Medically reviewed on Nov 15, 2018
(gri see oh FUL vin)
- Griseofulvin Microsize
- Griseofulvin Ultramicrosize
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Generic: 125 mg/5 mL (118 mL [DSC], 120 mL)
Grifulvin V: 500 mg [DSC] [scored]
Gris-PEG: 125 mg [DSC], 250 mg [DSC] [scored]
Generic: 125 mg, 250 mg, 500 mg
Brand Names: U.S.
- Grifulvin V [DSC]
- Gris-PEG [DSC]
- Antifungal Agent, Oral
Inhibits fungal cell mitosis at metaphase; binds to human keratin making it resistant to fungal invasion
Ultramicrosize griseofulvin absorption is almost complete; absorption of microsize griseofulvin is variable (27% to 72% of an oral dose); enhanced by ingestion of a fatty meal (GI absorption of ultramicrosize is ~1.5 times that of microsize); absorbed from the duodenum
Deposited in the keratin layer of skin, hair, and nails; concentrates in liver, fat, and skeletal muscles; Vd: ~1.5 L (Vozeh 1988)
Urine (<1% as unchanged drug); feces (~33%); perspiration
Time to Peak
Serum: 4 hours
9 to 24 hours
Use: Labeled Indications
Dermatophyte infections: Treatment of the following dermatophyte infections of the skin, hair, and nails not adequately treated by topical therapy: Tinea corporis, tinea pedis, tinea cruris, tinea barbae, tinea capitis, tinea unguium (onychomycosis) when caused by one or more of the following species of fungi: Trichophyton rubrum, Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton interdigitalis, Trichophyton verrucosum, Trichophyton megnini, Trichophyton gallinae, Trichophyton crateriform, Trichophyton sulphureum, Trichophyton schoenleini, Microsporum audouini, Microsporum canis, Microsporum gypseum, and Epidermophyton floccosum.
Limitations of use: Use for the prophylaxis of fungal infections has not been established; not effective for the treatment of tinea versicolor.
Hypersensitivity to griseofulvin or any component of the formulation; hepatic failure; porphyria; pregnancy
Dermatophyte infections: Oral:
Microsize: 500 mg/day in single or divided doses; for more widespread lesions initial doses of 750 to 1,000 mg/day in single or divided doses may be needed; may decrease gradually to 500 mg/day or less if patient responds to higher dose.
Ultramicrosize: 375 mg daily in single or divided doses; doses up to 750 mg/day in divided doses have been used for infections more difficult to eradicate such as tinea unguium and tinea pedis
Duration of therapy depends on the site of infection:
Tinea corporis: 2 to 4 weeks
Tinea cruris: Duration not specified in manufacturer’s labeling; in pediatric patients 6 weeks has been recommended (Red Book, 2015)
Tinea capitis: 4 to 6 weeks
Tinea pedis: 4 to 8 weeks
Tinea unguium: 4 to 6 months or longer
Refer to adult dosing.
General dosing; susceptible infection (Bradley 2018; Red Book [AAP 2018]): Children >2 years of age and Adolescents:
Microsize: Oral: 20 to 25 mg/kg/day in single or 2 divided doses; maximum daily dose: 1,000 mg/day
Ultramicrosize: Oral: 10 to 15 mg/kg/day once daily; maximum daily dose: 750 mg/day
Tinea capitis: Note: Preferred therapy for Microsporum canis infection; may be used in combination with adjunctive topical therapy (eg, selenium or antifungal shampoo) (Red Book [AAP 2018]). Patients receiving doses on the lower end of the dose range may require longer durations of treatment for fungal eradication (Shemer 2013).
Children >2 years of age and Adolescents:
Microsize: Oral: 20 to 25 mg/kg/day in single daily dose or in 2 divided doses (maximum daily dose: 1,000 mg/day) for 6 to 8 weeks or until fungal cultures clear; in some cases, treatment up to 12 to 18 weeks may be necessary (Ely 2014; Fuller 2014; Gupta 2017; Kakourou 2010; Red Book [AAP 2018]). Although lower doses (10 to 15 mg/kg/day) have been suggested previously by experts (Higgins 2000) and by the manufacturer, they are associated extended treatment durations and/or potentially lower cure rates and have fallen out of favor (Bradley 2018; Red Book [AAP 2018]).
Ultramicrosize: Oral: 10 to 15 mg/kg/day once daily (maximum daily dose: 750 mg/day) for 6 to 8 weeks or until fungal cultures clear; in some cases, treatment up to 12 to 18 weeks may be necessary (Ali 2007; Ely 2014; Kakourou 2010; Red Book [AAP 2018])
Dosing: Renal Impairment
There are no dosage adjustments provided in the manufacturer's labeling.
Dosing: Hepatic Impairment
Use is contraindicated in hepatic failure.
Oral: Administer with a fatty meal to increase absorption (Red Book [AAP 2015])
Gris-PEG tablets: May be swallowed whole or crushed and sprinkled onto 1 tablespoonful of applesauce and swallowed immediately without chewing.
Suspension: Shake well before use.
Store at 20°C to 25°C (68°F to 77°F). Protect from light.
Alcohol (Ethyl): Griseofulvin may enhance the adverse/toxic effect of Alcohol (Ethyl). A disulfiram-like reaction may occur. Monitor therapy
Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Avoid combination
Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Monitor therapy
Barbiturates: May decrease the serum concentration of Griseofulvin. Exceptions: Methohexital; Thiopental. Monitor therapy
Carbocisteine: Griseofulvin may enhance the adverse/toxic effect of Carbocisteine. Specifically, griseofulvin may enhance adverse effects of alcohol that is present in liquid formulations of carbocisteine-containing products. Monitor therapy
CycloSPORINE (Systemic): Griseofulvin may decrease the serum concentration of CycloSPORINE (Systemic). Monitor therapy
Estrogen Derivatives (Contraceptive): Griseofulvin may increase the metabolism of Estrogen Derivatives (Contraceptive). Contraceptive failure is possible. Management: Use an alternative, nonhormonal form of contraception, or use an alternative to griseofulvin. Consider therapy modification
Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Monitor therapy
Progestins (Contraceptive): Griseofulvin may diminish the therapeutic effect of Progestins (Contraceptive). Contraceptive failure is possible. Avoid combination
Saccharomyces boulardii: Antifungal Agents (Systemic, Oral) may diminish the therapeutic effect of Saccharomyces boulardii. Avoid combination
Ulipristal: Griseofulvin may decrease the serum concentration of Ulipristal. Avoid combination
Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Monitor therapy
Vitamin K Antagonists (eg, warfarin): Griseofulvin may decrease the serum concentration of Vitamin K Antagonists. Monitor therapy
False-positive urinary VMA levels (Rampini 1989)
Frequency not defined.
Central nervous system: Confusion, dizziness, fatigue, headache, insomnia
Dermatologic: Dermatological reaction (erythema multiforme-like drug reaction), skin photosensitivity, skin rash (most common), urticaria (most common)
Gastrointestinal: Diarrhea, epigastric distress, gastrointestinal hemorrhage, nausea, oral candidiasis, vomiting
Hematologic & oncologic: Granulocytopenia
<1%, postmarketing, and/or case reports: Angioedema, increased serum bilirubin, increased serum transaminases, leukopenia, lupus-like syndrome, paresthesia, proteinuria, Stevens-Johnson syndrome, toxic epidermal necrolysis
Concerns related to adverse effects:
• Hematologic effects: Leukopenia has been reported (rare); discontinue therapy if granulocytopenia occurs.
• Hepatic effects: May cause jaundice and elevated liver function tests or bilirubin (may be serious or even fatal); monitor hepatic function and discontinue therapy if necessary.
• Penicillin allergy: Hypersensitivity cross reaction between penicillins and griseofulvin is possible, however, known penicillin-sensitive patients have been treated successfully without complications.
• Photosensitivity: Avoid exposure to intense sunlight to prevent photosensitivity reactions.
• Skin reactions: Severe skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been reported (may be serious or even fatal); discontinue use if severe skin reactions occur.
• Lupus erythematosus: Development of lupus erythematosus, lupus-like syndromes or exacerbation of existing lupus erythematosus has been reported.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
• Appropriate use: Use for the prophylaxis of fungal infections has not been established; not effective for the treatment of tinea versicolor.
Periodic renal, hepatic, and hematopoietic function tests especially with long-term use
Pregnancy Risk Factor
Teratogenic effects have been observed in animal reproduction studies. Griseofulvin crosses the placenta (Pacifici, 2006). Because adverse events have also been observed in humans (two cases of conjoined twins), use during pregnancy is contraindicated. Effective contraception should be used during therapy and for 1 month after therapy is discontinued in women of reproductive potential. Men should avoid fathering a child for at least 6 months after therapy.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience headache, dizziness, nausea, vomiting, abdominal pain, loss of strength and energy, insomnia, or diarrhea. Have patient report immediately to prescriber signs of lupus (rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs), signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes), confusion, burning or numbness feeling, redness or white patches in mouth or throat, or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
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