Travellers familiar with Fungoral from Scandinavia or Southeast Asia are unlikely to encounter the same brand elsewhere — it is registered in only seven countries. The active ingredient is ketoconazole, classified as a broad-spectrum antifungal, and the brand's footprint stretches unusually across very different regions rather than clustering in a single area.
Ketoconazole is used in the management of a range of fungal and yeast-related conditions, including seborrheic dermatitis, athlete's foot, jock itch, cutaneous candidiasis, and vaginal candidiasis, alongside other dermatological infections. As a broad-spectrum antifungal it is positioned across several superficial mycoses rather than a single narrow indication, which is why the registered treatment list on this page is comparatively long. The structured indication block further down details each use as recognised by national regulators in the markets where Fungoral is sold.
The seven countries in which Fungoral is registered include Indonesia, Brazil, Norway, Greece, and Iceland — a scatter of markets that does not point to a single regional pattern. Outside these specific countries, the Fungoral brand will generally not appear on pharmacy shelves, but ketoconazole itself is one of the most widely distributed antifungal molecules in the world and circulates under many other brand names and generic labels.
Other molecules in the broad-spectrum antifungal class are also widely available internationally, in both topical and oral formulations, although they are not interchangeable without clinical input. A local pharmacist can identify a ketoconazole-containing product or a suitable alternative within the antifungal class in the destination country. Any decision to begin, continue, or substitute antifungal therapy is appropriately made together with a healthcare provider who knows the patient's situation.
In the event of accidental ingestion, supportive and symptomatic measures should be carried out. In order to avoid aspiration, neither emesis nor gastric lavage should be instigated.
No information provided.
Known hypersensitivity to ketoconazole or any of the excipients.
Fungoral Cream 2% is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.
Not applicable
The safety of ketoconazole 2% shampoo was evaluated in 2890 subjects who participated in 22 clinical trials. Ketoconazole 2% shampoo was administered topically to the scalp and/or skin. Based on pooled safety data from these clinical trials, there were no ADRs reported with an incidence >1%.
The following table displays ADRs that have been reported with the use of Ketoconazole 2% Shampoo from either clinical trial or postmarketing experiences.
The displayed frequency categories use the following convention:
Very common (>1/10)
Common (>1/100 to <1/10)
Uncommon (>1/1,000 to <1/100)
Rare (>1/10,000 to <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated form the available clinical trial data).
| System Organ Class | Adverse Drug Reactions | ||
| Frequency Category | |||
| Uncommon (>1/1,000 to <1/100) | Rare (>1/10,000 and <1/1,000) | Not Known | |
| Immune System disorders | Hypersensitvity | ||
| Nervous System Disorders | Dysgeusia | ||
| Infections and Infestations | Folliculitis | ||
| Eye Disorders | Increased lacrimation | Eye irritation | |
| Skin and Subcutaneous Tissue Disorders | Alopecia Dry skin Hair texture abnormal Rash Skin burning sensation | Acne Dermatitis contact Skin disorder Skin exfoliation | Angioedema Urticaria Hair colour changes |
| General Disorders and Administration Site Conditions | Application site erythema Application site irritation Application site pruritus Application site reaction | Application site hypersensitivity Application site pustules | |
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard.
During clinical trials 45 (5.0%) of 905 patients treated with Fungoral Cream 2% and 5 (2.4%) of 208 patients treated with placebo reported side effects consisting mainly of severe irritation, pruritus and stinging. One of the patients treated with Fungoral Cream developed a painful allergic reaction.
In worldwide postmarketing experience, rare reports of contact dermatitis have been associated with Fungoral Cream or one of its excipients, namely sodium sulfite or propylene glycol.
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Prevention and treatment of infections in which the yeast Malassezia (previously called Pityrosporum) is likely to be involved, such as dandruff, seborrhoeic dermatitis and tinea (pityriasis) versicolor.
Fungoral Cream 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis.
Pharmacotherapeutic group: Imidazole and triazole derivatives
ATC Code: D01AC08
Ketoconazole is an imidazole-dioxolane antimycotic, active against yeasts, including Malassezia and dermatophytes. Its broad spectrum of activity is already well known.
Plasma concentrations of ketoconazole were not detectable after topical administration of Fungoral 2% shampoo on the scalp. Plasma levels were detected after topical administration of Fungoral 2% shampoo on the whole body.
In patients who have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using Fungoral 2% shampoo, to prevent any potential rebound effect.
Keep out of the eyes. If the shampoo should get into the eyes, they should be bathed with water.
WARNINGSFungoral Cream 2% is not for ophthalmic use.
Fungoral Cream 2% contains sodium sulfite anhydrous, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
PRECAUTIONS GeneralIf a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued. Hepatitis (1:10,000 reported incidence) and, at high doses, lowered testosterone and ACTH induced corticosteroid serum levels have been seen with orally administered Fungoral; these effects have not been seen with topical Fungoral.
Carcinogenesis, Mutagenesis, Impairment Of FertilityA long-term feeding study in Swiss Albino mice and in Wistar rats showed no evidence of oncogenic activity. The dominant lethal mutation test in male and female mice revealed that single oral doses of Fungoral as high as 80 mg/kg produced no mutation in any stage of germ cell development. The Ames'Salmonella microsomal activator assay was also negative.
Pregnancy Teratogenic effects : Pregnancy Category CFungoral has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day, (10 times the maximum recommended human oral dose). However, these effects may be related to maternal toxicity, which was seen at this and higher dose levels.
There are no adequate and well-controlled studies in pregnant women. Fungoral should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing MothersIt is not known whether Fungoral Cream 2% administered topically could result in sufficient systemic absorption to produce detectable quantities in breast milk. Nevertheless, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric UseSafety and effectiveness in children have not been established.
Not relevant
For topical administration.
Ketoconazole shampoo 2% is for use in adolescents and adults:
Wash affected areas and leave for 3-5 minutes before rinsing.
Treatment:
| Dandruff and seborrhoeic dermatitis: | Wash hair twice weekly for 2-4 weeks. |
| Tinea versicolor: | Once daily for a maximum of 5 days. |
Prophylaxis:
| Dandruff and seborrhoeic dermatitis: | Use once every 1-2 weeks. |
| Tinea versicolor: | Once daily for a maximum of 3 days before exposure to sunshine. |
Cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis and tinea (pityriasis) versicolor: It is recommended that Fungoral Cream 2% be applied once daily to cover the affected and immediate surrounding area. Clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks in order to reduce the possibility of recurrence. Patients with tinea versicolor usually require two weeks of treatment. Patients with tinea pedis require six weeks of treatment. Seborrheic dermatitis: Fungoral Cream 2% should be applied to the affected area twice daily for four weeks or until clinical clearing.
If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined.
No special requirements
Fungoral is prescribed for a range of fungal and yeast-related skin and mucosal conditions, including seborrheic dermatitis, athlete's foot, jock itch, cutaneous candidiasis, and vaginal candidiasis. As a broad-spectrum antifungal, ketoconazole is used across several superficial mycoses rather than a single indication. The structured indication block further down this page lists each registered use as recognised in the markets where Fungoral is sold.
Fungoral contains ketoconazole, classified as a broad-spectrum antifungal. Ketoconazole is a long-established molecule that circulates internationally under a wide variety of brand names and generic labels, both for topical and systemic use depending on the formulation. The Fungoral brand is one regional presentation of that same active ingredient rather than a unique chemical entity.
Fungoral is registered in seven countries, with a footprint that spans Northern Europe and reaches into Latin America and Southeast Asia. Examples include Indonesia, Brazil, Norway, Greece, Iceland, Sweden, and Latvia. The brand is not globally distributed, so if your country is not on this list, a local pharmacist can confirm whether a ketoconazole-containing product is available locally under a different name.
Ketoconazole is sold under numerous brand names worldwide, in both topical preparations and oral formulations depending on the indication and the regulatory market. Other molecules in the broad-spectrum antifungal class are also widely available internationally, although they are not freely interchangeable. To identify a local ketoconazole product or a comparable antifungal, search the active ingredient on Pill2Trip or ask a pharmacist in your country.
Yes. Antifungal therapy is selected based on the specific organism suspected, the body site involved, and the patient's broader medical context, and prescription requirements for ketoconazole differ significantly between countries — some formulations are pharmacy-sold, while oral ketoconazole is tightly restricted in many regulatory regimes. Travellers and expatriates encountering Fungoral or a local ketoconazole equivalent should involve a healthcare provider in any decision about its use.
