boxed warning
WARNING Metronidazole has been shown to be carcinogenic in mice and rats (see PRECAUTIONS ). Its use, therefore, should be reserved for the conditions described in the INDICATIONS AND USAGE section below.
Application 206191
- Type
- ANDA
- Sponsor
- INFORLIFE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METRONIDAZOLE IN PLASTIC CONTAINER | METRONIDAZOLE | INJECTABLE;INJECTION | 500MG/100ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206191-001 | METRONIDAZOLE IN PLASTIC CONTAINER | METRONIDAZOLE | 500MG/100ML | INJECTABLE / INJECTION | AP | RS | 2019-02-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A206191-001 | AP |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Metronidazole | METRONIDAZOLE | WG Critical Care, LLC | e4ea0c09-cdd1-4708-962c-6ba28b989df3 | 2026-05-12 | Boxed warning, Warnings, Adverse reactions | |
| Metronidazole | METRONIDAZOLE | Hospira, Inc. | 49360d6f-c8b3-420e-af75-154cf7b05255 | 2025-11-19 | Boxed warning, Warnings, Adverse reactions | |
| METRONIDAZOLE | METRONIDAZOLE | Henry Schein, Inc. | df7df946-c83f-4adf-9007-aff4f757a665 | 2025-08-27 | Boxed warning, Warnings, Adverse reactions | |
| Metronidazole | METRONIDAZOLE | Sagent Pharmaceuticals | d46870f5-e2b1-46bd-8413-4a0a8bcf3175 | 2025-08-14 | Boxed warning, Warnings, Adverse reactions |
Boxed warning cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
WARNINGS Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with the use of metronidazole. Symptoms can be serious and potentially life threatening. If symptoms or signs of SCARs develop, discontinue Metronidazole Injection immediately and institute appropriate therapy. Central and Peripheral Nervous System Effects Convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity, have been reported in patients treated with metronidazole products. Since persistent peripheral neuropathy has been reported in some patients receiving prolonged oral administration of metronidazole, patients should be observed carefully. The appearance of abnormal neurologic signs demands the prompt evaluation of the benefit/risk ratio of the continuation of therapy.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS The following are the most serious adverse reactions reported in patients treated with metronidazole and are also described elsewhere in the labeling: convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy (characterized mainly by numbness or paresthesia of an extremity) (see WARNINGS ). The following adverse reactions associated with the use of metronidazole products were identified in clinical studies or postmarketing reports or published literature. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal: Nausea, anorexia, vomiting, abdominal discomfort, diarrhea, an unpleasant metallic taste, epigastric distress, abdominal cramping, constipation and pancreatitis. Mouth: A sharp metallic taste. Furry tongue, glossitis, and stomatitis have occurred; these may be associated with a sudden overgrowth of Candida which may occur during therapy with metronidazole. Hematopoietic: Reversible neutropenia (leukopenia); thrombocytopenia, eosinophilia. Hepatobiliary Disorders: Hepatotoxicity and liver failure especially in patients with Cockayne syndrome (see CONTRAINDICATIONS ), jaundice. Cardiovascular: QT prolongation has been reported, particularly when metronidazole was administered with drugs with the potential for prolonging the QT interval. Flattening of the T-wave may be seen in electrocardiographic tracings. Skin and Subcutaneous Disorders: Toxic epidermal necrolysis, Stevens-Johnson syndrome, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), erythematous rash, bullae, pruritus, swelling face, urticaria, and hyperhidrosis. Central Nervous System: Encephalopathy, aseptic meningitis, convulsive seizures, optic neuropathy, peripheral neuropathy (mainly numbness or paresthesia of an extremity), dizziness, vertigo, incoordination, ataxia, confusion, psychosis, dysarthria, irritability, depression, weakness, headache, tinnitus, hearing impairment, hearing loss, and insomnia. Laboratory Investigations: Hepatic enzymes increased. Hypersensitivity: Toxic epidermal necrolysis (TEN), Stevens-Johnson Syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) (see WA...
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0409-0152 | Metronidazole | Metronidazole | Hospira, Inc. | ANDA | Current |
| 0409-0152 | Metronidazole | Metronidazole | Hospira, Inc. | ANDA | Current |
| 25021-131 | Metronidazole | Metronidazole | Sagent Pharmaceuticals | ANDA | Current |
| 25021-131 | Metronidazole | Metronidazole | Sagent Pharmaceuticals | ANDA | Current |
| 25021-131 | Metronidazole | Metronidazole | Sagent Pharmaceuticals | ANDA | Current |
| 25021-131 | Metronidazole | Metronidazole | Sagent Pharmaceuticals | ANDA | Current |