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Label gap

Adverse events reported to FDA more often for this drug than for others (FAERS disproportionality), checked against every brand's current label. Red rows are signals the label doesn't name in any safety section.

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Reaction MedDRA term Cases PRR, 95% CI log scale · dashed = 2 Label Where

How this works. For each reaction reported with the drug (as primary or secondary suspect), MedScry compares its share of the drug's FAERS cases with its share of all other FAERS cases: the proportional reporting ratio (PRR). A signal meets the chosen rule. Each signal is then searched in the current DailyMed label of every brand, using the MedDRA term, US spelling and common label wording (e.g. "impaired gastric emptying" also matches "gastroparesis"). Terms that report lack of effect or measure the treated condition are marked explained instead of gaps.

FAERS reports are voluntary and unverified. A signal is a reason to look closer, not evidence that the drug causes the event, and never an incidence rate. "Not on label" means the wording wasn't found; check the quoted text. Not medical advice. Data: FDA FAERS quarterly files and NLM DailyMed.