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
Navinta LLC
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
6fed6052-f159-46d6-8be1-31e18a7ba918
SPL ID
f8822b9f-00ff-4ad4-a2ed-31bc220528d3
Version
8
Effective date
2024-12-19
Source export date
2026-10-27
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-27/6f51a1483736359ffd78ed7be27289bc51f2a8463b934465bee40efbdef4dfd7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run
20261027T193451Z
Imported at
2026-10-27 21:06:49
Harmonized routes table
Harmonized routes
INTRAVENOUS

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

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 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.