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Prescription medicine · generic available

Fomepizole

Drug class: Antidote

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
0Recalls (FDA reports)
6Companies
2007First FDA approval on file

Quick answers

What is Fomepizole used for?
The FDA-approved label (Fomepizole, Zydus Pharmaceuticals USA Inc., November 20, 2025) says: “Fomepizole is indicated as an antidote for ethylene glycol (such as antifreeze) or methanol poisoning, or for use in suspected ethylene glycol or methanol ingestion, either alone or in combination with hemodialysis ( see DOSAGE AND ADMINISTRATION ).” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Fomepizole have a boxed warning?
No. None of the 7 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Fomepizole?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Fomepizole been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Fomepizole?
6 companies list prescription products of Fomepizole in the FDA NDC Directory, including American Regent, Inc., Zydus Pharmaceuticals USA Inc. and Sagent Pharmaceuticals.

What Fomepizole is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Fomepizole is indicated as an antidote for ethylene glycol (such as antifreeze) or methanol poisoning, or for use in suspected ethylene glycol or methanol ingestion, either alone or in combination with hemodialysis ( see DOSAGE AND ADMINISTRATION ).

— FDA label: Fomepizole, Zydus Pharmaceuticals USA Inc., effective November 20, 2025. Read the full label on DailyMed →

The FDA has 7 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 7 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsInjection, solution · Injection
RouteIntravenous
Prescription products6 in the FDA NDC Directory

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (4)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

RxCUI (RxNorm)310414
SPL set ID of the quoted label256910fe-91f2-48f6-b0b4-55edc52dacd4
FDA labels (SPL)7
FDA applications4 ANDA
Active ingredients (FDA)FOMEPIZOLE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Fomepizole, Zydus Pharmaceuticals USA Inc., effective November 20, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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