Nystatin

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Nystatin on Prescriptsy

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Nystatin is a polyene antifungal medicine used to treat and prevent oral candidiasis (oral thrush) and intestinal candidiasis.

It is one of the oldest antifungal agents in clinical use, first isolated in 1950 from the soil bacterium Streptomyces noursei by Elizabeth Lee Hazen and Rachel Fuller Brown.

Nystatin remains a first-line treatment for uncomplicated oral thrush due to its local action, excellent safety profile, and lack of systemic absorption.

It is available as an oral suspension (100,000 units per mL), pastilles, and tablets. Nystatin is a prescription-only medicine (POM) in the UK for oral preparations.

Oral candidiasis is a common fungal infection of the mouth and throat caused predominantly by Candida albicans, a yeast that is part of the normal oral flora in approximately 30% to 50% of healthy adults.

When the balance of the oral microbiome is disrupted, Candida can overgrow and cause symptomatic infection.

Oral thrush presents as creamy white patches on the tongue, inner cheeks, palate, or throat that can be wiped away to reveal a red, sometimes bleeding surface.

Other forms of oral candidiasis include erythematous (atrophic) candidiasis, which appears as red, sore patches without white plaques, and angular cheilitis, which causes cracking and soreness at the corners of the mouth.

This page provides a comprehensive clinical overview of nystatin, including how it works, dosage guidance, side effects, warnings, and how to obtain it in the United Kingdom.

Important safety information about nystatin

Before reading further, please note these essential safety points.

• Nystatin is for the treatment of oral and intestinal candidiasis only. It is not effective for systemic fungal infections.
• Continue treatment for at least 48 hours after symptoms have resolved to prevent relapse.
• If symptoms do not improve within 7 days, or if oral thrush recurs frequently, consult your prescriber for investigation of underlying causes.
• Nystatin is not absorbed into the bloodstream and has an excellent safety profile. Serious side effects are extremely rare.
• Check the sugar content of the oral suspension if you have diabetes or a rare sugar intolerance.

Understanding oral candidiasis

Candida species are commensal organisms that colonise the oral cavity, gastrointestinal tract, and skin of most healthy individuals without causing symptoms.

Symptomatic infection occurs when host defences are impaired or local conditions favour fungal overgrowth.

Risk factors for oral candidiasis include antibiotic use (which disrupts the normal bacterial flora and allows Candida to proliferate), inhaled corticosteroid use (common in asthma and COPD management), diabetes mellitus (particularly if poorly controlled), iron or vitamin B12 deficiency, dry mouth (xerostomia, which may be caused by medicines, radiotherapy, or Sjogren syndrome), immunosuppression (HIV/AIDS, chemotherapy, organ transplant recipients), denture wearing (especially if dentures are worn overnight or are poorly fitting), extremes of age (neonates and elderly adults), and smoking.

In neonates, oral thrush is particularly common during the first few weeks of life, as the immune system is immature and the oral microbiome is still being established.

Thrush can be acquired during passage through a colonised birth canal or through contact with caregivers.

It is usually self-limiting in healthy term neonates but may require treatment if it causes feeding difficulties or discomfort.

How nystatin works: mechanism of action

Nystatin is a polyene macrolide antifungal antibiotic.

Its mechanism of action centres on its high affinity for ergosterol, a sterol found exclusively in the cell membranes of fungi but not in mammalian cells (which contain cholesterol instead).

When nystatin molecules bind to ergosterol, they insert into the fungal cell membrane and aggregate to form pore-like structures.

These pores disrupt membrane integrity, allowing essential intracellular contents, particularly potassium ions, amino acids, and sugars, to leak out of the cell.

The resulting loss of intracellular solutes and the disruption of the electrochemical gradient across the membrane lead to fungal cell death.

The selectivity of nystatin for ergosterol over cholesterol is the basis of its safety in humans: because mammalian cell membranes lack ergosterol, nystatin does not damage human cells at therapeutic concentrations.

This selectivity, combined with the fact that oral nystatin is virtually unabsorbed from the gastrointestinal tract, accounts for its remarkably low toxicity and the rarity of systemic side effects.

Nystatin is active against a broad range of Candida species, including Candida albicans (the most common cause of oral and intestinal candidiasis), Candida glabrata, Candida tropicalis, Candida krusei, and Candida parapsilosis.

Resistance to nystatin is uncommon but has been reported, particularly in immunocompromised patients who have received prolonged or repeated courses.

Cross-resistance with amphotericin B (another polyene antifungal) may occur because both agents share the same ergosterol-binding mechanism.

Clinical evidence and UK prescribing guidance

Nystatin has been in clinical use for over 70 years and has an extensive track record of safety and efficacy.

Clinical trials and systematic reviews have confirmed its effectiveness in treating oral candidiasis, particularly in immunocompetent patients.

In immunocompromised patients, systemic antifungals such as fluconazole are generally more effective for oral and especially oesophageal candidiasis, and are often preferred as first-line treatment in this population.

The BNF lists nystatin oral suspension as a treatment for oral candidiasis and recommends it for both treatment and prophylaxis.

NICE Clinical Knowledge Summaries (CKS) on oral candidiasis advise nystatin suspension as a first-line option for uncomplicated oral thrush in immunocompetent adults and children.

For immunocompromised patients, or when nystatin fails, fluconazole 50 to 100 mg daily for 7 to 14 days is recommended.

In neonatal practice, nystatin remains widely used for oral thrush. NICE and the BNF for Children recommend nystatin oral suspension for neonates.

Miconazole oral gel is an alternative, but it is not licensed for infants under 4 months and carries a risk of choking in very young infants if not applied carefully.

Nystatin is generally considered the safer choice in this age group.

Nystatin compared with other antifungal options for oral thrush

Several treatment options exist for oral candidiasis. Nystatin oral suspension is a topical treatment that acts locally without systemic absorption, making it one of the safest options.

Miconazole oral gel (Daktarin) is an imidazole antifungal that is also applied locally but is partially absorbed; it has drug interactions (particularly with warfarin) that nystatin does not.

Fluconazole is a triazole antifungal taken as an oral capsule; it is systemically absorbed and is highly effective for oral and oesophageal candidiasis, but it carries a greater potential for drug interactions and systemic side effects.

Itraconazole oral solution is used for fluconazole-resistant cases. Amphotericin B lozenges were formerly available but have been discontinued in the UK.

For most cases of uncomplicated oral thrush in immunocompetent patients, nystatin or miconazole are appropriate first-line treatments.

Fluconazole is reserved for cases that do not respond to topical treatment, for immunocompromised patients, and for oesophageal candidiasis.

The choice depends on patient factors, drug interactions, and local guidelines.

Dosage and administration

The recommended adult dose of nystatin oral suspension for oral thrush is 100,000 units (1 mL) four times daily.

Measure the dose using the dropper or oral syringe provided.

Place the suspension in your mouth, hold it near the affected areas (tongue, inner cheeks, palate) for as long as possible, swish it around, then swallow.

This ensures maximum contact between the medicine and the infected mucosa. Ideally, use nystatin after meals and before bedtime.

Avoid eating or drinking for at least 30 minutes after each dose to allow the medicine to remain in contact with the oral mucosa.

For intestinal candidiasis, the dose is higher: 500,000 units (5 mL) three to four times daily for 7 to 14 days. Nystatin tablets (500,000 units) may be used instead of the suspension for intestinal treatment.

In neonates and infants, the dose is 100,000 units (1 mL) four times daily, applied to each side of the mouth using the dropper.

Continue treatment for at least 48 hours after symptoms have cleared. For children aged 1 to 18 years, the same dose applies.

For prophylaxis in immunocompromised patients, nystatin 100,000 units four times daily is typically started at the beginning of the at-risk period (for example, the start of chemotherapy) and continued until the risk has resolved.

Side effects of nystatin

Common side effects

Side effects from oral nystatin are uncommon because the medicine is not absorbed into the bloodstream.

The most frequently reported effects are mild gastrointestinal symptoms: nausea, vomiting, diarrhoea, and abdominal discomfort. These are generally transient and dose-related.

The taste of nystatin suspension is sometimes described as unpleasant, which can affect compliance, particularly in children. Flavoured formulations may improve acceptance.

Rare and serious side effects

Allergic reactions to nystatin are very rare. Signs of an allergic reaction include skin rash, itching, hives, swelling of the face, lips, tongue, or throat, and difficulty breathing.

Anaphylaxis is extremely rare. If you experience signs of a severe allergic reaction, call 999 immediately. Stevens-Johnson syndrome has been reported in isolated cases.

There are no known significant drug interactions with oral nystatin.

When to seek medical advice

Contact your GP or call NHS 111 if symptoms do not improve within 7 days, if they worsen, or if thrush recurs within a short time.

If you develop difficulty swallowing, this may suggest oesophageal candidiasis, which requires systemic antifungal treatment. Report suspected adverse reactions to the MHRA at yellowcard.mhra.gov.uk .

Warnings and precautions

Contraindications

Nystatin is contraindicated only in individuals with a known allergy to nystatin or any excipient in the formulation. There are no other absolute contraindications due to its lack of systemic absorption.

Underlying causes of recurrent thrush

If oral thrush recurs repeatedly, your prescriber should investigate for underlying predisposing conditions.

These include diabetes mellitus, iron deficiency anaemia, vitamin B12 or folate deficiency, HIV infection or other immunodeficiency, medicines that suppress the immune system, inhaled corticosteroids (rinsing and spitting after use can prevent thrush), dry mouth, and denture-related factors.

Treating the underlying cause is essential for long-term resolution.

Sugar content

Some nystatin oral suspension formulations contain sucrose. Patients with diabetes should be aware of the sugar content. Those with rare hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should avoid sucrose-containing formulations. Sugar-free alternatives may be available.

Pregnancy and breastfeeding

Nystatin is considered safe during pregnancy and breastfeeding because it is not absorbed systemically. It has been used in pregnant women for decades without evidence of harm. Use during pregnancy should be on the advice of a prescriber or midwife.

Immunocompromised patients

In patients with significant immunosuppression (HIV with low CD4 count, neutropenia, organ transplant recipients), nystatin may be insufficient for oral candidiasis, and oesophageal involvement is more likely.

Systemic antifungals such as fluconazole are usually more effective in this population. If you are immunocompromised and develop oral thrush, discuss treatment options with your prescriber or specialist.

How to get nystatin in the UK

Nystatin oral suspension is available on NHS prescription from your GP, dentist, or an authorised online prescriber registered with the General Pharmaceutical Council (GPhC).

The standard NHS prescription charge in England is 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland.

Some topical nystatin preparations (creams and ointments for skin infections) may be available as pharmacy (P) medicines from a pharmacist without a prescription.

Sources

• Nystatin Oral Suspension, Summary of Product Characteristics (EMC)
• Nystatin, British National Formulary (BNF)
• NICE CKS: Candida, oral
• Oral thrush, NHS
• MHRA Yellow Card Scheme