阳性对照药的SUSAR是需要上报FDA的。根据美国FDA 21 CFR 312.32(c)(1)(i) Serious and Unexpected Suspected Adverse Reaction规定：The sponsor must report in an IND safety report any suspected adverse reaction to study treatment (i.e., including active comparators) that is both serious and unexpected (21 CFR312.32(c)(1)(i)).