How to read a prescription medicine label

Who the label is written for

The FDA describes prescribing information as a summary of the essential scientific information health professionals need to use a medicine safely and effectively. The drug company proposes it, the FDA reviews it, and a medicine is not approved until the two agree on the text ^[1].

That makes it the most reliable public source about a medicine, but also a technical one. Sections on dosing, for example, are instructions for prescribers. Reading them helps you understand your treatment; it does not replace the person who prescribed it.

One layout for every newer medicine

The FDA calls this layout the Physician Labeling Rule format, after a final rule of January 2006. All new prescription drugs approved since June 2001 must use it; some older products still carry the earlier format, without Highlights or numbered sections ^[12]. Every GLP-1 label discussed on this site uses the newer layout.

A second rule, from December 2014, rewrote how pregnancy and breastfeeding are described. That is why section 8 of a current label has separate subsections for pregnancy (8.1), lactation (8.2) and females and males of reproductive potential (8.3) ^[6][12]. The FDA also asks companies to review their prescribing information at least once a year for outdated information ^[12].

Highlights: the first page

• A reminder that the Highlights do not contain everything needed to use the medicine safely ^[3].
• Initial U.S. Approval: the year the active ingredient was first approved. The Wegovy® label shows 2017, because semaglutide was first approved then; the Zepbound® label shows 2022, and the Foundayo™ label shows 2026 ^[4][5][9].
• Recent Major Changes, with the month and year. The current Wegovy® label lists, for example, a warning on suicidal behaviour removed in 01/2026 and a new warning about never sharing the FlexTouch® pen added in 06/2026 ^[4].
• The pharmacologic class, such as “GLP-1 receptor agonist” for Wegovy® and Foundayo™, or “GIP receptor and GLP-1 receptor agonist” for Zepbound® ^[4][5][9].
• The most common side effects, with the cut-off used: the Zepbound® Highlights list those reported in at least 5% of patients ^[5].
• A phone number and web address for reporting suspected side effects, and the revision date of the whole document ^[3].
• Numbers in brackets, such as (5.2), point to the full section with more detail ^[1].

The boxed warning

When a medicine has a serious risk that may lead to death or serious injury, the FDA places a warning in a black-bordered box at the top of the full information. People often call it a black-box warning ^[1].

All the GLP-1 labels checked open with the same type of box, including Ozempic®, Wegovy®, Rybelsus®, Victoza®, Saxenda®, Trulicity®, Mounjaro®, Zepbound® and Foundayo™: a warning about thyroid C-cell tumours seen in rodents, and a contraindication for anyone who has had medullary thyroid carcinoma or has a relative who did, and for people with MEN 2 ^{[4][5][6][7][8][9]}. The articles on boxed warnings and on the thyroid warning cover what it means.

Sections 1 to 17 at a glance

• 1 Indications and Usage: the approved uses. 2 Dosage and Administration: doses, dose steps and how the medicine is given. 3 Dosage Forms and Strengths: pens, vials, tablets and their strengths ^[1].
• 4 Contraindications: situations in which the medicine must not be used. 5 Warnings and Precautions: important risks, how often they occur and how they are monitored ^[1].
• 6 Adverse Reactions: side effects in trials and after approval. 7 Drug Interactions. 8 Use in Specific Populations: pregnancy, breastfeeding, children, older adults, kidney or liver problems ^[1].
• 9 Drug Abuse and Dependence. 10 Overdosage. 11 Description: the chemistry and ingredients. 12 Clinical Pharmacology: mechanism, half-life and other drug-level data. 13 Nonclinical Toxicology: animal findings ^[1].
• 14 Clinical Studies: the trials behind each use. 15 References. 16 How Supplied/Storage and Handling. 17 Patient Counseling Information: what prescribers should tell patients ^[1].

Missing numbers are normal

The FDA says a section that does not apply to a medicine is left out ^[1]. The Wegovy® table of contents, for instance, goes from 8 to 10 and from 14 to 16, because there is no Drug Abuse and Dependence section and no References section. A footnote under the table of contents says omitted sections are not listed ^[4].

Section 15 is usually absent, because the FDA reserves it for authoritative references that hold important information not found elsewhere in the label ^[1]. The Saxenda® label is an exception among the GLP-1 labels: its section 15 cites a published definition of childhood overweight and obesity ^[7].

Subsections are numbered too, so 5.1, 5.2 and so on are separate warnings. When an article here cites “section 5.6”, that is the exact place to look. The same warning can carry a different number on another label: never sharing the pen is 5.4 on Ozempic® but 5.10 on Mounjaro® ^[6][8].

What the 2025–2026 revisions changed

Because the Recent Major Changes list must keep each entry for at least a year ^[3], it works as a short change log. The table summarises what each GLP-1 label listed on 20 October 2026. A removed warning appears only here; the section itself is gone from the full text.

Reading the numbers with care

Section 6 often lists side effects with percentages for the medicine and for placebo. The cut-off matters: the Zepbound® table counts reactions seen in at least 2% of patients and more often than with placebo, while its Highlights list only those of 5% or more ^[5]. The Zepbound® label also warns that trial conditions vary, so side effect rates from one medicine’s trials cannot be compared directly with another’s and may not match what happens in everyday use ^[5].

European documents use words rather than a percentage table: very common means at least 1 in 10 people, common at least 1 in 100, uncommon at least 1 in 1,000, rare at least 1 in 10,000 and very rare fewer than that ^[10].

Section 14 reports average results for groups of people in specific trials, with their own entry criteria and durations. An average weight change or a hazard ratio tells you what happened in that trial population, not what will happen to you.

The same topics in European and Canadian documents

Outside the US the prescriber’s document has a different name and numbering. In the EU it is the summary of product characteristics, printed with the package leaflet; in Canada it is the product monograph, which ends with Patient Medication Information ^[10][11]. The table maps common questions onto each.

Leaflets, versions and where to find them

Many labels end with FDA-approved patient labeling: a Medication Guide in plain language and one or more Instructions for Use for each device. These can carry their own revision dates. In the Ozempic® document revised in 05/2026, for example, the attached Medication Guide shows a revision date of 01/2025 ^[6]. Some companies publish the guide as a separate file instead of at the end of the label.

The FDA notes that labeling posted on DailyMed may differ from the last FDA-approved version on Drugs@FDA, because companies can make minor changes in an annual report, or add or strengthen a warning in a supplement that is still under FDA review ^[2]. Checking the revision date tells you which version you are reading.

Using the label alongside your log

A practical habit is to note the revision date of the label you read and the question it raised, then bring both to your next appointment. Your prescriber or pharmacist can say how a section applies to you.

Wegovy®, Ozempic®, Rybelsus®, Victoza®, Saxenda® and FlexTouch® are registered trademarks of Novo Nordisk A/S. Zepbound®, Mounjaro® and Trulicity® are registered trademarks, and Foundayo™ is a trademark, of Eli Lilly and Company. PepLabo is not affiliated with or endorsed by Novo Nordisk or Eli Lilly.