Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS There have been postmarketing reports of severe skin and hepatic adverse events associated with griseofulvin use (see WARNINGS section).
When adverse reactions occur, they are most commonly of the hypersensitivity type, such as skin rashes, urticaria, and rarely, angioneurotic edema, and erythema multiforme.
These may necessitate withdrawal of therapy and appropriate countermeasures.
Peripheral neuropathy and paresthesias of the hands and feet have been reported and may be related to treatment duration.
Most patients treated with griseofulvin for less than six months experienced improvement or resolution of their neuropathy upon withdrawal of the griseofulvin.
Other side effects reported occasionally are oral thrush, nausea, vomiting, epigastric distress, diarrhea, headache, fatigue, dizziness, insomnia, mental confusion, and impairment of performance of routine activities.
Proteinuria, nephrosis (sometimes associated with existing systemic lupus erythematosus), leukopenia, coagulopathy, hepatitis, elevated liver enzymes, hyperbilirubinemia, and GI bleeding have been reported rarely.
Administration of the drug should be discontinued if granulocytopenia occurs.
WARNINGS Prophylactic Usage Safety and efficacy of griseofulvin for prophylaxis of fungal infections have not been established.
Serious Skin Reactions Severe skin reactions (e.g.
Stevens-Johnson syndrome, toxic epidermal necrolysis) and erythema multiforme have been reported with griseofulvin use.
These reactions may be serious and may result in hospitalization or death.
If severe skin reactions occur, griseofulvin should be discontinued (see ADVERSE REACTIONS section).
Like all medications, Grisofulvin can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: