Plain-language summary, compiled from the cited regulatory records
Nystatin is an antibiotic [1]. It belongs to the drug class of Antibiotics (A07AA) [1].
Nystatin is approved for the treatment of skin and mucous membrane fungal infections caused by *Candida albicans* and other susceptible *Candida* species [1]. It is not indicated for systemic, oral, intravaginal, or ophthalmic use [1].
This medication is available under several brand names, including Nyamyc, Nystop, and KLAYESTA [1]. In the past 12 months, there have been 1355 adverse event reports associated with nystatin [2]. The most frequently reported adverse events include nausea, off-label use, vomiting, pneumonia, and diarrhea [2].
This is not medical advice. Consult a qualified healthcare professional.
USOfficial regulatory label· revised February 23, 2026[1]
INDICATIONS AND USAGE
Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
How to take
US
GBUnited Kingdom· MHRA
9 products
Uses
GBOfficial regulatory label· revised May 29, 2026[2]
Clobetasone 17-butyrate is a moderately potent topical corticosteroid indicated for adults, elderly, children and infants for the relief of the inflammatory and pruritic manifestations of steroid responsive dermatoses. Nystatin is a polyene antifungal.
Oxytetracycline is a broad spectrum antibiotic. Topical preparations combining clobetasone with nystatin and oxytetracycline are indicated for the treatment and management of steroid responsive dermatoses where candidal or bacterial infection is present, suspected or likely to occur.
These include the following: - Atopic dermatitis - Nappy rash - Intertrigo - Anogenital pruritis - Seborrhoeic dermatitis
How to take
CACanada· Health Canada
8 products
Uses
CAOfficial regulatory label· revised March 22, 2025[3]
AND CLINICAL USE...................................................................................... 3 CONTRAINDICATIONS........................................................................................................... 3 WARNINGS AND PRECAUTIONS .........................................................................................
4 ADVERSE REACTIONS ........................................................................................................... 6 DOSAGE AND ADMINISTRATION .......................................................................................
6 OVERDOSAGE ......................................................................................................................... 6 ACTION AND CLINICAL PHARMACOLOGY ......................................................................
7 STORAGE AND STABILITY ................................................................................................... 7 DOSAGE FORMS, COMPOSITION AND PACKAGING....................................................... 7 PART II: SCIENTIFIC INFORMATION .................................................................................
Drug interactions
Known interactions involving Nystatin. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 340. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]FDA DailyMed · 17b9e33d-da9c-46… · revised February 23, 2026 [PDF]
[2]MHRA (UK) · PL556120001 · revised May 29, 2026
[3]Health Canada (DPD) · 00550507 · revised March 22, 2025
[4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
DOSAGE AND ADMINISTRATION INFANTS 2 mL (200,000 units) four times daily (in infants and young children, use dropper to place one-half of dose in each side of mouth and avoid feeding for 5 to 10 minutes).
NOTE:
Limited clinical studies in premature and low birth weight infants indicate that 1 mL four times daily is effective. CHILDREN AND ADULTS 4 to 6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth).
The preparation should be retained in the mouth as long as possible before swallowing. Continue treatment for at least 48 hours after perioral symptoms have disappeared and cultures demonstrate eradication of Candida albicans .
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 1,355 reports total. [4]
Nausea 157
Off Label Use 150
Vomiting 121
Pneumonia 96
Diarrhoea 95
Fatigue 85
Dyspnoea 72
Drug Ineffective 71
Headache 68
Product Dose Omission Issue 64
Death 58
Cholelithiasis 56
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised February 23, 2026[1]
ADVERSE REACTIONS
Nystatin is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported. (See PRECAUTIONS: General ).
Gastrointestinal:
Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances.
Dermatologic:
Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely.
Other:
Tachycardia, bronchospasm, facial swelling, and non-specific myalgia have also been rarely reported.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised February 23, 2026[1]
CONTRAINDICATIONS
The preparation is contraindicated in patients with a history of hypersensitivity to any of its components.
This is not medical advice. Consult a qualified healthcare professional.
GBOfficial regulatory label· revised May 29, 2026[2]
Adults, Elderly, Children and Infants For topical use only. Creams are especially appropriate for moist or weeping surfaces. Apply thinly and gently rub in using only enough to cover the entire affected area once or twice a day for up to seven days.
If the infection worsens, treatment and diagnosis should be re-evaluated as soon as possible. If the condition does not improve within seven days, treatment and diagnosis should be re-evaluated. Treatment should not be continued for more than seven days without medical supervision.
Allow adequate time for absorption after each application before applying an emollient. Patients should be advised to wash their hands after applying clobetasone with nystatin and oxytetracycline, unless it is the hands that are being treated.
Rebound of pre-existing dermatoses can occur with abrupt discontinuation of topical corticosteroids especially with potent preparations. If further treatment is required to achieve control of the pre-existing dermatoses, it may be necessary to continue therapy with another corticosteroid preparation not containing nystatin and oxytetracycline Children Children are more likely to develop local and systemic side effects of topical corticosteroids and, in general, require shorter courses and less potent agents than adults (see Warnings and Precautions).
Care should be taken when using clobetasone with nystatin and oxytetracycline to ensure the amount applied is the minimum that provides therapeutic benefit. Elderly Clinical studies have not identified differences in responses between the elderly and younger patients.
The greater frequency of decreased hepatic or renal function in the elderly may delay elimination if systemic absorption occurs. Therefore the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.
Renal / Hepatic Impairment In case of systemic absorption (when application is over a large surface area for a prolonged period) metabolism and elimination may be delayed therefore increasing the risk of systemic toxicity. Therefore the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised May 29, 2026[2]
Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 and <1/1,000) and very rare (<1/10,000), not known (cannot be estimated from the available data), including isolated reports.
Post-marketing data Infections and Infestations Not known:
Opportunistic infection Immune System Disorders Not known: Hypersensitivity Endocrine Disorders Not known: Hypothalamic-pituitary adrenal (HPA) axis suppression: (see also Skin and Subcutaneous Tissue Disorders). g. moon face, central obesity), delayed weight gain/growth retardation in children, osteoporosis, glaucoma, hyperglycaemia/glucosuria, cataract, hypertension, increased weight/obesity, decreased endogenous cortisol levels Skin and Subcutaneous Tissue Disorders Common or very common: Telangiectasia Not known (cannot be estimated from available data): Allergic contact dermatitis/dermatitis, urticaria, skin atrophy*/skin thinning, pigmentation changes*, exacerbation of underlying symptoms, local skin burning/skin pain, hypertrichosis, rash (including erythematous and macropapular), pruritus, erythema, photosensitivity reaction Withdrawal reactions – redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin, peeling, oozing pustules.
4) *Skin features related to hypothalamic-pituitary adrenal (HPA) axis suppression.
General Disorders and Administration Site Conditions Not known:
Application site pain/reaction Eye disorders Not known: Vision, blurred Vascular disorders Not known: Vasodilation Reporting of suspected adverse reactions Reporting of suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
GBOfficial regulatory label· Warnings and precautions· revised May 29, 2026[2]
Instruct patients not to smoke or go near naked flames - risk of severe burns. ) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
Pseudomembranous colitis Pseudomembranous colitis has been reported with the use of antibiotics and may range in severity from mild to life-threatening. Therefore, it is important to consider its diagnosis in patients who develop diarrhoea during or after antibiotic use.
Although this is less likely to occur with topically applied oxytetracycline, if prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further.
Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression Manifestations of hypercortisolism (Cushing’s syndrome) and reversible hypothalamic-pituitary-adrenal (HPA) axis suppression can occur in some individuals as a result of increased systemic absorption of topical corticosteroids.
If either of the above are observed, withdraw the drug gradually by reducing the frequency of application or by substituting a less potent corticosteroid. 8). g. on intertriginous areas or under occlusive dressings (in infants the nappy may act as an occlusive dressing).
- Increasing hydration of the stratum corneum - Use on thin skin areas such as the face - Use on broken skin or other conditions where the skin barrier may be impaired. Paediatric population In comparison with adults, children and infants may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects.
This is because children have an immature skin barrier and a greater surface area to body weight ratio compared with adults. In infants and children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression can occur.
Infection risk with occlusion Bacterial infection is encouraged by the warm, moist conditions within skin folds or caused by occlusive dressings. When using occlusive dressings, the skin should be cleansed before a fresh dressing is applied.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised May 29, 2026[2]
The following should not be treated with clobetasone with nystatin and oxytetracycline: - Patients with known history of hypersensitivity to clobetasone butyrate, nystatin, oxytetracycline or any components of the formulation - Primary cutaneous viral infections - Primary infected skin lesions caused by infection with fungi, bacteria or yeasts - Cutaneous infections caused by Acinetobacter species, methicillin resistant Staphylococcus aureus (MRSA), Pseudomonas species, Proteus species Serratia species or Streptococcus B.
8 PHARMACEUTICAL INFORMATION ................................................................................... 8 PART III: PATIENT MEDICATION INFORMATION ....................................................... 25 mg / g gramicidin Aluminum hydroxide, ceteareth-20, cetearyl alcohol, glyceryl monostearate, glyceryl stearate, methylparaben, petrolatum, polysorbate 60, propylene glycol, propylene glycol monostearate, propylparaben, purified water, sorbitol and titanium dioxide INDICATIONS AND CLINICAL USE TEVA-TRIACOMB is indicated for the relief of corticosteroid-responsive inflammatory or pruritic dermatoses caused, threatened or complicated by infection due to bacteria and/or candida.
TEVA-TRIACOMB is indicated for Pruritus ani and pruritus vulvae. Conditions most commonly infected include acute atopic dermatitis, exfoliative eythrodermas, neurodermatitis, nummular eczema, acute contact dermatitis, chronic eczema (except of lower leg), chronic familiar benign pemphigus and intertriginous lesions.
TEVA-TRIACOMB contains antibiotic ingredients, gramicidin and neomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of gramicidin and neomycin, TEVA-TRIACOMB should only be used for the authorized indication and clinical use.
CONTRAINDICATIONS TEVA-TRIACOMB is contraindicated as follow:
In patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging section of the product monograph. 4 In Tuberculous and most viral lesions of the skin (including herpes simplex, vaccinia and varicella) and fungal skin lesions except candidiasis.
In primary skin infections. For ophthalmic use. For application to the external auditory canal of patients with perforated eardrums or patients with otitis media. As Occlusive therapy in patients with atopic dermatitis. WARNINGS AND PRECAUTIONS General Patients should be advised to inform subsequent physicians of the prior use of corticosteroids.
TEVA-TRIACOMB should not be used under occlusive dressings (see ADVERSE REACTIONS). Cardiovascular Topical corticosteroids should be used with caution in patients with stasis dermatitis and other skin diseases associated with impaired circulation.
If a symptomatic response is not noted within 7 days, the patient should be re-evaluated. Prolonged use of topical antibiotics should be avoided. Endocrine and Metabolism Although adrenal suppression and other systemic adverse effects are rare with topical corticosteroid preparations, their possible occurrence must be kept in mind, particularly when these preparations are used over large areas or for an extended period of time.
Prolonged use may lead to steroid withdrawal when the medication is discontinued. Because of the potential hazard of nephrotoxicity and ototoxicity, avoid prolonged use or the use of large amounts in the treatment of skin infections following burns, tropic ulceration and other conditions when absorption of neomycin is possible.
Gramicidin absorption following topical administration is unlikely; however, hemolysis may occur should the drug enter the blood. If gramicidin is allowed in close proximity to the sub- arachnoid space, a chemical arachnoiditis may occur (see ADVERSE REACTIONS).
Ophthalmologic Topical corticosteroids should be used with caution on lesions close to the eye. Posterior subcapsular cataracts have been observed following systemic corticosteroid therapy (see ADVERSE REACTIONS). Sensitivity Hypensitivity of nystatin is extremely uncommon.
Sensitivity reactions following the topical use of gramicidin or triamcinolone acetonide are rarely encountered. Burning, itching, irritation, 5 dryness, erythema, folliculitis, hypertrichosis, acnelform eruptions, tinnitus, deafness and hypopigmentation have been reported with topical corticosteroids.
An increase in the incidence of patients allergic to neomycin has been reported in literature. Neomycin itself may cause an allergic otitis extema. Systemic neomycin toxicity has occurred rarely following topical administration; tinnitus and deafness have been reported (see ADVERSE REACTIONS).
Susceptibility/Resistance Development of Drug Resistant Bacteria:
Prescribing TEVA-TRIACOMB in the absence of the authorized indications is unlikely to provide benefit to the patient and risks the development of resistant organisms. Potential for […]
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[3]
Adverse Drug Reaction Overview The following adverse skin reactions have been reported with the use of topical corticosteroids: dryness, itching, burning, local irritation, skin atrophy, striae, atrophy of subcutaneous tissue, folliculitis, acneiform eruptions, hypertrichosis, change in skin pigmentation and telangiectasia.
Adrenal suppression has also been reported following topical corticosteroid therapy. Posterior subcapsular cataracts have been observed following systemic corticosteroid therapy. Hypersensitivity reactions to neomycin, gramicidin, and nystatin have been reported.
Systemic neomycin toxicity has occurred rarely following topical administration; tinnitus and deafness have also been reported. Overgrowth of non-susceptible organisms has occurred. 25 mg. Apply a small quantity two or three times daily.
Do not apply more than prescribed by physician. For external use only. OVERDOSAGE For management of a suspected drug overdose, contact your regional Poison Control Centre immediately. Percutaneous absorption of corticosteroids can occur, especially if used over a large area for prolonged periods of time.
If large amounts of corticosteroids are absorbed, toxic effects may include mild reversible suppression of adrenal function, ecchymoses of the skin, peptic ulceration, hypertension, aggravation of infections, hirsutism, acne, edema and muscle weakness due to protein depletion.
Prolonged use of large amounts of TEVA-TRIACOMB would likely increase the absorption of neomycin which in turn would enhance the potential for nephrotoxicitiy and ototoxicity as well as ulceration. No specific antidote is available, treatment should be primarily symptomatic and administration of the cream discontinued.
This is not medical advice. Consult a qualified healthcare professional.
Infection Extension of infection may occur due to the masking effect of the steroid. Any spread of infection requires withdrawal of topical corticosteroid therapy and administration of appropriate antimicrobial therapy. Application to the face Prolonged application to the face is undesirable as this area is more susceptible to atrophic changes.
Application to the eyelids If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as cataract and glaucoma might result from repeated exposure. Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use.
If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Chronic leg ulcers Topical corticosteroids are sometimes used to treat the dermatitis around chronic leg ulcers. However, this use may be associated with a higher occurrence of local hypersensitivity reactions and an increased risk of local infection.
8). If signs of hypersensitivity appear, application should be stopped immediately. Contact sensitisation Extended or recurrent application of clobetasone with nystatin and oxytetracycline may increase the risk of contact sensitisation.
Staining Clobetasone with nystatin and oxytetracycline may cause slight staining of hair, skin or fabric, but this can be removed by washing. The application may be covered with a non-occlusive dressing to protect clothing. Dilution Products which contain antimicrobial agents should not be diluted.
Photosensitivity reactions Photosensitivity reactions may occur in hypersensitive persons and such patients should be warned to avoid direct exposure to natural or artificial sunlight and to discontinue therapy at the first sign of skin discomfort.
g. contact dermatitis). Chlorocresol may cause allergic reactions. Long term continuous or inappropriate use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome).
A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated.
Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advice is recommended in these cases or other treatment options should be considered.