Fomepizole is an antidote 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. MedsAcross supplies Fomepizole for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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.
Source: US FDA prescribing information
Fomepizole is a competitive inhibitor of alcohol dehydrogenase. Alcohol dehydrogenase catalyzes the oxidation of ethanol to acetaldehyde. Alcohol dehydrogenase also catalyzes the initial steps in the metabolism of ethylene glycol and methanol to their toxic metabolites. Ethylene glycol, the main component of most antifreezes and coolants, is metabolized to glycoaldehyde, which undergoes subsequent sequential oxidations to yield glycolate, glyoxylate, and oxalate. Glycolate and oxalate are the metabolic byproducts primarily responsible for the metabolic acidosis and renal damage seen in ethylene glycol toxicosis. The lethal dose of ethylene glycol in humans is approximately 1.4mL/kg. Methanol, the main component of windshield wiper fluid, is slowly metabolized via alcohol dehydrogenase to formaldehyde with subsequent oxidation via formaldehyde dehydrogenase to yield formic acid.
Source: US FDA prescribing information
Do not use polycarbonate syringes or polycarbonate-containing needles (including polycarbonate filter needles) when diluting or administering Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL). Fomepizole can interact with polycarbonate, compromising the integrity of the syringe and/or needle component containing polycarbonate. Treatment Guidelines: If ethylene glycol or methanol poisoning is left untreated, the natural progression of the poisoning leads to accumulation of toxic metabolites, including glycolic and oxalic acids (ethylene glycol intoxication) and formic acid (methanol intoxication). These metabolites can induce metabolic acidosis, nausea/vomiting, seizures, stupor, coma, calcium oxaluria, acute tubular necrosis, blindness, and death.
Source: US FDA prescribing information
Fomepizole should not be administered to patients with a documented serious hypersensitivity reaction to fomepizole or other pyrazoles.
Source: US FDA prescribing information
General: Fomepizole should not be given undiluted or by bolus injection. Venous irritation and phlebosclerosis were noted in two of six normal volunteers given bolus injections (over 5 minutes) of fomepizole at a concentration of 25 mg/mL. Do not use polycarbonate syringes or polycarbonate-containing needles (including polycarbonate filter needles) when diluting or administering Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL). Fomepizole can interact with polycarbonate, compromising the integrity of the syringe and/or needle component containing polycarbonate. Minor allergic reactions (mild rash, eosinophilia) have been reported in a few patients receiving fomepizole. Therefore, patients should be monitored for signs of allergic reactions.
Source: US FDA prescribing information
The most frequent adverse events reported as drug-related or unknown relationship to study drug in the 78 patients and 63 normal volunteers who received fomepizole injection were headache ( 14% ), nausea (11%), and dizziness, increased drowsiness, and bad taste / metallic taste (6% each). All other adverse events in this population were reported in approximately 3% or fewer of those receiving fomepizole and were as follows: Body as a Whole: Abdominal pain, fever, multiorgan system failure, pain during fomepizole injection, inflammation at injection site, lumbalgia/backache, hangover. Cardiovascular: Sinus bradycardia/bradycardia, phlebosclerosis, tachycardia, phlebitis, shock, hypotension. Gastrointestinal: Vomiting, diarrhea, dyspepsia, heartburn, decreased appetite, transient transaminitis.
Source: US FDA prescribing information
Store at controlled room temperature, 20° to 25°C (68° to 77°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Fomepizole, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Fomepizole 1.5 g/1.5 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 4 December 1997 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Fomepizole in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 1 presentations of Fomepizole and sources them for licensed hospitals, importers and physicians against valid import documents.
Yes. The US FDA first approved Fomepizole on 4 December 1997, according to Drugs@FDA.
No listed presentation of Fomepizole is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Fomepizole is classified under ATC code V03AB34 (Fomepizole).
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