Reaction

Congenital Oral Malformation reporting signals

Last recalculated 2026-09-14T18:28:35.993900+00:00 · 217 reports · 3 co-occurring drugs

As of the last recalculation, Congenital Oral Malformation appears in 217 FAERS reports alongside 3 co-occurring drug terms. The strongest observed disproportionality signal is VALPROATE SODIUM (PRR 161.4).

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
Valproate Sodium30161.4161.6
Tranexamic Acid778.078.0
Valproic Acid2066.967.0

Related reactions

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