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griseofulvin Side Effects

Also known as: Grifulvin V

Analysis of 278 adverse event reports submitted to the FDA from 2004 to 2025.

Total Reports

278

Death-Related

15

5.4% of reports

Hospitalizations

94

33.8% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

DRUG INEFFECTIVE
38
HEADACHE
15
OFF LABEL USE
12
PYREXIA
11
RASH
11
DIARRHOEA
10
DRUG HYPERSENSITIVITY
10
PATHOGEN RESISTANCE
10
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS
9
DRUG RESISTANCE
9
PAIN
9
DELIRIUM
8
DIZZINESS
8
DRUG INTERACTION
8
LINEAR IGA DISEASE
8
STEVENS-JOHNSON SYNDROME
8
ANXIETY
7
ERYTHEMA MULTIFORME
7
FATIGUE
7
ACUTE KIDNEY INJURY
6

Who Reports Side Effects

Gender Distribution

Female 107 (44%)
Male 135 (56%)
Unknown 1

Age Distribution

0-17 55 (29%)
18-44 56 (30%)
45-64 44 (23%)
65-74 25 (13%)
75+ 9 (5%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 15 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 6
CEREBELLAR INFARCTION 3
CEREBRAL TOXOPLASMOSIS 3
DIARRHOEA 3
ORAL CANDIDIASIS 3
DRUG INEFFECTIVE 2
DYSPNOEA 2
MENINGITIS 2
ABSCESS FUNGAL 1
ACUTE RESPIRATORY DISTRESS SYNDROME 1
ASTHENIA 1
DERMATOPHYTOSIS 1
DISEASE RECURRENCE 1
DRUG HYPERSENSITIVITY 1
EOSINOPHILIC PNEUMONIA 1
FISTULA 1
FOETAL EXPOSURE DURING PREGNANCY 1
GANGRENE 1
GLOMERULONEPHRITIS PROLIFERATIVE 1
GRANULOMA 1

Reactions in Hospitalization Reports

Top reactions in 94 reports where hospitalization was an outcome.

Reaction Reports
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS 9
DELIRIUM 8
DRUG INTERACTION 8
DIARRHOEA 7
LINEAR IGA DISEASE 7
PAIN 7
ERYTHEMA MULTIFORME 6
ACUTE KIDNEY INJURY 5
DRUG INEFFECTIVE 5
OEDEMA PERIPHERAL 5
TUBULOINTERSTITIAL NEPHRITIS 5
ANXIETY 4
FATIGUE 4
FOCAL SEGMENTAL GLOMERULOSCLEROSIS 4
PYREXIA 4
RASH 4
RENAL FAILURE 4
TOXIC EPIDERMAL NECROLYSIS 4
CEREBELLAR INFARCTION 3
CEREBRAL TOXOPLASMOSIS 3

Nearby — Related Medications

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What the FAERS Data Reveals About griseofulvin Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 278 voluntary reports linked to griseofulvin and its brand equivalents (Grifulvin V), spanning 2004 through 2025. Of those, 15 (5.4%) listed death as an outcome and 94 (33.8%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 44% were female and 56% male; age distribution skews toward 18-44, with 56 reports in that bracket. The single most reported reaction is drug ineffective with 38 submissions, followed by headache and off label use.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.