Gris-PEG Side Effects
Generic Name: griseofulvin
Note: This document contains side effect information about griseofulvin. Some of the dosage forms listed on this page may not apply to the brand name Gris-PEG.
For the Consumer
Applies to griseofulvin: oral capsule, oral suspension, oral tablet
Along with its needed effects, griseofulvin (the active ingredient contained in Gris-PEG) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking griseofulvin:More common
- Blistering, peeling, or loosening of the skin
- joint or muscle pain
- red, irritated eyes
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- unusual tiredness or weakness
- increased sensitivity of the skin to sunlight
- skin rash, hives, or itching
- soreness or irritation of the mouth or tongue
- Black, tarry stools
- chest pain
- cloudy urine
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- numbness, tingling, pain, or weakness in the hands or feet
- painful or difficult urination
- shortness of breath
- swollen glands
- unusual bleeding or bruising
- yellow eyes or skin
- Abdominal or stomach pain
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- clay-colored stools
- dark urine
- loss of appetite
- unpleasant breath odor
- vomiting of blood
Some side effects of griseofulvin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Hives or welts
- redness of the skin
- Trouble with sleeping
- pain or discomfort in the chest, upper stomach, or throat
- unable to sleep
- white patches in the mouth or throat or on the tongue
- white patches with diaper rash
For Healthcare Professionals
Applies to griseofulvin: compounding powder, oral capsule, oral suspension, oral tablet
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 (the active ingredient contained in Gris-PEG) therapy. Lesions have commonly begun on sun-exposed areas.
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.
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.[Ref]
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.[Ref]
Renal side effects have included interstitial nephritis.[Ref]
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.[Ref]
Genitourinary side effects have included proteinuria and menstrual irregularities.
Hematologic side effects have included leukopenia.[Ref]
Metabolic side effects have included exacerbation of porphyria.
A disulfiram-like reaction, including flushing, nausea, vomiting, diarrhea and paresthesia of the extremities, occurred in one patient who ingested griseofulvin (the active ingredient contained in Gris-PEG) with alcohol.[Ref]
Other side effects have included fever, fatigue, and a disulfiram-like reaction. Impairment of performance of routine activities has been reported occasionally.[Ref]
Musculoskeletal side effects have included at least one case of griseofulvin-induced myositis.
1. Feinstein A, Sofer E, Trau H, Schewach-Millet M "Urticaria and fixed drug eruption in a patient treated with griseofulvin." J Am Acad Dermatol 10 (1984): 915-7
2. Taylor B, Duffill M "Toxic epidermal necrolysis from griseofulvin." J Am Acad Dermatol 19 (1988): 565-6
3. Rustin MH, Bunker CB, Dowd PM, Robinson TW "Erythema multiforme due to griseofulvin." Br J Dermatol 120 (1989): 455-8
4. Mion G, Verdon R, Le Gulluche YL, Carstein H, Garcia A, Guilbaud J "Fatal toxic epidermal necrolysis after griseofulvin." Lancet 2 (1989): 1331
5. Miyagawa S, Sakamoto K "Adverse reaction to griseofulvin in patients with circulating anti-ssa/ro and ssb/la autoantibodies." Am J Med 87 (1989): 99-102
6. Miyagawa S, Okuchi T, Shiomi Y, Sakamoto K "Subacute cutaneous lupus erythematosus lesions precipitated by griseofulvin." J Am Acad Dermatol 21 (1989): 343-6
7. Boudghene-Stambouli O, Merad-Boudia A "Fixed drug eruption induced by griseofulvin." Dermatologica 179 (1989): 92-3
8. "Product Information. Fulvicin P/G (griseofulvin)." Schering Laboratories, Kenilworth, NJ.
9. Gupta AK, Ryder JE "The use of oral antifungal agents to treat onychomycosis." Dermatol Clin 21 (2003): 469-79, vi
10. Lecky BR "Griseofulvin-induced neuropathy." Lancet 1 (1990): 230-1
11. Debruyne D, Coquerel A "Pharmacokinetics of antifungal agents in onychomycoses." Clin Pharmacokinet 40 (2001): 441-72
12. Haskell LP, Mennemyer RP, Greenman R, Pelczar C "Isolated erythroid hypoplasia and renal insufficiency induced by long-term griseofulvin therapy." South Med J 83 (1990): 1327-30
13. Fett DL, Vukov LF "An unusual case of severe griseofulvin alcohol interaction." Ann Emerg Med 24 (1994): 95-7
Some side effects of 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.
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- Drug class: miscellaneous antifungals
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