Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Nystatin
Drug ID BADD_D01591
Description Nystatin is a polyene antifungal drug that has broad-spectrum fungicidal and fungistatic activity against a number of yeasts and fungi, most notably _Candida_ species.[L10686] It is one of the most effective antifungal agents synthesized by bacteria, in this case a strain of _Streptomyces noursei_,[L10776] and is closely related to [amphotericin B], differing only slightly in structure.[A188562] Nystatin has a greater antifungal activity than amphotericin B - parenterally administered nystatin, however, is associated with significant toxicity and is not available in a formulation appropriate for systemic use.[A188562] As it undergoes very little absorption following oral or topical administration, nystatin's efficacy is limited to the treatment/prevention of cutaneous, mucocutaneous, and gastrointestinal fungal infections.[L10686,L10728]
Indications and Usage Nystatin is available in oral formulations for the treatment and/or prevention of oral candidiasis (a.k.a. thrush), intestinal candidiasis, and anal candidiasis.[L10686,L10728] It is indicated topically for the treatment of vulvovaginal candidiasis and other cutaneous candida infections.[L10728] A combination product containing nystatin alongside [neomycin], [gramicidin D], and [triamcinolone] (Viaderm K.C.®) is indicated in the treatment of corticosteroid-responsive dermatoses caused by bacterial or candidal infections and for pruritus ani/vulvae.[L10731] It is also available in combination with [metronidazole] for the treatment of mixed infections due to _Trichomonas vaginalis_ and _Candida albicans_.[L10776] Nystatin is also sometimes used off-label for the prevention of invasive candidiasis in low birth weight neonates,[A188565] though it is generally reserved as a second-line option after [fluconazole].
Marketing Status approved; vet_approved
ATC Code A07AA02; D01AA01; G01AA01
DrugBank ID DB00646
KEGG ID D00202
MeSH ID D009761
PubChem ID 11286230
TTD Drug ID D08XAC
NDC Product Code 61813-701; 76003-9999; 17856-1008; 45802-059; 68071-2621; 68308-152; 65415-1372; 0121-0810; 55154-1578; 63187-422; 63629-8694; 63629-8697; 68071-2556; 71205-106; 71205-575; 72189-408; 75834-235; 43386-530; 68382-370; 70518-3284; 63629-2493; 63629-2515; 68788-6792; 68788-8436; 70166-331; 0574-2008; 0832-0465; 65415-1371; 23155-051; 55154-5788; 63187-464; 63187-847; 63629-8521; 63629-8695; 63629-8698; 73141-221; 0093-0983; 38779-0242; 0904-7276; 62991-2785; 13668-595; 50090-2854; 50090-5845; 53002-9380; 63629-2492; 63629-2516; 63629-8519; 66689-008; 68071-2819; 51927-0095; 53734-336; 61813-702; 61813-802; 33342-481; 0121-0868; 42291-651; 45802-048; 53489-400; 63629-8520; 68788-9516; 16714-769; 33342-469; 39822-3015; 50090-2763; 51672-4117; 63629-8350; 63629-8696; 67296-1519; 72189-278; 0168-0007; 50090-3772; 51672-1289; 63187-703; 66689-037; 67296-1860; 68071-2887; 68094-599; 69315-306; 69315-307; 69315-504; 70771-1357; 70771-1585; 72578-089; 61813-801; 0121-4810; 50090-5315; 63739-160; 68788-7949; 0472-0166; 51552-0041; 76003-0827; 0168-0054; 50090-1740; 53002-8220; 55154-4056
UNII BDF1O1C72E
Synonyms Nystatin | Fungicidin | Mycostatin | Stamicin | Nystatin A1 | Nystatin A2 | Nystatin A3 | Nystatin G | Stamycin | Nilstat
Chemical Information
Molecular Formula C47H75NO17
CAS Registry Number 34786-70-4
SMILES CC1C=CC=CCCC=CC=CC=CC=CC(CC2C(C(CC(O2)(CC(C(CCC(CC(CC(CC(=O)OC(C(C1O)C)C)O)O)O)O )O)O)O)C(=O)O)OC3C(C(C(C(O3)C)O)N)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 discomfort07.01.06.001---
Anaphylactic shock10.01.07.002; 24.06.02.004---
Anaphylactoid reaction10.01.07.003; 24.06.03.007---
Bronchospasm10.01.03.012; 22.03.01.004--
Burning sensation08.01.09.029; 17.02.06.001---
Dermatitis23.03.04.002---
Diarrhoea07.02.01.001--
Diarrhoea haemorrhagic07.02.01.002; 24.07.02.004---
Eczema23.03.04.006--
Erythema multiforme10.01.03.015; 23.03.01.003--
Gastrointestinal disorder07.11.01.001---
Hypersensitivity10.01.03.003--
Myalgia15.05.02.001--
Nausea07.01.07.001--
Pain08.01.08.004--
Pruritus23.03.12.001--
Rash23.03.13.001---
Stevens-Johnson syndrome10.01.01.045; 11.07.01.005; 12.03.01.014; 23.03.01.007--
Stomatitis07.05.06.005--
Swelling face08.01.03.100; 10.01.05.018; 23.04.01.018---
Tachycardia02.03.02.007---
Urticaria10.01.06.001; 23.04.02.001--
Vomiting07.01.07.003--
Musculoskeletal discomfort15.03.04.001---
Sensitisation08.01.05.009; 10.02.01.012---
Gastrointestinal tract irritation07.08.03.008---
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ADReCS-Target
Drug Name ADR Term Target
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