Previous changes

December 2024 — minor update. Length of course of treatments amended to align with BNF recommendations. 

October 2023 — minor update. Information added that the manufacturers of fluconazole advise a washout period of approximately 1 week (5-6 half-lives) before becoming pregnant, in line with the updated summary of product characteristics.

May 2022 — reviewed. A literature search was conducted in April 2022 to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials (RCTs) published since the last revision of the topic. No major changes to recommendations have been made.

May 2021 — minor update. Information that unexplained oral candidiasis is an HIV indicator condition has been added to this topic in line with the British HIV Association/British Association for Sexual Health and HIV/British Infection Association Adult HIV testing guidelines 2020.

September 2019 — minor update. The section on management of oral candida in children, and the prescribing section have been updated to clarify that the use of oral miconazole gel in children aged under 4 months is unlicensed.

August 2017 — minor update. Changes to the drug interactions section for miconazole gel in accordance with changes to the manufacturer's summary of product characteristics. 

May 2017 — reviewed. A literature search was conducted in April 2017 to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials (RCTs) published since the last revision of the topic. No major changes to recommendations have been made, but the topic has been restructured.

December 2016 — minor update. The adverse effects of miconazole oral gel have been updated in line with the manufacturer's Summary of Product Characteristics (SPC).

November 2016 — minor update. The use of miconazole gel in people taking warfarin has been clarified, to take into account the Medicines and Healthcare products Regulatory Agency (MHRA) Drug safety update Topical miconazole, including oral gel: reminder of potential for serious interactions with warfarin. 

January 2014 — minor update. Text updated in line with the SPC for miconazole oral gel in the Prescribing Information section to highlight the risk of choking in infants and young children when miconazole oral gel is applied to the mouth.  

December 2013 — minor update. Text updated to reflect that the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) has suspended the marketing authorization for oral ketoconazole. It should no longer be prescribed for the treatment of fungal infections.

August 2013 — minor update to the text to reflect recent guidance from the EMA regarding the use of oral ketoconazole.

July 2013 — reviewed. A literature search was conducted in June 2013 to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials (RCTs) published since the last revision of this topic. No major changes to recommendations have been made.

November 2012 — minor update. The links to the electronic medicines website (www.medicines.org.uk) have been updated.

October 2009 — minor update. Minor wording change regarding the use of miconazole oral gel in children aged 4 months and younger.

April to September 2009 — converted from CKS guidance to CKS topic structure. The evidence base has been reviewed in detail, and recommendations are more clearly justified and transparently linked to the supporting evidence. There are no major changes to the recommendations.

September 2008 — minor correction to the Changes section.

June 2008 — minor update to remove nystatin pastilles because they have been discontinued. Text regarding nystatin pastilles has been removed as well as prescriptions. Minor update to text to reflect the change in licence for miconazole oral gel.

April 2008 — minor update to the text for oral ketoconazole to reflect the most recent MHRA guidance.

July 2007 — minor update to text and prescription added for miconazole oral gel (children under 2 years).

July to September 2006 — reviewed. Validated in December 2006 and published in January 2007. This guidance has been reviewed, restructured and updated following a full literature review. There are no major changes to the recommendations. An evidence section has been added.

November 2005 — minor technical update. 

October 2003 — written. Validated in December 2003 and published in February 2004.

New evidence

Evidence-based guidelines

No new evidence-based guidelines since 1 May 2022.

HTAs (Health Technology Assessments)

No new HTAs since 1 May 2022.

Economic appraisals

No new economic appraisals relevant to England since 1 May 2022.

Systematic reviews and meta-analyses

No new systematic reviews or meta-analysis which reach the CKS threshold for inclusion since 1 May 2022.

Primary evidence

No new primary evidence which reaches the CKS threshold for inclusion published since 1 May 2022.

New policies

No new national policies or guidelines since 1 May 2022.

New safety alerts

No new safety alerts since 1 May 2022.

Changes in product availability

No changes in product availability since 1 May 2022.

Basis for recommendation

These recommendations (and the clinical features of the different types of oral candidiasis) are based on expert opinion in the guidelines Oral lesions/and other dermatological conditions of the mouth published by the Primary Care Dermatology Society (PCDS) [Primary Care Dermatology Society, 2017], BMJ Best Practice - Oral candidiasis [BMJ Best Practice, 2019], and Oral candidiasis: causes, types and treatment [Hughes, 2020] and on expert opinion in review article Oral candidosis: pathophysiology and best practice for diagnosis, classification and successful management [Lu, 2021].

• Expert opinion in review articles is that the diagnosis of oral candidiasis is fundamentally clinical. Microbiological techniques are only required when the clinical diagnosis needs to be confirmed, for establishing a differential diagnosis, and when there are signs of resistance to antifungal treatment [BMJ Best Practice, 2019]. 
• The information on the percentage of denture wearers affected by denture stomatitis is based on information in a review article [Martonffy, 2015].
• The information on the oral carriage of Candida is based on information in a review article [Patil, 2015].

Basis for recommendation

The differential diagnoses of oral candidiasis are based on expert opinion in the Primary Care Dermatology Society (PCDS) guideline on Oral lesions/and other dermatological conditions of the mouth [Primary Care Dermatology Society, 2017], and the British Medical Journal (BMJ) Best Practice review article Oral candidiasis [BMJ Best Practice, 2019].

How should I manage oral candidiasis in a child younger than 16 years of age who is not immunocompromised?

• Admit the child if:
  • There is evidence of systemic illness (candidaemia).
  • There is widespread infection (such as oesophageal candidiasis, characterized by difficulty or pain on swallowing, or retrosternal pain).
• Refer to a paediatrician or seek specialist advice if the child has extensive or severe oral candidiasis.
• If the child can be managed in primary care:
  • Exclude risk factors for oral candidiasis, such as diabetes, haematinic deficiencies, and poor dental hygiene. 
    • Oral candidiasis is uncommon in people other than infants, denture wearers, and the elderly. In otherwise healthy people, it may be the first presentation of an undiagnosed risk factor.
  • Prescribe topical antifungal treatment.
    • Offer miconazole oral gel first-line for children aged 4 months and over (unlicensed for use in a child aged younger than 4 months, or 5–6 months for an infant born pre-term). Treatment should be for at least 7 days after lesions have healed or symptoms have cleared. 
    • If miconazole oral gel is unsuitable, offer oral nystatin suspension (unlicensed for use in neonates).
    • See the prescribing information sections on miconazole oral gel and nystatin suspension for information on prescribing these treatments, including contraindications, cautions, adverse effects, and possible drug interactions.
  • Give appropriate lifestyle advice to aid healing and prevent recurrence. In particular:
    • Advise on good dental hygiene.
    • If the child is using an inhaled corticosteroid, advise the following: good inhaler technique; rinsing the mouth with water (or cleaning the teeth) after inhalation, to remove any drug particles; using a spacer device to reduce the impaction of particles in the oral cavity; and stepping down the dose of inhaled corticosteroid when appropriate. See the section on Minimizing the risks of adverse effects in the CKS topic on Corticosteroids - inhaled for more information. 
  • Refer to a paediatrician or seek specialist advice if the child:
    • Does not respond adequately to at least 2 weeks of treatment with miconazole and/or nystatin. 
    • Has recurrent episodes of oral candidal infection, or there is suspicion the child is immunocompromised.

How should I manage oral candidiasis in a person aged 16 years or older who is not immunocompromised?

Admit the person if:

• There is evidence of systemic illness (candidaemia).
• There is widespread infection (such as oesophageal candidiasis, characterized by difficulty or pain on swallowing, or retrosternal pain).

If the person can be managed in primary care:

• Exclude risk factors for oral candidiasis, such as diabetes and haematinic deficiencies.
  • Oral candidiasis is uncommon in people other than infants, denture wearers, and the elderly. In otherwise healthy people, it may be the first presentation of an undiagnosed risk factor.
• Prescribe antifungal treatment.
  • If the infection is mild and localized, prescribe topical antifungal treatment.
    • Offer miconazole oral gel first-line.
    • Treatment should be continued for at least 7 days after lesions have healed or symptoms have cleared. 
    • If miconazole is unsuitable, offer nystatin suspension.
      • Nystatin treatment is recommended for 7 days and continued for 48 hours after lesions have resolved. 
    • See the prescribing information sections on Miconazole oral gel and Nystatin suspension for information on prescribing these treatments, including contraindications, cautions, adverse effects, and possible drug interactions.
  • If the infection is extensive or severe infection, consider one of the following: 
    • Prescribe fluconazole 200–400 mg on day one, followed by 100–200 mg once daily for 7–21 days. See the prescribing information section on oral fluconazole for information on prescribing this treatment.
    • Seek specialist advice or refer to an oral surgeon.
• Give appropriate lifestyle advice to aid healing and prevent recurrence. In particular:
  • Advise on good dental hygiene.
  • If the person is a smoker, offer advice on smoking cessation. See the CKS topic on Smoking cessation for detailed information.
  • If the person is using an inhaled corticosteroid, advise the following: good inhaler technique; rinsing the mouth with water (or cleaning the teeth) after inhalation, to remove any drug particles; using a spacer device to reduce the impaction of particles in the oral cavity; and stepping down the dose of inhaled corticosteroid when appropriate.
    • See the section on Minimizing the risks of adverse effects in the CKS topic on Corticosteroids - inhaled for more information. 
  • If the person wears dentures, advise them to:
    • Leave the dentures out for at least 6 hours in each 24-hour period to promote healing of the gums. If the gums are inflamed, they may benefit from the dentures being left out for longer.
    • Clean dentures by brushing and then soaking them in a disinfectant solution (for example chlorhexidine or hexetidine) overnight. The dentures can be soaked in any solution marketed to sterilize baby's bottles (providing the dentures contain no metal).
    • Allow the dentures to air-dry after disinfection — this also kills adherent Candida.
    • Brush the mucosal surface regularly with a soft brush.
    • See a dentist to correct ill-fitting dentures.
  • If the person has diabetes, review diabetic control and manage accordingly, particularly if there are recurrent episodes of oral candidiasis. See the CKS topic on Diabetes - type 2 for detailed information.
    • For people taking a sulfonylurea (such as gliclazide), be aware of drug interactions with miconazole or fluconazole.
    • For people taking warfarin, be aware of the drug interaction with miconazole.
    • Do not prescribe miconazole to people who are taking a statin. Use nystatin.
• Follow up people who have extensive or severe oral candidiasis (requiring oral fluconazole) after 14 days.
  • If the infection has completely resolved, stop treatment.
  • If the infection has not completely resolved, consider the following: extend the course of fluconazole for a further 7 days (refer to an oral surgeon if the infection persists after this); swab to identify the causative organism; seek specialist advice; or refer to an oral surgeon — use clinical judgement, taking into account the severity of infection (there should be a low threshold for early referral if infection is severe), the level of immunocompromise, and the response to treatment. 
• Also consider referring to an oral surgeon (or seeking specialist advice) if:
  • The person has recurrent episodes of oral candidiasis.
  • The person has breakthrough candidal infection while receiving preventive treatment (which may indicate candidal resistance).
  • There is doubt about the diagnosis. 
• Consider referring for biopsy people with chronic plaque-like oral candidiasis that is unresponsive to treatment, as it carries a risk of malignancy.

How should I manage oral candidiasis in an adult who is receiving treatment(s) that may cause immunosuppression?

Admit the person if:

• There is evidence of systemic illness (candidaemia).
• There is widespread infection (such as oesophageal candidiasis, characterized by difficulty or pain on swallowing, or retrosternal pain).
  • Lower the threshold for admission in people who are markedly immunocompromised.

If the person can be managed in primary care:

• Seek specialist advice before starting antifungal treatment if the person is:
  • Taking ciclosporin or oral tacrolimus, especially if these drugs are being used to suppress tissue rejection following transplantation.
  • Receiving chemotherapy.
• For people taking oral corticosteroids or disease-modifying anti-rheumatic drugs (DMARDs):
  • If the infection is mild and localized, prescribe topical treatment.
    • Offer miconazole oral gel first-line.
      • Treatment should be continued for at least 7 days after lesions have healed or symptoms have cleared. 
    • If miconazole is unsuitable, offer nystatin suspension. Nystatin may be preferable when considering possible adverse effects.
    • See the prescribing information sections on Miconazole oral gel and Nystatin suspension for information on prescribing these treatments.
  • If the infection is extensive or severe, consider one of the following options:
    • Prescribe fluconazole 200–400 mg on day one, followed by 100–200 mg once daily for 7–21 (or longer if necessary). See the prescribing information section on oral fluconazole for information on prescribing this treatment.
    • Seek specialist advice or refer to an oral surgeon.
  • If there is suspicion that DMARDs are causing marked immunosuppression, seek specialist advice and ensure blood parameters are being adequately monitored. See the CKS topic on DMARDs for more information.
• Give appropriate lifestyle advice. In particular:
  • Advise on good dental hygiene.
  • If the person is a smoker, offer advice on smoking cessation. See the CKS topic on Smoking cessation for detailed information.
  • If the person is using an inhaled corticosteroid, advise the following: good inhaler technique; rinsing the mouth with water (or cleaning the teeth) after inhalation, to remove any drug particles; using a spacer device to reduce the impaction of particles in the oral cavity; and stepping down the dose of inhaled corticosteroid when appropriate.
    • See the section on Minimizing the risks of adverse effects in the CKS topic on Corticosteroids - inhaled for more information. 
  • If the person wears dentures, advise them to:
    • Leave the dentures out for at least 6 hours in each 24-hour period to promote healing of the gums. If the gums are inflamed, they may benefit from the dentures being left out for longer.
    • Clean dentures by brushing and then soaking them in a disinfectant solution (for example chlorhexidine or hexetidine) overnight. The dentures can be soaked in any solution marketed to sterilize baby's bottles (providing the dentures contain no metal).
    • Allow the dentures to air-dry after disinfection — this also kills adherent Candida.
    • Brush the mucosal surface regularly with a soft brush.
    • See a dentist to correct ill-fitting dentures.
  • If the person has diabetes, review diabetic control and manage accordingly, particularly if there are recurrent episodes of oral candidiasis. See the CKS topics on Diabetes - type 1 and Diabetes - type 2 for detailed information.
    • For people taking a sulphonylurea (such as gliclazide), be aware of drug interactions with miconazole or fluconazole.
• Follow up the person after 7–14 days. If treatment has not been fully effective despite adequate adherence to treatment:
  • For people receiving topical treatment, consider:
    • Extending the course of treatment for a further 7 days, or
    • Switching to nystatin suspension (if miconazole was tried first-line) or oral fluconazole.
  • For people receiving oral fluconazole:
    • Consider the following: extend the course of fluconazole for a further 7 days (refer to an oral surgeon if the infection persists after this); swab to identify the causative organism; seek specialist advice; or refer to an oral surgeon. 
    • Use clinical judgement, taking into account the severity of infection (there should be a low threshold for early referral if infection is severe), the level of immunocompromise, and the response to treatment. 
• Also consider referring to an oral surgeon (or seeking specialist advice) if:
  • The person has recurrent episodes of oral candidiasis.
  • The person has breakthrough candidal infection while receiving preventive treatment (which may indicate candidal resistance).
  • The person has clinical features that preclude management in primary care.
  • There is doubt about the diagnosis. 
• Consider referring for biopsy people with chronic plaque-like oral candidiasis that is unresponsive to treatment, as it carries a risk of malignancy.

How should I manage an adult with oral candidiasis who is HIV positive?

Admit the person if:

• There is evidence of systemic illness (candidaemia).
• There is widespread infection (such as oesophageal candidiasis, characterized by difficulty or pain on swallowing, or retrosternal pain).
  • Lower the threshold for admission in people who are markedly immunocompromised.

If the person can be managed in primary care:

• Prescribe oral fluconazole 200–400 mg on day one, followed by 100-200 mg once daily for 7–14 days provided the person is otherwise well and is not taking prophylactic antimycotic treatment.
• Seek specialist advice before starting treatment if:
  • Oral candidiasis is extensive or severe.
  • Treatment with fluconazole for a previous episode of candidiasis was ineffective.
• Give appropriate lifestyle advice. In particular:
  • Advise on good dental hygiene.
  • If the person is a smoker, offer advice on smoking cessation. See the CKS topic on Smoking cessation for detailed information.
  • If the person is using an inhaled corticosteroid, advise the following: good inhaler technique; rinsing the mouth with water (or cleaning the teeth) after inhalation, to remove any drug particles; using a spacer device to reduce the impaction of particles in the oral cavity; and stepping down the dose of inhaled corticosteroid when appropriate.
    • See the section on Minimizing the risks of adverse effects in the CKS topic on Corticosteroids - inhaled for more information. 
  • If the person wears dentures, advise them to:
    • Leave the dentures out for at least 6 hours in each 24-hour period to promote healing of the gums. If the gums are inflamed, they may benefit from the dentures being left out for longer.
    • Clean dentures by brushing and then soaking them in a disinfectant solution (for example chlorhexidine or hexidine) overnight. The dentures can be soaked in any solution marketed to sterilize baby's bottles (providing the dentures contain no metal).
    • Allow the dentures to air-dry after disinfection — this also kills adherent Candida.
    • Brush the mucosal surface regularly with a soft brush.
    • See a dentist to correct ill-fitting dentures.
  • If the person has diabetes, review diabetic control and manage accordingly, particularly if there are recurrent episodes of oral candidiasis. See the CKS topics on Diabetes - type 1 and Diabetes - type 2 for detailed information.
    • For people taking a sulphonylurea (such as gliclazide), be aware of drug interactions with miconazole or fluconazole.
• Review the person after 7 days. 
  • If the infection has not completely resolved, consider the following: extend the course of fluconazole for a further 7 days (refer to an oral surgeon if the infection persists after this); swab to identify the causative organism; seek specialist advice; or refer to an oral surgeon.
  • Use clinical judgement, taking into account the severity of infection (there should be a low threshold for early referral if infection is severe), the level of immunocompromise, and the response to treatment. 
• Also consider referring to an oral surgeon (or seeking specialist advice) if:
  • The person has breakthrough candidiasis while taking preventive treatment (this may indicate candidal resistance).
  • The person has recurrent episodes of oral candidiasis.
  • There is doubt about the diagnosis. 
• Consider referring for biopsy people with chronic plaque-like oral candidiasis that is unresponsive to treatment, as it carries a risk of malignancy.

What are the licensed doses?

• Miconazole oral gel (24 mg/mL) is indicated for the treatment of fungal infections of the oropharynx and gastrointestinal tract (unlicensed for use in a child aged younger than 4 months, or 5–6 months for an infant born pre-term).
• The licensed doses for oral candidiasis are:
  • Children aged 4–24 months — 1.25 mL (1/4 measuring spoon) of gel applied four times a day after meals. 
    • Each dose should be divided into smaller portions, and the gel should be applied to the affected area(s) with a clean finger.
    • The gel should not be applied to the back of the throat due to possible choking. 
  • Adults and children 2 years of age and older — 2.5 mL (1/2 measuring spoon) of gel applied four times a day after meals.
• Also advise that:
  • The gel should not be swallowed immediately but kept in the mouth as long as possible.
  • The treatment should be continued for at least 7 days after the symptoms have disappeared.
  • Dental prostheses should be removed at night and brushed with the gel.

[ABPI, 2015; BNF, 2022]

What are the contraindications and cautions?

• Do not prescribe miconazole oral gel to:
  • Children whose swallowing reflex is not yet sufficiently developed.
  • People with liver dysfunction.
• Prescribe miconazole oral gel with caution to:
  • Children aged under 4 months (or younger than 5–6 months for pre-term children) — this is an unlicensed indication.
  • Children aged 4 months – 2 years.
    • Take into consideration the variability of the maturation of the swallowing function in infants, especially when giving miconazole gel to infants aged 4–6 months.
    • Advise parents and/or carers that the gel should not be applied to the back of the throat; that each dose should be divided into smaller portions and applied into the mouth with a clean finger; and to observe the child for possible choking.
  • Pregnant women.
    • The manufacturer advises that miconazole oral gel should be avoided in pregnant women if possible. The potential hazards should be balanced against the possible benefits. In animal studies, miconazole has shown no teratogenic effects but is foetotoxic at high oral doses.
  • Breastfeeding women.
    • The manufacturer advises that caution should be exercised when miconazole oral gel is prescribed for a breastfeeding woman, as it is not known whether it is excreted in human milk.
    • Advise that, due to the risk of choking, the gel must not be applied to the nipple for administration to an infant.

[ABPI, 2015; BNF, 2022]

What are the possible adverse effects?

• Common adverse effects of miconazole oral gel include dry mouth, nausea, oral discomfort, vomiting, and regurgitation.
• Other adverse effects include:
  • Uncommon — dysgeusia.
  • Frequencies unknown — anaphylactic reaction, hypersensitivity, choking, diarrhoea, stomatitis, tongue discolouration, hepatitis, angio-oedema, urticaria, rash, acute generalised exanthematous pustulosis, and drug reaction with eosinophilia and systemic symptoms.
• Serious skin reactions (such as toxic epidermal necrolysis and Stevens-Johnson syndrome) have also been reported.
  • Inform the person about the signs of serious skin reactions, and advise that they should discontinue treatment and seek specialist advice at the first appearance of a skin rash.

[ABPI, 2015; BNF, 2022]

What drug interactions are associated with miconazole oral gel?

• Miconazole can inhibit the metabolism of drugs metabolized by the CYP3A4 and CYP2C9 enzyme systems, resulting in an increase and/or prolongation of their effects, including adverse effects.
  • Concurrent treatment with miconazole oral gel and the following drugs is contraindicated [ABPI, 2015; BNF, 2022]:
    • Drugs known to prolong the QT-interval, for example mizolastine and pimozide.
    • Ergotamine — increased risk of ergotism when imidazoles are given with ergotamine.
    • Simvastatin — possible increased risk of myopathy when miconazole is given with simvastatin.
    • Quetiapine. 
    • Triazolam and oral midazolam.
    • Warfarin. The manufacturer's summary of products characteristics details the interaction with warfarin which has been updated to state that patients should not use if they are taking warfarin. Concomitant use can substantially increase INR, and fatal outcomes (due to bleeding) have been reported. See the SPC here. 
  • Concurrent treatment with miconazole oral gel and the following drugs should be done with caution or avoided if possible (concurrent use should be monitored; dose adjustments may be indicated) [ABPI, 2015; BNF, 2022]:
    • Carbamazepine — miconazole possibly increases plasma concentration of carbamazepine.
    • Certain calcium channel blockers (such as dihydropyridines and verapamil).
    • Ciclosporin — miconazole possibly inhibits metabolism of ciclosporin (increased plasma concentration).
    • HIV Protease Inhibitors (such as saquinavir).
    • Phenytoin and fosphenytoin — miconazole enhances anticonvulsant effect of these drugs, leading to an increased plasma concentration.
    • Reboxetine — avoidance of imidazoles is advised by the manufacturer of reboxetine.
    • Sulfonylureas — miconazole enhances the hypoglycaemic effect of sulphonylureas (such as gliclazide and glipizide). If concurrent treatment is necessary, advise the person to seek medical advice if they have symptoms of hypoglycaemia (for example nervousness, sweating, and/or trembling) during concurrent treatment.
    • Tacrolimus and sirolimus — miconazole oral gel possibly increases plasma concentration of tacrolimus, and increases plasma concentration of sirolimus.
• For a complete list of possible drug interactions of miconazole oral gel, see the electronic Medicines Compendium (eMC) or the British National Formulary (BNF).

What are the licensed doses?

• Nystatin suspension (100,000 units/mL) is indicated for the prevention and treatment of candidal infections of the oral cavity, oesophagus, and intestinal tract.
• The licensed dose for oral candidiasis is 1ml (100,000 units) dropped into the mouth four times a day, usually for 7 days.
• Advise that:
  • Nystatin should be taken after food or drink.
  • The suspension should be kept in contact with the affected areas for as long as possible.
  • The treatment should be continued for 48 hours after lesions have resolved.

[ABPI, 2017; BNF, 2022]

What are the contraindications and cautions?

• Do not prescribe nystatin suspension to:
  • People with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency — nystatin suspension contains sucrose.
• Prescribe nystatin suspension with caution to:
  • People on a controlled sodium diet — nystatin suspension contains 0.3 mmol (or 1.3 mg) sodium per 1 mL dose.
  • People with diabetes mellitus — nystatin suspension contains sucrose.
  • Pregnant women.
    • Absorption of nystatin from the gastrointestinal tract is negligible. However, the manufacturer advises that it should be prescribed during pregnancy only if the potential benefits to be derived outweigh the possible risks involved, as it is not known whether nystatin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity [ABPI, 2017].
    • Breastfeeding women. The manufacturer advises that caution should be exercised when nystatin is prescribed for a breastfeeding woman, as it is not known whether nystatin is excreted in human milk.

[ABPI, 2017; BNF, 2022]

What are the adverse effects?

• Nystatin is generally well tolerated by all age groups, even during prolonged use. However:
  • Nausea has been reported occasionally during treatment. 
  • Large oral doses of nystatin have occasionally produced diarrhoea, gastrointestinal distress, nausea, and vomiting.
  • Rash, including urticaria, has been reported rarely. Steven-Johnson Syndrome has been reported very rarely.
  • Hypersensitivity and angio-oedema, including facial oedema, have been reported.
• If irritation or sensitization develops, treatment should be discontinued.

[ABPI, 2017; BNF, 2022]

What drug interactions are associated with nystatin suspension?

• There are no known drug interactions with nystatin suspension.

[ABPI, 2017; BNF, 2022]

What are the contraindications and cautions for oral fluconazole?

• Do not prescribe:
  • Oral fluconazole to:
    • People with acute porphyria.
    • Pregnant women.
      • The manufacturer recommends a washout period of approximately 1 week (corresponding to 5-6 half-lives) after a single-dose or discontinuation of a course of treatment for women before they become pregnant.
    • People taking certain drugs.
  • High or repeated doses of oral fluconazole to:
    • Breastfeeding women.
• Prescribe oral fluconazole with caution to people:
  • At risk of QT interval prolongation — this includes people with cardiomyopathy, sinus bradycardia, arrhythmias, hypokalaemia, hypomagnesaemia, hypocalcaemia, and those taking other drugs known to cause QT interval prolongation (such as tricyclic antidepressants, antipsychotics, and antiarrhythmics).
  • With hepatic impairment or taking concurrent hepatotoxic drugs, due to the risk of hepatic necrosis — discontinue treatment if signs or symptoms of hepatic disease develop (such as severe abdominal pain, jaundice, or weakness). 
  • With renal impairment (estimated glomerular filtration rate [eGFR] less than 50 mL/min/1.73m²) — use the usual initial dose then halve any subsequent doses.
  • Who are taking certain drugs.

[EMC, 2023; BNF, 2022]

What adverse effects are associated with oral fluconazole?

• Adverse effects of oral fluconazole include:
  • Common or very common
    • Abdominal discomfort, diarrhoea, nausea, and flatulence.
    • Headache.
    • Rash — discontinue treatment if the infection becomes invasive or systemic.
  • Uncommon
    • Alopecia.
    • Adrenal insufficiency.
    • Dizziness.
    • Vomiting, dyspepsia, and taste disturbance.
    • Hepatic disorders.
    • Hyperlipidaemia.
    • Seizures.
    • Pruritus, anaphylaxis, angioedema (in children), hypersensitivity reactions (in adults), Stevens-Johnson syndrome, and toxic epidermal necrolysis.
  • Frequency unknown
    • Hypokalaemia.
    • Leucopenia and thrombocytopenia.
• Severe cutaneous reactions are more likely in people with AIDS.

[EMC, 2023; BNF, 2022]

What drug interactions are associated with oral fluconazole?

• Fluconazole inhibits the metabolism of drugs metabolized by the cytochrome P450 enzymes CYP2C9 (potently), CYP3A4 (moderately), and CYP2C19. This may result in a higher and/or prolonged action of these drugs, including adverse effects. The enzyme-inhibiting effect of fluconazole persists 4–5 days after discontinuation of fluconazole treatment due to the long half-life of fluconazole. 
  • The following drugs are contraindicated (or should be avoided) during treatment with fluconazole:
    • Ergotamine — there is an increased risk of ergotism.
    • Erythromycin — concurrent use with fluconazole has the potential to increase the risk of cardiotoxicity (prolonged QT interval and Torsades de Pointes) and consequently sudden heart death.
    • Pimozide — concurrent use with fluconazole may lead to QT prolongation and rare occurrences of Torsade de Pointes.
    • Quetiapine.
    • Reboxetine.
  • Concurrent treatment with fluconazole and the following drugs should be done with caution (concurrent use should be monitored; dose adjustments may be indicated):
    • Aminophylline and theophylline.
    • Avanafil.
    • Ciclosporin.
    • Coumarins, such as warfarin. 
    • Diazepam (risk of prolonged sedation).
    • Fentanyl.
    • Midazolam (risk of prolonged sedation).
    • Phenytoin.
    • Rifabutin (increased risk of uveitis).
    • Statins — the risk of myopathy and rhabdomyolysis increases when fluconazole is given with statins metabolized through CYP3A4 (atorvastatin and simvastatin) or through CYP2C9 (fluvastatin). If concurrent treatment is necessary, monitor for symptoms of myopathy and rhabdomyolysis, and monitor creatine kinase. Discontinue the statin if a marked increase in creatine kinase is observed or if myopathy/rhabdomyolysis is diagnosed or suspected.
    • Sulfonylureas (such as gliclazide and glipizide) — if concurrent use is indicated, advise the person to seek medical advice if they have symptoms of hypoglycaemia (for example nervousness, sweating, and/or trembling).
    • Tacrolimus and sirolimus.
    • Tretinoin — fluconazole possibly increases the risk of tretinoin toxicity.
    • Zidovudine — fluconazole increases the risk of zidovudine toxicity. 
• Other possible drug interactions of fluconazole include:
  • Clopidogrel — fluconazole possibly reduces the antiplatelet effect of clopidogrel.
  • Hydrochlorothiazide — the plasma levels of fluconazole may be increased by 40%; however, no adjustment in dosage of fluconazole is required. 
  • Rifampicin — metabolism of fluconazole may be accelerated by rifampicin, leading to reduced plasma concentrations.
• For a complete list of possible drug interactions of fluconazole, see the electronic Medicines Compendium (eMC) or the British National Formulary (BNF).

[EMC, 2023; BNF, 2022]