adverse reactions
ADVERSE REACTIONS The following adverse experiences have been reported with the topical use of metronidazole: burning, skin irritation, dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.
Metronidazole
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
- Metronidazole
- Generic name
- METRONIDAZOLE
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 4a233572-2471-4e99-a45e-2de978abcf16
- SPL ID
- 56a64806-9414-af6c-e063-6394a90ab053
- Version
- 6
- Effective date
- 2026-07-15
- Source export date
- 2026-11-06
- Source partition
- 10
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-11-06/b0d9ca61dc485ebaf55e14a76d7d677668e40ef1e1978cdbcc4d73d58eba0b99/drug-label-0010-of-0014.json.zip
- Source manifest SHA-256
- 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
- Import run
- 20261108T063105Z
- Imported at
- 2026-11-08 07:46:20
| Harmonized routes |
|---|
| TOPICAL |
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 | 077819 | derived:openfda.application_number |
| application number | ANDA077819 | openfda.application_number | |
| brand name | Metronidazole | openfda.brand_name | |
| generic name | METRONIDAZOLE | openfda.generic_name | |
| manufacturer name | Sun Pharmaceutical Industries, Inc. | openfda.manufacturer_name | |
| ndc | package | 51672-4116-6 | openfda.package_ndc |
| ndc | package | 51672-4116-5 | openfda.package_ndc |
| ndc | package | 51672-4116-2 | openfda.package_ndc |
| ndc | product | 51672-4116 | openfda.product_ndc |
| ndc11 | package | 51672411606 | derived:openfda.package_ndc |
| ndc11 | package | 51672411602 | derived:openfda.package_ndc |
| ndc11 | package | 51672411605 | derived:openfda.package_ndc |
| rxcui | 311679 | openfda.rxcui | |
| spl id | 56a64806-9414-af6c-e063-6394a90ab053 | id | |
| spl set id | 4a233572-2471-4e99-a45e-2de978abcf16 | set_id | |
| unii | 140QMO216E | openfda.unii |
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.