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.

VOQUEZNA DUAL PAK (NDA-215153)

(AMOXICILLIN; VONOPRAZAN FUMARATE)

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

Download Data

Expand all

10/31/2025 (SUPPL-12)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

Additions and/or revisions underlined:

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK during pregnancy. Healthcare providers are encouraged to register patients by calling 1-866-609-1612 or visiting https://voqueznapregnancyregistry.com/.

…

8.2 Lactation

Additions and/or revisions underlined:

Risk Summary Vonoprazan:

Data from a clinical lactation study indicate that vonoprazan is present in human breast milk in amounts less than 0.03% of the administered maternal dose. Assuming an infant body weight of 6 kg and an exclusively breastfed infant, the estimated mean daily infant dose was less than 0.3% of the maternal weight-adjusted dose (see Data). There are no data on the effects of vonoprazan on the breastfed child or the effects on milk production. In animal studies, liver injury occurred in offspring from pregnant and lactating rats administered oral vonoprazan at AUC exposures approximately equal to and greater than the MRHD (see Data).

…

Risk and Benefit Statement for VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK:

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK and any potential adverse effects on the breastfed child from VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK or from the underlying maternal condition.

Clinical Considerations

Monitor infants exposed to clarithromycin or amoxicillin through breast milk for diarrhea, vomiting or rash.

Data

Human Data Vonoprazan

Concentrations of vonoprazan were measured in breast milk from 15 healthy lactating women following administration of vonoprazan 20 mg once daily (not an approved dosage for VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK) (N=5) or twice daily (N=10) for 4 days (not an approved duration for VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK).

Following administration of a 20 mg vonoprazan twice daily dosage regimen, the mean average concentration (Cavg) of vonoprazan in breast milk at steady state was 13.3 ng/mL. The estimated mean total amount of vonoprazan present in breast milk over 24 hours was 0.009 mg. Assuming an infant body weight of 6 kg and an exclusively breastfed infant, the estimated mean daily infant dose was 0.0015 mg/kg/day, representing 0.27% of the maternal weight-adjusted dose.

Following administration of a 20 mg vonoprazan once daily regimen (not an approved dosage for VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK), the mean average concentration (Cavg) of vonoprazan in breast milk at steady state was 7.55 ng/mL. The estimated mean total amount of vonoprazan present in breast milk over 24 hours was 0.0024 mg. Assuming an infant body weight of 6 kg and an exclusively breastfed infant, the estimated mean daily infant dose was 0.0004 mg/kg/day, representing 0.13% of the maternal weight-adjusted dose.

…

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Pregnancy

Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK during pregnancy [see Use in Specific Populations (8.1)].

Lactation

Advise breastfeeding women to monitor their infants for diarrhea, vomiting, and rash [see Use in Specific Populations (8.2)].

…

06/12/2025 (SUPPL-14)

Approved Drug Label (PDF)

6 Adverse Reactions

Addition of the following to the bulleted line listing:

. . .

Drug-Induced Enterocolitis Syndrome (DIES) [see Warnings and Precautions (5.1)]

. . .

6.3 Postmarketing Experience with Components of VOQUENZA TRIPLE PAK and VOQUENZA DUAL PAK

Additions and/or revisions underlined:

. . .

Amoxicillin

Infections and infestations: mucocutaneous candidiasis.

Gastrointestinal: Drug-induced enterocolitis syndrome (DIES), black hairy tongue, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [see Warnings and Precautions (5.1)].

. . .

07/31/2024 (SUPPL-3)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Warnings and Precautions for VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK

Additions and/or revisions underlined:

…

Acute Tubulointerstitial Nephritis

Acute tubulointerstitial nephritis (TIN) has been reported with vonoprazan, a component of VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK [see Adverse Reactions (6.1)]. If suspected, discontinue VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK and evaluate patients with suspected acute TIN.

…

6 Adverse Reactions

Addition of the following to the bulleted line listing:

Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.1)]

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

…

Other Adverse Reactions

…

Investigations: increased liver function test

…

6.2 Postmarketing Experience

Additions and/or revisions underlined:

…

Vonoprazan

Blood and lymphatic system disorders: thrombocytopenia.

Immune system disorders: anaphylactic shock, urticaria [see Contraindications (4.1)].

Infections and Infestations: C. difficile (with concomitant antibacterials) [see Warnings and Precautions (5.1)].

Investigation: hypomagnesemia, hypokalemia, hypocalcemia, vitamin B12 deficiency.

Hepatobiliary disorders: hepatic injury, hepatic failure, jaundice.

Skin and subcutaneous tissue disorders: drug eruption, erythema multiforme, SJS, TEN [see Warnings and Precautions (5.1)].

…

7 Drug Interactions

Addition of the following unlined text to Table 4:

Table 4: Effects of Other Drugs on VOQUEZNA TRIPLE PAK

…

Interaction with Secretin Stimulation Test

Clinical Effect: Hyper-response in gastrin secretion in response to secretin stimulation test, falsely suggesting gastrinoma.

Prevention or Management: Test should be performed at least 4 weeks after stopping VOQUEZNA DUAL PAK to allow gastrin levels to return to normal [see Clinical Pharmacology (12.2)].

8 Use in Specific Populations

8.6 Renal Impairment

Additions and/or revisions underlined:

No dosage adjustment of VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK is recommended in patients with mild to moderate renal impairment (eGFR 30 to 89 mL/min). Use of VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK is not recommended in patients with severe renal impairment (eGFR < 30 mL/min) [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)].

8.7 Hepatic Impairment

Additions and/or revisions underlined:

No dosage adjustment of VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK is recommended in patients with mild hepatic impairment (Child-Pugh A). Use of VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK is not recommended in patients with moderate to severe hepatic impairment (Child-Pugh B or C) [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3)].

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Acute Tubulointerstitial Nephritis

Advise patients to call their healthcare provider if they experience signs and/or symptoms associated with acute tubulointerstitial nephritis [see Warnings and Precautions (5.1)].

…

05/01/2024 (SUPPL-7)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Warnings and Precautions for VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK

Newly added information:

Drug-Induced Enterocolitis Syndrome

Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK [see Adverse Reactions (6.2)], with most cases occurring in pediatric patients less than or equal to 18 years of age. DIES is a non-IgE mediated hypersensitivity reaction characterized by protracted vomiting occurring 1 to 4 hours after drug ingestion in the absence of skin or respiratory symptoms. DIES may be associated with pallor, lethargy, hypotension, shock, diarrhea within 24 hours after ingesting amoxicillin, and leukocytosis with neutrophilia. If DIES occurs, discontinue VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK and institute appropriate therapy.

6 Adverse Reactions

Additions and revisions underlined:

The following serious adverse reactions are described below and elsewhere in labeling:

Hypersensitivity Reactions [see Warnings and Precautions (5.1)]
Drug-Induced Enterocolitis Syndrome (DIES) [see Warnings and Precautions (5.1)]
. . .

6.2 Postmarketing Experience with Components of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK

Additions and revisions underlined:

. . .

. . .

Skin and subcutaneous tissue disorders: TEN, SJS, DRESS, AGEP and linear IgA bullous dermatosis.

. . .

08/16/2023 (SUPPL-4)

Approved Drug Label (PDF)

4 Contraindications

4.2 Additional Contraindications to VOQUEZNA TRIPLE PAK Due to the Clarithromycin Component

Additions and/or revisions underlined:

…

Lurasidone: Coadministration of clarithromycin and lurasidone may lead to an increase in lurasidone exposure and the potential for serious adverse reactions [see Drug Interactions (7)].

7 Drug Interactions

Addition of Lurasidone to the Antipsychotics section of table 4; please refer to label for complete information