# ISI (Important Safety Information)

> ISI is the standardized block of a drug's key risk information — warnings, contraindications, adverse events — that accompanies US promotional materials to satisfy fair balance.

> **Important Safety Information (ISI)** is the standardized block of key risk content — boxed warnings, contraindications, warnings and precautions, common adverse events — that accompanies US pharmaceutical promotional material. It is the primary vehicle for satisfying [fair balance](/glossary/fair-balance/): the benefit claims in the piece are counterweighted by the ISI's risk presentation.

MLR review checks the ISI three ways: **content** (does it reflect the current approved label — a label update instantly stales every deliverable's ISI), **placement** (does it travel with the claims: scrolling ISI on websites, facing-page ISI in print, persistent ISI in e-details), and **prominence** (type size and contrast comparable to the promotion). "ISI buried below the fold" is a classic OPDP citation.

For writers, the operational rule is pairing: claims and their required safety context should be managed together, so a claim can't be reused in a new deliverable without dragging its safety obligations along. Claims-matrix rows that record the required pairing make this mechanical rather than remembered.

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Source: https://medcom.claims/glossary/important-safety-information/ · Updated 2026-07-13 · © Mantir, Inc.