Important Safety Information

Q: How is ISI shown in digital and display ads?

Because ad space is limited, ISI is often placed in a scrolling sidebar or a fixed panel, sometimes called an ISI Tray, next to the creative so the risk information stays visible as the viewer engages with the ad.

Categories: Media Planning & Buying|By Justin Mosgrober|5.5 min read|Last Updated: 04-Aug-2026|

Important Safety Information

If you live in an area of the world with Important Safety Information regulations, you’ve probably heard the rambling of side effects that follows a video commercial for medication. You may have also seen medical ads online with thick sidebars of text detailing safety information for the product in question, whether on a website or ad unit, though a bottom ISI tray is the industry-standard pattern on the page.

Mobile ISI designs often fail because limited space reduces user access to the ISI section.

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Important Safety Information is very useful for consumers who need to know the potential side effects of a product they are considering. It is also a good way for brands and advertisers to cover their bases when it comes to legal problems or poor brand reputation.

Let’s look at what ISI actually is and what it typically includes in pharmaceutical advertising.

What Does “Important Safety Information” Refer To?

“Important Safety Information” or ISI is a pharmaceutical and medical business term that refers to associated risks for specific treatments. ISI enables pharmaceutical advertisers to clearly disclose associated risks for specific drugs, treatments or devices when running advertising campaigns.

Globally, ISI is becoming a legal trend in which pharmaceutical companies around the world have been forced to adapt to. In FDA review, advertisers should assume current enforcement standards will apply, and that regulatory context affects how ISI is present in promotional content.

When it comes to direct to consumer advertising, it makes sense why important safety information needs to be included in advertisements. Consumers need to be informed of potential risks in using a medical device or medication for the benefit of their health, and drug benefits and drug risks must appear together for fair balance.

What Does “Important Safety Information” Typically Contain?

A “product claim ad” is a type of advertisement that explicitly names a drug or medical device and discusses its benefits. These types of ads in most countries must not be false or misleading to viewers. One way to avoid this is to include important safety information in the ad itself.

Important safety information will typically contain the name of the drug (both generic and brand name), any (but not all) FDA-approved uses for the drug, the indication and treatment information where relevant, and the most significant risks and side effects of the drug. This information should be present on the main page in very understandable language, accessible to the user, and supported by links or navigation rather than hidden. Important safety information should also be very well balanced. For example: An advertisement for a drug that contains 500 words describing the benefits should have a similarly hefty list of important safety information, rather than just one sentence, and that prominence should demonstrate fair balance and focus on what matter most for compliance and understanding.

Healthy Ads as a Medical Advertising Solution

At Healthy Ads, we want to make sure our advertisers and clients have their bases covered. That’s why we do our best to implement important safety information within advertisements for our pharmaceutical clients.

Healthy Ads is an advertising platform for pharmaceutical, health, wellness, fitness, and medical brands. We’ll walk you through all of the options available to make sure that your advertising campaign delivers those coveted leads and conversions. We want your ads to reach very engaged and health-obsessed consumers online and will use our substantial reach to get you there.

Important Safety Information FAQs

What is Important Safety Information (ISI)?

Important Safety Information, or ISI, is the summary of a drug or medical device’s most significant risks, warnings and side effects. It runs alongside the promotional claims in Pharmaceutical Advertising so consumers see the benefits and the risks together within the approved indication or treatment context.

What does ISI mean in Pharmaceutical Advertising?

In Pharmaceutical Advertising, ISI is the part of an ad that discloses a product’s associated risks. It lets advertisers promote a drug’s benefits while clearly presenting its safety information, which is what keeps Direct-to-Consumer drug ads compliant and not misleading.

Is Important Safety Information required by the FDA?

Yes. In the United States the FDA requires a Product Claim Ad that names a drug and its benefits to also carry that drug’s Important Safety Information. The FDA guidance, Presenting Risk Information in Prescription Drug and Medical Device Promotion, sets out how it should be shown, and the rule published in 2023 is now part of the baseline for review.

What does Important Safety Information typically contain?

It usually includes the drug’s generic and brand name, its FDA-approved uses, and its most significant risks and side effects, written in plain language a general audience can understand.

Who writes the Important Safety Information for a drug?

The pharmaceutical manufacturer writes and owns its ISI, and the content has to match the FDA-approved product labeling. Ad platforms, agencies, and publishers then make sure it is implemented correctly within the ad unit, with internal legal feedback addressed during creative review before an ad is published.

What is Fair Balance in ISI?

Fair Balance means the risk information carries similar weight and prominence to the benefit claims. An ad that spends hundreds of words on benefits cannot dismiss the risks in a single line, and any judgment about that balance should rely on evidence rather than opinion.

How is ISI shown in digital and display ads?

Because ad space is limited, ISI is often present on a website in an ISI Tray or dedicated ISI section next to the creative so the risk information stays visible as the viewer engages with the ad. Bottom trays are common because modals can limit access on mobile, and the goal is to present the information clearly without disrupting the experience. Mobile data also shows some patterns reduce usability on the main page.

What is a Product Claim Ad?

A Product Claim Ad names a specific drug or device and talks about its benefits. Because it makes those claims, it cannot be false or misleading, which is why it has to include Important Safety Information.

What is the difference between ISI and a Black Box Warning?

ISI is the broader set of risks and side effects included in an ad. A Black Box Warning is the FDA’s most serious safety alert for a particular drug, and when one exists it has to appear within that drug’s ISI, be clearly identified, and be displayed with enough prominence to demonstrate its importance.

Does ISI apply to Over-the-Counter products or only prescription drugs?

The FDA’s ISI framework centers on prescription drugs and Medical Devices. Over-the-Counter products follow separate labeling rules, though their advertising still cannot be false or misleading.