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 Antizol® (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 Antizol and were as follows:
Body as a Whole: Abdominal pain, fever, multiorgan system failure, pain during Antizol 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
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