MedeliX
Start asking

Griseofulvin

ATC code D01AA08

Also known as: Ultramicrosize Griseofulvin

Key facts
Active substance
Griseofulvin
ATC code
D01AA08
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Key facts

Griseofulvin is an oral antifungal (here in ultramicrosize form). Per the US prescribing information, it is used for dermatophyte (ringworm) infections of the skin, hair and nails.

What it is used for

  • Tinea corporis, tinea pedis, tinea cruris, tinea barbae, tinea capitis and tinea unguium (onychomycosis)
  • Only when caused by susceptible fungal genera (Trichophyton, Microsporum, Epidermophyton); identify the fungus before therapy
  • Not for minor infections responding to topical agents; not effective in bacterial infections, candidiasis, tinea versicolor and others

Dosing

  • Adults: 375 mg daily (single or divided) for tinea corporis, cruris and capitis; for tinea pedis and unguium 750 mg in divided doses
  • Children: approximately 7.3 mg per kg body weight per day; 16-27 kg: 125 mg to 187.5 mg daily; over 27 kg: 187.5 mg to 375 mg daily
  • Children 2 years and younger: dosage not established
  • Continue until the organism is eradicated, e.g. tinea capitis 4 to 6 weeks, fingernails at least 4 months, toenails at least 6 months
  • Swallow tablets whole, or crushed on applesauce without chewing

Contraindications

  • Pregnancy
  • Porphyria or hepatocellular failure
  • History of hypersensitivity to griseofulvin

Important warnings

  • Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) and erythema multiforme, sometimes fatal; discontinue if they occur
  • Hepatotoxicity with elevated AST, ALT, bilirubin and jaundice, sometimes fatal; monitor the liver
  • On prolonged therapy, periodically monitor renal, hepatic and hematopoietic function
  • Photosensitivity: avoid intense natural or artificial sunlight; lupus-like syndromes reported
  • Possible cross-sensitivity with penicillin

Side effects

  • Hypersensitivity reactions such as rash, urticaria, rarely angioneurotic edema
  • Paresthesia of the hands and feet after extended therapy
  • Occasionally oral thrush, nausea, vomiting, diarrhea, headache, fatigue, dizziness, insomnia, confusion
  • Rarely proteinuria and leukopenia; discontinue if granulocytopenia occurs

Interactions

  • Warfarin-type anticoagulants: activity decreased, dose adjustment may be needed
  • Barbiturates: usually depress griseofulvin activity
  • Oral contraceptives: possible interactions reported
  • Alcohol: effect may be potentiated (tachycardia, flush)

Pregnancy and breastfeeding

  • Contraindicated; cases of conjoined twins reported after use in the first trimester

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

USA

  • Ultramicrosize GriseofulvinSigmapharm Laboratories, LLC, Ayurax, LLC., Chartwell RX, LLC, Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc, Chartwell RX, LLC., Sandoz Inc · 6 register entries

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29

Brand names in 4 more European countries
Cyprus
Griseofulvin Remedica, Medofulvin, Syntofulvin
France
Grisefuline
Ireland
Griseofulvin Brown & Burk Ir
Italy
Fulcin

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. U.S. Food and Drug Administration. Ultramicrosize Griseofulvin (Sigmapharm Laboratories, LLC) – Prescribing Information, 2022-01-14. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=37b4d132-84f1-4394-b468-7e74eeec61eb
  2. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.