Fulvicin U/F Side Effects

Generic Name: griseofulvin

Please note - some side effects for Fulvicin U/F may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects by Body System

Hypersensitivity

Fixed-drug eruptions have been verified by rechallenge.

One reported case of toxic epidermal necrolysis resulted in death.

One fatal case of SLE exacerbation occurred after ingestion of approximately 1 gram of griseofulvin.

A patient with Hailey-Hailey disease (chronic benign familial pemphigus) experienced a widespread bullous eruption due to griseofulvin therapy.

Lesions commonly begin on sun-exposed areas.

Hypersensitivity side effects have been reported most commonly. These have included rash, urticaria, fixed-drug eruptions, and photosensitivity. Toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson Syndrome and exacerbation of systemic lupus erythematosus (SLE) and SLE-like syndrome have been reported less often. A single case of griseofulvin-induced myositis has been reported.

Renal

One patient developed interstitial nephritis after one year of griseofulvin therapy. The patient presented with renal insufficiency, hematuria, pyuria, eosinophiluria, and anemia. Renal function returned to normal after one year.

Renal side effects including proteinuria and interstitial nephritis have been reported.

Nervous system

Neuropathy and paresthesias have been reported in a few cases of long-term griseofulvin therapy. One woman reportedly developed paresthesias in the fingers and feet after 6 months of griseofulvin therapy. Neuropathy progressed for 4 months after the drug was discontinued but resolved 8 months after therapy was discontinued.

Nervous system side effects have included headache, fatigue, insomnia, and mental confusion. Neuropathy and development of paresthesias of the hands and feet have been reported with long-term use. Dizziness has also been reported occasionally.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, abdominal distress, and thrush.

Endocrine

Endocrinologic adverse effects have included menstrual irregularities.

Hematologic

Hematologic side effects including leucopenia and exacerbation of porphyria have been reported.

Hepatic

Hepatic side effects including hepatotoxicity have been reported.

Other

Other side effects including fever and a disulfiram-like reaction have been reported. Impairment of performance of routine activities has been reported occasionally.

A disulfiram-like reaction, including flushing, nausea, vomiting, diarrhea and paresthesias of the extremities, occurred in one patient who ingested griseofulvin with alcohol.

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