Gris-PEG Side Effects
Generic Name: griseofulvin
Note: This page contains information about the side effects of griseofulvin. Some of the dosage forms included on this document may not apply to the brand name Gris-PEG.
Not all side effects for Gris-PEG may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to griseofulvin: oral capsule, oral suspension, oral tablet
In addition to its needed effects, some unwanted effects may be caused by griseofulvin (the active ingredient contained in Gris-PEG). In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when 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 of the side effects that can occur with griseofulvin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional: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
Hypersensitivity side effects have been reported most commonly. These have included skin rashes, urticaria, erythema multiforme-like drug reactions, and rarely, angioneurotic edema.[Ref]
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]
Hepatic side effects have included hepatotoxicity, jaundice, and elevations in AST, ALT, and bilirubin.[Ref]
Gastrointestinal side effects have included nausea, vomiting, epigastric/abdominal distress, and oral thrush.[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. Taylor B, Duffill M "Toxic epidermal necrolysis from griseofulvin." J Am Acad Dermatol 19 (1988): 565-6
2. 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
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
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