Diagnogreen Adverse Reactions

Clinical Studies: Liver Function Test and Circulatory Function Test (Including Adverse Reactions Information From Circulatory Function Tests Which is Approved Indication in Japan): Adverse reactions associated with the use of indocyanine green have been reported in 0.17% (36 patients) of 21,278 patients who received the drug based on the Japanese literature (The reporting of adverse reactions is not included in the reexamination). Common adverse reactions included shock 0.02% (5 reactions), nausea 0.08% (16 reactions), vascular pain 0.04% (8 reactions) and pyrexia/hot feeling 0.02% (4 reactions).
Chorioretinal Angiography Diagnostic: In Japanese clinical study of chorioretinal angiography diagnostics, queasy was observed in 1 (1.8%) of 57 patients who received indocyanine green.
In Japanese post-marketing study of chorioretinal angiography diagnostics, adverse reactions were observed in 6 (0.62%) of 967 patients who received indocyanine green.
Undesirable Effects from Post-Marketing Studies and Adverse Drug Reactions Reports: The following undesirable effects are recognized for indocyanine green. The frequency are not defined:
Immune System Disorder: Anaphylactoid symptoms (see Precautions), Quincke’s oedema.
Vascular Disorders: Shock (see Precautions).
Gastrointestinal Disorders: Nausea, queasy, vomiting, feces discoloration (green).
Skin and Subcutaneous Tissue Disorder: Urticaria, pruritus, diaphoresis, hot flush, rash.
General Disorders and Administration Site Condition: Pyrexia.
Central Nervous System: Headache, dizziness.
Other Reactions: Transient elevation in serum unconjugated bilirubin.