Nystatin
Candio, Mycostatin, Nysfemin Kombipackung · ATC code A07AA02
Also known as: Nistatin · Brand names: Candio, Mycostatin, Nysfemin Kombipackung, Adiclair, Biofanal, Biofanal® Bei Scheidenpilz, Biofanal® Kombipackung Bei Scheidenpilz Und Candida-Infektion Des Äußeren Genitalbereichs, Candio-Hermal, Candio-Mundgel, Lederlind, Moronal, Mykundex, Nystaderm, Nystatin Acis, Nystatin Holsten …
- Key facts
- Active substance
- Nystatin
- Drug class
- Antidiarrhoeal
- ATC code
- A07AA02
- Authorisation
- authorised nationally; no central EU authorisation
- Information as of
- 2026-10-27
Key facts
Nystatin is a polyene antifungal that is barely absorbed from the gut. Per this US label (oral suspension), it is used to treat candidiasis of the oral cavity.
What it is used for
- Candidiasis (thrush) in the oral cavity
- Not for the treatment of systemic mycoses
Dosing
- Infants: 2 mL (200,000 units) four times daily; half the dose in each side of the mouth, avoid feeding for 5 to 10 minutes
- Premature and low birth weight infants: limited studies indicate 1 mL four times daily is effective
- Children and adults: 4 to 6 mL (400,000 to 600,000 units) four times daily, half in each side of the mouth, retained as long as possible
- Continue for at least 48 hours after perioral symptoms have disappeared and cultures show eradication of Candida albicans
Contraindications
- History of hypersensitivity to any of its components
Important warnings
- Not to be used for the treatment of systemic mycoses
- Discontinue if sensitization or irritation is reported
- In renal insufficiency, significant plasma concentrations may occasionally occur
Side effects
- Well tolerated even with prolonged therapy; oral irritation and sensitization reported
- Gastrointestinal: diarrhea, nausea, vomiting, gastrointestinal upset
- Rash including urticaria rarely; Stevens-Johnson syndrome very rarely
- Rarely tachycardia, bronchospasm, facial swelling, myalgia
Pregnancy and breastfeeding
- Pregnancy: no animal reproduction studies; give only if clearly needed
- Nursing: unknown whether excreted in human milk; use with caution
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
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For patients
Patient information (US)
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
Austria
- CandioAlmirall Hermal Gmbh · 1 register entry
- MycostatinDermapharm Gmbh · 2 register entries
- Nysfemin KombipackungGynial Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- AdiclairArdeypharm Gmbh · 2 register entries
- BiofanalDr. Pfleger Arzneimittel Gmbh · 3 register entries
- Biofanal® Bei ScheidenpilzDr. Pfleger Arzneimittel Gmbh · 1 register entry
- Biofanal® Kombipackung Bei Scheidenpilz Und Candida-Infektion Des Äußeren GenitalbereichsDr. Pfleger Arzneimittel Gmbh · 1 register entry
- Candio-HermalAlmirall Hermal Gmbh · 2 register entries
- Candio-MundgelAlmirall Hermal Gmbh · 1 register entry
- LederlindAbanta Pharma Gmbh · 2 register entries
- MoronalDermapharm Ag · 3 register entries
- MykundexEsteve Pharmaceuticals Gmbh · 1 register entry
- NystadermDermapharm Ag · 4 register entries
- Nystatin AcisMibe Gmbh Arzneimittel · 3 register entries
- Nystatin HolstenHolsten Pharma Gmbh · 1 register entry
Show all 15 brand names
- Nystatin Pharma-ZentralePharma Zentrale Gmbh · 1 register entry
- Nystatin Smartpractice Europe GmbhSmartpractice Europe Gmbh · 1 register entry
- Nystatin StadaStada Consumer Health Deutschland Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- DistatinOSEL İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- FungostatinNOBEL İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- MikoralBİLİM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- MikostatinDEVA HOLDİNG A.Ş. · 1 register entry
- NiostaSABA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- NistalinNOBEL İLAÇ SAN. VE TİC. A.Ş. · 5 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
USA
- KlayestaEpic Pharma, LLC · 1 register entry
- NyamycUpsher-Smith Laboratories, LLC · 1 register entry
- Nystop6 register entries
Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28
Brand names in 24 more European countries
- Belgium
- Nilstat, Skandyra
- Bulgaria
- Нистатин Абр, Нистатин Актавис, Фунгостатин
- Croatia
- Pronigyn
- Cyprus
- Nystamysyn, Restatin
- Czechia
- Fungicidin Léčiva
- Denmark
- Nystatin Orifarm, Nystimex, Nyvigan
- Finland
- Nystatin Orifarm, Nystimex
- France
- Mycostatine
- Greece
- Nystamysyn
- Hungary
- Nystatin Pannonpharma
- Iceland
- Nystatin Orifarm, Nystimex
- Ireland
- Mycostatin (Ready Mixed)
- Italy
- Mycostatin
- Lithuania
- Nystatin Actavis
- Luxembourg
- Biofanal Kombi, Candio-Hermal, Nilstat
- Netherlands
- Nystatine Labaz, Nystatine Rph
- Norway
- Nystatin Orifarm, Nystimex, Nyvigan
- Poland
- Nyscandin, Nystapol, Nystatin Tzf, Nystatyna Teva, Nystatyna Vp
- Portugal
- Mycostatin
- Romania
- Nistatina Atb, Nistatină Atb
- Slovakia
- Fungicidin Léčiva, Nystatin Galvex
- Slovenia
- Pronigyn
- Spain
- Mycostatin
- Sweden
- Nystatin Evolan, Nystatin Orifarm, Nystimex, Nyvigan
EMA – Article 57 product data (EU/EEA), 2026-10-28
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- U.S. Food and Drug Administration. Nystatin (PAI Holdings, LLC dba PAI Pharma) – Prescribing Information, 2026-07-21. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=28b4e26e-206a-4e8a-abfe-774b780e91c3
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/
- Wikidata (CC0): ATC A07AA.
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.