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.

LUPRON (NDA-019010)

(LEUPROLIDE ACETATE)

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

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09/30/2025 (SUPPL-42)

Approved Drug Label (PDF)

6 Adverse Reactions

Clinical Trials

Additions and/or revisions underlined:

In the majority of patients testosterone levels increased above baseline during the first week, declining thereafter to baseline levels or below by the end of the second week of treatment. This transient increase was occasionally associated with a temporary worsening of signs and symptoms, usually manifested by an increase in bone pain (see WARNINGS section). Cases of temporary worsening of existing hematuria and urinary tract obstruction have occurred during the first week. Temporary weakness and paresthesia of the lower limbs have been reported.

…

Postmarketing

Additions and/or revisions underlined:

…

General disorders and administration site conditions – injection site reactions including induration, abscess, and necrosis;

…

09/23/2025 (SUPPL-43)

Approved Drug Label (PDF)

5 Warnings and Precautions

WARNINGS

Additions and/or revisions underlined:

…

Severe Cutaneous Adverse Reactions

LUPRON can cause severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). SCARs, including SJS/TEN, DRESS, and AGEP, occurred in patients receiving LUPRON; including cases with visceral involvement and/or requiring skin grafts [see Adverse Reactions].

Monitor patients for the development of SCARs.

If a SCAR is suspected, interrupt LUPRON until the etiology of the reaction has been determined. Consultation with a dermatologist is recommended. If a SCAR is confirmed, or for other grade 4 skin reactions, permanently discontinue LUPRON.

…

6 Adverse Reactions

Clinical Trials

Additions and/or revisions underlined:

…

Skin and Subcutaneous Tissue Disorders – Rash, Urticaria, Photosensitivity, Hair growth, SJS/TEN, DRESS, AGEP, Dermatitis exfoliative, Bullous dermatitis, Erythema multiforme;

…

12/10/2018 (SUPPL-41)

Approved Drug Label (PDF)

5 Warnings and Precautions

PRECAUTIONS

Newly added information:

Based on findings in animal studies, LUPRON may cause fetal harm when administered to a pregnant woman. In animal developmental and reproductive toxicology studies, administration of the monthly formulation of leuprolide acetate on day 6 of pregnancy (sustained exposure was expected throughout the period of organogenesis) caused adverse embryo-fetal toxicity in animals at doses less than the human dose, based on body surface area, using an estimated daily dose. Advise pregnant patients and females of reproductive potential of the potential risk to the fetus.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Additions and/or revisions underlined:

Two-year carcinogenicity studies were conducted with leuprolide acetate in rats and mice.

Leuprolide may reduce male and female fertility. Administration of leuprolide acetate to male and female rats at dose of 0.024, 0.24, and 2.4 mg/kg as monthly depot formulation for up to 3 months (approximately as low as 1/30 of the human dose based on body surface area using an estimated daily dose in animals and humans) caused atrophy of the reproductive organs, and suppression of reproductive function. These changes were reversible upon cessation of treatment.

Pregnancy

Lactation

Females and males of Reproductive Potential

Extensively changed; please refer to label for complete information.

WARNINGS

Addition of the following statement:

LUPRON may cause fetal harm.

6 Adverse Reactions

Postmarketing

Additions and/or revisions underlined:

Cardiovascular System – Hypotension, Myocardial infarction, Pulmonary embolism;

Hepato-biliary disorder – Serious drug-induced liver injury;

Central/Peripheral Nervous System – Convulsion, Peripheral neuropathy …

Respiratory System – … Interstitial lung disease;

Urogenital System – Prostate pain.

05/19/2017 (SUPPL-38)

Approved Drug Label (PDF)

5 Warnings and Precautions

WARNINGS

(Additions and/or revisions are underlined)

Psychiatric events have been reported in patients taking GnRH agonists, including leuprolide acetate. Postmarketing reports with this class of drugs include symptoms of emotional lability, such as crying, irritability, impatience, anger, and aggression. Monitor for development or worsening of psychiatric symptoms during treatment with LUPRON.

Postmarketing reports of convulsions have been observed in patients receiving GnRH agonists, including leuprolide acetate. These have included patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs. Convulsions have also been reported in patients in the absence of any of the conditions mentioned above.

PRECAUTIONS

(Additions and/or revisions are underlined)

Information for Caregivers

• Inform caregivers that symptoms of emotional lability, such as crying, irritability, impatience, anger and aggression, have been observed in patients receiving GnRH agonists, including leuprolide acetate. Alert caregivers to the possibility of development or worsening of psychiatric symptoms, including depression, during treatment with LUPRON.

• Inform caregivers that reports of convulsions have been observed in patients receiving GnRH agonists, including leuprolide acetate. Patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions may be at increased risk.

6 Adverse Reactions

(Table subheading revision)

Psychiatric System

(Additions and/or revisions are underlined)

Postmarketing

Cardiovascular System – Hypotension, Pulmonary embolism; Gastrointestinal System – Hepatic dysfunction; Hemic and Lymphatic System – Decreased WBC; Integumentary System – Hair growth; Psychiatric adverse events: Emotional lability, such as crying, irritability, impatience, anger, and aggression, has been observed with GnRH agonists, including leuprolide acetate; Depression, including rare reports of suicidal ideation and attempt, has been reported for GnRH agonists, including leuprolide acetate, in children treated for central precocious puberty. Many, but not all, of these patients had a history of psychiatric illness or other comorbidities with an increased risk of depression.