Gentian Violet (Monograph)

Drug class: Astringents, Anti-infective

Medically reviewed by Drugs.com on May 10, 2024. Written by ASHP.

Introduction

Gentian violet (hexamethylpararosaniline chloride) is a triphenylmethane (rosaniline) dye that exhibits antifungal and some antibacterial activity.

Uses for Gentian Violet

Gentian violet has been used topically in the treatment of cutaneous or mucocutaneous infections caused by Candida albicans (monilia), such as oral (thrush), intertrigenous, vaginal, and paronychial candidiasis, but more effective, nonstaining agents such as nystatin and amphotericin B are available. Gentian violet is generally not recommended for use in dermatophytic infections because of its local irritant and staining properties. Gentian violet has also been used topically for local geotrichosis, impetigo, necrotizing ulcerative gingivitis (Vincent’s infection), superficial infections and various dermatitides; however, the drug’s effectiveness in these conditions has not been conclusively determined.

Gentian Violet Dosage and Administration

Gentian violet is usually administered topically as a solution or intravaginally.

For topical use, gentian violet solution should be applied to lesions with cotton 2 or 3 times daily for 3 days. A 0.25 or 0.5% solution has been reported to be as effective as, and less irritating than, 1–2% solutions. Topical geotrichosis reportedly may respond to topical application of a 0.01% solution. For instillation into closed cavities, the concentration should be 0.01%. In the treatment of candidiasis, conditions which favor growth of yeast and release of its irritating endotoxin, such as use of occlusive dressings, should be avoided. Concomitant therapy should include attention to proper hygiene and skin care to prevent spread of infection and reinfection. In addition, the affected areas should be kept dry and exposed to air, if possible.

Related/similar drugs

fluconazole, nystatin, clotrimazole, Diflucan, itraconazole, miconazole, micafungin

Cautions for Gentian Violet

Adverse Effects

Although topical gentian violet is usually well tolerated, the drug may cause irritation or sensitivity reactions and ulceration of mucous membranes. Esophagitis, laryngitis, or tracheitis may result from swallowing a solution of gentian violet, and laryngeal obstruction has been reported following frequent and prolonged use of the drug in the treatment of oral candidiasis. Tattooing of the skin may occur when gentian violet is applied to granulation tissue; therefore, the drug should not be used on ulcerative lesions of the face.

Precautions and Contraindications

If irritation or sensitization occurs, application of gentian violet should be discontinued. Gentian violet should not be used in the presence of extensive excoriation or ulceration.

When gentian violet is used in the treatment of oral candidiasis (thrush), only individual lesions should be painted, since serious adverse effects have occurred following frequent and prolonged use of the drug in the treatment of this condition or when a solution of the drug was swallowed. Infants should be turned face downward after application to minimize the amount of drug ingested.

When gentian violet is used for the treatment of vaginal candidiasis, patients should be advised to refrain from coitus during treatment.

Because gentian violet is a dye, preparations of the drug stain skin and clothing.

Gentian violet is contraindicated in patients who are sensitive to the drug.

Mutagenicity and Carcinogenicity

Long-term studies in animals to determine the mutagenic and carcinogenic potentials of gentian violet have not been performed.

Pregnancy and Lactation

Pregnancy

Animal reproduction studies have not been performed with gentian violet. It is not known whether gentian violet can cause fetal harm when administered to pregnant women or can affect reproduction capacity. Use of gentian violet in pregnant women is not recommended.

Lactation

Since it is not known whether gentian violet is distributed into milk, the drug should be used with caution in nursing women.

Mechanism of Action

No information is available on the mechanism of antifungal action of gentian violet. The effectiveness of the drug against gram-positive bacteria, however, is believed to be related to the characteristics of the bacterial cell which underlie the differential gram stain (e.g., the permeability and thickness of the cell wall).

Spectrum

Gentian violet inhibits the growth of many fungi, including yeasts and dermatophytes. The drug has been reported to be effective against Candida, Epidermophyton, Cryptococcus and Trichophyton species, and against Geotrichum candidum. Gentian violet is also active against some gram-positive bacteria, especially Staphylococcus species.

Resistance

Although gentian violet has been reported to inhibit the growth of the causative agent of necrotizing ulcerative gingivitis (Vincent’s infection), this condition is currently believed to be caused by gram-negative bacteria, which are generally resistant to the drug. Gentian violet is ineffective against acid-fast bacteria and bacterial spores.

Gentian Violet Pharmacokinetics

Information on the systemic absorption of gentian violet following topical application is not available.

Chemistry and Stability

Chemistry

Gentian violet, hexamethylpararosaniline chloride, is a triphenylmethane (rosaniline) dye. Commercially available gentian violet often contains up to 4% of tetramethylpararosaniline chloride and pentamethylpararosaniline chloride. Gentian violet occurs as a dark green powder or greenish, glistening pieces having a metallic luster and not more than a faint odor. The drug is sparingly soluble in water and soluble in alcohol.

Stability

Gentian violet topical solution should be stored in a tight container at a temperature less than 40°C, preferably between 15–30°C; freezing should be avoided.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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