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Drug side effects

griseofulvin Side Effects

The reactions most often reported to the FDA for griseofulvin (also sold as Grifulvin V), with demographics, serious outcomes, and reporting trends.

Data updated 2026-05-15

278
FAERS reports

Data from the FDA Adverse Event Reporting System (FAERS), 2004 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.

The most commonly reported side effects of griseofulvin come from 278 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.

This page analyzes 278 reports to the FDA Adverse Event Reporting System (FAERS) for griseofulvin (Grifulvin V): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.

Total Reports

278

Reports Mentioning Death

15

5.4% of reports — not proof the medicine caused the death

Hospitalizations

94

33.8% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

HEADACHE
15
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
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
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

Compare griseofulvin vs acyclovir →

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 headache with 15 submissions, followed by pyrexia and rash.

How to read these numbers

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.

Drugs With a Similar FAERS Report Volume

Other medications with a total FDA adverse-event report count closest to griseofulvin's 278.