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Griseofulvin

    Brands

    DEA Class; Rx , Discontinued

    Common Brand Names; Grifulvin V, Gris-PEG

    • Antifungals,
    • Systemic

    Oral antifungal antibiotic produced by certain species of Penicillium. Marketed in several formulations to increase bioavailability and decrease GI intolerance. Used for tinea and other fungal infections, including onychomycosis.NOTE: On April 10, 2007, Ortho-McNeil and the FDA informed of a nationwide recall of griseofulvin oral suspension, due to 2 reports of glass fragments found in bottles of this liquid. The recall is limited to this liquid formulation (roughly 100 lots) from this manufacturer and does not include any other dosage form. The voluntary recall is being conducted by Ortho Dermatological, Division of Ortho-McNeil Pharmaceutical, Inc., manufacturer of GRIFULVIN V® and also of griseofulvin oral suspension under the Patriot Pharmaceuticals, L.L.C., label. Consumers should contact their pharmacy to see if they have the product that has been recalled. It is not clear that the recall will cause any shortages.

    Infections affecting skin, body, hair/beard, or nails

    Hypersensitivity

    Porphyria

    Hepatocellular failure

    Pregnancy

    Rash (most common)

    Urticaria (most common)

    Headache

    Fatigue

    Dizziness

    Insomnia

    Mental confusion

    Photosensitivity

    Nausea

    Vomiting

    Epigastric distress

    Diarrhea

    GI bleeding

    Leukopenia

    Hepatotoxicity

    Proteinuria

    Nephrosis

    Oral thrush

    Angioneurotic edema (rare)

    Drug-induced lupuslike syndrome (rare)

    Menstrual irregularities (rare)

    Paresthesia (rare)

    Severe skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis) and erythema multiforme reported, some resulting in hospitalization or death; discontinue if severe skin reaction occurs

    Elevations in AST, ALT, bilirubin, and jaundice reported, some resulting in hospitalization or death; discontinue if jaundice occurs

    Patients on prolonged therapy with any potent medication should be under close observation; periodic monitoring of organ system function, including renal, hepatic and hematopoietic, should be done

    Pregnancy category: X; no adequate and well-controlled studies in pregnant women, but animal studies have shown embryotoxic and teratogenic effects

    Lactation: Excretion in milk unknown; avoid use because of potential tumorigenicity

    Adults

    1 g/day PO of microsize griseofulvin; 750 mg/day PO of ultramicrosize griseofulvin.

    Geriatric

    1 g/day PO of microsize griseofulvin; 750 mg/day PO of ultramicrosize griseofulvin.

    Adolescents

    10 mg/kg/day (Max: 500 mg/day) PO of microsize griseofulvin is FDA-approved; however, doses up to 25 mg/kg/day PO (Max: 1 g/day) have been used off-label; 7.3 mg/kg/day (Max: 375 mg/day) PO of ultramicrosize griseofulvin is FDA-approved; however, doses up to 15 mg/kg/day PO (Max: 750 mg/day) have been used off-label.

    Children

    3 to 12 years: 10 mg/kg/day (Max: 500 mg/day) PO of microsize griseofulvin is FDA-approved; however, doses up to 25 mg/kg/day PO (Max: 1 g/day) have been used off-label; 7.3 mg/kg/day (Max: 375 mg/day) PO of ultramicrosize griseofulvin is FDA-approved; however, doses up to 15 mg/kg/day PO (Max: 750 mg/day) have been used off-label.
    1 to 2 years: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Griseofulvin

    oral suspension, microsize

    • 125mg/5mL

    tablet, microsize

    • 500mg (Grifulvin V)

    tablet, ultramicrosize

    • 125mg (Gris-PEG)
    • 250mg (Gris-PEG)