Reaction

Therapeutic Product Ineffective For Unapproved Indication reporting signals

Last recalculated 2026-09-14T18:28:35.993900+00:00 · 453 reports · 6 co-occurring drugs

As of the last recalculation, Therapeutic Product Ineffective For Unapproved Indication appears in 453 FAERS reports alongside 6 co-occurring drug terms. The strongest observed disproportionality signal is DALFAMPRIDINE (PRR 29.5).

Important: FAERS is a spontaneous, voluntary, unverified reporting system. PRR and ROR identify reporting patterns for investigation; they are not incidence rates and do not establish causation.
DrugCo-reportsPRRROR
Dalfampridine4229.529.6
Vigabatrin928.928.9
Zonisamide928.528.5
Clobazam1121.221.2
Brentuximab Vedotin418.118.1
Cannabidiol918.018.0

Related reactions

Data source: openFDA FAERS. See the OpenPV methodology and limitations.