Gris-PEG Side Effects

Generic name: griseofulvin

Medically reviewed by Drugs.com. Last updated on Jan 17, 2025.

Note: This document provides detailed information about Gris-PEG.

Applies to griseofulvin: oral suspension, oral tablet Side Effects associated with griseofulvin. Some dosage forms listed on this page may not apply specifically to the brand name Gris-PEG.

Applies to griseofulvin: oral suspension, oral tablet.

Precautions

It is very important that your doctor should check the progress of you or your child at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

If your symptoms do not improve, or if they become worse, check with your doctor. You may need to take this medicine for several weeks or months before your infection gets better.

Using this medicine while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.

Stop using this medicine and check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

Griseofulvin has been shown to cause liver and thyroid tumors in some animals. You and your doctor should discuss the good this medicine will do, as well as the risks of taking it.

Birth control pills containing estrogen may not work properly if you take them while you are taking griseofulvin (the active ingredient contained in Gris-PEG) Unplanned pregnancies may occur. To keep from getting pregnant, use another form of birth control for up to 1 month after your last treatment. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.

Griseofulvin may increase the effects of alcohol. If taken with alcohol it may also cause fast heartbeat, flushing, increased sweating, or redness of the face. If you have these symptoms, do not drink alcoholic beverages while you are taking this medicine, unless you have checked first with your doctor.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do other things that could be dangerous if you are dizzy or are not alert. If these reactions are especially bothersome, check with your doctor.

Griseofulvin may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your doctor.
• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Gris-PEG

Along with its needed effects, griseofulvin 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:

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:

For healthcare professionals

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

Nervous system adverse events

• 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]

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]

Gastrointestinal

• Common (1% to 10%): Diarrhea, nausea, vomiting, gastric discomfort
• Frequency not reported: Heartburn, flatulence, gastrointestinal bleeding, epigastric distress, oral thrush, increased fecal protoporphyrins^[Ref]

A moderate but inconsistent increase of fecal protoporphyrins has been observed when this drug was used for a prolonged duration.^[Ref]

Dermatologic

• 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]

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]

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

• Rare (0.01% to 0.1%): Nephrosis
• Frequency not reported: Interstitial nephritis^[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]

Genitourinary

• Rare (0.01% to 0.1%): Proteinuria, menstrual irregularities
• Frequency not reported: Albuminuria (without evidence of renal dysfunction)^[Ref]

Other

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

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

See also:

Further information

Gris-PEG side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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