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Fulvicin P / G Side Effects

Generic name: griseofulvin

Medically reviewed by Drugs.com. Last updated on Apr 26, 2021.

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 Fulvicin P / G.

For the Consumer

Applies to griseofulvin: oral suspension, oral tablet

Side effects requiring immediate medical attention

Along with its needed effects, griseofulvin (the active ingredient contained in Fulvicin P / G) 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
  • chills
  • cough
  • diarrhea
  • fever
  • itching
  • 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

Less common

  • Confusion
  • increased sensitivity of the skin to sunlight
  • skin rash, hives, or itching
  • soreness or irritation of the mouth or tongue

Rare

  • 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
  • dizziness
  • headache
  • loss of appetite
  • nausea
  • unpleasant breath odor
  • vomiting of blood

Side effects not requiring immediate medical attention

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

Less common

  • Trouble with sleeping

Incidence not known

  • Heartburn
  • pain or discomfort in the chest, upper stomach, or throat
  • sleeplessness
  • 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

Nervous system

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

Frequency not reported: Peripheral neuritis, lethargy, mental confusion, impairment of performance of routine activities/efforts, vertigo, neuropathy, paresthesia of the hands and feet[Ref]

Gastrointestinal

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

Frequency not reported: Heartburn, flatulence, gastrointestinal bleeding, epigastric distress, oral thrush, increased fecal protoporphyrins[Ref]

Dermatologic

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)

Rare (0.01% to 0.1%): Bullous reactions (including Lyell's syndrome), urticarial reactions, skin rashes, severe angioedema

Frequency not reported: Cold and warm urticaria, erythema eruptions, vesicular eruptions, morbilliform eruptions, fixed-drug eruptions, lesions (on sun-exposed areas), bullous eruption

Postmarketing reports: Severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis), erythema multiforme[Ref]

Psychiatric

Uncommon (0.1% to 1%): Insomnia, irritability[Ref]

Metabolic

Uncommon (0.1% to 1%): Anorexia

Frequency not reported: Thirst, exacerbation of porphyria[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Serum sickness syndromes

Frequency not reported: Hypersensitivity reactions (e.g., skin rashes, urticaria, erythema multiforme/erythema multiforme-like drug reactions, angioneurotic edema)[Ref]

Hepatic

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]

Hematologic

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]

Musculoskeletal

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]

Renal

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]

Genitourinary

Rare (0.01% to 0.1%): Proteinuria, menstrual irregularities

Frequency not reported: Albuminuria (without evidence of renal dysfunction)[Ref]

Other

A disulfiram-like reaction (including flushing, nausea, vomiting, diarrhea, paresthesia of the extremities) occurred in 1 patient who ingested this drug with alcohol.[Ref]

Frequency not reported: Fatigue, fever, disulfiram-like reaction[Ref]

References

1. "Product Information. Grifulvin V (griseofulvan)." Ortho Pharmaceuticals, Raritan, NJ. (1992):

2. Gupta AK, Ryder JE "The use of oral antifungal agents to treat onychomycosis." Dermatol Clin 21 (2003): 469-79, vi

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

4. "Product Information. Fulvicin P / G (griseofulvin)." Schering Laboratories, Kenilworth, NJ.

5. Cerner Multum, Inc. "Australian Product Information." O 0

6. Lecky BR "Griseofulvin-induced neuropathy." Lancet 1 (1990): 230-1

7. Taylor B, Duffill M "Toxic epidermal necrolysis from griseofulvin." J Am Acad Dermatol 19 (1988): 565-6

8. Boudghene-Stambouli O, Merad-Boudia A "Fixed drug eruption induced by griseofulvin." Dermatologica 179 (1989): 92-3

9. 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

10. Rustin MH, Bunker CB, Dowd PM, Robinson TW "Erythema multiforme due to griseofulvin." Br J Dermatol 120 (1989): 455-8

11. Meffert JJ, Davis BM, Campbell JC "Bullous drug eruption to griseofulvin in a man with hailey-hailey disease." Cutis 56 (1995): 279-80

12. Mion G, Verdon R, Le Gulluche YL, Carstein H, Garcia A, Guilbaud J "Fatal toxic epidermal necrolysis after griseofulvin." Lancet 2 (1989): 1331

13. 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

14. Debruyne D, Coquerel A "Pharmacokinetics of antifungal agents in onychomycoses." Clin Pharmacokinet 40 (2001): 441-72

15. Miyagawa S, Okuchi T, Shiomi Y, Sakamoto K "Subacute cutaneous lupus erythematosus lesions precipitated by griseofulvin." J Am Acad Dermatol 21 (1989): 343-6

16. Davidson BK "Myositis associated with griseofulvin therapy." Am Fam Physician 52 (1995): 1277

17. Madhok R, Zoma A, Capell H "Fatal exacerbation of systemic lupus erythematosus after treatment with griseofulvin." Br Med J (Clin Res Ed) 291 (1985): 249-50

18. Fett DL, Vukov LF "An unusual case of severe griseofulvin alcohol interaction." Ann Emerg Med 24 (1994): 95-7

Further information

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.