Gris-PEG Side Effects
Generic name: griseofulvin
Medically reviewed by Drugs.com. Last updated on Aug 11, 2023.
Note: This document contains side effect information about griseofulvin. Some dosage forms listed on this page may not apply to the brand name Gris-PEG.
Applies to griseofulvin: oral suspension, oral tablet.
Serious side effects of Gris-PEG
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:
- 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
Incidence not known
- 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
Other side effects of Gris-PEG
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:
- Hives or welts
- redness of the skin
- Trouble with sleeping
Incidence not known
- 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.
Headache was sometimes severe and usually disappeared during continued therapy.
Neuropathy and paresthesia have been reported in a few cases of long-term therapy with this drug. In 1 woman, paresthesia reportedly developed in the fingers and feet after 6 months of therapy. Neuropathy progressed for 4 months after the drug was discontinued but resolved 8 months after therapy was discontinued.[Ref]
Very common (10% or more): Headache (up to 15%)
Uncommon (0.1% to 1%): Impaired coordination, peripheral neuropathy, confusion, dizziness, drowsiness, taste sensation changes
A moderate but inconsistent increase of fecal protoporphyrins has been observed when this drug was used for a prolonged duration.[Ref]
Common (1% to 10%): Diarrhea, nausea, vomiting, gastric discomfort
At least 1 reported case of toxic epidermal necrolysis resulted in death.
Fixed-drug eruptions have been verified by rechallenge.
A patient with Hailey-Hailey disease (chronic benign familial pemphigus) experienced a widespread bullous eruption due to this drug.[Ref]
Uncommon (0.1% to 1%): Toxic epidermal necrolysis, erythema multiforme, photosensitivity (on exposure to intense natural/artificial sunlight)
Frequency not reported: Cold and warm urticaria, erythema eruptions, vesicular eruptions, morbilliform eruptions, fixed-drug eruptions, lesions (on sun-exposed areas), bullous eruption
Uncommon (0.1% to 1%): Insomnia, irritability[Ref]
Uncommon (0.1% to 1%): Anorexia
Frequency not reported: Thirst, exacerbation of porphyria[Ref]
Rare (0.01% to 0.1%): Serum sickness syndromes
Rare (0.01% to 0.1%): Hepatotoxicity
Very rare (less than 0.01%): Altered/elevated liver function tests, intrahepatic cholestasis, hepatitis
Frequency not reported: Elevated liver enzymes, hyperbilirubinemia
Postmarketing reports: Jaundice, elevated AST, elevated ALT, elevated bilirubin[Ref]
Liver function tests were elevated to greater than 3 times the upper limit of normal.[Ref]
Rare (0.01% to 0.1%): Leukopenia, neutropenia, anemia
Frequency not reported: Coagulopathy[Ref]
Leukopenia, neutropenia, and anemia generally resolved when therapy was stopped.[Ref]
Rare (0.01% to 0.1%): Precipitation of systemic lupus erythematosus, lupus-like syndromes, exacerbation of existing lupus
Frequency not reported: Drug-induced myositis[Ref]
At least 1 fatal case of systemic lupus erythematosus exacerbation occurred after ingestion of about 1 g of this drug.[Ref]
A patient developed interstitial nephritis after 1 year of therapy. The patient presented with renal insufficiency, hematuria, pyuria, eosinophiluria, and anemia. Renal function returned to normal after 1 year.[Ref]
Rare (0.01% to 0.1%): Nephrosis
Frequency not reported: Interstitial nephritis[Ref]
Rare (0.01% to 0.1%): Proteinuria, menstrual irregularities
Frequency not reported: Albuminuria (without evidence of renal dysfunction)[Ref]
Frequency not reported: Fatigue, fever, disulfiram-like reaction[Ref]
More about Gris-PEG (griseofulvin)
- Check interactions
- Compare alternatives
- Reviews (5)
- Drug images
- Dosage information
- During pregnancy
- Generic availability
- Drug class: miscellaneous antifungals
Related treatment guides
1. Lecky BR. Griseofulvin-induced neuropathy. Lancet. 1990;1:230-1.
2. Product Information. Grifulvin V (griseofulvin). Ortho McNeil Pharmaceutical.
3. Product Information. Fulvicin P/G (griseofulvin). Schering Corporation. 2002.
4. Gupta AK, Ryder JE. The use of oral antifungal agents to treat onychomycosis. Dermatol Clin. 2003;21:469-79, vi.
5. Cerner Multum, Inc. UK Summary of Product Characteristics.
6. Cerner Multum, Inc. Australian Product Information.
7. Feinstein A, Sofer E, Trau H, Schewach-Millet M. Urticaria and fixed drug eruption in a patient treated with griseofulvin. J Am Acad Dermatol. 1984;10:915-7.
8. Taylor B, Duffill M. Toxic epidermal necrolysis from griseofulvin. J Am Acad Dermatol. 1988;19:565-6.
9. Boudghene-Stambouli O, Merad-Boudia A. Fixed drug eruption induced by griseofulvin. Dermatologica. 1989;179:92-3.
10. Rustin MH, Bunker CB, Dowd PM, Robinson TW. Erythema multiforme due to griseofulvin. Br J Dermatol. 1989;120:455-8.
11. Mion G, Verdon R, Le Gulluche YL, Carstein H, Garcia A, Guilbaud J. Fatal toxic epidermal necrolysis after griseofulvin. Lancet. 1989;2:1331.
12. Meffert JJ, Davis BM, Campbell JC. Bullous drug eruption to griseofulvin in a man with hailey-hailey disease. Cutis. 1995;56:279-80.
13. Miyagawa S, Sakamoto K. Adverse reaction to griseofulvin in patients with circulating anti-ssa/ro and ssb/la autoantibodies. Am J Med. 1989;87:99-102.
14. Debruyne D, Coquerel A. Pharmacokinetics of antifungal agents in onychomycoses. Clin Pharmacokinet. 2001;40:441-72.
15. Madhok R, Zoma A, Capell H. Fatal exacerbation of systemic lupus erythematosus after treatment with griseofulvin. Br Med J (Clin Res Ed). 1985;291:249-50.
16. Miyagawa S, Okuchi T, Shiomi Y, Sakamoto K. Subacute cutaneous lupus erythematosus lesions precipitated by griseofulvin. J Am Acad Dermatol. 1989;21:343-6.
17. Davidson BK. Myositis associated with griseofulvin therapy. Am Fam Physician. 1995;52:1277.
18. Fett DL, Vukov LF. An unusual case of severe griseofulvin alcohol interaction. Ann Emerg Med. 1994;24:95-7.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.