GLP-1 FDA Label Changes: 14-Product Timeline and Safety Tracker

By Kaden Coziar, Founder & Managing Editor · The RX Index Research · Last verified: August 1, 2026 · Dataset version: 1.0

This is a regulatory-document tracker, not medical advice. It records what federal sources say, which product label a finding concerns, and what wording appeared in a label reviewed on a stated date. It does not estimate incidence, establish causality, or guide prescribing decisions. Data files: CSV · JSON

Across the 14 GLP-1 products the FDA grouped into a single safety-signal cohort, the verified GLP-1 FDA label changes break down this way: all 14 received pulmonary-aspiration labeling updates between October and November 2024. Nine of the 14 had alopecia added between December 2024 and May 2025; the FDA determined that existing labeling was adequate for the other five. Then, in January 2026, the agency asked two sponsors to delete suicidal-behavior-and-ideation language from three product labels.

That last change is where the GLP-1 FDA label changes story stops being a simple list. On the date we verified this page, the FDA's own signal table still listed suicidal ideation as being under evaluation even though the agency had requested removal and approved the three implementing supplements.

That is not a scandal. It is what happens when federal record layers answer different questions on different clocks. This page reconciles them.

Source: The RX Index analysis of the FDA July-September 2023 AEMS signal table, FDA April-June 2025 AEMS signal table, FDA's January 2026 Drug Safety Communication, product-specific supplement approval letters, and current FDA or DailyMed labels linked in the 14-product matrix. Fixed denominator: 14 FDA-listed product labels. Verified August 1, 2026.

What are the latest GLP-1 FDA label changes?

The newest completed FDA class-level safety evaluation in this tracker led to a removal, not an addition. On January 13, 2026, the FDA requested removal of suicidal-behavior-and-ideation language from Saxenda, Wegovy, and Zepbound after concluding that its comprehensive review did not identify an increased risk. The FDA approved the implementing supplements for all three product labels on February 25, 2026. Before that, the major cohort-wide outcomes were pulmonary aspiration for all 14 products and alopecia additions for nine.

One class signal remains open in the federal record used here: the FDA's April-June 2025 AEMS table lists intestinal obstruction and fecal impaction for the same 14 products and says the agency was still evaluating the need for regulatory action as of March 13, 2026.

Source: FDA AEMS July-September 2023; FDA AEMS April-June 2025; January 11, 2024 FDA communication; January 13, 2026 FDA communication; Ozempic S-020/S-021 letter; Mounjaro S-031 letter; Saxenda S-025 letter; Wegovy S-033/S-004 letter; Zepbound S-042 letter; Wegovy S-029 letter; Foundayo approval letter. Verified August 1, 2026.

One FDA date conflict the tracker preserves

The archived FDA communication itself is dated January 11, 2024. The FDA's January 2026 update page refers to that earlier communication as having been issued January 30, 2024. This tracker uses January 11 because that is the date printed on the contemporaneous document, while recording the later page's conflicting reference here rather than silently hiding it.

What this tracker shows — and what it does not

This is a regulatory-document tracker, not a clinical risk model. It records what a federal source says, which product label it concerns, when an action was approved, and what wording appeared in a label reviewed on a stated date. It does not estimate how often an adverse event occurs, prove that a medication caused an event, compare patient-level risk between products, or tell anyone whether to start, stop, or pause a prescription.

Three distinctions do most of the work on this page.

A signal is not a warning. When the FDA lists a potential signal of a serious risk, it is identifying information that warrants evaluation. The agency may later update labeling, decide existing labeling is adequate, request removal, or continue evaluating.

A postmarketing listing is not a rate. Postmarketing reports are voluntary and come from a population of uncertain size. Current labels state that frequency cannot always be reliably estimated and that a causal relationship cannot necessarily be established.

A label change is not a recall. None of the actions tracked here removed a product from the market.

Status vocabulary used throughout this page

Source: The RX Index source-role definitions derived from FDA AEMS pages, Drug Safety Communications, supplement approval letters, the SrLC database scope, and current labeling. These are operational definitions for this tracker, not FDA-created status categories.

How we built this tracker

We started with the FDA's own cohort rather than inventing one. The July-September 2023 AEMS page names 14 product labels and treats them as a unit for the three signals reported there. We kept those 14 as separate rows — including brands that share an ingredient and combination products with their own labels — then reconciled federal source records product by product on August 1, 2026.

Source layers

Retrieval procedure

Retrieval date for every matrix row: August 1, 2026.

For each product we: (1) confirmed its membership in the FDA's fixed cohort; (2) recorded FDA's cohort-level aspiration and alopecia outcomes; (3) opened the latest FDA or DailyMed label selected for the audit; (4) inspected the Postmarketing Experience and related safety sections; (5) searched for these strings:

The bowel-wording test was deliberately exact. A row is marked Present only when the reviewed label contained the phrase:

The three exenatide-brand labels are marked Exact phrase not found; ileus listed because the reviewed Postmarketing Experience text listed ileus but not that full phrase.

Rules applied

The visible table and downloadable files use the same 14 records: CSV · JSON

Methodology sources: FDA AEMS cohort page; FDA SrLC overview; DailyMed overview and disclaimer.

Which GLP-1 drugs got the pulmonary-aspiration labeling update?

All 14 products in the FDA's fixed cohort received aspiration-related labeling updates between October and November 2024. The FDA says the Warnings and Precautions, Adverse Reactions, and Patient Counseling Information sections were revised to address pulmonary aspiration during general anesthesia or deep sedation. In November 2024, the agency also required a postmarketing trial concerning temporary withholding, fasting duration, retained gastric contents, and delayed gastric emptying.

The label language matters because it stops short of a universal schedule. The aspiration subsection says the available data are insufficient to support recommendations for reducing the risk, including whether changing fasting instructions or temporarily discontinuing the medication would help. It tells patients to inform healthcare providers about planned procedures; it does not supply a single hold interval for every patient and procedure.

That leaves two facts that should travel together:

Source: FDA July-September 2023 AEMS outcome and the current product labels linked in the matrix. Verified August 1, 2026.

Which GLP-1 labels were updated for alopecia?

Nine of the 14 cohort product labels had alopecia added between December 2024 and May 2025. The nine are Adlyxin, Saxenda, Soliqua 100/33, Trulicity, Victoza, Mounjaro, Ozempic, Rybelsus, and Xultophy 100/3.6. For Byetta, Bydureon, Bydureon BCise, Wegovy, and Zepbound, the FDA determined that the existing labeling was adequate and that no further action was needed at that time.

That five-product split matters because existing labeling adequate is not the same as hair loss absent. Wegovy already described hair loss in its label. The FDA's stated cohort outcome — not a single keyword search — controls the alopecia column in this tracker.

Wegovy 7.2 mg safety-data comparison

The March 19, 2026 Wegovy supplement added a 7.2 mg weekly dose and safety data from a three-arm trial. The label gives this dose-group comparison:

Source: FDA-approved Wegovy labeling associated with NDA 215256/S-029 and NDA 218316/S-005. Trial groups: 1,311 patients assigned to 7.2 mg, 304 to 2.4 mg, and 303 to placebo. Verified August 1, 2026.

The dysesthesia detail is unusually specific. Among 288 patients who experienced dysesthesia on 7.2 mg, 18% had not recovered by the end of the trial. Of 38 patients re-escalated to 7.2 mg after recovery, 17 — 45% — experienced a recurrence.

Those are clinical-trial figures for the new dose. They are not estimates for every person using semaglutide and should not be mixed with the separate postmarketing label audit.

What is happening with intestinal obstruction and fecal impaction?

The FDA's April-June 2025 signal table lists intestinal obstruction and fecal impaction for the same 14 products, and the row says the agency was still evaluating the need for regulatory action as of March 13, 2026. Separately, The RX Index found the exact postmarketing phrase "intestinal obstruction, severe constipation including fecal impaction" in 11 of the 14 labels reviewed on August 1, 2026 — 78.6% of the fixed cohort.

Both facts are true at once.

The 14-product matrix

Each row links to the label reviewed on August 1, 2026. The footnotes beneath the table must travel with any citation of these figures.

Source: The RX Index reconciliation of FDA's July-September 2023 cohort outcomes, FDA's April-June 2025 bowel-signal row, the three 2026 SI/B supplement approval letters, and the row-level labels linked above. Verified August 1, 2026.

Why 11 of 14 does not close the FDA's open signal

The AEMS table asks: What is the status of this class-level potential signal?

A product label asks: What wording is in this product's label?

A supplement approval letter asks: What change did the FDA approve for this application, under which supplement, and on what date?

For 11 products, the exact phrase was already present in the label reviewed. The class-level AEMS row still said the FDA was evaluating the need for regulatory action. Reporting the audit as "FDA added the same bowel-obstruction warning to 11 GLP-1 drugs" would collapse separate regulatory facts into one claim. Reporting the open signal as "GLP-1 labels do not mention bowel obstruction" would also be wrong.

The three-product wording gap

The exact phrase was not found in the reviewed labels for Byetta, Bydureon, and Bydureon BCise. All three listed ileus. The narrow finding is about wording in a dated label audit; it is not a comparison of clinical risk or product safety.

Did the FDA remove suicidal-behavior-and-ideation warnings from GLP-1 labels?

Yes — from three labels, through three product actions approved on the same day. On January 13, 2026, the FDA requested removal from Saxenda, Wegovy, and Zepbound after concluding that its comprehensive review did not identify an increased risk. On February 25, 2026 — 43 days later — the FDA approved Saxenda S-025, Wegovy S-033/S-004, and Zepbound S-042.

The clock, end to end

Source: January 11, 2024 FDA communication; January 13, 2026 FDA communication; Saxenda S-025; Wegovy S-033/S-004; Zepbound S-042. Day counts are The RX Index calculations from dated FDA records.

What each approval removed

The other 11 cohort labels were not part of this removal request. The FDA said labeling for GLP-1 products approved for glycemic control did not include the SI/B language at issue.

The evidence the FDA reported

The FDA's January 2026 communication describes two large analyses:

The participant counts reconcile exactly: 60,338 plus 47,572 equals 107,910.

Source: FDA's January 13, 2026 Drug Safety Communication.

Why does an FDA signal page still show an issue the FDA resolved elsewhere?

In this case, the AEMS status lagged the safety communication and the product approvals. The suicidal-ideation row carries a status date of March 13, 2026 and still says the FDA is evaluating the need for regulatory action. That status date is 59 days after the January 13 removal request and 16 days after the February 25 supplement approvals.

That does not establish a hidden reversal. It shows that the records are scoped and updated separately.

Which source answers which question

Source: The RX Index source-role analysis based on the FDA SrLC overview, DailyMed disclaimer, AEMS pages, Drug Safety Communications, approval letters, and current labels. Verified August 1, 2026.

The practical rule: use the AEMS table for the dated class-signal status; use the approval letter and current label for a product-level statement about what changed and when. Do not force one source to answer the other's question.

When was ileus added to the Ozempic label?

September 22, 2023, through supplement S-021. The FDA's approval letter says S-021 added "Gastrointestinal: Ileus" under section 6.3, Postmarketing Experience. Supplement S-020, approved in the same letter, revised the Instructions for Use and did not add ileus.

The two supplement numbers sit together at the top of one approval letter. That makes the mix-up easy to repeat. The letter itself separates their purposes.

Three Ozempic supplement records that should not be confused

Source: FDA approval letter for Ozempic S-020 and S-021 and FDA approval letter for Ozempic S-038.

The current Ozempic label reviewed for this tracker also contains the exact intestinal-obstruction and fecal-impaction phrase counted in the 11-of-14 audit. That later wording does not change the identity of the 2023 ileus supplement.

How do product-level label changes move through a drug class?

The records show product-by-product implementation, not one universal class date. AEMS can report a class outcome over a date range, while supplement letters show separate requests, submissions, and approvals for individual applications.

Two letters make the mechanism visible:

Source: Mounjaro S-031 approval letter and Zepbound S-042 approval letter.

For Mounjaro, 114 days passed from the FDA's February 3 request to the May 28 approval. That is a product-specific interval, not a class benchmark.

The Mounjaro letter also records removal of two statements from the Limitations of Use portion of the label: that Mounjaro was not indicated for type 1 diabetes and that it had not been studied in patients with a history of pancreatitis. That was a change to the approved label's wording; it was not a new indication.

The Zepbound letter shows another pattern: one supplement can resolve more than one safety-label task. S-042 added gastrointestinal wording and removed the SI/B subsection in the same approval.

Where do U.S. and international labels differ on NAION?

International regulators took visible labeling action on non-arteritic anterior ischemic optic neuropathy, while no NAION wording was found in the current U.S. labels reviewed for Ozempic, Rybelsus, or Wegovy on August 1, 2026. That is a label-text comparison, not a claim that the FDA reached a conclusion in either direction.

NAION is an optic-nerve disorder that can cause sudden, usually painless vision loss.

Documented regulator actions and the U.S. label audit

Source: EMA/PRAC; WHO alert; MHRA Drug Safety Update; TGA Medicines Safety Update; current U.S. Ozempic, Rybelsus, and Wegovy labels reviewed August 1, 2026.

The two numerical formulations should not be treated as interchangeable. Up to 1 in 10,000 users is a regulatory frequency category. About one additional case per 10,000 treated per year is an estimated excess-risk expression reported by the MHRA from the European review.

The U.S. finding here is deliberately narrow: no NAION wording was found in the three current semaglutide labels reviewed. The absence of that wording is not evidence that the FDA has accepted or rejected the international assessment.

Which later products and formulations sit outside the 14-product denominator?

The fixed denominator stays fixed. Later products and formulations are documented, but they never enter the 14-product percentages.

Source: current Wegovy labeling; Wegovy S-029/S-005 approval letter; Foundayo original approval letter and FDA approval announcement.

Foundayo's initial FDA summary already lists hair loss among common adverse reactions and includes warnings for severe gastrointestinal reactions and pulmonary aspiration. It is relevant to the ongoing tracker, but adding it to a denominator created in 2023 would make every historical percentage shift.

What are the limits of this data?

We would rather state these plainly than have someone discover them after quoting us.

How to check a GLP-1 label-change claim

Step one: search the FDA SrLC database for the product and inspect the dated safety-information records.

Step two: open the relevant Drugs@FDA supplement approval letter. For a removal, do not rely on the absence of a database row; read the approval letter and current label.

Step three: for a class-level signal, open the relevant AEMS quarterly page and record the status date shown there.

Step four: distinguish FDA-approved labeling from DailyMed in-use labeling and note which one was reviewed.

A claim without a dated product record or class-signal source should remain unverified until the underlying document is identified.

Frequently asked questions

Citation information

Coziar, Kaden. "GLP-1 FDA Label Changes: 14-Product Timeline
and Safety Tracker." The RX Index Research. Dataset v1.0.
Last verified August 1, 2026.
https://therxindex.com/research/glp-1-fda-label-changes/
Accessed [Month Day, Year].

The RX Index Research. "GLP-1 FDA Safety Label Change Tracker,
2023-2026." Version 1.0. Published August 1, 2026.
Denominator: 14 product labels in FDA's July-September 2023
AEMS cohort. Verification date August 1, 2026.
https://therxindex.com/research/glp-1-fda-label-changes/

Each table includes the primary source, verification date, and relevant supplement or AEMS page directly beneath it.

Primary sources

Related research

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The RX Index Research is an independent research and reference resource for GLP-1 medications and obesity pharmacotherapy, published by Kozi Publishing LLC. This page is editorial and educational content. It has not been reviewed by a licensed clinician, and it is not medical advice. For guidance about your own medication, consult a qualified healthcare professional and the current FDA-approved prescribing information for your product. This page contains no sponsored content and no commercial relationship influenced the findings.