680

Pharmacologic Action:

Source	Code	Description
ATC	D01AC15	DERMATOLOGICALS ANTIFUNGALS FOR DERMATOLOGICAL USE ANTIFUNGALS FOR TOPICAL USE Imidazole and triazole derivatives
ATC	J01RA07	ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE COMBINATIONS OF ANTIBACTERIALS Combinations of antibacterials
ATC	J02AC01	ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOTICS FOR SYSTEMIC USE ANTIMYCOTICS FOR SYSTEMIC USE Triazole derivatives
FDA CS	M0002083	Azoles
MeSH PA	D058888	14-alpha Demethylase Inhibitors
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D000935	Antifungal Agents
MeSH PA	D065689	Cytochrome P-450 CYP2C19 Inhibitors
MeSH PA	D065688	Cytochrome P-450 CYP2C9 Inhibitors
MeSH PA	D065607	Cytochrome P-450 Enzyme Inhibitors
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D006727	Hormone Antagonists
MeSH PA	D065606	Metabolic Side Effects of Drugs and Substances
MeSH PA	D065088	Steroid Synthesis Inhibitors
FDA EPC	N0000175487	Azole Antifungal
FDA MoA	N0000182140	Cytochrome P450 2C19 Inhibitors
FDA MoA	N0000182141	Cytochrome P450 3A4 Inhibitors
FDA MoA	N0000185504	Cytochrome P450 2C9 Inhibitors
CHEBI has role	CHEBI:35703	xenobiotic
CHEBI has role	CHEBI:50183	cytochrome p450 inhibitor
CHEBI has role	CHEBI:78298	environmental contaminants

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Cryptococcal meningitis	indication	14232007
Candidiasis of the esophagus	indication	20639004	DOID:13146
Mucocutaneous candidiasis	indication	29147005
Disseminated candidiasis	indication	70572005
Candidal vulvovaginitis	indication	72605008	DOID:2272
Candidiasis of mouth	indication	79740000	DOID:14262
Candidal septicemia	indication	187022007
Candidemia	indication	432261003
Prevention of Disseminated Candidiasis	indication
Candidal Urinary Tract Infection	indication
Oropharyngeal Candidiasis	indication
Tinea capitis	off-label use	5441008
Tinea pedis	off-label use	6020002	DOID:12403
Histoplasmosis	off-label use	12962009	DOID:1731
Tinea manus	off-label use	48971001	DOID:13369
Pityriasis versicolor	off-label use	56454009	DOID:9060
Blastomycosis	off-label use	69996000	DOID:12663
Tinea corporis	off-label use	84849002
Disseminated coccidioidomycosis	off-label use	85055004
Cutaneous leishmaniasis	off-label use	240637006	DOID:9111
Tinea cruris	off-label use	399029005
Onychomycosis due to dermatophyte	off-label use	402134005
Pulmonary coccidioidomycosis	off-label use	417018008
Onychomycosis due to Candida	off-label use
Prevention of Vulvovaginal Candidiasis	off-label use
Kidney disease	contraindication	90708001	DOID:557
Prolonged QT interval	contraindication	111975006
Disease of liver	contraindication	235856003	DOID:409
Pregnancy, function	contraindication	289908002
Congenital long QT syndrome	contraindication	442917000

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	13.55	acidic
pKa2	1.84	Basic
pKa3	1.24	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
Lanosterol 14-alpha demethylase	Enzyme	Q16850	CP51A_HUMAN		Kd	4.40		CHEMBL
Cytochrome P450 3A4	Enzyme	P08684	CP3A4_HUMAN		IC50	5.10		CHEMBL
Cytochrome P450 2C9	Enzyme	P11712	CP2C9_HUMAN		IC50	4.54		CHEMBL
Cytochrome P450 2C19	Enzyme	P33261	CP2CJ_HUMAN		IC50	5.09		CHEMBL
Lanosterol 14-alpha demethylase	Enzyme		CP51_CANAL	INHIBITOR	IC50	6.70		WOMBAT-PK	CHEMBL
Lanosterol 14-alpha demethylase	Enzyme		CP51_MYCTU		Kd	6.70		CHEMBL
14-alpha sterol demethylase	Enzyme		Q96W81_ASPFM		Kd	5.39		CHEMBL
14-alpha sterol demethylase Cyp51A	Enzyme		Q4WNT5_ASPFU		Kd	4.92		CHEMBL
Mycocyclosin synthase	Enzyme		CP121_MYCTU		Kd	5.22		CHEMBL

External reference:

ID	Source
4019493	VUID
N0000147613	NUI
D00322	KEGG_DRUG
4019493	VANDF
C0699601	UMLSCUI
CHEBI:46081	CHEBI
TPF	PDB_CHEM_ID
CHEMBL106	ChEMBL_ID
DB00196	DRUGBANK_ID
D015725	MESH_DESCRIPTOR_UI
3365	PUBCHEM_CID
5851	INN_ID
8VZV102JFY	UNII
202813	RXNORM
3884	MMSL
4732	MMSL
59176	MMSL
d00071	MMSL
003534	NDDF
31865003	SNOMEDCT_US
387174006	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Diflucan	HUMAN PRESCRIPTION DRUG LABEL	1	0049-3410	TABLET	50 mg	ORAL	NDA	26 sections
Diflucan	HUMAN PRESCRIPTION DRUG LABEL	1	0049-3420	TABLET	100 mg	ORAL	NDA	26 sections
Diflucan	HUMAN PRESCRIPTION DRUG LABEL	1	0049-3430	TABLET	200 mg	ORAL	NDA	26 sections
Diflucan	HUMAN PRESCRIPTION DRUG LABEL	1	0049-3440	POWDER, FOR SUSPENSION	350 mg	ORAL	NDA	26 sections
Diflucan	HUMAN PRESCRIPTION DRUG LABEL	1	0049-3450	POWDER, FOR SUSPENSION	1400 mg	ORAL	NDA	26 sections
Diflucan	HUMAN PRESCRIPTION DRUG LABEL	1	0049-3500	TABLET	150 mg	ORAL	NDA	26 sections
Fluconazole	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9666	INJECTION	2 mg	INTRAVENOUS	ANDA	21 sections
Fluconazole	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9667	INJECTION	2 mg	INTRAVENOUS	ANDA	21 sections
Fluconazole	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9668	INJECTION	2 mg	INTRAVENOUS	ANDA	21 sections
Fluconazole	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9669	INJECTION	2 mg	INTRAVENOUS	ANDA	21 sections
Fluconazole	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9899	INJECTION	2 mg	INTRAVENOUS	ANDA	21 sections
Fluconazole	HUMAN PRESCRIPTION DRUG LABEL	1	0172-5410	TABLET	50 mg	ORAL	ANDA	13 sections
Fluconazole	HUMAN PRESCRIPTION DRUG LABEL	1	0172-5411	TABLET	100 mg	ORAL	ANDA	13 sections
Fluconazole	HUMAN PRESCRIPTION DRUG LABEL	1	0172-5412	TABLET	150 mg	ORAL	ANDA	13 sections
Fluconazole	HUMAN PRESCRIPTION DRUG LABEL	1	0172-5413	TABLET	200 mg	ORAL	ANDA	13 sections
Fluconazole	HUMAN PRESCRIPTION DRUG LABEL	1	0338-6045	INJECTION, SOLUTION	400 mg	INTRAVENOUS	ANDA	25 sections
Fluconazole	HUMAN PRESCRIPTION DRUG LABEL	1	0338-6046	INJECTION, SOLUTION	200 mg	INTRAVENOUS	ANDA	25 sections
Fluconazole in Sodium Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	0409-4688	INJECTION, SOLUTION	2 mg	INTRAVENOUS	ANDA	25 sections
Fluconazole	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6500	TABLET	100 mg	ORAL	ANDA	25 sections
Fluconazole	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6501	TABLET	200 mg	ORAL	ANDA	25 sections
Fluconazole	HUMAN PRESCRIPTION DRUG LABEL	1	10544-178	TABLET	200 mg	ORAL	ANDA	15 sections
Fluconazole	HUMAN PRESCRIPTION DRUG LABEL	1	10544-610	TABLET	200 mg	ORAL	ANDA	24 sections
Fluconazole	HUMAN PRESCRIPTION DRUG LABEL	1	10544-855	TABLET	150 mg	ORAL	ANDA	22 sections
Fluconazole	HUMAN PRESCRIPTION DRUG LABEL	1	12634-780	TABLET	150 mg	ORAL	ANDA	23 sections
Fluconazole	Human Prescription Drug Label	1	16571-210	TABLET	50 mg	ORAL	ANDA	18 sections
Fluconazole	Human Prescription Drug Label	1	16571-211	TABLET	100 mg	ORAL	ANDA	18 sections
Fluconazole	Human Prescription Drug Label	1	16571-212	TABLET	150 mg	ORAL	ANDA	18 sections
Fluconazole	Human Prescription Drug Label	1	16571-213	TABLET	200 mg	ORAL	ANDA	18 sections
FLUCONULLZOLE	HUMAN PRESCRIPTION DRUG LABEL	1	16590-282	TABLET	150 mg	ORAL	ANDA	24 sections
FLUCONULLZOLE	HUMAN PRESCRIPTION DRUG LABEL	1	16590-283	TABLET	200 mg	ORAL	ANDA	14 sections