When the FDA requires one
The regulation says Medication Guides are for medicines that the FDA judges to pose a serious and significant public health concern, mainly those used outside direct supervision by a health professional [2]. The FDA requires one in three situations [1][2]:
- When patient information could help prevent serious side effects.
- When a medicine has serious risks, relative to its benefits, that patients should know about because the information could affect whether they decide to use it or keep using it.
- When following the directions for use is crucial for the medicine to work.
- Not every prescription medicine has a Medication Guide. The FDA says that not all prescription drugs are required to have FDA-approved patient labeling [1].
Who writes it and how you get it
The drug company develops the Medication Guide and the FDA reviews and approves it before it can be distributed [1][2]. It is part of the official labeling, not a pharmacy handout.
The regulation sets out a chain. The manufacturer supplies enough guides, or the means to print them, to distributors and pharmacies; the container label tells the pharmacist to hand one to each patient; and the pharmacist gives it to you, or to the person collecting your medicine, each time it is dispensed [2]. The FDA adds that the default is paper, and you can ask for electronic delivery instead [1].
There is one exception. A prescriber who has serious concerns about the effect of the guide on a particular patient can direct that it not be given, but the pharmacist must still provide it to any patient who asks [2]. If you did not get one, you can ask the pharmacist.
What the regulation says must be inside
Section 208.20 of the federal rules sets both the style and the headings. The guide has to be in English, in non-technical language, in type no smaller than 10 points, scientifically accurate, not promotional, and consistent with the prescribing information it is based on. The words “Medication Guide” go at the top, and a line saying the FDA approved it goes at the bottom [2].
The headings are written as patient questions: what is the most important information I should know, what is the medicine, who should not take it, how should I take it, what should I avoid, and what are the possible side effects. A general section closes the guide. It must say the medicine is not for other conditions or other people, and it ends with the revision date [2]. Section 17 of each prescribing information, Patient Counseling Information, asks prescribers to have patients read the Medication Guide [4][8].
Nine GLP-1 guides side by side
Every US GLP-1 label checked for this article refers patients to a Medication Guide. Novo Nordisk prints its guides inside the prescribing information document; Eli Lilly publishes them as separate files. The table shows the revision date of each guide and what it puts first, checked on 20 October 2026.
| Medication Guide | Guide revision | What comes before “most important information” |
|---|---|---|
| Ozempic® injection [4] | 01/2025 | A boxed line on never sharing the pen, then a reminder to read it before starting and at each refill |
| Rybelsus® and Ozempic® tablets [6] | 1/2026 | A reminder to read it before starting and at each refill |
| Wegovy® injection and tablets [5] | 06/2026 | A line on never sharing the FlexTouch® pen, then the refill reminder |
| Victoza® [7] | 05/2025 | A reminder to read it before starting and at each refill |
| Saxenda® [8] | 02/2026 | Nothing; it opens with the most important information |
| Trulicity® [11] | 03/2026 | A reminder to read it before starting and at each refill |
| Mounjaro® [9] | 08/2026 | A line on never sharing the KwikPen or needles |
| Zepbound® [10] | 08/2026 | A line on never sharing the KwikPen or needles |
| Foundayo™ tablets [12] | Issued 07/2026 | Nothing; it opens with the most important information |
A GLP-1 example, heading by heading
- “What is the most important information I should know?” In the Ozempic® guide this is the possible risk of thyroid tumours, with the neck symptoms to report and who should not use the medicine [4].
- “How should I use it?” Training before the first injection, where to inject, the weekly schedule, changing the day, missed doses, rotating sites and what to do after taking too much [4].
- “What is it?” The approved uses in plain words, and the groups in which safety is not known [4].
- “Do not use if” and “Before using, tell your healthcare provider” Conditions such as pancreas problems, diabetic retinopathy, severe stomach problems, planned surgery, pregnancy and breastfeeding, plus a reminder to share your full medicine list [4].
- “What are the possible side effects?” Serious effects with the symptoms to watch for, the most common ones, and the FDA reporting line, 1-800-FDA-1088 [4].
- General information, including the line that the medicine is not to be given to other people even with the same symptoms, and the full list of ingredients [4].
Read it again when it changes
The Ozempic®, Wegovy®, Victoza®, Trulicity® and Rybelsus® guides ask you to read them before you start and every time you get a refill, because there may be new information, and add that the guide does not replace talking with your healthcare provider [4][5][6][7][11]. The regulation does not require that sentence, and the Mounjaro®, Zepbound®, Saxenda® and Foundayo™ guides do not include it [8][9][10][12]. The revision date at the end is the quickest way to see whether anything changed.
The guide can be revised separately from the prescribing information. In the Ozempic® document revised in 05/2026, the attached Medication Guide shows its own revision date of 01/2025 [4]. The Wegovy® guide covers both the injection and the tablets, with separate parts on how to use each [5].
Other leaflets you might see
- Patient Package Insert, also called Patient Information: FDA-approved labeling that is required for oral contraceptives and estrogen products and voluntary for other medicines [1].
- Instructions for Use: step-by-step written and visual instructions for medicines with complicated use, such as pens and syringes. Each GLP-1 pen has its own [1].
- Consumer medication information: written by someone other than the drug company. The FDA does not review or approve it [1].
- Patient Medication Information: a one-page format the FDA proposed in May 2023 to replace Medication Guides and Patient Package Inserts for outpatient medicines, over a planned five-year changeover [3]. In a July 2026 notice the FDA said comments on the proposal had been added to the rulemaking docket for continued consideration; no final rule had been issued [13].
Outside the United States
In the European Union the patient document is the package leaflet, and its layout is fixed: six numbered sections covering what the medicine is for, what to know before using it, how to use it, possible side effects, how to store it, and the pack contents [14]. It is printed in the same EU product information document as the prescriber’s summary of product characteristics.
Canada uses the name Patient Medication Information for the leaflet at the end of each product monograph, which is easy to confuse with the FDA proposal of the same name [3]. The Canadian leaflet for Mounjaro® describes itself as a summary that will not tell you everything about the medicine [15].
Using the guide day to day
The side-effect section is the part people return to most. It separates serious effects, with the symptoms that need prompt medical attention, from the most common ones, and it tells you who to call [4]. Keeping the guide where you store your pens, or a photo of it on your phone, makes it easier to check when something new happens.
If a symptom you notice is not in the guide, it can still be worth raising: the guide says it does not list every possible side effect [4].
Ozempic®, Rybelsus®, Wegovy®, FlexTouch®, Victoza® and Saxenda® are registered trademarks of Novo Nordisk A/S. Mounjaro®, Zepbound®, KwikPen® 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 and Company.
When to get help
| Sign | Who to contact | How fast | Source |
|---|---|---|---|
| After a dose: a swollen face, lips, tongue or throat, difficulty breathing or swallowing, or fainting | Stop the medicine and get emergency help (911 or your local number) | Emergency | Ozempic® Medication Guide [4] |
| You took more than prescribed | Your prescriber or a poison help line, or the nearest emergency room | Emergency | Ozempic® Medication Guide [4] |
| Severe stomach pain that does not ease, with or without vomiting, sometimes reaching the back | Stop the medicine and call your prescriber at once | Today | Ozempic® Medication Guide [4] |
| Nausea, vomiting or diarrhoea that keeps going, or signs of dehydration | Your prescriber | Today | Ozempic® Medication Guide [4] |
| Changes in your vision during treatment | Your prescriber | Today | Ozempic® Medication Guide [4] |
