Fomepizole

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 (canonical bytes are SHA-256 checked before publication)

Brand name
Fomepizole
Generic name
FOMEPIZOLE
Manufacturer
Gland Pharma Limited
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
7e133194-dacb-446a-a657-2d2430a02373
SPL ID
69c8a021-8f8d-4989-b5b5-976c1ec5b7b2
Version
4
Effective date
2023-07-07
Source export date
2026-09-28
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:24:13
Harmonized routes table
Harmonized routes
INTRAVENOUS

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS 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 injection 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 Hemic/Lymphatic : Eosinophilia/hypereosinophilia, lymphangitis, disseminated intravascular coagulation, anemia Nervous : Lightheadedness, seizure, agitation, feeling drunk, facial flush, vertigo, nystagmus, anxiety, "felt strange", decreased environmental awareness Respiratory : Hiccups, pharyngitis Skin/Appendages : Application site reaction, rash Special Senses : Abnormal smell, speech/visual disturbances, transient blurred vision, roar in ear Urogenital : Anuria

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.