Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

WEGOVY (NDA-218316)

(SEMAGLUTIDE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

Download Data

03/19/2026 (SUPPL-5)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

…

WEGOVY Tablet 25 mg Oral Daily Dosage

WEGOVY tablet was evaluated for safety in a randomized, double-blind, placebo-controlled trial that included 204 adult patients with obesity or overweight and at least one weight-related comorbidity, treated with WEGOVY 25 mg tablets for up to 64 weeks and a 7-week off drug follow-up period (Study 7) [see Clinical Studies (14.2)]. Patients with type 2 diabetes mellitus were excluded. Baseline characteristics included a mean age of 48 years, 76% were female, 93% were White, 0.5% were Asian, 6% were Black or African American, and 8% were Hispanic or Latino ethnicity. Mean baseline body weight was 106.4 kg and mean BMI was

37.5 kg/m2. The baseline characteristics were 44% with hypertension, 31% with dyslipidemia, 27% with a BMI greater than 40 kg/m2 and 1.5% with coronary artery disease.

…

In the clinical trial with WEGOVY 25 mg tablets, the types and frequency of common adverse reactions were similar to those listed in Table 3.

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Other Adverse Reactions in Adults and/or Pediatric Patients Treated with WEGOVY Injection or WEGOVY Tablets

The safety of WEGOVY tablets and WEGOVY 7.2 mg injection have not been established in pediatric patients or patients with MASH.

…

Dysesthesia

Dysesthesia, and related events of altered skin sensations including paresthesia, pain of skin, sensitive skin, and burning skin sensation, occurred in clinical trials with WEGOVY injection and tablet. The incidence of dysesthesia with WEGOVY increased with increasing dosage and drug levels in the blood.

In clinical trials evaluating patients with and without type 2 diabetes mellitus, WEGOVY 7.2 mg injection dysesthesia was reported at a higher rate in the WEGOVY 7.2 mg injection group (22%), compared to WEGOVY 2.4 mg injection (6%) and placebo (0.3%). Among 288 patients who experienced dysesthesia with WEGOVY 7.2 mg injection, 2% permanently discontinued treatment, 8% had temporary interruption, and 23% had dose reduction; most subjects with these actions taken to WEGOVY 7.2 mg injection (permanent discontinuation, temporary interruption, or dose reduction) recovered from the event. When an action was taken with WEGOVY, events resolved faster than the events where no action was taken with WEGOVY. Among patients who experienced dysesthesia with WEGOVY 7.2 mg injection, 18% did not report recovering during the trial duration; in most of the patients who did not recover, the WEGOVY dosage was unchanged and not discontinued. Of the patients who recovered after action taken with WEGOVY, 38 patients were re-escalated to

7.2 mg. Of these 38 patients, 17 (45%) subsequently reported recurrence of dysesthesia.

In a clinical trial with WEGOVY 25 mg tablets, 5% of WEGOVY-treated patients and no placebo-treated patients reported dysesthesia adverse reactions.

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