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ABIRATERONE ACETATE


DIR Classification


Classification:Less-DIR concern
Severity Score:1

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

  • ADVERSE REACTIONS
  • Postmarketing Experience
  • The following additional adverse reactions have been identified during post approval use of ZYTIGA with prednisone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Respiratory, Thoracic and Mediastinal Disorders: non-infectious pneumonitis.
  • Musculoskeletal and Connective Tissue Disorders: myopathy, including rhabdomyolysis.
  • Hepatobiliary Disorders: fulminant hepatitis, including acute hepatic failure and death.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
Rhabdomyolysis
42
42870
Other ADRs
9054
14108225

Odds Ratio = 1.527

Drug Property Information



ATC Code(s):
  • L02BX03 - abiraterone acetate
    • L02BX - Other hormone antagonists and related agents
    • L02B - HORMONE ANTAGONISTS AND RELATED AGENTS
    • L02 - ENDOCRINE THERAPY
    • L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:abiraterone acetate
Active Ingredient UNII:EM5OCB9YJ6
Drugbank ID:DB05812
PubChem Compound:132971
CAS Number:154229-19-3
Dosage Form(s):tablet; tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
  • 1000.0 mg/day L02BX03
Chemical Structure:
SMILE Code:
C[C@]12CC[C@@H](CC1=CC[C@@H]3[C@@H]2CC[C@]4([C@H]3CC=C4C5=CN=CC=C5)C)O

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

N/A

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