Immunotoxicity

Drug-induced adverse effects on the immune system, including immunosuppression (increased infection/cancer risk), unintended immunostimulation (autoimmunity, hypersensitivity), or hypersensitivity reactions. ICH S8 guidelines require immunotoxicity evaluation as part of standard toxicology testing. Encompasses drug-induced lupus, hemolytic anemia, Stevens-Johnson syndrome, and cytokine release syndrome.

Beispiele

• Checkpoint inhibitor-related autoimmune colitis and pneumonitis
• Hydralazine and procainamide drug-induced lupus
• Penicillin IgE-mediated anaphylaxis