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IOVERSOL


DIR Classification


Classification:Most-DIR concern
Severity Score:4

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

  • BOXED WARNING
  • Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. (5.1)
  • WARNINGS AND PRECAUTIONS
  • Risks Associated with Inadvertent Intrathecal Administration
  • Optiray is indicated for intravascular use only [see Dosage and Administration (2.1)]. Inadvertent intrathecal administration can cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
Rhabdomyolysis
0
42912
Other ADRs
3802
14113477

Odds Ratio = N/A

Drug Property Information



ATC Code(s):
  • V08AB07 - ioversol
    • V08AB - "Watersoluble, nephrotropic, low osmolar X-ray contrast media"
    • V08A - "X-RAY CONTRAST MEDIA, IODINATED"
    • V08 - CONTRAST MEDIA
    • V - VARIOUS
Active Ingredient:ioversol
Active Ingredient UNII:N3RIB7X24K
Drugbank ID:DB09134
PubChem Compound:3741
CAS Number:87771-40-2
Dosage Form(s):injection
Route(s) Of Administrator:intra-arterial; intravenous
Daily Dose:
Chemical Structure:
SMILE Code:
C(CO)N(C1=C(C(=C(C(=C1I)C(=O)NCC(CO)O)I)C(=O)NCC(CO)O)I)C(=O)CO

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

N/A

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