Drug Safety-related Labeling Changes (SrLC)

Get Email Alerts | Guide

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.

TYZAVAN (NDA-211962)

(VANCOMYCIN HYDROCHLORIDE)

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

Download Data

Expand all

08/18/2026 (SUPPL-23)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Infusion Reactions

Additions and/or revisions underlined:

Hypotension, including shock and cardiac arrest, wheezing, dyspnea, urticaria or pruritus, muscular and chest pain may occur with rapid TYZAVAN administration (e.g., over several minutes). The reactions may be more severe in pediatric patients (1 month and older) [see Use in Specific Populations (8.4)].

. . .

5.4 Severe Dermatologic Reactions

Additions and/or revisions underlined:

Severe dermatologic reactions such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and linear IgA bullous dermatosis (LABD) have been reported in association with the use of vancomycin. Cutaneous signs or symptoms reported include skin rashes (including exfoliative dermatitis), mucosal lesions, and blisters.

Discontinue TYZAVAN at the first appearance of signs and symptoms of TEN, SJS, DRESS, AGEP, or LABD.

5.7 Neutropenia

Additions and/or revisions underlined:

Reversible neutropenia has been reported in patients receiving vancomycin [see Adverse Reactions (6.1)]. Patients who will undergo prolonged therapy with vancomycin or those who are receiving concomitant drugs that may cause neutropenia should have periodic monitoring of the leukocyte count.

Reversible neutropenia, usually starting 1 week or more after onset of therapy with vancomycin or after a total dosage of more than 25 g, has been reported for several dozen patients. Neutropenia appears to be promptly reversible when vancomycin is discontinued. Thrombocytopenia has been reported. Although a causal relationship has not been established, reversible agranulocytosis (granulocytes <500/mm3) has been reported.

5.8 Phlebitis and Other Administration Site Reactions

Additions and/or revisions underlined:

. . .

Administration of TYZAVAN by intramuscular (IM), intraperitoneal, intrathecal (intralumbar or intraventricular), or intravitreal routes has not been approved and is not recommended. The safety and efficacy of vancomycin administered by these routes of administration have not been established by adequate and well controlled trials. Pain, tenderness, and necrosis occur with intramuscular (IM) injection of vancomycin or with inadvertent extravasation. There have been reports that the frequency of infusion-related events (including hypotension, flushing, erythema, urticaria, and pruritus) increases with the concomitant administration of anesthetic agents. Infusion-related events may be minimized by the administration of vancomycin of at least a 60-minute infusion prior to anesthetic induction.

Administration of sterile vancomycin by the intraperitoneal route during continuous ambulatory peritoneal dialysis (CAPD) has been reported to result in chemical peritonitis. Manifestations of this syndrome range from a cloudy dialysate alone to a cloudy dialysate accompanied by variable degrees of abdominal pain and fever. This syndrome appears to be resolved after discontinuation of intraperitoneal vancomycin.

. . .

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

. . .

Gastrointestinal Disorders: Clostridioides difficile colitis, nausea

. . .

6.2 Postmarketing Experience

Additions and/or revisions underlined:

. . .

Immune System Disorders: Acute myocardial ischemia with or without myocardial infarction may occur as part of an allergic reaction.

Skin and Subcutaneous Tissue Disorders: Severe dermatologic reactions such as toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and linear IgA bullous dermatosis (LABD).

Blood and Lymphatic System Disorders: Hemolytic anemia

7 Drug Interactions

7.3 Ototoxic and/or Nephrotoxic Drugs

Additions and/or revisions underlined:

Concurrent and/or sequential systemic or topical use of other potentially neurotoxic and/or nephrotoxic drugs with TYZAVAN requires more frequent monitoring of renal function.

8 Use in Specific Populations

8.1 Pregnancy

Additions and/or revisions underlined:

Risk Summary

The available data on the use of this formulation of TYZAVAN (which includes the excipient NADA) in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes (see Data). Available data over several decades of vancomycin (without the excipient NADA) use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data).

. . .

Data

Human Data

. . .

A published study evaluated hearing loss and nephrotoxicity in infants of 10 pregnant intravenous drug users treated with intravenously administered vancomycin (formulation did not include the excipient NADA) for suspected or documented methicillin-resistant Staphylococcus aureus (MRSA) in the second or third trimester. The comparison groups were 10 non-intravenous drug-dependent patients who received no treatment, and 10 untreated intravenous drug-dependent patients who served as substance abuse controls. No infant in the vancomycin exposed group had abnormal sensorineural hearing at 3 months of age or nephrotoxicity.

. . .

8.2 Lactation

Additions and/or revisions underlined:

Risk Summary

Vancomycin is present in human milk following intravenous administration, however, there are insufficient data to inform the levels. There are no data on the effects of vancomycin on the breastfed infant or milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for TYZAVAN and any potential adverse effects on the breastfed infant from TYZAVAN or from the underlying maternal condition.

8.6 Renal Impairment

Newly added subsection:

Dosage adjustment of Vancomycin Injection must be made in patients with impaired renal function [see Dosage and Administration (2.4)]. Measure trough vancomycin serum concentrations to guide intravenous therapy, especially in patients with impaired renal function or fluctuating renal function.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Infusion Reactions During or After Intravenous Use

Advise patients that generalized skin redness, skin rash, itching, flushing, muscle pain, chest pain, shortness of breath, wheezing, or dizziness may occur during intravenous infusion of TYZAVAN. These reactions can be lessened or prevented by infusing the drug over at least 60 minutes [see Warnings and Precautions (5.1)].

. . .

Severe Dermatologic Reactions

Advise patients about the signs and symptoms of serious skin manifestations. Instruct patients to stop TYZAVAN immediately and promptly seek medical attention at the first signs or symptoms of skin rash, mucosal lesions and blisters to their healthcare provider [see Warnings and Precautions (5.4)].

. . .