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.

ZITHROMAX (NDA-050733)

(AZITHROMYCIN)

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

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07/13/2026 (SUPPL-52)

Approved Drug Label (PDF)

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Allergic Reactions

Instruct patients to immediately contact a physician if any signs of an allergic reaction occur. [see Warnings and Precautions (5.1)].

Vomiting, Irritability, Diarrhea or Rash with Feeding in Infants

Direct parents or caregivers to contact their physician if vomiting, irritability, diarrhea or rash with feeding occurs in the infant. [see Warnings and Precautions (5.3) and Use in Specific Population (8.2)].

Diarrhea

Inform patients that diarrhea is a common problem caused by antibacterial drugs which usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial. If this occurs, patients should notify their physician as soon as possible.

Antibacterial Resistance

Patients should be counseled that antibacterial drugs including ZITHROMAX should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When ZITHROMAX is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by ZITHROMAX or other antibacterial drugs in the future.

11/22/2021 (SUPPL-50)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.5 Cardiovascular Death

Newly added information:

Some observational studies have shown an approximately two-fold increased shortterm potential risk of acute cardiovascular death in adults exposed to azithromycin relative to other antibacterial drugs, including amoxicillin. The five-day cardiovascular mortality observed in these studies ranged from 20 to 400 per million azithromycin treatment courses. This potential risk was noted to be greater during the first five days of azithromycin use and does not appear to be limited to those patients with preexisting cardiovascular diseases. The data in these observational studies are insufficient to establish or exclude a causal relationship between acute cardiovascular death and azithromycin use. Consider balancing this potential risk with treatment benefits when prescribing ZITHROMAX.

6 Adverse Reactions

Newly added information:

The following clinically significant adverse reactions are described elsewhere in

labeling:

• Hypersensitivity [see Warnings and Precautions (5.1)]

• Hepatotoxicity [see Warnings and Precautions (5.2)]

• Infantile Hypertrophic Pyloric Stenosis (IHPS) [see Warnings and Precautions (5.3)]

• QT Prolongation [see Warnings and Precautions (5.4)]

• Cardiovascular Death [see Warnings and Precautions (5.5)]

• Clostridioides difficile-Associated Diarrhea (CDAD) [see Warnings and Precautions

(5.6)]

• Exacerbation of Myasthenia Gravis [see Warnings and Precautions (5.7)]

6.2 Postmarketing Experience

Additions and/or revisions underlined:

Cardiovascular: Arrhythmias including ventricular tachycardia and hypotension. There

have been reports of QT prolongation, and torsades de pointes, and cardiovascular

death.

04/24/2019 (SUPPL-47)

Approved Drug Label (PDF)

7 Drug Interactions

7.3 Potential Drug-Drug Interaction with Macrolides

Additions and/or revisions underlined:

Interactions with digoxin, colchicine or phenytoin have not been reported … regarding drug interactions when digoxin, colchicine or …

8 Use in Specific Populations

8.1 Pregnancy

8.2 Lactation

PLLR conversion; please refer to label for complete information.

03/29/2017 (SUPPL-46)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Hypersensitivity

Additions and/or revisions underlined:

Serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including Acute Generalized Exanthematous Pustulosis (AGEP), Stevens-Johnson Syndrome, and toxic epidermal necrolysis,have been reported rarely in patients on azithromycin therapy.

6 Adverse Reactions

6.2 Post-marketing Experience

The following adverse reactions have been identified during post approval use of azithromycin … or establish a causal relationship to drug exposure.

Addtions and/or revisions underlined:

Skin/Appendages: Pruritus, and serious skin reactions including erythema multiforme, AGEP, Stevens-Johnson Syndrome, toxic epidermal necrolysis,and DRESS.

02/10/2017 (SUPPL-43)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.3 Infantile Hypertrophic Pyloric Stenosis (IHPS)

(new subsection added)

Following the use of azithromycin in neonates (treatment up to 42 days of life), IHPS has been reported. Direct parents and caregivers to contact their physician if vomiting or irritability with feeding occurs.

05/24/2016 (SUPPL-40)

Approved Drug Label (PDF)

5 Warnings and Precautions

Hypersensitivity

Fatalities have been reported. Cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have also been reported. Despite initially successful symptomatic treatment of the allergic symptoms, when symptomatic therapy was discontinued, the allergic symptoms recurred soon thereafter in some patients without further azithromycin exposure.Serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including Stevens-Johnson Syndrome, and toxic epidermal necrolysis, have been reported rarely in patients on azithromycin therapy.

6 Adverse Reactions

Postmarketing Experience

Skin/appendages: DRESS