Fungoral (Ketoconazole)
Antifungal Shampoo for Dandruff and Seborrhoeic Dermatitis
Quick Facts About Fungoral
Key Takeaways About Fungoral
- Effective antifungal treatment: Ketoconazole 2% shampoo is a well-established, evidence-based treatment for dandruff and seborrhoeic dermatitis caused by Malassezia fungi
- Easy to use: Apply to wet hair, massage into scalp, leave for 3–5 minutes, then rinse. Use twice weekly for 2–4 weeks, then once weekly for maintenance
- Safe during pregnancy: Fungoral shampoo can be used during pregnancy and breastfeeding as systemic absorption is negligible when used topically
- Not for young children: Fungoral shampoo should not be used by children under 12 years of age
- Minimal side effects: Most people tolerate Fungoral well. Uncommon side effects include local irritation, redness, and itching at the application site
What Is Fungoral and What Is It Used For?
Fungoral is a medicated shampoo containing ketoconazole 2%, used to treat dandruff and seborrhoeic dermatitis of the scalp. It belongs to the azole antifungal class and works by killing the Malassezia fungus responsible for these common scalp conditions.
Dandruff is one of the most common scalp conditions worldwide, affecting an estimated 50% of the adult population at some point in their lives. It is characterised by white or yellowish flakes of dead skin that shed from the scalp, often accompanied by itching and irritation. While dandruff is not a serious medical condition, it can be persistent, uncomfortable, and cosmetically distressing for those who experience it.
The primary cause of dandruff is Malassezia, a genus of yeast-like fungi that naturally colonise the skin of most healthy adults. Malassezia feeds on the natural oils (sebum) produced by the sebaceous glands in the scalp. In most people, this fungus coexists harmlessly with the skin. However, in some individuals, the metabolic byproducts of Malassezia – particularly oleic acid – trigger an inflammatory response in the scalp. This inflammation accelerates the turnover of skin cells, causing them to clump together and shed as visible flakes.
Seborrhoeic dermatitis is a more severe form of the same underlying condition. It involves not only flaking but also redness, greasy scales, and sometimes significant scalp inflammation. Seborrhoeic dermatitis can also affect other oily areas of the body, such as the face (particularly around the eyebrows and nose), ears, and chest. When a doctor diagnoses seborrhoeic dermatitis rather than simple dandruff, Fungoral may be prescribed as part of a broader treatment plan.
Ketoconazole, the active ingredient in Fungoral, works by inhibiting the enzyme lanosterol 14-alpha-demethylase (also known as CYP51), which is essential for the synthesis of ergosterol. Ergosterol is a critical component of the fungal cell membrane, similar in function to cholesterol in human cells. By blocking ergosterol production, ketoconazole disrupts the structural integrity of the Malassezia cell membrane, leading to fungal cell death and a reduction in the scalp’s fungal burden.
Ketoconazole was first developed in the late 1970s and approved for clinical use in the early 1980s. It was initially used as a systemic (oral) antifungal agent, but topical formulations such as shampoos and creams were later developed to treat superficial fungal infections with minimal systemic side effects. The World Health Organization includes ketoconazole on its Model List of Essential Medicines for its topical antifungal properties.
In addition to its antifungal properties, ketoconazole has demonstrated mild anti-inflammatory effects when applied topically. Research published in the Journal of the American Academy of Dermatology suggests that ketoconazole may inhibit the production of certain inflammatory mediators, such as thromboxane and leukotrienes, which contribute to the redness and irritation associated with seborrhoeic dermatitis. This dual mechanism of action – antifungal and anti-inflammatory – makes ketoconazole particularly effective for managing scalp conditions where both infection and inflammation play a role.
What Should You Know Before Using Fungoral?
Before using Fungoral shampoo, make sure you are not allergic to ketoconazole or any of its other ingredients. Avoid getting the shampoo in your eyes. Seek immediate medical attention if you experience swelling of the face, tongue, or throat, difficulty swallowing, hives, or breathing difficulties after use.
Contraindications
You should not use Fungoral if the following applies to you:
- Allergy to ketoconazole or any of the other ingredients in the shampoo (listed in the Ingredients section below). Allergic reactions can range from mild skin irritation to severe anaphylaxis
- Known hypersensitivity to other imidazole antifungal agents, as cross-reactivity may occur
Warnings and Precautions
While Fungoral shampoo is generally well tolerated, there are several important precautions to be aware of before and during use:
- Avoid contact with eyes: If the shampoo accidentally gets into your eyes, rinse them thoroughly with plenty of clean water. Ketoconazole can cause significant eye irritation if left in contact with the conjunctival membranes
- Open wounds or broken skin: Do not apply Fungoral to areas of the scalp that have open cuts, wounds, or significant skin damage. The excipients in the formulation may cause stinging and further irritation when applied to broken skin
- Chemical-treated hair: If you have chemically treated hair (e.g., permed or dyed), ketoconazole shampoo may alter the texture or appearance of your hair in rare cases. If you notice changes in hair quality, consult your pharmacist or doctor
Stop using Fungoral and contact a doctor or emergency services immediately if you experience any of the following symptoms: swelling of the face, tongue, or throat; difficulty swallowing; hives (urticaria) spreading across the body; or difficulty breathing. These symptoms may indicate angioedema, a serious allergic reaction that requires urgent treatment.
Pregnancy and Breastfeeding
Fungoral shampoo can be used during pregnancy. Because it is applied topically to the scalp and rinsed off after a few minutes, the amount of ketoconazole that is absorbed into the bloodstream is negligible. Studies have shown that plasma concentrations of ketoconazole following topical shampoo application are undetectable or far below levels that would be considered clinically significant.
Similarly, Fungoral shampoo can be used by women who are breastfeeding. The minimal systemic absorption means that ketoconazole is unlikely to pass into breast milk in meaningful quantities when used as a shampoo. However, as with all medications during pregnancy and breastfeeding, if you have any concerns you should discuss them with your doctor, pharmacist, or midwife before use.
It is important to note that this safety profile applies specifically to the shampoo formulation. Oral ketoconazole tablets have a very different risk profile during pregnancy and breastfeeding due to significant systemic absorption, and should only be used under strict medical supervision.
Driving and Using Machines
Fungoral shampoo does not affect your ability to drive or operate machinery. Because it is used topically and rinsed off, it has no sedative, cognitive, or neurological effects that would impair your capacity to perform these activities safely.
How Does Fungoral Interact with Other Drugs?
When used as a shampoo, Fungoral has no known clinically significant drug interactions because systemic absorption is negligible. However, oral ketoconazole tablets have numerous important drug interactions and should only be taken under medical supervision.
One of the significant advantages of using ketoconazole in its topical shampoo form is the absence of clinically meaningful drug interactions. When Fungoral shampoo is applied to the scalp and rinsed off after 3–5 minutes, the amount of ketoconazole absorbed into the systemic circulation is extremely low – typically undetectable in plasma. This means that the shampoo formulation does not interact with other medications you may be taking.
This is in stark contrast to oral ketoconazole, which is a potent inhibitor of the cytochrome P450 enzyme system, particularly CYP3A4. Oral ketoconazole can dramatically increase the blood levels of many other drugs metabolised by this enzyme pathway, potentially leading to serious adverse effects. The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have both issued safety warnings regarding the hepatotoxicity risk of oral ketoconazole, and its systemic use has been significantly restricted in many countries.
Topical Shampoo Interactions
There are a few practical considerations when using Fungoral shampoo alongside other topical scalp treatments:
- Topical corticosteroids: If you have been using a topical corticosteroid on your scalp (e.g., for psoriasis or severe seborrhoeic dermatitis), you may continue to use Fungoral alongside it. In fact, the combination of ketoconazole and a mild topical corticosteroid is a recognised treatment approach for moderate-to-severe seborrhoeic dermatitis
- Other medicated shampoos: You may use your regular (non-medicated) shampoo before or after Fungoral. However, avoid using two different medicated anti-dandruff shampoos at the same time unless advised by a healthcare professional, as this may increase the risk of scalp irritation
- Hair styling products: While there is no pharmacological interaction, it is advisable to apply Fungoral to clean, product-free hair for optimal contact between the active ingredient and the scalp
Oral Ketoconazole Interactions (Tablet Form)
If your doctor has prescribed ketoconazole in oral tablet form for a systemic fungal infection, be aware that it has numerous significant drug interactions. The following table lists some of the most important interactions for the oral formulation. These interactions do not apply to the shampoo.
| Interacting Drug | Effect | Severity |
|---|---|---|
| Simvastatin, Lovastatin | Increased statin levels; risk of rhabdomyolysis | Contraindicated |
| Cisapride | Increased cisapride levels; risk of QT prolongation | Contraindicated |
| Midazolam (oral), Triazolam | Increased sedation and respiratory depression | Contraindicated |
| Warfarin | Increased anticoagulant effect; bleeding risk | Major |
| Cyclosporine, Tacrolimus | Increased immunosuppressant levels | Major |
| Rifampicin | Reduces ketoconazole levels significantly | Major |
| Proton pump inhibitors (e.g., Omeprazole) | Reduced ketoconazole absorption (requires acid) | Moderate |
| Antacids, H2 blockers | Reduced ketoconazole absorption | Moderate |
What Is the Correct Dosage of Fungoral?
For dandruff treatment, apply approximately 5 ml of Fungoral shampoo to wet hair, massage into the scalp, leave for 3–5 minutes, and rinse. Use twice weekly for 2–4 weeks, then once weekly for maintenance. Fungoral is not recommended for children under 12.
Always use Fungoral exactly as described in the patient information leaflet or as directed by your doctor, pharmacist, or nurse. If you are unsure about any aspect of the treatment, seek advice from a healthcare professional before proceeding.
Adults and Adolescents (12 years and over)
Treatment Phase (Active Dandruff/Seborrhoeic Dermatitis)
Wet your hair and scalp thoroughly. Apply approximately 5 ml (one teaspoon) of Fungoral shampoo and massage it thoroughly into the scalp, ensuring good coverage of all affected areas. Allow the shampoo to remain on the scalp for 3 to 5 minutes before rinsing thoroughly with water. You may wash your hair with your regular shampoo either before or after the Fungoral treatment.
Frequency: Twice a week for 2 to 4 weeks.
Maintenance Phase (Preventing Recurrence)
Once your dandruff symptoms have resolved, you can continue using Fungoral as a maintenance treatment to prevent the condition from returning. Use the shampoo once a week or as needed when you notice early signs of flaking or itching returning.
| Patient Group | Dosage | Frequency | Duration |
|---|---|---|---|
| Adults – Treatment | ~5 ml (1 teaspoon) | Twice weekly | 2–4 weeks |
| Adults – Maintenance | ~5 ml (1 teaspoon) | Once weekly or as needed | Ongoing |
| Adolescents (12–17 years) | ~5 ml (1 teaspoon) | Twice weekly | 2–4 weeks |
| Children under 12 | Not recommended | ||
Children
Fungoral shampoo should not be used by children under 12 years of age due to insufficient safety data in this younger population. There are limited clinical studies evaluating the safety and efficacy of ketoconazole shampoo in children below 12 years. If your child under 12 is experiencing dandruff or scalp issues, consult a paediatrician or dermatologist who can recommend age-appropriate treatments.
For adolescents aged 12 to 17 years, the same dosage regimen as adults applies. If symptoms do not improve within 4 weeks of treatment, the young person should be reviewed by a healthcare professional to confirm the diagnosis and consider alternative or additional treatments.
Elderly
There is no need for dosage adjustment in elderly patients. Fungoral shampoo can be used by older adults using the same dosage recommendations as for younger adults. Because systemic absorption is negligible with the shampoo formulation, age-related changes in liver or kidney function do not affect the safety or efficacy of the treatment.
Missed Dose
If you forget to use Fungoral on a scheduled treatment day, simply use it at the next convenient opportunity. Do not apply a double amount to make up for a missed treatment session. Missing an occasional application is unlikely to significantly affect the overall treatment outcome, but try to maintain the recommended schedule as closely as possible for best results.
Overdose
Fungoral shampoo is a topical product that is designed to be rinsed off after application. Accidental overuse (e.g., leaving the shampoo on for longer than recommended or applying more than the recommended amount) is unlikely to cause harm, though it may increase the risk of local scalp irritation.
If Fungoral shampoo is accidentally swallowed (for example, by a child), contact your doctor, local hospital emergency department, or poison control centre immediately for an assessment of risk and appropriate advice. Do not induce vomiting unless specifically instructed to do so by a medical professional.
If your symptoms do not improve or worsen within 1 month of regular treatment, you should consult a healthcare professional. Persistent or worsening scalp conditions may indicate an alternative diagnosis (e.g., scalp psoriasis, tinea capitis, contact dermatitis) that requires different treatment.
What Are the Side Effects of Fungoral?
Fungoral shampoo is generally well tolerated. Uncommon side effects (affecting fewer than 1 in 100 users) include local reactions such as redness, irritation, itching, burning, and dry skin. Rare side effects include allergic reactions. Seek immediate medical attention for signs of angioedema such as facial swelling or breathing difficulties.
Like all medicines, Fungoral can cause side effects, although not everybody experiences them. The vast majority of people who use Fungoral shampoo tolerate it without any problems. When side effects do occur, they are typically mild and localised to the scalp where the product was applied.
The following side effect information is based on post-marketing surveillance data, clinical trial reports, and pharmacovigilance databases. Side effects are grouped by frequency according to international conventions established by the Council for International Organizations of Medical Sciences (CIOMS).
Uncommon
Affects fewer than 1 in 100 users
- Redness (erythema) at the application site
- Scalp irritation
- Itching (pruritus)
- Inflamed hair follicles (folliculitis)
- Burning sensation on the skin
- Dry skin
- Skin rash
- Hair loss (alopecia) or altered hair quality
- Increased tear production (lacrimation)
Rare
Affects fewer than 1 in 1,000 users
- Pus-filled blisters (pustules) at the application site
- Hypersensitivity reactions
- Altered taste perception (dysgeusia)
- Eye irritation
- Acne
- Contact dermatitis (allergic skin reaction)
- Skin peeling (exfoliation)
Not Known
Frequency cannot be estimated from available data
- Urticaria (hives)
- Change in hair colour
- Angioedema (allergic reaction with swelling of face and mouth)
Most local side effects (redness, itching, burning) are transient and resolve on their own without any specific treatment. If you experience persistent or severe local reactions, discontinue Fungoral and consult your pharmacist or doctor.
It is worth noting that some degree of scalp irritation may also be caused by the underlying condition (dandruff or seborrhoeic dermatitis) itself, rather than by the shampoo. If you are unsure whether your symptoms are due to the treatment or the condition, speak with your healthcare provider for guidance.
When to Seek Immediate Medical Help
While extremely rare with the topical shampoo formulation, angioedema has been reported. Seek emergency medical attention immediately if you experience:
- Swelling of the face, lips, tongue, or throat
- Difficulty swallowing or breathing
- Widespread hives (urticaria) over the body
- Dizziness, rapid heartbeat, or feeling faint
Reporting suspected side effects is important, as it allows ongoing monitoring of the benefit-risk balance of a medicine after it has been authorised. Healthcare professionals and patients are encouraged to report suspected adverse reactions to their national pharmacovigilance authority – for example, the Yellow Card Scheme (UK), MedWatch (USA), or the relevant medicines agency in your country.
How Should You Store Fungoral?
Store Fungoral at room temperature, below 25°C (77°F). Keep out of the sight and reach of children. Do not use after the expiry date printed on the packaging.
Proper storage of medicines is important to ensure they remain effective and safe to use throughout their shelf life. Follow these guidelines for storing Fungoral shampoo:
- Temperature: Store at or below 25°C (77°F). Avoid storing in places that may get very hot, such as a car dashboard in summer or near radiators
- Keep out of reach of children: As with all medicines, store Fungoral in a location that is not accessible to children. The reddish colour and liquid consistency of the shampoo may be appealing to young children
- Expiry date: Do not use Fungoral after the expiry date printed on the packaging. The expiry date refers to the last day of the indicated month
- Disposal: Do not dispose of medicines down the drain or in household waste. Return unused or expired medicine to your pharmacy for safe disposal, helping to protect the environment
Fungoral shampoo is available in bottles of 60 ml and 120 ml. The shampoo has a characteristic reddish colour due to the presence of the colouring agent erythrosin (E127). This colour is normal and does not indicate degradation of the product.
What Does Fungoral Contain?
The active ingredient is ketoconazole (20 mg per ml of shampoo). Inactive ingredients include surfactants, moisturisers, pH adjusters, a preservative (imidurea), and a colouring agent (erythrosin E127).
Active Ingredient
Each millilitre of Fungoral shampoo contains 20 mg of ketoconazole (equivalent to a 2% concentration). Ketoconazole is the ingredient responsible for the antifungal activity of the product.
Inactive Ingredients (Excipients)
The other ingredients in Fungoral shampoo serve various functions to ensure the product is stable, effective, and pleasant to use:
| Ingredient | Function |
|---|---|
| Sodium lauryl ether sulphate | Primary surfactant (cleansing agent) |
| Disodium monolauryl ether sulphosuccinate | Co-surfactant (mild cleansing) |
| Coconut fatty acid diethanolamide | Foam booster and viscosity agent |
| Laurdimonium hydrolysed animal collagen | Conditioning agent |
| Macrogol 120 methyl glucose dioleate | Emulsifier and thickener |
| Hydrochloric acid / Sodium hydroxide | pH adjustment |
| Sodium chloride | Viscosity modifier |
| Imidurea | Preservative (antimicrobial) |
| Erythrosin (E127) | Colouring agent (reddish colour) |
| Purified water | Solvent (vehicle) |
If you are allergic to any of the above excipients, do not use Fungoral. In particular, the preservative imidurea is a formaldehyde-releasing agent and may cause skin reactions in individuals with a known sensitivity to formaldehyde. If you have a history of contact allergy to formaldehyde, discuss this with your doctor or pharmacist before using Fungoral.
Frequently Asked Questions About Fungoral
Fungoral shampoo contains ketoconazole 2% and is used to treat dandruff and seborrhoeic dermatitis of the scalp. These conditions are caused by the Malassezia fungus, which naturally lives on the scalp but can trigger inflammation and excessive flaking in some people. Fungoral kills the fungus and reduces the associated symptoms of itching, flaking, and redness. It is available without a prescription in most countries.
For treating active dandruff or seborrhoeic dermatitis, use Fungoral shampoo twice a week for 2 to 4 weeks. Once symptoms have resolved, switch to a maintenance schedule of once a week or as needed to prevent recurrence. Apply approximately 5 ml (one teaspoon) to wet hair, lather and massage into the scalp, leave for 3 to 5 minutes, then rinse off thoroughly.
Yes, Fungoral shampoo can be safely used during pregnancy and breastfeeding. Because it is applied topically and rinsed off after a few minutes, systemic absorption of ketoconazole is negligible. This makes it highly unlikely to affect the developing baby or to pass into breast milk in any meaningful quantity. However, this applies specifically to the shampoo formulation; oral ketoconazole tablets require separate medical advice during pregnancy.
Fungoral shampoo is not recommended for children under 12 years of age due to limited safety data in this age group. For adolescents aged 12 to 17, the same dosage as adults applies. If your younger child has dandruff or a scalp condition, consult a paediatrician or dermatologist who can recommend an appropriate treatment for their age.
Ketoconazole works by targeting Malassezia, a yeast-like fungus that naturally lives on the scalp. In susceptible individuals, Malassezia triggers an inflammatory response that accelerates skin cell turnover, causing visible flakes (dandruff). Ketoconazole inhibits the fungal enzyme lanosterol 14-alpha-demethylase, which is essential for producing ergosterol – a critical component of the fungal cell membrane. Without ergosterol, the fungal cell membranes lose their integrity and the fungus dies. Ketoconazole also has mild anti-inflammatory properties that help reduce scalp redness and irritation.
If Fungoral shampoo accidentally gets into your eyes, rinse them immediately and thoroughly with plenty of clean, lukewarm water. Continue rinsing for several minutes. If irritation, redness, or pain persists after rinsing, seek medical advice. To help prevent eye contact, keep your eyes closed while the shampoo is on your scalp and tilt your head back when rinsing.
References
This article is based on the following peer-reviewed sources, international guidelines, and authoritative pharmaceutical references:
- Borda LJ, Wikramanayake TC. Seborrheic Dermatitis and Dandruff: A Comprehensive Review. J Clin Investig Dermatol. 2015;3(2):10.13188/2373-1044.1000019. doi:10.13188/2373-1044.1000019
- Gupta AK, Versteeg SG. Topical Treatment of Facial Seborrheic Dermatitis: A Systematic Review. Am J Clin Dermatol. 2017;18(2):193–213. doi:10.1007/s40257-016-0232-2
- European Medicines Agency (EMA). Ketoconazole-containing medicines – Article 31 referral. EMA/452011/2013. Available at: ema.europa.eu
- Faergemann J. Management of seborrheic dermatitis and pityriasis versicolor. Am J Clin Dermatol. 2000;1(2):75–80. doi:10.2165/00128071-200001020-00001
- Shuster S. The aetiology of dandruff and the mode of action of therapeutic agents. Br J Dermatol. 1984;111(2):235–242. doi:10.1111/j.1365-2133.1984.tb04032.x
- World Health Organization. WHO Model List of Essential Medicines – 23rd List (2023). Geneva: WHO; 2023.
- Pierard-Franchimont C, Pierard GE, Arrese JE, De Doncker P. Effect of ketoconazole 1% and 2% shampoos on severe dandruff and seborrhoeic dermatitis: clinical, squamometric and mycological assessments. Dermatology. 2001;202(2):171–176. doi:10.1159/000051626
- British Association of Dermatologists (BAD). Patient Information Leaflet: Seborrhoeic Dermatitis. Updated 2024. Available at: bad.org.uk
- National Institute for Health and Care Excellence (NICE). Clinical Knowledge Summary: Seborrhoeic Dermatitis. Last updated 2024. Available at: cks.nice.org.uk
- American Academy of Dermatology (AAD). Seborrheic dermatitis: Diagnosis and treatment. Available at: aad.org
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