Griseofulvin Side Effects

Some side effects of griseofulvin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to griseofulvin: oral suspension, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking griseofulvin: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• fever, chills, flu symptoms;

• white patches or sores inside your mouth or on your lips;

• confusion, trouble with daily activities;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling;

Less serious side effects of griseofulvin may include:

• flushing (warmth, redness, or tingly feeling);

• nausea, vomiting, or diarrhea;

• headache, dizziness, feeling tired;;

• sleep problems (insomnia);

• confusion;

• numbness or tingling in your hands or feet; or

• menstrual irregularities.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to griseofulvin: compounding powder, oral capsule, oral suspension, oral tablet

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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