ADReCS

Pharmaceutical Information

Drug Name	Fluconazole
Drug ID	BADD_D00912
Description	Fluconazole, commonly known as _Diflucan_, is an antifungal drug used for the treatment of both systemic and superficial fungal infections in a variety of tissues. It was initially approved by the FDA in 1990. This drug is an _azole_ antifungal, in the same drug family as [ketoconazole] and [itraconazole]. Fluconazole has many advantages over the other antifungal drugs including the option of oral administration. The side effect profile of this drug is minimal. It has been demonstrated as an efficacious treatment for vaginal yeast infections in one single dose.[A174325]
Indications and Usage	Fluconazole can be administered in the treatment of the following fungal infections[L11043]: 1) Vaginal yeast infections caused by Candida 2) Systemic Candida infections 3) Both esophageal and oropharyngeal candidiasis 4) Cryptococcal meningitis 5) UTI (urinary tract infection) by Candida 6) Peritonitis (inflammation of the peritoneum) caused by Candida A note on fungal infection prophylaxis Patients receiving bone marrow transplantation who are treated with cytotoxic chemotherapy and/or radiation therapy may be predisposed to candida infections, and may receive fluconazole as prophylactic therapy.[L11043] A note on laboratory testing Obtaining specimens for fungal culture and other important laboratory studies such as serology or pathology is advised before starting fluconazole therapy in order to isolate the organisms to be eliminated through treatment. It is permissible to start therapy before the results are available, however, adjusting the therapy once laboratory results confirm the causative organism may be necessary.[L11043]
Marketing Status	approved; investigational
ATC Code	D01AC15; J02AC01
DrugBank ID	DB00196
KEGG ID	D00322
MeSH ID	D015725
PubChem ID	3365
TTD Drug ID	D09LNI
NDC Product Code	82982-070; 53104-7569; 65015-601; 66039-857; 16714-694; 43063-642; 0143-9667; 0143-9669; 51672-4067; 62135-130; 62559-992; 65862-300; 67405-603; 68071-2557; 68462-101; 68788-7150; 70518-0560; 70710-1140; 71205-104; 71205-563; 71335-0686; 71335-1268; 0904-6501; 64567-0002; 65862-058; 16714-693; 0143-9666; 51407-426; 51655-435; 55111-144; 55289-824; 57237-149; 59762-5015; 0049-3420; 67296-1498; 68001-254; 70518-3100; 70771-1066; 70985-015; 71205-094; 71205-650; 71335-1037; 71335-1954; 72189-140; 38779-2442; 51552-1031; 53069-0380; 55111-039; 65862-061; 16571-210; 16571-212; 16714-692; 25021-184; 50268-337; 51672-4065; 57237-004; 57237-006; 59762-5017; 61919-493; 62559-990; 63629-9091; 0049-3440; 0049-3450; 65862-059; 68071-4501; 68462-104; 70518-3312; 70771-1065; 71205-081; 71335-1895; 55111-145; 59762-5030; 0338-6045; 68001-251; 68788-7293; 72189-149; 65862-060; 0143-9899; 51672-4066; 59762-5016; 0338-6046; 60760-113; 62559-993; 0049-3500; 68071-2601; 68071-2609; 70710-1139; 70985-014; 71205-573; 71205-796; 72189-143; 13371-418; 51407-301; 55111-143; 55700-916; 61919-380; 62135-132; 62135-133; 63187-584; 63629-1948; 67405-601; 67405-604; 68001-252; 68462-102; 68462-119; 70518-2415; 70710-1137; 70710-1138; 70985-016; 71335-1948; 0904-6500; 53104-7522; 16714-696; 50090-2195; 50090-5299; 50090-5764; 51407-424; 51407-425; 51407-427; 57237-005; 63187-096; 63629-8970; 68071-3428; 68084-735; 68788-7959; 68788-8220; 70518-2411; 70771-1063; 71205-283; 71335-0769; 72789-209; 49452-3149; 50090-4425; 51655-889; 51672-4064; 59762-5018; 59762-5029; 63187-613; 63187-878; 65862-299; 68071-2805; 68071-2906; 70518-3092; 70518-3111; 70771-1064; 71335-1448; 72189-342; 82982-058; 62991-2651; 65427-025; 16714-695; 0143-9668; 51407-299; 51407-302; 55154-7875; 57237-003; 60760-804; 62135-131; 62559-991; 63629-1947; 63629-1950; 63629-7986; 67405-602; 68001-253; 68084-728; 70985-013; 76420-164; 51927-3783; 16571-213; 16714-691; 43063-645; 57237-150; 60760-803; 63629-1949; 63629-8971; 63629-9134; 0049-3430; 71335-0764; 72789-096; 51686-0006; 60592-209; 65841-108; 65862-297; 16571-211; 50268-339; 51407-300; 55111-146; 55154-3400
UNII	8VZV102JFY
Synonyms	Fluconazole \| Zonal \| Béagyne \| Diflucan \| Fluc Hexal \| Flucobeta \| FlucoLich \| Fluconazol AbZ \| Fluconazol AL \| Fluconazol Stada \| Fluconazol von ct \| Fluconazol-Isis \| Fluconazol Isis \| Fluconazol-ratiopharm \| Fluconazol ratiopharm \| Flunazul \| Fungata \| Lavisa \| Loitin \| Neofomiral \| Oxifungol \| Solacap \| UK-49858 \| UK 49858 \| UK49858 \| Triflucan \| Apo-Fluconazole \| Apo Fluconazole

Chemical Information

Molecular Formula	C13H12F2N6O
CAS Registry Number	86386-73-4
SMILES	C1=CC(=C(C=C1F)F)C(CN2C=NC=N2)(CN3C=NC=N3)O
Chemical Structure

ADRs Induced by Drug

*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..

ADR Term	ADReCS ID	ADR Frequency (FAERS)	ADR Severity Grade (FAERS)	ADR Severity Grade (CTCAE)
Lymphadenopathy mediastinal	22.09.03.006; 01.09.01.025	0.000045%		Not Available
Pleocytosis	17.02.05.059	0.000045%		Not Available
Pulmonary artery stenosis	24.04.09.011; 22.06.03.006	-	-	Not Available
Pulmonary cavitation	22.01.02.022	0.000045%		Not Available
Genital erythema	23.03.06.019; 21.10.01.015	0.000090%		Not Available
Palatal oedema	07.05.04.008	0.000225%		Not Available
Angina bullosa haemorrhagica	07.05.01.013; 24.07.02.040	0.000112%		Not Available
Excessive eye blinking	17.17.02.010; 06.05.01.004	-	-	Not Available
Oral mucosal erythema	07.05.05.023	0.000045%		Not Available
Skin plaque	23.03.03.044	0.000112%		Not Available
Hyperlipasaemia	14.11.01.023	0.000112%		Not Available
Spinal pain	17.10.01.020; 15.02.01.008; 08.01.08.030	-	-	Not Available
Chronic spontaneous urticaria	10.01.06.011; 23.04.02.011	-	-	Not Available
Abdominal lymphadenopathy	07.11.01.018; 01.09.01.020	0.000045%		Not Available
Tongue discomfort	07.14.02.019	0.000099%		Not Available
Central nervous system vasculitis	24.12.04.005; 17.08.02.029; 10.02.02.030	0.000045%		Not Available
Drug effective for unapproved indication	12.09.02.001; 08.06.01.037	0.000045%		Not Available
Drug ineffective for unapproved indication	12.09.02.002; 08.06.01.038	0.000715%		Not Available
Eyelid vascular disorder	24.03.07.016; 23.06.04.006; 06.07.05.003	-	-	Not Available
Fixed eruption	23.03.05.008; 10.01.01.037; 08.01.06.025	0.000580%		Not Available
Generalised bullous fixed drug eruption	23.03.01.033; 10.01.01.038; 08.01.06.026	0.000045%		Not Available
Haemophagocytic lymphohistiocytosis	16.32.03.038; 10.02.01.077; 01.05.01.026	0.000067%		Not Available
Heavy menstrual bleeding	21.01.03.005	-	-	Not Available
Hepatic cytolysis	09.01.07.036	0.000067%		Not Available
Idiopathic intracranial hypertension	17.07.02.011	0.000135%		Not Available
Illness	08.01.03.091	-	-	Not Available
Immune thrombocytopenia	10.02.01.083; 01.08.01.013	0.000112%		Not Available
Intermenstrual bleeding	21.01.01.015	0.000189%		Not Available
Lung opacity	22.12.01.006	0.000045%		Not Available
Normocytic anaemia	01.03.02.022	0.000045%		Not Available

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