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.

UZEDY (NDA-213586)

(RISPERIDONE)

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

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10/10/2025 (SUPPL-8)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

Additions and/or revisions underlined:

Risk Summary

…

There are risks to the mother associated with untreated schizophrenia or bipolar I disorder and with exposure to antipsychotics, including UZEDY, during pregnancy (see Clinical Considerations).

…

Clinical Considerations

Disease-associated maternal and/or embryo/fetal risk

There is a risk to the mother from untreated schizophrenia or bipolar I disorder, including increased risk of relapse, hospitalization, and suicide. Schizophrenia or bipolar I disorder are associated with increased adverse perinatal outcomes, including preterm birth. It is not known if this is a direct result of the illness or other comorbid factors.

…

10/10/2025 (SUPPL-9)

Approved Drug Label (PDF)

5 Warnings and Precautions

WARNINGS AND PRECAUTIONS

Additions and/or revisions underlined:

5.11 Seizures

During premarketing studies, seizures occurred in 0.3% of patients (9 out of 2,607 in adult patients with schizophrenia treated with oral risperidone [two in association with hyponatremia] and 5 out of 1,499 treated with another risperidone long-acting injection given once every 2 weeks). Use UZEDY cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.

6 Adverse Reactions

6.1 Clinical Trials Experience

Extensive changes; please refer to the label for complete information

6.2 Postmarketing Experience

Newly added information:

…

In addition, the following adverse reactions have been observed during postapproval use of UZEDY: injection site pain.

In addition, the following adverse reactions have been observed during postapproval use of another risperidone long-acting injection, given intramuscularly once every 2 weeks: cerebrovascular disorders, including cerebrovascular accidents, and diabetes mellitus aggravated.

Retinal artery occlusion after injection of another risperidone long-acting injection, given intramuscularly once every 2 weeks, has been reported during postmarketing surveillance. This has been reported in the presence of abnormal arteriovenous anastomosis.

Serious injection site reactions including abscess, cellulitis, cyst, hematoma, necrosis, nodule, and ulcer have been reported with another risperidone long-acting injection, given intramuscularly once every 2 weeks, during postmarketing surveillance. Isolated cases required surgical intervention.

Very rarely, cases of anaphylactic reaction after injection with another risperidone long-acting injection, given intramuscularly once every 2 weeks, have been reported during postmarketing experience in patients who have previously tolerated oral risperidone.

…

01/22/2025 (SUPPL-7)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.6 Hyperprolactinemaia

Additions and/or revisions underlined:

Published epidemiologic studies have shown inconsistent results when exploring the potential association between hyperprolactinemia and breast cancer.