INS and Gynecomastia: The AFE of 10 was usually applied for one of two reasons: (1) for 61% (25 out of 41) it was based on endocrine side-effects (e.g., antidiuretic hormone effects, increased hormone levels, goitrogenic effects, gynecomastia) described in the warnings and precautions, pharmacodynamics, and adverse reactions sections of the label; or (2) for the remaining 39% (16 of 41) it was based on endocrine effects that were the intended therapeutic effect (e.g., insulin stimulation, regulation of thyroid activity) for APIs that were glucocorticoids, antidepressants, hormones, or lipid lowering drugs.