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.

TERCONAZOLE (NDA-021735)

(TERCONAZOLE)

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

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08/22/2025 (SUPPL-14)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Risk of Skin Irritation and Flu-Like Symptoms

Newly created subsection:

Discontinue Terconazole Vaginal Cream and do not retreat, if skin irritation, fever, chills or flu-like symptoms are reported during use.

5.2 Hypersensitivity

Newly created subsection:

There is no information regarding cross-hypersensitivity between terconazole and other azole antifungal agents. Monitor patients with a history of hypersensitivity to azoles.

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

…

During a controlled clinical trial conducted in the United States, patients with vulvovaginal candidiasis were treated with Terconazole Vaginal Cream, 0.8% for 3 days (n=231) or Terazol®3 for 3 days (n=229) [see Clinical Studies (14)]. Table 1 lists the adverse reactions occurring in ? 2% of patients receiving Terconazole Vaginal Cream in the trial. The therapy- related discontinuation rate was 2.0% for Terconazole Vaginal Cream. The adverse reaction most frequently causing discontinuation of Terconazole Vaginal Cream therapy was vulvovaginal itching (0.7%).Table 1: Adverse Reactions Occurring in greater than or equal to 2% of Patients Receiving Terconazole Vaginal Cream in a Randomized, Double-Blind Active Controlled Trial

Please refer to label to view Table 1.

Other adverse reactions reported in less than 2% of patients receiving Terconazole Vaginal Cream was fever (1%).

Photosensitivity reactions were observed in some normal volunteers following repeated dermal application of terconazole 2.0% (not an approved strength) and 0.8% creams under conditions of filtered artificial ultraviolet light. Photosensitivity reactions were not observed in U.S. and foreign clinical trials in patients who were treated with other terconazole formulations (i.e., terconazole suppositories or vaginal cream, 0.8%).

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

The safety and effectiveness of Terconazole Vaginal Cream have not been established in female pediatric patients for the treatment of vulvovaginal candidiasis.

8.1 Pregnancy

PLLR conversion:

Risk Summary

There are no available data on Terconazole Vaginal Cream use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Available data from observational studies with terconazole use in pregnancy are insufficient to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

In animal reproduction studies with oral terconazole, no adverse development effects were observed at clinically relevant systemic exposures (see Data).

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data

Animal Data

There was no evidence of malformations when terconazole was administered orally in rats, or rabbits.

There was a delay in fetal ossification at an oral dose of 10 mg/kg/day in rats. Higher doses resulted in decreased litter size, decreased number of viable young and reduced fetal weight in rats. There was also a delay in ossification and an increase incidence of skeletal variants.

The dose of 10 mg/kg/day resulted in a mean peak plasma level of terconazole in pregnant rats of 0.176 mcg/mL which exceeds by 30 times the mean peak plasma level (0.006 mcg/mL) seen in normal subjects after intravaginal administration of terconazole vaginal cream 0.8%. This safety assessment does not account for possible exposure of the fetus through direct transfer to terconazole from the irritated vagina by diffusion across amniotic membranes.

8.2 Lactation

PLLR conversion

Risk Summary

There are no data on the presence of terconazole in human milk, the effect on the breast-fed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Terconazole Vaginal Cream and any potential adverse effects on the breast-fed infant from Terconazole Vaginal Cream or from the underlying maternal condition.

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Risk of Skin Irritation and Flu-like Symptoms

Advise the patient to discontinue Terconazole Vaginal Cream, 0.8 % and not to retreat if skin irritation, fever, chills or flu-like symptoms are reported during use.

…

PATIENT INFORMATION

Additions and/or revisions underlined:

…

Common side effects of Terconazole vaginal cream include:

headache
painful menstrual periods
genital itching and burning
stomach pain
…