Gris-PEG Side Effects

Generic Name: griseofulvin

Please note - some side effects for Gris-PEG may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Gris-PEG - for the Consumer

Gris-PEG Ultramicrosize Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Gris-PEG Ultramicrosize Tablets:

Diarrhea; dizziness; headache; nausea; stomach upset; tiredness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); butterfly-shaped rash on the face; confusion; fever, chills, or sore-throat; flu-like symptoms (eg, headache, joint pain); mental or mood changes; numbness, burning, or tingling of the hands or feet; red, swollen, blistered, or peeling skin; symptoms of liver problems (dark urine, pale stools, severe or persistent stomach pain, yellowing of the skin or eyes); white patches in the mouth.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Gris-PEG Side Effects - for the Professional

Gris-PEG

There have been post-marketing reports of severe skin and hepatic adverse events associated with griseofulvin use.

When adverse reactions occur, they are most commonly of the hypersensitivity type such as skin rashes, urticaria, erythema multiforme-like drug reactions, and rarely, angioneurotic edema, and may necessitate withdrawal of therapy and appropriate countermeasures. Paresthesia of the hands and feet have been reported after extended therapy. 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 and leukopenia have been reported rarely. Administration of the drug should be discontinued if granulocytopenia occurs. When rare, serious reactions occur with griseofulvin, they are usually associated with high dosages, long periods of therapy, or both.

Side Effects by Body System - for Healthcare Professionals

Hypersensitivity

Hypersensitivity side effects have been reported most commonly. These have included skin rashes, urticaria, erythema multiforme-like drug reactions, and rarely, angioneurotic edema.

Dermatologic

Fixed-drug eruptions have been verified by rechallenge.

At least one reported case of toxic epidermal necrolysis resulted in death.

At least one fatal case of SLE exacerbation occurred after ingestion of approximately 1 gram of griseofulvin.

Dermatologic side effects have included severe skin reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis) and erythema multiforme. Fixed-drug eruptions, photosensitivity, exacerbation of systemic lupus erythematosus (SLE), and SLE-like syndromes have been reported. A patient with Hailey-Hailey disease (chronic benign familial pemphigus) experienced a widespread bullous eruption due to griseofulvin therapy. Lesions have commonly begun on sun-exposed areas.

Nervous system

Neuropathy and paresthesia have been reported in a few cases of long-term griseofulvin therapy. One woman reportedly developed paresthesia 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, insomnia, dizziness, and mental confusion. Neuropathy and development of paresthesia of the hands and feet have been reported with long-term use.

Hepatic

Hepatic side effects have included hepatotoxicity, jaundice, and elevations in AST, ALT, and bilirubin.

Gastrointestinal

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

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 have included interstitial nephritis.

Genitourinary

Genitourinary side effects have included proteinuria and menstrual irregularities.

Hematologic

Hematologic side effects have included leukopenia.

Metabolic

Metabolic side effects have included exacerbation of porphyria.

Other

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

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

Musculoskeletal

Musculoskeletal side effects have included at least one case of griseofulvin-induced myositis.

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