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What the label lists and what reports show

Griseofulvin side effects

Griseofulvin's FDA label lists its adverse reactions in its own words. FAERS holds 286 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is headache (15 reports).

  • Generic listed

Check it at the source: the griseofulvin FDA label on DailyMed (effective December 10, 2025); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

There have been post-marketing reports of severe skin and hepatic adverse events associated with griseofulvin use (see WARNINGS section). When adverse reactions occur, they are most commonly of the hypersensitivity type such as skin rashes, urticaria, erythema multiforme-like drug reactions, and rarely, angioneurotic edema, and may necessitate withdrawal of therapy and appropriate countermeasures. Paresthesia of the hands and feet have been reported after extended therapy. Other side effects reported occasionally are oral thrush, nausea, vomiting, epigastric distress, diarrhea, headache, fatigue, dizziness, insomnia, mental confusion, and impairment of performance of routine activities. Proteinuria and leukopenia have been reported rarely. Administration of the drug should be discontinued if granulocytopenia occurs. …

Source: FDA drug label, Chartwell RX, LLC., effective December 10, 2025 (SPL set efb8a660-802c-4ca6-bbff-ad7b48b91aef), via openFDA; the full label on DailyMed

What do FAERS reports show?

286 reports list griseofulvin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 15 are coded as a death and 95 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

  • Drug Ineffective (a use or a product term, not a reaction)39
  • Headache (named in the label)15
  • Off Label Use (a use or a product term, not a reaction)14
  • Rash12
  • Pyrexia11
  • Diarrhoea (named in the label)10
  • Drug Hypersensitivity10
  • Pathogen Resistance10
  • Drug Reaction With Eosinophilia And Systemic Symptoms9
  • Drug Resistance9
  • Pain9
  • Stevens-Johnson Syndrome (named in the label)9
  • Delirium8
  • Dizziness (named in the label)8
  • Drug Interaction (a use or a product term, not a reaction)8
  • Linear Iga Disease8
  • Acute Kidney Injury7
  • Anxiety7
  • Erythema Multiforme7
  • Fatigue (named in the label)7
  • Death (an outcome recorded in the report)6
  • Lymphadenopathy6
  • Nausea (named in the label)6
  • Oedema Peripheral6
  • Renal Failure6

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Griseofulvin: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions