Prescription medicine
Fomepizole First approved as Antizol
Fomepizole (Antizol) is a prescription medicine with an FDA approval on record since 1997. FDA's NDC Directory lists it from 6 generic labelers.
- Generic listed
Check it at the source: the fomepizole FDA label on DailyMed (effective December 19, 2024); the NDA 20696 record on Drugs@FDA; every fomepizole label on DailyMed.
Highlights of the record
FDA label of December 19, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageFomepizole 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 ).
Forms and strengths
- 1 g/ml
- 1.5 g/1.5ml
Injection (solution); injection.
On the market
- Earliest approval on file
- December 4, 1997 Antizol, Par Pharm Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 5 first December 14, 2007; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 6 under generic applications, 0 under brand applications, repackagers included
- Last listed patent
- June 30, 2027 Antizol injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2015 0 Class I among all firms' recalls; latest March 9, 2015
- FAERS reports
- 189 through July 30, 2026
What is fomepizole used for?
From the label: indications and usageFomepizole 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 pharmacologic class: Antidote.
Source: FDA drug label (Fomepizole), Navinta LLC, effective December 19, 2024 (SPL set 6fed6052-f159-46d6-8be1-31e18a7ba918), via openFDA; the full label on DailyMed
Is there a generic for fomepizole (Antizol)?
The FDA approved the first generic fomepizole on December 14, 2007. 5 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists fomepizole from 6 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Antizol injection: the compound patent runs to June 30, 2027. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1997 earliest approval on file
- 2007 first generic approved
- 2027 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has fomepizole been recalled?
The FDA's Enforcement Report lists 1 recall naming fomepizole since 2015: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 9, 2015 | Class II | Navinta LLC | Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for fomepizole?
The FDA Adverse Event Reporting System holds 189 reports that list fomepizole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 69 are coded as a death and 137 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other antidotes
- the pharmacologic class, with prices and generics
- Fomepizole side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other