Adverse Drug Reaction Classification System

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)
Abdominal pain07.01.05.002--
Abdominal pain lower07.01.05.0100.000189%-
Abdominal pain upper07.01.05.003--
Abortion spontaneous18.01.04.0010.003555%-
Acne23.02.01.001---
Acute febrile neutrophilic dermatosis01.02.01.006; 23.03.03.0330.000135%-
Acute hepatic failure09.01.03.0010.000270%-
Acute respiratory distress syndrome10.02.01.067; 22.01.03.001; 24.03.02.0340.000247%
Adrenal insufficiency05.01.02.001; 14.11.01.0040.000180%
Ageusia07.14.03.003; 17.02.07.0010.000121%-
Agitation17.02.05.012; 19.06.02.001--
Agranulocytosis01.02.03.0010.000144%-
Alanine aminotransferase increased13.03.04.005--
Alcohol abuse19.07.06.001---
Alopecia23.02.02.001--
Altered state of consciousness17.02.04.001; 19.07.01.0030.000112%-
Anaemia01.03.02.001--
Anaphylactic reaction10.01.07.001; 24.06.03.0060.000301%
Anaphylactic shock10.01.07.002; 24.06.02.0040.000067%-
Angina pectoris02.02.02.002; 24.04.04.0020.000112%
Angioedema10.01.05.009; 22.04.02.008; 23.04.01.001---
Angioimmunoblastic T-cell lymphoma01.11.05.001; 16.17.05.0010.000045%-
Apathy19.04.04.0020.000067%-
Arrhythmia02.03.02.0010.000135%-
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.001---
Ataxia08.01.02.004; 17.02.02.0010.000112%
Atrioventricular block02.03.01.0020.000112%-
Azotaemia20.01.01.0010.000067%-
Back pain15.03.04.005--
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ADReCS-Target
Drug Name ADR Term Target
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