warnings
WARNINGS Prophylactic Usage: Safety and efficacy of griseofulvin for prophylaxis of fungal infections have not been established.
Ultramicrosize Griseofulvin
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Ultramicrosize Griseofulvin
- Generic name
- GRISEOFULVIN
- Manufacturer
- Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- ae369582-2e4c-48a4-ac42-0a77466654fd
- SPL ID
- db35c070-b434-48f2-8ce8-e902d498459a
- Version
- 3
- Effective date
- 2025-11-06
- Source export date
- 2026-09-28
- Source partition
- 5
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:34:18
| Harmonized routes |
|---|
| ORAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 061996 | derived:openfda.application_number |
| application number | ANDA061996 | openfda.application_number | |
| brand name | Ultramicrosize Griseofulvin | openfda.brand_name | |
| generic name | GRISEOFULVIN | openfda.generic_name | |
| manufacturer name | Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc | openfda.manufacturer_name | |
| ndc | package | 23155-864-01 | openfda.package_ndc |
| ndc | package | 23155-863-01 | openfda.package_ndc |
| ndc | product | 23155-863 | openfda.product_ndc |
| ndc | product | 23155-864 | openfda.product_ndc |
| ndc11 | package | 23155086301 | derived:openfda.package_ndc |
| ndc11 | package | 23155086401 | derived:openfda.package_ndc |
| rxcui | 242831 | openfda.rxcui | |
| rxcui | 239239 | openfda.rxcui | |
| spl id | db35c070-b434-48f2-8ce8-e902d498459a | id | |
| spl set id | ae369582-2e4c-48a4-ac42-0a77466654fd | set_id | |
| unii | 32HRV3E3D5 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
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. When rare, serious reactions occur with griseofulvin, they are usually associated with high dosages, long periods of therapy, or both. To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc., at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.